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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, Critically Ill Acute Respiratory Failure A staged enrolment process will be used to identify patients eligible to be enrolled and randomized in the study. At each stage of the enrolment process, a patient must meet and not meet in order to pass. To progress to the next stage, patients must continue to pass from the prior stages. After enrolment, there are also specific tests to perform (with pass/fail criteria) to determine to be randomized. A A1. Age 18 years or older A2. Intubated and receiving any mode of invasive mechanical ventilation ≥ 24 hours A A3. Anticipating withdrawal of life support and/or shift to palliation as the goal of care A4. Severe central neurologic disorder (eg. Hemorrhage, stroke, tumour) causing elevated intracranial pressure, or impaired control of breathing, or requiring specific ventilator adjustments (i.e. To attain specific CO2 target) or requiring neurosurgical intervention A5. Known or suspected severe or progressive neuromuscular disorder likely to result in prolonged or chronic ventilator dependence (eg. Guillain-Barré syndrome, Myasthenia Gravis, ALS, MS, high spinal cord injury, kyphoscoliosis or other restrictive disorder) (Note that obesity hypoventilation syndrome that may be managed with nocturnal non-invasive ventilation is NOT an under A5) A6. Severe COPD: Baseline daytime hypercapnea (pCO2> 50 mmHg) OR GOLD 4 airflow limitation (FEV1<30% predicted) OR MRC class 4 symptoms ("I am too breathless to leave the house" OR "I am breathless when dressing") A7. Broncho-pleural fistula A8. Tracheostomy present at ICU admission for the purpose of chronic or prolonged mechanical ventilation (>21 days). (Note that a patient who was endotracheally intubated for acute respiratory failure and received a tracheostomy during their ICU admission, prior to enrolment, is not excluded under A8) A9. Current enrolment in a confounding study, as assessed by the steering committee
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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, Dynamic T2 Preparation patients with atrial septal defect (ASD) or ventricular septal defect (VSD) and COPD written informed consent patients with ST-elevation contraindication for MRI heavy kidney disease pregnant or breast feeding 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): 18.0-999.0, Atelectasis Pneumonia Acute Respiratory Distress Syndrome Pulmonary Embolism Hypoxemia Dyspnea Hospitalized or visiting the emergency room Will undergo a computed tomographic scan for dyspnea or hypoxemia Poor echogenicity (morbid obesity, multiple thoracic dressings) Contraindications to superior limbs or torso mobilization
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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): 16.0-999.0, Choledocholithiasis Gallstone Migration Cholecystitis Gallstone Pancreatitis Cholangitis Admission through emergency department for an acute gallstone-related condition (cholecystitis, gallstone pancreatitis, ascending cholangitis, suspicion of gallstone migration, choledocholithiasis) Severe sepsis or septic shock contra-indication to surgery previous surgery interfering with common bile duct assessment procedures (roux-en-y gastric bypass, etc.) previous cholecystectomy
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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, Post-ERCP Pancreatitis Any patient undergoing ERCP in whom pancreatic stent placement is planned for post-ERCP pancreatitis prevention, is ≥ 18 years old, who provides informed consent, AND: Has one of the following: 1. Clinical suspicion of or known sphincter of Oddi dysfunction 2. History of post-ERCP pancreatitis (at least one prior episode of pancreatitis after ERCP) 3. Pancreatic sphincterotomy 4. Pre-cut (access) sphincterotomy (freehand pre-cut and septotomy) 5. Difficult cannulation: cannulation duration ≥ 6 minutes (starting at time of initial papillary engagement with at least 25% of the time in contact with the papilla) AND/OR ≥ 6 cannulation attempts (defined as sustained contact with papilla lasting at least 1 second). 6. Short-duration (≤ 1 min) balloon dilation of an intact biliary sphincter. Or has at least 2 of the following: 7. Age < 50 years old & female gender 8. History of recurrent pancreatitis (at least 2 episodes) 9. ≥3 pancreatic injections 10. Pancreatic acinarization 11. Pancreatic brush cytology Ampullectomy 2. Cases in which a pancreatic stent must be placed for therapeutic intent 3. Unwillingness or inability to consent for the study 4. Pregnancy 5. Breast feeding mother 6. Standard contraindications to ERCP 7. Allergy to Aspirin or NSAIDs 8. Known renal failure (Cr > 1.4 mg/dl) 9. Ongoing or recent (within 2 weeks) hospitalization for gastrointestinal hemorrhage 10. Ongoing or recent (within 1 week) hospitalization for acute pancreatitis 11. Known chronic calcific pancreatitis 12. Pancreatic head malignancy 13. Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas divisum (no manipulation of minor papilla) 14. ERCP for biliary stent removal or exchange without anticipated pancreatogram 15. Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram 16. Anticipated inability to follow protocol 17. Absence of rectum
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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, Open Wound of Abdominal Wall With Complication Reoperation Age over 80 years Generalised malignant decease (presence of distant metastases at the time of surgery) COPD (Chronic obstructive pulmonary disease). Grade III-IV according to the GOLD classification (FEV1 < 50% of the expected) Serum Albumin level <20 g/l Sepsis. Infection in combination with two or more of the following: abnormal body temperature, heart rate, respiratory rate or blood gas, and white blood cell count BMI 35-45 (for patients with BMI>45, no additional risk factors are required for inclusion) Hemoglobin <80 g/l Diabetes with secondary complications (angiopathia, nephropathia or neuropathia) and insulin treatment Steroid treatment (with at least 1 mg betamethasone daily or equivalent) for 7 days preoperatively Presence of mesh after previous surgery Presence of incisional hernia Wound length <10 cm Pregnancy Age < 18 years Infected wounds
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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, Congestive Heart Failure Presence of CHF signs and symptoms such as dyspnoea and peripheral or pulmonary oedema requiring diuretic administration (New York Heart Association [NYHA] functional class II-IV); and ejection fraction (EF) under 40% combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure Severe psychiatric disturbance diagnosed by DSM-IV-TR criteria. Any disability that may prevent the subject from completing the informed consent form or other study requirements. Medication or drug dependency or abuse (except for nicotine). Inability to handle the technological devices included in the study, for some other reason
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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, Resident Education and Assessment of Difficult and High Acuity Scenarios That Focus on Cardiac Anesthesia Resident physicians who have completed at least one month of cardiac rotation are included.This high fidelity simulation lab course if offerred to every resident that meets the criteria.This is a part of their educational activity.At the beginning of the course they are given the option to participate in the survey.If they do not wish to participate in the survey it will not affect their education.Participitaion in the survey is purely voluntary Resident physicians that did not wish to participate in filling out the survey or not able to fill out the survey
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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 Hypercapnia Interstitital Lung Disease COPD, ILD Unstable 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, Chronic Obstructive Pulmonary Disease Diagnosis of COPD confirmed according to GOLD score Hypoxemia group: resting arterial paO2 <55 mmHg Normoxemia group : resting arterial paO2 > 67 mmHg Unstable cardiorespiratory status (acute respiratory failure) Oxygen treatment started in a pulmonary rehabilitation program in the last 6 months Anticoagulant treatment
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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, Atrial Septal Defects Ventricular Septal Defects Previous repair for secundum ASD, VSD Other congenital heart disease Chronic lung disease or total lung capacity < 80% of predicted value History of pulmonary embolism
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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): 15.0-999.0, Chronic Obstructive Pulmonary Disease and Allied Conditions Advanced Pulmonary disease using home oxygen therapy; • Have a diagnosis of chronic hypoxemia proven by blood gas analysis on room air PaO 2 ≤ 55 mm Hg or SaO2 ≤ 88; or PaO2 between 55 and 60 mmHg or SaO2 between 89 and 90%, with evidence of pulmonary hypertension, or polycythemia (hematocrit> 55%) as GOLD Global Obstructive Lung Disease, 2015 No records found Patients who failed to perform the periodic reviews established by the team responsible
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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 Arterial Hypertension Adult patients Patients with Pulmonary Arterial Hypertension (idiopathic, heritable or due to anorexigens) Prevalent cases of pulmonary artery hypertension (≥ 6 months) confirmed by right heart catheterism Stable for at least 3 months Written consent Patients unable to proceed with six-minute walk test or CPET, or with contra-indication to exercise evaluation (syncope, low cardiac index, etc) Exercise induced abnormality (evaluated during the initial CPET) precluding to further evaluation
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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): 50.0-75.0, Heart Failure, Diastolic Diastolic Heart Failure Hypertension ALL estimated glomerular filtration rate (eGFR) > 60 ml/min preserved left ventricular ejection fraction (>= 50%) on echocardiography coronary artery disease diabetes mellitus contraindications to cardiac magnetic resonance imaging (CMR) weight >350 lbs inability to lie flat for imaging anemia contraindications to regadenoson or aminophylline normal cardiac structure and function on echocardiography BP < 140/90 known cardiovascular disease, cardiac risk factors or use of cardiac medications
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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): 20.0-999.0, Choledocholithiasis All of followings: 1. Any of following indications for ERCP ① Common bile duct stone ② Gallstone pancreatitis ③ Obstructive jaundice due to malignancy (ex. Pancreas cancer, bile duct cancer, ampulla of Vater cancer) ④ Common bile duct invasion metastasis of other organ malignancy (ex. Hepatocellular carcinoma with bile duct invasion, metastatic lymphadenopathy with bile duct invasion from malignancy other than pancreaticobiliary malignancy) ⑤ Benign biliary stricture 2. Naïve papilla 3. Aged over 20 years Any of followings: 1. History of endoscopic retrograde cholangiopancreatography 2. Altered gastric and duodenal anatomy due to intra-abdominal surgery (ex. Billroth gastrectomy, total gastrectomy) 3. Patients with severe infection or hemodynamic unstable (ex. septic shock, intubation, ventilator, inotropics) 4. Recent myocardial infarction (within 6 months) or uncontrolled arrhythmia, unstable angina, or congestive heart failure 5. Severe neurologic disease 6. Patients with possible prone position (ex. severe abdominal pain, severe abdominal distension, large amount of ascites, recent intra-abdominal surgery, neck surgery, intra-abdominal catheter insertion, severe obesity)
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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, Nausea Emesis Elective surgery Age 18-99 Patients who are capable to provide informed consent and answer questions in English For FA patients: Planned neuraxial anesthesia + nerve block for postsurgical analgesia For TSA patients: Planned brachial plexus nerve block + either general anesthesia or IV sedation Incapable to provide informed consent Contraindications for regional or LMA anesthesia (anticoagulation, infection at injection site) Anticipated difficult airway Body mass index>35 Anticipated surgical procedure time less than 1 hour or more than 4 hours History of severe postoperative nausea and/or vomiting American Society of Anesthesiologists physical status classification >3 Neuropathy Pregnant or nursing women Chronic opioid use (daily use of opioids one month prior to surgery/ patients requiring chronic pain interventions)
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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, Aortic Stenosis Severe, degenerative AS, defined as: 1. mean aortic valve gradient ≥40 mm Hg OR Vmax ≥4 m/sec AND 2. calculated aortic valve area ≤1.0 cm2 OR aortic valve area index ≤0.6 cm2/m2 2. Symptomatic AS, defined as a history of at least one of the following: 1. dyspnea that qualifies at New York Heart Association (NYHA) class II or greater 2. angina pectoris 3. cardiac syncope 3. The Heart Team, including at least one cardiothoracic surgeon and one interventional cardiologist, deem the patient to be reasonable for transfemoral TAVR with a commercially available bioprosthetic valve 4. The Heart Team agrees that the patient is low-risk, quantified by an estimated risk of ≤3% by the calculated STS score for operative mortality at 30 days; AND agrees that SAVR would be an appropriate therapy if offered. 5. The Heart Team agrees that transfemoral TAVR is anatomically feasible, based upon multislice CT measurements 6. Procedure status is elective 7. Expected survival is at least 24 months For the bicuspid cohort only: 8. Aortic Stenosis of a bicuspid aortic valve Concomitant disease of another heart valve or the aorta that requires either transcatheter or surgical intervention 2. Any condition that is considered a contraindication for placement of a bioprosthetic aortic valve (e.g. patient requires a mechanical aortic valve) 3. Aortic stenosis secondary to a bicuspid aortic valve (except for the bicuspid valve cohort) 4. Prior bioprosthetic surgical aortic valve replacement 5. Mechanical heart valve in another position 6. End-stage renal disease requiring hemodialysis or peritoneal dialysis, or a creatinine clearance <20 cc/min 7. Left ventricular ejection fraction <20% 8. Recent (<6 months) history of stroke or transient ischemic attack 9. Symptomatic carotid or vertebral artery disease, or recent (<6 weeks) surgical or endovascular treatment of carotid stenosis 10. Any contraindication to oral antiplatelet or anticoagulation therapy following the procedure, including recent or ongoing bleeding, or score >3 11. Severe coronary artery disease that is unrevascularized 12. Recent (<30 days) acute myocardial infarction 13. Patient cannot undergo transfemoral TAVR for anatomic reasons (as determined by supplemental imaging studies); this would inadequate size of iliofemoral access vessels or an aortic annulus size that is not accommodated by the commercially available valves 14. Any comorbidity not captured by the STS score that would make SAVR high risk, as determined by a cardiothoracic surgeon who is a member of the heart team; this includes: 1. porcelain or severely atherosclerotic aorta 2. frailty 3. hostile chest 4. IMA or other conduit either crosses midline of sternum or is adherent to sternum 5. severe pulmonary hypertension (PA systolic pressure > 2/3 of systemic pressure) 6. severe right ventricular dysfunction 15. Ongoing sepsis or infective endocarditis 16. Recent (<30 days) or ongoing bleeding that would preclude treatment with anticoagulant or antiplatelet therapy, including recent gastrointestinal bleeding 17. Uncontrolled atrial fibrillation (resting heart rate >120 beats per minute) 18. Severe chronic obstructive pulmonary disease, as demonstrated by forced expiratory volume (FEV1) <750 cc 19. Liver failure with Childs class C or D 20. Pre-procedure shock, inotropes, mechanical assist device, or cardiac arrest 21. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures 22. Known allergy to warfarin or aspirin
