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1,189 results for “randomized clinical trial”
Data from: Daridorexant, a new dual orexin receptor antagonist in elderly subjects with insomnia disorder: a randomized clinical trial
<p><b>Objective:</b> To assess the dose-response of daridorexant, a new dual orexin receptor antagonist, on wake after sleep onset (WASO).</p> <p><b>Methods:</b> Elderly (≥65 years) subjects (n = 58) with insomnia were randomly allocated (Latin square design) to receive five treatments (5, 10, 25, and 50 mg daridorexant and placebo) during five treatment periods, each consisting of two treatment nights followed by a 5–12-day washout period. Main efficacy endpoints were the absolute change from baseline in WASO (primary) and latency to persistent sleep (LPS; secondary) to Days 1&2 (mean of two treatment nights assessed by polysomnography) in each period. Safety and tolerability were also assessed.</p> <p><b>Results:</b> Of 58 subjects included, 67% were female and median age was 69 years [range 65–85]). WASO and LPS were dose-dependently reduced from baseline to Days 1&2 following daridorexant administration (multiple comparison procedure-modeling, p<0.0001 and p=0.004, respectively); reductions were statistically significant for doses 10 mg and above compared with placebo (WASO: –32.0, –45.1, –61.4 min; LPS: –44.9, –43.8, –45.4 min; for 10, 25, and 50 mg, respectively, p≤0.025). Treatment-emergent adverse events were similar for daridorexant and placebo; the most frequent were fatigue, nasopharyngitis, gait disturbance, and headache (≤7% in any group).</p> <p><b>Conclusions:</b> Daridorexant was well tolerated. Dose-dependent improvements in WASO and LPS were statistically significant (dose range 10–50 mg) in elderly subjects with insomnia disorder. ClinicalTrials.gov (NCT02841709).</p> <p><b>Classification of Evidence:</b> This study provides Class III evidence that for elderly subjects with insomnia, daridorexant reduced wake after sleep onset time.</p>
Data from: Reducing therapeutic misconception: a randomized intervention trial in hypothetical clinical trials
Background: Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. Methods: This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range=10-50), and willingness to participate in the clinical trial. Results: 154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p=0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p=0.017). Willingness to participate in the hypothetical trial was not significantly different (p=0.603) between intervention (52.1%, 95% CI [40.2 to 62.4]) and control (56.3%, 95% CI [45.3 to 66.6] groups. Conclusions: An enhanced educational intervention augmenting traditional informed consent led to a meaningful reduction in therapeutic misconception without a statistically significant change in willingness to enroll in hypothetical clinical trials. Additional study of this intervention is required in real-world clinical trials.
Effect of Structured Diet with Exercise Education on Anthropometry and Lifestyle Modification in Patients with Type 2 Diabetes: A 12-Month Randomized Clinical Trial
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Feasibility of a Randomized Controlled Trial of Large Artificial Intelligence-Based Linguistic Models for Clinical Reasoning Training of Physical Therapy Students.
<p>Data collected for students who participated in the study</p>
Evaluation of Clinical application of sclerotherapy combined with oral sirolimus in the treatment of tongue microcystic lymphatic malformation in children:A Randomized Controlled Trial
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Supplementary material 1 from: Abu-Samak MS, Hasoun LZ, Barham A, Mohammad BA, Mosleh I, Aljaberi A, Awwad SH (2021) The supplementary effects of omega-3 fatty acid alone and in a combination with vitamin D3 on serum leptin levels: A randomized clinical trial on men and women with vitamin D deficiency. Pharmacia 68(3): 517-525. https://doi.org/10.3897/pharmacia.68.e64422
Supplemental tables
Figure 1 from: Abu-Samak MS, Hasoun LZ, Barham A, Mohammad BA, Mosleh I, Aljaberi A, Awwad SH (2021) The supplementary effects of omega-3 fatty acid alone and in a combination with vitamin D3 on serum leptin levels: A randomized clinical trial on men and women with vitamin D deficiency. Pharmacia 68(3): 517-525. https://doi.org/10.3897/pharmacia.68.e64422
Figure 1 CONSORT flow diagram for the study, indicating the number of subjects screened, recruited, and randomly assigned to the different intervention groups.
