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.
Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known today are a group of chronic inflammatory conditions with autoimmune aetiology with few treatment options and difficult diagnosis.Brest team contribute to perform a new classification of the following systemic autoimmune diseases in a European Union's Seventh Framework Programme. The aim of this research is to reclassify the individuals affected by SADs into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.
The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
1. The use of imatinib in combination or in association with chemotherapy is now considered as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90% in patient aged 55 years and over. 2. However, despite high CR rates, the progression free survival rate at 12 months of patients treated with the combination of imatinib and chemotherapy is 30% to 50%. Relapses remain frequent and only patients intensified with allogenic haematopoietic stem cell transplantation are in long term remission. This strategy is not fully applicable to most patients aged 55 years and over. 3. Relapses after or during imatinib therapy in patients with Ph+ ALL are associated with BCR-ABL tyrosine kinase domain mutation in 80% of cases, predominantly of the p-loop. The exact incidence of the T315I mutation is controversial and can be estimated to be near 50%. Conversely, the detection of the T315I or F317 mutation in a patient is a very strong predictor of relapse. 4. Dasatinib is a potent SCR and BCR-ABL tyrosine kinase inhibitor with preserved in vitro activity in most of the BCR-ABL mutated cell lines, except for the T315I and F317 mutations. This is also the case in vivo, with patients harbouring BCR-ABL TK domain mutations remaining sensitive to dasatinib. The CHR rate in Ph+ ALL resistant to imatinib is 33% and the median progression-free survival is 3.7 months. Progression free survival (PFS) rate at 12 months is 22%. The goal of this trial is to evaluate the efficacy and the tolerance of the combination of dasatinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of dasatinib as concomitant therapy during induction and alternating with chemotherapy during consolidation and maintenance. A CR rate of 90% and a progression free survival of 60% at 12 months are expected. The patients will be prospectively monitored for minimal residual disease and mutation.
Rationale In Belgium, a unique situation exists for two reasons: on the one hand, the pneumococcal conjugate vaccine (PCV) program, which started in 2007, has quickly reached high coverage in infants: 3-dose coverage rose from 89 % in 2008 to 96.5 % in 2012 in Flanders and from 80.7 % in 2009 to 89.2 % in 2012 in Wallonia; and on the other hand, serotype coverage has moved from PCV7 (since 2007) to PCV13 (since 2011) and very recently to PCV10 (since July 2015 in Flanders and expected in May 2016 in the French Community). Invasive pneumococcal disease (IPD) surveillance has demonstrated a major impact on PCV13 serotypes in infants < 2 years of age. The impact of the current change in PCV-program is hard to predict, but could eventually result in a re-emergence of serotypes not covered by PCV10 (i.e. 3, 6A and 19A). With this unique situation the foundation was laid for a carriage study during which the nasopharyngeal carriage of Streptococcus pneumonia (Sp) and other common colonizers of the nasopharynx will be studied in infants with acute otitis media (AOM) and in healthy infants attending day-care centers (DCC), two populations with high reported pneumococcal carriage. Young children are an important reservoir and major source of transmission of bacteria to the whole community and thus the preferred population to study nasopharyngeal (NP) carriage. Aim of the study The main aim of this study is to evaluate if changes in the conjugate anti-pneumococcal vaccination program in Belgium have an impact on the nasopharyngeal carriage of Pneumococcus in infants aged 6-30 months suffering from AOM or attending day-care, in order to guide future pneumococcal vaccine program decisions and vaccine development, and to feed AOM treatment guidelines in a PCV-program environment. The study will monitor overall pneumococcal carriage, the serotypes involved and the sensitivity of the isolated strains to antibiotics. In addition, the rhinopharyngeal carriage of other common nasopharyngeal colonizers associated with disease, in particular Haemophilus influenzae, will be studied in order to evaluate if changes in pneumococcal carriage impact on the carriage of those pathogens. In infants with AOM, the study will also monitor the clinical course of the AOM and a second nasopharyngeal sample will be taken in case of antibiotic treatment failure or AOM recurrence to identify any association with the carried pathogen.
