43 results
See section 2.2. of the protocol.The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in NVAF patients undergoing AF…
Primary Objective: - To confirm the effect of dexamethasone on clinical outcome in patients admitted with CAP.Secondary Objectives: - To study what patients admitted with CAP benefit most from dexamethasone therapy. Predefined subgroup analysis…
PrimaryTo assess the extended overall response rates of orally administered TKI258, at 500 mg/day, on a five days on and two days off dosing schedule, in groups of patients with relapsed or refractory multiple myeloma who are* with t(4;14)…
To determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL.
Although these products have been used extensively in patients, the effect of these medications on experimental pain sensation has never been investigated. There is little knowledge about any direct effect of these medications on pain perception. In…
Evaluation of the effect of salvage therapy with R-DHAP followed by reduced-intensity conditioning and allogeneic stem cell transplantation from a sibling or unrelated donor
To compare progression-free survival in subjects with relapsed multiple myeloma who are receiving CRd vs PFS in subjects receiving Rd alone.
The aim of this phase I study is to assess the extent of intestinal absorption of rivaroxaban and dabigatran etexilate in adult patients with short bowel syndrome and treated with long-term TPN.
The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
The purpose of the study is to investigate how quickly and to what extent flurbiprofen is absorbed and eliminated from the body (this is called pharmacokinetics) when it is administered via a FTS. Furthermore, the pharmacokinetics of FTS will be…
The primary objective is to compare PFS after treatment with tabalumab, bortezomib, anddexamethasone to that of placebo, bortezomib, and dexamethasone in patients with relapsed/refractory MM.Secondary objectives will include comparison of treatment…
Does dexamethason reduce the levels of plasma inflammatory proteins in patients undergoing coronary artery bypass graft (CABG) surgery who have a normal or disturbed ejection fraction such that proapoptotic pathways are inhibited?Does a…
Phase I:-To determine the maximum tolerated dose (MTD) and recommended phase II dose level (RDL) of Bortezomib administered once weekly, and of Lenalidomide administered for 3 weeks when combined with Dexamethasone in a 28-days schedule.Phase II:-To…
Objective: The aim of this study is to investigate the in-vivo variability of hemostasis between patients when treated with a direct thrombin inhibitor (Dabigatran) or a direct Factor Xa (FXa) inhibitor (Rivaroxaban) by measuring thrombin generation…
To asses the comparability of the estimated dabigatran concentration in plasma via calibrated Hemoclot and the measured dabigatran concentrations assessed in a central lab in patients with moderate renal impairment undergoing primary unilateral…
To assess whether a single shot of dexamethasone reduces postoperative pain, and reduces the time children need to start with drinking and eating.
As of protocol Amendment 06, evaluation of the safety profile of MLN9708 and/or other study medication is the only endpoint being assessed. All other study endpoints will no longer be assessed.
* To establish the safety profile of daratumumab when given in combination with lenalidomide and dexamethasone in subjects with relapsed or relapsed and refractory MM
Objectives:To collect data on effect size for, and determine the feasibility of, a full scale multicentre RCT(Randomized Controlled Trial) that1. compares the efficacy and safety of NOACs with VKA treatment according to Dutchstandards, in VKA-…