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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, Congenital Heart Defects Tetralogy of Fallot Double outlet right ventricle Transposition of the great arteries with atrial or arterial switch Treated or untreated pulmonary valvular or pulmonary artery stenosis Reduced right ventricular function after correction of atrial septal defect (ASD), atrio-ventricular septal defect (AVSD) or ventricular septal defect (VSD) (≤40%) Ebstein anomaly Patients with a systemic right ventricle like d-transposition of the great arteries (d-TGA) with previous atrial switch operation or cc-TGA Inability to participate in a 3-month training program in Bern New York Heart Association class ≥ III Ventricular function ≤30% of either the systemic or the sub-pulmonary ventricle Moderate to severe LV outflow tract obstruction (valvular, subvalvular, due to asymmetric septum hypertrophy, or aortic coarctation) with mean gradient >30 mmHg by echo Severe RV outflow tract obstruction with peak gradient ≥60 mmHg by echo Moderate to severe pulmonary hypertension with mean pulmonary artery pressure≥40 mmHg Resting saturation at ambient air of <90% Pacemaker or Implantable Cardioverter Defibrillator Contraindication to perform a CMR (cerebral clips, iron-containing body implants, medical pumps) Recent episode of ventricular tachycardia
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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): 25.0-45.0, Hypoxia Bone Resorption Physically and mentally healthy subjects Body mass index < 25 kg/m2 Height 158 Waist circumference < 94 cm Volunteers that are able to declare their willingness to participate in the entire study Willing to be assigned randomly to the three groups Successfully passing the psychological and medical screening competent to sign informed consent Slovenian social insurance English language fluency Medication required that may interfere with the interpretation of the results Bone mineral density (as measured by DEXA) more than 1.5 standard deviations < t score Recent sub-standard nutritional status Family history of thrombosis or positive response in thrombosis screening procedure. (Biochemical analysis of the following parameters: ATIII, High sensitive C-reactive protein, S-Akt., Factor V-Leiden, Prothrombin, Lupus-partial thromboplastin time, Factor II) History of: thyroid dysfunction, renal stones, diabetes, allergies, hypertension, hypocalcemia, uric acidaemia, lipidaemia, or hyperhomocysteinaemia Gastro-esophageal reflux disease or renal function disorder, Hiatus hernia History of medical illness Smoker within six months prior to the start of the study Abuse of drugs, medicine or alcohol Participation in another study up to two months before study onset
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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, Pulmonary Edema Respiratory Distress Syndrome Patient with compatible episode with acute edema (tachypnea with respiratory rate> 25/min and/or oxygen saturation on room air <90%, auscultation, dyspnea, sudden onset of symptoms) Vital signs of distress requiring intubation tracheal immediately Myocardial infarction lower seat with extension to the right ventricle, in the acute phase
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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 Vascular Disease Male or female subjects with ventricular septal defect (VSD) repair at least 6 months before study enrolment No discrimination in type of VSD repair will be made (percutaneous or surgical) Subjects must be able to perform exercise testing Other congenital heart disease PAH of any aetiology other than VSD in other treatment protocols Impairment of organic function (renal, hepatic) Arterial hypotension (systolic blood pressure < 85 mmHg) Anaemia (Hb < 10 g/dl) Thrombocytopenia (< 50000/µl) Significant valvular disease, other than tricuspid or pulmonary regurgitation Chronic lung disease or total lung capacity < 80% of predicted value History of pulmonary embolism
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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, Langerhans Cell Histiocytosis proven diagnosis of pulmonary Langerhans cell histiocytosis based on histopathological or clinical and radiological findings lung transplantation cognitive or musculoskeletal disorders that preclude exercise test severe or decompensated heart 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): 20.0-100.0, Acute Biliary Pancreatitis Patients with age ≥ 20 years and acute biliary pancreatitis concomitant with either signs of acute cholangitis or bile duct obstruction will be enrolled in the study. They will be randomized into two treatment groups (sphincterotomy vs. balloon dilation). Patients diagnosed with acute gallstone pancreatitis and fulfill any two items from a to c, plus one item in d, and e: 1. abdominal pain typical of pancreatitis; 2. elevation of serum amylase and/or lipase up to three times above normal; 3. imaging studies (abdominal ultrasound or abdominal computed tomography) showed evidence of pancreatitis 4. common bile duct stones, acute cholangitis (Charcot's triad), total bilirubin (total bilirubin)> 4mg / dL, bile duct dilatation (diameter> 6mm with intact gallbladder, or> 10mm when the gallbladder has been removed) plus total bilirubin 1.8 ~ 4mg / dL; 5. other causes of acute pancreatitis septic shock serious coagulopathy (international normalized ratio 1.5, partial thromboplastin time greater than twice that of control, platelet count <50 x 1000 / Cumm) malignant tumors of the biliary and pancreatic tract severe cardiovascular or mental illness which can not cooperate with the exam and treatment pregnant women patient who had ever received surgery or endoscopic treatment for biliopancreatic tract
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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, Congestive Heart Failure FOCUS 1. Remotely monitored with CRT-CIED focus groups 1 & 2: implant ≤ 12 months focus groups 3 & 4: implant ≥ 12 months 2. Current patient of PPG-Cardiology 3. History of HFrEF (heart failure in the setting of reduced ejection fraction) 4. Access to computer and internet 5. *Ability to provide informed consent 6. *Age ≥ 18 years and 6 must apply to caregivers, partners, and/or support persons Not remotely monitored with CRT-CIED 2. Not current patient of PPG-Cardiology 3. No history of HFrEF 4. Pacemaker dependent 5. Does not have access to computer and internet 6. *Inability to provide informed consent 7. *Age < 18 years 8. *Does not meet Only 6, 7, and 8 apply to caregivers, partners, and/or support persons TRIAL 1. Remotely monitored with Biotronik CRT-CIED for more than 60 days 2. Ability to provide informed consent 3. Age ≥ 18 years 4. Willing to have MyChart or proxy to MyChart 5. Current patient of PPG-Cardiology 6. History of HFrEF Do not have a Biotronik CRT 2. Have a Biotronik CRT-CIED for less than 60 days 3. Not being remotely monitored with a Biotronik CRT-CIED 4. No history of HFrEF 5. Inability to provide informed consent 6. Age < 18 years 7. Lack of internet access or otherwise unable to access MyChart 8. Pacemaker dependency 9. Does not meet
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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, Hypoxia COPD Hyperoxia Age >18 years 2. Currently on or eligible for LTOT for respiratory failure LTOT flow rate ≥4 litres per minute 2. Exacerbation of underlying lung disease in the past 4 weeks 3. Inability to understand English 4. Significant co-morbidities 5. Patients who lack capacity to consent 6. Pregnancy
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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, Chronic Obstructive Pulmonary Disease Hospitalized adult patient with (clinically dominant in the case of multiple co-morbidities eg. absence of overt lobar pneumonia or acute congestive heart failure or alternate diagnosis such as acute coronary syndrome or pulmonary embolism) Diagnosis of severe COPD (post bronchodilator FEV1 <50%, FEV1/FVC ratio <0.7) made by standard spirometry within previous 12 months or within three days of admission if previous PFT data is not available Age >40 years >10 pack year smoking history At least one COPD exacerbation in the previous 12 months before enrollment, defined by having had documented inpatient or outpatient treatment by physician with antibiotics and/or prednisone for physician diagnosed COPD exacerbation Expected to live > 12 months Known severe hypersensitivity to immunoglobulin or its components (anaphylaxis) Underlying malignancy (including chronic lymphocytic leukemia) History of hematopoietic stem cell transplant or solid organ transplant Current treatment with a biological therapy for other conditions Concomitant significant immunodeficiency or on immunosuppressive treatment other than for COPD Alpha-1 antitrypsin deficiency Significant proteinuria (dipstick proteinuria ≥ 3+ or known urinary protein loss ≥ 2 g/day or nephrotic syndrome) and/or has acute renal failure and/or severe renal impairment (creatinine more than 2.5 times the upper limit of normal and/or on dialysis) IgA deficiency (IgA <0.1 g/L) Immunoglobulin therapy in the last 12 months or on current Ig therapy or have a clinical indication for Ig replacement therapy (www.nacblood.ca/resources/guidelines/IVIG.html) Obesity (BMI ≥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, Heart Defects, Congenital Pulmonary Arterial Hypertension Genetic Testing Previous diagnosis of secundum atrial septal defect (ASD) or ventricular septal defect (VSD), with or without repair Development of PAH, defined as mean PAP ≥ 25 mmHg by right heart catheterization, in combination with a pulmonary wedge pressure of ≤ 15 mmHg and a PVR (pulmonary vascular resistance) of > 3 Wood units Preferably, families with congenital shunt lesions (at least three family members affected with ASD or VSD) will be considered for Other congenital heart disease Mental retardation Dysmorphic characteristics Chronic lung disease or total lung capacity < 80% of predicted value History of pulmonary embolism
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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, Cystic Fibrosis Cystic Fibrosis as documented by clinical features, and documentation of a positive sweat test or two disease causing mutation of the CF gene use of supplemental oxygen, FEV1 < 40% predicted, inability to discontinue inhaled antibiotics for 4 weeks hospitalization within 4 weeks prior to enrollment change in maintenance CF therapies within 4 weeks of enrollment severe anemia, significant chronic liver disease, severe pulmonary hypertension, prior organ 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): 18.0-95.0, Atrial Fibrillation Ischemic Heart Disease Congestive Heart Failure Patients are included from the in-patient department of the Department of Cardiology, Hvidovre University Hospital. Patients are eligible for if diagnosed with one of the following diseases myocardial infarction atrial fibrillation heart failure Patients must not suffer from one of the follwing conditions malignant disease diabetes mellitus types I or II have a life expectancy of at least 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): 18.0-999.0, Hypoxemia Hypoxemic respiratory failure Cardiac or respiratory arrest
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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): 20.0-70.0, Protein-energy; Imbalance Both sexes aged between 20-70 years Received stable hemodialysis at least 3 months Written informed consent Patients with malignant disease, acute infectious disease, inflammatory disease (such as collagen disease), advanced liver disease, and those taking any type of immunosuppressive medication are 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): 20.0-80.0, Obstructive Sleep Apnea Non-alcoholic Fatty Liver Disease symptoms of obstructive sleep apnea with home sleep study showing apnea hypopnea index of 5/hour or more, subjects with non-alcoholic fatty liver disease (NAFLD) diagnosed by liver biopsy (a) unstable cardiovascular diseases (e.g. recent unstable angina, myocardial infarction, stroke or transient ischemic attack within the previous 6 months or severe left ventricular failure), (b) neuromuscular disease affecting or potentially affecting respiratory muscles,(c) moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake oxygen saturation <92% or (d) psychiatric disease that limits the ability to give informed consent or complete the study, (e) professional drivers, (f) gross structural ear-nose-throat abnormalities (large nasal polyps, gross nasal turbinate hypertrophy or septal deviation and enlarged "kissing" tonsils of significant size) who need early intervention
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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): 18.0-100.0, COPD have severe/very severe COPD diagnosis have had chronic respiratory insufficiency for at least 3 months and be in steady oxygen therapy (LTOT) with a minimal supplement of 1 litre of oxygen per minute for at least 16 hours per day understand and accept oral and written information in Danish be capable of handling the Airvo warm humidifier after instruction Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental illness) Bronchiectasis without simultaneous COPD diagnosis Treatment with BiPAP in the home Affected level of consciousness Smoking status change during project period
