{
    "info": {
        "nct_id": "NCT00785382",
        "official_title": "A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery",
        "inclusion_criteria": "1. American Society of Anesthesia physical status class I & II\n2. Age ¬< 65 years\n3. English-speaking\n4. Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- \"sentinal\" node biopsy)\nHealthy volunteers allowed\nMust be FEMALE\nMust have maximum age of 65 Years",
        "exclusion_criteria": "1. Known or suspected allergy, sensitivity, or contraindication to pregabalin\n2. Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone\n3. Morbid Obesity (Body Mass Index ≥ 45 kg/m2)\n4. History of a seizure disorder\n5. Pregnancy\n6. Current pre-operative therapy with pregabalin, gabapentin, or any opioid\n7. Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection\n8. CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. American Society of Anesthesia physical status class I & II",
            "criterions": [
                {
                    "exact_snippets": "American Society of Anesthesia physical status class I & II",
                    "criterion": "American Society of Anesthesia physical status class",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age ¬< 65 years",
            "criterions": [
                {
                    "exact_snippets": "Age ¬< 65 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. English-speaking",
            "criterions": [
                {
                    "exact_snippets": "English-speaking",
                    "criterion": "language",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": "English"
                        }
                    ]
                }
            ]
        },
        {
            "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 maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Known or suspected allergy, sensitivity, or contraindication to pregabalin",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected allergy, sensitivity, or contraindication to pregabalin",
                    "criterion": "allergy to pregabalin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known or suspected allergy, sensitivity, or contraindication to pregabalin",
                    "criterion": "sensitivity to pregabalin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known or suspected allergy, sensitivity, or contraindication to pregabalin",
                    "criterion": "contraindication to pregabalin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Morbid Obesity (Body Mass Index ≥ 45 kg/m2)",
            "criterions": [
                {
                    "exact_snippets": "Morbid Obesity (Body Mass Index ≥ 45 kg/m2)",
                    "criterion": "Body Mass Index",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "Morbid Obesity"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "kg/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of a seizure disorder",
            "criterions": [
                {
                    "exact_snippets": "History of a seizure disorder",
                    "criterion": "seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Current pre-operative therapy with pregabalin, gabapentin, or any opioid",
            "criterions": [
                {
                    "exact_snippets": "Current pre-operative therapy with pregabalin",
                    "criterion": "pre-operative therapy with pregabalin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current pre-operative therapy with ... gabapentin",
                    "criterion": "pre-operative therapy with gabapentin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current pre-operative therapy with ... any opioid",
                    "criterion": "pre-operative therapy with any opioid",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection",
            "criterions": [
                {
                    "exact_snippets": "Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection",
                    "criterion": "physical or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "impact on cooperation",
                            "expected_value": "may impair ability to cooperate with postoperative study data collection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]",
            "criterions": [
                {
                    "exact_snippets": "CrCl < 60 ml/min",
                    "criterion": "creatinine clearance (CrCl)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "4. Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- \"sentinal\" node biopsy)",
            "criterions": [
                {
                    "exact_snippets": "Unilateral breast cancer surgery",
                    "criterion": "breast cancer surgery",
                    "requirements": [
                        {
                            "requirement_type": "laterality",
                            "expected_value": "unilateral"
                        }
                    ]
                },
                {
                    "exact_snippets": "without axillary node dissection",
                    "criterion": "axillary node dissection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "simple mastectomies",
                    "criterion": "surgery type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "simple mastectomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "lumpectomies",
                    "criterion": "surgery type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "lumpectomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "sentinal node biopsy",
                    "criterion": "sentinal node biopsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "2. Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected allergy to morphine",
                    "criterion": "allergy to morphine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known or suspected allergy to NSAIDs",
                    "criterion": "allergy to NSAIDs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known or suspected allergy to acetaminophen",
                    "criterion": "allergy to acetaminophen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known or suspected allergy to oxycodone",
                    "criterion": "allergy to oxycodone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}