{
    "info": {
        "nct_id": "NCT00582920",
        "official_title": "Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From Breast Cancer",
        "inclusion_criteria": "* Patients receiving intravenous biphosphonate therapy (zoledronic acid 4 mg or renal dose equivalent) as part of their treatment regimen, who are diagnosed with metastatic breast cancer involving surrounding bone.\n* Patients must have had prior treatment zoledronic acid (4 mg or adjusted dose for renal function) within 8 weeks.\n* The patients clinical status as assessed by a treating physician must be deemed appropriate for continuing treatment with zoledronic acid\n* The patient's clinical status, as assessed by a treating physician, must be deemed appropriate for an evaluation with a bone scan\n* The patient's medical status as assessed by a treating physician must be medically appropriate to receive zoledronic acid within the study time frame and in association with the study bone scan\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 110 Years",
        "exclusion_criteria": "* No evidence of bone metastases, or less than 3 osseous lesions felt to be consistent with bone metastases, on most recent bone scan performed for clinical indications prior to study entry.\n* Patients with illnesses, or conditions that would prevent them from understanding the nature of the study and complying with the protocol requirements",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients receiving intravenous biphosphonate therapy (zoledronic acid 4 mg or renal dose equivalent) as part of their treatment regimen, who are diagnosed with metastatic breast cancer involving surrounding bone.",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving intravenous biphosphonate therapy",
                    "criterion": "intravenous biphosphonate therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "zoledronic acid 4 mg or renal dose equivalent",
                    "criterion": "zoledronic acid dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": [
                                "4 mg",
                                "renal dose equivalent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed with metastatic breast cancer",
                    "criterion": "metastatic breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "involving surrounding bone",
                    "criterion": "bone involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have had prior treatment zoledronic acid (4 mg or adjusted dose for renal function) within 8 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Patients must have had prior treatment zoledronic acid",
                    "criterion": "prior treatment with zoledronic acid",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(4 mg or adjusted dose for renal function)",
                    "criterion": "dose of zoledronic acid",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": [
                                "4 mg",
                                "adjusted dose for renal function"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "within 8 weeks",
                    "criterion": "time since prior treatment with zoledronic acid",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 8,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patients clinical status as assessed by a treating physician must be deemed appropriate for continuing treatment with zoledronic acid",
            "criterions": [
                {
                    "exact_snippets": "The patients clinical status ... must be deemed appropriate for continuing treatment with zoledronic acid",
                    "criterion": "clinical status",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness for treatment",
                            "expected_value": "appropriate for continuing treatment with zoledronic acid"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient's clinical status, as assessed by a treating physician, must be deemed appropriate for an evaluation with a bone scan",
            "criterions": [
                {
                    "exact_snippets": "The patient's clinical status, as assessed by a treating physician, must be deemed appropriate for an evaluation with a bone scan",
                    "criterion": "clinical status",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness for evaluation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient's medical status as assessed by a treating physician must be medically appropriate to receive zoledronic acid within the study time frame and in association with the study bone scan",
            "criterions": [
                {
                    "exact_snippets": "The patient's medical status as assessed by a treating physician must be medically appropriate to receive zoledronic acid",
                    "criterion": "medical status",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "medically appropriate to receive zoledronic acid"
                        }
                    ]
                },
                {
                    "exact_snippets": "within the study time frame",
                    "criterion": "study time frame",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "within the study time frame"
                        }
                    ]
                },
                {
                    "exact_snippets": "in association with the study bone scan",
                    "criterion": "study bone scan",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "in association with the study bone scan"
                        }
                    ]
                }
            ]
        },
        {
            "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 110 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 110 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 110,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* No evidence of bone metastases, or less than 3 osseous lesions felt to be consistent with bone metastases, on most recent bone scan performed for clinical indications prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "No evidence of bone metastases",
                    "criterion": "bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "less than 3 osseous lesions ... consistent with bone metastases",
                    "criterion": "osseous lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with illnesses, or conditions that would prevent them from understanding the nature of the study and complying with the protocol requirements",
            "criterions": [
                {
                    "exact_snippets": "illnesses, or conditions that would prevent them from understanding the nature of the study",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "illnesses, or conditions that would prevent them from ... complying with the protocol requirements",
                    "criterion": "ability to comply with protocol",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}