{
    "info": {
        "nct_id": "NCT00527982",
        "official_title": "Celecoxib as Adjuvant Biologic Therapy in Patients With Early Stage Head and Neck and Lung Cancer",
        "inclusion_criteria": "1. Patients with either: a) histologically proven stage I, II, or IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy).\n2. HNSCC patients: Definitive local treatment </= 12 months prior to trial enrollment. NSCLC patients: Surgery </= 12 months prior to trial enrollment.\n3. No evidence residual cancer\n4. Smoking history of at least 10 pack years. May be current or former smoker.\n5. Performance status of < = 2 (Zubrod)\n6. Age =>18 years\n7. Participants must have no contraindications for undergoing bronchoscopy.\n8. Patients must have no active pulmonary infections.\n9. Participants must not be taking oral non-steroidal anti-inflammatory drugs on a regular basis.\n10. Participants must have the following blood levels: total granulocyte count >1500; platelet count > 100,000; total bilirubin < = 1.5 mg. %; and creatinine < = 1.5 mg %.\n11. Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies.\n12. All subjects who agree to participate will be given a written and verbal explanation of the study requirements and a consent form that must be signed prior to registration. Subjects will be informed that (a) they must be willing to take capsules daily for the duration of the trial, (b) they must be willing to take biopsies through bronchoscopy and give blood samples at the specified times, (c) they must schedule and keep the specified follow-up visits with their physicians and the study clinics, and (d) side effects and health risks may occur, as described in the informed consent form.\n13. Participant must be enrolled in UT MD Anderson Cancer Center protocol #2003-0424 titled \"A Phase IIb Vanguard Study Characterizing the Occurrence of Recurrent or Second Primary Tumors in Patients with a Prior History of a Definitively Treated Stage I/II Head and Neck or Non-Small Cell Cancer who are Current or Former Smokers.\"\n14. Patients with prior head and neck cancer only: Participants must have no contraindications for undergoing laryngoscopy.\n15. Subject must be considered legally capable of providing his or her own consent for participation in this trial.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included.\n2. History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy.\n3. Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required)\n4. Participants with active gastric or duodenal ulcers or a history of ulcers requiring prophylactic H2 blockers.\n5. Participants with active pulmonary infections or recent history of pulmonary infection (within one month).\n6. Participants with acute intercurrent illness\n7. Participants requiring chronic ongoing treatment with Nonsteroidal anti-inflammatory drugs (NSAIDs). (Casual or non-prescribed use of NSAIDs is permitted as long as their use does not exceed one week at a time.)\n8. Participants who are allergic to aspirin or sulfanamides.\n9. Patients may not take high dose antioxidants (vitamins E or C) during the study period. \"High dose\" will be determined by the study investigators.\n10. Patients may not take high dose synthetic or natural Vitamin A derivatives (> 10,000 IU per day).\n11. History of biologic therapy\n12. Women of childbearing potential and men with partners of childbearing potential who are not using an effective method of contraception. Use of contraception will be verified at office visits during first year on study.\n13. History of cardiovascular diseases that might include one of the following: myocardial infarction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery.\n14. Diagnosis of diabetes\n15. History of deep venous thrombosis, pulmonary embolism, systemic lupus erythematosus, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, or known Factor V Leiden mutation.\n16. Family history of premature CAD. This is defined as individuals with either: 1) father with MI prior to age 55, or 2) mother with MI prior to age 60.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients with either: a) histologically proven stage I, II, or IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy).",
            "criterions": [
                {
                    "exact_snippets": "histologically proven stage I, II, or IIIa NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II",
                                "IIIa"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "complete surgical resection of the primary tumor",
                    "criterion": "surgical resection of primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": "complete"
                        }
                    ]
                },
                {
                    "exact_snippets": "stage I or II HNSCC",
                    "criterion": "HNSCC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "definitive local treatment (surgery or radiation therapy)",
                    "criterion": "local treatment for HNSCC",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "surgery",
                                "radiation therapy"
                            ]
                        },
                        {
                            "requirement_type": "definitiveness",
                            "expected_value": "definitive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. HNSCC patients: Definitive local treatment </= 12 months prior to trial enrollment. NSCLC patients: Surgery </= 12 months prior to trial enrollment.",
            "criterions": [
                {
                    "exact_snippets": "HNSCC patients: Definitive local treatment </= 12 months prior to trial enrollment.",
                    "criterion": "HNSCC patients",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "Definitive local treatment"
                        },
                        {
                            "requirement_type": "treatment timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "NSCLC patients: Surgery </= 12 months prior to trial enrollment.",
                    "criterion": "NSCLC patients",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "Surgery"
                        },
                        {
                            "requirement_type": "treatment timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. No evidence residual cancer",
            "criterions": [
                {
                    "exact_snippets": "No evidence residual cancer",
                    "criterion": "residual cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Smoking history of at least 10 pack years. May be current or former smoker.",
            "criterions": [
                {
                    "exact_snippets": "Smoking history of at least 10 pack years",
                    "criterion": "smoking history",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "pack years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "May be current or former smoker",
                    "criterion": "smoking status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "current",
                                "former"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Performance status of < = 2 (Zubrod)",
            "criterions": [
                {
