{
    "info": {
        "nct_id": "NCT00909831",
        "official_title": "A Phase I Trial of Hydroxychloroquine in Combination With Temsirolimus in Patients With Refractory Solid Tumors",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed refractory solid tumor for which no curative standard therapy exists\n\n  * Metastatic disease\n* Treated brain metastases that have been stable ≥ 3 months allowed\n\n  * At least 1 week since prior steroids\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status of 0-1\n* ANC ≥ 1,500/mm^3\n* Platelet count ≥ 100,000/mm^3\n* Creatinine ≤ 2 times upper limit of normal (ULN)\n* ALT and AST ≤ 5 times ULN\n* Total bilirubin ≤ 1.5 mg/dL\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety\n* No prior or other concurrent malignancy except for curatively treated carcinoma-in-situ at any site or basal cell carcinoma or squamous cell carcinoma of the skin\n\n  * Patients who have been free of disease (any prior malignancy) for ≥ 5 years are eligible\n* No porphyria\n* No psoriasis, except well controlled psoriasis under the care of a specialist\n* No previously documented macular degeneration or diabetic retinopathy\n* No HIV positivity\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Any number and type of prior anticancer therapies allowed\n* No prior mTOR inhibitors\n* At least 4 weeks since prior immunotherapy (i.e., aldesleukin, interferon, CTLA-4) or chemotherapy and recovered\n* At least 2 weeks since prior oral targeted therapy and recovered\n* At least 4 weeks since prior and no other concurrent investigational anticancer therapy (except for vaccines)\n* No other concurrent therapy\n* No concurrent combination antiretroviral therapy for HIV-positive patients\n* No concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs (i.e., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)\n* Concurrent non-enzyme inducing anticonvulsants, including felbamate, valproic acid, gabapentin, lamotrigine, tiagabine, topiramate, zonisamide, or levetiracetam allowed\n* Concurrent hematologic growth factors (filgrastim [G-CSF], pegfilgrastim, epoetin alfa) allowed in patients with severe myelosuppression"
    },
    "inclusion_lines": [
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                "line": "Healthy volunteers allowed",
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
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        },
        {
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                "line": "Must have minimum age of 18 Years",
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                    {
                        "exact_snippets": "minimum age of 18 Years",
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                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
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                                "value": 18,
                                "unit": "Years"
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        },
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                "line": "Must have maximum age of 120 Years",
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                        "exact_snippets": "maximum age of 120 Years",
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                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
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                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 120 Years",
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                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
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                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "DISEASE CHARACTERISTICS:",
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                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
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                    }
                ]
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        },
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                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        }
                    },
                    {
                        "exact_snippets": "no curative standard therapy exists",
                        "criterion": "curative standard therapy",
                        "requirement": {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
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                        "exact_snippets": "Histologically confirmed refractory solid tumor",
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                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        }
                    },
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                        "exact_snippets": "no curative standard therapy exists",
                        "criterion": "curative standard therapy",
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                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Metastatic disease",
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                        "exact_snippets": "Metastatic disease",
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                        }
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                ]
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        },
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                "criterions": [
                    {
                        "exact_snippets": "Treated brain metastases ... stable ≥ 3 months",
                        "criterion": "brain metastases",
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                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Treated brain metastases ... stable ≥ 3 months",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Treated brain metastases ... stable ≥ 3 months",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Treated brain metastases ... stable ≥ 3 months",
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                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least 1 week since prior steroids",
                "criterions": [
                    {
                        "exact_snippets": "At least 1 week since prior steroids",
                        "criterion": "time since prior steroids",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least 1 week since prior steroids",
                        "criterion": "time since prior steroids",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG performance status of 0-1",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status of 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status of 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ANC ≥ 1,500/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "ANC ≥ 1,500/mm^3",
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                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ANC ≥ 1,500/mm^3",
                        "criterion": "ANC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
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                ]
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                    {
                        "exact_snippets": "Platelet count ≥ 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
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                        }
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                        "exact_snippets": "Platelet count ≥ 100,000/mm^3",
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                                "value": 100000,
                                "unit": "mm^3"
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        },
        {
            "identified_line": {
                "line": "* ALT and AST ≤ 5 times ULN",
                "criterions": [
                    {
                        "exact_snippets": "ALT ... ≤ 5 times ULN",
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                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST ≤ 5 times ULN",
                        "criterion": "AST",
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                            "requirement_type": "level",
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            "logical_structure": {
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                        "exact_snippets": "ALT ... ≤ 5 times ULN",
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                            "requirement_type": "level",
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                                "unit": "times ULN"
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                    },
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                        "exact_snippets": "AST ≤ 5 times ULN",
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                            "requirement_type": "level",
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                ]
            }
        },
        {
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                        "exact_snippets": "Negative pregnancy test",
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                ]
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            "logical_structure": {
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                        "exact_snippets": "Negative pregnancy test",
