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Craniofacial Center

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Research

Leading-Edge Advancements in Craniofacial Care

The Children's Hospital at Montefiore is part of one of the nation's premier academic medical centers, internationally recognized as a leader of science-driven, patient-centered care, research and education. We have pioneered some of the most innovative and exciting techniques and methodology in the past decade.

All of our craniofacial surgeons were involved with the basic research that makes innovative medical treatments and techniques possible. We have a sophisticated knowledge of how advanced treatments can be best used to benefit each individual child. 

Our team has helped thousands of children who were born with craniofacial differences, and those who have suffered craniofacial trauma. We have developed particular expertise through the treatment of more than 8,000 patients with cleft lip and palate, craniosynostosis and other complex conditions.

Improved Craniofacial Technology and Technique

One of the most thrilling developments in craniofacial care has been the techniques of distraction osteogenesis. First used to lengthen short limbs, this technology can now be applied to the bones of the face, including the lower jaw, mid-face and cranium. These new techniques have vastly improved the outcomes we are able to achieve.

Another area where new techniques have been used is in the realm of bone fixation. Because of concerns regarding growth, we no longer use the metal wires, plates and screws that are used in surgeries performed on the skull. These plates were once typically left in place for a child's entire life, and while problems did not generally arise, surgeons were concerned about potential, as-yet-unknown side effects from this treatment method. Small plates and screws have since been developed that actually dissolve after bone healing has occurred.

We are currently conducting research and clinical trials into the genetic pathways that produce craniofacial deformities, in order to eventually prevent them, and when they cannot be avoided, to help physicians better prepare for their occurrence at the time of a child's birth.

 

Active Clinical Trials

Trial Description
Disease / Condition
Principal Investigator
Contact
Trial DescriptionA 12-Month, Open-Label, Repeat-Dose Safety Study of NRL-1 in Epilepsy Subjects - Click here for more information16-10-27-01
Disease/ConditionEpilepsy
Seizures
Neurology
Brain and Neurological
Principal InvestigatorAlexis Boro, MD
Contact Jeanne Gutierrez

Email Contact
Trial DescriptionA 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease (TARGET-IBD) - Click here for more information17-08-399-01
Disease/ConditionInflammatory Bowel Disease
Gastroenterology & Liver Diseases
Colitis and Crohn's Disease
Principal InvestigatorGitit Tomer, MD
Contact Preeti Malik

Email Contact
Trial DescriptionA 5-year Longitudinal Observational Study of Patients With Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Steatohepatitis (NASH) - Click here for more information16-10-402-01
Disease/ConditionLiver Diseases
Gastroenterology & Liver Diseases
Principal InvestigatorBryan Rudolph, MD
Contact Bryan Rudolph, MD

Email Contact
Trial DescriptionA Long-Term, Open-Label Follow-up Study of Tofacitinib for Treatment of Juvenile Idiopathic Arthritis (JIA) - Click here for more information15-10-199-01
Disease/ConditionArthritis
Autoimmune Diseases
Musculoskeletal Diseases
Pediatrics
Rheumatic Diseases
Principal InvestigatorDawn Wahezi, MD
Contact Marija Dionizovik-Dimanovski, MD

Email Contact
Trial DescriptionA Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications - Click here for more information2014-4194
Disease/ConditionAnemia
Hematologic Diseases
Immune System Diseases
Leukemia
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Non-Hodgkins Lymphoma
Oncology (Medical/Hematologic)
Pediatric Hematology/Oncology
Blood Disorders and Diseases
Principal InvestigatorDavid Loeb, MD
Contact Christopher Hall

Email Contact
Trial DescriptionA Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients - Click here for more information2015-5071
Disease/ConditionBlood and Bone Marrow Cancer
Blood Disorders and Diseases
Principal InvestigatorDavid Loeb, MD
Contact Christopher Hall

Email Contact
Trial DescriptionA Multicenter, Open-label, Randomized, Event-driven Study to Assess Efficacy, Safety and Pharmacokinetics of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension (PAH) (TOMORROW) - Click here for more information16-10-366-01
Disease/ConditionHeart and Vascular Diseases
Lung Diseases
Pediatrics
Pulmonary Hypertension
Principal InvestigatorNicole Sutton, MD
Contact Chelsie Cornelius

