5,857 Clinical Trials for Various Conditions
The principal investigator for this study plans to build upon the psilocybin-assisted therapy intervention used in prior completed trials to conduct an open-label trial of two psilocybin administration sessions combined with psychotherapy to investigate the safety, tolerability, and clinical efficacy of psilocybin-assisted therapy for the treatment of PTSD in US Veterans.
The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: - Can immediate autologous adipose and autologous layered composite grafting be effective for acute functional soft-tissue reconstruction? Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk. Participants will: * Receive immediate fat grafting into the wound. * Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.
The goal of this clinical trial is to learn if this intervention (Social Skills, Problem Solving, emotion Regulation, and psycho-Education on Trauma: A Trauma-Informed Peer Aggression and Teen Dating Violence Prevention Program; SPARE) can treat peer aggression and prevent teen dating violence in preteens receiving intensive mental health services. The main questions it aims to answer are: * Does receiving SPARE reduce proactive and reactive aggression at post-intervention and 3- and 9-month follow-ups? * Does receiving SPARE reduce positive attitude about TDV, prevent TDV behaviors, and improve mental health outcomes at post-intervention and 3- and 9-month follow-ups? Researchers will compare youth receiving SPARE to youth receiving treatment as usual to see if SPARE results in improved proactive and reactive aggression, TDV attitudes and behaviors, and mental health outcomes. Participants will: * Receive SPARE via group therapy incorporated into their daily programing at an intensive mental health program * Complete study questionnaires at program intake and discharge as well as at 3-month and 9-month follow-up assessments
Eye Movement Desensitization and Reprocessing therapy is a time-limited trauma-response therapy that treats symptoms of stress that result disturbing life experiences. Eye Movement Desensitization and Reprocessing therapy has been used to treat trauma-related symptoms for people living with HIV. People living with HIV tend to experience higher psychiatric morbidity rates of depression, anxiety, and post-traumatic stress symptoms than the general population. However, even with case studies of Eye Movement Desensitization and Reprocessing therapy on people living with HIV, there is no definitive protocol for the clinician as they navigate the therapy. This study aims to assess the feasibility and acceptability of delivering an Eye Movement Desensitization and Reprocessing therapy protocol tailored for people living with HIV and trauma. 20 people living with HIV will be recruited to participate in an eight-week Eye Movement Desensitization and Reprocessing therapy. The therapy will be focused on assessing the viability of an Eye Movement Desensitization and Reprocessing protocol that is specified for people living with HIV.
This pilot trial will leverage "PrEP Well," an ongoing multi-level implementation strategy for providing PrEP in transgender/gender diverse (TGD)-serving contexts by integrating peer-led PrEP navigation with programming that addresses other social and structural needs of the TGD community (e.g., housing, legal, employment, gender-affirmation, primary care). PrEP Well has been implemented at the Trans Wellness Center (TWC) in LA since 2021. TWC is a first-of-its-kind community-led, trans-affirming, TGD community center made up of 5 community-based TGD service organizations that serve the local racially and ethnically diverse TGD community. Together with our community and implementation partners this NIMH-funded R34 will adapt evidence-based Skills Training in Affect and Interpersonal Regulation (STAIR) into a trans-affirming, culturally appropriate trauma treatment for TGD persons affected by HIV and violence (Trans STAIR); evaluate the acceptability, appropriateness, and feasibility of the Trans STAIR intervention (Phase 1 beta test; Aim 1); and conduct a Type 1: Hybrid Effectiveness-Implementation pilot randomized controlled trail (Phase 2 pilot RCT; Aims 2 and 3) of PrEP Well + Trans STAIR vs. PrEP Well alone to provide preliminary support for a fully powered larger multisite R01 to test the efficacy of PrEP Well + Trans STAIR.
Traumatic injury followed by critical illness provokes pathophysiologic changes in the bone marrow and the gut that contribute to persistent anemia and changes in the microbiome which significantly impact long-term recovery. This project will define the interactions between the stress, chronic inflammation, bone marrow dysfunction, and an altered microbiome which will provide a strong foundation for future clinical interventions to help improve outcomes following severe trauma.
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.
