--- a +++ b/clusters/9knumclustersv2/clust_1402.txt @@ -0,0 +1,80 @@ +Patients requiring any daily supplemental oxygen +Subject requires continuous supplemental oxygen for any reason. Additional Exclusion Criteria for Arm B +Requirement for daily supplemental oxygen +Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation. +Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation. +Participant has a need for supplemental oxygen with the exception of using previously existing non-invasive continuous positive airway pressure (CPAP) at night. +Subjects with a history of interstitial lung disease; patients requiring continuous supplemental oxygen are excluded to avoid possible complications from pneumonitis +ARM - A: Pulmonary: patients with a requirement for supplemental oxygen or evidence of moderate-severe COPD by PFTs are permitted to enroll +Patients with baseline respiratory insufficiency severe enough to require supplemental oxygen. +Patients requiring ventilator support or oxygen supplementation exceeding % fraction of inspired oxygen (FiO) within days of enrollment. +Research participant requires supplemental oxygen to keep saturation greater than % and the situation is not expected to resolve within weeks +Research participant does not require supplemental oxygen to keep saturation greater than % and/or does not have presence of any radiographic abnormalities on chest x-ray that are progressive +Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation +Oxyhemoglobin saturation at rest >= % (off supplemental oxygen) +Pulmonary dysfunction defined as:\r\n* Severe pulmonary dysfunction with () a hemoglobin corrected DLCO < % of predicted at the Baseline Screening visit, or () FVC < % of predicted Baseline Screening visit, or\r\n* Partial pressure (pO) < mmHg or pCO >= mmHg without supplemental oxygen, or \r\n* O saturation < % at rest without supplemental oxygen as measured by forehead pulse oximeter +Patients requiring oxygen therapy +Patients requiring oxygen therapy +Patients requiring continuous supplemental oxygen are excluded to avoid possible complications from pneumonitis +Need for supplemental oxygen +No supplemental oxygen requirement +Patient is on supplemental home oxygen +ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Patient is on supplemental home oxygen +Research participant does not require supplemental oxygen to keep saturation greater than % and/or does not have presence of any radiographic abnormalities on chest x-ray that are progressive +Research participant requires supplemental oxygen to keep saturation greater than % and the situation is not expected to resolve within weeks +Within days of study registration: No oxygen requirement on room air or requiring =< L supplemental oxygen (O) +Current use of supplemental oxygen +Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation. +Any patient requiring supplemental oxygen therapy +Respiratory insufficiency with oxygen requirement > L nasal cannula +Patients must not require daily supplemental oxygen +No history of severe chronic obstructive pulmonary disease (COPD) or emphysema or interstitial lung disease currently on home supplemental oxygen; patients with NSCLC with stable COPD or emphysema not requiring supplemental oxygen are eligible +No requirement for supplemental oxygen therapy +Severe hypoxemia with room air pulmonary arterial oxygen tension (PaO) < , supplemental oxygen dependence, or DLCO < % predicted +Patients requiring supplemental oxygen +Participants requiring any daily supplemental oxygen +Patients requiring supplemental oxygen therapy +Patient is on supplemental home oxygen +Patients on supplemental home oxygen +May not be on supplemental oxygen +Patient must not have a requirement for supplemental oxygen +Requirement of supplemental oxygen. +History of interstitial pneumonitis and/or require supplemental oxygen therapy +Requiring supplemental oxygen at more than L/min +Dyspnea of any cause requiring supplemental oxygen therapy; +Participants requiring any daily supplemental oxygen +Patients with history of lung disease currently requiring any pharmacologic or supplemental oxygen treatment +Adequate pulmonary function defined as:\r\n* No dyspnea at rest\r\n* No known requirement for supplemental oxygen\r\n* No known active pneumonitis +Clinically significant pulmonary hypertension, as defined by the requirement for ongoing pharmacologic treatment or the consistent or intermittent use of supplemental home oxygen. +Patient currently requiring supplemental oxygen for his/her daily life +Requirement for supplemental oxygen to carry out activities of daily living +Patients with active infection defined as:\r\n* Positive blood culture within hours of study registration\r\n* Need for supplemental oxygen or vasopressors within hours of study entry +Oxygen saturation <% on room air by trans-cutaneous method or need for any supplemental oxygenation or ventilatory support, or increase in oxygen supplementation requirement of ? litres for subjects with chronic oxygen dependency. For those subjects with a history of chronic hypoxia (without supplemental oxygen), an oxygen saturation of at least % below the patient's historical baseline oxygen saturation will satisfy this criterion. +Oxygen saturation < % despite supplemental oxygen > L/minute. +Daily supplemental oxygen +Subjects currently on supplemental oxygen support +Patients with history of lung disease currently requiring any pharmacologic or supplemental oxygen treatment +Chronic supplemental oxygen requirement or hypoxemia < % blood oxygen saturation (SpO) +Any patients requiring oxygen at baseline +Currently requiring high flow oxygen for oxygenation +Supplemental oxygen dependency +Supplemental oxygen requirement > L per minute +Patients requiring oxygen more than liters +No requirement for supplemental oxygen (O) +Patients with history of lung disease currently requiring any supplemental oxygen treatment +Clinically significant pulmonary compromise (e.g. require supplemental oxygen) +Adequate pulmonary function as assessed by oxygen saturation >= % when ambulating and not requiring supplemental oxygen +Respiratory disease requiring continuous supplemental oxygen +Supplemental oxygen requirement > L per minute +Supplemental oxygen requirement > L per minute +Oxygen saturation < % despite supplemental oxygen > L/min +Severe hypoxemia with room air partial pressure of oxygen (PaO) < , supplemental oxygen dependence, or DLCO < % predicted +Hypoxemia (less than % saturation with supplemental oxygen) +Current use of supplemental oxygen +Significant valvular disease, or significant pulmonary disease requiring supplemental oxygen therapy +Patients that require supplemental oxygen are excluded +Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies +Patients with history of lung disease currently requiring any pharmacologic or supplemental oxygen treatment +Requires daily supplemental oxygen. +Patients that require supplemental oxygen are excluded +Oxygen saturation >= % when ambulating and not requiring supplemental oxygen