<!-- ========================================================================= -->
<!-- This DTD has been retired as of 12/14/2011                                -->
<!-- Please start using the XML schema available at                            -->
<!--   http://clinicaltrials.gov/ct2/html/images/info/public.xsd               -->
<!-- ========================================================================= -->

<!-- ========================================================================= -->
<!-- XML DTD for ClinicalTrials.gov public XML                                 -->
<!-- http://clinicaltrials.gov/ct2/html/images/info/public.dtd                 -->
<!-- National Library of Medicine, National Institutes of Health               -->
<!-- DTD Version: 2011.12.14                                                   -->
<!--                                                                           -->
<!-- This DTD is subject to change without notice.                             -->
<!-- Any data displayed to the public must include attribution                 -->
<!--  to http://ClinicalTrials.gov and contain the information                 -->
<!--  in the <required_header> from each trial record.                         -->
<!--                                                                           -->
<!-- Changes:                                                                  -->
<!-- 02/22/2006 Fixed error indicating citation contained textblock            -->
<!-- 05/19/2006 Added withdrawn status                                         -->
<!-- 12/12/2006 Added oversight_info                                           -->
<!-- 01/10/2007 Added nct_alias                                                -->
<!-- 03/02/2007 Added has_dmc, why_stopped                                     -->
<!-- 03/15/2007 Removed last_follow_up, last_data_entry dates                  -->
<!--            (end_date contains last_follow_up)                             -->
<!-- 04/11/2007 added acronym, removed erroneous abbrev                        -->
<!-- 04/16/2007 added expanded access status values to overall_status          -->
<!-- 04/19/2007 added measure, time_frame, and number_of_arms                  -->
<!--            Moved and renamed expected_enrollment to enrollment            -->
<!-- 07/18/2007 added tags related to arms and more intervention details       -->
<!--            <arm_group> and child nodes                                    -->
<!--            intervention /description, /arm_group_label, /other_name       -->
<!-- 07/21/2007 removed redundant tags (description, arm_group_label)          -->
<!-- 09/20/2007 changed possible values for overall_status                     -->
<!-- 10/08/2007 added new elements related to observational studies            -->
<!--            (number_of_groups, biospec_retention, biospec_descr,           -->
<!--            study_pop, sampling_method)                                    -->
<!-- 10/11/2007 added optional rank attribute to clinical_study                -->
<!-- 01/10/2008 added study_type                                               -->
<!-- 05/20/2008 added healthy_volunteers to eligibility                        -->
<!-- 06/19/2008 added primary_completion_date                                  -->
<!--            Date when measurement of the primary outcome measure           -->
<!--            will be complete                                               -->
<!-- 06/19/2008 added safety_issue to outcomes                                 -->
<!-- 02/20/2009 updated comment on phase to match reality                      -->
<!-- 05/12/2009 added tag <completion_date>                                    -->
<!--            This field is the last followup date, when available,          -->
<!--            otherwise, end date.  <end_date> tag is now obsolete.          -->
<!-- 05/12/2009 added optional type attribute to <enrollment>,                 -->
<!--            <completion_date>, and <primary_completion_date>.              -->
<!--            Attribute will be type="Actual" or type="Anticipated"          -->
<!--            when available.                                                -->
<!-- 06/04/2009 moved comment which caused validation failure                  -->
<!-- 10/15/2009 added responsible party when available                         -->
<!-- 12/01/2009 corrected format for a couple of dates that include day        -->
<!-- 03/04/2010 removed obsolete always-empty tags, first_name, middle_name,   -->
<!--            and degrees.  The tag, last_name holds the entire name.        -->
<!-- 03/04/2010 added description tag to primary_outcome and                   -->
<!--            secondary_outcome.                                             -->
<!-- 04/02/2010 removed obsolete end_date tag - use completion_date instead    -->
<!-- 05/21/2010 made more tags optional                                        -->
<!-- 07/01/2010 made more tags optional - trying to avoid writing empty tags.  -->
<!--            Most missing data is due to delayed posting of device records. -->
<!--            A device NOT previously approved or cleared by the US FDA for  -->
<!--            any use, as specified in US Public Law 110-85, Title VIII,     -->
<!--            Section 801 can delay full posting of the trial information    -->
<!--            on ClinicalTrials.gov until after the device has been approved -->
<!--            or cleared.  These records have the following title:  [Trial   -->
<!--            of device that is not approved or cleared by the U.S. FDA]     -->
<!-- 07/14/2010 Added keywords, is_fda_regulated, is_section_801, and          -->
<!--            has_expanded_access, when given by data provider               -->
<!-- 07/14/2010 Added condition_browse and intervention_browse, which are      -->
<!--            lists of mesh_terms that are (probably) relevant to the trial  -->
<!--            record.  Relevancy is determine programmatically, and can be   -->
<!--            wrong.  We fix errors when we see them.                        -->
<!-- 09/07/2010 Added firstreceived_results_date.  The presence of this tag    -->
<!--            indicates that results are available for this trial on         -->
<!--            ClinicalTrials.gov.  An XML format of the results info is      -->
<!--            currently under review and may soon be available for download. -->
<!-- 09/10/2010 Added agency_class to sponsor and collaborators.  Possible     -->
<!--            values: NIH, U.S. Fed, Industry, and Other                     -->
<!-- 10/12/2010 Added location_countries, a list of all countries with a       -->
<!--            trial location.  Added removed_countries, a list of all        -->
<!--            countries that no longer have a trial location, but had        -->
<!--            one in a previous version of the trial record.  The union      -->
<!--            of these two lists is all countries that have ever had a       -->
<!--            trial location listed in the trial record.                     -->
<!-- 08/03/2011 Indicate optionality of facility in location                   -->
<!-- 11/28/2011 Added 4 additional optional fields to <responsible_party>      -->
<!--            <responsible_party_type> <investigator_affiliation>            -->
<!--            <investigator_full_name> and <investigator_title>.             -->
<!--            See comments on responsible party definition below.            -->
<!-- 12/14/2011 Added optional element, clinical_results, but set no           -->
<!--            restrictions on its content.                                   -->
<!-- 12/14/2011 Retiring this DTD.  Now recommending use of XML Schema at      -->
<!--            http://clinicaltrials.gov/ct2/html/images/info/public.xsd      -->
<!-- ========================================================================= -->

