Gent

Researchers are evaluating whether the introduction of dedicated hospital-based HIV teams can improve HIV testing rates among patients with HIV indicator conditions across ten European countries. This real-world, multicenter, stepped-wedge cluster randomized effectiveness-implementation trial spans four years and involves hospitals in the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. The study aims to address the current gap in HIV testing and improve early diagnosis by comparing testing rates before and after the implementation of HIV teams. The intervention involves creating local HIV teams led by HIV specialists, supported by nurses and data collectors. These teams focus on auditing and providing feedback to healthcare professionals to encourage HIV testing when indicated, reducing stigma, educating staff on HIV prevention and care, and improving linkage to local prevention services. The HIV teams use electronic health records to identify patients with HIV indicator conditions and integrate their activities into routine hospital care. Participants' data are collected retrospectively from routine care and prospectively at the healthcare professional level. Researchers measure changes in HIV testing rates, new HIV diagnoses, and variations across countries and specialties. They also assess the HIV diagnosis and care cascade, healthcare professionals' knowledge and stigma levels, and implementation outcomes such as resource use and cost-effectiveness. Monitoring includes feedback loops and evaluation of barriers and facilitators to implementation, aiming to improve HIV testing and care sustainability in hospitals.

Researchers are investigating the effectiveness and cost-effectiveness of Attachment Based Family Therapy (ABFT) compared to Treatment As Usual (TAU) for young adults aged 18 to 25 who experience frequent suicidal thoughts. This mental health issue is a serious concern worldwide, especially in Belgium and the Netherlands, where suicide is a leading cause of death among young adults. Current treatments have limited success, and this study aims to see if ABFT, which focuses on improving family relationships, can better reduce suicidal thoughts and behaviors and support young adults and their families. The study is a randomized controlled trial involving 138 participants from multiple sites including hospitals, mental health centers, and private practices in Belgium and the Netherlands. Participants are assigned to either ABFT plus TAU or TAU alone. ABFT is a manualized therapy that strengthens parent-child attachment to create a secure support base, delivered in weekly sessions over about 16 weeks. TAU consists of existing standard treatments such as antidepressants, cognitive behavioral therapy, or dialectical behavior therapy, with limited family therapy. Parents or caregivers may be involved in both treatments. Participants will be assessed at baseline, immediately after treatment, and at 3, 6, and 12 months follow-up to measure changes in suicidality using questionnaires and therapist reports. Researchers will also evaluate cost-effectiveness, family functioning, depressive symptoms, and treatment adherence. The study aims to improve clinical guidelines and policymaking to enhance care for suicidal young adults and their families over a one-year period.

Researchers are studying how daily movement behaviors like sleep, sitting time, and physical activity throughout a 24-hour day affect people with type 2 diabetes mellitus (T2DM). This study aims to track these behaviors over two years, comparing T2DM patients with healthy adults. It also explores how personal and environmental factors, along with heart and metabolic health markers, relate to these movement patterns. The goal is to gain insights that could help design future interventions for managing T2DM. The study uses a longitudinal observational design without any treatment or intervention. Researchers will collect data from participants at three time points: baseline, after one year, and after two years. Participants include adults with T2DM and a control group of healthy adults. No specific treatments will be given; instead, the focus is on observing and analyzing participants' natural movement behaviors. Participants will be monitored through assessments of their 24-hour movement compositions at each time point. Researchers will gather data on sleep, sedentary behavior, physical activities of different intensities, as well as personal and environmental factors. The main outcome is to observe changes in these behaviors over time and their associations with health markers. The total study duration for each participant is two years, with follow-ups after one year and two years to track progress and changes.

Only about 25% of Belgian adults aged 25 to 50 with type 1 diabetes mellitus (T1DM) achieve good blood sugar control, partly due to the daily challenges of managing the condition. Maintaining tight glucose control is essential to prevent serious health complications. While continuous glucose monitors help, managing daily glucose levels remains difficult. Alongside monitoring blood sugar, a healthy lifestyle that includes enough physical activity, limited sedentary time, and good sleep is important for controlling glucose. This research aims to explore how daily 24-hour movement behaviors relate to glucose control and heart health in adults with T1DM. The study involves 150 adults with T1DM who will wear an Actigraph accelerometer for 14 consecutive days to track movement behaviors throughout the day. Participants will continue using their own continuous glucose monitors to measure daily glucose control. Additional information will be collected through questionnaires, diaries, and physical measurements such as blood pressure, weight, height, advanced glycation endproducts, and waist and hip circumference during a single visit at either the University Hospital of Ghent or the University Hospital of Antwerp. This cross-sectional observational approach focuses on understanding the link between daily behaviors and glucose control. Participants will be monitored for about one year on average, with primary outcomes including 24-hour movement behaviors, glucose variability (coefficient of variation), and time spent within target glucose ranges. The data collected will help researchers understand how day-to-day activity patterns affect glucose management and cardiometabolic health. This study's results aim to guide future interventions that promote healthier 24-hour movement habits to improve glucose control in adults with T1DM.

