<?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>IRCT201208139736N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-08-21</date_registration>
      <primary_sponsor>Faculty of Medicine, Tehran University of Medical science, Tehran, Iran</primary_sponsor>
      <public_title>Effects of ischemia and tissue hypoxia in the pathogenesis of ulcerative colitis: a case control study</public_title>
      <acronym></acronym>
      <scientific_title>Effects of ischemia and tissue hypoxia in the pathogenesis of ulcerative colitis: a case control study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10280</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ulcerative Colitis.</hc_freetext>
      <i_freetext>Intervention 1: Control group 1 included 20 people who are referred for screening with all the features of patients group except history of clinical or colonoscopic bowel disease.Endoscopy and colonoscopy will also apply for control group (they had referred for screening) with preparing one sample from colon and another from body of stomach. Systemic arterial blood gas sampling (ABG) is performed from radial artery after Allen testing. More over, Perirectal capillary blood gas analysis using endoscopic ultrasound (EUS) with 100 cc normal saline and 80 mg gentamycine enema immediately before the procedure is performed. Thirty minutes after perirectal capillary blood gas was taken, blood culture was done to rule out bacteremia .Lipid profile,CBC,FBS,EKGG and S/C was done for all of them.Pathological species transferred to department of pathology for measuring HIF1a. Blood gas samples were assessed within 5 minutes in laboratory by pathologist, and results were recorded. Intervention 2: Control group 2:Ten paraffin wax embedded tissue  species from mesenteric ischemia and ten paraffin wax embedded tissue species include infectious colitis entered the study.For this group just tissue ischemic factor by special kits will be assessed. Intervention 3: Patients group interventions:&#13;
Ten patients with Ulceratve Colitis  are selected.Patients should be known case of UC and are diagnosed by clinical symptoms, sigmoidoscopy or colonoscopy findings and pathological species on biopsy.patients group will go under colonoscopy and endoscopy. Three samples are taken from the colon; one from ulcerative tissue, one from normal intestinal tissue and the last one from body of the stomach&#13;
Systemic arterial blood gas sampling (ABG) are performed from radial artery after Allen testing. More over, Perirectal capillary blood gas analysis using endoscopic ultrasound (EUS) with 100 cc normal saline and 80 mg gentamycine enema immediately before the procedure was performed. Thirty minutes after perirectal capillary blood gas was taken, blood culture is done to rule out bacteremia .Pathological species transfer to department of pathology for measuring HIF1a. Lipid profile, CBC,FBS, S/C, EKG will be done for the patients.Blood gas samples شقثassessed within 5 minutes in laboratory by pathologist, and results were recorded.</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 Masih Ttajdini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Tehran University of Medical science</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6643 7147</telephone>
        <email>Drmasih84@yahoo.com</email>
        <affiliation>Faculty of Medicine, Tehran University of Medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Seyed Amir Mirbagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Tehran University of Medical science</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 146 2041</telephone>
        <email>Drmasih84@yahoo.com</email>
        <affiliation>Faculty of Medicine, Tehran University of Medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>We conducted a randomised clinical trial  study to assess the role of ischemia in UC. 20 patients with UC, 20 people without any history of bowel disease and ten paraffin wax embedded tissue  species from mesenteric ischemia and ten paraffin wax embedded tissue species include infectious colitis entered the study. UC is diagnosed by clinical symptoms, sigmoidoscopy or colonoscopy findings and pathological species on biopsy.1Patients who took NSAIDs, vasodilators, corticosteroids (some studies showed they might affect tissue oxygenation) and patients with past medical history of ischemic heart disease, pulmonary disorders (COPD, asthma), severe anemia and vascular disease ( vasculitis) and Diabetes which can cause tissue hypoxia were excluded. Control group included 10 people who were referred for screening with all the features mentioned above except history of clinical or colonoscopic bowel disease. Both group had the same age, sex and lived in the same height above the sea level.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ulcerative colitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group 1 included 20 people who are referred for screening with all the features of patients group except history of clinical or colonoscopic bowel disease.Endoscopy and colonoscopy will also apply for control group (they had referred for screening) with preparing one sample from colon and another from body of stomach. Systemic arterial blood gas sampling (ABG) is performed from radial artery after Allen testing. More over, Perirectal capillary blood gas analysis using endoscopic ultrasound (EUS) with 100 cc normal saline and 80 mg gentamycine enema immediately before the procedure is performed. Thirty minutes after perirectal capillary blood gas was taken, blood culture was done to rule out bacteremia .Lipid profile,CBC,FBS,EKGG and S/C was done for all of them.Pathological species transferred to department of pathology for measuring HIF1a. Blood gas samples were assessed within 5 minutes in laboratory by pathologist, and results were recorded.</i_keyword>
      <i_keyword>Control group 2:Ten paraffin wax embedded tissue  species from mesenteric ischemia and ten paraffin wax embedded tissue species include infectious colitis entered the study.For this group just tissue ischemic factor by special kits will be assessed.</i_keyword>
      <i_keyword>Patients group interventions:&#13;
Ten patients with Ulceratve Colitis  are selected.Patients should be known case of UC and are diagnosed by clinical symptoms, sigmoidoscopy or colonoscopy findings and pathological species on biopsy.patients group will go under colonoscopy and endoscopy. Three samples are taken from the colon; one from ulcerative tissue, one from normal intestinal tissue and the last one from body of the stomach&#13;
Systemic arterial blood gas sampling (ABG) are performed from radial artery after Allen testing. More over, Perirectal capillary blood gas analysis using endoscopic ultrasound (EUS) with 100 cc normal saline and 80 mg gentamycine enema immediately before the procedure was performed. Thirty minutes after perirectal capillary blood gas was taken, blood culture is done to rule out bacteremia .Pathological species transfer to department of pathology for measuring HIF1a. Lipid profile, CBC,FBS, S/C, EKG will be done for the patients.Blood gas samples شقثassessed within 5 minutes in laboratory by pathologist, and results were recorded</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pericapillary Blood Gas. Timepoint: Before intervention and after intervention. Method of measurement: Laboratory data reports.</prim_outcome>
      <prim_outcome>SystemicArterial Blood Gas. Timepoint: Before  intervention and after intervention. Method of measurement: Laboratory data repots.</prim_outcome>
      <prim_outcome>Tissue ischemic factors. Timepoint: Just after sampling. Method of measurement: Specila kits.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Faculty of Medicine, Tehran University of Medical science, Tehran, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-03-07</approval_date>
        <contact_name>Tehran University of Medical science</contact_name>
        <contact_address>Tehran,Keshavarz Boulevard,pursina Aveniue Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
