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Reduced Test code length by using resources

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Dean
2022-10-07 10:35:06 +01:00
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3 changed files with 390 additions and 1405 deletions
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src/test/resources/Issue593.xml Normal file
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<?xml version="1.0" encoding="UTF-8"?>
<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 July 19, 2020</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/show/NCT03874338</url>
</required_header>
<id_info>
<org_study_id>18-01323</org_study_id>
<secondary_id>1R01HL146206</secondary_id>
<nct_id>NCT03874338</nct_id>
</id_info>
<brief_title>CLEAR SYNERGY Neutrophil Substudy</brief_title>
<official_title>Studies on the Effects of Colchicine on Neutrophil Biology in Acute Myocardial Infarction: A Substudy of the CLEAR SYNERGY (OASIS 9) Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>NYU Langone Health</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Population Health Research Institute</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>NYU Langone Health</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 4, 2019</start_date>
<completion_date type="Anticipated">February 1, 2022</completion_date>
<primary_completion_date type="Anticipated">February 1, 2021</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Other</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>soluble L-selectin</measure>
<time_frame>between baseline and 3 months</time_frame>
<description>Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups.</description>
</primary_outcome>
<secondary_outcome>
<measure>Other soluble markers of neutrophil activity</measure>
<time_frame>between baseline and 3 months</time_frame>
<description>Other markers of neutrophil activity will be evaluated at baseline and 3 months after STEMI (myeloperoxidase, matrix metalloproteinase-9, neutrophil gelatinase-associated lipocalin, neutrophil elastase, intercellular/vascular cellular adhesion molecules)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Markers of systemic inflammation</measure>
<time_frame>between baseline and 3 months</time_frame>
<description>Markers of systemic inflammation will be evaluated at baseline and 3 months after STEMI (high sensitive CRP, IL-1β)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Neutrophil-driven responses that may further propagate injury</measure>
<time_frame>between baseline and 3 months</time_frame>
<description>Neutrophil-driven responses that may further propagate injury will be evaluated at baseline and 3 months after STEMI (neutrophil extracellular traps, neutrophil-derived microparticles)</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">670</enrollment>
<condition>Neutrophils.Hypersegmented &#X7C; Bld-Ser-Plas</condition>
<condition>STEMI - ST Elevation Myocardial Infarction</condition>
<arm_group>
<arm_group_label>Colchicine</arm_group_label>
</arm_group>
<arm_group>
<arm_group_label>Placebo</arm_group_label>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Colchicine Pill</intervention_name>
<description>Participants in the main CLEAR SYNERGY trial are randomized to colchicine/spironolactone versus placebo in a 2x2 factorial design. The substudy is interested in the evaluation of biospecimens obtained from patients in the colchicine vs placebo group.</description>
<arm_group_label>Colchicine</arm_group_label>
<arm_group_label>Placebo</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>19 Years</minimum_age>
<maximum_age>110 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Binita Shah, MD</last_name>
<role>Principal Investigator</role>
<affiliation>NYU School of Medicine</affiliation>
</overall_official>
<overall_contact>
<last_name>Fatmira Curovic</last_name>
<phone>646-501-9648</phone>
<email>fatmira.curovic@nyumc.org</email>
</overall_contact>
<overall_contact_backup>
<last_name>Binita Shah, MD</last_name>
</overall_contact_backup>
<location>
<facility>
<name>NYU School of Medicine</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Fatmira Curovic</last_name>
<phone>646-501-9648</phone>
<email>fatmira.curovic@nyumc.org</email>
</contact>
<contact_backup>
<last_name>Binita Shah, MD</last_name>
</contact_backup>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>September 2019</verification_date>
<study_first_submitted>March 12, 2019</study_first_submitted>
<study_first_submitted_qc>March 12, 2019</study_first_submitted_qc>
<study_first_posted type="Actual">March 14, 2019</study_first_posted>
<last_update_submitted>September 10, 2019</last_update_submitted>
<last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
<last_update_posted type="Actual">September 12, 2019</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>NYU Langone Health</investigator_affiliation>
<investigator_full_name>Binita Shah</investigator_full_name>
<investigator_title>Assistant Professor of Medicine</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Myocardial Infarction</mesh_term>
<mesh_term>ST Elevation Myocardial Infarction</mesh_term>
<mesh_term>Infarction</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Colchicine</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>