<?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>IRCT20220409054467N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Adalimumab in Iranian Pediatric with Inflammatory Bowel Disease</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Adalimumab in Iranian Pediatric with Inflammatory Bowel Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65147</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Inflammatory bowel disease.</hc_freetext>
      <i_freetext>Intervention group: Administration of adalimumab (40 mg/0.8 ml) which is injected in patients weighing less than 40 kg based on the following dose: 80 mg first, 40 mg two weeks later, 20 mg two weeks after the second dose and then depending on the response, 20 mg should be taken subcutaneously once every one or two weeks. Also, subcutaneous injection was performed for people weighing more than 40 kg based on the following dose: first 160 mg, two weeks later 80 mg, two weeks after the second dose 40 mg, then according to the response, 40 mg is injected every one or two 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>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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pejman Rohani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733151</zip>
        <telephone>+98 21 6693 0024</telephone>
        <email>cmcpr@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pejman Rohani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733151</zip>
        <telephone>+98 21 6693 0024</telephone>
        <email>cmcpr@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to cooperate and sign the informed consent form after full knowledge of the objectives and methods of the study.
Girls and boys aged 2 to 18 years
Diagnosis of IBD based on endoscopic, laboratory studies, and clinical examinations.
Absences other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, other gastrointestinal diseases, chronic diseases (including type one or two diabetes, cardiovascular, pulmonary and celiac disease), autoimmune diseases Known and inherited and metabolic disorders.
No history of alcohol consumption or alcohol consumption more than 10 grams per day in women and more than 20 grams per day in men.
No pregnancy or breastfeeding in women.
No substance abuse, no chronic inflammatory disease, no history of cancer, no hormone therapy.
Presence of perianal fistula.
Active disease despite the administration of corticosteroids
Failure to respond to immunomodulators</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any acute illness
The occurrence of any accident that affects a person's health.
Use of antibiotics during the study
Acceptance rate less than 80%
Immigration
Exclusion based on personal preference of participants or their parents
Changes in medications taken during the study period</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K51.412</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inflammatory polyps of colon with intestinal obstruction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Administration of adalimumab (40 mg/0.8 ml) which is injected in patients weighing less than 40 kg based on the following dose: 80 mg first, 40 mg two weeks later, 20 mg two weeks after the second dose and then depending on the response, 20 mg should be taken subcutaneously once every one or two weeks. Also, subcutaneous injection was performed for people weighing more than 40 kg based on the following dose: first 160 mg, two weeks later 80 mg, two weeks after the second dose 40 mg, then according to the response, 40 mg is injected every one or two weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disease activity index. Timepoint: Beginning and end of the study. Method of measurement: Software for calculating pediatric Crohn's disease activity index (PCDAI) and pediatric ulcerative colitis activity index (PUCAI).</prim_outcome>
      <prim_outcome>Fecal calprotectin level. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Beginning and end of the study. Method of measurement: scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum C-reactive protein (CRP) levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Beginning and end of the study. Method of measurement: Calculation.</sec_outcome>
      <sec_outcome>Serum Albumin. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-31</approval_date>
        <contact_name>Research Ethics Committees of Children’s Medical Center- Tehran University of Medical Sciences</contact_name>
        <contact_address>Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
