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.
There is a need to develop a stool scale for baby's and toddlers who are not potty-trained yet. The investigators try to get a uniform and approved Bristol stool scale for children who ware diapers.
Denutrition is defined as a measurable decrease in functions and/or as change in the body composition, associated with a worsening of the prognosis of the underlying medico-surgical pathology. It is induced by a deficiency in energy, proteins or any other micro or macronutrient and is the result of malnutrition, itself caused by a poor diet or a metabolic disorder. According to the National Nutrition and Health Plan for Belgium, denutrition is an independent risk factor for the increase of complications, morbidity and mortality rates, average length of hospitalisation and global medical care cost. It is necessary to invest in the prevention of denutrition as the costs of preventive measures are lower than the cost of treating a denutrished patient. The Belgian financing system of hospitalisation days is based on the structure of the treated pathologies, the age of the patient and the geriatric features of the patient. It encourages all hospitals to lower the length of hospitalisation to the national average for all these criteria. As a consequence, there is a mounting tendency to shorten the average length of stay within the hospital. The so-called 'Sp' hospital departments occupy a specific place within the organisation of Health Services in Belgium. They are specialized in the treatment and rehabilitation of patients with cardiopulmonary, neurological, locomotor, psycho-geriatric and chronic diseases. These services act as an extension of acute services (continuity of acute hospitalisation) but also as a first entry point for the medical care of patients with various specific diseases (multiple sclerosis, psycho-geriatric disorders, chronic pulmonary disorders...). The financing of the Sp departments is, as opposed to the financing of other departments, not linked to the patient length of stay. However, an increase in hospitalization duration decreases the rate of admissions and the possibility to accept patients coming from acute hospital units. The aim of the study is to evaluate the influence of denutrition of patients hospitalized in an Sp department on the length of revalidation stay, the associated costs and the patient's functional autonomy.
The financing of the Belgian hospitals is based on a system taking into account the length of hospitalization of a given patient according to his/her pathology, his/her age and his/her geriatric characteristics. This system encourages all hospital to lower the hospitalization duration to the national average for these criteria. This results in better efficiency in the management of hospitalizations but also means a swifter transfer to structures exempted from this system such as revalidation units, nursing homes and psychiatric units. An assessment of the differences in the medical practice, in terms of quality and outcomes of care, is essential for any reform willing to reduce medical costs. Pain management is part of the quality indicators within hospitals. Pain is defined by the International Association for the Study of Pain as "an unpleasant sensory and emotional experience, associated to present or potential tissue damage, or described in terms of such a damage". Several studies have showed that pain affects the quality of life and impacts the daily activities. Acute or chronic pain can cause adverse symptoms such as sleep disturbance, appetite loss, decreased concentration, mood changes and the disruption of familial, work and social activities. Pain might also slow down revalidation processes. A study performed by Aprile et al showed that pain negatively influenced the rehabilitation program of a quarter of the patients having had a stroke. The functional recovery was slower and the costs were higher. The aim of this study is to determine if the systematic evaluation of the pain of a patient hospitalized in a revalidation unit has an impact on his/her length of stay.
Open-label, multi-center clinical study is to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and efficacy of Risdiplam (RO7034067) in infants with Type 1 spinal muscular atrophy (SMA). The study consists of two parts, an exploratory dose finding part (Part 1) and a confirmatory part (Part 2) which will investigate Risdiplam (RO7034067) for 24-months at the dose selected in Part 1.
Severe aortic regurgitation is a common valvular heart disease with prevalence of approximately 1%, affecting rather younger patients. The surgical treatment is the only causal treatment; it is recommended in patients with severe symptomatic aortic regurgitation. The optimal timing of the surgery is crucial because there is a certain risk of perioperative mortality and most patients require lifelong anticoagulation therapy. It is widely accepted, that asymptomatic patients with severely dilated left ventricle with systolic impairment have worse postoperative prognosis. We aim to evaluate native myocardial T1 relaxation time derived from cardiac magnetic resonance and global longitudinal left ventricular strain measured by echocardiography. These parameters are related to diffuse myocardial fibrosis and we expect to identify the cut off values, which correlate with further clinical course. This might enable better timing of the surgical treatment with the optimal postoperative left ventricular reverse remodelling and improved patient prognosis.
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after 2 cycles of standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to Investigator's Choice chemotherapy. In March 2019, decision made to not proceed with phase 3.
This study is a prospective, randomized, double-blind, placebo-controlled with 3 parallel-groups and multicenter trial in patients suffering from knee OA (osteoarthrosis). A first exploratory non comparative study (TILFLEXY002, NCT01909037, Henrotin et al., 2014 BMC Complementary and Alternative Medicine) evaluated the efficacy of FLEXOFYTOL® at the dose of 2x3 caps/day, during a 3-month period, in 22 patients suffering from knee OA, on the serum levels of cartilage-specific and inflammatory biomarkers, on the evaluation of pain and on the global patient assessment of disease activity. This study demonstrated a statistically significant decrease of sColl2-1 cartilage specific biomarker, an early decrease of the ultrasensitive C-reactive protein (CRP), an improvement of the global assessment of the disease by the patient as well as a good tolerance and compliance for the treatment. Results of this exploratory study are encouraging and justify the setup of a randomized, placebo-controlled double blind and dose-ranging trial.
Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode
Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1) of Risdiplam for 12 weeks and a confirmatory part (Part 2) of Risdiplam for 24 months.
ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial, TTM at 33°C did not confer a survival benefit or improved neurological function, compared to TTM at 36°C. A lower target temperature might be beneficial compared with normothermia and early treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study any differences in mortality, neurological function and quality of life between a target temperature of 33°C and standard care avoiding fever.