Email Contact
Trial DescriptionA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus - Click here for more information18-02-68-01E
Disease/ConditionAutoimmune Diseases
Dermatology
Lupus
Pediatrics
Rheumatic Diseases
Geriatrics
Principal InvestigatorChaim Putterman, MD
Contact Nicole Jordan

Email Contact
Trial DescriptionA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease - Click here for more information18-10-218-01
Disease/ConditionColitis and Crohn's Disease
Gastroenterology & Liver Diseases
Pediatrics
Inflammatory Bowel Disease
Principal InvestigatorJohn Thompson, MD
Contact Preeti Malik

Email Contact
Trial DescriptionA Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients w/Influenza A Infection - Click here for more information17-02-306-01
Disease/ConditionGeriatrics
Infectious Diseases
Influenza
Pediatrics
Principal InvestigatorPaul Riska, MD
Contact Bola Omotosho

Email Contact
Trial DescriptionA Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis - Click here for more information18-10-220-01
Disease/ConditionDermatology
Pediatrics
Skin Disorders
Geriatrics
Immune System Diseases
Principal InvestigatorHolly Kanavy, MD
Contact Jose Jaller

Email Contact
Trial DescriptionA Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD) - Click here for more information18-10-59-01
Disease/ConditionHematologic Diseases
Kidney Diseases (incl Chronic Kidney Disease)
Metabolic Diseases
Nephrology
Urologic Diseases
Pediatrics
Principal InvestigatorAnna Zolotnitskaya, MD
Contact Patricia Flynn

Email Contact
Trial DescriptionA Phase II Multi-Center, Randomized, Double-Blind, 24-Week, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Children and Adolescents Age 5-17 With Autism Spectrum Disorder (ASD) - Click here for more information16-10-117-01
Disease/ConditionAutism Spectrum Disorder
Neurodevelopmental Disorders
Pediatrics
Psychiatry - Non Cancer
Mental Health and Disorders
Principal InvestigatorEric Hollander, MD
Contact Danya Schlussel

Email Contact
Trial DescriptionA Phase III Study for Patients With Newly Diagnosed Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide and All-Trans Retinoic Acid - Click here for more information2018-9045
Disease/ConditionLeukemia
Oncology (Medical/Hematologic)
Pancreatic Cancer
Pediatric Hematology/Oncology
Neoplasms
Principal InvestigatorLisa Gennarini, MD
Contact Joyce Brown

Email Contact
Trial DescriptionA Prospective, Observational, Non-Interventional, Post-Marketing, Patient Registry to Collect Data on Routine Clinical Care in Patients Treated With Cholbam®/Kolbam® (Cholic Acid) - Click here for more information17-08-442-01
Disease/ConditionGastroenterology & Liver Diseases
Pediatrics
Liver Diseases
Principal InvestigatorNadia Ovchinsky, MD
Contact Preeti Malik

Email Contact
Trial DescriptionA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF Therapy (COMBINE) - Click here for more information2017-7692
Disease/ConditionColitis and Crohn's Disease
Gastroenterology & Liver Diseases
Inflammatory Bowel Disease
Pediatrics
Principal InvestigatorGitit Tomer, MD
Contact Preeti Malik

Email Contact
Trial DescriptionA Study to Compare Bone Marrow Transplantation to Standard Care in Adolescents and Young Adults With Severe Sickle Cell Disease (BMT CTN #1503) - Click here for more information2016-6694
Disease/ConditionAnemia
Blood Disorders and Diseases
Sickle Cell
Pediatrics
Genetic Disorders
Hematologic Diseases
Principal InvestigatorCaterina Minniti, MD
Contact Andrew Crouch

Email Contact
Trial DescriptionA Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease - Click here for more information18-06-66Q-01
Disease/ConditionCardiology
Oncology (Medical/Hematologic)
Urogenital Neoplasms
Urologic Oncology (Med Onc)
Prostate Cancer
Principal InvestigatorBenjamin Gartrell, MD
Contact Gina Aracena

