{
    "info": {
        "nct_id": "NCT00661882",
        "official_title": "Integrated Cancer Repository for Cancer Research (iCaRe2)- Subproject: Pancreatic Cancer Collaborative Registry",
        "inclusion_criteria": "Must meet 1 of the following criteria:\n\n* Histologically confirmed adenocarcinoma of the pancreas\n\n  * Resectable stage I-IIA disease or stage IIB or higher disease Must have undergone complete surgical resection of the tumor with curative intent\n  * Pancreatic mass (solid) that is less than 4 cm as determined by any conventional imaging (MRI, EUS, or CT scan)\n  * No evidence of extension of the mass beyond the pancreas including vascular invasion or invasion into surrounding organs, with the exception of the bile duct\n  * No imaging evidence of metastatic disease or lymphadenopathy (lymph nodes greater than 1 cm and/or appearance suspicious for an advanced lesion by imaging criteria)\n* Has a family history of pancreatic cancer and is considered to be an at-risk individual for the disease (i.e., member of a family with 2 or more individuals with pancreatic cancer)\n\nPatients Participants\nHealthy volunteers allowed\nMust have minimum age of 19 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "* No prior malignancy, except nonmelanoma skin cancer, for 10 years\n* No prior preoperative chemoradiotherapy (neoadjuvant)\n\nControl participants Inclusion Criteria:\n\nMust meet 1 of the following criteria:\n\n* Chronic pancreatitis OR history of exocrine insufficiency meeting the following criteria:\n\n  o At least 2 of the following criteria are met (unless patient has a history of pancreatic exocrine insufficiency in which case only 1 criterion must be met): Abdominal ultrasound that is consistent with chronic pancreatitis by standard radiological criteria (i.e., echogenic foci in the parenchyma, large or small cavities, calcifications, or dilated pancreatic duct) Abdominal CT scan consistent with chronic pancreatitis by standard radiological criteria (i.e., calcifications, dilated pancreatic duct, irregular contour of the gland, or cystic lesions) Endoscopic retrograde cholangiopancreatography exam consistent with chronic pancreatitis by standard radiological criteria (i.e., dilated tortuous main pancreatic duct with irregular secondary branches or intraductal calculi) Endoscopic ultrasound consistent with chronic pancreatitis by standard radiological criteria (i.e., echogenic foci, focal regions of decreased echogenicity, or pancreatic ductal changes)Pancreatic calcifications identified on plain film of the abdomen\n* Must have an imaging study of the pancreas within 3 months of study enrollment that does not suggest a pancreatic mass\n* Stable clinical history over the past year with no suspicion for cancer due to weight loss, jaundice, or change in abdominal symptoms\n* Acute biliary obstruction (stones) including jaundice of benign etiology meeting the following criteria:\n* Elevation of serum bilirubin level greater than 2.0 mg/dL\n* Dilated extrahepatic biliary systems demonstrated on US, MRI, or CT scan\n* Blood sample available within 72 hours of admission and prior to any corrective intervention\n* Biliary obstruction must be of benign etiology such as common bile duct stone or benign biliary stricture\n* Must have complete imaging study performed of the pancreas that does not suggest a pancreatic cancer (i.e., discrete mass lesion)\n* Age, race, and sex-matched to qualified pancreatic cancer cases\n\nControl Participants Exclusion Criteria:\n\n* No family history of pancreatic cancer\n* No personal history of acute pancreatitis or biliary obstruction (stones) including jaundice of benign etiology\n* No concurrent abdominal pain\n* No concurrent unexplained weight loss",
        "miscellaneous_criteria": "Patients Participants"
    },
    "inclusion_lines": [
        {
            "line": "Must meet 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Must meet 1 of the following criteria",
                    "criterion": "eligibility criteria",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">= 1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed adenocarcinoma of the pancreas",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma of the pancreas",
                    "criterion": "adenocarcinoma of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Resectable stage I-IIA disease or stage IIB or higher disease Must have undergone complete surgical resection of the tumor with curative intent",
            "criterions": [
                {
                    "exact_snippets": "Resectable stage I-IIA disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "IIA"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IIB or higher disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.2,
                                "unit": "stage"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Must have undergone complete surgical resection of the tumor with curative intent",
                    "criterion": "surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pancreatic mass (solid) that is less than 4 cm as determined by any conventional imaging (MRI, EUS, or CT scan)",
            "criterions": [
                {
                    "exact_snippets": "Pancreatic mass (solid) ... less than 4 cm",
                    "criterion": "pancreatic mass size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Pancreatic mass (solid) ... determined by any conventional imaging (MRI, EUS, or CT scan)",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "modality",
                            "expected_value": [
                                "MRI",
                                "EUS",
                                "CT scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of extension of the mass beyond the pancreas including vascular invasion or invasion into surrounding organs, with the exception of the bile duct",
            "criterions": [
                {
                    "exact_snippets": "No evidence of extension of the mass beyond the pancreas",
                    "criterion": "extension of the mass beyond the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "vascular invasion",
                    "criterion": "vascular invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "invasion into surrounding organs, with the exception of the bile duct",
                    "criterion": "invasion into surrounding organs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No imaging evidence of metastatic disease or lymphadenopathy (lymph nodes greater than 1 cm and/or appearance suspicious for an advanced lesion by imaging criteria)",
            "criterions": [
                {
                    "exact_snippets": "No imaging evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "imaging evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No imaging evidence of ... lymphadenopathy",
                    "criterion": "lymphadenopathy",
                    "requirements": [
                        {
                            "requirement_type": "imaging evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lymph nodes greater than 1 cm",
