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 main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.
In this study, researchers will show to caregivers of patients how to use a tDCS device (this device was designed to be easy to use, with fixed parameters and only one button to press to run the stimulation). They will be asked to apply a stimulation every day, 5 days per week during for 4 weeks, in chronic patients in minimally conscious state (MCS). 2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a randomized order. Before and after each session, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 8 weeks after the end of the sessions to assess the long term effect of tDCS.
Sickle Cell Disease is a serious disease that is life-threatening for patients being homozygous for the SS form or heterozygous for the SC or βthal forms. The CHU Brugmann hospital currently regularly treats about 70 homozygous adult patients and this number is in constant augmentation. Sickle cell disease patients may develop a cardiomyopathy due to chronic anemia, the haemosiderosis risk or, less frequently, to coronary vaso-occlusive damages. The hypervolemia in patients with sickle cell disease causes an overestimation of the ejected left ventricular fraction measured by echocardiography, this parameter being very dependent of the blood volume.It has already been shown that the left ventricular ejection fraction was normal in most patients with sickle cell disease, but that its evaluation by parameters independent from the blood volume showed the existence of a dysfunction. Myocardial strain, as measured by speckle tracking, is a echographic evaluation method of the cardiac function, independent of the blood volume. This technique hasn't been used much in sickle cell disease patients. A study using 3D speckle tracking on a limited number of sickle cell disease patients failed to show a strain anomaly. Moreover, the study highlighted a higher global longitudinal strain in this patient population. The investigators find these data hard to explain and in contradiction with previous studies using other cardiac function evaluation techniques, independent from the blood volume. The primary goal of this study is thus - to study the longitudinal strain by 2D echography - to determine if anomalies of the longitudinal strain exist in sickle cell disease patients with a normal ejected left ventricular fraction, compared to a control group of healthy patients. The secondary goal of this study is to correlate, inside the sickle cell disease group, the possible strain anomalies with biological gravity parameters of the disease.
This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs. The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.
The purpose of this study is to evaluate the safety and efficacy in the frontline treatment of ovarian cancer in participants 70 years of age and older in routine clinical practice in Belgium. Bevacizumab will be used in combination with carboplatin/paclitaxel followed by bevacizumab as maintenance in accordance with the Summary of Product Characteristics (SmPC).
B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated.
The aim of this prospective study is to assess the prognostic value of bioactive plasma adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international multicenter study and to validate the findings concerning the association of ADM concentration and the use of vasopressor therapy, organ failure and outcome.
Hepatitis C is caused by the hepatitis C virus (HCV) that causes inflammation of the liver that can lead to diminished liver function or liver failure. The number of chronically infected persons worldwide is estimated to be about 170 million that is 2.35% of the world population. Most people infected with the hepatitis C virus have no symptoms of the disease until the advanced stages of liver disease have occurred, which may take several years. The long-term impact of HCV infection is highly variable, from minimal changes to extensive fibrosis and cirrhosis with or without hepatocellular carcinoma (HCC). Advanced liver disease (ALD) can lead to significant clinical and economic consequences, including liver transplantation. HCV can reduce life expectancy and impair quality of life. HCV-related complications as well as the highly debilitating effects on patients represent a significant item of expenditure for the National Health Service. Because of the latency of infection, numerous country-specific population analyses suggest that HCV will cause an increasing number of liver-related deaths despite the dramatic drop in incidence and prevalence. These deaths will be related to prevalent HCV infection especially during and after World War II through indiscreet and widespread treatment with intravenous injection using contaminated syringes, needles and remunerated blood donors. Eradicating HCV infection can prevent the complications of HCV-related liver and extrahepatic diseases, including liver necroinflammation, fibrosis, cirrhosis, HCC, and death. Newly discovered hepatitis C virus (HCV) therapy with direct acting antiviral agents (DAA) like Simeprevir, sofosbuvir open a new chapter in the treatment of chronic hepatitis C. Those new treatment regimens promise oral dosing, higher SVR, shorter duration of treatment and fewer side effects. In a near future all patients should qualify for future all-oral therapies. However recent analysis have shown that increasing efficacy of treatment alone will not be able to reduce the HCV disease burden. The largest reduction in HCV-related morbidity and mortality can be obtained when higher efficacy therapies is combined with increased diagnosis and treatment rate. With a treatment rate of 10% it is possible to achieve a > 90% decline in total infections by 2030. This would require a 3-5 fold increase in diagnosis and/or treatment for most countries. The implementation of screening criteria for hepatitis C virus (HCV) such as targeting birth cohorts has potential effect on reducing the progression of hepatitis C virus (HCV) to advanced liver disease (ALD) and could avoid unnecessary high financial costs and preserve quality of life. Robust data from public health surveillance, surveys of the general and risk populations are required to make decisions in allocating public health resources to diagnose, assess and treat HCV infection. In Belgium no recent prevalence studies have been conducted. The most cited anti-HCV prevalence is 0.87% based on a study in the Flemish population published in 1997 but collected in 1994. In a French Belgian population there was an overall seroprevalence of 0.6%. However, the population under study was not representative for the whole French community, because the recruited subjects were significantly younger. A survey among cirrhotic and hepatocellular patients in the French community revealed that 20% of cirrhosis and 47% of hepatocellular cancer were related to hepatitis C. The diagnosis rate of HCV in Belgium is estimated at 43%, signifying that more than 50% of HCV patients remains undiagnosed. Several studies have already mentioned that aged population especially those born after Second World War are carriers of hepatitis C virus infection. Early detection of HCV infection and treating before progress to advanced liver disease (ALD) is an excellent opportunity to rationalize resource allocation and to improve patients' quality of life. Recently birth cohort screening recommendations were developed in the United States. In Belgium, no formal screening strategy exists. However the Belgian association of the study of the liver (BASL) recommends targeted HCV screening for high-risk populations (including individuals with a blood transfusion or major medical event prior to 1 july 1990, intranasal or IDU and dialysis patients) in addition to nontargeted screening among pre-operative patients and pregnant women. A birth cohort analysis based on a model suggests a birth cohort between 1950 and 1975 in Belgium. This population should reflect 70% of the viremic population. In this study, the investigators want to estimate the prevalence of hepatitis C in Belgium in 2014 and to confirm the proposed targeted birth cohort and other risk factors. These data could provide an efficient source of identifying newly diagnosed patients as part of a national screening strategy.
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.