ANNEXa-1 (18-513): This is a randomized, multicenter clinical trial designed to determine the efficacy and safety of andexanet compared to usual care in patients presenting with acute intracerebral hemorrhage within 6 hours of symptom onset (from the baseline scan) and within 15 hours of taking an oral FXa inhibitor (from randomization). The study will use a prospective, randomized, open-label design, as it is unfeasible to blind the Investigator to the treatment assignment given the many potential therapeutic options available under usual care treatment.
The RECOVER study is a nationwide clinical trial that has been approved by Medicare to provide additional evidence for the benefits of Vagus Nerve Stimulation (VNS) Therapy. Vagus Nerve Stimulation Therapy is an FDA-approved device for treating patients with TRD (Treatment Resistant Depression). It is implanted in the left chest area during a short outpatient procedure. The device delivers mild, intermittently pulsed signals to the vagus nerve in the neck that activate various parts of the brain.
The purpose of this research study is to assess the impact of the BSC penile prostheses devices on quality of life in men with erectile dysfunction through the use of questionnaires. The study is an observation of your medical condition for a period of time after the initial implant of the device.