{
    "info": {
        "nct_id": "NCT03153982",
        "official_title": "Pharmacodynamic Effects and Predictive Biomarkers of Janus Kinases (JAK)/Signal Transducer and Activator of Transcription (STAT) Inhibition With Ruxolitinib in Operable Head and Neck Cancer: a Window Trial",
        "inclusion_criteria": "1. Histologically or cytologically confirmed, primary or recurrent, head and neck squamous cell carcinoma, including variants. Patients must have at least one measureable lesion in accordance with RECIST 1.1 (tumor diameter ≥ 1 cm; short-axis lymph node diameter ≥ 1.5 cm) OR by caliper measurement (tumor diameter ≥ 1 cm). Any diagnostic pretreatment biopsy sample is acceptable including fine needle aspiration (FNA).\n2. Primary tumors of any head and neck (oral cavity, oropharynx, hypopharynx, or larynx) site will be included.\n3. Surgical resection of head and neck must be planned, either as primary treatment or salvage. Patients must have submitted adequate pretreatment archival or fresh tissue.\n4. Age ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (See Appendix 1).\n6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (sensitivity ≤ 25 human chorionic gonadotropin (HCG) IU/L) within 4 weeks prior to registration and will be repeated within 72 hours prior to the start of study drug administration.\n7. Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 12 weeks after study drug is stopped. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n8. Adequate hematologic, renal and hepatic function, as defined by:\n\n   1. Absolute neutrophil count (ANC) ≥ 1,500/ul, platelets ≥ 150,000/ul.\n   2. Creatinine ≤ 1.5 x institutional upper limit of normal (ULN).\n   3. Bilirubin ≤ 1.5 x ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x ULN.\n9. Have signed written informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Subjects who fail to meet the above criteria.\n2. Prior therapy for head and neck cancer is allowed, and the number of treatments is not limited. However, any systemic therapy should have been completed at least 30 days prior to study enrollment. Any radiation to the head and neck should have been completed at least 30 days prior to study enrollment. Palliative radiation outside of the head and neck does not require a washout.\n3. Pregnancy or breastfeeding. Women (patients or partners of male patients) of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. All WOCBP must have a negative pregnancy test within 4 weeks prior to registration, and this must be repeated within 72 hours prior to first receiving ruxolitinib. If the pregnancy test is positive, the patient must not receive ruxolitinib and must not be enrolled in the study.\n4. Any unresolved chronic toxicity ≥ grade 2 from previous anticancer therapy (except alopecia and anemia), according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE).\n5. Current active infection requiring systemic antibiotic or antifungal therapy.\n6. Acute hepatitis or known HIV.\n7. Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment.\n8. New York Heart Association (NYHA) Class III or IV heart disease.\n9. History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (coumadin). Patients who are treated with low molecular weight heparin or fondaparinux are eligible.\n10. History of significant bleeding disorder unrelated to cancer, including: diagnosed congenital bleeding disorders (e.g., von Willebrand's disease, diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies, or ongoing or recent (≤ 3 months) significant gastrointestinal bleeding\n11. Concomitant Medications, any of the following should be considered for exclusion: Strong CYP3A4 inhibitors: (Patients must discontinue drug 7 days prior to starting ruxolitinib), including but not limited to boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, or voriconazole. In addition, patients will be instructed to avoid grapefruit or grapefruit juice, starfruit, or seville oranges.\n12. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically or cytologically confirmed, primary or recurrent, head and neck squamous cell carcinoma, including variants. Patients must have at least one measureable lesion in accordance with RECIST 1.1 (tumor diameter ≥ 1 cm; short-axis lymph node diameter ≥ 1.5 cm) OR by caliper measurement (tumor diameter ≥ 1 cm). Any diagnostic pretreatment biopsy sample is acceptable including fine needle aspiration (FNA).",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed, primary or recurrent, head and neck squamous cell carcinoma, including variants.",
                    "criterion": "head and neck squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "primary",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must have at least one measureable lesion in accordance with RECIST 1.1 (tumor diameter ≥ 1 cm; short-axis lymph node diameter ≥ 1.5 cm) OR by caliper measurement (tumor diameter ≥ 1 cm).",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1"
                        },
                        {
                            "requirement_type": "tumor diameter",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        },
                        {
                            "requirement_type": "short-axis lymph node diameter",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "cm"
                            }
                        },
                        {
                            "requirement_type": "measurement method",
                            "expected_value": "caliper"
                        }
                    ]
                },
                {
                    "exact_snippets": "Any diagnostic pretreatment biopsy sample is acceptable including fine needle aspiration (FNA).",
                    "criterion": "diagnostic pretreatment biopsy sample",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "sample type",
                            "expected_value": [
                                "fine needle aspiration (FNA)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Primary tumors of any head and neck (oral cavity, oropharynx, hypopharynx, or larynx) site will be included.",
            "criterions": [
                {
                    "exact_snippets": "Primary tumors of any head and neck (oral cavity, oropharynx, hypopharynx, or larynx) site",
                    "criterion": "primary tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "head and neck",
                                "oral cavity",
                                "oropharynx",
                                "hypopharynx",
                                "larynx"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Surgical resection of head and neck must be planned, either as primary treatment or salvage. Patients must have submitted adequate pretreatment archival or fresh tissue.",
