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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-90.0, Lung Diseases Bronchitis, Chronic Male or female out-patients >/= 45 years Subjects suffering from chronic bronchitis FEV1</= 70% and FEV1/FVC </= 70% predicted from age, height and sex No documented episode of AECB (requiring treatment) within 6 weeks of randomization and not experiencing an exacerbation at the time of screening Sputum production on most days, even when exacerbation free Subjects presented with at least two documented (i.e. requiring antibiotics and/or systemic steroid administration) acute exacerbation episodes during the last 12 monthsIf receiving chronic therapy with inhaled long acting bronchodilators and/or inhaled or systemic steroids, the treatment must have remained stable for the preceding 6 weeks prior to screening Smoking history of at least 20 pack-years Subjects willing and able to give fully informed written consent Subjects with contra-indications to moxifloxacin Known bronchial carcinoma, pulmonary tuberculosis, cystic fibrosis, documented chronic bronchial asthma or diffuse bronchiectasis Subjects who are actively participating in intensive pulmonary rehabilitation programs Subjects with a known history of chronic colonization of pathogenic organisms resistant to moxifloxacin, e.g. Pseudomonas spp, MRSA No systemic or inhaled antibiotic therapy during the 6 weeks prior to screening and any long term antibiotic usage Subjects requiring home ventilatory support for COPD and those who have a tracheostomy in situ (subjects requiring home/potable oxygen therapy or CPAP for sleep apnea can be included)
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-55.0, Pulmonary Disease, Chronic Obstructive Healthy Caucasian male subjects or healthy Caucasian female subjects of non-childbearing potential Aged between 18-55 years Non-smokers Normal spirometry (FEV1 = 80% of predicted, FEV1/FVC = 70%) A signed and dated written informed consent is obtained from the subject The subject is capable of giving informed consent Available to complete the study Subject has a BMI within the range 18.0-30.0kg/m2 inclusive Any clinically important abnormality identified at the screening medical assessment A history of breathing problems A mean QTc(B) value at screening >450msec, the QTc(B) of all 3 screening ECGs are not within 10% of the mean, or an ECG that is not suitable for QT measurements A history of elevated resting blood pressure or a mean blood pressure equal to or higher than 140/90 mmHg at screening A mean heart rate outside the range 40-90 bpm at screening History of use of tobacco products within 6 months of screening, or positive urine cotinine at screening Subjects with a 2D6 poor metabolizer genotype (Caucasian) The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study The subject is currently taking regular (or course of) medication, whether prescribed or not The subject has taken prescription medications within the past 2 weeks prior to dosing or OTC medications within 48 hours prior to dosing
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-999.0, Pulmonary Disease, Chronic Obstructive Admitted to the hospital for a COPD exacerbation FEV1 less than 60% of predicted level At least 10 pack years of smoking Any uncontrolled systemic disease Known hypersensitivity to zileuton Asthma Lobar pneumonia or pulmonary edema Interstitial lung disease Medical condition that is likely to limit survival to less than 30 days at the time of study entry History of liver disease Current use of theophylline Participation in another clinical trial in the COPD Clinical Research Network Incarceration
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Acute exacerbations (at least one criterion present: increase of dyspnoea, increase of sputum production and/or increase of purulence) of patients older than 40 years old smokers or ex-smokers of more than 10 pack-years with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio FEV1/FVC<0.7% Severe COPD (FEV1<50%) Pneumonia Active neoplasm Tracheotomy for hospitalisation Patients previously being on antibiotics Immunodepressed patients History of hypersensitivity to beta-lactams or intolerance to clavulanate Enrollment in other clinical trials Patients who refuse to take part in this study
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-80.0, Prostatic Hyperplasia Adrenergic Alpha-Antagonists Age between 50 and 80 years old Clinically diagnosed to have BPH Suffered from lower urinary tract symptoms with IPSS>=8 Detectable prostatic enlargement determined by DRE Urinary flow between 5 and 15ml/second in a total void volume >=150mL Serum PSA level less than 4ng/ml or in between 4-10 ng/ml with percent free PSA >25% or>=4 with cancer excluded by biopsy Acute retention of urine Congestive heart failure, unstable angina, arrhythmia, myocardial infraction Prostatic surgery Prostatic malignancy Gastrointestinal disease Renal impairment with serum creatinine >140 umol/l Hepatic disorder
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-80.0, Asthma COPD Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects between 18 years. 2. Any severity of exacerbation of obstructive airway disease attending the outpatient clinic. 3. History of at least two exacerbations in the past 12 months prior to recruitment that required a course of prednisone or antibiotic or long acting bronchodilator or inhaled corticosteroid, in addition to the daily maintenance therapy. 4. Signed written informed consent to participate in the protocol and ability to return to the outpatient clinic for repeated clinic visits If the exacerbation is severe enough to warrant hospitalization. 2. Active malignancy. 3. Significant gastrointestinal, hematological, cardiovascular or cerebrovascular disorder that would affect compliance with follow up visits. 4. Recent (within the past 2 months) or planned (within the study period) lung surgery. 5. Psychosis, alcoholism, active substance abuse or any personality disorder that would make compliance with the follow up visits problematic. 6. Pregnant or nursing females, as this could affect the compliance during the trial. 7. Any other medical or social condition, which in the opinion of the investigator could confound the interpretation of the data derived from this study
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 21.0-60.0, Alcoholism Alcohol-Dependent Subjects: Male, 21-60 yrs, DSM-IV diagnosis of alcohol dependence, 4-6 weeks abstinence; Alcohol intake of at least 80 grams of absolute alcohol (approximately one six-pack of beer or one-half pint of 100% proof distilled spirits) on a daily basis for at least two weeks prior to the cessation of drinking. Years drinking: at least 5 yr history of active alcohol dependence; Lifetime drug of choice is alcohol; requesting treatment in long-term residential program. Healthy Controls: Thirty men age-matched (plus or minus 5 years) with the patients will be studied. Previous studies have typically used the presence or absence of trauma to define trauma groups. However, these studies have focused on specific types of trauma (i.e. childhood, combat) rather than trauma as a cumulative experience. It is unlikely that we will be able to find subjects who have never experienced any trauma, including the death of loved ones, parental separation, natural disaster, crime, etc. Therefore, we will initially recruit controls without regard to trauma level. Following the recruitment of the first ten subjects, trauma scores will be reviewed. If our control group endorses low levels of trauma, we will direct further recruitment towards a group with at least one self-report of significant lifetime trauma such that at 50 percent of the control population has a least one significant lifetime traumatic event. Only English-speaking subjects will be included. Several of the study questionnaires are only available in English. In addition, these studies are exploratory and require the induction of anxiety. The investigators at TSMC believe it prudent to assure that all subjects are able to communicate easily with all staff during the fMRI and stress induction. Subjects will be recruited from subjects requesting treatment for alcohol dependence at the Dallas VA but no subjects will be seen at NIH Alcohol-Dependent Subjects Primary psychoactive dependence disorder other than alcohol, except nicotine and caffeine Active diagnosis of Axis I Schizophrenia, Mood, or Anxiety Disorders (except PTSD) Use of medications known to significantly affect HPA axis functioning or neural activity, including all psychotropics with the previous two weeks (or four weeks for fluoxetine) Use of medications known to significantly affect HPA axis functioning or neural activity, including all psychotropics with the previous two weeks (or four weeks for fluoxetine). Patients concomitantly using anxiolytics, antidepressants, opioids, lithium, anticonvulsants, sedative/hypnotics, buspirone, beta blockers, alpha adrenergic drugs, steroids, beta agonists, clonidine, dopamine agonists, naltrexone, acamprosate, or disulfiram will be excluded from the study Any medical conditions that might affect HPA axis functioning or possibly endanger the patient's health or behavioral stability. Medical conditions that might limit cooperation (e.g. dementia) or put the patient at medical risk (i.e. significant hematologic, hepatic, renal, or cardiovascular pathology) will be excluded. Patients with past or present neurologic disorders (i.e. head trauma with loss of consciousness requiring hospitalization, transient ischemic attacks, stroke, tumor, etc.) will be excluded. Healthy Controls Lifetime history of DSM IV Substance Use Disorder (except Nicotine or Caffeine Dependence) or other Axis I disorder One first-degree family member with a substance use disorder (other than nicotine) Medical, psychiatric, and medication exclusions will be the same as those described for the alcohol dependent patients
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Shortness of Breath Heart Failure Eighteen years of age or older The patients must be seen in the urgent care or emergency area with a chief complaint of shortness of breath not due to trauma Patient is unable to sign or understand the consent form Patient is on any dialysis Patient has trauma related shortness of breath (i.e. penetrating wounds, crush injury)
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Participating in the COPD Network Macrolide study Clinical diagnosis of at least moderate COPD Cigarette consumption of 10 pack years or more Diagnosis of asthma Predicted life expectancy of less than 3 years History of hypersensitivity to macrolide antibiotics Long-term kidney insufficiency Long-term liver insufficiency Prolonged QT interval Use of medications that may prolong the QT interval
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-75.0, Pulmonary Disease, Chronic Obstructive Male adults or female adults of non-childbearing potential who are between 40 and 75 years of age (inclusive) Subjects with a clinical diagnosis of COPD in accordance with the European Respiratory Society Consensus Statement and subjects categorised with moderate COPD as defined by the GOLD guidelines of 2006 [GOLD, 2006] Subjects with a cigarette smoking history of ≥ 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or the equivalent). Both current and former smokers are eligible to be enrolled. A former smoker is defined as a subject who has not smoked for ≥6 months at Visit 1 Subjects with a post-bronchodilator FEV1 to FVC ratio (FEV1/FVC) < 0.7 at Visit 1. Subjects will be assessed 30 (± 5) minutes after receiving salbutamol 400 μg Subjects with a post-bronchodilator FEV1 ≥ 50% and < 80% of predicted normal for height, age and sex at Visit 1. Subjects will be assessed 30 (± 5) minutes after receiving salbutamol 400 μg Subjects with a normal echocardiogram at screening, as defined by the absence of clinically significant wall motion, chamber size or valvular abnormalities The subject must be capable of giving informed consent and can comply with the study requirements and timetable Women who are pre-menopausal and of child-bearing potential Subjects weighing less than 50 kilograms (kg) Subjects who are obese defined as having a body mass index (BMI) > 30 Subjects with a current diagnosis of asthma Subjects who have required hospitalisation or treatment with oral corticosteroids and/or antibiotic therapy for acute worsening of COPD or lower respiratory tract infection in the 6 weeks prior to Screening Subjects who have received treatment with oral, intravenous, topical or intra-articular corticosteroids within 6 weeks of Screening or thereafter Subjects with active tuberculosis, sarcoidosis or clinically overt bronchiectasis Subjects with a history of any type of malignancy with the exception of successfully treated squamous cell cancer of the skin Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease) Subjects with chronic infections (lasting longer than 6 months) such as gingivitis, periodontitis, prostatitis, gastritis, and urinary tract infections
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease • Male subjects with COPD with FEV1/FVC<70%; predicted defined as either stage moderate GOLD II (n=15) and severe GOLD III (n=7) diagnosis according to GOLD (Global Strategy for the Diagnosis, Management, and Prevention of COPD) or Male subjects who are age-matched non-smokers (n=8) and male smokers (n=8) with normal lung function (FEV1>80%, FEV1/FVC>70%, n=8) Smokers: An active smoker with a pack history of >10 pack years [number of pack years = (number of cigarettes per day / 20) x number of years smoked]. Smokers need to report the time when last cigarette was smoked (no less than 6 hours before the study visit) Patients will be allowed to use their current anticholinergic bronchodilators and continue on the dose of inhaled corticosteroids they are currently using. However they should refrain from short and long-acting β2-agonists for 6 and 12 hours, respectively, before the study visit Aged 40 80 years inclusive Body mass index within the range 19-32kg/m2 inclusive FEV1 <15% reversibility (not % predicted) and an increase of <200ml after inhaled β2-agonists (400μg salbutamol) Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form Subject is available to complete the study • As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study The subject has participated in a study with a new molecular entity during the previous 3 months or any other clinical trial during the previous 3 months. In case of a non invasive, clinical trial not involving new molecular entities a 2 week washout will be sufficient The subject regularly, or on average, drinks more than 21 units of alcohol per week The subject has received oral steroids within 2 weeks prior to study entry The subject has history of an upper respiratory infection (including sinusitis) within 2 weeks prior to study entry The subject has been hospitalised for a COPD exacerbation within 1 month of study entry
