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.
This is an open, multicentre, prospective observational (non-interventional) study, performed in Belgium. Principal objectives: 1. To evaluate the prevalence of cardiovascular risk factors and cardiac function (as routinely evaluated) before treatment with anthracyclines of patients with metastatic breast cancer (MBC) aged > or = 65 years 2. To observe the management of cardiovascular risk during and after anthracycline treatment 3. To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac function, outcome and quality of life (EORTC QLQ-C30) Secondary objectives: 1. To evaluate the efficacy of anthracyclines on progression free survival and tumor response as routinely measured (e.g. recist criteria, tumor markers and other exams) 2. To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection fraction, heart failure and rate according to allocated treatment. 3. To find out how quality of life, e.g. such as described according to EORTC QLQ-C30 criteria or Karnofsky index is achieved in the various patient subgroups 4. To correlate the therapeutic choice and posology of anthracyclines for MBC with Cardiovascular risk at baseline 5. To calculate the cardiovascular risk according to SCORE
The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.
Late Cardiac Evaluation of the Three Arm Belgian Trial A phase III randomized trial involving node-positive early breast cancer patients with a long median follow-up (~ 15 years) OBJECTIFS Primary: • To compare the incidence of late cardiac events between anthracycline and non-anthracycline chemotherapy given to node-positive breast cancer patients in the Belgian three arm randomized clinical trial Secondary: - To compare the late incidence of cardiac events between higher and lower dose anthracycline treated node-positive breast cancer patients; - To compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy for: - left ventricular diastolic function assessed by Echo - exercise capacity assessed by 6-minute walk test (6MWT) - cardiac morphology (myocardial inflammation or injury, fibrosis, LVEF) assessed by MRI - serum cardiac biomarkers (BNP and TNT) - patient-reported cardiac symptoms - patient-reported cardiac symptoms assessed by QOL questionnaires are associated with subclinical findings on LVEF assessment - cognitive function, functional autonomy, and psychological distress
The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis subjects who are methotrexate-inadequate responders (MTX-IR).
This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by complete response rate at the end of treatment. Approximately 80 patients aged between 60 and 80 years will be included, to have 70 evaluable patients. The treatment consists of two phases of four 3-weeks cycles: induction phase and consolidation phase, for a total treatment duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will be administered in the hospital on day 1, prednisone is continued for 5 days and lenalidomide is taken for 14 days. Patients will be followed for at least 18 months after inclusion of the last patient.
This is an open-label, randomized, cross-over, single dose study in healthy volunteers to evaluate the potential effect of esomeprazole, a proton pump inhibitor, on the pharmacokinetics of crizotinib. Each subject enrolled will receive two single oral doses of crioztinib with or without esomeprazole separated by a washout period of at least 14 days.
This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood. Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the observation arm.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP. Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo. The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.
This research aims to give an overview of a number of aspects related to the quality of care for adult patients on home parenteral nutrition. Concretely this study follows up different aspects on different moments in the care of the patient pathways: - process indicators concerning indication, parenteral nutrition, training, team access roads and the succession of complications - Outcome indicators - the health-related quality of life - discrepancies in medication use - the role of the different health care providers
Movement slowness (bradykinesia) is one of the main motor symptoms in Parkinson Disease (PD). Several studies have shown that patients with PD exhibit slowness because they are unable to modulate, in an optimal way, the velocity of voluntary motor acts not induced by external stimulation. Indeed, these patients have difficulties to integrate multi-sensorial information, mainly proprioception. The investigators investigated changes in shoulder velocity during pointing movements by patients with PD after stimulation of soft tissues (aponeurosis) of upper limb muscles. The stimulation consisted of manipulating, with a hook (the diacutaneous fibrolysis method), the aponeurotic tissues enrobing the heads of the upper limb muscles. This technique has previously been shown to decrease passive tension and the tendon reflex response of the manipulated muscle group. The investigators hypothesis is that aponeurotic manipulation of shoulder muscles therefore creates a modification in the proprioceptive information, which in return temporarily decreases the bradykinesia of shoulder movements.