Email Contact
Trial DescriptionA Trial of Endocrine Response in Women With Invasive Lobular Breast Cancer - Click here for more information2016-7457
Disease/ConditionBreast Cancer
Neoplasms
Oncology (Medical/Hematologic)
Women`s Health
Principal InvestigatorJoseph Sparano, MD
Contact Amanda Erakky

Email Contact
Trial DescriptionAn Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in Patient Populations Diagnosed With Early-Onset Idiopathic Bilateral Cataracts - Click here for more information15-10-432-01
Disease/ConditionGenetic Disorders
Ophthalmic Diseases and Disorders
Pediatrics
Principal InvestigatorNorman Medow, MD
Contact Jose Rosado

Email Contact
Trial DescriptionARCHIVE: A registry for children with vasculitis: e-entry 08-04-111E
Disease/ConditionHeart and Vascular Diseases
Pediatrics
Rheumatic Diseases
Autoimmune Diseases
Principal InvestigatorMaria Yee, MD
Contact Marija Dionizovik-Dimanovski

Email Contact
Trial DescriptionAssessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control During Botox Injections for Spasticity Management: A Randomized Control Trial - Click here for more information2016-6501
Disease/ConditionAnesthesia and Pain Management
Pediatrics
Rehabilitation Medicine
Principal InvestigatorYuxi Chen, MD
Contact Beendu Pujar

Email Contact
Trial DescriptionAutism Genetics Network, Phase II: Increasing Representation of Human Diversity 2012-537
Disease/ConditionAutism Spectrum Disorder
Neurology
Pediatrics
Genetic Disorders
Principal InvestigatorSophie Molholm, PhD
Contact Danielle DeMaio
(718) 862-1860
Email Contact
Trial DescriptionBezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001) (MODIFY III) - Click here for more information17-10-212-01
Disease/ConditionImmune System Diseases
Infectious Diseases
Pediatrics
Principal InvestigatorDavid Goldman, MD
Contact Sonia Sheehan

Email Contact
Trial DescriptionBrentuximab Vedotin and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Hodgkin Lymphoma - Click here for more information2015-4877
Disease/ConditionLymphoproliferative Disorders
Neoplasms
Pediatric Hematology/Oncology
Blood and Bone Marrow Cancer
Immune System Diseases
Lymphatic and Spleen Diseases
Lymphoma
Principal InvestigatorLisa Gennarini, MD
Contact Joyce Brown

Email Contact
Trial DescriptionCannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD) - Click here for more information2017-8538
Disease/ConditionChild Development
Neurodevelopmental Disorders
Autism Spectrum Disorder
Principal InvestigatorEric Hollander, MD
Contact Erin Shanahan

Email Contact
Trial DescriptionChildhood Asthma Perception Study (CAPS) - Click here for more information2014-3257
Disease/ConditionAllergy & Immunology
Allergy and Immune Disorders
Asthma and other Respiratory Diseases
Pediatrics
Principal InvestigatorJonathan Feldman, PhD
Contact Jonathan Feldman, PhD

Email Contact
Trial DescriptionCOG-ANBL00B1 Neuroblastoma Biology Studies - Click here for more information1200011361
Disease/ConditionMedical and Hematologic Oncology
Neuroblastoma
Neoplasms
Principal InvestigatorLisa Gennarini, MD
Contact Joyce Brown

Email Contact
Trial DescriptionCombination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations - Click here for more information2015-4852
Disease/ConditionBlood and Bone Marrow Cancer
Immune System Diseases
Leukemia
Lymphatic and Spleen Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Pediatric Hematology/Oncology
Principal InvestigatorLisa Gennarini, MD
Contact Annette Pedro

Email Contact
Trial DescriptionConsideration of Pedicle Screw Misplacement on a Per-Patient Basis: Can we Better Delineate Surgical Risk? IRB# 12-07-237E
Disease/ConditionBones, Muscles & Joints (Orthopaedics)
Principal InvestigatorVishal Sarwahi, MD
Contact Rachel Gecelter
(718) 920-7739
Email Contact
Trial DescriptionDefensin and Innate Mucosal Immune Mediator Expression in Pediatric Inflammatory Bowel Disease 2012-529
Disease/ConditionGastroenterology & Liver Diseases
Inflammatory Bowel Disease
Pediatrics
Principal InvestigatorGitit Tomer, MD
Contact Preeti Malik