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-80.0, Asthma COPD For all patients: 1. The patient understands the study procedures and agrees to participate by signing the consent form. 2. The patient is male or female, at least 18 years of age but no more than 80 years of age at the entry into the study (screening visit). For patients with asthma (groups 1 and 2) 1. The patient has a history of intermittent or persistent symptoms of wheezing, breathlessness, chest tightness and cough. The diagnosis of asthma must have been confirmed by a specialist in pulmonary medicine. 2. The patient fulfils one or several of the following for reversible airway obstruction, as documented during the last 5 years before the study or at screening visit: 1. An increase in FEV1 more than 9% of predicted (or improvement by 200 mL) after administration of 4 puffs of 100 microg salbutamol dose-aerosol inhaler via a spacer, or after additional inhalation of four puffs of 20 microg ipratropium bromide (Atrovent) administered through a large volume spacer. 2. A mean diurnal variation in Peak Expiratory Flow (PEF) of more than 15% on more than 4 days/week for at least 2 weeks, as calculated by the following equation: (highest PEF-lowest PEF)/mean PEF 3. An increase in FEV1 of at least 400 mL after a course of prednisolone 0.5mg/kg/day for 14 days. 4. In patients with a FEV1 more than 70% predicted, demonstrated bronchial hyperresponsiveness to histamine, methacholine, isocapnic hyperventilation, exercise or other indirect challenges (according to established local methods). 3. The patient is a non-smoker or has a total smoking history of less than 5 pack years. In the case the patient is smoking, it must be less than 10 cigarettes a day and the asthma must have started before smoking. Specific for patients with mild to moderate asthma (group 1) 1. The patient has stable disease with minimal symptoms, no exacerbations or hospitalisations during the last year. 2. The patient uses inhaled steroids regularly, but not more than 800 microg/day budesonide or beclomethasone, or up to 500 microg/day fluticasone. 3. The patient uses prescribed short-acting beta agonists as needed. 4. The patient does not require treatment with long-acting beta-agonists. Specific for patients with severe asthma (group 2) 1. The patient has been under specialist treatment for at least one year. 2. The patient requires continuous treatment with high doses of inhaled steroids. If the patient does not take oral steroids, the inhaled dose of steroids must be more than 1600 microg/day budesonide or beclomethasone, or more than 800 microg/day fluticasone or equivalent. In case the patient does take oral steroids, the inhaled dose of steroids must be more than 800 microg/day budesonide or beclomethasone, or more than 400 microg/day fluticasone or equivalent. 3. The patient requires continuous treatment with long acting inhaled beta-agonists or oral theophylline, as documented for at least one year. 4. The patient experienced at least one asthma exacerbation during the previous year. Specific for patients with COPD (group 3) 1. The diagnosis of COPD must have been made by a specialist in pulmonary medicine. The patient may or may not have chronic symptoms (cough, sputum production, dyspnoea). 2. The patient has a FEV1/Forced Vital Capacity (FVC) ratio of less than 70%. 3. The patient's post bronchodilator FEV1 value is more than 30% but less than 80% of predicted. 4. The patient has a smoking history of more than 15 pack years, either as current or ex-smoker. 5. The patient displays a negative reversibility test to inhaled bronchodilators as defined by an increase in FEV1 of less than 9% of predicted (or an improvement by less than 200 mL) after administration of 4 puffs of 100 microg salbutamol dose-aerosol inhaler via a spacer, and four puffs of 20 microg ipratropium bromide (Atrovent) administered through a large volume spacer. 6. The patient has no history of asthma. 7. The patient has no current allergy, as shown by a negative skin-prick test. 8. The patient has used inhaled steroids in the range 800-1600 microg/day (budesonide or equivalent) for at least 3 months prior to the study General exclusions 1. The patient is pregnant. 2. The patient has a recent history of incapacitating psychotic disorders. 3. The patient is a current or recent past abuser of alcohol or illicit drugs. 4. The patient has a history of malignancy, is known to be positive for HIV, or other states that are considered to interfere with study conduct or scientific interpretations. 5. The patient cannot read or comprehend written material, or is in the opinion of the investigator, for other reasons unlikely to understand and follow the study procedures. 6. The patient is mentally or legally incapacitated preventing informed consent from being obtained. Exclusions because of pulmonary disorders 1. The patient is unable to perform acceptable spirometry, peak flow measurements and/or complete diary cards in a satisfactory way during the period between visit 1 and visit 3B (optimisation period and prednisolone/placebo trial). If the patient is unable to use the electronic Peak Flow meters/Diary cards, it is acceptable to use an ordinary mechanical meter (e.g. Mini-Wright) together with a paper version of the diary card. Patients that are unable to use the mechanical meter and paper diary card during the period between visit 1 and 3B cannot enter the follow-up year. 2. The patient has, in addition to asthma or COPD, any other pulmonary disorder that according to the investigator would interfere with the study procedures or scientific evaluation (e.g. tuberculosis). 3. The patient suffers from chronic hypercapnic respiratory failure as indicated by an elevated pCO2 (>47 mm Hg or 6,25 kPa). In case of doubt this should be confirmed with pulse oximetry or blood gas sampling. Exclusions because of medications 1. The patient has received immunosuppressants other than corticosteroids (i.e., methotrexate, gold, troleandomycin, cyclosporin or any other experimental anti-inflammatory drug) within three months of study entry. 2. The patient is currently undergoing immunotherapy. 3. The patient receives chronic oxygen therapy. Specific criterion for patients with asthma (groups 1 & 2) 1. The patient has smoked more than five (5) pack years. Specific criterion for patients with mild asthma (group 1) 1. The patient requires treatment with long-acting beta-agonists. Specific for patients with severe asthma (group 2) 1. The patient is not treated with high doses of inhaled steroids (see above). 2. The patient has not had an exacerbation of asthma during the last year. 3. The patient does not require treatment with long-acting beta-agonists or theophylline as documented during one year. Specific criterion for patients with COPD (group 3) 1. The patient has a history of asthma confirmed by a specialist in pulmonary medicine. Specific for bronchoscopy (all groups) 1. The patient has had a severe exacerbation of asthma requiring high doses of oral steroids during the last three (3) months. 2. The patient has had a severe exacerbation of COPD requiring intensive outpatient treatment or hospitalisation during the last three (3) months. 3. The patient has had three or more severe exacerbations of asthma or COPD during the last year. 4. The patient displays more than 10% fall in FEV1 at 2 minutes after inhalation of 0.9% saline (during induction of sputum at visit 2). 5. The patient has shown signs of uncontrolled disease during the last three days, e.g. the patient has required more than four puffs/day of rescue medication above baseline use during the last three days. (In the case 1-4 are not met, such patients may be rescheduled for bronchoscopy in two weeks time. The start of the oral prednisolone intervention will then be postponed by the number of days passing before the bronchoscopy). 6. If a patient who otherwise has qualified for bronchoscopy has received more than 6 mg per kg BW of lidocaine during the preparation for the procedure, the bronchoscopy must be terminated and cannot be continued the same day. 7. Patients who have experienced severe bronchoconstriction or other adverse reactions at previous attempts to perform bronchoscopy. 8. The patient has a post-bronchodilator FEV1 < 40% predicted. 9. Do not start or proceed bronchoscopy if Transcutaneous oxygen saturation by pulse-oximeter < 90% (despite giving oxygen by nasal cannula when saturation is < 94%) Heart frequency > 130 Heart rhythm disturbances. Specific for induced sputum (all groups) 1. A post-bronchodilator (after administration of 4 puffs of 100 microg salbutamol dose-aerosol inhaler via a spacer) FEV1 percent of predicted being less than 60%, or in absolute values less than 1.0 L. 2. A peak flow variability of more than 30% during the previous four days. 3. Patients who display more than a 15% fall in FEV1 at 2 minutes after inhalation of saline (0.9% NaCl) during induction of sputum.. 4. Patients who have experienced severe bronchoconstriction or other adverse reactions at previous attempts to induce sputum
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 41.0-999.0, COPD Stable mild COPD FEV1/FVC<0.7 and FEV1>60% predicted Activity-related dyspnea (i.e., Baseline Dyspnea Index focal score <9, MRC dyspnea scale >2) Cigarette smoking history ≥20 pack-years Presence of a significant disease other than COPD that could contribute to dyspnea and exercise limitation Important contraindications to clinical exercise testing Use of daytime oxygen History of Asthma
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 20.0-85.0, COPD Clinical diagnosis of copd Current non-smoker Not on oral corticosteroids Must be able to use Advair discus or salmeterol discus Pregnancy Current smoker On corticosteroids Clinically unstable
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-85.0, COPD Emphysema moderate to severe copd unable to tolerate tiotropium unable to perform metronome paced hyperventilation induced dynamic hyperinflation
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-70.0, COPD Age 45-70 yrs of age, incl, women as described above as far as child-bearing potential and subjects who if they have coexisting disease, the disease is stable and does not place an untoward risk or result in compromise of data Non smokers will be lifelong and have not worked in a chronic dusty environment Smokers will require a minimum of 10 pkyr history and currently smoking at least a pack per day. The smokers without symptoms of COPD must demonstrate a pulmonary function with an FEV1 > 80%. The FEV1/FVC ratio may be less than .7 however they can not demonstrate symptoms of chronic bronchitis by medical history. Smokers with symptoms must demonstrate an FEV1 < 80% and FEV1/FVC <.7 Any female subject who is pregnant or breast-feeding or a female subject who is of child-bearing potential who is unwilling to sue two acceptable methods of birth control Any condition that would place the subject at risk for endobronchial brushings(such as bleeding diathesis) or subjects who are currently taking anticoagulants Any subject who has had an exacerbation of COPD within the last six months of screening or who has been hospitalized for any reason within the last three months Illicit substances indicated by positive urine drug screen
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-82.0, Cancer of the Esophagus years of age or older Histologically or cytologically documented squamous cell carcinoma or Siewert's classification adenocarcinoma of the esophagus or proximal stomach T1-4, N0-2, M0-1, for which bimodality treatment with chemotherapy and radiation therapy is indicated Measurable Disease ECOG Performance Status 0-1 Laboratory values must be as follows Absolute neutrophil count > or = 2,000/mm3 Platelets > or = 100,000/mm3 Hemoglobin > 9.0 Total bilirubin <1.5 x institutional upper normal limit Serum creatinine <1.5 x institutional upper normal limit Tumors extending above the level of the thoracic inlet or beyond 5 cm below the gastroesophageal junction Patients with radiographic or bronchoscopic evidence of esophageal perforation Patients with known evidence of brain metastases, lymphangitic lung metastases, or carcinomatous meningitis Dementia or significantly altered mental status Major surgery within 4 weeks of the start of study treatment Prior chemotherapy, radiation therapy, hormonal or biologic therapy within the past 6 months Subjects requiring chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine, corticosteroids) Currently requiring medications that may interact with the metabolism or disposition of capecitabine/5-FU: dipyridamole, folinic acid, allopurinol, trimethoprim, misonidazole, metoclopramide, flucytosine or cimetidine Hypersensitivity to platinum containing compounds or capecitabine or any of the excipients of this product. Prior unanticipated severe reaction to fluoropyrimidine/platinum therapy, or known sensitivity to 5-fluorouracil/platinum containing compounds Serious, uncontrolled, concurrent infection(s)
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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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
