8 results
7.2 Primary ObjectiveThe primary objective is to assess the incidence of FVIII inhibitory antibodies(>=0.6 Bethesda units [BU] using the Nijmegen modification of the Bethesda assay).7.3 Secondary Objectives1. To evaluate the PK parameters of…
AdOpt CRT is designed to compare indices of cardiac function at device settings optimized using an investigational Adaptive CRT (aCRT)algorithm versus CRT with nominal programming. The comparison will be performed during rest and submaximal exercise…
The aim of this pilot-study is to examine the accuracy of MRL compared to current nodal staging methods. We expect an acceptable accuracy of the MRL based on earlier studies with gadofosveset enhanced MRI in rectum cancer patients. A positive MRL…
To study the feasiblity of cardiac MRI at 3T and the potential benefits of the intravascular contrast agent gadofosveset for studying and quantifiaction of heart function and -perfusion.
Primary objective• To validate the potential of Vasovist®-enhanced MRI for accurate prediction of nodal status in patients with primary rectal cancer using histopathological examination after surgery as the SOR.Secondary objectives• To compare the…
The aim of this pilot-study is to examine the accuracy of MRL compared to current nodal staging methods. We expect anacceptable accuracy of the MRL based on earlier studies with gadofosveset enhanced MRI in rectum cancer patients. Then the MRL could…
Study Purpose* To continue the evaluation of the safety and efficacy of prophylaxis with BAX 855 for the prevention and treatment of bleeding episodes in PTPs (children and adults from 0 to 75 years of age) with severe hemophilia A.Primary…
Primary Objective:The primary objective of the study is to determine the safety including immunogenicity of BAX 855 based on the incidence of inhibitor development to FVIII (* 0.6 Bethesda unit (BU)/mL using the Nijmegen modification of the Bethesda…