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/NCT06032741</url>
    </required_header>
    <id_info>
      <org_study_id>GBS</org_study_id>
      <nct_id>NCT06032741</nct_id>
    </id_info>
    <brief_title>Prognosis in Patients With Guillain-Barre Syndrome</brief_title>
    <official_title>Prognosis in Patients With Guillain-Barre Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital of Wenzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital of Wenzhou Medical University</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>
        The goal of this observational study is to explore significant indicators to predict the&#xD;
        early prognosis and late prognosis in patients with Guillain-Barre syndrome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multicenter study(approximately three) with over 450 subjects.Clinical data were&#xD;
        collected by consulting the patient's electronic history. The data included demographic&#xD;
        information, blood biochemical markers, clinical characteristics and electromyography. All&#xD;
        participants provided their written informed consent to participate in this study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 2, 2013</start_date>
    <completion_date type="Anticipated">January 31, 2025</completion_date>
    <primary_completion_date type="Actual">December 1, 2022</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>the severity of Guillain-barre syndrome</measure>
      <time_frame>baseline, at 1 week, at 26 weeks</time_frame>
      <description>The Guillain-Barre syndrome disability score is a wide scale for the severity of Guillain-Barre syndrome (0, optimal health; 1, minor symptoms, able to run; 2, able to walk unaided 10 m, unable to run; 3, able to walk 10 m across an open space with help; 4 bedridden or wheelchair users; 5, require assisted ventilation; 6, dead)(deceased).The higher the score, the worse the prognosis.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">450</enrollment>
    <condition>Guillain-Barre Syndrome</condition>
    <arm_group>
      <arm_group_label>mechanical ventilation group</arm_group_label>
      <description>Patients with Guillain-Barré Syndrome require mechanical ventilation during hospitalization</description>
    </arm_group>
    <arm_group>
      <arm_group_label>no mechanical ventilation group</arm_group_label>
      <description>Patients with Guillain-Barré Syndrome do not require mechanical ventilation during hospitalization</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This is a multicenter study(approximately three) with over 450 subjects.Clinical data were&#xD;
          collected by consulting the patient's electronic history. The data included demographic&#xD;
          information, blood biochemical markers, clinical characteristics and electromyography. All&#xD;
          participants provided their written informed consent to participate in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients fulfilled clinical, biological, and electrophysiology criteria for&#xD;
               Guillain-barre syndrome.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Binbin Deng</last_name>
      <phone>dbinbin@aliyun.com</phone>
    </overall_contact>
    <location>
      <facility>
        <name>First Affiliated Hospital of Wenzhou Medical University</name>
        <address>
          <city>Wenzhou</city>
          <state>Zhejiang</state>
          <zip>325000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Binbin Deng, Doctor</last_name>
        <phone>+8613695720610</phone>
        <email>dbinbin@aliyun.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>December 2022</verification_date>
    <study_first_submitted>December 26, 2022</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Guillain-Barre Syndrome</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Guillain-Barre Syndrome</mesh_term>
      <mesh_term>Syndrome</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/NCT06032741
  org study id: GBS
  nct id: NCT06032741
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to explore significant indicators to predict the
        early prognosis and late prognosis in patients with Guillain-Barre syndrome.
  This is a multicenter study(approximately three) with over 450 subjects.Clinical data were
        collected by consulting the patient's electronic history. The data included demographic
        information, blood biochemical markers, clinical characteristics and electromyography. All
        participants provided their written informed consent to participate in this study.
  observational model: Cohort
  time perspective: Retrospective
  measure: the severity of Guillain-barre syndrome
  time frame: baseline, at 1 week, at 26 weeks
  description: The Guillain-Barre syndrome disability score is a wide scale for the severity of Guillain-Barre syndrome (0, optimal health; 1, minor symptoms, able to run; 2, able to walk unaided 10 m, unable to run; 3, able to walk 10 m across an open space with help; 4 bedridden or wheelchair users; 5, require assisted ventilation; 6, dead)(deceased).The higher the score, the worse the prognosis.
  arm group label: mechanical ventilation group
  description: Patients with Guillain-Barré Syndrome require mechanical ventilation during hospitalization
  arm group label: no mechanical ventilation group
  description: Patients with Guillain-Barré Syndrome do not require mechanical ventilation during hospitalization
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Binbin Deng
  phone: dbinbin@aliyun.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Guillain-Barre Syndrome
  mesh term: Syndrome