[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"wounds-and-injuries\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:wounds-and-injuries":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,48,78,121,155,188,211,236,258,286,317,342,366,400,436,469,495,516,588,615,640,666],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100206500","phase-2-feasibility-study-for-fibroblast-autologous-skin-grafts-100206500",false,"NCT01964859","Feasibility Study for Fibroblast Autologous Skin Grafts","Feasibility Study for Fibroblast Autologous Skin Grafts: Biopsy of Skin Fibroblasts, Expansion in Cell Therapy Core, Topical Injection of Fibroblasts, and Subsequent Removal of Graft for Laboratory Studies.","Inclusion Criteria:\n\n* May be male or female\n* Must be between 18 years and 65 years of age\n* In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained within 7 days before baseline for which the investigator identified no clinically significant abnormality.\n* Be able to comprehend the informed consent document and provide consent for participation\n* Females of childbearing potential must:\n\n  * have a negative pregnancy test at screening\n  * agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study\n  * be willing to use a reliable form of contraception during the study\n* Have healthy skin as determined by the PI or study Nurse Practitioner.\n* Be willing and able to comply with the scheduled visits, biopsy\u002Finjection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study.\n\nExclusion Criteria:\n\n* Having received any investigational drug within 30 days prior to study entry\n* An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, or hetastarch\n* Pregnant, lactating, or trying to become pregnant\n* A history of keloid formation\n* An active nonhealing wound\n* Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, metastatic cancer, infectious diseases such as HIV, Human T-lymphotropic virus (HTLV) I\u002FII, Hepatitis B, Hepatitis C). Biopsies taken from individuals with infections that are not allowed to enter the cell therapy core will make it such that these individuals cannot participate.\n* Specifically we will exclude those with autoimmune diseases affecting the skin such as lupus.\n* Having current skin diseases (i.e. extreme and active eczema, psoriasis, lichen planus) that the investigator feels is not safe for study participation\n* A diagnosis of uncontrolled diabetes\n* Active smoker during the study\n* We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation.\n* Known bovine or meat sensitivity or severe allergies manifested by anaphylaxis to any product\n* Known bleeding disorder",true,"ALL","18 Years","65 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This research is being done to determine if investigators can change skin from one type to another. Specifically, investigators are interested in making normal skin into the thicker skin found on our palms and soles.",[28],"Wounds and Injuries",[30,31,32,33,34],"healthy skin","wounds and injuries","prosthetics","amputations","dermal fibroblasts","RECRUITING","2026-06-08",{"date":38,"type":39},"2026-06-09","ACTUAL",{"date":41,"type":39},"2015-01-07",{"date":43,"type":22},"2028-11-01",{"name":45,"class":46},"Johns Hopkins University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":47},"100167904","phase-2-human-upper-extremity-allotransplantation-100167904","NCT01459107","Human Upper Extremity Allotransplantation","Recipient Inclusion Criteria:\n\n* Recent (≥6 months) or remote (i.e., several decades) unilateral or bilateral upper limb loss (below the shoulder) desiring limb transplantation.\n* Below-shoulder amputation.\n* Functionless or minimally functional hand desiring removal of functionless \u002F minimally functional hand followed by transplantation.\n* Male or female and of any race, color or ethnicity.\n* Aged 18-69 years.\n* Completes the protocol informed consent form.\n* No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (see Donor and Recipient Exclusion Criteria below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of upper extremity transplantation.)\n* No co-existing psycho-social problems (i.e., alcoholism, drug abuse).\n* Negative for malignancy for past 5 years.\n* Negative for HIV at transplant.\n* Negative crossmatch with donor.\n* If female of child-bearing potential, negative serum pregnancy test.\n* If female of child-bearing potential, consent to use reliable contraception for at least one year following transplantation.\n* Consents to bone marrow infusion as part of the treatment regime.\n* USA citizen or equivalent, or foreigner with documentation of ability to pay for transplant and required follow-up care.\n* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.\n\nDonor Inclusion Criteria:\n\nDonors will be selected by the upper extremity transplant team in conjunction with the organ procurement organization (OPO) according to the following criteria:\n\n* Brain dead meeting the criteria for Determination of Death.\n* Family consent for limb donation.\n* Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure).\n* Aged 16 - 65 years.\n* Limb matched for size with recipient.\n* Same blood type as recipient.\n* Negative lymphocytotoxic crossmatch.\n* Accurately matched for gender, skin tone, and race (relative requirements depending on recipient consent).\n\nExclusion Criteria:\n\n• Positive for any of the following conditions:\n\n* Untreated sepsis.\n* HIV (active or seropositive).\n* Active tuberculosis.\n* Hepatitis B or C.\n* Viral encephalitis.\n* Toxoplasmosis.\n* Malignancy (within past 5 years).\n* Current\u002Frecent (within 3 months of donation\u002Fscreening consent) IV drug abuse.\n* Paralysis of ischemic or traumatic origin.\n* Inherited peripheral neuropathy.\n* Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.\n* Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).\n* Mixed connective tissue disease.\n* Severe deforming rheumatoid or osteoarthritis in the limb.\n\nDonor Only:\n\n• Tattoos:\n\n* Non-professional tattoo within last 6 months, or\n* Personally identifiable tattoo (i.e., donor name) on potential transplant.\n\nRecipient Only:\n\n* Type I (insulin-dependent) diabetes mellitus\n* Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.\n* Sensitized recipients with high levels (50%) of panel-reactive human leukocyte antigen (HLA) antibodies.\n* Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.\n* Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery.\n* Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration) or rare disorders of bone healing like osteopetrosis.\n* Patients considered unsuitable per the consulted Psychiatrists appraisal.","69 Years",{"count":56,"type":22},30,[25],"Background: Millions of people each year sustain injuries, have tumors surgically removed, or are born with defects that require complex reconstructive surgeries to repair. In the case of hand, forearm, or arm amputation, prostheses only provide less than optimal motor function and no sensory feedback. However, hand and arm transplantation is a means to restore the appearance, anatomy, and function of a native hand. Although over 70 hand transplants have been performed to date and good functional results have been achieved, widespread clinical use has been limited due to adverse effects of life-long and high-dose immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the potential benefits of hand transplantation.\n\nStudy Design: This non-randomized, Phase II clinical trial will document the use of a new immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing hand transplantation as a safe and effective reconstructive treatment for upper extremity amputations by minimizing maintenance immunosuppression therapy in unilateral and bilateral hand\u002Fforearm transplant patients. This protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled graft survival using low doses of a single immunosuppressive drug followed by weaning of treatment. Initially designed for living-related solid organ donation, this regimen has been adapted for use with grafts donated by deceased donors. The investigators propose to perform 30 human hand transplants employing this novel protocol.