<?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>IRCT20190109042305N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-25</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>nebulized Furosemide and spirometric indexes in Chronic Obstructive Pulmonary Disease exacerbation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of nebulized Furosemide in Chronic Obstructive Pulmonary Disease exacerbation patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>47</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37031</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method is Numbered drug containers. So that the drugs of each group are already in the boxes of the same shape, color, size and weight and are completely sealed and Encoding becomes A and B. Doctor prescribing medications and patients with prescription drugs (furosemide and placebo) are unaware. To collect data, a questionnaire was prepared and pre-coded according to A and B and randomly placed in a folder.The nurse will use the package of treatment for each patient based on the leaflet taken from this folder (randomly), Blinding description: The drugs of each group are already in the boxes of the same shape, color, size and weight and are completely sealed and Encoding becomes A and B. Doctor prescribing medications and patients with prescription drugs (furosemide and placebo) are unaware. To collect data, a questionnaire was prepared and pre-coded according to A and B and randomly placed in a folder.The nurse will use the package of treatment for each patient based on the leaflet taken from this folder (randomly).</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic obstructive pulmonary disease exacerbation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The case group received 40 mg of furosemide (Chemidarou Industrial Company, Tehran, Iran, 20 mg/2 cc) in a 15-minute period. Intervention 2: Control group: The control group received 4 ml of normal saline serum of 0.9% as an nebulized in 15 minutes.</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:
In this Study, all the Information on the main Outcome as well as the Side Effects are Shared

When:
The time to Start Accessing Data will be one Month after the Data is Printed

To whom:
The Data in this Study is Available to Researchers in Academic and Scientific Institutions as well as in Non-Related Fields.

Conditions:
The Data is Available after Printing and the Specified time Period and is used to Improve the Scientific Level

Where to obtain:
Dr Mir Saeid Ramezani .Email: mramezani@mazums.ac.ir

How to obtain:
This Data will be Available to the Applicant one Month after Printing

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mir Saeid Ramezani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam khomeini Hospital, Amir Mazandarani street, Sari</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816633131</zip>
        <telephone>+98 11 3336 1700</telephone>
        <email>mramezani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mir Saeid Ramezani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam khomeini Hospital, Amir Mazandarani street, Sari</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816633131</zip>
        <telephone>+98 11 3336 1700</telephone>
        <email>mramezani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>COPD exacerbation patients
FEV1/FVC less than 70%
No need for ventilator</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>FEV1  Increase greater than 200 cc or 12% after salbutamol administration in spirometry
The history of infectious diseases such as tuberculosis, recent respiratory infections, bronchiectasis and acute or chronic diarrhea
Probability of malignancy based on examination
Rheumatic arthritis, degenerative joint disease, vasculitis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic obstructive pulmonary disease with (acute) exacerbation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The case group received 40 mg of furosemide (Chemidarou Industrial Company, Tehran, Iran, 20 mg/2 cc) in a 15-minute period.</i_keyword>
      <i_keyword>Control group: The control group received 4 ml of normal saline serum of 0.9% as an nebulized in 15 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Forced expiratory volume in 1 second (FEV1). Timepoint: Before prescribing medications, 30 minutes and one hour after administration. Method of measurement: spirometry.</prim_outcome>
      <prim_outcome>Forced vital capacity. Timepoint: Before prescribing medications, 30 minutes and one hour after administration. Method of measurement: spirometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Peak Expiratory Flow Rate. Timepoint: Before prescribing medications, 30 minutes and one hour after administration. Method of measurement: spirometry.</sec_outcome>
      <sec_outcome>Severity of respiratory distress. Timepoint: Before prescribing medications, as well as 30 minutes and one hour after administration. Method of measurement: Accessory muscle score.</sec_outcome>
      <sec_outcome>Adverse effect. Timepoint: Before prescribing medications, as well as 30 minutes and one hour after administration. Method of measurement: Patient evaluation.</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>Sari University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-26</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Imam Khomeini Hospital Amir Mazandarani Street Sari Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