                    "criterion": "lymph node size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "appearance suspicious for an advanced lesion by imaging criteria",
                    "criterion": "advanced lesion",
                    "requirements": [
                        {
                            "requirement_type": "appearance",
                            "expected_value": "suspicious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a family history of pancreatic cancer and is considered to be an at-risk individual for the disease (i.e., member of a family with 2 or more individuals with pancreatic cancer)",
            "criterions": [
                {
                    "exact_snippets": "Has a family history of pancreatic cancer",
                    "criterion": "family history of pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "considered to be an at-risk individual for the disease ... member of a family with 2 or more individuals with pancreatic cancer",
                    "criterion": "at-risk individual for pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "family members with pancreatic cancer",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "individuals"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients Participants",
            "criterions": [
                {
                    "exact_snippets": "Patients Participants",
                    "criterion": "participant status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 19 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 19 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 100 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 100 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* No prior malignancy, except nonmelanoma skin cancer, for 10 years",
            "criterions": [
                {
                    "exact_snippets": "No prior malignancy, except nonmelanoma skin cancer, for 10 years",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior malignancy, except nonmelanoma skin cancer, for 10 years",
                    "criterion": "nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior malignancy, except nonmelanoma skin cancer, for 10 years",
                    "criterion": "time since last malignancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior preoperative chemoradiotherapy (neoadjuvant)",
            "criterions": [
                {
                    "exact_snippets": "No prior preoperative chemoradiotherapy (neoadjuvant)",
                    "criterion": "prior preoperative chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must meet 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Must meet 1 of the following criteria",
                    "criterion": "eligibility criteria",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">= 1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic pancreatitis OR history of exocrine insufficiency meeting the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Chronic pancreatitis",
                    "criterion": "chronic pancreatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of exocrine insufficiency",
                    "criterion": "exocrine insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "o At least 2 of the following criteria are met (unless patient has a history of pancreatic exocrine insufficiency in which case only 1 criterion must be met): Abdominal ultrasound that is consistent with chronic pancreatitis by standard radiological criteria (i.e., echogenic foci in the parenchyma, large or small cavities, calcifications, or dilated pancreatic duct) Abdominal CT scan consistent with chronic pancreatitis by standard radiological criteria (i.e., calcifications, dilated pancreatic duct, irregular contour of the gland, or cystic lesions) Endoscopic retrograde cholangiopancreatography exam consistent with chronic pancreatitis by standard radiological criteria (i.e., dilated tortuous main pancreatic duct with irregular secondary branches or intraductal calculi) Endoscopic ultrasound consistent with chronic pancreatitis by standard radiological criteria (i.e., echogenic foci, focal regions of decreased echogenicity, or pancreatic ductal changes)Pancreatic calcifications identified on plain film of the abdomen",
            "criterions": [
                {
                    "exact_snippets": "Abdominal ultrasound that is consistent with chronic pancreatitis by standard radiological criteria",
                    "criterion": "abdominal ultrasound",
                    "requirements": [
                        {
                            "requirement_type": "consistency with chronic pancreatitis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Abdominal CT scan consistent with chronic pancreatitis by standard radiological criteria",
                    "criterion": "abdominal CT scan",
                    "requirements": [
                        {
                            "requirement_type": "consistency with chronic pancreatitis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Endoscopic retrograde cholangiopancreatography exam consistent with chronic pancreatitis by standard radiological criteria",
                    "criterion": "endoscopic retrograde cholangiopancreatography exam",
                    "requirements": [
                        {
                            "requirement_type": "consistency with chronic pancreatitis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Endoscopic ultrasound consistent with chronic pancreatitis by standard radiological criteria",
                    "criterion": "endoscopic ultrasound",
                    "requirements": [
                        {
                            "requirement_type": "consistency with chronic pancreatitis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pancreatic calcifications identified on plain film of the abdomen",
                    "criterion": "pancreatic calcifications on plain film",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have an imaging study of the pancreas within 3 months of study enrollment that does not suggest a pancreatic mass",
            "criterions": [
                {
                    "exact_snippets": "imaging study of the pancreas",
                    "criterion": "imaging study of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 3 months of study enrollment",
                    "criterion": "imaging study timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 3 months of study enrollment"
                        }
                    ]
                },
                {
                    "exact_snippets": "does not suggest a pancreatic mass",
                    "criterion": "pancreatic mass",
                    "requirements": [
                        {
                            "requirement_type": "suggestion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stable clinical history over the past year with no suspicion for cancer due to weight loss, jaundice, or change in abdominal symptoms",
            "criterions": [
                {
                    "exact_snippets": "Stable clinical history over the past year",
