This study is for patients that have been diagnosed with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received at least 1 and no more than 3 prior systemic lines of anticancer therapy. The investigational drug used in this study is Raludotatug Deruxtecan (R-DXd). Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the optimal dose of R-DXd for further clinical development. In Phase 3, participants will be randomized between R-DXd and investigator's choice of chemotherapy. Randomization is like flipping a coin, essentially meaning that each option has an equal likelihood of being selected. The drug is given to participants through infusion. Participants can continue to receive the study drug until it no longer gives them benefit. Researchers will continue to follow up with patients long-term.
This phase 3 study is recruiting patients who have Essential Thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. This study will measure the safety and effectiveness of an inhibitor treatment called bomedemstat. Bomedemstat is an "investigational" (not yet FDA approved) treatment. The main purpose of the study is to how bomedemstat compares to BAT (best available therapy) as an effective treatment for ET. The study will enroll approximately 300 patients who will be randomly assigned 1:1 (like flipping a coin) to either bomedemstat or BAT. The study includes a screening phase, initial treatment phase, extended treatment phase, and posttreatment phase. The initial treatment portion of the study begins on study Day 1 and continues until the participant completes treatment at Week 52. The primary endpoint analysis will be performed on data from the first 52 weeks of treatment. Patients who have not discontinued study treatment at Week 52 will be eligible to continue receiving study treatment in the Extended Treatment Phase for up to Week 156. Patients in the BAT arm who have received a minimum of 52 weeks of treatment and discontinued study treatment due to intolerance/resistance/refractoriness/inadequate response (defined by the investigator as per the local product labels of BAT regimens) may be eligible to switch to the bomedemstat arm during the Extended Treatment Phase at the investigator's discretion (as per protocol defined eligibility to receive bomedemstat). Patients 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 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.
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 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.
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 research study is focused on evaluating the effectiveness of a new imaging technique for a procedure called Prostate Artery Embolization (PAE), which is used to treat an enlarged prostate. The study compares two groups of patients: one group receives PAE with advanced imaging called 3D CTA fusion, and the other group receives PAE using the standard imaging method. The goal is to determine if using 3D CTA fusion can make the procedure faster, reduce the amount of radiation exposure, and decrease the need for contrast dye during the procedure. By studying these two groups, researchers hope to identify ways to make PAE safer and more efficient
The purpose of the study is to examine whether certain neck strengthening exercises result in change in size of the neck muscles being targeted.
Musculoskeletal Ultrasound is a non invasive, safe tool that will be used to measure the size of certain muscles in your neck. This will allow us to determine if these muscles actually get bigger in response to targeted exercise. Muscle size is a factor associated with strength.
This study will help us tease out the time it takes to create neck muscle hypertrophy, or increase in muscle size, in order to develop effective protocols for neck strengthening which may be useful in the management of chronic neck pain.
Weakness in certain neck muscles may be associated with the development of neck pain and we hope to determine effective training protocols for these neck muscle groups.