{
"info": {
"nct_id": "NCT04182594",
"official_title": "A Phase-II, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Cardiovascular Events in Patients With Prostate Cancer and Cardiovascular Risk Factors Receiving Degarelix or GnRH Agonist",
"inclusion_criteria": "1. Locally advanced high-risk prostate cancer OR metastatic prostate cancer patients.\n2. Patients are scheduled to receive a combination of either\n\n 1. primary ADT for 12 months + either chemotherapy with docetaxel OR\n 2. primary ADT for 12 months + second line hormonal treatment with abiraterone/ enzalutamide/ apalutamide\n3. Patients with a medical history of either of the following:\n\n 1. Myocardial infarction\n 2. Ischaemic or haemorrhagic cerebrovascular conditions\n 3. Arterial embolic and thrombotic events\n 4. Ischaemic heart disease\n 5. Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures)\n 6. Peripheral vascular disease (e.g. significant stenosis (ABPI<0.9), claudication, prior vascular surgery/intervention(\n 7. Two out of three cardiovascular risk factors: hypertension, diabetes, current smoking.\n4. Patients age 18-90 years.\n5. Life expectancy of over 12 months.\n6. WHO performance status of 0-2\n7. Subject is able and has agreed to sign a consent form.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 90 Years",
"exclusion_criteria": "1. Prior use of ADT in past 6 months prior to randomization. We will, however, allow prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat.\n2. Known allergic reaction to Degarelix.\n3. Any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Locally advanced high-risk prostate cancer OR metastatic prostate cancer patients.",
"criterions": [
{
"exact_snippets": "Locally advanced high-risk prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced high-risk"
}
},
{
"exact_snippets": "metastatic prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "metastatic"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Locally advanced high-risk prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced high-risk"
}
},
{
"exact_snippets": "metastatic prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "metastatic"
}
}
]
}
},
{
"identified_line": {
"line": "2. Patients are scheduled to receive a combination of either",
"criterions": [
{
"exact_snippets": "Patients are scheduled to receive a combination",
"criterion": "treatment schedule",
"requirement": {
"requirement_type": "planned treatment",
"expected_value": "combination therapy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients are scheduled to receive a combination",
"criterion": "treatment schedule",
"requirement": {
"requirement_type": "planned treatment",
"expected_value": "combination therapy"
}
}
]
}
},
{
"identified_line": {
"line": "1. primary ADT for 12 months + either chemotherapy with docetaxel OR",
"criterions": [
{
"exact_snippets": "primary ADT for 12 months",
"criterion": "primary ADT",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 12,
"unit": "months"
}
}
},
{
"exact_snippets": "chemotherapy with docetaxel",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "drug",
"expected_value": "docetaxel"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "primary ADT for 12 months",
"criterion": "primary ADT",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 12,
"unit": "months"
}
}
},
{
"or_criteria": [
{
"exact_snippets": "chemotherapy with docetaxel",
"criterion": "chemotherapy",
"requirement": {
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"expected_value": "docetaxel"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "2. primary ADT for 12 months + second line hormonal treatment with abiraterone/ enzalutamide/ apalutamide",
"criterions": [
{
"exact_snippets": "primary ADT for 12 months",
"criterion": "primary ADT",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 12,
"unit": "months"
}
}
},
{
"exact_snippets": "second line hormonal treatment with abiraterone/ enzalutamide/ apalutamide",
"criterion": "second line hormonal treatment",
"requirement": {
"requirement_type": "medications",
"expected_value": [
"abiraterone",
"enzalutamide",
"apalutamide"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "primary ADT for 12 months",
"criterion": "primary ADT",
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"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 12,
"unit": "months"
}
}
},
{
"exact_snippets": "second line hormonal treatment with abiraterone/ enzalutamide/ apalutamide",
"criterion": "second line hormonal treatment",
"requirement": {
"requirement_type": "medications",
"expected_value": [
"abiraterone",
"enzalutamide",
"apalutamide"
]
}
}
]
}
},
{
"identified_line": {
"line": "3. Patients with a medical history of either of the following:",
"criterions": [
{
"exact_snippets": "medical history",
"criterion": "medical history",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "medical history",
"criterion": "medical history",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "1. Myocardial infarction",
"criterions": [
{
"exact_snippets": "Myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Arterial embolic and thrombotic events",
"criterions": [
{
"exact_snippets": "Arterial embolic and thrombotic events",
"criterion": "arterial embolic events",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Arterial embolic and thrombotic events",
"criterion": "arterial thrombotic events",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Arterial embolic and thrombotic events",
"criterion": "arterial embolic events",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Arterial embolic and thrombotic events",
"criterion": "arterial thrombotic events",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "4. Ischaemic heart disease",
