{
    "info": {
        "nct_id": "NCT03706027",
        "official_title": "Three- Versus Five-Fraction Regimens of Stereotactic Body Radiotherapy for Peripheral Early-Stage Non-Small-Cell Lung Cancer: A Prospective Randomized Phase II Study",
        "inclusion_criteria": "* Histological confirmation of non-small cell cancer will not be required as primary goal of this phase II trial is to look at toxicity. However, all primary non-small cell lung cancers otherwise of following types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified.\n* Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC stage I or II based on only one of the following combinations of TNM staging:\n* T1, N0, M0\n* T2 (≤ 5 cm), N0, M0\n* Patients with hilar or mediastinal lymph nodes ≤ 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. All patients with suspicious nodes will be evaluated for mediastinal and hilar staging with bronchoscopy and (if amenable) bronchoscopic biopsy (preferably navigational biopsy and/or endobronchial US guided biopsy).\n* Zubrod performance status 0-2 within 4 weeks of study entry.\n* Women of childbearing potential and male participants must use an effective contraceptive method.\n* Evaluations required at time of study entry:\n* History & Physical by a radiation oncologist within 4 weeks of study entry;\n* Vitals within 4 weeks of study entry;\n* Evaluation by a thoracic surgeon (either via clinical examination and/or input at multidisciplinary tumor board) prior to study entry;\n* PFTs: Routine spirometry, lung volumes, diffusion capacity, and arterial blood gases within 8 weeks prior to study entry;\n* CT Chest within 6 weeks of study entry (preferably with intravenous contrast, unless medically contraindicated) - to include the entirety of both lungs, the mediastinum, liver, and adrenal glands; primary tumor dimension will be measured on this CT;\n* Whole body positron emission tomography (PET) scan using FDG with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions within 6 weeks prior to study entry.\n* Informed consent signed by the subject and a member of the study team.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with central tumors. Specifically; central location implies a tumor inside the zone of the proximal bronchial tree defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi\n* Evidence of regional or distant metastases after appropriate staging studies.\n* Synchronous primary NSCLC.\n* Those with prior malignancy in the past 2 years other than non-melanomatous skin cancer or in situ cancer or thyroid cancer.\n* Previous lung or mediastinal radiotherapy.\n* Plans for the patient to receive concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol.\n* Patients with active systemic, pulmonary or pericardial infection.\n* Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histological confirmation of non-small cell cancer will not be required as primary goal of this phase II trial is to look at toxicity. However, all primary non-small cell lung cancers otherwise of following types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified.",
            "criterions": [
                {
                    "exact_snippets": "Histological confirmation of non-small cell cancer will not be required",
                    "criterion": "histological confirmation of non-small cell cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "all primary non-small cell lung cancers otherwise of following types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified",
                    "criterion": "type of non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "squamous cell carcinoma",
                                "adenocarcinoma",
                                "large cell carcinoma",
                                "bronchioalveolar cell carcinoma",
                                "non-small cell carcinoma not otherwise specified"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC stage I or II based on only one of the following combinations of TNM staging:",
            "criterions": [
                {
                    "exact_snippets": "appropriate staging studies",
                    "criterion": "staging studies",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "specific subsets of AJCC stage I or II",
                    "criterion": "AJCC stage",
                    "requirements": [
                        {
                            "requirement_type": "subset",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "TNM staging",
                    "criterion": "TNM staging",
                    "requirements": [
                        {
                            "requirement_type": "combination",
                            "expected_value": "only one"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T1, N0, M0",
            "criterions": [
                {
                    "exact_snippets": "T1",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T1"
                        }
                    ]
                },
                {
                    "exact_snippets": "N0",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T2 (≤ 5 cm), N0, M0",
            "criterions": [
                {
                    "exact_snippets": "T2 (≤ 5 cm)",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T2"
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N0",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with hilar or mediastinal lymph nodes ≤ 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. All patients with suspicious nodes will be evaluated for mediastinal and hilar staging with bronchoscopy and (if amenable) bronchoscopic biopsy (preferably navigational biopsy and/or endobronchial US guided biopsy).",
            "criterions": [
                {
                    "exact_snippets": "hilar or mediastinal lymph nodes ≤ 1cm",
                    "criterion": "hilar or mediastinal lymph nodes size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no abnormal hilar or mediastinal uptake on PET",
                    "criterion": "hilar or mediastinal uptake on PET",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "> 1 cm hilar or mediastinal lymph nodes on CT",
                    "criterion": "hilar or mediastinal lymph nodes size on CT",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal PET (including suspicious but non-diagnostic uptake)",
                    "criterion": "abnormal PET",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "directed tissue biopsy of all abnormally identified areas are negative for cancer",
                    "criterion": "tissue biopsy of abnormally identified areas",
                    "requirements": [
                        {
                            "requirement_type": "cancer presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "suspicious nodes will be evaluated for mediastinal and hilar staging with bronchoscopy",
                    "criterion": "suspicious nodes evaluation",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "bronchoscopy"
                        }
                    ]
                },
                {
                    "exact_snippets": "suspicious nodes will be evaluated for mediastinal and hilar staging with ... bronchoscopic biopsy",
                    "criterion": "suspicious nodes evaluation",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "bronchoscopic biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Zubrod performance status 0-2 within 4 weeks of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Zubrod performance status 0-2",
                    "criterion": "Zubrod performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks of study entry",
                    "criterion": "timeframe for performance status assessment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 4 weeks of study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential and male participants must use an effective contraceptive method.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male participants",
                    "criterion": "male participants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must use an effective contraceptive method",
                    "criterion": "contraceptive method usage",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History & Physical by a radiation oncologist within 4 weeks of study entry;",
            "criterions": [
                {
                    "exact_snippets": "History & Physical by a radiation oncologist within 4 weeks of study entry",
                    "criterion": "History & Physical by a radiation oncologist",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 4 weeks of study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vitals within 4 weeks of study entry;",
