Sint Truiden

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating the effectiveness, safety, and costs of the NAVIO174 system compared to the conventional intramedullary alignment guide in total knee replacement surgery for people with knee osteoarthritis. They hypothesize that using the NAVIO system in total knee arthroplasty (TKA) is at least as efficient and safe as the traditional method. This is a prospective, randomized, controlled, single-blind study focused on clinical outcomes and alignment. Participants will undergo total knee arthroplasty using either the NAVIO system or the conventional alignment guide. The first 52 participants will receive CT scans of the hip, knee, and ankle before and after surgery to assess alignment. The study compares planned and achieved alignment, mechanical axis, and prosthesis positioning between the two methods. Various outcomes including operation time, blood loss, hospital stay length, and complication rates will also be evaluated. During the study, researchers will measure pain using visual analogue scale scores at multiple time points from before surgery up to 10 years after. They will assess knee function through scores like the American Knee Society Score, Oxford Knee Score, Lower Extremities Activity scale, and the WOMAC index. Additional monitoring includes X-rays to evaluate prosthesis wear and alignment over time. Safety outcomes such as infections, thrombo-embolic events, wound problems, and prosthesis loosening will be tracked through the study duration, which averages 10 years.

Pre-eclampsia (PE) is a pregnancy condition marked by high blood pressure (greater than 140/90 mm Hg) and significant protein in the urine after 20 weeks of pregnancy. It affects about 5-8% of pregnant women worldwide and can lead to serious complications for both the mother and child if left untreated. Researchers are investigating cardiovascular changes during pregnancy to improve early detection and treatment of PE, focusing on women at high risk. This study involves pregnant women starting at 10 weeks of pregnancy. At 10 and 20 weeks, participants will have several measurements including NICCOMO (an impedance cardiograph), Maternal Venous Doppler Echography, Maltron bio-electronic impedance analysis, blood pressure, activity tracking, and weight monitoring. If abnormal results appear at 20 or 30 weeks, participants will join a remote monitoring program using devices such as a wireless blood pressure monitor (twice daily), an activity tracker (day and night), and a smart body analyzer for weight (once daily). Participants will be monitored through repeated assessments at 10, 20, and potentially 30 weeks of pregnancy. These include heart and vein imaging, blood pressure checks, activity tracking, and weight measurements. The study aims to track cardiovascular health and detect early signs of PE. Up to 2000 pregnant women from eight hospitals will take part, with ongoing remote monitoring for those showing abnormal test results to support intensive follow-up and care.

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.