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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Breathlessness Dyspnea Age ≥ 18 years Self-reported overall breathlessness intensity ≥ 3 on a 0-10 numerical rating scale (NRS) during the prior 2 weeks, that was not entirely caused by an acute infection such as a cold or pneumonia Able to walk without personal aid (rollator allowed) Can use a device (smart phone/pad) with Internet access regularly Ability to read and complete data entry at baseline Clinical stability with no expected need for hospital admission within one week Have not participated before in the present study
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 12.0-80.0, Pulmonary Regurgitation Congenital Heart Disease Patient with CHD involving the RV Chronic RV volume and/or pressure overload as defined by more than mild pulmonary regurgitation and/or more than mild tricuspid regurgitation and/or a gradient across the RV outflow tract of ≥ 3 m/s on echocardiography and/or estimated RV systolic pressure > 65 mmHg Clinical indication for cardiac catheterization Age 12 to 80 years Informed consent Contraindication for magnetic resonance imaging or cardiopulmonary exercise testing Pregnancy RV systolic function on magnetic resonance imaging < 45%
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Critical Illness Family Members Psychological Distress Informal Caregivers Palliative Care ≥18 years of age Receive mechanical ventilation in a study ICU for ≥48 hours under care of a study ICU physician (pre-consent) Decisional capacity Death expected within 24 hours Admission to an ICU at the index hospital >14 days Comfort care or withdrawal of treatment planned Imprisoned Extubated and possess decisional capacity prior to informed consent Died before T2 survey complete No known family or surrogate Care assumed by a non-study ICU attending after consent by patient/family but before T1
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Hypoventilation Syndrome Chronic Obstructive Pulmonary Disease Obesity Hypoventilation Syndrome Restrictive Lung Disease Neuromuscular Diseases Patients with chronic hypercapnic respiratory failure secondary to one or more identified condition(s) (chronic obstructive pulmonary disease, obesity hypoventilation syndrome, neuromuscular diseases, restrictive lung diseases) Home mechanical ventilation for ≥ 6 months Stable condition for ≥ 1 month Previous adjustment of the noninvasive ventilation therapy under sleep studies in the last 6 months Current respiratory exacerbation Any current comorbidity decompensation Any medical or psychological condition impairing the patient's ability to provide informed consent Missing signed informed consent Total sleep time during polysomnography <180 min
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Pulmonary Disease, Chronic Obstructive Main diagnosis of Chronic Obstructive Pulmonary Disease Stable status at enrollment Able to come to pulmonary rehab center Infection or acute excerbation condition at enrollment Severe neuromuscular, cardiac disease or dementia Unable to perform six minute walk test
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2
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-79.0, Pulmonary Arterial Hypertension Male and female subjects with PAH, ≥18 and ≤ 79 years of age, who are symptomatic and have reduced exercise capacity due primarily to their PAH diagnosis and have been assessed by a qualified individual (i.e. physician, physician assistant, nurse practitioner) to be in NYHA/WHO functional class II or III Willing and able to sign a written informed consent prior to all study-related procedures Subjects with PAH belonging to one of the following subgroups of the Nice Clinical Classification of Pulmonary Hypertension Group 1: a. Idiopathic, b. Heritable, c. Drug or toxin-induced, d. Associated with connective tissue disease, HIV infection, portal hypertension, congenital heart disease (pulmonary-to-systemic shunt Two 6MWD test results > 50 m and < 550 m prior to randomization with results +/ of each other. Note: Up to four tests may be conducted between Screening and Randomization for purposes Hemodynamic assessment of PAH demonstrating elevated mPAP and PVR as indicated below during the Screening Period: a. mean pulmonary artery pressure (mPAP) of ≥ 25 mmHg; and, b. pulmonary vascular resistance (PVR) ≥ 400 dyne•sec/cm5; and, c. pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of ≤ 12 mmHg if PVR ≥ 400 and < 500 dynes•sec/cm5; or PCWP/LVEDP ≤ 15 mmHg if PVR ≥ 500 dynes•sec/cm5 Body mass index ≥ 18 kg/m2 and ≤ 40 kg/m2 at screening Meet the following determined by pulmonary function tests completed no more than 24 weeks prior to screening: a. Forced expiratory volume in one second (FEV1) ≥ 55% of predicted normal, b. FEV1: FVC (forced vital capacity) ratio ≥ 0.60 Agrees to use a medically acceptable method of contraception (both male and female patients) throughout the entire study period and continuing for 30 days after their last dose of study drug Stable background medical regimen of up to 3 oral PAH therapies for at least 30 days prior to Screening and having been on PAH therapy for at least 3 months Concomitant medical disorder, condition, or history, that in the opinion of the Investigator would impair the subject's ability to participate in or complete the requirements of the study Concomitant medical disorder that is expected to limit the subject's life-expectancy to ≤ 1 year Pregnant or lactating female subjects First positive result from serology testing at visit 1 (screening labs) for HIV, HBsAg, or HCV prior to randomization Participation in another investigational drug study within 30 days prior to screening or participating in a non-medication study which, in the opinion of the Investigator, would interfere with the study compliance or outcome assessments Use of chronic subcutaneous prostanoid/prostacyclin therapy for PAH within 30 days prior to screening, including prostacyclin receptor agonists More than mild mitral or aortic valve disease, left ventricular ejection fraction < 50%, or left ventricular regional wall motion abnormality suggestive of active coronary artery disease on documented 2D-echocardiography occurring within 12 months of Screening Sustained systolic blood pressure (SBP) < 95 mmHg and/or diastolic blood pressure (DBP) < 50 mmHg (confirmed by a duplicate seated reading) on at least 3 consecutive readings (self-monitored or office) at screening and prior to dosing, or overt symptomatic hypotension Sustained resting heart rate >110 beats per minute (BPM) (confirmed by duplicate assessments of office vital signs or consecutive ECG assessments) on at least 3 consecutive readings at screening and prior to dosing Clinically significant renal dysfunction at the Screening Visit as measured by the estimated glomerular filtration rate (eGFR)
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-6.0, Retinoblastoma Retinoblastoma requiring selective ophthalmic artery chemotherapy under general anaesthesia Obesity pre-existing significant heart or pulmonary disease
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Incisional Hernia Malignancy scheduled operative treatment due to malignant tumor of the alimentary system (including liver, bile ducts, and pancreas) through transverse incision in the epigastric region provision of informed consent to participate in the study necessity to perform an urgent operation a history of previous surgery performed with transverse incision in the epigastric region body mass index >35 kg/m2
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Atrial Septal Defect Pulmonary Hypertension years and above Informed consent to participate Patients: Diagnosed with an atrial septal defect. More than 3 years have passed since closure of the atrial septal defect Controls: No history of heart or lung disease Lung disease Ischemic heart disease Diabetes Hypertension Valve pathology Patients: Concomitant heart disease Controls: Usage of prescription drugs interfering with the cardiopulmonary function
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2
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Dyspnea severe COPD (post bronchodilator FEV1/FVC < 70% and FEV1 < 50% predicted) stable clinical condition(no exacerbation in the 4 weeks prior to study participation with no change in medications) dyspnea as a main symptom that limited daily activities obvious pulmonary bullae demonstrated by chest CT scan or X-ray examination facial trauma/malformation; recent facial, upper airway or upper gastrointestinal tract surgery systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg at rest unstable angina or a myocardial infarct in the previous four weeks resting sinus tachycardia ( > 120 beats/min) patients with musculoskeletal or neurological disorders patients who are unable to give informed consent
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-85.0, COPD A diagnosis of COPD (FEV1/FVC < 70% in a stable phase of the disease) Age > 18 years Referred for conventional COPD rehabilitation Compliant patient willing to fulfill the study requirements Signed informed consent (Oxygen therapy is not an obstacle for participation) Musculoskeletal disorders limiting training Dizziness, significant sensory or motor disabilities, dementia or terminal malignant disease precluding training Severe comorbidities such as i.e. unstable heart disease, dysregulated diabetes, known malignant disease, any other illness making the patient inappropriate for participating in the study Non-compliant patient Severe vision or hearing impairment Non-Danish speaking Unwillingness or inability to follow the protocol COPD exacerbation in the preceding 6 weeks
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2
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 20.0-999.0, Chronic Obstructive Pulmonary Disease age > 20 years old 2. patients with chronic respiratory disease diagnosed by physician that referred to pulmonary rehabilitation in National Taiwan University Hospital including, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, bronchiectasis 3. can cooperate with pulmonary rehabilitation clinic angina, acute myocardial infarction in the previous one month 2. pregnancy
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2
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Liver Disease Hepatitis D Age 18 years or above, male or female Presence of anti-HDV in serum Presence of quantifiable HDV RNA in serum at three time pre-treatment points with a mean HDV RNA level >2 log10 above the lower limit of quantification (LLOQ) of the HDV RNA assay Demonstration of chronicity as evidenced by the presence of HDV RNA in serum for >/= 6 months, or presence of Anti-HDV antibody >/= 6months Decompensated liver disease, defined by bilirubin >4mg/dL, albumin <3.0 gm/dL, prothrombin time >2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Laboratory abnormalities that are not thought to be due to liver disease may not necessarily require exclusion. Patients with ALT levels greater than 1000 U/L (>25 times ULN) will not be enrolled but may be followed until three determinations are below this level. Patients with an absolute neutrophil count <1000/dL and platelets <75,000/dL will be excluded from the study as well Pregnancy, active breast-feeding, or inability to practice adequate contraception, in women of childbearing potential or in partners of such women. Adequate contraception is defined as vasectomy in male sexual partners of female participants, tubal ligation in women, or use of two contraceptive methods such as condoms and spermicide combination with an intrauterine device or Depo-Provera, or Norplant Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR <50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the NIH psychiatric consultation service), or active coronary artery disease Systemic immunosuppressive therapy within the previous 2 months before enrollment Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, alcoholic liver disease, ongoing drug induced liver disease, nonalcoholic steatohepatitis (but not steatosis), hemochromatosis, or alpha-1-antitrypsin deficiency) Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 3.0-999.0, Heart Septal Defects, Atrial Atrial Septal Defect Age ≥3 , weight ≥10Kg Secundum left-to-right shunt ASD with hemodynamic significance Distance from the defect edge to coronary vein sinus, superior and inferior vena cava, pulmonary vein≥5mm and AV valve should be ≥7mm The atrial septum length (stretched diameter) should be greater than the diameter of left disk Patients of primum, venous sinus and coronary sinus ASD Patients with atrial septum defect ≥26mm Patients with other structural heart disease in addition to ASD Patients with complication of obstructive pulmonary arterial hypertension, Eisenmenger syndrome Infective endocarditis patients Patients with hemolysis or hemorrhagic disease, unhealed ulcer or any taboo about aspirin (except being able to take other anti-platelet agent for consecutive six months) within one month before implantation Patients with thrombosis(especially in left atrium or left atrial appendage thrombus) as shown by echocardiography Patients with known condition of hypercoagulation status Patients ever received heart operation Patients allergic to PLLA
