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 is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.
This clinical pharmacology study is performed to evaluate the total systemic exposure and the lung availability of CHF 5993 DPI and pMDI with and without valved holding chamber, in healthy volunteers.
Diffusion-weighted sequences have been routinely performed for years to study the pelvis. They have been so far mainly qualitatively interpreted, that is to say as the absence or presence of an hypersignal at a high b value. The quantitative analysis involves placing the region of interest (ROI) on the apparent diffusion coefficient (ADC) map. The manual placement is very operator dependent, and does not reflect the entirety of the studied mass. In all fields of Magnetic Resonance Imaging, a multiparametric approach integrating diffusion analysis is flourishing. However, the quantitative analysis of the diffusion is still little studied for tumor heterogeneity analysis, including in the gynecological sphere. The investigators will therefore retrospectively evaluate the apparent diffusion coefficient (ADC) histograms, extracted from the diffusion ponderation sequences, of the magnetic imaging resonance analysis of adnexal masses and confront the results with the anatomo-pathology results, for patients having undergone surgery, and/or with the clinical and imagery follow-up results. The investigators goal will be to improve the performance of conventional MRI in the analysis of adnexal masses. The expected benefits of this study are: - a correlation with the histology analysis or the clinical monitoring - an improved prediction of the malignancy of the tumor - an improved magnetic resonance imaging performance for adnexal masses, with better surgical therapeutic management - an improved negative predictive value, thereby ultimately limiting unnecessary surgical explorations.
This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).
This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended phase II dose (RP2D), by assessing the maximum tolerated dose (MTD), safety and preliminary efficacy of selinexor in adult patients with relapsed/refractory B-cell malignancies receiving either R-DHAOx (Group A) or R-GDP (Group B). This dose escalation phase will be followed by an exploratory expansion phase in the same population with 12 patients enrolled in each group, who will receive selinexor at the RP2D. The "3+3" design will be applied for dose escalation. The escalation will be performed independently in two distinct groups: - Group A : Oral selinexor + R-DHAOx for 3 cycles (3-week cycles) - Group B: Oral selinexor + R-GDP for 3 cycles (3-week cycles) The choice of the conventional immunotherapy regimen which will be administered to each patient, R-DHAOx (Group A) or R-GDP (Group B), is left at the investigator's decision before patient's inclusion. Different dose levels for selinexor administration will be examined sequentially in each group by the Dose Escalation Committee (DEC): 4 doses of selinexor per 3-week cycle at 20 mg flat (Dose Level -1, DL-1), 40 mg flat (DL1), 60 mg flat (DL2) or 80 mg flat (DL3) will be taken orally by the patient on D1, D3, D8 and D10 of each cycle (dosing weeks = week 1 and week 2 of each 3-week cycle). Dose escalation will begin at DL1 and will continue until the MTD is exceeded or until the highest dose level defined in the study (DL3) is reached. Dose escalation to the next planned dose level will be decided by the DEC based on the number of DLTs observed during the DLT assessment period. The dose escalation phase will be followed by an exploratory expansion phase in the same two groups (Groups A and B), depending on the decision of the Independent Data Monitoring Committee (IDMC) after review of safety data at the end of dose escalation part. Patients enrolled in the expansion phase will receive selinexor at the RP2D defined by the IDMC, together with either of the conventional regimen R-DHAOx or R-GDP (left at the investigator's choice).
The primary objective of this study was to assess the effects of subcutaneous sumatriptan alone and the effects of a single dose of erenumab (AMG 334) intravenous (IV) and sumatriptan concomitant therapy on resting blood pressure in healthy adults.
The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.
Among patients with a first episode of unprovoked venous thromboembolism (VTE), the contemporary one-year risk of detecting occult cancer is approximately 4% to 7%. Of these cases, 30% to 60% are missed by routine limited screening for cancer. RNA profiling of platelets is a promising, highly accurate biomarker for cancer detection, but its clinical utility in patients with unprovoked VTE is unknown. The objective of the present study is to evaluate the diagnostic accuracy of platelet RNA profiling in detecting occult cancer in patients with unprovoked venous thromboembolism. Secondary objectives include evaluation of other biomarkers for cancer, prediction of bleeding, and prediction of recurrent VTE.
In patients under general anesthesia, episodes of hypotension are often treated with phenylephrine. The effect of phenylephrine is conventionally attributed to afterload increase. The aim of the study is to describe the time course of the effects of phenylephrine on the cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive alpha-mimetic, could be beneficial for preload optimisation.
NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis. This is a prospective randomized controlled trial. Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at admission and will be followed until 3 months after discharge.