<?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>IRCT20081202001483N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-16</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of effect injection of diltiazem into middle ear on the hearing loss due to Cisplatin</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of cisplatin otoprotection using intratympanic diltiazem and placebo among patients with solid cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33465</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: With using of Pass software , randomly assigned  control Ear and intervention Ear, Blinding description: In order to maintain double blindness in the study, both patients and all researchers will be unaware of the received drug.  A researcher will explain about the drug to the patients and assign each ear to control ear or intervention ear according to the Random Number Table (PASS software). Same researcher will inject drug or placebo in middle ear under local anesthesia.  Another researcher will evaluate the patients before and after intervention. Audiologist and patients will be blinded about type of intervention of each ear.</study_design>
      <phase>3</phase>
      <hc_freetext>Hearing Loss.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At first, Case-ear is filled with Xyla-P ointment. After 5 minute local anesthesia , ointment was suctioned under microscope. 0.7-1 cc of Diltiazem solution (5mg/ml) is injected through inferior-posterior quadrant of tympanic membrane into middle ear( near round niches). Then participation is asked to supine on opposite ear,  avoid swallow, and cough for 20 minute. Intervention 2: Control group: At first, control-ear is filled with Xyla-P ointment. After 5 minute local anesthesia , ointment was suctioned under microscope.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is not more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mirmohammad Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralamomenin Hospital, 17 Shahrivar St</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41396-37459</zip>
        <telephone>+98 13 3322 5242</telephone>
        <email>mmjalali@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mirmohammad Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralamomenin Hospital, 17 Shahrivar St</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41396-37459</zip>
        <telephone>+98 13 3322 5242</telephone>
        <email>mmjalali@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years old
Presence of Acoustic Reflex or Tympanometry A
In PTA, average hearing threshold at frequencies of 3000-5000 or 8000 to 4000 less than 40 dB
In PTA, the hearing threshold on either side should not be asymetric within 3000 to 5000 or 8000-4000 Hz frequencies or there is less than 10 dB
The karnofsky index is equal to or greater than 70</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of previous internal ear disease that may reduce the sensory nervous system hearing
History of Meniere's disease Or fluticating hearing loss
Observing pathologic findings in otoscopy
Previously cisplatin has not been treated
Radiation History to the head and neck Area
Candidate for radiation to the head and neck
Liver and Renal failure
Conductive hearing loss more than 5 dB
Heart problems, such as hypotension or AV block</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H91.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ototoxic hearing loss</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: At first, Case-ear is filled with Xyla-P ointment. After 5 minute local anesthesia , ointment was suctioned under microscope. 0.7-1 cc of Diltiazem solution (5mg/ml) is injected through inferior-posterior quadrant of tympanic membrane into middle ear( near round niches). Then participation is asked to supine on opposite ear,  avoid swallow, and cough for 20 minute</i_keyword>
      <i_keyword>Control group: At first, control-ear is filled with Xyla-P ointment. After 5 minute local anesthesia , ointment was suctioned under microscope</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hearing Loss. Timepoint: One week and one month after the last dose of cisplatin. Method of measurement: Audiometry Test.</prim_outcome>
      <prim_outcome>Low-frequency Average hearing threshold. Timepoint: One week and one month after the last dose of cisplatin. Method of measurement: Audiometry Test.</prim_outcome>
      <prim_outcome>High-frequency Average hearing threshold. Timepoint: One week and one month after the last dose of cisplatin. Method of measurement: Audiometry Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ototoxicity Grade. Timepoint: One week and one month after the last dose of cisplatin. Method of measurement: Audiometry( Grade changes).</sec_outcome>
      <sec_outcome>Complications of cisplatin injection. Timepoint: One week and one month after the last dose of cisplatin. Method of measurement: Questions From Patient.</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>2018-08-18</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Vice-chancellor for Research Building, opposite of Sepah Bank,Shahid Beheshti Blvd Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
