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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): 4.0-95.0, Healthy Subjects Chronic Obstructive Pulmonary Disease Asthma Interstitial Lung Disease Upper Airway Obstruction for healthy subjects life-long non-smokers no symptoms and history of chronic cardiopulmonary diseases (chronic bronchitis, asthma, lung cancer, pulmonary fibrosis, pulmonary tuberculosis, chronic heart diseases, etc.) no abnormal findings on physical examination written informed consent was obtained for COPD Diagnosis of chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and post-bronchodilator FEV1/FVC (forced vital capacity) < 70%. for asthma Diagnosis of asthma, as classified by national and international asthma guidelines. for ILD ILD diagnosis confirmed by lung biopsy, X ray or BALF analysis. for UAO Diagnosis of UAO for healthy subjects upper or lower respiratory infection within 4 weeks long-term exposure to harmful gas or particles using β-blocker for treatment pregnant women, epileptic other diseases or surgeries potentially affecting lung function
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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, Pneumonia Chronic Obstructive Pulmonary Disease Asthma Clinical diagnosis of chronic obstructive pulmonary disease (COPD; ICD-9 codes 490-492, 494, 496) Clinical diagnosis of Asthma (ICD-9 code 493) Clinical diagnosis of pneumonia (ICD-9 codes 480-488) Underage incapacity Pregnant women Psychiatric history Unfamiliar with Chinese
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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, COPD Age ≥ 40 years Current or former smoker, with at least 10 pack-years previous history of COPD with concordant spirometry results Admission to the emergency department for an exacerbation defined as an acute event which is characterized by a degradation of respiratory symptoms greater than the usual daily variations and requiring a change in therapeutic management Patient with mild exacerbation characterized by a DECAF score at 0 or 1. (DECAF score: Dyspnea, Eosinopenia, Consolidation on chest x-ray, Acidaemia, and atrial Fibrillation. One point for each criterion. Mortality at one month is less than 3% if the DECAF score is 0 or 1) Residence within 30km of Grenoble Alps University Hospital Patient legally able to give consent Person affiliated to a medical insurance Dementia or non-communicating patient in French language Patient unable to call the emergency department at any time in case of sudden worsening Pregnancy or breastfeeding woman patient under administrative or judicial supervision DECAF Score > 1. Patient's with DECAF score > 1 are considered at too high risk of mortality to be managed at home (they are usually hospitalized)
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, COPD Provide written informed consent Diagnosis of COPD as defined by the American Thoracic Society/European Respiratory Society guidelines characterized by progressive airflow limitation associated with abnormal inflammatory response of the lungs to noxious particles or gases primarily caused by cigarette smoking Have an established COPD clinical history, symptomatic with dyspnea, chronic cough, chronic sputum production or wheezing. At Visit 1, FEV1/FVC ratio must be less than 0.70 or at least 10% less than the FEV1/FVC ratio determined by the predicted normal value. FEV1 must be less than 70% of the predicted normal value and greater than 25% of the predicted normal value Must be using one or more inhaled bronchodilators for treatment of COPD at the time of Visit 1 Current or former smokers, with a history of at least 10 pack-years of cigarette smoking. Number of pack-years = (number of cigarettes per day/20) X (number of years smoked) Willing, and in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol Current diagnosis of other respiratory disorder(s) including, but not limited to: alpha-1-antitrypsin deficiency; lung cancer; cystic fibrosis; tuberculosis; sarcoidosis; idiopathic pulmonary fibrosis; primary pulmonary hypertension; or pulmonary thromboembolic disease. Patients with concomitant COPD and asthma will be allowed to participate Diagnosis of non-respiratory disorder(s) that are currently affecting lung function, as determined by he principal investigator including, but not limited to: congestive heart failure; symptomatic cardiac arrhythmia; symptomatic seizure disorder; dementia; lupus; rheumatoid arthritis; or liver cirrhosis Unable to abstain from protocol defined prohibited medications during the screening and testing period Unable to withhold short acting bronchodilators for 6 hours prior to spirometry testing at the study visit Unable to perform acceptable or repeatable spirometry or comply with other study procedures Known allergic reaction to albuterol sulfate or ipratropium bromide Diagnosis of cancer that is not presumed to be in remission or cured Active alcohol or drug abuse Pregnant or lactating women. Pregnancy confirmed by a positive hCG test Treatment with another investigational study drug in another clinical study within the last 30 days 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): 18.0-999.0, Pulmonary Disease, Chronic Obstructive Age > 18 Known Chronic Obstructive Pulmonary disease (COPD) respiratory rate or presence of accessory respiratory muscles activity on physical exam moderate exacerbation of COPD as defined by an arteria pH between 7.25 and 7.35 and an arterial carbon dioxide partial pressure (PaCO2) equal or above 45 mm Hg Age below 18 Pregnancy Known sleep apnea syndrome Patent treated by noninvasive ventilation at home Not affiliated to French scial security Contraindication to aither Noninvasive ventilation or to High-Flow Nasal Oxygen therapy Previous in the study
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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): 60.0-999.0, Physical Disability Physical Activity Person over the age of 60 Availability at home during their participation period (walking exercise weeks + physical activity assessment weeks) Patient with a volunteer close caregiver to participate in the study and receive training from the investigator/APA investigator and then manage autonomy sessions Person who would like to train more regularly in the walk and at home because unable to get out. Person who uses or does not use technical assistance to walk or move Person in a State to sign informed consent alone Possibility of installation of the device in the patient's home (the dimensions of the lift/doors/parts allow the device to be entered in the apartment, as well as not to hinder the daily life of the patient too heavily) Patient affiliated with a Social security plan Person who has a partial limitation of walking activity (partial inability to walk) and in whom, re-education of walking is relevant to improve performance (whether or not the patient does this re-education at the time of the visit of selection). The for limiting walking activity are Speed limitation Endurance limitation Uncontrolled heart failure Uncontrolled respiratory insufficiency Uncontrolled coronary insufficiency Impossibility of installing the device at home Severe cognitive impairment with risk of using the device alone, outside of the instructions Absence of a caregiver to follow a continuous training of the physiotherapist / APA investigator to supervise independently one or two sessions per week
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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, Scaphoid Bone Fracture Acute scaphoid fracture (Herbert B1 B2) Concomitant fractures
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Acute Heart Failure all admitted at Houston Methodist Hospital with a primary diagnosis of acute heart failure or similar type of medical diagnosis stable medical state (HR equal or greater than 50 bpm, mean BP of 60 mmHg or better, Oxygen saturation (with or without oxygen supplement) of 90% or better; RR of 15 or better years old and over and able to follow 2 simple commands establish discharge recommendation to home settings ambulatory with or without assitive device(s) history of psychiatric disorder diagnosis of acute kidney injury requiring continuous renal replacement therapy diagnosis of major cognitive impairment (dementia, Alzheimer's dse, etc) inability to read and understand basic english language establish discharge recommendation to post-acute care settings (e.g. SNF, inpatient rehab, LTACH) inability to complete any functional mobility test due to musculoskeletal or other disorders
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Patient has signed informed consent Patient age is 18 years or older at time of informed consent Patient will undergo prostatic artery embolization with Embosphere Microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms Patient is unable or unwilling to provide follow-up information Patient is undergoing prostatic artery embolization for reasons that do not symptomatic benign prostatic hyperplasia with lower urinary tract symptoms Any other reason the investigator deems cause for
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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): 0.0-999.0, Acute Exacerbations of COPD -≥ 40 years old of age Able to adequately understand written and verbal A signed and dated written informed consent must be obtained prior to the visits Patients see doctors due to suffering respiratory disease below: Disease type 1 diagnosed moderate and severe stable COPD Patients with a diagnosis of COPD and documented record with predicted ratio of FEV1 to forced vital capacity (FVC) < 0.70 before the study visit COPD with moderate to severe airflow obstruction (FEV1<0.8 predicted) Disease type 2 Patients with a diagnosis of COPD and documented record with predicted ratio of FEV1 to forced vital capacity (FVC) < 0.70 before the study visit Patients consult the clinic or the emergency department because of acute worsening with an (diagnosed by more than 2 clinical experts and refer to diagnosis of Appendix 2) Disease type 3 -Non-COPD patients with chronic respiratory symptoms such as cough, sputum and wheeze, dyspnea etc. (≥2 high risk factors ) Patients with severe cardiovascular disease, including uncontrolled hypertension with drug treatment, unstable angina, myocardial infarction within the last 6 months, NYHA class II congestive heart failure, severe arrhythmia, pericardial effusion, etc Patients with lung cancer, esophageal cancer or mediastinal tumors Patients who participated in any drug clinical trials within 4 weeks before enrollment Patients with severe infection, indicated for intravenous antibiotics, antifungal or antiviral therapy Patients suffering from mental illness and poor compliance Patients inappropriate for decided by investigator
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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): 12.0-999.0, Asthma Subjects who will be able to give written informed consent prior to participation in the study, which will the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials Subjects with at least 12 years of age at Visit 0 and a minimum weight of 40 kilograms Persistent airflow obstruction as indicated by: For subjects >=18 years of age at visit 1, a pre-bronchodilator FEV1 <80 percent predicted (National Health and Nutrition Examination Survey [NHANES] III).;For subjects 12 to 17 years of age at Visit 1: A pre-bronchodilator FEV1 <90 percent predicted (NHANES III) recorded at Visit 1 or FEV1: Forced vital capacity (FVC) ratio <0.8 recorded at Visit 1 Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma as per Randomization 1 (Documented peripheral blood eosinophil count of >=300 cells per microliters that is related to asthma in the past 12 months prior to Visit 1 or a peripheral blood eosinophil count of >=150 cells per microliters at Visit 1 that is related to asthma) Regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1, of which at least 9 months accumulated documented is required, the 3 months prior to Visit 1 is mandatory. With or without maintenance oral corticosteroids (OCS). ICS dose must be >=500 microgram per day fluticasone propionate (FP) or equivalent daily (for ICS/long-acting beta-2-agonists combination preparations, Seretide 50/250 micrograms twice daily and above or equivalent will meet this ICS criteria). (Maintenance OCS is defined as a prescribed regimen of a minimum average daily dose of prednisone 5 milligrams [or equivalent]) Current treatment with an additional controller medication, besides ICS, for at least 3 months. (Example given [e.g.], long-acting beta-2-agonist, leukotriene receptor antagonist [LTRA], or theophylline) Previously confirmed history of two or more exacerbations requiring treatment with systemic corticosteroid (intramuscular [IM], intravenous, or oral), in the 12 months prior to Visit 1, despite the use of high-dose ICS. For subjects receiving maintenance corticosteroid, the corticosteroid treatment for the exacerbations must have been a two-fold increase or greater in the dose for at least 3 days is required A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1 percent, during the intervention period and for at least 4 months after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test before the first dose of study intervention. If urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive. Follicle-stimulating hormone will be assessed to confirm child-bearing status as needed in non WOCBP Current smokers or former smokers with a smoking history of >=10 pack years (number of pack years = (number of cigarettes per day/20) x number of years smoked). A former smoker is defined as a subject who quit smoking at least 6 months prior to Visit 1 Presence of a known pre-existing, clinically significant lung condition other than asthma, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study. This includes current bacterial or viral infection of the upper or lower respiratory tract, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer. Clinically Significant is defined as any disease/condition that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study A chest X-ray that reveals evidence of clinically significant abnormalities not believed to be due to the presence of asthma Bronchial Thermoplasty and Radiotherapy are excluded for 12 months prior to visit 1 and throughout the study A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Subjects that had localized carcinoma of the skin which was resected for cure will not be excluded) Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice or cirrhosis. Subjects with ALT >2 times Upper Limit of Normal (ULN), bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent) Subjects who have known, pre-existing severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to: known ejection fraction of <30 percent or severe heart failure meeting New York Heart Association Class IV classification or hospitalized in the 12 months prior to Visit 1 for severe heart failure meeting New York Heart Association Class III or angina diagnosed less than 3 months prior to Visit 1 or at Visit 1 QT interval corrected by Fridericia's formula (QTc[F]) >450 milliseconds (msec) or QTc(F) >480 msec for subjects with Bundle Branch Block at Visit 1 is exclusive Subjects who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment. Current malignancy except for basal and squamous skin cancer Subjects with other conditions that could lead to elevated eosinophils such as Hypereosiniophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-80.0, Pulmonary Disease, Chronic Obstructive Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome Small Airway Disease Quality of Life Male or female patients 18 to 80 years-old A diagnosis of chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Disease(GOLD 2018) guidelines are recruited to the chronic obstructive pulmonary disease group.A diagnosis of asthma-chronic obstructive pulmonary disease overlap according to Global Initiative for Chronic Obstructive Disease(GOLD 2018),Global Initiative for Asthma(GINA 2018) and Spanish COPD Guidelines(GesEPOC 2017) are recruited to the asthma-chronic obstructive pulmonary disease overlap group Willing and able to provide written informed consent Willing and able to attend all study visits and adhere to all study assessments and procedures Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions including unstable ischemic heart disease,unstable cardiac arrhythmia or heart failure,life threatening arrhythmias,etc Recent history of chronic obstructive pulmonary disease exacerbation requiring hospitalization or need for increased treatments for chronic obstructive pulmonary disease within 6 weeks