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-999.0, Urological To be eligible for the study, potential participants must meet all of the following 1. Male at least 45 years of age. 2. Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml. 3. AUA symptom score ≥ 8 and ≤ 24 at both screening visits. 4. Voluntarily signed informed consent agreement prior to the performance of any study procedures Potential participants that meet any of the following will be excluded from the full-scale trial: 1. Any prior invasive intervention for BPH. 2. Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months. 3. Alpha blocker within one month. 4. Reported allergic reaction to Serenoa repens. 5. Taken phenylephrine, pseudoephedrine, tricyclic antidepressants, and anticholinergic or cholinergic medication within 4 weeks of the first screening visit, with the following exception: topical anticholinergic eye drops used for glaucoma. 6. Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 6 months. 7. Known clinically significant renal impairment (i.e., creatinine greater than 2.0 mg/dl). 8. Alanine aminotransferase(ALT)serum glutamic pyruvic transaminase(SGPT), aspartate aminotransferase(AST)serum glutamic oxaloacetic transaminase (SGOT) or gamma-glutamyltranspeptidase (GGT) value greater than 3 times the upper limit of normal in the clinical center lab at SV1.0; confirmed on a second measurement. 9. Prothrombin time greater than 3 seconds above the upper limit of normal, or more than 3 seconds above the control value in the clinical center at SV1.0; confirmed on a second measurement. 10. Electrocardiogram (ECG) reading at the clinical center at SV1.0 suggesting active ischemia or recent myocardial infarction until appropriate consultation confirms the absence of an acute coronary syndrome. 11. Prostate-specific antigen (PSA) level greater than 10 ng/ml at the first screening visit. 12. Requires the daily use of a pad or device for incontinence, or International Continence Society male incontinence symptom (ICSmaleIS) score >14 at screening. 13. Unstable medical condition within the past 3 months. 14. History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, or prior surgery for bladder neck obstruction. 15. Active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within one month prior to the first screening visit or has an imminent need for urologic surgery. 16. Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function. 17. Documented bacterial prostatitis within the past year. 18. Two documented independent urinary tract infections of any type in the past year. 19. Known severe bleeding disorder or need for ongoing therapeutic anticoagulation with coumadin or heparin. 20. Cancer, which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization. A history of bladder cancer or prostate cancer is exclusionary whether the participant is considered cured or not. 21. Unable to follow protocol directions due to organic brain or psychiatric disease. 22. History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol. 23. Any serious medical condition likely to impede successful completion of the study
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-80.0, Pulmonary Disease, Chronic Obstructive Emphysema Bronchitis, Chronic At least 10 pack-years of cigarette smoking (although a of nonsmoking controls is also being enrolled) Self-designation of non-Hispanic white or African-American Other lung diseases (except for asthma in participants with COPD) Pregnant Cancer (other than skin cancer) in the 5 years prior to study entry Received antibiotics for a COPD exacerbation in the 1 month prior to study entry First or second-degree relative of a previously enrolled study participant
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Clinical diagnosis of COPD, with symptoms for more than 1 year Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year) Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator Clinical suspicion of active tuberculosis Any current clinically significant respiratory tract disorder other than COPD History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Subjects eligible for enrollment in the study must meet all of the following Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation Males or females ≥ 40 years of age. A female is eligible to participate in this study if she is of: 1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal [i.e., >1 year without menses in the absence of hormone replacement therapy]); or, 2. child-bearing potential, has a negative pregnancy test (urine) at screen, and one of the following applies Abstinence from intercourse, or Male partner was sterile prior to the female subject's entry into the study, or Use of implants of levonorgestrel; or Injectable progesterone; or Oral contraceptive (combined or progesterone only), contraceptive patch, vaginal ring; or Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (e.g., Paragard), or Double barrier technique simultaneously using two of the following: spermicide, male condom, diaphragm, or female condom Subjects meeting any of the following must not be enrolled in the study A current diagnosis of asthma Any clinically significant and uncontrolled disease, including but not limited to the following: neurological, psychiatric, renal, immunological, endocrine/metabolic (including uncontrolled diabetes, hypokalemia or thyroid disease), cardiovascular, neuromuscular, hepatic, gastric, or hematological abnormalities, or peripheral vascular disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would affect the efficacy analysis if the disease/condition exacerbated during the study A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis), including subjects with a diagnosis of alpha-1-antitrypsin deficiency. Allergic rhinitis is not exclusionary An abnormal and clinically significant chest x-ray or computed tomography (CT) scan not believed to be due to the presence of COPD. A chest x-ray must be taken if the subject has not had one within 6 months of Visit 1 An abnormal and clinically significant 12-lead electrocardiogram (ECG). For the purposes of this study, an abnormal ECG is defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following Myocardial ischemia Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome) Clinically significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia) The study investigator will determine the clinical significance of any ECG abnormality and determine if a subject is precluded from entering the study Previously diagnosed cancer unless it is in complete clinical remission (no evidence of any tumor burden) at Visit 1. Localized carcinomas of the skin that have been resected for cure are not considered exclusionary
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Moderate Chronic Obstructive Pulmonary Disease Asthma Asthma Physician diagnosis of asthma with history of any or all of the following: recurrent wheezing, recurrent chest tightness, recurrent difficulty breathing, or cough, particularly worse at nighttime Never smoked or former smokers (= 6 months since cessation) ≥18 years of age Prebronchodilator Forced Expiratory Volume in 1sec (FEV1) ≥ 60% Third National Health and Nutrition Examination Survey (NHANES III) predicted, prebronchodilator total lung capacity (TLC) ≥ 80% predicted Intermountain Thoracic Society (ITS), and prebronchodilator single breath carbon monoxide diffusing capacity of the lung (DLco) (unc) ≥70% predicted (Miller) < 30% day-to-day variability in daily morning Peak expiratory Volume (PEF) during the 2-week run-in period Significant improvement in pre to postbronchodilator spirometry (defined as an increase from baseline of ≥ 12% and ≥ 200 mL in FEV1 or Forced Vital Capacity [FVC]) at Screening/Visit 1 or documented significant improvement in pre to postbronchodilator spirometry (as defined above) within past 12 months in subject's medical records or a documented positive methacholine challenge test within the past 12 months COPD Physician diagnosis of COPD (including emphysema and/or chronic bronchitis), history of dyspnea and/or intermittent or daily chronic cough with or without sputum production, not attributable to any other known cause History of pulmonary exacerbation within 8 weeks of screening/V1 or between V1 and V2 Use of systemic corticosteroids or antibiotics for respiratory illness within 8 weeks of screening/V1 OR between V1 and V2 Increase from baseline in the use of short-acting bronchodilator or short-acting anticholinergic agents, or the combination of the 2, by ≥6 puffs or ≥3 nebulizer treatments per day for ≥ 2 days Treatment with supplemental oxygen therapy, room air oxygen saturation, 94% or history of intubation or ICU admission for respiratory illness in the past 5 yrs Greater than 2 hospitalizations or ER or urgent care visits or required >3 courses of systemic steroid in the past 12 months for respiratory illness Use of Symlin® (pramlintide acetate) within the preceding 90 days Two or more severe hypoglycemic episodes within 6 months of screening or episode of severe hypoglycemia between Screening and Baseline Previous exposure to any inhaled insulin product Currently using an insulin delivery pump Requires significant change (define as initiation of a new medication or change in the dose or frequency of the controller medications) in the asthma or COPD therapeutic regimen within 8 weeks of Screening/Visit 1 (Week -4) or between Visit 1 and Baseline/Visit 2
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Men with symptomatic BPH requiring treatment IPSS score > 15 Age > 50 years Prostate size of 25 g or greater Prostatic urethra length between 2.0 cm and 5.5 cm Ability to understand and consent to participate in this investigation Willingness and ability to participate in all required follow-up evaluations Allergy towards Silicone Peak Urinary Flow > 15 mL/s Penile or urinary sphincter implant Patients with active urinary tract infection indicated by a positive urinary culture >105 CFU (Note: These patients may be treated after successful treatment of the infection.) Clinical (historical), paraclinical (i.e. PSA> 10ng/mL) or histological evidence of prostatic cancer or bladder cancer Evidence of a non-symmetric prostatic median lobe enlargement, or a prostatic lobe which is prominent with an obstructing "ball valve", as determined by cystoscopy or ultrasound Patients with any previous prostate surgery, procedure for BPH, or any other invasive treatment to the prostate (such as TUR-P) Previous rectal surgery (Exception: hemorrhoid surgery), radical pelvic surgery or pelvic irradiation Patients with confirmed or suspected bladder cancer Patients with a history of cystolithiasis or bladder pathology, or who have experienced relapsing bacterial prostatitis within the last 6 months
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Benign Prostatic Hypertrophy Benign Prostatic Hyperplasia, based on medical history Voiding symptoms Urgent need for prostate surgery or prior surgical treatment of the prostate or bladder Major organ dysfunction Eczema (atopic dermatitis) treated during the last 6 months Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior randomization or with α blockers or saw palmetto within the last 6 weeks prior to randomization Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Benign Prostatic Hypertrophy Benign Prostatic Hyperplasia, based on medical history Voiding symptoms Uroflow (max) 5-15mL/sec Urgent need for prostate surgery History of allergic reaction to peptide Major organ dysfunction Prior surgical treatment of the prostate or bladder Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to trial medication at Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial medication at Week 0 Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive A signed and dated written informed consent prior to study participation Male or female adults. A female is eligible to enter and participate in this study if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post-menopausal; or child-bearing potential, has a negative pregnancy test at Visit 1/Visit 1A, and agrees to one of the protocol-specified acceptable contraceptive methods used consistently and correctly (i.e. according to the approved product label and the instructions of the physician for the duration of the study - Screening through follow-up contact) to 80 years of age at Visit 1 An established clinical history of COPD Current or previous cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years 1 A post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 and a post-albuterol/salbutamol FEV1 of ≥35 and ≤70% of predicted normal values Subjects meeting any of the following must not be enrolled in the study Women who are pregnant or lactating A current diagnosis of asthma Known respiratory disorders other than COPD including but not limited to α-1 antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease Any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy) Clinically significant Chest X-ray or computed tomography (CT) scan abnormalities within 6 months prior to Visit 1 that are not believed to be due to COPD Use of oral corticosteroids or antibiotics for COPD within 6 weeks prior to Visit 1 Hospitalization for COPD or pneumonia within 3 months prior to Visit 1 Use of antibiotics for a lower respiratory tract infection within 30 days prior to Visit 1 Clinically significant and uncontrolled cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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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
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive Moderate to severe COPD Smoking history of greater or equal to 10 pack-years Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive Postbronchodilator FEV1/FVC ratio < 0.70 History or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm Hospitalization for an acute COPD exacerbation in the 3 months prior to study entry Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry Eosinophil count of at least 600 cells/mm3 Long term oxygen therapy > 15 hours a day
