[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-injuries-acute\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-injuries-acute":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,83,123,145],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100643795","bridge-us-bridging-readiness-in-deployed-neurotrauma-gaps-for-excellence-100643795",false,"NCT07636213","BRIDGE-US: Bridging Readiness in Deployed Neurotrauma Gaps for Excellence","BRIDGE-US","Inclusion Criteria:\n\n1. Age: Subjects aged 16 years and older\n2. Injury Type\u002FEvidence: Patients with a confirmed PBI as demonstrated by head imaging or physical exam (evidence of dural penetration by a projectile)\n3. Timeframe: Patients must be enrolled within 8 hours of injury\n\nExclusion Criteria:\n\nNo subjects will be excluded based on gender or ethnicity for this study. Subjects under the age of 16 will be excluded. These subjects differ significantly in terms of neurodevelopment, physiology, and trauma response, which introduces heterogeneity that could confound study results. Additionally, pediatric PBI has distinct etiologies, treatment pathways, and prognostic indicators compared to adult PBI (note that age 16 and up are treated medically as adults).\n\nFULL EXCLUSION CRITERIA:\n\n1. Dead on Arrival (DOA): Patients who receive CPR with no return of pulse\n2. Non-penetrating injury: Patients with head injuries that do not include dural penetration\n3. Polytrauma: Patients with penetrating or blunt injuries to other parts of the body\n4. Known or suspected pregnancy\n5. Known or suspected prisoner","ALL","16 Years",{"count":19,"type":20},270,"ESTIMATED","7 Days","OBSERVATIONAL","The purpose of this research study is to prospectively collect biospecimens, imaging, and clinical data from patients with penetrating brain injuries across high-volume PBI sites in the US (including UChicago). Biospecimens will undergo biomarker analysis - biomarker data specific to PBI is extremely limited, and could provide critical insight to outcome identification and clinical decision making.\n\nThis data will be used to build the first comprehensive PBI Data Commons, biorepository, and imaging repository which will create the infrastructure necessary to close critical knowledge gaps, advance biomarker discovery specific to PBI, and provide the foundation for future research aimed at improving prognostication and treatment for patients with this devastating injury.",[25,26,27,28],"Brain Injuries, Acute","Brain Trauma","Penetrating Head Injury","Traumatic Brain Injury","NOT_YET_RECRUITING","2026-06-08",{"date":32,"type":33},"2026-06-09","ACTUAL",{"date":35,"type":20},"2026-07-01",{"date":37,"type":20},"2035-12-31",{"name":39,"class":40},"University of Chicago","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":63,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":41},"100638098","pire-20-a-stepped-care-model-for-involving-relatives-across-sectors-100638098","NCT07590726","PIRe 2.0: A Stepped-Care Model for Involving Relatives Across Sectors","PIRe","Inclusion Criteria\n\n* Primary relative of an adult diagnosed with acquired brain injury (ABI) or malignant brain tumor (MBT), admitted to a participating hospital department.\n* Formally identified as the primary relative by the patient.\n* Aged ≥18 years.\n* Ability to read, understand, and complete questionnaires in Danish.\n\nExclusion Criteria\n\n* Insufficient proficiency in Danish to complete questionnaires and participate in structured conversations.\n* Concurrent participation in another interventional study with a similar aim that may interfere with the present study.","18 Years",{"count":51,"type":20},160,"INTERVENTIONAL",[54],"NA","Serious brain diseases and injuries affect not only the person who becomes ill or injured, but also their family. Relatives of people with acquired brain injury (ABI) or malignant brain tumor (MBT) often take on a major role in daily care, decision-making, and coordination across healthcare services. This role can include managing information, supporting rehabilitation, and acting as a link between hospital care and community rehabilitation. Many relatives report high levels of stress, uncertainty, and emotional burden, especially during transitions between care settings.\n\nDespite recommendations for greater involvement of relatives, support for this group is often uneven and poorly coordinated across healthcare sectors. Relatives frequently experience lack of overview, limited guidance, and unclear expectations regarding their role. These challenges may increase caregiver burden and negatively affect both relatives' well-being and the continuity of care.\n\nThe PIRe 2.0 study aims to further test, and implement a structured intervention to support systematic involvement of relatives of people with ABI or MBT across hospital and community rehabilitation services. The intervention is designed as a \"caregiver compass\" that helps relatives understand their role, clarify their needs and wishes for involvement, and gain better overview of the care pathway.