Active clinical trials for "Wounds and Injuries"

Traumatic brain injury (TBI) is the most common cause of death and disability in young adults. Patients can experience significant problems with concentration, attention, and memory (so called 'cognitive impairments') following TBI. These cognitive impairments can drastically impact on a patient's well-being, and can lead to significant economic and social consequences. Roughly a quarter of TBI patients improve but an equal number deteriorate over time. The investigators know little about why patients vary so much in how they recover. Crucially, the investigators have no treatments to improve brain functioning or recovery after TBI. Trials investigating ways of protecting the brain just after injury have been disappointing. An alternative strategy, however, is to improve the function of brain regions that remain intact, but that function inefficiently after TBI. The investigators know that dopamine (a chemical in the brain) is known to influence many brain functions and the investigators know that pathways in the brain that use dopamine are affected by TBI. In humans, drugs that increase dopamine in the brain, such as methylphenidate, are sometimes used to enhance cognitive function after TBI, but the response to treatment can be highly variable between patients. Therefore, what is needed in the clinic is a way to target the use of these drugs to patients who are likely to respond. In a single centre study, the investigators will use SPECT (Single Photon Emission Tomography) imaging to measure dopamine levels in the brain. MRI (Magnetic Resonance Imaging) scans will assess brain structure and function. The investigators will test whether treatment with methylphenidate improves cognitive functions in TBI patients who have ongoing cognitive problems, whether the mechanism involves a normalisation of brain functioning and whether brain dopamine levels can predict the magnitude of any improvement in symptoms.

The present pilot study is designed to assess the extent to which BOTOX and MYOBLOC cause muscle atrophy in spastic patients. The primary objective is to assess whether there is statistically significant difference in muscle atrophy between the two groups over a one year period.

The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in high risk surgical wounds to evaluate the rate of surgical site infections (SSIs). Hypothesis: Historically, the average rates of infective complications in surgical wounds types are 7.7% in clean wounds, 15% for contaminated and 35-40% for dirty wounds. The application of Prevena ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX) is expected to reduce these rates by 50%.

The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.

The TOPHR HIT trial is a clinical trial of patients experiencing blunt trauma who present with an injury to their head which makes them unconscios. The study compares two different fluids given to the patient in the out of hospital setting by a paramedic. The two fluids are salt water (standard treatment) versus a higher concentration of salt water mixed with a sugar (study fluid). The patients have an equal chance of receiving either fluid and the paramedic and the patient and the treating trauma surgeon do not know which fluid was provided in the out of hospital setting.

This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe traumatic brain injury.

The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter prospective randomized open-label trial to compare two strategies in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies: an "early" strategy where RRT is started immediately when a RIFLE F status is documented a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy. The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.

To evaluate the efficacy of a structured outpatient couples intervention program (Therapeutic Couples Intervention, TCI) on couples' marital quality after acquired brain injury (ABI). To assess the impact of the TCI on the emotional well-being of persons with ABI and their partners. To ascertain the impact of the TCI on caregiver burden and unmet needs as reported by partners of persons with ABI. To examine the extent to which treatment benefits for survivors and their caregiving partners are sustained in the longer-term.

The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help children ages 6-16 with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this drug may have on adults with attention deficits caused by TBI have been investigated prior. The exact effects this drug may have on children with attention deficits caused by TBI are not known, but the investigators expect that Vyvanse will be of some help in treating this population as well.

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.