[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"London Health Sciences Centre Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100611000","phase-2-study-to-evaluate-the-effects-of-av-001-on-hd-induced-brain-injury-100611000",false,"NCT07234890","Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.","A Randomized, Double-Blind, Placebo-Controlled Phase 2 Exploratory Study to Evaluate the Neuroprotective Effects of AV-001 on Hemodialysis-induced Brain Injury Via Cerebrovascular Stabilization in Chronic Hemodialysis Patients","Inclusion Criteria:\n\n* Ability to provide informed consent\n* Male and non-pregnant female patients (\\>18 years old)\n* HD for ≥ 3 months\n* Thrice weekly HD schedule\n\nExclusion Criteria:\n\n* HD \\\u003C90 days\n* Contraindication to MRI\n* Established severe cognitive impairment (Montreal Cognitive Assessment test (MoCA) \\\u003C18 or formal diagnosis of dementia)\n* Previous clinical stroke\n* Pregnancy, breastfeeding, or intending pregnancy\n* Intradialytic hypotension event (defined as: drop in SBP ≥40mmHg + symptoms + intervention) in previous month as evidenced by HD record","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Cognitive decline is increasingly recognized among patients receiving maintenance hemodialysis (HD). This can include trouble remembering, slower thinking or mentally feeling foggy.\n\nThis research is being done to determine if a new medication (AV-001) can protect the brain from injury caused by hemodialysis by strengthening blood vessels in the brain and reducing inflammation.\n\nIf successful, this research could lead to better protection for the brains of people undergoing regular dialysis, potentially reducing the risk of cognitive decline and stroke.",[26],"Hemodialysis","RECRUITING","2026-04-15",{"date":30,"type":31},"2026-04-17","ACTUAL",{"date":33,"type":31},"2025-12-16",{"date":35,"type":20},"2027-12-31",{"name":37,"class":38},"London Health Sciences Centre Research Institute","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":5},"100631065","predictors-of-maladaptive-behaviors-in-children-undergoing-procedural-sedation-100631065","NCT07495826","PRedictors Of Maladaptive Behaviors in Children Undergoing Procedural SEDation","Predictors of Maladaptive Behaviors in Children Undergoing Procedural Sedation","PRoSEED","Inclusion Criteria:\n\n* Children and adolescents 1-17 years undergoing procedural sedation or anxiolysis with any agent for any indication in the ED and dental clinics\n\nExclusion Criteria:\n\n* Patients where the primary caregiver lacks English or French (if applicable to site) comprehension in the absence of a native language interpreter\n* Lack a smartphone able to receive SMS text messages\n* Caregiver and\u002For patient are not available for all of the planned follow-up dates\n* Previously enrolled in the study","1 Year","17 Years",{"count":51,"type":20},2145,"OBSERVATIONAL","Procedural sedation for children outside of the operating room is a common practice in emergency departments, outpatient clinics, radiology suites, and dental offices for painful and anxiety-provoking procedures. However, there is emerging evidence that so-called \"delayed maladaptive behaviors\" (disordered sleep, anxiety, and aggression) affect nearly a quarter of children for up to 2 weeks following sedation. This can lead to poor school attendance, reduced extracurricular involvement, disruptions to caregivers' employment obligations, and poor patient satisfaction. As this phenomenon has only recently been identified, very little is known about what factors predispose children to delayed maladaptive behaviors, however, small studies suggest younger age and pre-procedural anxiety may be involved. The aim of our study is to characterize risk factors for delayed maladaptive behavior in a large multicentre study involving emergency departments, dental offices, and hospital sedation services. Understanding these risk factors may help healthcare workers prevent delayed maladaptive behaviors and provide patients with anticipatory guidance, akin to post-operative recovery instructions.\n\nThere is emerging evidence that maladaptive behaviors, including significant negative behavioral changes, can occur in children following procedural sedation. These include disordered sleep, anxiety, and aggression)1,2 and affect up to 24% of children following inhalational anesthetics3 and intravenous sedatives such as ketamine.1 Moreover, these appear to be more pronounced in children \\\u003C4 years4 and can persist for up to 2 weeks post-sedation. Unfortunately, only two trials have reported delayed maladaptive behaviors.1,2 Data on immediate and delayed AEs are urgently needed for safe clinical decision-making and anticipatory guidance surrounding ED anxiolytics. In a prospective cohort study of children undergoing emergency department procedural sedation with intravenous ketamine, 22% exhibited significant negative behavioral changes 1-2 weeks after discharge, as measured by the Post-Hospitalization Behavior Questionnaire. High pre-procedure anxiety have been identified as independent predictors of these maladaptive behaviors.5 Additionally, irritability, hyperactivity, and hallucinations during recovery have been reported and are associated with lower parental satisfaction.6",[55],"Procedural Sedation and Analgesia",[57,58,59,60],"procedural sedation","pediatrics","maladaptive behavior","pain","2026-03-24",{"date":63,"type":31},"2026-03-27",{"date":65,"type":31},"2026-03-18",{"date":67,"type":20},"2030-05-30",{"name":37,"class":38},""]