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive Subjects eligible for enrollment in the study must meet all of the following 1. Informed consent: Subjects must give their signed written informed consent to participate. 2. Gender: Male subjects or female subjects of non-child bearing potential (e.g. post-menopausal or surgical sterile) 40 years of age at screening (Visit 1) Post-menopausal females are defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However if indicated this can be confirmed by estradiol and FSH levels consistent with menopause (according to laboratory ranges) at screening (Visit 1) Surgically sterile females are defined as those with a documented (medical report verification) hysterectomy and/or bilateral oophorectomy or Tubal Ligation Furthermore, male subjects in this study must use double-barrier (condom/spermicide) birth control methods or abstain from sexual intercourse with female partners who are pregnant, lactating, or able to bear children in addition to any birth control methods the female partner is using, from the first dose of the study medication until 90 days after the last dose of the study medication. 3. COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004] : COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences. 4. Tobacco use: subjects with a current or previous history of ≥ 10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. • Number of pack years = (number of cigarette per day/20)) x number of years smoked 5. Severity of Disease: subjects who conform to the current severity classification for Stage II/III disease in terms of post-bronchodilator spirometry at Screening Visit 1 Subject with a measured post-salbutamol FEV1/FVC ratio of ≤0.70 Subjects with a measured post-salbutamol FEV1 ≥ 40 % and ≤ 80 % of predicted normal values calculated using III reference equations Subjects meeting any of the following must not be enrolled in the study: 1. Pregnancy: Women who are pregnant or lactating 2. Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if COPD is the current diagnosis) 3. α1 antitrypsin deficiency: Subjects with α-1 antitrypsin deficiency as the underlying cause of COPD 4. Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases 5. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening 6. Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Screening if a chest X-ray or CT scan is not available within 6 months prior to Screening 7. Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of any of the following in the 6 weeks prior to Screening Acute worsening of COPD that is managed by subject with corticosteroids or antibiotics, or Acute worsening of COPD that requires treatment prescribed by a physician Subjects who are hospitalized due to poorly controlled COPD within 12 weeks of the Screening Visit 8. Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1 9. 12-lead ECG (Electrocardiogram): An abnormal and clinically significant 12-lead ECG that results in an active medical problem. For this study, an abnormal ECG is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following Clinically significant conduction abnormalities (e.g. left bundle branch block, Wolff-Parkinson-White syndrome) Clinically significant arrhythmias (e.g. atrial fibrillation, ventricular tachycardia) The independent cardiologist, contracted by GSK, will determine the clinical significance of any ECG abnormalities and determine if a subject is precluded from entering the study. However, the following predetermined ECG abnormalities are considered clinically significant and will result in of a subject Ventricular rate < 45 bpm PR interval > 240 msec Evidence of Second-Degree (Mobitz type II) or Third-Degree atrioventricular (AV) block Pathological Q waves
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 8.0-18.0, Chronic Illness children of mentally ill parents (chronic illness) children of somatically ill parents (chronic illness) children of drug addicted parents
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, SIRS Sepsis Shock Critically Ill Multiple Organ Dysfunction Syndrome Critically ill, postoperative/posttraumatic patients with severe systemic inflammatory response syndrome (SIRS) or severe sepsis Life expectancy < 24 hours Participation in other trials Known or suspected pregnancy Contraindications for transesophageal echocardiography (TEE): severe disease of the esophagus (hernia, strictures, esophageal resection, severe bleeding disorders)
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia (BPH) (All must be answered yes): 1. Has the patient given written informed consent? 2. Is the patient at least 50 years old? 3. Is the patient diagnosed with BPH and has he had clinical signs and symptoms of BPH for ≥ 6 months? 4. Does the patient have an IPSS ≥ 13? 5. Does the patient have a peak urinary flow rate (Qmax) of 4-15 mL/sec (utilizing the 2-second rule) established on a voided volume of at least 125 mL? 6. Does the patient have an IPSS QoL score of ≥ 3? 7. Does the patient have a PSA > 0.8 ng/mL? 8. For patients with a PSA between 4 and 10 ng/mL or suspicion of prostate cancer, has the patient had a diagnostic evaluation (e.g., biopsy, PSA, velocity, etc.) that reasonably excludes the diagnosis of prostate cancer? 9. Is the patient willing to agree not to use any other approved or experimental pharmacologic BPH treatments including but not limited to alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during the study? 10. Is the patient willing to restrict use of PDE 5 inhibitors exclusively to the use of Viagra, one dose per week only and with no dosing in the 5 days immediately preceding scheduled study visit? 11. Is the patient willing and able to abide by the protocol? 12. Does the patient have an IPSS ≥ 13? 13. Does the patient have an IPSS QoL score of ≥ 3? 14. Does the patient have a post-void residual ≤ 350cc? (all must be answered No): 1. Does the patient have a history of prostate cancer or a serum PSA >10 ng/mL? 2. Has the patient had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy? 3. Does the patient have a prevoid total bladder volume assessed by ultrasound > 550 mL? 4. Does the patient have a post void residual urine volume ≥ 350 mL by ultrasound? 5. Has the patient taken or is the patient currently taking any of the following: 1. Estrogens, phytoestrogens, androgens, antiandrogens or LHRH agonists within the past 4 months (e.g. testosterone gel [Androgel ®1%, Testim ® 1%], testosterone buccal [Striant®], oxymetholone [Anadrol®-50], oxandrolone [Oxandrin®], esterified estrogen and methyltestosterone [Estratest®]), bicalutamide [Casodex®], nilutamide [Nilandron®], flutamide [Eulexin®], leuprolide acetate [Lupron®, Eligard®, Viadur®], goserelin acetate [Zoladex®] or, 2. 5 α-reductase inhibitors within the past 4 months (e.g. finasteride[Proscar®, Propecia®], dutasteride [Avodart®]) or, 3. Alpha blockers or anti-cholinergic preparations within the past 6 weeks (e.g. doxazosin [Cardura®], terazosin [Hytrin®], tamsulosin [Flomax®], alfuzosin [Uroxatrol®], oxybutinin [Ditropan®], tolteredine [Detrol-LA®], amytriptyline [Elavil®, Limbitrol®]) or, 4. Class 1A (e.g. quinidine, procainamide, disopyramide) or Class III Anti-arrhythmic (e.g.sotalol [Betapace®], amiodarone [Cordarone®]) 6. Does the patient have or has the patient ever had a diagnosis of acute or chronic prostatitis or chronic pelvic pain syndrome? 7. Has the patient had a urinary tract infection or instrumentation (e.g catheterization, cystoscopy, prostate biopsy) within the past 4 weeks? 8. Does the patient have a history of urethral stricture, bladder stones, obstructing median lobe or neurogenic bladder dysfunction? 9. Does the patient have microscopic hematuria greater than trace by dipstick urine at Visit 1? 10. Did the patient have a positive drug screening result? 11. Does the patient have a history of urinary retention? 12. Does the patient have any serious medical condition (e.g., CHF, poorly controlled diabetes (HgbA1c > 9), psychiatric disorder, drug or alcohol abuse) that might interfere with his ability to comply with or complete the protocol? 13. Is the patient's QTc interval on the screening ECG > 450ms, or does he have a family history of long QT syndrome? 14. Does the patient anticipate or plan to have an elective surgery or surgical procedure requiring general, spinal or epidural anesthesia during the course of the double-blind treatment portion of the study(within the next 12 months)? 15. Has the patient ever received ozarelix, cetrorelix, tevarelix or degarelix? 16. Has the patient participated in any other study of an investigational drug or treatment for the signs and symptoms LUTS or BPH in the past 12 months? 17. Has the patient participated in any other clinical research study or study of an investigational drug in the past 90 days?
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive male and females 40 to 80 years of age (inclusive) COPD diagnosis Current or previous smokers with a cigarette smoking history of at least 10 pack- Post-albuterol FEV1/FVC of 0.70 or less Post-albuterol FEV1 of 35% to 80% (inclusive) Pregnant or lactating females current diagnosis of asthma respiratory disorders other than COPD clinically significant cardiovascular, neurological, psychiatric, renal, immunological, endocrine, or hematological abnormalities that are uncontrolled clinically significant sleep apnea previous lung resection surgery clinically significant abnormalities confirmed by chest x-ray that are not related to COPD hospitalization for COPD within 3 months of screening use of antibiotics for lower respiratory tract infection within 6 months of screening abnormal and clinically significant 12-lead ECG findings
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Diagnosis of COPD for 1 month Men or postmenopausal women Spirometry values indicating reduced lung function Smoking history equivalent to using 20 cigarettes a day for 10 years Any current respiratory tract disorders other than COPD Requirement for regular oxygen therapy Use of oral or parenteral glucocorticosteroids within 30 days prior to the study
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Diagnosis of COPD for 1 month Men or postmenopausal women Spirometry values indicating symptomatic patients Smoking history equivalent to using 20 cigarettes a day for 10 years Any current respiratory tract disorders other than COPD Requirement for regular oxygen therapy Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Pancreatic Cancer Pancreatic Adenocarcinoma Pathologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma, AJCC stage IV 2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as =/>20 mm with conventional techniques or as =/>10 mm with spiral CT scan. See Section 11 for the evaluation of measurable disease. Measurable disease must be present outside a previous radiation field or if inside, it must be a new lesion. 3. At least 6 months must have elapsed after completion of adjuvant therapy (if applicable). 4. Age =/>18 years. 5. ECOG Performance Status 0-1 (Karnofsky =/>60%). 6. Patients must have adequate organ and marrow function as defined below: 1) leukocytes =/>3,000 cells/mm^3; 2) absolute neutrophil count =/>1,500 cells/mm^3; 4) platelets =/>100,000 cells/mm^3; 5) total bilirubin <1.5mg/dl; 6) AST(SGOT)/ALT(SGPT) =/<2.5 X institutional upper limit of normal for patients without liver metastasis, =/< 5X institutional upper limit of normal for patients with liver metastasis; 7) creatinine within normal institutional limits OR creatinine clearance =/>60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal 7. Fasting blood glucose =/<160 mg/dl, prior to study enrollment. (For higher values, blood glucose may be controlled by dietary intervention, oral hypoglycemics and/ or insulin prior to enrollment). 8. Women of child-bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use adequate contraception for the duration of study participation. Acceptable contraception is defined as double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable contraception must be used for 90 days after last dose of study drugs. 9. (Continuation of # 8) Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 10. Ability to understand and the willingness to sign a written informed consent document. Signed informed consent form must be obtained prior to initiation of study evaluations and/or activities. 11. INR <1.5 (or =/<3 if on anticoagulation therapy) 12. Both men and women and members of all races and ethnic groups are eligible for this trial. 13. In phase II expansion cohort, which is primarily for predictive biomarker correlation, patients enrolled will be those with pre-existing core biopsies of primary tumor or metastatic site or must be willing to undergo a biopsy for correlative studies Prior systemic chemotherapy or biological therapy for metastatic disease 2. Prior exposure to IGF-1R inhibitors. 3. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 6. Pregnant or nursing women are excluded from this study because there is an unknown but potential risk for adverse events in infants secondary to treatment of the mother the study agents. If a pregnancy test (serum or urine) is positive, patient will be excluded. 7. Patients who are known to be HIV-positive are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. 8. No other prior malignancy is allowed except for the following: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for two years. 9. Patients must not be currently enrolled in a therapeutic study for pancreatic cancer
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Healthy Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is she willing .to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the stndy? Is s/he considered .reliable and capable of understanding his/her responsibility and role in the study Has s/he provided written informed consent? A no answer to any of the above questions indicated that the individual was ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to amlodipine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety'? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant h/story (within the past year) or clinical evidence of alcohol or drug abuse? • Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7rday period preceding study initiation? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation? Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)?
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-64.0, Healthy Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is she willing .to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the stndy? Is s/he considered .reliable and capable of understanding his/her responsibility and role in the study Has s/he provided written informed consent? A no answer to any of the above questions indicated that the individual was ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to amlodipine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety'? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant h/story (within the past year) or clinical evidence of alcohol or drug abuse? • Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7rday period preceding study initiation? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation? Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)?