            "criterions": [
                {
                    "exact_snippets": "Surgical resection of head and neck must be planned",
                    "criterion": "surgical resection of head and neck",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must have submitted adequate pretreatment archival or fresh tissue",
                    "criterion": "pretreatment tissue",
                    "requirements": [
                        {
                            "requirement_type": "submission",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "archival",
                                "fresh"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Age ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (See Appendix 1).",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (sensitivity ≤ 25 human chorionic gonadotropin (HCG) IU/L) within 4 weeks prior to registration and will be repeated within 72 hours prior to the start of study drug administration.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential (WOCBP)",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "Women of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "sensitivity ≤ 25 human chorionic gonadotropin (HCG) IU/L",
                    "criterion": "pregnancy test sensitivity",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 25,
                                "unit": "IU/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks prior to registration",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to registration"
                        }
                    ]
                },
                {
                    "exact_snippets": "will be repeated within 72 hours prior to the start of study drug administration",
                    "criterion": "timing of repeated pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 72 hours prior to the start of study drug administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 12 weeks after study drug is stopped. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.",
            "criterions": [
                {
                    "exact_snippets": "Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 12 weeks after study drug is stopped.",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout treatment and for at least 12 weeks after study drug is stopped"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation",
                    "criterion": "pregnancy avoidance",
                    "requirements": [
                        {
                            "requirement_type": "advisement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Adequate hematologic, renal and hepatic function, as defined by:",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic ... function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Absolute neutrophil count (ANC) ≥ 1,500/ul, platelets ≥ 150,000/ul.",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1,500/ul",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "ul"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets ≥ 150,000/ul",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 150000,
                                "unit": "ul"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Creatinine ≤ 1.5 x institutional upper limit of normal (ULN).",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 1.5 x institutional upper limit of normal (ULN).",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit of normal (ULN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Bilirubin ≤ 1.5 x ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x ULN.",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤ 1.5 x ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x ULN",
                    "criterion": "AST or ALT level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Have signed written informed consent",
            "criterions": [
                {
                    "exact_snippets": "signed written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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": "1. Subjects who fail to meet the above criteria.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who fail to meet the above criteria",
                    "criterion": "previous criteria",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Prior therapy for head and neck cancer is allowed, and the number of treatments is not limited. However, any systemic therapy should have been completed at least 30 days prior to study enrollment. Any radiation to the head and neck should have been completed at least 30 days prior to study enrollment. Palliative radiation outside of the head and neck does not require a washout.",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy for head and neck cancer is allowed",
                    "criterion": "prior therapy for head and neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the number of treatments is not limited",
                    "criterion": "number of treatments",
                    "requirements": [
                        {
                            "requirement_type": "limit",
                            "expected_value": "not limited"
                        }
                    ]
                },
                {
                    "exact_snippets": "any systemic therapy should have been completed at least 30 days prior to study enrollment",
                    "criterion": "systemic therapy completion",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Any radiation to the head and neck should have been completed at least 30 days prior to study enrollment",
                    "criterion": "radiation to the head and neck completion",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Palliative radiation outside of the head and neck does not require a washout",
                    "criterion": "palliative radiation outside of the head and neck",
                    "requirements": [
                        {
                            "requirement_type": "washout requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Pregnancy or breastfeeding. Women (patients or partners of male patients) of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. All WOCBP must have a negative pregnancy test within 4 weeks prior to registration, and this must be repeated within 72 hours prior to first receiving ruxolitinib. If the pregnancy test is positive, the patient must not receive ruxolitinib and must not be enrolled in the study.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy or breastfeeding",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnancy or breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women (patients or partners of male patients) of childbearing potential (WOCBP) must practice acceptable methods of birth control",
