696 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn whether a single dose of ketamine during surgery can help lower pain, reduce the need for opioid medications, and improve mental health recovery in adults with serious orthopedic injuries. The main questions it aims to answer are: Does ketamine lower pain after surgery? Does ketamine help reduce how much opioid medicine participants need? Does ketamine improve symptoms of depression and post-traumatic stress disorder (PTSD)? Researchers will compare participants who receive ketamine during surgery to those who receive standard anesthesia without ketamine. Participants will: Receive either ketamine or standard anesthesia during surgery Answer survey questions about pain, depression, and PTSD at several points after surgery (from a few days up to 6 months) Be followed by the research team through clinic visits and phone calls
This is a Phase 1b study to assess the safety, tolerability, PK, and PD of investigational phage therapy (IP) in adults with SCI and bladder colonization (ASB). It is a single-center, randomized, double-blind, placebo-controlled study in adults with SCI with neurogenic bladders and bacteriuria who use indwelling catheters, or who require intermittent catheterization for bladder drainage.
This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 1:1 to either enhanced nutrition or control arm. Subjects randomized to the enhanced nutrition arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.
The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without SCI).
Atrophy and weakness of the shoulder are a common problem following treatment of a number of shoulder and elbow pathologies. Even with relatively short periods of reduced activity, the magnitude of muscle loss can be quite substantial.
The early use of blood products as a part of Massive Transfusion Protocol (MTP) during trauma resuscitation has been increasingly supported by providers and backed by the literature. However, the incidence of hypocalcemia during MTP has also been recorded and continues to be studied as an exacerbating factor in coagulopathy during trauma.
Gamification may be one solution that can increase the compliance in the use of devices like incentive spirometry.
Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.
The study's aim is to ascertain the best approach for providing sedation and pain management for patients who have sustained trauma and are requiring respiratory support from a mechanical ventilator. The common approach to patients who need mechanical ventilation is to provide continuous drips of sedatives and pain medicine and awaken the patient once a day to check the brain functions. Another approach is to provide pain medicine and reserve sedatives for only a short duration when needed. The difference between approaches has not been studied in Trauma patients.
This project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture.
The project will consist of subjects who have suffered Traumatic Brain Injury (TBI) and who are able to ambulate on treadmill with or without a harness system. This will be a 4-week controlled study consisting of two groups of TBI patients, high-intensity intervention group and low-intensity control group. Both groups will receive physical therapy treatment 3 times per week for 1 hour. The intervention group will undergo 30-minute sessions of high-intensity walking on a treadmill with an overhead harness attached for safety. In addition, they will also get up to 30-minutes of low-intensity physical therapy in order to receive 1 hour of treatment time. The control group will undergo only low-intensity physical therapy activities for 1-hour. Low-intensity physical therapy will include strength exercises, stretches, balance, and low-intensity gait training. All participants in both groups will complete these outcome measures on the first day of the study, after 2 weeks of participation, and again at the end of 4 weeks or on their last day before discharge from Carilion's services. Later on, all participants in both groups will be followed up to complete the same set of outcome measures at the end of 1 month since completion of the protocol. This follow up session will take up to 45 minutes to complete.
This is a Pilot study designed to set up for an randomized clinical trial (RCT) comparing the SeND Home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 3:1 to either SeND Home precision nutrition pathway or control arm. Subjects randomized to the SeND Home arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.
This is a three arm study, comparing the Novadress, Mepilex Ag, and Xeroform Occlusive dressings for healing, drainage, and pain management. NovaDress is constructed of pure cellulose derived from tree pulp. Mepilex Ag is a antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. Xeroform Occlusive Dressing is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.
This research will aid in understanding of slow-breathing and its effect on heart rate and blood pressure in people with a spinal cord injury (SCI). This research will investigate if traditional 'yogic' breathing exercises can be performed by subjects with SCI and its influence on the cardiovascular system.
Gastric ultrasound has become increasingly utilized to examine volume and quality of gastric contents in the preoperative setting to guide anesthetic management and relay risk of aspiration in both adult and pediatric medicine. Gastric fluid volumes in trauma patients are thought to be elevated due to delayed gastric emptying in the setting of an over-attenuated sympathetic response to physical pain and stress, opioid analgesia, and other associated injuries (traumatic brain). However, there is a paucity of literature examining gastric fluid volumes (GFV), measured by gastric ultrasound, in the pediatric trauma population. The purpose of the study is to assess whether preoperative gastric ultrasound is an accurate method to identify pediatric trauma patients who have elevated GFV (\>0.8mL/kg) and high-risk gastric contents (solids, complex liquids, in addition to large volumes).
