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Wounds and Injuries clinical trials

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NCT ID: NCT02655354 Completed - Depression Clinical Trials

A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity

TSOS6
Start date: October 2015
Phase: N/A
Study type: Interventional

The overarching goal of this UH2-UH3 proposal is to work with the NIH Health Care Systems Research Collaboratory to develop and implement a large scale, cluster randomized pragmatic clinical trial demonstration project that directly informs national trauma care system policy targeting injured patients with presentations of Posttraumatic Stress Disorder (PTSD) and related comorbidity. Each year in the United States (US), over 30 million individuals present to trauma centers, emergency departments, and other acute care medical settings for the treatment of physical injuries. Multiple chronic conditions including enduring PTSD, alcohol and drug use problems, depression and associated suicidal ideation, pain and somatic symptom amplification, and chronic medical conditions (e.g., hypertension, coronary artery disease, diabetes, and pulmonary diseases) are endemic among physical trauma survivors with and without traumatic brain injuries (TBI). Evidence-based, collaborative care/care management treatment models for PTSD and related comorbidities exist. These care management models have the potential to be flexibly implemented in order to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries; care management models may also be effective in mitigating the impact of the acute injury event on symptom exacerbations in the large subpopulation of injury survivors who already carry a substantial pre-injury burden of multiple chronic medical conditions.

NCT ID: NCT02650765 Completed - Brain Injury Clinical Trials

S100 Biomarker in the Acute Management of Mild Head Injuries

S100
Start date: November 2015
Phase:
Study type: Observational

A prospective validation study of the "Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults". Enrolling a consecutive sample of 1000 adult head injury patients from the emergency department of the Tampere University Hospital (Tampere, Finland). A venous blood sample with S100 analytics (+storage blood) is drawn from every patient. The patients are head CT-scanned according to the SNC guidelines. Outcome assessment (GOSE, MRS, Rivermead PCS Questionnaire) is completed as follows: 1 week, 6 months, 1 year, and 2 years.

NCT ID: NCT02646176 Completed - Brain Injuries Clinical Trials

Comparative Effectiveness of Rehabilitation Interventions for Traumatic Brain Injury

TBI-CER
Start date: October 2008
Phase:
Study type: Observational

Traumatic brain injury (TBI) is increasingly recognized as a significant public health issue, but the most effective rehabilitation methods have yet to be identified. The Institute of Medicine and the Agency for Healthcare Quality and Research sponsored systematic reviews of evidence for comparative effectiveness of rehabilitation interventions for TBI. Both reviews concluded that substantially more research is needed to identify interventions best suited for different individuals. The practice-based evidence (PBE) approach employed to create the data used in the proposed study was a research method recommended to provide greater clarity, along with use of patient-centered outcomes obtained over a longer period of time than used in previous studies. The following specific aims will be addressed in the proposed study: 1. Determine the comparative effectiveness of different therapeutic approaches used in inpatient TBI rehabilitation after statistically adjusting for patient need and ability to benefit from various approaches. Investigators hypothesize: 1.1. Patients who receive a greater proportion of therapy time in Advanced Training (versus Standard of Care) will achieve better outcomes than similar patients who receive a lesser proportion of treatment time in Advanced Training. 1.2. Patients with the greatest initial levels of disability will experience larger effects from Advanced Training therapeutic approaches in comparison to the effects experienced by patients with less disability at admission. 1.3. Patients who receive a greater proportion of therapy in contextualized treatment (versus decontextualized) will achieve better outcomes than similar patients who receive a lesser proportion of time in contextualized treatment. 2. Determine the comparative effectiveness of difference in the delivery of inpatient rehabilitation therapies, after statistically adjusting for patient need and ability to benefit. Investigators hypothesize: 2.1 The level of effort that patients are able to apply in treatment moderates the effectiveness of time in treatment. 2.2 Family involvement in treatment is associated with better outcomes. Data will be drawn from the database established for the TBI Practice-Based Evidence Study (TBI-PBE Study). Data on 2130 persons who received inpatient TBI rehabilitation at any of 10 sites (9 in US, 1 in Canada) were obtained for the study. Detailed longitudinal data were collected prospectively on rehabilitation therapies (with point of care data completed for every clinical encounter), course of recovery, person and injury characteristics and outcomes during and after rehabilitation. Advanced analytic methods (e.g. propensity scores, generalized linear mixed models) will be used to compare the effects of different rehabilitation interventions on outcomes at discharge and during the 9 months following rehabilitation.

