<?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>IRCT20181009041284N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-28</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Oral Ibuprofen in Bone Marrow Biopsy Pain</public_title>
      <acronym></acronym>
      <scientific_title>The Study of Oral Ibuprofen Effect on Pain , anxiety and Physiological Indexes in Patients Undergoing Bone marrow Biopsy in kowsar hospital from 2019 to 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34376</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization was performed by simple randomization method. Numbers from 1 to 30 were written on paper and placed in sealed envelopes. It was then distributed among the samples and patients who had even numbers in the envelope were in the intervention group and those who had odd numbers were in the control group, Blinding description: All patients were kept blind. Because the control group was given a drug very similar to Ibuprofen.</study_design>
      <phase>3</phase>
      <hc_freetext>Pain and anxiety and physiological parameters during bone marrow biopsy and aspiration.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:One hour before the procedure, the patient receives one 400 mg ibuprofen tablet orally. The number of drugs is one and a single dose.This method of drug therapy is to reduce pain and is a non-steroidal anti-inflammatory drug and is done only once. The manufacturer is Abaidi. Intervention 2: Control group: One hour before the procedure, they receive a placebo similar to ibuprofen 400 mg tablet. This pill has no therapeutic effects and looks similar to ibuprofen. It is taken orally and once.</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 data and results can be shared after the study

When:
-Will be available in December.

To whom:
Only available to scholars working in academic institutions.

Conditions:
In case of relevant studies.

Where to obtain:
Rozita Hedayati. Neuromuscular Rehabilitation Research Center, Ghods Blvd. +98 912 331 1988

How to obtain:
After making the necessary edits, these documents will be registered in the form of articles and will be available at December

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Foroozesh Fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar Hospital , Amin Blvd, Golestan Town , Semnan City</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519899951</zip>
        <telephone>+98 23 31420</telephone>
        <email>Mff45@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Foroozesh Fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar Hospital , Amin Blvd, Golestan Town , Semnan City</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519899951</zip>
        <telephone>+98 23 31420</telephone>
        <email>Mff45@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Satisfaction of the patient to participate in the plan
Compelete consciousness
Be in the adult age category (over 18 years old)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking sedative drug and opioid
History of asthma, urticaria, and any hypersensitivity reactions to non-steroidal anti-inflammatory drugs and aspirin
Pacemaker
Third trimester of pregnancy or lactation
Active liver disease
Brain bleeding or other active bleeding
Uncontrolled heart failure
Inflammatory bowel disease
Thrombocytopenia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D75.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disease of blood and blood-forming organs, unspecified</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:One hour before the procedure, the patient receives one 400 mg ibuprofen tablet orally. The number of drugs is one and a single dose.This method of drug therapy is to reduce pain and is a non-steroidal anti-inflammatory drug and is done only once. The manufacturer is Abaidi.</i_keyword>
      <i_keyword>Control group: One hour before the procedure, they receive a placebo similar to ibuprofen 400 mg tablet. This pill has no therapeutic effects and looks similar to ibuprofen. It is taken orally and once.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score at visual analogue scale questionnaire. Timepoint: After the end of the procedure. Method of measurement: Visual analogue scale questionnaire.</prim_outcome>
      <prim_outcome>Anxiety score at clinical Global Impression questionnaire. Timepoint: After the end of the procedure. Method of measurement: Clinical Global Impression questionnaire.</prim_outcome>
      <prim_outcome>The amount of blood pressure. Timepoint: Before the intervention, the second minute, the fourth minute, the end of the intervention. Method of measurement: Mercury sphygmomanometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before the intervention, the second minute, the fourth minute, the end of the intervention. Method of measurement: Cardiac monitoring device.</prim_outcome>
      <prim_outcome>Percentage of blood oxygen saturation. Timepoint: Before the intervention, the second minute, the fourth minute, the end of the intervention. Method of measurement: Pulse Oximeter.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-23</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Kosar hospital , Amin blvd, Golestan town , Semnan City Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
