<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201305204811N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-23</date_registration>
      <primary_sponsor>Vice chancellor for research, Iran University of Medical Sciences</primary_sponsor>
      <public_title>Determining intestinal metaplasia and dysplasia in obese patients candidate for surgery</public_title>
      <acronym></acronym>
      <scientific_title>Gastric mapping for intestinal metaplasia and dysplasia in morbid obese patients candidate for bariatric surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>174</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5163</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Condition 1: Obesity and sleep apnea. Condition 2: Obesity. Condition 3: all types of obesity. Condition 4: Morbid obesity.</hc_freetext>
      <i_freetext>All patients who sign an informed consent form will be endoscopically evaluated and gastric biopsy will be done. CBC, platelet, ESR, CRP, FBS, TG, Chol, HDL, and LDL will also be determined after taking blood sample. Endoscopy will be done before surgery under sedation with propofol and after confirming by a cardiologist..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Kabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Minimally invasive surgery research center and Endoscopy ward of the Hazrat Rasoul-e- Akram Hospital, Mansouri St., Sattarkhan Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>aikabir@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Kabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Minimally invasive surgery research center and Endoscopy ward of the Hazrat Rasoul-e- Akram Hospital , Mansouri St., Sattarkhan Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6655 5448</telephone>
        <email>aikabir@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Morbid obese patients (BMI &gt; 35 kg/m2), aged between 18 and 70 years old who are not involved in any other interventional study, have tendency for doing upper endoscopy and gastric biopsy.&#13;
Exclusion criteria: Cases with any severe diseases of kidney and heart and any other end stage diseases.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.2</hc_code>
      <hc_code>E66.0</hc_code>
      <hc_code>E66.9</hc_code>
      <hc_code>E66.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Extreme obesity with alveolar hypoventilation</hc_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
      <hc_keyword>Simple obesity NOS</hc_keyword>
      <hc_keyword>Morbid obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>All patients who sign an informed consent form will be endoscopically evaluated and gastric biopsy will be done. CBC, platelet, ESR, CRP, FBS, TG, Chol, HDL, and LDL will also be determined after taking blood sample. Endoscopy will be done before surgery under sedation with propofol and after confirming by a cardiologist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gastric dysplasia. Timepoint: At the beginning of study. Method of measurement: gastric biopsy.</prim_outcome>
      <prim_outcome>Mucosal atrophy. Timepoint: At the beginning of study. Method of measurement: gastric biopsy.</prim_outcome>
      <prim_outcome>H. pylori infection. Timepoint: At the beginning of study. Method of measurement: gastric biopsy.</prim_outcome>
      <prim_outcome>Gastric metaplasia. Timepoint: At the beginning of study. Method of measurement: gastric biopsy.</prim_outcome>
      <prim_outcome>Chronic gastritis. Timepoint: At the beginning of study. Method of measurement: gastric biopsy.</prim_outcome>
      <prim_outcome>Reactive atypia of glandular epithelium. Timepoint: At the beginning of study. Method of measurement: gastric biopsy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>FBS. Timepoint: at the beginning of study. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>TG. Timepoint: at the beginning of study. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Total Cholestrol, LDL, HDL. Timepoint: at the beginning of study. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>CRP, ESR. Timepoint: at the beginning of study. Method of measurement: ELISA.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-11</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>5th Floor, Central Building of Iran University of Medical Sciences,Hemmat Expway, between Sheikh fazlollah and Chamran Expway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