\n\nPIRe 2.0 is delivered through a stepped-care model, which allows the level of support to be adjusted over time based on each relative's level of burden and support needs. All relatives receive basic information and screening for caregiver burden using the 4-item Zarit Burden Interview (ZBI-4). Relatives who show signs of increased burden are offered additional support in steps, ranging from structured conversations with nurses to extended cross-sector coordination and specialized support for relatives with high or complex needs. Decisions about stepping up or down are based on both screening results and clinical assessment to ensure flexibility and person-centered care.\n\nThe study includes two groups of relatives: an intervention group receiving support through the PIRe stepped-care model, and a control group receiving usual care only. A total of 160 relatives will participate. Data are collected at baseline, at transitions between hospital and community care, and three to six months after the intervention.\n\nThe primary outcome is change in caregiver burden, measured with the Caregiver Burden Scale (CBS). Secondary outcomes include relatives' roles and responsibilities, perceived support and involvement in care, and mental well-being, assessed using validated patient-reported outcome measures.\n\nIn addition to evaluating the effect of the intervention, the study examines how the PIRe model can be implemented and sustained in everyday practice across healthcare sectors. The results are expected to show whether a structured, stepped-care approach can reduce caregiver burden, improve coordination between hospital and community services, and support more coherent and secure care pathways for people with ABI or malignant brain tumor and their relatives.",[25,57,58,59,60,61,62],"Brain Tumor Adult","Brain (Nervous System) Cancers","Traumatic Brain Injuries","Glioblastom WHO Grade 4","Glioblastoma (GBM)","Stroke",[64,65,66,67,68,69,70,71,72,73],"Acquired brain injury","Malignant brain tumor","Relatives","Caregiver Burden","Involvement","Communication","Care transitions","Rehabilitation","Implementation","Stepped-care","2026-05-15",{"date":76,"type":33},"2026-05-19",{"date":78,"type":20},"2026-10-01",{"date":80,"type":20},"2029-09-30",{"name":82,"class":40},"Rigshospitalet, Denmark",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":95,"conditions":96,"keywords":106,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100544564","screening-emotions-in-adolescents-at-the-hospital-for-mtbi-100544564","NCT06370520","Screening Emotions in Adolescents at the Hospital for mTBI","Screening Emotions in Adolescents Receiving Care at the Hospital for mTBI (SEARCH-mTBI)","SEARCH-mTBI","Inclusion Criteria:\n\nChildren 11 to less than 18 years old who meet the Centers for Disease Control and Prevention (CDC) definition of mTBI\\*. In brief, this is defined as a Glasgow Coma Scale (GCS) score of 13 to 15 with:\n\n\\- Head injury (e.g., direct blow or sudden deceleration\u002Facceleration) plus any neurological sign and\u002For symptom such as headache, nausea, history of loss of consciousness, confusion, dizziness, amnesia (not limited to these symptoms\u002Fsigns)\n\nAND\u002FOR\n\n\\- Traumatic intracranial abnormalities on CT or MRI (such as intracranial hemorrhage, skull fracture, or diffuse axonal injury)\n\n\\*mTBI is defined as an acute brain injury resulting in neurological symptoms such as confusion or disorientation, headache, nausea, loss of consciousness, amnesia, seizure, focal signs or symptoms, and\u002For have traumatic intracranial abnormalities on CT or MRI imaging. mTBI patients have GCS scores of 13 to 15. Per CDC precedent, we will use the term mTBI which encompasses other commonly used terms such as \"concussion\" or \"minor head injury\". This will include patients who may have neuroimaging findings of traumatic abnormalities (e.g., intracranial hemorrhage, diffuse axonal injury, skull fractures) which are risk factors for mental health problems; however, neuroimaging is not required for enrollment into the study.\n\nExclusion Criteria:\n\n* Presentation to the ED \\>72 hours post-injury\n* TBI requiring emergent neurosurgical intervention at the time of enrollment\n* Other injuries requiring emergent surgery at the time of enrollment\n* Parent or child unable to accurately complete the study questionnaires due to preexisting functional limitations (e.g., severe developmental delay)\n* Previous known enrollment into the study\n* Patient or parent does not speak English or Spanish","11 Years","17 Years",{"count":94,"type":20},2592,"The goal of this observational study is to develop and validate a clinical tool to predict which adolescents aged 11 to less than 18 years of age with mild traumatic brain injury (mTBI) are at an increased risk for developing significant new or worsening mental health conditions.\n\nThe main aims the study wish to answer are:\n\n* Does the adolescent have new or worsening depression or anxiety defined as a change from their previous medical history using self-reported questionnaires at either one or three months post-injury?