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/NCT05986825</url>
    </required_header>
    <id_info>
      <org_study_id>29BRC22.0225 (QUALIVER)</org_study_id>
      <nct_id>NCT05986825</nct_id>
    </id_info>
    <brief_title>Validation of the French Version of the Score on Quality of Life (HiSQOL) in Hidradenitis Suppurativa (QUALIVER)</brief_title>
    <acronym>QUALIVER</acronym>
    <official_title>Validation of the French Version of the Score on Quality of Life (HiSQOL) in Hidradenitis Suppurativa (QUALIVER)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Brest</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Brest</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>
        Validation of the French Version of the Score on Quality of Life in Hidradenitis Suppurativa.&#xD;
        The French HiSQOL will be completed by 60 patients with hidradenitis suppurativa a first&#xD;
        time, and a second time 1 week later.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 29, 2023</start_date>
    <completion_date type="Anticipated">September 2024</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>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Validation of the questionnaire</measure>
      <time_frame>During the visit and 1 week later</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Hidradenitis Suppurativa</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <description>Patients with Verneuil disease</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Verneuil questionnaire Validation</intervention_name>
      <description>Request patient to Complete the questionnaire for validation of the French version</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with Verneuil disease&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
            -  Patient with Verneuil disease&#xD;
  &#xD;
            -  Beneficiary of or affiliated to a social security insurance&#xD;
  &#xD;
            -  Participation agreement&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients physically or mentally unable to complete questionnaires.&#xD;
  &#xD;
            -  Refusal to participate&#xD;
  &#xD;
            -  Patient under legal protection (guardianship, curatorship) or deprived of liberty&#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_contact>
      <last_name>Emilie BRENAUT, PH</last_name>
      <phone>+33298223315</phone>
      <email>emilie.brenaut@univ-brest.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sébastien BERROS</last_name>
      <phone>+33298223315</phone>
      <email>sebastien.berros@chu-brest.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU Brest</name>
        <address>
          <city>Brest</city>
          <zip>29200</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emilie BRENAUT, PH</last_name>
        <email>emilie.brenaut@univ-brest.fr</email>
      </contact>
      <investigator>
        <last_name>Emilie BRENAUT, PH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hidradenitis Suppurativa</mesh_term>
      <mesh_term>Hidradenitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All collected data that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>All collected data that underlie results in a publication</ipd_time_frame>
      <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.</ipd_access_criteria>
    </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/NCT05986825
  org study id: 29BRC22.0225 (QUALIVER)
  nct id: NCT05986825
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Validation of the French Version of the Score on Quality of Life in Hidradenitis Suppurativa.
        The French HiSQOL will be completed by 60 patients with hidradenitis suppurativa a first
        time, and a second time 1 week later.
  observational model: Other
  time perspective: Prospective
  measure: Validation of the questionnaire
  time frame: During the visit and 1 week later
  arm group label: Experimental
  description: Patients with Verneuil disease
  intervention type: Other
  intervention name: Verneuil questionnaire Validation
  description: Request patient to Complete the questionnaire for validation of the French version
  arm group label: Experimental
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Emilie BRENAUT, PH
  phone: +33298223315
  email: emilie.brenaut@univ-brest.fr
  last name: Sébastien BERROS
  phone: +33298223315
  email: sebastien.berros@chu-brest.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Hidradenitis Suppurativa
  mesh term: Hidradenitis
  sharing ipd: Yes
  ipd description: All collected data that underlie results in a publication
  ipd info type: Study Protocol
  ipd time frame: All collected data that underlie results in a publication
  ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.