NCT ID: NCT02645097 Completed - Foot Injury Clinical Trials

Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation

Start date: July 2014
Phase: N/A
Study type: Interventional

This research is being done to compare two different saphenous nerve block locations and will help to determine which site best maintains knee strength and pain control.

NCT ID: NCT02644564 Completed - Rotator Cuff Tear Clinical Trials

Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries

Start date: October 5, 2015
Phase: N/A
Study type: Observational

The purpose of the study is to determine whether the introduction of early ultrasonography screening will change the diagnostic spectrum of soft tissue shoulder injuries in patients aged forty years or more. We also want to study whether certain physical tests will be able to predict or rule out full-thickness tears of the rotator cuff (shoulder tendons) in the acute phase. Another purpose is to explore the course of soft tissue shoulder injuries over a year, as well as to compare the results to studies on the prevalence of rotator cuff full-thickness tears.

NCT ID: NCT02642731 Completed - Acute Kidney Injury Clinical Trials

Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty

dexpolvi
Start date: September 2013
Phase: N/A
Study type: Observational

Sensitive renal markers have been studied abundantly in connection with open heart, liver and transplantation surgery; however in major orthopaedic surgery their use is anecdotal. The aim of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type fatty acid-binding protein), and IL-18 (interleukin -18), in patients coming for elective TKA (total knee arthroplasty) as a pilot study before large study concerning acute kidney injury in orthopaedic surgery.

NCT ID: NCT02639923 Completed - Clinical trials for Brain Injuries, Traumatic

The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury

mRNA
Start date: January 2016
Phase:
Study type: Observational

The aim of this study is to investigate the early serum measurement (<6h after injury) of mRNA miR Let-7i, miR-16 and miR-92 in patients with MHI and intracranial traumatic lesions (CCT pos.) as compared to those in patients with MHI without intracranial traumatic lesions (CCT neg.). S100B serum levels will be measured in both groups. The usual risk factors for the occurrence of an intracranial hematoma (diagnostic algorithm) will be recorded. Additionally, a group of healthy individuals will serve as a control group.

NCT ID: NCT02637505 Completed - Cartilage Injury Clinical Trials

Norwegian Cartilage Project - Microfracture

Start date: January 2016
Phase: N/A
Study type: Interventional

114 patients between 18 and 50 years with an isolated focal cartilage defect in the knee will be randomized to either receive arthroscopic microfracture or arthroscopic debridement. Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D as well as clinical examination and radiological findings at 2 years (MRI).

NCT ID: NCT02635893 Completed - Spinal Cord Injury Clinical Trials

Lower Limb Function After Spinal Cord Injury

Start date: June 21, 2019
Phase: Phase 4
Study type: Interventional

This is a randomized, experimental study that examines the physiology of central nervous system pathways contributing to the control of bilateral movements in individuals with spinal cord injuries and promotes the recovery of lower-limb motor function through the use of stimulation and locomotor training.

NCT ID: NCT02630290 Completed - Hand Injuries Clinical Trials

Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Block (ADRIB Trial)

ADRIB
Start date: December 2015
Phase: Phase 4
Study type: Interventional

Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent influences on the filed of perineural block. It could shorten the onset time and prolong the duration of the nerve block and improved postoperative pain. However, Dexmedetomidine-induced bradycardia or hypotension has recently attracted considerable attention because of potentially grave consequences, including sinus arrest and refractory cardiogenic shock. A low dose may help minimize cardiovascular risks associated with dexmedetomidine. However, few studies have addressed the clinical effects of low-dose dexmedetomidine as an perineural adjuvant. The present study was designed to test the hypothesis that low-dose dexmedetomidine added to ropivacaine would safely enhance the duration of analgesia without adverse effects when compared with ropivacaine alone. Investigators will conduct a single-center, prospective, randomized, triple-blind, controlled trial in patients undergoing elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block using either ropivacaine or ropivacaine plus low-dose dexmedetomidine. The primary outcome is self-reported duration of analgesia . Secondary outcomes include onset time and duration of motor and sensory block, total postoperative analgesics, and safety assessment (adverse effects and postoperative abnormal sensation).