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A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 21.0-999.0, Heart Failure Hospitalized for heart failure Prescribed loop diuretic medication at discharge Age less than 21 years New York Heart Association Class IV heart failure Terminal illness (<6 mo prognosis) Unable to self-administer medications due to mental illness or cognitive impairment Non-English/Spanish speaking Discharged to an institutional setting (e.g., nursing home) Cardiologist or primary care provider refusal Unavailable for follow-up No access to telephone Enrolled in another cardiac trial | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure With Reduced Ejection Fraction Key Adult patients (18 years or older); must give written informed consent before any assessment is performed Patients with a diagnosis of Chronic heart failure (CHF) NYHA class II-IV and reduced ejection fraction (LVEF =< 35%) Patient had a hospitalization for HF within the last 12 months Patients must be on an angiotensin converting enzyme inhibitors (ACEIs) or an angiotensin receptor blocker (ARB) at a stable dose for at least 4 weeks Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks Key The patient is eligible for participation in any of the Investigational Medicinal Product's ongoing clinical trials The patient has recently completed a clinical trial that has been terminated and other options (e.g., trial extensions, amendments, etc.) are available to continue a similar treatment The patient is being transferred from an ongoing clinical trial for which the patient is still eligible for participation History of hypersensitivity or allergy to LCZ696 or to any of its metabolites; to drugs of similar chemical classes, ARBs, or neutral endopeptidase (NEP) inhibitors; as well as known or suspected contraindications to LCZ696 Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer Previous history of intolerance to recommended target doses of ARBs Known history of angioedema Requirement of concomitant treatment with both ACEIs and ARBs Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy) Symptomatic hypotension and/or a SBP less than 100 mm Hg | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure 18 years or older patients with congestive heart failure Hypervolemic by at least 2 of the following 1) Peripheral edema; 2) jugular venous distention greater than 7 cm; 3) radiographic pulmonary edema or pleural effusion; 4) enlarged liver or ascites; 5) pulmonary rales, paroxysmal nocturnal dyspnea or orthopnea Diuretic resistance as defined by loop diuretic requirements of furosemide greater or equal to 160 mg IV total daily dose or equivalent dose of torsemide or bumetanide. ( 1 mg bumetanide = 10 mg torsemide = 20 mg furosemide) Estimated glomerular filtration rate (eGFR) of > 30ml/min. according to the MDRD Study equation at the time of admission Female patients of child bearing potential must have a negative urine pregnancy test to be eligible Acute coronary syndrome Patients with a baseline eGFR < 30 ml/min according to the MDRD equation Baseline potassium serum concentration 5.3 meq/L Requirement for intravenous pressors Systemic infection Patients with concomitant end-stage liver disease Significant valvular disease Patients with pulmonary embolism Patients with high output heart failure Pregnant patients | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Obstructive Sleep Apnoea Pregnancy Pregnant women Body mass index ≥ 40 at first midwife appointment Women ≥ 18 years of age Pre-existing obstructive sleep apnoea on treatment Pre-existing restrictive or obstructive respiratory disease Women with another cause of sleep apnoea (e.g. central sleep apnoea) Women under 18 years of age Women who do not provide or refuse consent Women lacking capacity to consent | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Heart Failure Patient with "de novo" heart Failure and LVEF <= 40% admitted in hospital, without contraindications for BB prescription with cardiologist up-titration prescription and without having achieved BB target dose previous discharge and signing informed consent Contraindications for BB Living in a nursing home Life expectancy < 6 months Unable to self-care or mental disease without caregiver Unable to weight Without phone Unable to go to clinic visit | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Bronchial Secretion Retention Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following Clinical and radiologic diagnosis of pulmonary infection Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data Stable of hydration status or positive fluid balance at least 2 days before collects the data Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 30 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia Good conscious and well cooperation Pneumothorax (nontreated) Massive hemoptysis Acute myocardial infarction (with angina chest pain) High intracranial pressure (>20 mm Hg) Major arrhythmia | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure age of 18 years or older hospital admission for hypervolemic decompensated heart failure complicated by loop diuretic resistance hour telemetry monitoring on an inpatient ward basic metabolic panel laboratory assessment twice daily during the study period Hypervolemia will be diagnosed by the admitting provider as either (i) pulmonary artery catheterization with a pulmonary capillary wedge pressure greater than 19mmHg plus a systemic physical exam finding of hypervolemia (peripheral edema, ascites, or pulmonary edema on auscultation) or (ii) in the absence of pulmonary artery catheterization data 2 of the following signs or symptoms: peripheral edema ascites, jugular venous pressure > 10mmHg, or pulmonary edema on chest x-ray Loop diuretic resistance is defined as a provider decision to pursue combination diuretic therapy because of failure to reach provider defined adequate diuresis (can not exceed urine output of 2 L in past 12 hours) despite receipt of an intravenous loop diuretic dose of a furosemide equivalent of at least 240mg/day over at least the past 12 hours (40mg furosemide = 20mg torsemide = 1mg bumetanide) decision to pursue hemodialysis by a nephrologist estimated glomerular filtration rate by the MDRD equation < 15ml/min/m2 systolic blood pressure < 85mmHg pregnancy serum potassium < 3.0mEq/L serum sodium > 145mEq/L or < 130mEq/L severe malnutrition advanced liver disease inability to perform standing weights inability to collect and measure urine with either a foley catheter or urine collection containers | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Breast Carcinoma Cardiovascular Complication European American patients with DNA available European American patients who developed CHF and patients who did not develop CHF following a full course of treatment with an anthracycline and bevacizumab African American cases (based on a drop in left ventricular ejection fraction [LVEF] < 50 or a drop from baseline > 20 points) and African American controls | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Eisenmenger Syndrome Congenital Heart Disease Sleep-disordered Breathing Eisenmenger Syndrome (definition: Pulmonary ≥ systemic vascular resistance with pulmonary-to-systemic shunt and cyanosis (periphery oxygen saturation < 92% at rest and/or < 87% during exercise) Stable for ≥ 3 months (no hospitalization, no change of medication, no deterioration) Down's syndrome Iron deficiency (definition: Ferritin < 12 µg/l and/or transferring saturation < 20%) Regular phlebotomy Suspicion of risk of non-compliance | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Acute Decompensated Heart Failure Age 18 years or older Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to inclusion Chronic heart failure will be defined as requiring treatment for a minimum of 30 days prior to current admission, NYHA Class III or IV at the time of hospitalization, and left ventricular ejection fraction less than 40% within one year or evidence of heart failure with preserved ejection fraction and evidence of diastolic dysfunction on echocardiogram Admitted with clinical decompensated heart failure based on history, physical exam, and parameters indicating extracellular volume expansion such as including JVP ≥ 8 cm of water and 1+ or greater peripheral edema Is able to be dosed with study medication within six (6) hours of first dose of IV diuretics Baseline severe hypotension (Mean arterial pressure < 55 mm Hg) Creatinine clearance less than 20 ml/min or creatinine greater than 2.5 mg/dl Serum sodium less than 128 meq/L Serum Potassium < 3.0 meq/L Known adverse reaction to metolazone Inability to take oral medications Severe Aortic Stenosis (AVA < 0.8cm2) History of Hypertrophic obstructive cardiomyopathy Metastatic Carcinoma per history Severe COPD, FEV < 1L | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 21.0-999.0, Congestive Heart Failure Age > 21 years of age Left ventricular ejection fraction ≤ 50% (at any time in the past) Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level) Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment Severe renal insufficiency defined as serum creatinine > 2.5 mg/dl United Organ Network Sharing status 1B for heart transplantation (outpatient inotrope use, LV assist device) Inoperable aortic valvular heart disease Life expectancy <1 year due to causes other than HF such as advanced cancer Cardiac transplantation or revascularization indicated or expected within 6 months Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care) Subject unable or unwilling to provide written informed consent Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Chronic Obstructive Lung Disease Age greater than or equal to 40 years Cigarette smoking greater than or equal to 30 pack years Obstructive Spirometry First degree relative with smoking history willing to participate | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 5.0-11.0, Asthma Siblings of a birth cohort recruited 1997-1999 Age less than 11 years Physician diagnosed asthma Active symptoms (wheeze, persistent cough, chest tightness, shortness of breath) or medication use in the 12 months prior to enrollment | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease COPD Patients must have moderate or severe COPD Patients must have at least one episode of COPD-related symptoms (eg, cough, sputum production, shortness of breath) within 2 months prior to screening Patients must not have asthma as main component of obstructive airway