• Milrinone in Congenital Diaphragmatic Hernia

    Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction. In patients with CDH, left ventricular dysfunction, either caused by right ventricular overload or a relative underdevelopment of the left ventricle, is associated with poor prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during the management of CDH although no randomized trials have been performed to test its efficacy. Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND) and 22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone. In the recently published VICI trial, 84% of patients with CDH received a vasoactive medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis of CDH will be randomized to receive milrinone or placebo to establish safety of this medication in CDH and test its efficacy in improving oxygenation.

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  • Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor

    RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in treating germ cell tumor.

    PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well it works compared to chemotherapy and radiation therapy in treating patients with newly diagnosed primary CNS germ cell tumor.

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  • Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults

    This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations.

    After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.

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  • Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C

    The response rate to interferon-based anti-viral therapy for chronic hepatitis C is lower in patients who are obese. However, it is not clear whether this is related to suboptimal dosing of the medication or alterated response in obese patients. Alterated immune response had been reported in obese patients. The goal of current study is to determine the immune response to interferon in obese compared to non-obese chronic hepatitis C in an tissue culture system.

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  • Ixabepilone in Treating Young Patients With Refractory Solid Tumors

    This phase II trial is studying how well ixabepilone works in treating young patients with refractory solid tumors. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

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  • Study of Oral LBH589 in Adult Participants With Refractory/Resistant Cutaneous T-Cell Lymphoma (CTCL)

    This study evaluated the safety and efficacy of LBH589B in adult participants with refractory/resistant Cutaneous T-Cell Lymphoma and prior Histone Deacetylase (HDAC) inhibitor therapy.

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  • Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB

    The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.

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  • Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

    RATIONALE: New diagnostic procedures such as microsatellite analysis of sediment in the urine may improve the ability to detect bladder cancer without invasive procedures.

    PURPOSE: Diagnostic trial to study the effectiveness of microsatellite analysis of sediment in the urine in detecting bladder cancer in healthy participants, participants who have genitourinary conditions requiring cystoscopy, and patients who have bladder cancer.

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  • Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

    The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.

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  • N2004-04: Fenretinide LXS in Treating Patients With Recurrent, Refractory, or Persistent Neuroblastoma

    RATIONALE: Drugs used in chemotherapy, such as fenretinide LXS, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

    PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide LXS in treating patients with recurrent, refractory, or persistent neuroblastoma.

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  • Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

    This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. The participants will have one of the standard care procedures as part of their care. The two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While newer, RARC is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. The reported complication rates of RARC appear comparable to open surgery. This means there is no significant difference in the risk between the two standard procedures. However, despite these potential advantages, true comparison between the open and robotic technique with regards to long term cancer related and functional outcomes has not been accomplished because previous studies did not compare patients of equal health status. The researchers hope to learn whether or not patients undergoing RARC recover more quickly than or at the same rate as patients undergoing an open radical cystectomy while having non inferior cancer related outcomes. This study is funded by the National Institutes of Health (NIH).

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  • Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

    The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

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  • Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors For The Treatment Of Multiple Myeloma

    The purpose of the study is to determine the toxicity and feasibility of non-myeloablative allogeneic hematopoietic cell transplants for multiple myeloma from unrelated donors.

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  • PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

    The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

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  • Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain

    The purpose of this research is to determine if an investigational thin shield over the cornea can safely and effectively reduce or eliminate pain following Post Photorefractive Keratectomy (PRK).

    The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.

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  • Prostate Cancer Upgrading Reference Set

    Research repository designed to establish prostate cancer upgrading reference set and development of a risk prediction tool. Repository will include clinical information and biologics on a cohort of 240 men, to predict presence of high grade cancer at time of prostatectomy (removal of prostate) among patients with a low grade cancer diagnosis at time of biopsy.

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  • Investigation of Dysynchrony in Patients With Pulmonary Hypertension

    The purpose of the study is to determine whether patients with pulmonary hypertension (PH) have dysynchrony, and if so whether it is electrical or mechanical. Once this has been determined, during a catheterization the investigators will test if pacing the heart improves blood circulation.

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  • (HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis

    This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of BLU-263 + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. Parts 1 and 2 will enroll patients with ISM. Patients enrolled in Part 1 or Part 2 will roll over onto Part 3 to receive treatment with BLU-263 in an open-label fashion following completion of the earlier Part. Part M will enroll patients with monoclonal mast cell activation syndrome (mMCAS). The study also includes PK groups that will enroll patients with ISM.

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  • HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

    The investigators propose a prospective single arm pilot cohort study of 100 youth (ages 15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a district of the Southern province, in Rwanda.

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  • Methylphenidate Treatment of Attention Deficits in Epilepsy

    Methylphenidate (MPH) has long been used to improve attention and cognitive difficulties associated with ADHD, including in children with ADHD and epilepsy (Torres et al., 2008). Methylphenidate (MPH) is also helpful in treating attention and other cognitive difficulties in a variety of other neurological and medical conditions (Kajs-Wyllie, 2002; Prommer, 2012). We seek to evaluate the potential efficacy and safety of this medication in treating attention deficits, as well as other cognitive difficulties, experienced by adult patients with epilepsy.

    To our knowledge, there are currently very few studies which explicitly examine the impact of MPH on measureable attention deficits and other cognitive deficits in adult patients with epilepsy. We hope to quantify what impact, if any, methylphenidate has on attention, in addition to other specific measureable cognitive functions, in patients with cognitive complaints and epilepsy, and contribute to a growing body of evidence which supports the safety of methylphenidate's use for attention deficits in patients with epilepsy. As other effective treatments for attention and other cognitive difficulties in patients with epilepsy are not currently available, MPH could represent an important option in the treatment of such patients.

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Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.