[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autism-spectrum-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autism-spectrum-disorders":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,72,110,141,170,197],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100641659","a-comparative-study-of-driving-performance-among-adolescents-with-autism-spectrum-disorder-and-neurotypical-adolescents-100641659",false,"NCT07630298","A Comparative Study of Driving Performance Among Adolescents With Autism Spectrum Disorder and Neurotypical Adolescents","Perf-TSA","Inclusion Criteria:\n\nASD Group\n\n* Adolescents aged 15 to 17,\n* With a confirmed diagnosis of ASD by a physician,\n* Without an intellectual disability, with a Fluid Reasoning Index (IRF) greater than 80,\n* Who have passed the written driver's license exam,\n* With no or very limited driving experience (\\\u003C5 hours),\n* Enrolled in the social security system.\n\nNeurotypical group:\n\n* Adolescents aged 15 to 17,\n* Without a diagnosis of neurodevelopmental disorders or learning disabilities,\n* With a standard educational background,\n* Who have passed the written driver's license exam,\n* With no or very limited driving experience (\\\u003C5 hours),\n* Enrolled in the social security system.\n\nExclusion Criteria:\n\n* Adolescents with ADHD (attention-deficit\u002Fhyperactivity disorder) and\u002For ODD (oppositional defiant disorder) and\u002For IDD (intellectual disability) and\u002For SLI (specific language impairment) with associated comprehension difficulties,\n* Adolescents who already have a driver's license,\n* Adolescents currently taking driving lessons and\u002For with more than 5 hours of driving experience,\n* Adolescents who have suffered a head injury during childhood,\n* Other serious medical conditions that may interfere with participation in the sessions,\n* Participation in another research protocol.",true,"ALL","15 Years","17 Years",{"count":21,"type":22},22,"ESTIMATED","INTERVENTIONAL",[25],"NA","The primary objective of this study is to compare the number of driving errors made by novice adolescents (0-5 hours of driving instruction) with ASD to those made by neurotypical adolescents during a standardized driving simulator assessment. The secondary objectives of the study are to:\n\n* Compare the visual strategies used by adolescents with ASD to those of neurotypical adolescents during a driving assessment on a simulator.\n* Compare the types of errors and driving performance (i.e., speed, reaction time, following distance, and braking distance) of adolescents with ASD to those of neurotypical adolescents during the driving simulator assessment.\n* Compare the driving performance of these two groups during a real-world road assessment using the TRIP scale.\n* Examine the consistency between driving performance measured in the simulator and that observed in real-world conditions for both groups.\n* Compare the anxiety levels of these two groups during driving tests on the simulator and on the road.",[28],"Autism Spectrum Disorders",[30,31,32,33],"Drive","learning","Driving simulator","ASD","NOT_YET_RECRUITING","2026-06-15",{"date":37,"type":38},"2026-06-17","ACTUAL",{"date":40,"type":22},"2026-07-01",{"date":42,"type":22},"2027-08-31",{"name":44,"class":45},"Hopital La Musse","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100641217","phase-3-single-dose-double-blind-placebo-controlled-cross-over-sddbpcco-shiftability-study-will-be-followed-by-a-10-week-open-label-study-with-arbaclofen-4-weeks-of-titration-and-then-6-weeks-of-activestable-treatment-the-effects-of-arbaclofen-on-target-eeg-and-erg-metrics-will-be-associated-with-th-100641217","NCT07655115","Single Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active\u002FStable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th","A Follow-Up Shiftability Study of Arbaclofen With an Open-Label Extension for the Study of Biomarkers in Children and Adolescents With Autism Spectrum Disorders.","Inclusion Criteria:\n\n* Signed Written Informed Consent a.Participants or their legal representative must have signed and dated an IRB\u002FIEC approved written informed consent form\n* Diagnosis of an Autism Spectrum Disorder according to the DSM-5 criteria\n* Participation in the AIMS-2 CT1 (ages at recruitment 5 to 17).