<?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>IRCT20150410021677N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-06</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Botulinum Toxin in Facial Emotion Recognition</public_title>
      <acronym></acronym>
      <scientific_title>changing facial emotion recognition before and after cosmetic botulinum toxin type A injection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29098</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Basic scienece.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Disorder of the skin and subcutaneous tissue, unspecified.</hc_freetext>
      <i_freetext>Intervention group:patients with frown lines in forehead area. 500 unit of botulinum toxin type A(Dysport,Epsen,UK)dissolve in 0.9%injectable NACL solution and inject 20Unit to the procerus muscle,35 U bilaterally to the corrugator muscles and 15U in lateral sentiment of orbicularis occuli.The MERT score calculate before and 8 week after injection.MERT test of the Swiss centre for affective science at the university of Geneva,during 45 minutes,test participitanta asked to choose the emotion presented by actors in different modalities(still picture,video only,audio only and audio-visual),At the end of calculate the score..</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 deidentified of IPD

When:
Starting 6 month after publication

To whom:
Only available for people working in academic institutions

Conditions:
Only for scentific research

Where to obtain:
Doctor Amir sherafat, neurology resident of kerman university of medical sciences,amirsherafat@mail.com,
Doctor Kaveh shafiee,neurology assitant professor of kerman university medical sciences.kshafiee@gmail.com,

How to obtain:
Documents will be send 2weeks after direct request by email to the corresponding author

Comments:
no further comments</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kaveh shafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar square., shafa hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>768751151</zip>
        <telephone>+98 34 3212 4727</telephone>
        <email>amirsherafat@mail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kaveh shafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar square., shafa hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>768751151</zip>
        <telephone>+98 34 3212 4727</telephone>
        <email>amirsherafat@mail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>first time of botulinum toxin injection
age above 18 years
presence of frown lines in forehead</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>allergy to botulinum toxin
pregnancy
history of facial trauma
history of surgery in forehead area of face
history of dementia and psychiatric disorder
visual and speech abnormalities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L98.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorder of the skin and subcutaneous tissue, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:patients with frown lines in forehead area. 500 unit of botulinum toxin type A(Dysport,Epsen,UK)dissolve in 0.9%injectable NACL solution and inject 20Unit to the procerus muscle,35 U bilaterally to the corrugator muscles and 15U in lateral sentiment of orbicularis occuli.The MERT score calculate before and 8 week after injection.MERT test of the Swiss centre for affective science at the university of Geneva,during 45 minutes,test participitanta asked to choose the emotion presented by actors in different modalities(still picture,video only,audio only and audio-visual),At the end of calculate the score.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Incidence frown line in forehad. Timepoint: before intervention and 2 weeks after injection botulinum. Method of measurement: visual evaluation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Evaluation of emotion recognition. Timepoint: before intervention, 8  after intervention. Method of measurement: multi modal emotion recognition test (MERT).</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-17</approval_date>
        <contact_name>Ethics committee of Kerman university of medical Sciences</contact_name>
        <contact_address>Kosar square, shafa hospital Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
