<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04414020</url>
  </required_header>
  <id_info>
    <org_study_id>623-4/2020</org_study_id>
    <nct_id>NCT04414020</nct_id>
  </id_info>
  <brief_title>Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors</brief_title>
  <official_title>Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical&#xD;
      trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone&#xD;
      is a neurotransmittern , trail to use in abolishing neurotoxcicty&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Progesterone is a natural neurosteroid that we are trying to use to impede both direct&#xD;
      neuronal injury cauesd by and indirectly by surgical trauma. Progesterone can decreas&#xD;
      vasogenic brain oedema. Our primary outcome is to ameliorate microscopic cytoplasmic injury&#xD;
      and decrease brain oedema exploited by biopsy from brain tumor interface. Exclusion criteria&#xD;
      demonstratd as refusal to participate in the trial , emergency craniotomy, recurrent brain&#xD;
      tumor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With craniotomy-Related Adverse Events</measure>
    <time_frame>3 months</time_frame>
    <description>Degree of microscopic cellular injury and brain odema in brain biopsy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with neuronal deficit</measure>
    <time_frame>2 months</time_frame>
    <description>Sensory, motor or autonomic dysfunction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Diffuse Traumatic Cerebral Edema</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group receiving conventional treatment without progesterone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>progesterone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Progesteron</intervention_name>
    <description>intramusculer progesterone</description>
    <arm_group_label>progesterone group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All elective brain tumors elligible for craniotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participare&#xD;
&#xD;
          -  Emergency craniotomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mina Raouf, MD</last_name>
    <phone>01015752424</phone>
    <email>drmina2015@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Al Minyā</city>
        <state>Abohelal</state>
        <zip>6115</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>mina raouf, MD</last_name>
      <phone>01015752424</phone>
      <email>Drmina2015@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>omaima mohammad, MD</last_name>
      <phone>01061762894</phone>
      <email>Omayamshehata@yahoo.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Minya</city>
        <state>Abohelal</state>
        <zip>6115</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>mina raouf, MD</last_name>
      <phone>01015752424</phone>
      <email>Drmina2015@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>omaima mohammad, MD</last_name>
      <phone>01061762894</phone>
      <email>Omayamshehata@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Health and Population, Egypt</investigator_affiliation>
    <investigator_full_name>Mina Maher</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>Progesterone</keyword>
  <keyword>brain tumor</keyword>
  <keyword>Neuronal biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Brain Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Progesterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04414020
org study id: 623-4/2020
nct id: NCT04414020
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical
      trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone
      is a neurotransmittern , trail to use in abolishing neurotoxcicty
Progesterone is a natural neurosteroid that we are trying to use to impede both direct
      neuronal injury cauesd by and indirectly by surgical trauma. Progesterone can decreas
      vasogenic brain oedema. Our primary outcome is to ameliorate microscopic cytoplasmic injury
      and decrease brain oedema exploited by biopsy from brain tumor interface. Exclusion criteria
      demonstratd as refusal to participate in the trial , emergency craniotomy, recurrent brain
      tumor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With craniotomy-Related Adverse Events
time frame: 3 months
description: Degree of microscopic cellular injury and brain odema in brain biopsy
measure: Number of Participants with neuronal deficit
time frame: 2 months
description: Sensory, motor or autonomic dysfunction
arm group label: Control
arm group type: No Intervention
description: Control group receiving conventional treatment without progesterone
arm group label: progesterone group
arm group type: Active Comparator
description: 1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface
intervention type: Drug
intervention name: Progesteron
description: intramusculer progesterone
arm group label: progesterone group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mina Raouf, MD
phone: 01015752424
email: drmina2015@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ministry of Health and Population, Egypt
investigator full name: Mina Maher
investigator title: Principle investigator
mesh term: Brain Neoplasms
mesh term: Brain Edema
mesh term: Progesterone
sharing ipd: No