\n\nSpecific Aims: 1) To establish hand transplantation as a safe and effective reconstructive strategy for the treatment of upper extremity amputations; 2) To reduce the risk of rejection and enable allograft survival while minimizing the requirement for long-term high dose multi-drug immunosuppression.\n\nSignificance of Research: Hand transplantation could help upper extremity amputees recover functionality, self-esteem, and the capability to reintegrate into family and social life as \"whole\" individuals. The protocol offers the potential for minimizing the morbidity of maintenance immunosuppression, thereby beneficially shifting the risk\u002Fbenefit ratio of this life-enhancing procedure and enabling widespread clinical application of hand transplantation.",[60,28,61],"Amputation, Traumatic","Hand Injuries",[63,64,65,66,67,68,69],"Hand Transplant","Composite Tissue Allotransplantation (CTA)","Vascularized Composite Allotransplantation (VCA)","Composite Tissue","Amputation","Upper limb","Immunosuppression","2026-05-11",{"date":72,"type":39},"2026-05-12",{"date":74,"type":39},"2011-07-21",{"date":76,"type":22},"2036-06-30",{"name":45,"class":46},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100377988","effect-of-giving-reduced-fluid-in-children-after-trauma-100377988","NCT04201704","Effect of Giving Reduced Fluid in Children After Trauma","Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Trauma patients older than 6 months and younger than 15 years admitted to the pediatric intensive care unit (PICU)\n* Patients admitted to the PICU directly from the Emergency Department (ED)\n* Patients admitted to the PICU from the operating room (OR)\n* Patients transferred to PICU from outside facility ED (need to have been in ED 12 hours or less)\n\nExclusion Criteria:\n\n* Patients transferred to PICU from outside PICU or inpatient floor\n* Patients transferred to PICU from outside facility ED if \\>12 hours\n* Patients expected to be discharged from the PICU within 24 hours\n* Patient with congenital heart disease as defined by a congenital cardiac defect requiring surgery or medication\n* Patient with diagnosis of chronic cardiac condition (e.g. hypertension, cardiac arrhythmia)\n* Patients with chronic kidney disease as defined by an abnormality of kidney structure or function, present for more than 3 months, with implications to health\n* Post-operative transplant, cardiac, and neurosurgical patients\n* Patients with traumatic brain injury\n* Patients with any disease that may affect baseline blood pressure and heart rate (endocrine disorders, certain genetic disorders, mitochondrial diseases)\n* Hypotension requiring vasopressor therapy\n* If massive transfusion protocol initiated","6 Months","15 Years",{"count":88,"type":22},250,[90],"NA","This study is designed to help decide how much intravenous (IV) fluid should be given to pediatric trauma patients. No standard currently exists for managing fluids in critically ill pediatric trauma patients, and many fluid strategies are now in practice. For decades, trauma patients got high volumes of IV fluid. Recent studies in adults show that patients actually do better by giving less fluid. The investigators do not know if this is true in children and this study is designed to answer that question and provide guidelines for IV fluid management in children after trauma.",[93,94,95,96,28],"Critical Illness","Pediatrics","General Surgery","Fluid Therapy",[96,98,99,28,100,101,102,103,104,105,106,107,108,109,110],"Intensive Care Units, Pediatric","Critical Care","Multiple Trauma","Treatment Outcome","Postoperative Complications","Resuscitation","Hemodynamics","Infusions, Intravenous","Isotonic Solutions","Crystalloid Solutions","Diuretics","Organism Hydration Status","Body Water","2026-05-04",{"date":113,"type":39},"2026-05-07",{"date":115,"type":39},"2018-08-27",{"date":117,"type":22},"2027-09",{"name":119,"class":46},"Columbia University",4,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":139,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100586924","pilot-trial-for-woundx-clinical-decision-support-tool-100586924","NCT06921707","Pilot Trial for WounDx™ Clinical Decision Support Tool","SC2i-WounDx-001-WounDx™ Pilot Trial: Proof of Concept Feasibility for the Clinical Operations of WounDx™ in Aiding Clinicians Identify Wounds That Are Ready For Surgical Closure","Inclusion Criteria:\n\n* Wound surface area ≥75cm 2\n* Extremity injury (including shoulder and buttock - without visceral communication)\n* Wound amenable to Negative Pressure Wound Therapy using 3M™ V.A.C. ® canisters without gel pack\n\nExclusion Criteria:\n\n* Insulin Dependent Diabetes\n* Peripheral Vascular Disease\n* Connective Tissue Disorders\n* Preexisting immunosuppressive conditions or immunosuppression therapy\n* Pregnancy\n* Prisoners",{"count":129,"type":22},40,[90],"The purpose of this research is to evaluate the overall use of the WounDx medical device in a clinical setting, such as a hospital. The WounDx device is experimental and not yet approved by the United States Food and Drug Administration (FDA). WounDx uses information about a patient's wound to generate a report that a surgeon may use to help determine when to close or not close the wound. The final decision to close the wound remains with the surgeon. The results from this pilot trial will inform a larger pivotal trial.",[133,28,134,135,136,137,138],"Wounds","Extremity Injury","Traumatic Wounds and Injuries","Amputation, Traumatic\u002FSurgery","Amputation, Wound","Open Fracture Wounds",[133,134,140,141,142,143,144],"Clinical Decision Support Tool","Delayed Wound Closure","Cytokine Biomarkers","Wound Effluent","Traumatic Extremity Wounds","2026-04-14",{"date":147,"type":39},"2026-04-17",{"date":149,"type":22},"2026-03-21",{"date":151,"type":22},"2026-09-20",{"name":153,"class":46},"Henry M. Jackson Foundation for the Advancement of Military Medicine",5,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":172,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100571143","confirming-the-effects-of-acupuncture-treatments-to-relieve-symptoms-of-gulf-war-illness-100571143","NCT06716411","Confirming the Effects of Acupuncture Treatments to Relieve Symptoms of Gulf War Illness","CARE","Inclusion Criteria:\n\n* Deployed to the Gulf Theater of operations (as defined by 38 CFR 3.317, includes Iraq, Kuwait, Saudi Arabia, Bahrain, Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the Gulf of Oman, the Persian Gulf, the Arabian Sea, the Red Sea, and the airspace above all of these locations) between August 1990 and the present date\n* Have at least 2 of the following symptoms from the 3 CDC clusters of symptom that have lasted for more than 6 months. Each symptom cluster must be characterized as mild-moderate or severe, with at least one symptom in each cluster required to be severe. The clusters are:\n\nA. Fatigability: fatigue 24 hours or more after exertion B. Mood and Cognition: feeling depressed; feeling irritable; difficulty thinking or concentrating; feeling worried, tense, anxious; problems finding words; or problems getting to sleep C. Musculoskeletal: joint pain or muscle pain\n\nExclusion Criteria:\n\n* Currently enrolled in another clinical trial\n* Have another disease that likely could account for the symptoms, as determined by our Medical Monitor\n* Severe psychiatric illness (in the last 2 years psychiatric hospitalization, suicidal attempt, alcohol or substance abuse, use of antipsychotic medication) as measured by the Primary Care Evaluation of Mental Disorder (Prime MD).