12 results
To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remissionTo determine whether restarting of Imatinib in case of molecular relapse results in a…
Primary:- To determine the MTD and/or a recommended phase II dose (RP2D) of BYL719 when administered orally in combination with imatinib 400 mg q.d.Secondary:- Assess the safety and tolerability profile of imatinib and BYL719 administered in…
This phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib
The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee…
Primary objective: The primary purpose of the research is to determine the difference in pain experience during rest, measured by means of an 11-point Numerical Rating Scale (NRS), between peroperatieve Local infiltration with Analgesics (LIA) vs.…
The primary objective of this study is to describe a pharmacokinetic profile of bound and unbound plasma concentrations of ropivacaïne, when used in the LIA technique for the knee. Especially describing the Cmax and Tmax gives arguments for dosage…
In this prospective, double-blind, randomized controlled trial, we investigate the hypothesis that regional anesthesia provided by WCI with ropivacaine will reduce pain postoperatively (as measured with COMFORT behavior scale and Numeric Rating…
The primary objective of this study is to describe the pharmacokinetic profile of total and unbound plasma concentrations of ropivacaine, when used for LIA in TKA surgery without tourniquet.
Primary: To evaluate the long-term safety and tolerability of QTI571.Secondary: * Continue to evaluate the long-term efficacy of QTI571 as measured by the change in6MWD from baseline.* Continue to assess time to clinical worsening (TTCW) endpoints…
Primary: To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated PBPK and pop PK approaches
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…
Primary:* Determine the maximum tolerated dose (MTD) and/or a recommended Phase II dose (RP2D) of BKM120 when administered in combination with imatinib 400 mg q.d.Secondary:* Assess the safety and tolerability profile of imatinib and BKM120…