This study is an open label, Comparative Effectiveness Research study in patients who receive a heart transplant. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. The study objective is to compare the effectiveness of rejection surveillance of heart transplant recipients with Prospera dd-cfDNA to rejection surveillance with endomyocardial biopsy (EMB) in the first post-transplant year.
The Prospera™ test is a non-invasive test intended to detect and quantify the fraction of donor-derived cell-free DNA (dd-cfDNA) to supplement management and surveillance of allograft rejection in patients who have undergone organ transplantation. The subjects may undergo blood draws, echocardiogrphys, medical history and physical exams, antibody testing, nuclear imaging, and MRI as apart of the study. The study period will be during the first 12 months post-transplant. Quality of life questionnaires will be completed at week 4, month 6 and month 12 post-transplant.
This phase 3 study is recruiting patients who have myelofibrosis who have never had a JAK inhibitor. This study will measure the safety and effectiveness of a tumor protein inhibitor treatment called navtemadlin combined with another tumor protein inhibitor called ruxolitinib. Navtemadlin is an "investigational" (not yet FDA approved) treatment, Ruxolitinib is FDA approved. The main purpose of the study is to see if navtemadlin combined with ruxolitinib is an effective treatment for myelofibrosis. The study will enroll approximately 180 patients with each patient initially receiving ruxolitinib. The study includes a screening period, run-in period, and a randomized (like flipping a coin) add-on period. The first two periods will be over the course of 18-24 weeks while the randomized add-on period is for those whose treatment with ruxolitinib is not effective enough and will last for a different amount of time for each patient. In the run-in period after screening, patients will take ruxolitinib at the dose determined by their study doctor for 18-24 weeks. If treatment with ruxolitinib alone is not effective, the participate will be randomized into one of two groups. In the randomized add-on period, participants will either receive ruxolitinib with navtemadlin 240 mg or a matching placebo (a pill that contains no medicine) daily for one week out of the 28-day cycle in combination with ruxolitinib at a dose determined by their study doctor. Patients in this group will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. 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 study is for patients that have been diagnosed with high risk neuroblastoma. This study is testing an investigational drug called Dinutuximab, which will be combined with standard care induction and transplant. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA).
The primary purpose of this study is to compare treatment outcomes of participants who are assigned to early chemoimmunotherapy (Dinutuximab and Sargramostim) during Induction to treatment outcomes of participants who are not assigned to treatment that includes early chemoimmunotherapy. Participants will be randomized to the standard of care arm of the trial or the standard of care arm plus chemoimmunotherapy (like flipping a coin). The investigational drug is given to participants through IV infusion. Participants in this study can expect to be in this study for a total of five years.
This study is designed as a prospective, multi-centered, double-blind, randomized, delayed-stimulation/ sham-stimulation controlled 12-month study to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using the Infinity™ Deep Brain Stimulation (DBS) system as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) for adults who are experiencing a Major Depressive Episode (MDE) with inadequate response to 4 or more antidepressant treatments.
The purpose of this research study is to learn how Deep Brain Stimulation (DBS), which targets a part of the brain called the subthalamic nucleus (STN), may affect thinking and memory in people with Parkinson's Disease (PD). We plan to include about 55 people with PD who have already had DBS surgery at MUSC's Clinical DBS Program.
As part of the study, participants will attend two visits after their DBS surgery. The first visit, which will last about three hours, includes going over the study information and consent form, collecting background information (demographics), and completing tests that measure thinking and memory (cognitive assessments) and speech. The second visit, also about three hours, will involve an MRI scan to look at how the brain's networks change when the DBS device is turned on and off. Participants have the option to combine visits 1 and 2. Participant's will also be invited to undergo an optional second scan. If participants consent, the second scan will be performed on a separate day than the first scan and therefore, there will be a total of 3 study visits.
These findings may help doctors and researchers make better decisions about which patients are most likely to benefit from DBS surgery and how to choose the best stimulation settings to reduce unwanted changes in thinking and memory.
This study is enrolling subjects with heart failure and a reduced ejection fraction meaning the heart does not pump enough blood to meet the body's needs. This study is researching an investigational device (study device) called the Alleviant ALV1 System. Investigational means it has not been approved for commercial use by the Food and Drug Administration. (FDA) This study will test the safety and effectiveness of the Alleviant ALV1 System. The Alleviant ALV1 System is intended to create a shunt (an opening) in the heart to allow for proper blood flow through the heart which may improve your symptoms. No device is left in your heart it is just used to create the shunt. This is a randomized study which means subjects are assigned by chance to either have the study device create this shunt or not have the study device create the shunt. Randomization is 50/50 meaning there is a 50% chance to have the study device create a shunt and a 50% chance the study device will not be used. Using the study device to create the shunt is performed during a right heart catheterization (RHC) so all subjects will undergo the RHC but only 50% will have the shunt. Neither the subjects nor the study doctor will know which group subjects are randomized to but other study staff will know in the event this information is needed. All subjects will stay overnight in the hospital after the procedure. Other study related procedures include echocardiograms - ultrasound test of the heart, electrocardiograms (ECG) - a tracing of the heart's electrical activity, blood work, questionnaires, 6 minute hall walk test, and assessments of heart failure status. Risks include risks related to the study device including blood vessel damage from placing the device in the vein to get to the heart, risks from the right heart catheterization such as bleeding or bruising, abnormal heart beats, and risks related to study related procedures. There may be risks that are not known at this time. Participation in this study is expected to last about 60 months and include approximately 15 in person visits and 3 telephone calls.
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. This project is designed to learn more to facilitate improving treatment approaches aimed at reducing symptoms of co-occurring PTSD-AUD and improving functioning among Veterans and their partners. The goal of this project is to learn 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.
This study is for patients that have been diagnosed with metastatic castration-resistant prostate cancer. The study is testing an investigational drug called JANX007. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 when administered as a single agent. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study until disease progression or unacceptable toxicity.
This is a non-invasive, observational study aiming to collect data on the impact chest tubes have on inpatients during their hospitalizations. Sleep and activity patterns, as well as select vital signs will be tracked using an MUSC-owned Apple Watch, which subjects will wear, and an MUSC-owned iPhone, for up to seven days during admission to the hospital. Each day, a study coordinator will visit subjects to collect a brief sleep survey. Participation may last up to 7 days while subjects are admitted and have a chest tube in place. Upon completion of the study, a study coordinator will collect the Apple Watch and iPhone for data analysis.
This pilot data will provide initial information on the feasibility of collecting and performing a larger study on the inpatient mobility, activity, and sleep.
This is a Phase III study is for patients that have been diagnosed with with early-stage non-small cell lung cancer. The primary purpose of this study is to see if there is a difference in overall survival rate in patients changes based on when they start their drug treatment, either before or after surgical intervention. Participants in this study can expect to be followed for up to 10 years. This study has two groups and a computer will be used to assign study groups. Participants will be randomly assigned to receive either neoadjuvant therapy followed by surgery and adjuvant therapy, or surgery followed by adjuvant therapy. This is called randomization. Patients will have an equal chance of being in either group, similar to flipping a coin.