Education and Training

  • Optimizing Ventilation to Improve Health

    Our overall goal is to optimize preferred, ventilating windows/apertures/vents in low-income neighborhoods of Dhaka, Bangladesh. We will:

    I. Collect baseline data on housing types and finalize windows/vents protoypes.

    II. Measure the impact of improved ventilation on air exchange rates in houses in low-income neighborhoods of Dhaka and characterize the current and potential market for windows/vents in households in low-income neighborhoods of Dhaka, Bangladesh.

    III. Understand recipients' (tenants and landords) perceived benefits of installed window/vent designs and difficulties faced with adoption of each design

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  • Dexmedetomidine Use in SZMN Blocks for Pediatric T&A Pain Control

    The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures. However, it has not been studied for patients undergoing tonsillectomy and adenoidectomy (T&A) procedures. The goal of this study is to determine whether the SZMN block can be utilized to improve pain control and decrease morbidity in pediatric patients undergoing T&A. An additional goal will be to determine whether the use of dexmedetomidine as a local anesthetic adjunct can prolong the analgesic effects of the SZMN block to cover the entire duration of pain experienced.

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  • Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2

    The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation of the device.

    Investigator

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  • Immunobiology of Cancer

    To learn whether or not an Interferon defect in cell signaling, recently discovered in immune cells from melanoma patients as well as breast cancer patients, is common to all cancers.

    Investigator

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  • Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

    This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy 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. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

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  • Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder

    Upon successful screening and registration, enrollment to durvalumab monotherapy (cohort 1) will begin. If DLT criteria outlined in the protocol are exceeded with durvalumab monotherapy (cohort 1), the study will close. Provided the safety of durvalumab monotherapy is established, enrollment to combination regimen cohorts will proceed. Cohorts will simultaneously enroll in parallel to each other with patients assigned to cohorts based on patient slot availability and study site choice of radiation arm participation. Patient assignment to future phase 1 arms would proceed similarly.

    Within BCG-containing cohorts, treatment will begin at full-dose BCG. If DLT criteria outlined in Section 5.1.4 are exceeded with full-dose BCG, a one level dose reduction of BCG will be implemented. If DLT criteria outlined in Section 5.1.4 are exceeded with reduced-dose BCG, the BCG-containing cohort will not proceed to Phase 2 of the study. Similarly, if DLT criteria outlined in Section 5.1.4 are exceeded within non-BCG containing cohorts, the non-BCG containing cohort will not proceed to phase 2 of the study. Due to the prolonged half-life of antibody therapies, no dose adjustments are planned for durvalumab in any of the cohorts.

    Investigator

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  • Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

    Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this sleepiness. The idea behind this treatment is that sleepiness that leads to napping during the day prevents a patient from being tired or sleepy enough to get good sleep at night. This study is designed to determine if the medication can "reset" participants' sleep/wake rhythm to a more normal rhythm.

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  • Integrin Alpha-v-Beta and [18F]-R01-MG-F2 PET/CT in Measuring Response in Patients With Pancreatic Cancer and Healthy Volunteers

    This pilot clinical trial studies the use of integrin alpha-v-beta [18F]-R01-MG-F2 Positron Emission Tomography/Computed Tomography (PET/CT) and Positron Emission Tomography-Magnetic Resonance Imaging in (PET/MRI) in measuring response in patients with pancreatic cancer and healthy volunteers. Integrins, such as integrin alpha-v-beta-6 (avb6), are a family of membrane receptors that are overexpressed on the cell surface of pancreatic cancers. [18F]-R01-MG-F2 targets avb6, which may improve early detection of and better stratify treatment options for patients with pancreatic cancer.

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  • Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients

    The objective is to treat elderly AML and MDS patients with sapacitabine.

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  • Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas

    Basal cell carcinomas (BCCs) are the most common human cancer in the US and affect over 1 million people. There is no effective drug to prevent basal cell carcinomas of the skin.

    We hope to learn if an oral anti-fungal drug, itraconazole, might inhibit a marker of proliferation and a biomarker (tumor signaling pathway) of BCC development.

    Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and has been used for the past 25 years with relatively few side effects. It has been shown in mice to reduce a BCC biomarker and to reduce growth of BCCs.

    Thus, it may reduce BCC growth in humans.

