Herentals

Researchers are evaluating an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. This Phase 3 study aims to assess the safety, tolerability, and effectiveness of odronextamab alone and compared to the current standard treatments, including rituximab combined with different types of chemotherapy. The study also examines side effects, drug levels in the blood, antibody responses against odronextamab, and the impact on quality of life and daily activities. The study consists of two parts: Part 1 is non-randomized and focuses on the safety and tolerability of odronextamab given alone. Part 2 is randomized and controlled, comparing odronextamab to rituximab combined with chemotherapy regimens such as CHOP, CVP, or Bendamustine-containing therapies. All treatments are administered according to the study protocol. Participants receive these treatments to evaluate how well odronextamab works versus standard care. Participants will undergo various assessments including imaging scans like CT or MRI to measure disease, blood tests to monitor bone marrow and liver function, and evaluations of side effects up to two years. Researchers will track dose-limiting toxicities within 35 days and assess complete response rates over 30 months. Safety and side effects will be monitored continuously, and quality of life will also be evaluated. The total length of participation depends on treatment and follow-up schedules defined in the protocol.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

Researchers are investigating whether an oral supplement containing Cetylated Fatty Acids can help improve healing in long bone fractures of the lower limbs, such as the femur and tibia. This study compares the effects of this dietary supplement against a placebo over a 12-week period following surgical stabilization of the fracture. The trial focuses on the early stages of bone healing and aims to assess potential benefits in recovery. Participants receive either the CFA-based oral gel supplement or a placebo gel that looks and tastes similar. The supplement is taken daily for 12 weeks after surgery, during which participants are allowed to bear weight on the affected limb as tolerated. The study uses standard imaging methods, including X-rays and ultrasound, to monitor bone healing progress. During the study, participants undergo radiographic evaluations to measure bone healing at 6 weeks using a specialized scoring system. Blood samples are collected, and participants complete quality of life questionnaires to assess overall well-being. The study includes regular follow-ups to monitor safety and treatment adherence, with total participation lasting at least 12 weeks.

Researchers are evaluating a structured rehabilitation pathway called the R³ pathway for patients undergoing lumbar surgery due to radicular pain, such as lumbar radiculopathy and radicular low back pain. This multicenter cluster randomized controlled trial compares the R³ pathway to usual care, aiming to see if this approach can reduce the time it takes for patients to return to work after surgery. The study focuses on a person-centered rehabilitation that supports patients through pre-, peri-, and postoperative phases while promoting early activity and work resumption. The R³ rehabilitation pathway involves a case manager guiding patients from before surgery up to one year after surgery. It includes prehabilitation, perioperative care, and postoperative rehabilitation emphasizing minimal activity restrictions, eliminating the use of braces, and active encouragement to resume work early. Hospitals participating in the trial are randomly assigned to either implement this pathway or continue with their usual care methods. The pathway specifically targets fear reduction and structured support to improve recovery. Participants will be monitored from surgery through 15 months postoperatively, with the main outcome being the time it takes to return to work. This involves regular assessments throughout the year following surgery to evaluate recovery progress and work reintegration. The study includes ongoing follow-up to understand the impact of the rehabilitation pathway compared to standard care on patient outcomes related to work and recovery.

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.