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-55.0, Healthy Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests (including a normal coagulation profile), ECGs, vital signs and spirometry Normal spirometry FEV1 (Forced Expiratory Volume in the first second)≥80% of predicted, FEV1/Forced Vital Capacity (FVC) ratio ≥70%) at screening Non-smokers for at least one year and with a smoking history of less than 5 pack-years [number of pack years = (number of cigarettes per day/20) x number of years smoked] Body weight of ≥50 kg and a body mass index BMI (body mass index) of 20 to 24.9 kg/m2 Height 170 to 195 cm Significant history of or current cardiovascular, respiratory (eg asthma, chronic obstructive pulmonary disorder (COPD), bronchiectasis, active Tuberculosis [TB]), hepatic, renal, gastrointestinal, endocrine, hematological, autoimmune or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data Skin lesions in the area used for the dermal application such as dermographism, dermatitis or eczema Use of prescription or non-prescription drugs (except paracetamol), including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) before the first dose of study medication, unless, in the opinion of the investigator, the medication will not interfere with the study procedures or compromise participant safety History of sensitivity to enrofloxacin, ciprofloxacin or any other fluoroquinolones, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates their participation Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months The participant has participated in a clinical trial and has received an investigational product within the following time period before the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) Regular use of known drugs of abuse or a positive drugs of abuse test at screening, positive cotinine test at screening History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits Upper or lower respiratory tract infection 4 weeks prior to screening
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 8.0-12.0, Asthma in Children Obesity, Childhood Exercise Induced Bronchospasm no history of smoking, no history or evidence of heart disease, no history of uncontrolled hypertension, no documented and/or diagnosed sleep disorders, no diagnosed diabetes, no metabolic disorders, no history of significant mental illness, no dietary restrictions, no serious health conditions, or no musculoskeletal abnormality that would preclude exercise Normal weight children with a body mass index between the 16th and 84th percentile Obese children with a body mass index > 95th percentile but less than 170% above the 95th percentile and less than an absolute body mass index of 40 kg·m2 Pulmonary function 1) forced vital capacity ≥ 80% predicted, 2) forced expiratory volume in the first second (FEV1) ≥ 75% predicted, and total lung capacity ≥ 80% predicted Children with significant diseases other than obesity and mild asthma will be excluded. A significant disease is defined as either a disease that in the opinion of the PI or medical consultant Dr. Craig Nakamura may put the participant at risk because of participation in the study or a disease that may influence the results of the study or the patient's ability to participate in the study Children who cannot follow directions (e.g., eating before testing), adequately perform procedures (e.g., pulmonary function tests), or keep appointments (e.g., no shows for testing), will be excluded from study participation Because the risk of severe exercise induced bronchoconstriction increases in children with moderate or severe obstructive airway disease, children with FEV1 < 75% predicted will be excluded from the study. Diagnosis of asthma (i.e., airway responsiveness with reversible obstruction) will be established by spirometry (i.e., improvement of FEV1 of ≥8% after administration of bronchodilator) Children without reversible airway obstruction will also be excluded from the study Children who have been hospitalized for an asthma exacerbation or who have taken oral glucocorticoids for asthma in the past year, and children who have been admitted to an intensive care unit or been intubated because of their asthma in the past five years, will be excluded to reduce the risk of exacerbation during the study
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 21.0-999.0, Swallowing Disorder Respiratory Insufficiency years of age or older No cognitive impairments Less than 21 years old History of swallow dysphagia History of disease/condition that may cause dysphagia Use of medications that may alter swallow function Nasal obstruction Presence of tracheostomy tube
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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, Smokers Human Bronchial Epithelial Cells Lung Pathogenesis Biomarkers >18 year-old Lack of informed consent Drug treatment Professional exposure Evolutive pregnancy Bradycardia Respiratory assistance required Diagnosed respiratory distress (e.g. COPD, asthma) Infectious pneumopathy Bronchial cancer
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, SAA Level and SAA/Lipoxin A4 Ratio Patients with COPD GOLD 3-4 confirmed by anamnesis and pulmonary function test Patient has provided written informed consent other reasons for worsening of symptoms (cough, dyspnea): e.g. pneumothorax, pneumonia, pulmonary embolism, myocardial infarction malignant 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): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Written informed consent prior to participation 2. Female and male patient ≥ 40 years of age 3. Chronic Obstructive Pulmonary Disease (COPD) diagnosis more than 2 years before the study visit 4. Previously confirmed Chronic Obstructive Pulmonary Disease (COPD) diagnosis (post-bronchodilator FEV1/FVC ratio <70%) 5. Clinical data available 2 years before the study visit 6. Ability to complete CAT COPD Assessment Test Current participation in any clinical trial involving a drug or device 2. A moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) during the study visit or within 4 weeks before the study visit
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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, Copd Dyspnea Lung Diseases a diagnosis of COPD Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale) Clinically stable exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise exacerbation during the study Inability to chew or patients with swallowing disorders
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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): 16.0-48.0, Polycystic Ovary Syndrome Vitamin D Deficiency Vitamin D deficient premenopausal women Pregnant women Women during their postpartum period Breastfeeding women Women taking any kind of exogenous hormones Women receiving any form of oral vitamin D replacement
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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 Provision of signed and dated, written ICF prior to any study-specific procedures, sampling, and analyses. 2. Patient must be 40 to 85 years male and/or females of non-childbearing potential who are not pregnant/lactating at the time of signing the ICF (Screening; Visit 1). 3. Patient with an established clinical history of moderate to severe COPD for more than 1 year at Screening, according to the GOLD COPD guidelines. 4. Patient who is a current or former smoker (defined as one who has stopped smoking for at least 6 months prior to Screening) with a history of ≥10 pack-years of cigarette smoking [Number of pack-years=(number of cigarettes per day/20)* number of years smoked (eg, 1 pack-year=20 cigarettes smoked per day for 1 year)]. 5. Patient with post-bronchodilator FEV1/forced vital capacity (FVC) ratio <70% based on the value reached after inhalation of salbutamol (400 µg) at Visit 2. If criterion is not met, the test can be repeated at the latest, up to Day -14. 6. Patient with post-bronchodilator FEV1 that must be ≥40% and <80% predicted normal value at Visit 2. If criterion is not met, the test can be repeated at the latest, up to Day -14. 7. Patient is willing and, in the opinion of the Investigator, able to change current COPD therapy as required by the protocol and willing to use ipratropium following the approved dosage and regimen (during run-in and wash-out periods) with or without ICS for maintenance therapy of COPD and rescue medication salbutamol (as needed) from Visit 1 to Visit 11. 8. Patient must be able to read, speak and understand local language, and be willing to remain at the study centre as required per-protocol to complete all visit assessments. 9. Body mass index (BMI) <40 kg/m2 at the time of Screening. 10. Female patients must be of non-childbearing potential defined as Permanently or surgically sterilised, including hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy Post-menopausal; aged <50 years and amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post menopausal range of the local laboratory Post-menopausal; aged ≥50 years and amenorrhoeic for 12 months or more, following cessation of all exogenous hormonal treatments. 11. Male patients should use a condom and spermicide to prevent pregnancy and drug exposure of a partner, regardless of the gender or childbearing potential of the partner from the day of the first administration of the IP until 3 months after the last administration of the IP. In addition to a condom with spermicide, a second highly effective method of contraception (oral, intravaginal or transdermal hormonal contraceptives, intrauterine device, intrauterine hormone-releasing system, or sexual abstinence until 3 months after the last administration of the IP) should be used with female partners of childbearing potential. Double barrier methods (a combination of male condom with either a cap, diaphragm or sponge with spermicide) are not considered to be highly effective methods of contraception. Male patients with a pregnant partner should use a condom and spermicide Patient has significant diseases other than COPD, (ie, clinically relevant disease or condition or an abnormality in prior ECGs, medical history or physical examinations) which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patient's ability to participate in the study. 2. Patient has alpha-1 antitrypsin deficiency as the cause of COPD. 3. Patient has other active pulmonary disease such as predominant asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnoea. Allergic rhinitis is not exclusionary. 4. Lung surgery for volume reduction or lung transplantation: Patient has undergone lung volume reduction surgery, lobectomy, or bronchoscopic lung volume reduction (endobronchial blockers, airway bypass, endobronchial valves, thermal vapour ablation, biological sealants, massive pulmonary embolism and airway implants) within 1 year of Screening (Visit 1). 5. Patient is using nocturnal positive pressure (eg, continuous positive airway pressure or bi level positive airway pressure). Patient is using any non-invasive positive pressure ventilation device. Note: A patient using continuous positive airway pressure or bi level positive airway pressure for Sleep Apnoea Syndrome is allowed in the study. 6. Patient who had 2 or more exacerbations of COPD (moderate or severe in intensity) within the last year prior to Screening (see Section 7.1 for definition of exacerbation of COPD). 7. Patient has been hospitalised due to poorly controlled COPD within 3 months of the Screening period. 8. Patient has acute worsening of COPD that requires treatment with corticosteroids or antibiotics in the 6 week interval prior to or during the Screening period. 9. Patient has had lower respiratory tract infection(s) that required antibiotics within 6 weeks prior to the Screening period. 10. Patient has significant cardiovascular disease that may be vulnerable to cardiovascular instability. Note: Some examples of clinically significant cardiovascular conditions are Myocardial infarction within the 6 months prior to Screening Visit (Visit 1) Unstable angina or unstable arrhythmia which has required changes in the pharmacological therapy or other intervention within 12 months prior to Screening (Visit 1), or newly diagnosed arrhythmia within the previous 3 months prior to Screening (Visit 1) Second degree atrio-ventricular block Use of pacemaker Hospitalisation within 12 months prior to Screening (Visit 1) for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV per the "New York Heart Association". 11. Patient with a QT interval corrected using Fridericia's formula (QTcF) value >450 ms for male and >470 ms for female or an ECG that is not suitable for QT measurements (eg, poorly defined termination of the T wave). 12. Patient with a heart rate <50 or >120 beats per minute (bpm). 13. Patient has clinically significant uncontrolled hypertension (>180 mmHg) as assessed by the Investigator. 14. Patient has seizures or a history of seizures requiring anticonvulsants within 12 months prior to Screening. 15. Patient is taking selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors whose dose has not been stable for at least 4 weeks prior to Screening, or exceeds the maximum recommended dose. 16. Patient has a symptomatic bladder neck obstruction, acute urinary retention or symptomatic non-stable prostate hypertrophy. 17. Any laboratory abnormality or suspicion of any clinically relevant disease or disorder (on history or examination), including uncontrolled diabetes or hypokalaemia (serum potassium <3.5 mmol/L), which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study, or any other safety concerns in the opinion of the Investigator. Note: Potassium replacement and re-test is allowed once if serum potassium concentration was <3.5 mmol/L at Screening or prior to randomisation. 18. Patient has known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C infection. 19. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin. 20. Patient has known narrow-angle glaucoma. 21. Patient has a history of drug of abuse within the past 2 years or consuming more than 14 (female patients) or 21 (male patients) units of alcohol a week, or shows positive for drugs of abuse and alcohol tests at Screening and prior to randomisation. Note: If a patient tests positive to any drugs of abuse tests, which cannot be explained by use of prescription medication, he/she will be excluded from the study. Unit=1 glass of wine (125 mL)=1 measure of spirits=½ pint of beer. 22. Patient has a history of hypersensitivity (including paradoxical bronchospasm) to β2-agonists, muscarinic anticholinergics or lactose/milk protein. Lactose intolerance is not an criterion. 23. Patient has received a live attenuated vaccination within 30 days prior to Screening. Note: Inactivated influenza vaccination, pneumococcal vaccination, or any other inactivated vaccine is acceptable provided it is not administered within 7 days prior to Screening or randomisation (Visit 3). 24. Patient who, in the opinion of the Investigator, is unable to abstain from protocol-defined prohibited medications during the study. 25. Patient was treated with an investigational drug or device in another clinical trial within the last 30 days or 5 half-lives (whichever is longer) prior to Screening. Note: Patient participation in observational studies (ie, studies that do not require change to medication or an additional intervention) is not exclusionary. 26. Previous participation or prior screen failure in the present study. 27. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 28. Patient has changed their smoking status (ie, restarted or stopped smoking) or initiation of a smoking cessation program within 6 weeks of Screening. 29. Patient has participated in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or who will enter the acute phase of a pulmonary rehabilitation program during the study. A patient in the maintenance phase of a pulmonary rehabilitation program is not to be excluded. 30. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. Inability to comply with requirements includes having an e-Diary completion rate of <70% during the run-in period. 31. Patient who have donated or lost >500 mL of blood and/or plasma within the previous 3 months prior to Screening. 32. Vulnerable patients (who has been placed in an institution due to a regulatory or court order)