<!ELEMENT clinical_study (
          required_header,
          id_info,
          brief_title,
          acronym?,
          official_title?,
          sponsors,
          source,
          oversight_info?,
          brief_summary?,
          detailed_description?,
          overall_status,
          why_stopped?,
          start_date?,
          completion_date?,
          primary_completion_date?,
          phase,
          study_type,
          study_design,
          primary_outcome*,
          secondary_outcome*,
          number_of_arms?,
          number_of_groups?,
          enrollment?,
          condition*,
          arm_group*,
          intervention*,
          biospec_retention?,
          biospec_descr?,
          eligibility?,
          overall_official*,
          overall_contact?,
          overall_contact_backup?,
          location*,
          location_countries?,
          removed_countries?,
          link*,
          reference*,
          results_reference*,
          verification_date?,
          lastchanged_date?,
          firstreceived_date,
          firstreceived_results_date?,
          responsible_party?,
          keyword*,
          is_fda_regulated?,
          is_section_801?,
          has_expanded_access?,
          condition_browse?,
          intervention_browse?,
          clinical_results?)>

<!ATTLIST clinical_study rank CDATA "0">

<!-- === Required Header =================================================== -->

<!ELEMENT required_header (
          download_date,
          link_text,
          url)>

<!ELEMENT download_date (#PCDATA)>
<!ELEMENT link_text (#PCDATA)>
<!ELEMENT url (#PCDATA)>


<!-- === Id Info =========================================================== -->

<!ELEMENT id_info (
          org_study_id,
          secondary_id*,
          nct_id,
          nct_alias*)>

<!ELEMENT org_study_id (#PCDATA)>
<!ELEMENT secondary_id (#PCDATA)>
<!ELEMENT nct_id (#PCDATA)>
<!ELEMENT nct_alias (#PCDATA)>


<!-- === Titles ============================================================ -->

<!ELEMENT brief_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT official_title (#PCDATA)>


<!-- === Sponsors ========================================================== -->

<!ELEMENT sponsors (
          lead_sponsor,
          collaborator*)>

<!ELEMENT lead_sponsor (
          agency, 
          agency_class)>
          
<!ELEMENT collaborator (
          agency, 
          agency_class)>
          
<!ELEMENT agency (#PCDATA)>
<!ELEMENT agency_class (#PCDATA)> <!-- Possible values: NIH | U.S. Fed | Industry | Other -->

<!ELEMENT source (#PCDATA)>


<!-- === Oversight ========================================================= -->

<!ELEMENT oversight_info (
          authority*,
          has_dmc?)>

<!ELEMENT authority (#PCDATA)>
<!ELEMENT has_dmc (#PCDATA)>       <!-- data monitoring committee: Yes | No -->


