{
    "info": {
        "nct_id": "NCT01333631",
        "official_title": "Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Gemcitabine for Unresectable Locally Advanced Pancreatic Cancer",
        "inclusion_criteria": "1. Age > 18 years.\n2. Newly-diagnosed, histologically/cytologically or CA 19.9 confirmed ULAPC\n3. KPS > 60\n4. No previous RT to abdomen\n5. No serious comorbid condition Version 1, December 1, 2010\n6. No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry, apart from induction chemotherapy with gemcitabine\n7. No participation in clinical trial using any investigational drug or device within four weeks prior to study entry\n8. No serious complication of malignant condition\n9. No previous or concurrent malignancy at other sites except cone biopsied in situ carcinoma of the uterine cervix and adequately treated basal cell or squamous cell carcinoma of the skin\n10. Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:\n\n    * Hemoglobin > 9.0 Gm/dL\n    * WBC count > 4.0x109/L\n    * Neutrophile count > 1.5 cells x 109/L,\n    * Platelet count > 100 x 109/L,\n    * Creatinine < 1.5 mg/dL\n    * Total bilirubin < upper limit of normal (ULN)\n    * AST/SGOT < ULN\n    * Calcium < ULN\n11. Ability to sign informed consent\n12. Ability to attend follow-up visits\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Operable disease\n2. Distant metastases\n3. KPS < 60\n4. Previous RT to abdomen\n5. Treatment with biological response modifiers or cytotoxic agents other then induction gemcitabine within four weeks prior to study entry\n6. Participation in clinical trial using any investigational drug or device within four weeks prior to study entry\n7. Major surgical procedure within two weeks prior to study entry\n8. Serious comorbid condition, inclusive but not limited to myocardial infarction within previous six months, uncontrolled cardiac arrhythmias, uncontrolled angina pectoris, active infection including acute hepatitis\n9. Serious complication of malignant condition\n10. Previous or concurrent malignancy\n11. Inadequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:\n\n    * Hemoglobin < 9.0 Gm/dL\n    * WBC count < 4.0x109/L\n    * Neutrophile count < 1.5 cells x 109/L,\n    * Platelet count < 100 x 109/L,\n    * Creatinine > 1.5 mg/dL\n    * Total bilirubin > ULN (upper limit of normal)\n    * AST/SGOT > ULN\n    * Calcium > ULN\n12. Inability to sign informed consent\n13. Psychological, familial, sociological or geographical conditions which do permit regular medical follow-up and compliance with the protocol.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age > 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Newly-diagnosed, histologically/cytologically or CA 19.9 confirmed ULAPC",
            "criterions": [
                {
                    "exact_snippets": "Newly-diagnosed",
                    "criterion": "diagnosis status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "newly-diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically/cytologically ... confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "CA 19.9 confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "CA 19.9"
                        }
                    ]
                },
                {
                    "exact_snippets": "ULAPC",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. KPS > 60",
            "criterions": [
                {
                    "exact_snippets": "KPS > 60",
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. No previous RT to abdomen",
            "criterions": [
                {
                    "exact_snippets": "No previous RT to abdomen",
                    "criterion": "previous RT to abdomen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. No serious comorbid condition Version 1, December 1, 2010",
            "criterions": [
                {
                    "exact_snippets": "No serious comorbid condition",
                    "criterion": "serious comorbid condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry, apart from induction chemotherapy with gemcitabine",
            "criterions": [
                {
                    "exact_snippets": "No treatment with biological response modifiers",
                    "criterion": "treatment with biological response modifiers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No treatment with ... cytotoxic agents",
                    "criterion": "treatment with cytotoxic agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within four weeks prior to study entry",
                    "criterion": "treatment timing",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "apart from induction chemotherapy with gemcitabine",
                    "criterion": "induction chemotherapy with gemcitabine",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. No participation in clinical trial using any investigational drug or device within four weeks prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "No participation in clinical trial using any investigational drug or device within four weeks prior to study entry",
                    "criterion": "participation in clinical trial using investigational drug or device",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. No serious complication of malignant condition",
            "criterions": [
                {
                    "exact_snippets": "No serious complication of malignant condition",
                    "criterion": "serious complication of malignant condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. No previous or concurrent malignancy at other sites except cone biopsied in situ carcinoma of the uterine cervix and adequately treated basal cell or squamous cell carcinoma of the skin",
            "criterions": [
                {
                    "exact_snippets": "No previous or concurrent malignancy at other sites",
                    "criterion": "malignancy at other sites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except cone biopsied in situ carcinoma of the uterine cervix",
                    "criterion": "cone biopsied in situ carcinoma of the uterine cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal cell or squamous cell carcinoma of the skin",
                    "criterion": "adequately treated basal cell or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin > 9.0 Gm/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 9.0 Gm/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9.0,
                                "unit": "Gm/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC count > 4.0x109/L",
            "criterions": [
                {
                    "exact_snippets": "WBC count > 4.0x109/L",
                    "criterion": "WBC count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 4.0,
                                "unit": "x109/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutrophile count > 1.5 cells x 109/L,",
            "criterions": [
                {
                    "exact_snippets": "Neutrophile count > 1.5 cells x 109/L",
                    "criterion": "neutrophile count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "cells x 109/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count > 100 x 109/L,",
            "criterions": [
                {
                    "exact_snippets": "Platelet count > 100 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine < 1.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine < 1.5 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin < upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin < upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST/SGOT < ULN",
            "criterions": [
                {
                    "exact_snippets": "AST/SGOT < ULN",
                    "criterion": "AST/SGOT level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calcium < ULN",
            "criterions": [
                {
                    "exact_snippets": "Calcium < ULN",
                    "criterion": "calcium level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Ability to sign informed consent",
            "criterions": [
                {
                    "exact_snippets": "Ability to sign informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Ability to attend follow-up visits",
            "criterions": [
                {
