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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): 30.0-85.0, Mobility After Total Knee Arthroplasty TKA within 72 hours and VAS>60 during 45 degrees active flexion of the knee despite conventional pain medication informed consent ASA 1-3 BMI 18-40 Unable to communicate in Danish Allergic reactions toward ropivacaine Alcohol and or drug abuse Unable to cooperate Known sensory disturbances in the lower limbs
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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 Airway Disease Post-bronchodilator FEV1/VC < LLN and post-bronchodilator FEV1 ≤ 60% of the predicted value (VC Vital Capacity, LLN Lower Limit of Normal) Definite clinical diagnosis of COPD (can be overlaps: COPD + asthma / COPD + bronchiectasis) Stable course of COPD (≥ 8 weeks free of acute exacerbations and/or free of any acute conditions) Informed consent "Pure" bronchial asthma without COPD "Pure" bronchiectasis without COPD Cystic fibrosis End-stage of COPD Non-curable malignancy Total non-compliance Immobility
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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): 40.0-75.0, Coronary Artery Disease Age between 40-75 years old 2. Male sex 3. History of known coronary artery disease (by either history of myocardial infarction, angiogram demonstrative >=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography) Unstable angina or myocardial infarction by history, ECG, and/or enzymatic within 1 month of enrollment. 2. Left ventricular dysfunction as defined by an left ventricular ejection fraction documented as < 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging. 3. Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the screening visit. 4. Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment. 5. Known history of cognitive impairment or inability to follow study procedures 6. Patient with an implanted defibrillator or permanent pacemaker on with the potential participant is known to rely upon for greater than 50% of ventricular depolarizations. 7. Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks. 8. Patients with dosing changes of vasoactive medications and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors in the 6 weeks prior to enrollment
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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, Chronic Illness Upcoming Non-VA provider appointment Take 5 or more prescribed medications Have or obtain a My HealtheVet premium account Access to computer, printer, & Internet to complete study protocol No non-VA provider or upcoming appointment Less than 5 medications No premium MHV account
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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, Cerebral Vascular Accident (CVA) All patients, male or female, may be included if they meet the following patients with suspected ischemic CVA admitted in an acute stroke unit (thrombolysis unit) aged 18 and over MRI Scan undertaken under the current protocol which includes the following sequences: distribution, T2* (gradient echo), ARM, TOF and FLAIR after information given the consent form is signed by the patient .or for those unable to express their consent (in case of coma or severe neurological disorder) by a relative or next of kin. .the patient will be informed as soon as he has recovered his faculties in order to be able to express, if he wishes, his opposition to the pursuit of the research (sample destruction before tested) the patient must be registered with the Social Security All patients with a contraindication to MRI Scan Pacemaker Implanted cardiac defibrillator Implanted Neuro-stimulator Cochlear Implants Implanted Insulin pump Other implanted electronic medical device Vascular intracerebral Clip Cardiac Valve Other metallic implant
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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, Moderate COPD Adult patients with stable moderate COPD (FEV1 45-80%pred) Emphysema on CT with a defined target lobe CT thorax must demonstrate intact interlobar fissures adjacent to the target lobe Hyperinflation TLC ≥100% predicted, RV ≥150% predicted Exertional breathlessness with MRC dyspnoea score ≥3 Optimum COPD treatment for at least 6 weeks No COPD exacerbation for at least 6 weeks Fewer than 3 admissions for infective exacerbations in the preceding 12 months Six minute walk distance of <450m Inability to obtain informed consent Significant co morbidity which limits exercise capacity or prognosis Co-morbidities that would render bronchoscopy or sedation unsafe Clinically significant bronchiectasis Lung nodule requiring further investigation or treatment Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
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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 Male or female >=40 and <=80 years of age at the time of signing the informed consent A female subject is eligible to participate if she is of: Non-childbearing potential defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone >40 milli international unit per milliliter (mIU/mL) and oestradiol <40 picogram [pg]/mL [<147 picomole per liter (pmol/L)] is confirmatory); females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study from Screening to follow-up contact) if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrolment. For most forms of HRT, at least 2 to 4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. After confirmation of their postmenopausal status, they can resume use of HRT during the study without use of a contraceptive method; child-bearing potential and is abstinent or agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) before the start of dosing to sufficiently minimise the risk of pregnancy at that point. Female subjects must agree to use contraception until at least 2 days post the last dose of study treatment; abstinence from penile-vaginal intercourse must be consistent with the preferred and usual lifestyle of the subject COPD Diagnosis: An established clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society Severity of Disease: A measured pre and post-salbutamol/albuterol FEV1/forced vital capacity (FVC) ratio of <0.70 at Visit 1 (Screening and Run-in Visit) A measured pre-salbutamol/albuterol FEV1 <50% of predicted normal values at Visit 1 (Screening and Run-in Visit). A measured post-salbutamol/albuterol FEV1 >=30% of predicted normal values at Visit 1 (Screening and Run-in Visit). Predicted values will be calculated using the National Health and Nutrition Examination Survey (NHANES) III reference equations Tobacco Use: Current or prior history of at least 10 pack-years of cigarette smoking (e.g., 20 cigarettes/day for 10 years). One pack-year is defined as 20 manufactured cigarettes (1 pack) smoked per day for 1 year. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1 (Screening and Run-in Visit). Former smokers are eligible to enter the study provided they have at least 10 pack-years smoking history. Subjects making a conscious decision to stop smoking at any time during the study and who refrain from smoking for >4 weeks will be discontinued from the study. Additionally, subjects who start smoking during the study and smoke for at least 7 consecutive days will be discontinued from the study Dyspnoea: A score of >=2 on the Modified Medical Research Council Dyspnoea Scale (mMRC) at Visit 1 (Screening and Run-in Visit) Liver Safety Alanine aminotransferase (ALT) <=2 the upper limit of normal (ULN), alkaline phosphatase and bilirubin <=1.5 ULN (isolated bilirubin >1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%) at Visit 1 (Screening and Run-in Visit) Electrocardiogram (ECG) Safety The subject must have no ECG abnormalities that would, in the opinion of investigator, compromise subject safety, or significantly affect subject's ability to complete the trial. As such the investigator will determine the clinical significance of any ECG abnormality and determine if a subject is precluded from entering the study. At Visit 1 (Screening and Run-in Visit), ECG safety must be: QT interval corrected for heart rate (QTc) or QT interval corrected for heart rate according to Fridericia formula (QTcF) <450 milliseconds (msec) or QTc <480 msec for subjects with a bundle branch block. Investigators will be responsible for ensuring appropriate clinical interpretation of ECGs Able to use the inhaler devices adequately after training 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, hypokalaemia or thyroid disease), cardiovascular, neuromuscular, hepatic, gastric, or haematological 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 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 film or computed tomography scan not believed to be a result of the presence of COPD. A chest X-ray must be taken if the subject has not had 1 within 6 months of Visit 1 (Screening and Run in Visit) Lung resection surgery (e.g., lung volume reduction surgery, or lobectomy) within 1 year of Visit 1 (Screening and Run-in Visit) A COPD exacerbation and/or infection of the upper or lower respiratory tract requiring treatment with systemic (oral or parenteral) corticosteroids and/or antibiotics that has not resolved within 30 days of Visit 1 (Screening and Run-in Visit) A COPD exacerbation that resulted in hospitalisation that has not resolved within 3 months of Visit 1 (Screening and Run-in Visit) Use of nocturnal-positive pressure (e.g., continuous positive airway pressure or bilevel positive airway pressure) Oropharyngeal Examination: A subject will not be eligible for the Run-in Period if he/she has clinical visual evidence of candidiasis at Visit 1 (Screening and Run-in Visit) An abnormal and clinically significant 12-lead ECG result. For the purposes of this study, an abnormal ECG result is defined as a 12-lead tracing that is interpreted as demonstrating (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
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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, Osteoarthritis, Knee Nociceptive Pain Virtual Reality patients who were transferred to RM after unilateral TKA patients cannot freely move the contralat. leg d/t neurologic or musculoskeletal problems patients are not enough clear to indicate VAS patients cannot look at the virtual reality monitor d/t visual problem refusal of the 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, Chronic Obstructive Pulmonary Disease COPD All study subjects should be able to provide informed consent Males or females ages 18 years and older Must provide HIV informed consent WITH LUNG Must provide informed consent Males and females age 18 years and older Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and/or (6) diseases of organs with known association with lung disease Must provide HIV informed consent Individuals not deemed in good overall health by the investigator will not be accepted into the study Habitual use of drugs and/or alcohol within the past six months (Acceptable: - Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria) Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study Individuals with allergies to atropine or any local anesthetic will not be accepted into the study Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study Females who are pregnant or nursing will not be accepted into the study WITH LUNG Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria) Females who are pregnant or nursing
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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, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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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, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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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 Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 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): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL
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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, Blood Pressure Depression Panic Attack Fibromyalgia POTS Inappropriate Sinus Tachycardia Coronary Heart Disease Acute Coronary Syndrome (ACS) Acute Myocardial Infarction (AMI) Cerebrovascular Disease (CVD) Transient Ischemic Attack (TIA) Atrial Fibrillation Diabetes Mellitus Cancer Systolic Heart Failure Diastolic Heart Failure Chronic Fatigue Syndrome Syncope Vasovagal Syncope Any patient regardless of the age of gender Any non-correctable secondary cause of increase or decrease in blood pressure or a pathology that alters the prognosis before the entrance of the patient into this registry nephropathy prior to the admission familial dyslipidemia previous gastric bypass pre-existing heart failure chemotherapy-induced cardiotoxicity arrhythmogenic right ventricular dysplasia long QT syndrome hypertrophic cardiomyopathy
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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): 18.0-75.0, Refractory Ascites Hepatic Hydrothorax Hepatic Encephalopathy Cirrhosis Cirrhosis (any etiology) Refractory ascites or hepatic hydrothorax and plan for TIPS placement Well-documented overt hepatic encephalopathy, either persistent or at the time of screening Any contraindication for TIPS placement Except for coagulopathy and thrombocytopenia (decided on an individual basis) Uncontrolled depression/anxiety disorder or use of antipsychotic drugs Active use of alcohol or illicit drugs History of dementia TIPS planned for another indication Active alcoholic liver disease
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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): 18.0-75.0, Prostatic Diseases Men who be referred a new urological outpatient and satisfy the following Wanted examined because of elevated PSA Not strong family history of prostate cancer It is taken biopsy as part of routine investigation. 2. Control group: Men referred to urological outpatient clinic, and who satisfy the following urination complaints Normal PSA examination shows prostate size> 40cc 3. Control group: Men first time referred urological / gastroenterological outpatient clinic, and which satisfy the following - symptoms that might indicate cancer suspicion in colorectum 4. Age> 40 years and <75 years known prostate cancer 2. Reduced consent 4 Familial occurrence of prostate cancer (one or more 1st degree relatives with CaP)
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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): 19.0-95.0, Chronic Obstructive Pulmonary Disease years of age or older diagnosis of COPD patients admitted to the hospital for a COPD exacerbation OR attending the COPD clinic and not experiencing a COPD exacerbation under 19 years of age patients seen in the COPD clinic who are experiencing an exacerbation