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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): 40.0-999.0, Heart Failure Age ≥ 40 years 2. Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea 3. EF ≥ 50% as determined on imaging study within 12 months of enrollment with no change in clinical status suggesting potential for deterioration in systolic function 4. One of the following Previous hospitalization for HF with radiographic evidence (pulmonary venous hypertension, vascular congestion, interstitial edema, pleural effusion) of pulmonary congestion or Catheterization documented elevated filling pressures at rest (PCWP ≥15 or LVEDP ≥18) or with exercise (PCWP ≥25) or Elevated NT-proBNP (>400 pg/ml) or BNP(>200 pg/ml) or Echo evidence of diastolic dysfunction/elevated filling pressures manifest by medial E/e' ratio≥15 and/or left atrial enlargement and chronic treatment with a loop diuretic for signs or symptoms of heart failure 5. Heart failure is primary factor limiting activity as indicated by answering # 2 to the following question: My ability to be active is most limited by: 1. Joint, foot, leg, hip or back pain 2. Shortness of breath and/or fatigue and/or chest pain 3. Unsteadiness or dizziness 4. Lifestyle, weather, or I just don't like to be active 6. Peak VO2 ≤75% predicted with peak respiratory exchange ratio≥1.0 CPET Normal Values for Peak VO2* (ml/kg/min) 7. No chronic nitrate therapy or not using intermittent sublingual nitroglycerin (requirement for >1 SL nitroglycerin per week) within last 7 days 8. No daily use of phosphodiesterase 5 inhibitors or soluble guanylyl cyclase activators and willing to withhold prn use of phosphodiesterase 5 inhibitors for duration of study 9. Ambulatory (not wheelchair / scooter dependent) 10. Body size allows wearing of the accelerometer belt as confirmed by ability to comfortably fasten the test belt provided for the screening process (belt designed to fit persons with BMI 20-40 kg/m2 but belt may fit some persons outside this range) 11. Willingness to wear the accelerometer belt for the duration of the trial 12. Willingness to provide informed consent Recent (< 1 month) hospitalization for heart failure 2. Ongoing requirement for PDE5 inhibitor, organic nitrate or soluble guanylyl cyclase activators 3. Hemoglobin (Hgb) < 8.0 g/dl within 90 days prior to randomization 4. GFR < 20 ml/min/1.73 m2 within 90 days prior to randomization 5. Systolic blood pressure < 115 mmHg seated or < 90 mmHg standing just prior to test dose 6. Resting HR > 110 just prior to test dose 7. Previous adverse reaction to the study drug which necessitated withdrawal of therapy 8. Significant chronic obstructive pulmonary disease thought to contribute to dyspnea 9. Ischemia thought to contribute to dyspnea 10. Documentation of previous EF < 45% 11. Acute coronary syndrome within 3 months defined by electrocardiographic (ECG) changes and biomarkers of myocardial necrosis (e.g., troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent) 12. PCI, coronary artery bypass grafting, or new biventricular pacing within past 3 months 13. Primary hypertrophic cardiomyopathy 14. Infiltrative cardiomyopathy (amyloid) 15. Constrictive pericarditis or tamponade 16. Active myocarditis 17. Complex congenital heart disease 18. Active collagen vascular disease 19. More than mild aortic or mitral stenosis 20. Intrinsic (prolapse, rheumatic) valve disease with moderate to severe or severe mitral, tricuspid or aortic regurgitation 21. Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR > 1.7 in the absence of anticoagulation treatment 22. Terminal illness (other than HF) with expected survival of less than 1 year 23. Regularly (> 1x per week) swims or does water aerobics 24. Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months. 25. Inability to comply with planned study procedures 26. Pregnancy or breastfeeding mothers
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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): 40.0-75.0, Chronic Obstructive Pulmonary Disease COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise (paO2<60mmHg) Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL) Written informed consent General for exercise tests, e.g. acute coronary syndrome, acute myo or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency Signs of acute exacerbation Any orthopedic or neurological disabilities that prevent patient from walking
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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): 18.0-100.0, Asthma OSA clinical diagnosis of asthma chronic obstructive pulmonary disease (COPD) bronchiectasis cystic fibrosis
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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, Patent Foramen Ovale Obstructive Sleep Apnea Age 18 years and older Diagnosis of obstructive sleep apnoea-hypopnoea syndrome (OSAHS) Epworth Sleepiness Scale score of 11 or greater Oxygen Desaturation Index of 20 or greater (and/or oxygen desaturation index/apnoea-hypopnoea index greater than 0.67) Naive to Continuous Positive Airway Pressure (CPAP) treatment, or CPAP intolerant (defined at any review as: CPAP use less than 4 hours per night and unable to tolerate/receive no benefit, or at clinical discretion), or poor CPAP responders (defined at any review as: failure to improve Epworth Sleepiness Scale score by more than 4 points from Epworth Sleepiness Scale score at diagnostic visit plus persistent symptoms suggesting poorly controlled OSAHS and/or a prior failure to tolerate CPAP therapy) Moderate to large Patent Foramen Ovale (PFO) as seen on a transthoracic echocardiogram bubble study CPAP naive patients with moderate-large PFO will start CPAP treatment during the study, but outcomes will be assessed at baseline (before starting CPAP treatment) and at six months post PFO closure (after one week of CPAP abstinence) Coexistent significant respiratory disease (FEV1 <50% predicted) Weight >180kg (maximum weight allowance for echocardiogram table) Known or suspected pregnancy Other cardiac disease (valve disease, known cardiomyopathy, left ventricular failure, known congenital heart disease) Previous atrial septal closure device Inability to give informed consent or comply with the protocol Anatomically unsuitable for percutaneous PFO closure with Gore™ septal occluder device
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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 A signed and dated informed consent form prior to any study procedure Adult male subjects and female subjects without childbearing potential Clinical diagnosis of CHF with history of NYHA class II-III for at least 3 months before randomisation Documented left ventricular ejection fraction (LVEF) < 40% measured by any modality within the previous 12 months in the subject's medical history Subjects must also have at least one local measurement of BNP level ≥ 300 pg/mL or NT-proBNP level ≥ 1200 pg/mL (preferred assay, local laboratory) at the screening visit (maximum 7 days before randomisation) eGFR > 30 mL/min/1.73 m2 (MDRD) at screening Serum potassium < 5.0 mmol/L at screening Systolic blood pressure < 110 mmHg (average of 3 consecutive measurements) at screening Prescribed to optimal pharmacologic therapy per "ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2016", or based on the updated current clinical practice, unless contra-indicated or not-tolerated, and on a stable dose for at least 30 days prior to enrolment (the dosage of the drugs cannot be increased or decreased respectively by more than double or half of initial dosage) Taking oral loop diuretics at doses < 250 mg furosemide daily (or equivalent) BMI > 45 kg.m-2 Patients who require the use of HF IV therapy or oral furosemide > 250 mg (or equivalent) at any time during the 48 hours immediately before randomisation Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 3 months (90 days) before enrolment Patients whose primary cause of heart failure is mitral or aortic valve disease or congenital heart disease or hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) or myocarditis Patients with "new" permanent atrial fibrillation (AF), discovered within 3 months prior to randomization Heart rate > 110 beats/min at screening Patients scheduled for Pacemaker (including ICD, CRT), Angioplasty, CABG or LVAD within the next 3 months Patients with severe documented chronic obstructive lung disease (COPD), defined as chronic need for oxygen therapy eGFR < 30 mL/min/1.73 m2 (MDRD) at screening Decrease in eGFR greater than 20% within 3 weeks prior to the screening visit
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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, Healthy Dyspnea healthy volunteers pregnancy ongoing pain respiratory disease high levels of depression, panic disorder, or other significant mental health problems not fluent in french
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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, Pancreatitis Diagnosis of gallstone pancreatitis. Patients will be considered to have gallstone pancreatitis if they have: 1. upper abdominal pain, nausea, vomiting, and epigastric tenderness 2. absence of ethanol abuse 3. elevated lipase level above the upper limit of normal (>370 U/L) 4. imaging confirmation of gallstones or sludge Low predicted mortality using the Bedside Index of Severity in Acute Pancreatitis (BISAP) -Diagnosis of mild pancreatitis (i.e.,no evidence of organ failure or local or systemic complications) Scheduled for laparoscopic cholecystectomy prior to discharge Lack of any very strong indicator for choledocholithiasis based on the American Society for Gastrointestinal Endoscopy (ASGE) guidelines Clinical stability as denoted by admission to a non-monitored floor bed Pregnancy Severe preexisting medical comorbidities precluding surgery, organ failure, local or systemic complications of acute pancreatitis Chronic pancreatitis Native language other than English and Spanish Patient refusal to participate
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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, Hypertension Hypertensive Heart Disease Participants with clinically suspected or known HT/Hypertensive Heart Disease who have been scheduled for echocardiography examination and/or cardiac catheterization. 2. Participants with history of high BP and stable medication for at least 2 weeks. 3. Presence of the following : Elevated BP measurement or Left ventricular hypertrophy (LVH) on either prior ECG or prior echo for patient 1. Participants with heart muscle disease. 2. Participants with significance valve disease for volunteer: 1. Strictly hypertensive for Normal healthy volunteers. 2. Not on any anti-hypertensive agents
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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, Pancreatitis patients at age between 18-65 years old undergoing first time ERCP Ongoing acute pancreatitis Chronic pancreaittis Prior sphincterotomy Ongoing hypotension including those with sepsis Cardiac insufficiency (CI, >NYHA Class II heart failure) Renal insufficiency (RI, creatinine clearance <40mL/min) Severe liver dysfunction (albumin < 3mg/dL) Respiratory insufficiency (defined as oxygen saturation < 90%) Pregnancy Hyponatremia (Na+ levels < 130mEq/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): 35.0-80.0, Chronic Obstructive Pulmonary Disease One previous chronic obstructive pulmonary disease exacerbation in last year Can not be oxygen dependant PaCO2 < 60
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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, Cardiovascular Diseases Severe primary mitral regurgitation (grade 3+ or 4+) Class I indication for MV Surgery according to ESC/EACTS and AHA/ACC guidelines: 1. Symptomatic patients and/or 2. LV (Left Ventricular) dysfunction : LVESD ≥45 mm and/or 30≤ LVEF ≤60% Leaflet prolapse of P2 and/or A2 Predicted coaptation length > 4 mm Candidates for surgical mitral valve repair according to heart team Patient able to sign an informed consent form Patient benefiting from a social insurance system or a similar system Asymptomatic patients with preserved LV function Complex mechanism of MR (leaflet perforation, severe calcifications, commissural extension, etc) Secondary MR Predicted post-repair coaptation length less than 4 mm Atrial fibrillation Inflammatory or infective valve disease Severe LV dilation (DTD > 65 mm) Significant mitral annulus dilatation (D > 45 mm) Surgical indication of tricuspid annulus Contraindication to TEE (transesophageal echocardiographic ) or inadequate image quality
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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): 65.0-99.0, Pulmonary Complication Dyspnea Pneumonia COPD CHF Atelectasis PE Patients presenting to the ED with chief complaint of "shortness of breath," admitted to the hospitalist service Age >65 yrs of age Patients who can not follow instructions/use IS device Cognitive impairment (Dementia/delirium/Developmental delay) Heavy sedation Inability to take part in deep breathing due to pain or diaphragmatic dysfunction Suicide or psych watch Patients under isolation ICU admission or care within the last 48 hours Recent hospitalization 30 days
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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, Pulmonary Hypertension stable disease hypoxemic respiratory disorder decompensation acute illness
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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): 1.0-80.0, Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases atrial septal defect 20ventricular septal defect 3.patent ductus arteriosis 4.pulmonary stenosis 5.residual leakage after surgical treatment for congenital heart disease 6.coronary artery fistula 7.pulmonary arteriovenous malformations 8.tetralogy of Fallot, and other cyanotic heart disease 9.mitral stenosis and insufficiency 10.tricuspid stenosis and insufficiency 11.aortic stenosis and insufficiency 12.pulmonary stenosis and insufficiency 13.coarctation of aorta 14.paravalvular leakage 15.hypertrophic obstructive heart disease 16.dilated cardiomyopathy 17.structural heart disease need surgery combined with interventional hybrid treatment 18.structural heart disease need surgeryor interventional treatment primary arrhythmia cardiac disease,like tachycardia and ventricular fibrillation 2. circulation disease, like coronary heart disease,hypertension,arterial aneurysm 3. patients were not received any treatment 4. patients were hard to follow-up 5. 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): 65.0-999.0, Frail Elderly Exercise Therapy Physical Therapy Techniques volunteers above the age of 65 who are community residents and classified as frail according to the established by Fried et al. will be selected for in the study previous lower extremities orthopedic surgery, a history of fractures within the past year, an inability to walk unaided, carriers of neurological diseases, diagnosed acute inflammatory disease that could interfere in the assessments and the program, tumor growth in the last five years and cognitive impairment based on the mini-mental state examination [4]. Moreover, will be excluded volunteers who are absent more than three consecutive training and / or more than 25% of the sessions, and / or present the course of the physical program changes or decompensation and / or disease injury