\n* Current pharmacological treatment regimen affecting behaviour has been stable for at least 6 weeks prior to screening and is expected to be stable during the duration of the study\n* Current psychotherapeutic\u002Fpsychosocial interventions affecting behaviour stable for 3 months prior to screening and expected to be stable during the duration of the study\n* Participants with a history of seizure disorder must currently be receiving stable treatment with anticonvulsant medication and must have been seizure free for 6 months prior to screening or must be seizure free for 3 years prior to screening if not currently on a stable (\\>3 months) dose of antiepileptics\n* Male or female participants 7 to 23 years of age at the time of providing consent, inclusive.\n* Reside or regular contact (at least twice a week) with the parent\u002Fcarer who is interviewed for the study.\n* Negative pregnancy test for females of childbearing potential (participant has experienced onset of menses)\n* Females of childbearing potential who are sexually active must agree to use a highly effective form of contraception (i.e., existing surgical sterilization, complete or abstinence or a combination of two affective forms of contraception, such as, for example, condoms plus hormonal treatment). Please, refer to Appendix 4 for a complete list of acceptable contraception methods.(protocol)\n* Male participants with female partners of childbearing potential are eligible to participate if they agree to the conditions stated in section 8.2.1.(protocol)\n\nExclusion Criteria:\n\n* Participants with any condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.\n* Participants who are currently receiving treatment with racemic baclofen, vigabatrin, tiagabine, or riluzole or other GABA-related medications (e.g. gabapentin or pregabalin) other than arbaclofen in the context of AIMS-2 CT1\n* Participants who are currently receiving pharmacologic treatment affecting behaviour (see concomitant medication section) need to have a stable dose during the 6 weeks prior to the screening visit and for the duration of the study.\n* Participating in programs including non-pharmacologic educational, behavioural, and\u002For dietary interventions affecting behaviour, participation in these programs must have been continuous during the 3 months prior to screening and participants or their parent\u002Fcaregiver\u002FLAR may not electively initiate new or modify ongoing interventions for the duration of the study. Typical school vacations are not considered modifications of stable programming\n* Participants who have taken another investigational drug within the last 30 days.\n* Participants with evidence of any significant haematological, endocrine, cardiovascular (including uncorrected symptomatic congenital heart disease), respiratory, renal, hepatic, or gastrointestinal disease, not including mild common paediatric diseases in these areas that are stable (e.g. mild asthma, constipation, etc.), as judged by the investigator.\n* Participants who are not able to take oral medications.\n* Participants who have a history of hypersensitivity to racemic baclofen\n* Participants with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption should not take this medicine.\n* Active peptic ulceration as Baclofen stimulates gastric acid secretion.\n* Porphyria.\n* Participants who are currently engaged in illicit drug use or alcohol abuse, according to DSM-5 criteria.\n* Participants who have previously participated in a clinical trial with arbaclofen (other than our AIMS-2-CT1).\n* Women who are breastfeeding","0 Years","64 Years",{"count":57,"type":22},103,[59],"PHASE3","study with arbaclofen (4 weeks of titration and then 6 weeks of active\u002Fstable treatment). The effects of arbaclofen on target EEG and ERG metrics will be associated with the clinical response in measures of social and general function, adaptive behaviour, social anxiety, sensory behaviours, global functioning, and quality of life in Children and Adolescents with Autism Spectrum Disorders",[28],"RECRUITING","2026-06-12",{"date":37,"type":38},{"date":66,"type":38},"2025-11-20",{"date":68,"type":22},"2026-12-31",{"name":70,"class":45},"Hospital General Universitario Gregorio Marañon",5,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":46},"100587940","early-phase-1-prednisone-in-adults-with-an-immune-mediated-subtype-of-autism-spectrum-disorder-100587940","NCT06934915","Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder","Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups Trial of Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder","PREDICT","Inclusion Criteria:\n\n1. 18 to 50 years of age (inclusive) and assigned male at birth.\n2. Diagnostic Statistical Manual of Mental Disorders (DSM), Fourth Edition, Text Revision (DSM-IV-TR) diagnosed autistic disorder, and DSM, Fifth Edition, Text Revision (DSM-5-TR) diagnosed autism spectrum disorder (ASD), level 2 or 3. A qualified (board-eligible or board-certified) psychiatrist or psychologist, with experience in diagnostic determinations of ASD, will make a final diagnostic determination based on clinical history, clinical observations, medical records, mental status exams, and screening measures.