{
    "info": {
        "nct_id": "NCT05396872",
        "official_title": "A Multi-stage Study to Improve Informed Decision-making for Precision Oncology in Veterans With Advanced Prostate Cancer",
        "inclusion_criteria": "Patient participants:\n\n1. Participated in Stage 1.\n2. Completed either germline or tumor testing for prostate cancer.\n3. Able to understand study procedures and to comply with them for the entire length of the study.\n\nCaregiver-participants:\n\n1. Participated in Stage 1.\n2. Partner, family-member, or friend of a Stage 2 participant (identified by the patient-participant as a caregiver).\n\nSFVAHCS Provider-participants:\n\n1. Participated in Stage 1.\n2. Meets one of the two following criteria:\n\n   * Physician specializing in medical oncology (MD, post-first year clinical fellows allowed) who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 30 days of being contacted for this study.\n   * Physician specializing in genetics who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 90 days of being contacted for this study.\n\nNon-SFVAHCS provider-participants:\n\n1. Meets one of the three following criteria:\n\n   * Principal investigator of a Precision Oncology Program for Cancer of the Prostate (POPCaP) site.\n   * Physician specializing in medical oncology who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 30 days of being contacted for this study.\n   * Physician specializing in genetics who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 90 days of being contacted for this study.\n\n   Note: For Non-SFVAHCS providers, fellows are not eligible.\n2. Able to understand study procedures and to comply with them for the entire length of the study.\n\nStage 3: Inclusion Criteria\n\nPatient-participants\n\n1. Age 18 years or older.\n2. Able to understand study procedures and to comply with them for the entire length of the study.\n3. Able to understand a written informed consent document and willing to sign it.\n4. Able to speak, read, and understand English.\n5. Documentation of high-risk localized, very high-risk localized, locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report.\n6. Scheduled to attend a hematology/oncology appointment (in person or remote) during which provider anticipates discussing germline testing.\n\nCaregiver-participants\n\n1. Age 18 years or older.\n2. Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interview.\n3. Able to provide verbal consent.\n4. Able to speak and understand English.\n\nProvider-participants\n\n1. SFVAHCS physician (MD) trained in medical oncology or undergoing training as a clinical fellow.\n2. Has discussed germline testing for prostate cancer with an SFVAHCS patient within the past year of being contacted about the study, or plans to discuss germline testing for prostate cancer with an SFVAHCS patient.\n3. Able to provide verbal consent.\n\nStage 1: Exclusion Criteria\n\nPatient-participants:\n\n1. For patient-participants undergoing genetic testing, if results of the genetic tests have already been disclosed to the participant, they are not eligible.\n\n   Caregiver and Provider-Participants\n2. If they do not meet any of the inclusion criteria above.\n\nStage 2: Exclusion Criteria\n\n1. Participants who do not meet the inclusion criteria above.\n\nStage 3: Exclusion Criteria\n\nPatient-participants:\n\n1. Prior receipt of germline testing.\n2. Prior participation in Stage 1 for germline testing.\n\nCaregiver and Provider-Participants\n\n1. If they do not meet any of the inclusion criteria above.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Stage 1: Inclusion Criteria\n\nPatient-participants:\n\n1. Age 18 years or older.\n2. Able to understand study procedures and to comply with them for the entire length of the study.\n3. Able to understand a written informed consent document and willing to sign it.\n4. Able to speak, read, and understand English.\n5. Documentation of locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report.\n6. Scheduled to attend a hematology/oncology appointment (in person or remote) during which provider anticipates discussing germline testing, somatic tumor testing, or targeted therapy.\n\nCaregiver-participants:\n\n1. Age 18 years or older.\n2. Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interviews.\n3. Able to provide verbal consent.\n4. Able to speak and understand English.\n\nProvider-participants:\n\n1. Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed).\n2. Has discussed germline testing, somatic testing, or targeted therapy for an San Francisco Veteran Health Care System (SFVAHCS) patient with locally advanced or metastatic prostate cancer (as defined above) within the past 90 days of being contacted about the study.\n3. Able to provide consent via email.\n\nStage 2:"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Participated in Stage 1.",
                "criterions": [
                    {
                        "exact_snippets": "Participated in Stage 1",
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                            "expected_value": true
                        }
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        },
        {
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                "line": "2. Completed either germline or tumor testing for prostate cancer.",
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                        }
                    },
                    {
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                    }
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        },
        {
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        },
        {
            "identified_line": {
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                        "criterion": "relationship to participant",
                        "requirement": {
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                                "partner",
                                "family-member",
                                "friend"
                            ]
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                    },
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                    },
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        {
            "identified_line": {
                "line": "SFVAHCS Provider-participants:",
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                            "requirement_type": "type",
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                        }
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                ]
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        },
        {
            "identified_line": {
                "line": "1. Participated in Stage 1.",
                "criterions": [
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                        "exact_snippets": "Participated in Stage 1",
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                        }
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            "logical_structure": {
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                            "expected_value": true
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                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Meets one of the two following criteria:",
                "criterions": [
                    {
                        "exact_snippets": "Meets one of the two following criteria",
                        "criterion": "eligibility criteria",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": ">= 1"
                        }
                    }
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            "logical_structure": {
