7 results
We hypothesize that the CardioMEMS HF system will be safe and superior to standard care in improving the quality of life and health status in patients with chronic HF in the Netherlands. Additionally, we hypothesize the CardioMEMS HF system is cost-…
The objective of this clinical investigation is to assess and characterize the clinical management of HeartMate 3 LVAD patients guided by hemodynamic parameters provided by the CardioMEMS HF System as a clinical hybrid construction to optimize…
The primary objective of this study is: * To assess the safety and tolerability of single ascending volumes of placebo as well as volumes and doses of AC102-suspension by intratympanic injection in healthy male and female subjects.The secondary…
The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week (eow) subcutaneously (SC) starting at Week 1 compared with placebo in subjects with inactive non-…
The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week (eow) subcutaneously (SC) starting at Week 1 compared with placebo as maintenance therapy in subjects…
To evaluate the effectiveness and safety of concentration controlled combination of once daily dosed low-dose sirolimus (trough levels: 3-5 ng/ml) and extended-release tacrolimus (trough levels:3-5 ng/ml), in order to provide superior renal function…
To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone with respect to overall survival (OS)