Education and Training

  • Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)

    Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells to build up in certain parts of the body, where they can damage tissue or form lesions.

    For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line therapy while cytarabine therapy has been used as therapy for patients who develop recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH.

    The purpose of this research study is to compare previously used vinblastine/prednisone to single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study called a positron emission tomography (PET) scan to more accurately assess areas of LCH involvement not otherwise seen in other imaging studies as well as response to therapy. We also want to identify if genetic and other biomarkers (special proteins in patient's blood and in patient's cancer) relate to the response of patients LCH to study treatment.

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  • Vitamin D Supplementation in Multiple Sclerosis

    Low vitamin D levels have been shown to increase a person's risk of developing multiple sclerosis (MS), and patients with MS who have lower vitamin D levels are at increased risk of having attacks. However, it is not known if giving supplemental vitamin D to those with MS reduces the risk of attacks, and some research suggests that vitamin D could even be harmful to people with MS.

    In this clinical trial, patients with relapsing-remitting MS will receive high-dose or low-dose oral vitamin D in addition to an approved therapy for MS, glatiramer acetate. Patients will be evaluated for two years, and the effect of high-dose vitamin D supplementation on the rate of MS attacks and on the number of new lesions and change in brain volume on MRI will be determined. Establishing this association will have major implications for the treatment of individuals with MS throughout the world.

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  • Walk to School and Physical Activity

    The purpose of the proposed study is to determine the effect of walking to school for one week on total physical activity and patterns of physical activity in third, fourth and fifth grade students.

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  • Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia

    The investigators plan to use functional neuroimaging (fMRI) to understand the brain systems affected when hypnosis and hypnotic analgesia are augmented with repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation to 100 people with fibromyalgia, a chronic pain condition. The investigators will measure the effect of rTMS-augmentation on the brain networks underlying hypnotizability, as well as the effect of rTMS-augmentation on hypnotic analgesia networks. The investigators hope to demonstrate that a combination of these psychological and neuromodulatory treatments will be more effective than hypnosis alone, thereby enhancing the depth of hypnosis, range of hypnosis and the efficacy of hypnotic analgesia and hopefully creating a new treatment modality for individuals suffering from pain syndromes such as fibromyalgia pain.

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  • Topical KB105 Gene Therapy for the Treatment of TGM1-deficient Autosomal Recessive Congenital Ichthyosis (ARCI)

    This study is an intra-patient comparison of KB105 and placebo-administered Target Areas. The primary objectives of this study are to evaluate safety and Investigator Global Assessment (IGA) scale improvement of topically administered KB105.

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  • Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

    Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).

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  • 68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy

    This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.

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  • Virtual Empowered Relief for Chronic Pain

    The purpose of the current pilot study is to examine a feasibility and the preliminary efficacy of Empowered Relief (ER) class when it is delivered 'virtually' to patients with chronic pain who take methadone or buprenorphine. The ER class is a single-session pain management class, which has demonstrated to be effective in improving pain and pain-related distress in patients with chronic low back pain, but its efficacy has not been examined in patients with chronic pain who take methadone or buprenorphine. Class participants will learn self-regulatory skills and develop a personalized plan to use the skills every day. The current study will examine a feasibility and participant's perception and satisfaction of this class at post-class. The study will also follow participants 3 months by administering 5 surveys (baseline, 2 weeks and 1 month, 2 months, and 3 months post-treatment) to determine whether the class confers the short-term and medium-term benefits across various aspects of health.

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  • The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.

    The study determines the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD).

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  • 5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence

    Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects (such as agitation and nausea) if opioid medications are suddenly stopped. This study aims to test the use of the drug ondansetron to reduce the symptoms associated with opioid withdrawal and to prevent the progression of opioid physical dependence, thereby allowing future investigators to better test the role of physical dependence in the development of addiction and also possibly improving acceptance of abstinence-based programs for addiction.

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  • Virtue® Male Sling Fixation Study

    This study is a multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male Sling.

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  • The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)

    This is a 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial. Upon completion of the NIH 3-month extension study, subjects will be invited to participate in a continued use phase with Control-IQ Technology, funded by Tandem Diabetes Care, until the equipment has received FDA approval for commercial use.

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  • Vitamin D and Type 2 Diabetes Study

    The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism.

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  • The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression

    Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the potential to reduce key barriers to ART care retention. The aim of this study is to determine whether CHW-led home delivery of ART for patients who are stable on ART combined with facility-based care for those not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression. The primary endpoint of this trial is the proportion of ART patients (regardless of whether they were clinically stable on ART at enrollment) who are in viral failure at the end of the study period. The non-inferiority design applies only to this primary endpoint. The margin of non-inferiority was set at a Risk Ratio (comparing intervention to control) of 1.45. This is a cluster-randomized controlled trial set in Dar es Salaam. The unit of randomization is a healthcare facility with its surrounding neighborhoods (the 'catchment area'). We matched all 48 healthcare facilities offering ART services and having affiliated public-sector CHWs in Dar es Salaam into pairs (stratified by district) based on having a similar number of patients currently on ART. In each pair, one cluster was randomized to the intervention and one to the control arm. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART care and CHW home visits at least every three months without ART home delivery). In addition, within each study arm, half of the healthcare facilities were randomized to enhanced CHW-led nutrition counseling and half to standard counseling.

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  • Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma

    The goal of this clinical study is to learn more about the safety and dosing of the study drug, magrolimab, in combination with other anticancer therapies in participants with relapsed/refractory multiple myeloma.

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  • 68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

    This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard imaging.

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  • Tofacitinib for the Treatment of Alopecia Areata and Its Variants

    The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

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  • Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

    The primary objective of this study is to evaluate the safety and efficacy of intravenous (IV) infusion of ulinastatin compared to placebo with respect to time to recovery, disease severity, need for ventilator support, and mortality in patients with COVID 19.

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  • Using Technology to Improve Eating Disorders Treatment

    The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce eating disorder outcomes in college-age women.

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  • Venetoclax + Azacitidine vs. Induction Chemotherapy in AML

    This research is being done to assess the therapeutic activity of a promising combination (azacitidine and venetoclax) versus conventional cytotoxic chemotherapy in induction-eligible patients with acute myeloid leukemia.

    This study involves the following:

    - Venetoclax and azacitidine (investigational combination)

    - Cytarabine and idarubicin or daunorubicin (per standard of care) or Liposomal daunorubicin and cytarabine (per standard of care)

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