<?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>IRCT20181010041299N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-08</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of midazolam on blood pressure control</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of midazolam on blood pressure control in patients attending to emergency ward with hypertension crisis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>129</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34390</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Patients were randomly assigned to three groups of 43 individuals using Random allocation software and from the first patient who has met criteria for the allocation of treatments based on randomization, everyone is treated with their medication, Blinding description: Participant: The use of placebo in addition to the current drug was administered in a group of captopril tablets and placebo, distilled water, and in the second group, the drug was injected with midazolam and vitamin B tablets, and in the third group of captopril tablets and midazolam injectable drug.
Outcome evaluator: The blood pressure meter will be measured before and after the intervention by the nurse present in the shift, who is unaware of how the medications are allocated to the patient.
DATA ANALYSIS: No information is available on how to allocate drugs to the groups.</study_design>
      <phase>2</phase>
      <hc_freetext>Crease blood pressure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Intravenous Midazolam injection of 1 mg and placebo vitamin B tablets. Intervention 2: Intervention group 2: intravenous Midazolam injection of 1 mg and Captopril 25 mg. Intervention 3: Control group 1: 25 mg captopril tablets and injected placebo distilled water.</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:
All collected data will be shared after being unidentified and analyzed

When:
By the end of 2019

To whom:
For all scholars

Conditions:
For use in studies

Where to obtain:
Supervisor

How to obtain:
By email and correspondence and justification for use

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Reza Khorsand Kemachali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 409. Third floor. medical School. Shahroud University of Medical Sciences. Hafte-Tir Square. Tehran Avenue. Shahroud. Iran.</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۴۷-۷۳۹۴۷</zip>
        <telephone>+98 23 3239 5009</telephone>
        <email>dr_khorsandmd@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Amir Noyani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 409. Third floor. medical School. Shahroud University of Medical Sciences. Hafte-Tir Square. Tehran Avenue. Shahroud. Iran.</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۴۷-۷۳۹۴۷</zip>
        <telephone>+98 23 3239 5009</telephone>
        <email>a.noyani@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Systolic or diastolic blood pressure above 180 on 110 mm Hg
age group is 18-18 years old
Have the power to understand and sign a conscientious informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Chronic renal failure
Cardiovascular disease
History of stroke
History of myocardial infarction
Benzodiazepines consumed in the last week
Use of muscle relaxants such as baclofen or anti-anxiety drugs Other groups such as zoolpidum or baspirone
Acute left heart failure
Captopril susceptibility
Sensitivity to midazolam
Sensitivity to midazolam
Pregnant and lactating women
The occurrence of a critical condition, according to the doctor's opinion, requires the administration of a blood pressure lowering medication other than midazolam and captopril
Patients with a difference between the two arms are more than 15 mm Hg</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Intravenous Midazolam injection of 1 mg and placebo vitamin B tablets</i_keyword>
      <i_keyword>Intervention group 2: intravenous Midazolam injection of 1 mg and Captopril 25 mg</i_keyword>
      <i_keyword>Control group 1: 25 mg captopril tablets and injected placebo distilled water</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic or diastolic blood pressure. Timepoint: Blood pressure measurement at the beginning of the study and 10 minutes after (before the intervention). Then at 15, 30, 45 and 60 minutes after the intervention. Method of measurement: How to measure blood pressure in a standardized manner using a mercurial barometric device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleepiness rate. Timepoint: 15, 30, 45 and 60 minutes after intervention. Method of measurement: Examination by a specialist.</sec_outcome>
      <sec_outcome>Shortness of breath. Timepoint: 15, 30, 45 and 60 minutes after intervention. Method of measurement: Examination by a specialist.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-24</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Room 409. Third floor. medical School. Shahroud University of Medical Sciences. Hafte-Tir Square. Tehran Avenue. Shahroud. Ira Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
