Clinical Trials
Category Added in a WPeMatico Campaign
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Optimizing Metabolic Assessment: Maximal Fat Metabolism, Lactate Dynamics, and Cardiorespiratory Determinants at Different Pedaling Frequencies
CONCLUSIONS: Metabolic assessments should prioritize absolute MFO and BLC dynamical changes over Fatmax intensities, when interpreting fat-oxidation capacity, particularly under varying pedaling frequencies. By jointly characterizing blood-based and respiratory-based diagnostics under different exercise assessment conditions, this study helps improve the reliability of diagnosing the metabolic status in both healthy individuals and patients with metabolic disease.
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Stem cell therapy for female stress urinary incontinence: Results, limitations and lessons learned from a pilot clinical study
CONCLUSION: Autologous MSC‑based therapy for SUI was feasible and showed an acceptable short‑term safety profile in this pilot research setting; however, clinical efficacy remained modest. The manufacturing and quality control methodology is reproducible in specialized cell processing centers, but its application should remain confined to clinical research conducted in compliance with current regulations governing human…
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Laser interstitial thermal therapy and adjuvant pembrolizumab in recurrent high-grade astrocytoma: a Phase 1/randomized Phase 2b trial
Immune checkpoint inhibitors (ICIs) show minimal efficacy in recurrent high-grade astrocytoma (rHGA). Laser interstitial thermal therapy (LITT), a minimally invasive cytoreductive approach, may prime rHGA for ICI response. A phase 1/randomized phase 2b trial (ClinicalTrials.gov: NCT02311582 ) was designed to test pembrolizumab in combination with LITT in patients with rHGA. Nine patients were enrolled in…
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Redox Water Consumption Attenuates Exercise-Induced Inflammation and Oxidative Stress in Physically Active Adults: A Randomized Controlled Trial
CONCLUSIONS: Redox water intake was associated with lower immediate post-exercise IL-6 compared with controls after baseline adjustment; however, pronounced baseline imbalance limits causal interpretation and warrants confirmation in larger trials with balanced inflammatory profiles. These findings highlight a potential biochemical mechanism linking hydration redox properties with inflammatory regulation during physical stress.
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Effect of a supervised intermittent exercise program on insomnia in breast cancer patients undergoing chemotherapy
CONCLUSIONS: The training did not increase total sleep time, likely due to insomnia’s multifactorial origin. However, training yielded beneficial effects on objective sleep quality and exercise-induced adaptation. Future research is needed to investigate the various etiologies of insomnia to develop tailored and personalized management approaches.
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Effects of time-restricted eating on blood pressure in children: A cluster randomized controlled trial
CONCLUSIONS: A 12-hour eating window, particularly with the last meal completed before 8 PM, may be associated with lower BP over 12 months in children and adolescents with elevated BP; interpretation should consider the cluster design and attrition.
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Effects of Blood Flow Restriction Training Combined With Conventional Physical Therapy on Pain, Muscle Architecture, Strength, Function, and Psychosocial Outcomes in Chronic Lateral Epicondylitis: A Pilot Randomized Controlled Trial
BACKGROUND Chronic lateral epicondylitis (LE) causes persistent pain and functional impairment. Blood flow restriction training (BFRT) can improve strength and pain under low-load conditions, but evidence in chronic LE remains limited. This study investigated the effects of combining BFRT with conventional therapy on pain, muscle strength, function, and psychosocial outcomes. MATERIAL AND METHODS A single-blind…
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Clinical study of acupuncture at force-sensitive acupoints in treatment of diarrhea-predominant irritable bowel syndrome
CONCLUSIONS: Acupuncture at force-sensitive acupoints has a definite curative effect on IBS-D. This therapy is high in safety and satisfactory in long-term effect. In the aspects of the alleviation of the severity of symptoms and the improvement of the quality of life in the patients with IBS-D, acupuncture at force-sensitive acupoints with high sensitivity is…
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MRD-driven initial therapy of acalabrutinib and lenalidomide plus rituximab or obinutuzumab for mantle cell lymphoma
This phase 2 study evaluated the efficacy and safety of combining acalabrutinib and lenalidomide with either rituximab (ALR) or obinutuzumab (ALO), with longitudinal minimal residual disease (MRD) monitoring in frontline MCL treatment. The primary objective was molecular complete response (CR) after 12 cycles of induction, defined by Lugano criteria, and undetectable MRD of <10-6 (uMRD6)…
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Feasibility Trial of Prolonged versus Single-Dose Challenge in Penicillin Allergy
CONCLUSIONS: Conducting a double-blind, placebo-controlled randomized trial of single-dose versus multidose oral amoxicillin challenge was feasible. A fully powered efficacy trial is needed to assess between-group differences in immune-mediated adverse events. (Funded by Austin Health and others; trial registration: ANZCTR — ACTRN12623001242617, registered on November 30, 2023.).