topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Type of subject: Outpatient Informed Consent: Capable of giving signed informed consent, which includes compliance with pre-specified requirements and restrictions Age and gender: Male and female subjects, 40 years of age or older at the time of signing the informed consent, are eligible to participate in the study. Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies: 1. Non-reproductive potential defined as: Pre-menopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral oophorectomy Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. 2. Reproductive potential and agrees to follow one of the options listed below 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer after the last dose of study medication and completion of the follow-up visit. This list does not apply to females of reproductive potential with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis: Contraceptive subdermal implant that meets the standard operating procedure (SOP) effectiveness including a <1% rate of failure per year, as stated in the product label Intrauterine device or intrauterine system that meets the SOP effectiveness including a <1% rate of failure per year, as stated in the product label Oral Contraceptive, either combined or progestogen alone Injectable progestogen Contraceptive vaginal ring Percutaneous contraceptive patches Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception Chronic Obstructive Pulmonary Disease (COPD): An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society COPD Disease severity: A post-albuterol forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of =<0.70 and a post-albuterol FEV1 >=30 and =<80% of predicted normal values calculated using the European Respiratory Society Global Lung Function Initiative reference equations at Visit 1 Smoking history: Current or former cigarette smokers with a history of cigarette smoking of >= 10 pack-years at Visit 1. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Number of pack years = (number of cigarettes per day / 20) x number of years smoked (for example, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years both equal 10 pack-years). Note: Pipe and cigar use cannot be used to calculate pack-year history Asthma: A current diagnosis of asthma (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD) Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. Other excluded conditions and not limited to clinically significant bronchiectasis, pulmonary hypertension unrelated to COPD, sarcoidosis, or interstitial lung disease. Or a subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study Poorly controlled COPD: defined as the occurrence of 'acute worsening of COPD that is managed with corticosteroid and/or antibiotics or that requires treatment prescribed by a physician in the 6 weeks prior to Screening (Visit 1)', or 'subjects who are hospitalized due to acute worsening of COPD within 12 weeks of Visit 1' History of COPD exacerbation: subject who have had more than one exacerbation (moderate or severe) within the 12 months prior to Visit 1 Pneumonia and lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1; or subjects hospitalized due to pneumonia within 12 weeks of Visit 1 Use of long-term oxygen therapy (LTOT): Oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (that is, =<12 hours per day) is not exclusionary Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (for example, albuterol) via nebulized therapy Lung Resection: Lung volume reduction surgery within the 12 months prior to Visit 1 Clinically significant abnormal laboratory finding at Visit 1
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, COPD COPD, post-bronchodilator FEV1/FVC < 70%; post-br FEV1 < 80%pred 2. Active mastery of Dutch 3. Written informed consent 4. At least 40 years old 5. Participants must be able to understand and complete protocol requirements, Instructions, and questionnaires provided in Dutch Non invasive ventilation 2. Saturation by pulse oxymetry <88% 3. Documented history of asthma 4. Instable cardiac disease within 6 months. 5. Known long corrected QT interval (QTC) syndrome 6. Known estimated Glomerular Filtration Rate (EGFR) ( <30 ml/min *1,73m2 7. Exacerbations of COPD or change of medication for COPD in the last 6 weeks prior to 8. Allergic reaction or intolerance for a substance used in one of the products or atropine or atropine derived substances 9. Pregnant or lactating females
