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romanegloo/clinical_trial-sample.xsd

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TREC precision medicine document samples
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clinical_trial-sample.xsd
public.xsd:
<?xml version="1.0" encoding="UTF-8" ?>
<!-- ============================================================================================
XML Schema for ClinicalTrials.gov public XML
http://clinicaltrials.gov/ct2/html/images/info/public.xsd
National Library of Medicine, National Institutes of Health
Version: 2017.02.13
Change History for schema:
12/13/2011 Initial Version
Replaces XML DTD at:
http://clinicaltrials.gov/ct2/html/images/info/public.dtd
Includes specification of study results
12/21/2011 Minor revision to remove declaration of namespace
07/20/2012 Added other_outcome tag, similar to secondary_outcome
07/15/2013 In clinical_results, added population tag to baseline measure.
Holds population description
Matches population tag in outcome measure
07/15/2013 In clinical_results, marked several tags as optional
07/15/2013 In clinical_results, added optional comment as text of measurements
tag - used to be just attributes with no text
03/27/2014 Added optional target_duration
06/05/2015 Added data type restrictions and key/keyref constraints to better
document the possible values of most fields. If no constraints are
specified in the schema, assume any value is possible.
06/30/2016 Added structured data under patient_data tag
06/30/2016 Added structured data under study_docs tag
06/30/2016 Added firstreceived_results_disposition_date tag
11/24/2016 Added last_known_status tag and a new allowed value for overall_status
If a study is open (overall status of recruiting, not yet recruiting, or expanded
access available), the overall status is supposed to be verified occasionally, and
updated when it changes. If the status has not been verified in 2 years, and the
current date is past the study primary completion date or completion date, then the
status is inconsistent. In this case, the inconsistent value is kept in the new
last_known_status tag and the overall_status tag is changed to "Unknown status".
12/02/2016 Changes in results structure to enhance baseline and outcome measures
Category tags now imply categorical variables with mutually exclusive values.
Categories are now contained in new class tags, which are not mutually exclusive.
Obese/Smoker are example classes. Male/Female are example categories.
Although it is possible to have multiple classes containing multiple categories,
in practice there is usually either 1) one unnamed class containing multiple named
categories or 2) multiple named classes, each containing one unnamed category.
Baseline measures have been expanded to describe measures of non-participant units.
Fingers/Lesions are example units. Info about the participants/units has been broken
out into analyzed tags. The analyzed structure contains a units tag, scope tag, and
list of count tags.
If non-participant units exist, each baseline measure will have a units_analyzed tag
that selects which was analyzed, participants or units.
Overall counts of participants/units are given for all baseline measures. These
counts can be overridden by the presence of an analyzed tag in an individual measure,
or even in an individual class. Example: measure six minute walk test, classes
include obese with categories of male/female. To get male/female percentages, you
need the number of participants in the obese class. To get obese percentage, you
need the number of participants completing the walk test. Either of these numbers can
differ from the overall number of participants, and now there is a way to define them.
Outcome measures have been adjusted to be consistent with baseline measures
Outcome measures used to show counts of participants/units as separate measures.
Now that they have been moved to analyzed tags, there is only one measure and no
need for a measure_list tag.
More changes are expected in the beginning of 2017 due to implementation of
final rules for FDAAA 801.
01/11/2017 Dates will optionally include a day, especially those that are used to calculate deadlines
Start dates will optionally include a type attribute of Actual or Anticipated
Added 5 new Yes/No flags to <oversight_info>: <is_fda_regulated_drug>,
<is_fda_regulated_device>, <is_unapproved_device>, <is_ppsd>, and <is_us_export>.
Removed <authority> tags from <oversight_info>.
This field is no longer collected and legacy data abandoned
Removed <is_fda_regulated> and <is_section_801> tags. Obsolete and abandoned.
Created <expanded_access_info> section to hold 3 new protocol Yes/No flags:
<exp_acc_type_individual>, <exp_acc_type_intermediate>, and <exp_acc_type_treatment>.
These flags only appear on records with study type, "Expanded Access"
Study design has changed from a comma delimited list in a string into structured data.
A new <study_design_info> section contains the following new tags: <allocation>,
<intervention_model>, <intervention_model_description>, <primary_purpose>,
<time_perspective>, <masking>, and <masking_description>.
Removed endpoint classification data from study design.
This field is no longer collected and legacy data abandoned
By default, the <gender> tag indicates patients' biolgical sex and has values Male,
Female, or All (which replaces Both). The Yes/No tag <gender_based> and discussion
<gender_description> indicate and explain any distinctions between patient gender
and biological sex.
We replaced the Yes/No tag <non_inferiority> in outcome analysis with a new tag
<non_inferiority_type> which can have additional values. Also, outcome analysis
has a new tag <other_analysis_desc>
Serious adverse events get another total, all-cause mortality, both <subjects_affected>
and <subjects_at_risk>. This is new content, but no new tags
Removed safety issue data from outcome measures in protocol and results.
This field is no longer collected and legacy data abandoned
measure_dispersion is no longer an enum. Data providers can use any confidence
interval limit they wish
01/25/2017 Added two additional values for the intervention type enum: 1) Diagnostic test and
2) Compound Product
02/08/2017 Corrected intervention type enum: Compound Product becomes Combination Product
02/13/2017 Corrected phase_enum: "Phase 0" becomes "Early Phase 1"
05/12/2017 Added "Geometric Least Squares Mean" to measure_param_enum
============================================================================================ -->
<!--
Note: information on some device trials cannot be provided by ClinicalTrials.gov.
The public site displays the following disclaimer for such trials:
This trial has been identified as being associated with a clinical device
that has not been approved or cleared by the US Food and Drug
Administration. Under the terms of US Public Law 110-85, Title VIII,
Section 801, the details of this study are not available to the public.
The XML for such trials will contain very little usable information. These
trials (and only these trials) will have the study_type set to "N/A".
