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70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 19.0-999.0, Respiratory Tract Infections Corona Virus Infection COVID SubStudy Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol Men and Women ≥ 19 years of age unless local laws dictate otherwise English speaking Suspected of exposure to SARS-CoV-2 with fatigue and at least a fever (>37.90 C) or cough or sore throat or a positive swab for SAR-CoV-2 within 5 days of the of enrollment Must be willing to use an adequate form of contraception (or abstinence) from the time of the first dose with the IMP until after the last dose of IMP Prior Tracheostomy Concomitant treatment involving high flow nasal cannula Any clinical contraindications, as judged by the attending physician Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study Prior COVID-19 infection or a positive swab for SARS-CoV-2 greater than 5 days from enrollment Family members in the same household already on the study Hydroxychloroquine, colchicine and other experimental antiviral medications unwilling to practice a medically acceptable form of contraception from screening to Day 26 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent). Recruitment on hold for following during COVID-19 Pandemic Written informed consent Has been previously diagnosed with NTM, Burkholderia spp and Aspergillus spp. or Corona-like viral infection: 1. NTM, Burkholderia spp and Aspergillus spp defined as positive culture(s) of at least one species of Mycobacterium avium Complex (MAC) or Mycobacterium abscessus Complex (MABSCor Burkholderia spp and Aspergillus spp) or Corona-like viral infection: 2. History of repeatedly positive cultures (2 or more), irregardless of therapy | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | 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) | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Hepatitis B Vaccines Any gender Age ≥ 18 years In stable health as determined by a physical examination and laboratory tests values. Common chronic conditions such as, but not limited to, type 2 diabetes, high blood pressure, Chronic Obstructive Pulmonary Disease (COPD) and asthma will be accepted if the condition is well controlled, as determined by the investigator, and not meeting the For subjects > 65 years old, Frailty Index ≤3 If female, either is not of childbearing potential or is of childbearing potential and must agree to use an adequate birth control method during the screening period and until the end of her participation in the study Able and willing to give consent Previous vaccination with any Hep B vaccine (licensed or experimental) Treatment by immunosuppressant within 30 days of enrollment including but not limited to corticosteroids at a dose that is higher than an oral or injected physiological dose, or a prednisolone-equivalent dose > 20 mg /day (Inhaled and topical steroids are allowed) Known history of immunological function impairment Pregnancy or breastfeeding Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment Immunization with inactivated vaccines (e.g. influenza) within 2 weeks prior to enrolment Has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 50.0-80.0, Total Knee Arthroplasty Meet the diagnostic for knee osteoarthritis Planned spinal anesthesia; American Society of Anesthesiologists (ASA) physical status I-II Scheduled for unilateral TKA Patients aged 50 to 80 years old Willingness to give written informed consent and willingness to participate in and comply with the study Unwillingness of the patient Presence of neuropathic pain or sensory disorders in the leg to be operated on Intolerance to the study drugs Failure of spinal anesthesia Previous major knee surgery, re-operation or trauma to the knee within the study period | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-85.0, Ventricular Tachycardia Ischemic Cardiomyopathy Ischemic cardiomyopathy with reduced ejection fraction (EF ≤ 40%) estimated by cardiac MRI or echocardiography within 30 days before enrollment 2. Coronary Chronic Total Occlusion (CTO) associated with a previous MI confirmed by coronary angiography and late gadolinium enhancement MRI or myocardial perfusion imaging within 30 days before enrollment 3. Implantable cardioverter-defibrillator (ICD) indication for primary prevention 4. Patient has provided written informed consent Age < 18 years or > 85 years 2. Documented sustained ventricular tachycardia before enrollment 3. Class IV New York Heart Association (NYHA) heart failure 4. CTOs not associated with a prior infarction in their territory 5. Acute myocardial infarction (MI) or acute coronary syndrome 6. Subjects with active ischemia that are eligible for revascularization 7. Documented history of MI less than 6 months before enrollment 8. Patients requiring chronic renal dialysis 9. Thrombocytopenia or coagulopathy 10. Pre-existing implantable cardioverter-defibrillator (ICD) 11. Pregnancy or breastfeeding women 12. Acute illness or active systemic infection 13. Life expectancy less than 12 months 14. Unwillingness to participate or lack of availability for follow-up 15. Valvular heart disease or mechanical heart valve precluding access to the left ventricle | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | 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 | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Obstructive Sleep Apnea Age: >40 years Primary language: English Diagnosed with both Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) Prescription for positive airway pressure therapy (PAP). There should be no minimum or maximum flow required (i.e., no limitation on PAP modality) Access to the internet viand a PC, tablet, or smart phone to complete all study activities from home or remotely PAP device with wireless modem Non-English speakers Life expectancy less than or equal to six months | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | 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 | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-80.0, Obesity Hypoventilation Syndrome aged between 18 and 80 years Obesity hypoventilation syndrome diagnosis (OHS) clinically stable for at least 4 weeks prior to the enrolmenT above-elementary school education refusal to participate refusal of PAP therapy central sleep apnea syndromes restrictive ventilation syndromes severe congestive heart failure a history of life-threatening arrhythmias severe cardiomyopathy significant chronic kidney disease untreated hypothyroidism family or personal history of mental illness | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Ventricular Tachycardia Patients undergoing ventricular tachycardia patients with ischemic cardiomyopathy according to European Society of Cardiology Guidelines patients with implanted cardiac defibrillator Contra-indication to stress test permanent atrial fibrillation permanent ventricular pacing left bundle block | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Hypoxia Regardless of gender, at least 18 years of age and diagnosed with Hypoxia (PaO2/FiO2 < 380 mm Hg), dyspnea, respiratory rate (RR) ≥ 25 CPM, PaCO2 ≤ 45 mmHg, patient with an arterial catheter and without hemodynamic instability, Glasgow Coma Scale ≥ 12/15, written consent. Participants were also required to have a sufficient level of education to understand study procedures and be able to communicate with site personnel Patients were excluded if they Hypercapnia (> 45 mm Hg with respiratory acidosis), COPD, pulmonary fibrosis, hypoventilation obesity syndrome, arterial pressure < 60 mm Hg or treatment by epinephrine > to 0,1 gamma/kg/minute, deterioration of awareness (Glasgow scale < or = 12), acute confusional state. Participants were randomized in a 1:1 ratio to receive either classical oxygenation with nasal cannula (NC) for 20 minutes or NC with an adjunctive of a Double Trunk Mask | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 30.0-70.0, Osteoarthritis symptomatic early knee OA full weight-bearing status have elected to receive PRP treatment Male veterans Female veterans or non-veterans inflammatory arthritis, gout or recurrent pseudogout symptomatic OA of other lower extremity joints BMI >35 kg/m2 use of walking, orthopedic, or prosthetic assistive device severe systemic disease defined as American Society of Anesthesiologists (ASA) 3 or above56 inability to have MRI pregnant or intending to become pregnant during the study predominantly patellofemoral disease | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 35.0-999.0, COPD Exacerbation Hypoxia Hyperoxia Respiratory Failure Respiratory Insufficiency Copd Exacerbation Acute COPD verified by FEV1/FVC < 0,70 Admission due to exacerbation in COPD COPD exacerbation and pneumonia can be included Duration of admission > 48 hours Need for oxygen supplementation at (SpO2 <= 88 % without O2 suppl.) Cognitively able to participate in the study Willing to participate and give informed consent Need or anticipated need for mechanical ventilation (except intermittent CPAP) Major co-morbidities (cancer, heart disease, thromboembolic disease, uncontrolled diabetes) Asthma or other respiratory condition requiring higher SpO2 than normal for COPD- patients Pregnancy Acute thromboembolic disease (< 2 weeks) Cognitive barriers for participation | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-70.0, Overweight and Obesity Body mass index (BMI) between 25-45 kg/meters-squared one or more cardiovascular risk factor (type 2 diabetes, hypercholesterolemia, or hypertension) currently in another active weight loss program taking weight loss medication currently pregnant, lactating <6 months post-partum plan to become pregnant during the next 12 months a medical condition that would affect the safety of participating in unsupervised physical activity inability to walk 2 blocks without stopping | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Pulmonary Disease, Chronic Obstructive Age > 18 Known Chronic Obstructive Pulmonary disease (COPD) respiratory rate or presence of accessory respiratory muscles activity on physical exam moderate exacerbation of COPD as defined by an arteria pH between 7.25 and 7.35 and an arterial carbon dioxide partial pressure (PaCO2) equal or above 45 mm Hg Age below 18 Pregnancy Known sleep apnea syndrome Patent treated by noninvasive ventilation at home Not affiliated to French scial security Contraindication to aither Noninvasive ventilation or to High-Flow Nasal Oxygen therapy Previous in the study | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Critical Illness Family Members Psychological Distress Informal Caregivers Palliative Care ≥18 years of age Receive mechanical ventilation in a study ICU for ≥48 hours under care of a study ICU physician (pre-consent) Decisional capacity Death expected within 24 hours Admission to an ICU at the index hospital >14 days Comfort care or withdrawal of treatment planned Imprisoned Extubated and possess decisional capacity prior to informed consent Died before T2 survey complete No known family or surrogate Care assumed by a non-study ICU attending after consent by patient/family but before T1 | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Hypoventilation Syndrome Chronic Obstructive Pulmonary Disease Obesity Hypoventilation Syndrome Restrictive Lung Disease Neuromuscular Diseases Patients with chronic hypercapnic respiratory failure secondary to one or more identified condition(s) (chronic obstructive pulmonary disease, obesity hypoventilation syndrome, neuromuscular diseases, restrictive lung diseases) Home mechanical ventilation for ≥ 6 months Stable condition for ≥ 1 month