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-70.0, Pulmonary Disease, Chronic Obstructive Cohort 1 (COPD) >=45 years and <=70 years Cohort 2 (Asthma) >=18 years and <=70 years Cohort 1; subjects with a confirmed diagnosis of COPD (Gold stage 2 and 3, COPD patients will be classified according to Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines) as defined by post-bronchodilator spirometry FEV1 >=40% and <80% predicted, and FEV1/FVC <0.7 Cohort 2; subjects with documented, physician-diagnosed asthma BMI within the range 19 to 32 kilogram(kg)/m^2 (inclusive) Male or female; A female of childbearing potential is eligible to enter and participate in the study if she has a negative pregnancy test at screening and day 1 Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Women who are pregnant or lactating or are planning on becoming pregnant during the study Alpha1-antitrypsin deficiency: Subjects with a diagnosis of alpha1-antitrypsin deficiency as the underlying cause of COPD, if known Other respiratory disorders: Subjects with tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases Pneumonia or other respiratory tract infection that has not resolved at least 14 days prior to screening. In addition, any subject that experiences pneumonia during any period between the screening visit and the study visit will be excluded COPD or asthma exacerbation (in this case defined as a change in symptoms requiring increased doses of current medicines or the prescription of new medicines, e.g., corticosteroids or antibiotics) that has not resolved at least 28 days prior to screening. COPD or asthma exacerbation during any period between the screening visit and the study visit will be excluded Presence of severe and/or poorly controlled asthma that in the opinion of the investigator renders participation in the study unsafe Any co-morbid medical condition that in the opinion of the investigator would make participation in the study unsafe or unfeasible, including conditions that prohibit completion of exercise testing: orthopaedic, neurological, cardiovascular or other complaints that significantly impair normal biomechanical movement patterns and limit the ability to walk/cycle as judged by the investigator Resting oxyhemoglobin saturation <94% Use of supplemental oxygen therapy during the day or night Drug/alcohol abuse: Subjects with a known or suspected history of alcohol (males >21 units per week and females >14 units per week) or drug abuse within the last 2 years. One unit is equivalent to 8 gram (g) of alcohol: a half-pint (~240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 45.0-65.0, Chronic Obstructive Pulmonary Disease Emphysema Chronic Bronchitis Chronic Airways Obstruction Smoking For smokers, at least 10 pack-years of cigarette smoking For smokers, at least 10 cigarettes/day the past 6 months before study entry Spirometry that meets stage I-II of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages (postbronchodilator forced expiratory volume in 1 second (FEV1) of 50%-100% of predicted level and FEV1/forced vital capacity [FEV1/FVC] less than 0.7) or normal (postbronchodilator FEV1 greater than 80% of predicted level and forced expiratory volume in 1 second/forced vital capacity [FEV1/FVC] greater than 0.7) Other lung diseases Atopy (defined as positive specific IgE test) Asthma Received antibiotics for a COPD exacerbation in the 3 months prior to study entry Treatment with oral or inhaled glucocorticoids within past 3 months prior to study entry Significant ischaemic heart disease or arrhythmia
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 35.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Within 72 hours of admission with an Acute Exacerbation of COPD (AE COPD) defined as "an acute change in a patient's baseline dyspnoea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in therapy" as per ATS/ERS consensus guidelines[ ] where "a change in therapy" includes the following: Prescription of antibiotics and / or systemic steroids Diagnosis of COPD based on GOLD Able to give informed consent Willing to participate in the study Admission reason other than AE COPD or breathlessness primarily caused by another pathology Already enrolled in the study Receiving palliative care Severe cognitive impairment or psychological disorder that results in inability to give informed consent or complete investigations required for the study Physical impairment resulting in inability to complete physiological tests
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.083-18.0, Critical Illness Pediatric patients who required radial artery cannulation for hemodynamic monitoring or frequent blood samples in intensive care unit Wound at area of cannulation Can not palpate or weak radial artery pulse
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Is male or female and aged 40 or olderThe BMI≥ 19.0 kg/m2; 2. The patient with severe to very severe COPD as difine by the 2015 Gold strategy .(postbronchodilator ≤0.7,，and a postbronchodilator FEV1≤50% predicted); 3. Has a history of chronic obstructive pulmonary disease (COPD) (according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015) for at least 12 months prior to Screening (Visit V0), At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 0); 4. Must be a former smoker (defined as smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years; 5. Women of childbearing age must take reliable contraceptive measures 6. Signed informed consent Severe or very severe COPD exacerbations is still exist in screen visit(V0); 2. Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0; 3. History of asthma diagnosis in patients < 40 years of age or relevant lung disease other than COPD; 4. relevant lung disease other than COPD,as: Bronchiectasis, Cystic fibrosis, capillary bronchitis, lung resection, lung cancer, interstitial lung disease and active tuberculosis 5. Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0 6. Known alpha-1-antitrypsin deficiency; 7. Clinically significant abnormal Laboratory examination,may due to one Undiagnosed disease 8. The patient with severe Mental or neurological disease; 9. Has a history with Suicidal ideation or depression; 10. Congestive heart failure New York Heart Association Functional Classification (NYHA) severity grade III-IV; 11. Used disabled combination medicine; 12. A serious autoimmune disease; 13. Liver dysfunction according to Child-Pugh B/C; 14. Serious acute Infectious diseases; 15. Has a history Malignant in the last 5 years