Email Contact
Trial DescriptionDiabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM - Click here for more information18-10-275-01
Disease/ConditionDiabetes and Endocrine
Metabolic Diseases
Pediatric Endocrinology
Principal InvestigatorLisa Underland, MD
Contact Ranjitha Katikaneni

Email Contact
Trial DescriptionDoes Pedicle Morphology Change with Age? IRB# 11-04-158E
Disease/ConditionBones, Muscles & Joints (Orthopaedics)
Principal InvestigatorVishal Sarwahi, MD
Contact Rachel Gecelter
(718) 920-7739
Email Contact
Trial DescriptionEfficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker - Click here for more information2017-8362
Disease/ConditionKidney Diseases (incl Chronic Kidney Disease)
Nephrology
Pediatrics
Urologic Diseases
Principal InvestigatorFrederick Kaskel, MD
Contact Patricia Flynn

Email Contact
Trial DescriptionFollow-up study of children with early diagnosis of autism spectrum disorder IRB# 2007-546
Disease/ConditionAutism Spectrum Disorder
Principal InvestigatorLisa Shulman, MD
Contact Lisa Shulman, MD
(718) 430-3901
Email Contact
Trial DescriptionGene Discoveries in Subjects with Crohns Disease of African Descent IRB# 13-01-024
Disease/Condition -
Principal InvestigatorGitit Tomer, MD
Contact Sharon Thomas
(718) 741-2557
Email Contact
Trial DescriptionHydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial - Click here for more information2017-8570
Disease/ConditionAnemia
Hematologic Diseases
Pediatric Hematology/Oncology
Pediatrics
Genetic Disorders
Principal InvestigatorDeepa Manwani, MD
Contact Karen Ireland

Email Contact
Trial DescriptionIbrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD) (INTEGRATE) - Click here for more information17-10-17-01
Disease/ConditionGraft Versus Host Disease (GVHD)
Principal InvestigatorOlga Derman, MD
Contact Kailashben Thummar

Email Contact
Trial DescriptionInfantile Spasms Multicenter Database IRB# 13-01-027
Disease/ConditionBrain and Neurological
Principal InvestigatorElissa Yozawitz, MD
Contact Elissa Yozawitz, MD
(718) 920-4378
Email Contact
Trial DescriptionInternational Registry for Severe Chronic Neutropenia - Click here for more informationIRB# 03-01-015E
Disease/ConditionBlood Disorders and Diseases
Principal InvestigatorKerry Morrone, MD
Contact Joyce Brown
(718) 741-2356
Email Contact
Trial DescriptionIntravenous Gammaglobulin for Sickle Cell Pain Crises - Click here for more informationIRB # 09-06-172
Disease/ConditionBlood Disorders and Diseases
Anesthesia and Pain Management
Principal InvestigatorDeepa Manwani, MD
Contact Karen Ireland
(718) 741-2401
Email Contact
Trial DescriptionMaintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients With Newly Diagnosed Ependymoma - Click here for more information10-07-196
Disease/ConditionBrain and Neurological
Principal InvestigatorLisa Gennarini, MD
Contact Joyce Brown

Email Contact
Trial DescriptionMatched Targeted Therapy (MTT) Recommendation for Patients with Recurrent, Refractory, or High Risk Leukemias - Click here for more information2016-5971
Disease/ConditionPediatric Hematology/Oncology
Leukemia
Neoplasms
Blood Disorders and Diseases
Cancer
Principal InvestigatorLisa Gennarini, MD
Contact Annette Pedro

Email Contact
Trial DescriptionMetformin in Children With Relapsed or Refractory Solid Tumors - Click here for more information12-05-190
Disease/ConditionSolid Tumor
Principal InvestigatorDaniel Weiser, MD
Contact Joyce Brown
(718) 741-2356
Email Contact
Trial DescriptionMolecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction - Click here for more information2018-8749
Disease/ConditionNeonatology
Pediatrics
Overweight, Obesity and Weight Loss
Principal InvestigatorMamta Fuloria, MD
Contact Sonia Sheehan