Previous adjustment of the noninvasive ventilation therapy under sleep studies in the last 6 months Current respiratory exacerbation Any current comorbidity decompensation Any medical or psychological condition impairing the patient's ability to provide informed consent Missing signed informed consent Total sleep time during polysomnography <180 min | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Apnea, Obstructive Sleep Pregnancy Complications Pre-Eclampsia Obesity age >18 years BMI > 35 > 24th weeks of pregnancy informed consent health assurance no informed consent twin pregnancy or more no health assurance | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 20.0-65.0, Obstructive Sleep Apnea Obesity BMI ≥40 kg/m² and ≤ 49,9 kg/m² Female and male patients (Both of gender patients) with ages between 20 to 65 years old Obstructive Sleep Apnea (OSA) diagnosis by polysomnography sedative drugs users Oxygen-dependent or decompensated lung disease Decompensated congestive heart failure Signs and symptoms of other sleeping disorders (narcolepsy, restless legs syndrome, insomnia) craniofacial deformities carriers previous OSAS Diagnosis and treatment Active Oncological diseases in the last ten years Patients with less than 8 teeth per arcade Patients with advanced periodontitis | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-80.0, Ventricular Tachycardia 80 years old, both males and females Single or dual chamber ICD or BiVentricular ICD in situ Ischemic or non-ischemic cardiomyopathy Receive a single shock from their ICD for monomorphic ventricular tachycardia ICD shock for polymorphic VT/VF or inappropriate shock Previous ventricular tachycardia ablation within 1 year NYHA Class IV heart failure or current inotrope therapy Ventricular tachycardia storm Listed for heart transplant or LVAD Pregnant as determined by urine pregnancy test prior to NIPS | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Incisional Hernia Malignancy scheduled operative treatment due to malignant tumor of the alimentary system (including liver, bile ducts, and pancreas) through transverse incision in the epigastric region provision of informed consent to participate in the study necessity to perform an urgent operation a history of previous surgery performed with transverse incision in the epigastric region body mass index >35 kg/m2 | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obesity Hypoventilation Syndrome Obesity Hypoventilation Syndrom defined by a diurnal PaCo2> 45 mmHg, in stable conditions, in a patient presenting an obesity (BMI > 30 kg/m²) treated by non invasive ventilation since at least 3 weeks, and seen in follow-up consultation minors refusal to participate under guardianship or trusteeship pregnant woman other etiology of hypoventilation : copd, kyphoscoliosis, neuromuscular disorders, diaphragmatic pathology | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-85.0, Chronic Obstructive Pulmonary Disease chronic obstructive pulmonary disease (COPD) on long term oxygen therapy (LTOT) affiliated to French social security system or equivalent informed consent signed Diurnal PtCO2 >55mmHg Patient who has had an exacerbation of COPD requiring a change in management or treatment in the last 4 weeks prior to the visit Pregnant or breathfeeding women Prisonners or persons who require protection by the law period from another study Persons who, according to the investigator, are expected no to meet all study obligations | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, Chronic Disease Children attending the High-Risk Children's Clinic or more chronic conditions High healthcare utilization in the year prior to enrollment (of ≥3 ED visits, ≥2 hospitalizations, or ≥1 pediatric ICU admissions) >50% estimated risk of hospitalization in the year after enrollment (as judged by Program's Director [Dr. R. Mosquera] based on patient's diagnosis, clinical course, and socioeconomic risk factor) Unrepaired congenital heart disease Mitochondrial disorders Active cancer Do-Not-Resuscitate (DNR) order Patients receiving compassionate care No Internet access | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Ventricular Tachycardia history of sustained monomorphic VT or termination of monomorphic VT by ICD (appropriate therapy) during previous 6 months prior to enrollment implantation ICD inducibility at least one of monomorphic ventricular tachycardia by ICD during EP study with programmed ventricular stimulation history of myocardial infarction (MI) left ventricular scar and decreased systolic function of the left ventricle (ejection fraction of left ventricle less than 40%) based on transthoracic ultrasound stable chronic heart failure (NYHA II-III) older than 18 years signed an IRB approved written informed consent document failed at least one invasive catheter ablation procedure or have a contraindication to a catheter ablation procedure acute myocardial infarction chronic heart failure NYHA IV channelopathy reversible cause of VT (e.g. ionic dysbalance, intoxications) pregnancy or breastfeeding history of chest radiotherapy arrhythmic substrate larger than 100 ccm | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Stroke Diaphragmatic Function Men and women (age ≥ 18 years), hospitalized in the neuro-vascular or neurology department of the Groupe hospitalier Paris Saint-Joseph First episode of ischemic or hemorrhagic stroke diagnosed in the imaging and responsible for a unilateral motor deficit Minimum National Institute of Health Stroke Score of 5 for the total of items 4, 5 and 6 (paralysis facial and functioning of upper and lower limbs) Patient with medical insurance Francophone History of neuromusclar pathology History of severe chronic respiratory pathology Malformation, chronic lesion or surgery of the diaphragm Recent thoracic and abdominal surgery National Institute of Health Stroke Score > 20 Limiting health care or life support patient Impossibility to understand and to make simple orders (whatever is the cause: change of consciousness, cognitive disorders, aphasias, etc...) Major handicap before stroke (Rankin modified score) Refusal to participate in the study Patient under guardianship or curatorship | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 50.0-85.0, Cardiovascular Diseases Cardiovascular Disease 1. be able to give written, informed consent 2. be diagnosed with CVD 3. be between 50-85 years old 4. be postmenopausal, meaning having had cessation of menses for at least 12 consecutive months Healthy Control 1. be able to give written, informed consent 2. no CVD conditions 3. be between 50-85 years old 4. be postmenopausal, meaning having had cessation of menses for at least 12 consecutive months (Both Groups): 1. chronic kidney/renal disease 2. chronic heart failure 3. neuromuscular disease 4. known cancer 5. already supplementing with antioxidants or vitamins within 5 days of the study 6. pregnant or nursing women | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea Chronic Obstructive Pulmonary Disease Kaiser Permanente member Males or females, any race, and age 18 and older OSA-predominant (AHI at or above 5) sleep disordered breathing Primary diagnosis upon admission of chronic obstructive pulmonary disease Appropriate to perform portable sleep study while on room air (no oxygen) Patients who are able and willing to give informed consent Use of CPAP within 6 months of enrollment Patients with CSA-predominant sleep disordered breathing Patients who are "sleepy": ESS at or above 11 Commercial driver's license or other occupational hazards (operating heavy machinery) Non-English speaking (validated questionnaires are currently limited to English) Patients with chronic respiratory failure requiring oxygen therapy or non-invasive ventilation Patients requiring tracheostomy Pregnant patients | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 35.0-999.0, COPD Exacerbation Hypoxia Hypoxemia Hyperoxia Respiratory Failure Respiratory Insufficiency Copd Exacerbation Acute COPD verified by Forced Expiratory Volume in 1. second (FEV1) divided by Forced Vital Capacity (FVC) < 0,70 Admission due to exacerbation in COPD COPD exacerbation and pneumonia can be included Expected duration of admission > 48 hours Need for oxygen supplementation (SpO2 <= 88 % on room air) Cognitively able to participate in the study Willing to participate and give informed consent Need or anticipated need for mechanical ventilation (intermittent Continuous Positive Airway Pressure (CPAP) is allowed) Major comorbidities causing hypoxemia (Cancer, heart disease, pulmonary emboli) Asthma or other respiratory condition requiring higher SpO2 than normal for COPD Pregnancy Cognitive barriers for participation | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-75.0, Bowel; Functional Syndrome The rectal adenocarcinoma is proved by pathology before surgery The lower margin of the tumor is less than 12cm higher from the anal verge under no anesthesia measured The tumor can be excised discussed by MDT Anus preserving operation can be performed ECOG score ranges between 0 and 2 The estimate life is supposed to be more than 12 months The informed consent should be signed The patient can not follow the experimental scheme The case is an emergency The patient is in pregnant or breast-feeding TME surgery can not be performed One-stage anastomosis can not be performed The patient has a history of anus surgery or rectal surgery The patient has a history of left hemicolectomy The patient has a long history of bowel dysfunction，such as diarrhea or dysporia before surgery The patient has cognitive disorder or communication disorder The patient has repeat infection or other disorders poorly controlled | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-100.0, Pulmonary Disease, Chronic Obstructive Criteria:• Enrollment in the CATCH Study program Adults 40 years and older, as per of the CATCH study Subjects with diagnosis of COPD (with and without chronic respiratory failure) Gold 3 & 4 Ability and willingness to correctly execute and comply with study requirements o Ability and willingness to use the Life2000 Ventilation System a minimum of 6 hours/day (24 hr period) Requirement of supplemental oxygen to maintain an SpO2 > 88% at rest or during exercise Acceptable health status as assessed by medical history and/or physical exam Fluency in written and spoken English language Provision of written informed consent to participate in the study • History of pneumothorax secondary to lung bullae Musculoskeletal or other non-pulmonary impairment that limits exercise tolerance Intolerance or unwillingness to utilize the Life2000 Ventilation System Women who are pregnant or nursing a child Presence of any condition or abnormality that in the opinion of the principal investigator may compromise the subject's safety or the quality of the study data | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-70.0, Obstructive Sleep Apnea Hypoxia Insulin Resistance Sixty nondiabetic men and women Ages 40-70 BMI 25 to 35 kg/m2 Participants newly diagnosed obstructive sleep apnea (OSA) must meet the for one of the two following groups OSA with hypoxia (H-OSA) defined as those with an H-AHI≥15 so as to match the NH-OSA subjects in event frequency and because this is the range defined as more than mild OSA such that we would be likely to see pathology associated with OSA; or OSA without hypoxia (NH-OSA) defined as having a rate of non-hypoxic respiratory events ≥ 15 per hour (NH-AHI≥15) and having a rate of hypoxic events of less than 5 per hour (H-AHI<5,(52)) Type 1 or 2 diabetes mellitus (fasting glucose ≥126 mg/dL or 2-h glucose ≥200 mg/dL or