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Heart Failure Noninvasive Ventilation Oxygen Therapy (1) Clinical diagnosis of acute left heart failure (2) The patient receives invasive ventilation for more than 24 hours (3) Must pass spontaneous breathing trials (4) Patient's next of kin agrees to sign the informed consent (1) Chronic Obstructive Pulmonary Disease (COPD) (2) Disturbance of consciousness (3)Bulbar paralysis, dysphagia (4) Facial deformity (5) Terminal tumor (6) Neuromuscular disease
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2
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease Hospitalized COPD patients with a diagnosis of with no clinically significant arterial hypoxemia at rest or on exercise (resting percutaneous oxygen saturation (SpO2) > 90% or a sustained decrease of < 4% during exercise) were recruited. Diagnosis of COPD, and spirometric assessment of airflow limitation severity was based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Patients with a prior diagnosis of other cardiorespiratory conditions (i.e., bronchial asthma, interstitial lung diseases, primary pulmonary hypertension, chronic congestive heart failure), as well as other conditions such as orthopedic, muscular and peripheral vascular diseases that could cause or contribute to breathlessness and exercise intolerance and/or could interfere with carrying out of exercise testing, were excluded
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Heart Failure Patients admitted to the hospital with the primary or secondary diagnosis of heart failure The intra-hospital stay extends for at least 24 hours The patient shows new symptoms (or worsening of known symptoms) due to the presentation of heart failure, including at least one of the following: dyspnea (dyspnea at rest, at exertion, orthopnea, nocturnal paroxysmal dyspnea), decreased exercise capacity, fatigue or other symptoms of target organ hypoperfusion or volume overload The patient has at least two physical examination findings; or at least one finding to the physical examination and at least one complementary criterion, including: physical examination findings that are considered to be due to heart failure (peripheral edema, increase in the abdominal perimeter or ascites in the absence of primary liver disease, signs of pulmonary congestion including crackles, subcrepitant rales or decrease in vesicular murmur, increase in jugular venous pressure and / or hepatojugular reflux, gallop by third sound (S3) or rapid weight gain, clinically significant, attributed to water retention); and/or complementary findings that are considered to be due to heart failure, including Increase in levels of N-terminal-pro-BNP (NT-proBNP) compatible with decompensation of heart failure (> 2,000 pg / mL), radiographic evidence of pulmonary congestion, or invasive or non-invasive evidence of significant increase in ventricular filling pressures or decreased cardiac output Non interpretable lung ultrasound imaging or false positive findings (chronic lung interstitial disease, pneumonia, large pleural effusion) Lack of willing to provide informed consent Life expectancy lesser than 6 months Surgically correctable cause of heart failure (aortic stenosis, mitral regurgitation, multi-vessel coronary artery disease) Chronic kidney injury with an estimated or measured creatinine clearance rate lower than 15ml/min/1.73m2
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2
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-90.0, Heart Failure With Normal Ejection Fraction presence of typical HF symptoms and signs 2. LV ejection fraction ≥ 50 3. elevated levels of NT-proBNP (at least >125 pg/ml) 4. echocardiographic structural (a left atrial volume index > 34 mL/m2 or a left ventricular mass index ≥115 g/m2 for males and ≥95 g/m2 for females) or functional alterations (E/e'≥13 and a mean e' septal and lateral wall < 9 cm/s) chronic renal failure (creatinine > 250 μmol/L) 2. significant hepatic disease, significant coronary artery disease (CAD) (coronary artery stenosis >70% without intervention or positive stress test), 3. secondary hypertension, 4. pericardial disease 5. significant valvular heart disease (>mild stenosis, >moderate regurgitation), 6. active cancer, 7. cor pulmonale 8. congenital heart disease 9. high-output heart failure 10. subjects receiving long-term treatment with phosphodiesterase 5 in-hibitors 11. chronic atrial fibrillation
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2
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 50.0-85.0, Cardiovascular Diseases Cardiovascular Disease 1. be able to give written, informed consent 2. be diagnosed with CVD 3. be between 50-85 years old 4. be postmenopausal, meaning having had cessation of menses for at least 12 consecutive months Healthy Control 1. be able to give written, informed consent 2. no CVD conditions 3. be between 50-85 years old 4. be postmenopausal, meaning having had cessation of menses for at least 12 consecutive months (Both Groups): 1. chronic kidney/renal disease 2. chronic heart failure 3. neuromuscular disease 4. known cancer 5. already supplementing with antioxidants or vitamins within 5 days of the study 6. pregnant or nursing women
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 20.0-90.0, COPD Diagnosed COPD, pulmonary spirometry test FEV1/FVC<70% and FEV1<80% At least 20 years old and has communicative capacity Can walk by self or assistive device prior hospitalization acute exacerbation attack or recurrent acute exacerbation and SpO2< 90% Can perform respiratory regulation correctly within exercising regularly Know cancer Comorbidity with sever pulmonary and cardiac disease Diseases of musculoskeletal system Psychotic or cognitive disorder that likely not be available to complete study procedures the hearing-impaired or visually disabled
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 35.0-999.0, COPD Exacerbation Hypoxia Hypoxemia Hyperoxia Respiratory Failure Respiratory Insufficiency Copd Exacerbation Acute COPD verified by Forced Expiratory Volume in 1. second (FEV1) divided by Forced Vital Capacity (FVC) < 0,70 Admission due to exacerbation in COPD COPD exacerbation and pneumonia can be included Expected duration of admission > 48 hours Need for oxygen supplementation (SpO2 <= 88 % on room air) Cognitively able to participate in the study Willing to participate and give informed consent Need or anticipated need for mechanical ventilation (intermittent Continuous Positive Airway Pressure (CPAP) is allowed) Major comorbidities causing hypoxemia (Cancer, heart disease, pulmonary emboli) Asthma or other respiratory condition requiring higher SpO2 than normal for COPD Pregnancy Cognitive barriers for participation
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 21.0-90.0, Exercise Therapy Physical Activity Respiratory Failure Oxygen Inhalation Therapy (participants are required to fulfill all of the following criteria): 1. Patients aged 21-90 years old who are able to provide informed consent and have their consent signed and dated. Subjects must be able to complete questionnaires. 2. Patients who meet for LTOT i.e. PaO2 ≤55mmHg on room air or PaO2 ≤59mmHg (with pulmonary hypertension, RV hypertrophy, Cor pulmonale, haematocrit ≥55%). 3. Patients should be on LTOT on ≥3 months (to avoid the of patients who were prescribed oxygen following acute illness). 4. Patients should have clinical stability of their underlying chronic cardiac (e.g. pulmonary hypertension) or respiratory diseases (e.g. COPD, ILD), as demonstrated by no recent acute exacerbation of respiratory/cardiac illness, acute healthcare utilisation (presentation to GP, polyclinic or hospital) or change in medication (or adjustments of non-invasive ventilation) for ≥6 weeks before enrolment. 5. Patients who are sufficiently mobile to perform a 6-minute walk test Patients with any life-threatening condition with a low probability (in the opinion of the investigator) of survival for at least 3 months or who has been hospitalised more than 3 times in the preceding 1 year for respiratory failure. 2. Patients who are not able to ambulate with the lightweight POC (they must be able to perform a 6-minute walk test this can be unaided or with walking aid) or who have significant limitation of ambulation due to non-respiratory causes such as musculoskeletal (e.g. osteoarthritis) or neuromuscular disease (e.g. Parkinson's disease or stroke), or who are assessed to have no rehabilitation potential. 3. Patients who are actively smoking. 4. Patients who are currently participating in a pulmonary rehabilitation programme. 5. Patients who are pregnant. 6. Patients who are unable or unwilling to complete questionnaires (e.g. patients on LTOT and home mechanical ventilation)
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 16.0-75.0, Crohn Disease Non-Fatigued CD Patients Harvey Bradshaw index <4 CRP<5mg/dl or Faecal calprotectin <50ug/g or As evidenced by recent endoscopy or cross-sectional imaging General fatigue and physical fatigue score on the Multiple Fatigue Inventory-20 <13 Score of <3 in the Fatigue questionnaire. Fatigued CD Patients Harvey Bradshaw index <4 and CRP<5mg/dl or Faecal calprotectin <50ug/g or (CD and Healthy volunteer participants) Potential participants with any of the following will be excluded >8 on the Hospital Anxiety and Depression score Haematological or biochemical abnormalities (e.g. anaemia (haemoglobin <13g/dl in a male and 12g/dl in a female) Renal failure Hypokalaemia Pregnancy or childbearing in the last 6 months Vitamin B complex deficiencies) Active or previous prescriptions of corticosteroids in the last 12 weeks Overt muscle wasting (defined as 2 standard deviations outside the age-related norm as measured by DEXA) Fatigue starting after the onset of thiopurine therapy
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 5.0-999.0, Asthma COPD Heart Failure Community-acquired Pneumonia Healthy Breathlessness (i) Able to give informed consent for participation in the study. (ii) Male or Female, aged 16 years or above (adult cohort) and 5-15 years for paediatric patients attending the acute care paediatric pathway. (iii) Capable (in the opinion of the EMBER clinical research investigator(s) of providing serial breath samples. (iv) Diagnosed with acute breathlessness as one of the primary indicator reasons by the clinical acute care team. This is not a requirement for healthy subjects or matched controls. (v) One of the indicator provisional diagnoses identified in section 7.1 following senior review by the clinical acute care team. This is not a requirement for healthy subjects or matched controls (vi) Able (in the Investigators opinion) and willing to comply with all study requirements. (vii) Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. (viii) Ability to understand English (i) Female participants who are known to be pregnant, lactating or planning pregnancy during the course of the study. (ii) Current participation in a clinical trial of an investigative medicinal product or within 3 months or 5.5 half-lives of the IMP whichever is longer. (iii) Active or clinically suspected pulmonary tuberculosis (iv) In the opinion of the treating physician, breath sampling during the acute admission would be clinically unsafe or inappropriate due to the patient's condition or poor prognosis. Examples malignancy or autoimmune disease with anticipated survival of under 1 year, and chronic renal replacement therapy. (v) Unable or unwilling to give informed consent by visit 1b. (vi) Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-85.0, Dyspnea COPD Patients No significant cardiovascular disease No significant metabolic disease No significant neuromuscular disease Participants will range from 18-85 years old Control Patients Age and sex-matched to COPD patients Normal lung function Minimal smoking history Individuals with significant cardiovascular, metabolic, neuromuscular or any other disease Individual with musculoskeletal injuries Individuals currently on oral steroids (i.e. prednisone), phosphodiesterase type 5 (PDE5) inhibitors or supplemental O2 therapy