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  • Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement

    PEPPER is a randomized study comparing the three most commonly used anticoagulants in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The anticoagulants being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.

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  • Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

    The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

    Investigator

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  • Designing Food Voucher Programs to Reduce Disparities in Healthy Diets

    Improving diets through increased food and vegetable (F&V) consumption significantly reduces the risk of cardiovascular disease (CVD). Programs increasing the accessibility and affordability of F&Vs among low-income Americans have been hindered by the food consumption cycle associated with poverty: the tendency to over-consume calories shortly after receiving funds at the beginning of each month, draining the budget for F&V purchases, or for all food purchases, by month's end. An emerging theory about dietary behavior suggests that providing funds for food in smaller installments distributed throughout the month will smooth the consumption cycle and improve healthy eating-counteracting the tendency to respond to lump sum, once-monthly funding installments by purchasing calorie-dense foods immediately after funds are received. The theory also suggests that funds targeted toward specific healthy foods (e.g., F&Vs) will improve diets more than untargeted funds, despite the inconvenience of utilizing targeted funds. We will rigorously test both hypotheses in a real-world setting by comparing alternative approaches for delivering food purchasing vouchers. We have established and tested the infrastructure to provide vouchers accepted by numerous food sellers (e.g., supermarkets, corner shops) in low-income neighborhoods. Leveraging this infrastructure, we will conduct a randomized trial with a two-by-two factorial design, comparing $20 of vouchers valid for one month to four $5 vouchers each valid for a sequential week of the month (lump sum versus distributed funding), and comparing vouchers restricted to F&V purchases to vouchers redeemable for any food (targeted versus untargeted funding). Low-income adults (N=288) recruited through our community partners will be randomized to one of four 6-month interventions: monthly targeted, monthly untargeted, weekly targeted, or weekly untargeted vouchers. Participants will be assessed through efficient verbal 24-hour dietary recalls validated among low-literacy populations, to determine daily consumption of F&Vs and metrics of overall dietary quality at months 0, 6 and 12 (6 months after vouchers end). Additional surveys will identify moderators and mediators of dietary improvement.

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  • Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade

    One of the most frequently performed peripheral nerve blocks (the injection of local anesthetic near nerves to block sensation/ movement to a specific part of the body) is the interscalene brachial plexus block for upper extremity surgeries. This type of block can unmask underlying respiratory issues such as shortness of breath due to a well-known and typically insignificant side effect of temporary diaphragmatic paralysis.

    The nerve block may be able to use saline solution to wash out the local anesthetic and potentially reverse this respiratory side effect. Specifically, the goal of this study is to determine if the injection of saline through the nerve block catheter reverses blockade of the phrenic nerve supplying the diaphragm, without affecting the ability of the nerve block to provide pain control after surgery.

    Investigator

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  • Prospective Observational Epidemiologic Study of Maraviroc's Safety

    The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

    Investigators

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  • HCV Target

    Hepatitis C Therapeutic Registry and Research Network

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  • Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)

    This study is a prospective, multicenter phase II study with patients receiving haploidentical transplantation for Severe Aplastic Anemia (SAA). The primary objective is to assess overall survival (OS) at 1 year post-hematopoietic stem cell transplantation (HSCT).

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  • Early-Onset Sepsis Surveillance Study

    In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis. The study will: establish current hospital-based rates of EOS among term and preterm infants in the era of intrapartum antibiotic prophylaxis; monitor the organisms associated with EOS and meningitis; compare asymptomatic and symptomatic infants by gestational age and pathogen; and monitor sepsis-associated mortality rates by pathogen group.

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  • Epidemiologic Study of Hepatocellular Carcinoma in the US

    The purpose of this study is:

    - to investigate the risk factors of HCC among Americans with focus on lifestyle factors and energy balance.

    - to identify single nucleotide polymorphisms (SNPs) and haplotypes that are associated with HCC risk through a genome-wide search.

    - to assess if genetic susceptibility differs by hepatitis virus infection or lifestyle factors, and to explore if there are interplays or effect modifications between genetic factors and viral infection or lifestyle factors.

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  • Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    The purpose of this study is to evaluate progression-free survival among subjects with KRAS mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib (ARQ 197) compared to single agent chemotherapy.

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