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.
Sleep-disordered breathing (SDB) describes a group of disorders in which partial or complete cessation of breathing occurs many times throughout the night, resulting in daytime sleepiness or fatigue that interferes with a person's ability to function and reduces quality of life. Transplantation has become an important treatment modality for end-stage organ failure. Transplant recipients are now living longer and, hence, develop chronic adverse medical conditions. Furthermore, transplantation is associated with weight gain. Despite the high prevalence of poor sleep and cardiovascular conditions among transplant patients, SDB is not well studied in these patients.
Adequate antifungal therapy is a critical determinant of survival in patients admitted to an Intensive Care Unit (ICU) with suspected or proven fungal infections. Critical illness can alter the way human body handles antifungal agents, i.e. how the drugs are distributed in the body and removed from the body. Consequently, these changes can increase the risk of inappropriate antifungal exposure that may lead to adverse consequence on patients' outcome. Developing an evidence-based antifungal dosing guideline is of global significance and should be considered a priority to improving clinical outcomes for patients receiving antifungal agents The aim of the SAFE-ICU Study is to develop optimised antibiotic dosing guidelines for ICU patients with life-threatening infections that account for patient characteristics. This will be achieved through completion of the following aims: i) Describe detailed demographic, clinical and plasma antibiotic concentration-time data in a large ICU patient cohort; ii) Perform a robust statistical analysis of the data collected in Aim 1 to develop an enhanced preliminary prediction algorithm for antifungal dosing. This is a multi-national study and will enrol ICU patients who are prescribed an antifungal agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin, micafungin or amphotericin B). A minimum of 12 patients per drug will be enrolled across at least 15 countries and up to 80 ICUs. Eligible patients are those admitted to the ICU, who are prescribed an antifungal agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin, micafungin or amphotericin B). Blood samples will be taken to measure drug concentration. Sampling will occur on two occasions, first during study days 1-3 and then a second time between days 4-7, each over an 8-24 hour period. Blood samples will be taken from a vascular access device already inserted for ICU patient care. Abdominal samples from abdominal indwelling drains already inserted peri operatively will also be collected on these two occasions in the subgroup of patients with intra-abdominal infection. Data on infection, various blood tests and patient specific data will be collected using a structured case report form (CRF). Patients will also be followed up 30 days after enrolment into the study to evaluate 30-day mortality. Collected samples will be frozen and stored locally and then shipped in large batches for processing at Burns Trauma and Critical Care Research Centre, The University of Queensland, Australia. Data analysis for development of antifungal dosing algorithms will also be undertaken at The University of Queensland, Australia.
The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).
In this prospective observational study, the investigators want to document pharmacokinetic/pharmacodynamic (PK/PD) target attainment of frequently used antimicrobials in an adult non critically ill surgery population (abdominal surgery, traumatology and septic orthopedic surgery). Furthermore, the investigators want to identify risk factors for not attaining predefined PK/PD targets. The antibiotics of interest are amoxicillin(-clavulanic acid), flucloxacillin, piperacillin-tazobactam, meropenem and clindamycin.
Validate the use of fetal urine peptidome-analysis and explore amniotic fluid markers for the stratification of fetuses with Posterior Urethral Valve for post-natal renal function.
The purpose of this study is to compare the effect of the autogenic drainage and the intrapulmonary percussive ventilation on the levying of the lung atelectasis, by means of the thoracic imaging (thoracic ultrasound and radiography), at the intubated or extubated child with the ventilatory support.
The AIM of this study is to investigate whether the FMT success rate in active UC patients can be increased by intensive donor pre-screening, anaerobic preparation of the FMT and by repeated FMT. The investigators will start a national multi-centre double-blind randomized sham-controlled trial in April 2017 at 6 hospitals in Belgium and 2 in The Netherlands. They will randomly allocate 108 patients with active ulcerative colitis (Mayo score 4-10, endoscopic Mayo score 2 or 3) in a 1:1 ratio, using a pre-established randomization list, to either 'superdonor' faecal microbiota transplantation or autologous fecal microbiota transplantation (=sham). Each patient will receive 4 FMT's. At baseline FMT will be performed during sigmoidoscopy. At week 1, 2 and 3, the FMT will be administered through rectal instillation. Each FMT will be derived from one donor. Donors will be pre-selected based on a species richness and abundance of taxa of interest. The primary outcome will be steroid-free clinical and endoscopic remission at week 8 (Mayo score ≤2, all subscores ≤ 1, and ≥1 point reduction in endoscopy subscore). Fecal, blood and mucosal samples and questionnaires will be collected at different time points. 16S rRNA stool analysis will be performed to assess the microbial changes after FMT.
Impact of a personalized video in oral hygiene motivation: The study hypothesis is that the use of a personalized oral hygiene video, made available to the patient via a cloud-based system, in conjunction with a text-based two-way recall system will increase patient compliance, hence leading to improvement or oral hygiene.
A randomised, single-blind, active controlled, multi-centre trial to evaluate the efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to a conventional PEG-electrolyte solution in paediatric subjects requiring a diagnostic procedure concerning the colon.
Metabolomics consists in the study of metabolites in body fluids or tissues. It investigates the consequences of the activity of genes and proteins. One of its advantages is that it is able to do a simultaneous measurement of metabolic changes in living organisms as a response to a disturbance (disease, diet, environment, others) and because a metabolic profile is summative of all the biochemical processes occurring in the body at a given time, it makes no presumption about the relative importance of these processes. Ultimately it is a fingerprint of the organism's health status, at a given time. Metabolomic analysis of serum, plasma and urine has revealed panels of metabolites that distinguish patients with cardiovascular disease, breast cancer, Parkinson disease, Alzheimer's disease and diabetes from control patients. Regarding ocular diseases only few studies have been published, related to diabetic retinopathy, retinal detachment, age-related macular degeneration, uveitis and glaucoma. Glaucoma is one of the leading causes of blindness in the world, according to the World Health Organization, and there are still no biomarkers that can provide an early diagnosis. Nowadays, glaucoma classification relies substantially in the measurement of intraocular pressure (IOP), which can be rather artificial and also unreliable since IOP values can fluctuate during the day. Moreover, patients with normal IOP values can also develop glaucomatous neuropathy (normal-tension glaucoma, NTG) and progress even when IOP is decreased. Several studies have shown that NTG patients suffer from a systemic vascular dysregulation, with higher rates of systemic hypotension, Raynaud phenomenon and migraine. Hence, other mechanisms than an increased IOP are of importance in the development and progression of glaucoma. Only one metabolome-wide study has been made in glaucoma (Burgess, I.; 2015). In a sample of 72 american patients with primary open angle glaucoma (POAG), the authors found significant differences in comparison to controls. The hypothesis for this study is that glaucoma patients will differ from controls, and POAG patients will differ from NTG patients. The investigators will look into metabolomics as a way to create a method to diagnose and stratify patients, as an add-on or alternative to the currently available diagnostic tools like IOP, functional and structural measurement.