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1
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 40.0-89.0, COPD Emphysema or COPD COPD Exacerbation COPD Exacerbation Acute Respiratory Failure Ventilatory Failure for with Ventilatory Failure Cohort Emergency Department (ED) or ICU physician diagnosis of an acute exacerbation of COPD Age ≥ 40 years of age Need for ventilator support in the ED or ICU during the first 24 hours for Stable COPD Cohort Physician diagnosis of COPD Age ≥ 40 years of age Frequency matched to subjects for Age (± 10 year increments) Current/Former smoking status (former smoker = no smoking for ≥ 1 month) Lung function (FEV1% predicted by ± 10% increments) for with Ventilatory Failure Cohort Systemic steroid use ≤ 30 days prior to return visit Infection requiring antibiotics ≤ 1 month prior to return visit Hemoglobin < 8.0 g/dl Acute pulmonary embolism Diabetes History of immunodeficiency, interstitial lung disease, neuromuscular disorder or heart failure with respiratory exacerbation Tracheostomy Drugs that induce cytochrome P450 3A enzyme activity (e.g. barbiturates, phenytoin or carbamazepine) or drugs that inhibit cytochrome P450 3A activity (e.g. ketoconazole and chronic macrolide antibiotics) Age ≥ 90 year of age
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1
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 40.0-85.0, Heterozygous Familial Hypercholesterolemia Non-familial Hypercholesterolemia Key Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug. Key Significant protocol deviation in the parent study (neurocognitive function study, R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance 2. Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study, (R727-CL-1532: NCT02957682). 3. Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study 4. Known hypersensitivity to monoclonal antibody or any component of the drug product 5. Pregnant or breastfeeding women Note: Other inclusion/ apply
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, ERCP Biliary Disease Tract Biliary Disease Patients, ages > 18, with an intact sphincter undergoing ERCP by at Kingston Health Sciences Center for therapeutic purposes who can provide informed consent. This includes patients who have confirmed choledocholithiasis on imaging and those who have a high suspicion of it based on imaging and lab values. Patients with and without a high suspicion for cholangitis will be eligible for the study. Other indications type 1 sphincter of Oddi dysfunction, gallstone pancreatitis or other benign pancreaticobiliary duct diseases including strictures, primary sclerosing cholangitis and Mirizzi's syndrome. Furthermore, patients with suspected diagnosis of biliary leak following cholecystectomy will also be considered for enrollment in this study. 2. Ability to read and understand the English language Bleeding disorder (Von Willebrand disorder, platelet count <100 000, or INR >1.5) 2. Therapeutic level anticoagulation with low molecular weight heparin (LMWH), warfarin, or a direct-acting oral anticoagulant (DOAC) 3. Prior biliary sphincterotomy 4. Altered upper GI tract anatomy (e.g. prior gastric bypass surgery such as Roux-en-Y or Billroth 2 gastrojejunostomy) 5. Evidence of Malignant infiltration of the ampulla or peri-ampullary area. 6. Inability to identify intra-duodenal portion of the bile duct, including deep peri-ampullary diverticulum
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 19.0-40.0, Altitude Hypoxia Sildenafil Exercise between age 19 (18 if a University of British Columbia student) and 40 healthy competitive cyclist (hold current racing license of professional, category 1, or 2 or have a measured VO2max greater than 60 ml.min.kg) smokers anyone unable to complete the exercise protocol individuals with a history of cardiovascular or respiratory illness those with an atrial or ventricular septal defect (e.g. patent foramen oval) anyone currently prescribed sildenafil, tadalafil, vardenafil or any other PDE-5 inhibiting medication anyone who has lived more than 15 days at moderate altitude in the last three months
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 55.0-999.0, Pulmonary Disease, Chronic Obstructive New users of long-acting bronchodilators, Long-acting beta2-agonist (LABA) and long-acting muscarinic antagonists (LAMA) on the same date or of LABA, LAMA and inhaled corticosteroids (ICS), either as a fixed-dose combination (LABA-ICS) or free combination, on the same date between January 2002 and December 2016 Diagnosis of Chronic obstructive pulmonary disease (COPD) prior to first maintenance inhaler and age ≥ 55 years at first maintenance inhaler Less than one year of medical history information prior to the date of combined treatment initiation (study cohort entry) Asthma diagnosis prior to study cohort entry
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, COPD Exacerbation COPD Patients with COPD with two or more exacerbations every year or at least one leading to hospitalization long-term oxygen therapy cognitive impairment a life expectancy limited to one year
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 21.0-99.0, Dry Eye Patients with dry eye symptoms, who cannot be satisfactorily managed by currently available dry eye medication 2. TBUT ≤10s 3. Presence of corneal fluorescein staining 4. Visual acuity affected by poor tear film quality 5. No contraindication for blood extraction/ plasmapheresis 6. Age between 21 to 99 years old 7. Skin lesions The skin at the site of venepuncture in the antecubital area should be free of lesions. Donors with boils, open wounds, chronic eczema or any severe skin infection must be rejected Active ocular infection. 2. Any other specified reason as determined by clinical investigator 3. Severe cardiovascular disease 4. Severe respiratory disease 5. Uncontrolled epilepsy 6. Abnormal bleeding conditions 7. Pregnancy 8. Infectious diseases Patients who are known or diagnosed to have HIV, Hepatitis B or Hepatitis C carriers should not be accepted for donation Patients who have risk factors for infectious diseases should not be accepted for donation. 9. Patients who have been or are being treated for bacteraemia, or have a significant bacterial infection that can be associated with bacteraemia. 10. Unable to come for follow up at the required frequencies and duration. This includes non-Singapore residents who are patients of the dry eye clinic. 11. In order to avoid serious infections, especially corneal keratitis, we will not patients with high risks for infection in this study, such as those patients with a persistent epithelial defect, wearing of contact lenses, previous ocular surgery such as penetrating keratoplasty or any other ocular surgery. 12. Patients with persistent epithelial defect that requires bandage contact lens
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Dyspnea; Uremic End Stage Renal Disease Chronic Lung Disease Chronic Heart Disease Hemodialysis-Induced Symptom Sodium Excess Age equal to or greater than 18 years Dialysis vintage equal to or greater than 3 months Smoking history of more than 10 packs/year Active tobacco and/or cannabis smoking Diagnosed chronic pulmonary disease Severe heart failure (NYHA class IV) Active infection (including tuberculosis) or malignancy Pregnancy Inability to give consent or understand written information Peripheral oxygen saturation (by pulse oxymetry) dropping below 80% when performing a 12-seconds breathhold Inability to perform spirometry or plethysmography maneuvers Inability to tolerate MRI due to patient size and/or known history of claustrophobia
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-85.0, Heart Failure Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months. 2. ACC/AHA Stage C, NYHA Class III or ambulatory Class IV HF documented at Baseline Visit. 3. Receiving maximally tolerated medical therapy for heart failure as indicated per ACC/AHA or ESC Heart Failure Guidelines (guideline-directed medical therapy or GDMT), such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), beta-blocker (BB), and mineralocorticoid receptor blocker (MRB) for at least 3 months prior to the Baseline visit. 4. Receiving rhythm management device therapy as recommended by the ACC/AHA or ESC Guidelines. Specifically: cardiac resynchronization therapy (CRT) should be implanted for at least 90 days prior to enrollment; an implanted cardioverter-defibrillator (ICD) or a pacemaker should be implanted at least 30 days prior to enrollment. If subject is clinically contraindicated for these therapies this criterion may be waived. 5. Have a minimum of one (1) prior hospital admission within the last 12-months for acute worsening of HF associated with signs/symptoms of congestion of at least one (1) calendar date change duration requiring treatment with an intravenous diuretic. If CRT device previously implanted, the heart failure hospitalization must be ≥ 30 days after CRT implantation. Alternatively, if patients have not had a HF hospitalization within the prior 12-months, they must have a corrected* elevated Brain Natriuretic Peptide (BNP) level of at least 300pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500pg/ml, according to local measurement, within 30-days of the Baseline Visit. *Thresholds for NT-proBNP will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 20 kg/m2, If patient is on ARNI, NT-proBNP should be used exclusively. 6. Provide informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits. - Age <18 or >85 years old. 2. Patients who are NYHA class IV not ambulatory and ACC stage D. 3. Patients with evidence/history of an intra-cardiac thrombus or history of stroke, transient ischemic attack, systemic or pulmonary thromboembolism, deep vein thrombosis (DVT), within the last 6 months. 4. Patients with a resting systolic blood pressure <90 or >180 mmHg and/ or Severe pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg on screening baseline echocardiogram. 5. Left ventricular end-diastolic diameter (LVEDD) > 8cm. 6. Have an atrial septal defect or patent foramen ovale with more than trace shunting on color Doppler or intravenous bubble study or surgical or interventional correction of congenital heart disease involving atrial septum including placement of a PFO or ASD closure device and have a hypermobile septum or a septal aneurysm 7. Patients with untreated severe valve lesions, which are indicated for surgical or percutaneous intervention, severe regurgitant (grade 4+) valve lesions, active valvular vegetations, atrial myxoma, hypertrophic cardiomyopathy with significant resting or provoked subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion, constrictive pericarditis, infiltrative cardiomyopathy (including cardiac sarcoidosis, amyloidosis, and hemochromatosis), or congenital heart disease, as cause of HF. 8. Uncontrolled tachyarrhythmia or bradycardia (heart rate <45). 9. Intractable HF with resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D), including patients receiving continuous or intermittent outpatient IV vasoactive medications (e.g., IV inotropes, IV vasodilators), patients treated with a ventricular assist device (VAD). 10. Intolerant to diuretics, ACEI and ARB and beta-blocker medical therapy for patients classified as HFrEF (EF ≤40%). 11. The presence of an acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), rhythm management system revision, lead extraction, or cardiac or other major surgery within the preceding 90 days. 12. Patients not eligible for emergency open-heart, thoracic or vascular surgery. 13. Women of childbearing age 14. Patients with a life expectancy that is shorter than 12 months, or those who have received a cardiac transplant or are listed for cardiac transplantation and likely to be transplanted within 12 months. 15. Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for all of the forms of antiplatelet/anticoagulant treatments anticipated in the protocol 16. Have an estimated glomerular filtration rate <25 ml/min/1.73 m2 by the MDRD method or on dialysis. 17. Hepatic impairment with at least one liver Function Test (transaminases, total bilirubin, or alkaline phosphatase) ≥ 3 times upper limit of normal. 18. Gastrointestinal bleeding in the last 6 months 19. Have severe chronic pulmonary disease requiring continuous home oxygen, chronic oral steroid therapy, hospitalization for exacerbation during prior 6 months, or has severe obstructive physiology on PFTs (FEV1/FVC <0.70 and FEV1 < 50% normal). 20. Patients who have an active infection requiring systemic antibiotics or an elevated white blood count (above the local laboratory reference ranges) 21. Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years. 22. Are currently participating in a clinical investigation that includes an active treatment arm. 23. Subject otherwise not appropriate for study as determined by the investigator. The reasons must be documented. 24. Patients contraindicated for trans-septal puncture, TEE or ICE. Intra Procedural (Intra Procedural will be determined immediately after intracardiac echocardiography or transesophageal echocardiography determination of left atrial anatomy and just before trans-septal puncture) 25. Anatomical anomaly on TEE or ICE that precludes implantation of the V-LAPIM across the interatrial septum (Fossa Ovalis) including: Septal thickness at fossa > 5 mm, FO Dimension <16mm, ASD or PFO with more than a trace amount of shunting, Intra cardiac thrombus felt to be acute and not present on prior exams and Abnormal septum, e.g. a hypermobile septum or a septal aneurysm. 26. Inadequate vascular access for implantation of V-LAPIM or are unable to tolerate an RHC. 27. Hemodynamic at time of Index Procedure including: Severe pulmonary hypertension defined as PASP>70 mmHg or PVR >4.0 Woods Units (mmHg L-1 min-1); Resting systolic Blood Pressure <90 or >180 mmHg, not corrected with IV fluid administration or vasodilators, respectively