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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 Arterial Hypertension Male and female patients 18 years of age or older with symptomatic PAH Subjects with PAH belonging to one of the following subgroups of the Updated Clinical Classification Group 1 (Nice, 2013) Idiopathic PAH familial PAH PAH associated with connective tissue disease, congenital heart disease (surgically repaired at least 12 months prior to screening) or drug or toxin induced (for example, anorexigen use) Subjects must have persistent symptoms due to PAH despite therapy with at least one of the following PAH medications: an endothelin receptor antagonist, asoluble guanylate cyclase stimulator or a phosphodiesterase inhibitor. The subjects' PAH medication regimen, with typical medications including calcium channel blockers, endothelin receptor antagonists, soluble guanylate cyclase stimulators and/or phosphodiesterase inhibitors, must have been used at a stable dose and frequency for at least 12 weeks before the screening visit and during the screening period Diagnosis of PAH established according to the standard before the screening visit Resting mean pulmonary arterial pressure > 25 mmHg PVR > 240 dynes s/cm5 Pulmonary capillary wedge pressure or left ventricular end diastolic pressure < 15 mmHg Subjects with clinically unstable right heart failure within the last three months (New York Heart Association (NYHA) Class IV) Subjects with PAH associated with portal hypertension, Human Immunodeficiency Virus (HIV) infection or unrepaired congenital systemic to pulmonary shunts Subjects who have received or have been scheduled to receive long-term treatment with epoprostenol or any prostacyclin within the three months prior to the screening visit or during the screening period Hypotensive subjects (systemic systolic blood pressure < 85 mmHg) Subjects with a history of left sided heart disease, chronic left sided heart failure, congenital or acquired valvular disease and/or pulmonary venous hypertension Subjects with significant obstructive (forced expiratory volume in one second [FEV1]/forced vital capacity [FVC] < 70% predicted) or restrictive (total lung capacity < 70% predicted) lung disease at screening
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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, Obstructive Sleep Apnea Adult patient Obstructive Sleep Apnea Patient previously treated by Continuous positive airway pressure non-compliant to therapy Patient naive of bilevel Positive Airway Pressure therapy Bilevel positive airway pressure Contraindication Severe respiratory disease diagnostic
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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, Sleep Apnea, Obstructive Hypertension, Pulmonary Heart Failure Age 18 years or more 2. Decompensated Congestive Heart Failure with systolic Pulmonary Artery pressures of ≥50 mmHg (including Right Atrial pressure) 3. Prior clinical diagnosis of heart failure 4. Moderate to Severe predominately obstructive sleep disordered breathing documented by polygraphy with Apnea Hypopnea Index (AHI) ≥20e/h and 5% of the time spent <90% O2 Sat (minimum 2hr recording time) 5. Patient is able to fully understand study information and sign informed consent Chronic renal insufficiency (Hemodialysis or serum creatinine > 2) 2. Hemodynamically significant valvular disease 3. Severe arthritis or inability to complete 6 Minute Walk Test 4. Left Ventricular Assist Device/ heart transplant or hemodynamically unstable 5. Patient taking any Pulmonary vasodilators, including home oxygen. 6. Known diagnosis of Obstructive Sleep Apnea (OSA) and on active therapy 7. 80% of the respiratory events being central/Cheyne-Stokes breathing 8. Recent cardiac surgery (within 30 days of admission) 9. Recent stroke (within 30 days of admission or with persistent neurological deficits) 10. Severe Chronic Obstructive Pulmonary Disease defined as forced expiratory volume at one second (FEV1) < 50%
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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, GERD for Healthy Persons: -Patients 18 years of age or older with no symptoms of GERD for Patients Patients 18 years of age or older with symptoms of GERD Upper gastrointestinal endoscopy within the past 6 months and a prior diagnostic pH impedance study showing predominantly upright reflux for Patients; Items indicated with an asterisk (*) are also for healthy persons Patient who fulfil ROME IV for rumination disorder20 Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological (e.g., spinal cord injuries, dementia, multiple sclerosis, Parkinson's disease), psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.* Any prior gastric or esophageal surgery and significant intestinal or colonic resection* Hiatal hernia measuring 3 cm or larger as assessed by endoscopic or radiological studies Prior history of Los Angeles Grade C or D esophagitis, or esophageal stricture Current use opioid analgesics or anticholinergic drugs.* We will permit low doses of tricyclic antidepressants, nortriptyline (up to 50 mg/day) or amitriptyline (up to 25 mg/day) provided they were commenced 3 months prior to the screening period, calcium channel or adrenergic1 antagonists Current use of proton pump inhibitors Known significant esophageal motor disorder (ie achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)* Inability to read due to: blindness, cognitive dysfunction, or English language illiteracy *
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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, Cardiogenic Pulmonary Oedema Participants suffering from CPE, defined as having the presence of dyspnea, respiratory rate >25 breaths/minute, the use of accessory respiratory muscles, cyanosis, cold sweats, bilateral crackles and/or wheezing on pulmonary auscultation, hypoxaemia, hypertension, and a predominance of bilateral pulmonary infiltrates upon a chest radiography (if available) The potential causes of CPE have been understood to be Acute Coronary Syndrome (ACS) with or without a persistent ST-segment elevation, hypertensive emergency, valvulopathy, acute arrhythmia, endocarditis, or decompensation due to a chronic heart failure The were: a refused consent, the patient's inability to cooperate, severe encephalopathy (Glasgow Coma Score <10) Anatomical difficulty when adjusting the face mask, non-cardiogenic Acute Respiratory Failure (pneumonia, blunt chest trauma, or chronic obstructive pulmonary disease) Respiratory or cardiac arrest on admission, together with the need for an immediate intubation Specific cardiac contraindications were also considered, including: cardiogenic shock on admission established by systolic blood pressure (SBP) <90 mmHg, or a dependence on vasoactive drugs (norepinephrine >0.5 µg/kg/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): 18.0-80.0, Hypertension, Pulmonary Heart Failure Subjects scheduled to undergo an exercise right heart catheterization at El Camino Hospital. 2. New York Heart Association (NYHA) II or III. 3. Subjects must be between 18 and 80 years of age. 4. A left ventricular ejection fraction ≥ 35%. 5. Subjective or objective evidence (e.g. 6 minute walk test) of impaired exercise capacity. 6. Is willing and able to sign an IRB-approved written informed consent Inability to peddle exercise while laying flat. 2. More than mild valve disease. 3. Clinical or objective evidence of inducible myocardial ischemia. 4. Significant lung disease, such as prior diagnosis of COPD. 5. Resting or dynamic outflow tract gradient. 6. Severe pulmonary HTN (>60mmHg at rest) 7. Moderate to severe RV dysfunction 8. History of DVT, PE 9. Pregnancy (women of child-bearing age, regardless of contraceptive measures, must be willing to take a pregnancy test prior to the study). 10. Recent major surgery or hospitalization (within 30 days) 11. Participation in another clinical study (within 30 days) 12. Advanced neurological disease (e.g. dementia)
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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, Functional Mitral Regurgitation Heart Failure Symptomatic moderate-to-severe (3+) or severe (4+) 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. Symptomatic heart failure as defined by New York Heart Association (NYHA) class II, III or ambulatory IV; 3. Treatment and compliance with optimal medical therapy for heart failure for at least 30 days; Optimal medical therapy is defined by: Maximum tolerated beta-blocker, angiotensin converting enzyme inhibitor (ACE) or angiotensin receptor blocker (ARB), and aldosterone antagonist (as per the ACCF/AHA Guidelines as judged by the HF specialist investigator on site and confirmed by the Clinical Committee). 4. Left ventricular ejection fraction ≤ 35%, as assessed by any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI); 5. Class IIa indication for cardiac resynchronization therapy: 1. Left bundle branch block (LBBB) and QRS duration of 120-149 ms; 2. Right bundle branch block (RBBB) and QRS ≥ 150 ms. 6. Clinical agreement amongst local investigators that the patient will not be offered surgical intervention; 7. 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; 8. 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; 9. Ability and willingness to give written informed consent and to comply with the requirements of the study Life expectancy less than 12 months due to noncardiac conditions; 2. ACC/AHA Stage D Heart Failure; 3. Left ventricular ejection fraction ≤ 15%; 4. Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support; 5. United Network for Organ Sharing (UNOS) status 1 heart transplantation or prior orthotopic heart transplantation; 6. Untreated clinically significant coronary artery disease requiring revascularization; 7. CABG within prior 30 days; 8. Percutaneous coronary intervention within prior 30 days; 9. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring continuous daytime home oxygen or chronic oral corticosteroid therapy; 10. Previous surgical mitral valve bioprosthesis, mitral annuloplasty, or transcatheter mitral valve procedure; 11. Positive pregnancy test, or woman of child bearing potential not using highly effective methods of contraception; 12. Mitral valve area <4.0 cm2 as assessed by planimetry of the mitral valve; 13. Subjects in whom trans-esophageal echocardiography is contraindicated or high risk; 14. 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. 15. Previously implanted Cardiac Resynchronization Therapy and Defibrillator (CRT-D) system; 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 Glomerular 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 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; 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, Cystic Fibrosis confirmed diagnosis of CF age over 18 years the requirement for 1 or more admission to hospital to receive intravenous antibiotics over the preceding 24 months clinically stable at the time of recruitment Patients who give informed consent patients who are currently participating in another clinical trial (excluding observational studies) pneumothorax or lung surgery within the previous 3 months, eye surgery (e.g. cataract operation) in the previous 4 weeks (since these factors prevent measurement of spirometry) Sputum infection with Burkholderia cenocepacia or Mycobacterium abscessus Current diagnosis of active allergic bronchopulmonary aspergillosis (ABPA) Previous lung transplantation procedure
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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, Chronic Obstructive Pulmonary Disease (COPD) Adult patients with frequent exacerbations of COPD (clinically dominant COPD in the case of multiple co-morbidities eg. bronchiectasis, interstitial lung disease, congestive heart failure) Confirmed diagnosis of COPD (bronchodilator FEV1/FVC ratio <0.7 on spirometry within previous 12 months) Age >40 years >10 pack year smoking history Frequent COPD exacerbations in the previous 12 months before enrollment, defined by one or both of the following Treatment as an outpatient with antibiotics or prednisone (physician diagnosed COPD exacerbation) on 2 previous occasions OR One hospitalization for COPD exacerbation (as defined by 2/3 of increased dyspnea, sputum volume, or sputum purulence in patients with known airflow limitation) Expected to live > 12 months Known severe hypersensitivity to immunoglobulin or its components (anaphylaxis) Active or metastatic malignancy (including chronic lymphocytic leukemia) excluding local skin cancers History of hematopoietic stem cell transplant or solid organ transplant Current treatment with a biological therapy for other conditions Concomitant significant immunodeficiency or use of immunosuppressive treatment (other than for COPD) Alpha-1 antitrypsin deficiency (based on enzyme level from bloodwork) Significant proteinuria (dipstick proteinuria ≥ 3+ AND known urinary protein loss ≥ 2 g/day or nephrotic syndrome) and/or has a history of acute renal failure and/or severe renal impairment (creatinine more than 2.5 times the upper limit of normal and/or on dialysis) IgA deficiency (IgA <0.1 g/L) Immunoglobulin therapy in the last 12 months or on current Ig therapy or have a clinical indication for Ig replacement therapy (www.nacblood.ca/resources/guidelines/IVIG.html) 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, Chronic Obstructive Pulmonary Disease Moderate Moderate-severe Chronics Obstructive Pulmonary Disease (COPD) (FEV1 <80% of predicted) Smoking failure to complete physical testing on-going participation in rehabilitation programs pacemaker or use of nicotine products oxygen mask beta blockers antibacterial mouthwash chewing gum or stomach-neutralizing medicine during the intervention
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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): 21.0-999.0, Subarachnoid Hemorrhage Cerebral Vasospasm Age >= 21 2. Onset of symptoms within 72 hours from presentation 3. Subarachnoid hemorrhage from ruptured cerebral aneurysm 4. Cerebral vasospasm diagnosed on transcranial doppler, CT angiography, or digital subtraction angiography Pregnancy 2. Subarachnoid hemorrhage secondary to traumatic or mycotic aneurysm 3. Pre-ictal sildenafil therapy (last dose within 1 week of presentation) 4. Contraindications to sildenafil therapy (i.e. use of nitrates, left ventricular outflow obstruction, impaired autonomic blood pressure control)
