Clinical Trials
Category Added in a WPeMatico Campaign
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Effect of Lung Cancer Screening, Smoking Cessation, and Cessation Smartphone App to Health-Related Quality of Life Among Heavy Smokers: Randomized Controlled Trial
CONCLUSIONS: This is the first study to test a smoking cessation smartphone app in the context of lung cancer screening. The use of the developed app correlated with improved HRQoL, mainly by decreased pain and fatigue. To conclude, the studied app provides a feasible and effective cessation intervention that is readily implementable in population-based lung…
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Naldemedine for the Prevention of Recurrent Acute Pancreatitis: A Randomised, Double-Blind, Placebo-Controlled Trial
CONCLUSIONS: Treatment with naldemedine was safe and well-tolerated and may reduce the risk of recurrent acute pancreatitis. A larger confirmatory trial is needed to verify these findings.
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Digital Cognitive Behavioral Therapy for Chronic Insomnia in South Korea: Cost-Effectiveness Analysis Using Decision Tree and Markov Modeling Based on a Secondary Analysis of a Randomized Clinical Trial
CONCLUSIONS: Digital CBT for insomnia offers favorable clinical and economic value in South Korea. Using Korean clinical trial data and locally relevant societal cost inputs, this study provides policy-relevant evidence supporting early integration of digital CBT into routine insomnia care, employer health strategies, and national digital health policy.
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Surgical decision-making strategies in preterm neonates with necrotizing enterocolitis: A randomized controlled clinical trial
CONCLUSIONS: The strategy based on MD7 and paracentesis was superior to Bell’s criteria for guiding surgical decisions in preterm neonates with NEC, reducing mortality. The main limitation was a small number of non-therapeutic laparotomies, expected due to the greater sensitivity of the strategy.
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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.