Active clinical trials for "Wounds and Injuries"

Bleeding from intra-abdominal injuries is a leading cause of traumatic deaths in children. Abdominal CT is the reference standard test for diagnosing intra-abdominal injuries. Compelling reasons exist, however, to both aggressively evaluate injured children for intra-abdominal injuries with CT and to limit abdominal CT evaluation to solely those at non-negligible risk. The focused assessment sonography for trauma (FAST) examination can help focus patient evaluation in just this manner by potentially safely decreasing abdominal CT use in low risk children. This research study is a multicenter, randomized, controlled trial to determine whether use of the FAST examination, a bedside abdominal ultrasound, impacts care in 3,194 hemodynamically stable children with blunt abdominal trauma. The overall objectives of this proposal are 1) to determine the efficacy of using the FAST examination during the initial evaluation of children with blunt abdominal trauma, and 2) to identify factors associated with abdominal CT use in children considered very low risk for IAI after a negative FAST examination. The long-term objective of the research is to determine appropriate evaluation strategies to optimize the care of injured children, leading to improved quality of care and a reduction in morbidity and mortality.

Spinal cord injury (SCI) results in damage to the descending neural pathways and leads to the immediate dysfunction of multiple physiological systems below the level of injury. Like adults, children with SCI suffer from neuromuscular paralysis which results in the inability to sit, stand, and walk. Current therapeutic interventions largely aim to compensate for paralysis to achieve mobility based on the assumption that damage to the central nervous system is permanent and irreversible, e.g. use of braces, standers, and wheelchairs. The objective of this proposal is to investigate the use of transcutaneous spinal stimulation (TcStim) to enable stepping in children with chronic SCI. The investigators will recruit 8 participants, ages 4-12 years with chronic, acquired SCI, T10 and above and non-ambulatory. The aims of this proposal are to 1) investigate the mechanisms of locomotor-specific regulation in the spinal neural circuitry of children with acquired SCI using single vs. multi-site TcStim, 2) investigate the capacity of the lumbosacral spinal cord for integration of task-specific input (e.g. load, speed) during facilitated stepping with and without TcStim, and 3) investigate the training effects of TcStim on the ability to step. Outcomes will provide a necessary initial step in the translation of scientific findings for neuromodulation from adults with SCI to children.

This is a randomized clinical controlled trial (RCT) to investigate the impact of a personalized nutritional intervention on functional and clinical outcomes the first year after traumatic spinal cord injury. The long term goal is to prevent gain of body fat mass and obesity.

The ORALEV Study found that preoperative oral antibiotics can reduce the incidence of surgical site infections after colonic resection, compared with no preparation. The role of mechanical bowel preparation in patients needing colonic surgery is yet to be elucidated. No randomised controlled trials have assessed the impact of mechanical bowel preparation combined with oral antibiotics on the incidence of surgical site infections after colonic surgery, compared with oral antibiotics only.

PrimECC is a colloid priming solution for cardiopulmonary bypass/ extracorporeal circulation (ECC) based on Ringers Lactate, supplmeneted with Dextran 40 and Dextran 1. In a previous RCT comparing PrimECC with crystalloid priming fluid, patients in the PrimECC group experienced less hemolysis, less tubular cell injury and beneficial effect on the fluid balance. This study will investigate if, in a population at high risk of acute kidney injury (AKI), priming the ECC circuit with PrimECC instead of crystalloid solution will lead to a reduction of postoperative AKI. The hypothesis is that PrimECC, compared to crystalloid prime, will reduce postoperative AKI. The study is a Swedish multicenter, double-blinded, randomized, controlled clinical trial. The trial will include 366 patients aged ≥18 years, scheduled for cardiac surgery with cardiopulmonary bypass, with an "Acute kidney injury risk score" ≥30% according to Birnie et al. (2014). The primary outcome of the study is the incidence of postoperative AKI of any stage according to the KDIGO creatinine criteria (serum-creatinine increase ≥ 27 μmol/l within 48 h or ≥ 50 % increase from baseline) within 96 hours after arrival to the ICU. Secondary outcomes are between-group differences in hemolysis, tubular cell injury (NAG-excretion), estimated GFR, and incidence of AKI of different stages according to the KDIGO creatinine criteria. In addition, differences in CNS (Tau, NFL, NSE, and S100B) and cardiac (TNT/TNI) injury markers will be investigated.

Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg exercise, resulting in the benefits of large muscle mass exercise. However, despite the potential for enhancing aerobic capacity by training the denervated leg skeletal muscle via hybrid FES exercise, the inability to increase ventilation beyond limits set by high level SCI restricts aerobic capacity. This research study will investigate two potential methods of improving ventilation in those with high-level SCI through a double-blind randomized trial. One method is non-invasive ventilation (NIV), which is an external breathing support machine. The second method is the use of Buspar, a drug, which has been used to treat respiratory dysfunction after SCI in rats and some human case reports. In this study, participants will engage in a 6-month FES row training program while receiving either NIV or shamNIV and Buspar or placebo, and under study tests to evaluate cardiopulmonary health and fitness.