\n3. A Clinical Global Impression-Severity (CGI-S) rating ≥ 4 (\"Moderate\") at screening (and baseline).\n4. A non-verbal IQ in the range of moderate intellectual disability or higher (≥ 35), as measured by the non-verbal Abbreviated IQ (ABIQ) score of the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), or mental age of at least 18 months, as measured by the Cognitive and Adaptive Behavior subscales of the Developmental Profile (DP-4) Parent\u002FCaregiver Interview form.\n5. Participation of a study partner who has consistent contact with the participant and is willing and able to attend visits, oversee the participant's compliance with the protocol and study medication, and report on the participant's status through study assessments.\n6. Participant reports ≥ 1 of the following:\n\n   * A diagnosed comorbid autoimmune disease (e.g., Crohn's disease, Graves' disease, Hashimoto's disease, psoriasis, rheumatoid arthritis, ulcerative colitis, type 1 diabetes mellitus, etc.).\n   * Current biomarker evidence of critical indicators of inflammation\u002Fautoimmunity, such as elevated levels of C-reactive protein (CRP) or abnormal value of antinuclear antibodies (ANA).\n   * A significant family history of autoimmunity, defined as having ≥ 1 first-degree relative or ≥ 2 second-degree relatives with autoimmune diseases. The Principal Investigator (PI) will make the final determination on this criterion.\n7. Any concomitant medications or interventions for ASD-related symptoms (e.g., alpha-2 agonists, anticonvulsants, antidepressants, antipsychotics, anxiolytics, gastrointestinal medications, medications for sleep disorders, probiotics, stimulants, behavioral therapies, psychosocial interventions, speech therapy, etc.) have been stable for at least 4 weeks prior to the screening visit and the participant\u002Fstudy partner intend to maintain a stable regimen throughout the trial.\n8. Participant can tolerate swallowing large capsules.\n9. Participant is willing and able, in the investigator's opinion, to comply with all study procedures.\n\nIndividuals must satisfy the following criteria to be enrolled as study partners:\n\n1. The study partner is fluent in English.\n2. The study partner is a caregiver or an individual who has consistent contact with the participant, knows the participant well, and is willing and able to attend visits, oversee the participant's compliance with the protocol and study medication, and report on the participant's status through study assessments. The PI will make the final determination on this criterion.\n\nExclusion Criteria:\n\n1. DSM-5-TR diagnosed ASD, level 1, or presence of another DSM-IV-TR diagnosed pervasive developmental disorder, such as Asperger's disorder, childhood disintegrative disorder, Rett syndrome, or pervasive developmental disorder not otherwise specified (PDD-NOS). A qualified psychiatrist or psychologist will make a diagnostic determination after reviewing clinical history, clinical observations, medical records, mental status exams, and screening measures.\n2. A CGI-S rating \\\u003C 4 at screening (or baseline).\n3. A non-verbal IQ in the range of severe or profound intellectual disability (\\\u003C 35), as measured by the non-verbal ABIQ score of the SB-5, or mental age below 18 months, as measured by the Cognitive and Adaptive Behavior subscales of the DP-4 Parent\u002FCaregiver Interview form. Individuals testing below 18 months may be enrolled after a case review by the PI and study psychologist, especially if testing scores were likely underestimated due to uncooperative behavior.\n4. Previous documentation of a prolonged electroencephalogram (EEG) suggestive of Landau-Kleffner syndrome or continuous spike and wave during sleep (CSWS) syndrome.\n5. Presence of a defined genetic disorder, such as Angelman syndrome, Fragile X syndrome, Noonan syndrome, Tuberous sclerosis, Williams syndrome, or any documented chromosomal or genetic abnormality with proven clinical significance in the etiology of ASD.\n6. Documented significant pre- or post-natal central nervous system insult, such as an in-utero cerebral vascular accident, that is believed to have significantly contributed to the development of the individual's ASD.\n7. Mitochondrial disorder verified by skin and\u002For muscle biopsy.