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Wounds and Injuries clinical trials

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NCT ID: NCT01338480 Completed - Surgery Clinical Trials

Improving Informed Consent Process for Trauma Patients in the Emergency Department

Start date: November 9, 2009
Phase: N/A
Study type: Interventional

This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing trauma patients in emergency department (ED) about risks, benefits, and alternatives to receiving surgery.

NCT ID: NCT01336413 Completed - Clinical trials for Brain Injuries, Traumatic

Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans

Start date: October 2013
Phase: Phase 2
Study type: Interventional

Purpose: Mild traumatic brain injury (TBI) is extremely common among Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) era Veterans. Mild TBI is frequently accompanied by post-traumatic stress disorder (PTSD) and depression symptoms, co-occurring disorders that contribute to increased disability and decreased quality of life. Neuroactive steroids (NS) represent promising pharmacological candidates for intervention for these diverse symptom domains, since a number of these molecules demonstrate pronounced neuroprotective and neurotrophic properties. The NS pregnenolone (PREG) is a logical therapeutic option, since it enhances learning and memory and also increases myelination in rodent models. Further, decreases in PREG have been associated with depressive symptoms, and PREG is also metabolized to allopregnanolone (ALLO), an anxiolytic downstream NS that is decreased in PTSD. ALLO also enhances neurogenesis in rodents. The investigators thus propose an randomized controlled trial (RCT) in OEF/OIF era Veterans with mild TBI. Methodology: The design of this study will be randomized, placebo-controlled, double-blind. Trial duration will be 10 weeks, consisting of a 2-week placebo lead-in period for all subjects, followed by 8 weeks of treatment with either pregnenolone or placebo. The primary cognitive outcome measure will be executive functioning (as assessed by the Tower of London test), and the primary behavioral outcome measure will be PTSD Cluster D symptoms (as assessed by the Clinician-Administered PTSD Scale, CAPS). The investigators will also determine if PREG administration in OEF/OIF Veterans with mild TBI increases downstream ALLO and/or other GABAergic NS levels, and the investigators will identify the specific metabolism profile of PREG following eight weeks of treatment with this neurosteroid. Anticipated Findings: The investigators hypothesize that treatment with PREG in OEF/OIF era Veterans with mild TBI will significantly improve executive functioning compared to the placebo condition. The investigators also predict that treatment with PREG will decrease Cluster D PTSD symptoms compared to treatment with placebo.

NCT ID: NCT01335932 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure

GRAIL
Start date: March 10, 2011
Phase: Phase 2
Study type: Interventional

To evaluate whether administration of ganciclovir reduces serum IL-6 levels (i.e. reduction between baseline and 14 days post-randomization) in immunocompetent adults with severe sepsis or trauma associated respiratory failure. Primary Hypotheses: - In CMV seropositive adults with severe sepsis or trauma , pulmonary and systemic CMV reactivation amplifies and perpetuates both lung and systemic inflammation mediated through specific cytokines, and contributes to pulmonary injury and multiorgan system failure, AND - Prevention of CMV reactivation with ganciclovir decreases pulmonary and systemic inflammatory cytokines that are important in the pathogenesis of sepsis and trauma related complications.

NCT ID: NCT01333319 Completed - Acute Kidney Injury Clinical Trials

The Role of Biomarkers in the Early Detection of Acute Kidney Injury Induced by Liver Transplantation

KILT
Start date: December 2011
Phase:
Study type: Observational

Renal dysfunction is a major risk factor for poorer outcome after liver transplantation. Nevertheless, mechanisms of renal dysfunction in liver transplant recipients are not clearly understood. Calcineurin inhibitors are generally perceived as the most important cause; however the liver transplant procedure itself represents a major surgical / hemodynamic / inflammatory trauma that - on its own - can cause renal dysfunction. Creatinine and creatinine clearance are late markers of acute kidney injury and changes in these parameters occur only after substantial injury has already occurred. Even a stable creatinine does not exclude structural kidney damage. A series of new markers of tissue injury have been identified and have the potential to identify acute kidney injury better and earlier than creatinine and creatinine clearance. The aim of this study is to determine whether and how liver transplantation affects these urinary and plasma biomarkers and to study whether the changes in these biomarkers may predict later changes in standard functional parameters (creatinine and creatinine clearance). For this purpose, the urinary and plasma biomarkers, together with creatinine, will be determined serially during the different phases of the liver transplant process and daily until day 5 after transplantation.

NCT ID: NCT01329757 Completed - Spinal Cord Injury Clinical Trials

Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury

GHSCI
Start date: April 2011
Phase: Phase 3
Study type: Interventional

Objectives: To evaluate the efficacy and safety of one year treatment based on daily doses of exogenous growth hormone (GH) in patients with traumatic spinal cord injury. The first six months the pharmacological treatment will be associated to rehabilitation treatment. The main hypothesis is that GH can improve motor function of patients with traumatic spinal cord injury below the lesion level. The hypothesis is based on possible effects of GH at muscle and synaptic level. GH can also promote axonal growth and regeneration. Design: Clinical trial placebo-controlled, double-blind intervention with blind evaluation by third parties and blinding in the analysis of data (triple-blind design). Duration of intervention and monitoring: 364 days. Primary outcome measures. Changes of the American Spinal Injury Association (ASIA) scale (motor score)

NCT ID: NCT01325103 Completed - Spinal Cord Injury Clinical Trials

Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury

Start date: July 2010
Phase: N/A
Study type: Interventional

This research investigates the use of autologous bone marrow stem cells in patients with spinal cord injury.

NCT ID: NCT01322048 Completed - Clinical trials for Traumatic Brain Injury

DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Traumatic Brain Injury

Start date: August 2011
Phase: Phase 2
Study type: Interventional

The investigators intend to determine the effect of adrenergic blockade on 1) short-term physiology, behavior, and cognition and 2) long-term neuropsychological outcomes after severe Traumatic Brain Injury (TBI). The primary hypothesis is that adrenergic blockade after severe TBI will be associated with increased ventilator-free days.

NCT ID: NCT01320384 Completed - Clinical trials for Acute Respiratory Failure

Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury (FLORALI Study)

FLORALI
Start date: March 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation : 1. conventional oxygen therapy (O2 conventional) 2. high flow nasal oxygen therapy (O2-HFN) 3. association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).

NCT ID: NCT01298557 Completed - Clinical trials for Traumatic Brain Injury

MEG and DTI of Neural Function and Connectivity in Traumatic Brain Injury

Dana-REAC
Start date: February 2007
Phase:
Study type: Observational

The overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) are due to selective disruption of the long association white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI) and that the impaired cortical activation can be detected with magnetoencephalography (MEG), and that the results of these imaging examinations will correlate with neurocognitive status and functional recovery after TBI.

NCT ID: NCT01297673 Completed - Spinal Cord Injury Clinical Trials

Reflux in Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction

Start date: January 2010
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the incidence of reflux in patients with spinal cord injury in relation to the lesion level, duration of injury and bladder management