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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 Low Output Heart Failure criteria. Each patient must fulfill ALL of the following and details: 1. Age ≥18 years 2. Heart failure resulting in NYHA class III or IV ambulatory 3. Ongoing management of heart failure according to ESC (European Society of Cardiology) (15) -guidelines during previous ≥6 months 4. Control with Arrhythmia with heart rate <110bpm 5. Life expectancy of at least 1 year 6. The patient should have the ability to fluently speak and understand the language in which the study is being conducted 7. Written, informed consent by the patient for participation in the study and agreement to comply with the follow-up schedule 8. Patient has had a successful Balloon Atrial Septostomy (BAS) procedure and is in a stable hemodynamic state, as assessed by the investigator 9. LVEF > 15% and < 70%, EF measured via Echocardiography 9.1. And for LVEF > 40% (HFpEF): elevated NT-pro-BNP of > 125 pg/ml 10. Elevated left ventricular filling pressure documented by 10.1. Either Pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure at rest > 15 mmHg and greater then central venous preassure (CVP) 10.2. Or: End-expiratory >25mmHg at Exercise and CVP < 20 mm Hg 11. Transseptal catheterization and femoral vein access is determined to be feasible Local or generalized sepsis or other acute infection(s) 2. Any coagulation disorder, if clinically relevant in the opinion of the operator. 3. Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable 4. Allergy to anti-platelet, -coagulant, or -thrombotic therapy, if not medically manageable 5. Intolerance to contrast agents, if not medically manageable 6. Participation in another medical trial testing a therapy less than 30 days before the intended AFR implantation procedure 7. Trans-oesophageal echocardiography and / or use of general anaesthetic is contraindicated 8. Breast feeding women 9. Pregnancy Processes which would technically disturb the safe intervention as planned: 10. Occluded inferior vena cava access 11. History of ASD and/or atrial septal repair or closure device in place 12. Intracardiac thrombus Clinical conditions: 13. Moderate valvular diseases requiring therapy according to current ESC guidelines. Patients are eligible in case therapy is formally indicated but cannot be performed due to technical or medial reasons if the latter is confirmed in writing by the PI in mutual agreement with the heart team and Severe aortic stenosis with valve area < 1.5cm² and Severe AR, TR or MR. Classification of severity of regurgitation should follow the definition provided in Lancelotti et al, Eur Heart J Cardiovasc Imaging 2013 [22] 14. Patients who has unstable and intractable angina pectoris 15. Evidence of right heart failure defined as (by ECHO) 1. Severe Right Ventricular Dysfunction (TAPSE < 14 mm) 2. Severe Right Ventricular Dilatation (RV volume ≥ LV volume) 3. Severe pulmonary hypertension (PASP > 60 mm Hg) 16. Active malignancy 17. Severe valve disease, or implanted mechanical valve prosthesis 18. Congenital heart defect 19. Large PFO with significant atrial septal aneurysm (bubble test shows more than 20 bubbles) 20. Inability to perform 6-minutes walking test 21. Clinically relevant thrombocytopenia, thrombocytosis, leukopenia, or anemia 22. Symptomatic carotid artery disease 23. Mitral valve stenosis 24. Has any condition that, in the opinion of the Investigator, might interfere with the Implantation, might affect the patients well-being thereafter or might interfere with the conduct of the study 25. Systolic blood pressure of >170 mmHg, despite medical therapy 26. Severe lung disease (causing PHT with systolic PAP >60mmHg) 27. Pulmonary Hypertension (Systolic PAP >60mmHg) 28. TIA or stroke within the last 6 months 29. Scheduled for heart transplantation 30. Bleeding disorders (INR > 2.0, Thrombocytes < 100.000, Hemoglobin <8.0 gr/dl) 31. Myocardial infarction or percutaneous intervention or CABG (all within the last 3 month) or indication for a coronary intervention 32. Resyncronization therapy started within the last 6 months 33. Aneurysm of the septum 34. Hypertrophied Inter Atrial Septum (IAS) > 10mm depth 35. Hypertrophic Obstructive Cardiomyopathy (HOCM) or infiltrative CM as cause of HF 36. Thromboembolic events within the last 6 months 37. Dialysis and renal insufficiency requiring dialysis
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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 Males or females ≥ 18 years and < 80 years of age Patients exhibiting physical signs of excessive fluid retention (i.e. elevated JVD, peripheral edema, ascites, pulmonary edema, weight gain etc.) Patients with an eGFR by the Modification of Diet in Renal Disease (MDRD) of > 15 to < 60 mL/min/1.73m2 Patients with a brain natriuretic peptide (BNP) ≥ 150 pg/mL and/or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥ 600 pg/mL at time of screening or BNP ≥ 100 pg/mL and/or NTproBNP ≥ 400 pg/mL Patients who have a Six Minute Walk Test (SMWT) exercise capacity between 100 and 400 meters Patients presenting with NYHA Class III or ambulatory NYHA Class IV heart failure who have been on optimal medical management (OMM) based on current heart failure practice guidelines and who are failing to respond to or cannot tolerate one or more of the following interventions: 1. Treatment with diuretic therapy 2. Treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) for at least 30 days 3. Treatment with nitrates and/or vasodilators at the investigator's discretion 4. Treatment with beta-blockers for at least 90 days 5. Treatment with cardiac resynchronization therapy (CRT) 6. Treatment with an automatic implantable cardioverter defibrillator (AICD) Patients who demonstrate compliance with the current medical regimen as reported by the treating physician Enrollment Patients presenting with acute decompensated heart failure requiring hospitalization for management of their symptoms (i.e. hospitalization for exacerbation of chronic heart failure manifested by signs and symptoms requiring intravenous and/or more aggressive therapy) Patients with ascites on physical examination resulting predominantly from right heart failure Patients who have an indication for and are candidates for CRT but who have not been treated with CRT Patients who have an indication for and are candidates for an AICD but who have not been implanted with an AICD Patients with reversible causes of heart failure which may be remedied by conventional surgery or other interventions Patients with an eGFR by MDRD < 15 or > 60 ml/min/1.73m2 Patients with a body mass index (BMI) < 18 kg/m2or > 35 kg/m2 Patients with severe pulmonary disease by history (i.e. severe chronic obstructive pulmonary disease, severe hypoxia or a pulmonary artery mean pressure >40 mm Hg) Patients who have experienced a myocardial infarction (MI) within the past 90 days Patients who have experienced a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 90 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): 18.0-999.0, Healthy Volunteers healthy volunteers pregnancy ongoing pain respiratory disease high levels of depression, panic disorder, or other significant mental health problems not fluent in french
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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, Pulmonary Hypertension Heart Failure Patients undergoing right heart catheterization Inability or unwillingness to follow or to sign the study protocol
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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, Heart Failure Patients ≥ 18 years of age with a clinical diagnosis of HF seen in outpatient clinics or inpatient hospital wards of the participating centres Written informed consent Patients considered unreliable by the investigator concerning the requirements for follow-up visits
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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): 18.0-65.0, Air Pollution Age 18-65 years old. People older than 65 years are excluded as the impact of PM2.5 on their BP is not known from our prior studies (which included younger individuals) and they have age-related increases in BP and SNS activity which may alter their associations with PM2.5 exposures and thus produce too heterogeneous a population to evaluate the linkages between PM2.5 and health outcomes Self-reported nonsmoker (100% abstinence for at least 1 year) living in non-smoking households (no one living in the household that smokes indoors) and no known routine exposures to air pollutants by known point sources at home, travel or occupationally (e.g., fumes, dust, secondhand smoke). Smoking and other exposures may alter any effect that ambient PM2.5 has on the health outcomes Able to understand the informed consent, legally provide informed consent, and able to participate for the entire duration of the study Any facial hair (beard or mustache) that does not allow for proper fitting and air tight seal of the N95 facemask during the study that would compromise the ability of the mask to prevent exposures Any prior cardiovascular diseases (coronary artery disease (CAD), congestive heart failure (CHF), stroke, peripheral arterial disease (PAD), aneurysms, any revascularization)* Prior diagnosis of hypertension, diabetes, sleep apnea* Prior diagnosis of chronic lung diseases (asthma, chronic obstructive lung disease (COPD))* Prior diagnosis of neurological disorders (Parkinson's disease, autonomic failure, peripheral neuropathy, seizure disorder) or other conditions at discretion of investigators* Prior diagnosis of chronic kidney disease, any type of dialysis* Active or history of any known cancer* History of HIV* Being treated for any infection with antibiotics within past month* Mental health issue(s) including anxiety disorders, mood disorders, schizophrenia, or other conditions at discretion of investigators*
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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): 18.0-79.0, Heart Failure Dilated Cardiomyopathy Heart Failure With Reduced Ejection Fraction The patients must be able and willing to give written informed consent 2. The patients will be adult (age ≥ 18 years and ≤ 79 years) males or females 3. The patients must be on stable, evidence-based therapy for heart failure Evidence-based therapy for heart failure is defined as an ACE-inhibitor (ACE-I), and/or angiotensin II receptor blockers (ARB) for patients at stable doses for 1 month prior to enrollment, if tolerated, and a beta blocker (carvedilol, metoprolol succinate, Nebivolol or bisoprolol) for 3 months prior to enrollment, if tolerated. Recent up-titration of the beta blocker is acceptable if the patient has been stable on this dose for 1 month prior to enrollment. Stable is defined as no more than a 100% increase or a 50% decrease in dose. Contraindications or intolerance to therapies should be documented. In those intolerant to both ACE-I and ARB, combination therapy with hydralazine and oral nitrate should be considered. Therapeutic equivalence for ACE-I substitutions is allowed within the enrollment stability timelines. Aldosterone inhibitor therapy should be added when NYHA Class III or IV symptoms occur on standard therapy. If aldosterone inhibitor therapy is to be administered in NYHA Class II patients, it must be initiated and optimized prior to enrollment. Eplerenone requires dosage stability for 1 month prior to enrollment. Diuretics should be used as necessary to keep the patient euvolemic. All heart failure therapeutics and dosages should be documented in the Case Report Forms. 4. The patient must have cardiac resynchronization therapy (CRT) if clinically indicated, implanted ≥3 months prior to randomization. * Note: In those patients not receiving CRT or CRT-D therapy the investigator should not anticipate initiating this therapy within 6 months after randomization 5. The patient must have an implanted cardio-defibrillator (ICD) if clinically indicated, implanted at least 30 days prior to randomization. *Note: If the patient has clinical indications for an ICD but refuses the ICD, this refusal of ICD therapy must be document in the medical record and the patient may be enrolled with this documentation. 6. The patients will have a left ventricular ejection fraction equal to or less than 35% via echocardiography, cardiac catheterization, radionuclide scan, or magnetic resonance imaging (measured within the last 30 days) 7. The patients will have a left ventricular end diastolic dimension indexed to body surface area (LVEDDi) of greater than or equal to 30 mm/m2 (LVEDD/BSA) and an LVEDD of greater than or equal to 85 mm (measured within the last 30 days) 8. Patients must have symptomatic heart failure with a Peak VO2 of 9.0 0 ml/min/kg (performed using a treadmill). Patients must perform two CPX tests (within 30 days of randomization and performed at least 20 hours apart) that differ by no more than 15% in the observed value for Peak VO2 and have a mean value of 9.0 0 ml/min/kg from these two tests. All CPX tests performed for the study must have a Peak Respiratory Exchange Ratio (RER) of at least 1.0 to be accepted as a valid test. 9. Patient's surgical risk must be considered reasonable and the evaluation of surgical risk should review of coronary and left ventricular angiography. Surgical risk assessment should the consideration of risk presented by prior surgical procedures such as prior mid-sternotomy surgical procedures. *Note: investigators should observe standard clinical practice for the management of antithrombotic therapy in patients undergoing surgical procedures in accordance with the American College of Chest Physicians Guidelines: Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th edition 10. If female, the patients must be (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of study device Patients for whom it is planned to receive CABG, MVR, heart transplantation or LVAD within the next 6 months. 2. Patients presenting with cardiogenic shock. 3. Patients presenting with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis 4. Patient with a history of constrictive pericarditis 5. Patients with a Q wave myocardial infarction (MI) within the last 30 days 6. Patients with a recent history of stroke (within 60 days prior to the surgical procedure) 7. A left ventricular (LV) wall thickness of the LV free-wall, at the mid-ventricular level, of less than 8 mm (screening echocardiography must confirm a minimum wall thickness of 8 mm) 8. Patients with an estimated glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 9. Clinically significant liver enzyme abnormalities, i.e., AST(SGOT) and ALT (SGPT) more than 2.5 times the upper limit of normal 10. History of severe COPD (i.e., FEV 1< 1 liter or FEV1 < 50% predicted) 11. The patients will not be receiving concurrently an Investigational Product in another clinical trial or have received an investigational Product in another clinical trial in the 30 days prior to enrollment 12. A life expectancy of less than 1 year or any other condition that, in the opinion of the clinical investigator, might compromise any aspect of the trial
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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): 45.0-90.0, Pulmonary Disease, Chronic Obstructive Hypertension, Pulmonary Hypoxia Chronic Obstructive Pulmonary Disease (COPD) Forced Expiratory Volume 1 second (FEV1) <60% of predicted FEV1%FVC <70 % of predicted (FVC = Forced Vital Capacity) Qualify for Long term oxygen therapy (LTOT), or presence of significant desaturation on exercise Unstable ischaemic heart disease or valvular heart disease Active malignant disease Substance abuse Physical or mental disability that prevents participation in the exercise programme or testing Pregnancy Exacerbation of COPD or respiratory tract infection last 6 weeks before Completed pulmonary rehabilitation programme or other organised exercise programme last 3 month Use of high doses of systemic steroids
