<?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>IRCT20210123050123N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-30</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Effect of vitamin C on head truama ;</public_title>
      <acronym></acronym>
      <scientific_title>The effect of high dose of vitamin C on brain acute phase biomarker in patients with diffuse axonal brain injury .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62606</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Identified patients are randomly divided into two groups of drugs and placebo based on a random block, and the method of selecting patients is that each patient is randomly assigned to the hospital by an emergency physician who is familiar with the type of study but not familiar with assignment of patients . They are divided into two groups, A and B, based on RANDOM software, Blinding description: The attending physician will inject the type of drug or placebo based on the choice of A and B at the time of the study and the drug will be written as codes A and B. The injector, patient and donor have no information about its type. Patients' legal guardians will also be given the necessary explanations regarding the objectives of the study and the method of conducting the study, and they will be informed that they may receive one of the types of drugs A or B and will obtain their informed consent.</study_design>
      <phase>3</phase>
      <hc_freetext>Description of patients with diffuse brain injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Receiving vitamin C in a dose of 10 g / 100 ml daily as a continuous infusion (4.166 ml / h) for 7 days. Intervention 2: Control group: ormal saline (100 ml with the same color and shape as the drug) as a continuous infusion (4.166 ml / h) daily for 7 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:
Published in prestigious journals

When:
2 years

To whom:
Professors and students

Conditions:
Publication of a scientific article

Where to obtain:
The person in charge of the project

How to obtain:
Processing and receiving

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Anoush  Dehnadi  Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poursina Hospital,Namjo ave,Rasht Town,Gilan,IRI</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713194</zip>
        <telephone>0133325783</telephone>
        <email>dehnadi@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Anoush  Dehnadi  Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poursina Hospital,Namjo ave,Rasht Town,Gilan,IRI</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713194</zip>
        <telephone>0133335783</telephone>
        <email>dehnadi@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult patients aged 16 years or older and &lt;60 years
Moderate to severe diffuse axonal injury with a Glasgow coma  score of 4 to12
Admission with diagnosis of diffuse brain injury as defined by ICD-10  S06.2  within the first 24 hours of injury
Radiological diagnosis of diffuse axonal brain injury</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a specific pathology on a CT scan of the brain that is inconsistent with the diagnosis of DAI
Patients with acute  and chronic  liver injuries
Ptients with acute and chronic renal insufficiency and those at high risk for urinary stones.
people with underlying conditions such as uncontrolled diabetes, high blood pressure , chronic obstructive pulmonary disease , blood diseases ,Malnutrition or unusual diets.
Previous central nervous system injury , concomitant spinal cord injury, space-occupying lesions requiring emergency evacuation
Patients whose guardians do not consent to participate in the study
patients with a previous diagnosis of severe psychiatric illness or substance abuse
patients with shock or hypoxia or Cardiopulmonary arrest following trauma.</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 - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Receiving vitamin C in a dose of 10 g / 100 ml daily as a continuous infusion (4.166 ml / h) for 7 days</i_keyword>
      <i_keyword>Control group: ormal saline (100 ml with the same color and shape as the drug) as a continuous infusion (4.166 ml / h) daily for 7 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Acute Brain Biomarker S100B Protein. Timepoint: First ,Third and Eighth Day. Method of measurement: ELISA  kit  S100B.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glasgo Coma Score. Timepoint: The begining of the intervention,Third and Eighth Day. Method of measurement: Glasgo Coma Score Table.</sec_outcome>
      <sec_outcome>Acute Oxalate Nephropathy. Timepoint: The begining of Study,Third and Eighth day. Method of measurement: Measurement of urinary output,oxalate amount and specific gravity of urine,urea ,uric acid and creatinin of plasma.</sec_outcome>
      <sec_outcome>Glasgow Outcome Score. Timepoint: The begining of study,first and Third month. Method of measurement: Glasgow Outcome Score Scale.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-09</approval_date>
        <contact_name>Gilan Ethics Committee for biosafety&amp; laboratory Standards</contact_name>
        <contact_address>Guilan University of Medical Sciences ,Namjo ave,Rasht Town,Gilan,IRI Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