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations Age ≥ 18 years. 2. At least 2 but no more than 4 prior lines of therapy for the treatment of de novo DLBCL and ineligible for (or failed) autologous or allogeneic stem cell transplant (SCT) (salvage therapy, conditioning therapy and maintenance with transplant will be considered one prior treatment). NOTE: For follicular lymphoma transformed to DLBCL (t-FL/DLBCL), single agent non-cytotoxic therapy will not be considered as a line of therapy. 3. Histopathologically confirmed diagnosis of one of the following RR DLBCL per the 2008 World Health Organization (WHO) classification of hematopoietic and lymphoid tumors (Swerdlow et al, 2008) High grade B-cell lymphoma (HGBL), with MYC and BCL2 and/or BCL6 rearrangements or DLBCL, NOS per the 2016 revision of the WHO classification of lymphoid neoplasms (Swerdlow et al, 2016) Diagnosis of t-FL/DLBCL is allowed. However, other B-cell lymphomas including other transformed indolent lymphomas/DLBCL per the 2008 WHO classification, and Burkitt lymphoma are not eligible Known primary mediastinal, ocular, epidural, testicular or breast DLBCL. 2. Active CNS involvement of their malignancy. 3. Known allergy or hypersensitivity to phosphatidylinositol 3 kinase (PI3K) inhibitors or any component of the formulations used in this study. 4. Cytotoxic anticancer therapy (e.g., alkylating agents, anti-metabolites, purine analogues) or any other systemic anticancer therapy within 2 weeks of study entry. 5. Radiotherapy delivered to non-target lesions within one week prior to starting study treatment or delivered to target lesions that will be followed on the study (note: prior sites of radiation will be recorded). 6. Treatment with experimental therapy within 5 terminal half-lives (t1/2) or 4 weeks prior to enrollment, whichever is longer. 7. Current or planned glucocorticoid therapy, with the following exceptions Doses ≤ 10 mg/kg/day prednisolone or equivalent is allowed, provided that the steroid dose has been stable or tapering for at least 14 days prior to the first dose of CUDC-907 Inhaled, intranasal, intraarticular, and topical steroids are permitted
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hypertrophy Lower Urinary Tract Symptoms Patients selected for this study must meet all of the following Age ≥ 50 years Lower urinary tract symptoms secondary to BPH as defined by IPSS Symptom Index ≥ 12 Maximum Uroflow rate (Qmax) of ≤ 12cc per sec Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the prostate (TRUS) Patients meeting any of the following will be excluded from the study Age less than 50 years Prostate cancer Bladder cancer Severe, life-threatening allergy to iodinated contrast Bilateral internal iliac artery occlusion Causes of obstruction other than BPH such as stricture disease Neurogenic bladder or other causes of bladder atonia Post void residual greater than 250 cc Any contraindication to embolization, including
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 21.0-85.0, Chronic Obstructive Pulmonary Disease Age > 21 years of age; < 85 years of age Participants that have been physician diagnosed (primary diagnosis) with Obstructive Airway Disease (to include:Chronic Obstructive Pulmonary Disease (COPD); Bronchiectasis; Severe Asthma); forced expiratory volume in 1 second (FEV1) < 60% FEV1/ forced vital capacity (FVC) <60% Arterial CO2 > 45 mmHg as determined by blood gas (PaCO2) or transcutaneous (tcCO2) >50 within the past month Ability to provide consent Participant has not used Non-Invasive Ventilation (BiPAP/CPAP) therapy in the past 8 hours Participant has no child bearing potential OR a negative pregnancy test in a woman of childbearing potential Participants that have not returned to their baseline health status from an exacerbation of COPD or other pulmonary problems or have not established at least two weeks of stability at a new baseline Use of antibiotics or prednisone for a COPD exacerbation within the previous 4 weeks Uncontrolled Hypertension Participants that require greater than 3 liters of oxygen at rest History of cardiovascular instability, including uncontrolled ventricular arrhythmias, angina, diastolic BP > 100 mmHg and all Participants with pacemakers Any major non-COPD uncontrolled disease or condition, such as congestive heart failure, malignancy, end-stage heart disease, liver or renal insufficiency (that requires current evaluation for liver or renal transplantation or dialysis), amyotrophic lateral sclerosis, or severe stroke, or other condition as deemed appropriate by investigator as determined by review of medical history and / or participant reported medical history History of pneumothorax Apnea Hypopnea Index (AHI) > 15 via in-home sleep study Excessive alcohol intake (> 6oz hard liquor, 48 oz. beer or 20 oz. wine daily), or illicit drug use by review of medical history and / or participant reported medical history Daily use of prescribed narcotics (greater than 30 mg morphine equivalent)
