Active clinical trials for "Wounds and Injuries"

Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body. SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP). This pain typically develops several months after the injury. In 30-40% of SCI patients, severe CNP affects their everyday living including sleep and mood. Many patients give up work, not because of the injury, but because of pain. Medical treatment of CNP is moderately effective and costly, both to the patient and to the health care system. In previous research, characteristic 'signatures' of brain waves that are probably related to CNP have been defined. Based on this, a novel treatment for CNP based on neurofeedback was developed and clinically tested on five SCI patients. Electroencephalograph (EEG) was used to record patients' brain waves and these were shown to patients on a computer screen in a simple graphical form (e.g. bars). Patients were trained to change their brain activity at will and, as a consequence, their pain was reduced. Patients who had suffered from CNP for years received up to 40 neurofeedback treatment sessions, reducing their pain for several days after each session. The primary aim of this study is to apply neurofeedback therapy to a larger number of recently injured patients, who are still in a hospital. It is hypothesised that neurofeedback treatment will be more effective in people who have suffered from CNP for a shorter period of time. The secondary aim of the study is to define EEG predictors of CNP. EEG will be recorded in recently injured patients with no chronic pain, knowing that a certain number of patients will develop CNP within weeks or months. These patients will be followed up for a year and the EEGs of patients who develop CNP will be compared with those who do not.

Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such infections double the length of hospitalization and risk of dying, and increase U.S. health care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA SSI. A potential prevention approach is routine pre-operative screening of patients, followed by decolonization of identified SA carriers.

Oxygen treatment is widely used in acutely ill patients. In particular, oxygen treatment is routinely used in acute coronary syndrome (ACS) patients with suspected acute myocardial infarction and variably recommended in ACS-guidelines, despite very limited data supporting a beneficial effect. Immediate re-opening of the acutely occluded infarct-related bloodvessel via primary percutaneous coronary intervention (PCI) is the treatment of choice to limit ischemic injury in the setting of ST-elevation ACS (STE-ACS). However, the sudden re-initiation of blood flow achieved with primary PCI can give rise to further damage, so-called reperfusion injury. Ischemia and reperfusion associated myocardial injury (IR-injury) involves a wide range of pathological processes. Vascular leakage, activation of cell death programs, transcriptional reprogramming, no reflow phenomenon and innate and adaptive immune activation all contribute to tissue damage, thereby determining the infarct size. The effect of oxygen treatment on these pathological processes, on the extent of IR-injury and the final infarct size in STE-ACS patients has not previously been studied. ACS is characterized by a systemic inflammation with typical elevations of soluble inflammatory markers as well as changes in white blood cells. The inflammatory reaction might be considered helpful in restoring myocardial tissue structure and function, but on the other hand it might worsen IR-injury by activating various pathological processes. In human experimental studies, Salmonella typhi vaccine has been used to create a standardized model of systemic inflammation and when administered to healthy volunteers the vaccination has not been associated with any adverse events. In an ongoing register randomized multicentre clinical trial, the DETO2X (Determination of role of oxygen in suspected acute myocardial infarction) study, the effect of oxygen on morbidity and mortality in ACS patients is being investigated. In a substudy of the DETO2X-trial, the investigators have planned to evaluate the effect of oxygen treatment on IR-injury in STE-ACS as assessed by biomarkers reflecting various aspects of the pathological processes involved. The presented study is an experimental pilot study performed in healthy volunteers with a Salmonella typhi vaccine-induced inflammation with the purpose of studying effects of oxygen treatment on biological systems involved in the pathogenesis of IR- injury.