Raw Data for the article: Donor Simvastatin Treatment Is Safe and Might Improve Outcomes After Liver Transplantation: A Randomized Clinical Trial
<p><strong>Background: </strong>The current curative approaches for ischemia/reperfusion injury on liver transplantation are still under debate for their safety and efficacy in patients with end-stage liver disease. We present the SIMVA statin donor treatment before Liver Transplants study.</p> <p><strong>Methods: </strong>SIMVA statin donor treatment before Liver Transplants is a monocentric, double-blind, randomized, prospective tial aiming to compare the safety and efficacy of preoperative brain-dead donors' treatment with the intragastric administration of 80 mg of simvastatin on liver transplant recipient outcomes in a real-life setting. Primary aim was incidence of patient and graft survival at 90 and 180 d posttransplant; secondary end-points were severe complications.</p> <p><strong>Results: </strong>The trial enrolled 58 adult patients (18-65 y old). The minimum follow-up was 6 mo. No patient or graft was lost at 90 or 180 d in the experimental group (n = 28), whereas patient/graft survival were 93.1% ( P = 0.016) and 89.66% ( P = 0.080) at 90 d and 86.21% ( P = 0.041) and 86.2% ( P = 0.041) at 180 d in the control group (n = 29). The percentage of patients with severe complications (Clavien-Dindo ≥IIIb) was higher in the control group, 55.2% versus 25.0% in the experimental group ( P = 0.0307). The only significant difference in liver tests was a significantly higher gamma-glutamyl transferase and alkaline phosphatase at 15 d ( P = 0.017), ( P = 0.015) in the simvastatin group.</p> <p><strong>Conclusions: </strong>Donor simvastatin treatment is safe, and may significantly improve early graft and patient survival after liver transplantation, although further research is mandatory.</p>
Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
ClinicalTrials.gov study NCT00758745. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Effectiveness of Video Monitoring and Care Transition for Heart Failure Patients (EVIT-HF): Randomized Clinical Trial
ClinicalTrials.gov study NCT06731166. IPD Sharing: NO. Countries: 0. Publications: 0.
The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial
ClinicalTrials.gov study NCT06900868. IPD Sharing: Not stated. Countries: 0. Publications: 2.
Low-dose Evaluation of Aspirin After STEMI Patients With PCI: A Multicenter, Double-blind, Randomized Controlled Clinical Trial
ClinicalTrials.gov study NCT06756945. IPD Sharing: Not stated. Countries: 0. Publications: 1.
A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration)
ClinicalTrials.gov study NCT01124006. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
ClinicalTrials.gov study NCT05639946. IPD Sharing: Not stated. Countries: 1. Publications: 0.
The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
ClinicalTrials.gov study NCT01857661. IPD Sharing: Not stated. Countries: 0. Publications: 1.
STRATOB: a Randomized Controlled Clinical Trial of Cognitive Behavioural Therapy and Brief Strategic Therapy With Telecare for Binge-eating Disorder
ClinicalTrials.gov study NCT01096251. IPD Sharing: Not stated. Countries: 0. Publications: 2.
Efficacy Analysis of Personalized-Target Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Tinnitus: A Single-Center, Single-Blind Randomized Clinical Trial
ClinicalTrials.gov study NCT07267455. IPD Sharing: NO. Countries: 1. Publications: 0.
Randomized Clinical Trial of Non-Surgical Reperfusion of the Coronary Arteries
ClinicalTrials.gov study NCT00000503. IPD Sharing: Not stated. Countries: 0. Publications: 2.
Combination of Dental Bleaching Techniques, Randomized Clinical Trial
ClinicalTrials.gov study NCT02682329. IPD Sharing: UNDECIDED. Countries: 0. Publications: 1.
The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
ClinicalTrials.gov study NCT03879863. IPD Sharing: NO. Countries: 1. Publications: 0.
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Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.