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Male or female patients Patients 40 years of age or older Patients with a smoking history > 10 pack years Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) >= 30% and <80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70% at screening Symptomatic patients with CAT (COPD Assessment Test TM) score >= 10 at screening Further apply COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening Patients with a current diagnosis of asthma Further apply
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-70.0, Anesthesia 70 years old ASA physical status classification 1 to 3 Personal history of cocaine abuse Scheduled for a non-emergent operation that requires general anesthesia Vital signs within generally accepted ranges for normal [HR 60-100, RR 12-20, SpO2 > 96% on room air, BP 90-140/60-90 unless a diagnosis of hypertension is present, T 36-38 degrees) Willing and able to consent in English or Spanish Age less than 18 or older than 70 Unable to give informed consent for participation in the study Patient refusal Monitored anesthesia care (MAC) or regional anesthesia planned Pregnant or lactating Emergent surgery Acute cocaine intoxication based on clinical symptomatology (hypertension, tachycardia, agitation, delirium, hyperthermia) History of cardiac disease including coronary artery disease (CAD) and cardiac dysrhythmia History of stroke History of seizure disorder
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 20.0-80.0, Obstructive Sleep Apnea Patients ranging from 20 years 2. Body mass index (BMI) of 20-38 to the typical obese OSA patients and avoid the practical difficulties in blood drawing from the massively obese 3. Hypertension with blood pressures > 140/90 but less than 180/105 mmHg. 4. Apnea-hypopnea index above 10 Receiving medications other than anti-hypertensives known to influence the sympathetic nervous system, sleep medicines (including heavy alcohol use) or drugs with adverse interactions with study medication. 2. Women who have premenstrual syndrome, or those who are pregnant or capable of pregnancy and unwilling to use effective non-hormonal contraception 3. Shift workers or have symptoms of narcolepsy, restless legs syndrome or insomnia, in order to minimize confounding effects of other sleep disorders 4. Have apneas which are primarily central 5. Have sleep fragmentation caused by syndromes such as chronic pain or movement disorders 6. Have diseases such as asthma or chronic obstructive pulmonary disease that compromises respiration. 7. Have known coronary or cerebral vascular disease, history of arrhythmias, cardiomyopathy, history of psychosis, current alcohol or drug abuse. 8. Have any contraindications to any study materials, such as heart block. 9. Have secondary hypertension 10. Have creatinine levels above 2.5 mg %, more than 1+ proteinuria by dipstick, hematuria or electrolyte disorders
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-90.0, Lung Diseases, Interstitial lung emphysema, lung interstitial fibrosis, lung cancer patients lung infectious diseases (bronchiectasis, lung abscess, pneumonia) pulmonary edema
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Chest Pain Dyspnea ED patients with a chief complaint of chest pain or shortness of breath Cardiac Ultrasound ordered by provider as part of diagnostic workup All providers have already reviewed the ultrasound images (unable to obtained pre- ultrasound assessment) Age < 18 Known to be pregnant
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Pulmonary Disease, Chronic Obstructive a diagnosis of COPD (Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) < 0,70) no exacerbations within the last 6 weeks valid driver's license and having driven a car within the last 3 months lacking the ability to use the driving simulator no valid driver's license alcohol abuse (> 21 units per week) a known diagnosis of obstructive sleep apnea uncorrected impaired vision or hearing unstable ischemic heart disease, left-sided heart failure, severe neurologic diseases, cancer, severe peripheral vascular disease, severe psychiatric diseases, former apoplexia and uncontrolled hypertension, thyroid diseases or diabetes
