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/NCT06041074</url>
    </required_header>
    <id_info>
      <org_study_id>1968</org_study_id>
      <nct_id>NCT06041074</nct_id>
    </id_info>
    <brief_title>Adenoid Vegetations in Adult Patients</brief_title>
    <official_title>The Clinical Characteristics of Adenoid Vegetations in Adult Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Varazdin General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Varazdin General Hospital</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>
        In this observational cross-sectional study &quot; the clinical characteristics of adenoid&#xD;
        vegetations in adulthood will be investigated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Adenoid vegetations typically appear in childhood and are well described in this population.&#xD;
        However, in adulthood, adenoid vegetations appear rarely and their characteristics have not&#xD;
        been described.&#xD;
  &#xD;
        The clinical characteristics of adenoid vegetations in adulthood will be investigated, and&#xD;
        compared with clinical characteristics of adenoid vegetations in childhood.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Symptoms</measure>
      <time_frame>2 months</time_frame>
      <description>The leading symptom (patient's main complaint, the reason for seeing the doctor) will we recorded for each participant</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of symptoms</measure>
      <time_frame>2 months</time_frame>
      <description>The duration of leading symptom (in months) will be recorded for each participant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OTS (otoscopic)</measure>
      <time_frame>2 months</time_frame>
      <description>The otoscopic findings will be recorded in both groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RNS (rhinoscopic)</measure>
      <time_frame>2 months</time_frame>
      <description>The rhinoscopic findings will be recorded in both groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OFS (oropharyngoscopic)</measure>
      <time_frame>2 months</time_frame>
      <description>The oropharyngoscopic findings will be recorded in both groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PRNS (post-rhynoscopic)</measure>
      <time_frame>2 months</time_frame>
      <description>The post-rhynoscopic findings will be recorded in both groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Referring physician</measure>
      <time_frame>2 months</time_frame>
      <description>The physician (primary or secondary level) who referred the patient to ENT (Ear Nose and Throat doctor) will be recorded in both groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PHD ( pathohistological findings)</measure>
      <time_frame>2 months</time_frame>
      <description>The pathohistological findings will be recorded in both groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgery</measure>
      <time_frame>2 months</time_frame>
      <description>The type of surgery will be recorded in both groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Outcome</measure>
      <time_frame>2 months</time_frame>
      <description>The outcome (the relief of the leading symptom) will be recorded in both groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recurrence</measure>
      <time_frame>2 months</time_frame>
      <description>The recurrence will be recorded in both groups</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Adenoid Vegetation</condition>
    <arm_group>
      <arm_group_label>Adults</arm_group_label>
      <description>Patients with adenoid vegetations, 14 years old and older</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Children</arm_group_label>
      <description>Patients with adenoid vegetations, 13 years old and younger</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Adult group: All patients aged 14 and more treated for adenoid vegetations in Varazdin&#xD;
          General Hospital from 1 January 2013 to 31 December 2018&#xD;
  &#xD;
          Children group: All patients aged 13 and less treated for adenoid vegetations in Varazdin&#xD;
          General Hospital from 1 January 2018 to 31 December 2018&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patient with adenoid vegetations&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  other concomitant otorhinolaryngological diagnoses&#xD;
  &#xD;
            -  hypertrophy of the tonsils&#xD;
  &#xD;
            -  oropharyngeal carcinomas&#xD;
  &#xD;
            -  chronic sinuitis&#xD;
  &#xD;
            -  allergic rhinitis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>105 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Drazen Shejbal</last_name>
      <role>Principal Investigator</role>
      <affiliation>Varazdin General Hospital, Varazdin, Croatia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Drazen Shejbal, MD, PhD</last_name>
      <phone>+38542393139</phone>
      <email>dr.azen@vip.hr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shejbal, MD, PhD</last_name>
      <phone>+38542393139</phone>
      <email>dr.azen@vip.hr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Varazdin General Hospital</name>
        <address>
          <city>Varazdin</city>
          <zip>42000</zip>
          <country>Croatia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Drazen Shejbal, Md, PhD</last_name>
        <phone>+385958236723</phone>
        <email>dr.azen@vip.hr</email>
      </contact>
    </location>
    <location_countries>
      <country>Croatia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 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 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06041074
  org study id: 1968
  nct id: NCT06041074
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this observational cross-sectional study " the clinical characteristics of adenoid
        vegetations in adulthood will be investigated.
  Adenoid vegetations typically appear in childhood and are well described in this population.
        However, in adulthood, adenoid vegetations appear rarely and their characteristics have not
        been described.
  
        The clinical characteristics of adenoid vegetations in adulthood will be investigated, and
        compared with clinical characteristics of adenoid vegetations in childhood.
  observational model: Cohort
  time perspective: Retrospective
  measure: Symptoms
  time frame: 2 months
  description: The leading symptom (patient's main complaint, the reason for seeing the doctor) will we recorded for each participant
  measure: Duration of symptoms
  time frame: 2 months
  description: The duration of leading symptom (in months) will be recorded for each participant
  measure: OTS (otoscopic)
  time frame: 2 months
  description: The otoscopic findings will be recorded in both groups
  measure: RNS (rhinoscopic)
  time frame: 2 months
  description: The rhinoscopic findings will be recorded in both groups
  measure: OFS (oropharyngoscopic)
  time frame: 2 months
  description: The oropharyngoscopic findings will be recorded in both groups
  measure: PRNS (post-rhynoscopic)
  time frame: 2 months
  description: The post-rhynoscopic findings will be recorded in both groups
  measure: Referring physician
  time frame: 2 months
  description: The physician (primary or secondary level) who referred the patient to ENT (Ear Nose and Throat doctor) will be recorded in both groups
  measure: PHD ( pathohistological findings)
  time frame: 2 months
  description: The pathohistological findings will be recorded in both groups
  measure: Surgery
  time frame: 2 months
  description: The type of surgery will be recorded in both groups
  measure: Outcome
  time frame: 2 months
  description: The outcome (the relief of the leading symptom) will be recorded in both groups
  measure: Recurrence
  time frame: 2 months
  description: The recurrence will be recorded in both groups
  arm group label: Adults
  description: Patients with adenoid vegetations, 14 years old and older
  arm group label: Children
  description: Patients with adenoid vegetations, 13 years old and younger
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 105 Years
  healthy volunteers: No
  last name: Drazen Shejbal
  role: Principal Investigator
  affiliation: Varazdin General Hospital, Varazdin, Croatia
  last name: Drazen Shejbal, MD, PhD
  phone: +38542393139
  email: dr.azen@vip.hr
  last name: Shejbal, MD, PhD
  phone: +38542393139
  email: dr.azen@vip.hr
  facility: 
  status: Recruiting
  contact: 
  country: Croatia
  responsible party type: Sponsor