                    "exact_snippets": "Performance status of < = 2 (Zubrod)",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Zubrod"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Age =>18 years",
            "criterions": [
                {
                    "exact_snippets": "Age =>18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Participants must have no contraindications for undergoing bronchoscopy.",
            "criterions": [
                {
                    "exact_snippets": "no contraindications for undergoing bronchoscopy",
                    "criterion": "contraindications for bronchoscopy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients must have no active pulmonary infections.",
            "criterions": [
                {
                    "exact_snippets": "no active pulmonary infections",
                    "criterion": "pulmonary infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Participants must not be taking oral non-steroidal anti-inflammatory drugs on a regular basis.",
            "criterions": [
                {
                    "exact_snippets": "Participants must not be taking oral non-steroidal anti-inflammatory drugs on a regular basis.",
                    "criterion": "oral non-steroidal anti-inflammatory drugs",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Participants must have the following blood levels: total granulocyte count >1500; platelet count > 100,000; total bilirubin < = 1.5 mg. %; and creatinine < = 1.5 mg %.",
            "criterions": [
                {
                    "exact_snippets": "total granulocyte count >1500",
                    "criterion": "total granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count > 100,000",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin < = 1.5 mg. %",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg %"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine < = 1.5 mg %",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg %"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies.",
            "criterions": [
                {
                    "exact_snippets": "Participants must complete the pretreatment evaluation",
                    "criterion": "pretreatment evaluation",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must consent to bronchoscopy",
                    "criterion": "bronchoscopy",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must consent to ... endobronchial biopsy",
                    "criterion": "endobronchial biopsy",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. All subjects who agree to participate will be given a written and verbal explanation of the study requirements and a consent form that must be signed prior to registration. Subjects will be informed that (a) they must be willing to take capsules daily for the duration of the trial, (b) they must be willing to take biopsies through bronchoscopy and give blood samples at the specified times, (c) they must schedule and keep the specified follow-up visits with their physicians and the study clinics, and (d) side effects and health risks may occur, as described in the informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "must be willing to take capsules daily for the duration of the trial",
                    "criterion": "willingness to take capsules",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must be willing to take biopsies through bronchoscopy and give blood samples at the specified times",
                    "criterion": "willingness to undergo biopsies and give blood samples",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must schedule and keep the specified follow-up visits with their physicians and the study clinics",
                    "criterion": "willingness to attend follow-up visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Participant must be enrolled in UT MD Anderson Cancer Center protocol #2003-0424 titled \"A Phase IIb Vanguard Study Characterizing the Occurrence of Recurrent or Second Primary Tumors in Patients with a Prior History of a Definitively Treated Stage I/II Head and Neck or Non-Small Cell Cancer who are Current or Former Smokers.\"",
            "criterions": [
                {
                    "exact_snippets": "Participant must be enrolled in UT MD Anderson Cancer Center protocol #2003-0424",
                    "criterion": "enrollment in specific protocol",
                    "requirements": [
                        {
                            "requirement_type": "protocol number",
                            "expected_value": "2003-0424"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with a Prior History of a Definitively Treated Stage I/II Head and Neck or Non-Small Cell Cancer",
                    "criterion": "prior history of cancer",
                    "requirements": [
                        {
                            "requirement_type": "cancer type",
                            "expected_value": [
                                "Head and Neck",
                                "Non-Small Cell"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "I/II"
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "definitively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "who are Current or Former Smokers",
                    "criterion": "smoking status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "current smoker",
                                "former smoker"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Patients with prior head and neck cancer only: Participants must have no contraindications for undergoing laryngoscopy.",
            "criterions": [
                {
                    "exact_snippets": "Patients with prior head and neck cancer only",
                    "criterion": "prior head and neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no contraindications for undergoing laryngoscopy",
                    "criterion": "contraindications for laryngoscopy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Subject must be considered legally capable of providing his or her own consent for participation in this trial.",
            "criterions": [
                {
                    "exact_snippets": "Subject must be considered legally capable of providing his or her own consent",
                    "criterion": "legal capability to provide consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included.",
            "criterions": [
                {
                    "exact_snippets": "History of radiation therapy to the chest",
                    "criterion": "radiation therapy to the chest",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "head and neck cancer who received radiation",
                    "criterion": "head and neck cancer radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no more than 10% of the lung volume (apices) may be included",
                    "criterion": "lung volume included in radiation",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy.",
            "criterions": [
                {
                    "exact_snippets": "History of systemic chemotherapy",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy",
