<?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>IRCT20170120032069N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Desmopressin effects on bleeding after functional endoscopic sinus surgery on patients with chronic rhinosinusitis with and without polyposis</public_title>
      <acronym></acronym>
      <scientific_title>desmopressin effects on bleeding after functional endoscopic sinus surgery on patients with chronic rhinosinusitis with and without polyposis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>19</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25077</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients eligible for inclusion in the study are interviewed first and explained to the project, and, if satisfied, to participate in the study, the patients will receive written consent to be included in the plan and informed of them. They will be randomly assigned to either group.
The blocking method will be used to select patients in one of the two intervention and control arms so that they are selected using the random numbers table of the 4 blocks and then the items will be selected and introduced with time review.
It should be noted that in this study, the patients, the team of surgeons, the anesthetic team and the operating room team did not know the control or intervention of the patients, and the intervention group and the placebo group were both surgically operated by a professor, and for both groups 100 cc My head is ready to be used, which the surgical team and the data analyst do not know about its nature, Blinding description: In this study, the patients, the team of surgeons, the anesthetic team and the operating room team were unaware of the control or intervention of the patients, and the intervention group and the placebo group were both surgically treated by a professor.</study_design>
      <phase>3</phase>
      <hc_freetext>chronic rhinosinositis with and without polyposis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: 100mg normal saline containing 0.1μgr / kg desmopressin will be injected 1 min before surgery in case group. If the surgeon is dissatisfied from the operation field, a second dose of the drug is injected 30 minutes after surgery. Intervention 2: Control group: In this group, 100 ml of normal saline is injected 30 minutes before surgery.</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:
Demographic information and information of samter's Triad and Land McKay Score and the results of some tests are available.

When:
Access is available 2 years after the final results are published

To whom:
The results are accessible to researchers working in academic institutions and universities.

Conditions:
To access the data, they must specify the type of data and specify the type of data to use.

Where to obtain:
To receive the type of information, they can email the following email
jawadhosseini.md@gmail.com

How to obtain:
After submitting the request by email, their request will be reviewed by the research team and Up to 6 months after the request is submitted, their request will be sent to their email address.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jawad Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Darvaze Dolat, Saadi st, Engelab st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1145765111</zip>
        <telephone>+98 21 6670 6106</telephone>
        <email>jawadhosseini.md@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jawad Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>north Sadi Ave., Enqelab Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1145765111</zip>
        <telephone>+98 21 6670 3037</telephone>
        <email>jawadhosseini.md@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with chronic rhinosinusitis in the age group of 15-60 years old
No heart disease
without Background coagulation disorders
Without high blood pressure
No history of previous FESS surgery</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If patients are not satisfied with entering the project</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>chronic Rh</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>chronic Rhinosinositis, polyposis, Desmopressin, FESS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: 100mg normal saline containing 0.1μgr / kg desmopressin will be injected 1 min before surgery in case group. If the surgeon is dissatisfied from the operation field, a second dose of the drug is injected 30 minutes after surgery.</i_keyword>
      <i_keyword>Control group: In this group, 100 ml of normal saline is injected 30 minutes before surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduce bleeding during FESS surgery - better view of surgeon on operating field -- Reduce the time of surgery. Timepoint: Measuring the amount of bleeding at the end of surgery .... Measuring surgeon satisfaction at the end of surgery .... Measuring the time of surgery at the end of surgery. Method of measurement: Calibrated container to measure the amount of bleeding. A numerical questionnaire is used to measure the surgeon's satisfaction .measure the time of operation by clock.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reduce the need for postoperative blood transfusions .... Reduce the need for intraoperative anesthesia. Timepoint: Both outcomes are measured at the end of surgery. Method of measurement: The rate of hemoglobin loss at the end of surgery and the amount of anesthetic drugs used during surgery.</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>2019-06-22</approval_date>
        <contact_name>Vice-Chancellor in Research Affairs- Tehran University of Medical</contact_name>
        <contact_address>Amiralam hospitla, north sadi av. Enqelab av. تهران Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