-->
<xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema">
<!-- === Generic data types ========================================== -->
<xs:simpleType name="actual_anticipated_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Actual" />
<xs:enumeration value="Anticipated" />
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="yes_no_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Yes" />
<xs:enumeration value="No" />
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="recruitment_status_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Active, not recruiting" />
<xs:enumeration value="Completed" />
<xs:enumeration value="Enrolling by invitation" />
<xs:enumeration value="Not yet recruiting" />
<xs:enumeration value="Recruiting" />
<xs:enumeration value="Suspended" />
<xs:enumeration value="Terminated" />
<xs:enumeration value="Withdrawn" />
</xs:restriction>
</xs:simpleType>
<!-- === Required Header ============================================= -->
<xs:complexType name="required_header_struct">
<xs:sequence>
<xs:element name="download_date" type="xs:string"/>
<xs:element name="link_text" type="xs:string"/>
<xs:element name="url" type="xs:string"/>
</xs:sequence>
</xs:complexType>
<!-- === Id Info ===================================================== -->
<xs:complexType name="id_info_struct">
<xs:sequence>
<xs:element name="org_study_id" type="xs:string" minOccurs="0"/>
<xs:element name="secondary_id" type="xs:string" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="nct_id" type="xs:string"/>
<xs:element name="nct_alias" type="xs:string" minOccurs="0" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
<!-- === Sponsor ===================================================== -->
<xs:simpleType name="agency_class_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="NIH" />
<xs:enumeration value="U.S. Fed" />
<xs:enumeration value="Industry" />
<xs:enumeration value="Other" />
</xs:restriction>
</xs:simpleType>
<xs:complexType name="sponsor_struct">
<xs:sequence>
<xs:element name="agency" type="xs:string"/>
<xs:element name="agency_class" type="agency_class_enum"/>
</xs:sequence>
</xs:complexType>
<!-- === Sponsors ==================================================== -->
<xs:complexType name="sponsors_struct">
<xs:sequence>
<xs:element name="lead_sponsor" type="sponsor_struct"/>
<xs:element name="collaborator" type="sponsor_struct" minOccurs="0" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
<!-- === Oversight =================================================== -->
<xs:complexType name="oversight_info_struct">
<xs:sequence>
<xs:element name="has_dmc" type="yes_no_enum" minOccurs="0"/> <!-- data monitoring committee -->
<xs:element name="is_fda_regulated_drug" type="yes_no_enum" minOccurs="0"/>
<xs:element name="is_fda_regulated_device" type="yes_no_enum" minOccurs="0"/>
<xs:element name="is_unapproved_device" type="yes_no_enum" minOccurs="0"/>
<xs:element name="is_ppsd" type="yes_no_enum" minOccurs="0"/>
<xs:element name="is_us_export" type="yes_no_enum" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Expanded Access ============================================= -->
<xs:complexType name="expanded_access_info_struct">
<xs:sequence>
<xs:element name="expanded_access_type_individual" type="yes_no_enum" minOccurs="0"/>
<xs:element name="expanded_access_type_intermediate" type="yes_no_enum" minOccurs="0"/>
<xs:element name="expanded_access_type_treatment" type="yes_no_enum" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Study Design ================================================ -->
<xs:complexType name="study_design_info_struct">
<xs:sequence>
<xs:element name="allocation" type="xs:string" minOccurs="0"/>
<xs:element name="intervention_model" type="xs:string" minOccurs="0”/>/
<xs:element name="intervention_model_description" type="xs:string" minOccurs="0"/>
<xs:element name="primary_purpose" type="xs:string" minOccurs="0"/>
<xs:element name="observational_model" type="xs:string" minOccurs="0"/>
<xs:element name="time_perspective" type="xs:string" minOccurs="0"/>
<xs:element name="masking" type="xs:string" minOccurs="0"/>
<xs:element name="masking_description" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Protocol Outcome ============================================ -->
<xs:complexType name="protocol_outcome_struct">
<xs:sequence>
<xs:element name="measure" type="xs:string"/>
<xs:element name="time_frame" type="xs:string" minOccurs="0"/>
<xs:element name="description" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Enrollment ================================================== -->
<xs:complexType name="enrollment_struct">
<xs:simpleContent>
<xs:extension base="xs:integer">
<xs:attribute name="type" type="actual_anticipated_enum" use="optional"/>
</xs:extension>
</xs:simpleContent>
</xs:complexType>
<!-- === Arm Group =================================================== -->
<xs:complexType name="arm_group_struct">
<xs:sequence>
<xs:element name="arm_group_label" type="xs:string"/>
<xs:element name="arm_group_type" type="xs:string" minOccurs="0"/>
<xs:element name="description" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Intervention ================================================ -->
<xs:simpleType name="intervention_type_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Behavioral" />
<xs:enumeration value="Biological" />
<xs:enumeration value="Combination Product" />
<xs:enumeration value="Device" />
<xs:enumeration value="Diagnostic Test" />
<xs:enumeration value="Dietary Supplement" />
<xs:enumeration value="Drug" />
<xs:enumeration value="Genetic" />
<xs:enumeration value="Procedure" />
<xs:enumeration value="Radiation" />
<xs:enumeration value="Other" />
</xs:restriction>
</xs:simpleType>
<xs:complexType name="intervention_struct">
<xs:sequence>
<xs:element name="intervention_type" type="intervention_type_enum"/>
<xs:element name="intervention_name" type="xs:string"/>
<xs:element name="description" type="xs:string" minOccurs="0"/>
<xs:element name="arm_group_label" type="xs:string" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="other_name" type="xs:string" minOccurs="0" maxOccurs="unbounded"/> <!-- synonyms for intervention_name -->
</xs:sequence>
</xs:complexType>
<!-- === Textblock =================================================== -->
<xs:complexType name="textblock_struct">
<xs:sequence>
<xs:element name="textblock" type="xs:string"/>
</xs:sequence>
</xs:complexType>
<!-- === Eligibility ================================================= -->
<xs:simpleType name="sampling_method_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Probability Sample" />
<xs:enumeration value="Non-Probability Sample" />
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="gender_enum">
<xs:restriction base="xs:string”>
<xs:enumeration value="Female" />
<xs:enumeration value="Male" />
<xs:enumeration value="All" />
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="age_pattern">
<xs:restriction base="xs:string">
<xs:pattern value="N/A|([1-9][0-9]* (Year|Years|Month|Months|Week|Weeks|Day|Days|Hour|Hours|Minute|Minutes))"></xs:pattern>
</xs:restriction>
</xs:simpleType>
<xs:complexType name="eligibility_struct">
<xs:sequence>
<xs:element name="study_pop" type="textblock_struct" minOccurs="0"/>
<xs:element name="sampling_method" type="sampling_method_enum" minOccurs="0"/>
<xs:element name="criteria" type="textblock_struct" minOccurs="0"/>
<xs:element name="gender" type="gender_enum"/>
<xs:element name="gender_based" type="yes_no_enum" minOccurs="0"/>
<xs:element name="gender_description" type="xs:string" minOccurs="0"/>
<xs:element name="minimum_age" type="age_pattern"/>
<xs:element name="maximum_age" type="age_pattern"/>
<xs:element name="healthy_volunteers" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Contact ===================================================== -->
<xs:complexType name="contact_struct">
<xs:sequence>
<xs:element name="first_name" type="xs:string" minOccurs="0"/>
<xs:element name="middle_name" type="xs:string" minOccurs="0"/>
