<?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>IRCT20200911048685N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-21</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>corticosteroids in chronic subdural hematoma</public_title>
      <acronym></acronym>
      <scientific_title>The effect of topical corticosteroids combined with surgery in patients with chronic subdural hematoma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51249</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>chronic SubDural hematoma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A cross-sectional study will be performed on patients who have referred to hospitals related to Ahvaz University of Medical Sciences during subdural hematoma during 1398. Accordingly, after presenting the plan in the form of a research proposal and approving it in the relevant committees, the researcher, after receiving a license from Ahvaz Jundishapur University of Medical Sciences and a letter of introduction from the Vice Chancellor for Research and Technology, sampled based on the study process. And inclusion and exclusion criteria, in such a way that the goals and process of the study were stated as needed for patients, patients or patients' companions are asked to read and sign the informed consent form for the study and then patients enter Are studied. Accordingly, patients requiring surgical evacuation of subdural chronic hematoma who met the inclusion and exclusion criteria after nude craniotomy on the hematoma and drainage and rinsing of the hematoma with Ringer's serum implant a drain in the nostril of the craniotomy and the patient after surgery. The surgery is transferred to the neurosurgery department and monitored. On the third day after the operation, after monitoring the discharge of the drain, the drain is pulled and before removing the drain, 40 mg of methylprednisolone succinate is injected through the drain into the hematoma drain chamber. And the drain is completely stretched. Intervention 2: Control group: Distilled water is used for this group.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Street.North Esfand Street</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715753</zip>
        <telephone>+98 61 3333 0074</telephone>
        <email>Davood.mahmoudi68@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Street,North Esfand</address>
        <city>Aََhvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715753</zip>
        <telephone>+98 61 3333 0074</telephone>
        <email>Mahmoudi.d@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>chronic subdural hematoma</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute subdural hematoma
traumatic ICH
Epidural hematoma
depress fx
Intracranial mass and lesions
open lesion
CSF leak
previous shunt</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I62.03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nontraumatic chronic subdural hemorrhage</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: A cross-sectional study will be performed on patients who have referred to hospitals related to Ahvaz University of Medical Sciences during subdural hematoma during 1398. Accordingly, after presenting the plan in the form of a research proposal and approving it in the relevant committees, the researcher, after receiving a license from Ahvaz Jundishapur University of Medical Sciences and a letter of introduction from the Vice Chancellor for Research and Technology, sampled based on the study process. And inclusion and exclusion criteria, in such a way that the goals and process of the study were stated as needed for patients, patients or patients' companions are asked to read and sign the informed consent form for the study and then patients enter Are studied. Accordingly, patients requiring surgical evacuation of subdural chronic hematoma who met the inclusion and exclusion criteria after nude craniotomy on the hematoma and drainage and rinsing of the hematoma with Ringer's serum implant a drain in the nostril of the craniotomy and the patient after surgery. The surgery is transferred to the neurosurgery department and monitored. On the third day after the operation, after monitoring the discharge of the drain, the drain is pulled and before removing the drain, 40 mg of methylprednisolone succinate is injected through the drain into the hematoma drain chamber. And the drain is completely stretched.</i_keyword>
      <i_keyword>Control group: Distilled water is used for this group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Recurrence of chronic subdural hemorrhage. Timepoint: 6 months. Method of measurement: Designed questionnaire.</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>Vice Chancellor for Research, Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-27</approval_date>
        <contact_name>Ethics committee of Ahvaz jundishapur univercity  of medical sciences</contact_name>
        <contact_address>Golestan, jundishapur university of medical sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
