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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating brenipatide, compared to a placebo, for adults with Alcohol Use Disorder AUD and hazardous alcohol use. This phase 3 study aims to assess whether brenipatide affects drinking patterns and cravings over approximately 56 weeks. The study is sponsored by Eli Lilly and Company and involves participants motivated to reduce or stop alcohol consumption. Participants receive escalating doses of brenipatide or placebo via subcutaneous injection. The study includes two experimental periods with LY3537031 brenipatide and a placebo group, all administered by injection. Participants who cannot self-inject may have assistance from a trained support person. The treatment phase lasts up to 56 weeks. During the study, participants attend scheduled visits and complete questionnaires and diaries to track alcohol use and cravings. Researchers monitor changes in drinking patterns using the Timeline Followback Method and assess alcohol craving, health outcomes, body weight, and potential immune responses to the drug. Safety and pharmacokinetics are also evaluated throughout the study duration.

Age: 18Years - 75YearsAll GendersPhase 3
116 locations
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Actively Recruiting

Researchers are evaluating brenipatide for adults with moderate-to-severe Alcohol Use Disorder AUD to see how it compares to a placebo in effectiveness and safety. This Phase 3, multicenter, randomized, double-blind study is led by Eli Lilly and Company and aims to better understand treatment options for AUD. Participants in this study will be adults aged 18 to 75 years and will remain in the study for about 56 weeks. Participants will receive either brenipatide or a placebo through subcutaneous injections. The study has multiple treatment periods with escalating doses of brenipatide administered under medical supervision. Both the active drug and placebo are given by injection under the skin. The study uses a randomized design to assign participants to one of the study groups to compare outcomes. During the study, participants will be regularly assessed using questionnaires and diaries to track drinking patterns, alcohol cravings, and overall health. Researchers will also monitor changes in alcohol consumption, body weight, and health survey scores. Blood tests will check drug levels and the presence of antibodies against brenipatide. Safety and treatment effects will be observed for up to 56 weeks, with study visits scheduled throughout this period.

Age: 18Years - 75YearsAll GendersPhase 3
119 locations
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Actively Recruiting

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

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

Healthy Volunteer

This research aims to improve prediction of surgery success for patients with borderline resectable BR and locally advanced pancreatic ductal adenocarcinoma LAPDA undergoing neoadjuvant chemotherapy with FOLFIRINOX. The study focuses on combining diffusion-weighted magnetic resonance imaging DW-MRI, radiomics, and multi-omics profiling of blood samples to better identify which tumors can be surgically removed. This approach seeks to reduce unnecessary surgeries and improve treatment decisions due to challenges in current imaging and tumor marker accuracy. Participants will receive standard care including CT scans, CA 19-9 blood tests, and FOLFIRINOX chemotherapy. Additional DW-MRI scans and blood samples for genetic and molecular analysis will be collected before and after chemotherapy. If imaging shows no tumor progression and CA 19-9 levels decrease, surgical exploration may be pursued. Blood samples will also be taken during surgery and at the first follow-up visit to further evaluate tumor characteristics and treatment response. Throughout the study, participants will undergo imaging tests, blood draws, and questionnaires about health status and quality of life. Researchers will analyze data to predict surgical resectability, assess complications, and evaluate disease-free and overall survival over several years. This comprehensive monitoring aims to enhance personalized treatment plans while minimizing risks from unnecessary procedures.

Age: 18Years +All GendersPhase Not Applicable
8 locations
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Actively Recruiting

Researchers are collecting detailed data about suicide attempts and suicidal thoughts among people who come to healthcare services in Flanders. The study aims to understand how often these behaviors occur, the methods used, and how many receive proper follow-up care after a suicide attempt. This observational study uses a structured interview tool called the Guideline for Suicide Care and Evaluation LOES to gather comprehensive information. Participants undergo a two-part semi-structured interview administered by trained nurses, psychologists, or psychiatrists. The first part happens soon after admission to a healthcare facility and collects information on emotional state, mental health history, social support, hopelessness, and suicidal behavior. The second part provides a deeper evaluation of risk factors, treatment needs, motivations, planning, and coping strategies related to suicidality. Throughout the study, participants provide demographic, clinical, and psychological information through interviews. Researchers assess suicidal intent, planning, past behavior, substance use risk, and care needs. The study tracks treatment agreements and care pathways after assessment. Data collection occurs at the initial presentation, with no drug or medical treatment being tested. The total participation time varies depending on the individuals healthcare encounters and follow-up.

Age: 12Years +All Genders
33 locations