Trial Data Project

Steps Followed to Extract the Trial Data

Extracting Data from XML Files

All the historical USPTO data is available as XML files. Here is the tree structure for the XML files:

-<clinical_study rank="61205">
    +<required_header>
    +<id_info>
    <brief_title>
    +<sponsors>
    <source>
    +<oversight_info>
    +<brief_summary>
    +<detailed_description>
    <overall_status>Completed</overall_status>
    <phase>Phase 1/Phase 2</phase>
    <study_type>
    <study_design>
    <condition>
    +<intervention>
    +<eligibility>
    +<location>
    +<location_countries>
    <verification_date>
    <lastchanged_date>
    <firstreceived_date>
    <has_expanded_access>
    +<condition_browse>
    +<intervention_browse>

Corresponding tables are:

• Study
• Location
• Sponsors
• Eligibility
• Dates
• MeSH (Medical Subject Headings)

Eligibility

-<eligibility>
    -<criteria>
        <textblock> Inclusion Criteria: - diagnosed with Congenital Adrenal Hyperplasia (CAH) - normal ECG during baseline evaluation Exclusion Criteria: - history of liver disease, or elevated liver function tests - history of cardiovascular disease </textblock>
    </criteria>
    <gender>Both</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
</eligibility>

Dates

The corresponding nodes are:

<verification_date>January 2004</verification_date>
<lastchanged_date>June 23, 2005</lastchanged_date>
<firstreceived_date>November 3, 1999</firstreceived_date>

MeSH

The corresponding nodes are:

-<condition_browse>
    <mesh_term>Hyperplasia</mesh_term>
    <mesh_term>Adrenal Hyperplasia, Congenital</mesh_term>
    <mesh_term>Adrenogenital Syndrome</mesh_term>
    <mesh_term>Adrenocortical Hyperfunction</mesh_term>
</condition_browse>
-<intervention_browse>
    <mesh_term>Nifedipine</mesh_term>
</intervention_browse>