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Actively Recruiting

Researchers are evaluating the effectiveness and safety of colchicine and non-enteric coated aspirin, alone or combined, to improve heart-related outcomes in high-risk patients with type 2 diabetes. This Phase 3 trial focuses on adults aged 55 to 80 years who have type 2 diabetes and no prior coronary artery disease events but have additional risk factors like long diabetes duration, high blood sugar levels, smoking, or other markers of cardiovascular risk. The study aims to reduce serious cardiovascular events such as heart attacks, strokes, or urgent hospitalizations. Participants are randomly assigned to receive either colchicine 0.5 mg once daily, aspirin 40 mg twice daily, both medications together, or matching placebos. The aspirin is given as a non-enteric-coated tablet twice daily. Those who cannot take aspirin or have certain conditions may still receive colchicine or its placebo. The treatment and follow-up period lasts up to 60 months, during which the occurrence of serious cardiovascular events is closely monitored. During the study, participants will undergo regular assessments including monitoring for cardiovascular events like heart attacks and strokes. Safety labs and clinical evaluations will be conducted to track any side effects or adverse events. The main outcome measured is the time until the first major cardiovascular event occurs. Researchers will also ensure participants adhere to the medication schedule and will follow all patients for up to five years to evaluate long-term safety and effectiveness.

Age: 55Years - 80YearsAll GendersPhase 3
39 locations
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Actively Recruiting

Researchers are evaluating the use of a capillary medical device to measure C-reactive protein (CRP) in children with fever aged between 0.25 months and 15 years. Fever is a common reason for outpatient visits among children, and distinguishing between viral and bacterial infections can be challenging. Since current CRP test results take several hours and cause delays in treatment, this study aims to assess whether rapid CRP measurement in primary care can reduce unnecessary referrals to emergency laboratories and ease overcrowding in emergency rooms and clinics. The study involves using the ACTIM-CRP device for semi-quantitative measurement of capillary CRP levels in febrile children during primary care visits. Children with fever meeting specific criteria related to fever duration and concern for bacterial infection are included. The intervention is designed to streamline the care pathway for these children by providing faster test results directly in primary care settings. Participants will be monitored for referral rates to facilities equipped for emergency laboratory testing on Day 1 and Day 7 after the initial consultation. The study also tracks treatment decisions and the impact on healthcare utilization. Parents and children will be informed about the study, and consent will be obtained. The overall goal is to improve fever management in children and reduce unnecessary emergency visits, benefiting both families and healthcare systems.

Age: 3Months - 15YearsAll GendersPhase Not Applicable
16 locations
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