Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-25 @ 1:25 PM
Study NCT ID:
NCT06848959
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2025-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Application of a Diagnosis and Treatment System for Children's Brain Diseases Based on Knowledge Graphs and Large Models
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-22', 'studyFirstSubmitDate': '2025-02-18', 'studyFirstSubmitQcDate': '2025-02-22', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Childhood Autism Rating Scale', 'timeFrame': '4 mouths', 'description': 'The total score ranges from 15 to 60, with the higher the score the worse the symptoms are'}, {'measure': 'meridian and acupointological features', 'timeFrame': '4 mouths', 'description': 'After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".'}, {'measure': 'Yale Global Tic Severity Scale', 'timeFrame': '4 mouths', 'description': 'It has a score range of 0-100, with higher scores representing more severe symptoms.'}, {'measure': 'Gross Motor Function Assessment Scale (GMFM)-88', 'timeFrame': '4 mouths', 'description': 'GMFM-88 scores range from 0-264, with higher scores being better.'}, {'measure': 'Autism Behavior Checklist', 'timeFrame': '4 mouths', 'description': 'It has a score range of 0-174, with higher scores representing more severe symptoms.'}, {'measure': 'acupuncture point status', 'timeFrame': '4 mouths', 'description': 'After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".'}, {'measure': 'Tongue texture', 'timeFrame': '4 mouths', 'description': 'After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".'}, {'measure': 'Wechsler intelligence scale (WIS)', 'timeFrame': '4 mouths', 'description': 'FIQ = 100: Indicates that the individual has an average level of intelligence. FIQ \\> 100: Indicates an above average level of intelligence. FIQ \\< 100: Indicates a below average level of intelligence.'}, {'measure': 'Resting heart rate', 'timeFrame': '4 mouths'}, {'measure': 'blood pressure (systolic, diastolic) after 10 minutes of rest', 'timeFrame': '4 mouths'}, {'measure': 'Conners Rating Scales', 'timeFrame': '4 mouths', 'description': 'Scores are converted to standardized T-scores for comparison with the mean of the peer group. T-scores above 65 are usually considered clinically significant.'}, {'measure': 'tongue coating, pulse', 'timeFrame': '4 mouths', 'description': 'After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".'}, {'measure': 'respiratory rate', 'timeFrame': '4 mouths'}, {'measure': 'Body temperature', 'timeFrame': '4 mouths'}], 'secondaryOutcomes': [{'measure': 'Saliva', 'timeFrame': '4 mouths', 'description': 'Destruction after use. Metabolomics after sample collection.'}, {'measure': 'blood', 'timeFrame': '4 mouths', 'description': 'Destruction after use. Metabolomics after sample collection.'}, {'measure': 'Urine', 'timeFrame': '4 mouths', 'description': 'Destruction after use. Metabolomics after sample collection.'}, {'measure': 'Faeces', 'timeFrame': '4 mouths', 'description': 'Destruction after use. Metabolomics after sample collection.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cerebral Palsy', 'Mental Retardation', 'Tourette's Syndrome', 'Attention Deficit Hyperactivity Disorder', 'Autism Spectrum Disorders']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Childhood encephalopathy', 'healthyVolunteers': False, 'eligibilityCriteria': '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);'}, 'identificationModule': {'nctId': 'NCT06848959', 'briefTitle': "Development and Application of a Diagnosis and Treatment System for Children's Brain Diseases Based on Knowledge Graphs and Large Models", 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Nanjing University of Chinese Medicine'}, 'officialTitle': 'Jiangsu Provincial Hospital of Traditional Chinese Medicine', 'orgStudyIdInfo': {'id': 'HospitalNanjingU'}, 'secondaryIdInfos': [{'id': 'Nanjing Science and Technology', 'type': 'OTHER', 'domain': 'HospitalNanjingU'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Pediatric Encephalopathy Science and Prevention Decision Aid Follow-Up Q\\&A'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dong Chen Dr.', 'role': 'CONTACT', 'email': '648728749@qq.com', 'phone': '+86 134 0587 1656'}], 'facility': 'Jiangsu Provincial Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yun Liu PhD', 'role': 'CONTACT', 'email': '20200413@njucm.edu.cn', 'phone': '+86 13023876996'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yun Liu,PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Yun Liu,PhD', 'investigatorAffiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine'}}}}