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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Nanjing, China
        • Recruiting
        • Jiangsu Provincial Hospital of Traditional Chinese Medicine
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yun Liu,PhD

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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