<?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>IRCT201310221155N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-03</date_registration>
      <primary_sponsor>Guilan Univercity of Medical Sciences</primary_sponsor>
      <public_title>The effect of gemifloxacin in treatment of  H.pylori infection</public_title>
      <acronym></acronym>
      <scientific_title>Comparision of  two quadriple regimen amoxicillin, bismuth subsalicylate, pantoprazole, clarythromycin and amoxicillin, bismuth subsalicylate, pantoprazole, gemifloxacin in eradication of H.pylori infection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>182</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/241</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Dyspepsia.</hc_freetext>
      <i_freetext>Intervention 1: Control group take cap amoxicillin 500 miligram two numbers every 12 hours, tab bismuth subsalicylate 120 miligram two numbers every 12 hours, tab pantoprazole 20 miligram one number daily, tab clarythromycin 500 miligram one number every 12 hours for 10 days period. Intervention 2: Intervention group take cap amoxicillin 500 miligram two numbers every 12 hours, tab bismuth subsalicylate 120 miligram two numbers every 12 hours, tab pantoprazole 20 miligram one number daily, tab gemifloxacin 320 miligram one number daily for 10 days period.</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>Farahnaz Joukar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi hospital, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>955655-41448</zip>
        <telephone>+98 13 1553 5116</telephone>
        <email>info@gldrc.org</email>
        <affiliation>Gastrointestinal and Liver Diseases Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Fariborz Mansour-Ghanei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>95655-41448</zip>
        <telephone>+98 13 1553 5116</telephone>
        <email>info@gldrc.org</email>
        <affiliation>Gastrointestinal and Liver Diseases Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: New cases of H.pylori infection; patients  between 18 to 80 years old &#13;
Exclusion criteria: The pregnant and brest feeding women; gastric and esophagial malignancies; pylor stenosis; iiver cirrhosis; opium addicts; hypersensitivity to amoxicillin; bismuth subsalicylate; pantoprazole; clarythromycin; gemifloxacin; using cholestyramine; renal failure; history of sizzure; favism and hematologic disorders; incomplete treatment (under 80%); consent to continue treatment; history of H.pylori treatment</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dyspepsia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group take cap amoxicillin 500 miligram two numbers every 12 hours, tab bismuth subsalicylate 120 miligram two numbers every 12 hours, tab pantoprazole 20 miligram one number daily, tab clarythromycin 500 miligram one number every 12 hours for 10 days period</i_keyword>
      <i_keyword>Intervention group take cap amoxicillin 500 miligram two numbers every 12 hours, tab bismuth subsalicylate 120 miligram two numbers every 12 hours, tab pantoprazole 20 miligram one number daily, tab gemifloxacin 320 miligram one number daily for 10 days period</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Helicobacter pylori eradication. Timepoint: 12 weeks. Method of measurement: Ureas Breath Test with C14.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Comparision of two quadriple regimen amoxicillin, bismuth subsalicylate, pantoprazole, clarythromycin and amoxicillin, bismuth subsalicylate, pantoprazole, gemifloxacin in eradication of H.pylori infection. Timepoint: 8-12 weeks. Method of measurement: UBT.</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>Guilan Univercity of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Guilan University of Medical Sciences. Ethics Committee of Gastrointestinal and Liver Diseases Resea</contact_name>
        <contact_address>Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
