{
    "info": {
        "nct_id": "NCT00383331",
        "official_title": "A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* histologic or cytologic diagnosis of NSCLC Stage IIIB or IV\n* no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer\n* Prior radiotherapy must be completed at least 4 weeks before study enrollment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* estimated life expectancy of 12 weeks\n* a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease\n* documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment\n* significant weight loss (that is, > 10%) over the previous 6 weeks before study entry.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* histologic or cytologic diagnosis of NSCLC Stage IIIB or IV",
            "criterions": [
                {
                    "exact_snippets": "histologic or cytologic diagnosis of NSCLC",
                    "criterion": "NSCLC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologic",
                                "cytologic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage IIIB or IV",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIB",
                                "IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer",
            "criterions": [
                {
                    "exact_snippets": "no prior systemic chemotherapy",
                    "criterion": "prior systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced Non-Small Cell Lung Cancer",
                    "criterion": "Non-Small Cell Lung Cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiotherapy must be completed at least 4 weeks before study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Prior radiotherapy must be completed at least 4 weeks before study enrollment.",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* estimated life expectancy of 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "estimated life expectancy of 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease",
            "criterions": [
                {
                    "exact_snippets": "a serious cardiac condition, such as myocardial infarction within 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "a serious cardiac condition, such as ... angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a serious cardiac condition, such as ... heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment",
            "criterions": [
                {
                    "exact_snippets": "documented brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "completed successful local therapy for central nervous system metastases",
                    "criterion": "local therapy for central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "success",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "off of corticosteroids for at least 2 weeks before enrollment",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "duration off",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* significant weight loss (that is, > 10%) over the previous 6 weeks before study entry.",
            "criterions": [
                {
                    "exact_snippets": "significant weight loss ... > 10% ... over the previous 6 weeks",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "previous 6 weeks"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}