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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): 6.0-999.0, Attention-Deficit/Hyperactivity Disorder Patients will be male or female outpatients who are at least 6 years of age (there is no upper age limit) 2. Patients must meet DSM-IV for ADHD 3. Patients and parents/guardians must have a degree of understanding sufficient to be able to communicate suitably with the investigator and study coordinator 4. Patients must have tolerated the drug at therapeutic doses, but have shown a true lack of improvement in symptoms 5. Must have shown clinically significant superiority in improvement in ADHD symptoms on amphetamine relative to MPH Must not have a true allergy to methylphenidate or amphetamines 2. Must not have a history of serious adverse reactions to methylphenidate | 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, Pulmonary Disease Chronic Obstructive Hypercapnia Hypoxemia Arrhythmias, Cardiac COPD (FEV1 < 80 % of pred. and FEV1/FVC < 0,7) other serious disease (like lung cancer, sarcoidosis, restrictive lung disease) exacerbation of COPD within 3 weeks before coronary heart disease with unstable angina pectoris or myocardial infarction within 3 months of incl uncontrolled hypertension cerebral infarction neurological, muscular or skeletal disease/disorder that affect abdominal and/or thoracal movements (kyphoscoliosis, paresis, etc) unstable diabetes mellitus or signs of organ failure (anaemia, kidney failure, liver failure, etc) misuse/dependency of alcohol, sedatives, neurostimulating or narcotic drugs) obstructive sleep apnoea/hypopnoea syndrome | 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 Cardiogenic Pulmonary Edema CPE confirmed radiologically and/or clinically 2. Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired oxygen (FIO2) less than 250) 3. Dyspnea of sudden onset with respiratory 4. Systolic blood pressure < 180 mmHg Immediate need for endotracheal intubation Severe sensorial impairment Shock Ventricular arrhythmias Life-threatening hypoxia (SpO2 [oxygen saturation as indicated by pulse oximetry] less than 80% with oxygen) Acute myocardial infarction necessitating thrombolysis Cardiac or respiratory arrest 2. Severe chronic renal failure 3. Pneumothorax. 4. Contraindication of non invasive ventilation (NIV) | 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, Nausea and Vomiting Pain Sleep Disorders Unspecified Adult Solid Tumor, Protocol Specific Patients diagnosed with cancer and experiencing chronic neuropathic pain syndrome Pain syndrome diagnosed by the investigator Pain syndrome related to the effects of cancer or its treatment (i.e., chemotherapy, radiotherapy, and surgery) Meets 1 of the following Need to be started on strong opioids Require an increase in opioid dose and are currently taking ≤ 75 mg of total daily dose of oral morphine equivalent Experiencing pain for ≥ 4 weeks with an average pain score of ≥ 4 or a worst pain score of ≥ 5 (using the 0-10 Brief Pain Inventory Scale) during the past 24 hours Requires strong opioids to control pain and is using an oral morphine-equivalent dose of 0-75 mg per day, on average, including breakthrough analgesia, within the past 3 full calendar days Mixed pain syndrome allowed provided the neuropathic component is the predominant pain Meets 1 of the following | 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, Advanced Cancer Cachexia Age: Patients must be older than 18 years of age Tumour situation: Patients with any type of advanced (defined as locally recurrent or metastatic), incurable solid tumour Cachexia: defined as involuntary loss of weight of ≥2% in 2 months or ≥5% in 6 months, and ongoing in the last 4 weeks No simple starvation: Patients must be able to eat, defined as no severe structural barriers in the upper gastrointestinal tract and no bowel obstruction No late cachexia: Patient must have an expected life expectancy > 3 months No anti-cachexia or appetite-stimulating medications: Patients are not allowed to have corticosteroids unless for maximum 2 days for chemotherapy, no progestin therapy within the last 2 weeks, no anabolic drugs within the last month. Prokinetic medication, NSAR (paracetamol and novamin sulphate are allowed, if given in a fixed dose for two weeks before visit 1, and expected to be given during the whole trial period Laboratory test results within these ranges: Absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, serum creatinine ≤ 2.0 mg/dL (177 μmol/L), creatinine clearance ClCr ≥ 50ml/min, total bilirubin ≤1.5 mg/dL (25μmol/L), and AST (SGOT)/ ALT (SGPT) ≤2 x ULN or if hepatic metastases are present ≤ 5 x ULN No other trial: Patient is not or was not participating in any other clinical trial within 28 before visit 2 Women of childbearing potential: A negative pregnancy test & effective contraception are mandatory in child-bearing age Men agree not to father a child (i.e. use adequate birth control if sexually active) during participation in the trial | 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 Syndrome Suspected sleep apnea syndrome > 18 yr Outpatient Able and willing to use the necessary equipment for registration of nasal pressure and O2 saturation at home hospitalized patients < 18 yr Not able to use the necessary equipment | 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, Obesity Hypoventilation Syndrome Obesity degree I-III (Body mass index, BMI >30 Kg/m2) Stable daytime PCO2 >45 mmHg Age < 75 years Absence of other parenchymal, respiratory or neuromuscular diseases, diseases of the chest wall which may occur concomitantly with hypoventilation Absence of Cognitive disorders that interfere with the administration of the clinical questionnaires Severe comorbidity FEV1/FVC ratio < 65% in the forced spirometry | 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): 18.0-70.0, Obstructive Sleep Apnea Acute Kidney Failure Chronic Kidney Disease Males with high risk of obstructive sleep apnea syndrome as clinically assessed by coincidence of typical symptoms (e.g. daily somnolence, witnessed apnea, non-refreshing sleep), obesity and high score on Epworth sleepiness scale (ESS) with age range from 18 to 70 years 2. Glomerular filtration rate (MDRD formula-based) > 60 ml/min 3. Arterial hypertension diagnosed according to the European Society of Hypertension 2007 Guidelines Mental illness 2. Proteinuria >2 g/24h 3. Acute and chronic inflammation 4. Heart failure III or IV grade 5. Uncontrolled diabetes mellitus 6. Severe lipid disturbances (triglyceride and/or total cholesterol concentration > 300 mg/dl) 7. Chronic administration of drugs with confirmed nephrotoxicity and/or sympathicomimetics 8. Obstructive and restrictive pulmonary diseases which may deteriorate the function of the respiratory system | 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): 60.0-85.0, Alzheimer´s Disease Men and women (non-childbearing potential) with a diagnosis of probable Alzheimer's disease according to the clinical criteria. 2. Age 60 years (patients over 85 years could be included after a previous assessment by the investigator and in agreement with the sponsor) 3. MRI or CT-scan assessment within 12 months before baseline corroborating the clinical diagnosis (diffuse brain atrophy predominating in medial temporal regions) and excluding other potential causes of dementia, especially cerebrovascular lesions (see number 3). 4. Mild to moderate stage of Alzheimer's disease according to MMSE 16-26. 5. Modified Hachinski ischemic score equal to or below 4. 6. Geriatric Depression Scale below or equal 7. 7. Female patients must be either surgically sterilized or at least 1 year postmenopausal (confirmed by FSH >20, for women not surgically sterilized). 8. A caregiver/nurse is available and is living in the same household, or interacts with the patient to assure the correct preparation and administration of the study drug to the patient. 9. Patients living at home or old people's home. 10. General health status acceptable for a participation in a 6 months clinical trial. 11. Ability to swallow 100 -150 ml of water suspension. 12. No daily-regular/chronic intake of medications acting on central nervous system, immunosuppressants, steroids or non-steroid anti-inflammatory agents except the following allowed treatments SSRIs as antidepressants if they are administered at a stable and well tolerated dose for two months prior to baseline evaluation the following drugs at a stable and well tolerated dose to symptomatic treatment of mild behavioral disorder, sleep onset-insomnia or mild depressive mood Risperidon max 1mg/day Quetiapin max 25mg/day Zolpidem max 10mg in the evening Lorazepam max 1mg/day Triazolam max 0,25mg/day Alprazolam max 1mg/day Mirtazapin max 30mg/day | 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, Subclinical Hypothyroidism Subjects with subclinical hypothyroidism Patients taking L-thyroxin therapy Patients with known cardiovascular, cerebral or peripheral atherosclerotic 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): 21.0-89.0, Obstructive Sleep Apnea OSA, Apnea-hypopnea index > 5/hour Prior CPAP Uncontrolled Depression Moderate to Severe chronic obstructive pulmonary disease (COPD) Hypoventilation Average estimated nightly total sleep time < 4 hours Shift work Unstable depression Upper airway surgery Uncontrolled Restless legs syndrome (RLS), narcolepsy Use of supplemental oxygen | 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 Patients with COPD Acute hypercapnic exacerbation of COPD at least 2 weeks previously Tolerated non-invasive ventilation during acute hypercapnic exacerbation Chronic hypoxia requiring LTOT (PaO2 <7.3kPa or a PaO2 >7.3 and <8.0kPa and one of the following: secondary polycythaemia; nocturnal hypoxaemia SaO2 <90% for >30% of the time; peripheral oedema; or PHT) Chronic hypercapnia (PaCO2 >7kPa) ≥20 pack year smoking history FEV1/FVC <60% FEV1 at <50% predicted Persistent hypercapnic respiratory failure with acidosis (defined as pH <7.30 after bronchodilators) Development of worsening hypercapnic respiratory failure with acidosis during initiation of LTOT therapy Failure to tolerate NIV during the acute illness preceding trial identification Post extubation or decannulation following AHRF requiring intubation Restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the FEV1/FVC ratio is <60% and the FEV1 <50% if the predominant defect is considered to be obstructive by the center clinician Clinical features of severe OSA BMI >35kg/m2 Unstable coronary artery syndrome Cognitive impairment that would prevent informed consent into the trial Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge | 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, Cancer Survivor Fatigue Psychosocial Effects of Cancer and Its Treatment Sleep Disorders Prior diagnosis of cancer At least 2 months and ≤ 24 months since completed curative-intent treatment (chemotherapy, surgery, and/or radiotherapy) Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex) Concurrent trastuzumab and maintenance rituximab allowed Sleep difficulty defined as self report of sleep latency of ≥ 30 minutes on 3 out of 7 nights in a week and wishing therapeutic intervention, and/or self report of waking up after first falling asleep and not being able to fall back asleep for ≥ 30 minutes on 3 out of 7 nights in a week No history of diagnosis of primary insomnia (patient medical record, defined by having had behavioral, cognitive, or pharmacologic treatment) for > 30 consecutive days in the year before cancer diagnosis No active cancer (i.e., not considered no evidence of disease) No concurrent CNS malignancy No history of diagnosed sleep disorder (i.e., obstructive sleep apnea, restless legs, or periodic leg movement disorder) ECOG performance status 0-1 | 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 Chest Wall Disease Neuromuscular Disease Obesity Hypoventilation Patients with chest wall