\n8. History of bipolar disorder or psychotic disorder, including major depressive disorder with psychotic features, schizoaffective disorder, or schizophrenia. History of a significant and interfering comorbid major psychiatric disorder, including obsessive-compulsive disorder, post-traumatic stress disorder, or substance use disorder requiring \\> 1 psychiatric hospitalization for treatment of specific comorbid psychiatric disorders above and beyond target symptoms associated with ASD, such as aggression, irritability, self-injury, property destruction, mood swings, or severe tantrums. Minor psychiatric disorders, such as adjustment disorder, attention-deficit hyperactivity disorder, generalized anxiety disorder, major depressive disorder, persistent depressive disorder, or social anxiety disorder, may not exclude participation. The PI will make the final determination on this exclusion criterion.\n9. Concomitant medications or interventions for ASD-related symptoms (e.g., alpha-2 agonists, anticonvulsants, antidepressants, antipsychotics, anxiolytics, gastrointestinal medications, medications for sleep disorders, probiotics, stimulants, behavioral therapies, psychosocial interventions, speech therapy, etc.) have not been stable for at least 4 weeks prior to the screening visit.\n10. An active bacterial, fungal, helminthic, protozoan, or viral infection that could be exacerbated by a course of prednisone, as determined by the PI.\n11. Significant medical findings from history, physical examination, or laboratory testing that may be incompatible with prednisone use (e.g., participants with chronic infectious conditions or unstable diabetes mellitus).\n12. Individuals with a history of seizures being treated with an anticonvulsant may be eligible if seizure-free for at least 6 months and the anticonvulsant dose has been stable for at least 4 weeks prior to the screening visit.\n13. Use of immunosuppressive agents within the 6 months prior to the screening visit or concurrent use of immunosuppressive agents that, in the judgment of the PI, would interfere with study outcomes or pose unreasonable risk with prednisone administration.\n14. A known hypersensitivity to prednisone or any other component of the study product.\n15. The participant is deemed unsuitable for any reason by the PI, including an inability to complete or comply with study requirements.\n\nIndividuals may be excluded from enrollment as study partners if either of the following criteria are met:\n\n1. The study partner is not fluent in English.\n2. The study partner is deemed unsuitable for any reason by the PI, including an inability to complete or comply with study requirements.","MALE","18 Years","50 Years",{"count":84,"type":22},32,[86],"EARLY_PHASE1","The goal of this clinical trial is to learn how prednisone affects adults with autism spectrum disorder (ASD). It will also learn about the safety of prednisone. The main questions it aims to answer are:\n\n* How does prednisone affect the core features and associated target symptoms of ASD in adults with an immune-mediated subtype of ASD?\n* Is prednisone safe for autistic adults without causing too many side effects?\n* Does this study warrant larger trials studying anti-inflammatory drugs in this subject population?\n\nResearchers will compare the drug prednisone to a placebo (a look-alike substance that contains no drug) to see how prednisone affects autistic adult males.\n\nParticipants will:\n\n* Visit the clinic 2 times for a screening and baseline visit.\n* Take prednisone or a placebo every day for 16 weeks.\n* Visit the clinic 2 times for checkups, tests, questionnaires, and dose changes, and 1 time for a follow-up visit 4 weeks after stopping the study drug.\n* Provide blood and urine samples for testing up to 4 times.\n* Complete 8 remote calls every 1-2 weeks for checkups and dose changes.\n* Keep a diary of the dose and times they take the study drug every day and any symptoms or side effects they experience.",[89,28,90,91],"Autism Spectrum Disorder","Autistic Disorder","Autism",[89,90,91,93,94,95,96,97,98,99,100],"Autoimmunity","Autoimmune Disorders","Inflammation","Neuroinflammation","Anti-Inflammatory Agents","Corticosteroids","Glucocorticoids","Prednisone","2026-05-08",{"date":103,"type":38},"2026-05-12",{"date":105,"type":22},"2026-11",{"date":107,"type":22},"2029-02",{"name":109,"class":45},"Christopher John McDougle, M.D.",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":118,"enrollmentInfo":119,"targetDuration":121,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100623170","pilot-study-on-collaborative-comprehensive-multidimensional-and-quality-of-life-tools-for-priority-definition-shared-decision-making-outcome-evaluation-and-quality-of-care-improvement-in-asd-individuals-and-programs-in-the-real-world-100623170","NCT07393152","Pilot Study on Collaborative, Comprehensive, Multidimensional