{
    "info": {
        "nct_id": "NCT03199560",
        "official_title": "A Randomized Controlled Double-blinded Study Comparing the Intraoperative Injection of Lymphatic Mapping Agents Tc 99m Tilmanocept to Tc 99m Filtered Sulfur Colloid in Breast Cancer Patients Undergoing Breast Conservation and Sentinel Lymph Node Biopsy",
        "inclusion_criteria": "* Women above 18 years of age with biopsy proven, clinically stage 1 or 2 breast cancer who will be undergoing partial mastectomy with SLNBx at Memorial Health\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Women under the age of 18,\n* Clinically positive axillary nodes\n* Neoadjuvant therapy for current breast cancer diagnosis\n* Women with previous SLNBx or axillary node dissection\n* Pregnant women\n* Women with previous radiation above the diaphragm, and below the neck",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Women above 18 years of age with biopsy proven, clinically stage 1 or 2 breast cancer who will be undergoing partial mastectomy with SLNBx at Memorial Health",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "above 18 years of age"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 18
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "biopsy proven"
                    ],
                    "criterion": "breast cancer",
                    "requirement_type": "confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "clinically stage 1 or 2"
                    ],
                    "criterion": "breast cancer",
                    "requirement_type": "stage",
                    "expected_value": [
                        "1",
                        "2"
                    ]
                },
                {
                    "exact_snippets": [
                        "undergoing partial mastectomy"
                    ],
                    "criterion": "surgical procedure",
                    "requirement_type": "type",
                    "expected_value": "partial mastectomy"
                },
                {
                    "exact_snippets": [
                        "SLNBx"
                    ],
                    "criterion": "surgical procedure",
                    "requirement_type": "type",
                    "expected_value": "SLNBx"
                },
                {
                    "exact_snippets": [
                        "at Memorial Health"
                    ],
                    "criterion": "location",
                    "requirement_type": "specificity",
                    "expected_value": "Memorial Health"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": [
                        "Must be FEMALE"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Women under the age of 18,",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women under the age of 18"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Clinically positive axillary nodes",
            "criterions": [
                {
                    "exact_snippets": [
                        "Clinically positive axillary nodes"
                    ],
                    "criterion": "axillary nodes",
                    "requirement_type": "clinical status",
                    "expected_value": "positive"
                }
            ]
        },
        {
            "line": "* Neoadjuvant therapy for current breast cancer diagnosis",
            "criterions": [
                {
                    "exact_snippets": [
                        "Neoadjuvant therapy",
                        "current breast cancer diagnosis"
                    ],
                    "criterion": "neoadjuvant therapy",
                    "requirement_type": "association",
                    "expected_value": "current breast cancer diagnosis"
                }
            ]
        },
        {
            "line": "* Women with previous SLNBx or axillary node dissection",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specific",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "previous SLNBx"
                    ],
                    "criterion": "SLNBx",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "axillary node dissection"
                    ],
                    "criterion": "axillary node dissection",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Pregnant women",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnant women"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Women with previous radiation above the diaphragm, and below the neck",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "previous radiation"
                    ],
                    "criterion": "radiation history",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "above the diaphragm"
                    ],
                    "criterion": "radiation location",
                    "requirement_type": "location",
                    "expected_value": "above the diaphragm"
                },
                {
                    "exact_snippets": [
                        "below the neck"
                    ],
                    "criterion": "radiation location",
                    "requirement_type": "location",
                    "expected_value": "below the neck"
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}