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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 Chronic symptomatic Heart Failure (HF) documented by the following: 1. New York Heart Association (NYHA) Class III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit, and signs (e.g. any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND 2. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify), or one emergency department visit with IV treatment for HF within the 12 months prior to study entry 2. Ongoing stable GDMT for HF (Class I, and IIa recommendations) according to the 2016 ACC/AHA Guidelines for the management of Heart Failure (with no significant changes [>100% increase or 50% decrease], excluding diuretic dose changes for a minimum of 3 months prior to screening), which is expected to be maintained without change for 6 months 3. Age ≥ 18 years old 4. Reduced Left ventricular ejection fraction between 20% and 40% as documented by echocardiography, radio nuclide ventriculography, or MRI within the past 3 months 5. Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by: a. Resting end expiratory PCWP ≥ 18 mmHg, and greater than RAP by ≥ 5 mmHg 6. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, as approved by the IRB 7. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams 8. Trans-septal catheterization by femoral vein access is determined to be feasible Patients who are not receiving GDMT for specified reasons 2. NT-Pro BNP < 100 pg/mL (if in sinus rhythm), or <300 pg/mL (if in atrial fibrillation); or BNP < 70 pg/mL (if in sinus rhythm), or < 200 pg/mL (if in atrial fibrillation) 3. Myocardial infarction (MI) and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization 4. Cardiac Resynchronization Therapy initiated within the past 3 months 5. Automated Implantable Cardioverter Defibrillator (AICD) placed within past 3 months 6. Severe heart failure defined by all of the following: 1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF; 2. Cardiac Index < 2.0 L/min/m2 3. Requiring inotropic infusion (continuous or intermittent) within the past 3 months. 4. Listed on transplant waiting list 7. Ability to perform the 6 minute walk Test >600m 8. Known clinically significant un-revascularized coronary artery disease, defined as: epi-cardial coronary artery stenosis associated with angina or other evidence of coronary ischemia. 9. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months or recurrent DVT/pulmonary emboli 10. Presence of significant valve disease defined by echocardiography as: 1. Mitral valve regurgitation defined as grade > 2+ MR 2. Tricuspid valve regurgitation defined as grade > 2+ TR; 3. Aortic valve disease defined as ≥ 2+ AR or moderate AS 11. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin analogue; or has a documented coagulopathy 12. Atrial fibrillation with resting HR > 100 BPM 13. Arterial Oxygen saturation < 95% on room air 14. Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase; Hepatic cirrhosis; Hypoalbuminemia 15. Resting RAP > 14 mmHg 16. Right ventricular dysfunction, defined as 1. More than mild RV dysfunction as determined by TTE: OR 2. TAPSE < 1.4 cm: OR 3. RV volume ≥ LV volume on echo estimate; OR 4. Evidence of RV dysfunction defined by echo as an RV fractional area change < 35% 17. Evidence of pulmonary hypertension with PVR ≥4 Woods Units 18. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 <1L. 19. Currently participating in an investigational drug or device study that may interfere with the conduct and outcome of this study. 20. Life expectancy less than 12 months for non-cardiovascular reasons 21. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation 22. Known or suspected allergy to nickel 23. Women of child bearing potential 24. Currently requiring dialysis; or e-GFR <25ml/min 25. Systolic blood pressure >170 mmHg despite appropriate medical management 26. Subjects with existing or surgically closed (with a patch) Atrial Septal Defects. Subjects with a Patent Foramen Ovale (PFO), who have elevated filling pressure despite the PFO are allowed 27. Subjects on immunosuppression or systemic steroid treatment 28. In the opinion of the investigator, the subject is not an appropriate candidate for 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): 18.0-999.0, COPD Patients with COPD (n=100) based in Gold 2017. Patients with Stable COPD and PaCO2 > 52 mmHg in blood gases. These patients might have a polygraph or polysomnographic sleep study AHI/RDI <15/h Patients with ventilatory treatment Without diagnosis of COPD Polygraph or polysomnographic sleep study AHI/RDI >=15/h
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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 Hypertension Male or females between 18 to 75 years of age at Diagnosis of PAH due to the following Idiopathic Primary Pulmonary Arterial Hypertension (IPAH) Hereditary PAH PAH secondary to connective tissue disease PAH diagnosis confirmed by right heart catheterization performed within 3 months prior to study enrolment Subjects must weigh at least 40 kg at Subject must have a current diagnosis of being in World Health Organisation (WHO) Functional Class II or III. Treatment PAH naïve subjects PAH documented by mPAP ≥25mmHg pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15mmHg and PVR ≥3 Wood Units. Subject must walk a distance of ≥125m and ≤500m at the screening visit History of pulmonary embolism No prior treatment with PDE-5 inhibitors History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function Current treatment with nitrates or nitric oxide Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
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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, Functional Mitral Regurgitation Heart Failure Mitral Valve Insufficiency Heart Diseases Cardiovascular Diseases Heart Valve Diseases Diagnosis of ischemic or non-ischemic cardiomyopathy 2. Symptomatic functional (secondary) mitral regurgitation defined as both (Moderate), 3+ (Moderate/Severe), or 4+ (Severe). Note: 4+ can only be included if multidisciplinary site assessment (including a surgeon) determines that surgery is not necessary within the 1-year follow-up period for this study. 3. NYHA Class II, III, or IV 4. Six Minute Walk distance ≥ 150 meters and ≤ 450 meters 5. Left Ventricular Ejection Fraction ≤ 50% 6. LVESD ≤ 70 mm Note: As assessed by Imaging Core Laboratory. 7. Corrected BNP of > 300 pg/ml, or corrected NT-proBNP > 1500 pg/ml, or one or more heart failure hospitalizations within one year prior to consent 8. Guideline directed heart failure medication regimen. 9. Age ≥ 18 years old 10. implant can be sized and placed in accordance with the IFU 11. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent Recipient of intravenous positive-inotrope infusion or intra-aortic balloon pump support within the past 30 days 2. Heart failure hospitalization within the past 30 days 3. Anticipated need of left ventricular assist device within twelve (12) months 4. Class I indication for cardiac resynchronization therapy (CRT), or anticipated need for CRT within twelve (12) months 5. Primary renal dysfunction or compromised renal function as reflected by an estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, as assessed by MDRD formula, or patients on dialysis 6. Heart transplant candidate or prior orthotopic heart transplantation 7. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device. 8. Hypertrophic cardiomyopathy, infiltrative cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis 9. Echocardiographic documentation of non-compaction cardiomyopathy as assessed by the Imaging Core Laboratory 10. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV) 11. Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture), as assessed by the Imaging Core Laboratory 12. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory 13. Severe mitral annular calcification 14. Severe aortic stenosis 15. Not a candidate for right internal jugular venous cannulation 16. Hospitalization in past 30 days due to myocardial infarction, coronary artery bypass graft surgery or unstable angina 17. Cerebral vascular event within the past 30 days 18. Hospitalization in the past 30 days for coronary angioplasty or stent placement or ICD implant 19. Pulmonary embolus or deep vein thrombosis within the past six (6) months 20. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year 21. Expected to require any percutaneous coronary intervention within 30 days of the index procedure. 22. Hemodynamic instability defined as sustained systolic blood pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device 23. Presence of left atrial appendage (LAA) clot or presence of LAA occluder 24. Anemia defined as hemoglobin < 9.0 mg/dL 25. Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints 26. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically 27. Active infections requiring current antibiotic therapy 28. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months 29. Female subjects pregnant or planning to become pregnant in the next five (5) years 30. Subjects unable to perform the required study assessments (e.g., 6 minute walk test) 31. Any other medical condition that, in the judgment of the Investigator, makes the patient a poor candidate for this study 32. Subjects belonging to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or comply with 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): 18.0-65.0, Heart Failure New York Heart Association (NYHA) Class III or IV CHF refractory to maximal medical therapy (ACE inhibitor, B-blocker, digoxin and diuretics, resynchronization therapy or Implantable Cardioverter Defibrillator when applicable) and/or conventional surgery Inoperable coronary artery disease with intractable anginal symptoms Malignant ventricular arrhythmias unresponsive to medical or surgical therapy 65 years of age Obtained agreement for participation from the transplant cardiology team No evident contraindication to liver transplantation other than the underlying cardiac disorder Able to travel to the University of Pennsylvania for routine post-transplant visits and study visits for a minimum of 6 months after transplantation No active illicit substance abuse Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) following transplant due to the increased risk of birth defects and/or miscarriage Both men and women must agree to use at least one barrier method of birth control or remain abstinent following transplant due to risk of HCV transmission Hepatocellular carcinoma HIV positive HCV antibody positive and/or RNA positive Hepatitis B surface antigen, core antibody, and/or DNA positive Any other chronic liver disease (excluding non-alcoholic fatty liver disease (NAFLD) with abnormal liver enzymes Persistently elevated liver transaminases Congenital heart disease Fibrosis by liver biopsy or total bilirubin > 2.5 with associated evidence of synthetic dysfunction Pregnant or nursing (lactating) women Known allergy or intolerance to tacrolimus that would require post-transplant administration of cyclosporine, rather than tacrolimus given the drug-drug interaction between cyclosporine and
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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): 50.0-80.0, Chronic Obstructive Pulmonary Disease COPD stage III or IV according to the global initiative for chronic obstructive lung disease impaired exercise capacity (6 Minute walk distance of less than 70% of the reference value from Troosters et al.) current acute exacerbation of COPD carbon dioxide pressure of more than 45 mmHg at rest any contraindication for vibration Training (e.g. acute deep vein thrombosis)
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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, Heart Failure, Congestive Patient 1. English-speaking and able to complete baseline interview 2. Age ≥65 (Age was reduced to ≥50 y/o given regional experience with HF population) 3. NYHA Stage III/IV heart failure; American College of Cardiology (ACC) Class C/D 4. Have a land-based phone or reliable cellular phone service 5. Have an agreeable partner willing to participate in the study* (recommended) *In our previous studies we have not required patients to have a care partner for eligibility. In this study it is essential that we have an adequate number of caregivers to test the caregiver intervention. Therefore patients without a care partner will still be considered but the final study sample size may need to be adjusted to ensure an adequate caregiver sample. Patient Non-correctable hearing loss 2. Dementia or significant confusion (as measured by a Callahan score of ≤3 3. Diagnostic and Statistical Manual (DSM) -IV Axis I diagnosis (e.g. schizophrenia, bipolar disorder) or active substance use disorder Caregiver 1. "Caregiver" is identified by the patient as "a person who knows you well and is involved in your medical care". May be a spouse or adult family member or friend living in the same household or considered by the patient to be the primary caregiver and be willing to participate." 2. English-speaking and able to complete baseline interview 3. Have a land-based phone or reliable cellular phone service. Caregiver Non-correctable hearing loss
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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): 40.0-85.0, COPD Pulmonary Hypertension Stable for over 1 month mean pulmonary artery pressure ≥35mmHg, pulmonary wedge pressure≤ 15mmHg never received target therapy before Patients with other serious respiratory diseases Patients with pulmonary hypertension other than group 3 Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases Patients with limited life expectancy Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months Psychopath or addict Nonstable patients with type Ⅰor Ⅱ respiratory failure Patients with contraindication for sildenafil Patients in pregnancy or breastfeeding
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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, Chronic Respiratory Disease Hypoxemia chronic respiratory disease patients with chronic hypoxemia First prescribed long term oxygenotherapy patients with NIV and CPAP vital pronostic < 3 months
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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, Pulmonary Hypertension clinically indicated right heart catheterisation diagnosis of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension or control without pulmonary hypertension hemodynamically unstable partial pressure of Oxygen < 7.3kPa no informed consent pulmonary hypertension due to left heart disease, chronic lung disease or miscellaneous (Groups II, III and V) according to Galié ERJ 2015
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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): 18.0-100.0, Diastolic Dysfunction Septic Shock Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h No echocardiographic window Fatal prognosis with do not resuscitate orders at admission Previous history of Ischemic cardiomyopathy Valvular prosthesis Advanced degree of valvular disorder Advanced degree of pericardial effusion