disease Patients must not have had a moderate or severe exacerbation of COPD within previous 1 month | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 21.0-70.0, Healthy Volunteers (Non-smoker) Healthy Volunteers (Smoker) Chronic Obstructive Pulmonary Disease Healthy non-smokers Normal spirometry (FEV1 >90 % predicted; exhaled NO bigger than or equal to 10 ppb; flow 50 ml/s) At risk (current smokers) Normal spirometry, with or without chronic symptoms (cough, sputum production) FEV1 reversibility of <15% after inhaled beta2-agonists* Moderate COPD FEV1 greater than or equal to 30% and < 80% FEV1/FVC < 70% predicted FEV1 reversibility of <15% after inhaled beta2-agonists With or without chronic symptoms (cough, sputum production, dyspnea) Concomitant use or pre-treatment within the last 4 weeks with oral steroids Respiratory infection within 4 weeks prior to entry into the trial Females who are pregnant or lactating History of current or past drug or alcohol abuse | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease (COPD) diagnosis of mild COPD OR healthy control subjects 80 years old able to perform all study procedures Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years (for healthy control subjects) allergy to atrovent history of asthma, atopy or nasal polyps Oxygen desaturation < 80 % during exercise recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, COPD Osteoporosis Osteopenia Age > 18 years Men and women COPD according to the ATS-guidelines, divided in severity according to the GOLD Written consent Age < 18 years No written consent | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Respiratory Tract Infections General Conditions Outpatients Fulfillment of clinical diagnostic for one of the following indications Mild to moderate Community Acquired Pneumonia (CAP) Acute bacterial Exacerbation of Chronic Bronchitis (AECB) Acute Sinusitis (AS) For CAP The to be fulfilled are New onset of at least two of the following Cough General Conditions Subjects presenting with any of the following will not be included in the study Treatment required during the study with ergot alkaloid derivatives, pimozide, astemizole, terfenadine, cisapride, simvastatin, atorvastatin and lovastatin, and the oral use of the benzodiazepines midazolam, triazolam and alprazolam History of congenital or family history of long QT syndrome (if not excluded by ECG) or known acquired QT interval prolongation Known hypersensitivity to telithromycin or to macrolide antibiotics Hospital acquired infections (hospitalization for more than 72 hours within 7 days of study entry) Pregnant or breast-feeding women. For the women of childbearing potential it is left to the investigators discretion to establish a lack of pregnancy, e.g. with contraceptive use, menstrual pattern, urinary pregnancy test Subjects with severely impaired renal function (creatinine clearance <30 ml/min) Subjects that had received anti-bacterials for more than 24 hours within 7 days prior to enrollment in the study, unless the treatment has failed Subjects receiving medications, including other anti-microbials or anti-cancer drugs, that could interfere with the evaluation | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 35.0-999.0, Pulmonary Disease, Chronic Obstructive Outpatient with the diagnosis or referral diagnosis of COPD COPD must be the primary reason for this outpatient contact (for both new patients and controls) Any co-morbidity that hampers the diagnosis and treatment of COPD in accordance with the COPD guidelines used locally (e.g. malignant disease, dementia or sequelae of apoplexy) Asthma without the presence of COPD | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-80.0, COPD Acute Exacerbation COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Established clinical history of moderate to severe COPD Post bronchodilator FEV1 of < 50% of predicted normal FEV1 / FVC ratio <70% Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1 Free from exacerbation in the 6 weeks prior to screening Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations Current asthma, eczema, atopic dermatitis and/or allergic rhinitis Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study Has undergone lung transplantation and/or lung volume reduction Female who is a nursing mother Requires regular (daily) long-term oxygen therapy (LTOT) Is receiving beta-blockers (except eye drops) Has a serious, uncontrolled disease likely to interfere with the study Has received any other investigational drugs within the 4 weeks prior to Visit 1 Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-75.0, COPD Pulmonary Hypertension Confirmed moderate to severe COPD with or without pulmonary hypertension Male and female patients Aged 18 years Written consent Adequate contraception in female patients of childbearing age Negative pregnancy test (four-weekly test repetition) Lack of consent Pregnancy (four-weekly tests) Lactation Presumed non-cooperativeness Patients outside the stipulated age range Myocardial infarction within the last 12 months Stroke within the last 12 months Malignant diseases in anamnesis Legal incapacity Parallel participation in a clinical trial | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) diagnosis of COPD history of 15 pack-years or more of cigarette smoking evidence of irreversible obstruction (FEV1<70% of predicted value, ratio FEV1/FVC<70%, and improvement of FEV1of less than 20% after bronchodilator in previous respiratory tests done when they were stable) history of asthma or atopy need of being hospitalized use of oral or intravenous steroid within the preceding 30 days history of multiresistant bacterial infection (not applicable if absence of multi-resistant bacterial infection has been proved by a negative expectoration culture in the previous 6 months), bronchiectasis or recent COPD exacerbation (< 6 weeks) or diabetes oxygen-dependant COPD patients or patients previously known with hypercapnia (PCO2>45 mmHg) at steady state use of high doses of Advair (more than 50/500 bid) or Symbicort (more than 12/400 bid) known cardiac arrhythmia such as atrial fibrillation, supraventricular tachycardia or paroxysmal auricular tachycardia | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Asthma Pulmonary Disease, Chronic Obstructive No change from the MIA and LEUKO trials No change from the MIA and LEUKO trials | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 35.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. age >35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following Current smoking Suffering from COPD according to the GP's diagnosis In command of the Dutch language Too ill Under control of a chest physician Serious physical or psychological comorbidity | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive Pulmonary Emphysema Chronic Bronchitis Subject must have a diagnosis of moderate or severe COPD Subject must have a post-bronchodilator FEV1/FVC ratio < 0.7 Subject must have a post-bronchodilator FEV1 % predicted value ≥ 30% and < 70% Subject must be between 40 and 80 years of age, of either sex, and of any race Subject must be a current or ex-smoker, with a cigarette smoking history of ≥ 10 years or > 10 pack-years Subject has been diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer) Subject has been diagnosed with α1-Antitrypsin deficiency Subject has a body mass greater than 150 kg (330 lb) or less than 40 kg (88 lb) Subject has active infection Subject has had a significant exacerbation of COPD or has required mechanical ventilation within 4 weeks of screening Subject with clinically relevant uncontrolled medical condition not associated with COPD Subject has documented history of uncontrolled heart failure Subject has pulmonary hypertension due to left heart condition Subject has atrial fibrillation or significant congenital heart defect/disease Subject has initiated pulmonary rehabilitation within 3 months of screening | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 45.0-999.0, Emphysema Pulmonary Disease, Chronic Obstructive for All Participants Able to read and write English At least 30 pack-year smoking history (the equivalent of smoking a pack a day for 30 years) Able to participate in the informed consent process Relatively stable clinical status for the past six weeks (i.e., no illness in the 6 weeks before study entry) for Participants with Emphysema Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II, III, or IV COPD, as determined by post-bronchodilator spirometry values OR More than minimal emphysema on an acceptable-quality chest CT scan for Participants without Emphysema GOLD class I COPD or GOLD class 0 (2005 classification), as determined post-bronchodilator spirometry values AND Pregnant Prisoner Vulnerable populations Recent illness (defined as increased cough, sputum production, worsening malaise, or need for unscheduled physician visit in the 6 weeks prior to enrollment) Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant Congenital abnormalities of the lung or previous lung surgery Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated) CT evidence of lung disease other than emphysema (including significant fibrosis, bronchiectasis, consolidation, or indeterminate nodules) | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Phase 1 & Gene Expression: --Current hospitalization for COPD exacerbation Phase 1 & 2: COPD & ONE of the following History of hospitalization for COPD exacerbation, OR Currently on supplemental oxygen, OR History of evaluation for lung transplant or LVRS, OR >/= 6 months post-LVRS Phase 1 or 2 Current or former smoker, >/= 20 pack-yr. smoking history FEV1 </= 70%; FEV1/FVC </= 70% Life expectancy of > 6 months < 20 pack-yr. smoking history Diagnosis of pulmonary fibrosis, bronchiectasis, mediastinal mass, or presence of a pulmonary mass Asthma FEV1 > 70% or FEV1/FVC >70% | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, COPD COPD, smoker COPD, non smoker | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-75.0, Chronic Obstructive Pulmonary Disease Age 18-75 years Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 5 groups described above Able to stop smoking for 10 days and start smoking 3-4 cigarettes within 1 hour Physically and mentally able to undergo the total study protocol Written informed consent Participation in another study Alpha-1-antitrypsin deficiency Selected grade 1-3 co-morbidity listed in the ACE-27 Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, metotrexate, azathioprine,Acenocoumarol | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 0.0-4.0, Asthma Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation Subject's parent/legal guardian must be willing and able to comply with the study procedures and visit schedules Subject, male or female, must be between the ages of birth and <48 months, exclusive, at the time of consent Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma (defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea) Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease Subject must be in good health and not affected by any other chronic conditions, including respiratory disorders other than asthma In subjects with a chest radiograph (taken 12 months prior to screening visit), no evidence of any chronic cardiopulmonary condition other than asthma should be present as discerned by the Investigator Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars (MEC) reliably on a daily basis and understand dosing instructions and questionnaire completion Subject who requires or is expected to require any disallowed medications Subject who has participated in an investigational drug study within 30 days prior to screening, or who is currently participating in another clinical trial Subject or parent/legal guardian who has daily commitments during the study that would interfere with trial measurements, compliance, or both Subject who has a history of hospitalization for asthma, reactive airways disease, or bronchospasm within 4 weeks prior to screening or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial Subject who has experienced significant blood loss within 60 days of study drug Subject with a clinical diagnosis of cystic fibrosis Subject who was born prematurely, defined as less than 38 weeks gestational age at birth, and is <1 year of age at screening Subject whose body weight is less than 7.0 kg at screening. This minimum weight requirement is based upon standard pediatric growth charts [CDC 2000] Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 30.0-999.0, Right Heart Failure Cor Pulmonale Hospitalized patients Adults Right heart failure secondary to pulmonary hypertension (cor pulmonale) Pronounced leg edema Patients in sepsis Hemodynamically unstable Renal failure (creatinine >2 mg%) Deep vein thrombosis Pregnancy Psychiatric/noncompliant patients Patients who will not sign the informed consent form | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-50.0, Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Asthma Specific allergy to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .75 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma History of nasal allergy, including episodic, perennial, or seasonal sneezing, nasal congestion or cough, or such symptoms associated with specific exposures (such as cat or dog) for classification as having asthma with allergic rhinitis vs. allergic rhinitis alone History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma Provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used (see below) Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable Use of daily theophylline within the past month Pregnancy or nursing a baby Cigarette smoking > 1 pack per month Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to prophylactic use of albuterol prior to exercise) | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 0.0-999.0, Dyspnea Heart Failure Asthma COPD patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea) age <18 years history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea pneumonia pulmonary embolism carcinoma pneumothorax pleural effusion intoxications (drugs) anaphylactic reactions upper airway obstruction | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Smoking Smoking Cessation Chronic Bronchitis Emphysema Group A Healthy nonsmokers Enrolled in the "Normal" protocol #0005004439 "Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy" Healthy according to the "Normal" protocol #0005004439 Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies Male and Female subject ≥18 years of age smoked < 100 cigarettes per lifetime and whose urine nicotine <2 ng/mL and urine cotinine <5 ng/mL, at entry into the study Group B Healthy current smokers Enrolled in the "Normal" protocol #0005004439 Groups A Unable to provide proper informed consent Drug and/or alcohol abuse within the past six months Individuals with asthma and with recurrent or recent (within three months) and/or acute pulmonary infection Allergy to lidocaine Significant kidney disease or subjects on dialysis Females who are pregnant or lactating or intending to become pregnant in the next 12 months Major depression or other significant psychiatric disorder HIV+ Subjects that have unstable coronary artery disease as evidenced by unstable angina, >Class II NYHA cardiac status, history of congestive heart failure or MI within the last 12 months | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Cardiovascular Disease Smoking Bronchodilation COPD Gold stage II-III (FEV1/FVC<0,70 and FEV1 30-80% of predicted value) Current cigarette smoking (at the time of performing the study) Willing to provide written informed consent Refrain from smoking and bronchodilators > 8 hours (depends on treatment) before the test Registered in one of the recruitment institutes COPD gold stage I or IV Asthmatic component: History of asthma, present asthma by complaints, eosinophilia or reversibility ≥ 10% of predicted Unable to communicate Physically unable to perform any of the tests Non-COPD respiratory disorders Previous lung-volume reduction surgery and/or lung transplantation Evidence of alcohol, drug or solvent abuse Known α-1 antitrypsin deficiency | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | 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 | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, NSCLC Dyspnea Histologically or cytologically proven incurable stage IIIb or stage IV non-small cell lung cancer Dyspnea as defined by a score of 2 or higher on the 10-point Dyspnea Numeric Scale (Appendix 2) New dyspnea or worsening dyspnea within the last 6 months per patient reporting Age < 18 An FEV1 / FVC ratio < 0.7 with an FEV1 of < 80% predicted post-bronchodilator Life expectancy < 3 months Significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure) Myocardial infarction within the previous month Heart rate ≥ 120 Active tuberculosis or tuberculosis receiving antibiotic therapy Current or previous use of ipratropium, tiotropium, or oxitropium (see Appendix 6) Sensitivity to atropine Pre-existing diagnosis of asthma or moderate to severe Chronic Obstructive Pulmonary Disease | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, COPD Signed informed consent Age ≥ 40 years Patients fulfilling for COPD according to the Global initiative for chronic obstructive pulmonary disease (GOLD) stage I or higher Smokers or ex-smokers of at least 10 pack-years Patients suffering an either Admitted to hospital due to (severe exacerbation) or Confirmed at GP (general practitioner) setting (moderate exacerbation) Definition Increase in respiratory symptoms requiring treatment with oral corticosteroids, antibiotics or both Patients who have never smoked Patients with active long-term respiratory disease (e.g. bronchial asthma, cystic fibrosis, severe bronchiectasis, malignancy, restrictive lung diseases etc.) Exacerbation of COPD due to other causes such as pneumothorax and acute decompensated congestive heart failure Difficulties in communication (cognitive deterioration, sensorial disability, language barriers) Severe disease with poor vital prognosis (life length expectancy less than one year) | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Type of subject: Outpatients Informed consent: Subjects must give their signed and dated written informed consent to participate Gender: Male or Female Age: 40 years of age or older at Visit 1 COPD diagnosis: Documented diagnosis of COPD at least 6 months prior to Visit 1 in accordance with the following definition by the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guideline: Post bronchodilator FEV1/FVC < 0.7 History of exacerbations: At least one COPD exacerbation which required the use of any additional treatment in the last 12 months prior to Visit 1 For subjects who were diagnosed between 6 to 12 months prior to Visit 1, they should have at least one COPD exacerbation that required the use of any additional treatment since diagnosis Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis Non-compliance: Subjects unable to comply with any aspect of this study protocol or scheduled visits to the study centre | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-75.0, Chronic Obstructive Airway Disease Asthma Chronic Cough General Adult subjects aged 18 years and over Meet for subject groups as outlined below (1) Healthy volunteers Non-smokers No history of respiratory disease (2) Healthy smokers Current smokers with smoking history of ≥10 pack years Spirometry within normal limits i.e. FEV1>80% predicted and FEV1/FVC ratio >75% predicted (3) Asthma Symptoms of upper respiratory tract infection within the last 6 weeks 2) Participation in another clinical trial of an investigational drug within the last 4 weeks 3) Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate, 4) Patients with severe respiratory disease i.e. FEV1 < 1 litre, 5) Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-80.0, COPD Main Willingness to sign a written informed consent Chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2009 Chinese or Malay or Indian ethnicity History of chronic obstructive pulmonary disease symptoms for at least 12 months prior to baseline visit V0 Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio (post-bronchodilator) < 70% Forced expiratory volume in the first second (FEV1) (post-bronchodilator) < 50 % of predicted Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years Main Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics not stopped at V0 Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0 History of asthma diagnosis in patients < 40 years of age or relevant lung disease other than COPD Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0 Known alpha-1-antitrypsin deficiency | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease age 40-80 years old cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment non-smoking controls: no COPD (spirometry based) + < 1 pack year Respiratory disorder other than COPD