<?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>IRCT20170609034406N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-06</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of pralidoxime in the treatment of organophosphorus poisoning</public_title>
      <acronym></acronym>
      <scientific_title>Study of the efficacy of pralidoxime in the treatment of organophosphorus poisoning</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37966</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: None, Randomization description: Simple random randomization is performed by creating random numbers between 10 and 90 by the computer. For numbers less than 45 and 45  people enter the control group and for numbers less than 45 people enter the intervention group. It should be noted that all patients will randomly enter the control or intervention group after selecting to enter the study by assigning a random number generated by the computer.</study_design>
      <phase>3</phase>
      <hc_freetext>Orghanophosphate poisonous patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 43 patients selected by simple random, concomitant treatment with atropine (0.5 mg / ml, Daropakhsh Company) (initial dose of 1-6 mg, which will be repeated every 3-5 minutes if necessary. Double the application will be applied) and pralidexime (2% of SERB) (loading dose 30 mg / kg and up to a maximum dose of 2000, then a maintenance dose of 8-10 mg / kg / h to a maximum of 650 mg / h). Intervention 2: Control group: 43 randomly selected patients, only receive atropine (0.5 mg / ml, Darupakhsh Company) with initial dose of 1-6 mg, that will be repeated every 3-5 minutes if necessary. Dose will doubled if no response reported.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Threre is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afshin Gharekhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of pharmacy - Tabriz University of medical science - Golgasht Avenue</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165665811</zip>
        <telephone>+98 41 3335 5921</telephone>
        <email>gharekhania@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afshin Gharekhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of pharmacy - Tabriz University of medical science - Daneshgah Avenue - Golghasht - Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5147663419</zip>
        <telephone>+98 41 3230 5153</telephone>
        <email>gharekhania@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 12 years
poisoning with a specific type of orghanophosphate
similar patients in terms of severity of toxicity
Not receiving pralidoxime before arrive hospital</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Non-orghanophosphorous toxicity
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T60.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Toxic effect of organophosphate and carbamate insecticides</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: 43 patients selected by simple random, concomitant treatment with atropine (0.5 mg / ml, Daropakhsh Company) (initial dose of 1-6 mg, which will be repeated every 3-5 minutes if necessary. Double the application will be applied) and pralidexime (2% of SERB) (loading dose 30 mg / kg and up to a maximum dose of 2000, then a maintenance dose of 8-10 mg / kg / h to a maximum of 650 mg / h).</i_keyword>
      <i_keyword>Control group: 43 randomly selected patients, only receive atropine (0.5 mg / ml, Darupakhsh Company) with initial dose of 1-6 mg, that will be repeated every 3-5 minutes if necessary. Dose will doubled if no response reported.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum level of acetylcholinesterase enzyme. Timepoint: Daily measurement of serum acetylcholinesterase until the patient's day off. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Investigating the need for oxygen therapy in two groups including control and intervention. Timepoint: Momentary monitoring of the patient to assess the need for oxygen therapy. Method of measurement: Using the pulse oximeter device.</prim_outcome>
      <prim_outcome>Investigating the need for intubation and the duration of intubation in the two groups of control and intervention. Timepoint: Using checklist to record the time of initiation and duration of intubation in patients with indication for intubation using data extracted from the patients medical files. Method of measurement: Already designed checklist for recording the time.</prim_outcome>
      <prim_outcome>Investigating the need for mechanical ventilation and the duration of mechanical ventilation in two groups of control and intervention. Timepoint: Using checklist to record the time of mechanical ventilation and duration of mechanical ventilation in patients with indication for mechanical ventilation using data extracted from the patients medical files. Method of measurement: According to criteria exist for mechanical ventilation, the time of initiation and the time spent on mechanical ventilation for each patients will be recorded using data extracted from patients medical files.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-24</approval_date>
        <contact_name>Ethics Committee of Tabriz University of medical Sciences</contact_name>
        <contact_address>Center of Research and Technology - No 2 Centeral Building - Tabriz University of Medical Sciences - golghasht Street - Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
