Internal DisordersNCT03274908
Real-world Clinical Study and Medical Machine Intelligence Study for Traditional Chinese Internal Medicine
An observational study of Internal Disorders, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
Trial summary
This real-world study aimed at 1. exploring the relationships of traditional Chinese medicine (TCM) syndrome and internal diseases, 2. investigating the relationships of TCM treatment and internal diseases, and 3. creating medical machine intelligence to help internal physician in clinical practice. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Internal Disorders
- What is being tested?
- regular medical treatment
- How many people
- 2,000,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 30 Dec 2022
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients of internal medicine in hospital to include hospital of Chinese medicine and morden hospital in China
Who may be able to join
- all patient records of internal medicine in hospital
Who cannot join
- subjects with major missing data
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huasha Hospital
Shanghai, Shanghai Municipality, 200040
Zihui Tang, M.D and Ph.D, +8615821993541, dr_zhtang@yeah.net
About this study
Official title: Real-world Clinical Study and Medical Machine Intelligence Study for Traditional Chinese Internal Medicine by Using Medical Big Data and Artificial Intelligence Methods
This real-world study aimed at 1. exploring the relationships of traditional Chinese medicine (TCM) syndrome and internal diseases, 2. investigating the relationships of TCM treatment and internal diseases, and 3. creating medical machine intelligence to help internal physician in clinical practice. Big data methods and artificial intelligence algorithms are used to assess the associations based on electronic case files of patients.
- Conditions
- Internal Disorders
- Being tested
- regular medical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular medical treatmentOther
regular medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Group | Not described Receives: Other: regular medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
internal diseases
all of internal diseases
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Apr 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Internal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 2,000,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, Puer Hospital of Chinese Medicine, Dangyang Hospital of Chinese Medicine, Changde Hospital affiliated to Hunan University of Chinese Medicine, Ruikang Hospital affiliated to Guanxi University of Chinese Medicine, Jining First People's Hospital, People's Hospital of Dangyang
- Responsible party
- Principal investigator, Zihui Tang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274908
- Sponsor's protocol ID
- 20170906
- Status last verified
- Jan 2021
- First submitted
- 5 Sep 2017
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu J, Xu F, Mohammadtursun N, Lv Y, Tang Z, Dong J. The Analysis of Constitutions of Traditional Chinese Medicine in Relation to Cerebral Infarction in a Chinese Sample. J Altern Complement Med. 2018 May;24(5):458-462. doi: 10.1089/acm.2017.0027. Epub 2017 Aug 18.
PubMed 28820606Li X, Lei T, Tang Z, Dong J. Analyzing the association between fish consumption and osteoporosis in a sample of Chinese men. J Health Popul Nutr. 2017 Apr 19;36(1):13. doi: 10.1186/s41043-017-0088-y.
PubMed 28424092Geng W, Qin X, Yang T, Cong Z, Wang Z, Kong Q, Tang Z, Jiang L. Model-Based Reasoning of Clinical Diagnosis in Integrative Medicine: Real-World Methodological Study of Electronic Medical Records and Natural Language Processing Methods. JMIR Med Inform. 2020 Dec 21;8(12):e23082. doi: 10.2196/23082.
PubMed 33346740
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Clinical Study and Medical Machine Intelligence Study for Traditional Chinese Internal Medicine by Using Medical Big Data and Artificial Intelligence Methods
- ClinicalTrials.gov ID
- NCT03274908
- Acronym / sponsor ID
- 20170906
- Conditions
- Internal Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000,000 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Collaborators
- Huashan Hospital, Puer Hospital of Chinese Medicine, Dangyang Hospital of Chinese Medicine, Changde Hospital affiliated to Hunan University of Chinese Medicine, Ruikang Hospital affiliated to Guanxi University of Chinese Medicine, Jining First People's Hospital, People's Hospital of Dangyang
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This real-world study aimed at 1. exploring the relationships of traditional Chinese medicine (TCM) syndrome and internal diseases, 2. investigating the relationships of TCM treatment and internal diseases, and 3. creating medical machine intelligence to help internal physician in clinical practice. Big data methods and artificial intelligence algorithms are used to assess the associations based on electronic case files of patients.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Other: regular medical treatment |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients of internal medicine in hospital to include hospital of Chinese medicine and morden hospital in China
Key inclusion criteria (1 listed)
- all patient records of internal medicine in hospital
Key exclusion criteria (1 listed)
- subjects with major missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regular medical treatmentregular medical treatment | Other | Group |
Primary outcome
internal diseases
Time frame: 10 years
all of internal diseases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Background: PubMed 28820606Liu J, Xu F, Mohammadtursun N, Lv Y, Tang Z, Dong J. The Analysis of Constitutions of Traditional Chinese Medicine in Relation to Cerebral Infarction in a Chinese Sample. J Altern Complement Med. 2018 May;24(5):458-462. doi: 10.1089/acm.2017.0027. Epub 2017 Aug 18.
- Background: PubMed 28424092Li X, Lei T, Tang Z, Dong J. Analyzing the association between fish consumption and osteoporosis in a sample of Chinese men. J Health Popul Nutr. 2017 Apr 19;36(1):13. doi: 10.1186/s41043-017-0088-y.
- Derived from this study: PubMed 33346740Geng W, Qin X, Yang T, Cong Z, Wang Z, Kong Q, Tang Z, Jiang L. Model-Based Reasoning of Clinical Diagnosis in Integrative Medicine: Real-World Methodological Study of Electronic Medical Records and Natural Language Processing Methods. JMIR Med Inform. 2020 Dec 21;8(12):e23082. doi: 10.2196/23082.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Internal Disorders, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
internal diseases (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03274908, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.