468 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…
The primary objectives are:- To evaluate clinical remission for the 2 subcutaneous (SC) maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn*s disease induced into clinical response with ustekinumab in the…
The primary objective of this randomized trial is to assess the beneficial effects of early administration of 5 mg Metoprolol intravenously before reperfusion on infarct size in patients with ST elevation myocardial infarction who are planned 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…
*To demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-CVP combination treatment to patients who receive MabThera®-CVP treatment. ORR will be determined during the combination treatment…
The goal of this clinical investigation is to assess the early migration and bone remodeling of the Symax hip stem and the Trident HA coated or Trident Tritanium acetabulum component with RSA and 18-F PET CT Also the sensitivity of the RSA…
Development of (f)MRI tasks and scan protocols and to define the optimal parameters in preparation of a (f)MRI study
The main objective is to compare the coronal Cobb angle correction of proximal hook claw fixation versus proximal pedicle screw fixation after two years of follow-up. The secondary objectives of the study are: comparison of coronal Cobb angle…
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…
Aim of the studyTo study the effectiveness and toxicity of dexamethasone to prevent the occurrence of a pain flare after short schedule radiotherapy for painful bone metastases and to define the optimal schedule of dosing.Research questions:1. What…
To study the effect of a nerve block of the infrapatellar nerve with local infiltration with lidocaine or saline on chronic anterior knee pain after tibial nailing.Secondairy objectives:- to measure knee pain on a VAS for eight different activities…