{
    "info": {
        "nct_id": "NCT03196180",
        "official_title": "A Feasibility Trial of Alternating Intravaginal Application of 5-Fluorouracil and Imiquimod for Treatment of High-Grade Cervical Squamous Intraepithelial Lesions",
        "inclusion_criteria": "* Women with biopsy confirmed high grade cervical squamous intraepithelial lesions (i.e., cervical squamous intraepithelial neoplasia 3 [CIN3] lesions, and cervical squamous epithelial neoplasia 2 [CIN2] lesions with diagnosis confirmed by positive p16 immunohistochemistry staining) within 12 weeks of baseline visit\n* Karnofsky >= 70%\n* Leukocytes >= 3,000/microliter\n* Absolute neutrophil count >= 1,500/microliter\n* Platelets >= 100,000/microliter\n* Serum creatinine =< the upper institutional limits\n* Participants must have a negative human immunodeficiency virus (HIV) antibody/antigen test and negative Chlamydia (C.) trachomatis/Neisseria (N.) gonorrhea nucleic acid amplification test (NAAT)\n* Agree to use an effective form of contraception; the effects of intravaginal 5-fluorocuracil and imiquimod on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because 5- fluorouracil is known to be teratogenic, women of child-bearing potential must agree to use adequate dual methods of contraception (hormonal method of birth control, intrauterine device, or tubal ligation - plus condoms) or abstinence prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 45 Years",
        "exclusion_criteria": "* Women treated previously with 5-fluorouracil or imiquimod or other medications for high-grade squamous intraepithelial lesions will be excluded from the study\n* Concurrent vaginal, vulvar, anal lesions or symptomatic infections\n* Pregnant or planning pregnancy within the next 6 months, or breastfeeding; pregnant women are excluded from this study because 5-fluorouracil is an antimetabolite with the potential for teratogenic effects; because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with 5-fluorouracil, breastfeeding should be discontinued if the mother is treated with 5-fluorouracil\n* Inability to speak or read English or Spanish\n* Prior hysterectomy\n* Use of anticoagulant medications\n* Subjects who have a known immunocompromised condition (HIV positive [+], use of immunosuppressive medications or systemic steroids, organ transplant recipients) or autoimmune conditions (e.g. psoriasis, rheumatoid arthritis or other known autoimmune conditions)\n* Evidence of invasive anal, vulva, vaginal, or cervical carcinoma; prior loop electrosurgical excision procedure (LEEP) or ablative treatment within 6 months prior to study entry; other invasive malignancies, with the exception of non-melanoma skin cancer, within the last 5 years\n* Pathologic findings consistent with\n\n  * Atypical endometrial cells or serious glandular-cell atypia (atypical glandular cells, favor neoplasia cytology diagnosis)\n  * Evidence of cervical carcinoma on Pap smear or biopsy\n  * More than two cervical quadrants of CIN 3 as visualized by colposcopy\n  * Nonvisual squamous columnar junction on colposcopy with no concurrent endocervical sampling performed\n* Use of other investigational agents within 6 months prior to enrollment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-fluorouracil or imiquimod\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (other than human papilloma virus [HPV]), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Subjects with known partial or complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Women with biopsy confirmed high grade cervical squamous intraepithelial lesions (i.e., cervical squamous intraepithelial neoplasia 3 [CIN3] lesions, and cervical squamous epithelial neoplasia 2 [CIN2] lesions with diagnosis confirmed by positive p16 immunohistochemistry staining) within 12 weeks of baseline visit",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy confirmed high grade cervical squamous intraepithelial lesions",
                    "criterion": "cervical squamous intraepithelial lesions",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical squamous intraepithelial neoplasia 3 [CIN3] lesions",
                    "criterion": "CIN3 lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical squamous epithelial neoplasia 2 [CIN2] lesions with diagnosis confirmed by positive p16 immunohistochemistry staining",
                    "criterion": "CIN2 lesions",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "positive p16 immunohistochemistry staining"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 12 weeks of baseline visit",
                    "criterion": "time since diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky >= 70%",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky >= 70%",
                    "criterion": "Karnofsky",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Leukocytes >= 3,000/microliter",
            "criterions": [
                {
                    "exact_snippets": "Leukocytes >= 3,000/microliter",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "microliter"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count >= 1,500/microliter",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count >= 1,500/microliter",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "microliter"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets >= 100,000/microliter",
            "criterions": [
                {
                    "exact_snippets": "Platelets >= 100,000/microliter",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "microliter"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine =< the upper institutional limits",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine =< the upper institutional limits",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "upper institutional limits"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have a negative human immunodeficiency virus (HIV) antibody/antigen test and negative Chlamydia (C.) trachomatis/Neisseria (N.) gonorrhea nucleic acid amplification test (NAAT)",
            "criterions": [
