JSONObject jo = XML.toJSONObject(filereader, new JSONPointer("/clinical_study"));

<!-- This xml conforms to an XML Schema at:

<download_date>ClinicalTrials.gov processed this data on July 19, 2020</download_date>

<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>

<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 ; 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>[email protected]</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>[email protected]</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 -->