4 results
To establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve (THV) in subjects with moderate, calcific aortic stenosis (AS)
The main aim is to test whether cetuximab-IRDye800CW is a reliable marker for residual tumor remnants in resection margins after surgical removal of head and neck cancer. To increase the specificity of cetuximab-800CW, a specific frozen section can…
The design will be a prospective, single center phase I feasibility and dose finding study in patients with high-grade glioma, to establish the safety, feasibility, and optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery, in…
Primary ObjectiveTo assess the efficacy of Kamada-AAT for Inhalation administered at a dose of 80 mg daily versus (vs) placebo, with efficacy measured by FEV1 post bronchodilator change from baseline at 104 weeks.Secondary ObjectiveTo assess the…