Diagnosing and treating posture-related headache (PRH), such as tension-type and cervicogenic headache, is seriously hampered because of common features and complex interaction of the neurological and musculoskeletal system. Current therapies are therefore not as effective and the population of patients with PRH keeps on increasing. The diagnostic as well as the therapeutic process need more structure in order to select the most effective treatment; thereby contributing to preventive measures. This goal can be achieved through fundamental research with a clinically oriented background. Our study starts from a clinical problem, with a growing incidence, and is therefore highly relevant. Because sitting-posture seems to play an important role in PRH, the first step in the diagnostic process is to analyse postural differences between a PRH- and a control-group. In addition, the role of the dura mater in the headache-process will be examined. Patients with PRH will be classified in homogeneous groups based on these results. In a second phase individual-specific treatment programs will be composed. The general treatment-approach of postural abnormalities in the past failed because of the heterogeneous patient-populations. Sub-classifying musculoskeletal problems has been proven to be successful in the past (O'Sullivan & Dankaerts, non-specific low back pain). Our study is divided in 2 phases: - phase 1: profile analysis (no intervention, experimental headache-group vs. asymptomatic controls) - phase 2: interventional phase (clustered headache-groups, based on the results of phase 1
Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management based on a combination of several physiological variables (bispectral index [BIS], stroke volume [SV], and stroke volume variation [SVV]) using 2 independent physiologic closed-loop systems (PCLS) in patients undergoing high risk vascular surgery
The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).
Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age <28 weeks and/or a birth weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has been associated with serious complications. However, a common finding is that medical and/or surgical treatment of a PDA seems not to reduce the risk of mortality or major morbidity. This might be related to the fact that a substantial portion of preterm infants are treated unnecessarily, because the ductus arteriosus (DA) might have closed spontaneously without any specific intervention. An expectative approach is gaining interest, although convincing evidence is still missing. The objective of this study is to investigate whether in preterm infants <28 weeks' gestation with a PDA an expectative management is not inferior to early treatment with regard to the composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary dysplasia (BPD) at a postmenstrual age of 36 weeks.
The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction. Cognitive function will be assessed using a comprehensive battery of tests with an evaluation of longitudinal change of cognitive domains including memory, executive function, and attention.
ARCADIA is a national registry designed to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia (FMD). FMD is a group of arterial diseases that most commonly involve renal and carotid arteries. Patients with FMD may present with renovascular hypertension and/or with cerebrovascular symptoms. Angiographic classification includes the multifocal type and the focal type. FMD may affect one or more vascular beds and progress to more severe stenosis and to renal or cerebrovascular complications. FMD may be familial (OMIM #135580). Our main objective is to create a FMD registry that will collect standardized information from all consenting patients diagnosed with the condition in 16 participating centers. This registry, along with a collection of leukocyte DNA, will constitute a resource for further clinical research on FMD. The first application will be the assessment of the frequency of multi-site FMD, i.e. the frequency of cervical artery FMD in patients presenting with renal artery FMD and vice-versa. The second application will be a case-control study to identify susceptibility genes for FMD. Patients are eligible in the registry if: (a) they have renal or cervical artery FMD with either multifocal or focal lesions at CT-angiography, MR-angiography, or intra-arterial angiography; (b) they give informed consent to leukocyte DNA analysis and to the collection of bioclinical and morphologic information. Phenotypic assessment will be performed in accordance with current recommendations and best clinical practice. Given the multicenter nature of the study and the recruitment capacity of each centre, enrollment of 500 FMD cases is expected over 5 years. This number will 1) allow an accurate estimation of the frequency of multi-site FMD: when the sample size is 500, a two-sided 95% confidence interval will extend 0.035 from the observed proportion for an expected proportion of 0.20 based on a previous report and from our unpublished data. 2) In addition to a collection of 400 renal FMD already collected at HEGP, give sufficient power for a genome-wide association study seeking for susceptibility genes