{
    "info": {
        "nct_id": "NCT00356148",
        "official_title": "Phase IV Study of Determining the Efficacy of Ampicillin/Sulbactam Combination as Antibiotic Prophylaxis During Breast Cancer Surgery in Patients With a Body Mass Index (BMI) Over 25.",
        "inclusion_criteria": "* Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Ductal carcinoma in situ (DCIS; stage 0 cancer),\n* Advanced or distant metastatic stage,\n* Receiving any neoadjuvant therapy,\n* History of receiving any antibiotics within prior 3 months,\n* History of immunodeficiency,\n* Having a remote infection,\n* History of reaction to study antibiotics,\n* Denial of signing the consent form.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "any age"
                    ],
                    "criterion": "age",
                    "requirement_type": "N/A",
                    "expected_value": "any"
                },
                {
                    "exact_snippets": [
                        "early stage breast cancer",
                        "stage I-II"
                    ],
                    "criterion": "breast cancer stage",
                    "requirement_type": "specificity",
                    "expected_value": [
                        "I",
                        "II"
                    ]
                },
                {
                    "exact_snippets": [
                        "American Society of Anesthesiologists (ASA) score",
                        "I-II"
                    ],
                    "criterion": "ASA score",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1
                            },
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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": "specific value",
                    "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": "* Ductal carcinoma in situ (DCIS; stage 0 cancer),",
            "criterions": [
                {
                    "exact_snippets": [
                        "Ductal carcinoma in situ (DCIS; stage 0 cancer)"
                    ],
                    "criterion": "ductal carcinoma in situ",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Advanced or distant metastatic stage,",
            "criterions": [
                {
                    "exact_snippets": [
                        "Advanced or distant metastatic stage"
                    ],
                    "criterion": "cancer stage",
                    "requirement_type": "presence",
                    "expected_value": [
                        "advanced",
                        "distant metastatic"
                    ]
                }
            ]
        },
        {
            "line": "* Receiving any neoadjuvant therapy,",
            "criterions": [
                {
                    "exact_snippets": [
                        "Receiving any neoadjuvant therapy"
                    ],
                    "criterion": "neoadjuvant therapy",
                    "requirement_type": "receiving",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of receiving any antibiotics within prior 3 months,",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of receiving any antibiotics within prior 3 months"
                    ],
                    "criterion": "antibiotics",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within prior 3 months"
                    ],
                    "criterion": "antibiotics",
                    "requirement_type": "timeframe",
                    "expected_value": "3 months"
                }
            ]
        },
        {
            "line": "* History of immunodeficiency,",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of immunodeficiency"
                    ],
                    "criterion": "immunodeficiency",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Having a remote infection,",
            "criterions": [
                {
                    "exact_snippets": [
                        "Having a remote infection"
                    ],
                    "criterion": "remote infection",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of reaction to study antibiotics,",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of reaction to study antibiotics"
                    ],
                    "criterion": "reaction to study antibiotics",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Denial of signing the consent form.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Denial of signing the consent form"
                    ],
                    "criterion": "consent form",
                    "requirement_type": "signed",
                    "expected_value": false
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}