\n* Unable to complete the protocol on based on the evaluation of the Medical Monitor.",{"count":163,"type":22},200,[90],"This unblinded Phase II clinical trial will test the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners will have had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness will be randomized to either six months of biweekly acupuncture treatments (group 1, n=100) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=100). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P).",[167,168,169,170,171,28],"Persian Gulf Syndrome","Gulf War Syndrome","Multiple Chronic Illnesses","Occupational Diseases","War-Related Injuries",[173,174,175,176,177],"Acupuncture","Gulf War Illness","Complex Medical Illness","Chronic Multisymptom Illness","Veteran","2026-04-02",{"date":180,"type":39},"2026-04-03",{"date":182,"type":39},"2026-02-03",{"date":184,"type":22},"2028-09-30",{"name":186,"class":46},"University of Utah",10,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":209,"locationsCount":47},"100605969","food-is-medicine-prospective-study-100605969","NCT07169448","Food is Medicine Prospective Study","Impact of A Postoperative Meal Delivery Program on Malnutrition in Orthopaedic Trauma Patients","FIM","Inclusion Criteria:\n\n* Individuals 18 years old or older are included.\n* English or Spanish speaking\n* Reside in the following zip codes: 90001, 90002, 90003, 90004, 90005, 90006, 90007, 90008, 90009, 90010, 90011, 90012, 90013, 90014, 90015, 90016, 90017, 90018, 90019, 90020, 90021, 90023, 90026, 90027, 90028, 90029, 90031, 90035, 90036, 90037, 90038, 90039, 90043, 90044, 90046, 90047, 90048, 90052, 90057, 90059, 90061, 90062, 90065, 90068, 90069\n* Discharged home, either directly from Cedars-Sinai Medical Center or after time in a skilled nursing facility or acute rehab\n* Orthopaedic trauma surgical patients that have had an operation and inpatient stay at Cedars-Sinai Medical Center\n\nExclusion Criteria:\n\n* Any records flagged \"break the glass\" or \"research opt out.\"\n* Any pregnant patients.\n* Patients with any congenital metabolic conditions\n* Patients with dietary restrictions (ex. Kosher, Halal, vegan, gluten free, etc.) that are unable to be reasonably accommodated by St. Vincent Meals on Wheels\n* Any patients with mental illness the prevents them from giving consent.\n* Patients with dementia or cognitive impairment.\n* Patients who are homeless and\u002For unreliable to follow up",{"count":197,"type":22},75,"OBSERVATIONAL","The purpose of this study is to examine the impact of a medically tailored post-operative meal delivery program on surgical outcomes and metabolic lab markers in orthopaedic trauma patients. Patients will have 12 days of meals and shakes delivered to their house through our partnership with Meals on Wheels. Metabolic lab values will be drawn at the 2 week and 6 week post-op visits. All patients will be followed for up to 1 year postoperatively.",[28],[202],"Food is medicine","2026-03-18",{"date":205,"type":39},"2026-03-20",{"date":207,"type":39},"2025-09-01",{"date":117,"type":22},{"name":210,"class":46},"Cedars-Sinai Medical Center",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":47},"100561920","phase-2-4-aminopyridine-to-treat-skin-burns-100561920","NCT06596434","4-Aminopyridine to Treat Skin Burns","Inclusion Criteria:\n\n* Injured (burned) adults with a maximum severity of second-degree burns.\n* Burns involving at least 6cm2 of skin area\n* Acute burns within 7 days of injury\n* Cognitive ability to evaluate burn healing, report sensory and motor deficit during examination.\n* Adults aged 18-80\n* Ability to give written informed consent.\n* Capable of safely coming in for follow up visits on all scheduled appointments.\n\nExclusion Criteria:\n\n* History of multiple sclerosis, stroke or any other diagnosed neurological disorder\n* History of hypersensitivity to AMPYRA® or 4-aminopyridine\n* Current use of aminopyridine medications, including other compounded 4-AP\n* Suspected renal impairment based on the Choyke questionnaire.\n* History of difficult compliance with timely follow up\n* Patients outside the age range\n* Unable to provide informed consent.\n* Patients with a known history of a seizure disorder (4-AP overdose can, in selected cases, result in limited seizure activity).\n* Patients with a concomitant traumatic brain injury.\n* Patients unable to communicate.\n* Patients unwilling to complete the study requirements.\n* Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, e.g. Cimetidine.\n* Pregnancy, breastfeeding or incarcerated individuals.\n* Non-English speaking\n* Patients unable or unwilling to take calibrated (with gauge) photographs of their wounds",{"count":163,"type":22},[25],"Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin. There is a need to develop treatments to accelerate and improve healing of burn injuries. More research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational treatment will be used to test the hypothesis that 4-AP accelerates burn healing in traumatically burned patients.",[221,222,28],"Burns","Second Degree Burn",[224,225,221,226,133],"4-aminopyridine","4-AP","Second degree burn","2026-03-04",{"date":229,"type":39},"2026-03-05",{"date":231,"type":39},"2026-01-01",{"date":233,"type":22},"2028-09",{"name":235,"class":46},"John Elfar",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":47},"100280571","machine-learning-for-handheld-vascular-studies-100280571","NCT02932176","Machine Learning for Handheld Vascular Studies","Development and Validation of a Novel Machine-learning Algorithm to Assist in Handheld Vascular Diagnostics","DopplerZAM","Inclusion Criteria:\n\n* A clinically driven request for non-invasive vascular testing must be present\n\nExclusion Criteria:\n\n* None (other than patient declines to participate)",{"count":245,"type":22},180,"The use of handheld arterial 'stethoscopes' (continuous wave Doppler devices) are ubiquitous in clinical practice. However, most users have received no formal training in their use or the interpretation of the returned data. This leads to delays in diagnosis and errors in diagnosis.\n\nThe investigators intend to create a novel machine-learning algorithm to assist clinicians in the use of this data. This study will allow the investigators to collect sound files from the use of the devices and compare the algorithms output to established, existing vascular testing. There will be no invasive procedures, and use of these stethoscopes is part of routine clinical care.\n\nIf successful, this data and algorithm will be later deployed via smartphone app for point of case testing in a separate study",[248,28],"Atherosclerosis",[250],"Arteries",{"date":229,"type":39},{"date":253,"type":39},"2016-09-07",{"date":255,"type":22},"2026-12-31",{"name":257,"class":46},"Duke University",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":187},"100540790","effects-of-advanced-trauma-life-support-on-adult-trauma-patient-outcomes-100540790","NCT06321419","Effects of Advanced Trauma Life Support® on Adult Trauma Patient Outcomes","Effects of Advanced Trauma Life Support® Training Compared to Standard Care on Adult Trauma Patient Outcomes: A Cluster Randomised Trial","ADVANCE TRAUMA","Inclusion Criteria:\n\n* age of at least 15 years;\n* trauma occurred less than 48 hours before arrival at the hospital;\n* present to the emergency department of participating hospitals, with a history of trauma defined as having any of the reasons listed in the International Classification of Diseases chapter XX as the reason for presenting;\n* admitted or died between arrival at the hospital and admission, or referred\u002Ftransferred from the emergency department of a participating hospital to another hospital for admission; and\n* managed by a participating cluster in the emergency department.\n\nExclusion Criteria:\n\n* present with isolated limb injuries; or\n* are directly admitted to a ward without being seen by a physician in the emergency department.",{"count":267,"type":22},4320,[90],"Rationale:\n\nTrauma is a massive global health issue. Many training programmes have been developed to help physicians in the initial management of trauma patients. Among these programmes, Advanced Trauma Life Support® (ATLS®) is the most popular, having trained over one million physicians worldwide. Despite its widespread use, there are no controlled trials showing that ATLS® improves patient outcomes. Multiple systematic reviews emphasise the need for such trials.