This study aims to create a long-term Ehlers-Danlos syndrome (EDS) biorepository and clinical research database to support gene and biomolecular discovery. The repository will serve as a sustainable resource for advancing EDS-related research by collecting both clinical data and biological samples. Participants who consent will be included in the EDS registry, which stores demographic and operative information, contact details, and biological specimens for current and future studies. Enrolled patients may also choose to be recontacted for future research opportunities. The database will link participants across specialties using identifiers such as name, date of birth, and medical record number. Data collected will include information from electronic health records, such as clinical notes, diagnoses, medications, labs, imaging, anthropometric measures, and procedure reports.
Genicular Artery Embolization (GAE) is a newer treatment aimed at reducing knee pain caused by osteoarthritis by targeting and reducing inflammation. In people with knee osteoarthritis, inflammation in the joint leads to the growth of tiny new blood vessels, called neovessels. These vessels are not normally present in a healthy joint and contribute to ongoing inflammation and pain.
GAE works by selectively injecting tiny particles into specific arteries that supply blood to these abnormal vessels. This process is called embolization, and it temporarily blocks the flow of blood through the neovessels.
Doctors use a special imaging technique called angiography to guide the procedure. This allows them to see the inflamed area and locate the neovessels, which are larger than normal due to the ongoing inflammation—usually about 1–2 millimeters in diameter.
By blocking these abnormal vessels, GAE helps to reduce the number of inflammatory cells and signaling chemicals (called cytokines) that enter the joint through the bloodstream. This decreases the overall inflammation in the area.
Additionally, the growth of pain-sensing nerves, which often occurs alongside these new vessels, may also be reduced. These nerves—called unmyelinated sensory nerves—can worsen pain when they are activated by inflammation. By decreasing both inflammation and nerve growth, GAE may significantly reduce knee pain in people with osteoarthris
The FDA has not currently approved the study device. Patients will undergo 8 visits over a 12 month period. screening, screening 2,treatment, 30 day follow up,90 days,180,270,365 follow up.
This study is evaluating the use of a new technique in ablation of ventricular tachycardia. During a heart procedure called an ablation, doctors must map the heart to find the small areas causing the abnormal rhythm. The study compares two different mapping methods: the standard high-density voltage mapping and a newer method called ILAM, which may help doctors find the problem areas more quickly and precisely. If you join the study, you will be randomly placed—like flipping a coin—into one of the two mapping groups during your procedure. Both methods are already FDA-approved and used for treating VT. You will also have several follow-up visits over 12 months so the study team can check your heart rhythm, device activity (if you have one), and overall health. The goal is to learn whether the newer ILAM method works better or just as well as the standard approach for treating VT.
This research study is being done to evaluate a heart valve called the Navitor Transcatheter Aortic Valve, which may help treat people with severe aortic stenosis, a condition where the heart valve becomes too narrow to open properly. You are being asked to participate because your doctor believes you may benefit from a less-invasive valve replacement instead of open-heart surgery. The study will compare the Navitor valve to other FDA-approved transcatheter valves to see how safe and effective it is for people at low or intermediate surgical risk. The Navitor is considered investigational, meaning it is not yet approved in this population, by the Food and Drug Administration (FDA). Participation may last up to 10 years and involve up to 14 visits, some of which may be done remotely. If you join the study, you will have screening tests, the valve procedure, and regular follow-up visits for several years to check your heart health and how well the valve is working. The risks of participating are similar to those of standard transcatheter valve procedures, such as bleeding, stroke, heart rhythm changes, or infection. While you may experience symptom relief and improved heart function, personal benefit is not guaranteed. Your participation may also help improve future treatment options for patients with aortic stenosis.
This study is being done to see how well a device called FibroScan can detect high pressure in the large vein that carries blood to the heart. FibroScan is a quick, painless test that measures how stiff the liver is, and researchers want to know if those measurements can help identify people with elevated central venous pressure. You are being asked to participate because you have been suspected of having, or diagnosed with, heart failure. Everyone in the study will have the same tests, which include a FibroScan exam, heart ultrasound, EKG, blood work, and a right-heart catheterization. The study lasts about one week and includes a screening visit, a baseline visit, and a phone check-in. By taking part, you may help researchers learn whether this noninvasive device can provide useful information about heart function. Participation is completely voluntary, and choosing not to join will not affect your medical care.
This study is an expanded access protocol for AMTAGVI that has not yet been released for commercial use.
Making the AMTAGVI product involves collecting immune cells from your cancer, growing more of them in the laboratory, and giving them back to you to treat your cancer. AMTAGVI is a commercially available treatment approved by the FDA (US Food and Drug Administration) for advanced melanoma. However, sometimes during the manufacturing of AMTAGVI, the final product is Out of Specification (OOS). This means that the test results for your product do not meet the accepted established criteria. The purpose of this study is to allow expanded access use of out of specification (OOS) AMATAGVI.
Expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. While this use involves an investigational product, this is not a research study.
Risks include vitiligo, swelling of the middle layer of the eye (uveitis), shortness of breath, and increased heart rate. There will be approximately 8-10 study visits over a 24-month period. Visit durations will vary. Patients may or may not benefit from receiving OOS AMTAGVI when compared to receiving no treatment at all.
This study is for patients diagnosed with unresectable locally recurrent or metastatic head and neck cancer. The purpose of this study is to test if adding an investigational drug called amivantamab to the usual chemotherapy (carboplatin and paclitaxel) is more effective in treating head and neck cancer when compared to being treated with carboplatin and paclitaxel alone. Carboplatin and paclitaxel are FDA approved to treat head and neck cancers; however, adding the study drug, amivantamab, is still being investigated and is not approved by the FDA.
Patients may participate in this study for up to 2 years. Procedures include CT, MRI, blood tests, chemotherapy, and regular visits with your doctor including follow-up study visits or phone calls every 3 months. There will be about 50 people taking part in this study, approximately 3 participants will be enrolled at MUSC.
Risks include constipation, nausea, rash, vomiting, swelling of arms and/or legs. Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.
This study is testing a new medicine called Visugromab (CTL-002) to see if it helps people with a type of lung cancer called metastatic non-squamous non-small cell lung cancer. Everyone in the study will get standard cancer treatment, but some will also get Visugromab while others get a placebo (a look-alike with no active drug), and who gets what is decided randomly—like flipping a coin. The goal is to find out if Visugromab makes the treatment more effective and safe. The study will last up to two years, with Treatment in cycles lasting 3 weeks, about once a month. Researchers will closely monitor participants to see how well the treatment works and how their bodies respond. Serious risks of treatment may include heart problems, low oxygen levels, infections, organ failure, and inflammation in various parts of the body such as the lungs, liver, intestines, pancreas, and thyroid.
The purpose of the study is to learn more about an experimental drug called ORC-13661 that may be helpful in treating hearing loss due to antibiotic use. The study is researching whether the drug is safe and tolerable, and trying to find out whether the drug may be able to mitigate or prevent hearing loss in patients being treated with intravenous (IV) amikacin. Participation in the study will consist of up to 10 visits over up to 129 days. The Day 1 visit (following the screening visit) will last up to 8 hours, while other visits will last up to 5 hours Participants will be randomly assigned to receive either ORC-13661at a higher dose or a lower dose or a placebo (a pill that looks the same as the study drug but has no real medicine in it), for up to 90 days to be taken along with IV amikacin. Participants will be asked to have a number of tests and procedures, which include questionnaires about family, medical, and hearing history, physical and hearing examination, and assessments of hearing.