Hgb A1c ≥6.5%) History of chronic obstructive pulmonary disease (COPD) or parenchymal lung disease Unstable hypertension Treatment for asthma Current tobacco use Current alcohol consumption exceeding 1 drink/day in women and 2 in men HIV infection or infectious hepatitis Pregnancy or lactation within the past six months Use of any hypolipidemic agent History of surgery for obesity | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obesity Obstructive Sleep Apnoea Syndrome Patient with moderate to severe OSA (apnea and hypopnea index > 15/h) for whom a CPAP is indicated Obese patient (body mass index > 30 kg/m2) Adult Patient Patient who has given oral consent Patient speaks and reads French Patient affiliated to a the national health insurance system Person subject to a legal protection measure (curatorship, guardianship) Person subject to a measure to judiciary protection Pregnant, parturient or breastfeeding woman Major unable or unwilling to consent Psychiatric, cognitive or neurological disorders making it impossible to assess food preferences Eating disorders (anorexia, bulimia) Patient suffering from an acute infection, progressive cancer or under treatment interfering with taste (anti-cancer, antibiotics...) Patient consuming alcohol daily Patient who smokes actively or has quit for less than 6 months Weight change of more than 10% in body weight in the six months before | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-75.0, Lipedema Obesity, Morbid weight stable over the last three months (+ 2-3 kg) not currently dieting to loose weight willing to meet for weekly follow-ups during the intervention and the reintroduction of a regular diet sign an informed consent before entering the study pregnant or breast feeding history of infectious diseases medication known to affect obesity enrolment in any other obesity treatment have had a bariatric surgery history of psychological disorders mentally disabled not mastering a Scandinavian language having a malign disease or any disease that leads to dietary advice that is not consistent with intervention advices in the study | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 50.0-999.0, Dementia Psychiatric Disorders Mood Behavior Disorders Score <26 on the Alabama Brief Cognitive screen or <24 on the Montreal Cognitive Assessment. 2. Have a caregiver/informant/family member who spends at least 10 hours per week with the affected person and who is willing to participate 3. Be rated by a caregiver/informant as scoring ≥9 on the Functional Activities Questionnaire, including at least one domain score of 3 (dependent). 4. Have BPSD sufficient for the treating clinician to begin or change psychotropic drugs, and of sufficiently mild severity that a delay of 5 days before changing the prescription would not be harmful to the patient BPSD of sufficient severity or intensity that (in clinician's opinion) require immediate medication change or referral for emergency services 2. Lack of reliable informant with adequate exposure to patient and ability to communicate with study staff in English | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, COPD Exacerbation COPD Patients with COPD with two or more exacerbations every year or at least one leading to hospitalization long-term oxygen therapy cognitive impairment a life expectancy limited to one year | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 5.0-12.0, Functional Abdominal Pain Syndrome functional abdominal pain according to Rome III consent to participate in the study positive decision of gastroenterologist concerning enrolment of the patient to the trial organic causes for gastrointestinal tract disorders occurrence of an abdominal migraine, IBS, food allergies or intolerances, other significant disorders, acute infection antibiotic treatment within the last 8 weeks | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease Age 18 years or older; 2. Physician diagnosis of COPD; 3. Hospitalized as an inpatient, 23-hour observation, or clinical decision unit 4. Admitting respiratory conditions sensitive to the Centers for Medicare and Medicaid Services Hospital Readmission Reduction Program as listed below COPD exacerbation Asthma/COPD overlap Decompensated heart failure Pneumonia Chronic Airway Disease Physical inability to participate in a walking program; 2. Oxygen saturation <90% by pulse oximetry refractory to supplemental oxygen, or in a patient unable or unwilling to use supplemental oxygen; 3. Fall in the previous 6 months; 4. Resting electrocardiogram (ECG) with new ST changes or tachyarrhythmia; 5. Planned discharge home to hospice or to long term care facility/skilled nursing facility; 6. Life expectancy <3 months; 7. Medical contraindication to participating in a physical activity promotion program as determined by the inpatient treating clinician; 8. Unable to communicate in English; 9. Unable or declines to provide informed consent | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Hip Arthropathy Regional Anesthesia Patients undergoing primary hip arthroplasty ASA 1, 2, and 3 Patients age ≥18 years Patient refusal Inability to understand and sign consent Infection at the injection site Known allergy or hypersensitivity to ropivacaine or other amide local anesthetics Contraindication or patient refusal to get spinal anesthesia Thrombocytopenia (platelets < 100,000) Coagulopathy (INR > 1.4) Use of anticoagulant drugs that have not been discontinued in an appropriate amount of time before the surgery ASA 4 and 5 | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Chronic Respiratory Failure COPD Obesity Hypoventilation Syndrome Patient established on home non invasive ventilation for more than 6 months With a compliance >4hours/day Who brought their ventilator for the assessment Diagnosed with COPD or Obesity hypoventilation syndrome (OHS) Who consent With an age > 18 years Age under 18 Ongoing exacerbation Not able to consent Pregnant or breastfeeding | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 2.0-12.0, Obstructive Sleep Apnea Hypopnea Syndrome Age between 2 and 12 years child having performed a ventilatory polygraph for suspicion of obstructive hypopnoea apnea syndrome over 12 years old | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 30.0-999.0, Ventricular Tachycardia Patients with structural heart disease (ischemic and non-ischemic cardiomyopathy, previous surgery for congenital heart disease) Implanted ICD or CRT-D (cardiac resynchronization therapy defibrillator) Prior ≥1 catheter ablation procedure for monomorphic VT VT recurrence early (<12 months) after the last ablation with at least 2 episodes of recurrent VT, including 1 episode while on amiodarone (if not contraindicated) Age ≥30 years Signed an IRB-approved (Institutional Review Board) written informed consent Acute myocardial infarction or recent percutaneous coronary intervention (PCI) or cardiac surgery (<3 months) Primary electrical disease (channelopathy) Reversible cause of VT (e.g. drug-induced, intoxications, etc) Pregnancy or breastfeeding Chronic heart failure New York Heart Association (NYHA) Class IV Serious comorbidities with presumed life expectancy less than one year Significant peripheral artery disease precluding retrograde aortic mapping History of chest radiotherapy | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 7.0-12.0, Irritable Bowel Syndrome Functional Abdominal Pain Syndrome Functional Gastrointestinal Disorders Functional Bowel Disorder Functional Abdominal Pain Functional Abdominal Pain Disorders A child 7-12 years of age with a FGID will be recruited if the medical evaluation reveals no organic reason for the abdominal pain and the child has abdominal pain that meets the definition of a FGID (i.e., IBS, functional abdominal pain) according to the pediatric Rome III (Rome IV will be substituted when validated). Parents and children must speak and understand English because of the psychological assessment and CBT requirements Children who have: had past bowel surgery; documented GI disorders (e.g., Crohn's disease); a serious chronic medical condition (e.g., diabetes); weight and/or height < 2 SD for age; chronic conditions with GI symptoms (e.g., cystic fibrosis); autism spectrum disorder, significant developmental delay, psychosis, or a history of bipolar disorder; been treated with antibiotics/probiotics within 2 mo. (because of effects on gut microbiome analysis), and children who for some reason could not be randomized to the low diet.Vegetarian; children who are currently on the Diet or receiving CBT Children who speak only Spanish are not eligible because the Rome questionnaire and psychological testing are not available in Spanish. Despite this, a large proportion of the children enrolled will be Hispanic | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 21.0-85.0, Major Depressive Disorder to 85 Years of age Diagnosis of Stage I, II or III cancer Histologically-proven malignancy Receiving or within one year of having received cancer treatment with radiation and/or chemotherapy Montgomery and Åsberg Depression Rating Scale (MADRS) ≥ 20 (moderate to severe depressive symptoms) Duration of depressive symptoms ≥ 2 weeks by patient report No active/acute suicidality requiring immediate care or psychiatric hospitalization Sufficient English language proficiency to complete all assessments without assistance Able to swallow pills No severe anemia, defined as hemoglobin < 10 g/dL Have a current or previous diagnosis of or history consistent with obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episodes, schizophrenia, major Axis II disorders which might compromise the study, or major depression with psychotic symptoms, as assessed using the MINI International Neuropsychiatric Interview (MINI Plus) Have a documented history of an intellectual disability Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for fluoxetine) Currently being treated with tamoxifen Subjects who were non-responsive to two or more courses of antidepressant medications given at an adequate dosage* for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (TRD), or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year Have a history of any seizure disorder Any clinically significant abnormal vital sign, ECG, or laboratory values as determined by the investigator which might interfere with the study Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). High suicidal risk is indicated by: 1. A positive response to question 4 or 5, indicating endorsement of suicidal ideation with at least some intent to act in the past month; and/or 2. A positive response to part two of question 6, indicating the presence of any suicidal behavior in the past 3 months Have a history of substance dependence/abuse** within the past 6 months or a positive drug screen result during the screening period Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Oxygen Toxicity COPD Exacerbation Hyperoxia Hypoxemia Hypoxic Respiratory Failure COPD or suspected COPD ( Age>40, active or smoking history > 10pack/years), - Acute exacerbation (increasing dyspnea recently) One or more of the following increased sputum, modification of sputum purulence,increased dyspnea Moderate oxygen therapy: Oxygen flow < 8 lpm (or FiO2 < 0.60) to maintain a SpO2 >or = 92% (for long term oxygen therapy, the oxygen flow must be greater than baseline flow to maintain SpO2 > or = 92%) Patient refusal COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiac pulmonary edema, pneumothorax or sedative overdose No SpO2 signal Encephalopathy score > 2 Delirium Other respiratory support needed (intubation or NIV) Patient on withdrawal life support