\n\nAim:\n\nTo compare the effects of ATLS® training with standard care on outcomes in adult trauma patients.\n\nTrial Population:\n\nAdult trauma patients presenting to the emergency department of a participating hospital.\n\nEligibility Criteria:\n\nHospitals are secondary or tertiary hospitals in India that admit or refer\u002Ftransfer for admission at least 400 patients with trauma per year. Clusters are one or more units of physicians providing initial trauma care in the emergency department of tertiary hospitals in India. Patients participants are adult trauma patients who presents to the emergency department of participating hospitals and are admitted or transferred for admission.\n\nEthical Considerations:\n\nThe study will use an opt-out consent approach for in-hospital collection of routinely recorded data, in which consent is presumed unless actively declined. Informed consent for non-routinely recorded data including out of hospital follow up will be obtained. Patients who are unconscious or lack a legally authorized representative will be included under a waiver of informed consent. Note that consent here refers to consent to data collection, as it will not be possible for patients to opt out from being subjected to the intervention. This approach is justified because the trial can be considered to involve only minimal risk and the data collection is non-invasive and mostly involve extracting routinely collected data from medical records.\n\nFunding:\n\nSwedish Research Council (reg. no. 2023-03128), Laerdal Foundation (reg. no. 2023-0297).\n\nSpecial considerations:\n\nThis trial is not yet fully funded. The Trial Management Group has decided to proceed with the trial with the expectation that additional funding will be secured. The Joint Trial Steering and Data Monitoring Committee will be informed of the funding status at each meeting. If funding is not secured, the trial will be stopped. This will likely result in an underpowered trial. The justification for this decision is that the intervention is considered standard of care in many countries and the data collection is considered minimal risk. There is therefore a very small risk of harm to patient participants, but a potential direct benefit to those.",[28],[272,273,274,275,276],"Advanced Trauma Life Support","Mortality","Disability","Return to work","Quality of Life","2026-01-21",{"date":279,"type":39},"2026-01-23",{"date":281,"type":39},"2025-02-27",{"date":283,"type":22},"2029-11",{"name":285,"class":46},"Karolinska Institutet",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":23,"phases":297,"briefSummary":298,"conditions":299,"keywords":304,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":316},"100509218","a-research-study-of-abdominal-ultrasound-fast-in-children-with-blunt-torso-trauma-100509218","NCT05910567","A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma","A Randomized Controlled Trial of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma","FAST","Children younger than 18 years of age (0 to 17.9999 years) with blunt abdominal trauma presenting to the participating EDs within 24 hours of the traumatic event will be eligible if the do not meet any exclusion criteria and meet any one of the following inclusion criteria.\n\nInclusion Criteria:\n\n1. Blunt torso trauma resulting from a significant mechanism of injury:\n\n   * Motor vehicle collision: greater than 60 mph, ejection, or rollover\n   * Automobile versus pedestrian\u002Fbicycle: automobile speed \\> 25 mph\n   * Falls greater than 20 feet in height\n   * Crush injury to the torso\n   * Physical assault involving the abdomen\n2. Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma\n3. Blunt traumatic event with any of the following (regardless of the mechanism):\n\n   * Extremity paralysis\n   * Multiple long bone fractures (e.g., tibia and humerus fracture)\n4. History and physical examination suggestive of blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)\n\nExclusion Criteria:\n\nThe following patients will be excluded from the study:\n\n1. Age-adjusted low blood pressure (Hemodynamic instability)\n\n   * Patients will be excluded for prehospital or initial age-adjusted ED low blood pressure. This is because the standard evaluation of these patients involves immediate FAST based on prior work by our group. Low blood pressure is determined based upon the patient's age, and will be defined as a systolic blood pressure less than 70 mm Hg for patients younger than 1 month, less than 80 mm Hg for ages 1 month to 5 years, and less than 90 mm Hg for ages over 5 years.\n2. Penetrating trauma: Patients who are victims of stab or gunshot wounds\n3. Traumatic injury occurring \\> 24 hours prior to the time of presentation to the ED\n4. Transfer of the patient to the ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed\n5. Transferred with FAST exam already performed at outside hospital\n6. Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts\n7. Initial GCS score ≤ 8 as it is standard for children with GCS scores ≤ 8 to undergo abdominal CT if blunt abdominal trauma is suspected\n8. Known pregnancy\n9. Known prisoner\n10. Known intra-abdominal injury diagnosed within 30 days prior of this ED visit","17 Years",{"count":296,"type":22},4346,[90],"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.",[300,28,301,302,303],"Blunt Trauma to Abdomen","Abdomen Injury","Abdominal Injury","Abdomen, Acute",[305,28,300,301,306],"Child","Blunt Abdominal Trauma","2025-12-05",{"date":309,"type":39},"2025-12-11",{"date":311,"type":39},"2023-04-17",{"date":313,"type":22},"2027-04-30",{"name":315,"class":46},"University of California, Davis",6,{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":316},"100471859","phase-4-acute-partial-thickness-burn-study-comparing-transforming-powder-dressing-to-standard-of-care-dressing-100471859","NCT05424354","Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing","Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds","Inclusion Criteria:\n\n* Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment.\n* Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old\n* Wounds must be partial thickness, involving up to 20% of the total body surface area.\n* Burn injury should be less than 72 hours old\n* Willing and able to comply with protocol mandated scheduled study visits\u002Fclinical evaluations.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Known allergy to TPD or its components\n\n  * Women who are pregnant, breast feeding, or plan to get pregnant during the study period.\n* Infected wounds\n* Presence of any full thickness (third degree) burns\n* Electrical burns\n* Heavily draining burns due to underlying chronic lymphedema or other conditions\n* Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study.\n* History of poor wound healing and\u002For skin\u002Fimmune system condition\n\n  * Deemed by clinician not to be suitable\n* Unwilling or not able to provide consent or comply with protocol or required visits\n* Developmental disability\u002Fsignificant psychological disorder which can impair the subjects ability to provide informed consent, or participate in the study protocol\n* Active alcohol or substance abuse",{"count":325,"type":22},60,[327],"PHASE4","This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 72 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.",[28],[331],"burn","2025-11-16",{"date":334,"type":39},"2025-11-19",{"date":336,"type":39},"2022-05-26",{"date":338,"type":22},"2026-09-30",{"name":340,"class":341},"ULURU Inc.","INDUSTRY",{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":356,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":47},"100541692","phase-2-4-aminopyridine-for-skin-wound-healing-100541692","NCT06333171","4-aminopyridine for Skin Wound Healing","Inclusion Criteria:\n\n* Otherwise healthy adult patients without skin conditions effecting the skin of the axilla or upper inner arm.