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This study begins with a screening period that lasts about 28 days to see if a person can join. If eligible, participants will receive a study medicine called JANX014. This is a new immune based drug that is given through a vein at a clinic or hospital. The medicine may be given once every week, every two weeks, or every three weeks, depending on the study group and safety results. The study has two parts. In the first part, small groups receive different dose levels to find a safe amount of the medicine. In the second part, more people receive selected doses to learn more about safety and early effects. During the study, participants will have regular visits that include physical exams, blood and urine tests, heart tests, and imaging scans such as CT or PET scans. Some early treatment visits may require short hospital stays so doctors can watch closely. Participants may also check their temperature and blood pressure at home.

You will be in this study for about 122 weeks. The study has three parts called Screening, Treatment, and Follow up. During screening, which can last up to six weeks, doctors will do tests to see if you can join. If you qualify, you will be placed by chance into one of two groups. One group will get a study drug called anifrolumab, and the other will get a placebo, which looks like the medicine but has no active drug. You will also keep taking your regular medicines for polymyositis or dermatomyositis. You must stay on the same dose of your regular medicines for at least the first eight weeks of the study.

In this study, people will take a study medicine called JZP 3507 by mouth as tablets. They will take the medicine twice a day for three days in a row each week. This pattern repeats in cycles that last 28 days. The study has several parts, including a screening period to see if someone can join, a treatment period, a safety follow up, and a long term follow up that can last up to three years. The whole study may last about four years and includes many study visits. During the study, participants will have regular checkups such as physical exams, blood and urine tests, heart tests, and scans like MRI. Everyone in the study will receive the study medicine, and both the participant and the doctor will know what treatment is being given.

Copilot said: Participation in this study requires very little time. The research muscle biopsy will be done at the same time as the biopsy that is already planned as part of regular medical care. After that, no additional study visits or time commitments are needed.

Researchers will review participants medical records and collect health information for a research repository. During routine blood draws, participants may provide a blood sample, and urine samples may be collected every 3 months. If a participant has a muscle biopsy, leftover tissue may also be stored for research if they agree.

We are doing this study to find out if an experimental drug called KTX-1001 (the study drug) is a safe and effective treatment for multiple myeloma. We want to identify the most appropriate dose and dosing schedule of the study drug for patients with multiple myeloma.

When a patient arrives at Duke and qualifies for the study, they will be placed into one of three treatment groups. Some will get only levetiracetam, while others will get levetiracetam with either a low or high dose of ketamine. The medical team will watch the patient closely and check how they are doing at 15 minutes and 1 hour after the study medicine is given. An monitoring headband device will also be placed on the patient's head to measure brain activity and watch for seizures. The study team will continue to check on the patient for up to 24 hours, or until the patient leaves the hospital-whichever happens first. Once the patient goes home, their part in the study will be finished.

We are doing this study to compare a ketogenic diet (a diet with high fat, moderate protein, very low carbohydrate) versus a normal diet. We want to find out if it has any effect on survival time for people with glioblastoma multiforme (GBM). We also want to know how biomarkers change when people follow a ketogenic diet. A biomarker is a biological molecule found in blood, other body fluids, or tissues. Biomarkers may be a sign of a condition or disease and can be used to predict someone's response to a specific treatment.