                    "criterion": "platinum-based doublet therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "cycles"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required)",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours of enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Participants with active gastric or duodenal ulcers or a history of ulcers requiring prophylactic H2 blockers.",
            "criterions": [
                {
                    "exact_snippets": "active gastric or duodenal ulcers",
                    "criterion": "active gastric ulcers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active gastric or duodenal ulcers",
                    "criterion": "active duodenal ulcers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ulcers requiring prophylactic H2 blockers",
                    "criterion": "history of ulcers requiring prophylactic H2 blockers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Participants with active pulmonary infections or recent history of pulmonary infection (within one month).",
            "criterions": [
                {
                    "exact_snippets": "active pulmonary infections",
                    "criterion": "pulmonary infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recent history of pulmonary infection (within one month)",
                    "criterion": "pulmonary infection history",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Participants with acute intercurrent illness",
            "criterions": [
                {
                    "exact_snippets": "acute intercurrent illness",
                    "criterion": "acute intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Participants requiring chronic ongoing treatment with Nonsteroidal anti-inflammatory drugs (NSAIDs). (Casual or non-prescribed use of NSAIDs is permitted as long as their use does not exceed one week at a time.)",
            "criterions": [
                {
                    "exact_snippets": "Participants requiring chronic ongoing treatment with Nonsteroidal anti-inflammatory drugs (NSAIDs)",
                    "criterion": "chronic NSAID treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Casual or non-prescribed use of NSAIDs is permitted ... does not exceed one week at a time",
                    "criterion": "casual NSAID use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Participants who are allergic to aspirin or sulfanamides.",
            "criterions": [
                {
                    "exact_snippets": "allergic to aspirin",
                    "criterion": "aspirin allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... sulfanamides",
                    "criterion": "sulfanamide allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients may not take high dose antioxidants (vitamins E or C) during the study period. \"High dose\" will be determined by the study investigators.",
            "criterions": [
                {
                    "exact_snippets": "Patients may not take high dose antioxidants (vitamins E or C)",
                    "criterion": "antioxidant intake",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "\"High dose\" will be determined by the study investigators.",
                    "criterion": "high dose definition",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "determined by study investigators"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients may not take high dose synthetic or natural Vitamin A derivatives (> 10,000 IU per day).",
            "criterions": [
                {
                    "exact_snippets": "Patients may not take high dose synthetic or natural Vitamin A derivatives (> 10,000 IU per day)",
                    "criterion": "Vitamin A derivatives intake",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10000,
                                "unit": "IU per day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. History of biologic therapy",
            "criterions": [
                {
                    "exact_snippets": "History of biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Women of childbearing potential and men with partners of childbearing potential who are not using an effective method of contraception. Use of contraception will be verified at office visits during first year on study.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men with partners of childbearing potential",
                    "criterion": "men with partners of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not using an effective method of contraception",
                    "criterion": "use of contraception",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. History of cardiovascular diseases that might include one of the following: myocardial infarction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery.",
            "criterions": [
                {
                    "exact_snippets": "History of cardiovascular diseases ... myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of cardiovascular diseases ... angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of cardiovascular diseases ... coronary angioplasty",
                    "criterion": "coronary angioplasty",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of cardiovascular diseases ... congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of cardiovascular diseases ... stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of cardiovascular diseases ... coronary bypass surgery",
                    "criterion": "coronary bypass surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Diagnosis of diabetes",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. History of deep venous thrombosis, pulmonary embolism, systemic lupus erythematosus, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, or known Factor V Leiden mutation.",
            "criterions": [
                {
                    "exact_snippets": "History of deep venous thrombosis",
                    "criterion": "deep venous thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic lupus erythematosus",
                    "criterion": "systemic lupus erythematosus",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "family history of protein S or C deficiencies",
                    "criterion": "protein S or C deficiencies",
                    "requirements": [
                        {
                            "requirement_type": "family history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior heparin-induced thrombocytopenia",
                    "criterion": "heparin-induced thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known Factor V Leiden mutation",
                    "criterion": "Factor V Leiden mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Family history of premature CAD. This is defined as individuals with either: 1) father with MI prior to age 55, or 2) mother with MI prior to age 60.",
            "criterions": [
                {
                    "exact_snippets": "Family history of premature CAD",
                    "criterion": "family history of premature CAD",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "father with MI prior to age 55",
                    "criterion": "father with MI",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 55,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "mother with MI prior to age 60",
                    "criterion": "mother with MI",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}