Airway is the first step in the initial assessment of a trauma patient. Often this assessment determines the need for endotracheal intubation, most commonly by rapid sequence intubation (RSI). Currently, there is no consensus on best practice for RSI drug regimens. Given the fragmented nature of this topic, most RSI drugs are chosen by the intubating physician based on their experience (i.e., a "dealer's choice"). Overall, emergency medical care is moving towards standardization to decrease medical errors and improve outcomes. Clearly, the current approach to RSI drug regimens does not align with those goals. This study seeks first to define commonly used RSI drug regimens for trauma, and second to investigate hospital course and long-term health outcomes as a potential way to define best practice RSI drugs for trauma patients. The study will be a multi-center retrospective chart review of data collected from January 1, 2014 to January 1, 2019, and will include Level I trauma centers in Texas. The University of Texas at Austin (UTA) is hosting this study as a Texas Level I Trauma Centers Multicenter Trial. Additional sites will have their own institutional IRB approval and will provide de-identified data to the principal investigator (PI) via secure encrypted email. Data will be submitted for MDMC trauma patients to UTA and analyzed within the Dell Med Department of Surgery and Perioperative Care and treated in the same way with the same security as data collected at Dell Seton Medical Center. The plan to complete the data collection and analysis by January 1, 2021. After de-identification, descriptive statistical analysis will be performed. Statistics reported will include frequencies. Logistic regression model to predict outcome will be performed. Odds ratio, confidence interval, and P value will be reported using logistic regression for outcome models for both adjusted and unadjusted models. The statistical software package SAS 9.3 will be used for all calculations.
Given that there are only a few studies on the effects of cirrhosis on trauma patients and none have addressed the impact cirrhosis has on the incidence of infections, it is important that we study this to determine the mortality in cirrhotic trauma patients and ascertain the incidence of infectious complications in these patients. We hypothesize that trauma patients with cirrhosis will have higher rates of mortality and infectious complications.
In high-volume trauma centers, multi-slice CT scanners have become the routine imaging modality for screening trauma patients due to their speed and accuracy. In trauma patients with no known neurologic deficits, diagnostic CT is often obtained though it remains unclear whether this affects management of the patient \[1\]. With the growing cost of health care, a careful look at the benefit and cost of CT is needed to determine how to best utilize this modality in the evaluation of trauma patients. HYPOTHESIS: In trauma patients with absence of neurologic defects, the addition of comprehensive CT does not change overall clinical management.
All trauma patients receive Lovenox or other prophylactic medication to prevent deep vein clots from forming. For the trauma patients with orthopedic injuries requiring surgery there is controversy over safety and efficacy when prophylaxis is started preoperatively vs postoperatively. This study is to evaluate both approaches for safety in terms of bleeding events during and 24 hours after surgery as well as preventing deep vein clot formation. This will be a randomized double blinded study using Lovenox or placebo as the medications given preoperatively. Postoperative Lovenox will be given to both groups per routine regime.
Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion. Objectives 1. Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome) 2. Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate 3. Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome) 4. Evaluate ICU outcomes in each group
Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of "occult" injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases. Existing data suggest that a limited number of criteria can reliably identify blunt injury victims who have "no risk" of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies. This study seeks to determine whether "low risk" criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients. This goal will be accomplished in the following manner: All blunt trauma victims undergoing computed tomography of the abdomen/pelvis in the emergency department will undergo routine clinical evaluations prior to radiographic imaging. Based on these examinations, the presence or absence of specific clinical findings (i.e. abdominal/pelvic/flank pain, abdominal/pelvic/flank tenderness, bruising abrasions, distention, hip pain, hematuria, hypotension, tachycardia, low or falling hematocrit, intoxication, altered sensorium, distracting injury, positive FAST imaging, dangerous mechanism, abnormal x-ray imaging) will be recorded for each patient, as will the presence or absence of abdominal or pelvic injuries. The clinical findings will serve as potential imaging criteria. At the completion of the derivation portion of the study the criteria will be examined to find a subset that predicts injury with high sensitivity, while simultaneously excluding injury, and hence the need for imaging, in the remaining patients. These criteria will then be confirmed in a separate validation phase of the study. The criteria will be considered to be reliable if the lower statistical confidence limit for the measured sensitivity exceeds 98.0%. Potential reductions in CT imaging will be estimated by determining the proportion of "low-risk" patients that do not have significant abdominal or pelvic injuries.
