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.
The purpose of this study is to evaluate investigational treatments (study drug) in people with subjects with c-Met over-expressed refractory metastatic colorectal cancer
The purpose of this study is to determine the recommended ABBV-400 dose when ABBV-400 is given alone (monotherapy) in Stage 1, and to assess if ABBV-400 monotherapy is a safe and effective treatment compared to the standard of care (SOC) LONSURF [Trifluridine and Tipiracil] plus Bevacizumab in subjects with c-Met overexpressed (level of c-Met protein in your tumor cells is increased) uncontrolled metastatic colorectal cancer in Stage 2 of the study plan.
This is a phase 3 study; ABBV-400 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 3 years. The procedures include taking study drug intravenously, blood and urine samples, MUGA scans and CT scans. Risks include diarrhea, nausea, vomiting, anemia, muscle aches, and joint pain. 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.
This study is enrolling subjects with coronary artery disease (blockages in the arteries that supply blood to the heart) who need to undergo a procedure called a Percutaneous Coronary Intervention (PCI) to open up a blocked heart artery. At times, a heart pump is used during a PCI to help reduce the work the heart during the procedure. This study is evaluating a heart pump called the KARDION CORY P4 pump. The KARDION CORY P4 pump is investigational meaning it has not been approved for commercial use by the Food and Drug Administration (FDA). This study will randomize subjects, meaning assign by chance, to receive either the KARDION CORY P4 pump or the Impella CP, which is commercially available.
Study participation will last about 30 days and include up to 6 visits. The study includes blood work, questionnaires, an electrocardiogram (ECG) - a tracing of the heart's electrical activity and an echocardiogram (Echo) - an ultrasound test of the heart.
Risks include risks related to the study device including bleeding, infection, and injury to the blood vessel where the device is placed. There are also risks related to study procedures. There may be benefit and the information learned may benefit others in the future.
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.
The purpose of this study is to determine the best strategy to help individuals improve blood pressure control after a stroke. The study will test two different interventions (an intervention is an action taken to prevent or treat disease and/or improve health).
1) Intensive Clinic Management (ICM), which consists of clinic visits, home blood pressure monitoring, text message health reminder from Carium®, a care management application, and health education.
2) Intensive Tailored Telehealth Management (ITTM), which consists of telehealth (video) visits, health coaching with lifestyle coaching company INTERVENT International, LLC, and remote blood pressure monitoring captured in Carium®.
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.
Atrial fibrillation (AF) is an arrhythmia in which the heartbeat becomes irregular due to abnormal electrical signals in the upper chambers of the heart, called the atria. This leads to ineffective pumping of blood by the atria. Complications related to atrial fibrillation are heart failure, stroke, heart palpitations and fatigue. This study is motivated by the need to address the increasing prevalence of AF, which is the most common sustained arrhythmia worldwide. While treatment options for AF include the use of antiarrhythmic drugs which are a group of medications used to treat irregular heartbeats, and catheter ablation procedures, the latter have been associated with significantly better outcomes. Participation in this study consists of 2 phases, 1- randomization 2- ablation procedure and follow-up period.
The randomization to the different groups is considered the research part of the study. Subjects will have equal chance of being randomized (like tossing a coin) to one of two AF ablation treatment groups. All follow up will be according to stand of care practices. Risks include stroke, pericarditis, acute and delayed perforation, hemolysis, acute kidney injury, and coronary artery spasm.
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). 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.
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.
The study is for patient that are receiving camizestrant as a treatment. The main purpose of study is to change the dosage of camizestrant from 150mg to 75mg. This change was prompted by updated, emerging data from ongoing studies showing
no difference in efficacy between the 75 mg and 150 mg doses. Subject can expect to be in this study for up to 24 months.