                {
                    "exact_snippets": "negative human immunodeficiency virus (HIV) antibody/antigen test",
                    "criterion": "HIV antibody/antigen test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative Chlamydia (C.) trachomatis/Neisseria (N.) gonorrhea nucleic acid amplification test (NAAT)",
                    "criterion": "Chlamydia trachomatis/Neisseria gonorrhea NAAT",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agree to use an effective form of contraception; the effects of intravaginal 5-fluorocuracil and imiquimod on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because 5- fluorouracil is known to be teratogenic, women of child-bearing potential must agree to use adequate dual methods of contraception (hormonal method of birth control, intrauterine device, or tubal ligation - plus condoms) or abstinence prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately",
            "criterions": [
                {
                    "exact_snippets": "Agree to use an effective form of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "women of child-bearing potential must agree to use adequate dual methods of contraception (hormonal method of birth control, intrauterine device, or tubal ligation - plus condoms) or abstinence",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "hormonal method of birth control",
                                "intrauterine device",
                                "tubal ligation",
                                "abstinence"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "notification",
                            "expected_value": "inform study physician immediately"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and the willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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 45 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 45 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 45,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Women treated previously with 5-fluorouracil or imiquimod or other medications for high-grade squamous intraepithelial lesions will be excluded from the study",
            "criterions": [
                {
                    "exact_snippets": "Women treated previously with 5-fluorouracil",
                    "criterion": "previous treatment with 5-fluorouracil",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Women treated previously with ... imiquimod",
                    "criterion": "previous treatment with imiquimod",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Women treated previously with ... other medications for high-grade squamous intraepithelial lesions",
                    "criterion": "previous treatment with other medications for high-grade squamous intraepithelial lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent vaginal, vulvar, anal lesions or symptomatic infections",
            "criterions": [
                {
                    "exact_snippets": "Concurrent vaginal, vulvar, anal lesions",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "vaginal",
                                "vulvar",
                                "anal"
                            ]
                        },
                        {
                            "requirement_type": "concurrent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic infections",
                    "criterion": "infections",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or planning pregnancy within the next 6 months, or breastfeeding; pregnant women are excluded from this study because 5-fluorouracil is an antimetabolite with the potential for teratogenic effects; because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with 5-fluorouracil, breastfeeding should be discontinued if the mother is treated with 5-fluorouracil",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or planning pregnancy within the next 6 months",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "not pregnant",
                                "not planning pregnancy within the next 6 months"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to speak or read English or Spanish",
            "criterions": [
                {
                    "exact_snippets": "Inability to speak ... English or Spanish",
                    "criterion": "language ability",
                    "requirements": [
                        {
                            "requirement_type": "ability to speak",
                            "expected_value": [
                                "English",
                                "Spanish"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability to ... read English or Spanish",
                    "criterion": "language ability",
                    "requirements": [
                        {
                            "requirement_type": "ability to read",
                            "expected_value": [
                                "English",
                                "Spanish"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior hysterectomy",
            "criterions": [
                {
                    "exact_snippets": "Prior hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of anticoagulant medications",
            "criterions": [
                {
                    "exact_snippets": "Use of anticoagulant medications",
                    "criterion": "anticoagulant medications",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who have a known immunocompromised condition (HIV positive [+], use of immunosuppressive medications or systemic steroids, organ transplant recipients) or autoimmune conditions (e.g. psoriasis, rheumatoid arthritis or other known autoimmune conditions)",
            "criterions": [
                {
                    "exact_snippets": "known immunocompromised condition (HIV positive [+], use of immunosuppressive medications or systemic steroids, organ transplant recipients)",
