- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06848959
Development and Application of a Diagnosis and Treatment System for Children's Brain Diseases Based on Knowledge Graphs and Large Models
February 22, 2025 updated by: Yun Liu,PhD
Jiangsu Provincial Hospital of Traditional Chinese Medicine
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yun Liu PhD
- Phone Number: +86 13023876996
- Email: 20200413@njucm.edu.cn
Study Locations
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-
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Nanjing, China
- Recruiting
- Jiangsu Provincial Hospital of Traditional Chinese Medicine
-
Contact:
- Dong Chen Dr.
- Phone Number: +86 134 0587 1656
- Email: 648728749@qq.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Childhood encephalopathy
Description
Inclusion Criteria:
- 1. meet diagnostic criteria for CP ID TD ADHD ASD; 2. gender is not limited;
Exclusion Criteria:
- 1. CP ID TD ASD due to chorea hepatomegaly hearing abnormality and pharmacogenetic factors;
- 2. Children with other major mental illnesses (e.g. schizophrenia) or organic diseases (e.g. congenital heart disease);
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Childhood Autism Rating Scale
Time Frame: 4 mouths
|
The total score ranges from 15 to 60, with the higher the score the worse the symptoms are
|
4 mouths
|
|
meridian and acupointological features
Time Frame: 4 mouths
|
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".
|
4 mouths
|
|
Yale Global Tic Severity Scale
Time Frame: 4 mouths
|
It has a score range of 0-100, with higher scores representing more severe symptoms.
|
4 mouths
|
|
Gross Motor Function Assessment Scale (GMFM)-88
Time Frame: 4 mouths
|
GMFM-88 scores range from 0-264, with higher scores being better.
|
4 mouths
|
|
Autism Behavior Checklist
Time Frame: 4 mouths
|
It has a score range of 0-174, with higher scores representing more severe symptoms.
|
4 mouths
|
|
acupuncture point status
Time Frame: 4 mouths
|
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".
|
4 mouths
|
|
Tongue texture
Time Frame: 4 mouths
|
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".
|
4 mouths
|
|
Wechsler intelligence scale (WIS)
Time Frame: 4 mouths
|
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.
|
4 mouths
|
|
Resting heart rate
Time Frame: 4 mouths
|
4 mouths
|
|
|
blood pressure (systolic, diastolic) after 10 minutes of rest
Time Frame: 4 mouths
|
4 mouths
|
|
|
Conners Rating Scales
Time Frame: 4 mouths
|
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.
|
4 mouths
|
|
tongue coating, pulse
Time Frame: 4 mouths
|
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".
|
4 mouths
|
|
respiratory rate
Time Frame: 4 mouths
|
4 mouths
|
|
|
Body temperature
Time Frame: 4 mouths
|
4 mouths
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Saliva
Time Frame: 4 mouths
|
Destruction after use.
Metabolomics after sample collection.
|
4 mouths
|
|
blood
Time Frame: 4 mouths
|
Destruction after use.
Metabolomics after sample collection.
|
4 mouths
|
|
Urine
Time Frame: 4 mouths
|
Destruction after use.
Metabolomics after sample collection.
|
4 mouths
|
|
Faeces
Time Frame: 4 mouths
|
Destruction after use.
Metabolomics after sample collection.
|
4 mouths
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Estimated)
February 28, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
February 18, 2025
First Submitted That Met QC Criteria
February 22, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 22, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Brain Damage, Chronic
- Attention Deficit and Disruptive Behavior Disorders
- Autism Spectrum Disorder
- Cerebral Palsy
- Intellectual Disability
- Attention Deficit Disorder with Hyperactivity
Other Study ID Numbers
- HospitalNanjingU
- Nanjing Science and Technology (Other Identifier: HospitalNanjingU)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.