α1-antitrypsin deficiency Known history of significant inflammatory disease other than COPD COPD exacerbation within 4 weeks prior to study Lung surgery Recent diagnosis of cancer Therapy with oral corticosteroids in the last 6 weeks Significant cardiovascular comorbidity Significant orthopedic/musculoskeletal problems | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 21.0-70.0, Pulmonary Disease, Chronic Obstructive Asthma A subject will be eligible for in this study only if all of the following apply All volunteers must be aged between 21 to 70 years inclusive and be competent to understand and give informed consent All female volunteers of child bearing potential must have provided a negative pregnancy test before and prior to any HRCT scan Body weight < 120 kg and BMI within the range 18 kg/m2 (inclusive) Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Available to complete the study Subject will then be included only if they fulfil all for the following relevant cohort Healthy: Cohort Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history and physical. A subject with a clinical abnormality or parameters outside the reference range for the population being studied may be included if the Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures Non-smokers (never smoked or not smoking for >12 months with <1 pack year history) (Pack years = (cigarettes per day smoked/20) x number of years smoked)) A subject will not be eligible for in this study if any of the following apply As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study Any pregnant female Volunteers who have a past or present disease, which as judged by the Investigator, may affect subject safety or influence the outcome of the study The subject has received an investigational drug or participated in any other research trial within 30 days or five half-lives, or twice the duration of the biological effect of any drug (whichever is longer) The subject that has both asthma and COPD Previous in a research and/or medical protocol involving nuclear medicine Any Radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category IIb or above: No more than 10 mSv in addition to natural background radiation, in the previous 3 years including the dose from this study) The subject has a history of alcohol or drug abuse The subject has had a respiratory tract infection within four weeks of the start of the study | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Heart Failure With Preserved Ejection Fraction Pulmonary Disease Left Ventricular Hypertrophy/Hypertension Male or female; Age 18 or older Left ventricular ejection fraction ≥ 50% Symptomatic heart failure or appropriate comparator group Informed consent signed by the subject Symptoms of active ischemia Moderate or severe mitral or aortic stenosis, or severe aortic insufficiency Serum creatinine > 3.0 or chronic hemodialysis Known chronic hepatic disease; defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 3.0 times the upper limit of normal as read at the local lab Severe renal dysfunction, i.e. glomerular filtration rate (GFR) <30 ml/min Atrial fibrillation Myocardial infarction within the last year Coronary bypass surgery within the last 6 months Stroke within the last 6 months Known aortic aneurysm | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive minimum age 40 years at index continuously enrolled in health plan diagnosis of COPD (ICD-9 codes of 491, 492, 496) at least one moderate exacerbation event as defined previously Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, or sarcoidosis Patients excluded if they did not receive treatment within the treatment assessment period following moderate exacerbation Receipt of maintenance medication in the pre-period Presence of treatment switch, discontinuation of index drug, or any COPD-related exacerbation during the treatment assessment period | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 0.0-15.0, Asthma Bronchiolitis patient is admitted to the ER with shortness of breath patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including asthma management protocol bronchiolitis management protocol ages 0 patient's parent/guardian is able to comprehend and give informed consent for participating in the study patient has received any dose of inhaled bronchodilators in the hour prior to enrollment patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment ventilated patients, while ventilated chest skin lesions cystic fibrosis hemodynamic instability patient's parent/guardian objects to the study protocol concurrent participation in any other clinical study physician objection | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive at least 40 years of age continuously enrolled for medical and pharmacy benefits during their pre and post-period diagnosis of COPD (ICD 491.xx, 492.xx, 496.xx) Patients were excluded if they had MTx in the pre-index period (to ensure of MTx-naïve patients) or if they received their first MTx during 181 to 365 days of the post-period (as dispensing of MTx unlikely to be related to the index exacerbation) Additionally, patients were excluded if they had any of the following comorbid conditions anytime during the study period: respiratory cancer, cystic fibrosis, fibrosis due to, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, or sarcoidosis, and also if they had other doses (unapproved in the US) of fluticasone propionate-salmeterol xinafoate combination (100/50 mcg or 500/50 mcg) or budesonide dipropionate-formoterol fumarate fixed dose combination (any dose) | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Inflammatory Disease Endothelial Dysfunction presence of COPD according to standard acute exacerbation of COPD according to recommended international over 40 years of age history of at least 10 py pneumonia history or signs of congestive heart failure acute myocardial infarction thoracotomy incl. resection of lungtissue interstitial lung disease acute or chronic renal failure active malignancy autoimmune disease | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | 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 | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Community Acquired Bacterial Pneumonia age 18 years or older met ATS/ISDA rule of CABP CABP requiring hospitalization and treatment with a IV antimicrobial anticipated hospitalization for > 48 hours received ceftaroline in combination with a macrolide (clarithromycin, or azithromycin) for > 48 hours within the first 24 hours after presentation to the hospital and must have remained on therapy for at least 48 hours after admission Pneumonia Patient Outcomes Research Team (PORT)risk class III or IV CABP PORT Risk class I, II, III CABP requiring admission to an ICU CABP suitable for outpatient therapy with an oral microbial agent confirmed or suspected respiratory tract infection attributed to a source other than CABP pathogens noninfectious case of pulmonary infiltrates or pleural empyema infection with a pathogen know to be resistant to ceftaroline or epidemiological/ clinical context suggesting a high likelihood of a resistant pathogen previous therapy with another intravenous beta-lactam for CABP for between 24 and 96 hours prior to randomization receipt of chronic concomitant systemic steroids > 40 mg of prednisone equivalent significant hepatic disease hematologic disease | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 6.0-999.0, Filariasis Age 6 years or older of either gender Patients presenting with pulmonary symptoms a. Confirmed or suspected asthma patients: i. Patients presenting with symptoms consistent with an acute exacerbation of asthma, including Wheezing 2. Shortness of breath 3. Chest tightness 4. Cough ii. Disposition to the asthma room after triage and physician evaluation (disposition to other areas of the A&E allowed if due to no available space in the asthma room) iii. Patients are potentially eligible with or without a past history of health care provider diagnosed asthma iv. Patients are potentially eligible regardless of the number of previous episodes of wheezing (i.e. patients with a first episode of bronchospasm are potentially eligible) v. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if They have a dry cough (no production of purulent sputum) They have bronchospasm as manifested by wheezing or need for salbutamol (albuterol) breathing treatments vi. Patients with wheezing are not eligible if they Have purulent sputum production 2. Have known or suspected a. Tuberculosis b. Immunodeficiency c. Congestive heart failure d. Foreign body aspiration b. Patients presenting with a chief complaint of cough: i. Potentially eligible patients will have a cough of greater than one week (seven days) duration ii. Asthma room disposition is not required for these subjects iii. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if They have a dry cough (no production of purulent sputum) iv. Patients with cough are not eligible if Have purulent sputum production Have known or suspected Patients less than 6 years of age Patients who do not consent to the study Children (<18 years) without a parent/guardian present Prisoners Patients who appear to be medically or psychologically unstable or felt to be otherwise inappropriate for study enrollment, in the opinion of the investigator or any treating health care provider. This determination will be made on an individual basis, but some of the general to be used in making this determination will be i. The patient appears to be in significant pain ii. The patient appears acutely ill severe respiratory distress, diaphoretic, altered mental status, active bleeding, actively vomiting, etc iii. Those with respiratory difficulty to the point they cannot speak in complete sentences iv. Chief complaint of sexual assault v. The patient appears acutely intoxicated vi. The patient displays agitated, nervous, restless, or other behavior suggestive of an uncontrolled psychiatric emergency Patients with pulmonary findings felt to be secondary to congestive heart failure, foreign body, bacterial pneumonia, tuberculosis or other clearly defined cause Non-English speaking patients | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, COPD A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity [FVC] ratio < 70% and FEV1 ≥ 30% to <80% of the predicted value Current or former cigarette smokers with a smoking history of at least 10 pack-years History or current diagnosis of asthma Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1 Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1 Patients with any clinically significant respiratory conditions other than COPD | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) -Individuals over the age of 18 who have COPD or may be considered to be at increased risk for development of COPD -Individuals under the age of 18 | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, COPD Aged ≥40 years at initial date of COPD diagnosis COPD diagnosis with Quality Outcome Framework (QoF) approved read code has spirometry data supportive of a COPD diagnosis in the 5 years around initial date diagnosis of COPD (FEV1 % predicted) Patient has one year of data prior to initial date of COPD diagnosis Patient has a minimum of two years of data post initial date of COPD diagnosi Patients whose initial date of COPD diagnosis is before 1997 | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Completion of informed consent Adults over the age of 18 Diagnosis of IPF per ATS guidelines Clinically stable at the time of enrollment defined as no antibiotics within the past month, with the exception of those patients currently listed for Lung Transplantation No changes in immunosuppressive regimens (if applicable) over past month Inability to understand or complete paper and pencil questionnaires Patient not planning to return to Stanford for clinic visits | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) patients with diagnosed COPD via the medical records with code J44 terminal illness cognitive impairments | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, COPD Continuous health plan enrollment for 12 months before and after index Rx, at least one prescription for BFC or FSC during intake period, naive to ICS/LABA therapies in year prior to first prescription claim, COPD diagnosis, aged 40 or over at time of first prescription ICS/LABA combination during pre-index period, patients with a claim for BFC and FSC on the same day, patients diagnosed with cancer, patients with long-term OCS medication use during pre-index period | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 45.0-999.0, Insomnia COPD Chronic Obstructive Pulmonary Disease Fatigue mild to very severe COPD age ≥ 45 years of age with no other major healthproblems clinically stable at the time of enrollment into the study insomnia evidence of restrictive lung disease or asthma pulse oximetry reading of < 90% at rest or < 85% at night for > 5 min evidence of a major sleep disorder other than insomnia hypnotic use acute respiratory infection within the previous 2 months presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease a self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of > 11 currently participating in pulmonary rehabilitation | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-85.0, Chronic Obstructive Pulmonary Disease Endothelial Dysfunction COPD patients in stable condition ( without exacerbation min 1 months ago) Over 40 years History of at least 10 py acute exacerbation of COPD active malignancy autoimmune disease acute myocardial infarction diabetes mellitus with late complications congestive heart failure women of childbearing potential | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Chronic Bronchitis Written informed consent. 2. Age ≥ 40 years. 3. Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio (post-bronchodilator) <70%. 4. FEV1 (post-bronchodilator) < 80% of predicted Moderate and severe exacerbations during the last 4 weeks. 2. Pregnancy. 3. Already participated in the study (allowed to participate only once) | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, COPD Chronic Obstructive Pulmonary Disease Diagnosis of stable COPD years or older Smoking history of at least 10 pack-years Forced Expiratory Volume in one second (FEV1) ≤ 70 % of predicted value and FEV1 / Forced Vital Capacity (FVC) < 0.70 Dyspnea ≥ 2 on the Medical Research Council (MRC) scale At least 2 exacerbations requiring prednisone treatment in the past 3 years Using a written action plan and having demonstrated adequate use of the self-administered antibiotic & prednisone (adequate use defined as prednisone started by the patient within 72 hours of symptom worsening and patient called the case-manager as recommended for following the response) Already on Advair BID (twice a day) as a maintenance therapy or able to switch over to Advair if already taking another combination medication (Symbicort) as maintenance therapy for COPD History of asthma or allergic rhinitis before the age of 40 Regular use of oxygen, oral corticosteroids, antibiotics Unstable or life threatening co-morbid condition Medical conditions or taking medications known to affect tremor and/or heart rate (HR) Pre-existing medical conditions or on concomitant medications contraindicated with salmeterol or fluticasone propionate (e.g. monoamine oxidase inhibitors and tricyclic antidepressants, beta-adrenergic receptor blocking agents, non potassium-sparing diuretics, inhibitors of cytochrome P450 (ritonavir, ketoconazole)) On theophyllines Colonized with pseudomonas aeruginosa | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Male or female patients 40 years of age or older All patients had to have a diagnosis of COPD and had to meet the following spirometric and static lung volume Patients had to have relatively stable, moderate to severe airway obstruction with FEV1 ≤ 50 % of predicted value FEV1/SVC ≤ 70 % All patients had to have the presence of lung hyperinflation as demonstrated by RV ≥ 125 % of predicted value Predicted normal values were calculated according to European Community Coal and Steel (ECCS) Males FEV1 predicted (L) = 4.30 x height (metres) 029 x age (years) Patients with a history of asthma, allergic rhinitis or atopy Patients with significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator may have either put the patient at risk because of participation in the study or a disease which may have influenced the results of the study or the patient's ability to participate in the study Patients with a recent history (i.e. one year or less) of myocardial infarction Patients with a recent history (i.e. three years or less) of heart failure, pulmonary oedema, or patients with cardiac arrhythmia requiring drug therapy Patients who regularly used daytime oxygen therapy for more than one hour per day and in the investigator.s opinion was unable to abstain from the use of oxygen therapy Patients with known active tuberculosis Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis Patients who underwent thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reason were evaluated as per criterion No. 2 Patients with lower respiratory tract infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Age ≥ 40 years A diagnosis of relatively stable, moderate to severe COPD with Screening FEV1 ≤ 60% of predicted normal value (calculated according to European Community for Coal and Steel (ECCS) and screening FEV1/FVC ≤ 70% Smoking history ≥ 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent) Ability to be trained in the proper use of the HandiHaler® device and Metered Dose Inhaler (MDI) Ability to perform all study related tests including the Shuttle Walking Test, acceptable pulmonary function tests, including Peak expiratory flow rate (PEFR) measurements, and maintenance of diary card records Ability to give written informed consent in accordance with Good Clinical Practice and local regulations Clinically significant diseases other than COPD Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an criterion, will be excluded All patients with a serum glutamic oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic pyruvic transaminase (SGPT) > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition A recent history (i.e., one year or less) of myocardial infarction Any cardiac arrhythmia requiring drug therapy or hospitalisation for heart failure within the past three years Inability to abstain from regular daytime use of oxygen therapy for more than 1 hour per day Known active tuberculosis History of cancer within the last five years (excluding basal cell carcinoma) History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis Patients who have undergone thoracotomy with pulmonary resection | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-90.0, Chronic Obstructive Pulmonary Disease(COPD) Malnutrition Patients from Zhujiang Hospital affiliated from Southern Medical University Patients aged between 40 and 90 years old Patients gendered into male or female Patients with pulmonary function test of FEV1/FVC<70% and FEV1<80% predicted Patients presenting one or more of the following situations of malnutrition or nutritional risk: BMI <21 kg/m2 (or<23 kg/m2 in patients ≥ 65); unintentional weight loss >10% in the past 6 months; unintentional weight loss >5% in last month; FFMI <15 kg/m2 (women) or <16 kg/m2 (men) Patients able to answer question Patient able to eat and drink Patients who signed informed consent Patients with signs of an airway infection Patients with malignant disorders Patients with recent surgery Patients with gastrointestinal ,cardiovascular diseases,neurological diseases or endocrine disease Patients with bullae lung patients treated with oral steroids or immunosuppressors Patients requiring other nutritional supplements or parenteral nutrition Patients suffering from acute exacerbation over the previous 4 weeks Patients with lack of motivation or poor compliance | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 0.0-999.0, COPD Primary Health Care Centers (PHCC): >10.000 patients listed. >70% permanent employed general practitioners Patients: Diagnosis of COPD registered at the COPD. Grade of COPD 2-3 (GOLD) at the latest spirometry completed since 2008 | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease Age≥ 40years old The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease Chest radiography shows congestive heart failure Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases Serious cardiac failure, renal insufficiency or hepatic dysfunction | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Cough Dyspnea Wheezing Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) Referred for CXR and/or CT scan Life threatening medical condition requiring immediate treatment Unable to sit up for a chest ultrasound Unable to consent Pregnant Unable to speak, read and write in English | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive A confirmed diagnosis of severe to very severe