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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, ASTHMA Patients diagnosed with asthma Patients unable to perform the maneuver the measurement of the TAE
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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, Somatic Symptom and Related Disorders Intensive Short Term Dynamic Psychotherapy Patients aged 18-65 years Emergency department physician determines that physical symptoms and/ or impairment associated with the physical symptoms are not explained by physical pathology Patients must meet diagnostic for a Somatic Symptom or Related Disorder (SSRD) as assessed by the Structured Clinical Interview for DSM Disorders 5th Edition Research Version (SCID-5-RV) Symptom duration of at least 3 months or recurrently each month Cut off of at least 4 symptoms for men and 6 for women using the SOMS Participants consent to audio-visual taped sessions and the investigator accessing their electronic health records, if deemed necessary Stable with pharmacotherapy over previous 4 weeks Symptoms which can be entirely explained by a medical condition Already receiving ongoing psychological treatment The research physician determines that the physical symptoms and/ or impairment has definite physical pathology Any diagnosis of current psychosis, bipolar or manic depression, substance abuse/dependence or active suicidality as assessed by the SCID-5-RV Complaints which are considered to be malingering or factitious Patients who are unable to give informed consent to treatment
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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 (COPD) severe and very severe COPD (i.e. with an FEV1 (forced expiratory volume in 1 second) value under 50% of the predicted value, an FEV1/FVC (forced vital capacity) ratio < 70%, MRC (Medical Research Council Dyspnoea Scale) grade 3) ≥40 years hospitalization with exacerbation of COPD declined participation in the hospital based rehabilitation participation in videoconference sessions with a nurse for one week immediately after discharge inability to communicate via telephone and computer systolic BP <100mm Hg X-rays of the thorax showing abnormalities suspicious of thoracic malignancy or lobar pneumonia a diagnosis of cancer or recurrence of cancer within the last 5 years hospitalization with septic shock, acute myocardial infarction (AMI) or other serious medical conditions (e.g. kidney disorder) heart failure (EF<30%) if the patient did not wish to participate
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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): 8.0-30.0, Deformity of Chest Wall Males and females ages 8 to 30 years Undergoing surgical procedures on the chest wall region performed to correct Pectus Excavatum deformities 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): 18.0-999.0, Chronic Heart Failure Heart failure diagnosed on a first hospitalization for acute exacerbation during the last twelve months, without high age limit Men or women More than 18 years old Minimal knowledge of the French language (patient or his relatives) The patient need to fill an informed written consent Patient resides or is treated in Ile de France Patient is insured under the social security system Myocardial infarction or revascularization or Heart Valve Surgery < 3 months Inability to execute the feasibility test Major cognitive disorders do not allow access to the platform Patient does not have the necessary autonomy to use the equipment Sensitive subject, under Article L32 of the Code of Public Health Patient enrolled in another clinical trial Renal failure with creatininemia clearance (cockcroft) <15 ml/min /day oxygen
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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): 3.0-999.0, Chronic Granulomatous Disease Both HCT and non-HCT subjects must be over the age of 2 and actively enrolled and receiving treatment under a CGD protocol at NIAID
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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, Coronary Artery Disease All patients presenting to participating nuclear imaging facilities with Rb-82 PET for diagnosis and/or risk stratification for CAD (as listed in the approved Ruby-Fill product monograph), who are at least 18 years of age and have given informed consent or those who have consented to and are currently participating in an Ottawa Health Science Network Research Ethics Board (OHSN-REB) approved protocol utilizing Rb-82 PET will be eligible Patients with contraindications to stress radionuclide imaging including Severe reactive airway disease <3 days post myocardial infarction (MI) or acute coronary syndrome (ACS) presentation Unstable crescendo angina High grade atrioventricular (AV) block Severe claustrophobia Patients who are or may be pregnant will be 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, Obstructive Chronic Bronchitis With Acute Exacerbation Hospitalized patients with acute exacerbation of COPD age over 18 years hospitalized patients and acute exacerbation of COPD Previous history of any chronic respiratory disease and not to have performed any kind of general or respiratory training in the previous 3 months
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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 Chronic Bronchitis Written informed consent. 2. Age ≥ 40 years. 3. Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio (post-bronchodilator) <70%. 4. FEV1 (post-bronchodilator) < 80% of predicted Moderate and severe exacerbations during the last 4 weeks. 2. Pregnancy. 3. Already participated in the study (allowed to participate only once)
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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): 0.0-18.0, Chronic Illnesses Patients 18 years old or younger with a chronic illness, high healthcare utilization (>3 emergency department visits, >2 hospitalizations or >1 pediatric intensive care unit admission in the prior year), and a >50% likelihood of hospitalization in the coming year (as estimated from the patient's diagnosis and clinical course by our clinic's medical director), who lived within a one-hour commute of our center Patients with complex problems given primary care by a specialist at all hours (e.g. infants in our neonatal follow-up program and children with serious unrepaired congenital heart disease, a mitochondrial disorder, organ transplant, treatment with dialysis or central lines; or a do-not-resuscitate order)
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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): 18.0-60.0, Asthma Healthy Volunteers Be a man or woman between 18 to 60 years of age, inclusive, at the time of signing the informed consent Cohorts 1, 2 & 3 women of childbearing potential must have a documented menstrual period prior to the first dose and be willing to use 2 forms of appropriate methods of contraception from screening until 4 months after the final dose of RV1729, OR Women of non-childbearing potential must be spontaneously amenorrhoeic for at least 1 year or have been permanently sterilised, OR If a man, must be willing and able to use one of the contraception methods listed in the protocol and agree not to donate sperm from screening until 4 months after the final dose of RV1729 Women must agree not to donate eggs (ova, oocytes) from screening until at least 6 months after the final dose of RV1729 Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study Body mass index between 19 and 30 kg/m2 and body weight not less than 50 kg Vital sign assessments within normal ranges Have a 12-lead ECG recording consistent with normal cardiac function Capable of complying with all study restrictions and procedures including ability to use the study inhaler correctly Cohorts 1, 2 & 4 (healthy volunteers only) Upper or lower respiratory tract infection within 4 weeks before screening Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening or Day -1 Has a history of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease History of, or a reason to believe a subject has a history of drug or alcohol abuse within the past 5 years Positive test for alcohol or drugs of abuse, including cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines or barbiturates at screening or on Day -1 History of clinically significant allergies that, in the opinion of the Investigator or Medical Monitor, would contraindicate their participation Subjects known to suffer from hayfever, or other allergy, that may require antihistamine therapy during the course of the study Known allergy to the study drug or any of the excipients of the formulation or has previously been exposed to RV1729 Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months or intention to donate blood or blood products during the study Received an experimental drug or used an experimental medical device within 3 months or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
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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): 50.0-80.0, Chronic Obstructive Pulmonary Disease Chronic Bronchitis clinical diagnosis of Acute Exacerbation of COPD or Acute Exacerbation of Chronic Bronchitis Respiratory Rate>25 PaCO2> 45 mmHg 35 < PH < 7.38 intubation apnea glasgow coma scale < 8 pneumothorax FEV1 < 50% predicted Ischemic Hearth 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): 18.0-999.0, Chronic Obstructive Pulmonary Disease Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation or stable Signed written consent Medical approval for Heart disease Neurological patients Severe cognitive impairment in order not to complete the assessment
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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, Kidney Transplantation Kidney transplant patient for whom renal biopsies are stored in the "collection of the University Hospital Toulouse" (collection N° DC-2009-989) and who received information on the purpose of the study, use of biopsies and who has not manifested any opposition Kidney transplant patient with iterative biopsies with at least: post-surgery biopsy D0 (or early post-transplant biopsy D7 and at least one biopsy protocol Age> 18 years Case group Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR progressing to CTG between 2006 and 2013. Control group Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR without progressing to CTG between 2006 and 2013 patient with uncontrolled hypertension patient with diabetes mellitus - patient treated or who was treated with mTOR inhibitor recurrence of the initial glomerular pathology de novo glomerulopathy patient including in another study with an period still going
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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, COPD Healthy Constrictive Bronchitis Healthy subjects Normal PFT values: FEV1 > 90% predicted; and Forced vital capacity (FVC) > 90% predicted Normal chest x-ray (CXR) Medical history: No active pulmonary symptoms (cough, shortness of breath, sputum); Negative history of pulmonary disease; Negative smoking history (never smoked) Pulmonary Disease Subjects PFT values: FEV1/FVC < 70% (indicative of obstruction); and 30% < FEV1 < 50% predicted CXR normal except hyperinflation Symptoms chronic shortness of breath All test subjects, healthy and with COPD should have similar physical anthropometric characteristics Any condition for which a MRI procedure is contraindicated Presence of any non-MRI compatible metallic material in the body, such as pacemakers, metallic clips, etc Likelihood of claustrophobia Chest circumference greater than that of the helium MR coil Pregnancy, by report of subject. Clinically in the Department of radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging
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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): 18.0-80.0, HIV COPD Pulmonary Disease Aging Pregnancy or breast-feeding Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.) Increasing respiratory symptoms or febrile (temperature >100.40F [380C]) within 4 weeks of study entry Hospitalization within 4 weeks prior to study entry Uncontrolled hypertension at screening visit (systolic > 160 mm Hg or diastolic > 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled Active cancer requiring systemic chemotherapy or radiation Active infection of lungs, brain, or abdomen Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator HIV+ young HIV-1 infection, documented in medical record at any time prior to study entry Men and women age 45 years and below Ability and willingness to complete all tests Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community HIV+ old HIV-1 infection, documented in medical record at any time prior to study entry Men and women age 50 years and above Ability and willingness to complete all tests Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community HIV young
