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Wounds and Injuries clinical trials

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NCT ID: NCT03682757 Completed - Blood Platelets Clinical Trials

Post-Injury Platelet Biology: Mechanisms and Outcomes

Start date: September 20, 2018
Phase:
Study type: Observational

Trauma-induced coagulopathy is a central cause of preventable deaths from hemorrhage after injury. The contribution and impact of altered post injury platelet biology on trauma-induced coagulopathy is not well understood despite the pivotal contribution of platelets to normal coagulation and endothelial integrity. The central hypothesis for this study is that severe injury and shock drive altered platelet activation, platelet aggregation, and platelet-endothelial interactions that are associated with increased rates of transfusion, organ failure, and mortality. This study will investigate these causal pathways, mechanisms, and associated outcomes in a prospective observational trauma cohort through collection of biospecimens and detailed clinical data.

NCT ID: NCT03681288 Completed - Clinical trials for Post-traumatic Stress Disorder

Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD

Start date: July 8, 2019
Phase: N/A
Study type: Interventional

Veterans with co-occurring Posttraumatic Stress Disorder and Substance Use Disorder (PTSD-SUD) experience more severe symptomatology and poorer response to existing treatments than Veterans with either disorder alone. Guilt is a common posttraumatic reaction and has been implicated as a risk factor for the development and maintenance of PTSD and substance use. Combat Veterans often report experiencing moral injury defined as perpetrating, failing to prevent, or witnessing acts that violate the values they live by in their civilian lives, which can lead to feelings of guilt and shame. Accordingly, reduction in guilt and increase in self-compassion may lead to improved quality of life for Veterans. This project will conduct a pilot study to evaluate changes in self-compassion, guilt, and PTSD-SUD symptom severity in a sample of Veterans after receiving 8 sessions of Mindful Self Compassion treatment (via a telehealth modality during COVID-19 pandemic). Findings will have significant impact on effective treatment options and lead to improvements in Veterans' quality of life and posttraumatic symptoms.

NCT ID: NCT03678285 Completed - Acute Kidney Injury Clinical Trials

Acute Renal Injury During High Intensity Training

HIFRT-KH
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The proposed work is designed to be the first in a series of studies investigating the health benefits and risks related to high intensity training (HIT) exercise. Our specific aims are to determine, 1) if participation in a single bout of HIT induces hematological markers consistent with acute kidney injury (AKI), and 2) if risk is predicted by the pre-exercise concentration of plasma proenkephalin-A. This investigation is an observational case control study. In year one, data collection procedures will be refined with ~40 participants local to the University of Wyoming and training will occur for collaborators from Wyoming community and tribal colleges. In year two, data collection will expand to some of the 12 CrossFit® gyms in Wyoming with assistance from the community and tribal colleges. Blood and urine samples will be collected before and up to 48 h after a standardized bout of HIT exercise on ~100 participants. Baseline blood samples will be analyzed for proenkephalin-A. All blood samples will be analyzed for markers of muscle damage (e.g., creatine kinase and myoglobin), and markers of kidney function (e.g., serum creatinine and blood urea nitrogen). Urine will be analyzed for markers of filtration function (e.g., albumin, creatinine, neutrophil gelatinase-associated lipocalin [NGAL], and kidney injury molecule 1 [KIM-1]). Lastly, the severity of kidney damage will be compared with the number of risk alleles and proenkephalin-A concentration. The investigators envision that the bout of HIT exercise will induce markers consistent with skeletal muscle damage in most participants and, based on literature from other styles of intense exercise, that acute kidney injury will be diagnosable in between 50-75% of participants. Secondarily, the investigators predict that the concentration of proenkephalin-A will be inversely related to the change in kidney function from before to after the HIT exercise bout.

NCT ID: NCT03678077 Completed - Education Clinical Trials

Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury

Start date: September 20, 2018
Phase:
Study type: Observational

Mild traumatic brain injury (mTBI) accounts for 70-90% of all diagnosed traumatic brain injuries (TBI) affecting approximately 50-300 per 100.000 individuals annually. Persistent post-concussion symptoms are reported in 15-80% of hospital admitted and outpatient treated populations, affecting labour market attachment, academic achievement, income, socio-economic status, social interactions, home management, leisure activities and cohabitation status. The association between mTBI and long-term trends in cohabitation status, income, academic achievement and socio-economic status has not been thoroughly explored. Previous studies focus on children's academic performance after severe TBI and only few studies include early adulthood and patients with mTBI. Trends in divorce rates are frequently conducted on severe injuries or populations consisting of veterans. Additionally, all studies have failed to apply a national register based design. Aim The aim of the study is to examine the long-term associations between mTBI and trends in cohabitation status, academic achievement and socio-economic status between pre-injury rates and observed rates at 5 years post-injury. The hypothesis was that by 5 years mTBI would be associated with increased odds of marital breakdown, decreasing academic achievement, decreasing income, decreasing socio-economic status compared to the general population in Denmark. Methods: The study is a national register based cohort study with 5 years follow-up of patients with mild traumatic brain injury from 2008 - 2012 in Denmark. Population: Patients between 18-60 years diagnosed with concussion (ICD-10 S06.0) were extracted from the Danish National Patient Register between (2003-2007). Patients with major neurological injuries and previous concussions at the index date and 5 years before the index date (1998-2007) were excluded. Patients who were not resident in Denmark 5 years before and during the inclusion period were also excluded (1998-2007). Data will be retrieved from several national databases, including: the Danish national patient register, Danish Civil Registration System (CRS), the Danish Education Registers, the Income Statistics Register and the Employment Classification Module (AKM). One control of the general population were matched for each case on sex, age and municipality. Outcome measures are: Cohabitation status, Education, income and socio-economic status.