Email Contact
Trial DescriptionMood disorder and cognitive dysfunction in pediatric lupus IRB# 2000-154
Disease/ConditionRheumatic Diseases
Principal InvestigatorChaim Putterman, MD
Contact Tamar Rubinstein, MD
(718) 741-2459
Email Contact
Trial DescriptionMulticenter Cohort Study To Evaluate Outcomes After Receipt of Targeted Therapy Matched to an Individualized Cancer Therapy (iCat) Recommendations in Children and Young Adults With Solid Tumors: The iCat2, GAIN Consortium Study - Click here for more information2016-7341
Disease/ConditionCancer
Hematologic Diseases
Pediatric Hematology/Oncology
Solid Tumor
Principal InvestigatorDaniel Weiser, MD
Contact Annette Pedro

Email Contact
Trial DescriptionMulticenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease (IPSG1) - Click here for more informationIRB# 2013-2550
Disease/ConditionBones, Muscles & Joints (Orthopaedics)
Principal InvestigatorEric Fornari, MD
Contact Eric Fornari, MD
(718) 920-7739
Email Contact
Trial DescriptionMulticenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy (ALLELE) - Click here for more information16-10-296-01
Disease/ConditionEpstein-Barr Virus (EBV)
Lymphoproliferative Disorders
Pediatric Hematology/Oncology
Pediatrics
Solid Organ Transplant (SOT) Complications
Immune System Diseases
Principal InvestigatorDavid Loeb, MD
Contact Elodie Benard

Email Contact
Trial DescriptionMulticenter, Open-Label, Phase 3 Study of Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab (MATCH Study) - Click here for more information16-10-211-01
Disease/ConditionEpstein-Barr Virus (EBV)
Immune System Diseases
Lymphatic and Spleen Diseases
Lymphoma
Lymphoproliferative Disorders
Pediatric Hematology/Oncology
Cancer
Principal InvestigatorDavid Loeb, MD
Contact Elodie Benard

Email Contact
Trial DescriptionNatural History Study of the Development of Type 1 Diabetes - Click here for more information2018-9828
Disease/ConditionDiabetes and Endocrine
Endocrinology
Metabolic Diseases
Autoimmune Diseases
Principal InvestigatorLisa Underland, MD
Contact Doreen Newell

Email Contact
Trial DescriptionNephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network (NEPTUNE) - Click here for more information09-06-182
Disease/ConditionGeriatrics
Kidney Diseases (incl Chronic Kidney Disease)
Nephrotic Syndrome
Pediatrics
Urologic Diseases
Immune System Diseases
Principal InvestigatorFrederick Kaskel, MD
Contact Patricia Flynn

Email Contact
Trial DescriptionNeuropsychological and Behavioral Testing in Younger Patients With Cancer - Click here for more information09-04-137E
Disease/ConditionSupportive Cancer Care
Principal InvestigatorLisa Gennarini, MD
Contact Joyce Brown
(718) 741-2356
Email Contact
Trial DescriptionNon-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global) - Click here for more informationIRB# 15-02-306
Disease/ConditionAllergy and Immune Disorders
Principal InvestigatorArye Rubinstein, MD
Contact Gayle Kreinik
(718) 405-8530
Email Contact
Trial DescriptionNorth American Pediatric Renal Trials and Collaborative Studies IRB# 02-06-151E
Disease/ConditionKidney Diseases (incl Chronic Kidney Disease)
Principal InvestigatorMarcela Del Rio, MD
Contact Patti Flynn
(718) 655-1120
Email Contact
Trial DescriptionObservational Study of Pediatric Rheumatic Diseases: The CARRA Registry - Click here for more informationIRB# 2015-5327
Disease/ConditionRheumatic Diseases
Principal InvestigatorYonit Sterba Ruas, MD
Contact Marija Dionizovik-Dimanovski
(718) 696-2402
Email Contact
Trial DescriptionOpen-label, Phase I/II Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Anticancer Activity of Avelumab in Pediatric Subjects From Birth to Less Than 18 Years of Age With Refractory or Relapsed Solid Tumors and Lymphoma - Click here for more information17-10-398Q-01
Disease/ConditionImmune System Diseases
Lymphatic and Spleen Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Pediatric Hematology/Oncology
Solid Tumor
Principal InvestigatorDavid Loeb, MD
Contact David Loeb, MD