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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, HIV-1 Infection HIV-1 infection Currently on continuous ART for ≥48 weeks prior to study entry. NOTE: This is defined as continuous active therapy with no treatment interruption longer than 7 consecutive days and a total duration off-treatment of no more than 14 days during the 48 weeks prior to entry No change in ART regimen within the 12 weeks prior to study entry (except as noted below). NOTE: Modifications of ART dosing during within the 12 weeks prior to entry are permitted. In addition, the change in formulation (eg, from standard formulation to fixed dose combination or single tablet regimen) or dosing (eg, from once a day to twice a day) is allowed within 12 weeks prior to entry. Within-class single drug substitution (eg, switch from nevirapine to efavirenz or from atazanavir to darunavir), are not allowed within 12 weeks prior to entry. No other changes in ART in the 12 weeks prior to entry are permitted Screening HIV-1 RNA must be <50 copies/mL and performed by any FDA-approved assay at any US laboratory that has a CLIA certification or its equivalent within 45 days prior to study entry Maintain ART-mediated viral suppression for at least 48 weeks prior to study entry defined as: A. At least one HIV-1 RNA test result obtained at any time point greater than 48 weeks prior to study entry must be BLQ and must be performed by any FDA-approved assay at a CLIA-certified laboratory or its equivalent. AND B. All HIV-1 RNA tests reported during the 48 weeks prior to study entry must be BLQ and must be performed by any FDA-approved assay at a CLIA-certified laboratory or its equivalent. NOTE: A single RNA "blip" of ≤500 copies/mL is permissible if RNA levels most recent before and after (may the screening HIV-1 RNA test) are below the level of quantification (BLQ) for the assay. If the RNA level after the blip is the screening HIV-1 RNA test, the result must be <50 copies/mL The following laboratory values obtained within 45 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent Absolute neutrophil count (ANC) ≥750/mm^3 Hemoglobin ≥9.0 g/dL for female subjects and ≥10.0 g/dL for male subjects Platelet count >100,000/mm^3 Prothrombin time (PT) <1.2 x upper limit normal (ULN) Current malignancy (except non-melanoma cancer of the skin not requiring systemic chemotherapy or radiation therapy). NOTE: Carcinoma in situ of the cervix or anus is not considered exclusionary Prior history of malignancy if the subject is not disease free for 24 or more weeks prior to study entry Current use or indication for use of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin that cannot be interrupted for clinical reasons. Examples of clinical reasons but are not limited to, known and documented cardiovascular disease (history of MI, coronary artery bypass graft surgery, percutaneous coronary intervention, stroke, transient ischemic attack, peripheral arterial disease with ABI <0.9 or claudication) Current diagnosis of diabetes with HbA1c ≥8% within 24 weeks prior to screening Changes in lipid-lowering or antihypertensive medication within 90 days prior to study entry or expected need to modify these medications during the study. NOTE: Lipid-lowering medication includes: statins, fibrates, niacin (dose ≥250 mg daily), and fish-oil/omega 3 fatty acids (dose >1000 mg of marine oils daily) Known cirrhosis Known chronic active hepatitis B NOTE: Active hepatitis B is defined as hepatitis B surface antigen positive and hepatitis B DNA positive within 24 weeks prior to study entry; subjects with hepatitis B virus (HBV) DNA BLQ for greater than 24 weeks prior to study entry are eligible Known chronic active hepatitis C NOTE: Active hepatitis C is defined as a detectable plasma HCV RNA level within 24 weeks prior to study entry; subjects with HCV RNA BLQ for greater than 24 weeks prior to study entry are eligible Known inflammatory conditions, such as, but not limited to, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), sarcoidosis, inflammatory bowel disease (IBD), chronic pancreatitis, autoimmune hepatitis, Adult Stills disease, Rheumatic heart disease, bursitis Breastfeeding or pregnant
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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): 40.0-95.0, COPD Patients A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines. 4. Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year). 5. Post-bronchodilator FEV1/forced vital capacity (FVC) <0.7 (70%) and FEV1 ≤70% of predicted normal (PN) value. 6. Documented use of a short-acting inhaled bronchodilator (β2-agonists or anticholinergics) as rescue medication within 6 months prior to study start. 7. A score of ≥2 on the modified medical research council (MMRC) dyspnea scale. 8. Documented history of ≥1 moderate or severe COPD exacerbation(s) that required treatment with systemic (oral, IM, IV) corticosteroids (a minimum 3 day course of an oral corticosteroid treatment or single depot corticosteroid injection), or hospitalization (defined as an inpatient stay or >24 hour stay in an observation area in the emergency department or other equivalent facility depending on the country and healthcare system) within 2-52 weeks before Visit 1 (i.e., not within the 14 days prior to Visit 1). A history of an exacerbation treated exclusively with antibiotics will not be considered adequate A history of asthma at or after 18 years of age. 2. Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure (including significant cor pulmonale), uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator. 3. Known homozygous alpha-1 antitrypsin deficiency. 4. Any significant disease or disorder (e.g., gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study. 5. A history of malignancy (except basal cell carcinoma) within the past 5 years. 6. Active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, or other active pulmonary diseases. 7. Subjects who have needed additions or alterations to their usual maintenance or change in formulation of rescue therapy for COPD due to worsening symptoms within the 14 days prior to Visit 1 and up to Visit 3. 8. CXR (frontal and lateral) with suspicion of pneumonia or other condition/abnormality that will require additional investigation/treatment, or put the subject at risk because of participation in the study. 9. Risk factors for pneumonia: immune suppression (HIV, lupus) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's disease, myasthenia gravis, etc.). 10. Pneumonia not resolved within 14 days of Visit 1. 11. Moderate or severe COPD exacerbation that has not resolved within 14 days prior to Visit 1 or a moderate or severe COPD exacerbation that occurs between Visit 1 and Visit 2. 12. Long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. 13. Subjects who are currently in the intensive rehabilitation phase or scheduled to begin new participation (intensive rehabilitation phase) in a pulmonary rehabilitation program during the study or have started a new pulmonary rehabilitation program within 60 days of Visit 1. Subjects in the maintenance phase of pulmonary rehabilitation program are not excluded. 14. Treatment with oral, parenteral, or intra-articular corticosteroids within 4 weeks prior to Visit 1. 15. Omalizumab or any other monoclonal or polyclonal antibody therapy taken for any reason within 6 months prior to Visit 1
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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): 0.0-45.0, Sudden Unexplained Death Index case age between birth years Clinical presentation of sudden / unexplained death (believed to be cardiac in nature OR secondary to a massive unprovoked pulmonary embolism with no prior diagnosis of prothrombotic disease) Premature death secondary to murder, suicide or external causal event Premature death thought secondary to known chronic comorbid medical condition Premature death thought secondary to end-organ failure (kidney, liver, lung) other than heart Previously diagnosed with hypertrophic cardiomyopathy (HCM) Prior myocardial infarction (regardless of stenting or bypass) Prior cerebrovascular accident (stroke or TIA) History of open heart surgery (for any reason) History of severe, untreated hypertensive heart disease History of illicit drug use History of heavy alcohol abuse
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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 Age ≥ 40 years A diagnosis of relatively stable, moderate to severe COPD with Screening FEV1 ≤ 60% of predicted normal value (calculated according to European Community for Coal and Steel (ECCS) and screening FEV1/FVC ≤ 70% Smoking history ≥ 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent) Ability to be trained in the proper use of the HandiHaler® device and Metered Dose Inhaler (MDI) Ability to perform all study related tests including the Shuttle Walking Test, acceptable pulmonary function tests, including Peak expiratory flow rate (PEFR) measurements, and maintenance of diary card records Ability to give written informed consent in accordance with Good Clinical Practice and local regulations Clinically significant diseases other than COPD Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an criterion, will be excluded All patients with a serum glutamic oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic pyruvic transaminase (SGPT) > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition A recent history (i.e., one year or less) of myocardial infarction Any cardiac arrhythmia requiring drug therapy or hospitalisation for heart failure within the past three years Inability to abstain from regular daytime use of oxygen therapy for more than 1 hour per day Known active tuberculosis History of cancer within the last five years (excluding basal cell carcinoma) History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis Patients who have undergone thoracotomy with pulmonary resection
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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, COPD confirmed COPD GOLD stage I-IV, based on a post-bronchodilator spirometry (FEV1/FVC < 0.7) performed within the last 6 months age between 18 and 80 years at study entry healthy controls: normal spirometry COPD exacerbation within the last 6 weeks any lung disease other than COPD acute inflammatory disease (e.g. common cold) within the last 6 weeks acute or chronic hepatic disease renal failure or renal replacement therapy
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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, Pulmonary Disease, Chronic Obstructive All patients must have a diagnosis of COPD Male or female patients 40 years of age or older Patients must have a smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year Patients must be able to perform technically satisfactory pulmonary function tests Patients must be able to be trained in the proper use of a metered dose inhalator (MDI) All patients must sign an Informed Consent Form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medications Patients must be on at least one regular aerosol bronchodilator for control of their COPD symptoms and have symptoms of bronchospasm (wheeze or shortness of breath) present OR Patients must be on at least two classes of prescribed bronchodilators on a regular basis for control of their COPD symptoms for the three month period immediately preceding the screening visit Patients with significant disease other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an criterion, the patient is excluded All patients with a serum aspartate amino transferase (ASAT/SGOT) > 80 IU/L, serum alanine amino transferase (ALAT/SGPT) > 80 IU/L, bilirubin > 2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these patients Patients who have a total bood eosinophil count >= 600 mm**3. A repeat eosinophil count will not be conducted in these patients Patients with a recent history (i.e. one year or less) of myocardial infarction Patients with a recent history (i.e. three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis Patients who have undergone thoracotomy with pulmonary resection. Patients wth a history of thoracotomy for other reasons should be evaluated as per criterion No. 1 Patients with a history of asthma, allergic rhinitis or atopy
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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, Benign Prostatic Hyperplasia male adults > 40 years old severe symptomatic BPH with IPSS > 18 and/or QoL > 3 or maximum urinary flow rate (Qmax) ≤ 15 ml/sec or transurethral catheter for retention no improvement after or intolerance of medical treatment for at least six months prostatic volume > 30 cm³ female less than 40 years old eGFR < 45 ml/min * m² suspicion of prostatic malignancy prostatic malignancy acute prostatitis or cystitis hydronephrosis bladder stone or bladder diverticulum urethral stenosis major surgery within 4 weeks prior to the screening visit
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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): 18.0-90.0, Chronic Obstructive Pulmonary Disease should meet all the 1. Acute exacerbated chronic obstructive pulmonary disease 2. Invasive mechanical ventilation with intubation outside ICU no more than 48 hours Meet any of the 1. Asthma 2. Tracheotomy 3. Prolonged Mechanical Ventilation (Have been mechanical ventilated for more than 21 days) 4. Unstable hemodynamic status 5. Severe pneumonia 6. Contraindication for bronchodilator 7. Contraindication for sedation 8. Refusal to participate in study 9. Re-intubation in 48 hours 10. Mental disorder, could not understand and accomplish pulmonary function test
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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): 18.0-60.0, Multiple Sclerosis Male or female adult patients 60 years of age Diagnosis of multiple sclerosis, in accordance with the revised McDonald (2010) Patients naive to MS therapy or patients switching from an FDA-approved MS therapy, including IFN-B formulations, Cop-1, Teriflunomide, and Fingolimod to BG-12 Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive Primary progressive multiple sclerosis patients Patients with previous exposure or known allergies to fumarates MS patients switching from natalizumab, cyclophosphamide, or mitoxantrone to BG-12 Contraindications for MRI/MRS Known presence of other neurological disorders that may mimic multiple sclerosis Pregnancy or lactation Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study History of or currently active primary or secondary immunodeficiency Active infection, or history of or known presence of recurrent or chronic infection (e.g. hepatitis B or C, HIV, syphilis, tuberculosis_ History of progressive multifocal leukoencephalopathy
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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 Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease Age≥ 40years old The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease Chest radiography shows congestive heart failure Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases Serious cardiac failure, renal insufficiency or hepatic dysfunction
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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): 18.0-100.0, COPD Consenting adults over the age of 18 with COPD Apnea Hypopnea Index>15 events/hr 2. Use of Non-invasive positive pressure ventilation (CPAP + Bilevel) 3. Severe bilateral nasal obstruction (apparent mouth breathing at rest) 4. Documented clinical cardiovascular disease, as defined below: 1. myocardial infarction in past 3 months 2. revascularization procedure in past 3 months 3. implanted cardiac pacemaker or ICD 4. unstable arrhythmias 5. congestive heart failure with ejection fraction < 40% 6. uncontrolled hypertension (BP > 190/110) 5. History of end stage renal disease (on dialysis) 6. History of end stage liver disease, such as: 1. Jaundice 2. ascites 3. history of recurrent gastrointestinal bleeding 4. transjugular intrahepatic portosystemic shunt (TIPS) ; 7. Transportation industry worker (commercial truck or bus drivers, airline pilots) 8. Known pregnancy (by self report) 9. Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin. 10. Do you take medications for any of the following reasons: 1. Pain control (besides NSAIDs) 2. Sleep medication 3. Benzodiazepines 4. Methadone
