29 results
The aim of the present study is to investigate the differences in patient and endoscopist satisfaction and experiences and patient*s safety with different sedation protocols.
Study aims (see page 2 of the protocol)a. To assess the dose-response relationship of propofol on breathing.b. To assess the interaction of propofol and remifentanil on breathing.c. To qunatify the data under closed-loop conditions using an emprical…
1.To evaluate the influence of epidural blockade with ropivacaine on the pharmacokinetics of propofol.2.To evaluate the influence of epidural blockade with ropivacaine on the pharmacodynamics of propofol. This includes both the sedative and the…
To determine effective and safe age specific propofol dosing guidelines for neonates of different age groups (both gestational age and postnatal age). Secondary objective is to determine a new age specific PK/PD (pharmacokinetic/pharmacodynamic),…
The aim of this study is to determine the patients* and endoscopists experiences and patients* safety with different sedation protocols.
The primary objectives of this study consist of:1. To assess the accuracy of different pulse contour methods to measure CO compared to thermodilution CO measured with a PAC in major abdominal surgery patients.2. To assess the effect of propofol…
Previous investigations in our lab have provided insight in the requirements for development of such a system and shown the feasibility of the paradigm (Blokland et al., 2011, Blokland et al., 2012). We have been able to optimize the settings of our…
To evaluate the impact of electroencephalographic NarcotrendTM Index (NI) monitoring on the speed of emergence and recovery from PPS for PGE.
Primary Objective: The primary objective is to evaluate the efficacy of daratumumab plus CyBorD compared with CyBorDalone in the treatment of newly diagnosed AL amyloidosis patients.Secondary Objectives:# To evaluate the clinically observable…
Primary Objective:• To evaluate the proportion of patients with a response of very good partial response (VGPR) or better to IDd treatment.Secondary Objectives:• To measure progression-free survival (PFS), time to progression (TTP), and overall…
Primary ObjectiveThis is a confirmatory trial to establish non-inferior efficacy of remimazolam compared with propofol for induction and maintenance of GA for the purpose of elective surgery in patients classes III and IV based on the American…
The primary objective is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and T-cell ALL as measured by the complete response (CR) rate.The secondary…
* To establish the safety profile of daratumumab when given in combination with lenalidomide and dexamethasone in subjects with relapsed or relapsed and refractory MM
Evaluation of the effect of nivolumab and daratumumab with or without low dose cyclophosphamide in patients with relapsed/refractory multiple myeloma
Dose escalation phase:Primary• Determine the RP2D and if reached, the MTD of GEN3014• Evaluate the safety and tolerability of GEN3014 Secondary:• Characterize the PK properties of GEN3014• Characterize the pharmacodynamic properties of GEN3014•…
Primary objective* To determine the efficacy, defined as overall response rate (ORR; >= partial response (PR)), of 9 cycles of ixazomib, daratumumab and low dose dexamethasoneSecondary objectives* To determine the tolerability, defined as…
The primary hypothesis of this study is that the 6-month OS rate of patients with newly diagnosed stage 3B AL amyloidosis will exceed 50% after primary therapy with daratumumab
The primary objective is to compare the efficacy of Tec-Dara (Arm A) with DPd/DVd (Arm B) in participants who have received 1 to 3 prior lines of therapy, including a PI and lenalidomide.
Primary objective:-To compare the efficacy of elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C) as measured by PFS-To compare the efficacy of elranatamab + daratumumab (Arm B) vs. Arm C.- To assess the safety and tolerability…
Primary objective: To compare the efficacy of JNJ-68284528 with standard therapy, either pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).