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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, Asthma Age ≥60 years English or Spanish speaking Asthma diagnosis made by a health care provider Diagnosis of dementia Diagnosis of chronic obstructive pulmonary disease (COPD) or other chronic respiratory illness Smoking history of ≥15 pack-years owing to possible undiagnosed COPD Moderate or severe cardiac disease (including New York Heart Association stages 4 or 5 congestive heart failure, because dyspnea among patients with severe heart failure is more likely to be attributable to their heart condition than their asthma) Dependence on assistance for medication administration Uncorrectable visual impairment
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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, Colorectal Adenoma Colorectal Neoplasm Colorectal Cancer Obesity Metabolic Syndrome Non-Alcoholic Fatty Liver Disease Liver Fibrosis Aged 18 years and over 2. Able to give informed consent 3. Indications: 1. Patients with positive faecal occult blood test (FOBt) referred for index colonoscopy as part of Bowel Cancer Screening Programme 2. Colonoscopy conversion from Bowelscope 3. Index diagnostic colonoscopy due to new gastrointestinal symptoms (including but not restricted to diarrhoea, change in bowel habit, abdominal pain, PR bleeding, weight loss), iron deficiency anaemia, family history of CRC, abnormal findings on cross sectional imaging Absolute contraindication to colonoscopy 2. Unable to give informed consent 3. Known colorectal cancer 4. Known polyposis syndrome 5. Previous total/subtotal colectomy 6. Known colonic stricture which would prevent completion of colonoscopy 7. Attending for therapeutic procedure 8. Attending for assessment of a known lesion 9. Attending for assessment of known inflammatory bowel disease (IBD) 10. Attending for surveillance colonoscopy (polyp surveillance, post colorectal cancer surveillance, IBD surveillance) 11. Colonoscopy within the last 5 years
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 70.0-999.0, Sarcopenia Chronic Kidney Disease Older man or woman age over 70 years CKD stage 3B, 4 or 5 or a DFG <45ml / min according to CKD-EPI formula an SPPB (Short Physical Performance Battery test )<10 having received a complete and loyal information and having given his written and informed consent ability to rehabilitate Subject not presenting previous General condition not compatible for the realization of physical rehabilitation Patient protected under the terms of the law Inability to respect the follow-up of the study for geographical, social or psychological reasons depression or other psychiatric disorder Refusal to participate in the study Absence of affiliation to the social security system Subject in a period of an other study
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Reconstructive Surgery After Carcinological Excision Patient eligible for reconstructive surgery after carcinological excision following a decision taken in a multidisciplinary consultation, and for whom the envisaged oral defect concerns either the soft tissues of the oral cavity and oropharynx, or the mandibular bone Scheduled post-operative radiotherapy Coverage by the Social Security system Capacity to provide informed consent Post-traumatic substance loss (ballistic autolysis) Surgical or anesthetic contraindication (physiological age, other proposed therapeutic options) Pregnant or breastfeeding woman Subject incapable of full age or deprived of liberty Indication for chemotherapy with highly neurotoxic agents Inability to complete questionnaires or express feelings during the examination Any situation judged by the investigator as a contraindication to neurorrhaphy
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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): 40.0-89.0, COPD Emphysema or COPD COPD Exacerbation COPD Exacerbation Acute Respiratory Failure Ventilatory Failure for with Ventilatory Failure Cohort Emergency Department (ED) or ICU physician diagnosis of an acute exacerbation of COPD Age ≥ 40 years of age Need for ventilator support in the ED or ICU during the first 24 hours for Stable COPD Cohort Physician diagnosis of COPD Age ≥ 40 years of age Frequency matched to subjects for Age (± 10 year increments) Current/Former smoking status (former smoker = no smoking for ≥ 1 month) Lung function (FEV1% predicted by ± 10% increments) for with Ventilatory Failure Cohort Systemic steroid use ≤ 30 days prior to return visit Infection requiring antibiotics ≤ 1 month prior to return visit Hemoglobin < 8.0 g/dl Acute pulmonary embolism Diabetes History of immunodeficiency, interstitial lung disease, neuromuscular disorder or heart failure with respiratory exacerbation Tracheostomy Drugs that induce cytochrome P450 3A enzyme activity (e.g. barbiturates, phenytoin or carbamazepine) or drugs that inhibit cytochrome P450 3A activity (e.g. ketoconazole and chronic macrolide antibiotics) Age ≥ 90 year of age
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-80.0, Emphysema Candidates for this study must meet all of the following 1. Patient between 50 to 80 years old 2. High Resolution CT scan indicates homogeneous or heterogeneous emphysema. 3. Patient has post bronchodilator FEV1 less than or equal to 45% of predicted 4. Total Lung Capacity > 100% of predicted. 5. Residual volume≥ 200% of predicted. 6. Patient has marked dyspnea scoring >2 on mMRC scale of 0-4. 7. Patient has stopped smoking for a minimum of 8 weeks prior to entering the study, as confirmed by COHb ≤2.5% 8. Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form. 9. Subject has completed a pulmonary rehab within the last year and/or performs regularly physical activity. Candidates will be excluded from the study if any of the following conditions are present: 1. Patient has a change in FEV1 > 20% post-bronchodilator 2. Patient has a history of recurrent clinically significant respiratory infection, defined as with more than 3 hospital stays in the past 12 months. 3. Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure>50mmHg and/or evidenced by echocardiogram. 4. Patient has an inability to walk >140 meters (150 yards) in 6 minutes. 5. Patient has evidence of any other disease that may compromise survival such as lung cancer, renal failure, any other investigator identified such evidences. 6. Patient is pregnant or lactating. 7. Patient has an inability to tolerate bronchoscopy under anesthesia. 8. Any contraindication to bronchoscopy procedure, including but not limited to: 1. Untreatable life-threatening arrhythmias 2. Inability to adequately oxygenate the patient during the procedure 3. Acute respiratory failure with hypercapnia 4. Within 6 months myocardial infarction 5. Previously diagnosed high-grade tracheal obstruction 6. Uncorrectable coagulopathy 9. Patient has clinically significant bronchiectasis. 10. Patient has giant bullae > 1/3 lung volume. 11. Patient has had previous LVR surgery, lung transplant or lobectomy，or has still ELVR devices or other device to treat COPD in either lung. 12. Patient has been involved in other clinical studies within 30 days prior to this study. 13. Patient is taking > 20mg prednisone (or similar steroid) daily. 14. Patient on antiplatelet agent (eg, clopidogrel) or anticoagulant therapy (eg, heparin or coumadin) or has not been weaned off prior to procedure. 15. Patient has any other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes. 16. A known allergy to nitinol. 17. Patient with uncontrolled diabetes as well as overweight patient (BMI > 35 kg/m2) 18. Cancer needs chemotherapy in past two years 19. Patient with pleural effusion and/or pneumothorax 20. Patient with a disease history of asthma, cystic fibrosis, interstitial lung disease (ILD), active tuberculosis; 21. Patient with exacerbation of chronic obstructive pulmonary disease (COPD) which defined as: An acute event with the need of antibiotic treatment or hospitalization. 22. Subject has severe gas exchange abnormalities as defined by: PaCO2 >55 mm Hg,PaO2 <45 mm Hg on room air 23. Patient with acute ischemic heart disease, with proven pulmonary hypertension (SPAP> 45 mmHg) in echocardiography and/or need for double platelet aggregation inhibition
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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, Relapsed/Refractory Chronic Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia Written informed consent according to Swiss law and ICH/GCP regulations before registration and prior to any trial specific procedures Cytologically and immunophenotypically confirmed relapsed/refractory CLL (irrespective of the 17p deletion and/or TP53 mutation status and the duration of remission from last prior therapy) Patients in need of systemic treatment as defined by international workshop on chronic lymphocytic leukemia (iwCLL) (at least one of the following indications must be fulfilled) Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia. Cut-off levels of Hb < 100 g/L or platelet counts of < 100x109/L Massive (i.e., ≥ 6 cm below the left costal margin) or progressive or symptomatic splenomegaly Massive nodes (i.e., ≥ 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy Progressive lymphocytosis with an increase of ≥ 50% over a 2-month period, or lymphocyte doubling time of less than 6 months Disease-related symptoms as defined by any of the following: (a) Unintentional weight loss ≥ 10% within the previous 6 months. (b) Significant fatigue (i.e., ECOG PS 2 or worse; cannot work or unable to perform usual activities). (c) Fevers ≥38.0° C for 2 or more weeks without evidence of infection. (d) Night sweats for ≥ 1 month without evidence of infection Age at least 18 years WHO performance status 0-2 Any potential patient who meets any of the following has to be excluded from entering the trial Transformation of CLL (i.e. Richter's transformation, prolymphocyctic leukemia) Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low-risk of recurrence and/or no late recurrence Prior treatment with venetoclax and/or ibrutinib Major surgery and any systemic anti-cancer treatment within 3 weeks prior to registration Steroid therapy for anti-neoplastic intent; strong and moderate CYP3A inhibitors; strong and moderate CYP3A inducers must be stopped at least 7 days prior to the first dose of trial drug (see http://medicine.iupui.edu/ and useful tools for examples) Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia on direct oral anticoagulants (DOAC), Aspirin or low molecular weight heparins (LMWH) but not on Vitamin K antagonist), significant QT-prolongation, uncontrolled hypertension History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to registration and known bleeding disorders (e.g., von Willebrand's disease or hemophilia) Patients with a history of confirmed progressive multifocal leukoencephalopathy (PML) Concomitant diseases that require anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists. Patients being treated with factor Xa inhibitors (e.g. rivaroxaban, apixaban, edoxaban), direct thrombin inhibitors (e.g. dabigatran) LMWH, or anti-platelets agents (e.g. aspirin, clopidogrel) can be included, but must be properly informed about the potential risk of bleeding under treatment with ibrutinib
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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, Smoking Cessation Hong Kong residents aged 18 to 65 years have used any tobacco products in the past month able to read and speak Chinese have not used NRT for the past month Have severe angina, serious cardiac arrhythmias and hypertension Have suffered from acute myocardial event in the past 4 weeks Pregnant nor breastfeeding Under medication and treatment due to mental illness One of the was "smoke 10 cigarettes or more per day in the past week" and is amended to "have used any tobacco products in the past month". The initial intention of setting the of at least 10 cigarettes per day (CPD) is to recruit smokers who have moderate to strong level of craving and a greater need for NRT. However, we also recognize that one of the objectives of the research is to promote the use of NRT for quit attempts with NRT sampling. In fact, smokers who smoke less than 10 CPD can also benefit from using NRT gums. Therefore, the change in the does not deviate from our research aim. In contrast, with the removal of the criterion for CPD, we will be able to reach out to a larger group of smoking population and encourage more smokers to use NRT to quit smoking
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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 Respiratory Disease Hypoxia, Altitude COPD ILD Cystic Fibrosis Age ≥18 years old (at the time of HAST) Clinically stable Hypoxic altitude simulation test, scheduled as part of the clinical care Inability to provide informed consent Being part of a clinical trial, which would patients who are taking part in other studies including observational studies
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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, Lung Function Testing Cigarette Smoking Single-photon Emission Computed Tomography (SPECT) Ventilation Homogeneity Lung Disease Prevention For Smokers group Active tobacco smoking of at least 10 cigarettes/day AND total smoking history of at least 15 pack-years Normal lung function testing, defined as: FVC/FEV1 ratio, FEV1 and FVC all greater than the lower limit of normal; mean forced expiratory flow at 25 to 75% of CVF (FEF25-75%) >80% of predicted value and absence of concavity on the forced expiratory flow curve, as evaluated by a trained respirologist; total lung capacity (TLC) greater than the lower limit of normal; residual volume (RV), functional residual capacity (FRC), expiratory reserve volume (ERV), inspiratory capacity (IC) and VR/TLC ratio all >80% predicted value and diffusion capacity of the lung for carbon monoxide (DLCO) >80% predicted value when corrected for hemoglobin level Body mass index (BMI) <30 kg/m2 • Post-bronchodilator change in FEV1 and FVC of more than 6% and/or 100 ml. For Non-smokers group No history of tobacco-smoking Normal lung function testing, defined as: FVC/FEV1 ratio, FEV1 and FVC all greater than the lower limit of normal; mean forced expiratory flow at 25 to 75% of CVF (FEF25-75%) >80% of predicted value and absence of concavity on the forced expiratory flow curve, as evaluated by a trained respirologist; total lung capacity (TLC) greater than the lower limit of normal; residual volume (RV), functional residual capacity (FRC), expiratory reserve volume (ERV), inspiratory capacity (IC) and VR/TLC ratio all >80% predicted value and diffusion capacity of the lung for carbon monoxide (DLCO) >80% predicted value when corrected for hemoglobin level Body mass index (BMI) <30 kg/m2 • Post-bronchodilator change in FEV1 and FVC of more than 6% and/or 100 ml
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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 with COPD with two or more exacerbations every year or at least one leading to hospitalization long-term oxygen therapy cognitive impairment a life expectancy limited to one year
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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, COPD Exacerbation Admitted to Hospital with a primary diagnosis of exacerbation of COPD Greater then or equal to 20 pack year history of smoking Participating in Integrated Comprehensive Care (ICC) home care program Requirement for acute non-invasive ventilation in hospital Use of nocturnal non-invasive ventilation prior to hospitalization
