Co-occurring post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) disproportionately affects Veterans and has significant negative impacts on the safety, wellbeing, and quality of life of Veterans, their romantic partners, and their families. However, treatments that address co-occurring PTSD-AUD and restore Veterans' psychosocial functioning are lacking. The overall goal of this project is to improve treatment approaches aimed at reducing symptoms of co-occurring PTSD-AUD and improving functioning among Veterans and their partners. We plan to do this by learning from Veterans, family members, and treatment providers in order to inform an adaptation of a brief dyadic AUD intervention to be delivered alongside integrated PTSD-AUD treatment for Veteran couples and then conducting a pilot trial of an adapted Brief Family Involved Treatment (B-FIT) intervention with Veterans with PTSD-AUD and their romantic partners.
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 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 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 study is for patients who have non-small cell lung cancer that is stage IV or has returned after remission. The goal is to compare the usual treatment by itself to the usual treatment plus a drug called cemiplimab. "Investigational" means this drug combination has not been approved by the U.S. Food and Drug Administration (FDA). A computer will randomly assign patients to one of two groups. This process is called "randomization." Patients will be placed into a group by chance, like flipping a coin, and will have an equal chance of being in Group 1 or Group 2. The drug is given by infusion. Patients will keep getting treatment until the cancer gets worse. Each treatment cycle lasts 21 days. After the last cycle, patients will be followed for up to 3 years.
This is a clinical use of an FDA-approved Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) called Miltenyi Biotec CliniMACS CD34. The intent is to treat patients with Myelodysplastic Syndrome (MDS) in a clinical setting, not to conduct research or gather data on safety or effectiveness. No data will be collected beyond what is required for standard clinical care. Device-related processing will occur at an NMDP Advanced Cell Therapy Lab Solutions facility, and the resulting cell product will be transported to MUSC Hollings Cancer Center for infusion. Eligible patients are in first complete remission and undergoing allogeneic stem cell transplant (SCT) from an HLA-identical matched related donor. Patients will be provided MUSC's standard treatment consent per institutional policies. The HUD will be stored, dispensed, and used at NMDP in accordance with standard operating procedures.
This study is for women who have delivered a child in the past 18 months, have experienced one or more traumatic events during their lifetime, and use substances. First, the research involves completing brief screening questions over the phone to determine eligibility for the study. Second, eligible women will be invited to complete a 60- to 90-minute study visit comprised of an online survey and an interview about their opinions on postpartum substance use and potential future resources to help address substance use among postpartum women with trauma histories.
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.
The study will test an investigational drug known as 4D-710. An "investigational drug" is one that has not yet been approved for use by a Health Authority such as the United States Food and Drug Administration (FDA). 4D-710 is being studied as a potential treatment for cystic fibrosis lung disease. This is the first study to test 4D-710 in humans. The purpose of this study is to see if 4D-710 is safe for use in adults with cystic fibrosis and to see if 4D-710 can help lung function.