6 results
Primary Objective: Our primary objective is to study the influence of two routinely used drugs to increase systemic blood pressure (phenylephrine and ephedrine) on cerebral oxygenation and perfusion, estimated by changes in cerebral oxygenation (…
The main objective of this pilot study of n-of-one trials is to determine the effect of add-on treatment with ephedrine for all participants enrolled in this small series of n-of-one trials. Secondary objectives include determining the effect in…
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…
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 objective: To investigate the clinical effectiveness of the novel anal insert (Navina* Fecal Incontinence Insert) in ambulatory patients with faecal incontinence in comparison to care as usual (e.g. incontinence pads)Secondary objectives:1.…
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…