<?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>IRCT201201078640N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-13</date_registration>
      <primary_sponsor>Shahid Sadoughi University of Medical Sciences</primary_sponsor>
      <public_title>Comparison Of Two Methods In The Treatment Of Epistaxis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect Of Pressure On The Nose By Nose Stuck With The Gas Pressure On The Control Of Nose Bleeding In Patients Presenting  To The Emergency Department With Complaints Of Epistaxis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9131</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Epistaxis.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, we put the nose stuck on the patient's nose and after 15 min evaluate epistaxis scale compared to the initial state. Intervention 2: In the control group, patient wanted to hold his/her nose tightly and after 15 min evaluate epistaxis scale compared to the initial state.</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>Hosein Amiri Largani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Doctor Rahnemoon Hospital, Farrokhi Street, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3626 8111</telephone>
        <email>amirilargani@gmail.com</email>
        <affiliation>Shahid Sadoughi University of Medical Scienses</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hosein Amiri Largani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rahnemoon Hospital, Farrokhi Ave, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3626 8111</telephone>
        <email>amirilargani@gmail.com</email>
        <affiliation>Shahid Sadoughi University of Medical Scienses</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: For Patient Is Admitted With Complaints Of Epistaxis, And Must Have Active Bleeding At The Time Of The Study. Age Older Than 16 Years. Epistaxis Must Be  Anterior Type. Exclusion Criteria Were Bleeding Caused By Trauma Or Surgical Procedures. Anticoagulants Drugs Or Bleeding Disorders In Patients (Platelet Count Less Than 100,000, Hemophilia, INR Greater Than 1.5, Hematologic Malignancies), Intervention To Control Bleeding During 6 Months Ago (Cautery, Tampons, Local Treatment). Posterior Epistaxis. Hemodynamic Instability. Upper Respiratory Tract Infection. Accompanied By A Significant Other Complaints (Eg, Chest Pain). Lack Of Patient Consent To Participate In The Study. Deviation Of The Nasal Septum.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R04.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Haemorrhage from nose Nosebleed</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, we put the nose stuck on the patient's nose and after 15 min evaluate epistaxis scale compared to the initial state.</i_keyword>
      <i_keyword>In the control group, patient wanted to hold his/her nose tightly and after 15 min evaluate epistaxis scale compared to the initial state.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resolve Bleeding. Timepoint: 15 minutes later. Method of measurement: Direct Inspection.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>ENT specialist consult. Timepoint: At discharge time. Method of measurement: Case inspection.</sec_outcome>
      <sec_outcome>Patient satisfaction. Timepoint: At discharge time. Method of measurement: upon likert scale.</sec_outcome>
      <sec_outcome>Need for more intervention. Timepoint: at discharge time. Method of measurement: case inspection.</sec_outcome>
      <sec_outcome>Recurrenc of epistaxis. Timepoint: 24 houres after discharge from emergency unit. Method of measurement: Interview with patient.</sec_outcome>
      <sec_outcome>Care duration in emergency unit. Timepoint: After discharge. Method of measurement: Since the establishment of emergency cases until discharge in minutes.</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>Shahid Sadoughi University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-08</approval_date>
        <contact_name>Shahid Sadoughi University of Medical Scienses</contact_name>
        <contact_address>Centeral Organization of Shahid Sadoughi University of Medical Scienses, Bahonar Squr, Yazd Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