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Obesity Must have completed all randomized treatment visits in the reduced calorie diet (RCD, Shionogi protocol 0701A2823) or low calorie diet (LCD, Shionogi protocol 0702A2824) study up to and including Visit 13 Medically stable throughout the controlled clinical trial treatment period and in otherwise good health, with no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs Clinical laboratory evaluations (including clinical chemistry [fasted at least 8 hours], complete blood count, urinalysis, including creatine phosphokinase, amylase, lipase, lipid profile, insulin and Homeostatic Model Assessment of Insulin Sensitivity Index within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator Males will be sterile or agree to continue to use an approved method of contraception. Some of the approved methods of contraception for males includes a surgically sterile (for at least 3 months prior to Visit 13/20) female sexual partner; a postmenopausal (for at least 1 year since last menstrual cycle) female sexual partner; a female sexual partner who uses (for at least previous 3 months prior to Visit 13/20 and during study) oral, implantable, transdermal, or injectable contraceptives; or use of the following double-barrier method: male condom with spermicide Females will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year since last menstrual period, surgically sterile for at least 3 months prior to Visit 13/20, or agree to use an approved method of contraception. Some of the approved methods of contraception for females includes a sterile (for at least 3 months prior to Visit 13/20) male sexual partner; use of oral, implantable, transdermal, or injectable contraceptives; or use of one of the following double-barrier methods: intrauterine device with spermicide, diaphragm with spermicide, cervical cap with spermicide, female condom with spermicide, or a male condom with spermicide by the male sexual partner Able to understand and willing to sign an informed consent form and comply with all study procedures History or clinical manifestations of significant metabolic, hepatic, immunological (e.g., human immunodeficiency virus/acquired immunodeficiency syndrome), renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), urological, neurological or psychiatric disorders Current abnormal ECG, which, in the Investigator's opinion, is clinically significant Current evidence of a psychological disorder, other than stable or controlled anxiety or depression including, but not limited to the schizophrenias. Treatment with an antidepressant or anxiolytic drug(s) will be permitted if the medication is not precluded / excluded by this protocol because of potential effects on body weight and is not expected to change during the remainder of this clinical protocol A score above 10 in either the Anxiety or Depression portions of the Hospital Anxiety and Depression Scale (HADS) at Visit 13/20. Subjects whose HADS score at Visit 13/20 exceeds 10 in either the Anxiety or Depression portions of the HADS will be allowed in the study only after they are examined and it is determined that the symptoms of anxiety and/or depression are not of a severity that is incompatible with further treatment with velneperit. Permission must also be obtained from the Sponsor or Sponsor's designated medical representative for subjects with scores above 10 on these HADS subscores Current obesity of endocrine origin Current Type 1 or Type 2 diabetes mellitus Current clinically significant hypertension, defined as blood pressure >160/90 mmHg for either the systolic or diastolic values in either the untreated or treated state Current or planned clinically significant GI surgery. Note: Appendectomy and cholecystectomy will be allowed Current or planned gastric bypass surgery, stomach banding surgery, or any other surgical procedure(s) that attempt to promote/aid weight loss. Note: Liposuction will be allowed if done more than 3 months prior to Study Visit 20 Current polycystic ovarian syndrome
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-80.0, Asthma Chronic Obstructive Pulmonary Disease Healthy All subjects/patients Willing and able to complete the requirements of this study including the signature of the written informed consent Able to complete the study in 5 working days or less Able to perform pulmonary function tests Healthy volunteers Never smoker or subject who stopped smoking at least 6 months before selection (strictly less than 10 pack-years) Having pulmonary function tests within the normal range(according to predicted values for age, sex and height as referenced in ATS/ERS 1993 standards) Patients with moderate/severe persistent asthma Documented clinical diagnosis of moderate or severe persistent asthma (according to GINA 2006 guidelines) Stable asthma in the 4 weeks prior to selection as evidenced by no change in asthma medication, no treatment for asthma in an emergency,acute care setting and no admission to hospital for acute asthma Patients with moderate / severe COPD Obese subject/patient having a Body Mass Index (BMI) > 35 Past or present respiratory disease including being free from the common cold and rhinitis for at least 4 weeks before selection except asthma for asthmatic patients and COPD for COPD patients Daily need for 12 hours or more of long term oxygen therapy Pregnant or lactating woman Lack of efficient contraception according to CPMP/ICH 286/95 note 31 Any contra-indication to perform pulmonary function tests or light cycling exercise Clinically significant or uncontrolled pathologic conditions which may interfere with the study procedures Drug abuse or psychic disorders resulting in an inability to fully understand the requirements of the study Legal status which prohibits informed consent Participation in any interventional clinical trial within 30 days prior to selection
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 15.0-70.0, Asthma Patient is male or female, at least 15 years of age and no more than 70 years Patient has mild persistent asthma (step 2) of the Guidelines for the Diagnosis and Management of Asthma issued by the National Heart, Lung, and Blood Institute of the National Institutes of Health as defined by a history of symptoms at least once a week but less than daily (step 2) (5) Current asthma treatment includes short-acting inhaled β-agonist alone as needed Patient fulfils all the following signs and symptoms of asthma History of symptoms including, but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production for at least 12 months A forced expiratory volume in one second (FEV1) of at least 80% of the predicted value (pre-bronchodilator) while withholding β-agonist for at least six hours Patient has a diagnosis of asthma as defined by 1) an increase in FEV1 or PEF of ≥12% (absolute value), 20 to 30 minutes after inhaled β-agonist administration, OR 2) a positive methacholine PC20 (provocative concentration causing a 20% fall in FEV1) of 8 mg/ml or lower which was performed within the previous 12 months, OR 3) a fall in FEV1 of at least 15% after an exercise challenge which was performed within the previous 12 months. β-agonist reversibility and the methacholine and exercise challenge tests may be satisfied within the previous 12 months if there is adequate source documentation Patients demonstrate symptoms requiring β-agonist use on ≥2 and ≤6 days of the week for the previous two weeks Patient is able to chew a tablet Patient is judged to be in good, stable physical and mental health (except for his/her asthma) based on the medical history, physical examination, and routine laboratory data, and appears able to successfully complete this trial none
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-50.0, Healthy Controls Healthy, non-allergic, non-asthmatic 18-50 year old males and females with a < 0.5 pack year history of tobacco use who have a negative allergy skin test, normal lung function, defined as (Knudsen 1976/1984 predicted set): 1. FVC of > 80 % of that predicted for gender, ethnicity, age and height 2. FEV1 of > 80 % of that predicted for gender, ethnicity, age and height 3. FEV1/FVC ratio of > 75% of that predicted for gender, ethnicity , age and height Oxygen saturation of > 94 % Normal blood pressure (Systolic between 150 Diastolic between 90-60 mm Hg) Symptom Score no greater than 6 (out of a possible 24) for total symptom score with a value no greater than 2 for any one score. No score may be greater than 2 Negative methacholine inhalation challenge On the day of a challenge, body temperature must be no greater than 37.8 degrees, measured orally A history of significant chronic illnesses (to diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension) Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids, lactose) Positive pregnancy test within 48 hours of the time of challenge Medications which may impact the results of the endotoxin challenge, interfere with any other medications potentially used in the study (to steroids, beta antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics) Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 2 weeks Unspecified illnesses, which in the judgment of the investigator increase the risk associated with endotoxin inhalation challenge, will be a basis for exclusion Persons employed within the past 6 months in an occupation with high risk for endotoxin exposure (specifically persons working in a swine confinement facility, cotton storage or grain storage site)
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-50.0, Asthma Hypersensitivity for healthy controls Normal lung function, defined as (Knudson 1976/1984 predicted set): FVC of > 80 % of that predicted for gender, ethnicity, age and height FEV1 of > 80 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > .75 Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 Diastolic between 90-60 mm Hg) Symptom Score no greater than 6 (out of a possible 24) for total symptom score with a value no greater than 2 for any one score Negative methacholine inhalation challenge as performed in the screening protocol. (Less than a 20% decrease in FEV1 at a maximum methacholine concentration of 10 mg/ml) --Negative pregnancy test for females Negative allergy skin test (AST) for allergic asthmatics also History of episodic wheezing, chest tightness, or shortness of breath after age of 6 years consistent with asthma, or physician diagnosed asthma after age of 6 years Positive methacholine test FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours) 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 zafirlukast) except for use of cromolyn exclusively prior to exercise Use of daily theophylline within the past month Use of tricyclics and MAO inhibitors 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
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-80.0, Asthma Copd Have not smoked during the last year Have never smoked for as long as a year Have < 0.5 packyear Persons who used inhaled or oral corticosteroids during >5 years, or within the last 5 years FEV1 <1.2 L A subject is not eligible to enter and participate if he does not agree that we inform his general practicioner about participation in the study and also about any unexpected finding during the study Upper respiratory tract infection (e.g. colds), within 2 months Pregnancy, or the possibility of being pregnant (i.e. women who do not use adequate anticonception as judged by the investigator) Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence) Signs or symptoms of any other concomitant disease that, in the eyes of the investigator, can interfere with the study results Known recent substance abuse (drug or alcohol) Claustrophobia
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Pulmonary Embolism Diagnosis of acute PE requires symptoms of PE present <14 days with CT angiography interpreted as positive for acute PE. Initial evaluation for PE must be predicated upon the investigation of new or unexplained cardiopulmonary or chest-related clinical features consistent with PE, including shortness of breath, chest pain, respiratory distress, dizziness, unexplained tachypnea, tachycardia, syncope, cough or hemoptysis. All patients must have CT chest angiography with <2 mm collimation,(36) with or without indirect venography. Pulmonary arterial opacification will be achieved with power injection of non-ionic, low osmolar contrast in an antecubital vein with a timing run; the pitch, voltage, gantry speed and other technical details appropriate for each scanner.(37;38) Images will be interpreted as positive for intrapulmonary arterial filling defect consistent with acute PE using our published definitions(37;38) by a board-certified radiologist with specialty training in body CT or emergency medicine imaging in all cases. 2. SBP (SBP)> 89 mm Hg at the time of enrollment. We will allow enrollment for a patient with an SBP < 90 mm Hg prior to enrollment, or a patient with a SBP>80 mm Hg, if the patient has a documented or patient-identified history of low blood pressure and has no symptoms of shock, as described by Jones et al.(39) 3. SaO2% >80% at time of enrollment. 4. Patients must have a Borg score greater than 4/10 Altered mental status such that they are unable to provide consent. 2. Inability to use a nasal cannula or face mask (e.g., anatomic defect) 3. Supplemental oxygen requirement greater than can be administered via nasal cannula or face mask in order to maintain SaO2 >80%. 4. Pregnancy 5. Pneumothorax with decompression 6. A serum mtHb greater than 10% 7. Concurrent therapies including: 1. Viagra® (sildenafil) use within the past 24 hours 2. Levitra® (vardenafil) use within the past 24 hours 3. Cialis® (tadalafil) use within the past 72 hours 4. Use nitroprusside or nitroglycerine with in the past 4 hours 5. Concomitant use of pressor or inotropic agents 6. Use of fibrinolytic agent with in the past 14 days 7. Use of nitrates within the past 24 hours
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-64.0, Asthma Adults age 18-64 years old. 2. Doctor diagnosis of mild persistent asthma. Persistent asthma is defined by NAEPP guidelines as asthma symptoms (cough/wheeze/dyspnea/exercise limitation)of greater than 2 times/week daytime or greater than 2 times/month at night over the previous month but less than continual and less than 5 nights/week. 3. FEV1 greater than 60% predicted for age/gender/race/height based on normative data. 4. No unscheduled asthma related health visit in the 1 month prior to enrollment 5. School or work days missed less than or equal to 2 in the previous month for asthma. 6. Albuterol use less than 8 doses (2 puffs or one neb) in past week. 7. Ability to speak and understand English. 8. Telephone access. 9. Women of childbearing potential must confirm that they will use birth control while in the study and have a negative urine pregnancy screen at baseline Pregnant women, prisoners. 2. Chronic illness (other than asthma, allergic rhinitis and eczema) such as renal disease, diabetes, hypertension or terminal disease or abnormal vital signs: T> 100.3F, HR>130 bpm, SBP>155 mmHg, or DBP>100 mmHg, RR>25 bpm, or pox<93% room air. 3. Unable to perform spirometry, necessary for lung function assessment. 4. Received probiotic in past 6 months. 5. Subject or household member has immunosuppression such as HIV, history of organ transplantation, present cancer or chemotherapy, primary immune disease, or is taking an immune modulating drug. 6. Severe persistent asthmatics who have continual daily or frequent (greater than 5 nights/week) asthma symptoms and/or FEV1 less than 60% predicted . 7. Diarrhea or constipation (symptoms more than once in the past week) 8. Unable to feed orally or to consume cornstarch 9. Lung disease other than asthma (e.g. COPD, cystic fibrosis, lung cancer, bronchiectasis, interstitial lung disease). 10. Subjects at increased risk of developing infective endocarditis such as those with a history of cardiac surgery, IV drug abuse, recent invasive medical procedures or dental work (recent = last month). 11. Allergy to Vancomycin or Cefepime. The parameters of intestinal barrier function, intestinal flora, serum inflammatory cytokines, IgE, will have no ranges as these will be collected over time on product as a way of describing the population characteristics of study participants
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Pulmonary Disease, Chronic Obstructive Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation Males or females greater then or equal to 50 years of age A post-albuterol FEV1/FVC ratio of < or equal to 0.70 A post-albuterol FEV1 < 80% of predicted normal Patients can be current or fomer smoker and must have a cigarette smoking history of > greater then or equal to 10 pack-years A current diagnosis of asthma A body mass index (BMI) of > or equal to 35kg/m2 A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis)
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI between 19 and 30, inclusive? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does he have serious psychological illness? Does he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Has he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is he unable to refrain from the use of all concomitant medications during the study?
