Oudenaarde

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in adults with Alcohol Use Disorder (AUD) and hazardous alcohol use. This Phase 3, multicenter, randomized, double-blind study aims to understand if brenipatide can help participants reduce or stop drinking. The study lasts approximately 56 weeks and focuses on changes in drinking patterns using the Timeline Followback Method (TLFB). Participants will receive either brenipatide (LY3537031) or a placebo, both administered by subcutaneous injection. Participants who cannot self-inject will have assistance from a trained support person. They are expected to store and use the blinded study drug as directed, maintain electronic and paper diaries, and complete questionnaires throughout the study. During the study, participants will have scheduled visits to monitor their progress, including assessments of drinking behavior and safety evaluations. Researchers will measure changes in alcohol use patterns up to 56 weeks. Participants must be motivated to reduce or stop drinking and be available for all study visits and procedures. Safety and adherence will be closely monitored throughout the trial.

Researchers are evaluating the safety and effectiveness of brenipatide compared to a placebo for adults with moderate-to-severe Alcohol Use Disorder (AUD). This phase 3 study aims to better understand if brenipatide can help reduce drinking in this population. Participants will be followed for about 56 weeks to gather comprehensive information. Participants will receive either brenipatide (LY3537031) or a placebo, both given by subcutaneous injection. The study involves a randomized, double-blind design, meaning neither the participants nor the researchers know who receives which treatment during the trial. This method helps provide reliable results about the effects and safety of brenipatide. During the study, participants will attend scheduled visits, self-inject the study drug, and complete electronic and paper diaries as well as questionnaires. Researchers will monitor changes in drinking patterns using the Timeline Followback Method for up to 56 weeks. Safety monitoring and regular assessments will be performed throughout the study to track participants' health and adherence.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

This research focuses on patients with borderline resectable (BR) and locally advanced pancreatic ductal adenocarcinoma (LAPDA) undergoing neoadjuvant chemotherapy with FOLFIRINOX. The study aims to assess whether combining diffusion-weighted magnetic resonance imaging (DW-MRI), radiomics, and multi-omics profiling from liquid biopsies can better predict successful surgical removal of the tumor. It addresses the challenge that standard CT imaging and tumor marker CA 19-9 lack accuracy in predicting if surgery will be successful, potentially leading to unnecessary operations or missed treatment opportunities. Participants will receive standard care, including chemotherapy and routine CT imaging, along with additional DW-MRI scans and blood samples for advanced genetic and molecular analysis before and after chemotherapy. The study includes one treatment arm and uses specialized imaging and genetic tests to analyze tumor response and progression. If no tumor progression is detected and tumor markers decrease, patients will be considered for surgery, during which further blood samples will be collected to study circulating tumor cells. Throughout the study, participants will undergo imaging, blood tests, and complete questionnaires about their health and quality of life. Researchers will measure outcomes such as surgical resectability, cancer recurrence, and survival over two years. The study aims to refine surgical decision-making, reducing unnecessary surgeries and improving patient outcomes while monitoring safety and treatment responses for up to five years.

Researchers are collecting data in Flanders on how often suicide attempts and suicidal thoughts occur across various healthcare settings like hospitals, psychiatric centers, crisis teams, and general practitioners. The study aims to understand the methods used in suicidal behavior and see how many people receive proper aftercare following a suicide attempt. It uses a detailed tool called the Guideline for Suicide Care and Evaluation (LOES) to gather comprehensive information about individuals with suicidal thoughts or behaviors. The study includes a two-part semi-structured interview conducted by trained healthcare professionals such as nurses, psychologists, and psychiatrists. The first part happens shortly after admission to a healthcare facility following a suicide attempt or suicidal thoughts and collects demographic data, history, social support, hopelessness levels, and current suicidal ideation. The second part explores psychological factors more deeply, including motives, personal and interpersonal problems, and current thoughts of self-harm or suicide. Participants undergo detailed assessments on the first day covering demographics, clinical details, suicidal behavior methods, emotional state, suicidal intent and planning, past self-harm, social support, mental health history, substance use, coping strategies, and care needs. The study tracks participants’ openness to help and care pathways to formulate well-supported risk assessments. This comprehensive evaluation helps understand suicidal processes and needs in the Flanders region.