6 results
The primary objective is to measure the frequency of unexpected critical errors* of the Accu-Chek Combo® encountered during everyday normal use. (*Unexpected critical errors are device related events that may result in an adverse or serious adverse…
Primary objective:To compare the pharmacokinetics of testosterone and sildenafil citrate following administration of a sublingual solution of testosterone with an encapsulated tablet versus a combination product.Secondary objective:To investigate…
Primary Objective: To determine the safety and efficacy of 6000 IU Cinryze in patients with moderate and severe TBI (GCS <13 with a clinical indication for ICP measurements).Primary hypothesis: The hypothesis is that random assignment to…
Primary Objective: To determine the safety and efficacy of 6000 IU C1-INH in patients with subarachnoid hemorrhage (SAH)Primary hypothesis: The hypothesis is that random assignment to C1-INH in SAH will lead to a reduction in delayed cerebral…
The aim of the present *proof-of-principle* study is to test in patients suffering from AIHA whether co-administration of C1-inh improves the recovery of RBC transfusion by the inhibition of the activation of the classical pathway of complement. In…
The purpose of this investigation is to confirm long-term clinical performance and safety of the InterStim Micro System. The primary objectives of the study will evaluate data at 3 months post-implant; however, subjects will be followed for 2 years…