and Quality of Life Tools for Priority Definition, Shared Decision Making, Outcome Evaluation and Quality of Care Improvement in ASD Individuals and Programs in the Real World.","Studio Pilota su Strumenti Collaborativi, Globali, Multidimensionali e di qualità Della Vita Per la Definizione Delle priorità, lo Sviluppo di Processi Decisionali Condivisi, la Valutazione Degli Esiti e il Miglioramento Della qualità Delle Cure Per le Persone Con Disturbi Dello Spettro Autistico (ASD) Nella Pratica Clinica Quotidiana.","ASD Outcome","Inclusion Criteria:\n\n* ASD diagnosis according to the criteria shared by the regional NFA network\n* Age under 12\n* Consent from the person holding parental responsibility for health choices\n\nExclusion Criteria:\n\n* Subjects aged 12 years or older at the time of enrollment\n* No consent from the person holding parental responsibility for health choices","11 Years",{"count":120,"type":22},400,"12 Months","OBSERVATIONAL","ASD is a very complex and lifelong disorder. Patients' functioning is influenced by multiple factors, including treatments, inclusion and life contexts. Nonetheless, outcome measures are still point-specific and highly fragmented, rarely considering global or multidimensional functioning, development or long-term modifications, especially in the real world. The present study considers ongoing real-life treatments in three different NHS settings, in line with the Italian Guidelines. Two age classes will be considered, 0-5 and 6-11, adding new outcome tools pre-post intervention to those already used, to evaluate quality of life, global functioning, multidimensional needs and strengths and shared decision making. Correlations between the different outcome tools will be explored, and possible clusters will be investigated. Acceptability of the outcome tools for the operators, patients and families, as well as usefulness and sustainability in daily practice, will also be evaluated.",[28],[126,127,128,129,130],"Global functioning","Quality of life","Child and adolescent need and strenght","autism spectrum disorders","Outcome evaluation tools","2026-02-18",{"date":133,"type":38},"2026-02-20",{"date":135,"type":38},"2025-03-13",{"date":137,"type":22},"2026-10-31",{"name":139,"class":45},"Antonella Costantino",3,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":46},"100598805","water-competency-intervention-in-autism-100598805","NCT07076264","Water Competency Intervention in Autism","Water Competency Intervention for Children on the Autism Spectrum: The AquOTic Hybrid Effectiveness Implementation Trial","Children Participants (n=108)\n\nInclusion Criteria\n\n* Educational or medical diagnosis of autism\n* Age between 5 - 9 years\n* Having vision and hearing within normal limits with or without corrective modifications\n\nExclusion Criteria\n\n* Children who demonstrate swim proficiency, as defined by the ability to tread water for 1 minute or move the body through the water without flotation\n* Open wounds or infectious skin diseases\n* Allergy to chlorine\n* Severe co-occurring motor impairments or neurological conditions such as uncontrolled seizures, Rett's or Angelman's syndrome\n* The family is unable to commit to the sessions or evaluations\n\nInterventionists (n=64)\n\nInclusion Criteria\n\n* Aged 18 or over\n* Demonstrate swim proficiency, as defined by the ability to tread water for 1 minute and move the body through the water without flotation for 25 yards\n\nExclusion Criteria\n\n* Open wounds or infectious diseases\n* Failed background check\n* Unable to commit to Basic Swim Instructor and AquOTic training (\\~40 hours) and 10 AquOTic sessions (20 hours)","5 Years","9 Years",{"count":151,"type":22},108,[25],"AquOTic is an evidence-based, occupational therapy-led intervention designed to enhance water competency and swim safety skills in children on the autism spectrum. The 10-week program consists of weekly 60-minute group sessions, each including six children paired in a 1:1 ratio with an interventionist. Sessions follow a structured routine involving six rotating stations, targeting various swim and safety skills, with the flexibility for individualized support by the interventionist.