The study is designed to look at the usefulness and safety of Solriamfetol (versus placebo) for the treatment of excessive sleepiness associated with shift work disorder (SWD). Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 18-65 years old with a diagnosis of SWD. The study will last approximately 17 weeks, with 6 in-person visits and 8 remote visits for each participant.

This study involves a procedure called renal denervation with an investigational device called the TIVUS™ system for the treatment of resistant hypertension (high blood pressure). Investigational means it is not yet approved for commercial use by the Food and Drug Administration (FDA). Renal denervation is a procedure done by introducing a catheter (long tube) into the large blood vessel in your groin (top of leg) and guiding it to your renal arteries, which are the blood vessels that go to your kidneys. The catheter will be placed in the renal arteries and ultrasound energy will be delivered to the renal arteries.
This study is randomized, meaning you will be assigned to one of two groups, by chance, like drawing straws. Two out of three participants will be randomized to renal denervation while one out of three will be randomized to sham. Sham means you will go through all the steps of the procedure but will not receive the treatment. Those participants randomized to sham will have the option to crossover and have the procedure after the 6 month follow up.
This study will involve at least 12 visits over the course of 36 months. Study related procedures include CT scan, ultrasound test of your heart and kidneys, blood work, urine studies, physical exams, questionnaire, and keeping home blood pressure diaries.
Study related risks include risks related to the procedure including pain, bleeding, damage to the blood vessels, risks related to the study related testing such as radiation risks, blood draw risks and loss of confidentiality. There may be benefit to you as well as others in the future with high blood pressure.

This study is asking for volunteers who have been diagnosed with acute pulmonary embolism (PE). PE is a blood clot that blocks and stops blood flow to an artery in the lung. PE usually results from a blood clot in the leg that travels to the lung. Patients with PE may have shortness of breath, chest pain and/or an irregular heartbeat. This study will use a device known as the Vertex Pulmonary Embolectomy System. The Vertex Pulmonary Embolectomy System is a medical device which is indicated for use in the pulmonary arteries for the non-surgical removal of blood clots from blood vessels. The Vertex System has not yet been approved for use by the Food and Drug Administration (FDA) but is approved for use in this study for PE removal. Your study doctor will inform you about the risks that are related to your PE procedure. The risks associated with the study include loss of confidentiality and unknown risks. There will be no benefit to you, but it is hoped the information gained will add to the understanding of treatment options for others in the future. You do not have to participate to have your condition treated. This study will take 30 days to complete.

This registry is enrolling subjects who are indicated for renal denervation to treat high blood pressure that has remained high despite treatment. Renal denervation is a procedure where a catheter (a thin, flexible plastic tube with four electrodes near the end) is placed inside the blood vessels that go to the kidneys. Heat is delivered through the electrodes to disable the nerve activity and lower the blood pressure.

Participation in this registry will last about 1-3 years and include 3-6 visits depending on how often your doctor typically conducts follow up visits. Data will be collected including medical history, medications, blood pressure readings, labs, from the procedure and from any complications if applicable. There is a risk of loss of confidentiality and there may be risks that are not known. There may be no direct benefit but the information learned may help others in the future.