                    "criterion": "immunocompromised condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune conditions (e.g. psoriasis, rheumatoid arthritis or other known autoimmune conditions)",
                    "criterion": "autoimmune conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of invasive anal, vulva, vaginal, or cervical carcinoma; prior loop electrosurgical excision procedure (LEEP) or ablative treatment within 6 months prior to study entry; other invasive malignancies, with the exception of non-melanoma skin cancer, within the last 5 years",
            "criterions": [
                {
                    "exact_snippets": "Evidence of invasive anal, vulva, vaginal, or cervical carcinoma",
                    "criterion": "invasive carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "anal",
                                "vulva",
                                "vaginal",
                                "cervical"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "prior loop electrosurgical excision procedure (LEEP) or ablative treatment within 6 months prior to study entry",
                    "criterion": "loop electrosurgical excision procedure (LEEP) or ablative treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other invasive malignancies, with the exception of non-melanoma skin cancer, within the last 5 years",
                    "criterion": "other invasive malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "exception",
                            "expected_value": "non-melanoma skin cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pathologic findings consistent with",
            "criterions": [
                {
                    "exact_snippets": "Pathologic findings",
                    "criterion": "pathologic findings",
                    "requirements": [
                        {
                            "requirement_type": "consistency",
                            "expected_value": "consistent with"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Atypical endometrial cells or serious glandular-cell atypia (atypical glandular cells, favor neoplasia cytology diagnosis)",
            "criterions": [
                {
                    "exact_snippets": "Atypical endometrial cells",
                    "criterion": "atypical endometrial cells",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serious glandular-cell atypia",
                    "criterion": "serious glandular-cell atypia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "atypical glandular cells",
                    "criterion": "atypical glandular cells",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "favor neoplasia cytology diagnosis",
                    "criterion": "favor neoplasia cytology diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of cervical carcinoma on Pap smear or biopsy",
            "criterions": [
                {
                    "exact_snippets": "Evidence of cervical carcinoma on Pap smear",
                    "criterion": "cervical carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "Pap smear"
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of cervical carcinoma on ... biopsy",
                    "criterion": "cervical carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than two cervical quadrants of CIN 3 as visualized by colposcopy",
            "criterions": [
                {
                    "exact_snippets": "More than two cervical quadrants of CIN 3",
                    "criterion": "cervical quadrants of CIN 3",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "quadrants"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "as visualized by colposcopy",
                    "criterion": "visualization by colposcopy",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "colposcopy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Nonvisual squamous columnar junction on colposcopy with no concurrent endocervical sampling performed",
            "criterions": [
                {
                    "exact_snippets": "Nonvisual squamous columnar junction on colposcopy",
                    "criterion": "squamous columnar junction visibility",
                    "requirements": [
                        {
                            "requirement_type": "visibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no concurrent endocervical sampling performed",
                    "criterion": "endocervical sampling",
                    "requirements": [
                        {
                            "requirement_type": "performance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of other investigational agents within 6 months prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "Use of other investigational agents within 6 months prior to enrollment",
                    "criterion": "use of investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-fluorouracil or imiquimod",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-fluorouracil",
                    "criterion": "allergic reactions to compounds similar to 5-fluorouracil",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... imiquimod",
                    "criterion": "allergic reactions to compounds similar to imiquimod",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (other than human papilloma virus [HPV]), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (other than human papilloma virus [HPV])",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would limit compliance with study requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with known partial or complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency",
            "criterions": [
                {
                    "exact_snippets": "known partial or complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency",
                    "criterion": "dihydropyrimidine dehydrogenase (DPD) enzyme deficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "partial",
                                "complete"
                            ]
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}