<?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>IRCT20180514039657N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-22</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>effects of taurine in traumatic brain injury</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Taurine Powder Supplementation on Inflammatory Markers and Clinical Outcomes in Traumatic Brain Injury Patients Admitted to the Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31173</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients to each groups is done by random block method using block of size 6.In order to ensure that the selection bias does not occur, the allocation method is used to allocate a unique code to each patient, Blinding description: the type of blinding in our study is double-blind. Taurine powder is dissolved  by an individual except the researcher in the gavage solution and is coded as A and B, so that the investigator will not be informed of the patient's receipt or not of Taurine. Patients are randomly allocated to each group A and B.</study_design>
      <phase>2-3</phase>
      <hc_freetext>traumatic brain injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: standard entrameal of karen pharma with taurine powder with a dose 30 mg/kg in two divided doses per day for 14 days. Intervention 2: Control group: standard entrameal of karen pharma for 14 days.</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:
If the decision is to publicate the data, after the unidentified individuals all data will be publicated.

When:
The access period will be 6 months after the publication of the results.

To whom:
Researchers working in academic and industrial institutions can apply to get data.

Conditions:
To cite. Referring to reference or researcher's permission

Where to obtain:
Mahsa Vahdat. Faculty of Paramedicine, jundishapur University of Medical Sciences, golestan Blvd, Ahvaz. vahdat.m@ajums.ac.ir

How to obtain:
Access to articles related to this research Send email to the responsible author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Vahdat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Paramedicine, Jundishapur University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135815751</zip>
        <telephone>+98 61 3321 4578</telephone>
        <email>vahdat.m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Ahmad Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paramedical School,Ahvaz Jundishapur University of Medical Sceinces, Golestan Blvd, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3333 3050</telephone>
        <email>seyedahmadhosseini@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 18 years old
GCS=6-12
traumatic brain injury patients
receive entral nutrition</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking anti-inflammatory drugs or corticosteroids before entering the study
Patients with liver or kidney disorders
Pregnant or lactating women
Patients with Congenital Amino Acid Metabolism Disorder
Failure to provide more than 60% of the energy and protein requirement calculated through entral nutrition in the first week</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S06.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diffuse traumatic brain injury</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: standard entrameal of karen pharma with taurine powder with a dose 30 mg/kg in two divided doses per day for 14 days</i_keyword>
      <i_keyword>Control group: standard entrameal of karen pharma for 14 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>High sensitive C-Reactive Protein. Timepoint: The beginning and end of the study. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Tumor Necrosis Factor-alpha. Timepoint: The beginning and end of the study. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Interleukin-6. Timepoint: The beginning and end of the study. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Interleukin-10. Timepoint: The beginning and end of the study. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Weight. Timepoint: The beginning and end of the study. Method of measurement: Patient bedside scale.</prim_outcome>
      <prim_outcome>Clinical outcome measurement. Timepoint: day 1,7,14. Method of measurement: Sequential Organ Failure Assessment(SOFA) score.</prim_outcome>
      <prim_outcome>Disease severity. Timepoint: day 1,14. Method of measurement: APACHEII score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>30-day mortality. Timepoint: day 30. Method of measurement: Contact with patient's family.</sec_outcome>
      <sec_outcome>Length of stay to ICU. Timepoint: daily. Method of measurement: observation.</sec_outcome>
      <sec_outcome>Malnutrition. Timepoint: The beginning and end of the study. Method of measurement: subjective global assessment.</sec_outcome>
      <sec_outcome>Dependence on ventilator. Timepoint: daily. Method of measurement: Counting the number of ventilator attachment days.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-27</approval_date>
        <contact_name>Ethics committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