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-999.0, Mitral Valve Reconstruction surgery for mitral valve (reconstruction or replacement) (maybe combined with surgery for tricuspid valve and/ or surgery for atrial septal defects and/or patent foramen ovale) other surgical interventions then the surgical interventions mentioned in the pre existing neurological deficit; neurologic limitation in daily life emergency surgery
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-75.0, Pulmonary Arterial Hypertension Non smoker or tobacco stopped for minimum 2 years ans maximum 10 year-pack. - Idiopathic, heritable, related to drug or toxics, associated with controlled pulmonary hypertension. Diagnosis and treatment of pulmonary hypertension for more than 4 months Optimal control of pulmonary hypertension (no right heart failure symptom and NTproBNP < 300ng/L or Brain Natriuretic Peptide(BNP) < 50 ng/L and optimal hemodynamic results measured by a right heart catheterization in the last year: right atrial pressure < 8 mmHg, cardiac index > 2,5 L/min/m2, veinous saturation in oxygen > 65%) Informed and written consent Non-affiliation to a social security Existence of another form of pulmonary hypertension Existence of vocal cord dysfunction Pregnancy Obesity> stage 2 (BMI 35 kg / m2) Age ≥ 75 years
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1
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Bronchiectasis Symptomatic patient (wheezing, cough and dyspnoea) Proven and documented diagnosis of BE by high resolution computed tomography Stable pulmonary status as indicated by FEV1 (percent of predicted) ≥30% Stable clinically phase (ie, subjects free from acute exacerbation for at least 6 weeks prior to the start of the study) Stable regimen of standard treatment as chronic treatment for BE, at least for the past 4 weeks prior to screening. And/or macrolides if used as chronic treatment for BE at least for the past 6 months prior to screening Coughing on the majority of days for more than 8 weeks Ability to follow the inhaler device instructions Ability to complete questionnaires Written informed consent Possible asthma according to the definition of the Global Initiative for Asthma (GINA) Positive histamine provocation test Known intolerance for ICS or LABA Women who are pregnant, lactating, or in whom pregnancy cannot be excluded Expected to die within 72 hours after enrolment Cigarette smoking history of > 10 pack-years or current smokers Other cardiopulmonary conditions (other than bronchiectasis) that could modify spirometric values
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Unfractionated Heparin Cardiopulmonary Bypass Surgery Patients undergoing first time cardiopulmonary bypass surgery for correction of atrial septal defects or tissue mitral valve repair 2. Receiving intravenous Heparin for cardiopulmonary bypass Concomitant Aortic Stenosis which is associated with an acquired von Willebrand Syndrome (aVWS) Patients with a baseline platelet count of <100x109/L Patients with a known coagulation factor deficiency or platelet function disorder Patients receiving heparin therapy prior to CPB within last 7 days
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.083-99.0, Bone Marrow Transplant Complications Sinusoidal Obstruction Syndrome Veno Occlusive Disease, Hepatic Stem Cell Transplant Complications Any patient undergoing a myeloablative conditioning regimen for HCT between 4/1/2019 and 12/31/2120 defined as one of the following TBI >= 1200 cGy (fractionated) Cyclophosphamide + TBI (> 500 cGy (single) or > 800cGy (fractionated)) Cyclophosphamide + Etoposide + TBI (> 500 cGy (single) or > 800 cGy (fractionated)) Cyclophosphamide + Thiotepa + TBI (> 500 cGy (single) or > 800 cGy (fractionated)) Busulfan (Total dose > 7.2 mg/kg IV or >9.0mg/kg orally) + Cyclophosphamide Busulfan (Total dose >7.2 mg/kg IV or >9.0 mg/kg orally) + Melphalan Busulfan (Total dose >7.2 mg/kg IV or >9.0 mg/kg orally) + Thiotepa NOTE: Busulfan cumulative plasma AUC of >75 mg/L per hour or >18270 microMolar per minute could be used in the preceding in lieu of the mg/kg doses. OR 2. Any patient who has a myeloablative conditioning regimen (as defined by the local HSCT team) that includes sirolimus and tacrolimus for GVHD prophylaxis. OR 3. Any patient who is high risk for SOS irrespective of conditioning regimen: Neuroblastoma, HLH, Osteopetrosis, Thalassemia, treatment with inotuzumab or gemtuzumab within 3 months prior to HSCT admission, 2nd HSCT if it is myeloablative and within 6 months of prior, iron overload, steatohepatitis, active inflammatory or infection hepatitis or any other condition which puts the patient at a higher risk of developing SOS Any patient who has contraindication to US SWE (e.g. unable to hold still)
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-999.0, ASD2(Secundum Atrial Septal Defect) Patients with suitable indication for ASD closure according to recent guidelines : 1. Impaired functional capacity. 2. Right atrial and/or RV enlargement. 3. Left-to-right shunt with [Qp: Qs] ≥1.5:1. 4. Paradoxical embolism Patients with isolated secundum ASD with sufficient rims suitable for device closure Small ASD with Qp/Qs <1.5:1 or no signs of RV volume overload A single defect too large for closure (>38 mm) Multiple ASDs unsuitable for percutaneous closure Anterior, posterior, superior, or inferior rim <5 mm Abnormal pulmonary venous drainage Associated structural heart disease requiring cardiac surgery ASD with severe pulmonary arterial hypertension and bidirectional or right-to-left shunting Intracardiac thrombi diagnosed by echocardiography
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-99.0, Pulmonary Hypertension Written Informed Consent Patients with clinical indication for right heart catheterization known Pregnancy
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 50.0-79.0, Coronary Heart Disease Diastolic Dysfunction Aged between 50 and 79 years,male or female (without pregnancy) Diagnosed CHD by coronary angiography,with stenoses in main bifurcations less than 70% after PCI treatment Left ventricular ejection fraction(LVEF) more than 50% assessed by ultracardiography Characteristics of diastolic dysfunction by ultracardiography (more than 2 as following):(1)Average E/e'>14,(2)Septal e' velocity <7 cm/s or lateral e' velocity <10 cm/s,(3)Tricuspid regurgitation (TR) velocity >2.8m/s,(4)Left atrium (LA) volume index >34ml/m2 Not yet being treated by trimetazidine Provided informed consent Acute heart failure or acute exacerbation of chronic heart failure LVEF less than 50% at admission or in the past History of malignant tumor or life expectancy under 12 months Acute myocardial infarction or unstable angina pectoris within 3 months Scheduled coronary artery bypass grafting therapy within 6 months Diagnosed or considered valvular heart disease, hypertrophic cardiomyopathy,restrictive cardiomyopathy or pericardium diseases Significant hepatic impairment (Serum glutamate-pyruvate transaminase more than 3 times normal upper limit) or severe renal dysfunction (eGFR≤30 ml/min/1.73m2) Known or considered Parkinson's Disease Known hypersensitivity or intolerance to trimetazidine Pregnancy and lactation period
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-999.0, Ventricular Remodeling, Left Study participants must meet ALL of the following in order to be eligible for this study: 1. Moderate (2+,2-3+) functional mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL); 2. Left ventricular ejection fraction > 20%, as assessed by any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI) and evidence of LV dilatation defined as a baseline LVEDV of 75-110 ml/m2 measured by echocardiography; 3. Symptomatic heart failure as defined by NYHA class II, III or ambulatory IV and NT-pro BNP > 800ug/mL (sinus rhythm) or 1000ug/mL (AFIB); 4. Treatment and compliance with medical therapy for heart failure for at least 30 days; Optimal medical therapy is defined by: a. Maximum tolerated beta-blocker, angiotensin converting enzyme inhibitor (ACE) or angiotensin receptor blocker (ARB), Entresto (valsartan/sacubatril) and aldosterone antagonist (as per the ACC/AHA Guidelines as judged by the HF specialist investigator on site and confirmed by the Central Committee). 5. Clinical agreement amongst local investigators that the patient will not be offered surgical intervention; 6. The primary regurgitant jet, in the opinion of the MitraClip implanting investigator, can successfully be treated by the MitraClip. Treatment of commissural mitral regurgitation may be treated at the discretion of the operator. All major jets contributing the secondary MR will be treated with the MitraClip; 7. Ability to perform a six-minute walk test (6MWT) without substantial physical limitations and without use of a walker or wheelchair and distance walked in 6 minutes of ≤ 450m; 8. Ability and willingness to give written informed consent and to comply with the requirements of the study Study participants meeting any of the following by the day of randomization (visit 2) are NOT eligible for this study: 1. Life expectancy less than 12 months due to noncardiac conditions; 2. ACC/AHA Stage D Heart Failure; 3. Left ventricular ejection fraction ≤ 20%; indexed left ventricular end-diastolic volume > 110ml/m2 4. Severe (3-4+, 4+) secondary mitral regurgitation with an indication for intervention 5. Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support; 6. United Network for Organ Sharing (UNOS) status 1 heart transplantation (Canadian Cardiac Transplantation Network, CCTN, status 4) or prior orthotopic hear transplantation; 7. Untreated clinically significant coronary artery disease requiring revascularization; 8. CABG within prior 30 days; 9. Percutaneous coronary intervention within prior 30 days; 10. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring continuous daytime home oxygen or chronic oral corticosteroid therapy; 11. Previous surgical mitral valve bioprosthesis, mitral annuloplasty, or transcatheter mitral valve procedure; 12. Positive pregnancy test, or woman of child bearing potential not using highly effective methods of contraception; 13. Mitral valve area <4.0 cm2 as assessed by planimetry of the mitral valve; 14. Subjects in whom trans-esophageal echocardiography is contraindicated or high risk; 15. Mitral leaflet anatomy which may preclude MitraClip implantation: 1. Perforated mitral leaflets or clefts, lack of primary or secondary chordal support; 2. Severe calcification in the grasping area; 3. Rheumatic valve disease. 16. Stroke or transient ischemic event within 30 days before randomization; 17. Modified Rankin Scale >4 disability; 18. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months; 19. Severe renal impairment defined as an Estimated Glomelular Filtration Rate (eGFR) <30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula; 20. Severe anemia requiring transfusional support or therapy with erythropoietin; 21. Physical evidence of uncontrolled right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction; 22. Aortic valve disease requiring surgery or transcatheter intervention; 23. Significant tricuspid valve disease requiring surgical intervention or very severe tricuspid regurgitation with evidence of right ventricular dysfunction; 24. Active infection requiring antibiotic therapy; 25. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease; 26. Echocardiographic evidence of intracardiac mass, thrombus or vegetation; 27. Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits; 28. Presence of any of the following: 1. Pulmonary artery systolic pressure (PASP) > 70 mm Hg confirmed by right heart catheterization; 2. Infiltrative cardiomyopathies. 29. Any other condition(s) that would compromise the safety of the patient as judged by the site principal investigator