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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 Clinical diagnosis of COPD (according to GOLD guidelines, updated 2014) with a post-bronchodilator FEV1/FVC <0.70 Patients with a post-bronchodilator FEV1 ≥30% and <60% of the predicted normal value Resting daytime oxygen saturation levels measured by pulse oximetry of ≤95% SpO2 Smoking history of at least 10 pack years (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years) An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or glucocorticosteroids and/or hospitalization related to COPD) within 4 weeks prior to screening or during the run-in period Diagnosed asthma Patients receiving regular long term oxygen therapy (LTOT) Ongoing / planned rehabilitation during the study period Three or more awakenings during the night leading to toilet visit or other reasons for exiting the bed during the last week prior to the screening visit due to non-COPD reasons 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): 40.0-999.0, Chronic Obstructive Pulmonary Disease For COPD groups: post-bronchodilator forced expiratory volume in 1 sec (FEV1) ≥ 80% predicted and a FEV1/forced vital capacity (FVC) ratio < 0.70 For the "Asymptomatic mild COPD" group: modified Medical Research Council (mMRC) score equal to zero and absence of respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze For the "Symptomatic mild COPD" group: mMRC) score > 0 For the "Healthy controls" group: FEV1 > 80% predicted and FEV1/FVC > 0.7) and a mMRC score equal to zero and absence of respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze Able to perform all study procedures and provide informed consent Presence of a medical condition other than COPD that could cause or contribute to breathlessness (i.e., a respiratory disease other than COPD and/or a metabolic and/or a cardiovascular disease) Presence of disorders other than COPD that could interfere with exercise testing, such as neuromuscular diseases or musculoskeletal problems History or clinical evidence of asthma 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): 30.0-999.0, Chronic Obstructive Pulmonary Disease stable chronic obstructive pulmonary disease contra-indication for six minutes walking test difficulty to walk musculoskeletal disorder
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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, Pulmonary Disease, Chronic Obstructive Type of subject: outpatient Informed Consent: a signed and dated written informed consent prior to study participation Age: subjects 40 years of age or older at Visit 1 Gender: male and female subjects are eligible to participate in the study. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile. Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, eg, age appropriate, > 45 years, in the absence of hormone replacement therapy OR child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods used consistently and correctly i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study screening to follow-up contact Diagnosis: an established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society (ERS) Smoking history: current or former cigarette smokers with a history of cigarette smoking of >= 10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (eg. 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years both equal 10 pack-years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack-year history Severity of Disease: A pre and post-albuterol/salbutamol forced expiratory volume in one second/ forced vital capacity (FEV1/FVC ratio of <0.70 and a post-albuterol/salbutamol FEV1 of >=30% and =<70% of predicted normal values at Visit 1. Predicted values will be based upon the ERS Global Lung Function Initiative Dyspnea: A score of >=2 on the modified medical research council dyspnea scale (mMRC) at Visit 1 Pregnancy: women who are pregnant or lactating or are planning on becoming pregnant during the study Asthma: a current diagnosis of asthma Other respiratory disorders: known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease Other diseases/abnormalities: any subject who is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediate life-threatening illness (e.g. cancer). In addition, any subject who has any condition (e.g. neurological condition) that is likely to affect respiratory function should not be included in the study Severe hepatic impairment: patients with severe hepatic impairment (Child-Pugh class C) should be excluded unless, in the opinion of the investigator, the benefit is likely to outweigh the risk Severe renal impairment: patients with severe renal impairment (e.g., end-stage renal disease requiring dialysis) should be excluded, unless in the opinion of the investigator, the benefit is likely to outweigh the risk Unstable or life threatening cardiac disease: long-acting muscarinic antagonists (LAMA) should be used with caution in subjects with severe cardiovascular disease. In the opinion of the investigator, use should only be considered if the benefit is likely to outweigh the risk in conditions such as: Myocardial infarction or unstable angina in the last 6 months, Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months, New York Heart Association (NYHA) Class IV heart failure Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/ muscarinic receptor antagonist, sympathomimetic, lactose/milk protein or magnesium stearate Antimuscarinic effects: Subjects with medical conditions such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction should only be included if, in the opinion of the study physician, the benefit outweighs the risk Hospitalization: hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1
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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, Hypophosphatasia Patients or their legal representative must provide written informed consent or, if applicable, qualify for waiver of consent Patients must have a pre-established clinical diagnosis of HPP, as indicated by one or more of the following Serum alkaline phosphatase (ALP) below the age-adjusted normal range Plasma PLP at least twice the upper limit of normal (no vitamin B6 administered for at least 1 week prior to determination) Evidence of osteopenia or osteomalacia on skeletal radiographs Genetic analysis fof the ALPL gene Any patient without confirmation of clinical diagnosis of HPP
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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 All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric Patients must have relatively stable* airway obstruction with a pre-dose FEV1 ≤ 60% of predicted normal and FEV1 ≤ 70% of FVC at Visits 1 and 2 *The enrolment of patients who have had an exacerbation within six weeks prior to planned study entry should be postponed At Visit 1, patients must demonstrate an improvement in FEV1 of ≥ 12% over the pre-bronchodilator value 45 minutes after inhalation of 4 puffs of 100 μg salbutamol (Sultanol® MDI) Male or female patients 40 years of age or older Patients must be current or ex-smokers with a smoking history of more than 10 pack-years ((Patients who have never smoked cigarettes must be excluded) Patients must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol Patients must be able to inhale medication in a competent manner from the HandiHaler® 2 device and the Diskus® device Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study Patients with a recent history (i.e., six months or less) of myocardial infarction Patients who have been hospitalized for heart failure (New York Heart Association (NYHA) class III or IV) within the past year Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥600/mm3 Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis Patients with known active tuberculosis Patients with significant alcohol or drug abuse within the past two years Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per criterion No. 1
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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 All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric Patients must have relatively stable* airway obstruction with a pre-dose FEV1 <= 60% of predicted normal and FEV1 <= 70% of FVC at Visits 1 and 2 * The randomization of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period should be postponed. Patients may be randomized 6 weeks following recovery from the infection or exacerbation 3. At Visit 1, patients must demonstrate an improvement in FEV1 of >= 12% over the baseline FEV1 value 45 minutes after inhalation of 4 puffs of 20 µg ipratropium bromide (Atrovent® MDI) 4. Male or female patients 40 years of age or older 5. Patients must be current or ex-smokers with a smoking history of more than 10 pack-years (Patients who had never smoked cigarettes had to be excluded) 6. Patients must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol 7. Patients must be able to inhale medication in a competent manner from the HandiHaler® 2 and the HandiHaler® devices Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study 2. Patients with a recent history (i.e., six months or less) of myocardial infarction 3. Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year 4. Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year 5. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed 6. Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥600/mm3. A repeat eosinophil count will not be conducted in these patients 7. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis 8. Patients with known active tuberculosis 9. Patients with significant alcohol or drug abuse within the past two years 10. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per criterion No. 1 11. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study 12. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy 13. Patients who are being treated with antihistamines (H1 receptor antagonists), antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions. See criterion No 6 14. Patients who are being treated with cromolyn sodium or nedocromil sodium 15. Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day 16. Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system (Spiriva® HandiHaler®; tiotropium HandiHaler 2) 17. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous three months (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants, e.g.: Norplant®) 18. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Visit 1 19. Patients who have been treated with oral beta-adrenergics within one month prior to Visit 1 or during the run-in period 20. Patients who have been treated with theophylline preparations within one month prior to Visit 1 or during the run-in period 21. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within one month prior to Visit 1 or during the run-in period 22. Patients with any respiratory infections in the six weeks prior to the Screening Visit (Visit 1) or during the run-in period. In the case of a respiratory infection during the run-in period the latter may be extended up to six weeks 23. Patients who are currently participating in another study23. The randomisation of patients with any respiratory infection or COPD exacerbation in the six weeks prior to the Screening Visit (Visit 1) or during the baseline period should be postponed. Patients may be randomised six weeks following recovery from the infection or exacerbation
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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, Prostatic Hyperplasia Male patients (45 years of age or older) diagnosed with benign prostatic hyperplasia Patients with a total score on the AUA Symptom Index for BPH of at least 13 points at each of the three initial visits (Visits 1, 2 and 3) A baseline prostate specific antigen (PSA) of ≤ 4.0 ng/ml Patients who are able to give written informed consent before performing screening examinations or tests Patients being judged by the investigator to be reliable and able to follow protocol procedures (including the return visits schedule), and cooperate in the completion of tests related to safety and efficacy Patients with a history of an allergy to alpha blockers, alpha/beta blockers or patients who have had a "first dose hypotensive episode" upon starting therapy with an alpha blocker Patients who are currently being treated or who, in the last 3 months, have been treated with finasteride Participated in an investigational drug study within 4 weeks prior to starting placebo phase Patients taking medication in the following classes and unable to discontinue them at least two weeks before the study and for the duration of the study Alpha adrenergic blocking agents Alpha adrenergic agonists Drugs with anticholinergic activity (including antihistamines) Antispasmodics Parasympathomimetics and cholinomimetics Peripheral or central neurologic disease including, but not limited to, transient ischemic attacks, stroke, dementia, multiple sclerosis, spinal cord injury, recurrent episodes of dizziness, vertigo, or loss of consciousness, clinically evident diabetic neuropathy, brain and/or spinal cord tumors
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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, Prostate Hyperplasia Phase I Adult men, 45 years of age or older, diagnosed with acute urinary retention due to BPH Patients who have never taken alpha-blockers or discontinued taking alpha-blockers 72 hours or more prior to entrance into this study Patients that have been treated with an indwelling urethral catheter as treatment for acute urinary retention (AUR) due to BPH Patients must be judged by the investigator to be reliable and willing to comply with all tests and examinations stipulated in the protocol All patients must be willing to give meaningful, written, informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must also have sufficient understanding to communicate effectively with the investigator Phase II Patients who voided spontaneously, at least 100 mL and a post-void residual volume of ≤ 300 mL, at Visit 2 Phase I Patients diagnosed with a symptomatic/active urinary tract infection (UTI) or an abnormal urine culture at baseline or 2 or more UTIs within the last six months. An abnormal urine culture was defined as A bacterial colony count of greater than or equal to 100,000 CFU/mL or A bacterial colony count of greater than or equal to 100 CFU/mL of a known urinary pathogen in a symptomatic patient Patients that have a distended bladder volume greater than 1.5 liters (1500 ml) of retention as measured by initial catheter urine volume Patients with history of sexually transmitted disease within last two years Patients with active genital herpes disease whose urinary function was impacted due to the disease Patients who have a history of mechanical outlet obstruction excluding BPH (i.e., bladder neck contracture or stricture, bladder tumor, or bladder calculi) Patients with urethral stricture disease Patients with a history of bladder, prostate, or urethral surgery in the last three 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, Chronic Obstructive Pulmonary Disease Current or former smokers (> 10 pack years) or biomass exposure years of age Clinical diagnosis of COPD Post-bronchodilator FEV1 < 70% predicted Post bronchodilator FEV1/FVC ratio < 0.7 Life expectancy of less than 12 months Exacerbation or respiratory infection within 4 weeks prior to randomisation Patient is taking and requires maintenance oral corticosteroids Patient is on domiciliary oxygen There has been previous pulmonary resection Previous sensitivity to, or intolerance of theophylline Coexistent illness precluding participation in the study (epilepsy, chronic liver disease, unstable cardiovascular disease, diabetes, active malignancy) Inability to complete quality of life questionnaire Concomitant major illness that would interfere with visits, assessments and follow-up Have evidence of chronic liver disease, or transaminase or gamma-glutamyltransferase (GGT) elevation > 1.5 x upper limit of normal (ULN)
