Search Results

You are looking at 1 - 10 of 4,039 items for :

  • "clinical trial" x
  • Refine by Access: all x
Clear All
Restricted access

Stephen J. Haines

T he evaluation and eventual rejection of gastric freezing 31 and internal mammary artery ligation 2 as viable therapeutic techniques are clear examples of the hazards of inadequate early evaluation of new surgical procedures. Similar experiences in other areas of medicine have made the double-blind, randomized clinical trial the standard for evaluation of new medical therapies, especially in clinical pharmacology. 8, 14, 23, 24, 32 In a provocative paper by Deniston and Rosenstock, 15 non-randomized designs have been compared with randomized designs using

Full access

Charles H. Tator and Michael G. Fehlings

Financial assistance of the Joint Sections of Neurotrauma and Critical Care and Disorders of the Spine and Peripheral Nerves of the AANS/CNS which have encouraged the development of clinical trials in acute SCI. Dr. Fehlings is supported by a Career Scientist Award from the Ontario Ministry of Health.

Free access

Victor M. Lu, Ashish H. Shah, Frederic A. Vallejo, Daniel G. Eichberg, Evan M. Luther, Sumedh S. Shah, Ricardo J. Komotar, and Michael E. Ivan

with tumor cell–killing abilities. 5 Since those early days, our biological understanding of viral therapy has grown exponentially, to the point where multiple clinical trials for multiple cancer types are active. 6 Attention has turned to oncolytic viral therapy as a possible novel therapy that may confer a prognostic benefit to adult patients with GBM, particularly at recurrence. However, progress to date with respect to in-human clinical trials remains subject to highly heterogeneous reporting and result dissemination. Correspondingly, the aim of this study was

Restricted access

Jau-Ching Wu, Wen-Cheng Huang, Yu-Chun Chen, Tsung-Hsi Tu, Yun-An Tsai, Shih-Fong Huang, Hsueh-Chen Huang, and Henrich Cheng

spinal cord is usually not clinically applicable because of the scarcity of complete transection injury in actual clinical practice. Thus, the repair strategy has been modified according to clinical applicability, sparing the need for peripheral nerve grafting. This clinical trial was designed to test the efficacy and safety of using aFGF in combination with surgical intervention in human SCI. Spinal cord injury is one of the most catastrophic events in human life and poses incredible devastation to physical and psychological integrity of patients and their families

Restricted access

Guy L. Clifton, Sung C. Choi, Emmy R. Miller, Harvey S. Levin, Kenneth R. Smith Jr., J. Paul Muizelaar, Franklin C. Wagner Jr., Donald W. Marion, and Thomas G. Luerssen

A ll Phase III clinical trials of severely traumatic brain injury in recent years have been designed as multicenter studies. The primary reason for multicenter studies is that a single center cannot accrue a sufficient number of patients to achieve satisfactory statistical power in a reasonable time period. In addition, the study results are more likely to be generalized than would be possible if data were obtained in only a single-center trial. A multicenter trial, however, can be associated with an increased variance in outcomes that could reduce the overall

Free access

Andrew E. Sloan, Manmeet S. Ahluwalia, Jose Valerio-Pascua, Sunil Manjila, Mark G. Torchia, Stephen E. Jones, Jeffrey L. Sunshine, Michael Phillips, Mark A. Griswold, Mark Clampitt, Cathy Brewer, Jennifer Jochum, Mary V. McGraw, Dawn Diorio, Gail Ditz, and Gene H. Barnett

(white) thermal dose, including those with complications ( Fig. 9 upper ). There were only 2 deaths during the 6-month window of the study's prescribed follow-up period; one in a patient treated at the yellow thermal dose and another in one treated at the blue dose. Both patients suffered progression of the underlying disease and were entered into hospice rather than receiving additional treatment. No deaths were related to the treatment procedure or device. At least 3 patients entered into subsequent clinical trials after completing the mandated 14-day observation

Restricted access

Michael G. Fehlings, Jefferson R. Wilson, Ralph F. Frankowski, Elizabeth G. Toups, Bizhan Aarabi, James S. Harrop, Christopher I. Shaffrey, Susan J. Harkema, James D. Guest, Charles H. Tator, Keith D. Burau, Michele W. Johnson, and Robert G. Grossman

the evolution of secondary injury events. These therapies, which include methylprednisolone and GM-1 (Sygen), have been the subject of the largest clinical trials in SCI performed to date. 9–11 , 15 Although treatments from both of the described categories have shown exceptional promise at the preclinical stages of investigation, none have proven to be uniformly effective in the treatment of human patients with SCI. 18 Riluzole, a sodium channel–blocking drug with putative neuroprotective properties gleaned from the preclinical literature, falls into the second

Full access

Nazi Derakhshanrad, Hooshang Saberi, Mir Saeed Yekaninejad, and Mohammad Taghi Joghataei

-CSF regarding its wide neuroprotective action and its neurodegenerative mechanisms of action in the treatment of TSCI. 18 G-CSF has been successfully used clinically for acute 14 , 33 and chronic 6 , 27 TSCI, as well as subacute compressive myelopathy 28 , 29 and stroke in humans. 25 Previously, on the basis of the available preclinical and clinical results described, we have conducted phase I, 6 phase I/IIa, 27 and phase III 7 clinical trials with promising results regarding safety, feasibility, and efficacy of G-CSF as a neuroprotective therapy in patients with

Restricted access

James Guest, James S. Harrop, Bizhan Aarabi, Robert G. Grossman, James W. Fawcett, Michael G. Fehlings, and Charles H. Tator

for NACTN testing is the task of the TSC. The subject of this article is how the TSC function is structured to optimize its efficacy and impartiality. In addition, we propose a methodology to make evaluation and selection of therapeutics more rational, quantitative, and less biased. The mission statement of NACTN is “to carry out clinical trials of the comparative effectiveness of new therapies for SCI using an established consortium of neurosurgery departments at university-affiliated civilian medical center hospitals and military hospitals with medical, nursing

Restricted access

Jawad M. Khalifeh, Christopher F. Dibble, Anna Van Voorhis, Michelle Doering, Martin I. Boyer, Mark A. Mahan, Thomas J. Wilson, Rajiv Midha, Lynda J. S. Yang, and Wilson Z. Ray

below the SCI, while preserving the natural biomechanics, force, and excursion of the original muscles. 26 , 28 As discussed in part 1 of this study, numerous reports have demonstrated clinically meaningful improvements in upper-extremity strength and function with these procedures. 20 Despite these promising results, there are a paucity of data to guide clinical decision-making, particularly regarding the optimal timing of interventions and their long-term outcomes. The objective of this study was to present early results of a prospective clinical trial of nerve