374 results
Primary:To determine the MTD and/or RP2D of BKM120 and MEK162 in combination when administered orally to adult patients with selected advanced solid tumors. Secondary:• To characterize the safety and tolerability of the oral combination of BKM120…
1) Evaluating the effect and recovery of glioma surgery in eloquent areas on cognitive functioning.2) Examining the effec tof glioma surgery in eloquent areas on quality of life.3) Examining the effect of gliomas in eloquent areas on the…
Co-Primary Objectives* To evaluate the immunogenicity of N8-GP in previously treated patients with haemophilia A* To evaluate the clinical efficacy of N8-GP in bleeding prohylaxis (number of bleeds during prophylaxis)Secondary Objectives* To…
Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…
The goal of this study is to collect and clinically characterize a large cohort of patients with hereditary retinal dystrophies in the Netherlands. The study cohort will be used to identify the genetic causes underlying these diseases, and to…
In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antiemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed CINV induced by non-AC based…
Development of (f)MRI tasks and scan protocols and to define the optimal parameters in preparation of a (f)MRI study
Main study objective of this study is:To evaluate whether the 320-detector volumetric CT technology can replace carotid duplex scanning and TEE in the diagnostic workup in TIA/IS patients. Specific aims of this main study objective are:1. To assess…
The primary objective of this study is to monitor the safety and tolerability of PF 00547659 during long term treatment. Secondary objectives: * The secondary objective is to assess pharmacokinetics and immunogenicity of PF 00547659.* Exploratory…
Objective of the study is to quantify the microbiological etiology in immunocompromised patients, at least 18 years of age, with CAP needing hospitalization. And to determine the severity, antibiotic use and outcome of CAP in immunocompromised…
The primary objective for this study is to compare the level and time course of the patient work-of-breathing during PS ventilation with the work-of-breathing during SIMV-PS ventilation with a lower rate of breaths per minute delivered by the…
Primary Objective: * To evaluate the haemostatic effect of N8-GP during surgical procedures in patients with haemophilia A. Secondary Objectives * To evaluate the general safety including immunogenicity of N8-GP when used for prevention and…
Primary Objectives: - To investigate whether disease progression in individual patients with CHF can be accurately assessed by serial measurements of disease-related (novel) biomarkers.- To investigate whether dynamic biomarker patterns as…
Primary objective:- Collecting and setting up norm values for the Steep Ramp Test for healthy children and adolescents between 8 and 18 years (what is the maximal attained work rate (Wpeak) during the Steep Ramp Test in healthy children and…
Primary objective:To demonstrate that an individualized stabilization-criteria-driven PRN dosingregimen (PRN) with 0.5-mg ranibizumab administered with or without adjunctive lasertreatment has superior efficacy as compared to the current standard of…
Main objective: To quantify mumps transmission parameters in exposed individuals, comparing symptomatic and asymptomatic cases, to understand and model ongoing transmission; Secondary: to assess cellular immuunresponses in mumps exposed infected and…
In this study we want to apply heavy water labelling to investigate how ageing affects the dynamics of different leukocyte populations.The main objectives of this study are:(A) to get more insight in the dynamics of an ageing immune system, in order…
The primary objective of this randomized trial is to reduce the HbA1c levels by 10% through exercise training with or without oral anti-diabetic medication in patients with coronary artery disease (PCI or CABG in stable CAD, or post STEMI and post…
• To investigate the magnitude and time course of platelet reactivity and platelet activation in patients with a STEMI undergoing primary percutaneous coronary intervention (pPCI).• To investigate the magnitude and time course of thrombin generation…
In the present proposal, we aim to assess the cost-effectiveness of the use of CGMS in diabetic pregnancies.