deformity, neuromuscular disease or obesity hypoventilation syndrome with an FEV1/FVC ratio of >70% and VC <50% predicted or patients with COPD with a FEV1/FVC ratio of <70% an FEV1 <50% predicted Stable pH >7.35 ESS <18 Symptomatically stable with clinical resolution of intercurrent infection: normal C reactive protein, white cell count and afebrile Daytime symptoms compatible with nocturnal hypoventilation i.e. poor sleep, morning headache, daytime somnolence, shortness of breath Arterial carbon dioxide partial pressure (PaCO2) > 6.0kPa during day with evidence of nocturnal hypoventilation (TcCO2 >7.5KPa or a rise in TcCO2 of >1 KPa) No prior domiciliary ventilation use Patients with COPD must be established on optimal medical treatment prior to enrolment Psychological, social or geographical situation that would impair compliance with the schedule Patients who have underlying malignancy or severe cardiac dysfunction (ejection fraction <40%) Complex OSA | 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): 21.0-90.0, Stroke Impaired Upper Extremity Function An ischemic or hemorrhagic stroke more than 6 months prior to entry into the study trace ability to move the wrist and fingers in extension voluntary shoulder elevation to approximately 45 deg be between the ages of 21 and 90 Have cognitive deficits that could negatively affect their ability to complete protocols as evidenced by a score of 24 or less on the Folstein Mini Mental State Examination (Bleeker, 1988) have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols have an upper extremity injury or conditions prior to stroke that could limit participation have severe hemispatial neglect have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer 1975); and have severe sensory loss | 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, Obstructive Sleep Apnea Patients with high probability of OSA, defined by two or more of daytime sleepiness snoring recognized apnoeic episodes associating obesity and / or hypertension Patients with impaired lung function ( overlap syndrome, obesity-hypoventilation syndrome, restrictive disorders), associated pathology (psychiatric disorder, periodic limb movements, dyssomnias or other parasomnias) Patients treated with CPAP | 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): 40.0-70.0, Blood Pressure Platelet Function Inflammation mild hypertension (systolic blood pressure 130-159 mmHg, diastolic blood pressure 85-99 mmHg) smoking regular use of medications (except hormone replacement therapy) or dietary supplements intestinal disorders obesity (BMI> 35 kg/m2) vegetarianism pregnancy | 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): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 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): 40.0-80.0, Chronic Obstructive Pulmonary Disease Obstructive Sleep Apnea Syndrome Presence of Chronic Obstructive Pulmonary Disease stage II and III of Global Initiative for Chronic Obstructive Lung Disease, stable for three months, and with symptoms suggestive of Obstructive Sleep Apnea Syndrome Presence of Chronic Obstructive Pulmonary Disease stage II and III | 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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 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, Metabolic Syndrome Insulin Resistance Adipokines Cytokines for part A: Patients who are included in the obesity surgery program will be recruited if they fulfill the following Age between 18 and 65 years Body mass index (BMI) >40 kg/m2 or BMI > 35 kg/m2 with co-morbidity related to obesity. for part B: In the treatment response study we will patients diagnosed at the baseline polysomnography with severe OSA (AHI >= 30) who fulfill the for part A and who do not present specific for part B. General (for part A) Prior treatment with CPAP Severe or unstable cardiovascular disease (severe or surgically treated valvulopathy, myocardial infarction, unstable angina, cardiac surgery) during the 6 months prior to in the study Evidence of acute or chronic inflammatory illness different to obesity itself (connective tissue disease, active neoplasia) or associated infectious process during the 6 weeks prior to in the study Severe cognitive or psychiatric disorder that would make it difficult to complete the clinical questionnaires Severe chronic diseases that may interfere in a significant way with the results of the study Chronic obstructive pulmonary disease defined by FEV1/FVC < 0.7 Pregnancy Alcohol abuse (daily alcohol consumption >80 g) | 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, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major 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): 18.0-999.0, Obstructive Sleep Apnea Chronic Obstructive Pulmonary Disease Obstructive sleep apnea (OSA) COPD Inability to perform exercise test due to musculoskeletal limitation Cardiac condition preventing patient from mild exercise Continuous oxygen supplement | 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 Nocturnal Desaturation Patients with a diagnosis of COPD supported by a history of past smoking and obstructive disease: FEV1<70% predicted, FEV1/FVC<70% and a total lung capacity by body plethysmography >80% predicted Stable COPD at study entry, as demonstrated by (1) no acute exacerbation and (2) no change in medications for at least 6 weeks before enrollment in the trial Non-smoking patients for at least 6 months before enrollment in the trial SpO2 at rest < 95% Patients fulfilling the current definition of nocturnal oxygen desaturation, i.e., >=30% of the recording time with transcutaneous arterial oxygen saturation <90% on at least one of two consecutive recordings Ability ot give informed consent Patients with severe hypoxemia fulfilling the usual for continuous oxygen therapy at study entry: PaO2 <=55 mmHg; or PaO2 <= 59 mmHg with clinical evidence of at least one of the following: (1) with right ventricular hypertrophy (P pulmonale on ECG:3 mm leads ll, lll, aVf); (2) right ventricular hypertrophy; (3)Peripheral edema (cor pulmonale); (4) hematocrit >=55% Patients with proven sleep apnea (defined by an apnea/hypopnea index of >=15 events/hour) or suspected sleep apnea on oximetry tracings Patients currently using nocturnal oxygen therapy Patients with known left heart or congenital heart diseases, interstitial lung diseases, bronchiectasis as the main cause of obstructive disease, lung carcinoma, severe obesity (body mass index >= 40 kg/m²), or any other disease that could influence survival | 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): 19.0-100.0, Cardiovascular Risk Factors Age ≥ 65 years 2. Hypertension (HTN) 3. Diabetes 4. Obesity (body mass index [BMI] >35) 5. Renal insufficiency 6. Tobacco usage 7. Hypercholesterolemia 8. Sleep apnea/heavy snoring at night 9. Clinical diagnosis of CHF as defined by: 1. Dyspnea on exertion 2. Paroxysmal nocturnal dyspnea 3. Orthopnea 4. Elevated jugular venous pressure 5. Pulmonary rales 6. Third heart sound 7. Cardiomegaly or pulmonary edema on chest x-ray 8. Peripheral edema 9. Hepatomegaly 10. Pleural effusion 10. Palpitations/irregular heart beats 11. Chest pain at rest and or exercise 12. Murmur on examination 13. Known coronary artery disease (CAD)/stents/coronary artery bypass graft (CABG) 14. Known valvular disease 15. Known stroke or transient ischemic attacks (TIA) Patients expected to say in the hospital for less than 24 hours. 2. Inability of undergo TEE and TTE 3. Clinical evidence or suspicion of elevated intracranial pressure. 4. Preoperative shock or systemic sepsis 5. Emergency Operation 6. ASA Class V 7. Inability of give informed consent 8. Participation in another clinical trial 9. Prisoner | 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): 18.0-65.0, Obstructive Sleep Apnea Adults, age 18-65 Recently diagnosed with obstructive sleep apnea, confirmed by polysomnography (sleep study) Experiencing daytime sleepiness, based on Epworth Sleepiness Scale Scheduled for a positive airway pressure (PAP) titration study (CPAP or BiPAP) Willing to use CPAP or BiPAP at pressures prescribed by the treating physician Willing to have facial photographs taken before treatment and 2-4 months after nightly use of CPAP or BiPAP Diagnosed with other sleep, medical or psychiatric disorders that might limit the effectiveness of PAP treatment (such as morbid obesity, emphysema, and neurodegenerative disorders) Conditions that may cause daytime sleepiness (such as narcolepsy, primary insomnia, seizure disorders, or major depression) Use of medications or herbal remedies that affect sleep and behavior History of facial plastic or reconstructive surgery or Botox injections or plans to undergo these types of treatments prior to completing the second study visit | 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 A current clinical diagnosis of Chronic Obstructive Pulmonary Disease Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years A smoking history of at least 10 pack years History and/or current clinical diagnosis of asthma History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis | 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): 20.0-75.0, Obesity Hypoventilation Syndrome Patients from 20 to 75 years old Body mass index > 32 kg/m2 Nocturnal oxygen desaturation 5 mn ≤ 88% under CPAP PaCO2 > 5,9 kPa in diurnal, spontaneous ventilation Patients with COPD and VEMS/FVC < 65% Patients with CHF and periodic breathing (Ejection Fraction <40%) Patients with a recent respiratory decompensation in the month preceding | 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): 40.0-90.0, Chronic Obstructive Pulmonary Disease Patients who are admitted to the Prince of Wales Hospital with will be screened for this study Patients with age over 40 years Patients with asthma Patients unable 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): 50.0-95.0, COPD Heart Failure, Congestive Caucasians Males and females Age > 50 years Smoking history > 10 pack years Diagnosis of COPD according to GOLD 2008 and/or diagnosis of CHF according to ESC 2008 History of bronchial asthma Fixed airflow limitation due to other chronic diseases such as cystic fibrosis, bronchiolitis obliterans organizing pneumonia (BOOP), bronchiectasis, TBC etc Combined restrictive-obstructive functional impairment | 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 Adult with healthy mind, who has attained his majority, and affiliated to Social Security Patient suffering from SAS confirmed by polysomnography (PSG) Written informed consent form signed Patients receiving neuroleptics or benzodiazepines and affiliated drugs will not be included in the study Patients suffering for severe SAS : those who have a number of IAH higher than 30 in a validated sleep hour, will be excluded for security reasons Pregnant women, nursing mothers or women susceptible to procreate without efficient contraception Patient presenting hypersensitivity to understudying products and their excipients | 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): 25.0-90.0, Chronic Obstructive Pulmonary Disease Patient with COPD and increased SPAP >55 on echocardiogram will be screened for the study. 2. Patients with normal wedge pressure ( [PCWP] ≤ 15 mm Hg), mean PAP ≥ 35 mm Hg and a pulmonary vascular resistance (PVR 0 wood unit)on right heart catheterization. 