Clinical Trials
Category Added in a WPeMatico Campaign
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Digital Mindfulness Intervention for Pregnant Women With Affective Disorders and Acute Stress Reactions: Prespecified Secondary Analysis of a Randomized Controlled Trial
CONCLUSIONS: In this prespecified subgroup of pregnant women with ICD-10 affective or stress-related disorders, the eMBI was associated with clinically meaningful reductions in depressive symptoms from late pregnancy to 4-6 weeks post partum. Effects at 6 months post partum were attenuated and less stable across missing-data assumptions. These findings support eMBIs as a scalable, nonpharmacological…
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Robotic Needle Insertion for CT-guided Percutaneous Biopsy of Thoracoabdominal Lesions: A Prospective Multicenter Randomized Trial
Purpose To compare safety and feasibility between a novel CT-guided robotic system and the conventional freehand technique for puncture biopsy of thoracoabdominal lesions. Materials and Methods In this prospective multicenter randomized trial, individuals with suspected lesions were enrolled between July 2023 and April 2024 across three university teaching hospitals and randomized to the robot-assisted group…
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Implementation of Expanding Primary Care Teams to Improve Anemia Diagnosis
Introduction/ObjectivesThis study examined factors affecting implementation of a primary care team expansion designed to improve timely diagnosis of causes of new anemia. This intervention introduced nurse navigators, who enrolled eligible patients and coordinated follow-up testing, and a clinical pathologist, who provided diagnostic interpretations to primary care providers.MethodsPatients were enrolled between December 2023 and December 2025…
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An Oxycodone-Based Conscious Analgesia Strategy with Supplemental Low-Dose Propofol Improves Safety in Elderly Obese Patients Undergoing Gastroscopy: A Prospective Randomized Controlled Trial
CONCLUSION: Compared with propofol-based deep sedation, the oxycodone-based conscious analgesia strategy was associated with a lower incidence of hypoxemia, fewer airway interventions, less hypotension, lower propofol exposure, and faster recovery. These findings reflect a comparison of two sedation strategies and do not establish improved respiratory function.
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Extracorporeal CO(2) elimination for acute exacerbation of severe COPD requiring invasive mechanical ventilation: a randomized controlled trial (the X-COPD trial)
CONCLUSIONS: In this prematurely terminated trial, ECCO₂R-facilitated early extubation using a device with a capacity to eliminate more than 50% of the average CO(2) production, was associated with a shorter duration of invasive mechanical ventilation. Numerical trends favored ECCO(2)R across several secondary outcomes, although interpretation is limited by premature termination and the very small sample…
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The effect of communication skills-focused psychoeducation on subjective well-being of caregivers of individuals with schizophrenia: a three-arm randomized controlled trial
CONCLUSIONS: These findings show that both interventions are effective in enhancing caregivers’ SWB, with CSFP providing longer-lasting effects. Future studies should further examine the effectiveness of these interventions and explore how they can be adapted to different groups. Additionally, integrating CSFP into psychosocial and rehabilitation programs could be beneficial in reducing caregiver burden and improving…
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Effect of repeated exposure to an identical multi-user virtual reality anaphylaxis scenario on paramedic trainee performance: a randomized controlled trial
Immersive virtual reality (VR) may provide reproducible environments for training time-critical emergency workflows, but evidence in paramedic education remains limited. In this single-center randomized controlled trial, 125 German paramedic trainees participated in dyadic simulations after allocation to either one standardized multi-user VR anaphylaxis scenario (VR-C, n = 61) or repeated exposure to the identical scenario…
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Effect of yoga-based lifestyle intervention on endothelial function and vascular ageing in adults with type 2 diabetes: a study protocol for a randomised controlled (Yoga V-AgE) trial
INTRODUCTION: Despite advances in diabetes care, cardiovascular disease (CVD) remains the leading cause of morbidity and mortality in type 2 diabetes mellitus (T2DM), with significant residual risk despite optimal glycaemic control. Targeting upstream vascular mechanisms beyond metabolic endpoints is therefore essential through more holistic and integrative approaches to effectively prevent cardiovascular complications in T2DM. Endothelial…
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Behavioral Modification as a Putative Mediator of Digital Therapeutic Response in Temporomandibular Disorders: Secondary Analysis of a Multicenter Sham-Controlled Randomized Trial
CONCLUSIONS: Sham-controlled randomized trials in TMD that empirically differentiate behavioral realization from digital engagement volume remain scarce. Behavioral modification, rather than engagement volume, appears to be an important pathway associated with DTx efficacy and may mediate approximately 29% of the pain-reduction effect under exploratory causal assumptions. This advances mechanism-based evaluation of DTx beyond engagement-based surrogates.…
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Scaffolded AI-Supported Problem-Based Learning for Medical Interns: Exploratory Retrospectively Registered Randomized Controlled Evaluation With a Voluntary Feasibility Follow-Up
CONCLUSIONS: MAPLE-CR was feasible and showed high learner acceptability. Its use was associated with larger short-term CR knowledge gains than case-matched self-study, while transcript analyses provided preliminary framework-aligned process evidence. However, the post hoc sensitivity analysis did not establish prospective power sufficiency, and the confidence interval could not exclude smaller educationally meaningful effects. These findings…