Email Contact
Trial DescriptionOutcomes of Neonatal Acute Kidney Injury In Premature Infants - Click here for more information2013-2900
Disease/ConditionKidney Diseases (incl Chronic Kidney Disease)
Principal InvestigatorMamta Fuloria, MD
Contact Mamta Fuloria, MD
(718) 904-4105
Email Contact
Trial DescriptionPed Cardiac Quality of LIfe IRB# 08-05-162
Disease/ConditionHeart and Vascular Diseases
Principal InvestigatorJacqueline Lamour, MD
Contact Kimberly Beddows
(718) 741-2315
Email Contact
Trial DescriptionPediatric Heart Transplant Study Group IRB# 08-05-166
Disease/ConditionHeart and Vascular Diseases
Principal InvestigatorJacqueline Lamour, MD
Contact Kimberly Beddows
(718) 741-2315
Email Contact
Trial DescriptionPeer Mentor Training to Reduce Hospitalizations for Children With Asthma - Click here for more information10-06-174E
Disease/ConditionLung Diseases
Pediatrics
Asthma and other Respiratory Diseases
Principal InvestigatorDeepa Rastogi, MD
Contact Deepa Rastogi, MD

Email Contact
Trial DescriptionPersonalized Medicine: Pediatric Total Cancer Care™ Protocol 2013-2690
Disease/ConditionSupportive Cancer Care
Principal InvestigatorDaniel Weiser, MD
Contact Annette Pedro
718-741-2356
Email Contact
Trial DescriptionPharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia (EMERALD) - Click here for more information16-10-391-01
Disease/ConditionKidney Diseases (incl Chronic Kidney Disease)
Principal InvestigatorAnna Zolotnitskaya, MD
Contact Anna Zolotnitskaya, MD

Email Contact
Trial DescriptionPhase 2 Study: Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Children and Adolescents With Prader-Willi Syndrome - Click here for more information2017-8076
Disease/ConditionPsychiatry - Non Cancer
Nervous System Diseases
Child Development
Pediatrics
Genetic Disorders
Principal InvestigatorEric Hollander, MD
Contact Danya Schlussel

Email Contact
Trial DescriptionPhase III Multicenter Open-label Randomized Clinical Trial Comparing Everolimus and Low Dose Tacrolimus to Tacrolimus and Mycophenolate Mofetil at 6 mo Post-Transplant to Prevent Long-term Complications After Pediatric Heart Transplantation - Click here for more information2017-8626
Disease/ConditionHeart and Vascular Diseases
Kidney Diseases (incl Chronic Kidney Disease)
Pediatrics
Urologic Diseases
Cardiovascular and Thoracic Surgery
Principal InvestigatorJacqueline Lamour, MD
Contact Helen Alexander

Email Contact
Trial DescriptionProject: Every Child for Younger Patients With Cancer - Click here for more information2016-5989
Disease/ConditionCancer and Genetics
Principal InvestigatorLisa Gennarini, MD
Contact Joyce Brown
(718) 741-2356
Email Contact
Trial DescriptionPromoting Asthma Guidelines and Management through Technology-Based Intervention and Care Coordination (PRAGMATIC) - Click here for more information2016-6258
Disease/ConditionAsthma and other Respiratory Diseases
Pediatrics
Lung Diseases
Principal InvestigatorMarina Reznik, MD
Contact Guadalupe Salazar

Email Contact
Trial DescriptionProphylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center International Randomized Controlled Trial Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections With Endoprosthetic Replacements - Click here for more information2014-4077
Disease/ConditionBone Cancer
Cancer
Infectious Diseases
Musculoskeletal Diseases
Neoplasms
Surgery
Principal InvestigatorDavid Geller, MD
Contact David Geller, MD

Email Contact
Trial DescriptionProtocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries - Click here for more information08-05-156E
Disease/ConditionNeoplasms
Oncology (Medical/Hematologic)
Pediatric Hematology/Oncology
Blood and Bone Marrow Cancer
Blood Disorders and Diseases
Hematologic Diseases
Principal InvestigatorIra Braunschweig, MD
Contact Novneet Sandhu

