<?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>IRCT20170527034146N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-18</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the occurrence, effect and side effects oFcyclophosfamid and rituximab in the tratment  of children with NEPHROTIC SYNDROM resistance to STEROID that referred to Hazrate Massumeh hospital .</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the occurrence, effect and side effects oFcyclophosfamid and rituximab in the tratment  of children with NEPHROTIC SYNDROM resistance to STEROID that referred to Hazrate Massumeh hospital .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37066</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The simple random sampling method was used for the selected sample and was divided into two groups of intervention and control by simple randomized distribution method.  The randomized random number tool is the unit of individual cadastre. The patients were divided into two equal groups, regardless of sex and age, and on the basis of resistant to steroid therapy.The intervention group, in addition to prednisolone, received Ritoximab, which received a cyclophosphamide drug control group.</study_design>
      <phase>2</phase>
      <hc_freetext>Nephrotic syndrome resistance to steroide.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:I ntervention group: In addition to prednisolone, ritoximab with 375 mg / m 2 / day was given intravenously and weekly for 4 weeks. Intervention 2: Control group: Control group: In addition to prednisolone, cyclosfamide dose of 2 mg per kg per day For three months.</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:
Some of the details, such as information about the original message or its lover, can be shared.

When:
Since 1399

To whom:
Researchers working in academia and academia

Conditions:
Clinical analyzes and clinical findings

Where to obtain:
Principal Principal Prose Mohsen Akhavan Sepahi. E-mail: makhavan@muq.ac.ir

How to obtain:
Apply by e-mail to Mohsen Akhavan Sepahi

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Akhavan sepahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam sereet</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719815532</zip>
        <telephone>+98 25 3665 1804</telephone>
        <email>makhavan@muq.ac.ir</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Akhavan sepahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam street</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719815532</zip>
        <telephone>+98 256651804</telephone>
        <email>makhavan@muq.ac.ir</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>َAll patient whit nephrotic syndrome resistance to steroid whit age 1-18 yr</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>All patient who do not have steroid-resistant Nephrotic Syndrome for example patient with steroids depended syndrome.
All patient who did not accept treatment
All patient who died
All patient who did not follow up</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N04.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nephrotic syndrome with other morphologic changes</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:I ntervention group: In addition to prednisolone, ritoximab with 375 mg / m 2 / day was given intravenously and weekly for 4 weeks.</i_keyword>
      <i_keyword>Control group: Control group: In addition to prednisolone, cyclosfamide dose of 2 mg per kg per day For three months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The frequency of relapse of the disease before and after taking the cyclofosfamide and ritoximab. Timepoint: Weekly. Method of measurement: Urin analysis of proteine.</prim_outcome>
      <prim_outcome>Dosage of the prednisolon before and after taking the medication. Timepoint: weekly. Method of measurement: check liste.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of relapses after receiving rutioxime and cyclolophosphamide. Timepoint: weekly. Method of measurement: Urinalysis. Patient's disease.</sec_outcome>
      <sec_outcome>Dosage of Steroids after receiving  medication. Timepoint: weekly. Method of measurement: check liste.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Assistant research in Qom medical univercity</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Ghoum University of Medical Sciences</source_name>
      <source_name>Assistant research in Qom medical univercity</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-05</approval_date>
        <contact_name>Ethics committee of QOM  University of Medical Sciences</contact_name>
        <contact_address>EMAM STREET. QOM Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