                    "exact_snippets": "Ability to attend follow-up visits",
                    "criterion": "ability to attend follow-up visits",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Operable disease",
            "criterions": [
                {
                    "exact_snippets": "Operable disease",
                    "criterion": "disease operability",
                    "requirements": [
                        {
                            "requirement_type": "operability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Distant metastases",
            "criterions": [
                {
                    "exact_snippets": "Distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. KPS < 60",
            "criterions": [
                {
                    "exact_snippets": "KPS < 60",
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Previous RT to abdomen",
            "criterions": [
                {
                    "exact_snippets": "Previous RT to abdomen",
                    "criterion": "previous radiotherapy to abdomen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Treatment with biological response modifiers or cytotoxic agents other then induction gemcitabine within four weeks prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Treatment with biological response modifiers",
                    "criterion": "treatment with biological response modifiers",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Treatment with ... cytotoxic agents",
                    "criterion": "treatment with cytotoxic agents",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "induction gemcitabine",
                    "criterion": "induction gemcitabine",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Participation in clinical trial using any investigational drug or device within four weeks prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Participation in clinical trial using any investigational drug or device within four weeks prior to study entry",
                    "criterion": "participation in clinical trial using investigational drug or device",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Major surgical procedure within two weeks prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure within two weeks prior to study entry",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Serious comorbid condition, inclusive but not limited to myocardial infarction within previous six months, uncontrolled cardiac arrhythmias, uncontrolled angina pectoris, active infection including acute hepatitis",
            "criterions": [
                {
                    "exact_snippets": "Serious comorbid condition, inclusive but not limited to myocardial infarction within previous six months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious comorbid condition, inclusive but not limited to ... uncontrolled cardiac arrhythmias",
                    "criterion": "cardiac arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious comorbid condition, inclusive but not limited to ... uncontrolled angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious comorbid condition, inclusive but not limited to ... active infection including acute hepatitis",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious comorbid condition, inclusive but not limited to ... active infection including acute hepatitis",
                    "criterion": "acute hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Serious complication of malignant condition",
            "criterions": [
                {
                    "exact_snippets": "Serious complication of malignant condition",
                    "criterion": "serious complication",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "malignant condition"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Previous or concurrent malignancy",
            "criterions": [
                {
                    "exact_snippets": "Previous or concurrent malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "temporal",
                            "expected_value": [
                                "previous",
                                "concurrent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Inadequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:",
            "criterions": [
                {
                    "exact_snippets": "Inadequate organ function as evidenced by the following peripheral blood counts",
                    "criterion": "peripheral blood counts",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate organ function as evidenced by the following ... serum chemistries",
                    "criterion": "serum chemistries",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin < 9.0 Gm/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin < 9.0 Gm/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 9.0,
                                "unit": "Gm/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC count < 4.0x109/L",
            "criterions": [
                {
                    "exact_snippets": "WBC count < 4.0x109/L",
                    "criterion": "WBC count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 4.0,
                                "unit": "x10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutrophile count < 1.5 cells x 109/L,",
            "criterions": [
                {
                    "exact_snippets": "Neutrophile count < 1.5 cells x 109/L",
                    "criterion": "neutrophile count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "cells x 109/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count < 100 x 109/L,",
            "criterions": [
                {
                    "exact_snippets": "Platelet count < 100 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine > 1.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine > 1.5 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin > ULN (upper limit of normal)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin > ULN (upper limit of normal)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST/SGOT > ULN",
            "criterions": [
                {
                    "exact_snippets": "AST/SGOT > ULN",
                    "criterion": "AST/SGOT level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calcium > ULN",
            "criterions": [
                {
                    "exact_snippets": "Calcium > ULN",
                    "criterion": "calcium level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Inability to sign informed consent",
            "criterions": [
                {
                    "exact_snippets": "Inability to sign informed consent",
                    "criterion": "ability to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Psychological, familial, sociological or geographical conditions which do permit regular medical follow-up and compliance with the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Psychological ... conditions which do permit regular medical follow-up and compliance with the protocol.",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "permit regular medical follow-up and compliance with the protocol",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "familial ... conditions which do permit regular medical follow-up and compliance with the protocol.",
                    "criterion": "familial conditions",
                    "requirements": [
                        {
                            "requirement_type": "permit regular medical follow-up and compliance with the protocol",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sociological ... conditions which do permit regular medical follow-up and compliance with the protocol.",
                    "criterion": "sociological conditions",
                    "requirements": [
                        {
                            "requirement_type": "permit regular medical follow-up and compliance with the protocol",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "geographical conditions which do permit regular medical follow-up and compliance with the protocol.",
                    "criterion": "geographical conditions",
                    "requirements": [
                        {
                            "requirement_type": "permit regular medical follow-up and compliance with the protocol",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}