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/NCT06011915</url>
    </required_header>
    <id_info>
      <org_study_id>RETUBO-N</org_study_id>
      <nct_id>NCT06011915</nct_id>
    </id_info>
    <brief_title>A Retrospective Study of Treatment Patterns and Clinical Outcomes in Patients With Central Nervous System Tuberculosis</brief_title>
    <official_title>A Retrospective Study of Treatment Patterns and Clinical Outcomes in Patients With Central Nervous System Tuberculosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tongji Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tongji Hospital</source>
    <brief_summary>
      <textblock>
        This is a retrospective clinical study to analyze the clinical characteristics,&#xD;
        complications, and effects of different treatment options on long-term prognosis in patients&#xD;
        with central nervous system tuberculosis. All cases of central nervous system tuberculosis&#xD;
        diagnosed between 2016 and 2021 were included in the electronic medical record system of one&#xD;
        center, and data such as demographics, hospitalization information, clinical information,&#xD;
        laboratory or imaging examinations, treatment plans, and outcomes were collected.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 22, 2017</start_date>
    <completion_date type="Actual">July 26, 2023</completion_date>
    <primary_completion_date type="Actual">July 26, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>2-year survival rate</measure>
      <time_frame>1 years,2 years</time_frame>
      <description>Calculate the 1-year survival rate and 2-year survival rate.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>2-year disability rate</measure>
      <time_frame>1 years,2 years</time_frame>
      <description>Calculate the 1-year disability rate and 2-year disability rate. Common disabilities include aphasia, hemiplegia, paraplegia, deafness, blindness, mental retardation, etc. For reference, please refer to the 《Grading of Human Injury and Disability Degree》 and 《Guidance for determination of cause-and-effect relationship between personal injury and disease》.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical features: age of onset, mode of onset</measure>
      <time_frame>2 years</time_frame>
      <description>age of onset, mode of onset</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The presense of clinical symptoms of patients</measure>
      <time_frame>2 years</time_frame>
      <description>The number and severity of clinical symptoms of patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of complications in patients with different treatment regimens</measure>
      <time_frame>2 years</time_frame>
      <description>The electronic medical record system was used to collect patients' complications from baseline (admission) to 24 months, and the incidence of complications of different treatment options was compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of hospital stay</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>proportion of patients admitted to ICU</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <enrollment type="Actual">638</enrollment>
    <condition>Central Nervous System Tuberculosis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Central nervous system tuberculosis patients came from Wuhan Pulmonary Hospital, which is a&#xD;
          third-class A-level specialized hospital integrating tuberculosis prevention and control,&#xD;
          clinical diagnosis and treatment of pulmonary diseases, science, teaching and research,&#xD;
          located in Wuhan, Hubei Province, China.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patient meets the following criteria 1) or 2) or 3):&#xD;
  &#xD;
                 1. The discharge diagnosis is central nervous system tuberculosis, refer to the&#xD;
                    ICD-10 code related to central nervous system tuberculosis.&#xD;
  &#xD;
                 2. The discharge diagnosis was tuberculous meningitis (ICD-10: A17.000), or&#xD;
                    tuberculous cerebrospinal meningitis (ICD-10: A17.001), or tuberculous&#xD;
                    meningoencephalitis (ICD-10: A17.803 ), or tuberculous encephalitis (ICD-10:&#xD;
                    A17.804), or tuberculous brain abscess (ICD-10: A17.805), or spinal tuberculosis&#xD;
                    (ICD-10: A17.806), or tuberculous encephalitis Water (ICD-10: A17.807).&#xD;
  &#xD;
                 3. Tuberculous meningitis diagnosed according to the &quot;Guidelines for Diagnosis and&#xD;
                    Treatment of Central Nervous System Tuberculosis in China (2019 Edition)&quot;&#xD;
  &#xD;
            -  Age and gender are not limited.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with no clear diagnosis at discharge.&#xD;
  &#xD;
            -  Patients judged by the investigator to be unsuitable for inclusion in this protocol.&#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>Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430030</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Wuhan Pulmonary Hospital(Wuhan Institute for Tuberculosis Control)</name>
        <address>
          <city>Hubei</city>
          <state>Wuhan</state>
          <zip>430030</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tongji Hospital</investigator_affiliation>
      <investigator_full_name>Qin Ning</investigator_full_name>
      <investigator_title>Director and Chair of Department of Infectious Diseases</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tuberculosis</mesh_term>
      <mesh_term>Tuberculosis, Central Nervous System</mesh_term>
    </condition_browse>
    <!-- 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/NCT06011915
  org study id: RETUBO-N
  nct id: NCT06011915
  lead sponsor: 
  This is a retrospective clinical study to analyze the clinical characteristics,
        complications, and effects of different treatment options on long-term prognosis in patients
        with central nervous system tuberculosis. All cases of central nervous system tuberculosis
        diagnosed between 2016 and 2021 were included in the electronic medical record system of one
        center, and data such as demographics, hospitalization information, clinical information,
        laboratory or imaging examinations, treatment plans, and outcomes were collected.
  observational model: Cohort
  time perspective: Retrospective
  measure: 2-year survival rate
  time frame: 1 years,2 years
  description: Calculate the 1-year survival rate and 2-year survival rate.
  measure: 2-year disability rate
  time frame: 1 years,2 years
  description: Calculate the 1-year disability rate and 2-year disability rate. Common disabilities include aphasia, hemiplegia, paraplegia, deafness, blindness, mental retardation, etc. For reference, please refer to the 《Grading of Human Injury and Disability Degree》 and 《Guidance for determination of cause-and-effect relationship between personal injury and disease》.
  measure: Clinical features: age of onset, mode of onset
  time frame: 2 years
  description: age of onset, mode of onset
  measure: The presense of clinical symptoms of patients
  time frame: 2 years
  description: The number and severity of clinical symptoms of patients.
  measure: Incidence of complications in patients with different treatment regimens
  time frame: 2 years
  description: The electronic medical record system was used to collect patients' complications from baseline (admission) to 24 months, and the incidence of complications of different treatment options was compared.
  measure: length of hospital stay
  time frame: 2 years
  measure: proportion of patients admitted to ICU
  time frame: 2 years
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Tongji Hospital
  investigator full name: Qin Ning
  investigator title: Director and Chair of Department of Infectious Diseases
  mesh term: Tuberculosis
  mesh term: Tuberculosis, Central Nervous System