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Wounds and Injuries clinical trials

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NCT ID: NCT01628874 Terminated - Lumbar Puncture Clinical Trials

Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children

JTIP
Start date: September 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of a needle-free jet-injection system with 1% buffered lidocaine for local anesthesia for lumbar punctures compared to a topical anesthetic agent. Our hypothesis is: A needle-free jet-injection system (J-Tip) with 1% lidocaine will provide local anesthesia that is comparable to that of a topical anesthetic agent (EMLA cream) when performing lumbar punctures in children.

NCT ID: NCT01606618 Terminated - Spina Bifida Aperta Clinical Trials

Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury

ESTIME
Start date: March 12, 2012
Phase:
Study type: Observational

With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. One of the major stakes for these patients is the preservation of a regular follow-up of uro-nephrologicals risk factors and of a respect for the rules of self management of their neurological bladder. The main objective of this study is to highlight a difference in the level of global self-esteem among a population of adult patients with spina bifida and a population of adult patients with traumatic spinal cord injury gained the same level of neurological.

NCT ID: NCT01606111 Terminated - Clinical trials for Traumatic Brain Injury

The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery

CAPTAIN
Start date: September 2013
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to investigate safety and efficacy of Cerebrolysin as add-on therapy to standard care in patients with acute traumatic brain injury (TBI). The study duration for each patient is 180 days.

NCT ID: NCT01605968 Terminated - Surgical Wound Clinical Trials

A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing

Start date: June 2012
Phase: N/A
Study type: Interventional

Study objective: The objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as effective and safe as Aquacel® Ag. Dressing. Study devices: - Study device: BCT Silver Bandage - Comparator device:"ConvaTec"Aquacel® Ag Hydrofiber Dressing Study design: - Randomized, Open-label, interventional, comparative, preventive study with Blinded evaluator. - All subjects must meet all the inclusion & exclusion criteria to enter this study in pre-operative phase. - Eligible subjects will be enrolled after a scheduled operative procedure. - There is SEVEN visits in this study (one screening eligibility phase up to 7 days before OP day, and four post-op treatment scheduled visits consisting on 1st , 3rd day, 5th day, 12th day and two follow up visit on the 28th and the 42nd post-operative day. - During each scheduled visit, each subject will have colored picture of his wound after dressing been removed, and on visit V6 for wound evaluation by blinded PI. Number of subjects: It is expected to recruit ≧150 eligible subjects. Study Duration: About eighteen month.

NCT ID: NCT01601782 Terminated - Tendon Injuries Clinical Trials

Impact of Volume Imaging Using Diagnostic Ultrasound

Start date: August 2009
Phase: N/A
Study type: Interventional

Determine if volume imaging can diagnose bone, ligament, muscle injuries.

NCT ID: NCT01597518 Terminated - Spinal Cord Injury Clinical Trials

Riluzole in Spinal Cord Injury Study

RISCIS
Start date: October 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of patients with acute SCI. The primary objective is to evaluate the superiority of riluzole, at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after injury, as compared to placebo, in change between 180 days and baseline in motor outcomes as measured by International Standards for Neurological Classification of Spinal Cord Injury Examination (ISNCSCI) Motor Score, in patients with acute traumatic SCI, presenting to the hospital less than 12 hours after injury. Secondary objectives are to evaluate the effects of riluzole on overall neurologic recovery, sensory recovery, functional outcomes, quality of life outcomes, health utilities, mortality, and adverse events. The working hypothesis is that the riluzole treated subjects will experience superior motor, sensory, functional, and quality of life outcomes as compared to those receiving placebo, with an acceptable safety profile.

NCT ID: NCT01564095 Terminated - Clinical trials for Ischemia Reperfusion Injury

TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion

TOP
Start date: October 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Utilisation of extended criteria donors due to critical organ shortage contributes to increased ischemia reperfusion injury as well as mortality following liver transplantation. Experimental data show protective effects on hepatic ischemia reperfusion injury (IRI) using the calcineurin inhibitor Tacrolimus applied intravenously or directly as a hepatic rinse. Moreover clinical data indicate a protective role of a Tacrolimus rinse in human liver transplantation when using normal, healthy grafts. The effects of Tacrolimus on hepatic injury in extended donor criteria (EDC) liver grafts remain unclear. Therefore, the aim of the present study is to examine the effects of a Tacrolimus ex vivo rinse (20 ng/ml) on cellular injury after transplantation of marginal liver grafts exhibiting 2 or more EDCs according to Eurotransplant's definition of EDC grafts.

