5 results
Compare the performance of an unobtrusive new medical device with a CE-marked esophageal and/or rectal reference sensor (Covedien Mon-a-Therm, General Purpose Temperature Probe 400TM) for core body temperature in patients undergoing surgery in which…
Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…
Primary: Part 1 • To determine the RP2D of avapritinib in patients with ISM for use in Part 2 and Part 3 of the study.Part 2 • To determine main change in ISM-SAF TSS from baseline to C7D1, compared to placebo. Part 3 • To assess the long-term…
1. find out the true time-in-AF per AF category and identify progression of AF,2. uncover genetic predisposing patterns for AF and AF progression,3. find out electrical basis of AF,4. investigate the relationship between genetic changes, electrical…
Primary: • The primary objective is to determine adjudicated ORR (CR/CR with partial recovery of peripheral blood counts [CRh] + PR + CI) based on modified IWG-MRT-ECNM consensus response criteria in patients with AdvSM treated with avapritinib and…