All Clinical Trials

This study is a first in human Phase 1 study that involves patients with a type of cancer called HER2 (Human Epidermal Growth Factor Receptor 2) positive cancer. This study asks patients to volunteer to take part in a research study investigating the safety and efficacy of using special immune cells called HER2 chimeric antigen receptor specific cytotoxic T lymphocytes (HER2 specific CAR T cells), in combination with intra-tumor injection of CAdVEC, an oncolytic adenovirus that is designed to help the immune system including HER2 specific CAR T cell react to the tumor. The study is looking at combining these two treatments together, because we think that the combination of treatments will work better than each treatment alone. We also hope to learn the best dose level of the treatments and whether or not it is safe to use them together. In this study, CAdVEC will be injected into participants tumor at one tumor site which is most easiest to reach. Once it infects the cancer cells, activation of the immune response will occur so it can attack and kill cancer cells. (This approach may have limited effects on the other tumor sites that have not received the oncolytic virus injection, so, patients will also receive specific T cells following the intratumor CAdVEC injection.) These T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells. Investigators want to see if these cells can survive in the blood and affect the tumor. Both CAdVEC and HER2-specific autologous CAR T are investigational products. They are not approved by the FDA. Read Less

Prolonged periods of reduced activity are associated with decreased vascular function and muscle atrophy. Physical inactivity due to acute hospitalization is also associated with impaired recovery, hospital readmission, and increased mortality. Older adults are a particularly vulnerable population as functional (vascular and skeletal muscle mitochondrial dysfunction) and structural deficits (loss in muscle mass leading to a reduction in strength) are a consequence of the aging process. The combination of inactivity and aging poses an added health threat to these individuals by accelerating the negative impact on vascular and skeletal muscle function and dysfunction. The underlying factors leading to vascular and skeletal muscle dysfunction are unknown, but have been linked to increases in oxidative stress. Additionally, there is a lack of understanding of how vascular function is impacted by inactivity in humans and how these changes are related to skeletal muscle function. It is our goal to investigate the mechanisms that contribute to disuse muscle atrophy and vascular dysfunction in order to diminish their negative impact, and preserve vascular and skeletal muscle function across all the lifespan. Read Less

This protocol is primarily looking to see if the IL-4Ra R576 polymorphism is associated with increased clinical, immunological and microbial markers of disease activity in patients with Atopic dermatitis. Read Less

This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM). Read Less

This study will examine the effects of brain stimulation on pain symptoms associated with Major depressive disorder. This study will enroll 54 Subjects. Study subjects will be asked to complete surveys about their mood and well-being, 2 blood draws, 2 MRIs, 3 electroencephalograms, and receive 30 treatments of blinded transcranial magnetic stimulation. There is no control group as all subjects will receive some form of active treatment. Subjects are required to participate in 30-33 study visits and volunteer 40 hours of their time. Compensation for this study is $150 for completing all study activities. Read Less

This study is being done to find out whether the study drug Retifanlimab, a monoclonal antibody against the PD-1 protein, combined with gemcitabine and docetaxel, is a safe and effective treatment for your disease. Gemcitabine and docetaxel are chemotherapy drugs that are commonly used to treat soft tissue sarcoma. Retifanlimab is an experimental drug that boosts the immune system's ability to fight cancer cells. The study researchers think that Retifanlimab may help gemcitabine and docetaxel work better against soft tissue sarcoma that is either locally advanced or has spread beyond its original location (metastasized), and it cannot be removed with surgery (unresectable). Read Less

This phase IV trial investigates how to personalize treatments (such as medications and/or counseling) for quitting smoking based on the unique character traits of participants. Nicotine replacement therapy, counseling, and/or drugs such as varenicline and bupropion may help participants quit smoking or change smoking behavior. This trial may also help doctors individualize smoking cessation treatment for participants who do not quit smoking after the first course of treatment. Read Less

The purpose of this study is to determine the safety of a cell therapy, T-allo10, after αβdepleted-HSCT in the hopes that it will boost the adaptive immune reconstitution of the patient while sparing the risk of developing severe Graft-versus-Host Disease (GvHD). The primary objective of Phase 1a is to determine the recommended Phase 2 dose (RP2D) administered after infusion of αβdepleted-HSCT in children and young adults with hematologic malignancies. A Phase 1b extension will occur after dose escalation, enrolling at the RP2D for the T-allo10 cells determined in the Phase 1 portion to evaluate the safety and efficacy of infusion of T-allo10 after receipt of αβdepleted-HSCT. Additionally, Phase 1b aims to explore improvements in immune reconstitution. All participants on this study must be enrolled on another study: NCT04249830 Read Less

The purpose of this study is to find out how cancer treatments (chemotherapy and/or radiation therapy) affect reproductive and sexual health in people with early onset colorectal cancer. The study researchers will observe and track changes in hormone levels and in sexual and reproductive health in people with early onset colorectal cancer. This information will help researchers know more about how cancer treatments affect reproductive and sexual health, including the ability to have children (fertility). Read Less

Heart failure with preserved ejection (HFpEF) disproportionately affects Veterans and is the number one reason for hospital discharge in the VA Health Care System. Exercise intolerance is a common complication experienced by patients with HFpEF, perpetuating physical inactivity and accelerating disease progression. This research proposal aims to elucidate mechanisms responsible for inadequate skeletal muscle blood flow and exercise intolerance in patients with HFpEF compared with healthy controls as well as following 8 weeks of exercise training in patients with HFpEF only. Read Less

Although effective treatments for PTSD exist, high rates of treatment dropout and sub-optimal response rates remain common. Incorporating family members in treatment represents one avenue for improving outcomes and providing Veteran-centered care, and surveys of Veterans in outpatient VA PTSD care indicate that 80% desire family involvement. The VA has invested many years and millions of dollars on the dissemination of Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) for PTSD. A family-based intervention that complements these two first-line treatments would capitalize on existing treatment infrastructure while also potentially boosting outcomes and retention. Preliminary testing of the proposed Brief Family Intervention (BFI) resulted in 50% less dropout from CPT/PE among Veterans whose family members received the BFI. There was also a large impact on PTSD symptoms at 16 weeks (d = 1.12) in favor of the BFI group. The goal of this study is to test the effectiveness of the BFI among a fully-powered sample. One hundred Veteran-family member dyads (n = 200) will be recruited. Veterans will be beginning a course of usual-care CPT or PE at one of two VA sites. Family members will be randomized to receive or not receive the BFI, a two-session psychoeducational and skills-based protocol. PTSD symptom severity and treatment retention will be the primary outcomes. Assessments will be conducted by independent evaluators at baseline, 6-, 12-, 18-, and 26-weeks. Veterans whose family members receive the BFI are expected to have lower dropout and a greater rate of change in their PTSD symptoms compared to Veterans whose family members do not receive the BFI. If the BFI is found to increase the effectiveness of and retention in CPT/PE, it will be a highly appealing option for incorporating families into Veterans' PTSD care. Read Less

Building upon formative research, this mixed methods study will be conducted in three phases to develop, refine, and pilot-test a multi-component Family Peer Navigator model designed to increase access to and initial engagement in coordinated specialty care for early psychosis among Black/African American families. Read Less