{
    "info": {
        "nct_id": "NCT02831582",
        "official_title": "Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation",
        "inclusion_criteria": "* Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the FDA-approved AIs (anastrazole, exemestane, letrozole)\n* Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed; concurrent breast related radiation therapy is allowed.\n* Prior tamoxifen use is allowed\n* Prior chemotherapy is allowed\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",
        "exclusion_criteria": "* Metastatic malignancy of any kind\n* Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease\n* AI use > 21 days prior to study enrollment\n* Known bleeding disorders\n* Current use of warfarin or other anticoagulants\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements\n* Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if > 375 mg per day of of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation\n* Pregnant or nursing women\n* Known sensitivity or allergy to fish or fish oil\n* Unable to give informed consent",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the FDA-approved AIs (anastrazole, exemestane, letrozole)",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed with breast cancer",
                    "criterion": "breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stages I-III",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "initiating first line adjuvant aromatase inhibitor (AI) therapy",
                    "criterion": "adjuvant aromatase inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "initiation",
                            "expected_value": "first line"
                        }
                    ]
                },
                {
                    "exact_snippets": "with any of the FDA-approved AIs (anastrazole, exemestane, letrozole)",
                    "criterion": "FDA-approved aromatase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "approved_drugs",
                            "expected_value": [
                                "anastrazole",
                                "exemestane",
                                "letrozole"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed; concurrent breast related radiation therapy is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed",
                    "criterion": "GnRH agonist therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrent breast related radiation therapy is allowed",
                    "criterion": "breast related radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior tamoxifen use is allowed",
            "criterions": [
                {
                    "exact_snippets": "Prior tamoxifen use is allowed",
                    "criterion": "tamoxifen use",
                    "requirements": [
                        {
                            "requirement_type": "prior use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy is allowed",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy is allowed",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "expected_value",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Metastatic malignancy of any kind",
            "criterions": [
                {
                    "exact_snippets": "Metastatic malignancy of any kind",
                    "criterion": "metastatic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease",
            "criterions": [
                {
                    "exact_snippets": "Rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other types of autoimmune and inflammatory joint disease",
                    "criterion": "autoimmune and inflammatory joint disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AI use > 21 days prior to study enrollment",
            "criterions": [
                {
                    "exact_snippets": "AI use > 21 days prior to study enrollment",
                    "criterion": "AI use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known bleeding disorders",
            "criterions": [
                {
                    "exact_snippets": "Known bleeding disorders",
                    "criterion": "bleeding disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current use of warfarin or other anticoagulants",
            "criterions": [
                {
                    "exact_snippets": "Current use of warfarin",
                    "criterion": "warfarin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use of ... other anticoagulants",
                    "criterion": "anticoagulant use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "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": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... psychiatric illness/social situation that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situation",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if > 375 mg per day of of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation",
            "criterions": [
                {
                    "exact_snippets": "Daily use of n-3 PUFA concentrates or capsules or any other supplements",
                    "criterion": "n-3 PUFA supplement use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if > 375 mg per day of of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA)",
                    "criterion": "eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 375,
                                "unit": "mg per day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within six months of study initiation",
                    "criterion": "timeframe of supplement use",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within six months of study initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or nursing women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing women",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known sensitivity or allergy to fish or fish oil",
            "criterions": [
                {
                    "exact_snippets": "Known sensitivity or allergy to fish",
                    "criterion": "sensitivity or allergy to fish",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known sensitivity or allergy to ... fish oil",
                    "criterion": "sensitivity or allergy to fish oil",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to give informed consent",
            "criterions": [
                {
                    "exact_snippets": "Unable to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}