17 results
Primary ObjectiveTo evaluate the effect of a single 84-mg dose of intranasal esketamine compared to placebo, on next day driving performance and repeated administration of 84 mg intranasal esketamine on same-day driving performance as assessed by…
To determine the influence of esomeprazole on the AUC of regorafenib in patients with mCRC or GIST.
To evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies.The primary efficacy endpoint of this study is * Overall survivalThe secondary efficacy endpoints of this…
The objective of this study is to evaluate efficacy and safety of regorafenib in patients with HCC who have progressed after sorafenib.
To evaluate the effect of intranasal esketamine 84 mg on cognition, and duration of cognitive effects (if present), as assessed using a computerized test battery (Cogstate®).
Primary Objective:In this pilot study, the authors aim is to investigate whether esketamine reduces the incidence of POD in elderly patientspresenting for noncardiac surgery.Secondary Objective(s):To examine whether esketamine has an effect on the…
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),…
Objective 1: To determine the effects of S-ketamine on brain activation in healthy women, healthy women prone to depression and fibromyalgia patients.Objective 2: To determine the effects of S-ketamine on mood and other depression-related behavioral…
Primary objectives* To assess the tolerability of regorafenib combined with paclitaxel.Secondary objectives* To assess the effect of regorafenib on uptake of paclitaxel in OGC metastases.* To assess the effect of regorafenib on regorafenib targets…
The aim of this study is to demonstrate that procedural sedation with propofol and esketamine is more effective and will result in less cardiopulmonary depression than sedation with propofol and the opioid alfentanil. Less side effects should also…
This protocol is designed to determine the safety, tolerability, and efficacy of SGI-110 in combination with irinotecan in previously treated patients with metastatic colorectal cancer who progressed on irinotecan.
The primary objective is to demonstrate non-inferiority of experimental esketamine administration of 6x 1 day per 2 weeks (in total 3 months) as compared with standard esketamine administration of 1x 6 consecutive days. The end of study is at 6…
The purpose of this study is to determine if the combination of relatlimab and nivolumab improves overall survival (OS) in all randomized participants and participants with PD-L1 CPS >= 1 with later-line metastatic colorectal cancer compared…
The main objective of this study is to investigate gender differences in P-gp function at the blood brain barrier, in order to gain further insight into the impact of these differences on the action of pharmaceuticals (antidepressants and…
Primary Objectives* To investigate the effects of PO and IV S-ketamine and its metabolite S-norketamine on functional CNS tests up to 6h (acute effects) and 24h (delayed effects) after administration using NeuroCart test battery in healthy subjects…
Primary objective:The primary objective of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release(XR), both in combination with a continuing selective serotonin reuptake inhibitor (…
General aim; To dertemine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety to warrant further evaluation as a first line treatment for metastatic GIST.