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/NCT06005636</url>
    </required_header>
    <id_info>
      <org_study_id>KY-2021-106</org_study_id>
      <nct_id>NCT06005636</nct_id>
    </id_info>
    <brief_title>Post-stroke Delirium in Ischemic Stroke Patients</brief_title>
    <official_title>Risk Factors and Risk Prediction Model for Post-stroke Delirium in Ischemic Stroke Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jinan University Guangzhou</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>First Affiliated Hospital of Jinan University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Jinan University Guangzhou</source>
    <oversight_info>
      <has_dmc>No</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 study is to investigate the predictors of post-stroke delirium, develop and validate a&#xD;
        nomogram of post-stroke delirium in the ischemic stroke patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction: Post-stroke delirium (PSD) is associated with unfavorable prognosis.&#xD;
        Effectively identifying risk factors of PSD and predicting PSD is of essential.&#xD;
  &#xD;
        Methods: This is a prospective, single-centered, cohort study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2021</start_date>
    <completion_date type="Actual">April 27, 2023</completion_date>
    <primary_completion_date type="Actual">September 10, 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>post-stroke delirium</measure>
      <time_frame>The first week of admission</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">985</enrollment>
    <condition>Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>with post-stroke delirium</arm_group_label>
      <description>ischemic stroke patients with post-stroke delirium</description>
    </arm_group>
    <arm_group>
      <arm_group_label>without post-stroke delirium</arm_group_label>
      <description>ischemic stroke patients without post-stroke delirium</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Test delirium state</intervention_name>
      <description>use scale to test whether ischemic stroke patients have post-stroke delirium</description>
      <arm_group_label>with post-stroke delirium</arm_group_label>
      <arm_group_label>without post-stroke delirium</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          ischemic stroke patients were recruited from a Grade 3A hospital in Southern China.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. aged ≥18 years old;(2) ischemic stroke, confirmed by computed tomography (CT) or&#xD;
               magnetic resonance imaging (MRI) scans;(3) patients or their agencies agree to&#xD;
               participate in this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. brain dysfunction caused by non-vascular causes such as traumatic brain injury, brain&#xD;
               tumor or metastatic brain tumor;(2) history of serious mental illness such as&#xD;
               schizophrenia;(3) unable to cooperate to the assessment as deafness, blindness,&#xD;
               aphasia, dysarthria;(4) be in coma [Glasgow Coma Scale (GCS)≤8 points] or sedation&#xD;
               [Richmond Agitation Sedation Scale (RASS)&lt;-3 points], and do not ameliorate during&#xD;
               study;(5) with incomplete data.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fengxia Yan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Jinan University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>the First Affiliated Hospital of Jinan University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510630</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Jinan University Guangzhou</investigator_affiliation>
      <investigator_full_name>Xiaoyan Cai</investigator_full_name>
      <investigator_title>Ms</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Cerebral Infarction</mesh_term>
      <mesh_term>Delirium</mesh_term>
      <mesh_term>Ischemia</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/NCT06005636
  org study id: KY-2021-106
  nct id: NCT06005636
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is to investigate the predictors of post-stroke delirium, develop and validate a
        nomogram of post-stroke delirium in the ischemic stroke patients.
  Introduction: Post-stroke delirium (PSD) is associated with unfavorable prognosis.
        Effectively identifying risk factors of PSD and predicting PSD is of essential.
  
        Methods: This is a prospective, single-centered, cohort study.
  observational model: Cohort
  time perspective: Prospective
  measure: post-stroke delirium
  time frame: The first week of admission
  arm group label: with post-stroke delirium
  description: ischemic stroke patients with post-stroke delirium
  arm group label: without post-stroke delirium
  description: ischemic stroke patients without post-stroke delirium
  intervention type: Diagnostic Test
  intervention name: Test delirium state
  description: use scale to test whether ischemic stroke patients have post-stroke delirium
  arm group label: with post-stroke delirium
  arm group label: without post-stroke delirium
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Fengxia Yan
  role: Principal Investigator
  affiliation: Jinan University
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Jinan University Guangzhou
  investigator full name: Xiaoyan Cai
  investigator title: Ms
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Cerebral Infarction
  mesh term: Delirium
  mesh term: Ischemia
  sharing ipd: No