This study is for patients that have been diagnosed with previously untreated, locally advanced, and metastatic pancreatic ductal adenocarcinoma PDAC. This study is testing two treatment regimens: NALIRIFOX (5-fluorouracil, liposomal irinotecan, oxaliplatin, and leucovorin) vs mGAP (gemcitabine, nab-paclitaxel, and cisplatin).
The primary purpose of this study is to see which of the two regimens is more effective in PDAC. Participants will continue on study medications if seeing clinical benefit, and can expect to be on the study for a maximum of 6 months.
This a blood draw study. Blood samples will be collected every 4 weeks on women diagnosed with fetal growth restriction. We hope it will help to determine other ways to evaluate patients with fetal growth restriction and thus improve outcomes.
To describe current real-world utilization of mcfDNA testing for CV infections using a multi-center retrospective registry. We will develop multi-center REDCap database of mcfDNA use in valvular IE and/or CIED lead infections and summarize patient demographics and clinical characteristics of IE and CIED lead infection cases. We will assess common scenarios/indications for which mcfDNA is sent and timing of the test. Clinically relevant microbiological yield of mcfDNA in IE and/or CIED lead infections will be described.
To identify clinical predictors where mcfDNA outperforms CMT. We will assess clinical characteristics of patients with IE and CIED lead infection in whom mcfDNA has higher microbiologic yield compared to CMT. We will develop a prediction model/scoring system to identify subgroup of patients in whom mcfDNA should be sent early (after 48 hours of negative CMT).
To analyze clinical impact of mcfDNA testing in patients with valvular IE and/or CIED lead infections. We will classify cases as having Positive vs. Negative vs. Neutral impact using pre-specified definitions and assess predictor of positive clinical impact.
This study is enrolling participants with heart failure, a condition where the heart muscle does not pump blood efficiently, with preserved ejection fraction, meaning the heart muscle contracts (squeezes) normally but is unable to relax appropriately. The study involves implanting a pacemaker, a small device that is placed in the upper left chest, and then programming it to either standard settings or personalized settings for you based on your height and heart function. The programming is randomized, meaning assigned by chance, like flipping a coin so you do not get to choose which group you are in nor does your doctor. The study is trying to determine if using the pacemaker to control your heart rate can help you heart failure.
Your participation will last at least 18 months and may be as long as 4.5 years depending on when you join the study. The study will include about 8 visits and include the pacemaker implant procedure as well as testing such as physical exams, 6 minute walk test, echocardiograms (ultrasound test of your heart), blood work, questionnaires and pacemaker checks.
There are risks associated with the pacemaker implant procedure, risks related to study related procedures and the risk of loss of confidentiality. There may be benefit to you and to others with this condition in the future.
This study is patients that have been diagnosed with high-risk renal cell carcinoma. This study will compare disease free survival (DFS) in patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone. Participants can expect to remain in the study for 10years. There will be a total of 14 patient enrolled locally.
This study is looking for individuals who have resistant hypertension. This is a non-interventional research study and it does not involve a new drug or treatment. The goal of this study is to find out how many people with resistant hypertension, a type of high blood pressure that is hard to control, also have high levels of a hormone called cortisol. High cortisol levels, a condition called hypercortisolism, may make it more difficult to manage blood pressure. If you join the study, you will attend two to three clinic visits. During the first visit, you will go to the clinic for a short checkup. You will have vitals and your medical history reviewed. You will also have a blood draw and be given a pill called dexamethasone which will help us assess your cortisol levels. At your second visit you will fast and have a your blood collected to review your cortisol levels. If necessary, you will be invited for a third visit where you will get a CT scan. The risks associated with the study include bruising, dizziness, or, in rare cases, infection from blood draws, allergic reactions from taking the dexamethasone pill, and exposure to radiation from the CT scan. The study will be completed over the course of 2-3 visits in one months timeframe.
This phase 2 study is screening patients who may have acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). This study is a non-treatment protocol and the first step of taking part in myeloMATCH, which is a clinical trial. The main purpose of the study is to see if testing on patient's bone marrow and blood results in finding certain biomarkers that will qualify participants for the treatment study or for Standard of Care (SOC) therapies. The study will enroll approximately 5000 patients. The study has two periods, initial and post-treatment screening. It takes about four days for the study doctor to receive the screening results and the patient's first treatment assignment in myeloMATCH. Patients will complete post-treatment screening after their participation in treatment trials or SOC therapies. It will take about 11 days for the study doctor to receive these results and decide their next treatment assignment. Further testing may match patients with myeloMATCH substudies in the future. The main risk is that biomarker test results may be wrong. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.
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.