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Dyspnea age >/= 18 years dyspnea as a dominating complaint At least one of respiratory frequency >25/minute oxygen saturation < 95% oxygen therapy initiated trama patients prior enrollment
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-999.0, Scoliosis; Adolescence Adolescent Quality of Life SRS AIS patients who attend the scoliosis clinic at specialized outpatient clinic in Prince of Wales hospital and require wearing brace, or patients who suffer from severe scoliosis and require surgery on their first clinic visit Can read and understand either English or Chinese To observe (i.e. not require to wear brace) after clinic visit Cannot read or understand either English or Chinese
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease Patients admitted to the hospital patients with malignancies patients with other systemic infection
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-65.0, Morbid Obesity Opioid-Related Disorders Surgery--Complications Sleep Apnea Syndromes Body mass index (BMI) equal or greater than 35 kg/m2 American Society of Anesthesiologists (ASA) physical status I III patients Scheduled to undergo laparoscopic roux-en-Y gastric bypass or gastric sleeve placement surgery for weight loss Chronic obstructive pulmonary disorder (COPD) Treatment with continuous positive airway pressure (CPAP) in the past three months Severe neurological, cardiopulmonary, psychiatric, or untreated thyroid disorder Chronic pain condition that was being treated with opioids Patients with a hematocrit lower than 35%
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Breast Cancer Myocardial Damage Cardiotoxicity Planned therapy with an anthracycline and at least 1 year follow up >18 years of age written informed consent prior cardiovascular disease diabetes mellitus previous therapy with anthracyclines
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-85.0, Spondylosis Spondylolisthesis Neurogenic Claudication Foraminal Stenosis Undergoing one or two level anterior lumbar interbody fusion 2. Diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication Previous bowel surgery 2. Diagnosis of an inflammatory bowel disease 3. Allergy to xylitol 4. Pregnancy Some participants may subsequently undergo a posterior spinal fusion on the same-day of surgery. They will not be excluded, but the investigators will this group in a different data subset
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Pulmonary Disease Patients scheduled for thoracic surgery procedures involving one-lung ventilation open thoracotomy Video-assisted thoracoscopic surgery (VATS) Robotic-assisted thoracoscopic surgery (RATS) Procedures to Lung resection for any purpose, esophagectomy, thymectomy Patients undergoing esophagectomy performed by a general surgeon Patients willing and able to independently perform incentive spirometry Trauma patients Lung Volume reduction surgery (LVRS) In-Patients Patients not undergoing one-lung ventilation Patients undergoing thoracoabdominal aortic aneurysm repair Transhiatal esophagectomy (does not involve one-lung ventilation) Lung transplantation
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 25.0-40.0, Traumatic Brain Injury Neurobehavioral Manifestation Sleep Disorder Fatigue Are 25 to 40 years of age Are active duty service members or veterans May be NIH employees/staff who are either active duty service members or veterans; except for those who are employed by NINR or subordinates, relatives, and/or co-workers of NINR employees/staff Have sustained at least 1 TBI, >= 6 months and <= 5 years since their most recent TBI, which includes any self-reported loss of consciousness (LOC) established by the OSU during the pre-screening phone call Are able to provide their own consent Are able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz Currently receiving treatment for a medical illness or recent injury that precludes protocol participation, may interfere with study participation, and/or should be treated/stabilized prior to study participation for safety reasons (e.g., cancer, recent fracture(s) requiring therapy and/or pain medication, severe infection). Individuals with stable medical conditions such as hypertension that are controlled by medication will be included Current physical health status will be assessed by self-report, history and physical exam by a credentialed physician or nurse practitioner, and standard laboratory tests Current unstable endocrine disorder (e.g., uncontrolled diabetes). Unstable endocrine disorders require treatment to ensure health and safety of the patient before participation is possible. Individuals with stable endocrine disorders (e.g., controlled diabetes) may participate in the protocol but they will be excluded from the hydrocortisone stimulation test. This will be assessed by self-report during the history and physical exam and by standard laboratory tests Have a major medical illness that is associated with fatigue (e.g., chronic fatigue [diagnosed prior to their TBI or less than 6 months following TBI], multiple sclerosis, or cancer). This will ensure that symptoms of fatigue are as a result of TBI and not another co-morbid illness. This will be assessed by self-report Currently consuming any of the following sleep modifying medications: benzodiazepines; benzodiazepine receptor agonists; opiates; or sedatives. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants currently taking these medications will be excluded. This will be assessed by self-report Currently using the sleep modifying medications melatonin and/or Benadryl greater than 2 times per week and/or unable or unwilling refrain from using them during protocol participation. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants who are unwilling/unable to refrain from using these medications will be excluded. This will be assessed by self-report Current psychiatric condition for which immediate treatment is required to prevent harm to self or others such as active suicidality or active manic phase in someone who has bi-polar disorder. This is to ensure patient safety and care. This will be assessed by self-report and as part of the history and physical exam Are pregnant. Pregnancy is associated with increased fatigue and sleep disturbances, as such this condition will affect the outcomes of this analysis.his will be assessed by self-report. This will also be assessed on visit 2 by a urine pregnancy test. Individuals who are nursing are eligible but will not participate in the hydrocortisone stimulation test Received a diagnosis of severe obstructive sleep apnea (OSA) and/or current reliance on continuous positive airway pressure (CPAP) therapy to aid sleep. Severe OSA and CPAP use will directly affect the result s of this study, as such these participants will be excluded. This will be assessed by self-report. **Participant may be able to participate in the protocol but will not be able to have an MRI if they have any of the following Metal in the body such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if they are a welder or metal worker
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease clinical features of Chronic obstructive pulmonary disease spirometry compatible with the GOLD (Forced expiratory volume 1/ Forced vital capacity <70%) post bronchodilator Patients with bronchial asthma Asthma -Chronic obstructive pulmonary disease overlap syndrome Atopic patients Pneumothorax Congestive heart failure Cancer of any kind A history of major surgery in the preceding 4 weeks Patients undergoing mechanical ventilation or presenting with azotaemia (serum creatinine >1.5 mg/dl)
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-90.0, Coronary Artery Disease Moderate Coronary lesion deemed to need iFR assessment Angiographic severity of 40-70% that operator feels needs physiologic assessment Age 18-90 year old Single worst lesion per patient Patients may have more than one lesion assessed but only 1 lesion will be evaluated per patient in this study STEMI Angiographic severity of 40-70% that operator feels needs physiologic assessment in setting of STEMI or 48hours within STEMI Atrial fibrillation Inability to provide informed consent No surrogate or healthcare proxy will be allowed to consent for this study Severe tortuosity Vessel tortuosity that the operator feels would be difficult to pass 2 pressure wires down or where pseudo lesions may be formed Saphenous Vein Graft Lesion
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Pulmonary Disease, Chronic Obstructive COPD Exacerbation Patient Readmission Recurrence Patients who have a primary diagnosis of COPD Patients admitted to hospital with an exacerbation Patients in whom an initial diagnosis of an is revised to an alternative at a later phase of the study Patients who have a predominant history of asthma Patients with a confirmed active malignancy Patients who have a predominant history of bronchiectasis Cognitive impairment patients with a Mental Test Score (MTS) of 6 or less Inability to give informed consent to take part in the study
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 40.0-80.0, COPD Pulmonary Hypertension Secondary Stable COPD patients with age ≥ 40 years Prior to the COPD diagnosis was verified by spirometry before and after bronchodilation treatment was optimized and Patients on regular medication Patients who refuse to participate in the study Patients underwent thorough pulmonary and cardiologic preinclusion screening, and those with pulmonary disease other than COPD and emphysema arrhythmia valvular or coronary heart disease left ventricle dysfunction obstructive sleep apnea syndrome pulmonary embolism systemic hypertension ≥160/90 mmHg inflammatory disease hyperthyroidism
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Hypoxemic Respiratory Failure Age ≥ 18 years 2. AHRF defined as: A ratio of partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2) between 100 mm Hg while breathing O2 from Venturi mask, or other delivery system that allows quantification of FiO2 such as Mask-NIPPV or HFNC. When no arterial blood gas (ABG) result available, use transcutaneous oxygen saturation measurement (SpO2) to impute PaO2 (Appendix A.2 for Table of PaO2 / FiO2 imputed from SpO2 [Brown 2017]. If no oxygenation data prior to use of Mask-NIPPV or HFNC are available, then P/F ratio 100 on Mask-NIPPV or HFNC meets this criterion. 3. Respiratory rate (RR) ≥24 /min and/or subjective shortness of breath (Modified Borg Dyspnea Scale ≥ 2) P/F Ratio < 100 (Severe ARDS) on quantifiable FiO2 2. More than 24 hours has elapsed since the patient met for AHRF (Inclusion #2 and 3, above) 3. Urgent need for intubation for intubation: i. RR>40 ii. Lack of improvement of respiratory muscle fatigue iii. Copious tracheal secretions that require frequent suctioning iv. Acidosis with a potential Hydrogen (pH) <7.35 v. Acute hypercarbia (PaCO2 > 45 mm Hg) vi. SpO2 < 88% for more than 5 minutes despite FiO2 and non-invasive support vii. Respiratory or cardiac arrest viii. Glasgow Coma Scale ≤ 8 4. Contraindication to HFNC, Helmet-NIPPV, or Mask-NIPPV 5. Upper airway obstruction, facial trauma 6. Copious secretions, airway bleeding, epistaxis or vomiting 7. Primary cause of respiratory failure is exacerbation of chronic obstructive pulmonary disease (COPD) or asthma 8. Elevated intracranial pressure >20 mm Hg 9. Home mechanical ventilation except for CPAP/BiPAP used solely for sleep disordered breathing 10. Persistent hemodynamic instability (systolic blood pressure (SBP)<90 or mean arterial pressure (MAP)<60 despite IV fluid resuscitation, or norepinephrine dose > 0.1 mcg/kg/min or equivalent vasopressor dose) 11. Plan for procedure during which NIPPV or HFNC is contraindicated. Okay to enroll if procedure is complete and AHRF persists within 24 hours. 12. Absence of airway protective gag reflex or cough 13. Tracheostomy 14. Lack of informed consent 15. Pregnancy 16. Actual body weight exceeding 1 kg per cm of height 17. Diffuse alveolar hemorrhage 18. Severe acute pancreatitis as etiology for hypoxemia 19. Recent upper gastrointestinal surgical anastomosis within the past 30 days 20. Enrollment in another clinical trial within the past 30 days 21. Unsuitable for non-invasive ventilation in the judgment of the treating MD 22. Decision to withhold life-sustaining treatment. Patients with Do-Not-Resuscitate (DNR) or No Cardiopulmonary resuscitation (No CPR) order may be enrolled. 23. Do not intubate order