3. Diagnosis of COPD according to GOLD guidelines 4. The patient can read, understand and sign the informed consent Other identified cause for pulmonary hypertension | 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): 0.0-80.0, Chronic Obstructive Pulmonary Disease Elderly patients < 80 years old COPD (ERS/ATS (FEV1 < 80%, FEV1/FVC < 70%, TLC > 80%)) Oxygen therapy indication (PaO2 < 55 mmHg or 55-59 associated to pulmonary arterial hypertension, chronic Cor Pulmonale, Chronic Heart failure, arrhythmias or polyglobulia) PaCO2 > 50 mm Hg Clinically stable at least prior to one month Hypercapnic response: increasing PaCO2 > 10 mmHg at 7 a.m after all night with oxygen compared with PaCO2 when awake and without oxygen therapy Active smoker Bronchiectasis or tuberculous after-effects Chronic respiratory failure secondary to thorax cage or neuromuscular diseases BMI > 35 kg/m2 OSAS Locomotor system problems that disable 6 minutes walking test execution Patients with tracheostomy Other serious comorbidity (i.e chronic heart failure functional class > II NYHA, cancer or chronic renal failure that requires dialysis | 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, Neoplasms Any solid tumor malignancies of any stage meeting all of the following Minimum tumor dimension is at least 1 cm (to ensure it is above the detection threshold of PET imaging). Examples but are not limited to: locally advanced squamous cell carcinoma of the head and neck to be treated by either initial surgery or primary chemoradiotherapy; inoperable non-small cell lung cancer or pancreatic carcinoma to be treated with stereotactic radiotherapy, which may be biopsied again at the time of percutaneous needle delivery of implanted fiducial markers Patients with newly diagnosed malignancies should not have initiated treatment for their disease before participating in this study. Patients with recurrent or second malignancies may have had prior therapy as appropriate for their disease, but should have completed all prior treatment at least 30 days before participation in this study and should not have initiated new treatment for the current problem Greater than or equal to eighteen years of age Sufficiently healthy to tolerate all study procedures Organ and marrow function sufficient to undergo planned therapy Ability to understand and the willingness to sign a written informed consent document • Pregnant or nursing | 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, Renal Function HIV Infection > 18 years old. 2. HIV RNA < 50 copies/ml (For ART-experienced group only) a history of Tc-99m DTPA allergy, 2. malnutrition (BMI <18m2), 3. amputation, 4. bed-ridden, 5. currently taking cotrimoxazole or cimetidine, 6. acute deterioration of renal function within the last 3 months, 7. serum creatinine > 1.5 mg/dl, or 8. pregnant/lactating | 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): 21.0-85.0, Sleep Apnea Obstructive Sleep Apnea (defined by Apnea-hypopnea index [AHI] > 5 per hour; with hypopneas defined as greater than 30% reduction in airflow with 4 or greater drop in oxygen saturation). AHI will be determined by full night or split-night polysomnography. 2. Age range 21 years old. 3. Stable medical history and no change in medications, including anti-hypertensive and thyroid replacement, in the previous 4 months. 4. No regular use (> 3 times/week) of sedative or hypnotic medications in the last 4 months Central sleep apnea (central apnea index > 5 per hour and >50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas). 2. Complex sleep apnea or CPAP emergent central apnea (Central apnea index > 5 per hour during CPAP titration with >50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas). 3. Requiring oxygen or bi-level positive airway pressure for treatment of OSA or hypoventilation. 4. Decompensated cardiac (heart failure or angina) or pulmonary (severe COPD or uncontrolled asthma) disease 5. Chronic narcotic use 6. Nasal obstruction (nasal congestion score > 15) or enlarged tonsils 7. Diagnosis of another sleep disorder in addition to OSA based on PSG (e.g., periodic limb movement disorder [ 15 limb movements/hour of sleep with arousal], central sleep apnea [ 50% of apneas on diagnostic PSG are central apneas], insomnia, obesity hypoventilation syndrome, or narcolepsy). 8. Previous treatment with positive airway pressure, home oxygen therapy, tracheotomy, uvulopalatopharyngoplasty, or other surgery for OSA. 9. Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months. 10. Routine consumption of more than 2 alcoholic beverages per day. 11. Recent or recurring history of recreational drug use leading to tolerance or dependence. 12. Unable to perform tests due to inability to communicate verbally, inability to write and read in English; less than a 5th grade reading level; visual, hearing or cognitive impairment (e.g. previous head injury); or upper extremity motor deficit (e.g., previous stroke that prevents patient from using CPAP treatment) | 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): 18.0-65.0, Obstructive Sleep Apnea Insulin Resistance Metabolic Syndrome Inflammation Subjects between 18 years old Able to understand and give informed written consent BMI > 35 kg/m2, and features of obesity hypoventilation syndrome known diabetes mellitus or hyperlipidemia on treatment known cardiovascular disease except hypertension stable on treatment unstable medical illness need for starting treatment for OSA or other medical conditions immediately | 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): 21.0-80.0, Sleep Apnea Central Cheyne-Stokes Respiration Obstructive Sleep Apnea Males and females, ages 21-80 Able and willing to provide written informed consent Diagnosis of complex sleep apnea (CompSAS) or Obstructive Sleep Apnea (OSA) within one year of study participation For participants with CompSAS: (a) Diagnostic PSG with an Apnea-Hyopnea Index (AHI) greater than or equal to 10 events/hour and central apnea index (CAI) greater than or equal to 5 events/hour of sleep or (b) PAP titration with a CAI greater than or equal to 5 events/hour of sleep For participants with OSA, a diagnostic PSG with an AHI greater than or equal to 15 events/hour of sleep Must have had a CPAP titration such that the necessary PAP level to treat the sleep disordered breathing is known Agreement to undergo a full-night, in-laboratory PSG on CPAP device Participation in an interventional research study within 30 days of study participation Pre-menopausal females known to be pregnant or who are sexually active and not using a reliable method of birth control Surgery of the upper airway, nose, sinus, or middle ear within the last 90 days Surgery at any time for the treatment of OSA such as uvulopalatopharyngoplasty (UPPP) Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe Chronic Obstructive Pulmonary Disease (COPD) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (> 45 mmHg) while awake Currently prescribed oxygen therapy Ventilatory induced barotrauma within 6 months of study participation Untreated insomnia Other major medical condition that, in the judgment of the investigator, precludes participation in 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): 1.0-30.0, Acute Lymphoblastic Leukemia Adult B Lymphoblastic Lymphoma Ann Arbor Stage I B Lymphoblastic Lymphoma Ann Arbor Stage II B Lymphoblastic Lymphoma Childhood B Acute Lymphoblastic Leukemia Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Childhood B Lymphoblastic Lymphoma Down Syndrome Hypodiploid B Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932 Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932 B-ALL patients must have an initial white blood cell count < 50,000/uL Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met With the exception of steroid pretreatment (defined below) 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 AALL0932 Patients receiving prior steroid therapy may be eligible for AALL0932 Patients with central nervous system 3 (CNS3) leukemia CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy B-ALL patients with testicular leukemia are not eligible for AALL0932 For B-LLy patients 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): 18.0-69.0, Decrease of Inflammation of Adipose Tissue Sleep Apnea Syndrome Male between 18 and 70 years old Apnea Hypopnea Index > 30/h and > 5% TST with SaO2 < 90% patients obese (BMI > 33kg/m2) or non obese (BMI < 27kg/m2) Female coronary ischemic disease, past history of CVA chronic pulmonary disease measured by arterial gasometry (PaO2 < 60mmHg and/or PaCO2 > 45mmHg) known hepatic disease alcohol consumption > 3 units/day sleepiness considered to be dangerous by the investigator patient having an hazardous work regarding to awareness patient being under anticoagulant, antiplatelet drug or having an active stent or bleeding disorder patient having an inflammatory syndrome (C-reactive Protein > 10) any allergy to local anaesthetics | 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): 21.0-40.0, Pro-inflammatory Activity Immunologic Activity Alteration male and non-pregnant female, non-smoking adults in good general health between the ages of 21-40 years old fluent in English with willingness to participate in the research study Supplementary Prescription Opioid Abusers DSM-IVR diagnosis of prescription opioid abuse or dependence disorder compliance in treatment and on a stable dose of buprenorphine (6-24mg/day) x at least 10 days prior to screening Participation in an ISAP treatment program or a qualified community-based opioid treatment program or private clinic for the entire duration of their study participation regular use of any medication that influences immune status or immune system function regular use of a medication that influences pain perception, including opioids (* only for healthy subjects population*) Regular use of a medication that influences pain perception, except for buprenorphine (** only for POA population**) known hypersensitivity to opioids or no previous opioid exposure (*only healthy controls) presence of acute or chronic pain syndrome neuropsychiatric illness (i.e., peripheral neuropathy, schizophrenia) known to affect pain perception presence of chronic immune compromise (hepatitis C, HIV) or acute infection within the last four weeks current or past history of high blood pressure, heart disease, or stroke, or currently have a pacemaker current DSM-IV diagnosis BMI less than 18.5 or greater than 29.9 | 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): 0.0-80.0, Chronic Obstructive Pulmonary Disease (COPD) Patient diagnosed with chronic obstructive pulmonary disease (COPD) 2. Age < or = to 80 years 3. Forced expiratory volume in one second (FEV1) < 50% of predicted value 4. FEV1/Forced vital capacity (FVC) < 70% of predicted value 5. Total lung capacity (TLC) > 90% predicted by plethysmography 6. Body Mass Index (BMI) < 35 7. Patient has provided written informed consent using a form that has been approved by the Internal Review Board (IRB) 8. Daytime PaCO2 ≥ 52 mm Hg, at rest on room air (Denver > 48 mm Hg) with one of the following symptoms of hypercapnia Fatigue Sleepiness Headaches 9. Post hospital discharge at least one month prior to screening visit 10. Participant is willing and able to complete all required assessments and procedures 11. Participant has no child bearing potential OR a negative pregnancy test in a woman of childbearing potential FEV1 < 15% of predicted value 2. Diagnosis of obstructive sleep apnea (OSA) [Apnea hypopnea index (AHI) > 15 per hour] 3. Current Non-invasive Positive Pressure Ventilation (NIPPV), Positive Airway Pressure (PAP) or Non-invasive Ventilation (NIV) users 4. Signs / symptoms of acute exacerbation within the previous month: two of the following Increasing cough Purulent sputum Current use of antibiotics pH < 7.35 5. Any major non COPD disease or condition that interferes with completion of initial or follow-up assessments, such as uncontrolled malignancy, end-stage heart disease, liver or renal insufficiency (that requires current evaluation for liver or renal transplantation or dialysis), amyotrophic lateral sclerosis, or severe stroke, or other as deemed appropriate by investigator as determined by review of medical history and / or patient reported medical history 6. History of pneumothorax 7. Anatomical facial abnormalities precluding placement of a nasal or facial mask 8. Diffuse parenchymal lung disease other than emphysema 9. Inability to maintain Oxygen (O2) saturation >90% on 5L/min ( five liters) nasal O2 at rest 