Clinical Trials
Category Added in a WPeMatico Campaign
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Evaluation of a combination adherence strategy to support HIV antiretroviral therapy for pregnancy and breastfeeding in Malawi: A pilot randomized clinical trial
CONCLUSION: These encouraging pilot findings suggest that this combination adherence package could be used to support ART adherence among pregnant and breastfeeding women living with HIV. We demonstrate feasibility of using a combined measure of adherence and viral suppression as an outcome measure.
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Effects of 12-Week Anti-Inflammatory Dietary Education on Depressive Symptoms Among Depressed Patients with Breast Cancer Undergoing Adjuvant Chemotherapy: A Randomized Controlled Trial
Background: Depressive symptoms (DepS) are prevalent among patients with breast cancer. Offering an anti-inflammatory diet is a promising strategy for DepS management, but it is costly and difficult to scale up. Instead, anti-inflammatory dietary education is cost-effective and may be more conducive to the promotion of an anti-inflammatory diet strategy. Methods: A prospective, assessor-blinded, two-arm…
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Feasibility and acceptability of the Comprehensive Oncology Rehabilitation and Exercise (CORE) clinical workflow algorithm in patients with newly diagnosed stage I-III breast cancer who undergo surgery as first-line treatment
CONCLUSIONS: The CORE clinical workflow algorithm is feasible and acceptable among women who have newly diagnosed stage I-III breast cancer with plans for surgery as first-line treatment. CORE was also acceptable among clinic staff.
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Improved overall survival in an anti-PD-L1 treated cohort of newly diagnosed glioblastoma patients is associated with distinct immune, mutation, and gut microbiome features: a single arm prospective phase I/II trial
This phase I/II trial aims to evaluate the efficacy of concurrent atezolizumab with radiation therapy and temozolomide (TMZ) followed by adjuvant atezolizumab and TMZ in newly diagnosed glioblastoma (GBM) patients and to identify pre-treatment correlates with outcome (N = 60). Trial number: NCT03174197. The primary outcome was overall survival (OS) whereas secondary outcomes were retrospective…
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Enteric-coated Mycophenolate Sodium plus hydroxychloroquine therApy versus hydroxychloroquine for the Remission of Proteinuria in IgA Nephropathy (EMSAR-IgAN trial): study protocol for a randomised trial
INTRODUCTION: The management of immunoglobulin A (IgA) nephropathy remains a topic of debate. Hydroxychloroquine and mycophenolate mofetil (MMF) are two immunosuppressive agents that have recently garnered increased attention among patients with IgA nephropathy in China. Several studies have shown the comparable efficacy between MMF and enteric-coated mycophenolate sodium (EC-MPS), with lower adverse event rates for…
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A Cluster Randomized Controlled Trial Comparing the Efficacy of Pre-School Language Interventions-Building Early Sentences Therapy and an Adapted Derbyshire Language Scheme
CONCLUSIONS: A low-dosage intervention can produce language gains with moderate to large effects. The accelerated progress after the BEST intervention underscores the significant potential of interventions designed with reference to usage-based theory, which precisely manipulates language exposure to promote the specific cognitive mechanisms hypothesized to promote language learning.
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Dark Chocolate Mitigates Premenstrual Performance Impairments and Muscle Soreness in Female CrossFit() Athletes: Evidence from a Menstrual-Phase-Specific Trial
Background: Hormonal fluctuations across the menstrual cycle can significantly impair physical performance, neuromuscular function, and cognitive processing in female athletes, particularly during the premenstrual phase. Emerging evidence suggests that dark chocolate (DC), rich in flavonoids, polyphenols, magnesium, and theobromine, may exert anti-inflammatory, analgesic, and neuroprotective effects. This study investigated the acute effects of 85% DC…
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Internet-Based Psycho-Physical Exercise Intervention Program in Mild-to-Moderate Depression: The Study Protocol of the SONRIE Randomized Controlled Trial
The COVID-19 pandemic has intensified depression due to isolation and reduced physical activity, highlighting the need for accessible remote treatments. The SONRIE study evaluates the effectiveness of a 12-week online intervention combining physical exercise and internet-based cognitive-behavioral therapy on depressive symptoms in adults with mild-to-moderate depression. This randomized controlled trial involved 80 adults aged 25-65…
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Gain-Framed Text Messages and Nicotine Replacement Therapy for Smoking Cessation Among Lung Cancer Screening Patients: A Brief Report of a Pilot Randomized Controlled Trial
People who undergo lung cancer screening (LCS) and continue to smoke are at risk for negative clinical outcomes and lowered survival and need effective smoking cessation interventions. This pilot study tested an 8-week intervention for smoking cessation after LCS. The participants (N = 40) were randomized to the intervention group (combination nicotine replacement therapy [NRT]…
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Initial Psychometric Evaluation of the Barth Syndrome Symptom Assessment (BTHS-SA) for Adolescents and Adults in a Phase 2 Clinical Study
CONCLUSION: Though the small sample size limits strong conclusions, this analysis suggests the BTHS-SA can produce reliable scores upon which valid inferences may be drawn. The BTHS-SA may be a useful tool to evaluate treatment benefits in this underserved population.