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 12.0-999.0, Complication of ERCP Those more than or equal to 12 years of age undergoing diagnostic or therapeutic ERCP between 1st August 2018 to 31st July 2019 either for the first time or after a previous failed cannulation attempt Surgically altered anatomy of Upper GI tract Failure of endoscopist to reach second part of duodenum due to pyloroduodenal obstruction despite endoscopic attempts to relieve the obstruction (e.g., balloon dilatation of stricture) Those undergoing side-viewing endoscopy only with or without ampullary biopsy Those undergoing stent removal without any biliary/pancreatic endotherapy Repeat biliary endotherapy (e.g., stent exchange, second attempt at difficult stone removal) without pancreatic endotherapy Repeat pancreatic endotherapy without biliary endotherapy Immunodeficiency (primary or secondary) Pregnancy
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Heart Valve Diseases The patient must give Informed Consent before being enrolled in the study Only elective cases will be eligible for inclusion. For mitral disease, patients were recruited with Severe degenerative or functional mitral regurgitation with the need for MVR according to the ESC/EACTS guidelines Degenerative mitral regurgitation symptomatic patients with LVEF >30% and LVESD < 55mm (I B) asymptomatic patients with LV dysfunction (LVESD ≥45 mm and/or LVEF ≤60% (I C) asymptomatic patients with LVEF > 50%, new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary pressure at rest >50 mmHg) (IIa C) patients with severe LV dysfunction (LVEF < 30% and LVESD > 55 mm) refractory to medical therapy with high likelihood of durable repair and low comorbidity. (IIa C) Functional mitral regurgitation patients with severe MR (EROA >= 20 mm², Regurgitation volume > 30 ml) undergoing CABG, and LVEF >30% (I C) patients with moderate MR undergoing CABG (IIa C) Inability or unwillingness to give formal consent Emergency interventions Active infective valvular disease or evidence of valvular damage by recent endocarditis Valvular malfunction directly associated with aortic root disease Aortic regurgitation as leading aortic valve pathology Inability or unwillingness to complete follow up MRI contraindications (Implanted pacemaker, Metallic foreign body, Severe claustrophobia) CT contraindications (Known iodine or contrast agent allergy, Hyperhidrosis, Pregnancy)
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 50.0-999.0, Chronic Obstructive Pulmonary Disease Smoking Cessation Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Competent and mature Have diagnosed COPD [spirometry verified and evaluated by pulmonary specialist] Current daily smoker [Minimum 1 cigarette daily] Have smoked minimum 20 pack years (1 pack year = 20 cigarettes daily in 1 year) Want to or try to stop smoking Do not mind taking varenicline or NRT during the trial Are willing to give blood and urine samples according to the protocol Previously included in the trial Hospitalized with COPD-exacerbation within the last 24 months Are associated with hospital outpatient clinic for COPD disease treatment Have FEV1<50% Pregnancy/breastfeeding Life expectancy less than 1 year Severe linguistic problems or inability to give informed consent Severe mental illness that is not controlled with medication Active alcohol or substance abuse Active cancer disease* *The person can participate if he or she has had a cancer disease that is now referred to as curative/radically treated. Basal cell carcinoma of the skin does not count as an criterion
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, COPD Exacerbation CHF OSA COPD COPD patients with acute exacerbation (Group I) CHF patients with acute decompensation (group II) stable COPD patients (group III) OSA patients with AHI>15 (group IV) Other severe acute diseases that contradict the participation in a clinical trial Simultaneous participation in another clinical trial Not capable of giving consent Language abilities and other disabilities that contradicts the understanding or completing of a clinical questionnaire
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2
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Elevated Left Atrial Pressure Patients aged of 18 years or more Scheduled for an elective cardiac surgery at the Montpellier University Hospital Requiring a pulmonary arterial catheter monitoring due to the complexity of cardiac surgery or severe cardiopulmonary comorbidities Failure of the pulmonary artery catheterization Failure of PCWP measurement Failure of TEE measure of the left upper pulmonary vein diameter and collapsibility Refusal to participate expressed secondarily. Non-inclusion Cardiac transplantation Left ventricule assist device Pulmonary vein stenosis Contraindications to TEE or PAC Refusal to participate Patient under juridical protection
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2
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 2.0-999.0, Atrial Septal Defect age≥2yrs, diameter of defect≥5 mm, central ASD with increased volume load of right heart. 2. edge of defect is ≥5 mm from coronary sinus, superior and inferior vena cava, and pulmonary vein, and≥7 mm from atrioventricular valve. 3. diameter of atrial septal > left-atrium-side diameter of occlude. 4. participants or guardians who can understand the purpose of this trial and voluntarily participate in and sign the informed consent form Primary atrial septal defect. 2. Sinus venosus atrial septal defects. 3. Accompany with endocarditis or hemorrhagic risks. 4. thrombosis in targeting area or venous thrombosis in inserting site. 5. severe pulmonary artery hypertension generated right-to-left shunt. 6. severe myocardial or valve disease unrelated with ASD. 7. suffered infection diseases or developing infection diseases within 1 month, thrombosis in left atrium or left appendage, part or total anomalous pulmonary venous drainage
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1
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive All patients who were continuously insured by the sickness fund for the entire period (01/01/2013-30/06/2018) or, in case a patient deceased after index date, for the time until death A patient will be included as an incident COPD patient if either a hospital documented at least one COPD diagnosis (International Statistical Classification of Diseases and Related Health Problems (ICD-10 J 44.-) or a specialist (pneumologist) documented at least 2 confirmed COPD diagnoses (above ICD-10) code) in two different quarters; the first of the above diagnoses is defined as index diagnosis; period is defined as lasting from 01/01/2014 until 30/06/2017 Patients should not have received any COPD diagnosis (ICD-10 J44.-) or any COPD-associated medication in the 12 months pre-index period Patient should have, at date of incident COPD diagnosis (index date), an age of at least 40 years Patients received , at least one confirmed inpatient asthma diagnosis or two confirmed outpatient diagnoses of asthma (ICD-10: J45) by pneumologists
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Renal Transplant Failure renal transplant patients at VGH undergoing donation after circulatory death (DCD) and donation after brain death (DBD) kidney transplants years of age able to provide consent Patients that are unable to understand the purpose of the study or cannot give written consent will be excluded Moreover, patients with contraindications to PDE5 inhibitors will be excluded from the study. PDE5 inhibitors are generally well tolerated, even in patients with severe renal disease, those on dialysis, and in transplant recipients. Patients will be excluded if they are taking nitrates of any form (contraindication), are allergic to sildenafil or any of the ingredients of this medication, are on an alpha-adrenergic blocker (potential risk) patients currently on any experimental drug in the last 3 months (confounding factor)
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Extubation Failure High-Risk Patients: Patients under mechanical ventilation for more than 24 hours considered at high risk according to the presence of more than 3 of the following risk factors >65 years Cardiac failure as the primary indication of mechanical ventilation Moderate to severe chronic obstructive pulmonary disease II >12 points the extubation day Body mass index >30 Inability to manage respiratory secretions Not simple weaning More than 1 comorbidity More than 7 days under mechanical ventilation <18 years Thacheotomized patients Contraindications for NIV (recent facial or cervical trauma/surgery, active gastro-intestinal bleeding, lack of cooperation) Unscheduled extubation Do not reintubate orders No informed consent
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 40.0-70.0, Chronic Obstructive Pulmonary Disease (COPD) Age 40-70 Diagnosed with COPD Emphysema on chest CT FEV1 between 35 and 80 % Screened for PH by echocardiography side effect for exercise side effect for MRI and contrast agent injection Pregnancy or breastfeeding Refusing to be informed of the discovery of an anomaly on chest MRI
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-18.0, Congenital Heart Disease Pulmonary Arterial Hypertension Age 0-18 years Patients with Pulmonary Arterial hypertension: diagnosis confirmed according to the standards of the National Expertise Center for PH in childhood Patients with CHD with an abnormally loaded right ventricle including tetralogy of Fallot (TOF), pulmonary (valve) stenosis (PS), pulmonary insufficiency (PI), atrial septal defect (ASD), ventricular septal defect (VSD) and total anomalous pulmonary venous return (TAPVR): diagnosis confirmed by echocardiography or cardiac MRI in UMCG-CCH Age >18 years Not familiar with Dutch language Pregnant Concomitant musculoskeletal disease No echocardiography available within three months before or after blood collection Being under examination for non-diagnosed disease at time of investigation
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease COPD COPD Exacerbation COPD Exacerbation Acute confirmed diagnosis of Chronic Obstructive Pulmonary Disease according to Global Association for Obstructive Lung Disease stage II to IV the ability to follow the rehabilitation protocol provided written informed consent current primary diagnosis of asthma
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-999.0, Pulmonary Hypertension Right heart catheterization for PH diagnosis in Giessen informed consent missing
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-80.0, Heart Failure, Diastolic (HFpEF) HFpEF, stable medication for at least 4 weeks instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Respiratory Distress Syndrome, Adult Acute respiratory distress syndrome (ARDS) Emphysema Asthma Pneumothorax Oxygen saturation ≤ 88% Severe shock Ventricular arrhythmia Myocardial ischemia. -
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 30.0-100.0, Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Pulmonary Fibrosis Hypoxemia Dyspnea Oxygen Inhalation Therapy Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged greater or equal to 30 years old Require Long Term Oxygen Therapy between 1 L/min and 4 L/min while at rest Have a peripheral blood saturation level above 80% with room air while seated Tolerate breathing while seated in room air Diagnosed with one of the following respiratory diseases: COPD (40% < Forced Expiratory Volume (FEV1) < 80% confirmed from pulmonary function test (PFT) within the last year), ILD (Confirmed with radiographic imaging), PH (Confirmed with radiographic imaging) Normal heart rate and blood pressure (Resting Heart Rate <120 bpm, Systolic BP <180 mmHg, Diastolic BP <100mmHg) PFT taken in the last three months Pregnancy or lactation Exacerbation that has resolved within the past 28 days Treatment with another investigational drug or other intervention within three months Has any of the following: unstable angina, recent revascularization, recent history of cerebrovascular accident