10. Sustained need for >10 mg prednisone daily or equivalent dose of other systemic corticosteroid 11. Pregnancy 12. Excessive alcohol intake (≥ 6oz hard liquor daily), or illicit drug use 13. Daily use of narcotics (greater than 30 mg morphine equivalent) 14. Patient is currently enrolled in another interventional clinical 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, Sleep Apnea Syndromes Diagnosed with Moderate to Severe Sleep Apnea Live in San Diego County Veteran Previous use of positive pressure airway therapy Residence outside of San Diego county | 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, Chronic Obstructive Airway Disease Both men and women with age more than 18 years Known diagnosis of COPD (GOLD stage 2 or higher) Already using CPAP or BPAP device Estimated GFR <30 ml/min/1.73 m2 or on hemodialysis Women known to be pregnant or planning to be pregnant in next 6 months Cardiac pacemaker, metallic heart valves, metallic implants, claustrophobic Chronic atrial fibrillation or frequent premature ventricular contractions Using lipid-lowering medications, aspirin, oral steroids, steroid-sparing medications or anti-oxidant vitamin supplements If taking sildenafil or related drugs, unable to stop it within 48 hours of the study visit Contraindications to stress cardiac testing: acute myocardial infarction within 48 hours, unstable angina not yet stabilized with medical therapy, ongoing chest pain, active broncho-constriction, uncontrolled cardiac arrhythmia, symptomatic severe aortic stenosis, aortic dissection, acute pulmonary embolism or pericarditis Uncontrolled COPD or acute COPD exacerbation Known chronic inflammatory diseases like lupus or active infection | 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): 55.0-999.0, Dementia Alzheimer's Type Patients with diagnosis of Alzheimer's Disease (AD) (Cannot be dementia from strokes or other causes) Patient is on stable and well-tolerated donepezil treatment at a dose of either 5 or 10 mg daily for at least 3 months prior to screening visit Age <55 years old Psychotic features, agitation, or behavioral problems within the last 3 months Patients unable to comply with ophthalmologic monitoring Lack of consistent and reliable caregiver. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial | 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): 18.0-90.0, Central Hypothyroidism Clinical evidence of central hypothyroidism: status post pituitary surgery and/or radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as ACTH, LH, FSH Primary hypothyroidism | 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 Adult patients (age > 18 years) admitted to participating ICUs with: 1. Primary diagnosis of COPD exacerbation defined as the presence of two or more of the following clinical features: worsening dyspnea, increase in sputum purulence, increase in sputum volume 2. respiratory failure [pH < 7,35 with a PaCO2 > 45 mm Hg and respiratory rate more than 23 breaths per minute] requiring mechanical ventilation, invasive or non-invasive mechanical ventilation Primary diagnosis of asthma exacerbation. 2. History of asthma or atopy. 3. Use of systemic corticosteroids within the preceding month. 4. Use of systemic corticosteroids for the treatment of COPD exacerbation at the time of ICU admission for more than 24 hours. 5. Clinical or radiological evidence of pneumonia. 6. Uncontrolled left-ventricular failure (patients with evidence of severe heart failure requiring inotropes or vasoactive drugs). 7. Uncontrolled hypertension arterial (systolic pressure > 180 mm Hg or diastolic pressure > 90 mm Hg despite antihypertensive therapy). 8. Uncontrolled diabetes mellitus. 9. Presence of a neuromuscular disease. 10. History of allergy and or adverse reaction to corticosteroids | 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): 40.0-999.0, COPD Dyspnea Hyperinflation Current or former cigarette smokers of at least 10 pack-years Clinically significant dyspnea, as determined by a score of at least 2 on the Medical Research Council Dyspnea Score questionnaire (0-4), or through pulmonary function test results of a residual volume (RV) of > 150% predicted or an FEV1 of <65% predicted Clinical diagnosis of chronic obstructive pulmonary disease Unable to use the slow-breathing device due to hearing impairment Poor motivation or lack of interest in using the device Pulmonary Rehabilitation ordered as a new therapy at the time of enrollment | 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): 25.0-89.0, Pneumococcal Infection Able to understand and give informed consent. 2. Immunocompetent community dwelling subjects between the ages of ages of 25-40 and 60-89 years Prior vaccination with pneumococcal vaccine. 2. Receipt of any of the following products: 1. Blood products within 3 months prior to study entry or expected receipt at any time after study entry*. 2. Any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry*. 3. Any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry*. 3. Presence of co-morbidities or immunosuppressive states such as Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, cerebrospinal fluid leaks, severe kidney disease, autoimmune diseases, severe gastrointestinal diseases and grade 4 hypertension per CTCAE criteria** Alcohol, drug abuse or psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data Impaired immune function or known chronic infections including, but not limited, to known HIV, hepatitis B or C; organ transplant; immunosuppression due to cancer; current and/or expected receipt of chemotherapy, radiation therapy, steroids*** (i.e., more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days , or high dose inhaled corticosteroids**** or any other immunosuppressive therapies (including anti-TNF therapy), functional or anatomic asplenia and congenital immunodeficiency. 4. Conditions that could affect the safety of the volunteers such as: o Severe reactions to prior vaccinations. o An allergy to any component of the study vaccines (phenol, aluminum, CRM197 protein, succinic acid, Polysorbate 80) History of Guillain-Barré syndrome History of bleeding disorders. 5. Volunteers with any acute illness* including, but not limited to fever (> 100.4 F [> 38 C], regardless of the route) within 3 days prior to study entry. 6. Volunteers with social conditions or occupational conditions or any condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation. 7. Pregnant or breast feeding or women expected to conceive within 30 days after vaccination ***** An individual who initially is excluded from study participation based on one or more of the time-limited (e.g., acute illness, receipt or expected receipt of live or inactivated vaccines ) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria Grade 4 hypertension per CTCAE is defined as Life threatening consequences(e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis) urgent intervention indicated. ***Subjects receiving > 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 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): 18.0-90.0, Acute Lung Injury Acute Respiratory Failure Hypoxemic and no hypercapnic acute respiratory failure severe dyspnea at rest with a respiratory rate >25 breaths/min PaO2/FiO2 <300 PaCO2 <45 mmHg age <18 years NPPV contraindications past history of respiratory chronic disease (COPD, cystic fibrosis…) cardiac pulmonary edema Pre-defined intubation other than respiratory organ failure : systolic pressure <90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12) profound aplasia (white cells count <1000/mm 3) | 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 Enlargement of Tonsil or Adenoid Children with OSA and/or increased end tidal C02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), 2-12 years of age, and both genders will be eligible to be part of the study. OSA and its severity will be diagnosed by a preoperative polysomnography Children with compromised cardiovascular, pulmonary or renal function, those with congenital syndromes, sickle cell disease, history of seizures and those receiving theophylline will be excluded | 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, COPD Exacerbation All COPD patients (according to the ATS definition) experiencing acute exacerbation originating in acute respiratory failure and requiring ICU admission will be included in the study. COPD exacerbation is defined by the increased frequency of cough, volume and purulence of sputum and that of wheeze. Acute respiratory failure is defined by the presence of hypercapnia with PaCO2 >45mmHg associated with pH > 7.35 and signs of respiratory muscle fatigue (contraction of accessory respiratory muscles, thoracoabdominal swinging ,..) Asthmatic patients defined by a reversible obstructive disease following nebulized bronchodilators Patients with uncontrolled left heart failure patients with a radiologically documented pneumonia Systemic corticotherapy within 30 days before screening contra-indication to corticosteroids (active gastroduodenal ulcer, uncontrolled sepsis, etc. ..) | 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): 30.0-70.0, Sleep Apnea, Obstructive Metabolic Syndrome Moderate to severe Obstructive Sleep Apnea Hypopnea Syndrome (AHI > 15/h) Sedentary patient (Activity Voorrips Questionnary score < 9,4) OSAS already treated by CPAP or other therapy (OAM,...) BMI > 40/m² Hypnotic and sedative medications Cranio-facial malformation Obstructive respiratory disease (COPD, asthma,...) Instable heart ischemic disease and all | 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, Obesity Hypoventilation Syndrome Age greater than or equal to 18 years of age; less than or equal to 70 years of age Diagnosis of Obesity Hypoventilation Syndrome via a diagnostic sleep study in the past 3 months but have not initiated therapy BMI greater than or equal to 30 kg/m2 Daytime PaCO2 greater than or equal to 45 mmHg Apnea Hypopnea index (AHI) > 5 Daytime pH > 7.35 Forced Expiratory Volume at 1 second / forced vital capacity (FEV1/FVC) > 70% Acutely ill, medically complicated or who are medically stable, or as otherwise determined by the investigator Respiratory alkalosis (pH > 7.45), per investigator discretion Emergency admissions on chronic respiratory failure Hospitalization for respiratory exacerbation < 6 weeks prior to screening visit Participants in whom PAP therapy is otherwise medically contraindicated Impaired upper airway function. For example, obstruction due to infections(laryngitis, epiglottis), craniofacial malformations, tumors, uvulopalatopharyngoplasty, presence of tracheostomy, or bilateral vocal cord palsy that does not allow tolerance of Non-invasive positive pressure ventilation (NPPV) Facial trauma, burns, surgery or anatomical abnormalities interfering with mask fit | 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 MD diagnosis of obstructive sleep apnea No previous use of CPAP No concurrent use of hypnotic medication Fatal comorbidities (i.e., life expectancy less than 6 months) Contraindications for CPAP use Pregnancy Liver Failure | 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): 16.0-999.0, Chronic Hypercapnic Respiratory Failure Obesity Hypoventilation Syndrome Neuromuscular Disease Chronic Obstructive Pulmonary Disease Patients over the age of 16 years. 2. Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome. 3. Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of >6.0 kPa in the morning. 4. Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of >6.0 kPa during the day. 5. No prior domiciliary ventilation Patients with other co-morbidities e.g. cancer or cardiac failure. 2. Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease. 3. Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation. 4. Patients who have an abnormal bleeding tendency (INR or APTTr >1.4 or platelets <100). 