{
    "info": {
        "nct_id": "NCT00153894",
        "official_title": "Pilot Study of the Effects of an Exercise Intervention on Insulin Levels in Breast Cancer Survivors",
        "inclusion_criteria": "* History of pathologically confirmed stage I-IIIa invasive breast cancer\n* Adjuvant chemotherapy and/or radiation must be completed at least 3 months prior to enrollment\n* Body mass index > 25 and/or a body composition analysis of >30\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients taking herceptin\n* Evidence of residual or distant disease\n* Use of any medication expected to affect insulin levels\n* Baseline exercise of more than 20 minutes two times per week\n* Active malignancy\n* Diabetes mellitus\n* Heart disease or uncontrolled hypertension\n* Presence of any condition that might be expected to impact a participant's ability to perform physical activity",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* History of pathologically confirmed stage I-IIIa invasive breast cancer",
            "criterions": [
                {
                    "exact_snippets": "pathologically confirmed stage I-IIIa invasive breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": "invasive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adjuvant chemotherapy and/or radiation must be completed at least 3 months prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "Adjuvant chemotherapy ... must be completed at least 3 months prior to enrollment",
                    "criterion": "adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation must be completed at least 3 months prior to enrollment",
                    "criterion": "radiation",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Body mass index > 25 and/or a body composition analysis of >30",
            "criterions": [
                {
                    "exact_snippets": "Body mass index > 25",
                    "criterion": "body mass index",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "body composition analysis of >30",
                    "criterion": "body composition analysis",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "N/A",
                            "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": "* Patients taking herceptin",
            "criterions": [
                {
                    "exact_snippets": "Patients taking herceptin",
                    "criterion": "herceptin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of residual or distant disease",
            "criterions": [
                {
                    "exact_snippets": "Evidence of residual ... disease",
                    "criterion": "residual disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of ... distant disease",
                    "criterion": "distant disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of any medication expected to affect insulin levels",
            "criterions": [
                {
                    "exact_snippets": "Use of any medication expected to affect insulin levels",
                    "criterion": "medication use",
                    "requirements": [
                        {
                            "requirement_type": "effect on insulin levels",
                            "expected_value": "expected to affect"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Baseline exercise of more than 20 minutes two times per week",
            "criterions": [
                {
                    "exact_snippets": "Baseline exercise of more than 20 minutes two times per week",
                    "criterion": "baseline exercise",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "minutes"
                            }
                        },
                        {
                            "requirement_type": "frequency",
                            "expected_value": "two times per week"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active malignancy",
            "criterions": [
                {
                    "exact_snippets": "Active malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diabetes mellitus",
            "criterions": [
                {
                    "exact_snippets": "Diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Heart disease or uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "Heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of any condition that might be expected to impact a participant's ability to perform physical activity",
            "criterions": [
                {
                    "exact_snippets": "Presence of any condition that might be expected to impact a participant's ability to perform physical activity",
                    "criterion": "condition impacting physical activity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}