13 results
Primary objectives-Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years.-Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an out…
Primary Objective: Assessment of a group difference in clinically important improvement in functional outcome of at least 10 points as measured by the DASH questionnaireSecondary Objective(s): 1. To determine if there is a group difference in…
Objective: To investigate the safety and efficacy of a therapy consisting Everolimus and corticosteroids maintenance immunosuppressive regime twelve months after renal transplantation in recipients of donor kidney graft on graft function and acute…
Objectives: A prospective, open label, randomized trial, in which we aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy,…
Primary: treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival for each of the two groups, namely 1) PI3K pathway activated patients and 2) full…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full…
The aim of the study is twofold. The first is the impact of DRL-21994 and the registered product on the release of vessels studied and compared. The second is the speed with which DRL-21994 is included in the body examined, as well as the degree of…
The aim of the study is twofold. The first is the impact of the investigational drugs and the registered product on safety, tolerability and the release of vessels studied and compared. The second is the speed with which the investigational drugs…
The objective of these studies is to identify the primary mechanisms of GC-induced dysmetabolic effects in humans and to find biomarkers that reflect these side effects of GC treatment and which can be followed during therapy and in future clinical…
The primary objectives are to determine the inhibitory effect of intravenously administered C1-inhibitor as well as the influence of depletion of the human microbiota on allergic lung inflammation induced by house dust mite (HDM) plus…
To evaluate the efficacy of Cinryze administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free intravenous immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft…
The main objective of the study is to demonstrate the utility and safetyof the IFN-γ ELISPOT marker for the stratification of kidney transplantrecipients into low and high IS regimens. The enrichment study will testnon-inferiority of low IS regimen…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…