The purpose of this pilot study is to establish the rate of cardiovascular events in patients with elevated troponins levels after major, non-cardiac surgery and to evaluate the efficacy and safety of FDA approved study drug (ticagrelor) compared to aspirin in these patients. Data from current studies suggest that myocardial injury detected by minor elevations in troponin levels within 3 days after non-cardiac surgery may occur in 10-24% of patients and is associated with an increased risk of mortality at 30 days and 1 year. There are no current guidelines for care of patients with elevated troponin levels in the absence of acute coronary syndrome. This study will assess if the increased risk of these patients is modifiable by an anti-platelet medication and evaluate the safety of this medication. Patients will be randomized in an open label fashion to receive ticagrelor (anti-platelet medication) or 81 mg. aspirin. Patients will be followed on study treatment for 12 months, with the last contact at one month post treatment discontinuation.

Spasticity is the most problematic self-reported secondary medical problem in patients with spinal cord injury. It has the potential to negatively influence quality of life through restricting activities of daily living. Problematic spasticity can cause pain and fatigue, disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a negative effect on patients morbidity. For this reason there is enormous interest in therapeutic interventions addressing to decrease spasticity in persons with spinal cord injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no studies are published, assessing the effect of extracorporeal shock wave therapy on focal spasticity in patients with spinal cord injury. The purpose of this study is to investigate the effect of a one-time ESWT on lower limb spasticity in patients with an incomplete spinal cord injury.

People with spinal cord injury (SCI) suffer from secondary health conditions that can result in undue physical challenges and impact participation in activities in everyday life. Locomotor Training (LT) has been shown to demonstrate improvements in balance and walking function in both the animal and humans by reactivating spinal circuits through intensive therapy of muscles below the level of the injury. However, it is not known if LT also has beneficial health effects and it is the focus of this study proposed to be undertaken at Stony Brook University (SBU) as the lead site. LT is thought to produce activation of spinal networks to help recover balance and walking after SCI and may correspond with improvements in health measures such as bladder function, breathing capacity, cholesterol and other cardiac risk factors markers, and the ability to stand upright without drops in blood pressure resulting in a sensation of dizziness. LT takes place on a treadmill with the body weight supported in a harness, while walking overground and with the practice of key exercises in the home and community. The emphasis is on loading the body through the legs without braces and other devices except where necessary to function at home. The overall objective of this study to capture and analyze health outcome data collected on 80 patients enrolled in the 7 NeuroRecovery Network (NRN) clinics in the USA who receive LT. The NRN is funded by the Christopher and Dana Reeve Foundation and the CDC to implement LT for people with SCI. The purpose of this application is to leverage the NRN funding, that provides support for LT and standardized outcome measures, to generate further knowledge on health outcomes after LT for individuals with SCI. The proposed project will be accomplished through the utilization of staff at each of the 6 NRN sites, lead by the study principal investigator and the lead clinical research coordinator at SBU. They will ensure the data are captured before and after LT in a standardized manner, at the correct time and entered into a de-identified database. The study hypotheses are that after LT, compared to before, patients with SCI will improve lipid profiles and insulin factors as measured by fasting blood tests; respiratory function as measured by specialized but easy to use breathing equipment; and blood pressure and heart rate during a maneuver to test for responses to abrupt changes in posture. The relevance of this proposal is that it will help to determine if there is an association between an intensive activity- based intervention (LT) and improvements in health and will be used to form the basis for a larger randomized clinical trial and clinical practice guidelines.

The purpose of this study is to determine if the addition of antiplatelet therapy (i.e. aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of venous thromboembolism (VTE) in high-risk critically injured patients. The investigators further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and enoxaparin for decreasing the incidence of VTE after trauma.

The purpose of this study is to investigate the influence of Methylphenidate in pediatric acquired brain injury population, regarding ecologic (every day) function. It is hypothesized that the function with treatment will improve when compared to function without treatment in the same patient. Improvement is expected by shortening time of execution in each specific task and by reduction of the amount of assistance needed.

This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain following spinal cord injury.

This is a proof-of-concept study designed to demonstrate whether increases in cerebral blood flow, improvements in brain functioning, and reductions in symptomology associated with traumatic brain injury (TBI) can result from treatments consisting of near-infrared phototherapy (NIR).