Ponta Grossa

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

This research aims to evaluate how active health education methods can increase the number of schoolchildren getting the HPV vaccine. The study addresses a recent drop in HPV vaccine adherence among young people in Brazil. It involves 80 schools and 5,000 students, using a stepped-wedge design where clusters of schools are randomized every two months to one of four different interventions. The study compares four approaches active training for both students and teachers, active training for students only, a nurse-led vaccination orientation session in schools, and usual care without specific interventions. Teacher training includes 30 hours of online self-instruction focused on vaccination, while students receive education and active vaccination efforts over two months. Each intervention is applied to clusters of schools in a randomized sequence. Participants are schoolchildren aged 9 to 14 years. Researchers will measure vaccination rates, including the proportion receiving at least one dose and those completing the full HPV vaccine series, along with tracking vaccination refusals among students and teachers over 12 months. The study monitors these outcomes following the interventions to understand their impact on vaccine coverage and refusal rates.

Researchers are evaluating whether low dose colchicine can reduce vascular events in patients with symptomatic peripheral artery disease PAD. This phase 3 randomized, double-blind, multicenter trial aims to prevent major adverse cardiovascular and limb events MACE and MALE such as heart attack, stroke, cardiovascular death, severe limb ischemia requiring intervention, or major vascular amputation. The study includes 6,150 participants and is sponsored by the Population Health Research Institute. Participants will be randomly assigned to receive either colchicine 0.5 mg daily or a placebo tablet that looks identical. Treatment lasts for the duration of the trial, which spans 3 to 5 years, including an active run-in period. The trial is designed to compare the effects of the colchicine drug against placebo in preventing serious vascular complications in PAD patients. During the study, participants will have regular assessments to monitor cardiovascular and limb health, including evaluations of major adverse events, hospitalizations, revascularizations, and quality of life. Researchers will collect data on outcomes like cardiovascular death, stroke, acute or chronic limb-threatening ischemia, and overall mortality over 3 to 5 years. Safety and adherence to the study medication will be monitored throughout the trial period, with follow-up visits to track health status and event occurrences.

This research aims to evaluate the effects of lowering blood phosphate levels in adults with end-stage kidney disease ESKD who are receiving dialysis. Elevated phosphate levels are common in ESKD and linked to higher risk of death and heart problems, but it is unclear if reducing phosphate improves important patient outcomes. The study will compare intensive lowering of phosphate to a more liberal phosphate target to see if this reduces heart-related deaths and events, improves physical health, and is cost-effective. Participants will be randomly assigned to one of two groups one aiming for a liberal serum phosphate target of 2.0 to 2.5 mmolL, and the other aiming for an intensive target of 1.50 mmolL or lower. Doctors will decide the type and dose of phosphate-lowering medications to help participants reach their assigned phosphate levels, following usual local practices. The study will last up to five years and is conducted internationally with 3600 adults on dialysis. During the study, researchers will monitor participants for major heart-related events and deaths, physical health, fatigue, quality of life, patient satisfaction, and itching. Regular assessments will include measuring time to cardiovascular death or major cardiovascular events and evaluating overall survival and quality of life using the EQ5D-5L tool. The study will also assess cost-effectiveness and continue to observe participants for five years to collect comprehensive data on these outcomes.

Researchers are conducting a multicenter, randomized, open-label trial to study women with microprolactinomas who have not previously been treated. The study compares two dosing regimens of cabergoline CAB, a dopamine agonist used to treat prolactinomas. The goal is to evaluate remission rates and potentially improve future treatments for this condition by testing a higher dose against the current standard dose over different time periods. Participants will be randomly assigned to one of two groups. The high-dose group will receive escalating doses of oral CAB over 7 weeks to reach 3.5 mg per week, maintain this dose for about 6 months, and then gradually reduce the dose over 1 month. The standard-dose group will take a lower dose of CAB sufficient to normalize prolactin levels, adjusted as needed, for 2 years. After treatment, CAB will be withdrawn for all patients regardless of tumor size or hormone levels. During the study, participants will be closely monitored with clinical evaluations and laboratory tests to assess remission at 3, 6, and 12 months after treatment starts. Researchers will track hormone levels, tumor size, and any side effects. The total duration of involvement varies by treatment group, ranging from about 6 months to 2 years, followed by dose discontinuation. This approach aims to provide detailed information on the safety and effectiveness of the different dosing strategies.

The VISIONAIRE trial studies patients with atrial fibrillation or atrial flutter who also have advanced chronic kidney disease. This phase 4, randomized clinical trial is designed to compare three blood-thinning strategies to manage the risk of blood clots in this population, aiming to understand their effects on safety and effectiveness. The trial is sponsored by Hospital Sirio-Libanes and includes 1500 participants. Participants will be randomly assigned to one of three groups full-dose warfarin adjusted to a target INR between 2.0 and 3.0, a fixed dose of 30 mg daily edoxaban, or no anticoagulation treatment. Warfarin dosing will be adjusted according to guidelines from Brazil for patients with low kidney function. The study will follow participants over a median period of 24 months to assess outcomes. During the trial, participants will be monitored regularly to evaluate both the benefits and risks of each treatment strategy. Researchers will measure primary and secondary outcomes related to efficacy and safety, including bleeding and stroke events. Follow-up evaluations will include clinical assessments and laboratory tests to track kidney function and blood clotting status throughout the study duration.