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-90.0, Chronic Obstructive Pulmonary Disease frequent exacerbators and 58 infrequent exacerbators (116 in total) who have been diagnosed with any severity of COPD (according to BTS i.e. >10 pack year smoking history and post bronchodilator spirometry FEV1/FVC ratio <0.70 and FEV<80%) Inability or unwillingness to sign informed consent Any unstable ongoing cardiovascular events which may be exacerbated by exercise Inability to complete walk tests due to physical or mental impairment Other active inflammatory conditions e.g. rheumatoid arthritis, cancer Known asthma, allergic rhinitis or other respiratory disease (bronchiectasis, pulmonary fibrosis) Healthy control group Patients who have not been diagnosed with COPD or any other respiratory condition and are characteristically (age (between 45-85 years old) & smoking status) matched to recruited COPD patients
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Pulmonary Disease, Chronic Obstructive patients with severe and very severe COPD, that is FEV1/FVC under 0,7, FEV1 under 50 % of the expected value and grade three and above on the Medical Research Council Dyspnoea Scale (MRC Dyspnoea Scale) The patients have rejected OUH's offer of training at the hospital The patients must be mobile enough to complete the training The patients are motivated to participate in individual adjusted telemedical training in teams The patients have at the same time been offered Telemedical consultations by a nurse The patients biggest problem concerning physical activity has to be their shortness of breath The patients live in either Svendborg or Odense patients with lacking ability to communicate via telephone and/or computer screen, severe kidney insufficiency or cardiac insufficiency, saturation less than 88 % and possibly malignant changes in lung(s)
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-90.0, COPD a clinical diagnosis of COPD in accordance with GOLD post-bronchodilator FEV1 < 50% of predicted value smoking history of ≥ 10 pack-years the ability to remain in supine position for at least 25 minutes exacerbation in the past 6 weeks
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Infiltrating Bladder Urothelial Carcinoma Recurrent Bladder Carcinoma Stage I Prostate Cancer Stage I Renal Cell Cancer Stage II Bladder Urothelial Carcinoma Stage II Renal Cell Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Stage III Renal Cell Cancer Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information NOTE: HIPAA authorization may be included in the informed consent or obtained separately Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 14 days prior to being registered for protocol therapy Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal Females must not be breastfeeding Cohort A T2, Transitional cell carcinoma (TCC) muscle invasive bladder cancer, (patients who are cisplatin ineligible, decline neoadjuvant and/or ineligible for neoadjuvant chemotherapy); must have histological proof of T2, muscle-invasive transitional cell carcinoma of the bladder with no evidence of metastatic; patient with any degree of fixation of the pelvic sidewall are not eligible Cohort B
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive >=40 years of age at Visit 1 Diagnosis of COPD with a documented history of COPD for at least 6 months Severity of Disease: Post albuterol/salbutamol forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio <0.70 and FEV1 <=70% of predicted obtained within two years of Visit 1 Smoking History: Current or former (defined as subjects who have quit smoking for at least 3 months prior to Screening/Visit 1) cigarette smokers with a >10 pack-year smoking history. Number of pack years = (number of cigarettes per day/20) x number of years smoked (for example, 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years) Current COPD Therapy: 1. Currently receiving maintenance therapy with one or more long-acting bronchodilators, such as a long-acting muscarinic antagonist (LAMA; also known as a long-acting anti-cholinergic), long-acting beta 2-agonist (LABA), or inhaled corticosteroid (ICS)/LABA combination for the treatment of COPD. Subjects must be able to continue using their currently prescribed COPD maintenance inhaler therapy throughout the study and as needed short acting beta-adrenergic agonist (SABA) or short acting muscarinic antagonist (SAMA) for rescue use. 2. Has been on current maintenance COPD treatment for at least 4 weeks prior to Screening/Visit 1 and evaluated as unlikely to change COPD treatment within 4 weeks of Visit 1 Males or Females who are not pregnant or not planning a pregnancy during the study or not lactating Capable of giving signed informed consent, which includes compliance with the requirements and restrictions defined for this study Subject understands and is willing, able, and likely to comply with study procedures and restrictions Subject must be able to read, comprehend, and record information in English Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD Recent experience with the inhaler: Subjects who used any inhaler within 6 months (180 days) prior to Visit 1 Recent experience with the inhaler: Subjects who used any inhaler within 6 months (180 days) prior to Visit 1 Poorly controlled COPD: Subjects with symptoms of poorly controlled COPD such as: 1. Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician, in the 4 weeks prior to Visit 1. 2. Hospitalization due to acute worsening of COPD within 4 weeks of Visit 1. 3. Use of a total of 8 puffs/day or more of short-acting symptom relief medications such as albuterol and ipratropium for 2 consecutive days or any 3 days within 7 days immediately preceding Visit 1. 4. Changes in COPD symptoms and signs, suggesting worsening COPD health status at Visit 1 Other Disease Abnormalities: 1. Subjects with suspected or evidence of oropharyngeal candidiasis. 2. Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study. 3. Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study Compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures, or unable to continue their current COPD medications Drug/alcohol abuse: Subjects with a known or suspected alcohol or drug abuse at Visit 1 which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement Drug/Food Allergy: A history of hypersensitivity to any components of the study inhaler (for example, lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded Investigational Product: Subjects who have received an investigational drug and/or medical device within 30 days of entry into this study (Screening/Visit 1), or within five drug half-lives of the investigational drug, whichever is longer Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Anesthesia Oxygen Adult, >18 years old 2. Emergency intubation where RSI is indicated 3. Capable of understanding the study information and signing the written consent. 4. Need for non-invasive ventilation BMI >35 2. Pregnancy
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, Secondhand Smoke Air Trapping Tobacco Airflow Limitation Hyperinflation Obstructive Lung Disease Never Smoking SHS-exposed Flight Attendants aircraft cabin SHS exposure of >1 year while working for airlines Never smoker as defined by use of <100 cigarettes lifetime and none within the last year Normal forced expiratory volume (FEV) FEV1/ forced vital capacity (FVC) ratio One of the following evidence of airflow obstruction Presence of any airflow limitation on spirometry during the baseline visit Development of airflow limitation on spirometry during any stages of exercise testing Residual volume to total lung capacity ratio of >0.35 2 History of active cardiac disease, uncontrolled hypertension, congestive heart failure History of direct tobacco use of over 100 cigarettes in their lifetime History of established respiratory diseases such as asthma, emphysema, chronic bronchitis, interstitial lung disease, or sarcoidosis History of debilitating chronic illnesses such as severe lupus or rheumatoid arthritis History of other illnesses or therapy for illnesses that could affect lung function such as radiation therapy for breast cancer Physical inability to perform exercise testing BMI >30 kg/m2 History of marijuana use of >100 joints lifetime, and none within the last year History of other recreational drug use
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Medication Adherence Self-care Heart Failure Chronic Obstructive Pulmonary Disease Patients aged 18 years or older with chronic obstructive pulmonary disease or congestive heart failure admitted at a short-term medical ward and who are living in their private home Diagnoses of dementia or cognitive impairment, and need of interpreter to participate in conversations. The are related to the patients' possibilities to participate in the motivational interviewing sessions by phone
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 35.0-80.0, Chronic Obstructive Pulmonary Disease One previous chronic obstructive pulmonary disease exacerbation in last year Can not be oxygen dependant PaCO2 < 60
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-85.0, Pulmonary Disease, Chronic Obstructive Subjects should be at their clinical baseline on the day of imaging Subjects must be clinically stable in order to participate in the study Smoking history >10 pack years Subjects must not be currently taking Advair or have taken it within 4 weeks prior to screening No subject will be withdrawn from Advair to participate in this study The subjects with COPD will be categorized according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD severity classification Class 1: forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) < 70 and FEV1 > 80% predicted Class 2: FEV1/FVC < 70 and 50% < FEV1 < 80% predicted Class 3: FEV1/FVC < 70 and 30% < FEV1 < 50% predicted Class 4: FEV1/FVC < 70 and FEV1 < 30% predicted Continuous oxygen use at home Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging FEV1 percent predicted less than 25% Pregnancy or lactation Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning Subjects with any implanted device that cannot be verified as MRI compliant will be excluded Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches History of congenital cardiac disease, chronic renal failure, or cirrhosis Inability to understand simple instructions or to hold still for approximately 10 seconds History of respiratory infection within 2 weeks prior to the MR scan