<xs:element name="last_name" type="xs:string" minOccurs="0"/>
<xs:element name="degrees" type="xs:string" minOccurs="0"/>
<xs:element name="phone" type="xs:string" minOccurs="0"/>
<xs:element name="phone_ext" type="xs:string" minOccurs="0"/>
<xs:element name="email" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Investigator ================================================ -->
<xs:simpleType name="role_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Principal Investigator" />
<xs:enumeration value="Sub-Investigator" />
<xs:enumeration value="Study Chair" />
<xs:enumeration value="Study Director" />
</xs:restriction>
</xs:simpleType>
<xs:complexType name="investigator_struct">
<xs:sequence>
<xs:element name="first_name" type="xs:string" minOccurs="0"/>
<xs:element name="middle_name" type="xs:string" minOccurs="0"/>
<xs:element name="last_name" type="xs:string"/>
<xs:element name="degrees" type="xs:string" minOccurs="0"/>
<xs:element name="role" type="role_enum" minOccurs="0"/>
<xs:element name="affiliation" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Address ===================================================== -->
<xs:complexType name="address_struct">
<xs:sequence>
<xs:element name="city" type="xs:string"/>
<xs:element name="state" type="xs:string" minOccurs="0"/>
<xs:element name="zip" type="xs:string" minOccurs="0"/>
<xs:element name="country" type="xs:string"/>
</xs:sequence>
</xs:complexType>
<!-- === Facility ==================================================== -->
<xs:complexType name="facility_struct">
<xs:sequence>
<xs:element name="name" type="xs:string" minOccurs="0"/>
<xs:element name="address" type="address_struct" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Location ==================================================== -->
<xs:complexType name="location_struct">
<xs:sequence>
<xs:element name="facility" type="facility_struct" minOccurs="0"/>
<xs:element name="status" type="recruitment_status_enum" minOccurs="0"/>
<xs:element name="contact" type="contact_struct" minOccurs="0"/>
<xs:element name="contact_backup" type="contact_struct" minOccurs="0"/>
<xs:element name="investigator" type="investigator_struct" minOccurs="0" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
<!-- === Location Countries ========================================== -->
<xs:complexType name="countries_struct">
<xs:sequence>
<xs:element name="country" type="xs:string" minOccurs="0" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
<!-- === Links ======================================================= -->
<xs:complexType name="link_struct">
<xs:sequence>
<xs:element name="url" type="xs:string"/>
<xs:element name="description" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === References ================================================== -->
<xs:complexType name="reference_struct">
<xs:sequence>
<xs:element name="citation" type="xs:string" minOccurs="0"/>
<xs:element name="PMID" type="xs:positiveInteger" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Responsible Party =========================================== -->
<xs:simpleType name="responsible_party_type_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Sponsor" />
<xs:enumeration value="Principal Investigator" />
<xs:enumeration value="Sponsor-Investigator" />
</xs:restriction>
</xs:simpleType>
<xs:complexType name="responsible_party_struct">
<xs:choice>
<xs:sequence> <!-- old style -->
<xs:element name="name_title" type="xs:string" minOccurs="0"/>
<xs:element name="organization" type="xs:string" minOccurs="0"/>
</xs:sequence>
<xs:sequence> <!-- new style, used in newer records -->
<xs:element name="responsible_party_type" type="responsible_party_type_enum"/>
<xs:element name="investigator_affiliation" type="xs:string" minOccurs="0"/>
<xs:element name="investigator_full_name" type="xs:string" minOccurs="0"/>
<xs:element name="investigator_title" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:choice>
</xs:complexType>
<!-- === Browse ====================================================== -->
<xs:complexType name="browse_struct">
<xs:sequence>
<xs:element name="mesh_term" type="xs:string" minOccurs="0" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
<!-- === Patient Data ================================================ -->
<xs:complexType name="patient_data_struct">
<xs:sequence>
<xs:element name="sharing_ipd" type="xs:string"/>
<xs:element name="ipd_description" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Study Docs ================================================== -->
<xs:complexType name="study_doc_struct">
<xs:sequence>
<xs:element name="doc_id" type="xs:string" minOccurs="0"/>
<xs:element name="doc_type" type="xs:string" minOccurs="0"/>
<xs:element name="doc_url" type="xs:string" minOccurs="0"/>
<xs:element name="doc_comment" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<xs:complexType name="study_docs_struct">
<xs:sequence>
<xs:element name="study_doc" type="study_doc_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
<!-- === Group ======================================================= -->
<xs:complexType name="group_struct">
<xs:sequence>
<xs:element name="title" type="xs:string" minOccurs="0"/>
<xs:element name="description" type="xs:string" minOccurs="0"/>
</xs:sequence>
<xs:attribute name="group_id" type="xs:string" use="required"/>
</xs:complexType>
<!-- === Participants ================================================ -->
<xs:complexType name="participants_struct">
<xs:simpleContent>
<xs:extension base="xs:string">
<xs:attribute name="group_id" type="xs:string" use="required"/>
<xs:attribute name="count" type="xs:integer"/>
</xs:extension>
</xs:simpleContent>
</xs:complexType>
<!-- === Milestone =================================================== -->
<xs:complexType name="milestone_struct">
<xs:sequence>
<xs:element name="title" type="xs:string"/>
<xs:element name="participants_list">
<xs:complexType>
<xs:sequence>
<xs:element name="participants" type="participants_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
</xs:sequence>
</xs:complexType>
<!-- === Period ====================================================== -->
<xs:complexType name="period_struct">
<xs:sequence>
<xs:element name="title" type="xs:string"/>
<xs:element name="milestone_list">
<xs:complexType>
<xs:sequence>
<xs:element name="milestone" type="milestone_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
<xs:element name="drop_withdraw_reason_list" minOccurs="0">
<xs:complexType>
<xs:sequence>
<xs:element name="drop_withdraw_reason" type="milestone_struct" minOccurs="0" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
</xs:sequence>
</xs:complexType>
<!-- === Participant Flow ============================================ -->
<xs:complexType name="participant_flow_struct">
<xs:sequence>
<xs:element name="recruitment_details" type="xs:string" minOccurs="0"/>
<xs:element name="pre_assignment_details" type="xs:string" minOccurs="0"/>
<xs:element name="group_list">
<xs:complexType>
<xs:sequence>
<xs:element name="group" type="group_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
<xs:element name="period_list">
<xs:complexType>
<xs:sequence>
<xs:element name="period" type="period_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
</xs:sequence>
</xs:complexType>
<!-- === Measure Count =============================================== -->
<xs:complexType name="measure_count_struct">
<xs:simpleContent>
<xs:extension base="xs:string">
<xs:attribute name="group_id" type="xs:string" use="required"/>
<xs:attribute name="value" type="xs:string"/>
</xs:extension>
</xs:simpleContent>
</xs:complexType>
<!-- === Measure Analyzed ============================================ -->
<xs:complexType name="measure_analyzed_struct">
<xs:sequence>
<xs:element name="units" type="xs:string"/>
<xs:element name="scope" type="xs:string"/>
<xs:element name="count_list">
<xs:complexType>
<xs:sequence>
<xs:element name="count" type="measure_count_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
