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/NCT06032585</url>
    </required_header>
    <id_info>
      <org_study_id>Dnr 2022-06697-01</org_study_id>
      <nct_id>NCT06032585</nct_id>
    </id_info>
    <brief_title>TRANSPARK_LONG: The Diagnostic Value of Early Transcranial Ultrasound in Patients With Extrapyramidal Diseases in a Swedish Population</brief_title>
    <official_title>TRANSPARK_LONG: The Diagnostic Value of Early Transcranial Ultrasound in Patients With Extrapyramidal Diseases in a Swedish Population: an Evaluation in the Form of a Retrospective Cohort Study With a Long Follow-up Time</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Region Skane</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Region Skane</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>
        Popular science summary of the project The purpose of the study is to investigate in a&#xD;
        Swedish population how well our previous ultrasound findings match the final diagnosis (PD,&#xD;
        APS or ET) after a particularly long follow-up time, which greatly increases the certainty&#xD;
        that the diagnosis does not change more and is thus correct. We also want to study whether&#xD;
        the initial ultrasound findings have changed during the control interval and whether&#xD;
        measurement results regarding the diameter in one of the fluid-filled rooms in the brain&#xD;
        (third ventricle) can be correlated with the development of cognitive impairment or dementia&#xD;
        later in the course of the disease. For this, we have got ethical permission to go into the&#xD;
        patients' medical records and to call a subgroup back to the clinic to be able to do a new&#xD;
        examination and a memory test.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Correlation</measure>
      <time_frame>over 7-10 yrs</time_frame>
      <description>Correlation between US findings and diagnosis</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Transcranial Ultrasound Parkinsonism Substantia Nigra</condition>
    <arm_group>
      <arm_group_label>Patients with parkinsonism</arm_group_label>
      <description>Parkinsonism incl. tremor, parkinsons, atypical parkinsons</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Newly diagnosted patients with parkinsonism between 2013-2017 at our centre&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with parkinsonism or essential tremor who came into contact with our clinic&#xD;
               before 2017&#xD;
  &#xD;
            -  Satisfactory transcranial bone window&#xD;
  &#xD;
            -  Previous TU (clinical indication)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No transcranial bone window&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Parkinsonian Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06032585
  org study id: Dnr 2022-06697-01
  nct id: NCT06032585
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Popular science summary of the project The purpose of the study is to investigate in a
        Swedish population how well our previous ultrasound findings match the final diagnosis (PD,
        APS or ET) after a particularly long follow-up time, which greatly increases the certainty
        that the diagnosis does not change more and is thus correct. We also want to study whether
        the initial ultrasound findings have changed during the control interval and whether
        measurement results regarding the diameter in one of the fluid-filled rooms in the brain
        (third ventricle) can be correlated with the development of cognitive impairment or dementia
        later in the course of the disease. For this, we have got ethical permission to go into the
        patients' medical records and to call a subgroup back to the clinic to be able to do a new
        examination and a memory test.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Correlation
  time frame: over 7-10 yrs
  description: Correlation between US findings and diagnosis
  arm group label: Patients with parkinsonism
  description: Parkinsonism incl. tremor, parkinsons, atypical parkinsons
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Parkinsonian Disorders
  sharing ipd: Undecided