Advance neoplasia (palliative stage) or terminal respiratory distress Unavailability of FreeO2 device at the randomisation Non optimal patient collaboration | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-80.0, Rib Fracture Rib Fracture Multiple Trauma Trauma Chest Trauma Injury Trauma, Multiple Adult person age 18-80 admitted with at least one acute traumatic closed rib fracture to the University of Vermont Medical Center Pediatric (<18 year old) and Geriatric (>80 year old) patients Patients who are intubated on arrival or within first 24 hours of admission or with Glasgow Coma Scale (GCS) < 14 (altered or depressed consciousness) Pregnant patients Patients who undergo operative rib fixation for their rib fractures (such as open reduction internal fixation, or rib plating) Patients with chest wall deformity, lacerations, burns, or soft tissue injuries that preclude placement of the RibFx belt Patients with an additional mechanism of injury that would create severe distracting pain, as determine by the admitting team Isolated 1st rib or 2nd rib fractures | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea Syndrome Moderate obstructive sleep apnea syndrome (AHI between 15 and 30 events per hour) Poor adherence to continuous positive airway pressure (< 4h per night) Craniofacial malformation Use of hypnotic medication Had stroke in the past Present a concurrent neuromuscular or severe obstructive nasal disease | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-80.0, Obesity Hypoventilation Syndrome patients with BMI > 30 and obesity-associated hypoventilation stages I patients with BMI > 30 and elevated OHS-risk (= obstructive sleep apnea without hypercapnia) age:18-80 years capacity to consent any other disease, that causes ventilatory insufficiency pacemaker, defibrillators or device for deep brain or vagus nerve stimulation esophagitis, Barrett-esophagus, esophageal cancer acute gastritis and ulcera ventriculi epilepsy any medical, psychological or other condition impairing the patient's ability to provide informed consent | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea Newly diagnosed obstructive sleep apnea indicated for positive airway pressure therapy, i.e. Apnea-Hypopnea index AHI> 15 Psychiatric treatment Treatment with psychoactive drugs | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-52.0, Schizophrenia Functional Magnetic Resonance Imaging Transcranial Magnetic Stimulation Patients met diagnostic for schizophrenia or schizoaffective disorder using the Structural Clinical Interview for Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-IV (SCID, Version 2.0) Patients remain their psychotropic medication at steady dosages for at least 4 weeks prior to study entry and for the duration of the trial Verbal intelligence quotient > 85 as measured by using a Chinese version of the National Adult Reading Test History of significant head trauma or neurological disorders Alcohol or drug abuse Focal brain lesions on T1 or T2-weighted fluid-attenuated inversion-recovery magnetic resonance images a prior history of a seizure not induced by drug withdrawal,first degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease, such as thyroid disease, significant unstable medical condition, recent aggression or other forms of behavioral dyscontrol left-handedness, pregnancy estimated intelligence quotient<80 current alcohol or drug abuse inability to provide informed consent Hamilton Anxiety Rating Scale or the Hamilton Depression Rating Scale score > 14 | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease COPD Exacerbation Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1)<65% AHRF (pH<7,35 and PaCO2≥45mm Hg (≥6kPa) treated more than 24h with Ventilation (non-invasive or invasive) 48h to 2 weeks with pH>7.35, and PaCO2>45 (>6kPa) after NIV withdrawal, during daytime at rest without oxygen or ventilatory support (or with O2 if patients are not able to avoid O2 with immediate desaturation below 80%) Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment; 2. Primary diagnosis of restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the "FEV1/Forced vital capacity (FVC)" ratio is <60% and the FEV1 <50% if the predominant defect is considered to be obstructive by the center clinician; 3. BMI > 35 kg/m2; 4. Sedative medication causing hypercapnia (> 3 drugs or more than 20mg of morphine/day); 5. Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI>30/h (French criteria); 6. Cognitive impairment that would prevent informed consent into the trial 7. Pregnancy; 8. Tobacco use < 10 pack-year; 9. Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge; 10. Unstable coronary artery syndrome; 11. Age <18 years; 12. Inability to comply with the protocol; 13. Expected survival<12 months due to any situation other than COPD disease; 14. Duration of ICU stay>10 days; 15. No affiliated to national health insurance; 16. Measure of legal protection (guardianship, wardship or judicial protection) for patients over the age of majority | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Sleep Apnea, Mixed Heart Failure Ability to provide consent Currently prescribed servo ventilation therapy at home At least two weeks of recent adherence and efficacy data from PAP device demonstrating adequate use of therapy (at least 4 hours of use per night and use on at least 10 of 14 nights) Individuals with complex sleep apnea (obstructive sleep apnea with central apneas) and preserved left-ventricular ejection fraction (LVEF > 45%) and/or heart failure with preserved ejection fraction (HFrEF) who are currently on ASV therapy Individuals with complex sleep apnea (predominantly obstructive sleep apnea with central apneas) and reduced left-ventricular ejection fraction (LVEF < 45%) and/or heart failure with reduced ejection fraction (HFrEF) who are currently on ASV therapy Participants who are acutely ill, medically complicated or who are medically unstable Participants in whom PAP therapy is otherwise medically contraindicated Participants who are claustrophobic Symptomatic ("Symptomatic" defined as hospitalized for heart failure or a change in cardiac medications, within the last two months) chronic heart failure (NYHA 2-4) AND moderate to severe predominant central sleep apnea Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 55mmHg) Participants requiring any kind of oxygen therapy Participants who have had surgery of the upper airway, nose, sinus, eyes, or middle ear within the previous 90 days | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Bowel; Functional Syndrome patients diagnosed with rectal cancer without metastasis signed consent form more than 5 years following the surgery unwilling to participate stage IV disease change in operative plan end colostomy formed | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-80.0, COPD (Chronic Obstructive Pulmonary Disease) Hypoxemia COPD diagnostic Both sex <Age <80 years old LTOT group : PaO2 ≥ 65 mmHg and SaO2≥ 92% LTOT+ group: long term oxygenotherapy prescribed for more than 3 months, with daily use between 12 and 15 hours. Patients in both groups will be matched for age (± 5 years), sex and physical activity estimated by GPAQ questionnaire (± 15% Mets.min/week) Recent cardiorespiratory exacerbation (<6 weeks) Pulmonary rehabilitation program during the last 2 months Continuous LTOT (24 hours) or deambulation O2 therapy alone Anticoagulant drugs Hematocrit outside the normal range (35-50%) | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Insomnia Fibromyalgia Meets diagnostic for fibromyalgia Has insomnia Have internet access and a device that can access the web-based program Active sleep disorder which is not treated (obstructive sleep apnea, obesity hypoventilation syndrome) Active psychiatric disorder (Bipolar affective disorder, anxiety, depression, schizophrenia) which is not optimally managed Chronic fatigue syndrome Morbid obesity | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-65.0, Morbid Obesity Opioid-Related Disorders Surgery--Complications Sleep Apnea Syndromes Body mass index (BMI) equal or greater than 35 kg/m2 American Society of Anesthesiologists (ASA) physical status I III patients Scheduled to undergo laparoscopic roux-en-Y gastric bypass or gastric sleeve placement surgery for weight loss Chronic obstructive pulmonary disorder (COPD) Treatment with continuous positive airway pressure (CPAP) in the past three months Severe neurological, cardiopulmonary, psychiatric, or untreated thyroid disorder Chronic pain condition that was being treated with opioids Patients with a hematocrit lower than 35% | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-100.0, Obstructive Sleep Apnea Pulmonary Edema Cardiac Cause Hypertensive acute Cardiogenic Pulmonary Edema Moderate to Severe OSA Professional drivers Pregnancy Non-Cardiogenic Pulmonary edema Terminal cancer | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-100.0, Pulmonary Disease, Chronic Obstructive COPD diagnosis by health care provider Post-bronchodilator FEV1/FVC <0.7 Post-bronchodilator FEV1%predicted <70% Chronic bronchitis, defined as chronic cough with daily sputum production ≥2 COPD exacerbations within the last year Smart phone Obstructive sleep apnea and using positive airway pressure treatment Patients that use oxygen supplementation continuously (patients that use oxygen supplementation only at exertion will NOT be excluded) Any planned procedure that the PI believes would cause the subject to be ineligible Unable to perform a spirometry, 6-minute walk test or chest CT Recent diagnosis (<4 weeks prior to study entry) of pneumonia, respiratory infection, COPD exacerbation, or acute bronchitis requiring antibiotics and new/increased dose of systemic corticosteroids Thoracic surgery or another procedure in the last six months that may result in instability of pulmonary status Recent medical or surgical history of upper airway disease that may interfere with intervention (e.g., sinus surgery, significant nasal polyps) Recent chest illness (trauma, pneumothorax etc) Basal skull surgery in the last 6 months Open skin ulcer or rash where the nasal cannula will be worn | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 70.0-999.0, Physical Activity years or older Acutely hospitalized in MUMC+ at the department of Internal and Geriatric Medicine Sufficient understanding of the Dutch language Living at home before hospitalization Able to walk independently 2 weeks before admission, as scored on the Functional Ambulation Categories (FAC >3) A life expectancy of less than three months as assessed by the attending physician Incapacitated subjects The inability to follow instructions due to cognitive problems or severe agitation A contraindication to wearing an accelerometer, fixated by a hypoallergenic plaster, on the upper leg (such as active bilateral upper leg infection, severe edema or bilateral transfemoral amputation) (Re)admittance to the intensive care unit Presence of contraindications to walking as assessed by the attending physician Previous participation to this study | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea All patients admitted in the Clinique Saint-Luc of Bouge for a polysomnography Patient's refusal | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 21.0-80.0, Stroke Hand Function Age between 21-80 Paresis confined to one side, with substantial motor impairment of the upper limb and some residual voluntary movement (UE FMA in the range of 10-40/66, CMSA_H stage of the hand section <=4) Normal Cognitive ability (MOCA score >=24) Capacity to provide informed consent Ability to elevate their limb against gravity up to at least 