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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, Cough Dyspnea Wheezing Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) Referred for CXR and/or CT scan Life threatening medical condition requiring immediate treatment Unable to sit up for a chest ultrasound Unable to consent Pregnant Unable to speak, read and write in English
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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): 18.0-64.0, Mental Illness aged 18-60 years, able to understand Cantonese/Mandarin having the first-onset of the mental illness (psychotic and mood disorders) within the past six months and new referral or contact with mental healthcare services presenting at least moderate to high levels of psychiatric symptoms (i.e., Brief Psychiatric Rating Scale score of >25 out of 126 and/or Chinese version of the Beck's Depression Inventory-II scores of >10 out of 63); and indicating no history and low risk of suicide and self-harm receiving other psychosocial interventions organized by the clinics or other healthcare organizations; and being classified as the highest priority of psychiatric consultation and treatment (i.e., starting their treatment and care plan with their attending psychiatrist and clinic nurse within one week). [Note: For SPBB study, the of the participants those who are: Hong Kong Chinese residents, aged 18-64; taking care of and living with a family member primarily diagnosed with one psychotic disorder in the past 12 months psychosis will be recruited; able to read and understand Cantonese/Mandarin; and perceived a moderate to high burden of care (measured by Family Burden Interview Schedule (>20 out of 50 scores) of family caregivers those: received or are receiving another family intervention; are having cognitive impairment or learning disability; and/or presented with a recent personal history of a serious mental illness or medical disease that may adversely affect their ability to participate in the intervention.]
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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): 0.083-17.0, Chronic Illness Children ages 0 to 17 years old who are enrolled in the Pediatric Medical Home Program at UCLA English and Spanish-speaking only Children older than 17 years old who are enrolled in the Pediatric Medical Home Program Non-English and Non-Spanish speakers
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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 Current or past cigarette smoking history of >/= 10 pack-years FEV1/FVC ratio </= 70% Known diagnosis of COPD Current hospitalization for a primary diagnosis of acute exacerbation of COPD Must be able to understand and willing to sign an informed consent document On a ventilator or mask ventilation Allergy or contraindication to Formoterol use Marked QTc prolongation (> 450 ms) Liver cirrhosis or chronic renal insufficiency (serum creatinine > 2 mg/dL) Atrial fibrillation with rapid ventricular response (heart rate > 110 bpm) or ventricular arrhythmia (frequent PVCs, ventricular tachycardia) Acute myocardial infarction within 12 weeks of patient study registration Known pulmonary embolism Known or suspected lung cancer Known neuromuscular disease, stroke with residual hemiparesis, or untreated Parkinsonism Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or sub dermal implants)
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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): 40.0-70.0, Chronic Obstructive Pulmonary Disease (COPD) Patients aged 40-70 years old; Patients with pulmonary function test of FEV1/FVC < 70% and FEV1%pred < 50%; Patients in a clinically stable state; Patients who signed informed consent Patients with signs of an airway infection; Patients with an acute exacerbation during the previous 4 weeks; Patients with giant bulla(≥3cm in diameter); Patients with recent upper abdominal surgery; Patients with one or more of the following diseases: esophageal cancer, reflux esophagitis, severe obstructive sleep apnea (apnea hypopnea index>15/hr), neuromuscular disease, or significant heart failure; Patients with poor compliance
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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, Pulmonary Disease, Chronic Obstructive COPD diagnosis and severity: Participants with a clinical history of COPD (established by a physician) in accordance with the following definition by the American Thoracic Society/European Respiratory Society, for at least 6 months prior to enrolment. Participants must have evidence of airflow obstruction, defined as post-bronchodilator FEV1 equal to or less than 80% of predicted normal value calculated using "Third National Health and Nutrition Examination Survey" (NHANES III) reference equation at Visit 1 and a FEV1 / FVC ratio <=70% at Screening (Visit 1). Note: Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the participants has self-administered 4 inhalations (i.e., total 400/360 [microgram] mcg) of salbutamol/albuterol via a Metered Dose Inhaler (MDI) (use of spacer will be optional). The study-provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values Exacerbation History: A documented history (e.g., medical record verification) in the 12 months prior to Visit 1 of >=2 COPD exacerbations resulting in prescription for antibiotics and/or oral corticosteroids or hospitalisation or extended observation in a hospital emergency room or outpatient centre. Note: Prior use of antibiotics alone does not qualify as a moderate exacerbation unless the use was specifically for the treatment of worsening symptoms of COPD Existing COPD maintenance treatment: Participants must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Notes: Participants receiving only "pro re nata" or as needed (PRN) COPD medications are not eligible for in the study. All participants will continue on their current Standard of Care (SoC) COPD medications throughout the entire duration of the study Tobacco use: Participants with a current or prior history of >=10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. One pack year =20 cigarettes smoked per day for 1 year or the equivalent. Number of pack years=(number of cigarettes per day/20) x number of years smoked Sex: Male or female participants aged >=40 years at Screening (Visit 1). A female participant is eligible to participate if she is of non-child bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international unit/milliliter (MIU/mL) and estradiol <40 picogram/milliliter (pg/mL) (<140 [Picomoles per liter] pmol/L) is confirmatory] or if of child-bearing potential is using a highly effective method for avoidance of pregnancy from 30 days before the first dose, for the duration of dosing and until 2 weeks post last-dose Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Corrected ECG QT interval (QTc)<450 milliseconds(msec) or QTc<480 msec for participants with bundle branch block. The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or manual over-read. For and withdrawal, ideally the same QT correction formula will be used for all participants. However, because this is not always possible, the same QT correction formula will be used for each individual participant to determine for and withdrawal from the study. The QTc will be based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period Eosinophils: >2.0% blood eosinophils at Screening (Visit 1) Concomitant medication: COPD Medication: Participants currently on chronic treatment with macrolides or Roflumilast; Long term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen PRN use (i.e. <=12 hours per day) is not exclusionary. Multidrug and toxin extrusion (MATE) transporter 1 (MATE1) inhibitors: cimetidine, pyrimethamine, trimethoprim (short course treatment with trimethoprim is allowed). Other medications: Chronic maintenance therapy with anti-Tumor Necrosis Factor (anti-TNF), anti-Interleukin-1 (anti-IL1), phosphodiesterase type 4 (PDE4) inhibitors, or any other immunosuppressive therapy (not including steroids) within 60 days prior to dosing. Any other investigational drug within 30 days or 5 half lives, whichever is longer prior to Screening Visit Other respiratory disorders: Participants with asthma (as primary diagnosis) lung cancer, bronchiectasis, active sarcoidosis, active lung fibrosis, cystic fibrosis, idiopathic pulmonary hypertension, active interstitial lung diseases or other active pulmonary diseases. Participants with alpha-1-antitrypsin deficiency as the underlying cause of COPD Participants with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device Participants who require a non-invasive positive pressure ventilation (NIPPV) device (Note: Use of non invasive ventilation (NIV) in hospital as part of the medical management of an acute exacerbation is permitted.) Lung resection: Participants who have undergone previous lung reduction surgery (e.g. lobectomy, pneumonectomy, or lung volume reduction) COPD stability: Less than 30 days prior to Visit 1 have elapsed from completion of a course of antibiotics or oral corticosteroids for a recent COPD exacerbation Evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD on chest X-ray (posteroanterior with lateral) or computerised tomography (CT) scan (historic data up to 1 year may be used) Pulmonary rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Participants who are in the maintenance phase of a pulmonary rehabilitation program are not excluded Alanine aminotransferase (ALT) >2x Upper limits of normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
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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, Pulmonary Disease, Chronic Obstructive Subject must be 18 years of age or older Subject has been diagnosed as having asthma and/or COPD Informed consent is required for independent sites initiating this protocol
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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): 18.0-75.0, Inflammatory Disorder of the Respiratory Tract Chronic Obstructive Pulmonary Disorder Informed consent Males following contraception requirements, and agree not to donate sperm during study lead ECG within normal range and no clinically significant abnormality Screening Holter report (minimum 18 hours) recording that is able to be evaluated for rhythm analysis which shows no abnormality which indicates a significant impairment of subject safety or which may significantly impair interpretation Capable of complying with all study restrictions and procedures including ability to use the study nebuliser correctly Body weight ≥50 kg Negative for HIV, HBV and HCV Negative cotinine tests prior to randomisation. Additional Healthy Subjects (Parts A and B) only Males aged 18 and 50 years Respiratory tract infection (both upper and lower) treated with antibiotics in last 12 weeks Clinically significant abnormal values for safety laboratory tests or physical examination History or suspected history of drug or alcohol abuse within the past 5 years Known allergy to the study drug or any of the excipients of the formulation Donated blood or blood products or had substantial loss of blood (more than 500 mL) in last 4 weeks or intention to donate blood or blood products during the study Received an experimental drug or used an experimental medical device within 3 months or within a period less than 5 times the drug's half-life, whichever is longer Pre-planned surgery or procedures that would interfere with the conduct of the study Employee of the Investigator or study site or family members of the employees or the Investigator History of regular alcohol consumption within last 6 months Unable or unwilling to comply fully with the study protocol
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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): 20.0-75.0, Chronic Obstructive Pulmonary Disease (COPD Stage 1 (healthy volunteers) The subject is a male or female 20 to 75 years of age, inclusive, weighing 50 to 80 kg with a body mass index (BMI) of less than 30 kg/m2. Note: Every effort should be made to enroll approximately equal numbers of men and women in each group The subject is in good health as determined by medical and psychiatric history, physical examination, electrocardiogram (ECG), serum chemistry, hematology, urinalysis, and serology Other apply, please contact the investigator for more information Stage 2 (COPD patients) Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack years at the SV (number of cigarette packs smoked per day multiplied by the number of years smoked; eg, 2 packs/day for 3 years equals a 6 pack year history) Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines Male or female; 40 to 75 years of age, inclusive Patient is free of any other medical conditions or concomitant treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study Other apply, please contact the investigator for more information Stage 1 (healthy volunteers) History or current evidence of a clinically significant or uncontrolled disease Any disorder that may interfere with the absorption, distribution, metabolism or excretion of study drugs History of severe allergy to milk protein Active smokers or former smokers who quit within 3 months of the first dose of study drug. Former smokers with greater than five-pack years (ie, the equivalent of one pack per day for five years) are also excluded Other apply, please contact the investigator for more information Stage 2 (COPD patients) Recent history of hospitalization due to an exacerbation of airway disease within 3 months Need for increased treatments of COPD within 6 weeks prior to the SV Occurrence of a COPD exacerbation, which is not resolved by 4 weeks or more prior to the SV/informed consent. (Note: An exacerbation of COPD is defined as any worsening of the patient's baseline COPD symptoms requiring any treatment other than rescue albuterol or the patient's regular maintenance therapy. This includes requiring the use of systemic corticosteroids, antibiotics, and/or emergency room visit or hospitalization.)