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI ≤30? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs? Does he smoke more than 25 cigarettes/day? Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration? Does he have a history of seizure, cranial trauma, or other predisposition to seizure? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have serious psychological illness? Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken?
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI ≤30? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs? Does he smoke more than 25 cigarettes/day? Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration? Does he have a history of seizure, cranial trauma, or other predisposition to seizure? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have serious psychological illness? Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken?
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Chronic Bronchitis After signing the informed consent, screening testing will be done to document that a subject meets the requirements of the study. Specific are Subjects between the ages of 40 and 80 years of age (Dates of Birth 1925-1965) Current smoker (with smoking history of > 10 pack/year) or ex-smoker (stopped within 1 year and has at least a 10 pack/year smoking history) Subjects will be included if they meet for mild and moderate COPD as defined by the American Thoracic Society and European Respiratory Society position paper. Mild COPD will be defined as a postbronchodilator (2 puffs of albuterol) FEV1/FVC ratio of <0.7 and a predicted FEV1 of > 80%. Moderate COPD will be defined as a postbronchodilator FEV1/FVC ratio of <0.7 and a predicted FEV1 50-80%. A response to bronchodilators is defined as an increase of 12% or 200cc in FEV1 from baseline after inhalation of 2 puffs of albuterol. Both subjects with and without a response to bronchodilators will be included in the study All subjects will be clinically stable for 4 weeks prior to inclusion. Clinical stability is defined as having no recent COPD exacerbations within the last 4 weeks and having received no antibiotics or change in their inhaled steroid dose during that time period. If a subject is on oral steroids, they will be required to be on 10 mg or less each day or no more than 20mg every other day to be eligible. If the oral steroid dose has been titrated over the previous 4 weeks (either up or down) or if the dose is higher than what has been described previously, they will be ineligible for the study All subjects will be off of tiotropium or ipratropium for 1 month prior to the start of the study Chronic cough: Chronic cough will be characterized by the presence of a productive cough for 3 months in each of 2 successive years in persons in whom other causes of chronic cough have been excluded Subjects will not be eligible for the study if they are Age of < 40 or > 80 years Refusal to volunteer for the study and not willing to sign the informed consent form Respiratory disorder other than COPD including asthma, chronic bronchiectasis or pulmonary fibrosis Oxygen or ventilator dependent COPD Received any antibiotics or had a change in their inhaled steroid dose during the last 4 weeks. If a subject is on oral steroids, they will be required to be on 10 mg or less each day or no more than 20mg every other day to be eligible. If the oral steroid dose has been titrated over the previous 4 weeks (either up or down) or if the dose is higher than what has been described previously, they will be ineligible for the study History of Congestive heart failure, cardiomyopathy, valvular heart disease, angina, cardiac arrhythmia, or myocardial infarction within the last 6 months or poorly controlled hypertension History of chronic hepatitis or hepatic cirrhosis End-stage renal disease History of neurologic or psychiatric disorder which would interfere with completion of the study
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and Smoking history of at least 20 pack-years Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value Post-bronchodilator FEV1/FVC (forced vital capacity) <70% Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period 2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 3. Patients with concomitant pulmonary disease 4. Patients with a history of asthma 5. Patients with diabetes Type I or uncontrolled diabetes Type II 6. Any patient with lung cancer or a history of lung cancer 7. Patients with a history of certain cardiovascular comorbid conditions 8. Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302) Other protocol-defined inclusion/
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Signed written informed consent years of age Fluency in written and spoken English Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods Current/former smokers with at least a 10 pack-year history of cigarette smoking A measured post-salbutamol FEV1/FVC ratio of < or = 0.70 A measured post-salbutamol FEV1 > or = 40 and < or = 80% of predicted normal values Demonstrated reversibility to a short acting beta agonist by either >12% and >150 ml improvement in baseline FEV1, 30 minutes following administration of 4 puffs of salbutamol MDI or an absolute improvement of >200 ml in baseline FEV1, 30 minutes following administration of 4 puffs of salbutamol MDI Competent at using the inhalation device Women who are pregnant or lactating Primary diagnosis of asthma Alpha-1 antitrypsin deficiency as the cause of COPD Active pulmonary diseases Prior lung volume reduction surgery Abnormal chest X-ray (or CT scan) not due to the presence of COPD Hospitalized due to poorly controlled COPD within 24 weeks of Screening Poorly controlled COPD in prior 6-weeks, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician Clinically significant medical conditions Lower respiratory tract infection requiring antibiotics in past 6 weeks
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Males and non-pregnant, non-lactating females aged 40 to 80 years of age at the time of the screening visit. (Women of childbearing potential will be allowed to enter the trial only if they are using one medically approved (i.e., mechanical or pharmacological) contraceptive measure. A female is considered to be of childbearing potential unless she has had an hysterectomy, is at least one year post-menopausal, or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at screening visit and week 12 (Visit 3) Patients with a clinical diagnosis of COPD, grade 2 or 3 according to the GOLD guidelines 2007 and stable airway obstruction Patients with a post salbutamol FEV1 ≥ 30% of the predicted value, < 80% of the predicted value (i.e., 30% ≤ 100 x observed post-salbutamol FEV1/predicted FEV1 <80%) or who is deemed suitable by the Investigator (at either screening or baseline) Post-salbutamol FEV1/forced vital capacity (FVC) <70% (i.e,. 100 x post-salbutamol FEV1/FVC <70%) Current, or ex-cigarette smokers with a smoking history of at least 10 pack-years Patients who have the ability to produce a viable sputum sample (≤ 50% squamous cells) Predominant current diagnosis of smoking related COPD Patients who were eligible and able to participate in the trial and who consented to do so in writing after the purpose and nature of the investigation had been explained to them History or current diagnosis of asthma, allergic rhinitis or atopy. N.B. Misdiagnosed asthma or childhood asthma is acceptable, however must be confirmed by the Investigator Eosinophil count >600 cells/mm3 A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to the screening visit Patients who have been hospitalised for an acute COPD exacerbation in the 12 months or an exacerbation in the last 3 months which was treated with oral steroids prior to the screening visit Use of long-term oxygen therapy (≥15 hours/day) Clinically significant respiratory conditions defined as: Known active tuberculosis, History of interstitial lung or pulmonary thromboembolic disease, Pulmonary resection during the past 12 months, History of life-threatening COPD, History of bronchiectasis secondary to respiratory diseases other than COPD (e.g., cystic fibrosis, Kartagener's syndrome, etc), Patients who in the Investigator's opinion may need pulmonary rehabilitation or a thoracotomy during the trial Clinically significant cardiovascular conditions defined as: Myocardial infarction during the last 6 months, Unstable arrhythmia which required changes in the pharmacological therapy or other intervention during the last 12 months, or newly diagnosed arrhythmia within the previous 3 months, Hospitalisation within the previous 12 months for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association Patients with any other serious or uncontrolled physical or mental dysfunction at the discretion of the Investigator, which could place the patient at higher risk derived from his/her participation in the study, could confound the results of the trial, or is likely to prevent the patient from complying with the requirements of the trial or completing the trial period Patients who are not able to perform reproducible spirometry attempts at the screening visit or during the repeat at baseline Clinically relevant abnormalities in the results of laboratory, ECG parameters (QTc > 470 milliseconds), or physical examination at the screening evaluation if the abnormality defines a disease state listed as an criterion, except for those related to COPD
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease COPD Referred for rehabilitation Age > 18 years Symptoms affecting ADL function minute walk distance (6MWD) < 400 meters Patients who smokes or has smoked during the last three months LTOT Patients who has another disability Patients who can't read or speak Norwegian
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-65.0, Chronic Obstructive Pulmonary Disease History of COPD for at least 6 months with pre-bronchodilator FEV1 ≥40% of predicted value and >15 pack-year history of cigarette smoking History of asthma, or any other acute or chronic pulmonary disease
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Provide signed informed consent prior to enrolment in the study 2. IPSS ≥ 15 3. Prostate Volume ≥ 30 mL ≤ 70 mL 4. Qmax < 15 mL/sec based on a minimum void of 125 mL 5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study History of illness or condition that may interfere with study or endanger subject 2. Use of prescribed medications that may interfere with study or endanger subject 3. Presence of a median lobe of the prostate 4. Previous surgery or MIST for treatment of BPH 5. Post-void residual urine volume > 200 mL 6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL 7. Participation in a study of any investigational drug or device within the previous 90 days 8. Prostate cancer
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease A clinical diagnosis of COPD FEV1 40 of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC < 70% Any clinically relevant abnormal findings at screening examinations Any clinically significant disease or disorder
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Diagnosis of COPD with symptoms over 1 year Smokers or ex-smokers Males or post-menopausal females between 40 and 80 years old Able to use electronic devices Past history or current evidence of clinically significant heart disease Current diagnosis of asthma Patients who require long term oxygen therapy Treatment with antibiotics within 4 weeks of study visit 1b
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Is male > 50 years of age at Screening Has a normal digital rectal exam with the exception of prostate enlargement Has suffered from symptoms of BPH for at least the 6 months before Screening Has a prostate volume ≥ 20 mL and ≤ 70 mL as assessed by ultrasound Has a serum PSA concentration > 1.5 ng/mL and ≤ 10 ng/mL at Screening Has an IPSS > 13 at Screening and Baseline Has a Qmax > 5 cc/sec and < 15 cc/sec with a voided volume ≥ 125 cc at Screening (and Baseline, if applicable) Has a known history of allergic reaction or clinically significant intolerance to ingredients of the study drug Neurogenic bladder dysfunction Has bladder neck contracture or urethral stricture Has acute or chronic prostatitis or urinary tract infection Has, or has a history of, prostate cancer or carcinoma of the prostate suspected on digital rectal exam or transrectal ultrasound, or has a serum PSA concentration > 10 ng/mL; patients with a PSA concentration > 4 ng/mL and ≤ 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator Has a residual void volume > 250 mL Has any clinically significant unstable condition that, in the opinion of the investigator, could compromise the patient's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation Shows presence of any manifest premalignant or malignant disease except treated skin cancers (except melanoma) Has a history of smoking more than 5 cigarettes daily within the year before Screening Has resting systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg or < 60 mmHg at Screening
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Post-bronchodilator forced expiratory volume in 1 sec (FEV1) ≥ 80%predicted and a FEV1/forced vital capacity (FVC) ratio < 0.70 Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospitalizations in the preceding 6 weeks A cigarette smoking history ≥ 20 pack-yrs Body mass index between 18.5 and 30 kg/m2 Able to perform all study procedures and provide informed consent A diffusing capacity of the lung for carbon monoxide (DLCO) < 40 %predicted Presence of active cardiopulmonary disease (or comorbidities) other than COPD that could contribute to dyspnea and exercise limitation Clinical diagnosis of sleep disordered breathing History or clinical evidence of asthma Presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s) Use of daytime oxygen or exercise-induced arterial oxygen desaturation to <80% on room air
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-75.0, Family Characteristics Health Status Family Research Male and Female Patients who receive primary care at one of the study selected Primary Care Practices are between 18-75 years old are English or Spanish speakers, and have appointments scheduled in the upcoming 1 months for an annual or comprehensive visit We will not individuals over the age of 75 because the role of family risk assessment and prevention is less established Also will not non-English or non-Spanish speakers Patients will also be excluded if they are hearing impaired
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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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