75 degrees of shoulder flexion and then to generate some active elbow extension Ability to open hand with a thumb-to-index finger distance ≥4 cm, with the assistance of the ReIn-Hand device with the help of a physical therapist Discharged from all forms of physical rehabilitation Intact skin on the hemiparetic arm Motor or sensory impairment in the non-affected limb Any brainstem and/or cerebellar lesion Severe concurrent medical problems (e.g. cardiorespiratory impairment, uncontrolled hypertension, inflammatory joint disease) History of neurologic disorder other than stroke (Parkinson's Disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Traumatic Brain Injury, peripheral neuropathy) Any acute or chronic painful condition in the upper extremities or spine, indicated by a score ≥5 on a 10-point visual analog scale Using cardiac pacemaker Seizure Severe upper extremity sensory impairment indicated by absent sharp-blunt discrimination on the tactile sensation subscale of the Revised Nottingham Sensory Assessment( the score >=1 on anterior and posterior forearm) Chemo denervation: botulinum toxin injection to any portion of the paretic UE within the last 6 months, or phenol/alcohol injections <12 months before participation Unable to passively attain 90 degrees of shoulder flexion and abduction, measured using a goniometer based on adapted methods | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 25.0-40.0, Traumatic Brain Injury Neurobehavioral Manifestation Sleep Disorder Fatigue Are 25 to 40 years of age Are active duty service members or veterans May be NIH employees/staff who are either active duty service members or veterans; except for those who are employed by NINR or subordinates, relatives, and/or co-workers of NINR employees/staff Have sustained at least 1 TBI, >= 6 months and <= 5 years since their most recent TBI, which includes any self-reported loss of consciousness (LOC) established by the OSU during the pre-screening phone call Are able to provide their own consent Are able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz Currently receiving treatment for a medical illness or recent injury that precludes protocol participation, may interfere with study participation, and/or should be treated/stabilized prior to study participation for safety reasons (e.g., cancer, recent fracture(s) requiring therapy and/or pain medication, severe infection). Individuals with stable medical conditions such as hypertension that are controlled by medication will be included Current physical health status will be assessed by self-report, history and physical exam by a credentialed physician or nurse practitioner, and standard laboratory tests Current unstable endocrine disorder (e.g., uncontrolled diabetes). Unstable endocrine disorders require treatment to ensure health and safety of the patient before participation is possible. Individuals with stable endocrine disorders (e.g., controlled diabetes) may participate in the protocol but they will be excluded from the hydrocortisone stimulation test. This will be assessed by self-report during the history and physical exam and by standard laboratory tests Have a major medical illness that is associated with fatigue (e.g., chronic fatigue [diagnosed prior to their TBI or less than 6 months following TBI], multiple sclerosis, or cancer). This will ensure that symptoms of fatigue are as a result of TBI and not another co-morbid illness. This will be assessed by self-report Currently consuming any of the following sleep modifying medications: benzodiazepines; benzodiazepine receptor agonists; opiates; or sedatives. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants currently taking these medications will be excluded. This will be assessed by self-report Currently using the sleep modifying medications melatonin and/or Benadryl greater than 2 times per week and/or unable or unwilling refrain from using them during protocol participation. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants who are unwilling/unable to refrain from using these medications will be excluded. This will be assessed by self-report Current psychiatric condition for which immediate treatment is required to prevent harm to self or others such as active suicidality or active manic phase in someone who has bi-polar disorder. This is to ensure patient safety and care. This will be assessed by self-report and as part of the history and physical exam Are pregnant. Pregnancy is associated with increased fatigue and sleep disturbances, as such this condition will affect the outcomes of this analysis.his will be assessed by self-report. This will also be assessed on visit 2 by a urine pregnancy test. Individuals who are nursing are eligible but will not participate in the hydrocortisone stimulation test Received a diagnosis of severe obstructive sleep apnea (OSA) and/or current reliance on continuous positive airway pressure (CPAP) therapy to aid sleep. Severe OSA and CPAP use will directly affect the result s of this study, as such these participants will be excluded. This will be assessed by self-report. **Participant may be able to participate in the protocol but will not be able to have an MRI if they have any of the following Metal in the body such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if they are a welder or metal worker | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 25.0-90.0, Dementia With Lewy Bodies Written informed consent 2. Capable of providing informed consent and complying with study procedures. Subjects who are unable to provide consent may use a Legally Authorized Representative (LAR). 3. Clinical diagnosis of DLB according to McKeith et al (7) with both dementia MoCA≥18 and Parkinsonian defined as bradykinesia in combination with rest tremor, rigidity or both. UPDRS I-III is less than 50 and UPDRS-III between 15-40. Dementia and Parkinsonism must be present with at least one other symptom such as fluctuation, visual hallucinations or REM sleep behavioral disorder (RBD) 4. 2.5 ≥Hoehn and Yahr stage ≤3 5. MDS-UPDRS-III 15-40 6. Abnormal DaTScan 7. Stable concomitant medical and/or psychiatric illnesses in the judgement of the PI 8. Patients between the age of 25-90 years, medically stable 9. Stable on mono-amine oxidase (MAO)-B inhibitors (Selegeline or rasagiline) for at least 4 weeks before enrollment and during Nilotinib treatment. 10. Must be medically stable on less than or equal to 800mg Levodopa daily for at least 4 weeks 11. QTc interval 350-460 ms, inclusive 12. Participants must be willing to undergo LP at baseline and 6 months after treatment Patients with hypokalemia, hypomagnesaemia, or long QT syndrome QTc≥461 ms 2. Concomitant drugs known to prolong the QTc interval and history of any cardiovascular disease, including myocardial infraction or cardiac failure, angina, arrhythmia 3. History or presence of cardiac conditions including: 1. Cardiovascular or cerebrovascular event (e.g. myocardial infarction, unstable angina, or stroke) 2. Congestive heart failure 3. First, second or third-degree atrioventricular block, sick sinus syndrome, or other serious cardiac rhythm disturbances 4. Any history of Torsade de Pointes 4. Treatment with any of the following drugs at the time of screening or the preceding 30 days, and/or planned use over the course of the trial: 1. Treatment with Class IA or III antiarrhythmic drugs (e.g. quinidine) 2. Treatment with QT prolonging drugs (www.crediblemeds.org) excluding Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g. Citalopram, Paxil, Zoloft, Cymbalta, Sertraline, etc...) 3. Strong CYP3A4 inhibitors (including grapefruit juice). The concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) must be avoided. Grapefruit products may also increase serum concentrations of Nilotinib. Should treatment with any of these agents be required, therapy with Nilotinib should be interrupted. 4. Anticoagulants, including Coumadin (warfarin), heparin, enoxaparin, daltiparin, xarelto, etc. 5. St. John's Wort and the concomitant use of strong other CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) must be avoided since these agents may reduce the concentration of Nilotinib. 5. Abnormal liver function defined as AST and/or ALT > 100% the upper limit of the normal 6. Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal 7. History of HIV, clinically significant chronic hepatitis, or other active infection 8. Females must not be lactating, pregnant or with possible pregnancy 9. Medical history of liver or pancreatic disease 10. Clinical signs indicating syndromes other than DLB, including, PD, PD with Dementia (PDD), corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, Babinski sign 11. Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or DSM-IV for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse 12. Evidence of any significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal or other systemic disease or laboratory abnormality 13. Active neoplastic disease, history of cancer five years prior to screening, including breast cancer (history of skin melanoma or stable prostate cancer are not exclusionary) 14. Contraindications to LP: prior lumbosacral spine surgery, severe degenerative joint disease or deformity of the spine, platelets < 100,000, use of Coumadin/warfarin, or history of a bleeding disorder 15. Must not be on any immunosuppressant medications or IVIG 16. Must not be enrolled as an active participant in another clinical study | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 70.0-999.0, Delirium Hypoxia age over 70 years old hospitalized in orthogeriatrics for hip fracture surgery information about the study and expression of non opposition Expected hospital stay of 5 nights or more patient under guardianship any other type of fracture associated oxymetry recording not possible (behavioral disorders, night stirring,...) | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Pain, Postoperative Knee Pain Chronic Subjects undergoing TKR Acceptance to participate ASA physical status II-III Age > 18 years Refusal to participate in the study Allergy to local anesthetics History of substance abuse | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 20.0-100.0, COPD COPD patients hemodynamics is unstable any other lung disease despite COPD； other diseases influencing experiments: Cognitive impairment disease、 mouth and nose trauma | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 50.0-999.0, Chronic Obstructive Pulmonary Disease Smoking Cessation Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Competent and mature Have diagnosed COPD [spirometry verified and evaluated by pulmonary specialist] Current daily smoker [Minimum 1 cigarette daily] Have smoked minimum 20 pack years (1 pack year = 20 cigarettes daily in 1 year) Want to or try to stop smoking Do not mind taking varenicline or NRT during the trial Are willing to give blood and urine samples according to the protocol Previously included in the trial Hospitalized with COPD-exacerbation within the last 24 months Are associated with hospital outpatient clinic for COPD disease treatment Have FEV1<50% Pregnancy/breastfeeding Life expectancy less than 1 year Severe linguistic problems or inability to give informed consent Severe mental illness that is not controlled with medication Active alcohol or substance abuse Active cancer disease* *The person can participate if he or she has had a cancer disease that is now referred to as curative/radically treated. Basal cell carcinoma of the skin does not count as an criterion | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, Obstructive Sleep Apnea All patients with a clinical suspicion