Collect data on various wound/injuries treatments and their related wound healing process, in real life settings. Over a 12-week period per wound treated. Analyze the safety and efficacy of wound treatments, including advanced biological/synthetic grafts with designations of 361 HCT/Ps or 510(k) FDA clearance and standard of care wound treatments.
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.
Penetrating injuries comprise roughly 30% of Methodist Health System (MHS) trauma patients. Firearm-related events have become more prevalent in the past few years. Active shooter events, mass casualties, assaults, and homicide are more commonplace which leads to an increase of trauma patients needing management of penetrating injuries.
The purpose of this study is to investigate the effects of a visuospatial task on memory reconsolidation and trauma symptoms for trauma-exposed individuals after exposure to traumatic memory reactivation paradigm.
Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.
The purpose of this study is to determine if a particular method of providing nutrition improves the outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery following trauma and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method being tested is a structured nutrition delivery plan, called the SeND Home pathway, that involves TPN, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. Participants will be randomly assigned (like the flip of a coin) to the SeND Home program or standard of care nutrition. In the SeND Home program, participants will receive TPN, followed by oral nutrition supplements (shakes) for 4 weeks after discharge. The control group will follow standard of care nutrition delivery that begins during ICU stay and concludes at hospital discharge. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass and complete walking and strength tests, and surveys about quality of life.
The CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Trial is a proposed 4 year, double-blind, mutli-center, prehospital and early in hospital phase randomized trial designed to determine the efficacy and safety of prehospital calcium and early in hospital vasopressin in patients at risk of hemorrhagic shock.
People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.
The purpose of this study is to investigate the effects of cannabidiol (CBD) broad-spectrum oil on memory reconsolidation (memory storage) and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation paradigm.
Major trauma frequently occurs in the deployed, combat setting and is especially applicable in the recent conflicts with explosives dominating the combat wounded. In future near-peer conflicts we will likely face even more profound weapons including mortars and artillery. As such, the number of severely wounded will likely increase. Hypocalcemia frequently occurs after blood transfusions secondary to the preservatives in the blood products, however, recent data suggests that major trauma in and of itself is a risk factor for hypocalcemia. Calcium is a major ion involved in heart contractility and thus hypocalcemia can lead to poor contractility. Smaller studies have linked hypocalcemia to worse outcomes, but it remains unclear what causes hypocalcemia and if intervening could potentially save lives. We are seeking to address the following scientific questions, (1) Is hypocalcemia present following traumatic injury prior to transfusion during resuscitation? (2) Does hypocalcemia influence the amount of blood products transfused? (3) To what extent is hypocalcemia further exacerbated by transfusion? (4) What is the relationship between hypocalcemia following traumatic injury and mortality? The investigators will conduct a multicenter, prospective, observational study. The investigators will gather ionized calcium levels at 0, 3, 6, 12, 18, and 24 hours as part of scheduled calcium measurements. This will ensure that the investigators have accurate data to assess the early and late effects of hypocalcemia throughout the course of resuscitation and hemorrhage control. These data will be captured by a trained study team personnel at every site. Our findings will inform clinical practice guidelines and optimize the care delivered in the combat and civilian trauma setting.
The goal of this single-group clinical trial is to learn about the initial efficacy and feasibility of telehealth-delivered Written Exposure Therapy (WET) for autistic adults with traumatic stress symptoms. The main questions the investigators aim to answer are: * Do symptoms of posttraumatic stress disorder (PTSD) and co-occurring mental health concerns decrease after receiving WET? * Do biobehavioral health outcomes, including objective (Fitbit indicators of activity, sleep, and heart rate) and subjectively-reported health variables (e.g., sleep, pain, health-related quality of life), improve after receiving WET? * How do autistic adults experience WET, and how can this program be modified and enhance in the future in collaboration with autistic adults? Participants will complete the following as part of the study, which is completed entirely over telehealth. * Participants will first complete an initial assessment, involving brief measures of cognition and autistic traits, as well as interviews and questionnaires about PTSD, mental health, and physical health. If eligible, participants will proceed to the following steps: * Eligible participants will then start wearing a Fitbit, to be used for the duration of the study. * Participants will then participate in 5 weekly virtual visits involving the WET protocol, including weekly brief assessment of PTSD and mental and physical health. * Then, participants will complete a sixth virtual visit the following week where PTSD, mental and physical health, and treatment feedback are assessed. * Lastly, participants will complete virtual visits 1 and 6 months later involving re-assessment of PTSD and mental and physical health. Therefore, this is a pre-post single group design, where all participants will receive WET to establish initial efficacy and feasibility. Investigators will also consult with an autistic advisory board throughout the project, and make adaptations as recommended in consultation with autistic adults. The goal is to better understand the initial efficacy and feasibility of WET for supporting autistic adults who have experienced trauma.
