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/NCT05981196</url>
    </required_header>
    <id_info>
      <org_study_id>22-008581</org_study_id>
      <nct_id>NCT05981196</nct_id>
    </id_info>
    <brief_title>Disparities Among Liver Transplant Patients</brief_title>
    <official_title>Individual and Structural-level Determinants Associated With Disparities Among Liver Transplant Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</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>
        The purpose of this study is to inform healthcare interventions to reduce the disparities in&#xD;
        liver transplant listing and in transplantation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim 1. Establish a longitudinal cohort of patients with end-stage liver dysfunction.&#xD;
  &#xD;
        Aim 2. Examine interpersonal and structural factors associated with liver transplant&#xD;
        evaluation and listing by patient characteristics (e.g., race, ethnicity, SES, gender).&#xD;
  &#xD;
        Aim 3. Examine the use of stigmatizing language among patients undergoing liver transplant&#xD;
        based on their demographic characteristics (e.g., race, ethnicity, SES, gender).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 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>Liver transplant waiting list</measure>
      <time_frame>Approximately one year</time_frame>
      <description>Number of subjects listed on the liver transplant waiting list</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Organ transplantation</measure>
      <time_frame>Approximately one year</time_frame>
      <description>Number of subject to receive an organ transplantation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Survival</measure>
      <time_frame>Approximately one year post-transplant, or until you are removed from the transplant list</time_frame>
      <description>Total number of subject alive</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Graft survival at six months</measure>
      <time_frame>Six months post transplant</time_frame>
      <description>Total number of subject to have a functioning graft at six months post transplant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Graft survival at one year</measure>
      <time_frame>One year post transplant</time_frame>
      <description>Total number of subject to have a functioning graft at one year post transplant</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Mortality</measure>
      <time_frame>Approximately one year post-transplant, or until you are removed from the transplant list</time_frame>
      <description>Total number of subject deaths</description>
    </other_outcome>
    <other_outcome>
      <measure>Hospital length of stay</measure>
      <time_frame>Approximately one year post-transplant, or until you are removed from the transplant list</time_frame>
      <description>Total number of days subjects were admitted to the hospital</description>
    </other_outcome>
    <other_outcome>
      <measure>ICU length of stay</measure>
      <time_frame>Approximately one year post-transplant, or until you are removed from the transplant list</time_frame>
      <description>Total number of days subjects were admitted to Intensive Care Unit (ICU)</description>
    </other_outcome>
    <other_outcome>
      <measure>30-day readmission</measure>
      <time_frame>Approximately one year post-transplant, or until you are removed from the transplant list</time_frame>
      <description>Number of subjects to experience a 30-day readmission</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>End Stage Liver DIsease</condition>
    <arm_group>
      <arm_group_label>Liver Transplant Patients</arm_group_label>
      <description>Subjects with end-stage liver disease and being referred for transplant evaluation will fill out questionnaires about their background, emotions, and behaviors.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects identified with end-stage liver receiving initial stage of transplant evaluation&#xD;
          at Mayo Clinic Arizona.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Patients with end-stage liver, kidney, or cardiac dysfunction.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with more than one system with end stage organ dysfunction, dementia,&#xD;
               cognitive or sensory impairment, prior solid organ transplant.&#xD;
  &#xD;
            -  Patients with potential medical exclusions for transplant.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Adam Milam, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mayo Clinic Arizona</name>
        <address>
          <city>Phoenix</city>
          <state>Arizona</state>
          <zip>85054</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Adam J. Milam</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Transplants</keyword>
    <keyword>Transplantation</keyword>
    <keyword>Healthcare Disparities</keyword>
    <keyword>Minority Health</keyword>
    <keyword>Communication</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Diseases</mesh_term>
      <mesh_term>End Stage Liver Disease</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/NCT05981196
  org study id: 22-008581
  nct id: NCT05981196
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to inform healthcare interventions to reduce the disparities in
        liver transplant listing and in transplantation.
  Aim 1. Establish a longitudinal cohort of patients with end-stage liver dysfunction.
  
        Aim 2. Examine interpersonal and structural factors associated with liver transplant
        evaluation and listing by patient characteristics (e.g., race, ethnicity, SES, gender).
  
        Aim 3. Examine the use of stigmatizing language among patients undergoing liver transplant
        based on their demographic characteristics (e.g., race, ethnicity, SES, gender).
  observational model: Cohort
  time perspective: Prospective
  measure: Liver transplant waiting list
  time frame: Approximately one year
  description: Number of subjects listed on the liver transplant waiting list
  measure: Organ transplantation
  time frame: Approximately one year
  description: Number of subject to receive an organ transplantation
  measure: Survival
  time frame: Approximately one year post-transplant, or until you are removed from the transplant list
  description: Total number of subject alive
  measure: Graft survival at six months
  time frame: Six months post transplant
  description: Total number of subject to have a functioning graft at six months post transplant
  measure: Graft survival at one year
  time frame: One year post transplant
  description: Total number of subject to have a functioning graft at one year post transplant
  measure: Mortality
  time frame: Approximately one year post-transplant, or until you are removed from the transplant list
  description: Total number of subject deaths
  measure: Hospital length of stay
  time frame: Approximately one year post-transplant, or until you are removed from the transplant list
  description: Total number of days subjects were admitted to the hospital
  measure: ICU length of stay
  time frame: Approximately one year post-transplant, or until you are removed from the transplant list
  description: Total number of days subjects were admitted to Intensive Care Unit (ICU)
  measure: 30-day readmission
  time frame: Approximately one year post-transplant, or until you are removed from the transplant list
  description: Number of subjects to experience a 30-day readmission
  arm group label: Liver Transplant Patients
  description: Subjects with end-stage liver disease and being referred for transplant evaluation will fill out questionnaires about their background, emotions, and behaviors.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  last name: Adam Milam, MD, PhD
  role: Principal Investigator
  affiliation: Mayo Clinic
  facility: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Adam J. Milam
  investigator title: Principal Investigator
  mesh term: Liver Diseases
  mesh term: End Stage Liver Disease
  sharing ipd: No