Santana Do Acarau

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are conducting an international, multicenter observational study to understand acute kidney injury requiring renal replacement therapy (AKI-RRT) in Latin American countries. The study focuses on the epidemiology, patient outcomes, and care processes for those with AKI-RRT. It also aims to identify how these factors vary across different Latin American countries and what demographic, clinical, and socioeconomic elements affect patient outcomes. The study collects a wide range of data including clinical details, laboratory results, treatments, care processes, and patient outcomes to create a comprehensive database. It includes adult patients admitted to intensive care units diagnosed with stage 3 acute kidney injury who begin renal replacement therapy within a specific timeframe relative to ICU admission. The study does not involve experimental treatments but observes current care practices across multiple sites. Participants are monitored from enrollment through hospital discharge or up to 90 days to track in-hospital mortality and other outcomes. The research helps compare care approaches and results between countries and supports further clinical research in AKI-RRT. The total participation duration depends on the patient's hospital stay or 90 days, whichever comes first.

This research aims to assess the benefits and risks of using hydrocortisone alongside standard treatment for children with septic shock that is resistant to fluids and vasoactive-inotropic drugs. Pediatric septic shock is a leading cause of death worldwide, and many children do not regain their normal health quality after the illness. The trial is a Phase III, multi-institutional, randomized, double-blinded study enrolling up to 500 children to evaluate whether hydrocortisone reduces new or worsening organ dysfunction and poor outcomes, including death or severely impaired health-related quality of life, measured 28 days after enrollment. Participants are randomly assigned to receive either hydrocortisone or a placebo (normal saline). Those in the hydrocortisone group receive an initial dose of 2 mg/kg intravenously, followed by 1 mg/kg every six hours for up to seven days or until vasoactive infusions are stopped for 12 hours. The placebo group receives an equal volume of saline on the same schedule. Treatments continue until the criteria are met, then are stopped. The study also monitors specific adverse events such as hyperglycemia requiring insulin, gastrointestinal bleeding, delirium, and hospital-acquired infections. Children are closely observed in pediatric intensive care units with daily monitoring during treatment and follow-up assessments at 28 and 90 days after enrollment. Researchers collect health data, including organ function using the Pediatric Logistic Organ Dysfunction score, quality of life measures, and adverse event occurrence. The study also explores whether biomarkers can help identify which children benefit most or are at risk from hydrocortisone therapy. Participation length depends on treatment duration and follow-up evaluations.

Researchers are conducting a prospective, observational, multicenter cohort study to evaluate patients with severe and very severe Chronic Obstructive Pulmonary Disease (COPD) in Brazil. The study focuses on patients classified by the GOLD 2024 guidelines, aiming to understand the relationship between COPD severity, exacerbation rates, disease progression, complications, and mortality. This research addresses the lack of national data on this specific subgroup of COPD patients in Brazil, considering regional differences in risk factors, population, and genetics. The study will include multiple medical centers across all five regions of Brazil, representing diverse environments with varying exposure to tobacco smoke, biomass burning, and pollution. Patients will be enrolled consecutively and followed over 12 months. Visits will occur on-site at the start, 6 months, and 12 months, with additional tele-consults at 3 and 9 months to collect clinical data, especially regarding exacerbations. Data collection will be managed locally at each site and reviewed by the ARO Team. Participants will undergo clinical assessments during on-site and remote visits, including spirometry and symptom evaluations with tests like the COPD Assessment Test (CAT) or Chronic Airway Assessment Test (CAAT). The study will monitor the incidence of hospitalizations, exacerbations, and mortality throughout the follow-up period. This comprehensive monitoring will help characterize the disease course and outcomes among severe COPD patients in different Brazilian regions over approximately one year.