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/NCT05964452</url>
    </required_header>
    <id_info>
      <org_study_id>22-010</org_study_id>
      <nct_id>NCT05964452</nct_id>
    </id_info>
    <brief_title>Efficacy of Methimazole Dosing Algorithm</brief_title>
    <official_title>The Efficacy of Cook County Health's Methimazole Dosing Algorithm in the Setting of ne Onset Graves' Hyperthyroidism</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cook County Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cook County Health</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To prospectively study the efficacy and safety of the Cook County Health (CCH) methimazole&#xD;
        (MMI) dosing algorithm in the setting of new onset Graves' disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        We aim to conduct a prospective observational study in 60 patients with newly diagnosed&#xD;
        Graves' disease who are either methimazole naive or who have been initiated on MMI within&#xD;
        previous 4-6 weeks per CCH algorithm. The patient number is based on 90% power and projected&#xD;
        efficacy of 70% patients reaching target.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 14, 2022</start_date>
    <completion_date type="Anticipated">February 14, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 14, 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Achievement of euthyroid state</measure>
      <time_frame>17 weeks</time_frame>
      <description>The proportion of patients achieving euthyroid state during the study period</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Factors influencing achievement of euthyroid state</measure>
      <time_frame>17 weeks</time_frame>
      <description>Identifying variables that correlate with achievement of euthyroid state</description>
    </secondary_outcome>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Graves Disease</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Methimazole Tablets</intervention_name>
      <description>Testing dosing algorithm for efficacy.</description>
      <other_name>Tapazole</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults with new onset Graves' disease.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Non-pregnant adults (&gt;18 years of age) with new diagnosis of Graves' Disease (elevated&#xD;
               free T4, Free T3, low or suppressed TSH, positive TSI and or thyroid eye disease) and&#xD;
  &#xD;
            -  either drug naïve or who have been initiated on MMI within previous 4-6 weeks per CCH&#xD;
               algorithm.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant patients&#xD;
  &#xD;
            -  hyperthyroidism due to other causes, example - Toxic Multinodular Goiter, Iodine&#xD;
               induced thyrotoxicosis, etc.&#xD;
  &#xD;
            -  Graves patients who present with atrial fibrillation, CHF or other end organ damage&#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>Dan Mihailescu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cook County Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dan Mihailescu, MD</last_name>
      <phone>312-864-0531</phone>
      <email>dan.mihailescu@cookcountyhhs.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bettina Tahsin, MS, RD</last_name>
      <phone>312 864 0531</phone>
      <email>btahsin@cookcountyhhs.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cook County Health</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60612</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dan Mihailescu, MD</last_name>
        <phone>312-864-0531</phone>
        <email>dan.mihailescu@cookcountyhhs.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cook County Health</investigator_affiliation>
      <investigator_full_name>Dan Mihailescu</investigator_full_name>
      <investigator_title>MD Endocrinology Cluster Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Graves Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Methimazole</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05964452
  org study id: 22-010
  nct id: NCT05964452
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To prospectively study the efficacy and safety of the Cook County Health (CCH) methimazole
        (MMI) dosing algorithm in the setting of new onset Graves' disease.
  We aim to conduct a prospective observational study in 60 patients with newly diagnosed
        Graves' disease who are either methimazole naive or who have been initiated on MMI within
        previous 4-6 weeks per CCH algorithm. The patient number is based on 90% power and projected
        efficacy of 70% patients reaching target.
  observational model: Case-Only
  time perspective: Prospective
  measure: Achievement of euthyroid state
  time frame: 17 weeks
  description: The proportion of patients achieving euthyroid state during the study period
  measure: Factors influencing achievement of euthyroid state
  time frame: 17 weeks
  description: Identifying variables that correlate with achievement of euthyroid state
  intervention type: Drug
  intervention name: Methimazole Tablets
  description: Testing dosing algorithm for efficacy.
  other name: Tapazole
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dan Mihailescu, MD
  role: Principal Investigator
  affiliation: Cook County Health
  last name: Dan Mihailescu, MD
  phone: 312-864-0531
  email: dan.mihailescu@cookcountyhhs.org
  last name: Bettina Tahsin, MS, RD
  phone: 312 864 0531
  email: btahsin@cookcountyhhs.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Cook County Health
  investigator full name: Dan Mihailescu
  investigator title: MD Endocrinology Cluster Director
  mesh term: Graves Disease
  mesh term: Methimazole