\n* Does the adolescent have unmet mental health care needs, defined as not receiving any mental or behavior health care in patients with new or worsening anxiety or depression as defined by the self reported questionnaires?\n\nParticipants will be enrolled after being diagnosed in the emergency department (ED) with an mTBI. During the ED visit, the child's parent\u002Fcaregiver and the adolescent will complete several questionnaires related to mental health which include tools to measure anxiety and depression. Participants will be asked to complete these questionnaires again at 1 month and 3 months post enrollment.",[97,98,25,99,100,101,102,103,104,105],"Brain Injury Traumatic Mild","Brain Injuries","Head Injury With Intracranial Hemorrhage","Head Injury Trauma","Brain Injury Traumatic Focal With Loss of Consciousness","Skull Fractures","Diffuse Axonal Injury","Intracranial Hemorrhages","Head Injury",[107,108,109,98,110,111],"Child","Concussion","Wounds and Injuries","Head Injuries Trauma","Loss of Consciousness","RECRUITING","2025-09-22",{"date":115,"type":33},"2025-09-26",{"date":117,"type":33},"2024-05-22",{"date":119,"type":20},"2028-12",{"name":121,"class":40},"University of California, Davis",6,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100431988","severe-acquired-brain-injuries-prognostic-factors-and-quality-of-care-100431988","NCT04905264","Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care","TIRESIA Project - Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care","Inclusion Criteria:\n\n* patients with Serious Acquired Brain Injuries\n* admission to rehabilitation units\n\nExclusion Criteria:\n\n\\- patients admitted more than 14 weeks after the acute event",{"count":131,"type":20},2500,"The main purpose of this project is to identify the medium-term prognostic factors for patients with Severe Acquired Brain Injuries and evaluate their impact.\n\nThe secondary aim is to create a system of continuous assessment of the quality of care for each rehabilitation unit.",[25],[71,98],"2025-08-08",{"date":137,"type":33},"2025-08-13",{"date":139,"type":33},"2022-01-03",{"date":141,"type":20},"2027-06",{"name":143,"class":40},"Mario Negri Institute for Pharmacological Research",27,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":41},"100564078","the-relationship-between-brain-injury-biomarkers-in-cerebrospinal-fluid-and-blood-of-patients-after-cardiac-arrest-and-prognosis-100564078","NCT06624488","The Relationship Between Brain Injury Biomarkers in Cerebrospinal Fluid and Blood of Patients After Cardiac Arrest and Prognosis","The Relationship Between Brain Injury Biomarkers in Cerebrospinal Fluid and Blood of Patients After Cardiac Arrest and Prognosis.","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Still lack of directive movements after restoration of spontaneous circulation through cardiopulmonary resuscitation.\n* Advanced life support and targeted temperature management are carried out within 6 hours after return of spontaneous circulation (ROSC).\n\nExclusion Criteria:\n\n* Patients with contraindications for lumbar puncture (severe cerebral edema indicated by brain imaging, disappearance of basal cisterns or occult intracranial mass lesions, receiving antiplatelet and anticoagulant therapy, and those with coagulation disorders).\n* Pregnant patients.\n* Patients with concomitant traumatic brain injury, stroke, cerebral hemorrhage and other diseases.\n* Patients whose families do not agree to be enrolled.","80 Years",{"count":154,"type":20},30,"This study is a single-center, prospective, observational study. After successful cardiopulmonary resuscitation for patients with cardiac arrest, they will be transferred to the emergency intensive care unit for further standardized targeted temperature management. When evaluating that the patient meets the indications for lumbar puncture and there are no contraindications for lumbar puncture, lumbar puncture examinations will be completed immediately after return of spontaneous circulation (ROSC), at 24 hours of hypothermia, at 72 hours of hypothermia, and after rewarming. Routine cerebrospinal fluid examinations such as cerebrospinal fluid routine, cerebrospinal fluid biochemistry, and cerebrospinal fluid lactate will be sent for inspection. At the same time, 6 ml of cerebrospinal fluid will be retained and stored in a refrigerator at -80°C. After sample collection is completed, enzyme-linked immunosorbent assay (ELISA) will be used to detect markers such as NSE, HCH-L1, NFL, tau, MBP, GFAP, and S100β. While performing the lumbar puncture examination, peripheral blood will be collected. After centrifugation for 10 minutes (4000 revolutions), serum will be retained and stored in a refrigerator at -80°C to complete the examination of the above markers. After 3 months, the patient\\'s neurological function prognosis will be followed up according to the Pittsburgh Cerebral Performance Category (CPC) scale.",[157,25],"Cardiac Arrest (CA)",[159,160,161,162],"cardiac arrest","brain injury","cerebrospinal fluid","biomarkers","2025-02-20",{"date":165,"type":33},"2025-02-21",{"date":167,"type":33},"2023-01-01",{"date":169,"type":20},"2025-05-01",{"name":171,"class":40},"Tang Ziren"]