The purpose of this study is to test whether adding cetuximab to standard of care (pembrolizumab) is more effective in shrinking tumor size and increasing survival when compared to being treated with pembrolizumab alone. This study seeks to find if this approach is the same, better, or worse than standard of care for returning or spreading head and neck cancer after previous treatment.
Treatment and follow up for this study may be up to 5 years. The procedures include blood tests, CT or MRI scans, and chemotherapy. Risks include tiredness, anemia, constipation, loss of appetite, joint stiffness, cough, swelling and redness of the skin.
You 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. Both drugs, pembrolizumab and cetuximab, are already individually approved by the FDA for use in head and neck cancers. However, the benefit of combining the two drugs is being investigated in this study and this study approach is not FDA approved.
There will be about 158 people taking part in this study, approximately 4 subjects will be enrolled at MUSC.
This study is for adults aged 18 to 39 who have a history of cancer and have not had inherited cancer genetic testing. The purpose of this study is to find out if a digital tool can be used as an alternative to meeting with a genetic counselor before inherited cancer genetic testing, and whether this approach can help support patients through the testing process. The study will compare the digital tool to the usual approach for genetic testing, which involves meeting with a genetic counselor before and after testing.
Participants will be randomly assigned (like flipping a coin) to one of two groups. One group will receive pre-test education through a digital tool, and the other group will meet with a genetic counselor through a telehealth visit. All participants will receive their genetic test results through a telehealth visit with a genetic counselor. Participants in the digital tool group will also have access to a chatbot called the Genetics Journey Chatbot that provides educational support, reminders, and answers to questions during the study.
The study involves completing surveys at several time points: before genetic testing, after the testing decision, after receiving results, and again about 6 and 12 months later. The total duration of participation is about 18 months.
This study does not involve an investigational drug. Participants may benefit from learning whether they have a genetic change that could increase their risk of cancer, which could inform their future screening or prevention options. The information learned from this study may also help improve genetic testing delivery for future patients.
There will be a total of 10 patients enrolled locally over the course of 24 months.
This study is an open label extension of the ACT-EARLY study. which included those with no evidence of ATTR but are known carriers of disease causing TTR gene. ATTR stands for transthyretin amyloidosis. It is a condition in which a protein called transthyretin (TTR) accumulates in various organs, including the heart (known as ATTR-CM), kidneys, and nerves (known as ATTR-PN). This accumulation can lead to damage and dysfunction in these organs.
This study will continue using the study drug acoramidis (AG-10) to determine if it can help people with the genetic TTR variant slow the progression of ATTR. AG-10 is an investigational drug. Investigational means that AG-10 is not yet approved for use in any settings outside of clinical research studies like this one. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time.
Participation in this study will last up to 60 month and will consist of about 13 clinic visits and about 11 telephone follow up visits. Some tests required include physical exams, medical and surgical history, bloodwork, questionnaire, electrocardiogram (test that records your heart's electrical activity), echocardiogram (ultrasound test of your heart) and study drug administration.
The purpose of this research study is to determine the best treatment goals for patients with active CD. Researchers are investigating how treating and monitoring CD to meet specific treatment goals will keep your disease under control (remission) and decrease complications such as hospitalizations and surgeries. Group 1 treatment goals include IUS response (if the drug is improving your CD) and IUS assessed transmural healing (healing of all bowel layers), clinical remission (normalization of CD symptoms), and biomarker remission (improvement in stool and blood tests that show inflammation). Group 2 treatment goals include clinical remission and biomarker remission. Comparing the treatment goals in these groups may inform doctors how best to manage CD in the future. Approximately 304 people will be enrolled in this study. This research study will involve receiving 300 mg of vedolizumab as an intravenous (IV) infusion into your arm at Weeks 0, 2, 6, 10, and 14, then every 4 or 8 weeks thereafter.
This study will recruit adults diagnosed with an oral potentially malignant disorder (OPMD). The purpose of this research study is to collect blood, saliva, and tissue samples to determine whether certain measurable characteristics (biomarkers) can be identified which may provide insight into the risk of developing cancer. Participation in this study is expected to last approximately 3 years.
This study aims to explore the prevalence of mental health symptoms, including trauma exposure and posttraumatic stress symptoms in a postpartum population. The study also aims to collect information related to medical and mental health treatment seeking before, during, and after pregnancy as well as feedback on adaptations of future mental health interventions delivered during the postpartum period. Participation in this study includes a 35 minute online survey with questionnaires related to the study aims. Depending on survey responses, participants may be invited to complete an interview with study personnel to provide more specific insight on mental health treatments for perinatal individuals.
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.