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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; Uremic End Stage Renal Disease Chronic Lung Disease Chronic Heart Disease Hemodialysis-Induced Symptom Sodium Excess Age equal to or greater than 18 years Dialysis vintage equal to or greater than 3 months Smoking history of more than 10 packs/year Active tobacco and/or cannabis smoking Diagnosed chronic pulmonary disease Severe heart failure (NYHA class IV) Active infection (including tuberculosis) or malignancy Pregnancy Inability to give consent or understand written information Peripheral oxygen saturation (by pulse oxymetry) dropping below 80% when performing a 12-seconds breathhold Inability to perform spirometry or plethysmography maneuvers Inability to tolerate MRI due to patient size and/or known history of claustrophobia
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-70.0, Stable COPD Patients Socioeconomic status: Middle class Smoker Stable patients of COPD with >1year duration Vitamin D3 deficient : Serum 25-hydroxycholecalciferol, [25(OH)D] level <30ng/ml (Vitamin D Council 2017) With acute exacerbation of any pulmonary diseases, as, with acute exacerbation of any cardiac disease, like - Uncontrolled systemic hypertension Chronic liver disease Malignancy Use of drugs known to affect vitamin D metabolism within 1 month prior to With biochemical evidence of - uncontrolled diabetes mellitus and renal insufficiency All the mentioned above were scrutinized by taking history and clinical examination, except vitamin D3 deficiency, uncontrolled diabetes mellitus and renal insufficiency, which were diagnosed biochemically
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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): 28.0-80.0, Chronic Obstructive Pulmonary Disease Asthma for all subjects: 1. Subject's written informed consent obtained prior to any study-related procedure; 2. Ability to understand the study procedures, the risks involved and ability to demonstrate correct use of the inhaler using the AIM™ (Aerosol Inhalation Monitor) Vitalograph® 3. Body Mass Index (BMI) between 18 and 32 kg/m2 extremes inclusive; 4. Good physical status, determined on the basis of the medical history and a general clinical examination, at screening; 5. Vital signs within normal limits: Diastolic BP 40-90 mmHg, Systolic BP 90-140 mmHg or 90-160 mmHg if >45 yrs 6. Males fulfilling one of the following 1. Males with non-pregnant Women of childbearing potential (WOCBP) partners: they and/or their partner of childbearing potential must be willing to use a highly effective birth control method in addition to the male condom from the signature of the informed consent and until 90 days after the follow-up visit. Subjects must not donate sperm during the study and for 90 days after the follow-up visit or 2. Males with pregnant WOCBP partner: they must be willing to use male contraception (condom) from the signature of the informed consent and until 90 days after the follow-up visit. Subjects must not donate sperm during the study and for 90 days after the follow-up visit or 3. Non-fertile male subjects (contraception is not required in this case) or 4. Males with partner not of childbearing potential (contraception is not required in this case). 7. WOCBP fulfilling one of the following 1. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method with low user dependency from the signature of the informed consent and until 30 days after the follow-up visit or 2. WOCBP with non-fertile male partners (contraception is not required in this case). 8. Females of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges) 9. 12 -lead digitised Electrocardiogram (12-lead ECG) considered as normal at screening and at Day -1 Additional only for Healthy Volunteers and Asthmatic patients: 1. Male and female subjects aged 28-55 years inclusive; 2. Non or ex-smokers who smoked < 5 pack years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking > 6 months prior to screening; Additional only for Healthy Volunteers: 1. Lung function measurements within normal limits at screening: FEV1 equal to or more than 80% of predicted Additional only for Asthmatic patients: 1. Diagnosis of asthma: Established diagnosis of permanent asthma for at least 12 months according to GINA guidelines 2. Patients with a pre-bronchodilator 60%≤ FEV1 < 80% of the predicted normal value 3. Patients with a documented reversibility defined as an increase ≥ 12% and 200mL over baseline within 30 min after inhalation of 400µg salbutamol pMDI Additional only for COPD patients: 1. Male and female patients aged 40-80 years inclusive 2. A smoking history of at least 10 pack-years 3. Current or ex-smokers are eligible. 4. Established diagnosis of COPD 5. A post-bronchodilator FEV1 ≤ 50% of the predicted normal value and a post-bronchodilator FEV1/FVC < 0.7 10-15 minutes after 4 puffs (4x100 µg) of Salbutamol pMDI for all subjects: 1. Pregnant or lactating women; 2. Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders 3. Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation 4. Subjects with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction 5. Positive HIV1 or HIV2 serology at screening 6. Blood donation or blood loss less than 2 months prior screening 7. Participation to another clinical trial where investigational drug was received and last investigations were performed less than 90 days prior to screening; 8. Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test 9. Documented history of drug abuse within 12 months prior to screening 10. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C at screening 11. Subjects who have cardiovascular condition such as, but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, acute ischemic heart disease in the last year prior to study screening, which may impact the safety of the subject or the evaluation of the result of the study according to the Investigator's judgment 12. Unsuitable veins for repeated venepuncture/cannulation 13. Intake of non-permitted concomitant medications in the predefined period prior to screening 14. Radiation exposure, including that from the present study, in the last 12 months 15. Known intolerance/hypersensitivity or contra-indication to treatment Additional only for Healthy volunteers and Asthmatic patients: 1. Positive urine test for cotinine at screening or prior Day 1 2. Current use of any nicotine or nicotine replacement product Additional only for Asthmatic and COPD patients: 1. Use of systemic corticosteroids medication within 4 weeks prior to the screening or slow release corticosteroids within 12 weeks before the screening or prior Day 1 2. A diagnosis of lung cancer or a history of lung cancer 3. A history of lung volume reduction surgery 4. Lower respiratory tract infection that requires use of antibiotics Additional only for Healthy volunteers: 1. Subjects with history of breathing problems Additional only for Asthmatic patients: 1. History of near fatal asthma, hospitalization for asthma in intensive care unit 2. Any change in dose, schedule or formulation in the treatment of asthma in the 4 weeks prior to the screening visit or prior Day 1 3. Non-persistent asthma: 4. Treatment with chronic systemic corticosteroids or anti IgE or other monoclonal antibodies 5. Known respiratory disorders other than asthma Additional only for COPD patients: 1. Any change in dose, schedule or formulation in the treatment for COPD in the 4 weeks prior to the screening 2. A concurrent diagnosis of asthma, in the opinion of the investigator 3. Known respiratory disorder other than COPD that in the Investigator's opinion would affect efficacy and safety evaluation or place the patient at risk. 4. Oxygen therapy: patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia. 5. Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit
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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): 51.0-999.0, Benign Prostatic Hyperplasia (BPH) Prostate Cancer International Prostate Symptom Score ≥ 12 Peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine Prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (US) or Magnetic Resonance Imaging (MRI) Obstructive median lobe of the prostate Active urinary tract infection Neurogenic non-obstructive voiding dysfunction Obstructive symptoms secondary to prostate cancer (via cystoscopy) Patients with prior Transurethral resection of the prostate (TURP) Patients with prior history of urethral stricture
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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 Rhinosinusitis (Diagnosis) ALL these need to be positive Endoscopic nasal polyp score ≥4 SNOT-22 ≥30 Sinus Computed tomography Lund-Mackay score ≥14. The new sinus CT scans are needed if the previous sinus CT scans have been performed over 36 months before recruitment visit or if there is a suspicion of complication of CRS (f.ex. mucocele, invasive fungal rhinosinusitis) ≥1 previous partial/total ethmoidectomy surgery. In addition, patient should have a history of at least one of the following: >1 oral corticosteroids during the past two years >3 antibiotic courses during the past two years. In patients with contraindication/adverse effects in using oral steroids additional are not required complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis) bleeding diathesis pregnancy/ breastfeeding cystic fibrosis primary ciliary dyskinesia (PCD) sarcoidosis granulomatosis with polyangitis (GPA) eosinophilic granulomatosis with polyangitis (EGPA) immunosuppression (diagnosed Spesific antibody deficiency (SAD), CVI, HIV use of biologicals/immunosuppressive medication
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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): 0.0-999.0, Benign Prostatic Hyperplasia Patients who have been diagnosed with benign prostatic hyperplasia by a urologist Have been treated with conventional first-line western medicine for more than three months Patients with moderate to severe benign prostatic hyperplasia (IPSS score >12 points) Participate voluntarily in the study At the same time, use other Chinese herbal medicines or alternative medicine (including drugs and acupuncture) for more than one month Syphilis, gonorrhea and other sexually transmitted diseases or urinary tract infections Urinary tract stones, prostate cancer, bladder cancer or acute and chronic renal failure Congenital abnormalities such as bladder neck fibrosis, interstitial cystitis or urethral stricture A history of genital trauma or surgery affecting the muscle or nervous system Patients with upper urinary tract obstruction, renal edema, etc. affecting renal function Unable to sign a consent form or unable to communicate with researchers
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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 Age 18 years and older 2. Physician-diagnosed COPD (prior to or during hospitalization) 3. Owns a wifi-enabled device (desktop, laptop, tablet, smart phone, etc.) 4. Discharged with a rescue and/or controller MDI, metered dose inhaler Currently in an intensive care unit 2. Physician declines to provide consent 3. Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent
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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, Rib Fracture Rib Fracture Multiple Trauma Trauma Chest Trauma Injury Trauma, Multiple Adult person age 18-80 admitted with at least one acute traumatic closed rib fracture to the University of Vermont Medical Center Pediatric (<18 year old) and Geriatric (>80 year old) patients Patients who are intubated on arrival or within first 24 hours of admission or with Glasgow Coma Scale (GCS) < 14 (altered or depressed consciousness) Pregnant patients Patients who undergo operative rib fixation for their rib fractures (such as open reduction internal fixation, or rib plating) Patients with chest wall deformity, lacerations, burns, or soft tissue injuries that preclude placement of the RibFx belt Patients with an additional mechanism of injury that would create severe distracting pain, as determine by the admitting team Isolated 1st rib or 2nd rib fractures
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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 Able to speak English Moderate to very severe COPD (GOLD C and D) as defined by the GOLD guidelines Clinically relevant disease, as defined by a history of exacerbation in the previous 12 months Previous spirometry or Pulmonary Function Test results of Forced Expiration Volume/Forced Vital Capacity (FEV1/FVC) <0.70 with an FEV1 below 80% predicted Patient resides at home (not long term care residence or another hospital) Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma Rapid lethal disease, e.g. lung cancer, advance heart failure, end-stage renal disease Any medical conditions that would impair their ability to participate in the study
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-18.0, Interstitial Lung Diseases of Childhood Genetic Testing The chILD syndrome exists when a child with DLD has had the common causes of DLD excluded as the primary diagnosis and has at least three of the following four (1) respiratory symptoms (e.g., cough, rapid and/or difficult breathing, or exercise intolerance);(2) respiratory signs (e.g., resting tachypnea, adventitious sounds, retractions, digital clubbing, failure to thrive, or respiratory fail ure); (3) hypoxemia; and (4) diffuse abnormalities on CXR or a CT scan These cystic fibrosis, congenital or acquired immunodeficiency, congenital heart disease, bronchopulmonary dysplasia, pulmonary infection, primary ciliary dyskinesia presenting with newborn respiratory distress and recurrent aspiration
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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 patients with chronic obstructive pulmonary disease, exacerbated or stable between the age of 40-80 years with sinus rhythm who gave informed written consent Inability to give written consent, acute myocardial infarction with ST-segment elevations in last 30 days, severe acute or chronic renal dysfunction, severe heart failure, atrial fibrillation, severe valve disease, severe hypotension, active malignant disease, active rheumatic 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): 30.0-60.0, Chronic Obstructive Pulmonary Disease Patient having mild to moderate stage of COPD Any facial injury and surgery Sinusitis Patient with respiratory failure Patient having dyspnea on cardiac origin Patient having allergic rhinitis and Bronchitis Patients having cystic fibrosis
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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, Heated Tobacco Respiratory Function Tobacco Toxicity Healthy smokers, 2. >10 pack/years 3. receiving no medications 4. no co morbidity aged <18 years 2. pregnant 3. receiving any medications 4. any co morbidity
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 20.0-999.0, Hip Fractures Cognitive Impairment Subjects are: 1. age 60 years or older, 2. admitted to CGMH due to one-side hip fracture, and being diagnosed as needing surgery, 3. assessed as having cognitive impairment by the Chinese Mini-Mental State Examination (CMMSE) (CMMSE score < 21 with < 6 years education, or CMMSE < 25 with ≥ 6 years education; Yip et al., 1992), 4. having a primary family caregiver, 5. living in northern Taiwan (i.e., greater Taipei area, Keelung, Taoyuan, or Shin-Ju province) Family caregivers: 1. age 20 years or older, 2. responsible for providing direct care to or supervising care received by the patient Subjects are 1. cognitively intact by CMMSE, 2. without a primary family caregiver, 3. terminally ill, 4. severe cognitive impairment such that they are completely unable to follow orders (CMMSE < 10; Yip et al., 1992)