                    "criterion": "clinical history",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no suspicion for cancer due to weight loss",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "suspicion for cancer",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no suspicion for cancer due to ... jaundice",
                    "criterion": "jaundice",
                    "requirements": [
                        {
                            "requirement_type": "suspicion for cancer",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no suspicion for cancer due to ... change in abdominal symptoms",
                    "criterion": "change in abdominal symptoms",
                    "requirements": [
                        {
                            "requirement_type": "suspicion for cancer",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute biliary obstruction (stones) including jaundice of benign etiology meeting the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Acute biliary obstruction (stones)",
                    "criterion": "acute biliary obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "jaundice of benign etiology",
                    "criterion": "jaundice of benign etiology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Elevation of serum bilirubin level greater than 2.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Elevation of serum bilirubin level greater than 2.0 mg/dL",
                    "criterion": "serum bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "elevation",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Dilated extrahepatic biliary systems demonstrated on US, MRI, or CT scan",
            "criterions": [
                {
                    "exact_snippets": "Dilated extrahepatic biliary systems",
                    "criterion": "extrahepatic biliary systems",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "dilated"
                        }
                    ]
                },
                {
                    "exact_snippets": "demonstrated on US, MRI, or CT scan",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "US",
                                "MRI",
                                "CT scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Blood sample available within 72 hours of admission and prior to any corrective intervention",
            "criterions": [
                {
                    "exact_snippets": "Blood sample available",
                    "criterion": "blood sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 72 hours of admission",
                    "criterion": "blood sample timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 72,
                                "unit": "hours"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to any corrective intervention",
                    "criterion": "blood sample timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to corrective intervention"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biliary obstruction must be of benign etiology such as common bile duct stone or benign biliary stricture",
            "criterions": [
                {
                    "exact_snippets": "Biliary obstruction must be of benign etiology",
                    "criterion": "biliary obstruction etiology",
                    "requirements": [
                        {
                            "requirement_type": "etiology",
                            "expected_value": "benign"
                        }
                    ]
                },
                {
                    "exact_snippets": "such as common bile duct stone",
                    "criterion": "common bile duct stone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "benign biliary stricture",
                    "criterion": "benign biliary stricture",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have complete imaging study performed of the pancreas that does not suggest a pancreatic cancer (i.e., discrete mass lesion)",
            "criterions": [
                {
                    "exact_snippets": "complete imaging study performed of the pancreas",
                    "criterion": "pancreas imaging study",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "imaging study ... does not suggest a pancreatic cancer (i.e., discrete mass lesion)",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "suggestion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age, race, and sex-matched to qualified pancreatic cancer cases",
            "criterions": [
                {
                    "exact_snippets": "Age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "matching",
                            "expected_value": "qualified pancreatic cancer cases"
                        }
                    ]
                },
                {
                    "exact_snippets": "race",
                    "criterion": "race",
                    "requirements": [
                        {
                            "requirement_type": "matching",
                            "expected_value": "qualified pancreatic cancer cases"
                        }
                    ]
                },
                {
                    "exact_snippets": "sex",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "matching",
                            "expected_value": "qualified pancreatic cancer cases"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No family history of pancreatic cancer",
            "criterions": [
                {
                    "exact_snippets": "No family history of pancreatic cancer",
                    "criterion": "family history of pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No personal history of acute pancreatitis or biliary obstruction (stones) including jaundice of benign etiology",
            "criterions": [
                {
                    "exact_snippets": "No personal history of acute pancreatitis",
                    "criterion": "acute pancreatitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No personal history of ... biliary obstruction (stones)",
                    "criterion": "biliary obstruction (stones)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No personal history of ... jaundice of benign etiology",
                    "criterion": "jaundice of benign etiology",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent abdominal pain",
            "criterions": [
                {
                    "exact_snippets": "No concurrent abdominal pain",
                    "criterion": "abdominal pain",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent unexplained weight loss",
            "criterions": [
                {
                    "exact_snippets": "No concurrent unexplained weight loss",
                    "criterion": "unexplained weight loss",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Patients Participants",
            "criterions": [
                {
                    "exact_snippets": "Patients Participants",
                    "criterion": "participant status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "Control participants Inclusion Criteria:",
            "criterions": []
        },
        {
            "line": "Control Participants Exclusion Criteria:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}