There are about 13446 clinical studies being (or have been) conducted in Belgium. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The ONYX study is an Open-Label, Multicenter, Extension study that will evaluate the long-term safety and efficacy of Apitegromab in Patients with Type 2 and Type 3 SMA who have completed TOPAZ or SAPPHIRE.
Patients with long lasting colonoscopy are characterized by higher risk of incompletion. Endorail is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. Endorail works as a magnetic anchor that is able to guide the colonoscope and to straighten colon curves and loops. The aim of this study is to test the safety and efficacy of Endorail in ensuring that incompletion rate in long-lasting colonoscopies is lower than the 10% threshold. Outpatients of either sex aged between 22-75 years undergoing elective diagnostic or surveillance colonoscopy with caecal intubation time greater than 10 minutes will take part in the study. The primary efficacy endpoint is the percentage minor or equal to 10% of incomplete long-lasting colonoscopies. The primary safety endpoints are the absence of device-related serious adverse events and the evaluation of the equality or reduction of the adverse events rates compared to diagnostic colonoscopies without Endorail.
The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.
The goal of this Delphi study is to identify the crucial steps and the errors in Chest Tube Insertion (CTI). These steps and errors will be used for the development of a new assessment tool based on international consensus.
This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP < 1.3). Maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.
This is a double-blind, randomized, multicenter, placebo-controlled, comparative phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 10, 20, or 40 mg Naronapride vs. placebo for the treatment of patients with Gastroparesis.
People with neurogenic detrusor overactivity have poor bladder control because of how their nerves to the bladder are wired. This can cause high pressure in the bladder. It can also cause the bladder to leak by accident (incontinence). In this study, the researchers are studying whether a medicine, mirabegron, can help young children with neurogenic detrusor overactivity. The children will be from 6 months to under 3 years old. Mirabegron has already been approved for adults with bladder problems. The main aim of this study is to learn if mirabegron increases the maximum bladder capacity (to prevent high pressure in the bladder) in young children after 24 weeks of treatment. Maximum bladder capacity is the maximum amount of urine that the bladder can hold before it releases urine or starts to leak. There will be 2 groups in the study. Young children who are not taking certain medicines for their condition will be in group A. Young children who are already taking certain medicines for this condition will be in group B. Children in group B will stop taking these medicines before taking mirabegron. Their treatment will be delayed by 2 weeks to allow the other medicines to be cleared from the body before treatment. Both groups (A and B) will take the same treatment and have the same checks throughout the study. Children will have their vital signs checked (blood pressure, heart rate and body temperature). They will also have an ECG to check their heart rhythm and give urine samples for laboratory tests. Other tests will include checking how the bladder fills and empties plus an ultrasound of the bladder area. The caregivers will be shown how to check their child's blood pressure. They will be given an electronic diary to record the blood pressure, as well as any other medicines taken. They will do this every day for 7 days before each visit. Mirabegron will be stirred into water, making it easier for children to drink. Children will drink mirabegron once a day for up to 52 weeks. They will start on a low dose, adjusted for their weight. If children are taking other medicines for this condition, they will wait an extra 2 weeks before starting mirabegron. At weeks 2, 4 and 8, the dose may be increased once to a higher dose if the study doctor thinks the child will benefit from the higher dose. The children and their caregivers will visit the clinic at 2, 4, 8, 12, 24, 52, and 54 weeks. There will be fewer clinic visits if a child stays on the lower dose of mirabegron. In this case, the clinic will phone the caregiver instead to check the information in the diary. During each visit, the children will have their vital signs checked and have an ECG. The caregiver will be asked if their child has had any medical problems. At some visits, the children will give urine and blood samples for laboratory tests. Other tests will include checking how the bladder fills and empties. 36 weeks after treatment starts, the clinic will phone the caregiver to ask if their child has had any medical problems, and will check the information in the diary. The children and their caregivers will visit the clinic 52 weeks after treatment starts. The caregiver will be asked if their child has had any medical problems. The children will have a physical exam and have their vital signs checked. Also, they will have an ECG and have urine and blood samples taken for laboratory tests. Other tests will include an ultrasound of the bladder area. There will be a final clinic visit at 54 weeks. The caregiver will be asked if their child has had any medical problems. The children will have a physical exam and will have their vital signs checked. They will also have an ECG. The caregiver will be asked to complete a survey on their child's experience with taking mirabegron. They will do this at 4, 24 and 52 weeks after their child starts treatment. Finally, the clinic will phone the caregiver 30 days after the last dose of mirabegron to check if there were any further medical problems. No other visits are planned during this study.
Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by - demonstrating clinical safety - evaluating performance based on sensing and pacing assessment - collecting additional data of interest to assess other aspects such as the handling and usability
The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo controlled period, followed by a 42-week extension period.