<!-- === Description ======================================================= -->

<!ELEMENT brief_summary (textblock)>
<!ELEMENT detailed_description (textblock)>
<!ELEMENT textblock (#PCDATA)>


<!-- === Status ============================================================ -->

<!ELEMENT overall_status (#PCDATA)>   <!-- Possible values:
          Not yet recruiting | Recruiting | Enrolling by invitation |
          Active, not recruiting | Completed | Suspended | Terminated |
          Withdrawn | Available | No Longer Available -->
          <!-- last two are for expanded access records -->

<!ELEMENT why_stopped (#PCDATA)>   <!-- brief explanation -->


<!-- === Misc ============================================================== -->

<!ELEMENT phase (#PCDATA)>            <!-- Phase [1,2,3,4] [/ Phase [1,2,3,4]] | N/A -->
<!ELEMENT study_type (#PCDATA)>       <!-- Interventional | Observational | Expanded Access -->
<!ELEMENT study_design (#PCDATA)>

<!ELEMENT number_of_arms (#PCDATA)>    <!-- integer -->
<!ELEMENT number_of_groups (#PCDATA)>  <!-- integer -->

<!ELEMENT enrollment (#PCDATA)>            <!-- integer -->
<!ATTLIST enrollment type CDATA #IMPLIED>  <!-- Can be missing.  Possible values: Actual | Anticipated -->


<!-- === Outcomes ========================================================== -->

<!ELEMENT primary_outcome (
          measure,
          time_frame?,
          safety_issue?,
          description?)>

<!ELEMENT secondary_outcome (
          measure,
          time_frame?,
          safety_issue?,
          description?)>

<!ELEMENT measure (#PCDATA)>
<!ELEMENT time_frame (#PCDATA)>
<!ELEMENT safety_issue (#PCDATA)>

<!ELEMENT description (#PCDATA)>         <!-- used in several contexts -->


<!-- === Conditions ======================================================== -->

<!ELEMENT condition (#PCDATA)>


<!-- === Arms ============================================================== -->

<!ELEMENT arm_group (
          arm_group_label,
          arm_group_type?,
          description?)>

<!ELEMENT arm_group_label (#PCDATA)>    <!-- join key with intervention field -->
<!ELEMENT arm_group_type (#PCDATA)> <!-- Possible values:
            Experimental | Active Comparator | Placebo Comparator |
            Sham Comparator | No Intervention | Other | Case |
            Control | Treatment Comparison | Exposure Comparison -->


<!-- === Interventions ===================================================== -->

<!ELEMENT intervention (
          intervention_type,
          intervention_name,
          description?,
          arm_group_label*,
          other_name*)>

<!ELEMENT intervention_type (#PCDATA)>   <!-- Possible values:
          Drug | Device | Biological/Vaccine | Genetic | Behavioral |
          Radiation | Procedure/Surgery Dietary Supplement | Other -->

<!ELEMENT intervention_name (#PCDATA)>
<!ELEMENT other_name (#PCDATA)>    <!-- synonyms for intervention_name -->


<!-- === Bio Specimen ====================================================== -->

<!ELEMENT biospec_retention (#PCDATA)>   <!-- None Retained | Samples With DNA | Samples Without DNA -->
<!ELEMENT biospec_descr (textblock)>     <!-- describes nature of specifimen -->


<!-- === Eligibility ======================================================= -->

<!ELEMENT eligibility (
          study_pop?,
          sampling_method?,
          criteria?,
          gender,
          minimum_age,
          maximum_age,
          healthy_volunteers?)>

<!ELEMENT study_pop (textblock)>
<!ELEMENT sampling_method (#PCDATA)>   <!-- Probability Sample | Non-Probability Sample -->
<!ELEMENT criteria (textblock)>
<!ELEMENT gender (#PCDATA)>  <!-- Both | Female | Male -->

<!-- Ages are a WholeNumber followed by units: eg. "12 Years" -->
<!-- Units may be one of: years, months, weeks, days, hours, minutes -->
<!ELEMENT minimum_age (#PCDATA)>         <!-- 12 years -->
<!ELEMENT maximum_age (#PCDATA)>         <!-- N/A -->

<!ELEMENT healthy_volunteers (#PCDATA)>


<!-- === Contacts ========================================================== -->

<!ELEMENT overall_official (
          last_name?,
          role?,
          affiliation?)>

<!ELEMENT last_name (#PCDATA)>      <!-- holds entire name -->
<!ELEMENT role (#PCDATA)>           <!-- Principal Investigator | Sub-Investigator -->
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT overall_contact (
          last_name?,
          phone?,
          phone_ext?,
          email?)>

