{
    "info": {
        "nct_id": "NCT00191620",
        "official_title": "Randomized Phase II Study of Cisplatin + Gemcitabine Administered Either as Short Infusion or at a Fixed Dose Rate in Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* At least 18 years of age\n* Histologically or cytologically confirmed diagnosis of NSCLC\n* Have provided written informed consent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate organ function\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior chemotherapy or biologic therapy (approved or experimental) for NSCLC\n* Presence of uncontrolled central nervous system (CNS) metastases\n* Inability to comply with protocol or study procedures\n* Pregnancy\n* Breast feeding",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* At least 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "At least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed diagnosis of NSCLC",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed diagnosis of NSCLC",
                    "criterion": "NSCLC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have provided written informed consent",
            "criterions": [
                {
                    "exact_snippets": "provided written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "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": "* Prior chemotherapy or biologic therapy (approved or experimental) for NSCLC",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy or biologic therapy (approved or experimental) for NSCLC",
                    "criterion": "prior chemotherapy or biologic therapy for NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of uncontrolled central nervous system (CNS) metastases",
            "criterions": [
                {
                    "exact_snippets": "Presence of uncontrolled central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to comply with protocol or study procedures",
            "criterions": [
                {
                    "exact_snippets": "Inability to comply with protocol or study procedures",
                    "criterion": "compliance with protocol or study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Breast feeding",
            "criterions": [
                {
                    "exact_snippets": "Breast feeding",
                    "criterion": "breast feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}