This purpose of this project is to specify and provide an initial test of a 10 session, individual-based cognitive therapy intervention to address symptoms of PTSD and poor engagement in HIV care among men who have sex with men (MSM) with trauma histories
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.
The goal of this clinical trial is to compare the effectiveness of unseparated whole blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured patients who require large-volume blood transfusions.
The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.
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.
The current proposal aims to enhance a mobile-delivered brief intervention for young adults with heavy alcohol use and interpersonal trauma by including adaptive coping strategies for managing trauma-related distress and using peer coaches after delivery of the intervention to maintain treatment gains. Individuals will be randomized to a modified brief intervention incorporating with peer coaches, a standard brief intervention, or assessment only. Participants will be followed up at 3 and 6 months post intervention. The investigators hypothesize that the trauma-informed and peer-supported brief intervention (TIPS-BI) will show low levels of dropout, will be perceived positively by participants, and will result in greater reductions in alcohol use compared to a standard brief intervention and assessment only.
Competitive sport increases risk for musculoskeletal injury (e.g., traumatic knee injury) and may position former athletes for early onset of chronic diseases, chronic pain, poor health-related quality of life, and disability. Quantifying function in former athletes with and without a prior injury and non-athlete controls is critical to understanding long-term health trajectories in athletes and informing potential interventional studies. One modifiable factor that may be associated with long-term health in athletes is physical activity patterns. The purpose of this study is to evaluate strength, function, physical activity, dietary patterns, and cardiometabolic health among current and former competitive athletes and in nonathlete controls to evaluate the impact of prior knee injury and sedentary behavior as two potential determinants of later poor health and reduced function.
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).
Investigators are adapting the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse.
This study will utilize a pre/post mix method design Quantitative data will be gathered through surveys (including satisfaction questionnaires) administered pre/post workshops. Qualitative data will be obtained through interviews post- workshop and consultations.
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.
The on-boarding of unregulatable trauma in the United States has reached 20%, which is 1/5 of the population. A population of this magnitude, by definition has now reached an epidemic classification. The population with chronic illness as stated: PTSD, Chronic Depression, MS, HIV, and SARS-CoV-2- Long Haulers Syndrome. These chronic conditions/illnesses many lead to death and are often the cause or perpetuate unregulated trauma and create an unstable population. Psychiatrists have testified before congress that the SSSRI medications are not fully functional cures and are not working for patients. Enchanced Psilocybin micro-dosing at the levels of 0.15g. ranging to 0.33g. every other day an 0.50g. for monthly maintenance of neural pathway production is proving to shave back the highjacked nervous system, thus stopping or rerouting the ruminating neurotransmitters, by rerouting thru new neural pathways. The body has a additional natural pathway in place then to decrease/stop these thoughts by have open pathways to process the thought differently. Serotonin is a neurotransmitter and which is the most famous of all the neurotransmitters. Serotonin is very similar in its compound structure to the plant medicine family of psilocybin, serotonin and psilocybin work very similarly with the 5h2A receptor in the human cortex ( the outer cortex of the brain ). Enhanced Microdosing of psilocybin at the levels of 0.15 to 0.33 and of 1 gram to 1.5 grams monthly for maintenance of the newly opened neural pathways is postulated to be a mental health game changer. Psilocybin helps shave back the highjacked nervous system which is a condition known as the diagnosis (SSD) Somatic Symptom Disorder. This research is believed accurate by proof on previous studies to process the subconscious held in the subconscious and shave back the somatic feelings resulting from the trauma of the individuals who have on-boarded chronic disease(s) of Trauma,PTSD, Unregulated Chronic Depression, MS, Cancer, HIV, and SARS-CoV-2- Long Haulers Syndrome.