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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): 45.0-999.0, COPD Established diagnosis of COPD with FEV1 <60% predicted FEV1/FVC <70% and <+15% FEV1 response to bronchodilator Patients of both genders will be included IRB approved written informed consent will be obtained from each subject Recent (<1 month) exacerbation of COPD, 2. Known hypersensitivity to beta agonists, theophylline, steroids, or roflumilast. 3. Current or recent (<2 weeks) treatment with oral steroids, theophylline or other methylxanthines, or roflumlast. 4. Diagnosis or history of asthma, uncontrolled hypertension, or congestive heart failure. 5. History of Cardiac arrhythmia 6. History of seizures. 7. History of Liver disease 8. Gastrointestinal disease, including history of peptic ulcer disease. 9. Current infection or antibiotic treatment. 10. History of depression or psychiatric disease
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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): 50.0-999.0, COPD Stable symptomatic patients with GOLD grade 1B mild COPD at least 50 years of age a cigarette smoking history ≥20 pack-years a Baseline Dyspnea Index focal score ≤9 post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥80 %predicted and an FEV1/forced vital capacity (FVC) ratio <0.7 and < lower limit of normal clinically significant comorbidities contraindications to exercise testing history/clinical evidence of asthma body mass index <18.5 or >30 kg/m2 use of supplemental oxygen
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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): 35.0-50.0, COPD **Inclusion COPD case Subjects between 35 and 50 years Post-bronchodilator spirometry with FEV1/FVC <70% Smoker or ex-smoker with total cumulative exposure > 10 pack-years Smoking control Subjects between 35 and 50 years Post-bronchodilator spirometry with FEV1/FVC >=70% Smoker or ex-smoker with total cumulative exposure> 10 pack-years For cases Chronic inflammatory diseases including autoimmune diseases under treatment HIV Active cancer Cystic or saccular bronchiectasis Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia… For controls Chronic inflammatory diseases including autoimmune diseases under treatment HIV Active cancer Chronic respiratory diseases
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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, Dyspnea Malignant Neoplasm Diagnosis of cancer, with evidence of primary or secondary lung involvement Average dyspnea Borg Scale >= 4 of 10 with severe exertion over the past week Oxygen saturation > 90% on ambient air at time of assessment Able to communicate in English or Spanish Karnofsky performance status >= 50% Seen at Supportive Care, cardiopulmonary center, thoracic radiation oncology or thoracic medical oncology Resting dyspnea modified Borg Scale > 7 of 10 at enrollment Severe obstructive lung disease (forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] < 70% post bronchodilator and forced expiratory volume in 1 second < 30% predicted) Delirium (i.e., Memorial Delirium Rating Scale > 13) History of unstable angina or myocardial infarction in the last week Acute pulmonary embolus or pulmonary infarction in the last week Thrombosis of lower extremities in the last week Acute myocarditis, pericarditis, or endocarditis in the last week Symptomatic aortic stenosis or syncope in the last week Suspected dissecting aneurysm Severe untreated resting arterial hypertension (> 200 mmHg systolic, > 120 mmHg diastolic) at the time of enrollment
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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, Sepsis Critical Illness i) ≥18 years of age ii) 1 or more of the following Saturation<90% without oxygen or <93% with oxygen or reported saturation<90%, Respiratory frequency >25/min, Altered mental awareness, Heart rate >120/min, Systolic blood pressure <100 mm Hg. iv) informed consent 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): 18.0-999.0, COPD Exacerbation COPD patients suffering from acute hypercapnic respiratory failure (PaCO2 > 50 mmHg) due to COPD exacerbation and requiring intermittent NIV treatment can be included in the study provided they do not require immediate intubation Patients younger than 18 years old Inability to give informed consent or denied informed consent Severe acute respiratory failure requiring immediate intubation defined as respiratory rate > 40/minute, severe hypoxemia with PaO2/FIO2 ratio < 150 mmHg despite high FIO2, severe respiratory acidosis with pH< 7.2, altered mental status) Very intensive NIV treatment required defined as an impossibility to stop NIV treatment during more than one hour Severe hypoxemia requiring more than 4l/minute of conventional oxygenotherapy between NIV treatments Poor short term prognosis (defined by the clinician in charge as a high risk of death during the next 7 days) or ongoing palliative treatment Patients with "Do not resuscitate" order already established
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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): 45.0-80.0, Arterial Hypertension Albuminuria Patient has signed and dated written informed consent to participate in the trial Arterial hypertension Stable antihypertensive treatment within the last 3 months Age ≥ 45 ≤ 80 years Micro or macroalbuminuria defined as UACR in morning urine > 20 mg/g in female and > 30 mg/g in male and/or arterial hypertension for more than 5 years currently treated with two or more antihypertensive drugs to control blood pressure and a history of cardiovascular disease or stroke Patient consents that his/her family physician will be informed of trial participation History of type 1 diabetes History of type 2 diabetes Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg) Acute infections Any history of glomerulonephritis Any kidney disease not caused by hypertension as judged by the Investigator Glomerular filtration rate (GFR) < 30 ml/min (estimated by use of the Modification of Diet in Renal Disease (MDRD) formula) Medical history of hypersensitivity to the study drugs or to drugs with similar chemical structures History of severe or multiple allergies Treatment with any other investigational drug within 3 months before trial entry
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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, Hepatic Encephalopathy Patients aged between 18 and 65 years of either gender Patients admitted to the hospital with liver cirrhosis and grade 3 or grade 4 (West Haven Criteria) HE Patients treated with lactulose retention enema within 48 hours of onset of grade 3 or 4 (West Haven Criteria) HE Patients treated with agents other than lactulose retention enema for grade 3 or 4 (West Haven Criteria) HE Patients who had significant concomitant diseases that could impair or contribute to the impairment of consciousness Patients who had a major neuropsychiatric illness Patients who had a contraindication to lactulose, including Hypersensitivity to the active substance or to any of the ingredients; Galactosaemia; Gastrointestinal obstruction, digestive perforation or risk of digestive perforation
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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 Male and female volunteers aged 40-80 years Stable moderate to severe COPD (Global initiative on Obstructive Lung Disease [GOLD] stage 2/3) Post-bronchodilator FEV1 30-80% predicted FEV1/FVC ratio <70% Stable defined as no exacerbation in previous 1 month Smoking history ≥10 pack-years Oxygen saturations ≥92% on room air at rest Electrocardiogram demonstrating sinus rhythm Use of domiciliary oxygen History of other primary obstructive lung disease including asthma or bronchiectasis Hospitalisation with exacerbation of COPD within past 3 months History of unstable angina, uncontrolled hypertension or heart failure (New York Heart Association class 3-4) Overt clinical signs of right heart failure Average resting systolic BP<110mmHg or average resting HR<55bpm Pregnancy or lactation Known or suspected sensitivity to/intolerance of investigational medicinal product Inability to comply with compulsory aspects of protocol Any degree (first, second or third) of heart block
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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, Myocardial Infarction Inflammation Critical Illness ≥21 years of age admitted to the Medical Intensive or Coronary Care Units sepsis or respiratory failure clinically indicated troponin measurement within 24 hours of ICU admission unstable angina or Type 1 MI percutaneous or surgical coronary revascularization within 7 days heart failure exacerbation primary valvular disorder aortic dissection infiltrative heart disease or hypertrophic cardiomyopathy myocarditis pulmonary embolism electrocardiogram with >1mm ST segment elevation in two consecutive leads serum cardiac troponin >99th percentile URL but no clear rise or fall pattern
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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): 18.0-60.0, Panic Disorder The subject voluntarily agrees to participate in the study under their own free will. 2. The subject meets the DSM-V for PD with or without Agoraphobia or has a PDSS score > 8 at the Baseline visit. 3. The subject is between the ages of 18-60 years old inclusive at the time of consent. 4. The subject is capable of understanding and complying with protocol requirements. 5. The subject has signed the Informed Consent Form. No study-related procedures may be performed before the subject has signed the form Female subjects who are pregnant or nursing, or may become pregnant during the course of the study. In addition, all subjects of childbearing potential who are sexually active most use adequate contraception from signing of informed consent and throughout the duration of the study. Male subjects who have been surgically sterilized, are at least one year post-vasectomy, are not required to use contraceptives. Females not of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as one year since last regular menses). 2. Subjects who have a past or present primary diagnosis with a psychotic disorder other than PD with or without Agoraphobia. 3. Subjects who have a current uncontrolled co-morbid psychiatric disorder other than PD with or without agoraphobia. 4. Subject who have a history of alcohol abuse or dependence within the 12 months prior to screening, as defined by the DSM-V criteria. 5. Subjects who have a comorbid severe medical diagnosis such as Cancer, adults with chronic heart failure, uncontrolled, long-term type 2 Diabetes, etc. 6. Subjects with a history of liver disease such as cirrhosis of liver, neoplasm of the liver, or active Hepatitis C. 7. Subjects weighing less than 100lbs at the Baseline visit. 8. Subjects with a history of cardiac abnormalities including but not limited to, acute cardiovascular events, serious cardiovascular risk, myocardial infarction (MI), unstable angina (UA), percutaneous coronary intervention, coronary artery bypass graft, stroke, or deep vein thrombosis/pulmonary embolism within 1 year of screening, or have planned cardiovascular surgery or percutaneous coronary angioplasty. 9. Subjects who are reasonably judged by the Investigator based on interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS) at the Baseline visit to present a significant suicide risk, or who are likely to require psychiatric hospitalization during the course of the study. 10. Subjects who are unable to fully understand the potential risks and benefits of the study and unable to give informed consent
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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, Crohn Disease Colitis, Ulcerative Intestinal Helminthiasis The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his in the study was that he was healthy N/A
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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): 40.0-150.0, COPD Patients with a diagnosis of COPD (FEV1/FVC<0.7 confirmed based on the past medical records) Patients aged 40 years and over at the diagnosis of COPD Outpatient or more pack-years of current or former smokers Patients who have traceable medical records of COPD (including the results of spirometry) going back more than a year Patients who meet any of the following two 1. Patients who have medical records of the results of spirometry at more than two different time points excluding the time point of COPD exacerbations* for the past 3 years 2. Patients who can provide the results of reversibility testing for respiratory tract Patients who give written informed consent regarding the participation in this study Patients currently with COPD exacerbations Patients who currently enroll in the other interventional study including clinical trials Patients who concurrently develop or have a history of lung cancer Patients who are disabled to understand the study procedure or answer the questionnaire (i.e. due to the history of alcohol or drug abuse)