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) We define advanced COPD as including those with severe COPD by CTS (i.e., severe shortness of breath resulting in the patient being too breathless to leave the house, or breathlessness after dressing/undressing (i.e., Medical Research Council (MRC) score of 5), or the presence of chronic respiratory failure (PaCO2>45) or clinical signs of right heart failure) We will also patients who are short of breath and stop walking after about 100 meters or a few minutes on the level (MRC score 4) with at least one the following BMI < 21 post-bronchodilator FEV1 < 30% predicted one or more hospital admissions for acute exacerbation of COPD in the previous year MRC 4 patients will be recruited only if their baseline Chronic Respiratory Questionnaire dyspnea domain (CRQ-D) score is < 5, an entry criterion used in a Canadian RCT involving patients with advanced lung disease Patients and/or caregivers with cognitive or other difficulties that would preclude questionnaire completion Inability to speak or understand English Patients considered to be dying or with an expected survival of less than 2 months
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, COPD Current or ex-smokers aged over 50years FEV1/FVC ratio less than 0.7 FEV1 less than 60% predicted Diagnosis of asthma, ABPA or bronchiectasis Recent RTI or steroid use Inability to perform study procedures or to give informed consent Known sensitivity to trial medications
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 21.0-999.0, Infective Complications Post-transrectal Prostate Biopsy All subjects scheduled at Vancouver General & UBC Hospitals for a transrectal ultrasound guided prostate biopsy are eligible for this study. The indication for biopsy is made according to standard clinical reasoning and judgment, and is not affected by this study All subjects must be willing and able to sign an informed consent and to take the ciprofloxacin prophylaxis before biopsy
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Heart Failure years and over attending heart failure clinic between 01/01/2002 12/07 less than 18 years. Pregnant females
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 30.0-87.0, Pulmonary Disease, Chronic Obstructive Patients aged 30 years or older Current or previous cigarette smoker with a history of cigarette smoking of ≥ 10 pack-years: number of pack years = (number of cigarettes per day/20) × 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). Previous smokers are defined as those who stopped smoking at least 3 months prior to the study visit Willing and able to provide written informed consent prior to study participation (on day of study visit) Able to read, write, and comprehend information in English Prior to enrollment, prospective subjects will be screened. A subject will be excluded from the study if he/she meets any of the following Regular use (i.e., prescribed for use on a daily basis) of the following respiratory medications within the 4 weeks prior to the study visit Ipratropium (Atrovent, ipratropium bromide) Ipratropium/albuterol combinations (e.g., Combivent) Tiotropium (Spiriva, tiotropium bromide) Salmeterol (SEREVENT™) Formoterol (Foradil) Inhaled corticosteroids (e.g., Azmacort Aerobid, Pulmicort, QVAR, Vanceril) Inhaled corticosteroid/long-acting beta-agonist combinations (e.g., , Symbicort) Theophyllines (e.g., Theo-dur, Slo-Bid, Uniphyl)
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-80.0, Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia Patients with BPH and sexual dysfunctions (erectile dysfunction or decrease in libido) IPSS > 4 BSFI, sexual drive questions < 5 Lack of libido which is due to a psychic disease or a depressive mood -Excessivly strong lack of libido in the judgement of the investigator within the last two months Patients with severe vascular disorders (microangiopathies) Patients with known neuropathies Severe diabetes mellitus Patients with hypertension who are for less than two months on a stable antihypertensive medication Known bad compliance of the patient
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-70.0, Chronic Obstructive Pulmonary Disease (COPD) Male and female subjects minimum 18 and maximum 70 years of age Body Mass Index (BMI) = 36 kg/m2 Subjects with COPD: Diagnosis of COPD (emphysema and/or chronic bronchitis) smoking history =10 years, chronic cough present intermittently or daily with or without sputum and/or dyspnea upon exertion Subjects with COPD: Pulmonary Function Tests FEV1 =50% (NHANES) III Predicted; FEV1/FVC < 70 % (NHANES) III; TLC =80% of Predicted (ITS) and DLco(unc) =50% of Predicted (Miller) Subjects without COPD: PFTs: FEV1 = 70% III Predicted; TLC =80% of Predicted (ITS) and DLco(unc) =80% of Predicted (Miller) History of pre-diabetes or diabetes Previous or current treatment with any anti-diabetic drugs Serum creatinine > 2.0 mg/dL in males and > 1.8 mg/dL in females Active smokers defined as having smoked their last cigarette, pipe, and/or cigar without the previous 6 months Previous exposure to any inhaled insulin product or investigational medicines/devices within the previous 30 days prior to entry or participation Clinically significant major organ disease Female subjects of childbearing potential not practicing adequate birth control Subjects with COPD: Significant improvement in pre-to post-bronchodilator spirometry (defined as an increase of 12% AND 200 mL in either FVC or FEV1) Any clinically important pulmonary disease except mild or moderate COPD Subjects without COPD: Any important pulmonary disease confirmed by pulmonary function testing and/or radiologic findings
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease (COPD) Diagnosis of COPD with symptoms over 1 year FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit Past history or current evidence of clinically significant heart disease Current diagnosis of asthma Patients who require long term oxygen therapy Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive A signed and dated written informed consent prior to study participation Males or females of non-childbearing potential or more years of age COPD diagnosis pack-years history or greater of cigarette smoking Post-bronchodilator FEV1/FVC ratio of 0.70 or less Post-bronchodilator FEV1 of 80% or less of predicted normal Current diagnosis of asthma Other significant respiratory disorders besides COPD, including alpha-1 deficiency Previous lung resection surgery Significant abnormalities in chest x-ray presentation Use of oral steroids, antibiotics or hospitalization for a COPD exacerbation within 3 motnhs prior screening Any significant disease that would put subject at risk through study participation BMI greater than 35 Pacemaker Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or C) Cancer
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, COPD Key Signed written informed consent years of age Fluency in written and spoken English Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods Current/former smokers with at least a 10 pack-year history of cigarette smoking A measured post bronchodilator FEV1/FVC ratio of < or = 0.70 A measured post bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values Women who are pregnant or lactating Primary diagnosis of asthma Alpha-1 antitrypsin deficiency as the cause of COPD Active pulmonary diseases Prior lung volume reduction surgery Abnormal chest X-ray (or CT scan) not due to the presence of COPD Hospitalized due to poorly controlled COPD within 12 weeks of Screening Poorly controlled COPD, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician within 6 weeks of screening or between screening and visit 2 Lower respiratory tract infection requiring antibiotics within 6 weeks of screening Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG or uncontrolled hypertension)
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Outpatients, men or women ≥ 40 years A clinical diagnosis of COPD according to guidelines, and current COPD symptoms Post-bronchodilator FEV1 < 80% of predicted normal value and FEV1/FVC < 70%, post-bronchodilator A history and/or current clinical diagnosis of asthma and atopic diseases such as Allergic rhinitis Patients who have experienced COPD exacerbation requiring at least one of the following treatment, hospitalisation and/or a course of systemic steroid within 4 weeks prior to the study start Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-75.0, Congestive Heart Failure Patients with resting left ventricular ejection fraction (LVEF) of less than 45% as determined by echocardiography Stable clinical condition as defined by no changes in drug therapy for at least one month before evaluation Patients with neurological, pulmonary, renal, musculoskeletal disease, unstable angina, primary valvular heart disease or previous diagnosis of sleep disordered breathing
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-45.0, Nicotine Dependence Smoking Sleep Disorders, Intrinsic Age 18-45 Not regularly exercising, defined as exercising fewer than three times per week and for no more than 20 minutes each time Free of medical illnesses (need to be cleared by a physician as able to exercise at 60% maximum heart rate (MHR)) Currently meeting DSM-IV for nicotine dependence (No Current or Past history of any other psychiatric disorder) Regularly smoking at least 08 cigarettes per day for at least 12 consecutive months, not attempted to quit smoking in the previous month, and not currently taking medication for smoking cessation Currently displaying carbon monoxide breath readings >10 and urine cotinine levels >3 Habitual bedtime between 9:30 p.m. and 1:30 a.m Body Mass Index (BMI) less than 40 Unable to exercise Currently diagnosed or treated for any psychiatric disorder; treatment with psychotropic medication will be considered on a case by case basis History or active treatment or any treatment in past year for any mood or psychotic disorder Current or past diagnosis of a sleep disorder Currently taking sleep medications or other medications known to alter sleep architecture Currently doing shift work or working at night History of travel across time zones in the past month For women of child bearing potential: pregnant or actively trying to become pregnant Parent of a child under two years of age Diagnosis of Sleep Apnea
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-65.0, Chronic Obstructive Pulmonary Disease Parts A and B only; Body mass index (BMI) between 18 and 30 kg/m2 Parts A and B only; Normal physical examination, laboratory values, and vital signs (blood pressure and pulse) unless the investigator considers an abnormality to be clinically irrelevant Part C only; clinical diagnosis of COPD for at least one year and Post-bronchodilator FEV1 30 predicted, FEV1/FVC ratio < 70% Participation in any clinical study with an investigational drug or new formulation of a marketed drug in the 3 months prior to Visit 2, or participation in a method development study one month prior to Visit 1 Part C only: An acute exacerbation or acute respiratory infection (upper or lower) in the 4 weeks prior to Visit 1 or Visit 2 Part C only: Concomitant diagnosis of significant pulmonary disease other than COPD, including symptomatic asthma, cystic fibrosis and allergic bronchopulmonary aspergillosis
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease A current clinical diagnosis of Chronic Obstructive Pulmonary Disease Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years A smoking history of at least 10 pack years History and/or current clinical diagnosis of asthma History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Critically Ill Intra-Abdominal Hypertension Abdominal Compartment Syndrome Acute Kidney Injury Adult patients (>18y old) of either gender Admitted to the ICU Sedated and mechanically ventilated (and expected to remain so for at least 48h) Informed consent given admitted to the ICU for <7 days or during the first 7 days of a new shock episode AKI requiring RRT according to treating physician IAP >12mmHg being attributed to fluid overload by treating physician Included in the same study before Vasopressor and/or inotrope dose needed above noradrenaline 1µg/kg/min and dobutamine 10µg/kg/min PaO2/FiO2 ratio <100
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Cardiac Diseases Patients needing cardiac surgery and who had both right cardiac catheterism and 24 hours ECG recording before Stable medications for at least 4 weeks Patient with pace-maker or atrial fibrillation
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-90.0, Chronic Obstructive Pulmonary Disease COPD diagnosis according to GOLD guidelines Hospitalization for any acute exacerbation of chronic obstructive pulmonary disease Failure of outpatient treatment Increasing of dyspnea in the last days Comorbidity that causes detriment of respiratory function Life expectancy of less than 6 months Mechanical Ventilation Cardiovascular condition that causes exacerbation Immunosuppression Pulmonary infiltrates that suggest pneumonia Antibiotic treatment in the last month Pregnancy ECG with a large QT segment Hypokalemia Hepatic failure or renal failure
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Present at screening with a history of benign prostatic hyperplasia (BPH) for >6 months Have an International Prostate Symptom Score (IPSS) greater than or equal to 13 at screening Have a total prostate volume by transrectal ultrasound greater than or equal to 30 milliliter (mL) at screening Show signs of bladder outlet obstruction as defined by a peak urinary flow rate (Qmax) greater than or equal to 4 and less than or equal to 15 milliliter/second (mL/sec) (from a prevoid total bladder volume [assessed by ultrasound] of greater than or equal to 150 to less than or equal to 550 ml and a minimum voided volume of 125 ml) at screening Have a prostate-specific antigen (PSA) greater than or equal to 1.4 and less than or equal to 10 nanogram/milliliter (ng/mL) at screening Demonstrate a Post Void Residual less than or equal to 300 mL by ultrasound at screening Have not received the following treatments within the specified time period: 1. Finasteride or dutasteride for at least 6 months prior to screening. 2. Any alpha-adrenergic antagonists for at least 4 weeks prior to screening. 3. Any other non-experimental BPH therapy (including an herbal preparation) for at least 4 weeks prior to screening. 4. Any other experimental or off-label BPH therapy such as injectable therapies with a protracted effect for at least 6 months prior to screening. 5. Any overactive bladder treatment for at least 4 weeks prior to screening. 6. Any Erectile Dysfunction treatment which may oral phosphodiesterase type 5 inhibitors or devices for at least 4 weeks prior to screening Have a morning fasting Total Testosterone concentration greater than or equal to 300 nanogram/deciliter (ng/dL) at screening If hyperlipidemic, based on history, be stable on statin treatment as determined by the investigator for at least 2 months prior to screening Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY500307 Have any history of BPH-related invasive procedures (for example, Transurethral Resection of the Prostate, open prostatectomy, and minimally invasive procedures that thermal-based therapies, transurethral microwave treatment, transurethral needle ablation, and stents) Have active cardiovascular disease as evidenced by the following: 1. Recent Myocardial infarction, unstable angina, stroke or Transient ischemic attack within 6 months of screening. 2. Recent coronary intervention that includes coronary artery bypass surgery, percutaneous coronary artery intervention, or stent placement within 6 months of screening. 3. Recent history of positive stress tests without any written documentation of effective intervention within 6 months of screening. 4. Evidence of heart disease categorized as greater than or equal to Class III functional classification of New York Heart Association (NYHA) within 6 months of screening Have known or suspected history of prostate cancer, breast cancer, or other clinically significant neoplastic disease (other than squamous cell or basal cell carcinoma of skin) Have a history of deep venous thrombosis or pulmonary embolism disease Have moderate to severe renal insufficiency Have a hemoglobin A1c (HbA1c) greater than 9.0% Are on testosterone replacement therapy, or drugs that influence the hypothalamus-pituitary-gonadal axis Are on pharmacological treatment other than statins for hyperlipidemia
