Clinical Trials
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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…
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Effects of Transcranial Direct Current Stimulation and Individualized Physical Therapy on Pain and Function in Individuals With Chronic Knee Pain: A Pilot Study
BACKGROUND AND PURPOSE: Noninvasive brain stimulation is a promising neuromodulatory intervention for chronic pain. This study aimed to determine the impact that transcranial direct current stimulation (tDCS) in combination with individualized physical therapy (PT) has on pain and function in individuals with chronic knee pain.
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Effects of 12-week supervised combined aerobic and resistance training on body composition and physical function in overweight or obese adults with multiple cardiometabolic risk factors: a randomized trial
CONCLUSION: In this single-center randomized trial, 12-week supervised combined aerobic and resistance training was associated with modest improvements in fat-related body composition and selected physical-function outcomes in overweight or obese adults with multiple cardiometabolic risk factors. Cardiometabolic biomarkers were not reassessed at follow-up, and findings should be interpreted as preliminary.
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Effects of Blood Flow Restriction Training on Muscle Strength and Physical Function in Older Adults With Sarcopenia
CONCLUSION: BFR training significantly improves muscle strength, physical function, functional mobility, and ADL in hospitalized older adults with sarcopenia, showing superior efficacy compared with conventional RT.
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Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics and the Pharmacokinetics of Balcinrenone When Dosed with a P-gp Inhibitor
Balcinrenone (AZD9977) is a novel selective non-steroidal mineralocorticoid receptor antagonist with a distinct mode of action being developed as a fixed-dose combination with the sodium-glucose cotransporter-2 inhibitor dapagliflozin for the treatment of heart failure with impaired kidney function, and chronic kidney disease. In this Phase 1 randomized open-label three-way crossover study we investigated the effect…
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Open-label randomized comparative clinical study of the efficacy and safety of the multicomponent complex in the treatment of male infertility
CONCLUSION: The use of the complex dietary supplement was associated with improved sperm motility parameters and reduced oxidative stress as early as during the first 1-2 months of administration, with the effect persisting through day 90.
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Effects of erector spinae plane block on postoperative pain in patients undergoing implant-based breast reconstruction for breast cancer: a randomized controlled trial
CONCLUSIONS: Single-shot T5 ESPB with perineural dexmedetomidine may reduce postoperative pain and opioid requirements and improve early recovery. Further large trials are warranted. Clinical relevance remains to be confirmed.
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Do Treatment Expectations Moderate the Effect of Manual Therapy in People With Knee Osteoarthritis? A Secondary Analysis of Randomized Clinical Trials
OBJECTIVE: To investigate whether treatment expectations for joint mobilization or massage moderated the effect of manual therapy on pain outcomes in knee osteoarthritis (OA). DESIGN: Secondary moderation analysis of two 2×2 factorial randomized controlled trials. METHODS: Data were pooled from two trials that compared manual therapy and exercise to exercise alone in 375 people with…