{
    "info": {
        "nct_id": "NCT01717482",
        "official_title": "A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria\n\n* Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC) (must be proven SCC at the time of surgery)\n* Medically fit for surgical resection (based on surgeon assessment)\n* Current or prior smoker\n* Age > 18 years old\n* Both Male and Female\n* Willing and able to consent to study, undergo study interventions, and take study drug\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2\n* Subject must start Metformin within 90 days of surgery.\n\nExclusion Criteria\n\n* Currently taking metformin or other diabetic drugs\n* Current or previous congestive heart failure, renal failure or liver failure\n* Creatinine in Women of 1.4 or greater and Creatinine in Men of 1.5 or greater\n* Existing untreated or prior cancer <5 years from diagnosis\n* Received neo-adjuvant platinum-based chemotherapy or targeted therapy\n* Receiving adjuvant platinum-based chemotherapy or targeted therapy after surgical resection"
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "* Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC) (must be proven SCC at the time of surgery)",
            "criterions": [
                {
                    "exact_snippets": "Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC)",
                    "criterion": "lung squamous cell carcinoma (SCC)",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "A"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "suspected",
                                "biopsy proven"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "must be proven SCC at the time of surgery",
                    "criterion": "lung squamous cell carcinoma (SCC)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "proven at the time of surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medically fit for surgical resection (based on surgeon assessment)",
            "criterions": [
                {
                    "exact_snippets": "Medically fit for surgical resection (based on surgeon assessment)",
                    "criterion": "medical fitness for surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "surgeon assessment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or prior smoker",
            "criterions": [
                {
                    "exact_snippets": "Current or prior smoker",
                    "criterion": "smoking status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "current smoker",
                                "prior smoker"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age > 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Both Male and Female",
            "criterions": [
                {
                    "exact_snippets": "Both Male and Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "Male",
                                "Female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to consent to study, undergo study interventions, and take study drug",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to consent to study",
                    "criterion": "consent to study",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergo study interventions",
                    "criterion": "undergo study interventions",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "take study drug",
                    "criterion": "take study drug",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject must start Metformin within 90 days of surgery.",
            "criterions": [
                {
                    "exact_snippets": "Subject must start Metformin within 90 days of surgery.",
                    "criterion": "Metformin initiation",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 90,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently taking metformin or other diabetic drugs",
            "criterions": [
                {
                    "exact_snippets": "Currently taking metformin",
                    "criterion": "metformin usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other diabetic drugs",
                    "criterion": "diabetic drug usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or previous congestive heart failure, renal failure or liver failure",
            "criterions": [
                {
                    "exact_snippets": "Current or previous congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current or previous ... renal failure",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current or previous ... liver failure",
                    "criterion": "liver failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine in Women of 1.4 or greater and Creatinine in Men of 1.5 or greater",
            "criterions": [
                {
                    "exact_snippets": "Creatinine in Women of 1.4 or greater",
                    "criterion": "creatinine level in women",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.4,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine in Men of 1.5 or greater",
                    "criterion": "creatinine level in men",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Existing untreated or prior cancer <5 years from diagnosis",
            "criterions": [
                {
                    "exact_snippets": "Existing untreated or prior cancer",
                    "criterion": "cancer status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "<5 years from diagnosis",
                    "criterion": "time since cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received neo-adjuvant platinum-based chemotherapy or targeted therapy",
            "criterions": [
                {
                    "exact_snippets": "Received neo-adjuvant platinum-based chemotherapy",
                    "criterion": "neo-adjuvant platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... targeted therapy",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receiving adjuvant platinum-based chemotherapy or targeted therapy after surgical resection",
            "criterions": [
                {
                    "exact_snippets": "Receiving adjuvant platinum-based chemotherapy",
                    "criterion": "adjuvant platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Receiving ... targeted therapy after surgical resection",
                    "criterion": "targeted therapy after surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        }
    ]
}