COPD medically stable Age between 40 and 80 years Syndrome differentiation belongs to syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney with a two-week wash-out period prior to randomization Without participations in other interventional trials in the previous one month With the informed consent signed Pregnant or breast-feeding women Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis) Complicated with a neuromuscular disorder, which affected the respiration Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics Complicated with malignancy, congenital or acquired immune deficiency Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation) Participating in other trials or allergic to the used medicine | 1 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Pulmonary Disease, Chronic Obstructive Clinical stable moderate to severe COPD (FEV1 <70%, FEV 1 / FVC <70%) total lung capacity (TLC> 80%) without conventional for LTOT, optimal medical therapy, mean SpO2 ≤ 88% during the 6 minuts walking test and active life outside the home, other than active smoking or are in program respiratory rehabilitation Current smokers Presence of respiratory failure and for LTOT (PO2 <55 mmHg or 55-60 mmHg associated with pulmonary arterial hypertension, chronic cor pulmonale, congestive heart failure, arrhythmias or polycythemia) Presence of impaired mobility Cognitive impairment or intellectual disability to fill in questionnaires No acceptance of liquid oxygen Presence of active comorbidities (cardiovascular disease, rheumatologic, renal, hepatic) Participation in pulmonary rehabilitation programs | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 50.0-75.0, Chronic Obstructive Pulmonary Disease male and female COPD with an FEV1 of under 60% of predicted non-smoker between 50 and 75 years old experiencing an acute exacerbation of COPD (24-48 hours, before treatment) all inflammatory disease (HIV, cancer, renal and cardiac deficiency) hormonal dysregulation inferior limb pathology neuromuscular pathology history of tobacco or alcool abuse oxygen dependent | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-60.0, Asthma Participants must meet all of the following for enrollment Male or female, 18 to 60 years of age Must have clinical evidence of moderate-severe atopic asthma -self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms) within the past year, and a positive methacholine test confirming diagnosis [provocative concentration causing a 20% fall in forced expiratory volume in 1 second (PC20 FEV1) < 16 mg/mL for participants on inhaled corticosteroids and < 8 mg/mL for participants not on inhaled corticosteroids] or postbronchodilator FEV1 with at least 12% or 200 mL increase in FEV1 or forced volume vital capacity (FVC) on bronchodilator challenge, and no other diagnosis that could explain symptoms If there is documentation of a recent methacholine challenge, those results may be used in lieu of conducting a secondary methacholine challenge Permanently resides within 50 miles of the CRU Able to present a valid government issued form of identification for entry to the NIEHS campus Participants meeting any of the following at screening will not be eligible for enrollment or to continue with study visits Women who are pregnant or lactating at the time of screening (this is in place because certain enrollment procedures, may pose an undue risk on the unborn fetus; women may rescreen at a later date once no longer pregnant or breastfeeding; women who are pregnant or lactating at the time of the baseline visit and are scheduled to complete the methacholine challenge will be withdrawn due to the potential risk to the fetus; women who become pregnant after completing the baseline visit will not be excluded from further participation but will also not be eligible for participation in the bronchoscopy sub-study) Current smoker, significant second-hand smoke exposure (defined by urine cotinine > 100 ng/mL at screening), or a history of smoking greater than 5 pack years. Smoking encompasses all inhaled products, including e-cigarettes piCO Smokealyzer value of > 11ppm History of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), emphysema, non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension Allergy or history of adverse reactions to methacholine Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures Comorbid diseases that affect global health or survival such as DVT, pulmonary embolism, class III IV congestive heart failure, or a malignancy under treatment | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-85.0, COPD, HEAD&NECK CANCER,SCREENING group of adult COPD patients Adult patients with smoking history and no clinical manifestation of COPD who will be recruited form the institute of pulmonary medicine and the otolaryngology outpatient clinic Adult patients with lung disease unrelated to smoking, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine Patients with an acute disease or COPD exacerbation Pregnant patients Patients who were intubated ≤3 months prior to Patients with a medical history of surgical intervention in the upper airway Patients with a medical history of malignant disease in the upper airway Patients who underwent radiotherapy of head and neck | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Disease Heart failure Ambulatory patients | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, COPD Patients with a diagnosis of COPD (FEV1/FVC<0.7 confirmed based on the past medical records) Patients aged 40 years and over at the diagnosis of COPD Outpatient or more pack-years of current or former smokers Patients who have traceable medical records of COPD (including the results of spirometry) going back more than a year Patients who meet any of the following two Patients who have medical records of the results of spirometry at more than two different time points excluding the time point of COPD exacerbations* for the past 3 years Patients who can provide the results of reversibility testing for respiratory tract Patients who give written informed consent regarding the participation in this study Patients currently with COPD exacerbations Patients who currently enroll in the other interventional study including clinical trials Patients who concurrently develop or have a history of lung cancer Patients who are disabled to understand the study procedure or answer the questionnaire (i.e. due to the history of alcohol or drug abuse) | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-65.0, Asthma COPD for Asthma History consistent with asthma: episodic wheezing, shortness of breath, or cough Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age >18yrs FEV1 >40% predicted Never smoker, current smoker, or quit smoking ≥5 years ago for COPD History consistent with COPD: dyspnea with exertion, productive cough, progressive course Smoking history of at least 20 pack years Current smoker or quit smoking ≥5 years ago Age >18yrs FEV1: Forced Vital Capacity (FVC) ratio < 0.70 following 2 puffs of albuterol for Asthma Other respiratory illness other than asthma Chronic infectious process Significant other medical illness Inability to consent Pregnancy for COPD Other respiratory illness other than COPD Chronic infectious process Significant other medical illness Inability to consent | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-75.0, COPD Asthma for Healthy Smoking Subjects Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Be between 18 and 75 years of age, inclusive, at informed consent Healthy as determined by a physician, based on medical history and physical examination Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of ≥ 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked) for All COPD Subjects Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Aged between 40 and 75 years of age inclusive, at the time of signing the informed consent COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli, 2004). Symptoms must be compatible with COPD for at least 1 year prior to screening and post-bronchodilator spirometry readings at screening Post-bronchodilator FEV1/FVC ratio of <0.7 for Healthy Smoking Subjects Any potential subject who meets any of the following will be excluded from the participating study Upper or lower respiratory tract infection within 4 weeks of the screening visit Positive test for alcohol at screening Taking prescription medication in the 14 days before screening Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded but are not limited to pipes, cigars and e-cigarettes Subjects who are unable to produce a total weight of at least 0.1 grams (g) of selected sputum at screening Urinary cotinine levels at screening < 30 ng/ml Subject is mentally or legally incapacitated Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO Any other reason that the Investigator considers makes the subject unsuitable to participate | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 18.0-999.0, Pulmonary Disease, Chronic Obstructive Patients Male of Female, aged 18 years or above Attended the clinic as a patient Participant is willing and able to give informed consent for participation in the study Patients The patient is unable or unwilling to give consent Health Care Professionals Male or Female, aged 18 or above Attended the clinic as a health care professional Participant is willing and able to give informed consent for participation in the study Health Care Professionals The health care professional is unable or unwilling to give consent | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Age: >=40 years of age at Visit 1 Diagnosis of COPD with a documented history of COPD for at least one year, in accordance with the definition by the American Thoracic Society/European Respiratory Society Severity of Disease: Post albuterol/salbutamol forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio <0.70 and FEV1 <=70% of predicted obtained within two years of Visit 1 Smoking History: Current or former (defined as subjects who have quit smoking for at least 3 months prior to Screening/Visit 1) cigarette smokers with a >10 pack-year smoking history (Number of pack years = [number of cigarettes per day divided by 20] x number of years smoked [e.g., 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]) Current COPD Therapy: Currently receiving maintenance (with one or more long-acting bronchodilators, such as a long-acting muscarinic antagonist (LAMA; also known as a long-acting anti-cholinergic) or long-acting beta 2-agonist (LABA) inhaler therapy (with no prior or ongoing use of inhaler) for the treatment of COPD. Subjects must be able to continue using their currently prescribed COPD maintenance inhaler therapy throughout the study and as needed short acting beta-adrenergic agonist (SABA) for rescue use Ability to Use Inhalers: Subject must be able to demonstrate correct use of inhaler within three attempts at Visit 1 Males Females who are not pregnant or not planning a pregnancy during the study or not lactating Informed Consent: Capable of giving signed and dated written informed consent which includes compliance with the requirements and restrictions listed in the consent form and in the protocol Subject understands and is willing, able, and likely to comply with study procedures and restrictions A subject will not be eligible for in this study if any of the following apply Asthma: Subjects with a current primary diagnosis of asthma COPD medications: Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their daily COPD therapy (as needed [prn] or regularly scheduled); Has changed maintenance COPD treatment within 4 weeks prior to Screening/Visit 1 or plans to change COPD treatment within 4 weeks of Visit 1 COPD/Exacerbations/Hospitalization: Subjects that have experienced a COPD exacerbation requiring systemic corticosteroids (oral, parenteral or depot) and/or antibiotics within four weeks of Visit 1. A subject must not have had any hospitalization for COPD within three months prior to Visit 1; Subjects with uncontrolled COPD, in the investigator's judgment that would affect subject's ability to evaluate "ease of use and correct use" Other Respiratory Disorders: Subjects with other respiratory disorders, including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening/Visit 1 Oxygen: Use of long-term oxygen therapy (LTOT; defined as oxygen therapy prescribed for greater than 12 hours per day) or nocturnal oxygen Other Disease Abnormalities: Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study; Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study Compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures, or unable to continue their current COPD medications Alcohol and Drug Abuse: A known or suspected history of alcohol or drug abuse within the last 2 years | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-84.0, Pulmonary Disease, Chronic Obstructive Male and female subjects, ≥ 40 and less than 85 years of age Clinical diagnosis of at least moderate COPD as defined by the Global Initiative for Obstructive Lung Disease (GOLD) (53) Post bronchodilator FEV1/FVC < 70% (Forced expiratory volume in 1 second/ forced vital capacity) Post bronchodilator FEV1 < 80% predicted, with or without chronic symptoms (i.e., cough, sputum production) Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers To enrich the population for patients who are more likely to have acute exacerbations (54), each subject must meet one or more of the following 4 conditions Have a history of receiving a course of systemic corticosteroids for respiratory problems in the past year Visiting an Emergency Department for a COPD exacerbation within the past year, or Being hospitalized for a COPD exacerbation within the past year Be using supplemental oxygen for 12 or more hours per day A diagnosis of asthma established by each study investigator on the basis of the recent American Thoracic Society/European Respiratory Society and National Institute for Health and Care Excellence guidelines The presence of a diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy < 2 years Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (hormone-based oral or barrier contraceptive) for the duration of the study Current tachy or brady arrhythmias requiring treatment Presence of a pacemaker and/or internal cardioverter/defibrillator Patients with a history of second or third degree (complete) heart block, or sick sinus syndrome Baseline EKG revealing left bundle branch block, bifascicular block, ventricular tachyarrhythmia, atrial fibrillation, atrial flutter, supraventricular tachycardia (other than sinus tachycardia and multifocal atrial tachycardia), or heart block (2nd degree or complete) Resting heart rate less than 70 beats per minute, or sustained resting tachycardia defined as heart rate greater than 120 beats per minute Resting systolic blood pressure of less than 100mm Hg Subjects with absolute (Class 1) indications for beta-blocker treatment as defined by the combined American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons Guidelines which myocardial infarction, acute coronary syndrome, percutaneous coronary intervention or coronary artery bypass surgery within the prior 3 years and patients with known congestive heart failure defined as left ventricular ejection fraction <40%.(29, 30) | 2 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 0.0-999.0, Cystic Fibrosis Volunteers with Cystic Fibrosis and lung disease with chest hemiperímetro ≥ 37 cm Episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used | 0 |
A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Patients who have signed Informed Consent Form prior to initiation of any study-related procedure Male and female adults aged ≥ 40 years Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines Patients with a post-bronchodilator FEV1 ≥40 and < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC < 0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 µg of salbutamol) Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at screening Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS) Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) for acceptability (one retest may be performed for patients that don't meet the acceptability criteria) Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1 Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation Other protocol-defined inclusion/ | 1 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 13.0-999.0, Cytomegalovirus Retinitis HIV Infections Concurrent Medication Allowed Topical anti-Herpesvirus agents Zidovudine (AZT) for patients in deferral or foscarnet treatment groups mg every 4 hours. For patients on ganciclovir mg every 8 hours Dideoxyinosine (ddI) and other antiretroviral available via expanded access programs, investigational triazoles, granulocyte-macrophage colony-stimulating factor, and erythropoietin to treat marrow toxicity. The use of other investigational drugs will be considered on a drug by drug basis It is not recommended that patients receiving ganciclovir take AZT simultaneously. If AZT is prescribed for patients taking ganciclovir, it should be prescribed at reduced doses and discontinued if hematologic toxicity develops Patients must have Diagnosis of AIDS by CDC or a documented HIV infection Co-existing Condition Patients with the following conditions or symptoms are excluded Sufficient media opacities to preclude fundus photographs in both eyes Concurrent Medication Excluded Other systemic treatments for Herpesvirus infections Other anti-cytomegalovirus therapy Excluded with foscarnet Parenteral pentamidine, amphotericin B, or aminoglycosides Use of marrow toxic agents with ganciclovir and nephrotoxic agents with foscarnet is discouraged, and alternative treatment should be used whenever possible | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 13.0-65.0, Cytomegalovirus Retinitis HIV Infections Concurrent Medication Allowed Zidovudine (AZT) 8/90 Other available antiretroviral therapy Pneumocystis carinii pneumonia (PCP) prophylaxis, either systemic or local (aerosolized) Chemotherapy for Kaposi's sarcoma Systemic therapy for intercurrent opportunistic infections Acyclovir or other treatment of Herpes simplex virus (HSV) or Varicella zoster virus (VZV) infections Systemic therapy deemed necessary for appropriate medical management Patients must have AIDS and cytomegalovirus (CMV) retinitis in at least one eye, diagnosed by an ophthalmologist and verified by fundoscopy and fundus photography Co-existing Condition Patients with the following are excluded Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography Concurrent Medication Excluded Prophylactic acyclovir at time of study entry Other anticytomegalovirus (CMV) therapy, particularly systemic ganciclovir, foscarnet, or CMV hyperimmune globulin Topical ophthalmic medications should be avoided Cytomegalovirus (CMV) therapies and chronic acyclovir, including necessary therapies for an intercurrent opportunistic infection | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 13.0-65.0, Cytomegalovirus Retinitis HIV Infections Concurrent Medication Excluded Acyclovir Zidovudine (AZT) Any potentially nephrotoxic agent, especially aminoglycosides, pentamidine, or amphotericin B Prior Medication Excluded Ganciclovir Foscarnet Excluded within 7 days of study entry | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 13.0-999.0, Cytomegalovirus Retinitis HIV Infections Concurrent Medication Allowed Chemotherapy for Kaposi's sarcoma (excluding interferon) if patient is hematologically stable for at least 30 days prior to entry Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC) after first two weeks of study period if absolute neutrophil count is > 1000 cells/mm3 and hemoglobin = or > 8 g/dl Vancomycin Fluconazole or investigational triazoles (e.g., itraconazole, SCH 39304) for disseminated fungal infection Pneumocystis carinii pneumonia prophylaxis (except parenteral pentamidine) Acyclovir or other appropriate medication may be instituted in the event of the appearance of Herpes simplex virus (HSV) or Varicella zoster virus (VZV) infections G-CSF or GM-CSF for grade 4 neutropenia Co-existing Condition Patients with the following conditions or symptoms are excluded Evidence of tuberculous, diabetic or hypertensive retinopathy Osteomalacia, neoplasm metastatic to bone or other bone disease Any clinically significant pulmonary or neurologic impairment (for example, patients who are intubated or comatose) Retinal detachment Corneal, lens, or vitreous opacification precluding funduscopic exam Concurrent Medication Excluded Immunomodulators, biologic response modifiers or investigational agents not specifically allowed | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 13.0-65.0, Cytomegalovirus Infections HIV Infections Concurrent Medication Allowed Pentamidine aerosol for prophylaxis of recurrent Pneumocystis carinii pneumonia (PCP) in patients currently receiving such treatment Prior Medication Allowed Zidovudine (AZT) but