<?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>IRCT2013010411996N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-26</date_registration>
      <primary_sponsor>Medical Univercity of Isfahan</primary_sponsor>
      <public_title>Analysis   Injection of Papaverine in the Brain Vessels  for to prevent some camplication of Brain bleeding</public_title>
      <acronym></acronym>
      <scientific_title>Analysis and Comparison of the Variations of Blood Flow velocity in Doppler Ultrasound of Brain Vessels  before and after the Intra arterial Injection of Papaverine during the Operation of Patients Suffering from Brain Aneurysm in Al-Zahra Hospital, Isfahan, Iran during 2011-2012</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12162</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>1</phase>
      <hc_freetext>Vasospasm of cerebral vessels.</hc_freetext>
      <i_freetext>The procedure was as follows: the qualified patients were examined under the Microvascular Doppler Ultrasound (MDS) during the operation and before the Papaverine injection; and the blood flow velocity in cerebral arteries of these patients were measured, then 200mg Papaverine, by Insulin Syringe through the main arterials of brain proximal to Aneurysm, is injected intra arterially. Thirty minutes after the injection of medicine, the patients were examined by Doppler Ultrasound (MDS) again and of the arterial blood flowvelocity was measured.&#13;
Information of the patients were recorded in a checklist that included personal and case features of the patient, age, sex and the blood flowvelocity, before and after Papaverine injection. At the end, the data were analyzed by SPSS software version 20 using chi-square, two independent sample T test and paired sample T test..</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>ghasem baghershahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>st.Hezar Jerib, Medical University of Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1668 5555</telephone>
        <email>parsa86@yahoo.com</email>
        <affiliation>Medical Univesity of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Motahari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>st.Hezar Jerib, Medical University of Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1668 5555</telephone>
        <email>m_motahari@resident.mui.ac.ir</email>
        <affiliation>Medical University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The entrance criteria to the study included the followings: infliction to cerebral Aneurysm suffering from Sub Arachnoidhemorrhage and were candidates of surgical operation for any reason regardless of the time of hemorrhage; not being inflected to Parkinson's disease; not being in complete heart block A.V condition; not being inflicted to Glaucoma; not being pregnant and the patient`s consent. The patients that encountered brain death after the hemorrhage under Arachnoid were disregarded 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>G45.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vasospasm of cerebral vessels</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The procedure was as follows: the qualified patients were examined under the Microvascular Doppler Ultrasound (MDS) during the operation and before the Papaverine injection; and the blood flow velocity in cerebral arteries of these patients were measured, then 200mg Papaverine, by Insulin Syringe through the main arterials of brain proximal to Aneurysm, is injected intra arterially. Thirty minutes after the injection of medicine, the patients were examined by Doppler Ultrasound (MDS) again and of the arterial blood flowvelocity was measured.&#13;
Information of the patients were recorded in a checklist that included personal and case features of the patient, age, sex and the blood flowvelocity, before and after Papaverine injection. At the end, the data were analyzed by SPSS software version 20 using chi-square, two independent sample T test and paired sample T test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decrease Blood Flow velocity. Timepoint: 30 min. Method of measurement: Doppler Ultrasound  sec/cm.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Increase Blood Flow velocity. Timepoint: 30 min. Method of measurement: Doppler Ultrasound.</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>Medical Univercity of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-02-20</approval_date>
        <contact_name>medical university of Isfahan</contact_name>
        <contact_address>st.hezarjerib, medical university of Isfahan Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