"criterions": [
{
"exact_snippets": "Ischaemic heart disease",
"criterion": "ischaemic heart disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ischaemic heart disease",
"criterion": "ischaemic heart disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures)",
"criterions": [
{
"exact_snippets": "Prior coronary artery ... revascularization (percutaneous or surgical procedures)",
"criterion": "coronary artery revascularization",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Prior ... iliofemoral artery revascularization (percutaneous or surgical procedures)",
"criterion": "iliofemoral artery revascularization",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Prior coronary artery ... revascularization (percutaneous or surgical procedures)",
"criterion": "coronary artery revascularization",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Prior ... iliofemoral artery revascularization (percutaneous or surgical procedures)",
"criterion": "iliofemoral artery revascularization",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "6. Peripheral vascular disease (e.g. significant stenosis (ABPI<0.9), claudication, prior vascular surgery/intervention(",
"criterions": [
{
"exact_snippets": "Peripheral vascular disease",
"criterion": "peripheral vascular disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "significant stenosis (ABPI<0.9)",
"criterion": "significant stenosis",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 0.9,
"unit": "ABPI"
}
}
},
{
"exact_snippets": "claudication",
"criterion": "claudication",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "prior vascular surgery/intervention",
"criterion": "prior vascular surgery/intervention",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Peripheral vascular disease",
"criterion": "peripheral vascular disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "significant stenosis (ABPI<0.9)",
"criterion": "significant stenosis",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 0.9,
"unit": "ABPI"
}
}
}
]
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "prior vascular surgery/intervention",
"criterion": "prior vascular surgery/intervention",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "7. Two out of three cardiovascular risk factors: hypertension, diabetes, current smoking.",
"criterions": [
{
"exact_snippets": "hypertension",
"criterion": "hypertension",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "diabetes",
"criterion": "diabetes",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "current smoking",
"criterion": "current smoking",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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{
"and_criteria": [
{
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"criterion": "hypertension",
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}
},
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}
}
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"criterion": "hypertension",
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}
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}
}
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}
},
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}
}
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}
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},
{
"identified_line": {
"line": "4. Patients age 18-90 years.",
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{
"exact_snippets": "Patients age 18-90 years",
"criterion": "age",
"requirement": {
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"expected_value": {
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{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
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"value": 90,
"unit": "years"
}
]
}
}
}
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},
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"unit": "years"
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]
}
}
}
]
}
},
{
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{
"exact_snippets": "Life expectancy of over 12 months.",
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"unit": "months"
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}
}
]
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{
"exact_snippets": "Life expectancy of over 12 months.",
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"unit": "months"
}
}
}
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}
},
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"identified_line": {
"line": "6. WHO performance status of 0-2",
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{
"exact_snippets": "WHO performance status of 0-2",
"criterion": "WHO performance status",
"requirement": {
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"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
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"value": 2,
"unit": "N/A"
}
]
}
}
}
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"value": 0,
"unit": "N/A"
},
{
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"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "7. Subject is able and has agreed to sign a consent form.",
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{
"exact_snippets": "Subject is able ... to sign a consent form.",
"criterion": "ability to sign consent form",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Subject ... has agreed to sign a consent form.",
"criterion": "agreement to sign consent form",
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}
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}
