<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/NCT03279822</url>
  </required_header>
  <id_info>
    <org_study_id>20170905</org_study_id>
    <nct_id>NCT03279822</nct_id>
  </id_info>
  <brief_title>Association Analysis for Chronic Diseases Based on Resident Health Records by Using Big Data Methods</brief_title>
  <official_title>Association Analysis for Chronic Diseases Based on Resident Health Records in China by Using Big Data 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>
  </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 is an observational study to analysis the association factors for common diseases,&#xD;
      including chronic obstructive pulmonary disease, coronary artery disease, hypertension,&#xD;
      diabetes etc, based on resident healthcare records. More than 10 million resident healthcare&#xD;
      records should be collected for the associations study by using big data methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>regular diagnosis and medical history of common diseases</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>resident health records for medical history of common diseases, questionnaire</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000000</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>Group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>not any intervention</intervention_name>
    <description>not any intervention</description>
    <arm_group_label>Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators collect data regarding residents health records from rural and urban in&#xD;
        China. This study needs more than 10 million resident records from 2010.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Survey Chinese residents aged 20 - 100 years, were included in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious hepatic or renal dysfunctions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Huasha Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </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 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <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/NCT03279822
org study id: 20170905
nct id: NCT03279822
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an observational study to analysis the association factors for common diseases,
      including chronic obstructive pulmonary disease, coronary artery disease, hypertension,
      diabetes etc, based on resident healthcare records. More than 10 million resident healthcare
      records should be collected for the associations study by using big data methods.
observational model: Ecologic or Community
time perspective: Retrospective
measure: regular diagnosis and medical history of common diseases
time frame: an average of 1 year
description: resident health records for medical history of common diseases, questionnaire
arm group label: Group
intervention type: Other
intervention name: not any intervention
description: not any intervention
arm group label: Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
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
mesh term: Chronic Disease
sharing ipd: No