Email Contact
Trial DescriptionProtocol for a Research Sample Repository and for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies, and Marrow Toxic Injuries - Click here for more information2015-5698
Disease/ConditionHematologic Diseases
Neoplasms
Pediatric Hematology/Oncology
Pediatrics
Oncology (Medical/Hematologic)
Principal InvestigatorDavid Loeb, MD
Contact Marissa Green

Email Contact
Trial DescriptionProtocol for a Research Sample Repository for Allogeneic Hematopoietic Stem Cell Transplantation - Click here for more information08-05-155E
Disease/ConditionAutoimmune Diseases
Blood and Bone Marrow Cancer
Blood Disorders and Diseases
Principal InvestigatorIra Braunschweig, MD
Contact Novneet Sandhu
(718) 405-8446
Email Contact
Trial DescriptionQuarenta Semanas: Innovative Intervention in Prenatal Care for Reduction of Prematurity (quarenta) - Click here for more informationIRB# 2014-3022
Disease/ConditionInfant Care
Principal InvestigatorJudy Aschner, MD
Contact Judy Aschner, MD
(718) 741-2499
Email Contact
Trial DescriptionRadiation Therapy With or Without Combination Chemotherapy or Pazopanib Hydrochloride Before Surgery in Treating Patients With Newly Diagnosed Non-Rhabdomyosarcoma Soft Tissue Sarcomas That Can be Removed by Surgery (PAZNTIS) - Click here for more information2015-4866
Disease/ConditionSoft Tissue Sarcoma/Cancer
Principal InvestigatorLisa Gennarini, MD
Contact Joyce Brown
(718) 741-2338
Email Contact
Trial DescriptionResponse and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma - Click here for more informationANBL1232
Disease/ConditionNeuroblastoma
Principal InvestigatorPeter Cole, MD
Contact Joyce Brown
(718) 741-2356
Email Contact
Trial DescriptionRisk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia - Click here for more information12-01-021
Disease/ConditionBlood and Bone Marrow Cancer
Principal InvestigatorPeter Cole, MD
Contact Joyce Brown
(718) 741-2356
Email Contact
Trial DescriptionRisk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL) - Click here for more information2015-4876
Disease/ConditionEpstein-Barr Virus (EBV)
Leukemia
Lymphoma
Lymphoproliferative Disorders
Oncology (Medical/Hematologic)
Neoplasms
Non-Hodgkins Lymphoma
Principal InvestigatorLisa Gennarini, MD
Contact Joyce Brown

Email Contact
Trial DescriptionSafety Study of Gene Modified Donor T-cells Following TCR Alpha Beta Depleted Stem Cell Transplant - Click here for more informationIRB# 15-11-347
Disease/ConditionBlood and Bone Marrow Cancer
Principal InvestigatorKris Mahadeo, MD
Contact Ruth Santizo
(718) 741-2287
Email Contact
Trial DescriptionSelf regulation in children with learning disabilities and inattention/hyperactivity IRB# 2006-425
Disease/ConditionChild Development
Principal InvestigatorKatherine Lawson, PhD
Contact Maria Valicenti-McDermott, MD
(718) 430-8600 6275
Email Contact
Trial DescriptionSensory Integration Therapy in Autism: Mechanisms and Effectiveness IRB# 2014-3795
Disease/ConditionAutism Spectrum Disorder
Principal InvestigatorSophie Molholm, PhD
Contact Maya Madzharova
(718) 862-1817
Email Contact
Trial DescriptionSimple Bone Cysts in Kids (SBoCK) - Click here for more information2015-4768
Disease/ConditionBones, Muscles & Joints (Orthopaedics)
Orthopaedic Surgery
Pediatrics
Neoplasms
Musculoskeletal Diseases
Principal InvestigatorJacob Schulz, MD
Contact Regina Hanstein

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Trial DescriptionStudy of Allogeneic EBV-CTLs in EBV-Associated Viremia or Malignancies - Click here for more information16-10-116-01
Disease/ConditionHematologic Diseases
Pediatrics
Principal InvestigatorDavid Loeb, MD
Contact Elodie Benard