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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 Main Males and females at least 40 years of age and no older than 80 years Patients with diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) [1] Post bronchodilator (BD) FEV1 / Forced Vital Capacity (FVC) ratio must be < 0.70 Post BD FEV1 must be < 80% predicted All patients must be receiving 1 or more inhaled maintenance therapies, including at least 1 long-acting bronchodilator, for the management of their COPD for at least 4 weeks prior to the Screening Visit Current or former smokers with a history of at least 10 pack-years of cigarette smoking. [Number of pack-years = (number of cigarettes per day/20) x number of years smoked (e.g. 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years represent 10 pack-years)]. Main Any significant disease or disorder (e.g. including but not limited to gastrointestinal, hepatic, renal/urinary tract, haematological, neurological, musculoskeletal, endocrine, metabolic, eye, psychiatric which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results of the study Respiratory: Current diagnosis of asthma, in the opinion of the Investigator. COPD due to α1-Antitrypsin Deficiency. Sleep apnoea that, in the opinion of the Investigator, is uncontrolled. Other Respiratory Disorders: known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution computerised tomography [CT] evidence of bronchiectasis that causes repeated acute exacerbations), immune deficiency disorders, severe neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease. Note: allergic rhinitis is not exclusionary. A moderate or severe exacerbation of COPD ending within 6 weeks prior to dosing (Day 1). The end date of an exacerbation is the last day of treatment with systemic corticosteroids or antibiotics. Prior pulmonary resection or Lung Volume Reduction Surgery [i.e., lobectomy, bronchoscopic lung volume reduction (endobronchial blockers, airway bypass, endobronchial valves, thermal vapor ablation, biological sealants, and airway implants)] Cardiovascular Patients 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 Current cancer diagnosis requiring treatment
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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): 18.0-85.0, Cannabis Use Cannabis Smoking Marijuana Smoking Marijuana Usage Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature Provision of written, informed consent prior to any study specific procedures Males and females aged 18-85 Current or former cannabis smoker (medicinal or recreational) with or without concurrent tobacco smoking history Participant is able to perform reproducible pulmonary function testing (i.e. the 3 best acceptable spirograms have Forced Expiratory Volume in 1 second (FEV1) values that do not vary more than 150 millilitres) Participant is able to perform a breathhold for 16s FEV1 > 25% predicted Forced Vital Capacity (FVC) > 25% predicted and >0.5 litres Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand written material Participant is medically unstable in the opinion of the Principal Investigator Participant has a daytime room air oxygen saturation <90% while lying supine Participant is unable to perform spirometry or plethysmography maneuvers Patient is pregnant at time of enrolment In the opinion of the investigator, patient suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia Patient has implanted mechanically, electrically or magnetically activated device or any metal in their body, which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) at the discretion of the MRI Technologist
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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): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
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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): 21.0-999.0, Chronic Obstructive Pulmonary Disease Age 21 years and above 2. Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio <0.7 3. Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis 4. Fit to participate in exercise therapy as determined by both physician and physiotherapist 5. Has the mental capacity to follow instructions 6. Experience shortness of breath on exertion 7. Have decreased ability to carry out activities due to shortness of breath 8. Willing to participate in the exercise program Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe 2. Pulmonary disorder other than COPD 3. Physical conditions that preclude the ability to participate in exercise or may impair exercise performance
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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): 21.0-65.0, Pharmacokinetics Subject has signed and dated the ICF and is able to understand the information provided in it Subject has been a smoker for at least the last 3 years prior to the Screening Visit and has smoked 5 to 15 commercially available cigarettes per day for the last 3 months prior to Screening Subject has a positive urinary cotinine test (cotinine ≥ 200 ng/mL) Subject does not plan to quit smoking within 2 months Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period Ready to switch from smoking cigarettes to using P3P for the duration of the study As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical (e.g., psychological and/or social reason) Subject has a clinically relevant disease which requires medication or any other clinically significant medical condition, which as per the judgment of the Investigator would jeopardize the safety of the subject Subject has asthma condition (post-bronchodilator FEV1/FVC < 0.75 and reversibility in FEV1 ≥ 12% and > 200 mL from pre to post-bronchodilator values) Subject has (FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at post-bronchodilator spirometry Subject has a BMI < 18.5 kg/m2 or > 32.0 kg/m2 Subject has received medication within 14 days or within 5 half-lives of the drug prior to Admission (whichever is longer) which has an impact on CYP2A6 activity Subject has a positive serology test for HIV 1/2, Hepatitis B, or Hepatitis C Subject has a positive alcohol breath test and/or a history of alcohol disorder within the past 2 years Subject has a positive urine drug test
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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 Subdural Hematoma Age greater than or equal to 18 years old; 2. Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) by Computed Tomography (CT); 3. Patients are joining the trial voluntarily with consent form signed Allergy to atorvastatin or other statins; 2. Deranged liver function; 3. Patients who are already on long term steroid for other condition(s); 4. Patients who are already on statin for other condition(s); 5. Presence of cerebrospinal fluid diversion device (e.g. ventriculo-peritoneal shunt); 6. Pregnant or on breast feeding; 7. Hematoma is secondary to tumour or haematological disorders; 8. Patients taking angiotensin converting enzyme (ACE) inhibitor
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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 Subjects must be able and willing to comply with the requirements of the protocol Subject must be aged greater than or equal to 40 years at the time of signing the informed consent form (ICF) Subjects must have a record of a clinical diagnosis of COPD, ACOS or CB Subjects must have moderate to severe airflow limitation based on spirometry:FEV1 percent predicted normal greater than or equal to 40 to less than or equal to 80% and post-bronchodilator FEV1/forced vital capacity (FVC) ratio less than 0.7 Subjects must be symptomatic, defined as having a CAT score greater than or equal to 10 Subjects must have a documented history of at least 1 LRTI treated with antibiotics and/or oral/systemic corticosteroids, which may an exacerbation of COPD, in the 12 months prior to Screening, and must have not experienced either of these in the 4 weeks prior to Screening, and must be determined to be stable-COPD by the investigator Subjects must be current or former tobacco (cigarette) smokers with a smoking history of greater than or equal to 10 pack-years Subjects may be male or female For female subjects: A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP) or Is a WOCBP and using an acceptable contraceptive method during the study period.The investigator should evaluate the effectiveness of the contraceptive method. A WOCBP must have had a highly sensitive urine pregnancy test within 2 weeks prior to enrolment that proved negative. If a urine pregnancy test cannot be confirmed as negative (example given [e.g.], an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive. The investigator is responsible for review of subject's medical history, menstrual history, and recent sexual activity to decrease the risk of including a woman with an early undetected pregnancy Subjects must be capable of giving signed informed consent Subjects with a diagnosed respiratory disorder other than COPD, ACOS or CB (such as: sarcoidosis; active tuberculosis or are receiving tuberculosis treatment; clinically significant bronchiectasis (greater than 20% lung damage on computed tomography [CT] scan), lung fibrosis, pulmonary embolism, or pneumothorax; lung cancer diagnosed within the previous 5 years; asthma only or a current primary diagnosis of asthma in the opinion of the investigator); or chest imaging revealing evidence of clinically significant abnormalities not believed to be due to the presence of COPD Subjects with a diagnosis of alpha-1 antitrypsin deficiency as the underlying cause of COPD Subjects who have had lung surgery within 12 months prior to Screening, or plans to have lung surgery within 12 months after study entry Subjects with any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required) Subjects who have a psychiatric disorder or any other condition that interferes with the ability to understand the study procedures Subjects who have received antibiotics within 1 month of Screening or have received antibiotics for more than 30 days within 90 days prior to Screening Subjects who have received systemic corticosteroids (oral/intravenous/intramuscular) for more than 14 consecutive days within 90 days prior to giving informed consent Subjects who have received macrolides for more than 30 days within 90 days prior to Screening Subjects who have received chemotherapy for cancer in the 12 months prior to Screening Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 12 months
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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): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
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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): 40.0-75.0, Pulmonary Disease, Chronic Obstructive Veterans Moderate or severe COPD with a forced expiratory volume in 1 second forced vital capacity ratio (FEV1/FVC) < 0.70 and FEV1 < 80% predicted Hospitalization with a primary diagnosis of defined as an increase in shortness of breath, cough, and/or sputum production beyond the normal day-to-day variation necessitating a change in regular medication when other causes of increased shortness of breath, cough, and/or sputum production have been ruled out Capable of operating a tablet independently with adequate vision and hearing Acute hypercapneic respiratory failure with a requirement for either non-invasive (i.e. bilevel positive airway pressure) or invasive mechanical ventilation during hospitalization Hospitalization < 72 hours A secondary diagnosis of acute congestive heart failure, myocardial infarction, or pneumonia during hospitalization or unstable cardiac or neurologic disease at discharge Enrollment in a pulmonary rehabilitation program within 12 months of hospitalization A medical condition that makes exercise unsafe (includes upper and lower limb strength training and lower limb cycle ergometry) This will be determined by the following screen for these through chart review, discussion with the patient (do they have any known cardiac issues, do they have chest pain with exertion, are they lightheaded with exertion), discussion with the physicians caring for the patient in the hospital, and direct observation and assessment during the bedside pulmonary rehab sessions (that were built into this study for safety purposes) in another greater than minimal risk study
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 25.0-40.0, Traumatic Brain Injury Neurobehavioral Manifestation Sleep Disorder Fatigue Are 25 to 40 years of age Are active duty service members or veterans May be NIH employees/staff who are either active duty service members or veterans; except for those who are employed by NINR or subordinates, relatives, and/or co-workers of NINR employees/staff Have sustained at least 1 TBI, >= 6 months and <= 5 years since their most recent TBI, which includes any self-reported loss of consciousness (LOC) established by the OSU during the pre-screening phone call Are able to provide their own consent Are able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz Currently receiving treatment for a medical illness or recent injury that precludes protocol participation, may interfere with study participation, and/or should be treated/stabilized prior to study participation for safety reasons (e.g., cancer, recent fracture(s) requiring therapy and/or pain medication, severe infection). Individuals with stable medical conditions such as hypertension that are controlled by medication will be included Current physical health status will be assessed by self-report, history and physical exam by a credentialed physician or nurse practitioner, and standard laboratory tests Current unstable endocrine disorder (e.g., uncontrolled diabetes). Unstable endocrine disorders require treatment to ensure health and safety of the patient before participation is possible. Individuals with stable endocrine disorders (e.g., controlled diabetes) may participate in the protocol but they will be excluded from the hydrocortisone stimulation test. This will be assessed by self-report during the history and physical exam and by standard laboratory tests Have a major medical illness that is associated with fatigue (e.g., chronic fatigue [diagnosed prior to their TBI or less than 6 months following TBI], multiple sclerosis, or cancer). This will ensure that symptoms of fatigue are as a result of TBI and not another co-morbid illness. This will be assessed by self-report Currently consuming any of the following sleep modifying medications: benzodiazepines; benzodiazepine receptor agonists; opiates; or sedatives. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants currently taking these medications will be excluded. This will be assessed by self-report Currently using the sleep modifying medications melatonin and/or Benadryl greater than 2 times per week and/or unable or unwilling refrain from using them during protocol participation. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants who are unwilling/unable to refrain from using these medications will be excluded. This will be assessed by self-report Current psychiatric condition for which immediate treatment is required to prevent harm to self or others such as active suicidality or active manic phase in someone who has bi-polar disorder. This is to ensure patient safety and care. This will be assessed by self-report and as part of the history and physical exam Are pregnant. Pregnancy is associated with increased fatigue and sleep disturbances, as such this condition will affect the outcomes of this analysis.his will be assessed by self-report. This will also be assessed on visit 2 by a urine pregnancy test. Individuals who are nursing are eligible but will not participate in the hydrocortisone stimulation test Received a diagnosis of severe obstructive sleep apnea (OSA) and/or current reliance on continuous positive airway pressure (CPAP) therapy to aid sleep. Severe OSA and CPAP use will directly affect the result s of this study, as such these participants will be excluded. This will be assessed by self-report. **Participant may be able to participate in the protocol but will not be able to have an MRI if they have any of the following Metal in the body such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if they are a welder or metal worker