NCT ID: NCT03677661 Completed - Clinical trials for Mild Traumatic Brain Injury

Cervico-vestibular Rehabilitation for Mild Traumatic Brain Injury

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Neck pain, dizziness and headache are common symptoms following mild traumatic brain injury (mTBI). The efficacy of cervical spine and vestibular-ocular system impairments intervention need to be determined. In this randomized clinical trial, a 6-week personalized clinical rehabilitation program on subacute mTBI will be compare to a conventional approach. The rehabilitation program will include cervical spine exercise combined with manual therapy as well as vestibular-ocular rehabilitation. Overall symptoms will be measured by the Post-Concussion Symptoms Scale (PCSS). Disability and symptoms severity related with neck pain, headache and dizziness will also be evaluated after the treatment period and at 6-week post-treatment.

NCT ID: NCT03676205 Completed - Muscle Injury Clinical Trials

Platelet-Rich Plasma in Acute Muscle Injuries

Start date: October 3, 2016
Phase: Phase 2
Study type: Interventional

OBJECTIVE: To evaluate the effect of Platelet Rich Plasma (PRP) injection in muscle injuries. The investigators check football players in the acute phase of hamstrings or quadriceps injuries. Efficacy and safety are evaluated. There are two intramuscular infiltration of PRP (Ortho pras ® system) or a homeopathic product (Traumeel ®) in each of the football players. The number of days between the date of injury and the return to play, the pain, the recurrence and the adverse reactions are registered.

NCT ID: NCT03674398 Completed - Clinical trials for Acquired Brain Injury

Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to compare a 4-week, moderately intensive, lab and home-based aerobic exercise program versus exercise plus cognitive training. Participants will include individuals who experience lingering symptoms of a head injury or concussion.

NCT ID: NCT03673371 Completed - Clinical trials for Lower Limb Amputation Above Knee (Injury)

Women's-Specific Footwear With Prosthetic Feet

WSF
Start date: March 4, 2019
Phase:
Study type: Observational

The purpose of this study is to address footwear challenges unique to women prosthesis users. Comparing the effectiveness of different footwear and prosthesis combinations will help guide clinical decision making regarding the prescription of prosthetic devices, while keeping what the patient wants in mind. It is expected that these results will be used to generate new knowledge for the development of versatile prosthetic devices that accommodate a user's unique lifestyle while helping the patient to make good progress in rehabilitation. Investigators will characterize perceived limitations in footwear among women prosthesis users. Investigators think that women prosthesis users will be restricted in footwear choices and clothing choices due to the use of a prosthetic device. Specifically, investigators expect perceived limitations in footwear will be greater for shoes with higher heels than shoes without heels.

NCT ID: NCT03667638 Completed - Clinical trials for Platelet-Rich Plasma

Influence of Platelet Concentrates on Wound Healing

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

Chronic soft tissues defects can extend into the fat layer or even deeper and can cause functional disadvantages. Split-thickness skin grafts (STSGs) used to cover these wounds have varying success rates. To improve wound healing in chronic wounds the authors have studied the application of autologous platelet concentrates in a human keratinocyte culture model in vitro and in a combination with surgical procedures in vivo as second line therapy in patients with initially failed wound closure.

NCT ID: NCT03667157 Completed - Liver Diseases Clinical Trials

Liver Function After Intravenous Methylprednisolone Administration

Start date: January 1, 2012
Phase: Phase 4
Study type: Interventional

Graves' orbitopathy (GO) is a characterized by orbital soft tissue inflammation and oedema associated with glycosaminoglycan deposition and fibrosis. The most frequent cause is Graves' disease. The classification is comprised based on the severity of orbital changes ranging from mild, moderate-to-severe GO and sight-threatening GO, which includes dysthyroid optic neuropathy (DON). Intravenous methylprednisolone (IVMP) pulse therapy is the first-line treatment in the active-phase of moderate-to-severe GO and DON. This therapy is more effective and better tolerated than oral glucocorticoids (GCs). The current recommendation of the European Group of Graves' Orbitopathy (EUGOGO) is that cumulative doses of IVMP should not exceed 8.0g in each treatment course, and pulses should not be given on consecutive or alternate days, except in the case of DON. According to EUGOGO recommendations patients with moderate-to-severe GO are treated with IVMP cumulative dose 4.5g during a 12-week period (for the first 6 weeks 0.5g IVMP per week, for the next 6 weeks 0.25g IVMP per week). According to EUGOGO recommendations patients with DON should receive 3.0g IVMP (1.0g/day for 3 consecutive days) as the basic treatment. This limitation in doses are due to the necessity of the prevention of severe side effects that are rare but may be fatal. One of the most severe adverse events is acute liver injury (ALI), in some cases irreversible and/or fatal. The estimated morbidity and mortality of ALI was found to be 1-4 % and 0.01-0.3%, respectively. Since 2000, there were 5 reported fatal cases. Mechanisms causing an IVMP-induced ALI remains incompletely elucidated. There are some possible hypotheses that may explain the occurrence of ALI. Firstly, GCs can lead to reactivation of autoimmune hepatitis: an immune "rebound phenomenon" following GCs withdrawal. The second mechanism of ALI is reactivation of viral hepatitis. Finally, there is well known direct toxic effect of GCs on hepatocytes, probably dose-dependent. This study was performed to evaluate the influence of two different, routinely used schemes of therapy with IVMP in patients with moderate-to-severe GO (first scheme) and DON (second scheme) on biochemical liver parameters. Patients included into the study were treated according to EUGOGO recommendations with routine doses of IVMP and routine scheme of administration for moderate-to-severe GO and DON. No additional treatment was performed during the study protocol.