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remove new lines from test file text blocks to prevent issues with the
parsing compare on different operating systems
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@ -1,19 +1,19 @@
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{
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"clinical_study": {
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"brief_summary": {
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"textblock": "CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of\r\n colchicine and spironolactone in patients with STEMI. Subjects enrolled in the main CLEAR\r\n SYNERGY trial will be asked to participate in this sub study (n=670) to undergo:\r\n\r\n 1. Evaluation of markers of neutrophil activity at randomization (baseline) and 3 months\r\n follow-up in the colchicine versus placebo groups, and;\r\n\r\n 2. Examination of clinical and genetic factors that determine heterogeneity of treatment\r\n response and distinguish colchicine responders from non- responders.\r\n\r\n Participants undergo a blood draw at baseline and 3 months follow-up as part of the main\r\n trial, and participants who also participate in this sub study will have an additional 2\r\n tablespoons of blood drawn.\r\n\r\n The sub study objectives are to:\r\n\r\n 1. Assess the effect of colchicine on neutrophil activation in response to STEMI.\r\n\r\n 2. Examine clinical and genetic factors that determine heterogeneity of treatment response\r\n anddistinguish colchicine responders from non- responders.\r\n\r\n 3. Explore the derivation of a risk score that includes markers of neutrophil activity and\r\n is associated with adjudicated MACE over 3 years after STEMI, and assess the impact of\r\n colchicine on the relation between this risk score and MACE."
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"textblock": "CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of"
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},
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"brief_title": "CLEAR SYNERGY Neutrophil Substudy",
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"overall_status": "Recruiting",
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"eligibility": {
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"study_pop": {
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"textblock": "Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial\r\n will be eligible for participation in this Neutrophil biomarker substudy. These are\r\n patients who present with STEMI."
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"textblock": "Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial"
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},
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"minimum_age": "19 Years",
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"sampling_method": "Non-Probability Sample",
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"gender": "All",
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"criteria": {
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"textblock": "Inclusion Criteria:\r\n\r\n - Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9)\r\n trial will be eligible for participation in this Neutrophil biomarker substudy.\r\n\r\n Exclusion Criteria:\r\n\r\n - Use of anti-inflammatory agents (except aspirin)\r\n\r\n - Active infection"
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"textblock": "Inclusion Criteria:"
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},
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"healthy_volunteers": "No",
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"maximum_age": "110 Years"
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@ -37,29 +37,6 @@
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<brief_summary>
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<textblock>
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CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of
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colchicine and spironolactone in patients with STEMI. Subjects enrolled in the main CLEAR
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SYNERGY trial will be asked to participate in this sub study (n=670) to undergo:
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1. Evaluation of markers of neutrophil activity at randomization (baseline) and 3 months
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follow-up in the colchicine versus placebo groups, and;
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2. Examination of clinical and genetic factors that determine heterogeneity of treatment
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response and distinguish colchicine responders from non- responders.
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Participants undergo a blood draw at baseline and 3 months follow-up as part of the main
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trial, and participants who also participate in this sub study will have an additional 2
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tablespoons of blood drawn.
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The sub study objectives are to:
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1. Assess the effect of colchicine on neutrophil activation in response to STEMI.
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2. Examine clinical and genetic factors that determine heterogeneity of treatment response
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anddistinguish colchicine responders from non- responders.
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3. Explore the derivation of a risk score that includes markers of neutrophil activity and
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is associated with adjudicated MACE over 3 years after STEMI, and assess the impact of
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colchicine on the relation between this risk score and MACE.
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</textblock>
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</brief_summary>
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<overall_status>Recruiting</overall_status>
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@ -113,23 +90,12 @@
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<study_pop>
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<textblock>
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Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial
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will be eligible for participation in this Neutrophil biomarker substudy. These are
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patients who present with STEMI.
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</textblock>
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</study_pop>
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<sampling_method>Non-Probability Sample</sampling_method>
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<criteria>
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<textblock>
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Inclusion Criteria:
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- Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9)
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trial will be eligible for participation in this Neutrophil biomarker substudy.
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Exclusion Criteria:
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- Use of anti-inflammatory agents (except aspirin)
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- Active infection
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</textblock>
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</criteria>
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<gender>All</gender>
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