of obstructive sleep apnea enrolled to the investigator's chest department Patients who previously treated as obstructive sleep apnea, or receiving opioid pain medications | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Acute Exacerbation of COPD Acute Exacerbation of Bronchiectasis Acute Exacerbation of Asthma Interstitial Lung Disease Neuromuscular Diseases Obesity Hypoventilation Syndrome Acute Respiratory Failure Chronic respiratory disease (COPD, ILD, OHS...) Admission in ICU for acute respiratory failure Patient's non-opposition Patients < 18 year-old Protected patients Pregnant women | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-75.0, Obesity Hypoventilation Syndrome Ketogenic Dieting Hypercapnic Respiratory Failure Obesity (BMI≥30 kg/m2) Hypercapnia (PaCO2>45 or PvCO2>50) on blood gas, OR a sleep study with end-tidal/transcutaneous CO2 monitoring showing an awake CO2 level >50 Participants without blood gas data may also have suspected OHS on the basis of serum bicarbonate >=28 mEq/L Lack of an alternative pulmonary diagnosis that adequately explains hypercapnia. Note that a documented pulmonary diagnosis (e.g. chronic obstructive pulmonary disease (COPD) or asthma) per se will not necessarily subjects, since OHS is often misdiagnosed as obstructive lung disease. Functional or radiographic data must corroborate the presence of the alternate diagnosis Subjects must have had a sleep study and clinical evaluation for sleep apnea. Most subjects with OHS are expected to have concomitant obstructive sleep apnea (OSA). This information is necessary to determine whether continuous positive airway pressure (CPAP)/noninvasive ventilation (NIV) will be used on the research sleep studies Concomitant participation in another weight loss or diet program Patients with diabetes taking Sodium-glucose Cotransporter-2 (SGLT2) inhibitors (due to risk of diabetic ketoacidosis) Patients with type 1 diabetes Any patients with a history of diabetic ketoacidosis Patients with incomplete sleep apnea diagnosis or management (i.e. those still acclimating to CPAP, or pending therapeutic decisions about OSA management) Known or suspected abuse of narcotics or alcohol Liver cirrhosis Uncontrolled gout History of chronic renal insufficiency requiring dialysis Females who are pregnant, breast-feeding, or intending to become pregnant | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 7.0-17.0, Dizziness Non-opposition of the holders of parental authority and the subject to participation in the study Subjects between 7 and 17 years of age Patients : patients followed in the clinic at Necker Hospital in pediatric department of otolaryngology and cervico-facial surgery and presenting with dizziness without associated ophthalmological or neurological disorder Controls : subject with no vestibular deficiency, symptoms of balance disorder, migraine, otological pathology or ophthalmological disorder at the time of or background Absence of diagnosis after etiological assessment | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Chronic Pain Back Pain Chronic low back pain, that is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months Willing and able to provide informed consent Speak English as the intervention manual is currently written in English In the past month, worsening of pain, unexplained fever, unexplained weight loss Back injury in the past 3 months Pregnancy Metastatic cancer | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Acute Respiratory Failure Hypercapnic Respiratory Failure Respiratory Acidosis Obesity Hypoventilation Syndrome Apnea, Obstructive Patient of age Patient benefitting of social security Informed patient who signed the information note and the research enlighted consent form Admission in respiratory intensive care unit for an acid-hypercapnic exacerbation (defined by pH≤ 7,35) BMI ≥ 30kg/m2 PaCO2 > 6.5 kPa on blood gases at ICU admission Confirmed COPD with a spirometry (VEMS/CVF < 70%) Pregnant women, or breast-feeding women Patient with a judiciary or administrative liberty deprivation Patients under guardianship Contraindication to NIV | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, COPD Exacerbation Oxygen Toxicity Abdominal Obesity Surgery (AECOPD) Respiratory acidosis (pH <= 7.35 and PaCO2 > 45 mmHg), with or without NIV (last blood gas available during hospitalization) Oxygen therapy and/or SpO2 <90% room air (FiO2 <= 50% or nasal cannula <= 7 L/min to maintain SpO2 90%) High flow nasal cannula with flow <= 30 L/min (Bariatric surgery post-op) Patients using CPAP before the surgery (obstructive sleep apnea documented) Patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included Age < 18 Pregnancy Respiratory distress or other clinical situation requiring continuous NIV or CPAP Glasgow < 12 or agitation/delirium/dementia (limiting NIV) Any contraindication to NIV (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery) Hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes) Refusal to consent to the study 5 patient with and 5 patient with bariatric surgery will be included | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea Syndrome newly diagnosed and untreated Obstructive sleep apnea syndrome (IAH >15/hour) with an indication of treatment with CPAP Patients who have given their informed written consent Pregnant or lactating women Patients not affiliated to the French social security system or equivalent Patient deprived of liberty by judicial or administrative decision Patients under guardianship or curatorship | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-999.0, COPD Willing and able to provide written informed consent Clinical diagnosis of COPD as defined by GOLD (Vogelmeier, et al., 2018; https://goldcopd.org/wp-content/uploads/2018/11/GOLD-2019-v1.7-FINAL-14Nov2018-WMS.pdf ), i.e. greater than 40 years old, ≥ 10 pack years smoking history, post-bronchodilator FEV1/FVC ratio of 0.7, with FEV1 less than 80% predicted Owns, or has access to, a smart phone Unwilling or unable to provide written informed consent Cognitive, visual, or hearing impairment which would affect communication in a group-setting or ability to see and use a smart phone | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, Obesity Liver Function Those undergoing oesophagectomy patients who only had chemotherapy/chemoradiotherapy without surgery | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Muscle Injury • Hip arthroplasty by anterior approach using Minimally Invasive Surgery • Revision arthroplasty Allergy or contra indications to use any of the drugs included in anesthesia Addiction to or chronic opioid use before surgery Major cardiovascular, pulmonary, liver or renal insufficiency before surgery requiring possible post-operative intensive care admission Contra indication for a general anesthesia with intubation and mechanical ventilation | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Pneumonia Hypoxemia Acute Respiratory Failure Severe Pneumonia defined as hospitalization for acute (< 7 days) onset of symptoms (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest radiograph or CT scan and evidence of systemic inflammation (temperature < 35oC or > 38oC or WBC > or < upper or lower limits for site or procalcitonin > 0.5 mcg/L), or known current immunosuppression preventing inflammatory response. and Hypoxemia defined as new requirement for supplemental oxygen with SpO2 < 90% on room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or NIV (regardless of SpO2) at enrollment. and No clinical suspicion for COVID-19 pneumonia or confirmed negative test for SARS CoV2 infection Inability to obtain consent within 24 hours of presentation to emergency room Intubation (or impending intubation) prior to enrollment (This does not those patients receiving High flow nasal cannula (HFNC) oxygen or Noninvasive ventilation (NIV) prior to enrollment) A condition requiring inhaled corticosteroids or beta-agonists, or chronic systemic steroid therapy equivalent to a dose >10 mg prednisone (this does not patients receiving inhaled beta-agonists in the Emergency Department without an established indication if treating clinician is willing to discontinue subsequent treatments) Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome Not anticipated to survive > 48 hours or not expected to require > 48 hours of hospitalization Contraindication or known allergy to inhaled corticosteroids or beta-agonists Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular tachycardia within last 4 hours will be potentially eligible for enrollment after the condition has resolved Patients with K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved Patient not committed to full support other than intubation or resuscitation (i.e., DNR/DNI status allowed) Pregnancy | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Oxygen Deficiency Pulmonary Arterial Hypertension CTEPH Patients in both groups (n = 20; n=10 each group) with precapillary PH, WHO class I -IV (mPAP ≥ 25 mm Hg, pulmonary arterial occlusion pressure ≤15 mm Hg), who are stable on optimized pharmacological treatment for at least six weeks and who do not suffer from other cardio-pulmonary disease will be recruited if arterial or capillary O2 partial pressure is (<60 mmHg; alternatively, 90% of O2 saturation) at rest and/or during physical activity (O2 partial pressure <60 mmHg pO2 90 % ) men and women 18 years of age or older patient is diagnosed with Pulmonary Arterial Hypertension (World Health Organization (WHO) Category Group 1 (by the WHO Clinical classification system)), including Idiopathic (IPAH), Heritable PAH (HPAH, Familial PAH), associated PAH (APAH) and CTEPH, with exceptions as noted in patient is willing and able to provide written informed consent patient is willing and able to comply with the protocol, including required follow-up visits Patients experiencing oxygen desaturations ≤90% (or pO2 below 60 mmHg) at rest and/or oxygen desaturations ≤90% (or pO2 below 60 mmHg) during physical activity patient has a stable functional class of PAH with no changes of medication during the last two weeks before Patient is a female who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control patient with pulmonary venous hypertension significant functional limitation in lung function tests (FEV1 <60%,TLC <60%) and CT morphological signs of pulmonary disease significant left heart disease, requiring acute pharmacological or interventional treatment unstable conditions requiring pharmacological or other treatment, intensive care or relevant severe concomitant disease patient is enrolled, has participated within the last thirty days, or is planning to participate, in a concurrent drug and/or device study during the course of this clinical trial. Co-enrolment in concurrent trials is only allowed with documented pre-approval from the study manager that there is not a concern that co-enrolment could confound the results of this trial | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease COPD Exacerbation Airflow Obstruction Age ≥ 18 years old 2. Known COPD or high probability of the disease according to treating physician based on clinical history, physical examination and chest imaging. 3. Hospital admission for acute exacerbation of COPD defined by 2018 GOLD report as acute worsening of respiratory symptoms (more than baseline cough, sputum purulence or volume, dyspnea or wheeze) that result in additional therapy. 4. Presence of one or more of following: increase in sputum production, change in sputum color or difficulty in expectorating sputum Inability to obtain informed consent from the patient or legally authorized representative. 