{
"info": {
"nct_id": "NCT02076672",
"official_title": "Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (The ABOCA Phase II Trial)",
"inclusion_criteria": "1. Asbestosis (defined as diffuse lung scarring based on increased profusion of interstitial fibrosis)\n2. Benign pleural disease (defined as thickening or fibrotic plaques on pleural surfaces of the lung bilaterally)\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "1. Prior systemic chemotherapy, radiation therapy or both.\n2. A current or previous history of primary malignancy.\n3. Known allergy to artichoke.\n4. Known bile duct obstruction.\n5. Known pregnancy or lactating women.\n6. Known psychiatric illness/social situations that would limit study compliance.\n7. Receiving any other investigational agents.\n8. Inability to understand or unable to provide written informed consent.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Asbestosis (defined as diffuse lung scarring based on increased profusion of interstitial fibrosis)",
"criterions": [
{
"exact_snippets": "Asbestosis (defined as diffuse lung scarring based on increased profusion of interstitial fibrosis)",
"criterion": "asbestosis",
"requirements": [
{
"requirement_type": "definition",
"expected_value": "diffuse lung scarring based on increased profusion of interstitial fibrosis"
}
]
}
]
},
{
"line": "2. Benign pleural disease (defined as thickening or fibrotic plaques on pleural surfaces of the lung bilaterally)",
"criterions": [
{
"exact_snippets": "Benign pleural disease (defined as thickening or fibrotic plaques on pleural surfaces of the lung bilaterally)",
"criterion": "pleural disease",
"requirements": [
{
"requirement_type": "type",
"expected_value": "benign"
},
{
"requirement_type": "characteristics",
"expected_value": [
"thickening",
"fibrotic plaques"
]
},
{
"requirement_type": "location",
"expected_value": "pleural surfaces of the lung bilaterally"
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Prior systemic chemotherapy, radiation therapy or both.",
"criterions": [
{
"exact_snippets": "Prior systemic chemotherapy",
"criterion": "systemic chemotherapy",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": true
}
]
},
{
"exact_snippets": "Prior ... radiation therapy",
"criterion": "radiation therapy",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": true
}
]
}
]
},
{
"line": "2. A current or previous history of primary malignancy.",
"criterions": [
{
"exact_snippets": "current or previous history of primary malignancy",
"criterion": "primary malignancy",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "3. Known allergy to artichoke.",
"criterions": [
{
"exact_snippets": "Known allergy to artichoke.",
"criterion": "allergy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "artichoke"
}
]
}
]
},
{
"line": "4. Known bile duct obstruction.",
"criterions": [
{
"exact_snippets": "Known bile duct obstruction",
"criterion": "bile duct obstruction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "5. Known pregnancy or lactating women.",
"criterions": [
{
"exact_snippets": "Known pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "6. Known psychiatric illness/social situations that would limit study compliance.",
"criterions": [
{
"exact_snippets": "Known psychiatric illness",
"criterion": "psychiatric illness",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "social situations that would limit study compliance",
"criterion": "social situations",
"requirements": [
{
"requirement_type": "impact on study compliance",
"expected_value": "limit"
}
]
}
]
},
{
"line": "7. Receiving any other investigational agents.",
"criterions": [
{
"exact_snippets": "Receiving any other investigational agents.",
"criterion": "investigational agents",
"requirements": [
{
"requirement_type": "receiving",
"expected_value": true
}
]
}
]
},
{
"line": "8. Inability to understand or unable to provide written informed consent.",
"criterions": [
{
"exact_snippets": "Inability to understand",
"criterion": "understanding ability",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
},
{
"exact_snippets": "unable to provide written informed consent",
"criterion": "ability to provide written informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}