View clinical trials related to Wounds and Injuries.
Filter by:Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistically significant decrease in the occurrence of symptomatic ETD and middle ear barotrauma (MEB). The Phase I Trial suggested the total time interval and rate (slope) of compression (ROC) may be a determining factor in ETD and MEB. This Phase II study investigates an optimal total time interval and rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation collectively as a group, rather than for each individual patient. Data will be collected prospectively on group patient-treatment exposures. Our investigators randomly assign patient-treatment group exposures to two different rates (slopes) of compression. These are limited to the linear versus the non-linear rates (slopes) of compression identical to two of four compression profiles used in the Phase I and Phase II trials. All patients experiencing symptoms of ETD and MEB requiring compression stops will be evaluated post treatment to confirm the presence of ETD and MEB using the O'Neill Grading System (OGS). Data will be analyzed using the IBM-SPSS statistical software program. The number of compression holds observed in each of the compression schedules/compression profiles using an identical 15-minute total time interval of compression but varying in the rate (slope) of compression will be recorded as in the Phase I and II studies. Symptomatic patients who required compression stops (as in the Phase I trial) using a USN TT 9 during elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber will be compared. Statistical analysis using descriptive and Inferential statistics will be applied to the patients requiring first stops in the compression profiles. This will be used to further evaluate the data restricted to the rate of compression (linear vs. non-linear) and whether this is associated with the number of compression holds. The 15-minute total time interval of compression will be identical in both compression profiles studied since this was found to be the total time interval of compression with the least number of treatment stops/holds in the phase I and phase II studies.
ORTHOPUS develops assistive technologies to address the lack of availability of medical devices in low and middle income countries. With the help of HI (Handicap International) Nepal, the need for upper limb prostheses was identified. Indeed, according to the literature - especially Efficiency of voluntary opening hand and hook prosthetic devices: 24 years of development? (JRRD, Volume 49, Number 4, 2012) -, today available solutions do not fully address patients' needs. In Nepal, only 2 upper limb prostheses options are generally proposed to patients because of supply and cost constraints. ORTHOPUS' objective is to extend patients' autonomy with a new set of prosthetic solutions. By offering low cost but high quality devices (according to CE marking requirements), another of the ORTHOPUS' missions is also to address supply and cost constraints. To improve patients' capabilities, ORTHOPUS aims at extending grasping capabilities compared to the usual passive aesthetic hand or voluntary opening one by proposing the following set of solutions: - an aesthetic articulated hand - a mechanical wrist - a work hook In order to assess the different stated hypotheses, a clinical trial is set jointly with HI Nepal. 14 patients will be enrolled in 2 cohorts (n1 = 7, n2 = 7), the first one is constituted with patients usually using an aesthetic passive hand whereas the second one comprise patients normally equipped with voluntary opening hand. After selecting and getting the informed consent of the patients, a month to make the sockets and adapt it to patients is planned. An evaluation of their quality of life will be done with the WHO QOL - BREF quality of life assessment before and after the test period of the trial. ORTHOPUS' set of prosthetic solutions will be tested by them over one month. They will have to fill on a daily basis a survey (OPUS) assessing their use of the prostheses. At the end of the test period, different questionnaires and surveys will be filled during a last interview to collect data. Data will be analysed in order to extract evidence for or against the trial hypotheses. With these results, a report will be written and submitted to the GATE (Global Cooperation on Assistive Health Technology) community managed by WHO. This report will also feed the ORTHOPUS R&D with patients' feedbacks and, research findings will be shared publicly on different social media in respect with patient privacy.
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. We propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after ART initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are initiating ART in order to take advantage of a window of opportunity in HIV care and maximize care engagement. The aims are to test the effectiveness of ImpACT+ and explore its potential for implementation.
The FIRST project compares the dose of robotic gait training (RGT) with usual care gait training for patients with spinal cord injury (SCI) undergoing rehabilitation at Baylor Scott & White Institute for Rehabilitation (BSWIR).
The aim of our study is to obtain data on the occurrence of injuries, their mechanisms and types among children and adolescents from a youth soccer club. In addition, in order to determine the potential risk of injury, the investigators will examine the prognostic factors on the basis of tests assessing the antropometric, anatomical, physical and fitness characteristics.
