<?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>IRCT2013030912758N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-03-25</date_registration>
      <primary_sponsor>Iraqi Board for Medical specializations</primary_sponsor>
      <public_title>Investigation for chronic Idiopathic Urticaria</public_title>
      <acronym></acronym>
      <scientific_title>Autologous Serum Skin Test as a Diagnostic Aid in Chronic Idiopathic Urticaria</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12756</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic.</study_design>
      <phase>N/A</phase>
      <hc_freetext>urticaria.</hc_freetext>
      <i_freetext>Intervention 1: The Autologous Serum Skin Test (ASST) was performed by drawing 2cubic centimeters of venous blood and stored in a plane tube(not heparinized) and allowed to clot at room temperature ,after that the serum is separated by centrifuging the blood in a  centrifuge for 10 minutes at 2000 RPM (Revolution per Minute). 0.05 ml of the patient’s serum is injected intradermally on volar aspect of the patient’s forearm at site not affected by a wheal in the last 24 hours. Intervention 2: At the same time a control test is done by injecting the same volume of normal saline at least 5 centimeters away from the serum injection site.</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>Professor Hayder R. Al-Hamamy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical city P.O. Box 61211.</address>
        <city>baghdad</city>
        <country1>Iraq</country1>
        <zip>12114</zip>
        <telephone>009647901309356</telephone>
        <email>Hayder317@gmail.com</email>
        <affiliation>Head of Department of Dermatology and Venereology, College of Medicine, University of Baghdad, Medic</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Ammar Faisal Hameed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical city61106</address>
        <city>Baghdad</city>
        <country1>Iraq</country1>
        <zip>12114</zip>
        <telephone>009647702475782</telephone>
        <email>amar@uobaghdad.edu.iq</email>
        <affiliation>Department of Dermatology-Baghdad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: All patients with chronic idiopathic urticaria who have active urticaria at time of presentation and the current attack started at least six week before the test.&#13;
Exclusion criteria: children younger than 15 years of age and pregnant women were excluded from the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L50.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Idiopathic urticaria</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The Autologous Serum Skin Test (ASST) was performed by drawing 2cubic centimeters of venous blood and stored in a plane tube(not heparinized) and allowed to clot at room temperature ,after that the serum is separated by centrifuging the blood in a  centrifuge for 10 minutes at 2000 RPM (Revolution per Minute). 0.05 ml of the patient’s serum is injected intradermally on volar aspect of the patient’s forearm at site not affected by a wheal in the last 24 hours</i_keyword>
      <i_keyword>At the same time a control test is done by injecting the same volume of normal saline at least 5 centimeters away from the serum injection site</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wheal and flare. Timepoint: 30 minutes after intradermal injection of 0.05 ml of the patient’s serum into patient’s forearm. Method of measurement: wheal and flare at the tested site of a diameter (measured by taking the mean of the largest two diameters) at least 1.5 millimeters more than the  wheal and flare induced at the control site.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Wheal and flare. Timepoint: 45 minutes after intradermal injection of the patient’s serum into patient’s forearm. Method of measurement: wheal and flare at the tested site of a diameter (measured by taking the mean of the largest two diameters) at least 1.5 millimeters more than the wheal and flare induced at the control site.</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>Iraqi Board for Medical specializations</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-10-09</approval_date>
        <contact_name>Iraqi Board for Medical specializations</contact_name>
        <contact_address>Medical Collection Office, P.O. Box 61080 Postal Code 12114, Baghdad, Iraq. Baghdad Baghdad Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