                        "criterion": "pregnancy test",
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                ]
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        },
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            "identified_line": {
                "line": "* Fertile patients must use effective contraception",
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                            "requirement_type": "status",
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                    },
                    {
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                            "requirement_type": "necessity",
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                        }
                    }
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                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety",
                "criterions": [
                    {
                        "exact_snippets": "No serious concurrent infection",
                        "criterion": "serious concurrent infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No serious ... medical illness that would jeopardize the ability of the patient to receive the treatment",
                        "criterion": "serious medical illness",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
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                        }
                    },
                    {
                        "exact_snippets": "No serious ... medical illness that would jeopardize the ability of the patient to receive the treatment",
                        "criterion": "serious medical illness",
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                            "requirement_type": "presence",
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                ]
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        },
        {
            "identified_line": {
                "line": "* No prior or other concurrent malignancy except for curatively treated carcinoma-in-situ at any site or basal cell carcinoma or squamous cell carcinoma of the skin",
                "criterions": [
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                        "exact_snippets": "No prior or other concurrent malignancy",
                        "criterion": "prior malignancy",
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                            "requirement_type": "presence",
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                        }
                    },
                    {
                        "exact_snippets": "No prior or other concurrent malignancy",
                        "criterion": "concurrent malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "except for curatively treated carcinoma-in-situ at any site",
                        "criterion": "curatively treated carcinoma-in-situ",
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                            "requirement_type": "presence",
                            "expected_value": true
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                        "exact_snippets": "except for ... basal cell carcinoma",
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                        }
                    },
                    {
                        "exact_snippets": "except for ... squamous cell carcinoma of the skin",
                        "criterion": "squamous cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
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                "and_criteria": [
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                        "and_criteria": [
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                                "exact_snippets": "except for ... basal cell carcinoma",
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                                    "requirement_type": "presence",
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                                }
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                                "criterion": "squamous cell carcinoma of the skin",
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                                    "expected_value": true
                                }
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* Patients who have been free of disease (any prior malignancy) for ≥ 5 years are eligible",
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                        "criterion": "disease-free duration",
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                                "unit": "years"
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                "line": "* No porphyria",
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                        "exact_snippets": "No porphyria",
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            }
        },
        {
            "identified_line": {
                "line": "* No psoriasis, except well controlled psoriasis under the care of a specialist",
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                    {
                        "exact_snippets": "No psoriasis",
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                            "criterion": "psoriasis",
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                                "requirement_type": "care",
                                "expected_value": "under the care of a specialist"
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                    ]
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        },
        {
            "identified_line": {
                "line": "* No prior mTOR inhibitors",
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                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least 4 weeks since prior immunotherapy (i.e., aldesleukin, interferon, CTLA-4) or chemotherapy and recovered",
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                        "exact_snippets": "At least 4 weeks since prior immunotherapy (i.e., aldesleukin, interferon, CTLA-4)",
                        "criterion": "time since prior immunotherapy",
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                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
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                    {
                        "exact_snippets": "At least 4 weeks since prior ... chemotherapy",
                        "criterion": "time since prior chemotherapy",
                        "requirement": {
                            "requirement_type": "duration",
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                                        "exact_snippets": "At least 4 weeks since prior ... chemotherapy",
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                                "operator": "<=",
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                        "exact_snippets": "Total bilirubin ≤ 1.5 mg/dL",
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                                "operator": "<=",
                                "value": 1.5,
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                        "exact_snippets": "Total bilirubin \u0010.5 mg/dL",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No previously documented ... diabetic retinopathy",
                        "criterion": "diabetic retinopathy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
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        {
            "identified_line": {
                "line": "* No HIV positivity",
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                        "exact_snippets": "No HIV positivity",
                        "criterion": "HIV status",
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                            "requirement_type": "positivity",
                            "expected_value": false
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        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY:",
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                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
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            "identified_line": {
                "line": "* See Disease Characteristics",
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                    {
                        "exact_snippets": "Disease Characteristics",
                        "criterion": "disease characteristics",
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                            "requirement_type": "N/A",
                            "expected_value": "see details"
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            "identified_line": {
                "line": "* Any number and type of prior anticancer therapies allowed",
                "criterions": [
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                        "exact_snippets": "Any number and type of prior anticancer therapies allowed",
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                        "requirement": {
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                            "expected_value": "any"
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}