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/NCT06041451</url>
    </required_header>
    <id_info>
      <org_study_id>Dengbinbin</org_study_id>
      <nct_id>NCT06041451</nct_id>
    </id_info>
    <brief_title>Early and Late Prognosis in Patients With Guillain-Barre Syndrome</brief_title>
    <official_title>Early and Late 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>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </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).The higher the score, the worse the prognosis.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">450</enrollment>
    <condition>Guillain-Barre Syndrome</condition>
    <arm_group>
      <arm_group_label>immunoglobulin group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group of patients was treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>methylprednisolone group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group of patients was treated with methylprednisolone 500 MG Injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group of patients was treated without immunoglobulin or hormone</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mixed group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group of patients was treated both with intravenous immunoglobulin and methylprednisolone.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Intravenous Immunoglobulins, Human</intervention_name>
      <description>patients were treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days</description>
      <arm_group_label>immunoglobulin group</arm_group_label>
      <arm_group_label>mixed group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Methylprednisolone 500 MG Injection</intervention_name>
      <description>patients were treated with methylprednisolone</description>
      <arm_group_label>methylprednisolone group</arm_group_label>
      <arm_group_label>mixed group</arm_group_label>
    </intervention>
    <eligibility>
      <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>
      <healthy_volunteers>No</healthy_volunteers>
    </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 27, 2022</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 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 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Guillain-barre syndrome</keyword>
    <keyword>prognosis</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Methylprednisolone</mesh_term>
      <mesh_term>Immunoglobulins</mesh_term>
      <mesh_term>Immunoglobulins, Intravenous</mesh_term>
      <mesh_term>gamma-Globulins</mesh_term>
      <mesh_term>Rho(D) Immune Globulin</mesh_term>
    </intervention_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/NCT06041451
  org study id: Dengbinbin
  nct id: NCT06041451
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Care Provider)
  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).The higher the score, the worse the prognosis.
  arm group label: immunoglobulin group
  arm group type: Experimental
  description: This group of patients was treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days
  arm group label: methylprednisolone group
  arm group type: Experimental
  description: This group of patients was treated with methylprednisolone 500 MG Injection
  arm group label: control group
  arm group type: No Intervention
  description: This group of patients was treated without immunoglobulin or hormone
  arm group label: mixed group
  arm group type: Experimental
  description: This group of patients was treated both with intravenous immunoglobulin and methylprednisolone.
  intervention type: Drug
  intervention name: Intravenous Immunoglobulins, Human
  description: patients were treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days
  arm group label: immunoglobulin group
  arm group label: mixed group
  intervention type: Drug
  intervention name: Methylprednisolone 500 MG Injection
  description: patients were treated with methylprednisolone
  arm group label: methylprednisolone group
  arm group label: mixed group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  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
  mesh term: Methylprednisolone
  mesh term: Immunoglobulins
  mesh term: Immunoglobulins, Intravenous
  mesh term: gamma-Globulins
  mesh term: Rho(D) Immune Globulin