xml: <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/NCT05976516</url>
    </required_header>
    <id_info>
      <org_study_id>20220224016</org_study_id>
      <nct_id>NCT05976516</nct_id>
    </id_info>
    <brief_title>CXCL2/CXCL8 Promote Intervertebral Disc Degeneration</brief_title>
    <official_title>Study on the Correlation Between CXCL2/CXCL8 and the Degree of Intervertebral Disc Degeneration and Radiological Progress</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongda Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongda Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Low back pain (LBP) is the largest cause of morbidity in the world, and about 80% of Chinese&#xD;
        people are affected in their lifetime. Although the prevalence of IDD gradually increases&#xD;
        with age, IDD is very common among subjects under 30 years old. In addition to age, there are&#xD;
        other factors, such as excessive or uneven mechanical load, obesity, genetics, nutrition,&#xD;
        trauma and gender. In addition, it is not clear whether the heavy physical load associated&#xD;
        with occupation is an important risk factor for IDD. Some studies have found that IDD is more&#xD;
        common among athletes than the general population. Due to the complexity and multifactorial&#xD;
        nature of IDD, its pathogenesis and risk factors are still unclear, which seriously hinders&#xD;
        the rational stratification of LBP patients and limits the development of personalized&#xD;
        treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>CXCL2/8 content</measure>
      <time_frame>1 month</time_frame>
      <description>CXCL2/CXCL8 content of nucleus pulposus</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Cytokine</condition>
    <condition>Intervertebral Disc, Degenerative</condition>
    <arm_group>
      <arm_group_label>pirffmann 2 grade</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>pirffmann 3 grade</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>pirffmann 4 grade</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>pirffmann 5 grade</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>CXCL2/CXCL8</intervention_name>
      <description>Detecte CXCL2/8 content in nucleus pulposus and peripheral blood of patients in each group</description>
      <arm_group_label>pirffmann 2 grade</arm_group_label>
      <arm_group_label>pirffmann 3 grade</arm_group_label>
      <arm_group_label>pirffmann 4 grade</arm_group_label>
      <arm_group_label>pirffmann 5 grade</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with lumbar disc herniation who went to the spinal surgery department of Zhongda&#xD;
          Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  It meets the diagnostic criteria of lumbar disc degeneration; No previous history of&#xD;
               spinal surgery; Good ability of independent behavior and cooperation in completing&#xD;
               research; The patient is aware of this study and has signed the consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with spinal tumor, infection, tuberculosis and other diseases; Patients with&#xD;
               claustrophobia; Parkinson's syndrome patients; Poor cooperation, Poor image quality;&#xD;
               Patients with osteoporosis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Zhongda Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lei liu, Dr</last_name>
        <phone>18934544893</phone>
        <email>18934544893@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>February 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongda Hospital</investigator_affiliation>
      <investigator_full_name>pengfei, xue</investigator_full_name>
      <investigator_title>Dr</investigator_title>
    </responsible_party>
    <keyword>cytokine</keyword>
    <keyword>chemokine</keyword>
    <keyword>Intervertebral Disc Degeneration</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976516
  org study id: 20220224016
  nct id: NCT05976516
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Low back pain (LBP) is the largest cause of morbidity in the world, and about 80% of Chinese
        people are affected in their lifetime. Although the prevalence of IDD gradually increases
        with age, IDD is very common among subjects under 30 years old. In addition to age, there are
        other factors, such as excessive or uneven mechanical load, obesity, genetics, nutrition,
        trauma and gender. In addition, it is not clear whether the heavy physical load associated
        with occupation is an important risk factor for IDD. Some studies have found that IDD is more
        common among athletes than the general population. Due to the complexity and multifactorial
        nature of IDD, its pathogenesis and risk factors are still unclear, which seriously hinders
        the rational stratification of LBP patients and limits the development of personalized
        treatment.
  observational model: Cohort
  time perspective: Prospective
  measure: CXCL2/8 content
  time frame: 1 month
  description: CXCL2/CXCL8 content of nucleus pulposus
  arm group label: pirffmann 2 grade
  arm group label: pirffmann 3 grade
  arm group label: pirffmann 4 grade
  arm group label: pirffmann 5 grade
  intervention type: Diagnostic Test
  intervention name: CXCL2/CXCL8
  description: Detecte CXCL2/8 content in nucleus pulposus and peripheral blood of patients in each group
  arm group label: pirffmann 2 grade
  arm group label: pirffmann 3 grade
  arm group label: pirffmann 4 grade
  arm group label: pirffmann 5 grade
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhongda Hospital
  investigator full name: pengfei, xue
  investigator title: Dr
  mesh term: Intervertebral Disc Degeneration
  sharing ipd: No