Education and Training

  • Umbrella Trial Testing Integrative Subtype-Targeted Therapeutics in HR+ /HER2-Negative Breast Cancer

    The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used to treat this type of breast cancer. Different therapies are being tested based on the specific gene changes in the tumor. Not every tumor will have a gene change that is being studied.

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  • The Use of Prophylactic Antibiotics In the Management of Dog Bites

    This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection.

    By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.

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  • Understanding and Testing Recovery Processes for PTSD and Alcohol Use Following Sexual Assault

    Sexual assault can lead to devastating consequences including the development of chronic conditions including posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD). Interventions delivered soon after exposure to assault can decrease the long-term negative consequences of sexual assault but existing interventions are limited in their ability to target concurrent PTSD symptoms and alcohol use and little is known about how to make best practice treatment decisions in the early period following sexual assault. A greater emphasis on transdiagnostic processes that are related to both PTSD and alcohol use, such as fear and reward systems, can elucidate mechanisms of recovery, lead to the development of more effective intervention approaches, and guide clinical decision making for patients recently exposed to sexual assault.

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  • The Influence of Chronic CMV Infection on Influenza Vaccine Responses

    In this study we are trying to understand whether previous infection with a particular virus, namely cytomegalovirus (CMV), influences the ability of the immune system to respond to new infections or vaccinations with age.

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  • Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme

    This, international, multi-center, Phase 2 study of verubulin will be conducted in patients with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts. Part A is an open-label dose finding study that will determine the safety and tolerability of verubulin in combination with standard treatment. Part B is a randomized open-label study that will investigate progression-free survival and overall survival of patients receiving verubulin, at the dose determined in Part A, in combination with standard treatment versus standard treatment alone.

    Investigator

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  • Use of Virtual Reality for Pediatric Minor Surgical Procedures

    This project is looking to use virtual reality for minor general surgery procedures in addition to local anesthesia instead of general anesthesia.

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  • T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009

    This study will compare influenza vaccine responses in monozygotic and dizygotic twins.

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  • Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation

    The purpose of this study is to evaluate whether addition of a low dose of total body irradiation (TBI) to a standard preparation for transplant [total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)] conditioning will help to augment donor chimerism without reducing tolerability of this regimen or increasing the risk of graft-vs-host disease (GVHD)

    Investigators

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  • Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions

    This clinical trial studies ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be a less invasive way to check for kidney or liver solid focal lesions.

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  • Tools for Health and Resilience Implemented After Violence Exposure (Project THRIVE)

    Sexual assault victimization is a common and particularly harmful form of trauma that is associated with increased risk for high-risk drinking and other conditions of public health concern, such as PTSD. Given evidence that sexual assault survivors who have low social support or receive negative social reactions to sexual assault disclosure are more likely to experience PTSD and drinking problems, improving social support is a novel target for intervention. The proposed study will attempt to prevent the onset of high-risk drinking and PTSD in sexual assault survivors by developing and testing a web-based early intervention aimed at increasing contact with social supporters and mitigating the harm of negative social reactions; ultimately, results will contribute to advancing the field's understanding of the potential for social support to mitigate the harm of trauma.

    Investigator

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  • Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation

    The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats originating in the upper chambers of the heart).

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  • Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate

    The purpose of this study is to determine the efficacy and safety of the addition of intravaginal isosorbide mononitrate to an established protocol of oral misoprostol for cervical ripening and labor induction.

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  • Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)

    To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic body radiotherapy in the treatment of patients with locally recurrent hepatocellular carcinoma (HCC) after TACE.

    Investigator

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  • Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)

    A study to evaluate safety and efficacy of topical sirolimus to treat plantar keratoderma in adults with PC. Subjects may receive either placebo or treatment with at least 1 foot receiving topical sirolimus at some time. For certain phases of the study treatment assignment to the right and left foot will be randomized in a double blind fashion. Blood levels will test systemic absorption of sirolimus. Other safety and efficacy measures will be taken through the 39-week study duration. Funding Source - FDA OOPD

    Investigator

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  • The Philani Mobile Video Intervention for Exclusive Breastfeeding (MOVIE) Study

    This cluster-randomized controlled trial seeks to evaluate the impact of a mobile video intervention for exclusive breastfeeding (MOVIE) on the infant feeding practices of mothers living in under-resourced communities in the Western Cape, South Africa. The trial will compare infant feeding practices in two groups of participants, enrolled in the Philani Mentor-Mother Outreach Program, a home-visiting program focused on community-based health promotion through peer-to-peer counseling. The participants in the intervention arm will receive the Philani Intervention Model (PIM), a perinatal health promotion intervention, together with the additional mobile, video intervention for exclusive breastfeeding. The participants in the control arm will receive only the standard PIM. Participants will be exposed to either the intervention or the control condition during pregnancy and the first five months after delivery. The central hypothesis in this trial is that, when compared with the control group, infant feeding practices in the intervention group will be significantly better aligned with current World Health Organization recommendations, after exposure to the Philani MOVIE intervention. The primary outcomes in this study are short-term exclusive breastfeeding, in the first month of life, and long-term exclusive breastfeeding, in the fifth month of life, (based on maternal 24-hour recall). Secondary outcomes include other infant feeding practices, such as early initiation of breastfeeding, any breastfeeding in the first month and in the fifth month of life, bottle-feeding, early introduction of complementary foods in the first month and in the fifth month of life and maternal knowledge in the first month and the fifth month post delivery.

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  • Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

    This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body.

    In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.

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  • Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

    The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).

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  • TMS for Complex Regional Pain Syndrome

    The aim of the current study is to assess the efficacy of TMS in the treatment of Complex Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1) relative to sham treatment (Group 2) once daily for two days will demonstrate a greater improvement in CRPS-related pain and other associated symptomology (i.e., cognitive, emotional and physical) compared to baseline. Participants will be followed until they reach their baseline for two consecutive weeks to assess safety and duration of symptom alleviation.

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  • The Effects of High and Low Blood Glucose Values on the Brain in Children With Type 1 Diabetes Mellitus

    Simplified Brochure

    Neuropsychological Testing/Assessment is like games for the child. They are asked to complete the sequence, identify pictures, explain what is happening, etc. There is no personality testing involved. Part of the standard IQ testing is done but no IQ score is obtained. Age appropriate testing is done for each child.

    The MRI is an enclosed machine. We have the child sit in a simulator after the neuropsychological testing to see what it will be like, including the sounds, etc. You will be given a video about MRI testing to view as well. The staff that does this has been doing this for years in a wide variety of children, young, developmental delayed, etc. The staff does this WITHOUT sedation. Some children cannot sit still through the entire series. We need to get six, 10 minute scans. Children are allowed movement such as the need to wiggle their toes and move in between each scan.

    The Neuropsychological Testing can be scheduled in the late afternoons if it is more convenient for your family. This visit may take 3-4 hours. The MRI scanning can be scheduled after 5pm and may take up to 2 hours depending on the child's cooperation. You maybe asked to repeat the Neuropsychological Testing and MRI scanning 24 months later.

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  • TAXUS Libertē Post Approval Study

    The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen.

    This study will also contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT Study).

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