5. Patients with a psychological, social or geographical situation that would impair compliance with the project | 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): 21.0-999.0, Periodic Breathing Breathing-Related Sleep Disorder years old Chronic ResMed ASV therapy patient Current ASV therapy for at least 4 weeks Able to understand fully the study information and participation requirements Provide signed informed consent Acute cardiac decompensation Acute myocardial infarction within last 3 months Resuscitation within last 3 months Stroke with swallowing disorders or persistent hemiparesis Blood pressure test at end expiratory pressure (EEP) 10cmH2O not passed Untreated restless legs syndrome Alcohol or drug abuse Known cancer Pregnancy Conditions that could interfere with patients participating in and completing the protocol and/or the investigator deems their enrolment unsuitable | 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): 16.0-999.0, Pathogenesis Sjogren's Syndrome Salivary Gland Ability to sign informed consent form 2. Fulfilling one the definitions below: 1. Sj(SqrRoot)(Delta)gren s defined by European-American (EA) classification for primary or secondary Sj(SqrRoot)(Delta)gren s syndrome (SS group) 2. Excluded from the EA because of a comorbid condition but otherwise fulfilling the European-American classification (EA excluded SS group) 3. Incomplete SS i. at least 2 of the EA with a common manifestation of SS not included in these (e.g., fatigue, vasculitis, arthritis, etc) ii. 2 or more common manifestations of SS which are not included in the EA (e.g.,: fatigue, vasculitis, arthritis, autonomic dysfunction, etc ) and are not explained by other conditions Age <16 years 2. inability or unwillingness to comply with follow up requirements 3. Any medical or psychological/psychiatric condition or treatment that, in the opinion of the Principal Investigator, would the subjects from the research studies (e.g., alternative explanation for subjects signs and symptoms) 4. NIH employees who report directly to the principal investigator or who are a co-worker or relative of the principal investigator | 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, Pulmonary Hypertension Breathing-Related Sleep Disorder percapillary pulmonary hypertension diagnosed by right heart catheterisation - stable therapy and clinical condition for at least 4 weeks sleep disordered breathing with apnea/hypopnea index > 10 events/h and/or median nocturnal oxygen saturation <90% Pregnancy severe daytime hypoxemia (PaO2 < 7.2 kPA) patients with predominantly obstructive sleep apnea | 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): 35.0-80.0, Chronic Obstructive Pulmonary Disease Obstructive Sleep Apnea Overlap Syndrome Patients aged > 35 years, the diagnosis of both OSA and COPD. OSA must have been diagnosed using an American Academy of Sleep Medicine (AASM)-protocol overnight Type I polysomnogram assessment with a resultant RDI of >5 events/hour in association with OSA-attributable diurnal symptoms COPD must be diagnosed using American Thoracic Society (ATS)-protocol pulmonary function testing Patients must have Global Obstructive Lung Disease (GOLD) stage II COPD FEV1/FVC < 70% predicted in conjunction with an FEV1 <80% predicted The patient must have a > 10 pack years smoking history and a documented history of at least one exacerbation leading to treatment with systemic glucocorticoids or antibiotics or hospitalization within the previous year Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may have put the patient at risk because of participation in the study or may have influenced either the results of the study or the patients' ability to participate in the study Patients with a diagnosis of asthma Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis Patients with known active tuberculosis Patients with brittle/unstable diabetes mellitus Patients with a history of and/or active significant alcohol or drug abuse. See criterion 1 Patients with a history of myocardial infarction within the year prior to Visit 1 Patients with cardiac arrhythmia that required medical or surgical treatment in the 3 months prior to enrollment Patients who had taken an investigational drug within 30 days or 6 half-lives (whichever is greater) prior to Visit 1 Use of systemic corticosteroid medication at unstable doses (i.e., less than 6 weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day or 20 mg every other day | 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): 45.0-75.0, Chronic Obstructive Pulmonary Disease Age 45 through 75 years Predicted (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II, III, and IV) at Screening History of previous acute exacerbations of chronic obstructive pulmonary disease (AECOPD) 12 months prior to Screening Clinically stable and free from an for 8 weeks prior to Day 1 Current smoker or ex-smoker with a tobacco history of more than or equal to (>=) 10 pack-years Past or present disease or disorder Significant or unstable ischemic heart disease etc Known history of allergy or reaction to any component of the investigational manufacturing product (IMP) Past or current malignancy within the past 5 years Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of malignancy or tuberculosis (TB) Use of immunosuppressive medication receipt of any biologic agent | 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, Obstructive Sleep Apnea Syndrome Obesity BMI > 35 Complaints of snoring, sleep apnea, daytime sleepiness use of home oxygen other sleep diseases inability to perform PSG | 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, Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure Key Age 50 years or greater Hospitalization due to worsening COPD and/or CHF Severe COPD subjects (Global Initiative for Obstructive Lung Disease Stage III/IV); FEV1 <50% Chronic CHF subjects (New York Heart Association Class III/IV or American College of Cardiology-American Heart Association Stage C/D); Ejection fraction < 40% Expects to have direct contact with children at least once a month Key Participation in another clinical study involving the use of investigational product | 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): 21.0-70.0, Sleep Apnea Syndromes Males and females, ages 21-70. 2. Able to provide written informed consent. 3. Diagnosis of chronic non-malignant pain (pain present for ≥ 6 months). 4. Stable regimen of opioids (oral, transdermal, and/or intravenous) for chronic pain for at least 4 weeks prior to study participation with a prescribed opioid dose equal to at least 100 milliequivalents of morphine per 24 hours (Appendix 1). 5. Agreement to undergo an in-lab Diagnostic polysomnography (PSG) demonstrating an Apnea-Hypopnea Index (AHI) of at least 20 and Central Apnea Index (CAI) ≥ 10 events per hour of sleep OR at least 25% of Total Sleep Time (TST) below 90% Oxygen Saturation (SAO2) saturation and AHI ≥ 10 6. Agreement to undergo 3 full-night, in-lab PSG's on positive airway pressure therapy. 7. Agreement to undergo breathalyzer testing prior to each PSG visit 8. Ability to provide reliable documentation of opioid medications (ex. Pharmacy records) as treatment for chronic pain for the previous 30 days. 9. Willingness to undergo urine drug screening Participation in other interventional, sleep or pharmaceutical related research studies within 30 days prior to giving consent. 2. Workers with variable shift schedules. 3. Previous treatment with positive airway pressure therapy within 90 days of providing consent. 4. Participants with any conditions in which positive airway pressure is medically contraindicated (e.g. recent pneumothorax, systolic BP < 80 mmHg). 5. BMI > 40 6. Unwilling to wear PAP. 7. Any surgery involving the upper airway, eye, nose, sinuses or middle ear within the last 90 days. 8. Major or poorly managed medical or psychiatric condition that would interfere with the demands of the study, to the use of positive airway pressure, or the ability to complete the study. 9. Previous diagnosis of severe chronic obstructive pulmonary disease (COPD) with an forced expiratory volume at one second (FEV1) < 1 liter or less than 50% predicted 10. Presence of elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 50mmHg) due to intrinsic lung disease, neuromuscular or musculoskeletal disorders. 11. Participants currently prescribed 24 hour oxygen therapy (nocturnal O2 therapy for obstructive sleep apnea (OSA) treatment is allowed) 12. Females who are pregnant or, if of child bearing potential, not currently using medically reliable birth control methods. 13. Participants prescribed opioids for reasons other than the management of chronic, non-malignant pain. 14. Failure of two consecutive breathalyzer tests from study PSG nights 15. Periodic Limb Movements (PLM's) with arousals > 15 | 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, Acute Respiratory Distress Syndrome early ARDS (establishment of the diagnosis within the preceding 72 hours) according to the of the American-European Consensus Conference (5), 2. Moderate-to-severe oxygenation disturbance [defined as ratio of partial pressure of arterial oxygen (PaO2) to inspired oxygen fraction (FiO2)<200 mmHg, while being ventilated with positive end-expiratory pressure (PEEP) set at ≥10 cmH2O for at least 12 hours, 3. age 18-75 years, body weight >40 Kg severe air leak (more than one chest tubes per hemithorax with persistent air leak for more than 72 hours), 2. systolic blood pressure lower than 90 mmHg and/or mean blood pressure lower than 65 mmHg, despite maximum support with fluids and vasopressor drugs (i.e., norepinephrine infusion rate exceeding 0.5 μg/kg/min, 3. significant heart disease (e.g. ejection fraction lower than 40%, history of pulmonary edema and active ischemic disease or myocardial infarction), 4. severe chronic obstructive pulmonary disease (COPD) or asthma (e.g. previous admission for COPD/asthma, chronic treatment with corticosteroids for COPD/asthma, and chronic CO2 retention more than 50 mmHg), 5. intracranial pathology with intracranial pressure >20 mmHg, not responsive to maximum conservative treatment (e.g. hemorrhage, head injury, tumor, infection or acute ischemic stroke), 6. chronic interstitial lung disease with bilateral lung infiltrates, 7. lung biopsy or incision during the current admission, 8. previous lung transplantation or bone marrow transplantation, i) pregnancy, 9. immunosuppression, and 10. participation in another clinical 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, Obesity Hypoventilation Syndrome Diagnosis of OHS Age >18 BMI > 30 kg/m2 Chronic hypercapnia , daytime PaCO2 >6kPa FEV1/FVC ≥70% Evidence of sleep disordered breathing on overnight studies Tolerated NIV > 4hrs on 1st night during initiation of NIV Hypercapnic respiratory failure secondary to an identifiable cause other than OHS Age <18 Respiratory acidosis (pH <7.35) Wheelchair/bedbound patients Cognitive impairment which would prevent the subject from complying with trial protocol Unstable coronary artery syndrome Patients postintubation or decannulation following treatment requiring acute hypercapnic respiratory failure Patients undergoing renal replacement therapy Critical peripheral vascular disease Disabling locomotor disability preventing participation in exercises involved in the rehabilitation programme | 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, Dyslipidemia Patients >18 years old With Subclinical hypothyroidism defined as serum TSH concentration above 5.0 IU/mL when serum FT4 level is within the reference range With OSA defined as mild OSA: AHI 5 to 15/h; moderate OSA:AHI 15 to 30/h; and severe OSA: AHI greater than 30/h (30) will be enrolled With confirmed sustained subclinical hypothyroidism, thus excluding patients with a temporary condition such as that in recovery from a non-thyroidal illness, measurement of TSH and FT4 will be conducted within four weeks before randomization Current treatment with Levothyroxine and lipid lowering medications or within two months before randomization