\n* Cognitive ability to evaluate wound healing, report sensory and motor deficit during examination.\n* Eligible for standard of care plan for wound closure by secondary intention (normal healing without intervention).\n* Adults subject aged 18-70\n* Ability to give written informed consent.\n* Capable of safely coming in for follow up visits on all scheduled appointments.\n\nExclusion Criteria:\n\n* History of multiple sclerosis, stroke or any other diagnosed neurological disorder\n* History of hypersensitivity to AMPYRA® or 4-aminopyridine\n* Current use of aminopyridine medications, including other compounded 4-AP\n* Suspected renal impairment based on the Choyke questionnaire.\n* History of difficult compliance with timely follow up\n* Patients outside the age range\n* Unable to provide informed consent.\n* Patients with a known history of a seizure disorder (4-AP overdose can, in selected cases, result in limited seizure activity).\n* Patients with a concomitant traumatic brain injury.\n* Patients unable to communicate.\n* Patients unwilling to complete the study requirements.\n* Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, e.g. Cimetidine.\n* Pregnancy, breastfeeding or incarcerated individuals.\n* Non-English speaking\n* Patients unable or unwilling to take calibrated (with gauge) photographs of their wounds","70 Years",{"count":350,"type":22},150,[25],"Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults.\n\nThe purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing.\n\nThe investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing.",[133,354,355,28],"Wound of Skin","Wound Heal",[357,358],"4 aminopyridine","wound healing",{"date":360,"type":39},"2025-09-03",{"date":362,"type":22},"2025-09",{"date":364,"type":22},"2028-03",{"name":235,"class":46},{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":399},"100488320","phase-3-trauma-resuscitation-with-low-titer-group-o-whole-blood-or-products-100488320","NCT05638581","Trauma Resuscitation With Low-Titer Group O Whole Blood or Products","TROOP","Inclusion Criteria:\n\n1. Adult trauma patient (estimated age \\> 15 or weight \\> 50 kg, if age unknown)\n2. Patient taken to trauma center directly from scene\n3. Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting\n4. Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol\n5. Traumatic injury with at least one of the following:\n\n   1. Confirmed or suspected acute major bleeding\n   2. Assessment of Blood Consumption (ABC) Score ≥2\n\nExclusion Criteria:\n\n1. Patients who have received, prehospital or in-hospital more than two units of LTOWB; the equivalent in components (two units of packed red blood cells and two units of plasma); or a combination of the two (more than one unit of LTOWB, one unit of packed cells, and one unit of plasma). Most trauma centers hold two units of either packed red blood cells (with two units of plasma) or two units of LTOWB in the emergency department. This stock is used to initiate transfusion, while the massive hemorrhage protocol is activated from the blood bank.\n2. Patients transferred from another hospital\n3. Children \\\u003C15 years (in most communities, patients aged 15-18 years are treated at adult trauma centers, and patients in this age group frequently suffer life-threatening injuries, and will therefore be included)\n4. Known prisoners, defined as individuals involuntarily confined or detained in a penal institution (including juvenile detention, involuntary psychiatric commitment, or court-ordered residential substance abuse treatment)\n5. Moribund patients expected to die within 1 hour\n6. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)\n7. Patients with known \"do not resuscitate\" orders prior to randomization\n8. Patients who refuse the administration of blood products\n9. Individuals with a research \"opt out\" bracelet.\n10. Greater than 20% total body surface area (TBSA) burns\n11. Suspected inhalation injury victims\n12. Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative",{"count":374,"type":22},1100,[376],"PHASE3","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.",[28,379],"Shock, Hemorrhagic",[381,382,383,384,385,386,387,388,389],"Massive Transfusion","Trauma","Shock","Hemorrhage","Plasma","Platelets","Red Blood Cells","Low-Titer Group O Whole Blood","Blood components","2025-08-15",{"date":392,"type":39},"2025-08-21",{"date":394,"type":39},"2023-07-27",{"date":396,"type":22},"2027-06-30",{"name":398,"class":46},"University of Alabama at Birmingham",13,{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":408,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":419,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":435},"100407660","phase-3-erythropoietin-alfa-to-prevent-mortality-and-reduce-severe-disability-in-critically-ill-trauma-patients-100407660","NCT04588311","ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients","A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury","EPO-TRAUMA","Inclusion Criteria: Patients with trauma admitted to the ICU who:\n\n* Are ≥ 18 to ≤ 75 years of age\n* Are \\\u003C 24 hours since primary traumatic injury\n* Are invasively mechanically ventilated\n* Are expected to stay in the ICU ≥ 48 hours\n* Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution\n* Have informed consent from a legal surrogate according to local law\n\nExclusion Criteria: Patients will be excluded from the study if any of the following criteria apply:\n\n* GCS = 3 and fixed dilated pupils\n* Recent history of DVT, PE or other thromboembolic event (within previous 12 months or receiving concomitant anticoagulant treatment for this indication)\n* A chronic hypercoagulable disorder, including known malignancy\n* Treatment with EPO in the last 30 days\n* First dose of study drug unable to be given within 24 hours of primary injury\n* Pregnancy or lactation or 3 months postpartum\n* Expected to die imminently (\\\u003C 24 hours)\n* Known sensitivity to mammalian cell derived products\n* Known contraindication to epoetin alfa\n* End stage renal failure (receives chronic dialysis)\n* Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome\n* The treating physician believes it is not in the best interest of the patient to be randomised to this trial","75 Years",{"count":410,"type":22},2500,[376],"The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients.\n\n2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.",[382,414,415,28,416,417,418,100],"Traumatic Injury","Traumatic Brain Injury","Penetrating Injury","Blunt Injury","Major Trauma",[420,382,421,422,423,424,425],"Intensive Care Unit","Major trauma","Traumatic injury","EPO","Erythropoietin","Epoetin alfa","2025-07-14",{"date":428,"type":39},"2025-07-16",{"date":430,"type":39},"2020-11-09",{"date":432,"type":22},"2027-08-31",{"name":434,"class":46},"Australian and New Zealand Intensive Care Research Centre",41,{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":442,"minAge":18,"maxAge":54,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":445,"conditions":446,"keywords":452,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":47},"100239468","phase-2-human-penile-allotransplantation-100239468","NCT02395497","Human Penile Allotransplantation","Donor Inclusion Criteria:\n\n* Males aged 16 - 65 years.\n* Brain dead meeting the criteria for Determination of Death.\n* Family consent for penile graft donation.\n* Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure).\n* Same blood type as recipient.\n* Negative lymphocytotoxic crossmatch.\n* Accurately matched for skin tone\n\nRecipient Inclusion Criteria:\n\n* Males of any race, color or ethnicity; aged 18-69 years.\n* Recent (≥6 months) or remote (i.e., several decades) penile injury resulting in the loss of ≥75% of the phallus.