Pasto

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

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 the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are assessing the safety and effectiveness of Pumitamig combined with chemotherapy compared to Nivolumab combined with chemotherapy in adults with untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. This phase 2/3 study focuses on participants with specific tumor characteristics, including PD-L1 status and HER2-negative cancer, aiming to provide new treatment options for this serious condition. Participants receive either Pumitamig along with chemotherapy drugs Folfox or Capox, or Nivolumab combined with chemotherapy, each given at specified doses on set days. The study is randomized and blinded, involving two parts: phase 2 and phase 3, with treatment tailored based on PD-L1 expression levels. During the study, researchers monitor tumor response using RECIST v1.1 criteria, track progression-free survival up to about 33 months, and overall survival up to approximately 47 months after randomization. Assessments include imaging and clinical evaluations to measure treatment effects and safety over the course of participation, which may last up to 2 years or more for certain outcomes.

Pediatric acute respiratory distress syndrome (PARDS) is a serious condition leading to admission and death in pediatric intensive care units (PICUs). Researchers are studying how living at different geographic altitudes and the availability of critical care resources affect outcomes for children with PARDS. This study collects data from PICUs worldwide at various altitudes to better understand how these factors influence the course of the illness and to identify areas needing improvement in care. Participants are grouped based on the altitude of the PICU where they receive care: low (0-1500 m), intermediate (1501-2500 m), high (2501-3500 m), and very high (>3500 m). The study does not involve any treatment intervention. Instead, it collects clinical, physiological, and hospital resource data both prospectively and retrospectively to evaluate how altitude and resource availability relate to oxygenation, ventilation, and patient outcomes. Children admitted to PICUs who meet study criteria will have their demographic and clinical information recorded. Researchers will monitor outcomes including in-hospital mortality from PICU admission until hospital discharge, up to 90 days. The data collected aims to support development of guidelines adapted to different settings worldwide, improving pediatric critical care practices and reducing care disparities.

Breast cancer is a leading health issue in Latin America, especially among women who tend to develop it at younger ages and are often diagnosed at more advanced stages compared to Western women. Mortality rates from breast cancer in this region have been rising rapidly over the past two decades. The study aims to better understand the causes and characteristics of breast cancer in premenopausal women in Latin America, focusing on molecular and pathological tumor subtypes, and the role of various risk factors including diet, obesity, and physical activity. The study, called PRECAMA, is a multicenter population-based case-control study conducted in Mexico, Costa Rica, Colombia, and Chile. It collects detailed clinical, pathological, and biological information from women aged 20 to 45 years who have been newly diagnosed with primary invasive breast cancer, as well as matched controls from the same regions. Participants provide information through questionnaires on socio-demographic factors, health history, reproductive history, diet, physical activity, and environmental exposures. Biological samples such as blood and urine are also collected for analysis. Participants undergo standardized measurements including body weight and height, and molecular analyses are performed on tumor samples for cases. The study evaluates breast cancer subtypes and investigates the interplay of endogenous and exogenous factors contributing to the disease. This research will help identify modifiable risk factors for breast cancer prevention and support public health strategies in Latin American countries.