Clinical Trials Directory
Being in this study lasts up to ten months. After screening and joining, participants may choose to use the Minder device or receive regular epilepsy care only. People who choose the device will have a small brain monitoring device placed under the scalp. About two weeks later, they will receive a wearable device and a study phone. People using the device will then be placed by chance into one of two groups. In one group, the study doctor can look at the device information during the study. In the other group, the information is collected but not reviewed until the study is over. Everyone in the study will have follow up visits around one month and six months, answer questionnaires, review medicines, and track seizures. Some visits may happen by phone or video.
Taking part in this study can last up to two years after joining. People will have a first visit and then follow up visits every six months, for up to five visits total. These visits may happen in person, by phone, or by video. At each visit, the study team will check overall health, seizures, medicines, hospital stays, and any problems with the implanted device. They will also review information collected by the Minder device and ask people to answer questions about mood, memory, anxiety, and quality of life. Between visits, the study doctor may review device information each month as part of regular care. Some people may be asked to come in for extra visits if needed. No new surgery is required because the device was already placed before the study.
We are doing this study to test the safety and effectiveness of the study drug, datopotamab deruxtecan (also known as dato-DXd), and find out if it is a potential option for patients with metastatic breast cancer that has spread to the brain and/or spinal cord.
The study team will collect medical record information from your hospitalization for pneumonia. You will also be asked to provide a urine (pee) sample for additional testing.
Participants will be admitted to the Duke Early Phase Unit for 2 nights, and receive an infusion of either the study drug or placebo. Safety will be monitored for at least 24 hours after the infusion, and there will be numerous blood draws.
People in this study will keep taking their regular HIV medicines. They will receive either a study medicine called GS 0415 or a placebo, which has no active medicine. The study medicine may be given as a shot under the skin or through a vein. During the study, participants will have clinic visits for physical exams, blood and urine tests, heart tests, and HIV testing. Depending on the study group, they may receive one dose or up to five doses of the study medicine. Some visits will include staying overnight in the clinic so doctors can watch for side effects and make sure the treatment is safe. The study lasts about three months and is designed to learn more about the safety and effects of GS 0415 in people living with HIV.
This study starts with a screening visit to see if a person can join. After that, there are thirteen study visits over about twenty weeks. During this time, participants will receive three shots of the study medicine called DISC 3045 given under the skin. All study visits include blood tests, and one visit will include two blood draws. People may also choose to stay in the study longer for another twelve weeks. If they continue, they will receive three more shots of the study medicine and have seven more study visits with blood tests.