            "criterions": [
                {
                    "exact_snippets": "Vitals within 4 weeks of study entry",
                    "criterion": "vitals",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks of study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evaluation by a thoracic surgeon (either via clinical examination and/or input at multidisciplinary tumor board) prior to study entry;",
            "criterions": [
                {
                    "exact_snippets": "Evaluation by a thoracic surgeon (either via clinical examination and/or input at multidisciplinary tumor board)",
                    "criterion": "evaluation by a thoracic surgeon",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PFTs: Routine spirometry, lung volumes, diffusion capacity, and arterial blood gases within 8 weeks prior to study entry;",
            "criterions": [
                {
                    "exact_snippets": "Routine spirometry",
                    "criterion": "spirometry",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 8 weeks prior to study entry"
                        }
                    ]
                },
                {
                    "exact_snippets": "lung volumes",
                    "criterion": "lung volumes",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 8 weeks prior to study entry"
                        }
                    ]
                },
                {
                    "exact_snippets": "diffusion capacity",
                    "criterion": "diffusion capacity",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 8 weeks prior to study entry"
                        }
                    ]
                },
                {
                    "exact_snippets": "arterial blood gases",
                    "criterion": "arterial blood gases",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 8 weeks prior to study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* CT Chest within 6 weeks of study entry (preferably with intravenous contrast, unless medically contraindicated) - to include the entirety of both lungs, the mediastinum, liver, and adrenal glands; primary tumor dimension will be measured on this CT;",
            "criterions": [
                {
                    "exact_snippets": "CT Chest within 6 weeks of study entry",
                    "criterion": "CT Chest timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "preferably with intravenous contrast, unless medically contraindicated",
                    "criterion": "intravenous contrast",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": "preferably"
                        },
                        {
                            "requirement_type": "contraindication",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "to include the entirety of both lungs, the mediastinum, liver, and adrenal glands",
                    "criterion": "CT Chest coverage",
                    "requirements": [
                        {
                            "requirement_type": "coverage",
                            "expected_value": [
                                "both lungs",
                                "mediastinum",
                                "liver",
                                "adrenal glands"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "primary tumor dimension will be measured on this CT",
                    "criterion": "primary tumor dimension measurement",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Whole body positron emission tomography (PET) scan using FDG with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions within 6 weeks prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "Whole body positron emission tomography (PET) scan using FDG",
                    "criterion": "whole body PET scan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate visualization of the primary tumor",
                    "criterion": "visualization of primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate visualization of ... draining lymph node basins in the hilar and mediastinal regions",
                    "criterion": "visualization of lymph node basins",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 weeks prior to study entry",
                    "criterion": "timing of PET scan",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent signed by the subject and a member of the study team.",
            "criterions": [
                {
                    "exact_snippets": "Informed consent signed by the subject",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Informed consent signed by ... a member of the study team",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed by study team member",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients with central tumors. Specifically; central location implies a tumor inside the zone of the proximal bronchial tree defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi",
            "criterions": [
                {
                    "exact_snippets": "central tumors",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "central"
                        }
                    ]
                },
                {
                    "exact_snippets": "central location implies a tumor inside the zone of the proximal bronchial tree",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "inside the zone of the proximal bronchial tree"
                        }
                    ]
                },
                {
                    "exact_snippets": "defined as a volume 2 cm in all directions around the proximal bronchial tree",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "distance from proximal bronchial tree",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of regional or distant metastases after appropriate staging studies.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of regional or distant metastases",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after appropriate staging studies",
                    "criterion": "staging studies",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Synchronous primary NSCLC.",
            "criterions": [
                {
                    "exact_snippets": "Synchronous primary NSCLC",
                    "criterion": "synchronous primary NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Those with prior malignancy in the past 2 years other than non-melanomatous skin cancer or in situ cancer or thyroid cancer.",
            "criterions": [
                {
                    "exact_snippets": "prior malignancy in the past 2 years",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanomatous skin cancer",
                    "criterion": "non-melanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ cancer",
                    "criterion": "in situ cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "thyroid cancer",
                    "criterion": "thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous lung or mediastinal radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Previous lung ... radiotherapy",
                    "criterion": "lung radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous ... mediastinal radiotherapy",
                    "criterion": "mediastinal radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Plans for the patient to receive concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol.",
            "criterions": [
                {
                    "exact_snippets": "Plans for the patient to receive concomitant antineoplastic therapy",
                    "criterion": "concomitant antineoplastic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "standard fractionated radiotherapy",
                    "criterion": "standard fractionated radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "biological therapy",
                    "criterion": "biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "vaccine therapy",
                    "criterion": "vaccine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with active systemic, pulmonary or pericardial infection.",
            "criterions": [
                {
                    "exact_snippets": "active systemic ... infection",
                    "criterion": "systemic infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active ... pulmonary ... infection",
                    "criterion": "pulmonary infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active ... pericardial infection",
                    "criterion": "pericardial infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Evaluations required at time of study entry:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}