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/NCT06011811</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-MS-23-0212</org_study_id>
      <nct_id>NCT06011811</nct_id>
    </id_info>
    <brief_title>Cluster Headache Treatment Survey</brief_title>
    <official_title>Cluster Headache Treatment Survey</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Clusterbusters, Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Texas Health Science Center, Houston</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 objective of this study is to survey patients with cluster headache about treatment&#xD;
        effectiveness and their views on treatments. Participants will complete one brief&#xD;
        questionnaire online.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 29, 2023</start_date>
    <completion_date type="Anticipated">June 28, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 28, 2025</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Effectiveness of cluster headache treatment as assessed by a survey</measure>
      <time_frame>at the time of survey completion, expected to be 6-12 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Opinions on new cluster headache treatment as assessed by a survey</measure>
      <time_frame>at the time of survey completion, expected to be 6-12 months</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>Cluster Headache</condition>
    <arm_group>
      <arm_group_label>Patients with episodic or chronic cluster headache</arm_group_label>
      <description>Patients with a diagnosis of episodic or chronic cluster headache, as diagnosed by a health care professional and to be confirmed by questions on the study survey.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The population is patients with episodic or chronic cluster headache that has been&#xD;
          diagnosed by a health care professional. The cluster headache diagnosis will be verified&#xD;
          via the survey using a validated cluster headache diagnostic screen.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with episodic or chronic cluster headache that has been diagnosed by a health&#xD;
               care professional (no documentation is needed, participant must simply state that he&#xD;
               or she has been diagnosed)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to speak English (the survey is only in English)&#xD;
  &#xD;
            -  Unable to use a computer to take the online survey&#xD;
  &#xD;
            -  Unable to provide consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mark J Burish, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center, Houston</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Celia K Tran, BS</last_name>
      <phone>713-486-7771</phone>
      <email>nctt.wec@uth.tmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mark J Burish, MD, PhD</last_name>
      <phone>713-486-7771</phone>
      <email>nctt.wec@uth.tmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Texas Health Science Center at Houston</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Celia K Tran, BS</last_name>
        <phone>713-486-7771</phone>
        <email>nctt.wec@uth.tmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Mark J Burish, MD, PhD</last_name>
        <phone>713-486-7771</phone>
        <email>nctt.wec@uth.tmc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://survey.alchemer.com/s3/7134634/Cluster-Headache-Medication-Psychedelic-Use-Survey-2023</url>
      <description>Link to study survey</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
      <investigator_full_name>Mark J Burish</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cluster Headache</mesh_term>
      <mesh_term>Headache</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/NCT06011811
  org study id: HSC-MS-23-0212
  nct id: NCT06011811
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to survey patients with cluster headache about treatment
        effectiveness and their views on treatments. Participants will complete one brief
        questionnaire online.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Effectiveness of cluster headache treatment as assessed by a survey
  time frame: at the time of survey completion, expected to be 6-12 months
  measure: Opinions on new cluster headache treatment as assessed by a survey
  time frame: at the time of survey completion, expected to be 6-12 months
  arm group label: Patients with episodic or chronic cluster headache
  description: Patients with a diagnosis of episodic or chronic cluster headache, as diagnosed by a health care professional and to be confirmed by questions on the study survey.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mark J Burish, MD, PhD
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center, Houston
  last name: Celia K Tran, BS
  phone: 713-486-7771
  email: nctt.wec@uth.tmc.edu
  last name: Mark J Burish, MD, PhD
  phone: 713-486-7771
  email: nctt.wec@uth.tmc.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  url: https://survey.alchemer.com/s3/7134634/Cluster-Headache-Medication-Psychedelic-Use-Survey-2023
  description: Link to study survey
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Mark J Burish
  investigator title: Associate Professor
  mesh term: Cluster Headache
  mesh term: Headache
  sharing ipd: No