                    "criterion": "birth control",
                    "requirements": [
                        {
                            "requirement_type": "practice",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "All WOCBP must have a negative pregnancy test within 4 weeks prior to registration",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to registration"
                        }
                    ]
                },
                {
                    "exact_snippets": "this must be repeated within 72 hours prior to first receiving ruxolitinib",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours prior to first receiving ruxolitinib"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Any unresolved chronic toxicity ≥ grade 2 from previous anticancer therapy (except alopecia and anemia), according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE).",
            "criterions": [
                {
                    "exact_snippets": "unresolved chronic toxicity ≥ grade 2 from previous anticancer therapy",
                    "criterion": "chronic toxicity from previous anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "anemia",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Current active infection requiring systemic antibiotic or antifungal therapy.",
            "criterions": [
                {
                    "exact_snippets": "Current active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring systemic antibiotic or antifungal therapy",
                    "criterion": "systemic antibiotic or antifungal therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Acute hepatitis or known HIV.",
            "criterions": [
                {
                    "exact_snippets": "Acute hepatitis",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "acute"
                        }
                    ]
                },
                {
                    "exact_snippets": "known HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment.",
                    "criterion": "treatment with non-approved or investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. New York Heart Association (NYHA) Class III or IV heart disease.",
            "criterions": [
                {
                    "exact_snippets": "New York Heart Association (NYHA) Class III or IV heart disease",
                    "criterion": "NYHA heart disease classification",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "Class III",
                                "Class IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (coumadin). Patients who are treated with low molecular weight heparin or fondaparinux are eligible.",
            "criterions": [
                {
                    "exact_snippets": "History of thromboembolic event",
                    "criterion": "thromboembolic event",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "condition currently requiring anticoagulation with warfarin (coumadin)",
                    "criterion": "anticoagulation with warfarin",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. History of significant bleeding disorder unrelated to cancer, including: diagnosed congenital bleeding disorders (e.g., von Willebrand's disease, diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies, or ongoing or recent (≤ 3 months) significant gastrointestinal bleeding",
            "criterions": [
                {
                    "exact_snippets": "History of significant bleeding disorder unrelated to cancer",
                    "criterion": "significant bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "relation to cancer",
                            "expected_value": "unrelated"
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed congenital bleeding disorders (e.g., von Willebrand's disease",
                    "criterion": "congenital bleeding disorders",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies",
                    "criterion": "acquired bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing or recent (≤ 3 months) significant gastrointestinal bleeding",
                    "criterion": "significant gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "ongoing",
                                "recent"
                            ]
                        },
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Concomitant Medications, any of the following should be considered for exclusion: Strong CYP3A4 inhibitors: (Patients must discontinue drug 7 days prior to starting ruxolitinib), including but not limited to boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, or voriconazole. In addition, patients will be instructed to avoid grapefruit or grapefruit juice, starfruit, or seville oranges.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant Medications, any of the following should be considered for exclusion: Strong CYP3A4 inhibitors",
                    "criterion": "concomitant medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must discontinue drug 7 days prior to starting ruxolitinib",
                    "criterion": "discontinuation of strong CYP3A4 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "time before starting ruxolitinib",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients will be instructed to avoid grapefruit or grapefruit juice, starfruit, or seville oranges",
                    "criterion": "consumption of certain fruits",
                    "requirements": [
                        {
                            "requirement_type": "avoidance",
                            "expected_value": [
                                "grapefruit",
                                "grapefruit juice",
                                "starfruit",
                                "seville oranges"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.",
            "criterions": [
                {
                    "exact_snippets": "Prisoners or subjects who are compulsorily detained (involuntarily incarcerated)",
                    "criterion": "detention status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "compulsorily detained"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment of either a psychiatric or physical (e.g., infectious) illness",
                    "criterion": "illness type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "psychiatric",
                                "physical (e.g., infectious)"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}