<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/NCT02214745</url>
  </required_header>
  <id_info>
    <org_study_id>0032-14-HYMC</org_study_id>
    <nct_id>NCT02214745</nct_id>
  </id_info>
  <brief_title>Demographic Characteristics of Children Suffering From Mental Retardation or Cerebral Palsy in the Israeli Arab Community</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the demographic characteristics of patients suffering from mental retardation or&#xD;
      cerebral palsy in the Israeli Arab community. Specific questionnaires will be developed and&#xD;
      will be distributed amongst this population in order to identify these characteristics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Demographic Characteristics</measure>
    <time_frame>One day</time_frame>
    <description>Demographic characteristics will be identified through a questionnaire and will be compared with control groups.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Mental Retardation</condition>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Mentally retarded Israeli Arab children</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Israeli Arab children with cerebral palsy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Israeli Jewish children with cerebral palsy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Mentally retarded Israeli Jewish children</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Questionnaire developed for this purpose by the investigators</description>
    <arm_group_label>Israeli Arab children with cerebral palsy</arm_group_label>
    <arm_group_label>Israeli Jewish children with cerebral palsy</arm_group_label>
    <arm_group_label>Mentally retarded Israeli Arab children</arm_group_label>
    <arm_group_label>Mentally retarded Israeli Jewish children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Israeli Arab and Israeli Jewsih children suffering from mental retardation or cerebral&#xD;
        palsy who have presented at the Child Development Institute at the Hillel Yaffe Medical&#xD;
        Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cerebral palsy&#xD;
&#xD;
          -  mental retardation&#xD;
&#xD;
          -  Israeli Arab&#xD;
&#xD;
          -  Israeli Jewish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  all others&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muhammad Mahajnah, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Muhammad Mahajnah, MD, PhD</last_name>
    <phone>972-5-624-6959</phone>
    <email>mohamedm@hy.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Muhammad Mahajnah, MD, PhD</last_name>
      <phone>972-5-624-6959</phone>
      <email>mohamedm@hy.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Israeli Arab population</keyword>
  <keyword>Israeli/ethnology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Intellectual Disability</mesh_term>
  </condition_browse>
  <!-- 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/NCT02214745
org study id: 0032-14-HYMC
nct id: NCT02214745
lead sponsor: 
has dmc: Yes
To evaluate the demographic characteristics of patients suffering from mental retardation or
      cerebral palsy in the Israeli Arab community. Specific questionnaires will be developed and
      will be distributed amongst this population in order to identify these characteristics.
observational model: Ecologic or Community
time perspective: Retrospective
measure: Demographic Characteristics
time frame: One day
description: Demographic characteristics will be identified through a questionnaire and will be compared with control groups.
arm group label: Mentally retarded Israeli Arab children
arm group label: Israeli Arab children with cerebral palsy
arm group label: Israeli Jewish children with cerebral palsy
arm group label: Mentally retarded Israeli Jewish children
intervention type: Other
intervention name: Questionnaire
description: Questionnaire developed for this purpose by the investigators
arm group label: Israeli Arab children with cerebral palsy
arm group label: Israeli Jewish children with cerebral palsy
arm group label: Mentally retarded Israeli Arab children
arm group label: Mentally retarded Israeli Jewish children
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Muhammad Mahajnah, MD, PhD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
last name: Muhammad Mahajnah, MD, PhD
phone: 972-5-624-6959
email: mohamedm@hy.health.gov.il
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Cerebral Palsy
mesh term: Intellectual Disability