Clinical Trials
Category Added in a WPeMatico Campaign
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Rituximab versus Ocrelizumab in Newly Diagnosed Relapsing Multiple Sclerosis
CONCLUSIONS: In participants with newly diagnosed relapsing multiple sclerosis and recent disease activity, rituximab was noninferior to ocrelizumab in suppressing disease activity as detected by MRI from 6 to 24 months, with a similar incidence of serious adverse events. (Funded by the Research Council of Norway and others; OVERLORD-MS ClinicalTrials.gov number, NCT04578639; EudraCT number, 2020-001205-23;…
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Major Depressive Disorder and PTSD Treatment Outcome in Interpersonal Psychotherapy and Prolonged Exposure
Objective: Trauma-focused psychotherapies are first-line treatments for posttraumatic stress disorder (PTSD). For veterans, however, response rates are low, and dropout tends to be high. Some evidence suggests that those with comorbid depression are less likely to complete treatment and improve less in trauma-focused treatments. This study examined treatment noncompletion and PTSD symptom outcomes among veterans…
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Impact of reinforced pancreaticojejunostomy with or without tissue adhesive glue modified cyanoacrylate following pancreaticoduodenectomy: a randomized controlled clinical trial
CONCLUSIONS: In this single-center randomized trial, reinforcement of pancreaticojejunostomy with Glubran^(®)2 was associated with a significantly lower rate of POPF (Grade B/C), shorter time to drain removal, lower overall morbidity, and shorter length of hospital stay, with an acceptable safety profile. These hypothesis-generating findings warrant confirmation in an adequately sized, multicenter trial with operator-independent application…
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Protocol for the economic evaluation of integrated longitudinal public health interventions in a cluster randomised controlled trial setting: the healthy life trajectories initiative
INTRODUCTION: In 2021, globally, cardiometabolic diseases (CMDs) accounted for 35% of the 1.73 billion disability-adjusted life years (DALYs) attributed to non-communicable diseases. The Healthy Life Trajectories Initiative (HeLTI), a four-country randomised controlled trial based on the developmental origins of health and disease(DOHaD) concept, evaluates whether integrated longitudinal public health interventions started prepregnancy reduce the risk…
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Effect of home-based cardiac rehabilitation on quality of life, health behaviours and cardiac anxiety in patients with coronary artery disease: findings from a single-blinded randomised controlled trial
CONCLUSION: The nurse-led HBCR programme significantly improved QoL and CHB and reduced CA among patients with CAD. HBCR may provide an effective and scalable secondary prevention strategy in settings where centre-based cardiac rehabilitation services are limited.
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The Kia Timata Pai Randomized Controlled Trial: ENRICH Early Childhood Teacher Training Improves Toddlers’ Oral Language and Self-Regulation
Children’s oral language and self-regulation skills are critical for healthy development and life trajectories. ENRICH is a preventive intervention developed for early childhood teachers to enhance these skills in toddlers. Kia Tīmata Pai (Best Start study) is a longitudinal cluster randomized controlled trial in 136 New Zealand early childhood education centers testing the impact of…
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Nasal Continuous Positive Airway Pressure vs Nasal Intermittent Positive Pressure Ventilation in Preterm Infants With Respiratory Distress Syndrome: A Randomized Clinical Trial
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of preterm infants with RDS, NIPPV with MISA as initial respiratory support significantly reduced NIV failure within 72 hours compared with NCPAP. These findings suggest that NIPPV may be the preferred primary respiratory strategy for this high-risk population, although further evaluation of long-term outcomes is warranted due…
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Knowledge of cancer genetics and attitudes about genetic counseling and testing: a randomized trial of the Know Your Risk intervention compared to conventional genetic counseling
CONCLUSION: Findings support that the components included in the KYR intervention are non-inferior for cancer genetic knowledge, risk perception, genetic counseling and testing attitudes, and genetic counseling satisfaction among women who screen at elevated risk for breast cancer. By using the combination of components included in the KYR intervention, genetic counseling and genetic testing are…
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Short-term responsiveness of DNA methylation-based aging biomarkers to a multimodal intervention comprising exercise and dietary guidance involving daily consumption of yogurt containing Bifidobacterium longum BB536: an exploratory randomized controlled trial
Aging-related chronic diseases are driven by multiple mechanisms, motivating efforts to develop feasible interventions that can attenuate biological aging. DNA methylation-based epigenetic clocks, particularly measures of the pace of aging such as DunedinPACE, are sensitive to relatively short-term changes in aging processes. However, evidence from randomized controlled trials remains limited. We conducted a randomized controlled…
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Efficacy of Customized Toothbrush Handles in Individuals With Down Syndrome and Autism Spectrum Disorder: A Non-Randomized Clinical Trial
CONCLUSION: Customized-handle toothbrushes showed similar effectiveness compared to conventional toothbrushes in reducing dental plaque in individuals with DS and ASD and may serve as a supportive tool for oral hygiene care, particularly when combined with supervision and caregiver assistance.