Ponta Grossa

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating how active health education methods affect adherence to the HPV vaccine among schoolchildren aged 9 to 14 years in Brazil. The study addresses recent declines in HPV vaccination among young people and aims to provide strong evidence on the effectiveness of direct educational interventions in schools. The trial involves approximately 5,000 students from 80 schools randomized into clusters. The study uses a stepped-wedge, cluster randomized design where clusters of schools switch to one of four intervention groups every two months. These groups include: active student education combined with teacher training and Basic Health Unit actions, active student education without teacher training plus Basic Health Unit actions, Basic Health Unit active orientation sessions led by nurses, and usual care with no specific intervention. Teacher training involves 30 hours of online self-instruction about vaccination. Participants will be monitored over 12 months to measure the proportion of children and adolescents receiving at least one dose of the HPV vaccine after the interventions. Researchers will assess vaccination coverage changes resulting from the different educational approaches. The study also includes training for teachers and health workers, school-based education for students, and community health unit involvement to promote vaccination.

Researchers are investigating the effect of low dose colchicine, an anti-inflammatory drug, on reducing vascular events in patients with symptomatic peripheral artery disease (PAD). This Phase 3 randomized, double-blind, multicenter trial involves 6,150 participants and aims to prevent major cardiovascular and limb complications such as heart attacks, strokes, cardiovascular deaths, acute limb ischemia, and vascular amputations. The study focuses on patients who have PAD with various levels of severity and associated vascular risks. Participants are randomly assigned to receive either a daily 0.5 mg colchicine tablet or a matching placebo. Both the active drug and placebo look the same to ensure that patients, investigators, and study staff remain unaware of the treatment assignments. The trial includes an active run-in period before randomization. The colchicine is administered orally each day, and the trial medication is securely stored according to specific guidelines. During the study, patients will be monitored for major adverse cardiovascular and limb events over 3 to 5 years. These events include cardiovascular death, heart attacks, strokes, severe limb ischemia requiring vascular intervention, or major amputation. Researchers will assess cardiovascular health and limb status regularly, tracking serious events to evaluate the drug's impact. Safety and adherence to treatment will be closely followed throughout the study period.

This research aims to evaluate whether lowering blood phosphate levels in people with end-stage kidney disease (ESKD) who are on dialysis can reduce the risk of death or major heart-related events compared to maintaining higher phosphate levels. The study also looks at whether lowering phosphate improves physical health, fatigue, quality of life, patient satisfaction, and itching, as well as whether it is cost-effective. Hyperphosphatemia, or high phosphate in the blood, is common in ESKD and linked to higher death risk, but there is no strong trial evidence that lowering phosphate improves important patient outcomes. Participants will be randomly assigned to one of two groups: an intensive phosphate target group aiming to keep serum phosphate at or below 1.50 mmol/L using phosphate-lowering medications, or a liberal phosphate target group aiming for a higher phosphate range of 2.0 to 2.5 mmol/L. In the liberal group, all phosphate-lowering drugs at baseline will be stopped and only restarted if phosphate rises above 2.5 mmol/L. Medication choice and doses will be based on physicians' and participants' decisions to meet target levels. The trial is multinational and will include 3600 adults on dialysis. During the study, researchers will track major outcomes including cardiovascular death or serious heart and artery events over 5 years. They will also assess physical health, quality of life using the EQ5D-5L questionnaire, fatigue, itching, and overall survival. The study involves monitoring serum phosphate levels and medication use, and measuring cost-effectiveness of the treatment strategies. Participants will be followed closely to understand the safety and impact of the phosphate targets on their health and well-being.

Researchers are evaluating the safety and effectiveness of different doses of cabergoline (CAB) in women with microprolactinomas, a common type of pituitary tumor that causes excess prolactin levels. This Phase 3, multicenter, randomized, open-label trial includes women who have not previously received treatment. The study aims to compare a high dose of CAB taken for about 6 months with the standard low dose taken for 2 years, focusing on remission rates as the main outcome. Participants will be randomly assigned to one of two groups. The high dosage group will start with oral CAB at 0.5 mg once a week, increasing weekly by 0.5 mg until reaching 3.5 mg per week, which they will maintain for 6 months followed by a gradual dose reduction over one month. The standard dosage group will receive a low CAB dose adjusted as needed to normalize prolactin levels over 2 years, with doses expected between 0.5 and 1 mg per week. After treatment, all patients will stop CAB regardless of tumor or prolactin status. During the study, women will undergo regular assessments including MRI scans to measure tumor size and blood tests to monitor prolactin levels and safety markers. Researchers will track remission at 3, 6, and 12 months after treatment. Participants must follow contraception guidelines and attend scheduled visits for dose adjustments and evaluations. The total participation time depends on the assigned treatment duration, with monitoring focused on treatment response and safety.

The VISIONAIRE trial is a Phase 4, prospective randomized study focusing on patients with atrial fibrillation or atrial flutter who also have advanced chronic kidney disease. This research aims to compare three different blood-thinning strategies to understand their effects and safety in this specific group with severe kidney dysfunction. Participants will receive one of the anticoagulant treatments: either 30 mg daily of edoxaban or a carefully adjusted dose of warfarin aiming for a specific blood clotting range (INR 2.0-3.0). The study will include 1500 patients and will follow them to assess outcomes related to efficacy and safety over a median period of 24 months. During the study, patients will be monitored for treatment effects and safety concerns, including bleeding risks and other health changes related to their heart and kidney conditions. The trial will use blinded endpoint adjudication to objectively evaluate the results. Follow-up will last up to two years, allowing researchers to measure long-term effects of the treatments on this population.