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Wounds and Injuries clinical trials

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NCT ID: NCT01548690 Completed - Acute Liver Failure Clinical Trials

Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury

STOP-ALF
Start date: June 2012
Phase: Phase 2
Study type: Interventional

This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute liver failure/acute liver injury (ALF/ALI) in regard to: - safety and tolerability; - metabolism of the compound to glutamine and phenylacetylglutamine (PAGN); - its effect on circulating ammonia levels and neurological function in patients with and without impaired renal function after continuous infusion at different infusion rates. Subjects will receive up to 120 hours (5 days) of drug infusion, followed by a 30 day follow-up visit post infusion. It is anticipated that this early safety and tolerability study, with appropriate PK/PD data, will lead to a development program for the use of OCR-002 in the treatment of hyperammonemia either due to ALF or possibly other liver conditions. The hypotheses are: - Treatment with OCR-002 is safe and tolerable in patients with acute liver failure/acute liver injury due to acetaminophen overdose or drug-induced liver injury, autoimmune hepatitis, viral hepatitis or indeterminate etiologies. - A dose of 10-20g/24h (0.42-.83g/h) will achieve steady state plasma concentrations within 6-12h with little additional accumulation in the ALI/ALF setting. - Treatment with OCR-002 will reduce ammonia and improve neurological function in patients with acute liver failure/severe acute liver injury.

NCT ID: NCT01548547 Completed - Clinical trials for Infant Lumbar Puncture

Patient Outcomes in Simulation Education (POISE) Intravenous (IV) and Lumbar Puncture (LP) Multi-institution Protocol

POISE
Start date: June 2008
Phase: N/A
Study type: Interventional

This study aims to compare the clinical efficacy of multimedia audiovisual training to hands on "practice till perfect" training for pediatric and emergency medicine residents' procedural skills. This initial study will explore the success rates on infant lumbar puncture and child intravenous access skills in post-graduate year one pediatric residents.

NCT ID: NCT01547780 Completed - Healthy Clinical Trials

Translocator Protein and Inflammation After Traumatic Brain Injury

Start date: January 20, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - People with traumatic brain injury (TBI) often have inflammation in the brain. A protein called the translocator protein (TSPO) is often present with inflammation. Researchers want to see if a radioactive chemical known as [11C]PBR28 can be used to study TSPO and inflammation in the brain of people with TBI. Objectives: - To test whether [11C]PBR28 can be used to study changes in the brain after a traumatic brain injury. Eligibility: - Individuals at least 18 years of age who have had TBI and have had a brain scan that shows signs of inflammation. - Healthy volunteers at least 18 years of age. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. - All participants will have two brain scans during an outpatient visit. A magnetic resonance imaging scan will study brain activity. A positron emission tomography (PET) scan will use [11C]PBR28 to look for signs of TSPO and brain inflammation. - Participants with TBI will have two PET scans within 10 days of the head injury, and a PET scan around 90 days after the injury. They may also have MRI scans under this or another study. Tests of thinking, memory, and concentration will be used to study the effects of the injury and inflammation

NCT ID: NCT01539109 Completed - Spinal Cord Injury Clinical Trials

Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation

Start date: November 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether combining a noninvasive method of brain stimulation, called Transcranial Direct Current Stimulation (tDCS), enhances the effect of training of the affected upper limbs in patients with incomplete Spinal Cord Injury.

NCT ID: NCT01538693 Completed - Spinal Cord Injury Clinical Trials

Molecular Markers of Neuroplasticity During Exercise in People With Incomplete Spinal Cord Injury

Start date: December 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether exercising (walking) at different intensities increases levels of factors in the blood and saliva that are known to impact neuroplasticity (how the connections in the spinal cord and brain can change) and if these levels are changed by pairing exercise with a single dose of commonly used prescription drugs or by your mood.

NCT ID: NCT01534117 Completed - Clinical trials for Head Injury Trauma Blunt

Platelet Function Analysis in Head Trauma: ASA/Plavix

ASA/Plavix
Start date: October 2009
Phase: N/A
Study type: Interventional

The investigators are assessing the platelet function analysis of those who sustained significant head trauma while on aspirin or plavix and to assess if any qualitative difference is obtained if platelets are administered.

