{
"info": {
"nct_id": "NCT01669369",
"official_title": "A Prospected Randomized Multicenter Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma",
"inclusion_criteria": "* histologically diagnosed primary classical osteosarcoma in extremities\n* staging IIB\n* MRI showing no skip lesion\n* receive standard neo-adjuvant chemotherapy, adjuvant chemotherapy,and standard surgical treatment\nHealthy volunteers allowed\nMust have minimum age of 8 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "* a history of non-standard treatment(chemotherapy or surgery)\n* secondary osteosarcoma or well-differentiated parosteal osteosarcoma\n* evident dysfunction of cardia,liver and kidney, or pregnant women or women during lactation",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* histologically diagnosed primary classical osteosarcoma in extremities",
"criterions": [
{
"exact_snippets": [
"histologically diagnosed"
],
"criterion": "osteosarcoma",
"requirement_type": "diagnosis method",
"expected_value": "histological"
},
{
"exact_snippets": [
"primary classical osteosarcoma"
],
"criterion": "osteosarcoma",
"requirement_type": "type",
"expected_value": "primary classical"
},
{
"exact_snippets": [
"osteosarcoma in extremities"
],
"criterion": "osteosarcoma",
"requirement_type": "location",
"expected_value": "extremities"
}
]
},
{
"line": "* staging IIB",
"criterions": [
{
"exact_snippets": [
"staging IIB"
],
"criterion": "cancer stage",
"requirement_type": "specific stage",
"expected_value": "IIB"
}
]
},
{
"line": "* MRI showing no skip lesion",
"criterions": [
{
"exact_snippets": [
"MRI showing no skip lesion"
],
"criterion": "skip lesion",
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"line": "* receive standard neo-adjuvant chemotherapy, adjuvant chemotherapy,and standard surgical treatment",
"criterions": [
{
"exact_snippets": [
"receive standard neo-adjuvant chemotherapy"
],
"criterion": "neo-adjuvant chemotherapy",
"requirement_type": "receipt",
"expected_value": true
},
{
"exact_snippets": [
"receive",
"adjuvant chemotherapy"
],
"criterion": "adjuvant chemotherapy",
"requirement_type": "receipt",
"expected_value": true
},
{
"exact_snippets": [
"receive",
"standard surgical treatment"
],
"criterion": "surgical treatment",
"requirement_type": "receipt",
"expected_value": true
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"line": "Must have minimum age of 8 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 8 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 8
}
}
]
},
{
"line": "Must have maximum age of 70 Years",
"criterions": [
{
"exact_snippets": [
"maximum age of 70 Years"
],
"criterion": "age",
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70
}
}
]
}
],
"exclusion_lines": [
{
"line": "* a history of non-standard treatment(chemotherapy or surgery)",
"criterions": [
{
"exact_snippets": [
"a history of non-standard treatment"
],
"criterion": "non-standard treatment",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"chemotherapy"
],
"criterion": "chemotherapy",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"surgery"
],
"criterion": "surgery",
"requirement_type": "history",
"expected_value": true
}
]
},
{
"line": "* secondary osteosarcoma or well-differentiated parosteal osteosarcoma",
"criterions": [
{
"exact_snippets": [
"secondary osteosarcoma"
],
"criterion": "osteosarcoma",
"requirement_type": "type",
"expected_value": "secondary"
},
{
"exact_snippets": [
"well-differentiated parosteal osteosarcoma"
],
"criterion": "osteosarcoma",
"requirement_type": "type",
"expected_value": "well-differentiated parosteal"
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "* evident dysfunction of cardia,liver and kidney, or pregnant women or women during lactation",
"criterions": [
{
"exact_snippets": [
"evident dysfunction of cardia"
],
"criterion": "cardia",
"requirement_type": "dysfunction",
"expected_value": true
},
{
"exact_snippets": [
"evident dysfunction of liver"
],
"criterion": "liver",
"requirement_type": "dysfunction",
"expected_value": true
},
{
"exact_snippets": [
"evident dysfunction of kidney"
],
"criterion": "kidney",
"requirement_type": "dysfunction",
"expected_value": true
},
{
"exact_snippets": [
"pregnant women"
],
"criterion": "pregnancy",
"requirement_type": "status",
"expected_value": true
},
{
"exact_snippets": [
"women during lactation"
],
"criterion": "lactation",
"requirement_type": "status",
"expected_value": true
}
]
}
],
"failed_miscellaneous": []
}