</xs:sequence>
</xs:complexType>
<!-- === Measurement ================================================= -->
<xs:complexType name="measurement_struct">
<xs:simpleContent>
<xs:extension base="xs:string">
<xs:attribute name="group_id" type="xs:string" use="required"/>
<xs:attribute name="value" type="xs:string"/>
<xs:attribute name="spread" type="xs:string"/>
<xs:attribute name="lower_limit" type="xs:string"/>
<xs:attribute name="upper_limit" type="xs:string"/>
</xs:extension>
</xs:simpleContent>
</xs:complexType>
<!-- === Measure Category ============================================ -->
<xs:complexType name="measure_category_struct">
<xs:sequence>
<xs:element name="title" type="xs:string" minOccurs="0"/>
<xs:element name="measurement_list">
<xs:complexType>
<xs:sequence>
<xs:element name="measurement" type="measurement_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
</xs:sequence>
</xs:complexType>
<!-- === Measure Class =============================================== -->
<xs:complexType name="measure_class_struct">
<xs:sequence>
<xs:element name="title" type="xs:string" minOccurs="0"/>
<xs:element name="analyzed_list" minOccurs="0">
<xs:complexType>
<xs:sequence>
<xs:element name="analyzed" type="measure_analyzed_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
<xs:element name="category_list">
<xs:complexType>
<xs:sequence>
<xs:element name="category" type="measure_category_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
</xs:sequence>
</xs:complexType>
<!-- === Measure ===================================================== -->
<xs:simpleType name="measure_param_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Geometric Mean" />
<xs:enumeration value="Geometric Least Squares Mean" />
<xs:enumeration value="Least Squares Mean" />
<xs:enumeration value="Log Mean" />
<xs:enumeration value="Mean" />
<xs:enumeration value="Median" />
<xs:enumeration value="Number" />
<xs:enumeration value="Count of Participants" />
<xs:enumeration value="Count of Units" />
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="measure_dispersion_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="80% Confidence Interval" />
<xs:enumeration value="90% Confidence Interval" />
<xs:enumeration value="95% Confidence Interval" />
<xs:enumeration value="97.5% Confidence Interval" />
<xs:enumeration value="99% Confidence Interval" />
<xs:enumeration value="Full Range" />
<xs:enumeration value="Geometric Coefficient of Variation" />
<xs:enumeration value="Inter-Quartile Range" />
<xs:enumeration value="Standard Deviation" />
<xs:enumeration value="Standard Error" />
</xs:restriction>
</xs:simpleType>
<xs:complexType name="measure_struct">
<xs:sequence>
<xs:element name="title" type="xs:string"/>
<xs:element name="description" type="xs:string" minOccurs="0"/>
<xs:element name="population" type="xs:string" minOccurs="0"/>
<xs:element name="units" type="xs:string" minOccurs="0"/>
<xs:element name="param" type="measure_param_enum" minOccurs="0"/>
<xs:element name="dispersion" type="xs:string" minOccurs="0"/>
<xs:element name="units_analyzed" type="xs:string" minOccurs="0"/>
<xs:element name="analyzed_list" minOccurs="0">
<xs:complexType>
<xs:sequence>
<xs:element name="analyzed" type="measure_analyzed_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
<xs:element name="class_list" minOccurs="0">
<xs:complexType>
<xs:sequence>
<xs:element name="class" type="measure_class_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
</xs:sequence>
</xs:complexType>
<!-- === Baseline ==================================================== -->
<xs:complexType name="baseline_struct">
<xs:sequence>
<xs:element name="population" type="xs:string" minOccurs="0"/>
<xs:element name="group_list">
<xs:complexType>
<xs:sequence>
<xs:element name="group" type="group_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
<xs:element name="analyzed_list" minOccurs="0">
<xs:complexType>
<xs:sequence>
<xs:element name="analyzed" type="measure_analyzed_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
<xs:element name="measure_list" minOccurs="0">
<xs:complexType>
<xs:sequence>
<xs:element name="measure" type="measure_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
</xs:sequence>
</xs:complexType>
<!-- === Analysis ==================================================== -->
<xs:simpleType name="non_inferiority_type_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Superiority" />
<xs:enumeration value="Non-Inferiority" />
<xs:enumeration value="Equivalence" />
<xs:enumeration value="Other" />
<xs:enumeration value="Non-Inferiority or Equivalence" />
<xs:enumeration value="Superiority or Other" />
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="n_sides_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="1-Sided" />
<xs:enumeration value="2-Sided" />
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="analysis_dispersion_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Standard Deviation" />
<xs:enumeration value="Standard Error of the Mean" />
</xs:restriction>
</xs:simpleType>
<xs:complexType name="analysis_struct">
<xs:sequence>
<xs:element name="group_id_list">
<xs:complexType>
<xs:sequence>
<xs:element name="group_id" type="xs:string" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
<xs:element name="groups_desc" type="xs:string" minOccurs="0"/>
<xs:element name="non_inferiority_type" type="non_inferiority_type_enum" minOccurs="0"/>
<xs:element name="non_inferiority_desc" type="xs:string" minOccurs="0"/>
<xs:element name="p_value" type="xs:string" minOccurs="0"/>
<xs:element name="p_value_desc" type="xs:string" minOccurs="0"/>
<xs:element name="method" type="xs:string" minOccurs="0"/>
<xs:element name="method_desc" type="xs:string" minOccurs="0"/>
<xs:element name="param_type" type="xs:string" minOccurs="0"/>
<xs:element name="param_value" type="xs:string" minOccurs="0"/>
<xs:element name="dispersion_type" type="analysis_dispersion_enum" minOccurs="0"/>
<xs:element name="dispersion_value" type="xs:string" minOccurs="0"/>
<xs:element name="ci_percent" type="xs:float" minOccurs="0"/>
<xs:element name="ci_n_sides" type="n_sides_enum" minOccurs="0"/>
<xs:element name="ci_lower_limit" type="xs:string" minOccurs="0"/>
<xs:element name="ci_upper_limit" type="xs:string" minOccurs="0"/>
<xs:element name="ci_upper_limit_na_comment" type="xs:string" minOccurs="0"/>
<xs:element name="estimate_desc" type="xs:string" minOccurs="0"/>
<xs:element name="other_analysis_desc" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Results Outcome ============================================= -->
<xs:simpleType name="outcome_type_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Primary" />
<xs:enumeration value="Secondary" />
<xs:enumeration value="Other Pre-specified" />
<xs:enumeration value="Post-Hoc" />
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="posting_date_type">
<xs:restriction base="xs:string">
<xs:pattern value="(((0[1-9])|(10|11|12))/)?[1-3][0-9]{3}"></xs:pattern> <!-- month/year or just year -->
</xs:restriction>
</xs:simpleType>
<xs:complexType name="results_outcome_struct">
<xs:sequence>
<xs:element name="type" type="outcome_type_enum"/>
<xs:element name="title" type="xs:string"/>
<xs:element name="description" type="xs:string" minOccurs="0"/>
<xs:element name="time_frame" type="xs:string" minOccurs="0"/>
<xs:element name="safety_issue" type="yes_no_enum" minOccurs="0"/>
<xs:element name="posting_date" type="posting_date_type" minOccurs="0"/>
<xs:element name="population" type="xs:string" minOccurs="0"/>
<xs:element name="group_list" minOccurs="0">
<xs:complexType>
<xs:sequence>
<xs:element name="group" type="group_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
<xs:element name="measure" type="measure_struct" minOccurs="0"/>
<xs:element name="analysis_list" minOccurs="0">
<xs:complexType>
<xs:sequence>
<xs:element name="analysis" type="analysis_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
</xs:sequence>
</xs:complexType>
<!-- === Vocab Term =================================================== -->