2. Inability of the subject to cooperate with protocol. 3. Presence of idiopathic bronchiectasis or cystic fibrosis. 4. Patients with poor short term prognosis not expected to survive the hospitalization. 5. Massive hemoptysis. 6. Patients presenting with coma (Glasgow coma scale <10) or circulatory shock. 7. Respiratory failure requiring non-invasive ventilation (NIV) or endotracheal intubation. 8. Severely impaired cough, impaired swallowing or chronic aspiration due to neuromuscular disorder. 9. Facial deformity or injury leading to difficulty in wearing high flow nasal cannula appropriately. 10. Enrollment in other investigative protocols with apparent overlap. 11. Prisoners | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, COPD Exacerbation Chronic Obstructive Pulmonary Disease Exacerbation age 18 years or older ability to give informed consent previously diagnosed COPD (either confirmed diagnosis at prior hospital contact or from their general practitioner or confirmed diagnosis by the treating physician in the emergency department (verified by use of relevant medication)) admitted with acute exacerbation (acute and worsened shortness of breath) of COPD requiring oxygen treatment Instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes Expected total length of stay in hospital < 12 hours Planned transfer to another hospital within 12 hours Unwilling to have repeated arterial blood gas analyses within the first 12 hours Patients judged terminal by treating physician in the emergency department Non-residents of the particular country Expected impossible follow-up Fertile women (<50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG Prior participation in the study | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-55.0, Shared Decision-making Kidney Stone Emergencies Radiation Exposure Communication Age 18-55, 2. with acute flank pain for whom clinician believes acute flank pain may be from renal colic 3. who are deemed by the treating clinician to be at low risk for dangerous alternative diagnoses. 4. Clinician is considering imaging patient for kidney stones (any imaging) Recent trauma related to pain (including minor such as lifting/turning) 2. Pregnancy (previous or discovered during ED visit) 3. Recent surgical procedure on abdomen or pelvis (30d) 4. Recent urologic procedure (30d) 5. Recent childbirth (30d) 6. Signs of Systemic Infection: Fever >100.9 (101 and up), SBP <90, HR>120 7. Moderate or severe abdominal tenderness or rebound/guarding, consistently present (present for more than one exam, or present after patient treated with pain medication) 8. Second doctor's visit (ED, PCP, urgent care) for THIS episode of pain (previous similar visits ok if pain gone for >30d in between episodes) (if seen at PCP or urgent care in same day or 24 hour period, this is not an but if seen at PCP/urgent care or ED 1-30 days prior to index visit, with same pain, excluded) 9. Known history of one kidney or other urological/renal abnormality (including neurogenic bladder, ESRD and paraplegia; or if solitary kidney discovered on US) 10. Known malignancy (any) within past year (or received treatment in the past 12 months) 11. Immunocompromised (chronic steroids, HIV, crohns, immunomodulators or severely ill chronically) 12. On anticoagulation 13. Crisis patient (behavioral health)/belligerent 14. Lacks capacity for medical decision-making 15. Unlikely to respond to follow-up calls (IVDA, homeless, no phone) 16. Clinician is concerned for alternative diagnosis requiring CT scan (appendicitis) (>5% likelihood by clinician gestalt) 17. Patient is not improving clinically and clinician is considering admission | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Overweight and Obesity seeking/being referred to a dietitian for the treatment of obesity (BMI≥25) or obesity in combination with type 2 diabetes (HbA1c>48mmol/mol) and/or elevated blood lipids (total cholesterol >4,5 mmol/l and/or LDL >2,5 mmol/l and/or triglycerides >2,0 mmol/l) and/or high blood pressure (>140/90 hg) other diagnoses requiring/might require nutritional treatment (eg cancer, COPD) dementia severe impairment of sight, hearing, or other disability where internet-based dietetic treatment is deemed difficult pregnancy need for interpreter | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-85.0, Painful Diabetic Peripheral Neuropathy Female and male patients aged 18-85 years. 2. Patients with a history of type 2 diabetes mellitus according to The American Diabetes Association (ADA). 3. Patients with a diagnosis of painful diabetic peripheral neuropathy (PDPN) caused by type 2 diabetes mellitus based on DN4 ≥4. 4. Patients whose average pain intensity in PDPN in last 24 hours (measured by VAS), evaluated on baseline visit, is equal or more than 40 mm (0 mm ='no pain' and 100 mm ='worst possible pain'). 5. Ability to adhere to trial protocol. 6. Written informed consent. The methods for assessment medical history, interview, completing the DN4 questionnaire, physical examination, assesment of pain on VAS and laboratory analyses Patients who took PDPN medication and/or analgesics on a day of baseline visit. 2. Patients with a known hypersensitivity to duloxetine, pregabalin, paracetamol or tramadol or any of the inactive ingredients or have any contraindication for the use of duloxetine, pregabalin, paracetamol or tramadol. 3. Patients with a history of inadequate pain response (pain reduced was equal or less than 30%) to: 3.1. pregabalin at maximum allowed treatment daily dose 600 mg, 3.2. duloxetine at maximum allowed treatment daily dose 120 mg, 3.3. venlafaxine at maximum allowed treatment daily dose 375 mg, 3.4. gabapentin on daily treatment dose more than 1800 mg 3.5. amitriptilin at maximum allowed treatment daily dose 150 mg. 4. Patients, who are currently treated with a daily dose that exceeds: 4.1. 150 mg of pregabalin, 4.2. 60 mg of duloxetine, 4.3. 150 mg of venlafaxine, 4.4. 600 mg of gabapentin. 5. Patients with an uncontrolled type 2 diabetes mellitus. 6. The average scores of less than 20 on MoCA. 7. Have any other type of neuropatic pain, contrasted to PDPN. 8. Evidence of another cause of distal polyneuropathy other than diabetic. 9. Have a serious (evaluated by physician) unstable cardiovascular (e.g. uncontrolled hypertension), hepatic, renal, respiratory, ophthalmologic, gastrointestinal, or hematologic illness, symptomatic peripheral vascular disease, malignant disease or other medical condition that could lead to hospitalisation during the course of the trial. 10. Have a diagnosis or history of uncontrolled glaucoma. 11. Known or suspected alcohol or drug abuse or addiction (excluding nicotine and caffeine). 12. Patients with a history of depression (less than one year after completing the last medical treatment), mania, bipolar disorder, psychosis or schizophrenia. 13. Pregnancy, lactation and women of child-bearing potential without highly effective* or at least acceptable** contraception (according to the Recommendations related to contraception and pregnancy testing in clinical trials). 14. Patients with a history of epilepsy, stroke or neurodegenerative disease. 15. Patients taking Monoamine oxidase (MAO) inhibitors or are within one year of their withdrawal. 16. Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C). 17. Patients with suspected Restless leg syndrome (RLS). 18. Abnormal thyroid-stimulating hormone (TSH) concentrations (according to the references value of the local laboratory). 19. Vitamin B12 and folic acid deficiency (according to the reference values of the local laboratory). 20. Surgical procedures planned to occur during trial (patients may be rescreened following completion of and recovery from the surgical procedure). 21. Concomitant treatment that might influence the final therapeutic effect of the tested active substances including non-medical treatments. 22. Patients who under the opinion of the investigator will not be compliant to the treatment or not be able to finish the trial for any other reason Highly effective contraception is combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation(oral, intravaginal, transdermal) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device (IUD) intrauterine hormone-releasing system (IUS) bilateral tubal occlusion vasectomised partner sexual abstinence **Acceptable contraception is progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive The study cohort will all patients who initiate Tiotropium/ Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period The following will then be applied to generate the unmatched cohort Aged <40 years on cohort entry Any LAMA, LABA, or ICS maintenance therapy (alone or in combination) during the 180-day baseline period prior to cohort entry for maintenance treatment and duration >30 days, or any prescription within the 30 days prior to cohort entry Patients without continuous enrolment (days since first inpatient/ outpatient encounter in the data) during the baseline period No prior diagnosis of COPD [International Classification of Diseases (ICD)-10: J41*, J43*, J44* and doubt (UTAGAIFLG) = 0 (no)] Patients without a second prescription claim of their index medication within 60 days after the cohort entry date Diagnosis of asthma [ICD-10: J45* and doubt (UTAGAIFLG) = 0 (no)] during the baseline period Diagnosis of lung cancer [ICD-10: C34*, D02.2, Z80.1, Z85.1 and doubt (UTALAIFLG) = 0 (no)] or lung transplant (Health claim code: 150317670, 150322510, 150322610, 150336510, 150336610, 150336710, 150399270) prior to the cohort entry date using all available data Patients who initiate both Tio/Olo and Tio simultaneously on the cohort entry date | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Ventilatory Failure Documented high-risk factors of interest [congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and/or positive fluid balance] The modified rapid shallow breathing index on day of extubation must be between 58-105 breaths per minute per liter (breaths/min/L) Patient must successfully complete spontaneous breathing trial and be determined eligible for extubation Only primary extubations will be included Undergoing terminal extubation or placed on comfort care Home ventilator use Any contraindication that would preclude the postextubation protocol (e.g., facial trauma, tracheotomy, or any other reason that would preclude use of BiPAP or HFNC) | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 20.0-45.0, Cough Participant must be 20 to 45 years of age inclusive, at the time of signing the informed consent Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ECG Non-smoker for at least 6 months and with a pack year history of equal to or less than 5 years Race: Japanese BMI: above or equal 18.0 and below or equal 30.0 kg/m² at the screening visit Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the ICF and 90 days after the last administration of study intervention Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance Relevant diseases potentially interfering with the study objectives within the 4 weeks before screening or between screening and randomization Any febrile illness within the four weeks before screening or between screening and randomization Any known presence or history of severe allergies, non-allergic drug reactions, or multiple drug allergies Known or suspected malignant tumors or carcinoma in situ Any history of malignant tumors Any known or suspected benign tumors of the liver and/or pituitary gland Known liver disease: existing acute or chronic progressive liver disease, e.g. disturbance of bilirubin excretion (Dubin-Johnson and Rotor syndromes); disturbances