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 55.0-999.0, Pulmonary Disease, Chronic Obstructive Diagnosed with COPD [based on ICD-10 code(J43.x-44.x except J430), as the primary or within the fourth secondary diagnosis and initiated LAMA or ICS/LABA more than twice a year from Jan 1, 2005 to Apr 30 2016] Age >55 years old Prescription history with any long acting bronchodilator for maintenance therapy (the patient should be inhaler naïve) Prescription history with ipratropium bromide Prescription history with Leukotriene receptor antagonist(LTRA) or ICS Patients with lung cancer, IPF, ILD or lung transplantation at the time of COPD diagnosis
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Metabolic Disease Diabetic: antecedent treatment or glycemia> = 1.26 g / dl or HbA1C> = 6.5% and or Obese: BMI> = 30 and or Metabolic syndrome defined AND Patient having given written consent to participate in the study or collection of the consent of the witness Social insured patient (excluding AME) Patient willing to comply with all procedures of the study and its duration AND Patient also presenting a pathology among Cardiology Unscheduled hospitalization less than 3 months old Ongoing treatment Cytotoxic chemotherapy Radiotherapy HIV and / or HCV and / or active HBV infection OMS score> = 2 Pregnant woman
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 5.0-12.0, ASD Child Behavior Problem Child is age 5 through 12 years 11 months 2. Diagnosed with autism spectrum disorder (ASD) and receives care for ASD at the Children's Hospital of Philadelphia (CHOP) in Developmental and Behavioral Pediatrics (DBP) or Child Neurology, or in Department of Child and Adolescent Psychiatry and Behavioral Sciences (DCAPBS) 3. Child exhibits disruptive behaviors characterized by tantrums, outbursts, self-injurious, or aggressive behaviors with a Clinical Global Impression severity (CGI-S) for the disruptive behavior of at least 4 4. A caregiver completed Aberrant Behavior Checklist (ABC-2) Irritability subscale score is greater than 13 5. A parent of the child who is involved in coordinating the child's care will also participate as a research subject Child requires crisis intervention or urgent psychiatric consultation 2. Referring physician or psychologist will not be providing ongoing management of the child's behavioral challenges. 3. Parent needs a different intervention or type of assistance than will be available through the study 4. Families who live outside a 40 mile radius from the Children's Hospital of Philadelphia (CHOP -main)
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 65.0-999.0, CHF - Congestive Heart Failure COPD Pneumonia Age 65 years and older Admitted from home with Pneumonia OR with a history of HF or COPD with symptoms of HF or COPD exacerbation or whose symptoms suggest a new HF or COPD diagnosis English and non-English speaking, able to respond to questions Reachable by telephone after discharge Resides within the geographic service area Consent to participation Enrolled in Medicare's Hospice or End-Stage Renal Disease programs Presence of active and untreated psychiatric conditions (ICD10: F10-F29) Long-term care resident Undergoing active cancer treatment Currently enrolled in another RCT
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Systolic Heart Failure Stage D (Disorder) Mitral Regurgitation aged 18 years or older acute decompensated heart failure due to severe left ventricular systolic dysfunction combined with hemodynamically significant mitral regurgitation. Severe systolic dysfunction and hemodynamically significant mitral regurgitation are defined as left ventricular ejection fraction less than 35% and mitral regurgitant volume more than 45 ml (more than moderate degree), respectively cancer or other significant co-morbid diseases with expected life span less than 3 years adverse effects of hydralazine surgical interventions of mitral regurgitation will be done in follow-up period which change the course of native condition other valvular conditions other than mitral regurgitation with severity more than or equal to moderate degree, particularly mitral stenosis, and aortic regurgitation/stenosis lack of written informed consent
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-21.0, Supraventricular Tachycardia Weight >15 kg 2. Age < 21 years old 3. Simple CHD acceptable to enroll (Table 1): Table 1. Diagnoses in Adult Patients with Simple Congenital Heart Disease Isolated congenital aortic valve disease Isolated congenital mitral valve disease (eg, except parachute valve, cleft leaflet) Small atrial septal defect Isolated small ventricular septal defect (no associated lesions) Mild pulmonary stenosis Small patent ductus arteriosus Repaired conditions Previously ligated or occluded ductus arteriosus Repaired secundum or sinus venosus atrial septal defect without residua Additional mechanism(s) for SVT in addition to AV nodal reentry tachycardia. 2. Moderate or Complex Congenital Heart Disease, see tables 2 and 3. Table 2. Diagnoses in Adult Patients with Congenital Heart Disease of Moderate Complexity Aorto-left ventricular fistulas Anomalous pulmonary venous drainage, partial or total Atrioventricular septal defects (partial or complete) Coarctation of the aorta Ebstein's anomaly Infundibular right ventricular outflow obstruction of significance Ostium primum atrial septal defect Patent ductus arteriosus (not closed) Pulmonary valve regurgitation (moderate to severe)
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive The study cohort will all patients who initiate Tiotropium/ Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period The following will then be applied to generate the unmatched cohort Aged <40 years on cohort entry Any LAMA, LABA, or ICS maintenance therapy (alone or in combination) during the 180-day baseline period prior to cohort entry for maintenance treatment and duration >30 days, or any prescription within the 30 days prior to cohort entry Patients without continuous enrolment (days since first inpatient/ outpatient encounter in the data) during the baseline period No prior diagnosis of COPD [International Classification of Diseases (ICD)-10: J41*, J43*, J44* and doubt (UTAGAIFLG) = 0 (no)] Patients without a second prescription claim of their index medication within 60 days after the cohort entry date Diagnosis of asthma [ICD-10: J45* and doubt (UTAGAIFLG) = 0 (no)] during the baseline period Diagnosis of lung cancer [ICD-10: C34*, D02.2, Z80.1, Z85.1 and doubt (UTALAIFLG) = 0 (no)] or lung transplant (Health claim code: 150317670, 150322510, 150322610, 150336510, 150336610, 150336710, 150399270) prior to the cohort entry date using all available data Patients who initiate both Tio/Olo and Tio simultaneously on the cohort entry date
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2
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 50.0-999.0, Cancer Survivor Age 50 years or older Residing in Bernalillo or Sandoval County, New Mexico Diagnosed with an invasive cancer (any type) Completed primary treatment (surgery, radiation, chemotherapy)(note: endocrine therapy is allowed) Able to read, speak, and understand English (The future larger trial will Spanish-Speaking participants) Not told by a physician to limit physical activity and no pre-existing medical condition(s) that would preclude home gardening, e.g., severe orthopedic conditions, hip or knee replacement surgery within 6 months), end-stage renal disease, paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of myocardial infarction, congestive heart failure, or pulmonary conditions that required oxygen or hospitalization within 6 months Currently not adhering to the recommended number of fruit and vegetable servings per day (consuming fewer than 5 servings of vegetables and fruits/day and not meeting the recommended guidelines for moderate-to-vigorous physical activity (< 150 minutes/week) Reside in a location that can accommodate a 4' x 8' raised garden bed or 4 (29" x 14") garden containers, or adequate (at least 4 hours) of sunlight per day and have access to running water No existing or recent (within the past year) experience with vegetable gardening Able to participate in the 10-month intervention (all three seasonal gardens; from mid-February through early November 2020)
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-60.0, Postural Tachycardia Syndrome Orthostatic Intolerance Physician diagnosis of Postural Tachycardia Syndrome (POTS) Age 18-60 years Male and Female Non smokers Able and willing to provide informed consent Ability to travel to Libin Cardiovascular Institute of Alberta Autonomic Testing Lab at the University of Calgary, Calgary, AB Overt cause for postural tachycardia, i.e., acute dehydration Participants with somatization or severe anxiety symptoms will be excluded Pregnant Inability to tolerate mask for the duration of the study Subjects who require portable oxygen at rest or with exercise Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Hypertension Age ≥ 18 years. 2. Residing in the local administrative area for at least 6 months. 3. Hypertension：defined as systolic blood pressure (SBP) ≥140 mmHg and/or /diastolic blood pressure (DBP) ≥90 mmHg and/or use of antihypertensive medication within two weeks. 4. Informed consent patients under pregnancy or lactation. 2. patients with severe liver or renal diseases. 3. patients with history of malignant tumor. 4. patients with mental illness that impair their consent
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-110.0, Atrial Septal Defect ≥18 years old referred for percutaneous (secundum) ASD closure with right atrial and ventricular enlargement; and/or clinically significant left-to-tight shunt (Qp:Qs≥1.5:1), or evidence of paradoxical embolism (with a TEE defect >10mm) written informed consent TEE defect diameter >30mm rim sizes of < 5 mm to the coronary sinus, inferior vena cava rim, an atrioventricular valve, or the right upper pulmonary vein multiple defects complex congenital heart disease requiring surgical repair within 3 years of device placement Eisenmenger-syndrome recent myocardial infarction < 6 weeks demonstrated intra cardiac thrombi on echocardiography (especially LA or LAA thrombi) unable to have TEE occluded bilateral femoral veins/IVC serious comorbidity with life expectancy <3 years (e.g., non-skin cancers not in remission, advanced renal failure serum creat >160 [Symbol]mol/l)
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 40.0-999.0, COPD Exacerbation Patients of both sexes A diagnosis of COPD made according to the of the American Thoracic Society (ATS) With hypoxemia at rest defined as mean arterial oxygen saturation below 90% Agreed to participate Unstable cardiovascular disease Orthopedic diseases in the upper and lower limbs Being in ICU or use of mechanical ventilation Motor sequelae from a neurological or cognitive impairment that interfere with the evaluation and the treatment Contraindications of electrotherapy
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 8.0-17.0, Suicidal Ideation In order to be eligible to participate in this study, an individual must meet all of the following Participants must be engaged in assessment or treatment in one of the inpatient or outpatient medical health settings from one of the study site hospitals that are part of this protocol Participants must be verbally fluent and have the ability to communicate verbally. This will, in part, be determined by one of the patient s clinicians, who will also be an associate investigator for this study and will already have routine access to information regarding the patient s verbal fluency If the parent/patient expresses interest in participating in a research study, verbal fluency will be further confirmed by asking the parents if the child is verbally fluent (e.g. regularly speaks in sentences), asking the parent if their child will be able to understand and answer the study questions, and by observing the subject as they are explaining the study. The observation will entail taking a verbatim language sample if needed and discussing the decision about whether the child meets this verbal fluency with a study supervisor if needed. The data collectors will be at least high school graduates and over the age of 18 and be trained in assessing fluency level through parent interview and observation. They will also be trained to understand the presentation of individuals with ASD, as well as in how to respond if the child is noncompliant or presents with suicidal thoughts and behaviors Age 8 years to 17 English speaking child and parent; may use an Augmentative and Alternative Communication (AAC) device to assist A legal guardian must provide permission and participant must sign an assent document or provide verbal assent An individual who meets any of the following will be excluded from participation in this study The parent or the legal guardian is unavailable/unwilling to sign consent The participant will not have prisoner status, e.g. not on probation or house arrest OF -Children: Children and adolescents with ASD/NDD are the focus of the study due to the lack of suicide risk screening tools available for this general population. Clients who do not speak English will be excluded from the study. Unfortunately, the screening tools that will be utilized in this study are not available at this time in any other languages besides English. OTHER The study sites health clinic or psychiatric units that serve children, adolescents or adults with ASD/NDD. Currently these sites service suicidal individuals and no validated instrument with which to assess these vulnerable individuals