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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 Acute meet the diagnostic of chronic obstructive pulmonary disease (COPD)[1] : In the examination of pulmonary function, after inhalation of bronchodilator, the volume of forced air in one second accounted for 70% of forced vital capacity (FEV1 / FVC%) , fev180% ; 2. meet the diagnostic of acute exacerbation of chronic obstructive pulmonary disease (AECOPD)[2] : compared with the stable phase, the patient's condition has continued to deteriorate, more than the normal changes in the daytime, that is, patients with chronic obstructive pulmonary disease foundation for acute onset, need to adjust the routine medication. There are at least 2 of the following 3 items in the continuous deterioration of clinical symptoms: 1 aggravation of shortness of breath; 2 increase of Sputum Volume; 3 purulent sputum; or at least 1 of the above 3 symptoms, but one of the other 5 indicators should be added, 1 fever; 2 increased respiratory frequency and heart rate by 20% compared with the baseline; 3 aggravated cough; 4 Pharyngodynia and runny in the last 5 days; 5 increased wheezing; 3. the age is over 40 years old and has the normal independent judgment ability patient, the male and the female are not limited; 4. patients requiring in-patient Care; 5. patients with BCSS score ≥6 at the time of admission; 6. patients who volunteer for the trial and sign an informed consent form screening period of intravenous or oral administration of more than 80 mg / day of methylprednisolone or equivalent dose of other hormones or serious need for continuous non-invasive ventilation patients; 2. having a significant disease other than COPD, which, according to the researchers'judgement, would put the participants at risk for participating in the study or have an impact on the results of the study and the participants'ability to participate in the study; 3. other respiratory diseases: subjects with other active pulmonary diseases, such as active tuberculosis, lung cancer, bronchiectasis disease (CT showed repeated acute exacerbations of bronchiectasis disease) , sarcoidosis, idiopathic interstitial pulmonary fibrosis (IPF) , primary pulmonary hypertension, uncontrolled Sleep apnea (i.e. , according to the researchers, the severity of the disease would influence the study) ; 4. Lung Rehabilitation: Participants in the Lung Rehabilitation Program during the study period; 5. a history of severe heart disease such as acute myocardial infarction, congestive heart failure (NYHA Class III and above) , Severe Arrhythmia and other acute heart disease; 6. serious primary diseases of important organs and systems, such as acute stroke, hypertension above moderate after treatment, active gastric ulcer, diabetes Mellitus (serious complication) , malignant tumor, etc. 7. confirmed and suspected cases of lung cancer; 8. a history of one or more lobectomies; 9. limited understanding and poor compliance; 10. lack of or restricted legal capacity; 11. those who have participated in clinical trials of other drugs or medical devices within 30 days prior to screening but have not reached the end point of the trial; 12. pregnant, lactating women and women of childbearing age who do not agree to effective contraceptive measures during the study period; 13. Persons with mental or physical disabilities; 14. a suspected or confirmed history of alcohol or Drug Abuse; 15. those who are known to be intolerant to inhalation therapy; 16. AST, ALT were 3 times higher than the normal upper limit, creatinine ≥176.8 MMOL / l; 17. shock or other Hemodynamics instability; 18. people with active Hepatitis A, hepatitis B, HIV, tuberculosis, and Infectious Disease Connective Tissue Disease; 19. intravenous hormone therapy for more than 5 days after an acute episode; 20. non expectorant antioxidants, including high doses of vitamin C and Vitamin E; 21. the researcher did not consider it appropriate to participate in this study
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Assessment Chest Pain ACS - Acute Coronary Syndrome Any patient over the age of 18 calling call center for chest pain No-inclusion Posttraumatic chest pain Age under 18 Patient not speaking French Patient refusing to participate in the study or refusing care Patient not affiliated with social security Patients incarcerated in a penitentiary center Patients under guardianship, curatorship or safeguard of justice Patient refusing to participate in the study or refusing care
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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, Vital Signs I1. Sufficiently conversant in the English language to satisfy I3 I2. Able and willing to comply with all study requirements I3. Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old) There are no
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-80.0, Overweight or Obesity male and female subjects age: 50 years post or peri-menopausal Smokers and non-smokers BMI 25 to 40 kg/m2 Dietary Inflammatory Index, DII: 0 to +10 Fruit and vegetable intake <4 servings/d Adherence to a 6-week "wash-out" period Age <50 and >79.9 years Dietary Inflammatory Index, DII 1 to -10 Subjects with any kind of food allergy or histamine intolerance Aversion to stop the intake of nutritional supplements and food, that could interfere with the study outcome Food supplements, functional foods and dietetic products with anti-inflammatory or redox-biological relevance like omega-3 fatty acids, plant/herbal extracts/concentrates, vitamin and mineral supplements Fruit and vegetable intake >3 servings per day Hypertension, starting with grade 2 according to the classification of the European Society of Hypertension: systolic blood pressure > 160 mmHg, diastolic blood pressure >100 mmHg Medication: any anti-inflammatory medication and medication with relevant antioxidant properties, blood pressure lowering medication, psychotropic drugs, immunosuppressives, cytostatics, anticoagulants, contraceptives, diuretics, pain medication
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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, Multiple Myeloma Relapse Multiple Myeloma Refractory Multiple Myeloma years and older Relapsed/refractory MM patients who have received 1 to 3 prior lines of therapy Is willing and able to sign informed consent (ICF) to participate Patients receiving carfilzomib equal or less than 2 months (≤2 cycles) according to regulatory approvals Is reporting to a site in this study for a second opinion (consultation only) or participants whose frequency of consult and follow-up are not adequate for case report form (eCRF) completion Is participating in another study (observational or interventional) that prohibits participation in this study Patients receiving carfilzomib more than 2 months (>2 cycles)
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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 Patients with a confirmed diagnosis of COPD (GOLD 1-4) Hospitalisation due to a COPD exacerbation and decision to start with steroids and/or antibiotics (severe exacerbation) Age ≥ 18 Cognitive impairment (dementia, delirium) Not speaking German, French, Italian, English, Spanish, Portuguese, Serbian, Tamil, Hindi, Turkish or Slovakian
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Pulmonologist diagnosed COPD patients Duration of COPD: 1-10 years Vitamin D3 deficient : Serum 25(OH)D <30 ng/ml Age: >40years Sex: Male Socioeconomic status: Middle class smoker With acute exacerbation of: any other pulmonary diseases like bronchial asthma respiratory tract infection bronchiectasis pneumothorax pleural effusion tuberculosis pulmonary fibrosis pneumonectomy or pulmonary lobectomy any cardiac disease, like - unstable angina pectoris congestive heart failure myocardial infarction cardiac arrhythmia
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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): 0.0-999.0, Severe COPD Referral to the LVR intervention team or LTx team of the (UMCG) Chronic Obstructive Pulmonary Disease (COPD) according the Global initiative for Chronic Obstructive Lung Disease (GOLD) (post bronchodilator FEV1/FVC < 0.7)[1] Written informed consent There are no for this study
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, COPD Patients hospitalised with an exacerbation of COPD FEV1/FVC <70% or FEV1 <80% Age>40 years smoking history Previously prescribed fluticasone/salmeterol inhaler No exacerbations in previous year Outpatients
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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, STEMI Oxidative Stress Oxidative Stress Induction Primary PCI hFABP Left Ventricular Dysfunction BCM Adults with ST elevation Myocardial Infarction (<12h) diagnostic confirmed Included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI) Patients who do not sign informed consent for primary PCI
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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, Tabagism Lung Cancer Chronic Obstructive Pulmonary Disease Age >= 18 years old Applitabac user who has received a notification directing him to his doctor Smoker or former smoker (current smoking cessation or ≤ 5 years) Patient informed of the use of his data and not opposing it Presence of another evolutionary neoplasia in the past 2 years Patient who did not use the Applitabac app
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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): 16.0-999.0, Asthma COPD Exacerbation • Male or Female, aged ≥16 years A confirmed, clinician made diagnosis of asthma for ≥ 6months supported by evidence of any of the following Airflow variability, with a variability in FEV1 or Peak Expiratory Flow (PEF) of >20% across clinic visits within the preceding 5 years, with concomitant evidence of airflow obstruction (FEV1/FVC ratio <70% on spirometry) Airway reversibility with an improvement in FEV1 by ≥12% or 200 ml after inhalation of 400 μg of salbutamol (or equivalent bronchodilator) via a metered dose inhaler and spacer within the preceding 5 years Airway hyper-responsiveness demonstrated by Methacholine challenge testing with a provocative concentration of Methacholine required to cause a 20% reduction in FEV1 (PC20) of ≤ 16mg/ml or equivalent test Mild Asthma defined as GINA steps 1 to 3 Severe asthma defined as GINA steps 4 or 5 OR a confirmed, clinician made diagnosis of COPD for ≥ 6months supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of FEV1/FVC <0.7) OR no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease) Willing and able to give informed consent for participation in the study. Healthcare Professionals The participant may not enter the study if ANY of the following apply Existing co-morbidities that may prevent them from performing spirometry, FeNO or other study measurements (at the discretion of the clinical investigator) Known lung, chest wall, neuromuscular, or cardiac disease or abnormality that would confound symptom scores and spirometry In the opinion of the clinical investigator, participant would not be able to perform any of the study procedures Unable to comprehend the study and provide informed consent, e.g. insufficient command of English in the absence of someone to adequately interpret
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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, Cochlear Prosthesis Implantation Age between 18 and 75 years inclusive Use of the second CI for at least 1 year Regular follow-up in the Ear Nose and Throat department of Edouard Herriot Hospital in Lyon Post-lingual deafness Average voice recognition over 80% with 2 Cochlear Implants Normal vision (with or without correction) Able to understand the experimental instructions Affiliated to a social security scheme Oculomotor disorder Bilateral vestibular areflexia
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Chronic Obstructive Pulmonary Disease Smoking Cessation Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Competent and mature Have diagnosed COPD [spirometry verified and evaluated by pulmonary specialist] Current daily smoker [Minimum 1 cigarette daily] Have smoked minimum 20 pack years (1 pack year = 20 cigarettes daily in 1 year) Want to or try to stop smoking Do not mind taking varenicline or NRT during the trial Are willing to give blood and urine samples according to the protocol Previously included in the trial Hospitalized with COPD-exacerbation within the last 24 months Are associated with hospital outpatient clinic for COPD disease treatment Have FEV1<50% Pregnancy/breastfeeding Life expectancy less than 1 year Severe linguistic problems or inability to give informed consent Severe mental illness that is not controlled with medication Active alcohol or substance abuse Active cancer disease* *The person can participate if he or she has had a cancer disease that is now referred to as curative/radically treated. Basal cell carcinoma of the skin does not count as an criterion
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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, High Flow Nasal Time of Flight Camera Lung Volume Healthy Volunteers Healthy and Major Volunteers Nasopharyngeal obstruction, facial trauma, or other contraindication to the use of Nasal High Flow, pregnant woman, major incompetent, lack of 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): 35.0-999.0, Chronic Obstructive Pulmonary Disease > 35 years old Accumulative tobacco rate > 10 paq-year that go to the tobacco detoxication consultation Unable to fulfill the questionnarie Unable to adequately perform the COPD-6 or forced spirometry maneuvers included in the study Reject to participate and sign the 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): 12.0-999.0, Asthma Provision of signed and dated informed consent form 2. Started willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, age ≥ 12 years 4. No change in asthma medications for the past 2 months and use of medium or high dose inhaled corticosteroids (ICS) (defined by Table 1A) + an additional asthma controller/biologic (defined in Tables 1B and 1C). Participants entered into the run-in on medium dose ICS will be switched to high dose ICS. They must meet all entry at the time of randomization including the for uncontrolled asthma as assessed by symptoms during the two weeks prior to the randomization. 5. Baseline poor or uncontrolled asthma, defined as meeting at least one of the following: 1. FEV1 <80% predicted (for adults ≥18) or FEV1<90% (pediatric participants <18) AND with 12% bronchodilator reversibility 2. Poor symptom control Asthma Control Questionnaire ( ACQ-6) Score ≥1.5 3. ≥1 exacerbation defined as a documented burst of systemic corticosteroids (>3 days for adults and adolescents or >1 day for adolescents treated with dexamethasone) in prior year for those not receiving chronic OCS or an increase in >50% of baseline corticosteroid dose for ≥3 days in those receiving chronic OCS For patients on a biologic agent, at least one asthma exacerbation must have occurred at least 2 months after the initiation of the biologic agent. The definition of acceptable documentation for asthma exacerbations can be found in Section 6.5.3. 6. Evidence of asthma demonstrated by either bronchodilator reversibility or methacholine responsiveness either during the run-in or by historical evidence of either criterion if testing was performed under the same standards of the PrecISE Network at a PrecISE recruitment center. These are defined as: 1. An increase in FEV1 ≥12% (and 200 ml) after up to 8 puffs of albuterol OR 2. Positive methacholine defined as PC20 ≤16 mg/ml, or PD20 ≤400 mcg/ml 7. Agreement to adhere to Lifestyle Considerations (see Section 5.4) throughout study duration 8. Owns a device compatible with the eDiary system used for CompEx, that is, an iOS 11+ device such as iPhone, iPad or iPod, or a smartphone or tablet running on Android 5.0+ Current participation in an interventional trial (e.g. drugs, diets, etc.) 2. Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater) 3. Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways 4. Receiving one or more immune-modulating therapies for diseases other than asthma 5. Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®) 6. Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy 7. Underwent a bronchial thermoplasty within the last two years 8. Born before 35 weeks of gestation 9. Uncontrolled hypertension, defined as systolic blood pressure >160 mm/Hg, or diastolic blood pressure >100 mm/Hg 10. History of malignancy except non-melanoma skin cancer within the last five years 11. History of smoking 1. If <30 years old: Smoked for ≥5 pack-years* Can still be enrolled if <30, smoked <5 5 pack years and none in past year, and normal (negative) urine cotinine 2. If 30-39 years old: Smoked for ≥10 pack years Can still be enrolled if ≥30, smoked <10 pack years and none in past year, provided participant demonstrates a normal (negative) urine cotinine 3. If ≥40 years old: Smoked ≥15 pack years Can still be enrolled if ≥40 years old, smoked <15 pack years and none in the last year, provided participant demonstrates normal (negative) urine cotinine. Patients with a smoking history of ≥10 to <15 pack years will also need to demonstrate a normal Diffusing Capacity for Carbon Monoxide (DLCO) (>70% predicted) * Smoking equivalent pack years. One pack of cigarettes a day for 1 year is equivalent to: 1. 