Clinical Trials
Category Added in a WPeMatico Campaign
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A Thorough QT Study to Assess the Effects of Milvexian on Cardiac Repolarization in Healthy Participants
Milvexian is an oral factor XIa inhibitor in development for prevention of major thromboembolic conditions. This randomized, double-blind, placebo- and positive-controlled, multiple-dose, four-period crossover study assessed the cardic safety of milvexian (including effects on the QT interval of the electrocardiogram), with a supporting in vitro component. Sixty-six participants were enrolled. In each treatment period, participants…
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Evaluation of a New Formulation That Improves the Bioavailability and Food Effect of Abiraterone: An Open-Label, Crossover, Randomized, Controlled, Phase I Clinical Trial
This first-in-human phase I trial evaluated RL001, a self-emulsifying soft-capsule abiraterone developed to overcome the low bioavailability and food sensitivity associated with the 1000-mg Zytiga tablet that is used with prednisone according to NCCN guidelines. Plasma concentrations were quantified by LC-MS/MS and modeled in Phoenix WinNonlin 8.1 and SAS; GeoMean confidence intervals compared pharmacokinetics. Against…
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Inflammation and insulin profiles in men assigned to exercise vs. usual care for prostate cancer: results from the active surveillance exercise (ASX) randomized controlled trial
CONCLUSIONS: We observed no changes in markers of insulinemia, inflammation, or PSA from a 16-week at-home walking intervention vs. control in individuals with low-risk PCa.
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Analysis of risk factors for recurrence in children with asthmatic bronchopneumonia during remission and discussion on the therapeutic effect of diprophylline combined with budesonide
CONCLUSION: DPL combined with BUD can quickly relieve the clinical symptoms and reduce the level of inflammation in children with ABP, with good safety. More attention should be paid to breastfeeding support, environmental tobacco control and nutritional intervention to reduce the risk of relapse during remission.
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Effectiveness of Closed Blood-Sampling Devices in Critically Ill Adults: A Feasibility Trial
CONCLUSIONS: A full-scale RCT evaluating CBSDs in ICU patients is feasible with protocol modifications, including broader site participation and improved device integration with advanced monitoring systems. Preliminary data suggest that CBSDs may reduce transfusion requirements and blood loss in critically ill patients.
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A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip
CONCLUSION: In a difficult-to-treat population with OA, fasinumab 1 mg Q4W achieved clinically meaningful improvements by week 16 versus placebo and naproxen. The safety profile was similar to that previously observed for fasinumab.
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An Internet-Delivered Intervention to Reduce LGBTQ+ Prejudice Among Romanian Teachers: Randomized Controlled Trial
CONCLUSIONS: The intervention offers initial evidence for the effectiveness of a cost-effective and portable online resource for educators and high school counselors, particularly in regions where negative attitudes toward the LGBTQ+ community are prominent. The results show that integrating blended cognitive (information), affective (indirect contact and perspective taking), and behavioral (self-efficacy and empowerment) approaches is…
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Berberine and Adiposity in Diabetes-Free Individuals With Obesity and MASLD: A Randomized Clinical Trial
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of diabetes-free individuals with obesity and MASLD, a 6-month berberine treatment at a daily dose of 1 g had an excellent safety profile but did not reduce VAT area or liver fat content.
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Brain Amyloid Plaque Levels Affect Clinical Progression in Alzheimer Disease: Assessment of Amyloid PET and Change in CDR-SB Utilizing Semi-Mechanistic Model
Lecanemab is a humanized IgG1 monoclonal antibody binding with high affinity to protofibrils of amyloid-beta (Aβ) protein. In clinical studies, lecanemab has been shown to reduce amyloid markers in early symptomatic Alzheimer’s disease and slow decline on clinical endpoints of cognition and function. Nonlinear mixed-effects modeling assessed the correlation between amyloid PET and change in…
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Does Past Myopia Progression Predict Future Progression?
CONCLUSIONS: Changes in SER and AL of children in the prior 12 months were poor predictors of future myopia progression, limiting their usefulness for clinical decision-making or selecting participants for clinical trials.