of bile secretion and flow (cholestasis); presence or history of liver tumors (benign or malignant). Note: According to this criterion there must have been an interval of at least 6 months between the subsidence of any viral hepatitis (normalization of liver parameters) and the screening visit | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 20.0-80.0, Secondary Hyperparathyroidism Due to Renal Causes age over 20 years 2. chronic renal failure with regular dialysis 3. iPTH> 800pg/mL, Ca > 10.1 mg/dL, and P > 5.5 mg/dL 4. symptoms of bone pain, skin itching, general weakness, insomnia and osteoporosis (T score< -2.5) pregnancy women 2. patients after kidney transplantation 3. a failure in surgery | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, COPD Exacerbation Patient suspected or with proven diagnosis of COPD Admission to hospital with life-threatening exacerbation of COPD requiring acute NIV (at admission evidence of decompensated Chronic Respiratory Insufficiencies (PaCO2 > 6kPa, pH <7.35) Arterial partial pressure of carbon dioxide (PaCO2) > 6kPa at discharge from hospital Discharge from hospital without combined home non-invasive ventilation and home oxygen therapy Patient willing to consider home non-invasive ventilation in addition to home oxygen therapy Patient suitable for home oxygen therapy (appropriate risk assessment) Patient already established on home non-invasive ventilation and home oxygen therapy Patient unable to support home non-invasive ventilation e.g. unable to apply mask, lacking social support Patient on palliative care pathway Patient outside of usual catchment area for Lane Fox Respiratory Service | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Endometrial Cancer Obesity Endometrial Intraepithelial Neoplasia A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities (including T2D, hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life) OR a BMI ≥ 40 AND a tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN Less than 18 years old BMI < 35 no tissue diagnosis of EIN or grade 1 endometrial carcinoma a grade 2 or greater endometrial cancer tissue diagnosis active smokers prior bariatric surgery active substance abuse recent suicide attempt bulimia nervosa poorly controlled psychiatric illness | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-80.0, Adherence, Treatment Diagnosed with COPD (FEV1/FVC < 70%) and long term indication for home NIV for initiated at least 3 months prior the inclusion Compliance with NIV (less than 5 hours and more than 1 hour) per night on average during the last 3 months prior to inclusion Naïve to Nasal High Flow (NHF) therapy, i.e. having not used NHF in the last 6 months prior to inclusion Able to understand, follow objectives and methods of protocol in French language Patient affiliated to social security insurance or beneficiary of social health insurance Willing and able to give written Informed Consent and to comply with the requirements of the study protocol Significant uncontrolled cardiac disease (investigator judgment), and/or Left Ventricular Ejection Fraction (LVEF) < 45% Known co-existing obstructive sleep apnea requiring expiratory pressure above 6 cmH20 Severe nasal obstruction, previous upper airway surgery preventing the usage of NHF, or, at the discretion of investigator, any other contraindication for using the NHF Patients who are unable or unwilling to give informed consent Participating in another research study Patient protected by the Law, under guardianship or curators Pregnancy and nursing mothers Patient not covered by a health insurance | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Sleep Apnea, Obstructive OSA Sleep Sleep Disorder Hypersomnia • Consecutive symptomatic OSAS patients with an AHI and an oxygen desaturation index (ODI) of >15/h in polysomnography (PSG) or Home Sleep Test (HST) consenting to start long term CPAP treatment Age <18 years Unable to communicate in Italian Previous usage of CPAP treatment Alcohol consumption > 4 units >4 times a week Acute manifestation of psychiatric diseases Life expectancy of < 6 months for any reason Surgical obesity treatment planned within the next 6 months Predominantly Central sleep apnea and cheyne stokes respiration | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 65.0-999.0, Alzheimer Disease Mild Dementia Mild Cognitive Impairment Dementia Dementia, Vascular Dementia Alzheimers Dementia, Mild Dementia, Mixed Dementia of Alzheimer Type Inclusion/ 65 years or older; 2. fluency in the English language; 3. availability of an informant reporter who has knowledge of the participant's daily functioning; 4. no lifetime history of severe psychiatric disorder (e.g., schizophrenia, bipolar disorder), nervous system infections or disorders (e.g., epilepsy, brain tumor, large-vessel stroke, major head trauma) other than Alzheimer's disease; 5. no current metabolic or systemic disorders (e.g., B12 deficiency, renal failure, cancer); 6. no current major depression or moderate-severe depression symptoms; 7. no current moderate severe, uncontrolled anxiety symptoms; 8. no severe sensory deficits that would preclude visual detection or identification of common everyday objects used in the study or the inability to hear the task directions (e.g., blindness, total hearing loss); 9. no severe motor weakness that would preclude the use of everyday objects or the VR Training computer touch screen (e.g., severe deformities or paralysis of both upper extremities) ; 10. intact estimated general intellectual functioning (i.e., no history of intellectual disability); 11. available to participate in the one-month follow-up session after the VR Training (i.e., no surgery, travel, etc. scheduled over the next month); 12. diagnosis of mild to moderate Alzheimer's disease within the past year, including confirmation of mild to moderate dementia on Mini Mental Status Exam (score approximately 25 or lower), significant functional difficulties reported by informant report, and cognitive impairment on demographically adjusted (age, education, sex, and race) cognitive test scores at baseline. An informant (N = 40) also will be recruited for each participant with dementia. Informants are people who know the participant well and interact with the participant on a daily basis. Informants will be asked to report on the participants' daily functioning and the extent to which the informant is burdened by the participants. Informants also will be asked to report on changes in medical or mental status during the study period. Informant is listed below: 1. 18 years of age or older 2. fluency in the English language 3. available and willing to complete study questionnaires in person or by phone 4. has daily contact with the participant 5. reports that he/she is knowledgeable of the participant's daily functioning | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-999.0, COPD COPD Exacerbation Signed and dated written informed consent must be obtained prior to initiating any study-related procedures Outpatient Male or female subjects aged ≥40 years A female is eligible to participate in the study if she is of non-childbearing potential defined as physiologically incapable of becoming pregnant OR childbearing potential with negative serum and urine pregnancy tests at screening, and is willing to use highly effective birth control methods for the full duration of the study COPD diagnosis for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report Current or ex-smokers who quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20] COPD Assessment Test (CAT) score ≥10 A pre and post-bronchodilator FEV1/FVC ratio <0.70 at screening A post-bronchodilator FEV1 <50% predicted normal at screening and a documented history of ≥1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator FEV1 ≥50% and <80% of predicted normal at screening and a documented history of ≥2 moderate COPD exacerbations or ≥1 severe COPD exacerbation in the previous 12 months Female subjects who are pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating Subjects using the following medications prior to the screening visit and during the run-in period: 1. Systemic/oral/parenteral corticosteroids in the prior 4 weeks 2. Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks 3. Any long-term chronic maintenance use of antibiotic treatment in the prior 4 weeks 4. Oral xanthine derivatives (e.g. theophylline) in the prior 7 days A moderate or severe COPD exacerbation or a respiratory tract infection (e.g., pneumonia) that has not resolved ≤14 days prior to the screening visit or during the run-in period Current treatment with non-cardioselective β-blockers Requirement of long term (> 15 hours daily) oxygen therapy Known respiratory disorders other than COPD which may impact the efficacy of the study drug according to investigator's judgement Lung transplant surgery or lung volume reduction surgery (subjects with lung volume reduction surgery are excluded if the procedure was performed within 1 year before the Screening visit) Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator, would prevent use of anticholinergic agents History of hypersensitivity to M3 receptor antagonists, β2 agonists, corticosteroids or any of the excipients contained in any of the study drugs used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator's judgement Subject has severe, acute or uncontrolled cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class IV, left ventricular failure, acute myocardial infarction or unstable angina) in the last 6 months | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 5.0-14.0, Functional Abdominal Pain Syndrome clinical diagnosis of recurrent abdominal pain the child can express and locate site of the pain children less than 5 and adolescents more than 14 mentally retarded children | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 14.0-80.0, Asthma Chest Syndrome Clinical Anxiety Clinical Depression Lung Function Quality of Life Eosinophilia Nitric Oxide Airway Responsiveness Induced Sputum all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent; 2. the age of more than 14 and less 80 years old, gender and ethnicity are not limited; 3. the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough; 4. no wheezing; 5. a diagnosis of asthma supported by one or more other characteristics bronchial provocation test positive improvement in forced expiratory volume at one second (FEV1) of more than 12% and 200 mL after inhaled salbutamol variability in diurnal peak expiratory flow (PEF) of more than 10% for one day during one week. 6. bronchodilator and glucocorticoid treatment is effective; 7. the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease(GERD), neuromuscular disease, and mental disease can not cooperate with related inspection or for other reasons; 2. patients with chronic obstructive pulmonary disease, interstitial pneumonia, active tuberculosis, community acquired pneumonia, lung cancer, bronchiectasis, cor pulmonale, pulmonary embolism, and accompanied with serious systematic disease (such as coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease, neuromuscular disease, etc); 3. history of drug abuse, alcohol abuse or anesthesia or with a history of mental illness (schizophrenia, obsessive-compulsive disorder, depression) and against personality, motivation, suspicious, or other emotional or mental issues that may affect participation in the study; 4. taking part in other drug clinical trial project, or drop out less than 3 months; 5. during pregnancy, lactation women; 6. obvious abnormal of High Resolution CT | 0 |
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