1 cigar or pipe per day for 1 year 2. Smoked hookah or shisha =1 session per day for 1 year 3. Vaped e-cigarettes =0.5 mLs e-liquid per day for 1 year, or =1 cartridge/tank/pod per day for 1 year 4. 1 use of marijuana per day for 1 year 12. Active use of any inhalant >1 time per month in the past year 1. Active smoking of conventional tobacco, inhaling of marijuana or other drugs, or vaping of e-cigarettes or vape pods >1 time per month in the past year 2. Any form of tobacco qualifies, such as: 1 cigarette, 1 hookah or shisha sessions, 1 cigar, 1 pipe, etc. 3. Any electronic (e)-device included: e-cigarette e-cig, mod, vape pen, JUUL vaping device, e-cigar, e-hookah, e-pipe, vape pods, etc. 4. Any form of inhaled marijuana, including smoking marijuana leaves or inhaling THC (tetrahydrocannabinol) via e-cigarette or device 13. Substance abuse within the last year 14. Unwillingness to practice medically acceptable birth control or complete abstinence during the study, current pregnancy, or lactation. Medically acceptable birth control/abstinence is defined as: 1. Career, lifestyle, or sexual orientation precludes intercourse with a male partner 2. For those in a monogamous relationship that precludes sexual activity with other partners, one of the sexual partners has been sterilized by vasectomy (in males) or hysterectomy and/or bilateral salpingo-oophorectomy (in females) 3. Use of highly effective methods of birth control defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Contraception should be used for at least 1 month prior to screening, throughout study participation and for an additional 16 weeks after the end of the final test treatment Pregnancy tests will be given to each female participant prior to study enrollment and at each clinic visit Each male participant will agree to inform his sexual partner(s) of the potential for harm to an unborn child. If a sexual partner becomes pregnant while he is participating in the study, he will notify study staff within 24 hours of receiving medical confirmation. His partner will be advised to promptly notify her doctor Any pregnancy (of a participant or a partner) will be monitored for adverse events with respect to pregnancy outcome until one month after birth. 15. Requirement for daily systemic corticosteroids above 10 mg of prednisone (or equivalent) per day for the past 2 months 16. Respiratory infection within 1 month of screening 17. Intubation for asthma in the last 12 months 18. Use of warfarin, current or last 30 days 19. Any clinically significant abnormal findings in the history, physical examination, vital signs, electrocardiogram, hematology or clinical chemistry during run-in period, which in the opinion of the site investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study 20. Additional exclusions for specific interventions (and not for others) are listed in the Appendices I-VI, Section 5.2 Safety Participants who meet the following will be excluded from the study: 1. Hemoglobin <10 g/dL 2. Absolute Neutrophil Count (ANC) <1000/µl for black participants, <1500/µl for other participants 3. Lymphocytes <500/µl 4. Platelet count <100,000/µl 5. Alanine Transaminase (ALT)/Aspartate Aminotransferase (AST) >2x upper limits of normal (ULN) 6. Bilirubin ≥2x ULN 7. Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 sq m 8. Positive Human Immunodeficiency Virus, Types 1 & 2 (HIV 1&2) Ab/Ag immunoassay followed by a confirmatory positive test (Geenius™ HIV-1/HIV-2 antibody differentiation immunoassay) 9. Positive Hepatitis B surface Ag (active infection) or Hepatitis B core total antibody (marker of past infection that could reactivate) 10. Positive Hepatitis C RNA test following positive Hepatitis C Antibody 11. EKG with significant clinical findings A positive QuantiFERON-TB (tuberculosis) Gold test requires further screening. A participant may be included in PrecISE if at least one of the following are met: 1. A chest radiograph (CXR) done within the last six months of the test that shows no evidence of active TB 2. A chest CT scan done within the last six months of the test that shows no evidence of active TB 3. Documentation of adequate treatment for latent TB In cases of an indeterminate QuantiFERON-TB test result, a second blood specimen must be drawn. A chest x-ray is not required if the participant has a negative QuantiFERON-TB Gold test. Comorbid Conditions: Comorbidities are commonly present in severe asthma. Specific questionnaires will be used to identify common comorbidities as follows: 1. Sleep apnea: STOP-BANG 2. GERD (GERD Questionnaire) 3. VCD (Pittsburgh vocal cord dysfunction index) 4. Chronic Rhinitis Sinusitis (Sinonasal questionnaire-SNQ5) 5. Depression-Anxiety (Hospital anxiety and depression Scale: HADS) These questionnaires are best used as screening tools. As such they typically have high sensitivity but relatively low specificity. Many of their symptoms overlap with the symptoms reported by participants with asthma who do not suffer from these conditions. Therefore, participants who meet the established cut offs for these questionnaires will need to be evaluated by the investigator to consider the clinical significance of the positive questionnaire based on history and physical and available testing. The investigator will need to judge the presence, severity and control of a specific condition and determine if it is sufficiently controlled to keep the participant in the PrecISE protocol. If the comorbid condition(s) is/are not adequately controlled, the investigator may refer the participant for further evaluation/treatment, prior to enrollment in PrecISE. Rescreening is permitted (after at least four weeks) to determine if the participant is able to move forward in PrecISE once the comorbid condition(s) is/are under adequate control. It is expected that some of the participants may also have other conditions such as cardiovascular disease, diabetes and obesity. These should be evaluated clinically as part of the complete history and physical done at initial evaluation. Their inclusions should be based on the investigator clinical judgement in line with good clinical practice principles
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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, Relapsed/Refractory Non-Hodgkin's Lymphoma Non-Hodgkin's lymphoma (NHL) confirmed by histopathology, preferably in the detection of tumor tissue PD-L1 expression. 2. A recurrent or refractory disease defined as: 1) recurrence of disease after complete remission (CR); or 2) partial remission (PR), disease stabilization (SD), or disease Progress (PD) when the treatment is completed prior to enrollment in the study. 3. Age≥18 years old, both men and women. 4. The ECOG score is 0-2. 5. There is at least one evaluable lesion (maximum diameter>15mm or shortest diameter>10mm). Preferably, PET-CT shows high metabolism of FDG. 6. Have received appropriate first-line and more-line treatment of the corresponding NHL. 7. Liver and kidney function: blood bilirubin≤35μmol/L, AST or ALT is less than 2 times the upper limit of normal value, serum creatinine≤150μmol/L. 8. The thyroid function is normal. 9. Women of childbearing age are required to undergo a pregnancy test before receiving treatment and must agree to take effective contraception during treatment. 10. Subjects must sign an informed consent form Age<18 years old； 2. Received ASCT within 90 days prior to the first use of the study drug; 3. Severe allergies, or patients known to be allergic or intolerant of the drug components of the chemotherapy regimen; 4. Active, unrecognized or suspected autoimmune disease, or a history of autoimmune disease within 2 years; 5. Previously exposed to any antibody against PD-1, PD-L1 or cytotoxic T lymphocyte-associated antigen 4 6. Exposure to any study drug within 4 weeks prior to the first use of the study drug 7. Expose to the last radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy or arterial embolization) within 3 weeks prior to the first use of the study drug. 8. Have a history of oncology and have received any treatment for this tumor in the past 3 years; 9. Patients during pregnancy and lactation; 10. Accompanied by severe heart disease, including acute myocardial infarction within 6 months, or in accordance with New York Heart Association cardiac function III or IV; 11. A serological test for HIV or active hepatitis C virus is known to be positive; 12. Hepatitis B virus carriers or hepatitis B virus DNA positive untreated patients are known; 13. TB patients active period 14. Other circumstances that the investigator believes are not suitable for inclusion
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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 COPD Exacerbation COPD Exacerbation Acute confirmed diagnosis of Chronic Obstructive Pulmonary Disease according to Global Association for Obstructive Lung Disease stage II to IV the ability to follow the rehabilitation protocol provided written informed consent current primary diagnosis of asthma
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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): 35.0-999.0, COPD COPD, Early-Onset patients at risk for COPD smoking history (at least 10 pack years) absence of airway obstruction (FEV1/FVC ≥ 70% after salbutamol 400µg) high symptom score (CAT ≥ 10) or long acting bronchodilator therapy age > 35 years respiratory infection within 4 weeks prior to other symptomatic pulmonary disease, except bronchial asthma patients with early COPD smoking history (at least 10 pack years) mild COPD (FEV1/FVC < 70% and FEV1 ≥ 70% after salbutamol 400µg) age > 35 years respiratory infection within 4 weeks prior to other pulmonary disease, except bronchial asthma
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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, Asthma COPD Have an ability to provide fully informed consent Have a diagnosis of asthma or COPD Male or female Age between 18 to 75 years Have a post bronchodilator Forced Expiratory Volume in the first second of less than 1 litre or less than 50 percent of the predicted value Have an exacerbation of asthma or COPD within the 30 days prior to the first visit Have a history or current evidence of an upper or lower respiratory infection, within the 30 days prior to the first visit Have any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the investigators to impact on the ability to participate in the study
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-60.0, Postural Tachycardia Syndrome Diagnosis of Postural Tachycardia Syndrome Age between 18-60 years Men and women are eligible Able and willing to provide informed consent Seated resting heart rate < 70 bpm in the absence of rate-lowering medications Supine blood pressure < 90/60 mmHg Overt cause for postural tachycardia, i.e., acute dehydration, prolonged bed rest Presence of underlying structural heart disease including Valvular disease (i.e. moderate or greater valvular stenosis or regurgitation) History of heart failure Greater than mild left ventricular systolic impairment Hypertrophic cardiomyopathy Known coronary artery disease or prior myocardial infarction History of tachyarrhythmias including
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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, COPD Emphysema Patients ages between 40-85 years old. 2. Smoking history of at least 10 pack year history 3. Active of former smokers 4. Diagnosis of COPD according to the GOLD definition (4): post bronchodilator spirometry FEV1/FVC ≤0.70, including those with other associated respiratory diseases like asthma, bronchiectasis, stable lung cancer or Interstitial Lung Disease. 5. Ability to perform all study procedures (complete pulmonary function tests, six minute walking test (6MWT) and chest computed tomography) and provide/sign informed consent Patients not willing to sign the consent form 2. Patients with a life expectancy of less than 3 yrs. 3. Patients in palliative care. 4. Patients with chronic airway obstruction ie: FEV1/FVC≤0.70 of other etiology and without a smoking history of less than 10 packs year history. 5. Patients unable ort not able to perform the pulmonary function test, the 6MWT or the chest CT
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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, Tracheobronchomalacia Excessive Dynamic Airway Collapse Patient with a diagnosis of ECAC either via bronchoscopy or CT Scan Age > 18 years Patients that will undergo a diagnostic or therapeutic bronchoscopy as part of their standard of care Patients with a baseline 6 MWT Patients that have never used CPAP devices in the past Patients with poorly-controlled respiratory comorbidities (asthma, COPD, obstructed sleep apnea, GERD, relapsing polychondritis) No evidence for acute respiratory tract infection, or respiratory tract infection within the prior 3 weeks Resting bradycardia (<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT Dysrhythmia that might pose a risk during exercise or training Any disease or condition that interferes with completion of initial or follow-up assessments Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea Subject has an inability to walk >140m (150 yd) in 6 minutes Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia Subject has a known sensitivity to drugs required to perform bronchoscopy
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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, Helminthiasis Helminth Infection The included volunteer is a researcher within parasitology with focus on Trichuris trichiura and Trichiura suis. He planned to infect himself under medical supervision. This was his third self-infection with Trichuris. 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): 18.0-75.0, Irritable Bowel Syndrome Patients who fulfil Rome IV for the diagnosis of IBS. 2. Patients were investigated to other gastrointestinal organic cause(s). 3. Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS Severity Scoring System (IBS-SSS) Pregnant or lactating women. 2. The use of antibiotics or probiotics within 1 month prior to FMT. 3. Immunocompromised patients defined as those treated by immune suppressive medications. 4. Patients with co-morbidity such as kidney failure or chronic heart disease. 5. System disease such as diabetes. 6. Patients with serious psychiatric disorders or drug 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): 13.0-60.0, Psoriasis minimum age 13 years maximum age 60 years both males and females affected with mild, moderate and severe psoriasis hypertension cardiovascular disorders pregnancy lactation renal failure liver failure hypersensitivity to drug
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-45.0, Asthma Allergic Asthma for all subjects Age between 18 and 45 years old Smoking history ≤2 packyears. Specific for the two groups Group 1. Patients with ongoing asthma Age of onset of asthmatic symptoms: 0 years Documented history of asthma diagnosed according to latest GINA guidelines, i.e. respiratory symptoms and either bronchodilator reversibility (improvement in FEV1 of more than 12% of baseline (and at least 200 mL) after inhalation of 800 µg salbutamol) Use of inhaled corticosteroids or either persistent symptoms of wheeze, cough, or dyspnea or regular use of β2 agonists at least once a week during the last 2 months PC20 methacholine < 8 mg/ml Group 2. Non-asthmatic controls FEV1 <1.2 L Subjects must be able to adhere to the study visit schedule and other protocol requirements A subject is not eligible to enter and participate if he has not signed and dated a written informed consent form prior to participation in the study A subjects is not eligible to enter and participate if he does not agree that we inform his general practitioner Upper respiratory tract infection (e.g. colds), within 6 weeks Serious acute infections (such as hepatitis, pneumonia or pyelonephritis) in the previous 3 months Signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence) Known recent substance abuse (drug or alcohol) Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL or the use of one or more of the following acceptable methods of contraception: 1. Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy). 2. Hormonal contraception (implantable, patch, oral, injectable). 3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository. 4. Continuous abstinence
