Neurosurgery Trials

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A Radiographic and Clinical Study Evaluating a Novel Allogenic, Cancellous, Bone Matrix Containing Viable Stem and Osteoprogenitor Cells (Trinity Evolution Viable Cryopreserved Cellular bone Matrix) in Posterior Lumbar or Transforaminal Lumbar Interbody Fusion (PLIF or TLIF) (CP-01006A)
Primary investigator: Carlos Bagley, MD
Sponsor: Orthofix Spinal Implants
Disease area: Spine
eIRB number: 18961
Contact: Jessica Morris, 919-668-6712

Pediatric Traumatic Brain Injury Consortium: Hypothermia
Primary investigator: Gerald Grant, MD
Sponsor: University of California -- San Diego, St. Joseph’s Hospital and Medical Center
Disease area: Brain injury
eIRB number: 1953
Contact: Joanna Stoner, 919-668-5275

Outcomes in Patients Undergoing Surgical Intervention for Chiari Type I Malformation with Syringomyelia
Primary investigator: Gerald Grant, MD
Sponsor: University of Wisconsin School of Medicine and Public Health
Disease area: Chiari type 1 malformation with syringomyelia
eIRB number: 24573
Contact: Peggy Harris, 919-681-0894

Randomized Controlled Trial of Galantamine, Methylphenidate, and Placebo for the Treatment of Cognitive Symptoms in Patients with Mild Traumatic Brain Injury (mTBI) and/or Posttraumatic Stress Disorder (PTSD) -- Cognitive REmediation After Trauma Exposure Trial = CREATE Trial
Primary investigator: Gerald Grant, MD
Sponsor: U.S. Army Medical Research and Materiel Command (USAMRMC) -- Contract # W81XWH-08-2-0159
Disease area: PTSD
eIRB number: 24573
Contact: Jody Hawes, 919-681-1608

Operative Patient Positioning in Lumbar Fusion Surgery and its Impact on Spinal Sagittal Balance and Surgeon Satisfaction
Primary investigator: Oren Gottfried, MD
Disease area: Lumbar fusion
eIRB number: 28159
Contact: Jessica Morris, 919-668-6712

A Prospective Multi-Center Randomized Evaluation of the Clinical and Radiographic Outcomes of XLIF® Compared with MAS® TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis with or without Central Stenosis (NUVA.X0901)
Primary investigator: Robert Isaacs, MD
Sponsor: NuVasive, Inc
Disease area: Lumbar degenerative spondylolisthesis
eIRB number: 22589
Contact: Angela Green, 919-668-3367

Evaluation of Recovery from Drug-Induced lymphopenia using Cytomegalovirus-specific T-cell Adoptive Transfer
Primary investigator: Duane Mitchell, MD
Sponsor: NIH
Disease area: Lymphopenia
eIRB number: 580
Contact: Beth Perry, 919-684-9291

Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial (RESTART)
Primary investigator: Duane Mitchell, MD
Sponsor: NIH
Disease area: Brain tumor
eIRB number: 6677
Contact: Beth Perry, 919-684-9291

Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor Adoptive T Cell Therapy during Recovery from Myeloablative Chemotherapy and Hematopoietic Stem Cell Transplantation
Primary investigator: Duane Mitchell, MD
Sponsor: Department of Defense
Disease area: Brain tumor
eIRB number: 18020
Contact: Beth Perry, 919-684-9291

Phase II single-arm study of preoperative stereotactic radiosurgery for brain metastases
Primary investigator: John Sampson, MD, PhD
Sponsor: Surgery
Disease area: Brain metastases
eIRB number: 6870
Contact: Beth Perry, 919-684-9291

In-Vitro Generation and Characterization of Cytotoxic T Lymphocytes (CTL) Using Dendritic Cells From Malignant Brain Tumor Patients Pulsed with Antigen Specific RNA or Peptides
Primary investigator: John Sampson, MD, PhD
Sponsor: Surgery
Disease area: Brain tumor
eIRB number: 9403
Contact: Beth Perry, 919-684-9291

Molecular Signatures for Targeting Brain Tumor Therapy: Phase I/II Evaluation of Genomically-Guided Therapy with Erlotinib and Lapatinib in addition to the Standard-of-Care in Patients with Newly-Diagnosed Glioblastoma
Primary investigator: John Sampson, MD, PhD
Sponsor: Department of Defense
Disease area: Brain tumor
eIRB number: 17232
Contact: Beth Perry, 919-684-9291

Determination of EGFRvIII Status in GBM Subjects at Recurrence
Primary investigator: John Sampson, MD, PhD
Sponsor: NIH
Disease area: Brain tumor
eIRB number: 26150
Contact: Beth Perry, 919-684-9291

Intraoperative Analysis of Reward and Inhibition in Human STN/SNr
Primary investigator: Dennis Turner, MD
Sponsor: Surgery
Disease area: Placement of deep brain stimulating electrodes (DBS)
eIRB number: 30504
Contact: Lynne Gasperson, 919-684-6706

Neuro-Oncology Trials

Effects of Dexamethasone Tapering Schedule of Functional Capacity and Neurocognition in Patients with Newly Diagnosed Glioblastoma Multiforme
Primary investigator: Katherine Peters, MD, PhD
Sponsor: Surgery
Disease area: Brain tumor
eIRB number: 24406
Contact: Miranda West, 919-681-5494

A Phase I Study of Immunotoxin, MR1-1
Primary investigator: James Vredenburgh, MD
Sponsor: NIH
Disease area: Brain tumor
eIRB number: 11617
Contact: Karen Carter, 919-668-2329