{
    "info": {
        "nct_id": "NCT02458391",
        "official_title": "Therapeutic Quantity of Complete Decongestive Therapy in Breast Cancer-Related Lymphedema: A Double Blinded Randomized Control Trial",
        "inclusion_criteria": "1. Have active unilateral breast cancer-related lymphedema\n2. Medically stable\n3. Have not participated in lymphedema therapy the past 3 months\n4. An affected limb volume measurement of >10% excess volume\n5. Ages 18-95 years old\n\n   * Patients undergoing any medical treatment for their breast cancer diagnosis will be included in this study.\n   * Patients with any stage breast cancer will be included in this study.\n   * Patients with a prior diagnosis of breast cancer, other cancer will be included in this study. There is no minimum time requirement that has prolapsed between their diagnosis and this study.\n\nAll subjects must have given signed, informed consent prior to registration on study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 95 Years",
        "exclusion_criteria": "1. Prophylactic treatment indicated\n2. A presence of upper extremity wounds present\n3. Active signs of infection or deep vein thrombosis (DVT)\n4. Bilateral lymphedema present\n5. Evidence of contraindications to CDT: uncontrolled hypertension, heart disease including congestive heart failure, and renal insufficiency\n6. Severe lymphedema present as defined by > 30% increase in limb volume",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Have active unilateral breast cancer-related lymphedema",
            "criterions": [
                {
                    "exact_snippets": "active unilateral breast cancer-related lymphedema",
                    "criterion": "breast cancer-related lymphedema",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "laterality",
                            "expected_value": "unilateral"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Medically stable",
            "criterions": [
                {
                    "exact_snippets": "Medically stable",
                    "criterion": "medical stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have not participated in lymphedema therapy the past 3 months",
            "criterions": [
                {
                    "exact_snippets": "Have not participated in lymphedema therapy the past 3 months",
                    "criterion": "participation in lymphedema therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. An affected limb volume measurement of >10% excess volume",
            "criterions": [
                {
                    "exact_snippets": "affected limb volume measurement of >10% excess volume",
                    "criterion": "affected limb volume",
                    "requirements": [
                        {
                            "requirement_type": "excess volume",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Ages 18-95 years old",
            "criterions": [
                {
                    "exact_snippets": "Ages 18-95 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 95,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients undergoing any medical treatment for their breast cancer diagnosis will be included in this study.",
            "criterions": [
                {
                    "exact_snippets": "Patients undergoing any medical treatment for their breast cancer diagnosis",
                    "criterion": "medical treatment for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with any stage breast cancer will be included in this study.",
            "criterions": [
                {
                    "exact_snippets": "any stage breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a prior diagnosis of breast cancer, other cancer will be included in this study. There is no minimum time requirement that has prolapsed between their diagnosis and this study.",
            "criterions": [
                {
                    "exact_snippets": "prior diagnosis of breast cancer",
                    "criterion": "breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other cancer",
                    "criterion": "other cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "All subjects must have given signed, informed consent prior to registration on study.",
            "criterions": [
                {
                    "exact_snippets": "All subjects must have given signed, informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "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 95 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 95 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 95,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Prophylactic treatment indicated",
            "criterions": [
                {
                    "exact_snippets": "Prophylactic treatment indicated",
                    "criterion": "prophylactic treatment",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. A presence of upper extremity wounds present",
            "criterions": [
                {
                    "exact_snippets": "presence of upper extremity wounds",
                    "criterion": "upper extremity wounds",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Active signs of infection or deep vein thrombosis (DVT)",
            "criterions": [
                {
                    "exact_snippets": "Active signs of infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "deep vein thrombosis (DVT)",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Bilateral lymphedema present",
            "criterions": [
                {
                    "exact_snippets": "Bilateral lymphedema present",
                    "criterion": "bilateral lymphedema",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Evidence of contraindications to CDT: uncontrolled hypertension, heart disease including congestive heart failure, and renal insufficiency",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "heart disease including congestive heart failure",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "renal insufficiency",
                    "criterion": "renal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Severe lymphedema present as defined by > 30% increase in limb volume",
            "criterions": [
                {
                    "exact_snippets": "Severe lymphedema present",
                    "criterion": "lymphedema",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "> 30% increase in limb volume",
                    "criterion": "limb volume",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}