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-80.0, Critical Illness Patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins Less than 18 years-old Patients with previous failed attempts with non-ultrasound guided technique Non-resolved pneumothorax/hemothorax at enrollment Refusal to sign 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): 40.0-80.0, Benign Prostatic Hyperplasia (BPH) Male aged 40-80 years old 2. 7 ≤ IPSS score <19 3. The subject did not take α-blocker or anticholinergic agents in the last 8 weeks. The subject did not take 5α-reductase inhibitor or androgen suppression agents in the last 16 weeks (depending on medical history). 4. The subject isn't diagnosed with cancer 5. The subject is able to read and finish the information on the questionnaire. 6. The subject must read and sign the informed consent form after the study has been fully explained The subject has a history of epilepsy or convulsions, liver and kidney disease, cancer, endocrine disease, mental illness, alcohol or drug abuse, and other major organic diseases (depending on medical history). 2. The lower urinary tract urination symptoms of the subject are not related to prostatic hypertrophy (depending on medical history). 3. Residual urine volume > 250 mL (depending on medical history) 4. Subjects have had pelvic radiation therapy or pelvic surgery (including prostate or bladder surgery, but those who only have had a prostate slice can participate in the trial). 5. Subjects have taken sexual hormone preparations including LHRH agonists, anti-androgens, feminine, or Penta-reductase inhibitors (Proscar and Avodart) 16 weeks prior to the trial. 6. Subjects have participated in other clinical trials 12 weeks prior to the trial
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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): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
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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, Glaucoma Open-Angle Primary Cataract General 1. Male and female patients, from 40 to 85 years of age, inclusive. 2. Patient is able and willing to attend scheduled follow-up examinations as per routine care for 2 year post-operatively. 3. Patient is able to understand the information sheet and give informed consent. for the study eye: 4. An operable age-related cataract with BCVA of 6/9 or worse that is eligible for phacoemulsification. 5. A diagnosis of POAG or pigmentary glaucoma treated with hypotensive medications (eye drops for glaucoma). 6. A previously documented unmedicated intraocular pressure of > 21 mmHg (i.e. IOP > 21 mmHg prior to the commencement of glaucoma treatment). 7. An optic nerve appearance characteristic of glaucoma with either: 1. visual field loss (no worse than -12dB) identified on examination using Humphrey 24-2 SITA standard, or 2. (in patients where the VF exam is not confirmatory for glaucomatous defect) OCT retinal nerve fibre layer imaging supporting the ophthalmoscopy findings indicating a diagnosis of mild glaucoma. (If OCT findings are not confirmatory of glaucoma and both the visual field and the OCT are normal, the patient should not be enrolled). 8. Shaffer grade ≥2 in all four quadrants on gonioscopy. 9. Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair surgical access to the ciliary processes Diagnosis of Primary angle closure glaucoma. 2. Any diabetic retinopathy. 3. Previous history of Central Serous Retinopathy or Cystoid Macular Oedema in either eye. 4. Congenital or developmental glaucoma. 5. Secondary glaucoma (such as neovascular, uveitic, pseudoexfoliative, lens-induced, steroid-induced, trauma induced, or glaucoma associated with increased episcleral venous pressure). 6. Previous trabeculectomy, tube shunts, or any other prior subconjunctival filtration or cycloderstructive surgery. 7. Inability to complete a reliable 24-2 SITA Standard Humphrey visual field on the study eye at screening (fixation losses, false positive errors and false negative errors should not be greater than 33%). 8. Patients with advanced glaucoma or any patient where the risk to the patient of a washout of ocular hypotensive medications (eye drops for glaucoma) is assessed as unacceptable (i.e. where there may be a risk of damage to vision if treatment is stopped for the washout). 9. Best corrected visual acuity worse than 6/36 in the fellow eye (i.e. not the eye undergoing the study intervention). 10. A 24-2 SITA Standard Humphrey visual field mean deviation (MD) of worse than -12dB in the study eye. 11. Previous vitreo-retinal surgery. 12. Previous corneal surgery or clinically significant corneal dystrophy, e.g. Fuch's dystrophy (>12 confluent guttae). 13. Unclear ocular media preventing visualization of the fundus or anterior chamber angle. 14. Degenerative visual disorders such as wet age-related macular degeneration. 15. Clinically significant ocular pathology other than cataract and glaucoma. 16. Clinically significant ocular inflammation or infection within 1 month prior to screening. 17. Presence of extensive iris processes that obscure visualization of the trabecular meshwork. 18. Uncontrolled systemic disease that in the opinion of the investigator would put the patient's health at risk and/or prevent the patient from completing all study visits. 19. Current participation or participation within the past 30 calendar days in another investigational drug or device clinical trial (which includes the fellow eye). 20. Pregnant or nursing women, or women of child bearing age planning pregnancy or not using medically acceptable contraceptives. 21. Unwilling or unable to give informed consent/unwilling to accept randomisation. 22. Unwilling or unable to return for scheduled protocol visits. 23. Any not met
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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, Emphysema Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation. 2. Subjects must understand and voluntarily sign an informed consent form Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements. 2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll. 3. Subjects who have incomplete screening or baseline data
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Patient is able and willing to comply with all the assessments of the study 2. Patient or patient's legal representative has been informed of the nature of the study, agrees to participate and has signed the informed consent form 3. ≥ 45 years of age 4. Baseline IPSS score > 13 5. Prostate volume 25 cc and prostatic urethral length between 2.5-4.5 cm measured within the past 90 days 6. Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS Obstructive intravesical median prostatic lobe which in the opinion of the operator would not benefit from treatment 2. Urethral stricture, meatal stenosis, or bladder neck obstruction either current, or recurrent requiring 2 or more dilations as reported in the patient's history 3. Requiring self-catheterization to void. 4. Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer 5. Any of the following, taken from a single uroflowmetry reading: 1. Post-void residual volume (PVR) > 250 ml 2. Peak urinary flow rate of > 15 ml/second 3. < 125 ml urinary volume voided at baseline (pre-bladder urinary volume of ≥150 ml required) 6. Other condition or disease that might cause urinary retention 7. History of other diseases causing voiding dysfunction 8. Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months) 9. Concomitant bladder stones 10. Previous pelvic irradiation or radical pelvic surgery 11. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate 12. Chronic prostatitis, or recurring prostatitis within the past 12 months 13. Known allergy to nickel 14. Life expectancy less than 24 months 15. Use of concomitant medications (e.g., anticholinergics, antispasmodics or tricyclic antidepressants) affecting bladder function 16. Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure (low dose aspirin therapy not prohibited). 17. Taking 5-alpha-reductase inhibitors within 3 months of pre-treatment (baseline) evaluation 18. Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation: 1. alpha-blockers, 2. imipramine, 3. anticholinergics, or 4. cholinergic medication gonadotropin releasing hormonal analogs 19. Taking androgens, unless evidence of eugonadal state for at least 6 months. 20. Taking one of the following within 24 hours of pre-treatment (baseline) evaluation: 1. phenylephrine, or 2. pseudoephedrine 21. Future fertility concerns 22. Any concurrent medical condition or illness that might prevent study completion or would confound study results
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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): 0.0-999.0, Atrial Fibrillation • Patients identified at PBMC with a documented diagnosis of AF (at any point in time) and who have undergone any cardioversion The patient would also need to have had an echocardiogram within six months pre-cardioversion (performed for any reason) with a well visualized atrial roof in order to perform the measurements accurately using the software • Patients with a mitral regurgitation greater than moderate (effective regurgitant orifice >= .2 mm2) Patients with post-surgical valve repair or replacement, if the procedure was done with a thoracotomy Any patient how has had any cardiac surgery requiring a thoracotomy
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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, Oncology Critical Illness Sepsis Hospital Infection Signed informed consent; 2. Age ≥18 years; 3. Suspected/proven sepsis/septic shock (Supplemental file 2); 4. II score ≥10 (Supplemental file 3); 5. Predictable invasive ventilatory support ≥ 48 hours; 6. Patient estimated survival ≥ 4 days Patient/legal representative refusal; 2. Age <18 years; 3. Chronic psychiatric/neurological disease with impaired decision-making capacity; 4. Pregnancy; 5. Invasive ventilatory support < 2 days; 6. Death in less than 4 days after ICU admission
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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 Written and signed informed consent form Subjects must be able to attend all planned visits and comply with all test procedures Beneficiary of or affiliated with the French social security system Man or woman with chronic obstructive pulmonary disease for at least 1 year defined according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) and validated by the clinical investigator Optimal treatment according to GOLD class severity C or D recommendations exacerbation in the past 12 months Spontaneous or induced sputum production Electrocardiogram: corrected distance between Q and T waves (QTC) <450 ms in men, QTC <470 ms in women Normal audiogram Pregnancy or breastfeeding Patients who are prisoners or under other forms of judicial protection Patients under any form of guardianship Participation in another interventional protocol, (current or during the month preceding inclusion) Received azithromycin in the past 3 months History of allergy or intolerance to macrolides / azithromycin Concomitant use of medication contraindicated with azithromycin (dihydroergotamine, ergotamine, cisapride, colchicine) Other respiratory diseases or associated lung infections Known history of severe hepatic impairment (a liver function test will be performed in case of clinical suspicion)
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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): 55.0-999.0, Cognitive Decline Patients Man or woman 55 years and over Patient received for the first time in Memory Consultation and not aware of his diagnosis Patient with a Mini-Mental State Assessment score (MMSE) ≥ 20 Patient accompanied by a primary caregiver Patient able to provide consent to participate in research Caregiver The caregiver accompanies the patient and is considered as the main caregiver during the consultation is able to provide consent to participate in research Patient living in a care homes Patient protected by law (under legal protection, guardianship or trusteeship) Patient with a hearing or visual impairment that does not allow to carry out assessments in Memory Consultation Patient opposing research
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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, Version of Uterus Patients > 18 years old ASA status I or II (healthy women or patient with mild well-controlled systemic disease) Elective ECV to 40 weeks of gestation Multifetal gestation Morbid obesity (BMI > 40 at first prenatal medical visit) Oligohydramnios or polyhydramnios (AFI <5 cm or > 23 cm) Fetal weight >4200g Active labor Uterine tumors or anomalies Abnormal placentation such as Placenta accreta/Previa Placental abruption Intrauterine fetal death Known allergy to sevoflurane
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia male patients with LUTS/BPH prostate size > 25 g urinary retention diabetes mellitus neurologic deficit LUTS medications prior lower urinary tract surgery concomitant bladder pathology small bladder capacity (< 150 ml) urethral stricture evident prostate carcinoma
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive Male or Female patients to 80 years of age English speaking Spirometry confirmed COPD (post-bronchodilator FEV1/FVC<0.70) and post-bronchodilator FEV1% predicted <80% at screening visit. (Target 50% of recruitment with post-bronchodilator FEV1<50% predicted (severe obstruction)) Increased COPD exacerbation risk defined as either of the following in the prior 12 months One hospitalization for COPD exacerbation Two outpatient COPD exacerbations requiring treatment with steroids and/or antibiotics Signed informed consent Unable to perform spirometry on their own following training Planned discharge to a nursing home or other extended care facility Co-morbid conditions likely to result in non-preventable readmissions (e.g., terminal malignancy, cirrhosis or end-stage liver disease, chronic wound infections, etc.) Uncontrolled or untreated medical conditions that would predispose the patient to recurrent COPD exacerbations (i.e., bronchiectasis) Patient refusal to or inability to comply with monitoring requirements, for any reason including but not limited to dementia, a history of dementia, or other significant mental impairment Patients enrolled in any other clinical trials or therapeutic studies of drugs, devices, or biologics
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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, Covid-19 Stress Disorders, Post-Traumatic Anxiety Depression Family member of a Covid-19 positive patient hospitalized in Intensive Care Unit who gave his oral agreement following the communication of the notice of non-opposition A patient is considered to be Covid + if the RT-PCR is positive OR if characteristic images are taken with a chest scanner The family member included in the study is preferably the patient's support person. In the absence of an expression of the patient's will, he is the close referent designated by the family as an interlocutor Difficulties in understanding French
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 30.0-80.0, Erectile Dysfunction Impotence for more than three months International index of erectile function, (IIEF) less than 21( including 21) Erectile hardness score, (EHS) less than 3( including 3) Age over 30 years old Hypogonadism Bleeding tendency Could not cooperate with the treatment AIDS, syphilis and condyloma victim Received radical prostatectomy Prostate cancer or pelvis malignant tumor victim Gonad dysfunction Penis deformities Penile prosthesis implantation Psychiatric disease victim
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0
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