<xs:complexType name="vocab_term_struct">
<xs:simpleContent>
<xs:extension base="xs:string">
<xs:attribute name="vocab" type="xs:string"/>
</xs:extension>
</xs:simpleContent>
</xs:complexType>
<!-- === Event Counts ================================================= -->
<xs:complexType name="event_counts_struct">
<xs:simpleContent>
<xs:extension base="xs:string">
<xs:attribute name="group_id" type="xs:string"/>
<xs:attribute name="subjects_affected" type="xs:integer"/>
<xs:attribute name="subjects_at_risk" type="xs:integer"/>
<xs:attribute name="events" type="xs:integer"/>
</xs:extension>
</xs:simpleContent>
</xs:complexType>
<!-- === Event ======================================================= -->
<xs:simpleType name="event_assessment_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Non-systematic Assessment" />
<xs:enumeration value="Systematic Assessment" />
</xs:restriction>
</xs:simpleType>
<xs:complexType name="event_struct">
<xs:sequence>
<xs:element name="sub_title" type="vocab_term_struct" minOccurs="0"/>
<xs:element name="assessment" type="event_assessment_enum" minOccurs="0"/>
<xs:element name="description" type="xs:string" minOccurs="0"/>
<xs:element name="counts" type="event_counts_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
<!-- === Event Category ============================================== -->
<xs:complexType name="event_category_struct">
<xs:sequence>
<xs:element name="title" type="xs:string"/>
<xs:element name="event_list">
<xs:complexType>
<xs:sequence>
<xs:element name="event" type="event_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
</xs:sequence>
</xs:complexType>
<!-- === Events ====================================================== -->
<xs:complexType name="events_struct">
<xs:sequence>
<xs:element name="frequency_threshold" type="xs:string" minOccurs="0"/>
<xs:element name="default_vocab" type="xs:string" minOccurs="0"/>
<xs:element name="default_assessment" type="event_assessment_enum" minOccurs="0"/>
<xs:element name="category_list">
<xs:complexType>
<xs:sequence>
<xs:element name="category" type="event_category_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
</xs:sequence>
</xs:complexType>
<!-- === Reported Events ============================================= -->
<xs:complexType name="reported_events_struct">
<xs:sequence>
<xs:element name="time_frame" type="xs:string" minOccurs="0"/>
<xs:element name="desc" type="xs:string" minOccurs="0"/>
<xs:element name="group_list">
<xs:complexType>
<xs:sequence>
<xs:element name="group" type="group_struct" maxOccurs="unbounded"/>
</xs:sequence>
</xs:complexType>
</xs:element>
<xs:element name="serious_events" type="events_struct" minOccurs="0"/>
<xs:element name="other_events" type="events_struct" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Certain Agreements ========================================== -->
<xs:simpleType name="pi_employee_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="All Principal Investigators ARE employed by the organization sponsoring the study." />
<xs:enumeration value="Principal Investigators are NOT employed by the organization sponsoring the study." />
</xs:restriction>
</xs:simpleType>
<xs:complexType name="certain_agreements_struct">
<xs:sequence>
<xs:element name="pi_employee" type="pi_employee_enum" minOccurs="0"/>
<xs:element name="restrictive_agreement" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Point Of Contact ============================================ -->
<xs:complexType name="point_of_contact_struct">
<xs:sequence>
<xs:element name="name_or_title" type="xs:string"/>
<xs:element name="organization" type="xs:string" minOccurs="0"/>
<xs:element name="phone" type="xs:string" minOccurs="0"/>
<xs:element name="email" type="xs:string" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Clinical Results ============================================ -->
<xs:complexType name="clinical_results_struct">
<xs:sequence>
<xs:element name="participant_flow" type="participant_flow_struct">
<xs:key name="participant_flow_group_key">
<xs:selector xpath="group_list/group" />
<xs:field xpath="@group_id" />
</xs:key>
<xs:keyref name="participant_flow_group_ref" refer="participant_flow_group_key">
<xs:selector xpath="period_list/period/milestone_list/milestone/participants_list/participants" />
<xs:field xpath="@group_id" />
</xs:keyref>
</xs:element>
<xs:element name="baseline" type="baseline_struct">
<xs:key name="baseline_group_key">
<xs:selector xpath="group_list/group" />
<xs:field xpath="@group_id" />
</xs:key>
<xs:keyref name="baseline_group_ref" refer="baseline_group_key">
<xs:selector xpath="measure_list/measure/category_list/category/measurement_list/measurement" />
<xs:field xpath="@group_id" />
</xs:keyref>
</xs:element>
<xs:element name="outcome_list">
<xs:complexType>
<xs:sequence>
<xs:element name="outcome" type="results_outcome_struct" maxOccurs="unbounded">
<xs:key name="outcome_group_key">
<xs:selector xpath="group_list/group" />
<xs:field xpath="@group_id" />
</xs:key>
<xs:keyref name="outcome_group_ref" refer="outcome_group_key">
<xs:selector xpath="measure_list/measure/category_list/category/measurement_list/measurement" />
<xs:field xpath="@group_id" />
</xs:keyref>
</xs:element>
</xs:sequence>
</xs:complexType>
</xs:element>
<xs:element name="reported_events" type="reported_events_struct" minOccurs="0">
<xs:key name="events_group_key">
<xs:selector xpath="group_list/group" />
<xs:field xpath="@group_id" />
</xs:key>
<xs:keyref name="serious_events_group_ref" refer="events_group_key">
<xs:selector xpath="serious_events/category_list/category/event_list/event/counts" />
<xs:field xpath="@group_id" />
</xs:keyref>
<xs:keyref name="other_events_group_ref" refer="events_group_key">
<xs:selector xpath="other_events/category_list/category/event_list/event/counts" />
<xs:field xpath="@group_id" />
</xs:keyref>
</xs:element>
<xs:element name="certain_agreements" type="certain_agreements_struct" minOccurs="0"/>
<xs:element name="limitations_and_caveats" type="xs:string" minOccurs="0"/>
<xs:element name="point_of_contact" type="point_of_contact_struct" minOccurs="0"/>
</xs:sequence>
</xs:complexType>
<!-- === Date ======================================================== -->
<!-- Dates may now include a day -->
<!-- Month Day, Year Or Month Year -->
<!-- Necessary to accurately calculate deadlines -->
<xs:simpleType name="variable_date_type">
<xs:restriction base="xs:string">
<xs:pattern value="(January|February|March|April|May|June|July|August|September|October|November|December) (([12]?[0-9]|30|31)\, )?[12][0-9]{3}" />
</xs:restriction>
</xs:simpleType>
<xs:complexType name="variable_date_struct">
<xs:simpleContent>
<xs:extension base="variable_date_type">
<xs:attribute name="type" type="actual_anticipated_enum" use="optional"/>
</xs:extension>
</xs:simpleContent>
</xs:complexType>
<!-- === Clinical Study ============================================== -->
<xs:simpleType name="expanded_access_status_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Available" />
<xs:enumeration value="No longer available" />
<xs:enumeration value="Temporarily not available" />
<xs:enumeration value="Approved for marketing" />
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="redacted_record_status_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Withheld"></xs:enumeration>
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="unknown_status_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Unknown status"></xs:enumeration>
</xs:restriction>
</xs:simpleType>
<!--
Valid values for overall status depend on the value for study type:
- For "Expanded Access", any value from expanded_access_status_enum
- For "N/A", any value from redacted_record_status_enum
- Otherwise, any value from recruitment_status_enum
-->
<xs:simpleType name="overall_status_enum">
<xs:union memberTypes="recruitment_status_enum
expanded_access_status_enum
redacted_record_status_enum
unknown_status_enum"></xs:union>
</xs:simpleType>