\n* Penectomy secondary to penile cancer\n* Penile Cancer Survivors \\> 5 years\n* Micropenis associated with congenital\u002Fbirth defect and severely ambiguous male genitalia\n* Must have completed a clinic appointment with one of the study surgeons to discuss all penile reconstructive options.\n* Completes the protocol informed consent form(s).\n* No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of penile transplantation.).\n* No co-existing psycho-social problems (i.e., alcoholism, drug abuse).\n* Negative for malignancy for past 5 years.\n* Negative for HIV at transplant.\n* Negative crossmatch with donor.\n* Consents to sample (i.e., skin biopsy) collection and storage and bone marrow infusion as part of the treatment regimen.\n* USA citizen or equivalent.\n* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regimen.\n\nRecipient and Donor Exclusion Criteria:\n\n* Untreated sepsis.\n* HIV (active or seropositive).\n* Active tuberculosis.\n* Active Hepatitis B infection.\n* Hepatitis C.\n* Viral encephalitis.\n* Toxoplasmosis.\n* Malignancy (within past 5 years).\n* Current\u002Frecent (within 3 months of donation\u002Fscreening consent) IV drug abuse.\n* Paralysis of ischemic or traumatic origin.\n* Inherited peripheral neuropathy.\n* Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.\n* Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).\n* Mixed connective tissue disease.\n* Severe deforming rheumatoid or osteoarthritis in the limb.\n\nDonor Only Exclusion Criteria:\n\n* Evidence of active herpes simplex virus-2 (HSV-2) infection.\n* Tattoos: non-professional tattoo within the last 6 months, or personally identifiable tattoo (i.e., donor name) on potential transplant.\n\nRecipient Only Exclusion Criteria:\n\n* Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.\n* Sensitized recipients with high levels (50%) of panel-reactive human leukocyte antigen (HLA) antibodies.\n* Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.\n* Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration).\n* Patients considered psychologically\u002Fpsychiatrically unsuitable.","MALE",{"count":325,"type":22},[25,376],"Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction.\n\nThe investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace \"like with like,\" restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results.\n\nStudy Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing\u002Ffrequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.",[67,28,60,447,136,448,449,450,451],"Urologic Surgical Procedures, Male","Penis\u002FTransplantation","Penis\u002FSurgery","Penis\u002FInjuries","Congenital Anomaly, Male Genitalia",[453,65,64,454,67,69,66,455,456,457,458,459,460],"Penile Transplant","Penis","Male","Humans","Allotransplantation","Micropenis","Severely Aambiguous Male Genitalia","congenital\u002Fbirth defect","2025-07-03",{"date":463,"type":39},"2025-07-07",{"date":465,"type":39},"2014-06",{"date":467,"type":22},"2039-06",{"name":45,"class":46},{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":17,"minAge":477,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":481,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":120},"100405041","blood-flow-restriction-training-after-patellar-instability-100405041","NCT04554212","Blood Flow Restriction Training After Patellar INStability","Blood Flow Restriction Training After Patellar INStability (BRAINS Trial)","BRAINS","Inclusion Criteria:\n\n* Diagnosis of traumatic patellar instability (either primary or recurrent) determined by an American Board of Family Medicine certified physician with a Certificate of Added Qualifications in Sports Medicine or licensed Physical Therapist utilizing clinical examination, radiographic imaging, and patients' reports of instability\n* Age 14 to 40 years\n* Skeletally mature with closed growth plates visualized by radiograph\n* A score of 80 or more on the Sports Activity Scale, which corresponds to participating in \"running, twisting, turning (tennis, racquetball, handball, ice hockey, field hockey, skiing, wrestling)\" at least 1-3 times per week\n* Desire to resume pre-injury activity level\n\nExclusion Criteria:\n\n* Concomitant osteochondral lesion requiring surgical fixation\n* Radiographic evidence of osteoarthritis (\\\u003C Kellgren-Lawrence Grade 2)\n* Previous ipsilateral or contralateral knee surgery\n* Most recent instability event more than 3 months before enrollment\n* History of any inflammatory disorder\n* BMI \\> 35 kg\u002Fm2\n* Diabetes or uncontrolled hypertension\n* Varicose veins or a history of personal or immediate family history (parental or sibling) of deep vein thrombosis\n* Pre-existing conditions or previous surgeries that effect the ability to walk\n* Planned trips or vacations that will result in the inability to attend 4 consecutive physical therapy sessions","14 Years","40 Years",{"count":480,"type":22},78,[90],"This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability.",[484,485,486,28],"Patellar Dislocation","Knee Injuries","Leg Injury","2025-07-02",{"date":461,"type":39},{"date":490,"type":39},"2020-09-09",{"date":492,"type":22},"2026-06-30",{"name":494,"class":46},"Caitlin Conley",{"id":496,"slug":497,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":503,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":47},"100525432","phase-1-appraise-20-live-trial-of-the-appraise-trauma-decision-support-system-100525432","NCT06121661","APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System","Inclusion Criteria:\n\n* Adult (≥18 yrs) Emergency Department (ED) patient\n* Triaged to the \"Acute\" area of the ED. (The \"Acute\" area is the designated area for ED patients with potential or established critical illness. Triage to Acute is a routine ED operation that is performed based on departmental guidelines and the professional judgement of an experienced triage nurse).\n* Clinical concern for acute injury (based on either an explicitly chief complaint of acute injury, or clinical team with documented concern for acute injury as a relevant part of patient presentation).\n\nExclusion Criteria:\n\n* Prisoners\n* Patients known to be pregnant, based on patient report, physical exam, or bedside ultrasound\n* Patients wearing an \"EFIC Opt-Out\" bracelet\n* Any concern about the suitability of the software system for a specific patient by any clinician involved in the patient's ED care, or by the patient themselves (or by any LAR \\[lawfully authorized representative\\] of the patient).",{"count":502,"type":22},20,[504],"PHASE1","This is a pilot evaluation of the APPRAISE trauma decision-support software system (\"the System\"). The specific objections are as follows:\n\n1. Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use);\n2. Evaluate whether the real-time display of the System causes distraction or confusion to clinicians treating the trauma patient such that its risks exceed its benefits;\n3. Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.",[28],"2025-05-05",{"date":509,"type":39},"2025-05-08",{"date":511,"type":39},"2023-02-21",{"date":513,"type":22},"2028-12-14",{"name":515,"class":46},"Andrew Tomas Reisner",{"id":517,"slug":518,"hasResults":11,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":11,"sex":442,"minAge":18,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":23,"phases":525,"briefSummary":526,"conditions":527,"keywords":547,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":585,"locationsCount":587},"100397880","phase-2-locomotor-training-with-testosterone-to-promote-bone-and-muscle-health-after-spinal-cord-injury-100397880","NCT04460872","Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury","Locomotor Training With Testosterone to Promote Bone and Muscle Health","Inclusion Criteria:\n\n* Men \\>18 years of age\n* Diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs (i.e., spasticity, hypertonicity) for \\>60-days\n* Low serum total testosterone (\\\u003C300 ng\u002FdL), bioavailable testosterone (\\\u003C110 ng\u002FdL), or free testosterone (\\\u003C46 pg\u002FmL or \\\u003C4.6 ng\u002FdL)\n* Presence of one or more sign or symptom that may be related to low testosterone, including: loss of body hair or reduced shaving, very small testes (\\\u003C6 mL), reduced sexual desire (libido) and activity, decreased spontaneous erections (e.g., morning erections) or erectile dysfunction, breast discomfort or gynecomastia, height loss, low-trauma fracture, or low BMD, hot flushes or sweats, decreased energy, motivation, initiative, or self-confidence, fatigue or irritability, feeling sad or blue, having a depressed mood, or having a persistent low-grade depressive disorder, poor concentration or memory, sleep disturbances or increased sleepiness, mild unexplained anemia (normochromic or normocytic), reduced muscle bulk, strength, or physical performance, Increased body fat or body mass index, any other sign or symptom commonly associated with low testosterone\n* Locomotor dysfunction, definted as self-selected walking pace ≤1.0 m\u002Fs on a 10mWT, either with or without gait devices or braces and with or without assistance, or as self-selected walking pace \\>1.0 m\u002Fs with reliance on a gait device or brace or with highly compensated movement impairments, as identified by a trained observer.\n* Diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology\n* Medically-stable condition that is asymptomatic for conditions that will interfere with the study participation\n* Willingness to administer TRT as instructed by the study staff and to abide by study protocol\n* Documented approval from the study physician verifying medical status\n\nExclusion Criteria:\n\n* Currently participating in another research protocol that may influence study outcomes.\n* Mental state that precludes understanding the study protocol.\n* Life expectancy \\\u003C12-months.\n* History of or current congenital SCI (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxis) or other degenerative spinal disorder (e.g., spinocerebellar degeneration) that may complicate study procedures\n* Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment or injury\n* Current prostate, breast, or other organ cancer or a history of prostate or breast cancer\n* Any other diagnosed or treated cancer within the past 24-months, with the exceptions of basal or squamous cell carcinoma of the skin that has been successfully treated\n* Serum prostate-specific antigen (PSA) \\>3.0 ng\u002FmL \\[men treated with 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are eligible to participate if PSA values are ≤1.5 ng\u002FmL\\]\n* Prostate nodule or induration noted on digital rectal exam (DRE) during screening that tests positive for prostate cancer\n* Currently seeking fertility or expected during the duration of the study\n* Gynecomastia\n* Hematocrit (HCT) \\>49%\n* Any major cardiovascular (CV) event within the last 12-months (defined as a history of acute myocardial infarction, any cardiac revascularization procedure including angioplasty, stenting, or coronary artery bypass grafting, revascularization of the carotid or middle cerebral artery or procedures to treat critical limb ischemia, or hospitalization due to unstable angina, transient ischemic attack, stroke, or peripheral vascular disease)\n* Angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)\n* Poorly compensated congestive heart failure (NYHA class III or IV)\n* Poorly controlled hypertension (consistently measured systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg), while on medications\n* Poorly controlled arrhythmia of any type\n* Severe valvular heart disease\n* Baseline electrocardiogram (ECG) findings such as left bundle branch block or marked ECG abnormalities that would preclude serial screening evaluations for occult ischemic events\n* History of unprovoked deep venous thrombosis (DVT), unprovoked pulmonary embolism, history of recurrent DVT or known thrombophilia\n* LDL cholesterol \\>160 mg\u002FdL with history of any major CV event, defined above, within the last 12-months\n* Major non-CV surgery (e.g., major abdominal or thoracic procedure) within 90-days prior to screening and\u002For a major surgery scheduled at the time of screening\n* Liver enzymes (AST or ALT) \\>1.5 times the normal upper limit\n* Severe or end-stage chronic kidney disease documented by estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n* Diagnosed, but untreated severe obstructive sleep apnea\n* Lower extremity fracture in the last 12-months (exclusion criterion for participation in LT+TRT group only)\n* Femoral neck, total hip, or lumbar spine t-score below -2.5 or distal femur BMD \\\u003C0.70 g\u002Fcm2, assessed via DEXA at screening (exclusion criterion for participation in LT+TRT group only)\n* Current anticoagulant therapy (contraindication for i.m. injections)\n* Use of any of the following pharmacologic agents in the previous 90-days: any TRT formulation, any compounded or over-the-counter androgenic hormones or androgen precursors, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or growth hormone\n* Use of anti-resorptive or bone anabolic drug therapy in the previous 180-days\n* Acute use (\\>5-days) of any opioids (e.g., oxycodone, hydrocodone, etc) or systemic glucocorticoids \\>7.5 mg\u002Fd prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) within 1-week before screening visit, except men who are taking these medications for a chronic condition and are anticipated to continue treatment for the study duration\n* Known allergy to any component of the TRT formulation (e.g., sesame oil or cottonseed oil)\n* Any other condition, therapy, lab abnormality, medical or psychiatric conditions, or reason that might pose a risk to the participant, make participation not in the person's best interest, confound the study results (e.g., inability to comply with study requirements), make the participant unsuitable to receive study intervention, or interfere with the person's ability to participate for the entire study duration",{"count":524,"type":22},21,[25],"This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.",[528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,28,543,544,545,546],"Spinal Cord Injury","Spinal Cord Injuries","Trauma, Nervous System","Wounds and Injury","Central Nervous System Diseases","Spinal Cord Diseases","Gonadal Disorders","Endocrine System Diseases","Hypogonadism","Genital Diseases, Male","Spinal Cord Trauma","Injuries, Spinal Cord","Walking, Difficulty","Gait Disorders, Neurologic","Locomotion Disorder, Neurologic","Nervous System Diseases","Testosterone Deficiency","Androgen Deficiency","Hormone Deficiency",[548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,563,564,565,566,567,568,569,570,571,572,573,574,575,576,577,578,528],"Testosterone","Testosterone enanthate","Testosterone undecanoate","Testosterone 17 beta-cypionate","Methyltestosterone","Androgens","Hormones","Hormone Substitutes, and Hormone Antagonists","Physiologic Effects of Drugs","Pharmacologic Actions","Therapeutic Uses","Anabolic Agents","Testosterone Replacement Therapy","Dual Energy X ray Absorptiometry","Lean Tissue Mass","Body Composition","Muscle Strength","Muscle Mass","Bone Mineral Density","Adipose Tissue","Body Fat","Density, Bone","Bone Formation","Bone Resorption","Bone Density Conservation Agents","Magnetic Resonance Imaging","Walking","Ambulation","Locomotor","Locomotion","Treadmill","2025-05-01",{"date":581,"type":39},"2025-05-06",{"date":583,"type":39},"2021-01-31",{"date":492,"type":22},{"name":586,"class":46},"North Florida Foundation for Research and Education",2,{"id":589,"slug":590,"hasResults":11,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":348,"enrollmentInfo":596,"targetDuration":4,"studyType":23,"phases":597,"briefSummary":598,"conditions":599,"keywords":602,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":316},"100578921","phase-1-ng004-in-spinal-cord-injury-patients-100578921","NCT06817577","NG004 