This is an observation study using the Flashback CRI T1 tablet to collect data on compensatory reserve index in pediatric trauma patients. Highest trauma activations at the institution will be enrolled in the study and data will be collected for 12-24 hours based on the patient's hemodynamic status. The device collects data via a pulse oximeter probe. No treatment decisions will be made based on the values of the on the CRI tablet. Data will be retrospectively reviewed to determine if any trends exist that correlate with blood loss, need for operation or blood transfusion.
The purpose of this study is to determine the effects of ultraMTP (\>/=30 units pRBC within 24 hours) in trauma patients on mortality and secondary outcomes. The aim is to determine if there is a set number of pRBC units transfused in adult trauma patients undergoing surgery within 24 hours, after which mortality is inevitable and further transfusions are futile.
Obesity is a national epidemic that affects all aspects of health care, including trauma care. According to the Centers for Disease Control and Prevention, 1% of US adults 20 years old and older are obese (body mass index \[BMI\], calculated as weight in kilograms divided by height in meters squared, \> 30), and 69% are overweight (BMI \> 25) (1, 2). Obesity is a major health concern because of its established relationship with serious medical diseases and increased likelihood of comorbid conditions (eg, diabetes mellitus, hyperlipidemia, heart disease, pulmonary disease) (3). As the number of obese adults continues to increase, the potential number of obese trauma patients with severe injury and complications will also increase (3). Management of prehospital and in-hospital trauma care, including complications associated with airway management, surgical procedures, and radiological imaging, of obese patients can be challenging. However, published reports on how obesity complicates hospital stays after trauma are conflicting (4, 5). Several studies have indicated that obese trauma patients are more likely than non-obese patients to have longer stays in the intensive care unit (ICU) and hospital, more days of mechanical ventilation, more complications, and comorbid conditions, and higher mortality (6,7,8). Other studies have indicated no differences between obese and nonobese patients in mortality, length of stay in the ICU and the hospital, duration of mechanical ventilation, complications, or comorbid conditions (9). Accordingly, the main aim of this study is to investigate and compare hospital course, clinical outcomes, disposition, and the cost of treatment between geriatric obese and non-obese patients hospitalized for treatment of traumatic injuries.
The purpose of this study is to determine the incidence of vestibular dysfunction in traumatic brain injury patients admitted to acute inpatient rehabilitation. This study also seeks to validate the AbilityLab Vestibular Screening Tool (AVeST) and the AVeST+, tools designed to quickly screen individuals for vestibular dysfunction following traumatic brain injury.
The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.
The purpose of this study is to find out if a drug called valproic acid (VPA) will protect organs (such as the kidneys) from damage when a person is injured and loses a large amount of blood. The organs may not get enough blood or oxygen when a patient loses a lot of blood. After the patient receives fluids such as blood, plasma, or saline and the bleeding is stopped, blood and oxygen return to the organs. This process called ischemia/reperfusion (I/R) is known to cause injury to organs such as the kidneys and heart. VPA is an approved drug for treating conditions like seizures and migraines for many years. However, it is not approved for use at the higher dose that will be used in this study or for protecting organs from I/R injury. This study will enroll trauma patients and randomly assign them to receive either VPA diluted in salt water or salt water without VPA (placebo) and then follow the patients and compare their organ function and overall outcome. This study is masked meaning that the patients, doctors, and nurses will not know which patient received which treatment. The study treatment will be given in addition to the care that trauma patients normally receive to treat their injuries. The researchers doing this study believe that VPA will lessen organ injury caused by I/R, meaning that patients who receive VPA will experience less kidney injury when compared to patients who receive the placebo.
The purpose of this research study is to investigate the safety and potential therapeutic effects of autologous, culture-expanded, adipose derived mesenchymal stem cell intrathecal injections in the treatment of spinal cord injury.
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of FDY-5301 compared to placebo in major trauma ICU patients at risk of intensive care unit acquired weakness (ICUAW)
This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury.