7 results
Demonstrate the sensitivity of the diagnostic feature "Physiological Diagnostic" (PhD) to detect clinically relevant HF-related events and to demonstrate a reasonable number of false positive indications.
In the present clinical investigation, we will perform an analysis of baseline risk factors to identify predictors for appropriate ICD intervention in patients with ischemic cardiomyopathy receiving an ICD for primary prevention (MADIT II population…
(1) to determine the feasibility to sense and pace the myocardium with an- ICD lead placed in an alternative position (2) to determine the best position for pacing and sensing in the alternative position(3) to determine the safety and feasibility to…
The primary objective of this study is to evaluate efficacy and safety. Secondary objectives: PK, PK-PD.
Primary Objective:The primary objective is to compare the incidence of drug-related Grade 3 - 5 AEs of N3I1 to N1I3 in subjects with previously untreated, unresectable or metastatic melanoma.Secondary Objective:• To evaluate the ORR, as determined…
This study will investigate whether treatment with Nivolumab in combination with radiation therapy, is comparable to Temozolomide in combination with radiation therapy in patients with Unmethylated MGMT Glioblastoma. We will measure this by…
To compare PFS of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes treated with RT plus TMZ combined with nivolumab or placebo. PFS will be determined by BICR based on RANO criteria.To compare OS of subjects with newly-…