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      A clinical trial of progesterone for severe traumatic brain injury.

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          Abstract

          Progesterone has been associated with robust positive effects in animal models of traumatic brain injury (TBI) and with clinical benefits in two phase 2 randomized, controlled trials. We investigated the efficacy and safety of progesterone in a large, prospective, phase 3 randomized clinical trial.

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          Classification of traumatic brain injury for targeted therapies.

          Kathryn E Saatman, Ann-Christine Duhaime, Ross Bullock … (2008)
          The heterogeneity of traumatic brain injury (TBI) is considered one of the most significant barriers to finding effective therapeutic interventions. In October, 2007, the National Institute of Neurological Disorders and Stroke, with support from the Brain Injury Association of America, the Defense and Veterans Brain Injury Center, and the National Institute of Disability and Rehabilitation Research, convened a workshop to outline the steps needed to develop a reliable, efficient and valid classification system for TBI that could be used to link specific patterns of brain and neurovascular injury with appropriate therapeutic interventions. Currently, the Glasgow Coma Scale (GCS) is the primary selection criterion for inclusion in most TBI clinical trials. While the GCS is extremely useful in the clinical management and prognosis of TBI, it does not provide specific information about the pathophysiologic mechanisms which are responsible for neurological deficits and targeted by interventions. On the premise that brain injuries with similar pathoanatomic features are likely to share common pathophysiologic mechanisms, participants proposed that a new, multidimensional classification system should be developed for TBI clinical trials. It was agreed that preclinical models were vital in establishing pathophysiologic mechanisms relevant to specific pathoanatomic types of TBI and verifying that a given therapeutic approach improves outcome in these targeted TBI types. In a clinical trial, patients with the targeted pathoanatomic injury type would be selected using an initial diagnostic entry criterion, including their severity of injury. Coexisting brain injury types would be identified and multivariate prognostic modeling used for refinement of inclusion/exclusion criteria and patient stratification. Outcome assessment would utilize endpoints relevant to the targeted injury type. Advantages and disadvantages of currently available diagnostic, monitoring, and assessment tools were discussed. Recommendations were made for enhancing the utility of available or emerging tools in order to facilitate implementation of a pathoanatomic classification approach for clinical trials.
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            Clinical trials in head injury.

            Raj Narayan, Mary Ellen Michel, Beth Ansell … (2002)
            Traumatic brain injury (TBI) remains a major public health problem globally. In the United States the incidence of closed head injuries admitted to hospitals is conservatively estimated to be 200 per 100,000 population, and the incidence of penetrating head injury is estimated to be 12 per 100,000, the highest of any developed country in the world. This yields an approximate number of 500,000 new cases each year, a sizeable proportion of which demonstrate significant long-term disabilities. Unfortunately, there is a paucity of proven therapies for this disease. For a variety of reasons, clinical trials for this condition have been difficult to design and perform. Despite promising pre-clinical data, most of the trials that have been performed in recent years have failed to demonstrate any significant improvement in outcomes. The reasons for these failures have not always been apparent and any insights gained were not always shared. It was therefore feared that we were running the risk of repeating our mistakes. Recognizing the importance of TBI, the National Institute of Neurological Disorders and Stroke (NINDS) sponsored a workshop that brought together experts from clinical, research, and pharmaceutical backgrounds. This workshop proved to be very informative and yielded many insights into previous and future TBI trials. This paper is an attempt to summarize the key points made at the workshop. It is hoped that these lessons will enhance the planning and design of future efforts in this important field of research.
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              Trends in Traumatic Brain Injury in the U.S. and the public health response: 1995-2009.

              Victor Coronado, Lisa C McGuire, Kelly Sarmiento … (2012)
              Traumatic Brain Injury (TBI) is a public health problem in the United States. In 2009, approximately 2.4 million [corrected] patients with a TBI listed as primary or secondary diagnosis were hospitalized and discharged alive (N=300,667) or were treated and released from emergency departments (EDs; N=2,077,350), outpatient departments (ODs; N=83,857), and office-based physicians (OB-P; N=1,079,338). In addition, 52,695 died with one or more TBI-related diagnoses. Federal TBI-related laws that have guided CDC since 1996 were reviewed. Trends in TBI were obtained by analyzing data from nationally representative surveys conducted by the National Center for Health Statistics (NCHS). CDC has developed and is implementing a strategy to reduce the burden of TBI in the United States. Currently, 20 states have TBI surveillance and prevention systems. From 1995-2009, the TBI rates per 100,000 population increased in EDs (434.1 vs. 686.0) and OB-Ps (234.6 vs. 352.3); and decreased in ODs (42.6 vs. 28.1) and in TBI-related deaths (19.9 vs. 16.6). TBI Hospitalizations decreased from 95.5 in 1995 to 77.9 in 2000 and increased to 95.7 in 2009. The rates of TBI have increased since 1995 for ED and PO visits. To reduce of the burden and mitigate the impact of TBI in the United States, an improved state- and territory-specific TBI surveillance system that accurately measures burden and includes information on the acute and long-term outcomes of TBI is needed. Published by Elsevier Ltd.
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                Author and article information

                Journal
                Journal ID (iso-abbrev): N. Engl. J. Med.
                Title: The New England journal of medicine
                ISSN (Electronic): 1533-4406
                ISSN (Print): 0028-4793
                Publication date (Electronic): Dec 25 2014
                Volume: 371
                Issue: 26
                Affiliations
                [1 ] From the Department of Neurosurgery, Cushing Neuroscience Institute, Hofstra North Shore-LIJ School of Medicine, Manhasset, NY (B.E.S., R.K.N.); the Department of Neurosurgery, University Hospital Antwerp and University of Antwerp, Edegem, Belgium (A.I.M.); BHR Pharma, Herndon (R.G.H., T.M., N.R.N.), and the Department of Neurosurgery, Virginia Commonwealth University, Richmond (J.D.W.) - both in Virginia; and the Department of Physiopathology and Transplantation, Milan University and Neuro Intensive Care Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Cà Granda Ospedale Maggiore Policlinico, Milan (N.S.).
                Article
                DOI: 10.1056/NEJMoa1411090
                PubMed ID: 25493978
                SO-VID: 262388f7-dcb1-464d-b649-437a7e0f1db0
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