8 results
The primary objective is to demonstrate that detoxification of benzodiazepines in high-dose benzodiazepine dependent patients using continuous subcutaneous infusion of flumazenil is feasible and safe.Secondary goals of the study are to explore 1)…
Primary• To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin• To assess the pharmacokinetics of brentuximab vedotin• To determine the overall response rate (complete…
The focus of this pilot study is to investigate the results of a sialendoscopy (with or without rinsing with hydrocortisone 100mg) on the unstimulated whole mouth (UWS) and stimulated parotid (SP) (ml/min) flow of saliva, oral dryness, reported…
Lead in phase 1Primary objective:• To identify the feasibility and RDL (recommended dose level) of brentuximab vedotin in combination with R-DHAPSecondary objective:• To assess the toxicity of brentuximab vedotin in combination with R-DHAP• To…
The main objective of this study is to investigate if the occurrence of cognitive impairment and functional reorganization *defined as increased functional activation in cognitively preserved patients- in MS can be explained by changes in GABA and…
primary objective of the trial is to demonstrate non-inferior efficacy of 4-6 cycles of BrECADD compared to 4-6 cycles of escalated BEACOPP, each followed by radiotherapy on PET-positive residual lesions, in terms of progression free survival (…
• Determine a feasible 89Zr-brentuximab-PET imaging schedule, to allow assessment of the biodistribution of 89Zr-brentuximab in tumor and non-target lesions or -organs.• Establish safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…