{
    "info": {
        "nct_id": "NCT05244382",
        "official_title": "OveRCoME: functiOnal Recovery Cancer MEtastasis",
        "inclusion_criteria": "1. Having breast cancer controlled primary and occurrence of one or more bone lesions (metastases osteoblastic) with location in the pelvis, lumbar spine and / or thoracic, attributable to breast cancer\n2. The bone metastasis is located only at bone level (low neurological risk).\n3. Not having exercised regular physical during last 3 months.\n4. ECOG (Eastern Cooperative Oncology Group) ≤ 1.\n5. > 4 weeks from a major surgery and full recovery.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Present cardiac toxicity secondary to treatments with decreased LVEF (If the LVEF percentage falls ≥ 10 points with respect to baseline or LVEF is below 50%) or QT prolongation\n2. Present any other toxicity greater than grade 2 in related to the treatments you are receiving or received in advance.\n3. Have spinal cord involvement, epidural involvement or instrumentation due to disease metastatic. (Moderate-high neurological risk)\n4. Have started or changed treatment hormonal during the last 3 months at recruitment.\n5. Present any pathology that prevents participation in a physical exercise program (PARQ-YOU).\n6. Present brain metastasis.\n7. Present uncontrolled hypertension (during recruitment, ≥2 / 3 evaluations <160/90 regardless of whether a regimen of antihypertensive therapy or not).\n8. Having had a serious cardiovascular event recently (in the last 12 months), including, but not limited to ischemic attack transient (TIA), cerebrovascular accident (CVA) or myocardial infarction (MI).\n9. Present a psychiatric illness, which would prevent the patient from signing the informed consent or adhere to the study protocol.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Having breast cancer controlled primary and occurrence of one or more bone lesions (metastases osteoblastic) with location in the pelvis, lumbar spine and / or thoracic, attributable to breast cancer",
            "criterions": [
                {
                    "exact_snippets": "breast cancer controlled primary",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "controlled primary"
                        }
                    ]
                },
                {
                    "exact_snippets": "occurrence of one or more bone lesions (metastases osteoblastic)",
                    "criterion": "bone lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "location in the pelvis, lumbar spine and / or thoracic",
                    "criterion": "bone lesions location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "pelvis",
                                "lumbar spine",
                                "thoracic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "attributable to breast cancer",
                    "criterion": "bone lesions cause",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. The bone metastasis is located only at bone level (low neurological risk).",
            "criterions": [
                {
                    "exact_snippets": "The bone metastasis is located only at bone level",
                    "criterion": "bone metastasis location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "bone level"
                        }
                    ]
                },
                {
                    "exact_snippets": "(low neurological risk)",
                    "criterion": "neurological risk",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Not having exercised regular physical during last 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Not having exercised regular physical during last 3 months.",
                    "criterion": "exercise",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time period",
                            "expected_value": "last 3 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. ECOG (Eastern Cooperative Oncology Group) ≤ 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG (Eastern Cooperative Oncology Group) ≤ 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. > 4 weeks from a major surgery and full recovery.",
            "criterions": [
                {
                    "exact_snippets": " > 4 weeks from a major surgery",
                    "criterion": "time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "full recovery",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "full"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Present cardiac toxicity secondary to treatments with decreased LVEF (If the LVEF percentage falls ≥ 10 points with respect to baseline or LVEF is below 50%) or QT prolongation",
            "criterions": [
                {
                    "exact_snippets": "Present cardiac toxicity secondary to treatments",
                    "criterion": "cardiac toxicity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "decreased LVEF",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": "decreased"
                        }
                    ]
                },
                {
                    "exact_snippets": "LVEF percentage falls ≥ 10 points with respect to baseline",
                    "criterion": "LVEF percentage change",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "points"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "LVEF is below 50%",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "QT prolongation",
                    "criterion": "QT interval",
                    "requirements": [
                        {
                            "requirement_type": "prolongation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Present any other toxicity greater than grade 2 in related to the treatments you are receiving or received in advance.",
            "criterions": [
                {
                    "exact_snippets": "toxicity greater than grade 2",
                    "criterion": "toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have spinal cord involvement, epidural involvement or instrumentation due to disease metastatic. (Moderate-high neurological risk)",
            "criterions": [
                {
                    "exact_snippets": "spinal cord involvement",
                    "criterion": "spinal cord involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "epidural involvement",
                    "criterion": "epidural involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "instrumentation due to disease metastatic",
                    "criterion": "instrumentation due to disease metastatic",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Have started or changed treatment hormonal during the last 3 months at recruitment.",
            "criterions": [
                {
                    "exact_snippets": "Have started or changed treatment hormonal during the last 3 months",
                    "criterion": "hormonal treatment",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Present any pathology that prevents participation in a physical exercise program (PARQ-YOU).",
            "criterions": [
                {
                    "exact_snippets": "pathology that prevents participation in a physical exercise program",
                    "criterion": "pathology",
                    "requirements": [
                        {
                            "requirement_type": "impact on exercise program participation",
                            "expected_value": "prevents participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Present brain metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Present brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Present uncontrolled hypertension (during recruitment, ≥2 / 3 evaluations <160/90 regardless of whether a regimen of antihypertensive therapy or not).",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥2 / 3 evaluations <160/90",
                    "criterion": "blood pressure evaluations",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "evaluations"
                            }
                        },
                        {
                            "requirement_type": "blood pressure",
                            "expected_value": {
                                "operator": "<",
                                "value": 160,
                                "unit": "systolic mmHg"
                            }
                        },
                        {
                            "requirement_type": "blood pressure",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "diastolic mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Having had a serious cardiovascular event recently (in the last 12 months), including, but not limited to ischemic attack transient (TIA), cerebrovascular accident (CVA) or myocardial infarction (MI).",
            "criterions": [
                {
                    "exact_snippets": "serious cardiovascular event recently (in the last 12 months)",
                    "criterion": "recent serious cardiovascular event",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ischemic attack transient (TIA)",
                    "criterion": "ischemic attack transient (TIA)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accident (CVA)",
                    "criterion": "cerebrovascular accident (CVA)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction (MI)",
                    "criterion": "myocardial infarction (MI)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Present a psychiatric illness, which would prevent the patient from signing the informed consent or adhere to the study protocol.",
            "criterions": [
                {
                    "exact_snippets": "Present a psychiatric illness, which would prevent the patient from signing the informed consent or adhere to the study protocol.",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "impact on consent",
                            "expected_value": "prevents signing informed consent"
                        },
                        {
                            "requirement_type": "impact on protocol adherence",
                            "expected_value": "prevents adherence to study protocol"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}