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Found 5 Actively Recruiting clinical trials

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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

Atrial fibrillation AF is a major cause of heart-related illness and death, especially among Asian patients who face higher risks of serious bleeding such as brain hemorrhage compared to non-Asians. This research, called the COhort of antithrOmbotic use and cLinical outcomes in patients with Atrial Fibrillation COOL-AF Phase 2, aims to study how antithrombotic medication use changes over time and how these changes affect health outcomes in people with AF. The study is observational and conducted across multiple centers in Thailand. Participants in this study have known or newly diagnosed non-valvular AF and are followed without any intervention or treatment assigned by the study. The study plans to enroll about 3680 patients over two years from 33 centers. Participants will be monitored every 6 months for up to 3 years to observe patterns of medication use, particularly warfarin and non-vitamin K antagonist oral anticoagulants NOACs, and clinical events including stroke, systemic embolism, bleeding, heart attacks, and heart failure. Throughout the study, patients will have regular check-ins every six months to track their medication usage and health status. Researchers will collect data on important outcomes such as rates of stroke, bleeding events, and quality of life. The studys primary focus is on long-term safety and effectiveness of antithrombotic treatments in this population. The total participation duration can be up to 3 years, ensuring thorough observation of clinical outcomes and treatment patterns.

Age: 18Years - 100YearsAll Genders
33 locations
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Actively Recruiting

Researchers are evaluating whether starting norepinephrine early with rapid dose adjustments can improve outcomes in adults with septic shock. The trial focuses on reducing 28-day mortality, speeding up shock control, and minimizing fluid needs without raising treatment-related side effects. It compares early norepinephrine use to standard treatment with delayed norepinephrine as needed. Participants will receive either norepinephrine or a placebo infusion within one hour of septic shock diagnosis. The norepinephrine starts at 0.05 mcgkgmin and is adjusted every 15 minutes based on blood pressure, with a maximum dose of 0.15 mcgkgmin. Both groups have rescue norepinephrine available if necessary. Limb ischemia and vital signs are closely monitored for 24 hours during the infusion. Throughout the study, participants receive standard sepsis care including fluids, antibiotics, and organ support. Researchers will monitor clinical outcomes and safety for up to 28 days. Key measures include survival at 28 days, time to shock control, and durations of intensive care, hospital stay, mechanical ventilation, and vasopressor therapy. Safety assessments focus on adverse events like cardiac arrhythmias and pulmonary edema.

Age: 18Years +All GendersPhase Not Applicable
6 locations
P

Actively Recruiting

Researchers are evaluating the safety and effectiveness of combining osimertinib tablets with Datopotamab Deruxtecan intravenous infusion compared to using osimertinib tablets alone as a first treatment for participants with locally advanced or metastatic non-small cell lung cancer NSCLC that has specific EGFR mutations Ex19del andor L858R. This global Phase III, open-label, randomized study targets participants who have not yet received treatment for advanced disease and aims to assess how well this combination works and how safe it is over an estimated 8-year event-driven study duration. Participants will be randomly assigned to one of two groups one will receive osimertinib 80 mg orally once daily combined with Datopotamab Deruxtecan 6 mgkg by intravenous infusion every three weeks, while the other will receive osimertinib 80 mg orally once daily alone. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. During treatment, visits occur every three weeks. For those receiving osimertinib alone or who stop Datopotamab Deruxtecan but remain on osimertinib, visits become every six weeks from cycle 7 to cycle 17 and then every twelve weeks until disease progression or stopping treatment. Participants will undergo regular assessments including scans and tests to monitor disease status and treatment effects as per the study schedule. Researchers will measure progression-free survival, overall survival, response rates, and other outcomes related to the cancer and treatment effects. Safety and drug levels will also be monitored. Participants can expect frequent visits and evaluations throughout the study, lasting up to about eight years or until specific stopping criteria are met.

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

Researchers are evaluating the safety and effectiveness of volrustomig in women with high-risk locally advanced cervical cancer FIGO 2018 stage IIIA to IVA who have not experienced disease progression following platinum-based concurrent chemoradiation therapy CCRT. This phase III, randomized, double-blind, placebo-controlled global study aims to compare volrustomig with a placebo to gain insights into treatment outcomes for this patient group. Participants will be randomly assigned in a 11 ratio to receive either volrustomig or a placebo by intravenous infusion. The study compares these two groups over time to assess progression-free survival and other important outcomes. Treatment is given after patients complete platinum-based CCRT and have no disease progression. The study includes long-term follow-up for up to approximately seven years to monitor various measures such as survival, response rates, and side effects. Throughout the study, participants will undergo regular assessments including tumor sample analysis, physical exams, and evaluations of organ function and overall health. Researchers will track progression-free survival, overall survival, response rates, and patient-reported symptoms and quality of life. Safety and adverse events related to volrustomig will also be monitored closely during the study and follow-up period. Participation involves a long-term commitment with ongoing monitoring for up to seven years.

Age: 15Years +FEMALEPhase 3
205 locations