<?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>IRCT20160318027097N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-12</date_registration>
      <primary_sponsor>Vice Chancellor for research of Ardebil University of Medical Sciences</primary_sponsor>
      <public_title>Treatment of Helicobacter Pylori infection in patients with dyspepsia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of three therapeutic regimens (Rabiprazole, Amoxicillin, Bismuth subcetate, Clarithromycin (1), Rabiprazole, Amoxicillin, Clarithromycin (2) Rabiprazole, Amoxicillin, Bismuth subcetate, Furazolidone (3)) in eradication of Helicobacter pylori in</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22287</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: 90 numbers will enter the random block, and randomly the numbers are divided into three groups. Accordingly, patients will receive one of three regimens with their randomly pre-assigned number, Randomization description: The randomization is block, individual and using a random number table in this study. 90 numbers will entered the random block and numbers are randomly assigned into three groups. Accordingly, the patients will receive one of three regimens with their randomly assigned number. In this study, participants, researchers are unaware of prescription drugs.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Dyspepsia.</hc_freetext>
      <i_freetext>Intervention 1: Case group (2): Rabiprazole, Tablet 40mg oral OD for 6 weeks. Amoxicillin, Tablet 1000mg oral BD for 2 weeks. Clarithromycin, Tablet 500mg oral BD for 2 weeks. Intervention 2: Case group (3): Rabiprazole, Tablet 40mg oral OD for 6 weeks. Amoxicillin, Tablet 1000mg oral BD for 2 weeks. Bismuth subcitrate, Tablet 120mg oral BD for 2 weeks. Furazolidone Tablet 200mg oral BD for 2 weeks. Intervention 3: Case group (1): Rabiprazole, Tablet 40mg oral OD for 6 weeks. Amoxicillin, Tablet 1000mg oral BD for 2 weeks. Bismuth subcitrate, Tablet 120mg oral BD for 2 weeks. Clarithromycin Tablet 500mg oral BD for 2 weeks.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Total potential data after unidentifiable individuals

When:
Start the access period from 2019

To whom:
Researchers in academic and scientific institutions

Conditions:
Data can be used for scientific and research studies.

Where to obtain:
Dr Masoud Tasoji; Internal Medicine Assistant; M.tasoji@arums.ac.ir

How to obtain:
After receiving the request email, data files will be sent in less than a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Masoud Tasoji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5163639888</zip>
        <telephone>+98 45 3351 2006</telephone>
        <email>naghizadeh73@yahoo.com</email>
        <affiliation>Ardebil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad Sadrkabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5163639888</zip>
        <telephone>+98 45 3351 2006</telephone>
        <email>M.sadrkabir@arums.ac.ir</email>
        <affiliation>Ardebil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Endoscopic and biopsied patients; Report of the Helicobacter pylori organism in the tissue sample.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy; Intolerance to drugs; Interaction with medications such as digoxin; drug complications during treatment.</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Case group (2): Rabiprazole, Tablet 40mg oral OD for 6 weeks. Amoxicillin, Tablet 1000mg oral BD for 2 weeks. Clarithromycin, Tablet 500mg oral BD for 2 weeks</i_keyword>
      <i_keyword>Case group (3): Rabiprazole, Tablet 40mg oral OD for 6 weeks. Amoxicillin, Tablet 1000mg oral BD for 2 weeks. Bismuth subcitrate, Tablet 120mg oral BD for 2 weeks. Furazolidone Tablet 200mg oral BD for 2 weeks</i_keyword>
      <i_keyword>Case group (1): Rabiprazole, Tablet 40mg oral OD for 6 weeks. Amoxicillin, Tablet 1000mg oral BD for 2 weeks. Bismuth subcitrate, Tablet 120mg oral BD for 2 weeks. Clarithromycin Tablet 500mg oral BD for 2 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fecal antigen of Helicobacter pylori. Timepoint: 4 weeks after Intervention. Method of measurement: ELISA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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 of Ardebil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-24</approval_date>
        <contact_name>Ethics committee of Ardebil University of Medical Sciences</contact_name>
        <contact_address>Ardebil University of Medical Sciences, daneshghah ave, Ardebil, Iran Ardebil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
