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.
Background: Each Belgian winter season is characterized by a wave of influenza like and respiratory symptoms. Especially, the elderly people are more vulnerable to be infected by influenza, but also RSV. The recent COVID-19 pandemic and eventually a next wave, will increase the prevalence of influenza like and respiratory symptoms. Method: A multicentre non-commercial cohort study will be conducted in nursing home staff and residents during the Winter season 2020-2021. Objectives: Primary objective is the difference in incidence of influenza like and respiratory symptoms between cases (cases have evidence of past infection with SARS-CoV-2, referred to as Covid +) and controls (controls have no evidence of previous infection and are referred to as Covid -). The primary outcome analysis as well as the secondary outcome analyses will use two strata: nursing home staff and nursing home residents. The secondary objectives are the difference in incidence of COVID-19, influenza, RSV infections confirmed by PCR between cases and controls, to define a correlate of protection in the covid + group against re-infection with SARS-CoV-2 based on the study of the pre-existing antibody profile (antigen specificity, antibody type and antibody level) at the time of re-exposure. A multiplex assay will be used to assess the antibody profile. Finally, to study the COVID-19 disease severity (7 point WHO ordinal scale, this includes a.o. hospitalisation, mechanical ventilation need and ICU admission, mortality) based on the presence/absence of pre-existing antibodies and the pre-existing antibody profile. For other respiratory infections we will study the need for hospitalization and mortality.
Understanding the impact of food/nutrients on body fluid metabolism is important for improving diagnosis and treatment of nocturia, polyuria in relation to lifestyle interventions. This study on "Food and Salt Handling in Diuresis" examines the role of certain food and nutrients in diuresis. The study design is to investigate the possible acute effects and mechanisms of selected food (which are known to be diuretic) and nutrients (e.g. salt) in diuresis in healthy individuals. The study will provide insights into the management of nocturia, nocturnal polyuria or oedema which are common clinical sign in a wide range of disorders as cardiovascular, renal and metabolic disorders. During the study the volunteers will be asked to ingest a certain dosage of a food/nutrient in capsules along with a defined amount of water (500 ml). 2 Blood and 3 urine samples will be collected at different time points to measure the urine output and urine composition derived by the ingestion of the particular food item. Renal Function Profiling is used as an easy and cheap tool to understand the mechanism of action behind the observed effect in diuresis. Renal function profiles distinguish the osmotic form water diuresis from a change in filtration. Bio-electrical impedance analysis (BIA) is also used to evaluate oedema and fluid volumes in body tissues. BIA is a non-invasive technique based on Ohm's law whereby the resistance of a tissue against an electric current is inversely proportional to the water content and directly proportional to the length of the tissue. For the BIA measurement, a device is used in which 8 tactile electrodes are placed: 2 in contact with the thumb and middle finger of each hand, and 2 in contact with the inside and outside of each foot. Before the start of the measurements, the length and body weight are measured. The resistance of the arms, torso and legs is measured at different frequencies.
The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).
This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE). Women with symptomatic prolapse (grade II-IV) who seek for a conservative treatment, with no history of previous POP-surgery will be randomised to either the laser-arm or the PFE-arm. There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators. The primary objective is to evaluate the effects of VEL treatment for reduction of prolapse symptoms and as a secondary outcome objective measurements. These endpoints are in line with the recommendations by Durnea et al., as being the most relevant and patient centered outcomes. The second goals are to register adverse events and to determine for how long the effects of laser are sustained, with a maximum of two years. To do so, the investigators will measure long term satisfaction with, and the longevity of the effect (measured by the need for repeat or alternative therapy) of laser therapy. Duration of follow-up per patient: max 27 months
In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug. Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
The effects of dietary fiber on psychobiological processes are examined in a sample of healthy volunteers.
Cerebral palsy (CP) results from damage to the developing brain of the fetus or infant. These non-progressive lesions cause a set of permanent movement and posture disorders, responsible for activity limitations. These disorders are often accompanied by sensory, perceptual, cognitive impairments, communication and behavioral disorders, and sometimes epilepsy and/or secondary musculoskeletal problems. It is the leading cause of motor disability in childhood and affects 200 newborns per year in Belgium. Cerebral palsy affects two to three people in every 1,000 of the world's population. The prevalence, incidence and most common causes have varied over time due to significant changes in obstetric care and pediatric care. In 75% of all cases of cerebral palsy, the lesions occurred before childbirth. The population of adults diagnosed with cerebral palsy is increasing as the survival rate of children born with a disability increases. This population requires adapted and expert care services for the continuous monitoring and management of their condition. In addition, the development of additional health problems in adulthood increases the need for permanent access to care structures. Adults with CP have a higher rate of chronic health problems (ischemic heart disease) and a deterioration in their functional status. They would also have difficulty having a social and professional life which negatively impacts their quality of life. A large number of adults with CP cannot access appropriate care or medico-social structures. This results in a significant involvement of caregivers (family environment or close entourage). The role of caregiver is at the origin of a significant physical and psychological burden, whether for underage patients or adult patients. The study of this burden is well known in certain neurological pathologies (head trauma, multiple sclerosis, brain tumors). In the field of cerebral palsy, a study showed that the primary caregivers of children with CP had higher levels of psychological and physical disorders than the control group studied (caregivers of healthy children). Currently, there are very few studies assessing the burden of caregivers of adults with cerebral palsy. The objective of this study is to analyze, through various specific questionnaires, the quality of life and the presence of depressive symptoms linked to the burden of caregivers of adults and children with cerebral palsy, taking into account socio-economic and environmental data.
The aim of this study is to investigate the effect of manipulating the optic flow speed in the virtual environment on the gait pattern during virtual reality (VR) - enhanced treadmill walking in people post-stroke. Furthermore, the study will also investigate if the level of immersion has an effect on the rehabilitation outcomes by manipulating the optic flow speed in two different VR devices: the semi-immersive GRAIL system and the fully-immersive 'Oculus Rift S' HMD. To properly understand the results of the people with a stroke, we will also investigate the effect of manipulating the optic flow speed and the level of immersion on the gait pattern in healthy people. That way, we can investigate whether virtual reality has a different influence on the gait pattern of people with a stroke than in healthy people.
Multi-centric open-label randomized controlled trial (RCT) with 11 Belgian centers and one Dutch center in pregnant women with type 1 diabetes to assess safety, efficacy, feasibility and cost-effectiveness of 780 MiniMed Medtronic hybrid closed-loop insulin system (intervention group) compared to standard of care therapy (control group).
The aim of this pilot was to study how body water behaves between the different internal water pools of the human body, what the role and influence of the interstitium is and what the effect is of body position on the distribution and allocation of BW between different body parts (trunk, legs, arms). To study this, 2 techniques that have not been used before in urological research were tested on their usefulness: - The first technique is a recent BIA device, which distinguishes itself from earlier devices by measuring impedance at different electrical currencies in different body parts (arm/limb/trunk). This technique made it possible to observe the influence of body position on the distribution of BW in these body compartments. Rationale for this research question is mainly the link between NP and edema that was found in earlier research and the fact that body position seemed to have an impact on the size of edema. For this reason, it can be suggested that body position and thus edema will have an impact on whether or not NP occurs. - The second technique uses deuterium as a biological marker. With this technique the distribution, storage, allocation and excretion of BW was examined among the urological most relevant water pools (blood, urine and interstitium).