<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03274908</url>
  </required_header>
  <id_info>
    <org_study_id>20170906</org_study_id>
    <nct_id>NCT03274908</nct_id>
  </id_info>
  <brief_title>Real-world Clinical Study and Medical Machine Intelligence Study for Traditional Chinese Internal Medicine</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Tongji Hospital, Tongji University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Puer Hospital of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dangyang Hospital of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changde Hospital affiliated to Hunan University of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruikang Hospital affiliated to Guanxi University of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Jining No.1 People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>People's Hospital of Dangyang</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Tongji Hospital, Tongji University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This real-world study aimed at 1. exploring the relationships of traditional Chinese medicine&#xD;
      (TCM) syndrome and internal diseases, 2. investigating the relationships of TCM treatment and&#xD;
      internal diseases, and 3. creating medical machine intelligence to help internal physician in&#xD;
      clinical practice. Big data methods and artificial intelligence algorithms are used to assess&#xD;
      the associations based on electronic case files of patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>internal diseases</measure>
    <time_frame>10 years</time_frame>
    <description>all of internal diseases</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000000</enrollment>
  <condition>Internal Disorders</condition>
  <arm_group>
    <arm_group_label>Group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>regular medical treatment</intervention_name>
    <description>regular medical treatment</description>
    <arm_group_label>Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patients of internal medicine in hospital to include hospital of Chinese medicine and&#xD;
        morden hospital in China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patient records of internal medicine in hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with major missing data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Huasha Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zihui Tang, M.D and Ph.D</last_name>
      <phone>+8615821993541</phone>
      <email>dr_zhtang@yeah.net</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>28820606</PMID>
  </reference>
  <reference>
    <citation>Li 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.</citation>
    <PMID>28424092</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huashan Hospital</investigator_affiliation>
    <investigator_full_name>Zihui Tang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03274908
org study id: 20170906
nct id: NCT03274908
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Other
measure: internal diseases
time frame: 10 years
description: all of internal diseases
arm group label: Group
intervention type: Other
intervention name: regular medical treatment
description: regular medical treatment
arm group label: Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
citation: 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.
PMID: 28820606
citation: Li 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.
PMID: 28424092
responsible party type: Principal Investigator
investigator affiliation: Huashan Hospital
investigator full name: Zihui Tang
investigator title: Principal Investigator
sharing ipd: No