This phase 3 study is recruiting patients who are at risk of graft-versus-host disease (GVHD) after a bone marrow transplant. This study will measure the safety and effectiveness of a prevention treatment combination called Tacrolimus/Methotrexate/Ruxolitinib compared to Standard of Care (SOC), Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil. Ruxolitinib (Rux) is an approved treatment for GVHD. This study is divided into two parts. The first part, called the run-in phase, will investigate the best dose of Ruxolitinib. The second part of the study will compare the SOC combination therapy with the investigational combination therapy (which will include Ruxolitinib). Participants will be randomly assigned to one of the two groups (like flipping a coin). The study will enroll up to 572 patients nationwide and 5 at MUSC. The participants can expect to be involved in the study for at least 24 months. The main risk is that medical treatments often cause side effects. The most common side effects expected from the investigational combination therapy are high cholesterol, increased liver enzymes, low platelet levels, and low red blood cell counts. There is no direct benefit for them in participating in this study.
The purpose of this study is to test the effectiveness and safety of the combination of an investigational vaccine, PDS0101, given by subcutaneous (beneath the skin) injection and the standard of care, Pembrolizumab (KEYTRUDA), given intravenously ("IV;" into the vein) compared to pembrolizumab (KEYTRUDA) alone for those with unresectable recurrent or metastatic head and neck cancer and high risk papillomavirus infection. "Investigational" means the combination of the study vaccine and pembrolizumab being tested has not been approved by the US Food and Drug Administration (FDA) nor any other Health Authority.
This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.
Enrolment of patients will be over at least a 5-year period. The follow up of patients will continue for 5 years from the time the last patient has been enrolled. Patients will be followed up regardless of whether they continue or discontinue efgartigimod.
Sharing Our Stories: The Realities of Living with Ehlers Danlos Syndromes (EDS) is a research study to help better understand what it is like to live with EDS. Adults with EDS will complete a one-time video interview with a member of the research team. We hope to better understand the challenges adults with EDS face and learn from them things that make it more difficult and easier to receive care, what their needs are and recommendations for improving an earlier diagnosis, care, and treatment.
This study is for patients that have been diagnosed with advanced solid tumors. This study is testing an investigational drug called BNT317. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the safety, tolerability, absorption of BNT317. BNT317 is administered via intravenous (IV) infusion. Participants can continue to receive this study drug until it no longer gives them benefit. Researchers will continue to follow-up with patients long-term.
This research study is for adult patients diagnosed with Upper Tract Urothelial Carcinoma (UTUC). The purpose of this study is to determine how often genetic variants are found in patients with UTUC. As part of this research study, the research team will collect health information about you from your medical record and blood, saliva, and tissue samples will be collected for genetic testing.
The purpose of this study is to explore whether 4 weeks of at-home transcutaneous auricular neurostimulation (tAN) can reduce chronic pain after a stroke. We will recruit up to 24 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.
The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational drug called bemnifosbuvir-ruzasvir (BEM/RZR) in comparison to the FDA approved comparator drug in treating chronic Hepatitis C Virus (HCV) infection.
The goal of this study is to utilize prospectively collected information from a multisite single-arm trial of 300 HIV uninfected people assigned female gender at birth with lower genital tract neoplasia ("WLGTN") to conduct a unique multidisciplinary study that will clarify issues surrounding anal cancer screening tests in this population as well as help to comprehend the natural history of anal dysplasia among WLGTN. This single arm clinical trial will evaluate screening (diagnostic) tests for anal cancer screening in a population that is not currently routinely screened, determine the prevalence and incidence of aHSIL and
collect data regarding the acceptability of different anal cancer screening approaches. The initial screening interventions will include the collection of (1) anal cytology, obtained by clinician using a water moistened cytobrush; (2) self-collected HPV testing specimens (by subjects, using a Dacron swab); (3) a clinician collected HPV specimen. Anal specimens will be collected by insertion of the cytobrush or moistened Dacron swab into the anal canal until resistance is not met; approximately 5 cm. These tests are followed by a brief standardized exam to determine any external anogenital lesions or pathology, performed by the investigator conducting anoscopy. A digital rectal exam will also be done on all patients. Results of these tests will be confirmed in all patients using high resolution anoscopy (HRA) with biopsy of suspicious lesions. Following standard practices, subjects are treated with 3% acetic acid and Lugol's iodine.
This trial will be a randomized controlled trial designed to determine if women with overactive bladder (OAB), treated with the prescription digital therapeutic (PDTx) demonstrate greater improvement in OAB-related health as compared to standard behavioral education with informational handouts.