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                        "exact_snippets": "Meets one of the two following criteria",
                        "criterion": "eligibility criteria",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": ">= 1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Physician specializing in medical oncology (MD, post-first year clinical fellows allowed) who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 30 days of being contacted for this study.",
                "criterions": [
                    {
                        "exact_snippets": "Physician specializing in medical oncology",
                        "criterion": "physician specialization",
                        "requirement": {
                            "requirement_type": "specialization",
                            "expected_value": "medical oncology"
                        }
                    },
                    {
                        "exact_snippets": "post-first year clinical fellows allowed",
                        "criterion": "physician experience",
                        "requirement": {
                            "requirement_type": "experience level",
                            "expected_value": "post-first year clinical fellows allowed"
                        }
                    },
                    {
                        "exact_snippets": "discussed genetic testing or targeted therapy with a patient",
                        "criterion": "discussion of genetic testing or targeted therapy",
                        "requirement": {
                            "requirement_type": "discussion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "advanced prostate cancer",
                        "criterion": "patient condition",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "advanced prostate cancer"
                        }
                    },
                    {
                        "exact_snippets": "within the past 30 days of being contacted for this study",
                        "criterion": "timeframe of discussion",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "within the past 30 days"
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
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                                        "requirement": {
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                                        }
                                    },
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                                            "requirement_type": "experience level",
                                            "expected_value": "post-first year clinical fellows allowed"
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                                "exact_snippets": "advanced prostate cancer",
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                                "requirement": {
                                    "requirement_type": "condition",
                                    "expected_value": "advanced prostate cancer"
                                }
                            },
                            {
                                "exact_snippets": "within the past 30 days of being contacted for this study",
                                "criterion": "timeframe of discussion",
                                "requirement": {
                                    "requirement_type": "timeframe",
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                                }
                            }
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                        "exact_snippets": "discussed genetic testing or targeted therapy with a patient",
                        "criterion": "discussion of genetic testing or targeted therapy",
                        "requirement": {
                            "requirement_type": "discussion",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Physician specializing in genetics who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 90 days of being contacted for this study.",
                "criterions": [
                    {
                        "exact_snippets": "Physician specializing in genetics",
                        "criterion": "physician specialization",
                        "requirement": {
                            "requirement_type": "specialization",
                            "expected_value": "genetics"
                        }
                    },
                    {
                        "exact_snippets": "discussed genetic testing or targeted therapy",
                        "criterion": "discussion of genetic testing or targeted therapy",
                        "requirement": {
                            "requirement_type": "discussion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patient with advanced prostate cancer",
                        "criterion": "patient condition",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "advanced prostate cancer"
                        }
                    },
                    {
                        "exact_snippets": "within the past 90 days of being contacted for this study",
                        "criterion": "timeframe of discussion",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Physician specializing in genetics",
                                "criterion": "physician specialization",
                                "requirement": {
                                    "requirement_type": "specialization",
                                    "expected_value": "genetics"
                                }
                            },
                            {
                                "exact_snippets": "discussed genetic testing or targeted therapy",
                                "criterion": "discussion of genetic testing or targeted therapy",
                                "requirement": {
                                    "requirement_type": "discussion",
                                    "expected_value": true
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                    },
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                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "advanced prostate cancer"
                        }
                    },
                    {
                        "exact_snippets": "within the past 90 days of being contacted for this study",
                        "criterion": "timeframe of discussion",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "days"
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Non-SFVAHCS provider-participants:",
                "criterions": [
                    {
                        "exact_snippets": "Non-SFVAHCS provider-participants",
                        "criterion": "provider affiliation",
                        "requirement": {
                            "requirement_type": "affiliation",
                            "expected_value": "Non-SFVAHCS"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Non-SFVAHCS provider-participants",
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                            "requirement_type": "affiliation",
                            "expected_value": "Non-SFVAHCS"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Meets one of the three following criteria:",
                "criterions": [
                    {
                        "exact_snippets": "Meets one of the three following criteria",
                        "criterion": "eligibility criteria",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": ">= 1"