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 70.0-999.0, Chronic Illness Person 70 years or above being discharged from the general hospital Will receive home care services within four weeks after being discharges from the hospital Do not agree or are not able to agree to participate Is already involved in other research studies affecting the home care services
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-85.0, Pulmonary Disease, Chronic Obstructive Subjects eligible for enrolment in this study must meet all of the following Male or female of at least 40 years of age at screening. To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control starting on the day of visit 1, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days), as defined by any one of the following Abstinence Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse Oral contraceptive (either combined estrogen/progestin or progestin only) Injectable progestogen Implants of levonorgestrel or etonogestrel Percutaneous contraceptive patches Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or Double-barrier method; condom or occlusive cap (diaphragm or cervical /vault caps) plus spermicide Subjects meeting any of the following must not be enrolled in the study Diagnosis of pneumonia, congestive heart failure (CHF), or other complicating co-morbid condition while hospitalized within the last 6 months for an exacerbation of COPD Historical or current evidence of clinically significant uncontrolled disease including, but not limited to, those listed below. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subjects at risk through study participation, or which would affect the safety analysis or other analyses if the disease/condition exacerbated during the study A previous lung resection surgery (e.g. lobectomy, pneumonectomy, etc) within the year preceding Visit 1 (Screening) Asthma as primary diagnosis Lung cancer Cystic fibrosis, pulmonary fibrosis, active tuberculosis, or sarcoidosis Clinically significant cardiac arrhythmias Uncontrolled hypertension Unstable angina
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Non-Small Cell Lung Cancer complete resection by lobectomy, bi-lobectomy or pneumonectomy of NSCLC pN1 or pN2 disease signed informed consent for participation in the study Karnofsky Performance Status (KPS) higher than 70% presence of distant metastases N2 diagnosed before surgery in imaging and/or mediastinoscopy previous radiotherapy to the chest no or inadequate mediastinal nodal dissection FEV1 after surgery lower than 1.0 liter any active infectious process (including fistula formation) in the chest
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-80.0, ST Elevation (STEMI) Myocardial Infarction of Other Sites *Selection Any patient hospitalised in the CCU of the participating centers with a diagnosis of a first MI with ST segment elevation and/or Q wave at admission with troponin elevation seen within the first 24 hours after symptom onset aged between 18 and 80 years is selected consent emergency clause: His/her informed consent is obtained and he/she signs the consent form or However, if a member of the patients' family is present, his/her consent must be obtained or no consent *Inclusion The first transthoracic echocardiography is performed at day 4±2 in all patients selected In the presence of at least 3 akinetic LV segments at the transthoracic echocardiography, the patient is included *Non-selection Informed consent not obtained Patients with diagnosis of previous MI, hypertrophic or dilated cardiomyopathy, significant valvular heart disease, chronic atrial fibrillation, or pace maker or any permanently implanted device susceptible to interfere with LV remodelling Patients with preexisting heart failure Patients having undergone previous cardiac surgery Patients having received chemotherapy susceptible to induce LV remodeling (anthracyclines) Patients with an associated short-time life-threatening disease Patients with poor echogenicity Patients without health insurance
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, COPD Exacerbation years old or over have known or suspected COPD based on pulmonary function test, arterial blood gas, clinical history, physical examination, and chest radiograph worsening of dyspnea within 2 weeks partial pressure of arterial carbon dioxide (PaCO2) >45 mmHg respiratory rate >24/min arterial pH <7.35 partial pressure of arterial oxygen (PaO2) <50 mmHg under room air hypersensitivity to anticholinergics and to magnesium sulfate patients that received anticholinergics within 6 hours before ED admission systolic arterial pressure <90 mmHg or need to vasoactive drugs
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, COPD CT Bronchodilation age 40 or more Smoking history > 10 pack-years post bronchodilator FEV1/VC < 0.7 COPD exacerbation or infection in the 4 weeks before the study Concomitant pulmonary disease (tuberculosis, significant bronchiectasis, lung cancer) pulmonary resection active malignancy or malignancy of any organ system within the past 5 years
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Male or female subject, age > 40 years, current or ex-smokers Planned lung resection for primary lung cancer of any size Patients with COPD: irreversible airflow limitation (postbronchodilator FEV1/FVC < 70% according to GOLD guidelines). Patients already receiving inhalative therapy can continue their medication. Patients showing a partial reversibility after bronchodilation (postbronchodilator FEV1 increase > 150 ml but < 200ml) and complaining respiratory symptoms (e.g. dyspnea at exertion) will be treated preoperatively with a short-acting beta-agonist to achieve optimal perioperative conditions Patients without COPD: postbronchodilator FEV1/FVC > 70% Patients have to be in clinical stable condition (no symptoms of respiratory tract infection for at least 2 weeks prior to the study) Written informed consent Patients with a history of asthma or other active lung disease Lung resection for other reasons than lung cancer (e.g. infective diseases like bronchiectasis)
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Cancer Neuroendocrine Ovarian Cancer Colon Cancer Male or female, ≥18 years of age 2. For the Pharmacokinetic Drug Interaction Study: Histologically or cytologically confirmed advanced solid tumors that are refractory to all standard of care therapy or for whom no standard therapy is available, or for whom other standard therapies the patient has denied. For the Pharmacodynamic Study: Histologically or cytologically confirmed metastatic/advanced ovarian carcinoma or metastatic/advanced KRAS mutant colorectal cancer or metastatic/advanced Head and neck squamous cell cancer (HNSCC) that are refractory to all standard therapies therapy or for whom no standard therapy is available, or for whom other standard therapies the patient has denied. 3. At least one measurable tumor as defined by 4. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy 5. Eastern Cooperative Oncology Group (ECOG) of 0 to 2 6. Organ &marrow function as defined in the protocol. 7. No evidence of preexisting uncontrolled hypertension as documented by two baseline blood pressure readings taken at least 1 hour apart 8. Clinically euthyroid 9. Normal range cardiac function 10. For female patients of child-bearing potential, a negative serum pregnancy test at Screening. 11. Current use of an acceptable form of double-barrier birth control 12. Have provided written informed consent Known brain or other central nervous system metastases metastases that are not stable for 3 months or longer 2. Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation. 3. Major surgery, radiotherapy, chemotherapy, or cytokine therapy within 28 days of Study Day 0; 4. History of intratumoral bleeding or evidence of bleeding diathesis or coagulopathy 5. Female patients who are pregnant, planning a pregnancy, or who are breastfeeding 6. Known allergy or hypersensitivity to JI-101 or everolimus or any component of the investigational products 7. Use of an investigational drug/device/biologic within 28 days of Study Day 0 8. Current drug or alcohol abuse or history of drug or alcohol abuse within the past two years 9. Known history of or serologic positivity for the Hepatitis B Virus (HBV), or the Hepatitis C Virus (HCV), or for the human immunodeficiency virus (HIV) 10. History of cardiac abnormalities 11. Gastrointestinal (GI) abnormalities 12. Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Study Day 0 13. History of cerebrovascular accident including transient ischemic attack within the past 6 months 14. History of pulmonary embolism or deep vein thrombosis within the past 6 months 15. History of significant retinopathy or any progressive eye disease that could lead to severe loss of visual acuity or visual field loss during the study period 16. Treatment with heparin or heparin analogs 17. Inability or unwillingness to meet the requirements of the study 18. Other current active malignancy or history of malignancy within the past five years, except for cervical carcinoma in situ, basal cell carcinoma that has been surgically removed, or prostate cancer that is being managed with watchful waiting. 19. Any clinically significant abnormal finding at screening that the investigator judges would interfere with study participation
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Malignant Skin Melanoma T0 Stage III Melanoma Stage IV Melanoma Amplification Patients with histologically proven melanoma with either c-KIT mutation or C-KIT amplification (without BRAF or NRAS mutation) Unresectable primary or stage III or stage IV melanoma Measurable disease (RECIST) The of patients with primary tumor or metastasis accessible to sequential biopsies will be favored. If such lesions are present, biopsies are mandatory and not optional No more than 1 previous specific therapy excluding tyrosine kinase inhibitors. 4 weeks wash out will be needed after cytotoxic therapy , 12 weeks wash out after anti -CTLA4 therapy or any immunological treatment No radiotherapy within 4 weeks ; previously irradiated lesion will not be considered as measurable unless progression at ECOG performance status < 2 WBC ≥ 3,000/mm³ PNN ≥ 1,500/mm³ (G-CSF allowed) platelets ≥ 100,000/mm³ Patients refusal Age < 18 years Fertile women who do not want or cannot use effective contraception during the study and up to 8 weeks after the end of study Women pregnant or nursing Women with positive pregnancy test at or before treatment initiation Fertile and sexually active men whose partner are fertile women who do not use effective contraception Clinical and/or radiographic evidence of active cerebral metastases Severe evolutive infection Known HIV infection Concomitant therapy with any other anti-cancer, immunomodulator or immunosuppressing agent or radiotherapy (except palliative care if bone metastases, after acceptance of principal investigator)
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 65.0-999.0, Vitamin D Deficiency in Older Persons Long term indication for living in a residential home for the elderly Age > 65 years Vitamin D deficiency (serum 25 hydroxycholecholecalciferol (25(OH)D3 < 50 nmol/l) Informed Consent Hypercalcemia (serum CA > 2.60 mmol/l) Life expectancy < 1/2 year Multivitamin use including > 400 IE vit D Non-functional dominant arm
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-70.0, Pulmonary Disease, Chronic Obstructive Asthma Healthy volunteers Males and females aged 18-65 years Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 Non or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year Normal blood pressure and heart rate Normal electrocardiogram (ECG,12 lead) Normal laboratory tests; Patients with Asthma Males and females aged 21-65 years BMI between 18.0 and 28.0 kg/m2 All subjects Blood donation or blood loss in the previous 8 weeks Positive HIV1 or HIV2 serology Positive acute or chronic Hepatitis B or Hepatitis C Unsuitable veins for repeated venipuncture Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception History of substance abuse or positive urine drug screen Abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation Uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric clinically significant disorder Participation in another clinical trial in the previous 8 weeks; participation in study using radioactive material within 1 calendar year
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 30.0-80.0, COPD Male or female subjects between and including the ages of 30 and 80 years. Females of childbearing potential may be included provided they are not pregnant or are not nursing. 2. Subjects with a diagnosis of moderate to very severe chronic obstructive pulmonary disease as defined by the Global Initiative for COPD (GOLD, 2008 update) and who meet the following for stage ll IV disease: a) Subjects must have a post-bronchodilator FEV1/FEV ratio <70% and FEV1 of <80% of the predicted value for age, height, and sex using the III standards (Hankinson, 1999). 3. Subjects must have a smoking history of at least 10 pack-years. 4. Subjects must have stable disease for at least 1 month prior to enrollment with no changes in the maintenance treatment for COPD in this period. - History of an exacerbation or other significant disease instability during the month preceding enrollment. 2. A primary diagnosis of asthma or bronchiectasis. 3. Inability to vibrate the reed of the Lung Flute® consistently because of severely expiratory flow rate. 4. Subject with any evidence of significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the conduct of the study or safety of the subject. 5. Pregnant or nursing females or females intending to become pregnant during the course of the study. 6. Use of any investigational drug within one month or 6 half-lives (which-ever is greater) of the enrollment visit. 7. Inability to comprehend or willingness to follow the study requirements including attendance at out-patient clinic visit and participation in testing as called for by the protocol. 8. Patients currently using the Lung Flute. -
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