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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 Hypercapnia Hypoxia admitted to the hospital for an acute exacerbation of COPD within the past 12 weeks have COPD as the primary diagnosis have smoked > 10 pack years receiving supplemental oxygen as part of their usual clinical care willing to give informed consent upper airway or nasal problems that prohibit the use of high flow oxygen current use (≤ 4 weeks of study entry) of any PAP-therapy (e.g., CPAP or NPPV) sleep apnea as follows: STOPBang scores ≥ 5 or STOPBang score ≥ 2 plus BMI > 35 kg/m2; or Berlin questionnaire scores suggesting high likelihood of sleep apnea with increased risk of sleep-related accident (e.g., occupation as a commercial driver or pilot) excessive daytime sleepiness (i.e., either of High (>15) score on the Epworth Sleepiness Scale or "fall asleep" accident or "near miss" accident in prior 12 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): 21.0-999.0, Coronary Artery Disease Coronary disease (S/p ACS, PCI, CABG or stable angina with documented coronary disease) Age ≥ 21 Smartphone with internet connection Willing and able to comply with study protocol and LVEF > 40% and Baseline METS ≥ 5 Able to follow the personalized exercise prescription, utilize smartwatch and upload exercise data per protocol Heart failure (clinical) or unresolved significant arrhythmia (i.e. symptomatic atrial fibrillation) Significant neurological or cognitive impairment Women of child-bearing potential Symptomatic hypotension, orthostatic hypotension or repeated blood pressure systolic value <100 mmHg without symptoms ACS or percutaneous coronary intervention (PCI) within 30 days prior to screening, or having undergone CABG surgery within 30 days prior to screening Inability to perform a CPET test due to physical limitations Ischemia per stress test \ nuclear scan or stress echocardiography Severe angina pectoris as defined by CCS >2 Pulmonary disease of severity greater than mild (COPD, Asthma, ILD, CTD with lung involvement) or chronic pulmonary thromboembolic disease (CTED) Severe orthopedic limitations
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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, Acute Respiratory Failure With Hypercapnia Hypoxemic and no hypercapnic acute respiratory failure severe dyspnea at rest with a respiratory rate >25 breaths/min PaO2/FiO2 <300 PaCO2 <45 mmHg age <18 years NPPV contraindications past history of respiratory chronic disease (COPD, cystic fibrosis…) cardiac pulmonary edema Pre-defined intubation other than respiratory organ failure : systolic pressure <90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12) profound aplasia (white cells count <1000/mm 3)
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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 Age > 18years Chronic obstructive pulmonary disease stade III to IV Referred for pulmonary rehabilitation. Non Pregnancy or likely to be History of psychiatric, neuro-vascular, cognitive disease or cranial trauma Active alcoholism Guardianship Hospitalisation for acute exacerbation of chronic obstructive pulmonary disease in the previous 4 weeks Interruption of the pulmonary rehabilitation program > 15 days Disruption of the training before the 18th session Less than 18 sessions in four month
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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, Dyspnea Patients referred to Pulmonary and/or Cardiology clinic for the evaluation of unexplained dyspnea Patients with a known cause of dyspnea such as established cardiopulmonary disease
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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): 18.0-85.0, Heart Failure Subject has provided informed consent prior to initiation of any study-specific activities/procedures Male and female subjects ≥ 18 to ≤ 55 years old with no history or evidence of clinically relevant medical disorders as determined by the investigator and the Amgen physician (Parts A and B only) Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening Physical examination including vital signs, clinical laboratory values, and ECGs are clinically acceptable to the investigator. Abnormal findings for healthy volunteers and unexpected findings for heart failure patient subjects will be discussed with Amgen prior to study enrollment Women must be of non-reproductive potential (ie, postmenopausal) Men must agree to practice an acceptable method of effective birth control while on study through 11 weeks after receiving the last dose of investigational product (AMG 986 or placebo). Acceptable methods of effective birth control sexual abstinence; vasectomy and testing that shows there are no sperm in the semen; or a condom with spermicide (men) in combination with barrier methods (diaphragm, cervical cap or cervical sponge), hormonal birth control or IUS (women) Men must be willing to abstain from sperm donation while on study through 11 weeks after receiving the last dose of investigational product (AMG 986 or placebo) This criterion only applies to Parts B and C cohorts. Before in the study, subjects will undergo a screening echocardiogram to ensure that the following parameters can be accurately measured: left ventricular end-systolic and end-diastolic volumes, left atrial end-systolic and end-diastolic volumes, ejection fraction, fraction shortening, and end-systolic septal and posterior wall thickness. For Part C Additional for HFrEF Patients Subject must be of age 18 to 85 years, have a diagnosis of HF confirmed by medical records for ≥ 3 months, and be in stable condition for at least 4 weeks Left ventricular ejection fraction (LVEF) ≤ 40% confirmed by echocardiogram, radionuclide ventriculography, cardiac magnetic resonance imaging, or contrast ventriculography within 12 months prior to randomization Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives (whichever is longer), since ending treatment on another investigational device or drug study(s) prior to receiving the first dose of investigational product (AMG 986 or placebo) Female subjects who are lactating/breastfeeding or who plan to breastfeed while on study through 11 weeks after receiving the last dose of investigational product (AMG 986 or placebo) Male subjects with partners who are pregnant or planning to become pregnant while the subject is on study through 11 weeks after receiving the last dose of investigational product (AMG 986 or placebo) Female subjects of reproductive potential Subjects in Parts A and B of the study: estimated glomerular filtration rate (eGFR) within the screening period of less than 60 mL/min/1.73m2 as calculated using the estimated Modification of Diet in Renal Disease (MDRD) formula Current or prior malignancy within 5 years of randomization, with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ, and adenocarcinoma of the prostate Stage I or IIa (defined as T1, T2a or T2b, N0, M0 with documented serum PSA < 20 ng/mL and Gleason score ≤ 7) per the American Joint Committee on Cancer (AJCC) primary tumor, regional lymph nodes, and distant metastasis system Positive results for Human Immunodeficiency Virus (HIV), antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HepCAb) Subject has known sensitivity to any of the products or components to be administered during dosing Subject likely to not be available to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge History or evidence of any other clinically significant disorder, condition or disease with the exception of those outlined above that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
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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, Chronic Obstructive Pulmonary Disease COPD Copd Exacerbation Acute COPD Exacerbation Admission with acute exacerbation of COPD within 24 hours of presentation to hospital Age >40 Confirmed COPD diagnosis (FEV1/FVC <0.70 on spirometry) Willing to participate in the study and provide informed consent Admission for reason other than COPD exacerbation e.g. Heart Failure Acute confusion as per clinical team Allergy or contraindication to combined bronchodilator medication Severe respiratory sepsis as evident by temperature >38 degrees and/or lobar pneumonia on Chest Radiograph Sustained tachycardia >120bpm Patients with very advanced COPD, admitted for palliative or long term care Patients re-admitted within 90 days who have already been enrolled 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): 18.0-999.0, Hypercapnic Respiratory Failure Chronic Obstructive Pulmonary Disease Obesity Hypoventilation Syndrome Sleep Disordered Breathing Neuromuscular Diseases Adult patients > 18 years of age Evidence of hypercapnia (PCO2 ≥ 45mmHg) secondary to COPD-OSA overlap, OHS, Neuromuscular disease / weakness Requiring NIV / NIPPV outpatient Ability to operate a smart device / tablet Informed consent Non-English or Non-Spanish speaking (device videos and surveys are available in English or Spanish only) Patients unable to give consent Pregnant women Prisoners Patients <18 years of age Patient already on NIPPV/ CPAP at home and compliant on therapy Significant non-pulmonary conditions (CHF with EF < 40%), Pulmonary hypertension with PASP> 60 mmGH, severe valvular heart disease, end-stage renal disease or end-stage liver disease Patients without health insurance Residing out of state (Pennsylvania)
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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, Heart Failure Age≥ 18 years Symptomatic and chronic heart failure (NYHA Class II and III) Patients on guideline directed medical therapy 90 days prior to enrollment Adequate home environment for at-home treatment Presenting or referred to the clinic because of evidence of worsening heart failure with fluid overload (decompensation) A modification in oral diuretics is not clinically appropriate as deemed by the investigator Estimated excess fluid weight of 4 lbs. or more from euvolemic state Participant able to give informed consent for participation in trial. Agreeing to sign informed consent and HIPAA authorization Understanding and willing to comply with the protocols of the trial Ability of the participant or caregiver to independently apply the investigational device and medication ACC/AHA Stage D heart failure or patients requiring IV inotrope therapy Massive volume overload (e.g. >20 lbs. of estimated fluid weight) or anasarca Suspected high risk clinical instability with outpatient treatment Pregnant females or women of child-bearing age who are not willing to use an adequate form of contraception Chronic Obstructive Pulmonary Disease (COPD) moderate or worse: FEV1/FCV ratio <0.7 and FEV1 <60 percent predicted Rapid atrial fibrillation (AF) (HR >100b/min) Hypoxia (resting O2 saturation <90%) Hypotension (systolic blood pressure (SBP) BP < 90 mmHg) Uncontrolled diabetes mellitus (DM) (admission glucose levels > 300 mg/dL) Advanced renal disease (eGFR < 30mL/min/1.73m2)
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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, Heart Failure ICD Sudden Cardiac Death stable heart failure; indication for a ICD and/or a CRT-d system; NYHA Class II-III; left ventricle ejection fraction <35%; patients receiving optimal medical therapy NYHA Class I, and IV; co-morbidities which may limit life to <6 months; history of cardiac surgery or intervention within the preceding 90 days; history of moderate to severe chronic obstructive pulmonary disease (COPD), defined as needing chronic oxygen therapy, or recent (within 30 days) hospitalization for COPD flare-up; pregnancy; history of primary pulmonary hypertension
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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, Cardiomyopathy Cardiovascular Diseases Congestive Heart Failure Coronary Artery Disease Heart Disease Valvular Heart Disease Mitral Valve Disease Patients with functional mitral regurgitation (FMR) from either ischemic or non-ischemic cardiomyopathies, referred for surgical or transcatheter mitral valve annuloplasty. Suitability for mitral annuloplasty is determined by the surgeon, using some or all the described below Left ventricular end diastolic diameter is less than or equal to 70mm Systolic tenting height is less than or equal to 12mm Mitral regurgitation of moderate or greater severity, as defined by the guidelines of the American society of echocardiography at the time of the study approval (via a transthoracic echo) Cardiomyopathy of ischemic or non-ischemic origins, with or without the need for coronary revascularization Able to sign informed consent and release of medical information forms, or able to assign a legal representative who can sign on the patient's behalf Any evidence of structural (chordal or leaflet) mitral lesions Planned concomitant intra-operative procedures (except for closure of patent foramen ovale or atrial septal defect) Planned concomitant intra-operative Maze procedure for symptomatic paroxysmal atrial fibrillation Persistent atrial fibrillation Prior mitral valve repair Contraindication for cardiopulmonary bypass Clinical signs of cardiogenic shock at the time of randomization ST segment elevation myocardial infarction within 14 days prior to in this study Congenital heart disease (except PFO or ASD) Chronic renal insufficiency defined by Creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac 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): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Asthma Adverse Effect of Beta-adrenoreceptor Antagonists years of age or older Mild to moderate COPD as defined by the American Thoracic Society Current treatment with a beta-blocker for either hypertension, myocardial infarction, or congestive heart failure Recent (within 30 days) COPD exacerbation or requirement for oral steroid therapy within the last 6 months Any history of ventilator support requirement for COPD Patients with asthma or reactive airway disease (RAD) defined as obstructive lung disease with a >15% improvement in FEV1 with beta-agonist therapy Relative or absolute contraindication to beta-blocker therapy Exposure to any investigational drugs within the previous 30 days Patients with any concurrent disease or condition, which in the judgment of the investigator would make the patient inappropriate for participation in the study were excluded from this study
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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): 40.0-999.0, COPD Exposed Cohort selection Have one or more prescription(s) of roflumilast with the date of first prescription/dispensation defined as the Cohort Entry Date Have active data in the respective database(s) for at least 1 year prior to the Cohort Entry Date Be at least 40 years old at Cohort Entry Date Have a diagnosis of COPD or chronic bronchitis prior to the Cohort Entry Date (databases with outpatient diagnoses) or (databases without outpatient diagnoses) either a hospital diagnosis of COPD or chronic bronchitis prior to the Cohort Entry Date or a proxy for such indication based on prescription data. Non-Exposed Cohort selection Patients meeting the following belong in the Non-Exposed Cohort and are eligible as Matched Non-Exposed controls. Each patient in the Non-exposed Cohort selected as matched exposed patient is assigned as a Cohort Entry Date the date of the first roflumilast prescription of the matched exposed patient