<xs:simpleType name="study_type_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="Expanded Access" />
<xs:enumeration value="Interventional" />
<xs:enumeration value="N/A" /> <!-- Redacted records only -->
<xs:enumeration value="Observational" />
<xs:enumeration value="Observational [Patient Registry]" />
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="phase_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="N/A" />
<xs:enumeration value="Early Phase 1" />
<xs:enumeration value="Phase 1" />
<xs:enumeration value="Phase 1/Phase 2" />
<xs:enumeration value="Phase 2" />
<xs:enumeration value="Phase 2/Phase 3" />
<xs:enumeration value="Phase 3" />
<xs:enumeration value="Phase 4" />
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="biospec_retention_enum">
<xs:restriction base="xs:string">
<xs:enumeration value="None Retained" />
<xs:enumeration value="Samples With DNA" />
<xs:enumeration value="Samples Without DNA" />
</xs:restriction>
</xs:simpleType>
<xs:element name="clinical_study">
<xs:complexType>
<xs:sequence>
<xs:element name="required_header" type="required_header_struct"/>
<xs:element name="id_info" type="id_info_struct"/>
<xs:element name="brief_title" type="xs:string"/>
<xs:element name="acronym" type="xs:string" minOccurs="0"/>
<xs:element name="official_title" type="xs:string" minOccurs="0"/>
<xs:element name="sponsors" type="sponsors_struct"/>
<xs:element name="source" type="xs:string"/>
<xs:element name="oversight_info" type="oversight_info_struct" minOccurs="0"/>
<xs:element name="brief_summary" type="textblock_struct" minOccurs="0"/>
<xs:element name="detailed_description" type="textblock_struct" minOccurs="0"/>
<xs:element name="overall_status" type="overall_status_enum"/>
<xs:element name="last_known_status" type="overall_status_enum" minOccurs="0"/>
<xs:element name="why_stopped" type="xs:string" minOccurs="0"/>
<xs:element name="start_date" type="variable_date_struct" minOccurs="0"/>
<xs:element name="completion_date" type="variable_date_struct" minOccurs="0"/>
<xs:element name="primary_completion_date" type="variable_date_struct" minOccurs="0"/>
<xs:element name="phase" type="phase_enum"/>
<xs:element name="study_type" type="study_type_enum"/>
<xs:element name="has_expanded_access" type="yes_no_enum" minOccurs="0"/>
<xs:element name="expanded_access_info" type="expanded_access_info_struct" minOccurs="0"/>
<xs:element name="study_design_info" type="study_design_info_struct" minOccurs="0"/>
<xs:element name="target_duration" type="xs:string" minOccurs="0"/>
<xs:element name="primary_outcome" type="protocol_outcome_struct" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="secondary_outcome" type="protocol_outcome_struct" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="other_outcome" type="protocol_outcome_struct" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="number_of_arms" type="xs:integer" minOccurs="0"/>
<xs:element name="number_of_groups" type="xs:integer" minOccurs="0"/>
<xs:element name="enrollment" type="enrollment_struct" minOccurs="0"/>
<xs:element name="condition" type="xs:string" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="arm_group" type="arm_group_struct" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="intervention" type="intervention_struct" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="biospec_retention" type="biospec_retention_enum" minOccurs="0"/>
<xs:element name="biospec_descr" type="textblock_struct" minOccurs="0"/>
<xs:element name="eligibility" type="eligibility_struct" minOccurs="0"/>
<xs:element name="overall_official" type="investigator_struct" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="overall_contact" type="contact_struct" minOccurs="0"/>
<xs:element name="overall_contact_backup" type="contact_struct" minOccurs="0"/>
<xs:element name="location" type="location_struct" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="location_countries" type="countries_struct" minOccurs="0"/>
<xs:element name="removed_countries" type="countries_struct" minOccurs="0"/>
<xs:element name="link" type="link_struct" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="reference" type="reference_struct" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="results_reference" type="reference_struct" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="verification_date" type="variable_date_type" minOccurs="0"/>
<xs:element name="lastchanged_date" type="variable_date_type" minOccurs="0"/>
<xs:element name="firstreceived_date" type="variable_date_type"/>
<xs:element name="firstreceived_results_date" type="variable_date_type" minOccurs="0"/>
<xs:element name="firstreceived_results_disposition_date" type="variable_date_type" minOccurs="0"/>
<xs:element name="responsible_party" type="responsible_party_struct" minOccurs="0"/>
<xs:element name="keyword" type="xs:string" minOccurs="0" maxOccurs="unbounded"/>
<xs:element name="condition_browse" type="browse_struct" minOccurs="0"/>
<xs:element name="intervention_browse" type="browse_struct" minOccurs="0"/>
<xs:element name="patient_data" type="patient_data_struct" minOccurs="0"/>
<xs:element name="study_docs" type="study_docs_struct" minOccurs="0"/>
<xs:element name="clinical_results" type="clinical_results_struct" minOccurs="0"/>
</xs:sequence>
<xs:attribute name="rank" type="xs:string" use="optional"/>
</xs:complexType>
</xs:element>
</xs:schema>
sample trial:
<?xml version="1.0" encoding="UTF-8"?>
<clinical_study rank="240132">
<!-- 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 April 10, 2017</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/show/NCT00000999</url>
</required_header>
<id_info>
<org_study_id>ACTG 020</org_study_id>
<secondary_id>10996</secondary_id>
<nct_id>NCT00000999</nct_id>
</id_info>
<brief_title>The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients With AIDS and Advanced ARC</brief_title>
<official_title>A Multicenter Uncontrolled Trial To Evaluate the Long Term Safety and Tolerance of Zidovudine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS and Advanced ARC</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
<brief_summary>
<textblock>
To obtain information about the long-term safety and toxicity of zidovudine (AZT). To
ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT
toxicity.
Because of the high incidence of toxicity and the relatively short-term follow-up of the
patients due to the early ending of the Phase II placebo-controlled experiment, it is
valuable to continue to get information on the long-term toxicity of AZT.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Because of the high incidence of toxicity and the relatively short-term follow-up of the
patients due to the early ending of the Phase II placebo-controlled experiment, it is
valuable to continue to get information on the long-term toxicity of AZT.
This study provides AZT for 6 months to AIDS patients who were previously enrolled in the
AZT Treatment IND protocol and to patients who qualify for AZT under the drug labeling.
Patients are randomized to 1 of 2 regimens for management of toxicity.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<completion_date type="Actual">March 1989</completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>Open Label</masking>
</study_design_info>
<enrollment>500</enrollment>
<condition>HIV Infections</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Zidovudine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria
Concurrent Medication:
Allowed:
- For fever control and mild analgesia, modest doses of aspirin or nonprescription
doses of ibuprofen may be used with caution; prolonged (&gt; 72 hours) administration is
not advised without dose supervision.
Patients must have a documented history of positive HIV antibody by ELISA, or positive
result by ELISA at study entry and be in one of the following categories:
- AIDS patients recovered from one or more episodes of categorically confirmed
Pneumocystis carinii pneumonia (PCP) who were previously enrolled in the zidovudine
(AZT) treatment IND protocol.