only if patient has been taking the drug for > 6 weeks at a dose = or < 600 mg/day, and had < 10 percent decrease in hematocrit, neutrophils, and platelets in the last 30 days. Those off AZT must have been off it for > 1 month Patients must Have documented cytomegalovirus (CMV) viremia or viruria Have a diagnosis of HIV infection by ELISA or Western blot Be able to participate as an outpatient Co-existing Condition Patients with the following are excluded HIV wasting syndrome (involuntary weight loss > 10 percent of baseline body weight and/or chronic diarrhea or weakness and documented fever for at least 30 days) Clinical or x-ray evidence of bronchitis, pneumonitis, pulmonary edema, effusion, or suspected active tuberculosis Any unstable medical condition including serious cardiovascular, infectious, oncologic, renal, or hepatic condition Cytomegalovirus end organ disease Kaposi's sarcoma requiring chemotherapy Systemic fungal infection requiring amphotericin therapy Diagnosis of idiopathic thrombocytopenic purpura (persistent platelet counts < 100000 platelets/mm3 for = or > 3 months) Patients with the following are excluded | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, HIV Healthy Volunteers ALL Greater than or equal to 18 years old Ability to sign informed consent For women of child-bearing potential, negative result on a serum or urine pregnancy test within 1 week prior to the procedure Willingness to allow storage of blood or biopsy samples for possible future use to study HIV/AIDS, related diseases or the immune system; willingness to permit HLA testing FOR No medical contraindication to tonsillar, lymph node, or intestinal biopsy For tonsillar biopsy, presence of visible tonsillar tissue; for lymph node biopsy, palpable lymph nodes No aspirin or piroxicam (Feldene) for 10 days prior to the procedure; other non steroidal anti-inflammatory drugs (e.g. ibuprofen) must be discontinued the day prior to the procedure. Acetaminophen [Tylenol] is permitted at any time FOR FOR ALL Platelet count less than 75,000 platelets/mm(3) PT or PTT prolonged by greater than 2 seconds Known underlying bleeding disorder Pregnancy FOR HIV-POSITIVE OR ICL FOR LYMPH NODE Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy FOR ALL FOR Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy Significant heart valve abnormalities | 1 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Atherosclerosis Chlamydia Infections Cytomegalovirus Infections Pneumonia, Bacterial Postmenopause Must be a postmenopausal woman 65 years of age or younger Time since last date of menses should be at least 12 months, with plasma estradiol less than 50 pg/ml and FSH greater than 50 pg/ml Women must be without clinical evidence of CAD as determined by history, cardiovascular physical examination, and EKG Must not have used hormone replacement therapy within past 6 months Must not have used dietary supplements and any medication (over-the-counter or prescribed) within 1 month. Acetaminophen use is allowed Must not have a history of alcoholism or binge-drinking Must not have diabetes mellitus or known abnormal glucose intolerance test Must not have a history of stroke, angina or myocardial infarction Must not have a history of deep venous thrombosis/pulmonary embolism Must not have a history of cancer (except for treated squamous cell and basal cell carcinomas) | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.25-999.0, Cytomegalovirus Infections Cytomegalovirus Retinitis HIV Infections Co-existing Condition Patients with the following are excluded Cytomegalovirus (CMV) disease who meet the for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency Hypersensitivity to acyclovir or ganciclovir Receiving antimetabolite treatment that cannot be discontinued Concurrent Medication Excluded | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-60.0, HIV Infections Concurrent Medication Allowed All drugs used for the standard treatment of Pneumocystis carinii pneumonia (PCP) Other drugs for treatment of other AIDS conditions if they have been started more than 3 months prior to study entry Patients must have Diagnosis of AIDS Weight loss > 10 percent of premorbid body weight First or second episode of acute Pneumocystis carinii pneumonia (PCP) Co-existing Condition Patients with the following conditions or symptoms are excluded Do Not Resuscitate (DNR) status Biliary stasis Patients with the following are excluded Do Not Resuscitate (DNR) status Biliary stasis Prior Medication Excluded within 3 months of study entry Immunomodulators | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Cardiovascular Diseases Coronary Disease Cerebrovascular Accident Heart Diseases Myocardial Infarction Infection Chlamydia Infections Cytomegalovirus Infections Helicobacter Infections Atherosclerosis | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 13.0-999.0, Cytomegalovirus Infections Cytomegalovirus Retinitis Pneumonia, Pneumocystis Carinii HIV Infections Patients may be eligible if they Are HIV positive (except Group 3b) Are at least 13 years old (consent of parent or guardian required if under 18) Patients may be eligible for Group 1a if they Have acute PCP Have never received potent anti-HIV drugs or have not received potent anti-HIV drugs for at least 8 weeks prior to getting PCP Have a CD4 cell count below 200 cells/mm3 Patients may be eligible for Group 1b if they Have CMV disease Meet 1 of the following requirements: (1) have never received potent anti-HIV drug containing a protease inhibitor (PI) or a nonnucleoside reverse transcriptase inhibitor (NNRTI), (2) have not received potent anti-HIV drugs for at least 8 weeks before getting CMV disease, or (3) have been on stable anti-HIV therapy for at least 3 months with no new anti-HIV drugs started before CMV disease returned Patients will not be eligible if they Have received a vaccine within 14 days of study entry or plan to receive one during the study Have taken GM-CSF, any investigational drugs, or any drugs that might affect the immune system within 30 days of study entry or plan to take 1 of these medications during the study. (Prednisone for patients with PCP and G-CSF is allowed.) Abuse drugs | 2 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Cytomegalovirus Infections Age 18-65 CMV seropositive Informed consent given CMV seronegative Abnormal blood counts (hemoglobin less than 12 g/dl, platelets less than 150,000/ul, absolute neutrophil count less than 1,500/ul, absolute lymphocyte count less than 1,000/ul) Known history of heart, lung, kidney, liver, or bleeding disorder Diagnosis of HIV infection Diagnosis or suspicion of immunodeficiency state History of intravenous drug use Currently pregnant | 1 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Pneumonia All eligible patients undergoing diagnostic bronchoscopy who provide consent for proteomic analysis of BAL fluid supernatant and chart review of patient characteristics will be included in this study Patients undergoing bronchoscopy but not wanting to participate with either the chart review or the proteomic analysis of BAL fluid supernatant will be excluded | 2 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, CMV Disease For Patient Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet Patients with HLA phenotype for which a relevant peptide for CMV exists For Donor Consenting sibling >18 years old HLA phenotype for which a relevant peptide for CMV exists For Patient Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes For Donor Consenting sibling >18 years old HLA phenotype for which a relevant peptide for CMV exists Donor with an infectious disease (e.g. HIV-1; HBV, etc.) | 1 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, CMV Disease Viral Resistance Rejection Death Age greater than 18 years 2) WBC greater than 2000/mm3 with ANC greater than 500/mm3 3) Platelet count greater than 50,000/mm3 4) Hematocrit greater than 24 5) Life expectancy greater than 1 year as determined by investigator 6) Females must have a negative pregnancy test and any sexual partner must also agree to practice a barrier and/or hormonal method of birth control while participating in this study and for 90 days after. Females must agree to have a pregnancy test if a menstrual cycle is missed, and if positive, this must be reported Patients receiving systemic therapy for acute opportunistic infection at time of enrollment Patients receiving investigational drugs Patients with malignancies within the last 5 years with the exception of excised basal or squamous cell skin cancers Patients with active substance abuse or other condition that would impair compliance Patients who are unable to give informed consent Any patient with a creatinine clearance < 40 after delayed graft function and or post-transplant ATN has completely resolved, or the patient is deemed not to have the prospect of any further improvement of creatinine clearance (>40) as would occur with resolving ATN Persistent ANC < 1,000 for 2 consecutive weeks despite treatment with G-CSF Any female patient who plans to become pregnant within one year | 1 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Cytomegalovirus Infections Patients receiving allogeneic peripheral blood stem cell transplant from either a related or unrelated donor at Washington University Medical Center An initial episode of CMV viremia At the time of randomization ANC greater than or equal to 1000 Age greater than or equal to 18 Adequate renal function with creatinine clearance greater than 10 ml/min Total bilirubin less than or equal to 3.0 Current GI graft versus host disease grade III-IV Development of CMV disease prior to or at the time of the first detection of CMV viremia by PCR Uncontrolled emesis or diarrhea (greater than or equal to 4 episodes per day) for 2 consecutive days Pregnant or nursing female patient Known hypersensitivity to ganciclovir | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Cytomegalovirus Infections Allogeneic stem cell transplant recipient Recipient or donor CMV seropositive Have transplant engraftment Able to swallow tablets CMV organ disease HIV infection Use of other anti-CMV therapy post-transplant | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 50.0-80.0, Influenza No contraindications to vaccination as specified in the "Green Book" Immunisation Against Infectious Disease, HMSO Written informed consent obtained Subject aged no less than 50 years 0 days and no older than 79 years and 364 days at enrollment | 1 |
Subsets and Splits