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Found 6 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Age: 18Years +All GendersPhase 3
769 locations
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Actively Recruiting

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.

Age: 18Years +All GendersPhase 3
1365 locations
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Actively Recruiting

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Age: 50Years +All GendersPhase 3
567 locations
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Actively Recruiting

This trial investigates the safety and efficacy of Pumitamig combined with chemotherapy compared to Nivolumab combined with chemotherapy in adults with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. Participants must have specific tumor characteristics including PD-L1 and HER2 status, and measurable disease according to established criteria. The study is a blinded, randomized phase 23 trial sponsored by Bristol-Myers Squibb. Participants will receive either Pumitamig or Nivolumab alongside chemotherapy regimens such as Folfox or Capox, with dosing given on specified days. The study uses a parallel design with multiple experimental arms to evaluate these combinations. Treatments and assessments will continue over several months following randomization. During the study, participants will undergo regular evaluations including tumor response assessments by RECIST criteria, survival monitoring, and safety checks. Researchers will measure objective response rates, progression-free survival, and overall survival up to several years after treatment starts. The trial includes long-term follow-up to monitor outcomes and safety over time, with the primary outcome tracked for up to two years after the last participant is randomized.

Age: 18Years +All GendersPhase 2Phase 3
161 locations
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Actively Recruiting

Researchers are investigating how geographic altitude and the availability of critical care resources affect health outcomes in children with pediatric acute respiratory distress syndrome PARDS. This multicenter observational study collects data on patient demographics, physiology, and hospital structures from pediatric intensive care units PICUs located at various altitudes worldwide. The goal is to identify differences in PARDS management and develop recommendations tailored to diverse healthcare settings. Participants are grouped based on the altitude of the PICU where they receive care low altitude 0-1500 meters, intermediate altitude 1501-2500 meters, high altitude 2501-3500 meters, and very high altitude above 3500 meters. No treatments are given as part of the study instead, the focus is on observing and analyzing existing care practices and patient outcomes across these different altitude groups. Throughout the study, researchers will collect clinical, physiological, and institutional data from children admitted to PICUs requiring mechanical ventilation and diagnosed with PARDS. They will measure key outcomes such as in-hospital mortality up to 90 days, new health issues at discharge, ventilator-free days, and ICU-free days within 28 days. The study aims to provide evidence to improve critical care practices for children with PARDS globally. Participation may last until hospital discharge or up to 90 days after PICU admission.

Age: 1Month - 18YearsAll Genders
20 locations
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Actively Recruiting

Healthy Volunteer

Breast cancer is a major health concern in Latin America, where it is the most common cancer among women. Women in this region tend to develop breast cancer at a younger age and are often diagnosed at a later stage compared to women in Western countries. Mortality rates have risen rapidly over the past twenty years, making breast cancer the leading cause of cancer death among Latin American women. There is limited knowledge about specific risk factors and tumor characteristics for premenopausal breast cancer in this population, which impacts treatment and survival outcomes. The PRECAMA study is an international, population-based case-control study conducted by the International Agency for Research on Cancer across Mexico, Costa Rica, Colombia, and Chile. It focuses on women aged 20 to 45 years, including both those diagnosed with primary invasive breast cancer and matched controls without cancer living in the same cities. Participants provide detailed questionnaire data on health, reproductive history, lifestyle factors, and diet. Biological samples such as blood and urine are collected, and tumor samples from cases undergo molecular and pathological analyses to characterize breast cancer subtypes. Participants complete standardized interviews and questionnaires, and physical measurements like body weight and height are taken. Researchers collect detailed lifestyle and environmental exposure data alongside biological specimens for biomarker studies. The main outcome is the presence of breast cancer at recruitment. This comprehensive approach aims to improve understanding of risk factors and breast cancer subtypes in young Latin American women to support prevention and public health strategies. The study is ongoing, with participant involvement lasting from recruitment through data collection and analysis phases.

Age: 20Years - 45YearsFEMALE
13 locations