<?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>IRCT201201231241N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-03-01</date_registration>
      <primary_sponsor>Department of Research and Technology, Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Sequential therapy for eradication of H. Pylori infection in  renal failure patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Sequential therapy for eradication of H. Pylori infection in  renal failure patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/454</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Helicobacter pylori infection.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group:Pantoprazul (BD40mg) and amoxicillin (If keratinize clearance is between 10-30:250-500mg BD and  if it is less than 10:250-500 mg Daily)for 5 days and Then Pantoprazul (40mg BD) and clarithromycin (250 mg BD) and tinidazole (500mg BD) for 5 days. Intervention 2: Control Group : Pantoprazul (40mg BD) and Claritromicine(250 mg BD)and Amoxicillin (If Kratinize Cearance is between 10-30:250-500mg BD and if it is less than 10:250-500 mg Daily).</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>Dr Atieh Makhlough</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Internal ward, Emam Hospital, Amir Mazandarani Boulevard</address>
        <city>ُSari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 15 1226 4047</telephone>
        <email>dr.makhloogh@mazums.ac.ir , makhlough_a@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Atieh Makhlough</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Internal ward, Emam Hospital, Amir Mazandarani Boulevard</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 15 1226 4047</telephone>
        <email>makhlough_a@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients with dyspepsia symptoms over the past one month from gastroenterology or nephrology clinic or hospital dialysis ward who have infection with H. Pylori confirmed by rapid urease test and biopsy in endoscopy. Exclusion Criteria : taking antibiotic regimen to eradicate H. pyloriand or receiving proton pump inhibitors, Bismuth, or NSAID during the last month; concomitant anticoagulant, corticosteroid or Ketoconazole; history of gastric or esophageal surgery; sensitivity to antibiotics; negative endoscopic biopsy; drinking alcohol and smoking; pregnancy and lactation; severe heart disease; diseases of the thyroid gland or liver cancer; chronic renal failure patients who are prior to stage 5 or have not received renal replacement therapy.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B98.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Helicobacter pylori</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>Intervention Group:Pantoprazul (BD40mg) and amoxicillin (If keratinize clearance is between 10-30:250-500mg BD and  if it is less than 10:250-500 mg Daily)for 5 days and Then Pantoprazul (40mg BD) and clarithromycin (250 mg BD) and tinidazole (500mg BD) for 5 days</i_keyword>
      <i_keyword>Control Group : Pantoprazul (40mg BD) and Claritromicine(250 mg BD)and Amoxicillin (If Kratinize Cearance is between 10-30:250-500mg BD and if it is less than 10:250-500 mg Daily)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Eradication of Helicobacter pylori Infection. Timepoint: At the end of four weeks after treatment. Method of measurement: Urea Test.</prim_outcome>
      <prim_outcome>Eradication of Helicobacter pylori Infection. Timepoint: At the end of four weeks after treatment. Method of measurement: Creatinine Clearance Test.</prim_outcome>
      <prim_outcome>Eradication of Helicobacter pylori Infection. Timepoint: At the end of four weeks after treatment. Method of measurement: Stool examination.</prim_outcome>
      <prim_outcome>Eradication of Helicobacter pylori Infection. Timepoint: At the end of four weeks after treatment. Method of measurement: Biopsy by Endoscopic.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Acute Renal Failure. Timepoint: At the first and second weeks of treatment. Method of measurement: Testing Urea.</sec_outcome>
      <sec_outcome>Acute Renal Failure. Timepoint: At the first and second weeks of Treatment. Method of measurement: creatinine clearance test.</sec_outcome>
      <sec_outcome>Acute Renal Failure. Timepoint: at the first and second weeks of treatment. Method of measurement: weight.</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>Department of Research and Technology, Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-08</approval_date>
        <contact_name>Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Building No. 2 of University, Moallem Square Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
