Clinical Trials
Category Added in a WPeMatico Campaign
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Genetic Testing for APOL1 in Adults With Hypertension: The GUARDD-US Randomized Clinical Trial
CONCLUSIONS AND RELEVANCE: Provision of APOL1 genotype high-risk results to participants and clinicians was not associated with SBP reduction overall. Among the subset of patients with uncontrolled BP, the intervention group had a significant SBP reduction. APOL1 disclosure also increased the rate of CKD screening and diagnosis. Effects of reporting APOL1 genotype merit further investigation…
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The feasibility of an early-years motor skill school-based intervention research project in a low-resource area of South Africa
CONCLUSION: The study highlights the feasibility of conducting intervention research in low-resource settings. It notes the challenges of using the MABC-2 due to its cost and time requirements and reports on the initial effect of the program on the motor skills of the participants. Statistical significance of positive results was affected by the small sample…
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Intermittent Pneumatic Compression to Prevent Venous Thromboembolism in Critically Ill Adult Patients
CONCLUSIONS: Intermittent pneumatic compression can prevent VTE in intensive care unit patients who are at high risk of hemorrhage.
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A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fenebrutinib and Effect on the QT/QTc Interval in Healthy Participants
Fenebrutinib is a Bruton’s tyrosine kinase inhibitor under investigation for the treatment of multiple sclerosis. The goal of this study was to investigate the effect of fenebrutinib on cardiac repolarization (QT interval) as well as its safety, tolerability, and pharmacokinetics in healthy participants. Part A was a randomized, double-blind, placebo-controlled, single-ascending dose study of therapeutic…
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Protocol for Head StART: A hybrid type II cluster randomized controlled trial evaluating community ART delivery for people newly diagnosed with HIV in refugee settlements in Uganda
BACKGROUND: Until recently, community-based antiretroviral therapy (ART) delivery was only available for people living with HIV on ART for ≥6 months with a suppressed viral load. However, early attrition from HIV care is common, particularly in refugee settlements where structural and psychosocial barriers to care are pronounced, and reducing barriers to life-saving ART sooner (e.g.,…
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Overall Survival of Glioblastoma Patients Treated With a Combination of 7 Micronutrients: A Nutraceutical Trial
CONCLUSION: This study has limitations but it acts as a proof of principle towards larger studies, as clearly sufficiently powered trials are crucial in determining the nature and size of the treatment effect. Future trials should consider subgroup analysis, with respect to such factors as patient’s age at diagnosis, gender, extent of surgery, MGMT mutation…
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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.