Herentals

Researchers are studying an investigational drug called linvoseltamab in adults who have a moderate risk of developing multiple myeloma. This group includes patients with precancerous conditions known as High-Risk Monoclonal Gammopathy of Undetermined Significance HR-MGUS and Non-High-Risk Smoldering Multiple Myeloma NHR-SMM. The main goal is to understand how well linvoseltamab can eliminate abnormal plasma cells and laboratory signs associated with these conditions. Participants will receive linvoseltamab following a step-up dosing regimen to assess safety and tolerability before moving to one of four full dosing regimens. The study is divided into a safety run-in phase and an expansion phase where participants are assigned to different dose groups without randomization. Linvoseltamab is given according to the study protocol, with dosing schedules designed to monitor effects and side effects. During the study, participants will be closely monitored through regular safety observations over 35 days and longer-term assessments up to 5.5 years. Researchers will track adverse events, treatment responses including complete response rates, laboratory results, and the presence of antibodies against the drug. Blood levels of linvoseltamab are measured up to 9 months. This comprehensive monitoring will help understand the drugs impact and safety over time.

Researchers are evaluating an experimental drug called odronextamab combined with chemotherapy in adults with Diffuse Large B-cell Lymphoma DLBCL, including those who have not been treated before as well as those with relapsed or refractory disease. The study aims to assess the safety, tolerability, and dosing schedule of odronextamab with chemotherapy, and to compare its effectiveness against the current standard treatment of rituximab combined with chemotherapy. Additional goals include understanding side effects, drug levels in the blood, immune responses to the drug, and impact on quality of life and daily activities. The study consists of three parts Part 1A involves dose escalation to find a safe dose, Part 1B explores two dosing regimens of odronextamab combined with chemotherapy, and Part 2 randomly assigns participants to receive either odronextamab plus chemotherapy Odro-CHOP or rituximab plus chemotherapy R-CHOP. Odronextamab and rituximab are given by intravenous infusion, with chemotherapy drugs including cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone administered as part of the treatment regimen. Participants will be closely monitored throughout the study for side effects, disease progression, and response to treatment. Assessments include measuring dose limiting toxicities, treatment-emergent adverse events, progression free survival, quality of life questionnaires, and blood tests for drug levels and antibodies. The study follows participants for up to 5 years to track long-term outcomes and safety, with regular visits and evaluations scheduled during and after treatment.

Researchers are studying an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. The trial is a Phase 3, open-label, randomized study comparing odronextamab to rituximab combined with different chemotherapy regimens, which represent the current standard treatment. The study aims to evaluate the safety, tolerability, and how well odronextamab works compared to standard care, including side effects, drug levels in the blood, antibody development against the drug, and quality of life impacts. The study has two parts Part 1 is a non-randomized safety run-in where all participants receive odronextamab alone to assess safety and tolerability. In Part 2, participants are randomly assigned to one of two groups one receiving odronextamab followed by maintenance therapy with odronextamab, and the other receiving rituximab combined with chemotherapy followed by rituximab maintenance. Chemotherapy regimens include CHOP, CVP, or bendamustine, administered as per protocol. Participants will be monitored regularly for treatment side effects, drug concentrations, and immune responses for up to 5 years. Researchers will assess responses using imaging and other tests at multiple time points, including complete response at 30 months and progression-free survival up to 5 years. Quality of life and physical function will also be evaluated using standardized questionnaires. Safety and adverse events will be tracked for up to 2 years, ensuring comprehensive follow-up throughout the study duration.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Researchers are evaluating the potential benefits of an oral formulation based on Cetylated Fatty Acids in helping heal fractures of long bones in the lower limbs, such as the femur or tibia. This clinical trial is randomized, double-blind, and placebo-controlled, aiming to support the early stage of bone healing after surgical stabilization of these fractures. The study is sponsored by Pharmanutra S.p.a. and involves adults aged 18 to 85 years. Participants will take two sachets of the assigned oral product daily for at least 12 weeks, starting from the baseline visit after all initial procedures are completed. There are two study groups one receiving the CFA-based food supplement and the other receiving a placebo gel matched in color and flavor. The intake continues until the morning of the last study visit Visit 3. Throughout the study, participants will undergo standard imaging tests like radiography and ultrasound to assess bone healing. Blood samples will be collected, and participants will complete quality of life questionnaires such as the Short Form-36. Researchers will measure callus formation using the modified Radiographic Union Score for Tibia mRUST and monitor pain levels, complications, medication use, and participant satisfaction at 4, 6, and 12 weeks after fracture stabilization. Adherence to the supplement and any adverse events will also be tracked during the trial.

Researchers are evaluating a structured, evidence-based rehabilitation pathway called the R pathway for patients undergoing lumbar surgery due to radicular pain. This multicenter cluster randomized controlled trial compares the R pathway against usual care to see if it can reduce the time it takes for patients to return to work after surgery. The study focuses on patients aged 18 to 65 scheduled for lumbar spinal surgery with radicular pain lasting at least six weeks. The R rehabilitation pathway involves coordinated care guided by a case manager, starting before surgery and continuing up to one year afterward. It includes prehabilitation, perioperative rehabilitation, and postoperative rehabilitation, aiming to reduce fear by minimizing unnecessary activity restrictions, eliminating bracing, and actively encouraging return to work. Hospitals are randomized to either implement the R pathway or continue with their usual variable rehabilitation care, which may include no rehabilitation or various types of therapy. Participants will be monitored from surgery through 15 months postoperatively. Researchers will assess the time to return to work as the primary outcome. Secondary outcomes include disability, percentage of patients returned to work, functional status, back and leg pain, health-related quality of life, work productivity, analgesic use, kinesiophobia, and pain catastrophizing at multiple time points. The study requires written consent and involves follow-up assessments to evaluate recovery and work reintegration.

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.