in Spinal Cord Injury Patients","A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients","SPROUT","Inclusion Criteria:\n\n* Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) C-D at Screening\n* 4-28 days post-injury\n* No required mechanical ventilation or patients that not completely depend on mechanical ventilation\n* Hemodynamically and clinical stable patient according to the acute SCI condition at baseline\n\nExclusion Criteria:\n\n* Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds\n* Multiple levels of clinically relevant spinal cord lesions\n* Major brachial or lumbar plexus damage\u002Ftrauma\n* Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function\n* Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy\n* History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis\n* History of refractory epilepsy\n* History of or current autoimmune disease\n* Patients with uncontrolled bleeding diathesis and\u002For who require concomitant therapeutic anticoagulation and not related to SCI\n* Presence of any unstable medical or psychiatric condition\n* Drug dependence any time during the 6 month's preceding trial entry\n* Pregnant or nursing women\n* History of a life-threatening allergic or immune mediated reaction\n* Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections\n* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations\n* Patients who are unconscious",{"count":524,"type":22},[504],"This is the FIH, multicenter, open-label, sequential, multiple ascending dose trial of NG004 in patients with acute incomplete cervical SCI. The trial will evaluate the safety, tolerability, and PK of 4 dose regimens of NG004, and will evaluate the maximum tolerated dose of NG004.",[600,533,532,543,530,601,28],"Acute Spinal Cord Injury (SCI)","Spinal Cord Injuries (SCI)",[603,604,594,605],"Acute spinal cord injury","Nogo-A","Regeneration","2025-02-04",{"date":608,"type":39},"2025-02-10",{"date":610,"type":39},"2024-12-18",{"date":612,"type":22},"2026-09",{"name":614,"class":341},"NovaGo Therapeutics AG",{"id":616,"slug":617,"hasResults":11,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":11,"sex":17,"minAge":622,"maxAge":4,"enrollmentInfo":623,"targetDuration":4,"studyType":23,"phases":624,"briefSummary":625,"conditions":626,"keywords":629,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":47},"100368594","oasis-donor-site-wounds-post-market-study-100368594","NCT04079348","Oasis Donor Site Wounds Post-Market Study","Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds","Inclusion Criteria:\n\n1. Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a covering material.\n2. Has at least 24 hours to consent to study participation.\n\nExclusion Criteria:\n\n1. Age \\\u003C 16 years\n2. Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as:\n\n   1. Chronic inflammatory skin condition\n   2. Chronic liver failure\n   3. Chronic renal failure\n   4. Blood-borne viruses (Hep B, Hep C, HIV)\n   5. Peripheral vascular disease\n   6. Clinically significant anaemia\n   7. Uncontrolled diabetes\n3. Need for use of the same harvest site (re-cropping)\n4. History of radiation therapy to proposed donor site\n5. Chronic use of medications known to impair wound healing\n6. Chronic use of opioids or neuropathic pain agents\n7. Suspected cellulitis, osteomyelitis or septicaemia\n8. Patients undergoing haemodialysis\n9. Patients requiring spinal\u002Fregional block\n10. Patients on current anti-coagulant therapy\n11. Unable or unwilling to provide informed consent\n12. Unable or unwilling to comply with the study follow-up schedule, and procedures\n13. Simultaneously participating in another investigational drug or device study (patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrolment in this study)\n14. Allergy or hypersensitivity to materials that are porcine-based\n15. Cultural or religious objection to the use of pig or porcine products\n16. Known intolerance\u002Fallergy to standard wound care products\n17. Presence of a local infection at the donor site and\u002For systemic infection","16 Years",{"count":129,"type":22},[90],"The purpose of this study is to demonstrate the safety and performance of Oasis extracellular matrix (ECM) when used as a treatment for donor site wounds in the United Kingdom. Oasis ECM is commercially available for the treatment of partial and full-thickness skin wounds, including chronic wounds, wounds from trauma, and wounds that occur during surgery, such as donor site wounds. The ability of the Oasis ECM to promote the healing of donor site wounds will be evaluated in this study.\n\nAbout 40 patients (20 in each arm) over 16 years old will be involved in this study at one center in the United Kingdom.",[627,628,28,355],"Surgical Wound","Wound",[630],"Donor Site Wound","2024-12-12",{"date":633,"type":39},"2024-12-17",{"date":635,"type":39},"2020-11-01",{"date":637,"type":22},"2025-12",{"name":639,"class":341},"Cook Biotech Incorporated",{"id":641,"slug":642,"hasResults":11,"nctId":643,"briefTitle":644,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":649,"conditions":650,"keywords":653,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":665},"100420916","prehospital-management-of-hypotensive-trauma-in-hems-100420916","NCT04760977","Prehospital Management of Hypotensive Trauma in HEMS","SPITFIRE","Inclusion Criteria:\n\n* Age \\> 18 years\n* Witnessed traumatic event managed by HEMS\n* Shock at first evaluation (Systolic blood pressure \\\u003C 90 mmHg)\n* Suspect or obvious ongoing haemorrage\n\nExclusion Criteria:\n\n* Patients in cardiac arrest at HEMS arrival in which resuscitation is not started or interrupted by HEMS crew",{"count":648,"type":22},500,"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.\n\nAlso 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.\n\nMoreover, 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.\n\nWith 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",[651,28,652,99],"Hypotension and Shock","Emergencies",[654,28,652,99],"Transportation of Patients","2024-08-10",{"date":657,"type":39},"2024-08-13",{"date":659,"type":39},"2021-05-01",{"date":661,"type":22},"2026-05-01",{"name":663,"class":664},"Azienda Usl di Bologna","OTHER_GOV",16,{"id":667,"slug":668,"hasResults":11,"nctId":669,"briefTitle":670,"officialTitle":671,"acronym":672,"eligibilityCriteria":673,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":674,"phases":4,"briefSummary":675,"conditions":676,"keywords":678,"overallStatus":684,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":688,"locationsCount":4},"100092011","phone-intervention-for-alcohol-etoh-use-in-emergency-department-motor-vehicle-crash-ed-mvc-patients-100092011","NCT00457548","Phone Intervention for Alcohol (ETOH) Use in Emergency Department Motor Vehicle Crash (ED MVC) Patients","Study of Effectiveness of BI Given to Injured MVC ED Patients Who Use Alcohol Harmfully and Hazardously","DIAL","Inclusion Criteria:\n\n* 18 years or older\n* Emergency department patient\n* Subacute injury\n* Motor vehicle crash or other injury\n* Alcohol use at harmful and hazardous levels\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* Does not meet alcohol use criteria\n* Non-English speaker\n* In police custody\n* Suicidal\n* Psychiatric diagnosis\n* No locator\n* Injury occurred \\> 72 hours prior to ED visit","EXPANDED_ACCESS","The purpose of this study is to determine if a brief counseling intervention, delivered by telephone, is more effective than standard ED care, to reduce future alcohol related injuries and alcohol related negative consequences, among patients treated in the ED for injuries from an MVC and other injury mechanisms.",[677,28],"Alcoholic Intoxication",[679,680,681,682,683],"Alcohol use","Brief Interventions","Injuries","Emergency Department Patients","Harmful and hazardous alcohol use among ED injured patients","AVAILABLE","2011-03-29",{"date":687,"type":22},"2011-03-30",{"name":689,"class":46},"Rhode Island Hospital"]