Clinical Trials
Category Added in a WPeMatico Campaign
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DIAMONDS-a diabetes self-management intervention for people with severe mental illness: protocol for an individually randomised controlled multicentre trial
INTRODUCTION: Type 2 diabetes mellitus (T2DM) is two to three times more common in people with severe mental illness (SMI) than in the general population. Supporting self-management in diabetes is fundamental to improving clinical outcomes. The DIAMONDS trial aims to evaluate the clinical and cost effectiveness of a novel, codesigned, supported diabetes self-management programme for…
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Pegylated Liposomal Doxorubicin Combined with Cytarabine and Granulocyte Colony-Stimulating Factor for Treating Newly Diagnosed Older and Unfit Acute Myeloid Leukemia Patients: A Prospective, Single-Center, Single-arm, Phase II Study
BackgroundEffective treatment options are limited for elderly patients with acute myeloid leukemia (AML). A prospective phase II study was conducted to investigate the safety and efficacy of pegylated liposomal doxorubicin (PLD) combined with low-dose cytarabine (LDAC) and granulocyte colony-stimulating factor (G-CSF) in newly diagnosed older and unfit AML patients.MethodsTwenty-two patients were enrolled and deemed evaluable.…
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Stress and Hypertension Among African American Female Family Caregivers of Persons Living With Alzheimer Disease and Related Dementias: Protocol for a Pilot Internet-Based Randomized Controlled Trial
CONCLUSIONS: This study’s findings demonstrate the feasibility of conducting an internet-based intervention (MIM DASH) for African American women with hypertension who also care for families living with ADRD. These results will inform the design of a larger randomized controlled trial to evaluate the intervention’s efficacy and scalability further.
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Long-term mortality outcome of a primary care-based mobile health intervention for stroke management: Six-year follow-up of a cluster-randomized controlled trial
CONCLUSIONS: Despite no observed statistically difference on stroke cause-specific mortality, the 12-month SINEMA intervention, compared with usual care, significantly associated with reduced all-cause and cardiovascular cause-specific mortality during 6 years of follow-up, suggesting potential sustained long-term benefits to patients experiencing stroke.
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Association of energy source with outcomes in en bloc TURB: secondary analysis of a randomized trial
CONCLUSIONS: Different energy sources might achieve comparable perioperative outcomes. Further perspectives involve the assessment of long-term differential oncological outcomes associated with various energy modalities.
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Comparative evaluation of aqueous solution and oil emulsion formulations of 0.05% cyclosporine eye drops in dry eye disease — A randomized clinical trial
CONCLUSION: Both aqueous solution and oil emulsion 0.05% cyclosporine formulations appear to be equally effective in the management of dry eye disease with a comparatively better response with oil emulsion formulations.
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Addressing Multiplicity in Retinal Sensitivity Analysis: An Alternative Approach to Assessing Gene Therapy Efficacy in Inherited Retinal Diseases
CONCLUSIONS: The proposed approach provides a balanced way to address multiplicity while maintaining reasonable statistical significance. Using ≥7 unspecified loci as the criterion for assessing sensitivity changes, offers a comprehensive assessment that can detect genuine treatment effects without being overly conservative.
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Impact of male peer-led outreach on uptake of HIV testing among male partners of pregnant women in Uganda: a randomized trial
CONCLUSIONS: Male peer outreach is a promising intervention to increase knowledge of HIV status among partners of pregnant women. Additional support is needed to increase HIV testing among partners of women with HIV.
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Cefazolin versus placebo for surgical antibiotic prophylaxis in low-risk cesarean delivery: a feasibility blinded randomized controlled trial
CONCLUSIONS: Feasibility was impacted by the high-risk population and patient desire for antibiotics. Adherence to perioperative infection prevention practices were high but incomplete. These study processes could be effectively applied in a larger population, targeting low risk maternity patients.
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Exploring the therapeutic impact of Salvia officinalis on lipid and oxidative stress markers in patients with polycystic ovary syndrome — a randomized placebo-controlled clinical trial
CONCLUSION: The study demonstrates that S. officinalis extract can significantly reduce triglyceride levels and OS in patients with PCOS, suggesting its potential as an adjunctive natural therapy for managing metabolic and oxidative imbalances associated with this condition. While the extract did not significantly alter other lipid profile markers, the observed improvements highlight the therapeutic promise…