{
    "info": {
        "nct_id": "NCT02688673",
        "official_title": "Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Extensive-Stage Small- Cell Lung Cancer: a Phase I/II Study",
        "inclusion_criteria": "* Histopathologically confirmed diagnosis of Small- Cell Lung Cancer\n* Age >18 years at time of consent\n* Received standardized treatment of Small-Cell Lung Cancer\n* Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks\n* KPS (Karnofsky performance scale) >60\n* Patient's written informed consent\n* No severe viral or bacterial infections\n* Predicted survival >3 months\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Clinically relevant diseases or infections (HBV, HCV, HIV)\n* Females who are pregnant or nursing\n* Immunosuppressant treatment\n* Currently participating in another clinical trial\n* Unfit for participating in this clinical trial in investigators' opinions",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histopathologically confirmed diagnosis of Small- Cell Lung Cancer",
            "criterions": [
                {
                    "exact_snippets": "Histopathologically confirmed diagnosis of Small- Cell Lung Cancer",
                    "criterion": "Small-Cell Lung Cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis confirmation method",
                            "expected_value": "histopathologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age >18 years at time of consent",
            "criterions": [
                {
                    "exact_snippets": "Age >18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received standardized treatment of Small-Cell Lung Cancer",
            "criterions": [
                {
                    "exact_snippets": "standardized treatment of Small-Cell Lung Cancer",
                    "criterion": "treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "standardized"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "Small-Cell Lung Cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks",
            "criterions": [
                {
                    "exact_snippets": "Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks",
                    "criterion": "interval between treatments",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* KPS (Karnofsky performance scale) >60",
            "criterions": [
                {
                    "exact_snippets": "KPS (Karnofsky performance scale) >60",
                    "criterion": "Karnofsky performance scale (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient's written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patient's written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe viral or bacterial infections",
            "criterions": [
                {
                    "exact_snippets": "No severe viral ... infections",
                    "criterion": "viral infections",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "No severe ... bacterial infections",
                    "criterion": "bacterial infections",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Predicted survival >3 months",
            "criterions": [
                {
                    "exact_snippets": "Predicted survival >3 months",
                    "criterion": "predicted survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Clinically relevant diseases or infections (HBV, HCV, HIV)",
            "criterions": [
                {
                    "exact_snippets": "Clinically relevant diseases or infections (HBV, HCV, HIV)",
                    "criterion": "clinically relevant diseases or infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "HBV",
                                "HCV",
                                "HIV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females who are pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Females who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Females who are ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Immunosuppressant treatment",
            "criterions": [
                {
                    "exact_snippets": "Immunosuppressant treatment",
                    "criterion": "immunosuppressant treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently participating in another clinical trial",
            "criterions": [
                {
                    "exact_snippets": "Currently participating in another clinical trial",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unfit for participating in this clinical trial in investigators' opinions",
            "criterions": [
                {
                    "exact_snippets": "Unfit for participating in this clinical trial in investigators' opinions",
                    "criterion": "fitness for participation",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "investigators' opinion"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}