NCT ID: NCT01533675 Completed - Sutured Wounds Clinical Trials

A Comparison Study of the Tensile Strength of Sutures Used in Dermatologic Surgery on the Day of Suture Removal, Following Wound Care With Two Different Products

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

Sutures are an integral part of surgery and available materials are diverse, as are the options for post-procedure care. Both saline and hydrogen peroxide are commonly used cleansing agents. This study aims to compare the effect of saline and hydrogen peroxide on the tensile strength of 4-0 nylon sutures following removal from a cutaneous surgical wound.

NCT ID: NCT01528033 Completed - Clinical trials for Wound Healing Disorder

Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments

SAWHI
Start date: August 2, 2011
Phase: N/A
Study type: Interventional

This clinical study is performed in several German, Dutch and Belgian hospitals to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) for the treatment of postsurgical abdominal wound healing impairments after surgery. Therefore the underlying layer of fibrous tissue that permeates the internal organs must be intact. Main outcome measure is the time until complete wound closure that sustained for a minimum of 14 days. Furthermore the therapy options will be examined regarding several other clinical, safety, patient reported and economic parameters. Patients will be assigned equally and by chance to both treatment groups. Study participants as well as the attending doctors and nurses will be informed about the assignment to the respective treatment arm. The primary outcome measure and some of the secondary parameters like reappearance of the wound and the development of the wound size over time, examined within an active study treatment time of 42 days, will be photographed and analysed under the use of a central computer system. The central analysing personal will not be informed about patient details or therapy allocation. Patients with at first closed belly wounds with wound healing disorder in the postoperative course after surgery without an opening of the underlying layer of fibrous tissue are eligible to be included in the trial if the diagnosis of a wound healing impairment in the postoperative course is manifested as a wound with spontaneous dehiscence, a wound that requires an active reopening of the suture by the treating physician or a wound that cannot be closed by primary intention and requires further treatment to achieve permanent closure. Study participants will be selected and enrolled within clinical surgical departments which provide the respective personal, structural and scientific background for the conduction of the trial project. Trial therapy will be started in-hospital and may be continued in ambulatory care. It is very important to examine the therapy options also in the ambulant care setting thus study participants with good health who are able to continue the specific wound treatment in ambulant should be transferred to the ambulant service as soon as possible.

NCT ID: NCT01523626 Completed - Clinical trials for Multiple Trauma/Injuries

A Multicenter, Randomized Study of Early Assessment by CT Scanning in Severely Injured Trauma Patients

REACT-2
Start date: April 2011
Phase: N/A
Study type: Interventional

Computed tomography (CT) scanning has become essential in the early diagnostic phase of trauma care because of its high diagnostic accuracy. The introduction of multi-slice CT scanners and infrastructural improvements made 'total body' CT scanning (TBCT) technically feasible and its usage is currently becoming common practice in several trauma centers. However, literature provides limited evidence whether immediate 'total body' CT scanning leads to better clinical outcome then conventional radiographic imaging supplemented with selective CT scanning in trauma patients. The aim of the REACT-2 trial is to determine the value of immediate TBCT scanning in trauma patients. The investigators hypothesize that immediate 'total body' CT scanning during the primary survey of severely injured trauma patients has positive effects on patient outcome compared with standard conventional ATLS based radiological imaging supplemented with selective CT scanning.

NCT ID: NCT01516281 Completed - Parkinson's Disease Clinical Trials

Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury

Start date: March 2012
Phase:
Study type: Observational

The purpose of this study is to learn if a new brain imaging technology called DaTscan can detect subtle changes in the brain that are similar to those seen in early Parkinson's disease (PD). The results of this study may provide more information about a possible association between mild to moderate traumatic brain injury (mTBI) and PD. The objectives of this study are to define and describe a group of approximately 7,122 mTBI subjects and 7,122 subjects without mTBI (mTBI-) seen in the Emergency Rooms of NorthShore University HealthSystem during the years 2006-2011, and to select from willing eligible subjects a random sample of 100 mTBI subjects and 100 mTBI- subjects (of the same age and gender) to undergo written informed consent, neurological examinations, blood drawing for DNA extraction and storage, and DaTscan brain imaging. The investigators will compare the findings from persons who experienced mTBI (cases) to persons without a history of brain injury (mTBI- or "controls").