Conditions known to cause dyslipidemia e.g. uncontrolled diabetes mellitus (HbA1c >9), alcoholism and some medication use e.g. Estrogens. Glucocorticoids, Retinoids or Interferons Conditions indicating levothyroxine treatment (34); including TSH levels more than 10 mU/l, clear symptoms or signs associated with thyroid failure and not related to OSA . e.g. goiter State of pregnancy, Breast feeding or allergy to levothyroxine | 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 Exacerbation of COPD according to the GOLD guidelines Age > 40 years Capability to use the devices provided Willing to participate included in previous COPD monitoring 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): 18.0-65.0, Community-acquired Infection AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) Healthy adult male Japanese or healthy adult Caucasian male. In Part B, healthy adult males or females (Part B only) as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with coagulation, reticulocyte, or Hgb values outside the normal range should always be excluded from enrollment Japanese defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity papers and being able to speak Japanese. Japanese subjects should also have lived outside Japan for less than 10 years The following genetic variants of ADH and ALDH will be acceptable: Group 1 Japanese: ADH1B (*/1*1), ADH1B (*1/*2), ADH1B (*2/*2); ALDH2 (*1/*1). Group 2 Japanese: ADH1B (*/1*1), ADH1B (*1/*2), ADH1B (*2/*2); ALDH2 (*1/*2); ADH1B (*/1*1), ADH1B (*1/*2), ADH1B (*2/*2); ALDH2 (*2/*2). Group 3 Caucasian: ADH1B (*/1*1); ALDH2 (*1/*1) Part A: Japanese or Caucasian Male between 20 and 65 years of age inclusive, at the time of signing the informed consent. Part B: Males or Females between 18 and 55 years of age inclusive, at the time of signing the consent Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 21 days after the final dose A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who: Has had a hysterectomy or Has had a bilateral oophorectomy (removal of the ovaries) or Has had a bilateral tubal ligation or Is post-menopausal (a demonstration of total cessation of menses for ≥ 1 year from the date of screening visit). A follicle stimulating hormone (FSH) level will be performed to confirm a post-menopausal state. For this study FSH levels ≥ 40mIU/mL are consistent with menopause. If a subject is on estrogen replacement and menopausal status is questionable, estrogen replacement should be discontinued for 2 weeks and then the subject rescreened, as estrogen replacement can suppress FSH Part A: For Japanese subjects: Body weight ≥ 50 kg and BMI within the range 18.5 - 29.0 kg/m2 (inclusive). For Caucasian subjects: Body weight ≥ 50 kg and BMI within the range 19 kg/m2 (inclusive). Part B: Body weight ≥ 50 kg for males and 45 kg for females and BMI within the range 18.5 0 kg/m2 (inclusive) As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study History of bleeding or clotting disorders including disseminated intravascular coagulation, hemophilia Henoch-Schönlein purpura (allergic purpura), hereditary hemorrhagic telangiectasia, thrombocytopenia, thrombophilia or Von Willebrand's disease A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening A positive test for HIV antibody The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) Exposure to more than four new chemical entities within 12 months prior to the first dosing day Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) A positive pre-study drug/alcohol screen History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits | 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, Nonhemorrhagic Ischemic Stroke Motor Function Male or female participants between 21 and 85 years, inclusive Participants had no prior history of stroke (unless the stroke was silent or not associated with a motor deficit) presented between 24 and 48 hours from onset with an acute stroke with clinical assessments and imaging studies (conducted as part of the standard of care procedures in stroke patients) indicating that the stroke was ischemic, with no secondary hemorrhage large enough to exert a mass effect that would contribute significantly to the neurological deficit (small punctate hemorrhages were permitted), in the vascular distribution of the middle cerebral artery and not classifiable as a lacunar stroke Participants understood and agreed to comply with the requirements of the study and they were willing to provide verbal/nonverbal informed consent indicating voluntary consent to participate in the study Participants were to have scored at least 16 on the Mini Mental Status Examination (MMSE) at screening. If the participant had an expressive aphasia and was unable to qualify based on the MMSE, the participant may have been evaluated with a language-modified form of the MMSE1 in conjunction with the investigator's clinical assessment that the participant was cognitively able to complete study procedures and stroke scales to determine eligibility. If the aphasia was too severe for the participant to complete the language-modified MMSE, the participant was excluded Participants had to have a total score between 20 and 85, inclusive, on the S-STREAM administered between 24 and 48 hours after stroke onset History of previous stroke; uncontrolled severe hypertension; dementia; advanced Parkinson disease or other significant movement disorders; or other clinically significant diseases which, in the opinion of the investigator, would have jeopardized the safety of the participant or impacted the validity of the study results Development of hemodynamic instability following the stroke as manifested by a persistent post stroke systolic blood pressure less than 80 mm Hg (or was dependent on medications to maintain a systolic blood pressure greater than or equal to 80 mm Hg) or greater than 190 mm Hg at the time of screening Presence of significant global or receptive aphasia that would have interfered with the participant's ability to understand and comply with study procedures or complete stroke assessments Abnormal clinical laboratory values on routine clinical laboratory test values at screening including alanine transaminase or aspartate transaminase greater than or equal to 3 times the upper limit of normal, serum creatinine greater than or equal to 3.0 mg/dL, or hemoglobin less than or equal to 10 g/dL, or any other laboratory investigation deemed by the investigator to be indicative of a clinically significant illness that could have prevented the participant from complying with study procedures or impacted on the outcome of the stroke scales History of drug or alcohol abuse History of any surgery or presence of any medical condition that, in the judgment of the investigator, may have affected the validity of the study results Current participation in another clinical study involving administration of an investigational product or history of such participation within 30 days of screening Unable to complete baseline S-STREAM and NIHSS assessments within 48 hours of stroke onset | 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, Respiratory Insufficiency Adults aged ≥ 18 years 2. Males 3. Females 4. Any patient requiring mechanical ventilation for 5 days or more and/or has a tracheostomy to assist weaning from mechanical ventilation who has one or more of following risk factors suggesting that they are at risk of needing post extubation continuous positive airway pressure (CPAP), BiLevel positive airway pressure (BiPAP) or non-invasive ventilation (NIV) BMI of 28 or more Underlying respiratory disease (including asthma, COPD and bronchiectasis) as documented in medical notes for this current hospital admission SpO2 < 95% on 35% FiO2 or more Smoker Ex-smoker less than 12 months Ex-smoker 10 pack year* or more history * Pack year = (Number of cigarettes per day X Number of years) ÷ 20 Age < 18 years 2. Patient/legal representative refusal or inability to consent 3. Adults with learning disabilities/ dementia 4. Any contraindication to non-invasive ventilation: Inability to use mask (trauma/surgery) Excessive secretions Haemodynamic instability/life threatening arrhythmia 5. High risk of aspiration Impaired mental status (Detained under the Mental Health Act) Un-co-operative/agitated patient Life threatening refractory hypoxemia Undrained pneumothorax Bullae on X-Ray Recent upper GI anastamosis 6. Patients already enrolled in an interventional 7. Females known to be pregnant | 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, Pulmonary Disease, Chronic Obstructive Obesity Hypoventilation Syndrome Metabolic Alkalosis Patients with COPD or obesity hypoventilation syndrome on invasive mechanical ventilation during less than 72 h with metabolic alkalosis, defined as a pH > 7.35 and actual bicarbonate > 28 mmol/L, and with potassium plasmatic levels >= 4 mEq/L Postoperative patients Previous psychiatric disease Epilepsy Pregnancy Hepatic cirrhosis Sulfonamide or acetazolamide allergy Plasmatic creatinine > 2.5 mg/dL or creatinine clearance < 20 mL/min or continuous renal replacement techniques Intolerance to enteral feeding Administration in the previous 72 h of bicarbonate or acetazolamide Terminal 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): 21.0-75.0, Obstructive Sleep Apnea Sleep Apnea Sleep-disordered Breathing Ability to give informed consent Obstructive sleep apnea (untreated) Ability to comply with study-related assessments Inability to consent or commit to the required visits Diabetes mellitus (fasting glucose > 126 mg/dl) Use of insulin or oral hypoglycemic agent Weight change of 10% in last six months Use of oral steroids in the last six months Severe pulmonary disease (i.e., COPD) Renal or hepatic insufficiency Recent Myocardial Infarction (MI) or stroke (< 3 months) Occupation as a commercial driver Active substance use | 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, Pulmonary Disease, Chronic Obstructive Exacerbation of COPD Age > 40 years Capability to use the devices provided Willing to participate • Participation in a previous COPD home telehealth 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): 0.0-999.0, Chronic Obstructive Pulmonary Disease Acute Exacerbation of Chronic Obstructive Airways Disease Chronic Hypercapnic Respiratory Failure Patient admitted with a NIV-requiring exacerbation of COPD COPD with a FEV1/FVC <0.7 after bronchodilatation ≥ 1 acute hypercapnic respiratory failure (AHRF *) Optimal medical treatment of COPD, ie. inhaled steroids, long-acting β2-agonist Tiotropium, according to GOLD guidelines Address in Capital Region Patients are able to give verbal consent and sign a written consent form and understand Danish- Severely depressed level of consciousness / confusion / non-cooperative Respiratory rate <12/min Severe hypoxia, such as requiring more than 15L O2/min Large amounts of sputum Vomiting and high risk for aspiration Inability to accept NIV Recent abdominal, facial or upper airway surgery Malignancy or life expectancy <6 months because of disease other than COPD Known obstructive sleep apnea syndrome (OSA) Metabolic acidotic component | 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) Decompensated COPD With (Acute) Exacerbation Patients with Chronic Obstructive Pulmonary Disease Age > 18 years Hospitalized in Intensive care for an acute exacerbation Requiring Non invasive mechanical ventilation Able to breath spontaneously without non invasive ventilation more than 4h/day Without bulbar dysfunction Hemodynamic instability Absence of consent Severe Hypoxemia pH < 7,30 No cooperation of the patient | 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, Overlap Syndrome Patient or legal representative of the patient is willing and able to sign an approved informed consent and privacy protection authorization in the United States. 2. Subject is >18 years old. 3. Diagnosed overlap syndrome(OSAS and COPD). 