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}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"expected_value": "healthy"
}
}
]
},
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"criterion": "volunteer health status",
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}
}
]
}
},
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"identified_line": {
"line": "Must be MALE",
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{
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"criterion": "gender",
"requirement": {
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"expected_value": "male"
}
}
]
},
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"criterion": "gender",
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"expected_value": "male"
}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
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"value": 18,
"unit": "Years"
}
}
}
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}
},
{
"identified_line": {
"line": "Must have maximum age of 90 Years",
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{
"exact_snippets": "maximum age of 90 Years",
"criterion": "age",
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"value": 90,
"unit": "Years"
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}
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"unit": "Years"
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],
"exclusion_lines": [
{
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"line": "1. Prior use of ADT in past 6 months prior to randomization. We will, however, allow prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat.",
"criterions": [
{
"exact_snippets": "Prior use of ADT in past 6 months prior to randomization.",
"criterion": "prior use of ADT",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "allow prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat.",
"criterion": "prior use of anti-androgens",
"requirement": {
"requirement_type": "allowed medications",
"expected_value": [
"Casodex",
"Chimax",
"Drogenil",
"Cyprostat"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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"exact_snippets": "Prior use of ADT in past 6 months prior to randomization.",
"criterion": "prior use of ADT",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
},
{
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"requirement": {
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"expected_value": [
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}
}
}
]
}
},
{
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{
"exact_snippets": "Known allergic reaction to Degarelix",
"criterion": "allergic reaction",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Known allergic reaction to Degarelix",
"criterion": "allergic reaction",
"requirement": {
"requirement_type": "substance",
"expected_value": "Degarelix"
}
}
]
},
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{
"exact_snippets": "Known allergic reaction to Degarelix",
"criterion": "allergic reaction",
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"expected_value": true
}
},
{
"exact_snippets": "Known allergic reaction to Degarelix",
"criterion": "allergic reaction",
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"requirement_type": "substance",
"expected_value": "Degarelix"
}
}
]
}
},
{
"identified_line": {
"line": "3. Any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.",
"criterions": [
{
"exact_snippets": "psychological ... situation potentially hampering compliance",
"criterion": "psychological situation",
"requirement": {
"requirement_type": "impact on compliance",
"expected_value": "potentially hampering"
}
},
{
"exact_snippets": "familial ... situation potentially hampering compliance",
"criterion": "familial situation",
"requirement": {
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"expected_value": "potentially hampering"
}
},
{
"exact_snippets": "sociological ... situation potentially hampering compliance",
"criterion": "sociological situation",
"requirement": {
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"expected_value": "potentially hampering"
}
},
{
"exact_snippets": "geographical situation potentially hampering compliance",
"criterion": "geographical situation",
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"expected_value": "potentially hampering"
}
}
]
},
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}
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]
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{
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}
}
]
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{
"and_criteria": [
{
"exact_snippets": "geographical situation potentially hampering compliance",
"criterion": "geographical situation",
"requirement": {
"requirement_type": "impact on compliance",
"expected_value": "potentially hampering"
}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "2. Ischaemic or haemorrhagic cerebrovascular conditions",
"criterions": [
{
"exact_snippets": "Ischaemic or haemorrhagic cerebrovascular conditions",
"criterion": "cerebrovascular conditions",
"requirement": {
"requirement_type": "type",
"expected_value": [
"ischaemic",
"haemorrhagic"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Ischaemic or haemorrhagic cerebrovascular conditions",
"criterion": "cerebrovascular conditions",
"requirement": {
"requirement_type": "type",
"expected_value": "ischaemic"
}
},
{
"exact_snippets": "Ischaemic or haemorrhagic cerebrovascular conditions",
"criterion": "cerebrovascular conditions",
"requirement": {
"requirement_type": "type",
"expected_value": "haemorrhagic"
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}