A common therapeutic intervention after spinal cord injury (SCI) is prolonged standing in a standing frame. For people with SCI, standing for 40 minutes or more, three to four times weekly improves several health-related issues including well-being, circulation, skin integrity, reflex activity, bowel and bladder function, digestion, sleep, pain, and fatigue. However, a person who experiences orthostatic hypotension (OH)-defined as a decrease of 20mm hg in systolic blood pressure or a decrease of 10mm hg in diastolic pressure within 3 minutes of standing from a sitting or supine position-secondary to SCI may not tolerate positioning in a standing frame, thus resulting in a loss of access to these health benefits. OH is common for people with SCI. It results from central nervous system dysregulation causing pooling of blood in the lower extremities that can lead to dizziness, light-headedness, blurred vision, weakness, fatigue, nausea, palpitations, headache, and/or syncope. Although an array of physical and pharmacologic interventions are available to people in the general population for managing OH, few such interventions have been evaluated for use by people with SCI, especially when the level of injury is C5 or above. One possible intervention that may be effective for people with OH secondary to SCI is functional electrical stimulation (FES) because its application results in a dose-dependent increase in blood pressure. An unanswered question is whether the placement of FES electrodes on various parts of the body has differential effects. Therefore, the purpose of this study is to evaluate blood pressure responses among people with OH secondary to cervical SCI when receiving FES intervention involving the placement of electrodes in three different positions as well as when receiving no FES intervention during tilt table sessions. The selected positions for electrode placement are: (a) the calves, (b) the quads and abdominals, and (c) the quads, abdominals, and calves. The researchers hypothesize that FES intervention, regardless of placement, will result in better control of OH than no FES intervention and that no significant blood pressure difference will occur across the three FES placements.

The Royal Canadian Mounted Police (RCMP), like all public safety personnel (PSP), are frequently exposed to potentially psychologically traumatic events that contribute to posttraumatic stress injuries (PTSI). Addressing PTSI is impeded by the limited available research. The RCMP are working to build evidence-based solutions to PTSI and other mental health challenges facing their members, which by extension will help all PSP, as part of the Canadian Government Federal Framework on Posttraumatic Stress Disorder. A key element is the "Longitudinal Study of Operational Stress Injuries / Étude longitudinale sur les traumatismes liés au stress opérationnel", a study which has been renamed "Risk and Resiliency Factors in the RCMP: A Prospective Investigation", and is referred to as the "RCMP Study" for short. The RCMP Study has been detailed online (www.rcmpstudy.ca) and in a recently published peer-reviewed protocol paper, "The Royal Canadian Mounted Police (RCMP) Study: protocol for a prospective investigation of mental health risk and resilience factors" (https://doi.org/10.24095/hpcdp.42.8.02). The RCMP Study, part of the concerted efforts by the RCMP to reduce PTSI by improving access to evidence-based assessments, treatments, and training as well as participant recruitment and RCMP Study developments to date. The RCMP Study has been designed to (1) develop, deploy and assess the impact of a system for ongoing annual, monthly and daily evidence-based assessments; (2) evaluate associations between demographic variables and PTSI; (3) longitudinally assess individual differences associated with PTSI; (4) augment the RCMP Cadet Training Program with skills to proactively mitigate PTSI; and (5) assess the impact of the augmented training condition (ATC) versus the standard training condition (STC). Participants in the STC (n = 480) and ATC (n = 480) are assessed before and after training and annually for 5 years on their deployment date; they also complete brief monthly and daily surveys. The RCMP Study results are expected to benefit the mental health of all participants, RCMP and PSP by reducing PTSI among all who serve.

Falls are the leading cause of accidental injury and injury-related death among older adults. Despite evidence that falls can be prevented, fall related injuries have not declined over time. Current fall injury prevention techniques targeting mobility and bone strength have merit yet their effectiveness is limited. Indeed, a recent Patient Centered Outcomes Research Institute/National Institute on Aging funded pragmatic trial of individualized multifactorial strategy to prevent serious fall injuries in over 5500 seniors revealed no difference in fall injuries between the intervention and standard care arm. The inconclusive results of the investigation may be due in part to focusing on fall prevention rather than mitigation of fall-related impact acceleration and forces - the "fundamental variables" for injury prevention. A fall-related injury occurs when the body hits the ground with force that is greater than tissue strength. Development of innovative approaches that focus on fundamental variables of injury prevention is needed.

The overall objective is to obtain an initial assessment of the value of using [18F]3F4AP for imaging demyelinating diseases such as traumatic brain injury (TBI), neurodegenerative diseases such as mild cognitive impairment (MCI) and Alzheimer's Disease (AD): Aim 1) Assess the safety of [18F]3F4AP in healthy volunteers and subjects with traumatic brain injury (TBI) and neurocognitive impaired subjects (AD/MCI). Hypothesis 1: Administration of [18F]3F4AP will result in no changes in vitals or other adverse events. Aim 2) Assess the radiation doses to the main organs in healthy volunteers. Hypothesis 2: the radiation doses to each organ will be comparable in all subjects and within the acceptable limits. Aim 3) Assess the pharmacokinetics of a bolus infusion of [18F]3F4AP in humans including healthy volunteers and patients. Hypothesis 3: the pharmacokinetics of [18F]3F4AP at the whole brain level will be similar in controls, TBI and AD/MCI subjects. The kinetics in demyelinated lesions will be slower than in healthy areas. Aim 4) Correlate MR images with [18F]3F4AP PET images. Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images. Hypothesis 4B: some of the lesions on the MRI will show increased signal (VT or SUV) on the PET but not all. Aim 5) Correlate [18F]3F4AP PET signal with neuropsychological testing in people with TBI and AD/MCI. Hypothesis 5A: increased PET signal (VT or SUV) will correlate with impaired Mini Mental State Examination (MMSE).