4. Expected to tolerate the ventilator therapy Patient is currently enrolled in another clinical study which may confound the result of this study. 2. Patient for who inform consent cannot be obtained. 3. Patients with a history of cerebrovascular accident within the 6 months prior to this study. 4. Patients with acute or chronic renal failure, diabetes and severe lung diseases. 5. Patients with unstable angina. 6. Patient who is of pregnant or during lactation period. 7. Patients with a history of injury or surgery within 6 months prior to 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): 18.0-999.0, Pancreatic Cancer Hypoxia Minimum age of 18 years old Histologic diagnosis of pancreatic adenocarcinoma TNM (7th edition) cT1-4, N0-1, M0-1 No cytotoxic anti-cancer therapy for advanced / metastatic pancreatic cancer prior to study entry Ability to provide written informed consent to participate in the study ECOG performance status 0, 1 or 2 Patient should have the following blood counts at baseline: ANC equal or greater to 1.5 x 109/L; Platelets equal or greater to 100 x 109/L; Hgb equal or greater to 9g/Dl Patient should have the following blood chemistry levels at baseline: AST (SGOT), ALT (SGPT) equal or less than 5 x upper limit of normal range (ULN) is allowed Patient has an identifiable tumor (pancreatic tumor and/or metastasis) by imaging (CT scan and/or MR) Patient must agree to use contraception considered adequate and appropriate by the investigator and if the patient is female of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (B-hCG) Inability to lie supine for more than 30 minutes Any other type of primary cancer Life expectancy of less than 12 weeks Patient has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids and stable in two scans at least 4 weeks apart) Patient has serious medical risk factors involving any of the major organ systems | 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): 60.0-89.0, Osteoarthritis, Knee Adults aged 60 years of age primary unilateral TKA 10-21 days prior to the outpatient PT evaluation received inpatient rehabilitation at Helen Hayes Hospital Any other lower extremity joint or back pain (not inclusive of recent Total knee arthroplasty) rated greater than four out of ten with weight-bearing any other lower extremity joint replacement surgery diagnosis of osteoporosis with history of fractures, uncontrolled hypertension, unstable cardiac or pulmonary problems, neurological disease affecting motor control, uncontrolled diabetes chest pain or shortness of breath on stair-climbing requirement of human assistance to walk in addition to the ambulation device inability to follow instructions to perform testing and/or exercise participants who stated that they would not be available to complete 12 exercise sessions individual adherence with performance of a home exercise program (HEP) less than five of seven days at the end of the treatment 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): 18.0-70.0, Sleep Apnea, Obstructive Obesity Hypoventilation Syndrome Patient or legal representative of the patient is willing and able to sign an approved informed consent and privacy protection authorization in the United States. 2. Subject is >18 years old. 3. Diagnosed OHS and OSAHS: 4. Expected to tolerate the ventilator therapy Patient is currently enrolled in another clinical study which may confound the result of this study. 2. Patient for whom inform consent cannot be obtained. 3. Patients with a history of cerebrovascular accident within the 6 months prior to this study. 4. Patients with acute or chronic renal failure, diabetes and severe lung diseases. 5. Patients with unstable angina. 6. Patient who is of pregnant or during lactation period. 7. Patients with a history of injury or surgery within 6 months prior to 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): 50.0-90.0, Chronic Obstructive Pulmonary Disease Pulmonary Hypertension Cor Pulmonale diagnosis of COPD stage II, III or IV according to the GOLD guidelines signed the informed consent ischemic cardiopathy severe valvular disease atrial fibrillation left bundle branch block | 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): 15.0-80.0, Chronic Obstructive Pulmonary Disease Neuromuscular Disease Chest Wall Disorders Obesity Hypoventilation Syndrome OHS PaCO2 > 45 mmHg IMC > 40 Kg/m2 COPD Age < 80 years Receiving appropriate medical therapy according to gold guidelines Long-term oxygen therapy (LTOT) for at least 3 months PaCO2 > 50 mmHg during room air ph > 7,35 and free from exacerbations in the 4 weeks preceding recruitment One exacerbation in the last year before preceding recruitment with necessity of NIV in the acute care setting FEV1 < 1,5l or < 50% predicted OHS COPD NMD COPD increase in FEV1 after inhaled Salbutamol (200 µg) Active smoking History of OSA (with AHI > 15 episodes.h-1) NMD and CWD COPD OHS PCF < 270 Severe bulbar weakness (ALSFRS bulbar subscore 0-3) | 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): 55.0-999.0, Alzheimer's Disease Meets for MCI due to AD or Mild AD All participants will be required to undergo assessment via the Mini Mental State Examination (MMSE) scale at screening Participants with MMSE scores of 20 to 26, inclusive, may be enrolled provided they meet the for mild AD, as follows Participant meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) for probable AD Clinical Dementia Rating Scale (CDR) score of 0.5 or 1 Positive scan for the presence of amyloid beta Participants with MMSE of 27 to 30, inclusive, may be enrolled as participants with MCI due to AD provided they meet the following Gradual and progressive change in memory function as reported by the participant or a caregiver during a period of more than 6 months Free and Cued Selective Reminding Test with Immediate Recall (FCSRT-IR): free recall ≤22 and total recall ≤46 Absence of dementia Preservation of functional independence Participant in another drug or device study Have a history of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease, Parkinson's disease, progressive supranuclear palsy (PSNP), or other movement disorder Participants are not on a stable standard of care (acetylcholinesterase inhibitors, memantine) initiated less than 2 months prior to entry or have less than 4 weeks of stable therapy. Note: Stable standard of care is allowed Have had a serious infectious disease affecting the brain in the past 5 years Have had a serious or repeat head injury Have significant retinal impairment or disease Have had a stroke or other circulation problems that are affecting current health Have had a seizure Have major depressive disorder and are not on a stable dose of medication. Participants who no longer meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV) for major depression may be included History of schizophrenia, bipolar disorder, or severe mental 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): 18.0-999.0, Postoperative Pain All patients over 18 years of age Isolated thoracoscopic procedure for therapeutic or diagnostic purposes Previous ipsilateral thoracic surgery Need for operative pleurectomy or pleurodesis Chronic use of pain medication (narcotics or sedatives or hypnotics Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl) Renal dysfunction (eGFR < 60ml/min/1.73m2) History of peptic ulcerative disease Sleep apnea in need of Bipap Severe COPD requiring continuous oxygen supplementation Inability to consent | 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, Hypopituitarism All patients with pituitary hypopituitarism Unavailability of data | 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): 18.0-90.0, Stroke Motor Function (1) All subjects must be between the ages of 18-90 History of Major depression, as defined by Beck Depression scale 30; 2. Any substantial decrease in alertness, language comprehension, or attention that might interfere with understanding instructions for motor testing; 3. Contraindications to TMS history of seizures unexplained loss of consciousness metal in the head frequent or severe headaches or neck pain implanted brain medical devices. 4. Contraindications to tDCS metal in the head implanted brain medical devices 5. Advanced liver, kidney, cardiac, or pulmonary disease; 6. A terminal medical diagnosis consistent with survival < 1 year; 7. Coexistent major neurological or psychiatric disease (to decrease number of confounders); 8. A history of significant alcohol or drug abuse in the prior 6 months; 9. Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and any other clinical trials; 10. Subjects with global aphasia and deficits of comprehension 11. Pregnancy. Female subjects of child bearing potential will be asked to take a pregnancy test. If the pregnancy test is positive, the subject may not enroll in the study. 12. Use of neuropsychotropic medications [healthy subjects only] Additional for stroke subjects: 1. First-time clinical ischemic or hemorrhagic cerebrovascular events evidenced by a radiological (or physician's) report 2. Weakness, defined as score of less than 55 (out of 66) on arm motor Fugl-Meyer (FM) scale 3. Stroke onset >6 months prior to study enrollment . Additional for stroke subjects: 1. Subjects may not have already received TMS and/or tDCS stimulation for stroke; 2. History of epilepsy before stroke or episodes of seizures within the last six months | 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, Pulmonary Thromboembolism Obstructive Sleep Apnea All consecutive patients diagnosed with pulmonary embolism less than 18 years of age any restrictive or obstructive lung 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): 21.0-90.0, COPD OSA Age ≥ 21 Diagnosis of COPD Currently using Bilevel device for COPD-OSA overlap syndrome Ability to provide consent Documentation of medical stability by PI Subjects, who are acutely ill, medically complicated or who are medically unstable Subjects in whom PAP therapy is otherwise medically contraindicated Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days Subjects with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLMI > 10) | 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, Chronic Obstructive Pulmonary Disease Is over the age of 35 years 2. Has a history of COPD confirmed by physician diagnosis 3. Has been admitted to the hospital with a working diagnosis of acute exacerbation of COPD (AECOPD) defined as at least two of the following progressive symptoms: increased dyspnea, increased sputum volume and/or increased sputum purulence that is beyond normal day-to-day variation 4. Has a history of incomplete airway reversibility (e.g., patient not responding clinically to short-acting ß-agonists in the ED) associated with a diagnosis of COPD 5. Smoking history of at least 20 pack years 6. FEV1/FVC ratio of < 0.7 and impaired FEV1 (< 80% predicted for age, sex, race and height) 7. Is willing to participate in a 7 days post discharge (± 2 days) in-person follow-up visit and a telephone follow-up call 30 days (± 5 days) after hospital discharge 8. Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent Has a confirmed history of asthma (by pulmonary functions, response to ß-agonists and variable symptoms) 2. Has a history of lung cancer or Talc lung 3. Is admitted to the emergency care facility with a diagnosis of the following, confirmed on CXR, ventilation/perfusion scanning or computerized tomography (CT) Pulmonary abscess Pneumonia (e.g., fever > 38.0° C, cough and new documented infiltrate) Acute pulmonary embolism Large pleural effusion and/or requiring thoracentesis; or Pneumothorax 4. Is admitted to the emergency care facility with a working diagnosis of Acute coronary syndrome Severe carotid artery disease (e.g., history of bruits, transient ischemic attack (TIA) or cerebrovascular accident (CVA); or Stage IV heart failure according to the NYHA classification 5. Is admitted to the emergency care facility and/or hospital with a working diagnosis of Cystic Fibrosis; or | 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, Obstructive Patients who underwent uvulopalatopharngoplasty (UPPP)for Obstructive sleep apnea syndrome (OSAS) Anormal nasopharyngeal computed tomography, chronic diseases such as diabetes mellitus, hypertension etc | 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): 18.0-75.0, Functional Dyspepsia Peptic Ulcer patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications | 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): 40.0-80.0, Chronic Obstructive Pulmonary Disease (COPD) With Cachexia Written informed consent must be obtained before any assessment is performed Males and females ages 40 to 80 years Smoking history of at least 10 pack-years Diagnosis of COPD according to GOLD guidelines (GOLD, 2010), with a post-bronchodilator FEV¬1 < 80% predicted and FEV1/FVC ratio < 0.70 BMI <20 kg/m2 or skeletal muscle mass index by DXA < 7.25 kg/m2 for men or <5.45 kg/m2 for women In general stable health, including managed COPD, by past medical history, physical examination, vital signs at baseline as determined by the investigator Patients with MRC dyspnoea grade 5 (i.e. patients too breathless to leave the house or breathless when dressing) Plans for lung transplantation or lung reduction surgery within four months of enrollment Patients participating in a formal pulmonary rehabilitation program within 3 months of dosing History of malignancy of any organ system (other than excised non-melanomatous carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases Diseases other than cancer known to cause cachexia or muscle atrophy, including but not limited to congestive heart failure of any stage, chronic kidney disease (estimated GFR < 30 mL/min using the MDRD equation), rheumatoid arthritis, primary myopathy, stroke, HIV infection, tuberculosis or other chronic infection, uncontrolled diabetes mellitus, etc Inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency Use of any prescription drugs known to affect muscle mass, including androgen supplements, anti-androgens (such as LHRH agonists), anti-estrogens (tamoxifen, etc.) recombinant human growth hormone (rhGH), insulin, oral beta agonists, megestrol acetate, dronabinol, metformin, etc Hemoglobin concentration below 11.0 g/dL at screening Liver disease or liver injury Use of other investigational drugs at the time of enrollment, or within 30 days and for any other limitation of participation in an investigational trial based on local regulations | 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): 16.0-999.0, Community-acquired Pneumonia Patients with community-acquired pneumococcal pneumonia, which was confirmed by 1. detection of Streptococcus pneumoniae in blood cultures, tracheal secretion or sputum OR/AND 2. positive urinary pneumococcal antigen AND 3. presence of cough and presence of one of the following signs/symptoms: new focal chest signs; dyspnoea; tachypnoea; fever AND 4. radiologic signs of pneumonia Pneumonia of other cause (e.g. non-pneumococcal pneumonia) Hospital-acquired or ventilator-associated pneumonia Patients referred from or transferred to another hospital | 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 All patients must sign an informed consent consistent with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions. 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric Patients must have a relatively stable airway obstruction with a post-bronchodilator FEV1 = 30 % and < 80% of predicted normal and a post-bronchodilator FEV1/FVC <70% at Visit 1. 3. Male or female patients, 40 years of age or older. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years 5. Patients must be able to: perform technically acceptable pulmonary function tests, and maintain records(paper diary). 6. Patients must be able to inhale medication in a competent manner from the Respimat Inhaler as well as the Handihaler Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patients ability to participate in the study. 2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an AST >x2 ULN, ALT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients). 3. Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count =600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition. 4. A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists). 5. A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists). 6. A history of myocardial infarction within 1 year of screening visit (Visit 1). 7. Unstable or life-threatening cardiac arrhythmia. 8. Hospitalization for heart failure within the past year. 9. Known active tuberculosis. 10. A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed). 11. A history of life-threatening pulmonary obstruction. 12. A history of cystic fibrosis. 13. Clinically evident bronchiectasis. 14. A history of significant alcohol or drug abuse. 15. Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per criterion No. 1). 16. Patients being treated with oral or patch ß-adrenergics. 17. Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. 18. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigators opinion will be unable to abstain from the use of oxygen therapy during clinic visits. 19. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program. 20. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1). 21. Patients with known hypersensitivity to ß-adrenergic drugs, BAC, EDTA, or any other component of the Respimat® inhalation solution. 22. Patients with known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler®. 23. Pregnant or nursing women. 24. Women of childbearing potential not using a highly effective method of birth control*. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. * as per ICH M3(R2) a highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year). 25. Patients who have previously been randomised in this study or are currently participating in another study. 26. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation | 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, Pulmonary Disease, Chronic Obstructive Diagnosis of chronic obstructive pulmonary disease 2. Relatively stable airway obstruction with post FEV1=<30% of predicted normal and< 80% predicted normal and post FEV1/FVC <70% 3. Male or female Japanese patients, 40 years of age or older 4. Smoking history of more than 10 pack years Significant disease other than COPD 2. Clinically relevant abnormal lab values 3. History of asthma 4. Diagnosis of thyrotoxicosis 5. Diagnosis of paroxysmal tachycardia 6. A marked baseline prolongation of QT/QTc interval 7. A history of additional risk factors for Torsade de Pointes (TdP) 8. History of myocardial infarction within 1 year of screening visit 9. Unstable or life-threatening cardiac arrhythmia 10. Hospitalization for heart failure within the past year 11. Known active tuberculosis 12. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 13. History of life-threatening pulmonary obstruction 14. History of cystic fibrosis 15. Clinically evident bronchiectasis 16. History of significant alcohol or drug abuse 17. Thoracotomy with pulmonary resection 18. Oral ß-adrenergics 19. Oral corticosteroid medication at unstable doses 20. Regular use of daytime oxygen therapy for more than one hour per day 21. Pulmonary rehabilitation program in the six weeks prior to the screening visit 22. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit 23. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA 24. Pregnant or nursing women 25. Women of childbearing potential not using a highly effective method of birth control 26. Patients who have previously been randomized in this study or are currently participating in another study 27. Patients who are unable to comply with pulmonary medication restrictions 28. Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc 29. Patients being treated with medications that prolong the QT/QTc interval | 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 Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with airflow obstruction of level 2 and 3 according to the current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy (2011). 2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and <80 % of the predicted normal, and FEV1/ Forced Vital Capacity (FVC) < 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide. 3. Current or ex-smokers with at least 10 cigarette pack years smoking history Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening. 2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 3. Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception. 4. Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study. 5. Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment. 6. Patients with a body mass index (BMI) of more than 40 kg/m2. 7. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines. 8. Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening. Other protocol-defined inclusion/ | 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): 45.0-999.0, COPD COPD subjects Ability to walk, sit down and stand up independently Age 45 years or older Ability to lie in supine or elevated position for 5.5 hours Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following Forced Expiratory Volume(FEV1)/Forced Vital Capacity (FVC) < 0.70 and FEV1 < 70% of reference FEV1 Clinically stable condition and not suffering from a respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever, and a decrease in FEV1 > 10% compared with values when clinically stable in the preceding year) at least 4 weeks prior to the first test day Shortness of breath on exertion Willingness and ability to comply with the protocol, including Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit healthy control subjects Healthy male or female according to the investigator's or appointed staff's judgment all subjects Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only) Established diagnosis of malignancy Established diagnosis of Insulin Dependent Diabetes Mellitus History of untreated metabolic diseases including hepatic or renal disorder Presence of acute illness or metabolically unstable chronic illness Recent myocardial infarction (less than 1 year) Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient BMI of < 18.5 or ≥ 35 kg/m2 Dietary or lifestyle characteristics | 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, Chronic Kidney Disease Subject is ≥ 18 and ≤75 years of age. 2. A serum creatinine level of 1.5 to 5.0 mg per deciliter (133 to 442 μmol per liter), a creatinine clearance of 20 to 70 ml per minute per 1.73 m2, with variations of less than 30 percent in the three months before randomization. 3. Persistent proteinuria (defined by urinary protein excretion of more than 0.3 g per day for three or more months which can evacuate urinary tract infection and overt heart failure [a New York Heart Association class of III or IV]). 4. Resistant hypertension. 5. Nondiabetic renal disease. 6. Subject is willing and able to comply with the protocol 7. Subject is expected to remain available for follow-up visits at the study center 8. Subject Informed Consent Current treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive drugs. 2. Connective-tissue disease. 3. Obstructive uropathy. 4. Congestive heart failure (New York Heart Association class III or IV). 5. Subject has significant renovascular abnormalities (a history of prior renal artery intervention, including balloon angioplasty or stenting; double renal artery on one side, distortion, and extension ), measured by abdominal ultrasound or renal angiograms. 6. Subject has a history of myocardial infarction, unstable angina, cerebrovascular accident or alimentary tract hemorrhage in the previous 3 months. 7. Subject with sick sinus syndrome. 8. Subject has a history of allergy to contrast media; psychiatric disorders; drug or alcohol abuse; and pregnancy. 9. Enrolled in a concurrent study that may confound the results of this study | 0 |
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