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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): 60.0-999.0, Depression COPD aged 60 or above with stable COPD suggested clinically and post-bronchodilator spirometry FEV1/FVC ratio <0.7 Patients were excluded if they had co-existing pulmonary diseases like active pulmonary tuberculosis, interstitial lung diseases etc if they were too demented or physically incapacitated to participate e.g wheelchair-bound for bedbound
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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): 30.0-65.0, Cigarette Smoking Current healthy smoker as judged by the Principal Investigator(s) or designee(s) Subject is aged from 30 to 65 years old (inclusive) Subject has smoked for at least the last 10 years Subject smoked more than 10 cigarettes/day on average over the last year Subject is willing to quit smoking within the next 30 days Subject has clinically relevant medical conditions that in the opinion of the Investigators would jeopardize the safety of the participant or affect the validity of the study results Subject has Forced Expiratory Volume in 1 second/Forced Vital Capacity(FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at post-bronchodilator spirometry Subject with FEV1/FVC < 0.75 (post-bronchodilator) and reversibility in FEV1 that is both > 12% and > 200 ml from pre to post-bronchodilator values Subject who took or is taking concomitant medication which may have an impact on the biomarkers of effect Female subject is pregnant or is a breast-feeding
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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, COPD Patients were eligible for the study if they presented to the Emergency Department with symptoms consistent of an exacerbation COPD. COPD was confirmed if the patient had a forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) quotient <70%. When COPD was newly diagnosed during the Emergency Department visit, to be included in the study a patient had to have COPD confirmed by spirometry within 60 days of the index episode at a time when he or she was stable Patients were excluded from the study if, at the time they were seen in the Emergency Department , the exacerbation COPD was complicated by a comorbidity such as pneumonia, pneumothorax, pulmonary embolism, lung cancer, or left cardiac failure. Patients who did not wish to participate were also excluded
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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, Dyspnea Patient in home hospice care with an estimated survival of 3-4 weeks, at risk for dyspnea secondary to lung cancer, COPD, or heart failure Family caregiver in patient's home must speak and read English Patients with bulbar ALS or quadriplegia
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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, Critically Ill Acute Respiratory Failure A staged enrolment process will be used to identify patients eligible to be enrolled and randomized in the study. At each stage of the enrolment process, a patient must meet and not meet in order to pass. To progress to the next stage, patients must continue to pass from the prior stages. After enrolment, there are also specific tests to perform (with pass/fail criteria) to determine to be randomized. A A1. Age 18 years or older A2. Intubated and receiving any mode of invasive mechanical ventilation ≥ 24 hours A A3. Anticipating withdrawal of life support and/or shift to palliation as the goal of care A4. Severe central neurologic disorder (eg. Hemorrhage, stroke, tumour) causing elevated intracranial pressure, or impaired control of breathing, or requiring specific ventilator adjustments (i.e. To attain specific CO2 target) or requiring neurosurgical intervention A5. Known or suspected severe or progressive neuromuscular disorder likely to result in prolonged or chronic ventilator dependence (eg. Guillain-Barré syndrome, Myasthenia Gravis, ALS, MS, high spinal cord injury, kyphoscoliosis or other restrictive disorder) (Note that obesity hypoventilation syndrome that may be managed with nocturnal non-invasive ventilation is NOT an under A5) A6. Severe COPD: Baseline daytime hypercapnea (pCO2> 50 mmHg) OR GOLD 4 airflow limitation (FEV1<30% predicted) OR MRC class 4 symptoms ("I am too breathless to leave the house" OR "I am breathless when dressing") A7. Broncho-pleural fistula A8. Tracheostomy present at ICU admission for the purpose of chronic or prolonged mechanical ventilation (>21 days). (Note that a patient who was endotracheally intubated for acute respiratory failure and received a tracheostomy during their ICU admission, prior to enrolment, is not excluded under A8) A9. Current enrolment in a confounding study, as assessed by the steering committee
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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, Chronic Obstructive Pulmonary Disease Patients with COPD eligible to moderate COPD according to the of gold GOLD (Global Initiative for Chronic Obstructive Lung Disease) and who had post-bronchodilator spirometry results in the last year of FEV1 (forced expiratory volume in one second) / FVC (forced vital capacity) <0.7 and FEV1 between 50% and 80% of previsto Besides being former smokers for at least three months and were clinically stable, no disease exacerbation in the past three months Accompanied by a pulmonologist Age between 40-85 years They are not practicing physical activity Without cardiovascular or orthopedic disease that makes it impossible to perform the exercises of the RP protocol Without presenting other comorbidities that put them at risk during the exercises Use of bronchodilators and oral theophylline, oxygen therapy or corticosteroids Patients who have musculoskeletal comorbidities that interfere with walking or performing upper extremity exercises lower peripheral saturation decrease of oxygen lower than 90% during the 6 minute walk test (six) minutes Presenting difficulty of cognitive understanding of body awareness and the ability to recall information for the questionnaire responses applied in the evaluation and re-evaluation in addition to this also children, adolescents and legally incapable
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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): 18.0-65.0, Asthma COPD for Asthma History consistent with asthma: episodic wheezing, shortness of breath, or cough Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age >18yrs FEV1 >40% predicted Never smoker, current smoker, or quit smoking ≥5 years ago for COPD History consistent with COPD: dyspnea with exertion, productive cough, progressive course Smoking history of at least 20 pack years Current smoker or quit smoking ≥5 years ago Age >18yrs FEV1: Forced Vital Capacity (FVC) ratio < 0.70 following 2 puffs of albuterol for Asthma Other respiratory illness other than asthma Chronic infectious process Significant other medical illness Inability to consent Pregnancy for COPD Other respiratory illness other than COPD Chronic infectious process Significant other medical illness Inability to consent
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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): 18.0-75.0, COPD Asthma for Healthy Smoking Subjects 1. Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. 2. Be between 18 and 75 years of age, inclusive, at informed consent. 3. Healthy as determined by a physician, based on medical history and physical examination. 4. Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of ≥ 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked). for All COPD Subjects 1. Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. 2. Aged between 40 and 75 years of age inclusive, at the time of signing the informed consent. 3. COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli, 2004). Symptoms must be compatible with COPD for at least 1 year prior to screening and post-bronchodilator spirometry readings at screening Post-bronchodilator FEV1/FVC ratio of <0.7 Post-bronchodilator FEV ≥40 % and ≤80 % of predicted normal values calculated using reference equations. Additional for Smoking COPD Subjects 1. Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of ≥ 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked) for Healthy Smoking Subjects Any potential subject who meets any of the following will be excluded from the participating study. 1. Upper or lower respiratory tract infection within 4 weeks of the screening visit. 2. Positive test for alcohol at screening. 3. Taking prescription medication in the 14 days before screening. 4. Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded but are not limited to pipes, cigars and e-cigarettes. 5. Subjects who are unable to produce a total weight of at least 0.1 grams (g) of selected sputum at screening 6. Urinary cotinine levels at screening < 30 ng/ml. 7. Subject is mentally or legally incapacitated. 8. Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO. 9. Any other reason that the Investigator considers makes the subject unsuitable to participate for COPD Subjects Any potential subject who meets any of the following will be excluded from the participating study 1. Upper or lower respiratory tract infection within 4 weeks of the screening visit. 2. Positive test for alcohol at screening. 3. Subjects who are unable to produce a total weight of at least 0.1g of selected sputum at screening. 4. Subject is mentally or legally incapacitated. 5. Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO. 6. Any other reason that the Investigator considers makes the subject unsuitable to participate. 7. A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation. 8. Taking theophylline in the 28 days before screening 9. Change in COPD medication in the 28 days before screening 10. Taking oral steroids in the 28 days before screening Additional Criterion for Smoking COPD Subjects 1. Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded but are not limited to pipes, cigars and e-cigarettes. 2. Urinary cotinine levels at screening < 30 ng/ml. Additional Criterion for Ex-Smoking COPD Subjects 1. The subject is a smoker (regular or irregular), or has smoked or used nicotine-containing products within the 6 months prior to screening
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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): 0.0-999.0, Severe Acute Respiratory Infection A history of feverishness or measured fever of ≥ 38 deg C Cough Dyspnoea (shortness of breath) OR Tachypnoea • No
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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, Benign Prostatic Hyperplasia (BPH) Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction Age from 45 to 80 years Subject has medical record documentation of a prostate volume between 30mL and 80mL (inclusive) by transrectal ultrasound (TRUS). (If TRUS testing documentation is available from less than 180 days prior to the informed consent date and the prostate volume is between 30mL and 80mL, it may be used for the inclusion/ Subject has an International Prostate Symptom Score (IPSS) score greater than or equal to 12 measured at the baseline visit Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15mL/s. (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 125mL, and the Qmax is less than 15mL/s it may be used for the inclusion/ Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured ≤ 30 days prior to the date of surgery History of inadequate response, contraindication, or refusal to medical therapy Body Mass Index (BMI) ≥ 42 History of prostate cancer or current/suspected bladder cancer Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds Subjects with a history of actively treated bladder cancer within the past two (2) years Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size) Active infection, including urinary tract infection
