{
    "info": {
        "nct_id": "NCT00130494",
        "official_title": "Multicenter, Open-label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-symptomatic Bone Lesions",
        "inclusion_criteria": "* Written informed consent.\n* Age >= 18 years old.\n* Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.\n* Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease.\n* A maximum of two chemotherapy lines for metastatic disease.\n* A maximum of two hormone therapy lines for metastatic disease.\n* Normal, minimally altered renal function (serum creatinine < 1.5 x Upper Normal Limit (UNL)).\n* Normal serum calcium levels.\n* Performance status 0,1 (World Health Organization (WHO)).\n* Negative pregnancy test before study recruitment.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization.\n* Metastasis in CNS.\n* History of hypersensitivity to bisphosphonates.\n* Pregnant or lactating women.\n* Third chemotherapy line for metastatic disease.\n* Third hormone therapy line for metastatic disease.\n* Males.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age >= 18 years old.",
            "criterions": [
                {
                    "exact_snippets": "Age >= 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.",
            "criterions": [
                {
                    "exact_snippets": "Metastatic breast cancer patients",
                    "criterion": "metastatic breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lytic, sclerotic or mixed bone lesions",
                    "criterion": "bone lesions",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "lytic",
                                "sclerotic",
                                "mixed"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease.",
            "criterions": [
                {
                    "exact_snippets": "Non-symptomatic bone lesions, defined as pain absence",
                    "criterion": "bone lesions",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "absence of pain"
                        }
                    ]
                },
                {
                    "exact_snippets": "Non-symptomatic bone lesions, defined as ... lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression)",
                    "criterion": "bone lesions",
                    "requirements": [
                        {
                            "requirement_type": "complications",
                            "expected_value": [
                                "no fracture",
                                "no hypercalcemia",
                                "no CNS compression"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Non-symptomatic bone lesions, defined as ... no need of analgesic chronic administration for bone disease",
                    "criterion": "bone lesions",
                    "requirements": [
                        {
                            "requirement_type": "analgesic administration",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A maximum of two chemotherapy lines for metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "A maximum of two chemotherapy lines for metastatic disease.",
                    "criterion": "chemotherapy lines for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A maximum of two hormone therapy lines for metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "A maximum of two hormone therapy lines for metastatic disease.",
                    "criterion": "hormone therapy lines for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal, minimally altered renal function (serum creatinine < 1.5 x Upper Normal Limit (UNL)).",
            "criterions": [
                {
                    "exact_snippets": "Normal, minimally altered renal function (serum creatinine < 1.5 x Upper Normal Limit (UNL))",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "serum creatinine level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x Upper Normal Limit (UNL)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal serum calcium levels.",
            "criterions": [
                {
                    "exact_snippets": "Normal serum calcium levels.",
                    "criterion": "serum calcium levels",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status 0,1 (World Health Organization (WHO)).",
            "criterions": [
                {
                    "exact_snippets": "Performance status 0,1 (World Health Organization (WHO))",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test before study recruitment.",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with bisphosphonates",
                    "criterion": "previous treatment with bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days prior to randomization"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous treatment with ... raloxifene",
                    "criterion": "previous treatment with raloxifene",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days prior to randomization"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastasis in CNS.",
            "criterions": [
                {
                    "exact_snippets": "Metastasis in CNS",
                    "criterion": "CNS metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hypersensitivity to bisphosphonates.",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to bisphosphonates",
                    "criterion": "hypersensitivity to bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Third chemotherapy line for metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Third chemotherapy line for metastatic disease.",
                    "criterion": "chemotherapy line",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Third chemotherapy line for metastatic disease.",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Third hormone therapy line for metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Third hormone therapy line",
                    "criterion": "hormone therapy line",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Males.",
            "criterions": [
                {
                    "exact_snippets": "Males",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}