{
    "info": {
        "nct_id": "NCT04394182",
        "official_title": "Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers",
        "inclusion_criteria": "1. Age > 18 years-old.\n2. Diagnosis of pneumonia due to COVID-19 serologically proven by polymerase chain reaction (PCR) or highly suspected to be COVID-related.\n3. Charlson Comorbidity Index (CCI) less than 6 score.\n4. Poor or no response to standard medical treatment, based on:\n\n   *% Sat02 <93%\n   * Oxygen therapy escalation (Understanding from less to more need for support: Nasal Cannula-NC-; Ventimask -VMK- and VMK with reservoir)\n   * Pa02 / Fi02 (blood gas analysis) <300 mmHg\n   * 1 or more inflammatory and immunological analytical parameters such as lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen with values above the normal range, except lymphocytes.\n   * Radiological impairment defined as worsening of TSS throughout admission or score at admission: TSS> 5 by a diagnostic baseline CT scan.\n5. Eastern Cooperative Oncology Group (ECOG) Status < or = 3\n6. Life expectancy (LE)> 1 month at hospital admission for COVID-19\n7. No previous thoracic RT (relative-individualization criteria) or chemotherapy (chemoinduced pulmonary toxicity, eg Bleomycin).\n8. Verbal information on the procedure, objective and secondary effects, acceptance and signing of informed consent by the patient or legal guardian.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "* Failure to meet the inclusion criteria.\n* Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.\n* Patients admitted in ICU.\n* Refusal of treatment after verbal information.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age > 18 years-old.",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years-old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years-old"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Diagnosis of pneumonia due to COVID-19 serologically proven by polymerase chain reaction (PCR) or highly suspected to be COVID-related.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of pneumonia",
                    "criterion": "pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "due to COVID-19",
                    "criterion": "COVID-19",
                    "requirements": [
                        {
                            "requirement_type": "cause of pneumonia",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serologically proven by polymerase chain reaction (PCR)",
                    "criterion": "COVID-19 diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "polymerase chain reaction (PCR)"
                        }
                    ]
                },
                {
                    "exact_snippets": "highly suspected to be COVID-related",
                    "criterion": "COVID-19 suspicion",
                    "requirements": [
                        {
                            "requirement_type": "suspicion level",
                            "expected_value": "highly suspected"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Charlson Comorbidity Index (CCI) less than 6 score.",
            "criterions": [
                {
                    "exact_snippets": "Charlson Comorbidity Index (CCI) less than 6 score",
                    "criterion": "Charlson Comorbidity Index (CCI)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "score"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Poor or no response to standard medical treatment, based on:",
            "criterions": [
                {
                    "exact_snippets": "Poor or no response to standard medical treatment",
                    "criterion": "response to standard medical treatment",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "poor",
                                "none"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "*% Sat02 <93%",
            "criterions": [
                {
                    "exact_snippets": "Sat02 <93%",
                    "criterion": "oxygen saturation",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 93,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Oxygen therapy escalation (Understanding from less to more need for support: Nasal Cannula-NC-; Ventimask -VMK- and VMK with reservoir)",
            "criterions": [
                {
                    "exact_snippets": "Oxygen therapy escalation (Understanding from less to more need for support: Nasal Cannula-NC-; Ventimask -VMK- and VMK with reservoir)",
                    "criterion": "oxygen therapy",
                    "requirements": [
                        {
                            "requirement_type": "escalation",
                            "expected_value": [
                                "Nasal Cannula",
                                "Ventimask",
                                "Ventimask with reservoir"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pa02 / Fi02 (blood gas analysis) <300 mmHg",
            "criterions": [
                {
                    "exact_snippets": "Pa02 / Fi02 (blood gas analysis) <300 mmHg",
                    "criterion": "Pa02 / Fi02 ratio",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 300,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 1 or more inflammatory and immunological analytical parameters such as lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen with values above the normal range, except lymphocytes.",
            "criterions": [
                {
                    "exact_snippets": "lymphocytes ... with values above the normal range, except lymphocytes",
                    "criterion": "lymphocytes",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "N/A"
                        }
                    ]
                },
                {
                    "exact_snippets": "IL-6 ... with values above the normal range",
                    "criterion": "IL-6",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "> normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "D-dimer ... with values above the normal range",
                    "criterion": "D-dimer",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "> normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "ferritin ... with values above the normal range",
                    "criterion": "ferritin",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "> normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "LDH ... with values above the normal range",
                    "criterion": "LDH",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "> normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "C Reactive Protein (CRP) ... with values above the normal range",
                    "criterion": "C Reactive Protein (CRP)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "> normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "fibrinogen ... with values above the normal range",
                    "criterion": "fibrinogen",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "> normal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiological impairment defined as worsening of TSS throughout admission or score at admission: TSS> 5 by a diagnostic baseline CT scan.",
            "criterions": [
                {
                    "exact_snippets": "Radiological impairment defined as worsening of TSS throughout admission",
                    "criterion": "radiological impairment",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "worsening of TSS throughout admission"
                        }
                    ]
                },
                {
                    "exact_snippets": "score at admission: TSS> 5 by a diagnostic baseline CT scan",
                    "criterion": "TSS score at admission",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Eastern Cooperative Oncology Group (ECOG) Status < or = 3",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Status < or = 3",
                    "criterion": "ECOG status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Life expectancy (LE)> 1 month at hospital admission for COVID-19",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy (LE)> 1 month",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. No previous thoracic RT (relative-individualization criteria) or chemotherapy (chemoinduced pulmonary toxicity, eg Bleomycin).",
            "criterions": [
                {
                    "exact_snippets": "No previous thoracic RT",
                    "criterion": "previous thoracic RT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No previous ... chemotherapy",
                    "criterion": "previous chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Verbal information on the procedure, objective and secondary effects, acceptance and signing of informed consent by the patient or legal guardian.",
            "criterions": [
                {
                    "exact_snippets": "Verbal information on the procedure, objective and secondary effects",
                    "criterion": "verbal information",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acceptance and signing of informed consent by the patient or legal guardian",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "signing",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 120 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 120 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Failure to meet the inclusion criteria.",
            "criterions": [
                {
                    "exact_snippets": "Failure to meet the inclusion criteria",
                    "criterion": "inclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Any uncontrolled intercurrent illness",
                    "criterion": "uncontrolled intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients admitted in ICU.",
            "criterions": [
                {
                    "exact_snippets": "Patients admitted in ICU",
                    "criterion": "ICU admission",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Refusal of treatment after verbal information.",
            "criterions": [
                {
                    "exact_snippets": "Refusal of treatment after verbal information",
                    "criterion": "treatment refusal",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}