Brain injury remains the leading cause of death in comatose patients resuscitated from OHCA. One of the most challenging aspects in the treatment of a post-cardiac arrest patient is the assessment of the extent of brain damage. Reliable, clinical measures of ongoing brain injury have potential to guide individualized treatment and potentially improve outcomes. Persistent candidate measures to fill this role is combined cerebral metabolism monitoring assessed by jugular bulb microdialysis (JBM) and positron emission tomography (PET) of 18-Fluor deoxyglucose ([F-18]-FDG). This multimodal neuromonitoring is cutting-edge technology used in a clinical setting
The incidence of gastrointestinal diseases is high in intensive care unit (intensive care unit,ICU). In critically ill patients, the intestinal tract is the "engine" of multiple organ dysfunction syndrome (Multiple organ dysfunction syndrome,MODS) and a component of multiple organ dysfunction syndrome, which is closely related to the poor prognosis of critically ill patients. In 2012, the abdominal working group of the European Association of critical Care Medicine (the European Society of Intensive Care Medicine,ESICM) put forward the concept of "acute gastrointestinal injury" (acute gastrointestinal injury,AGI), which was defined as gastrointestinal dysfunction caused by acute disease in critically ill patients. However, the grading system is complex and general, which does not reflect other gastrointestinal functions such as endocrine, immunity, barrier and so on, and lacks the support of objective laboratory results. When patients with acute gastrointestinal injury, gastrointestinal digestion and absorption, endocrine, immunity, barrier function are affected in varying degrees. The levels of indexes reflecting gastrointestinal digestion and absorption, endocrine and immunity were different among different AGI grades. The purpose of this study was to observe the characteristics of AGI bowel sounds in critically ill patients with ICU by digital continuous bowel sound monitoring, and to explore the clinical value of bowel sounds characteristics in AGI of critically ill patients combined with the changes of biomarkers of gastrointestinal injury.
Up to today, inadequate evidences and knowledge exist about the best prehospital management of hypotensive trauma patients and its clinical consequence on the in-hospital recovery and mortality. Also new emerging therapies such as prehospital blood transfusion and REBOA (resuscitative endovascular balloon occlusion of the aorta) are lacking strong evidences in, eventually, reducing hospital mortality and improving outcomes. Moreover, prehospital emergency medicine is throughout Italy an heterogeneous system that has no unique standard operating procedures and, even among HEMS (helicopter emergency medical service), management and therapies on complex trauma patients may vary upon local policies. With this study we aim to enroll hypotensive trauma patients and study factors of prehospital rescue that can be associated with in-hospital mortality and recovery, eventually even with hospital outcome. For each patients data as demographic, kind of trauma (mechanism, injury scores), therapies and maneuvers will be recorded and then analyzed in comparison with in-hospital data such as need for transfusion, ABG parameters, length of stay (in-ward and ICU), need of therapies like invasive ventilation and renal replacement therapy, recovery and outcome
Acute myocardial injury has been a finding of variable frequency among patients diagnosed with COVID-19. It is now recognized that cTnI levels are strongly associated with increased mortality. The mechanisms underlying the myocardial injury remain unknown, and it is not clear whether they reflect local/systemic inflammatory process and/or cellular ischemia. Both myocardial ischemia and ventricular dysfunction result in dramatic changes in mitochondrial oxidative metabolism. These changes involve an increase in the rate of cytoplasmic anaerobic glycolysis to compensate for the decrease in mitochondrial adenosine triphosphate (ATP) production. The rest of the mitochondrial oxidative metabolism originates mainly from the β-oxidation of free fatty acids, which occurs at the expense of glucose oxidation. Trimetazidine is a competitive inhibitor of the enzyme 3-ketoacyl coenzyme A (CoA) long-chain thiolase (3-KAT), the last enzyme involved in the oxidation of fatty acids. Stimulation of glucose oxidation by trimetazidine results in a better coupling between glycolysis and glucose oxidation, with a consequent decrease in lactate production and intracellular acidosis, present in situations of myocardial ischemia or heart failure. Thus, the PREMIER-COVID-19 study was designed to test the hypothesis that the use of trimetazidine associated with usual therapy in patients admitted with a diagnosis of moderate to severe acute respiratory syndrome by SARS-CoV2 infection reduces the extent of acute myocardial injury assessed by the peak release of ultra-sensitive troponin compared to usual therapy.
This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device improves functional arm/hand movements in individuals with paralysis or paresis due to a spinal cord injury or stroke and improves functional arm/hand or leg/foot movements in individuals with paralysis or paresis due to other brain or nerve injuries. In this study, eligible individuals that agree to participate will be asked to attend up to 5 study sessions a week for 1 year (depending on participant availability), with each session lasting up to 4 hours. At the first study session, participants will have their demographic information collected, vital signs assessed, and have measurements performed of their limbs and torso, as appropriate. They will also undergo clinical evaluations and tests to assess their current functional movement and sensation capabilities. During subsequent study sessions, participants will undergo many tasks designed to improve functional movements in paralyzed limbs. Specifically, participants will receive neuromuscular electrical stimulation to the limb(s) and/or electrical stimulation to the spinal cord to evoke specified movements. The stimulation parameters and locations on the spinal column and/or limb(s) that evoke specific movements will be noted. The movements will be assessed with visual inspection, electromyography, and/or sensors. The clinical evaluations and tests to assess functional movement and sensation capabilities will be repeated throughout the study and at the last study session to assess for functional improvements compared to the first study session. Upon completion of these study sessions, the individual's participation in the study is considered complete.