Researchers are evaluating the effects of switching from a classic three-drug regimen (3DR) to a dual therapy (2DR) in adults living with HIV-1 infection. This phase 4 study aims to monitor virological and immunological markers to understand if the switch impacts the severity of HIV disease, viral reservoir size, immune system function, and the presence of non-AIDS related health complications. The study also seeks to assess whether the 2DR regimen is a safe long-term alternative to 3DR by ensuring it does not increase the HIV reservoir or immune system exhaustion. Participants will receive either the dual therapy DTG/3TC (Dovato) or the triple therapy BIC/TAF/FTC (Biktarvy) and will be monitored over 48 weeks to compare the amount of intact replication-competent HIV-1 sequences in blood CD4 cells. Secondary assessments include measuring inflammation and immune activation markers, metabolic health parameters such as weight, BMI, waist circumference, insulin resistance, body composition via DXA scans, and liver health using FibroScans. Patient questionnaires will also evaluate the impact of switching treatments, with extended monitoring planned up to 144 weeks. Throughout the study, participants will undergo scheduled visits for blood sample collection to analyze viral and immune markers, metabolic assessments, and imaging procedures. Researchers will track adherence, safety, and virological outcomes to determine the non-inferiority of the 2DR regimen compared to 3DR. The primary outcome measure focuses on the difference in intact replication-competent HIV-1 sequences in CD4 cells at 48 weeks, with additional long-term evaluations planned to ensure comprehensive assessment of treatment effects.

It has been demonstrated that urethroplasty should be considered the gold standard treatment for urethral stricture disease as it yields higher long-term success rates than endoscopic treatment options such as direct vision internal urethrotomy (DVIU) or dilation. Many data about these procedures exist, although most of the publications about urethroplasty are retrospective and involve a tremendous risk of bias. To address these issues, this study is designed to prospectively gain evidence about this matter in all patient subgroups facing a potential treatment with urethroplasty: native men, native women, transmen, transwomen and children.

Researchers are evaluating the use of [18F]-MFBG PET scans to assess heart nerve function and compare its accuracy to [123I]-MIBG SPECT scans. The main goal is to see how well these methods can distinguish between Parkinson's disease (PD) and multiple system atrophy (MSA), and between dementia with Lewy bodies (DLB) and Alzheimer's disease (AD). This study is conducted at two centers and includes healthy volunteers and patients with confirmed diagnoses of PD, MSA-P, DLB, and AD. The study also investigates how well [18F]-MFBG PET detects changes in heart nerve uptake compared to healthy people and patients with other conditions, and whether it matches or exceeds the accuracy of the current standard imaging method. Participants will undergo several scans and tests, including dynamic cardiac [18F]-MFBG PET, [123I]-MIBG SPECT, and brain [18F]-PE2I PET scans. The [18F]-MFBG PET scan involves injecting a radioactive tracer and performing detailed imaging over periods of up to two hours, sometimes including whole-body scans. Healthy volunteers also participate in a dosimetry study to measure tracer distribution and safety. All scans use low-dose CT for imaging support, and blood samples are taken during the imaging sessions to monitor tracer levels. During the study, participants will have multiple hospital visits for screening, MRI brain scans, neurological assessments, and the PET and SPECT imaging procedures. Researchers will collect data on how well [18F]-MFBG PET matches or improves upon [123I]-MIBG SPECT for diagnosing these neurological disorders. They will also study the relationship between heart uptake changes and brain dopamine transporter changes, autonomic dysfunction, and regional heart differences. The total number of participants is 113, and the study will analyze diagnostic accuracy after completing scans for different patient groups over an estimated three-year period.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental. Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome. In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.