\n\nOverall, this study has 3 major aims. The first aim evaluates the effectiveness of the AquOTic intervention in improving water competency and swim skills, while comparing outcomes between two implementation models: professional student interventionists (occupational and physical therapy students) and trained community-based interventionists. A total of 108 autistic children will be enrolled and randomly assigned to one of three groups: (1) AquOTic with professional student interventionists, (2) AquOTic with community interventionists, or (3) a control group receiving no AquOTic intervention. The second aim explores the mediators and moderators of the intervention outcomes to assess fidelity and efficacy. The third aim identifies the cost and resources associated with AquOTic. A cost analysis will be conducted to evaluate the resources required for implementation and to inform the development of a scalable, cost-effective drowning prevention strategy for autistic populations.",[28],[156,157,158,159,160],"Swim Safety","Water Competency","Occupational Therapy","AquOTic","Drowning Prevention","2025-11-26",{"date":163,"type":38},"2025-12-04",{"date":165,"type":38},"2025-09-19",{"date":167,"type":22},"2029-04",{"name":169,"class":45},"Ohio State University",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":182,"conditions":183,"keywords":184,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":46},"100595469","intestinal-permeability-in-children-with-autism-spectrum-disorder-100595469","NCT07032857","Intestinal Permeability in Children With Autism Spectrum Disorder","Breaking Barriers: A Clinical Experimental Study of Intestinal Permeability in Children With Autism Spectrum Disorder","IP-ASD","* Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS-G.\n* Consumption of a gluten-containing diet.\n* Negative celiac disease serology (EMA and anti-TG2 IgA antibodies).\n* Absence of IgE- or non-IgE-mediated food allergies.\n\nExclusion Criteria:\n\n* Known neurological disorders.\n* Major congenital anomalies.\n* Severe head trauma.\n* Chronic gastrointestinal diseases.\n* Special diets (e.g., gluten-free or gluten\u002Fcasein-free).\n* Antibiotic or probiotic\u002Fprebiotic intake in the previous 4 weeks.","2 Years","14 Years",{"count":181,"type":22},55,"In recent years, increasing attention has been directed toward the role of the gut-brain axis in the pathogenesis of neurodevelopmental disorders, particularly Autism Spectrum Disorder (ASD). Among the multiple contributing factors, the integrity of the intestinal barrier appears to play a crucial role. Enhanced paracellular permeability (\"leaky gut\") may allow luminal antigens and microbial metabolites to translocate into the systemic circulation, triggering inflammatory responses that could impact neuropsychological functioning.\n\nSeveral studies suggest that, although intestinal permeability is not universally altered in all individuals with ASD, there exists a subset characterized by selective epithelial dysfunction, especially associated with repetitive and stereotyped behaviors.\n\nThis project aims to investigate, through a controlled sibling-based design, whether intestinal permeability indices are significantly altered in children with ASD and whether such alterations are specifically correlated with behavioral domains assessed through the ADOS instrument.",[28],[185,186,187],"autism spectrum Disorders","Intestinal permeability","Leaky gut","2025-06-24",{"date":190,"type":38},"2025-06-27",{"date":192,"type":38},"2023-01-01",{"date":194,"type":22},"2025-09-30",{"name":196,"class":45},"University of Bari",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":178,"maxAge":81,"enrollmentInfo":204,"targetDuration":206,"studyType":122,"phases":4,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":46},"100581334","development-and-application-of-a-diagnosis-and-treatment-system-for-childrens-brain-diseases-based-on-knowledge-graphs-and-large-models-100581334","NCT06848959","Development and Application of a Diagnosis and Treatment System for Children's Brain Diseases Based on Knowledge Graphs and Large Models","Jiangsu Provincial Hospital of Traditional Chinese Medicine","Inclusion Criteria:\n\n* 1\\. meet diagnostic criteria for CP ID TD ADHD ASD; 2. gender is not limited;\n\nExclusion Criteria:\n\n* 1\\. CP ID TD ASD due to chorea hepatomegaly hearing abnormality and pharmacogenetic factors;\n* 2\\. Children with other major mental illnesses (e.g. schizophrenia) or organic diseases (e.g. congenital heart disease);",{"count":205,"type":22},2000,"2 Months","Using the knowledge graph and big model technology of combining Chinese and Western medicine we construct a popularization and prevention system for childhood encephalopathy an assisted decision-making system for childhood encephalopathy and a follow-up tracking question and answer system for childhood encephalopathy patients.",[209,210,211,212,28],"Cerebral Palsy","Mental Retardation","Tourette's Syndrome","Attention Deficit Hyperactivity Disorder","2025-02-22",{"date":215,"type":38},"2025-02-27",{"date":217,"type":38},"2024-01-01",{"date":219,"type":22},"2025-12-31",{"name":221,"class":45},"Yun Liu,PhD"]