                        }
                    }
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            },
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                        "exact_snippets": "Meets one of the three following criteria",
                        "criterion": "eligibility criteria",
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                            "requirement_type": "quantity",
                            "expected_value": ">= 1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Principal investigator of a Precision Oncology Program for Cancer of the Prostate (POPCaP) site.",
                "criterions": [
                    {
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                        "criterion": "Principal investigator",
                        "requirement": {
                            "requirement_type": "program affiliation",
                            "expected_value": "Precision Oncology Program for Cancer of the Prostate (POPCaP) site"
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "exact_snippets": "Principal investigator of a Precision Oncology Program for Cancer of the Prostate (POPCaP) site.",
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                        "requirement": {
                            "requirement_type": "program affiliation",
                            "expected_value": "Precision Oncology Program for Cancer of the Prostate (POPCaP) site"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Age 18 years or older.",
                "criterions": [
                    {
                        "exact_snippets": "Age 18 years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "Age 18 years or older",
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                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Able to understand study procedures and to comply with them for the entire length of the study.",
                "criterions": [
                    {
                        "exact_snippets": "Able to understand study procedures",
                        "criterion": "understanding of study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "to comply with them for the entire length of the study",
                        "criterion": "compliance with study procedures",
                        "requirement": {
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                            "expected_value": true
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            "logical_structure": {
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                        "exact_snippets": "Able to understand study procedures",
                        "criterion": "understanding of study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "to comply with them for the entire length of the study",
                        "criterion": "compliance with study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Able to understand a written informed consent document and willing to sign it.",
                "criterions": [
                    {
                        "exact_snippets": "Able to understand a written informed consent document",
                        "criterion": "understanding of informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing to sign it",
                        "criterion": "willingness to sign informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "Able to understand a written informed consent document",
                        "criterion": "understanding of informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing to sign it",
                        "criterion": "willingness to sign informed consent",
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                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Able to speak, read, and understand English.",
                "criterions": [
                    {
                        "exact_snippets": "Able to speak ... English.",
                        "criterion": "English speaking ability",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Able to ... read ... English.",
                        "criterion": "English reading ability",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Able to ... understand English.",
                        "criterion": "English understanding ability",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
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                    {
                        "exact_snippets": "Able to ... read ... English.",
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                    {
                        "exact_snippets": "Able to ... understand English.",
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                            "requirement_type": "ability",
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                ]
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        },
        {
            "identified_line": {
                "line": "5. Documentation of high-risk localized, very high-risk localized, locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report.",
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                    },
                    {
                        "exact_snippets": "castration-resistant",
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                ]
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        },
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                    {
                        "exact_snippets": "provider anticipates discussing germline testing",
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            "identified_line": {
                "line": "Caregiver-participants",
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                        "exact_snippets": "Caregiver-participants",
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            "identified_line": {
                "line": "1. Age 18 years or older.",
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                        "exact_snippets": "Age 18 years or older",
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                    }
                ]
            }
        },
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                                "exact_snippets": "SFVAHCS physician (MD)",
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        },
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                    {
                        "exact_snippets": "plans to discuss germline testing for prostate cancer with an SFVAHCS patient",
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                            "requirement_type": "intention",
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        },
        {
            "identified_line": {
                "line": "1. For patient-participants undergoing genetic testing, if results of the genetic tests have already been disclosed to the participant, they are not eligible.",
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                        "exact_snippets": "results of the genetic tests have already been disclosed to the participant",
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                "else_criteria": null
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        },
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        },
        {
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                    {
                        "exact_snippets": "Prior receipt of germline testing",
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            "logical_structure": {
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        {