- Patients who qualify for AZT under the labeling:
- (a) patients with a prior episode of cytologically confirmed PCP; (b) patients with a
prior episode of any other AIDS defining opportunistic infection and &lt; 200 T4 cells;
(c) patients with advanced AIDS related complex (ARC) as defined by the clinical
diagnosis of mucocutaneous candidiasis and/or unexplained weight loss (= or &gt; 15 lbs
or &gt; 10 percent of total body weight within the previous 3 months) and &lt; 200 T4 cells
and one or more of the following symptoms:
- (1) fever &gt; 100 degrees F without infectious cause of &gt; 3 weeks duration; (2)
clinical diagnosis of hairy leukoplakia; (3) herpes zoster infection within 3 months
of entry; (4) unexplained diarrhea after 3 samples eliminating ova, parasites,
cryptosporidia, and Mycobacterium avium-intracellulare.
Note:
- Kaposi's sarcoma without any of the symptoms listed above, regardless of total T4
lymphocyte count, does not constitute an indication for AZT treatment under the
labeling.
Exclusion Criteria
Co-existing Condition:
- Patients whose symptoms do not fit into the categories described in Disease Status
and General Inclusion Criteria are excluded.
Concurrent Medication: Excluded:
- Acetaminophen.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Pettinelli C</last_name>
<role>Study Chair</role>
</overall_official>
<overall_official>
<last_name>Feinberg J</last_name>
<role>Study Chair</role>
</overall_official>
<location>
<facility>
<name>LaJolla Veterans Administration Med Ctr</name>
<address>
<city>LaJolla</city>
<state>California</state>
<zip>92037</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Los Angeles County - USC Med Ctr</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90033</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Univ of California / San Diego Treatment Ctr</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>921036325</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>San Francisco AIDS Clinic / San Francisco Gen Hosp</name>
<address>
<city>San Francisco</city>
<state>California</state>
<zip>941102859</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Stanford at Kaiser / Kaiser Permanente Med Ctr</name>
<address>
<city>San Francisco</city>
<state>California</state>
<zip>94115</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Stanford Univ School of Medicine</name>
<address>
<city>Stanford</city>
<state>California</state>
<zip>94305</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Louisiana State Univ Med Ctr / Tulane Med School</name>
<address>
<city>New Orleans</city>
<state>Louisiana</state>
<zip>70112</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Tulane Univ School of Medicine</name>
<address>
<city>New Orleans</city>
<state>Louisiana</state>
<zip>70112</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Johns Hopkins Hosp</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21287</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Beth Israel Deaconess - West Campus</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02215</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Beth Israel Deaconess Med Ctr</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02215</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Univ of Minnesota</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55455</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Bronx Municipal Hosp Ctr/Jacobi Med Ctr</name>
<address>
<city>Bronx</city>
<state>New York</state>
<zip>10461</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Jack Weiler Hosp / Bronx Municipal Hosp</name>
<address>
<city>Bronx</city>
<state>New York</state>
<zip>10465</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>SUNY / Erie County Med Ctr at Buffalo</name>
<address>
<city>Buffalo</city>
<state>New York</state>
<zip>14215</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Beth Israel Med Ctr / Peter Krueger Clinic</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10003</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Bellevue Hosp / New York Univ Med Ctr</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mem Sloan - Kettering Cancer Ctr</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10021</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mount Sinai Med Ctr</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10029</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Univ of Rochester Medical Center</name>
<address>
<city>Rochester</city>
<state>New York</state>
<zip>14642</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>SUNY / State Univ of New York</name>
<address>
<city>Syracuse</city>
<state>New York</state>
<zip>13210</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Duke Univ Med Ctr</name>
<address>
<city>Durham</city>
<state>North Carolina</state>
<zip>27710</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Univ of Pittsburgh Med School</name>
<address>
<city>Pittsburgh</city>
<state>Pennsylvania</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://aidsinfo.nih.gov/DrugsNew/DrugDetailNT.aspx?MenuItem=Drugs&amp;Search=On&amp;int_id=4</url>
<description>Click here for more information about Zidovudine</description>
</link>
<reference>
<citation>Jacobson MA, Bacchetti P, Kolokathis A, Chaisson RE, Szabo S, Polsky B, Valainis GT, Mildvan D, Abrams D, Wilber J, et al. Surrogate markers for survival in patients with AIDS and AIDS related complex treated with zidovudine. BMJ. 1991 Jan 12;302(6768):73-8.</citation>
<PMID>1671651</PMID>
</reference>
<reference>
<citation>Jacobson MA, Abrams DI, Volberding PA, Bacchetti P, Wilber J, Chaisson RE, Crowe S, Howard W, Moss A. Serum beta 2-microglobulin decreases in patients with AIDS or ARC treated with azidothymidine. J Infect Dis. 1989 Jun;159(6):1029-36.</citation>
<PMID>2566637</PMID>
</reference>
<reference>
<citation>Jacobson MA, Abrams D, Bacchetti P, Kocurek K, Wilber J, Moss AR. Change in beta-2 microglobulin (B2M) during zidovudine (ZDV) therapy (RX) predicts clinical outcome. Int Conf AIDS. 1989 Jun 4-9;5:339 (abstract no TBP312)</citation>
</reference>
<verification_date>March 2012</verification_date>
<lastchanged_date>March 15, 2012</lastchanged_date>
<firstreceived_date>November 2, 1999</firstreceived_date>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Acquired Immunodeficiency Syndrome</keyword>
<keyword>AIDS-Related Complex</keyword>
<keyword>Zidovudine</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Infection</mesh_term>
<mesh_term>Communicable Diseases</mesh_term>
<mesh_term>HIV Infections</mesh_term>
<mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Zidovudine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
Raw
pubmed_doc-sample.xml
<PubmedArticle>
<MedlineCitation Status="MEDLINE" Owner="NLM">
<PMID Version="1">9008730</PMID>
<DateCreated>
<Year>1997</Year>
<Month>02</Month>
<Day>19</Day>
</DateCreated>
<DateCompleted>
<Year>1997</Year>
<Month>02</Month>
<Day>19</Day>
</DateCompleted>
<DateRevised>
<Year>2013</Year>
<Month>11</Month>
<Day>21</Day>
</DateRevised>
<Article PubModel="Print">
<Journal>
<ISSN IssnType="Print">0027-5107</ISSN>
<JournalIssue CitedMedium="Print">
<Volume>371</Volume>
<Issue>3-4</Issue>
<PubDate>
<Year>1996</Year>
<Month>Dec</Month>
<Day>20</Day>
</PubDate>
</JournalIssue>
<Title>Mutation research</Title>
<ISOAbbreviation>Mutat. Res.</ISOAbbreviation>
</Journal>
<ArticleTitle>Simple and reliable enumeration of micronucleated reticulocytes with a single-laser flow cytometer.</ArticleTitle>
<Pagination>
<MedlinePgn>283-92</MedlinePgn>
</Pagination>
<Abstract>