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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): 40.0-90.0, Chronic Obstructive Pulmonary Disease Post-bronchodilator forced expiratory volume in 1 sec (FEV1) 30-79% predicted and FEV1/forced vital capacity (FVC) <70% 2. Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding 6 weeks 3. Male or female ≥40 yrs of age 4. Cigarette smoking history ≥20 pack-years 5. Moderate-to-severe chronic activity-related dyspnea as defined by a modified MRC dyspnea scale ≥2, COPD Assessment Test score ≥10 or Baseline Dyspnea Index focal score ≤6 (47-49) 6. Ability to perform all study procedures and provide/sign informed consent Women of childbearing age who are pregnant or trying to become pregnant 2. Diffusing capacity of the lung for carbon monoxide (DLCO) value of <40 %predicted 3. Active cardiopulmonary disease other than COPD that could contribute to dyspnea and exercise limitation 4. History/clinical evidence of asthma, atopy and/or nasal polyps 5. History of hypercapnic respiratory failure or a clinical diagnosis of sleep disordered breathing 6. History of allergy or adverse response to fentanyl 7. Important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s) 8. Use of daytime oxygen or exercise-induced O2 desaturation to < 80% on room air 9. Body mass index (BMI) <18.5 or ≥35.0 kg/m2 10. Use of antidepressant drugs (i.e., monoamine oxidase inhibitors, serotonin reuptake inhibitors) in previous 2 weeks 11. Use of opioid drugs (e.g., morphine, fentanyl, oxycodone, codeine, etc.) in the previous 4 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): 18.0-85.0, Heart Failure Hospital admission within the 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation. 2. All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm. 3. All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mEq/L (mmol/L). 4. Biomarker for persistent congestion: 5. At Screening, NT-proBNP > 2,500 pg/mL. 6. At the time of Randomization (within 2 days prior to discharge), NT-proBNP > 1,500 pg/mL (to ensure the persistence of congestion) that has decreased by more than 10% compared to Screening (to ensure the acuity of the index episode). 7. At 1 week prior to admission, at Screening, and at Visit 2 (just prior to Randomization) either (a) <= ½ the optimal dose of ACEi/ARB/ARNi (see Table) prescribed, no beta-blocker prescribed, and <= ½ the optimal dose of MRA prescribed or (b) no ACEi/ARB/ARNi prescribed, <= ½ the optimal dose of beta-blocker prescribed, and <= ½ the optimal dose of MRA prescribed. 8. Written informed consent to participate in the study Age < 18 or > 85 years. 2. Clearly documented intolerance to high doses of beta-blockers. 3. Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB). 4. Mechanical ventilation [not including continuous positive airway pressure (CPAP)/bilevel positive airway pressure (BIPAP)] in the 24 hours prior to Screening. 5. Significant pulmonary disease contributing substantially to the patients' dyspnea such as forced expiratory volume during the 1st second (FEV1)< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism. 6. Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening. 7. Index Event (admission for AHF) triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular arrhythmia <45 beats per minute), infection, severe anemia, acute coronary syndrome, pulmonary embolism, exacerbation of chronic obstructive pulmonary disease (COPD), planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion. 8. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy. 9. History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device. 10. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated. 11. Presence at Screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion of the left ventricular outflow tract. 12. Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated white blood cells (WBC) or need for intravenous antibiotics. 13. Stroke or transient ischemic attack (TIA) within the 3 months prior to Screening. 14. Primary liver disease considered to be life threatening. 15. Renal disease or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 [as estimated by the simplified Modification of Diet in Renal Disease (MDRD) formula] at Screening or history of dialysis. 16. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy < 6 months. 17. Prior (defined as less than 30 days from screening) or current enrollment in a congestive heart failure (CHF) trial or participation in an investigational drug or device study within the 30 days prior to screening 18. Discharge for the AHF hospitalization anticipated to be > 14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and within 2 days prior to anticipated discharge. 19. Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures 20. Pregnant or nursing (lactating) women
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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, COPD OSA Home Exercise Inflammation Veterans from the Salem VAMC pulmonary clinics will be screened for a diagnosis of OSA and treatment with CPAP therapy. In addition, an criterion also will be a recent PFT diagnostic of COPD (FEV1/FVC <0.7 and FEV1< 80%). Only Veterans with OS who are compliant with CPAP therapy will be enrolled in the study orthopedic problems, fall-risk, balance problems any regular participation in structured exercise sessions other concomitant sleep disorder unstable cardiovascular or pulmonary disease acute infectious illness in the prior month hospitalization in prior month prescription of systemic glucocorticoids or immune-suppressive agents in the prior month and weight above 330 pounds, the limit allowed by the Wii pressure sensor floor mat
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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): 19.0-80.0, Obstructive Sleep Apnea Age 19-80 years old who are able to freely provide informed consent Prior participation in the study Have been optimally titrated to PAP and MAS therapy Have both PAP and MAS appliances at home and ready for use Body mass index (BMI) of 35 or less ≥ 8 teeth per arch to support treatment with MAS Have an objective of diagnosis of OSA based on the following an Apnea-Hypopnea Index (AHI) within the range 10 ≤ AHI ≤ 70 documented with polysomnography in the last 2 years; ***OR*** a Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 70 documented with level III portable sleep test; ***OR*** an Oxygen Desaturation Index (ODI) ≥ 10 Use of a full face mask as the PAP interface Extensive periodontal disease with significant tooth mobility Inability to protrude jaw Insufficient vertical opening to accommodate treatment with MAS Uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cut-off of 40% or clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe in the opinion of the investigators for the subject to participate in the trial Coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease Any history of angina, myocardial infarction or stroke Any history of major depressive disorder along with current moderate-severe disease Active cancer management (unless in remission for more than 1 year) Known renal failure (with need for dialysis)
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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, Dietary Modification Diabetes Hypertension Health Behavior Full time employees of DH-KUH years or above of age Score 30 or more on Indian Diabetes risk score, No confirmation of diabetes and, not on diabetes medication. OR Have HbA1c of 5.7% to 6.4%. OR Prediabetes group with Fastening Blood Sugar (FBS) of 100 mg/dL Systolic blood pressure 120 mm Hg or more or Diastolic blood pressure 80 mm Hg or more and not on blood pressure medication Less than 18 years On diabetes medication On hypertension medication
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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, PAH Males and females between 18 to 80 years of age inclusive at Screening Weight ≥40 kg Must have a diagnosis of WHO Group 1 PH Have a World Health Organization (WHO) Classification of Functional Status Class II or III of patients with PH Must meet hemodynamic by means of a right heart catheterization Meet pulmonary function test parameters A 6 MWD test of ≥125m and ≤550m at the visit Subjects must have a resting arterial oxygen saturation (SaO2) ≥90%, with or without supplemental oxygen, as measured by pulse oximetry at Screening Subjects enrolled in a prescribed exercise program for pulmonary rehabilitation must be in a stable program for 3 months prior to Screening (Visit 1) and must agree to maintain their current level of rehabilitation throughout the study. If subjects are not enrolled in a prescribed exercise training program for pulmonary rehabilitation, they cannot enroll during the Screening/Baseline Period or throughout the study If receiving simvastatin-containing products: dose should not exceed 20 mg/day Contraindications for CMRI imaging WHO Groups 2, 3, 4 and 5 Pulmonary Hypertension Unrepaired congenital heart defects and significant congenital heart defects (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) repaired less than 1 year prior to Screening (Visit 1) (Group 1 classification of Pulmonary Hypertension) QTcF > 500 msec Acute myocardial infarction or acute coronary syndrome within the last 90 days Cerebrovascular accident/transient ischemic attack (CVA/TIA) within the last 90 days Hospitalization for left heart failure within the last 90 days Clinically significant aortic or mitral valve disease defined as greater than mild regurgitation or mild stenosis; pericardial constriction; restrictive or constrictive cardiomyopathy; left ventricular dysfunction (LVEF < 50%); left ventricular outflow obstruction; symptomatic coronary artery disease; autonomic hypotension; or fluid depletion Chronic atrial fibrillation and life-threatening cardiac arrhythmias Personal or family history of congenital prolonged QTc syndrome or sudden or sudden unexpected death due to a cardiac reason
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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): 20.0-85.0, Atrial Functional Mitral Regurgitation Heart Failure NYHA(New York Heart Association) Class III and, Functional Mitral Regurgitation 3+ (Moderate/Severe) or 4+ (Severe) in spite of optimal medical treatment. (For optimal medical treatments, ①ACE inhibitor or angiotensin receptor blocker ②β-blocker ③ aldosterone antagonists should be given for at least 3 months unless the subject has contraindication for each drug) and, Chronic Atrial Fibrillation in electrocardiography (Persistent AF or Permanent AF) Primary Mitral Regurgitation LV ejection fraction lower than 30% Pulmonary arterial pressure ≥ 60mmHg End-diastolic Left ventricular dimension ≥ 70mm Subjects with functional MR who need CABG or AVR performed Pre-existing stent in a coronary artery that is deemed to be in direct contact with the path of mitral loop cerclage along coronary sinus Subjects who have functional MR caused by aortic valve disease Subjects who have uncontrollable hyperthyroidism Subjects who have severe TR due to primary valve leaflet disease Anomaly of Coronary Sinus
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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 Pulmonary Hypertension Men and women 2. 18 years of age. 3. Outpatients with chronic HF. NYHA class II-III on optimal treatment in sinus rhythm or atrial fibrillation 4. LVEF ≤ 40% measured during the past 12 months 5. SPAP ≥ 40mmHg using echocardiography 6. 6MWTD < 475 meters 7. NT-pro BNP ≥ 400 pg/ml or BNP ≥100 pg/ml, measured during the past 12 months 8. Receiving optimal therapy, including diuretic, ACE-inhibitor, ARB, beta-blocker and aldosterone antagonist. Doses of all medication should be unchanged during the last 30 days before inclusion. 9. ICDs and CRTs (CRT-P, CRT-D) are permitted. Implantation should have been performed at > 3 months before to the trial - 1. Acute Coronary Syndrome, including myocardial infarction, or coronary angiography, with or without intervention, within the last 3 months 2. Stroke within the last 3 months 3. Planned coronary angiography or planned device-implantation 4. Moderate to severe obstructive valve disease 5. Documented episodes of sustained ventricular tachycardia 6. Prior (past 30 days before the baseline visit) or ongoing use of oral nitrate therapy. 7. Concomitant disease which interfere with assessment of dyspnea , severe COPD, asthma, restrictive lung disease, severe obesity 8. Anemia (hemoglobin < 10g/dL) 9. Uncontrolled hypertension ( SBP >160 mmHg and / or DBP > 90 mmHg) 10. Symptomatic or orthostatic hypotension or systolic blood pressure < 90 mmHg 11. Clinically important renal dysfunction (GFR < 40m ml/min) 12. Women with child-bearing potential 13. Prior (past 30 days before the baseline visit) or ongoing use of i) alpha-1 antagonist: doxazosin ii) CYP3A4 inhibitors: erytromycin, ritonavir, sakinovir, itrakonazole, ketokonazole iii) CYP3A4-inducers: rifampicin iv) Any calcium channel blockers 14. V) Pulmonary vasodilators at the treatment dose level for Pulmonary hypertensionRetinitis pigmentosa, previous diagnosis of NAION (non-arteritic ischemic opticus-neuropathy), unexplained visual disturbance. 15. Sickle cell anemia, multiple myeloma, leukemia or penile anatomic deformities (angulation, cavernosal fibrosis, Peyronie's disease) that increases the risk of priapism. 16. Hepatic failure. 17. Drug and alcohol abuse which precludes compliance with the protocol. 18. Inability to understand or sign the written informed consent form of 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): 4.0-95.0, Healthy Subjects Chronic Obstructive Pulmonary Disease Asthma Interstitial Lung Disease Upper Airway Obstruction for healthy subjects life-long non-smokers no symptoms and history of chronic cardiopulmonary diseases (chronic bronchitis, asthma, lung cancer, pulmonary fibrosis, pulmonary tuberculosis, chronic heart diseases, etc.) no abnormal findings on physical examination written informed consent was obtained for COPD Diagnosis of chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and post-bronchodilator FEV1/FVC (forced vital capacity) < 70%. for asthma Diagnosis of asthma, as classified by national and international asthma guidelines. for ILD ILD diagnosis confirmed by lung biopsy, X ray or BALF analysis. for UAO Diagnosis of UAO for healthy subjects upper or lower respiratory infection within 4 weeks long-term exposure to harmful gas or particles using β-blocker for treatment pregnant women, epileptic other diseases or surgeries potentially affecting lung function
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