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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, Asthma Healthy Volunteers Cohorts 1 to 13 (all subjects) Subject must be a man or woman aged between 18 to 65 years of age, inclusive: Women of non-childbearing potential only defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile or permanently sterilised. Men who are willing and able to use suitable contraception methods listed in Section 4.5.1, from the time of the first dose of study medication until 90 days after discharge from the study A woman must have a negative serum β human chorionic gonadotropin (β-hCG) test at screening and a negative urine pregnancy test at Day -1 Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol Each subject must sign an informed consent form (ICF) Body weight ≥50 kg and BMI within the range 19-29 kg/m2 (inclusive) Average QTcF <450 msec at screening and Day -1 visits Vital sign assessments within normal ranges. Cohorts 1 to 11 and 13 (healthy volunteers and smokers only) Healthy as determined by a physician, based on a full medical evaluation including medical history, physical examination, laboratory tests Cohorts 1 to 13 (all subjects) Upper or lower respiratory tract infection within 4 weeks of the screening visit and prior to randomisation A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result at screening Current or chronic history of liver disease, or known hepatic or biliary abnormalities Positive test for alcohol or drugs of abuse Use of prescription medications within 14 days prior to the screening visit and agree not to use prescription medications throughout the duration of the study Are taking over the counter (OTC) medications for 14 days prior to Screening visit and agree to refrain from taking such medications throughout the study History of regular alcohol consumption within 6 months of the study Definite or suspected history of drug or alcohol abuse within the previous 5 years A positive test for HIV antibody
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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 Respiratory Diseases Age: ≥ 18 years old Gender: Female and Male Signed informed consent Out-patients at the Pham Ngoc Thach Hospital One or several symptoms suggesting chronic respiratory disease (cough, chest tightness, wheezing, dyspnoea, sputum), lasting 3 months or more Lung function defect (FEV1/FVC < 0,7 or FEV1 < 80% PV with FEV1/FVC > 0,7 or FEV1> 80% PV and FEV1/FVC > 0,7 with a decrease of DLCO (< 80% PV). FEV1: Forced Expiratory Volume in 1 Second FVC : Forced Vital Capacity PV: predicted value DLCO: Diffusing Capacity of the Lung for Carbon Monoxide Patients are able to stop anti-histamine 5 days before evaluation Patients are able to stop bronchodilator treatment before performing lung function test according to standard practice (immediate release theophylline: 24 hours, long acting β2-agonist: 12 hours, short acting β2-agonist: 6 hours and short acting anticholinergic: 8 hours) The patients do not agree to participate in the study Presence of one or more chronic diseases: HIV, active tuberculosis, hypertension, heart failure, diabetes, low BMI (<18.5) or mental health disorders Treatment with B-blockers, drugs of vascular/heart 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): 18.0-999.0, Automated Measurement of Vital Signs Adult male and female hospital in-patients Vital signs considered 'stable' by clinical caregivers Pediatric patients Female patients who are pregnant Patients with internal or external defibrillators Patients who have undergone surgery and still have a fresh incision on the chest Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc Patients who are in the Critical Care Unit (CCU) Patients who otherwise satisfy any of the contraindications associated with the VSP system
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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, Vital Signs Adult male and female in-patients with vital signs considered 'stable' by clinical caregivers Pediatric patients Female patients who are pregnant Patients with internal or external defibrillators Patients who have undergone surgery and still have a fresh incision on the chest Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc Patients in the Critical Care Unit (CCU) Patients who otherwise satisfy any of the contraindications associated with the VSP system
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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): 18.0-75.0, Hypersensitivity Pneumonitis Airway Disease Small Diagnosis of chronic hypersensitivity pneumonitis confirmed by patients with known exposure to antigen, tomographic and absence of other diagnoses confirmation with histology obtained by transthoracic biopsy, surgical biopsy or bronchoalveolar lavage with lymphocytosis above 30% Age between 18 to 75 years Clinically stable (no exacerbations or hospitalizations related to the underlying disease) for at least 6 weeks Compliance with signing an informed consent for participation in the project Patients with FEV1 and / or DLCO <30% predicted Patients using supplemental oxygen Previous diagnosis of asthma or COPD Pregnant women Musculoskeletal disorders that limit exercise Another medical condition that might interfere with the execution of tests Current or past smoking history with tobacco intake greater than 30 pack-years Severe heart disease functional class New York Heart Association (NYHA) III-IV) and / or decompensated hear failure
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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, Vital Signs Adult male and female in-patients with vital signs considered 'stable' by clinical caregivers Pediatric patients Female patients who are pregnant Patients with internal or external defibrillators Patients who have undergone surgery and still have a fresh incision on the chest Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc Patients in the Critical Care Unit (CCU) Patients who otherwise satisfy any of the contraindications associated with the VSP system
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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): 20.0-90.0, Chronic Obstructive Pulmonary Disease (COPD) Asthma Asthma With Chronic Obstructive Pulmonary Disease Bronchiectasis Inactive Tuberculosis of Lung Chronic Obstructive Airway Disease COPD Postbronchodilator FEV1/FVC < 0.7 AND chronic respiratory symptom - Asthma Never smoker or <5PY of smoking history AND Recurrent episodes of asthma symptoms (wheezing, dyspnea, chest tightness, cough) AND (either Positive BDR OR positive metacholine/mannitol/exercise provocation test) - ACOS COPD AND Asthma (regardless of smoking status)
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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): 75.0-999.0, Acute Dyspnea Admission to the Emergency Department Age ≥ 75 years AND of acute dyspnoea Breathe rate ≥ 25 cycles/minute or PaO2 ≤ 70 mmHg or SpO2 ≤ 92% in room air or PacO2 ≥ 45 mmHg and pH ≤ 7.35 AND Electrocardiogram in sinus rhythm at admission None
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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): 40.0-70.0, Chronic Obstructive Pulmonary Disease Provide informed consent Males not donating sperm and using adequate contraception or females who are surgically sterile or postmenopausal lead ECG showing:Heart rate 45 to 90 bpm, QTcF≤450 msec, QRS ≤120 msec, PR interval ≤220 msec, no clinically significant abnormality Capable of complying with all study restrictions and procedures including ability to use the study nebuliser correctly BMI 18 to 33 kg/m2 with a minimum weight of 45 kg COPD diagnosis for at least 1 year and clinically stable COPD in previous 4 weeks Demonstrates reversibility to bronchodilator (two puffs of salbutamol followed by two puffs of ipratropium) via spirometry Post-bronchodilator FEV1/forced vital capacity (FVC) ratio of ≤0.70 Post-bronchodilator FEV1 ≥40 % and ≤80% of predicted normal ≥150 mL increase from pre-bronchodilator FEV1 History of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation COPD exacerbation requiring oral steroids in the previous 3 months History of one or more hospitalisations for COPD in the previous 12 months Respiratory tract infection (both upper and lower) treated with antibiotics in previous 12 weeks Evidence of cor pulmonale or clinically significant pulmonary hypertension Other respiratory disorders Previous lung resection or lung reduction surgery Oral therapies for COPD in the previous 3 months and throughout the study Drug or alcohol abuse in the past 3 years Received an experimental drug within 3 months or five half lives, whichever is longer
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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): 40.0-69.0, Prostate Cancer Prostate Biopsy Genetic Counselling Genetic Markers Men with either: 1. A positive family history of PrCa defined as Men with a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at <70 years Men with two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at <70 years Men with three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age 2. Of African or Caribbean ancestry defined as: Both parents and all 4 grandparents from that origin Age 40 years WHO performance status 02 (see Appendix A) Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow up schedule Previous cancer with a life expectancy of less than five years Previous PrCa Negative biopsy within one year before recruitment Comorbidities making prostate biopsy risk unacceptable (Warfarin or Clopidogrel) Contraindications to having an MRI (pacemakers, aneurysm clips, claustrophobia)
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0
|
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) confirmed diagnosis of COPD by spirometry (post-bronchodilator FEV1/FVC < 0.70) at least 2 self-reported exacerbations in the previous 12 months, i.e. a change for ≥ 2 consecutive days in either ≥ 2 major symptoms (dyspnea, sputum purulence, sputum amount) or any 1 major symptom plus any ≥ 1 minor symptoms (colds, wheeze, sore throat, cough) severe co-morbid conditions that prohibit participation unable to communicate in the Dutch language difficulties using a smartphone
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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): 50.0-64.0, Chronic Obstructive Pulmonary Disease for patients with COPD will be: 1. Signed informed consent prior to initiation of study-mandated vaccination. 2. Patients with spirometric data in the preceding 18 months confirming the diagnosis of COPD. 3. Patients meeting GOLD Classification of Stage C or Stage D COPD. 4. Patients 50 years old years old. for Healthy participants will be: 1. Signed informed consent prior to initiation of study-mandated vaccination. 2. No active symptoms of lung disease. 3. FEV1/FVC in the normal range > 70% age predicted value. 4. No history of tobacco use/abuse. 5. No prior history of alpha-1 antitrypsin deficiency. 6. Patients 50 years old years old Severe allergy to eggs. 2. Severe reaction to past doses of influenza vaccine. 3. Guillian-Barre syndrome. 4. Currently recieving dialysis. 5. Current, active, treatment for cancer. 6. History of transplant (allograft). 7. Dementia or Alzheimer's disease diagnosis. 8. Prior diagnosis of HIV or AIDS. 9. Moderate to severe pulmonary hypertension. 10. Serum AST/ALT > 3x the upper limit of normal. 11. Patients with exacerbations or respiratory infection during the 4 weeks preceding the onset of the study. 12. Active pregnancy. 13. Systemic immunomodulating 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): 40.0-70.0, Obstructive Sleep Apnea for COPD Subjects Age range 40-70 years Demonstrated moderate to severe COPD as determined by spirometry (post-bronchodilator spirometry FEV1/FVC < 0.70 for diagnosing CODP and FEV1<80% predicted for staging) Smoking history of ≥ 10 pack-years for Control Subjects Age range 40-70 years Demonstrated no COPD as determined by normal spirometry (post-bronchodilator spirometry FEV1/FVC > 0.70 for diagnosing CODP and FEV1<80% predicted for staging) No smoking history as defined by less than 100 cigarettes smoked in a lifetime for both COPD and Control Subjects Metal objects that may interfere with chest CT quantification including presence of a cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile or metal weapon fragment (bullet, shrapnel, shotgun shot) or metal shoulder prosthesis Subjects unable to perform spirometry due to chest or abdominal surgery in the past three months a heart attack in the last three months detached retina or eye surgery in the past three months hospitalization for any other heart problem in the past month History of hypersensitivity to Afrin, Lidocaine or albuterol A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day
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2
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