9 results
The main objective of the study is to determine the PK and PD of IVIg during maintenance treatment in patients with CIDP. These data will be used to conduct a NONMEM analysis in relation to the dosage, frequency and batch of IVIg used. The secondary…
The first objective is measuring striatal D2 receptor binding before and after dopamine depletion with AMPT in the UHR population compared to healthy controls, and investigate whether dopaminergic dysregulation is present prior to transition to…
Main goal is to gain more insight in the role of dopaminergic neurotransmission in rewards, motivation and the attribution of salience in the etiology of psychosis. Primary question is whether a change in blood oxygation level dependent (BOLD) fMRI…
We aim to establish proof-of-concept for use of pembrolizumab as novel neo-adjuvant therapy in dMMR and POLE-EDM UC. When ICB proves to be feasible as defined in the primary endpoint (see 2.1), we will follow-up with larger studies to determine…
Based on the success of the pilot feasibility study, we propose a follow-up efficacy study to explore neo-adjuvant ICB therapy as potential alternative for SoC adjuvant radio(chemo)therapy in MMRd UC.
Primary ObjectivesTo assess, as primary economic outcome measure, cost-utility of a personalised multimodal orthotic treatment approach to reduce the risk of plantar foot ulcer recurrence in diabetes.And, as primary patient-related outcome measure,…
Primary:To determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-5890 when used as monotherapy and in combination with pembrolizumab in the dose escalation and confirmation phase and the dose…
Main objective:English To determine the antitumor activity of SAR444245 in combination with other anticancer therapiesSecondary objectives: English - To assess the safety of SAR444245 when combined with other anticancer therapies- To assess other…
The primary efficacy objective of this trial is to evaluate the anti-tumor activity of pembrolizumab in subjects with any of a *basket* of rare malignancies (biomarker unselected and biomarker selected). ORR will be used as the primary endpoint per…