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 1.5-999.0, Coronavirus Infections Post-exposure Prophylaxis High risk close contact with a confirmed COVID-19 case during their symptomatic period, including one day before symptom onset, within the past 1-7 days. High risk close contact is defined as any of the following exposures without the consistent appropriate use of recommended personal protective equipment: 1. Provided direct care for the index case 2. Had close physical contact with the index case 3. Lived with the index case 4. Had close contact (within 2 metres), without direct physical contact, for a prolonged period of time 5. Had direct contact with infectious body fluids, including oral secretions, respiratory secretions, or stool. 2. Successfully contacted by the study team within 24 hours of study team notification of the relevant index COVID-19 case. This time window is necessary because the efficacy of PEP may be dependent on the timing of its initiation, and because randomization of a ring cannot be delayed while awaiting response from contacts that cannot be rapidly reached. 3. Age ≥6 months, since the safety and pharmacokinetic profiles of LPV/r in pediatric patients below the age of 6 months have not been established. 4. Ability to communicate with study staff in English Known hypersensitivity/allergy to lopinavir or ritonavir. 2. Current use of LPV/r for the treatment or prevention of HIV infection. 3. Receipt of LPV/r in the context of this trial or any other trial of COVID-19 PEP within 2 days or less prior to the last known contact with the index COVID-19 case. The two day time window is intended to ensure that exposure would not have occurred in the presence of clinically relevant drug levels (five times the elimination half-life of LPV/r, which is estimated at 4-6 hours with prolonged use). 4. Baseline respiratory tract specimen positive for COVID-19. Randomized participants whose baseline samples subsequently show COVID-19 will have study drug discontinued but still remain under observation. 5. Current breastfeeding, due to potential for serious adverse reactions in nursing infants exposed to LPV/r 6. Concomitant medications with prohibited drug interactions with LPV/r that cannot be temporarily suspended/replaced, including but not restricted to: 37 alfuzosin (e.g. Xatral®) amiodarone (e.g. Cordarone™) apalutamide (e.g. Erleada™) astemizole*, terfenadine* cisapride* colchicine, when used in patients with renal and/or hepatic impairment dronedarone (e.g., Multaq®) elbasvir/grazoprevir (e.g., ZepatierTM) ergotamine* (e.g. Cafergot®*), dihydroergotamine (e.g. Migranal®), ergonovine, methylergonovine*
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 14.0-80.0, Asthma Chest Syndrome Clinical Anxiety Clinical Depression Lung Function Quality of Life Eosinophilia Nitric Oxide Airway Responsiveness Induced Sputum all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent; 2. the age of more than 14 and less 80 years old, gender and ethnicity are not limited; 3. the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough; 4. no wheezing; 5. a diagnosis of asthma supported by one or more other characteristics bronchial provocation test positive improvement in forced expiratory volume at one second (FEV1) of more than 12% and 200 mL after inhaled salbutamol variability in diurnal peak expiratory flow (PEF) of more than 10% for one day during one week. 6. bronchodilator and glucocorticoid treatment is effective; 7. the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease(GERD), neuromuscular disease, and mental disease can not cooperate with related inspection or for other reasons; 2. patients with chronic obstructive pulmonary disease, interstitial pneumonia, active tuberculosis, community acquired pneumonia, lung cancer, bronchiectasis, cor pulmonale, pulmonary embolism, and accompanied with serious systematic disease (such as coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease, neuromuscular disease, etc); 3. history of drug abuse, alcohol abuse or anesthesia or with a history of mental illness (schizophrenia, obsessive-compulsive disorder, depression) and against personality, motivation, suspicious, or other emotional or mental issues that may affect participation in the study; 4. taking part in other drug clinical trial project, or drop out less than 3 months; 5. during pregnancy, lactation women; 6. obvious abnormal of High Resolution CT
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Dyspnea Primary reason for emergency Department admission is dyspnea Pregnant or breastfeeding women Persons not benefiting from a social security scheme Persons deprived of liberty Patient participates in another study The patient is in a period of determined by a previous study The patient is under legal protection, guardianship or trusteeship Patient refuses to participate It proves impossible to give informed information about the subject matter The patient is not fluent in French
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, COVID Hypoxic Respiratory Failure COVID-19 positive Pneumonia defined as hospitalization for acute (< 7 days) onset of symptoms (cough, sputum production, or dyspnea) Hypoxemia defined as ≥ 2 L/min oxygen Intubation Inability to lie supine
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, COVID-19 Patients >18 years old with nasopharyngeal swab confirmed COVID-19 PCR, CT involvement compatible with COVID, Fever and Dyspnea without hypoxemia Patient who is not willing to enter in study Known hypersensitivity to colchicine Hepatic failure Renal failure with eGFR<20 ml/min
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease confirmed diagnosis of chronic obstructive pulmonary disease including patients with alpha-1 antitrypsin deficiency listed for lung Transplantation or in the Evaluation process for lung transplantation performed a pulmonary rehabilitation program at the reference center patients that discontinued the pulmonary Rehabilitation program due to any reason and could therefore not perform assessement tests at the end of regular Rehabilitation program
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 35.0-999.0, COPD Hypoxia Closed-Loop Communication Dyspnea Anxiety Depression COPD veryfied by Forced Expiratory Volume in 1 sec (Fev1) divided by forced Vital Capacity (FVC)< 0,70 Admission due to exercabation in COPD COPD exacerbation and pneumonia can be included Expeted duration of admission >48 hours Need for oxygen supplementation (SpO2<= 88% in room air) Cognitive able to participate in the study Willing to participate and give informed consent Need or anticipated need for mechanical ventilation ( Intermittent continuous Positive Airway Pressure (CPAP) is allowed) Major comorbidities causing hypoxemia (cancer, heart disease, pulmonary embolia) Asthma or other respiratory conditions requiring higher SpO2 than normal for COPD Pregnancy Cognitive barrierers for participation
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 0.0-999.0, Covid-19 Patient admitted to ICU that is COVID-19 positive based on rt-PCR Ventilated or not ventilated No restrictions on age No restrictions on comorbidities or a diversity of underlying pathology (malignancies, COPD, …) Patients that are not COVID-19 tested (rt-PCR) or where the diagnosis is pending Patients that refuse their participation in the study Patients under legal protection, or deprived of their liberty Patients that are so critically ill that a minimum of 1 follow-up is very unlikely to be realised
|
0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 35.0-999.0, COPD Dyspnea Anxiety Depressive Symptoms Hypoxia Closed-Loop Communication • COPD veryfied by Forced Expiratory Volume in 1 sec (Fev1) divided by forced Vital Capacity (FVC)< 0,70 Admission due to exercabation in COPD COPD exacerbation and pneumonia can be included Expeted duration of admission >48 hours Need for oxygen supplementation (SpO2<= 88% in room air) Cognitive able to participate in the study Willing to participate and give informed consent • Need or anticipated need for mechanical ventilation ( Intermittent continuous Positive Airway Pressure (CPAP) is allowed) Major comorbidities causing hypoxemia (cancer, heart disease, pulmonary embolia) Asthma or other respiratory conditions requiring higher SpO2 than normal for COPD Pregnancy Cognitive barrierers for participation
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0
|
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
|
eligible ages (years): 0.0-999.0, COVID pcr positive for covid -19 who are survived dead patient uncooperative
|
0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Delirium Confusion Mental Status Change Back Pain Hip Pain Chronic Chest Pain Asthma COPD Cellulitis Soft Tissue Infections Cough Deep Vein Thrombosis Pulmonary Embolism Venous Thromboembolism Dyspnea Electrolyte Metabolism Abnormal Fever Failure to Thrive Weakness Protein-Calorie Malnutrition Headache Neck Pain Hypoxia Pneumonia Sepsis Syncope Vomiting Diarrhea Leg Pain Abdominal Pain Age 18 or older Adult patients admitted to General Medicine Services at Brigham and Women's Hospital during the 21-months study data collection period English speakers Patients who were diagnosed with any of the following conditions and symptoms upon admission Abdominal pain Altered mental status/ delirium / confusion Asthma / chronic obstructive pulmonary disease (COPD) Cellulitis / soft tissue infection Chest pain Cough Not pregnant women, prisoners and institutionalized individuals
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2
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
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eligible ages (years): 18.0-999.0, Septal Defect, Atrial Age ≥18 at the time of informed consent signature. 2. Capable of complying with Protocol requirements, including follow-up. 3. An Informed Consent Form signed by Subject or legal representative. 4. Patient has had successful reduction of mitral regurgitation to at most moderate regurgitation post-mitral-clip Remaining mitral regurgitation of ≥ moderate-severe 2. Subject unable or unwilling to provide informed consent 3. Concomitant severe aortic valve disease 4. Dialysis 5. Pregnancy or intent to become pregnant 6. Life expectancy < 1 year 7. Active bleeding 8. Inability to follow up with 6-month timepoint due logistical concerns
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
|
eligible ages (years): 18.0-102.0, Endoscopic Surgery Clinical diagnosis of Gallstone Disease. Must have anatomy of the esophagus of the stomach and duodenum for the introduction of a duodenoscope to the major duodenal papilla The acute form of viral hepatitis of any etiology. Acute decompensated heart failure complicated by respiratory failure
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0
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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone
|
eligible ages (years): 40.0-100.0, COPD Exacerbation Stable COPD (40 years or older with baseline post-bronchodilator forced expiratory volume in 1 s [FEV1]/forced vital capacity [FVC] ≤0.70) will be recruited during their regular follow-up. 2. Control group: age and sex-matched volunteers without previous diagnosis of COPD or 6 other respiratory conditions, and with post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity [FVC]=0.70. 3. Exacerbated patients (patients 48h after being admited in Hospital due to severe COPD exacerbation Patients with renal failure or other severe chronic or acute conditions. 2. Patients with exacerbations in the previous 6 weeks
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0
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