Education and Training

  • Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)

    This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them or by stopping them from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer cells more effectively.

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  • Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer

    To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration.

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  • Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy

    This study will investigate the effects of rosiglitazone, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. The primary purpose of the study is to determine whether treatment with an insulin-sensitizing medication will improve the heart's ability to metabolize glucose (sugar).

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  • Efficacy Trial of Stress Check-Up

    Untreated posttraumatic stress disorder (PTSD) is associated with high societal and individual costs. Effective interventions for symptoms of posttraumatic stress (PTS) exist but are underutilized by those who could benefit, especially among active duty military. This study will develop and test a brief telephone-delivered motivational enhancement intervention (MET) for military personnel (active, reserve, or national guard) serving in the Army, Air Force, or Navy who are experiencing symptoms of PTS, but who are not currently engaged in PTS treatment. The goal of the intervention is to decrease stigma around seeking care, increase knowledge about treatment options, increase engagement in help-seeking behavior, all leading to reductions in PTS symptoms.

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  • Diagnostic and Prognostic Biomarkers for High-impact Chronic Pain: Development and Validation

    To identify diagnostic and prognostic biomarker signatures of recovery versus having persisting high-impact chronic pain and functional disability in adults with Chronic Musculoskeletal Pain.

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  • Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

    RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma.

    PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.

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  • Caffeine/Propranolol Intervention for Acute Migraine

    This is a research study to assess the safety of caffeine/propranolol at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their migraines.

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  • Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma

    This randomized phase III trial is studying cyclophosphamide, prednisone, and immunoglobulin to see how well they work compared to cyclophosphamide and prednisone alone in treating patients with abnormal trunk muscle movements associated with neuroblastoma. Drugs used in chemotherapy, work in different ways to stop tumor cells from dividing so they stop growing or die. Steroid therapy decreases inflammation. Combining chemotherapy and steroid therapy with immunoglobulin may be effective in treating abnormal muscle movement associated with neuroblastoma.

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  • Breast Cancer Lymphedema: Role of Insulin Resistance/FOXC2

    To better understand the mechanisms leading to lymphedema development in breast cancer survivors, and the implications for potential innovative approaches to the screening, prevention and treatment of this condition.

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  • A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

    The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose PPIs.

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  • Acupuncture and Pain Processing

    The purpose of this study is to test the hypothesis that acupuncture will reduce Fibromyalgia pain, via alterations in the processing of pain in the central nervous system.

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  • CogT BEEM Study (a tDCS Study)

    Co-existing neuropsychiatric symptoms (NPS) in patients with mild cognitive impairment (MCI), especially those worsening over time, are associated with more rapid cognitive and functional decline and a greater risk of Alzheimer's disease (AD). Optimal NPS management, meaning effectively managing multiple NPS simultaneously, requires a solid understanding of the shared neural mechanism across NPS. The goal of this proof-of-concept mechanistic intervention study is to validate the causal relationship between a NPS-shared neural circuit the investigators previously discovered and various NPS. The investigators will modify a key region within the NPS-shared neural circuit [i.e. left precentral gyrus (LPG), critical for regulating visual attention] with anodal transcranial direct current stimulation (tDCS). Our central hypothesis is that an activation of LPG and a reorganization of NPS-shared neural circuit will link to improvement in multiple NPS. Using a Stage 0 pilot randomized control trial design the investigators will recruit n = 40 older adults with informant-rated NPS that has worsened in the past 2 years, which is considered the most detrimental type of NPS in MCI. The investigators will assign participants to 4-week active anodal vs. sham LPG online tDCS group. The investigators will assess resting-state and visual attention task-related functional MRI and informant-rated NPS at baseline, and the end of week 4 and week 8, and diffusion MRI at baseline. The two primary aims are to determine the effect of tDCS on NPS-shared neural circuit (Aim 1), as well as the relationship between NPS-shared neural circuit and informant-report NPS (Aim 2). The exploratory aim will be to examine the relationship between NPS and the coherence between structural and functional aspects of the NPS-shared neural circuit. Probing the LPG via anodal tDCS provides a way to experimentally test the causal relationship between our previously discovered NPS-shared neural circuit and informant-rated NPS. The proposed research is highly innovative, while scientifically grounded, for targeting one brain region that may affect multiple NPS. Validating the hypotheses has the potential for future R01 study that directly conducts a Stage 2 trial addressing NPS in MCI, and thus ultimately improves patient's quality of life and reducing caregiving burden.

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  • A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

    The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.

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  • Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread

    This phase II trial compares two treatment combinations: gemcitabine hydrochloride and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan in older patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine hydrochloride, nab-paclitaxel, fluorouracil, leucovorin calcium, and liposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help doctors find out which treatment combination is better at prolonging life in older patients with metastatic pancreatic cancer.

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  • DCM Precision Medicine Study

    The aims of the DCM Precision Medicine Study are to test the hypothesis that DCM has substantial genetic basis and to evaluate the effectiveness of a family communication intervention in improving the uptake and impact of family member clinical screening.

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  • Cabozantinib for Adults With Advanced Soft Tissue Sarcoma

    Background:

    - Cabozantinib is a cancer treatment drug that blocks the growth of new blood vessels in tumors. It can also block a chemical on tumor cells that allows the cells to grow. A similar drug, pazopanib, is used to treat types of cancer known as sarcomas. Researchers want to see if cabozantinib can be an effective treatment for types of soft tissue sarcoma that have not responded to earlier treatments.

    Objectives:

    - To test the effectiveness of cabozantinib for soft tissue sarcomas that have not responded to standard treatments.

    Eligibility:

    - Individuals at least 18 years of age who have soft tissue sarcomas that have not responded to standard treatments.

    Design:

    - Participants will be screened with a physical exam and medical history. Blood samples will be collected. Imaging studies and other tests will be used to study the tumor before the start of treatment.

    - Participants will take cabozantinib tablets daily for 28-day cycles of treatment. The tablets should be taken whole on an empty stomach.

    - Treatment will be monitored with frequent blood tests and imaging studies.

    - Participants will continue to take cabozantinib for as long as the tumor does not become worse and the side effects are not too severe.

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  • An Observational Study of Hepatitis C Virus in Pregnancy

    This multi-center observational study examines risk factors for HCV transmission from mother to baby.

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  • CAR-T Long Term Follow Up (LTFU) Study

    Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

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  • Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia

    This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking -- comparing care practices between different NICUs to see which practices prevent bronchopulmonary dysplasia (BPD) -- and quality improvement would change practices and improve rates of survival without BPD in inborn neonates with birth weights of <1250 grams. Benchmarking is a method involving detailed comparisons of processes between similar organizations. For this study, three NRN centers with the lowest rates of BPD have been identified as Benchmark centers. During a 6-month pre-intervention period, details of care practices and management style at these centers were carefully assessed. Based on practices at these Benchmarking sites, we developed a quality improvement program. For this study, 14 other NRN sites were randomized to either implement the benchmarking intervention (intervention sites) or continue with their usual care practices (control sites). After the 1-year intervention period, we compared changes in the rate of survival without BPD at 36 weeks corrected age between the intervention and control sites.

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  • Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL

    This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR20A in adult subjects with r/r B-cell NHL or r/r CLL/SLL.

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