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Trial DescriptionStudy of Kidney Tumors in Young Patients - Click here for more information08-05-181E
Disease/ConditionKidney Cancer
Principal InvestigatorLisa Gennarini, MD
Contact Joyce Brown
(718) 741-2356
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Trial DescriptionStudy of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia - Click here for more informationIRB# 15-08-314
Disease/ConditionHeart and Vascular Diseases
Principal InvestigatorScott Aydin,MD
Contact Helen Alexander, RN
(718) 741-2678
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Trial DescriptionThe Children’s Spine Registry IRB# 2016-6022
Disease/ConditionBones, Muscles & Joints (Orthopaedics)
Principal InvestigatorJaime Gomez, MD
Contact Regina Hanstein
(718) 920-7743
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Trial DescriptionThe Chimerix CMX001 Registry - Click here for more informationIRB# 14-06-233-01
Disease/ConditionBlood and Bone Marrow Cancer
Principal InvestigatorOlga Derman, MD
Contact Karen Fehn
(718) 405-8446
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Trial DescriptionThe Influence of Breakfast on Hormone Responses and Cognitive Performance, as Assessed by CTET in Lean and Obese Adolescent Males - Click here for more information2015-5542
Disease/ConditionMetabolic Diseases
Pediatric Endocrinology
Overweight, Obesity and Weight Loss
Principal InvestigatorLisa Underland, MD
Contact Liset Estanislao

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Trial DescriptionThe National Emergency Airway Registry for Children IRB# 2014-3877
Disease/ConditionAsthma and other Respiratory Diseases
Principal InvestigatorMichael Miksa, MD
Contact Michael Miksa, MD
(718) 741-2455
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Trial DescriptionThe Reliability of X-Ray Based Evaluation of Pedicle Screw Misplacement in Adolescent Spinal Deformity IRB# 11-04-159E
Disease/ConditionBones, Muscles & Joints (Orthopaedics)
Principal InvestigatorVishal Sarwahi, MD
Contact Stephen Wendolowski
(718) 920-7739
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Trial DescriptionThe use of Complementary and Alternative Medicine in Autism IRB# 2007-371
Disease/ConditionAutism Spectrum Disorder
Principal InvestigatorMaria Valicenti-McDermott, MD
Contact Maria Valicenti-McDermott, MD
(718) 430-8600 Ext 6275
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Trial DescriptionThe use of Virtual Reality Games to Enhance Therapy for Children with Cerebral Palsy. A pilot Study IRB# 2008-347
Disease/ConditionBrain and Neurological
Principal InvestigatorMaria Valicenti-McDermott, MD
Contact Maria Valicenti-McDermott, MD
(718) 430-8600 Ext 6275
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Trial DescriptionTreatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents - Click here for more information2017-8449
Disease/ConditionLeukemia
Lymphatic and Spleen Diseases
Neoplasms
Pediatric Hematology/Oncology
Lymphoproliferative Disorders
Principal InvestigatorLisa Gennarini, MD
Contact Lisa Gennarini, MD

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Trial DescriptionUS-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice - Click here for more information14-08-436-01
Disease/ConditionHeart and Vascular Diseases
Principal InvestigatorSandhya Murthy, MD
Contact Roy Park
718-904-3124
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Trial DescriptionVALENS: A Ph 1/2, Random'd, Open-Label, Ascending-Dose, Delayed-Treatment Concurrent Control Clinical Study to Evaluate Safety/Preliminary Efficacy of AT342, an AAV8-Delivered Gene Transfer Therapy in Crigler-Najjar Syndrome Subjects Aged 1 Yr and Older - Click here for more information2017-7918
Disease/ConditionBrain and Neurological
Crigler-Najjar Syndrome
Gastroenterology & Liver Diseases
Heart and Vascular Diseases
Metabolic Diseases
Pediatrics
Principal InvestigatorNadia Ovchinsky, MD
Contact Sharon Thomas

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Trial DescriptionWeb-based Peer Mentor Training to Reduce Hospitalizations for Children with Asthma - Click here for more information2014-3962
Disease/ConditionAsthma and other Respiratory Diseases
Pediatrics
Lung Diseases
Principal InvestigatorDeepa Rastogi, MD
Contact Toni Tobias

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