<!ELEMENT phone (#PCDATA)>
<!ELEMENT phone_ext (#PCDATA)>
<!ELEMENT email (#PCDATA)>

<!ELEMENT overall_contact_backup (
          last_name?,
          phone?,
          phone_ext?,
          email?)>


<!-- === Locations ========================================================= -->

<!ELEMENT location (
          facility?,
          status?,
          contact?,
          contact_backup?,
          investigator*)>

<!ELEMENT facility (
          name?,
          address?)>

<!ELEMENT name (#PCDATA)>

<!ELEMENT address (
          city,
          state?,
          zip?,
          country)>

<!ELEMENT city (#PCDATA)>
<!ELEMENT state (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT country (#PCDATA)>

<!ELEMENT status (#PCDATA)> <!-- Possible values:
          Not yet recruiting | Recruiting | Enrolling by invitation |
          Active, not recruiting | Completed | Suspended | Terminated -->

<!ELEMENT contact (
          last_name?,
          phone?,
          phone_ext?,
          email?)>

<!ELEMENT contact_backup (
          last_name?,
          phone?,
          phone_ext?,
          email?)>

<!ELEMENT investigator (
          last_name,
          role?)>

<!ELEMENT location_countries (
          country*)>

<!ELEMENT removed_countries (
          country*)>


<!-- === Links ============================================================= -->

<!ELEMENT link (
          url,
          description?)>


<!-- === References ======================================================== -->

<!ELEMENT reference (
          citation?,
          PMID?)>

<!ELEMENT citation (#PCDATA)>    <!-- full bibliographic citation -->
<!ELEMENT PMID (#PCDATA)>        <!-- pubmed identifier -->

<!ELEMENT results_reference (
          citation?,
          PMID?)>


<!-- === Dates ============================================================= -->

<!ELEMENT start_date (#PCDATA)>                  <!-- Month Year (e.g. January 2008) -->

<!ELEMENT completion_date (#PCDATA)>             <!-- Month Year (e.g. January 2008) -->
<!ATTLIST completion_date type CDATA #IMPLIED>   <!-- Can be missing.  Possible values: Actual | Anticipated -->

<!ELEMENT primary_completion_date (#PCDATA)>            <!-- Month Year (e.g. January 2008) -->
<!ATTLIST primary_completion_date type CDATA #IMPLIED>  <!-- Can be missing.  Possible values: Actual | Anticipated -->

<!ELEMENT verification_date (#PCDATA)>           <!-- Month Year (e.g. January 2008) -->
<!ELEMENT lastchanged_date (#PCDATA)>            <!-- Month Day, Year (e.g. April 1, 2008) -->
<!ELEMENT firstreceived_date (#PCDATA)>          <!-- Month Day, Year (e.g. April 1, 2008) -->
<!ELEMENT firstreceived_results_date (#PCDATA)>  <!-- Month Day, Year (e.g. April 1, 2008) -->


<!-- === Responsible Party ================================================= -->

<!ELEMENT responsible_party (
          name_title?,
          organization?,
          responsible_party_type?,               
          investigator_affiliation?,
          investigator_full_name?,
          investigator_title?)>

<!-- Original approach had these 2 fields -->
<!ELEMENT name_title (#PCDATA)>                
<!ELEMENT organization (#PCDATA)>

<!-- Updated approach, as of 11/28/2011, has these 4 fields -->
<!-- New records will use this new approach, but responsible party is still optional. -->
<!-- Old records may be converted to new approach when updated (possibly never). -->
<!ELEMENT responsible_party_type (#PCDATA)>    
<!ELEMENT investigator_affiliation (#PCDATA)>
<!ELEMENT investigator_full_name (#PCDATA)>
<!ELEMENT investigator_title (#PCDATA)>
<!-- responsible_party_type has values: -->
<!--   Sponsor, Principal Investigator, or Sponsor Investigator -->
<!-- If type is Sponsor, there is usually no investigator data -->


<!-- === Keywords ========================================================== -->

<!ELEMENT keyword (#PCDATA)>


<!-- === Flags ============================================================= -->

<!ELEMENT is_fda_regulated (#PCDATA)>
<!ELEMENT is_section_801 (#PCDATA)>
<!ELEMENT has_expanded_access (#PCDATA)>


<!-- === Browse ============================================================ -->

<!ELEMENT condition_browse (
          mesh_term*)>

<!ELEMENT intervention_browse (
          mesh_term*)>

<!ELEMENT mesh_term (#PCDATA)>

<!-- === Clinical Results ================================================== -->

<!ELEMENT clinical_results ANY>