<AbstractText>A flow cytometric procedure for scoring micronuclei in mouse peripheral blood erythrocytes, especially reticulocytes, is described. The methods reported herein were developed in an effort to simplify the techniques and to reduce the equipment requirements associated with automated micronucleus analyses. With this procedure, fluorescein-conjugated monoclonal antibodies which bind to the CD71-defined antigen (the transferrin receptor) are used to label reticulocytes. The nucleic acid dye propidium iodide is used to identify cells with micronuclei. Given 488 nm excitation, four populations of erythrocytes are clearly resolved: normochromatic erythrocytes with and without micronuclei, and reticulocytes with and without micronuclei. Since the method is capable of simultaneously providing the incidence of micronuclei in both mature and immature erythrocyte populations, it is compatible with either chronic or acute treatment regimens. To demonstrate cell handling and flow cytometric procedures for quantitatively analyzing peripheral blood micronuclei, an experiment with the model clastogen methyl methanesulfonate is described. Additionally, a reconstruction experiment was performed whereby three mouse blood samples were spiked with successively greater volumes of blood from a clastogen-treated animal so each preparation differed slightly, but definitely, in micronucleus content. Each sample was scored six times by conventional microscopy and by flow cytometry so that the two methods could be directly compared. Collectively, the results from the methyl methanesulfonate experiment and the reconstruction study demonstrate the accuracy and reliability of the flow cytometric method. Furthermore, advantages associated with objective, high throughout scoring methodology are clearly indicated.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Dertinger</LastName>
<ForeName>S D</ForeName>
<Initials>SD</Initials>
<AffiliationInfo>
<Affiliation>Litron Laboratories, Rochester, NY 14620, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Torous</LastName>
<ForeName>D K</ForeName>
<Initials>DK</Initials>
</Author>
<Author ValidYN="Y">
<LastName>Tometsko</LastName>
<ForeName>K R</ForeName>
<Initials>KR</Initials>
</Author>
</AuthorList>
<Language>eng</Language>
<GrantList CompleteYN="Y">
<Grant>
<GrantID>1 R43 ES07707-01</GrantID>
<Acronym>ES</Acronym>
<Agency>NIEHS NIH HHS</Agency>
<Country>United States</Country>
</Grant>
</GrantList>
<PublicationTypeList>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D013487">Research Support, U.S. Gov't, P.H.S.</PublicationType>
</PublicationTypeList>
</Article>
<MedlineJournalInfo>
<Country>Netherlands</Country>
<MedlineTA>Mutat Res</MedlineTA>
<NlmUniqueID>0400763</NlmUniqueID>
<ISSNLinking>0027-5107</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D014168">Transferrin</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>AT5C31J09G</RegistryNumber>
<NameOfSubstance UI="D008741">Methyl Methanesulfonate</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList>
<MeshHeading>
<DescriptorName UI="D000818" MajorTopicYN="N">Animals</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005434" MajorTopicYN="N">Flow Cytometry</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D007834" MajorTopicYN="N">Lasers</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008741" MajorTopicYN="N">Methyl Methanesulfonate</DescriptorName>
<QualifierName UI="Q000633" MajorTopicYN="N">toxicity</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D051379" MajorTopicYN="N">Mice</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008807" MajorTopicYN="N">Mice, Inbred BALB C</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D015162" MajorTopicYN="N">Micronucleus Tests</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012156" MajorTopicYN="N">Reticulocytes</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName>
<QualifierName UI="Q000648" MajorTopicYN="Y">ultrastructure</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D014168" MajorTopicYN="N">Transferrin</DescriptorName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
</MeshHeading>
</MeshHeadingList>
</MedlineCitation>
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<History>
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<Year>1996</Year>
<Month>12</Month>
<Day>20</Day>
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<PubMedPubDate PubStatus="medline">
<Year>1996</Year>
<Month>12</Month>
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<Hour>0</Hour>
<Minute>1</Minute>
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<Month>12</Month>
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<Hour>0</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
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<ArticleId IdType="pubmed">9008730</ArticleId>
<ArticleId IdType="pii">S0165-1218(96)90117-2</ArticleId>
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<PubmedArticle>
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<PMID Version="1">16784359</PMID>
<DateCreated>
<Year>2006</Year>
<Month>06</Month>
<Day>20</Day>
</DateCreated>
<DateCompleted>
<Year>2006</Year>
<Month>07</Month>
<Day>27</Day>
</DateCompleted>
<DateRevised>
<Year>2006</Year>
<Month>06</Month>
<Day>20</Day>
</DateRevised>
<Article PubModel="Print">
<Journal>
<ISSN IssnType="Print">0893-164X</ISSN>
<JournalIssue CitedMedium="Print">
<Volume>20</Volume>
<Issue>2</Issue>
<PubDate>
<Year>2006</Year>
<Month>Jun</Month>
</PubDate>
</JournalIssue>
<Title>Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors</Title>
<ISOAbbreviation>Psychol Addict Behav</ISOAbbreviation>
</Journal>
<ArticleTitle>College student alcohol use in context: the utility of goal constructs.</ArticleTitle>
<Pagination>
<MedlinePgn>143-4</MedlinePgn>
</Pagination>
<Abstract>
<AbstractText>Alcohol use occurs in the context of multiple goals that college students develop, pursue, and modify in their transition to adulthood. Consequently, the assessment of goal constructs provides a valuable tool for understanding the developmental context of college drinking. Conceptualizing student alcohol misuse in terms of its effects on valued goals has a number of advantages for understanding personality risk and protective factors, clarifying the contributions of social and environmental influences, and developing motivation-based interventions.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Palfai</LastName>
<ForeName>Tibor P</ForeName>
<Initials>TP</Initials>
<AffiliationInfo>
<Affiliation>Department of Psychology, Boston University, MA 02215, USA. palfai@bu.edu</Affiliation>
</AffiliationInfo>
</Author>
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<Language>eng</Language>
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<PublicationType UI="D016428">Journal Article</PublicationType>
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<Country>United States</Country>
<MedlineTA>Psychol Addict Behav</MedlineTA>
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<ISSNLinking>0893-164X</ISSNLinking>
</MedlineJournalInfo>
<CitationSubset>IM</CitationSubset>
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<CommentsCorrections RefType="CommentOn">
<RefSource>Psychol Addict Behav. 2006 Jun;20(2):131-4</RefSource>
<PMID Version="1">16784355</PMID>
</CommentsCorrections>
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<MeshHeadingList>
<MeshHeading>
<DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000428" MajorTopicYN="N">Alcohol Drinking</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000523" MajorTopicYN="Y">psychology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D019973" MajorTopicYN="N">Alcohol-Related Disorders</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000523" MajorTopicYN="Y">psychology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006040" MajorTopicYN="Y">Goals</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D009042" MajorTopicYN="Y">Motivation</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012931" MajorTopicYN="N">Social Environment</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D013334" MajorTopicYN="N">Students</DescriptorName>
<QualifierName UI="Q000523" MajorTopicYN="Y">psychology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D014495" MajorTopicYN="N">Universities</DescriptorName>
</MeshHeading>
</MeshHeadingList>
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<Year>2006</Year>
<Month>6</Month>
<Day>21</Day>
<Hour>9</Hour>
<Minute>0</Minute>
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<Year>2006</Year>
<Month>7</Month>
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<Hour>9</Hour>
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<ArticleId IdType="pii">2006-07521-009</ArticleId>
<ArticleId IdType="doi">10.1037/0893-164X.20.2.143</ArticleId>
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Raw
question-sample.xml
<topics task="2017 TREC Precision Medicine”>
<topic number="1" type="test”>
<disease>Acute lymphoblastic leukemia</disease>
<variant>ABL1, PTPN11</variant>
<demographic>12-year-old male</demographic>
<other>No relevant factors</other>
</topic>
</topics>
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