            "identified_line": {
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                        "exact_snippets": "Prior participation in Stage 1 for germline testing.",
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                    {
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                    {
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        {
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                    {
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        {
            "identified_line": {
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        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
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        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
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                    {
                        "exact_snippets": "minimum age of 18 Years",
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                            "requirement_type": "minimum",
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                                "operator": ">=",
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                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Note: For Non-SFVAHCS providers, fellows are not eligible.",
                "criterions": [
                    {
                        "exact_snippets": "Non-SFVAHCS providers",
                        "criterion": "provider affiliation",
                        "requirement": {
                            "requirement_type": "affiliation",
                            "expected_value": "Non-SFVAHCS"
                        }
                    },
                    {
                        "exact_snippets": "fellows are not eligible",
                        "criterion": "fellowship status",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Able to understand study procedures and to comply with them for the entire length of the study.",
                "criterions": [
                    {
                        "exact_snippets": "Able to understand study procedures",
                        "criterion": "understanding of study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "to comply with them for the entire length of the study",
                        "criterion": "compliance with study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Stage 3: Inclusion Criteria",
                "criterions": [
                    {
                        "exact_snippets": "Stage 3",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "3"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "1. Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed).",
                "criterions": [
                    {
                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
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                        "requirement": {
                            "requirement_type": "specialization",
                            "expected_value": [
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                                "Genetics"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
                        "criterion": "provider type",
                        "requirement": {
                            "requirement_type": "qualification",
                            "expected_value": [
                                "medical doctor (MD)",
                                "nurse practitioner (NP)"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
                        "criterion": "provider type",
                        "requirement": {
                            "requirement_type": "experience",
                            "expected_value": "post-first year clinical fellows allowed"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "or_criteria": [
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                                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
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                                            "expected_value": [
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                                    {
                                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
                                        "criterion": "provider type",
                                        "requirement": {
                                            "requirement_type": "qualification",
                                            "expected_value": [
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                                    {
                                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
                                        "criterion": "provider type",
                                        "requirement": {
                                            "requirement_type": "specialization",
                                            "expected_value": [
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                                    },
                                    {
                                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
                                        "criterion": "provider type",
                                        "requirement": {
                                            "requirement_type": "qualification",
                                            "expected_value": [
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                                        }
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                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
                                        "criterion": "provider type",
                                        "requirement": {
                                            "requirement_type": "specialization",
                                            "expected_value": [
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                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
                                        "criterion": "provider type",
                                        "requirement": {
                                            "requirement_type": "qualification",
                                            "expected_value": [
                                                "medical doctor (MD)"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
                                        "criterion": "provider type",
                                        "requirement": {
                                            "requirement_type": "specialization",
                                            "expected_value": [
                                                "Genetics"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
                                        "criterion": "provider type",
                                        "requirement": {
                                            "requirement_type": "qualification",
                                            "expected_value": [
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                        ]
                    },
                    {
                        "exact_snippets": "Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed)",
                        "criterion": "provider type",
                        "requirement": {
                            "requirement_type": "experience",
                            "expected_value": "post-first year clinical fellows allowed"
                        }
                    }
                ]
            }
        }
    ]
}