NCT ID: NCT01552577 Terminated - Clinical trials for Traumatic Brain Injury

The RETINA Project: Reliable Eye Tracking in Neurocognitive Assessment of Traumatic Brain Injury

RETINA
Start date: October 2010
Phase:
Study type: Observational

The purpose of this study is to develop and validate eye-tracking measures that can be used to evaluate neurocognitive dysfunction among individuals with traumatic brain injury (TBI).

NCT ID: NCT01545635 Terminated - Major Trauma Clinical Trials

RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma

Start date: March 2012
Phase: Phase 3
Study type: Interventional

Severe traumatized patients (ISS > 15) admitted to emergency department (ED) University Hospital Innsbruck with obvious bleeding and/or who are at risk for significant hemorrhage will be screened by rotational thrombelastometry (ROTEM) assays during ED treatment and subsequent surgical/radiological interventions for having coagulopathy (T0). If a patient meets the inclusion criteria (T1) and is recruited for the study, a first study related blood sample (40mL) will be drawn, and data collected. Subsequently, 100 patients will be randomized to receive Fibrinogen concentrate and/or Prothrombin complex concentrate and/or FXIII concentrate for reversal of coagulopathy, while the other 100 patients will receive fresh frozen plasma (FFP),respectively. Treatment failure will be registered if bleeding persists and ROTEM parameters do not improve after two times dosages of study drug. In these cases haemostatic rescue therapy will be administered. CFC (fibrinogen concentrate and/or PCC, and/or FXIII concentrate) will be administered to patients randomized to receive FFP and FFP will be administered to patients of the CFC group. In cases unresponsive to comprehensive treatment or normal ROTEM combined with diffuse bleeding, other haemostatic medications can be administered (e.g rFVIIa, DDAVP, VWF/FVIII concentrate) as judged by the anesthetist in charge. The need and type of any rescue therapy will be documented and a ROTEM will be performed thereafter. At admission to ICU (T0 ICU), 24h (T24 ICU) and 48h(T48 ICU) thereafter further study related blood samples are drawn (40mL each). The indications for transfusion of red blood cells or platelets, administration of antifibrinolytics, treatment of acidosis, hypothermia, hypocalcemia and volume replacement are similar for both groups and treatment is performed according to clinical routine. Besides coagulation management during ED treatment until 24h on ICU, patient's care is not influenced by the study and follows clinical routine.

NCT ID: NCT01502839 Terminated - Clinical trials for Traumatic Brain Injury

Role of NSI in Differentiating Between Mild Traumatic Brain Injury And Behavioral Health Conditions

Start date: March 2011
Phase: N/A
Study type: Observational

The purpose of this study is to examine differences in post-concussive (PC) symptom endorsement among four groups of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans: those with a history of target, service-related, mild traumatic brain injury (mTBI) and co-occurring posttraumatic stress disorder (PTSD) (Group 1); those with a history of target, service-related, mTBI only (Group 2); those with PTSD only (Group 3); and those with no history of target, service-related, mTBI or PTSD (Group 4) by examining scores on the Neurobehavioral Symptom Inventory (NSI). Support for this study is provided by previous research highlighting the complex relationship between mTBI, PTSD and subsequent PC symptom endorsement (Brenner et al. 2010; Terrio et al, 2009). HYPOTHESES ARE AS FOLLOWS: 1. Individuals with a history of target, service-related, mTBI only (Group 2) and individuals with PTSD only (Group 3) each will report significantly more PC symptoms, as measured by NSI total scores, when compared to those with no history of service-related mTBI or PTSD (Group 4). 2. Individuals with co-occurring target, service-related, mTBI history and PTSD (Group 1) will report significantly more PC symptoms, as measured by total NSI scores, than either those with target, service-related, mTBI only (Group 2) or those with PTSD only (Group 3).