<?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>IRCT20180209038673N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-02</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effects of bolus infusion versus continuous injection of doxorubicin in children with ALL</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of bolus infusion versus continuous injection of doxorubicin in children with ALL</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74204</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization of the  the two intervention groups is done based on quadruple blocks in Excel software. In this software, the intervention groups  (A, and B) are placed alternately. In the next column, there are quadruple blocks. At the end, the random digits created by the software RND0 function are placed. We then arrange the numbers based on block columns and random values, Blinding description: In this study, the researcher does not know about prescription drugs. This means that the researcher knows the two groups only as group A and group B and has no knowledge of which intervention group the patients have been placed in. In other words, the researcher does not know which intervention groups A and B have received.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute lymphoblastic leukemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A patients receive adriamycin through bolus injection. Before the intervention and 6 months after the intervention, the patients undergo echocardiography. The dose of Adriamycin is 40-60 mg/m2 and it is purchased from Türkiye. Intervention 2: Intervention group: Group B patients receive adriamycin through continuous infusion. Before the intervention and 6 months after the  intervention, the patients undergo echocardiography.  The dose of Adriamycin is 40-60 mg/m2 and it is purchased from Türkiye.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Elnaz Sheikhpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi hospital, Ebn Sina Blvd, Safaei, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915887857.</zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>r.sheikhpour@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Elnaz Sheikhpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi hospital, Ebn Sina Blvd, Safaei, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915887857.</zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>r.sheikhpour@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Normal echocardiography,
Written consent from parents,
patients under 18 years of age,
patients with ALL who usd doxorubicin in their drug regimen</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous history of chemotherapy or radiation therapy
Diagnosis of congenital heart disease
Diagnosis of heart failure
Diagnosis of  kidney failure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C91.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute lymphoblastic leukemia not having achieved remission</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: Group A patients receive adriamycin through bolus injection. Before the intervention and 6 months after the intervention, the patients undergo echocardiography. The dose of Adriamycin is 40-60 mg/m2 and it is purchased from Türkiye</i_keyword>
      <i_keyword>Intervention group: Group B patients receive adriamycin through continuous infusion. Before the intervention and 6 months after the  intervention, the patients undergo echocardiography.  The dose of Adriamycin is 40-60 mg/m2 and it is purchased from Türkiye</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiotoxicity effect. Timepoint: 6 months after treatment. Method of measurement: Echocardiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>WBC measurement. Timepoint: 6 months after therapy. Method of measurement: CBC instrument.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-26</approval_date>
        <contact_name>Ethics committee of Medical Schoole, Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Schoole of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone>+98 61 3311 4145</contact_phone>
        <contact_email>syadthsyn0@gmail.com</contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