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-85.0, Chronic Obstructive Pulmonary Disease Provision of informed consent prior to any study specific procedures History of moderate to very severe COPD with a post-bronchodilator forced expiratory volume/forced vital capacity (FEV1/FVC) <0.70 and a post-bronchodilator FEV1>20% and ≤80% of predicted normal value at screening Current smoker or ex-smoker with a tobacco history of ≥10 pack-years (1 pack year= 20 cigarettes smoked per day for 1 year) Clinically important pulmonary disease other than COPD (e.g. active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, and primary ciliary dyskinesia) and/ or radiological findings suggestive of a respiratory disease other than COPD that is contributing to the subject's respiratory symptoms Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: 1. Affect the safety of the subject throughout the study 2. Influence the findings of the study or their interpretation 3. Impede the subject's ability to complete the entire duration of study Subjects who have epilepsy must be on a stable dose of medication for 30 days prior to Visit 4 Unstable ischemic heart disease, or uncontrolled arrhythmia, cardiomyopathy, heart failure, and renal failure, or uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 8 weeks prior to enrolment (Visit 1), based on last dose of steroids or last date of hospitalization whatever occurred later Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to enrolment (Visit 1) Pneumonia within 8 weeks prior to enrolment (Visit 1), based on the last day of antibiotic treatment or hospitalization date, whatever occurred later Pregnant, breastfeeding, or lactating women Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which, in the opinion of the Investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to complete entire duration of the study Use of immunosuppressive medication, including rectal corticosteroids, high potency topical corticosteroids and systemic steroids within 28 days prior to randomization Receipt of blood products within 30 days prior to enrollment (Visit 1)
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-75.0, Pulmonary Disease, Chronic Obstructive Patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice guidelines prior to participation in the trial, including medication washout and restrictions Diagnosis of Chronic Obstructive Pulmonary Disease and relatively stable airway obstruction: post bronchodilator 30%<= Forced Expiratory Volume in 1st second (FEV1)<80% of predicted normal (European Coal and Steel Community) and a post bronchodilator FEV1/Forced Vital Capacity<0.70 at visit 1 Male or female patients >=40 and =<75 years of age on day of signing consent Current or ex-smokers with a smoking history > 10 pack-years. Patients who have never smoked cigarettes must be excluded Baseline Dyspnea Index score< 8 at visit 0 Hyperinflation at rest, defined as Functional Residual Capacity > 120% predicted at visit 1 Borg dyspnea score >=4 at the end of 3min Constant Speed Shuttle Test at visit 2 Perform technically acceptable pulmonary function tests (spirometry and body plethysmography) and complete multiple shuttle tests during the study period Inhale medication in a competent manner from the Respimat® inhaler and from a metered dose inhaler Significant disease other than Chronic Obstructive Pulmonary Disease (COPD); a significant disease which, in the investigator's opinion, may (i) put the patient at risk (ii) influence the study results or (iii) cause concern regarding the patient's ability to participate Clinically relevant abnormal baseline haematology, blood chemistry, in the investigator's opinion, or creatinine >x2 Upper Limit Normal will be excluded regardless of clinical condition Current documented diagnosis of asthma COPD exacerbation in the 6 weeks prior to screening Diagnosis of thyrotoxicosis History of myocardial infarction within 6 months of screening Life-threatening cardiac arrhythmia (investigator judgment) Known active tuberculosis Any malignancy unless free of disease for at least 5 years (treated basal cell carcinoma or squamous cell skin cancers are allowed) History of cystic fibrosis
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-130.0, Chronic Obstructive Pulmonary Disease (COPD For in the study subjects should fulfil the following Signed informed consent at Visit 1 prior to any study specific procedures Outpatient adults 40 years and older A diagnosis of COPD confirmed by a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) <0.70 at some point in the past 3 years Moderate to Very Severe COPD as defined by a post-bronchodilator FEV1 <80% of predicted on most recent spirometry Had been on an ICS/LABA combination therapy of a brand and dose approved forCOPD, for at least 3 months prior to screening Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year) Willing to discontinue all medications containing both a LABA and an ICS and to begin Symbicort 160/4.5 μg, 2 inhalations bid Must be willing to make a return visit, and complete all study assessments for the duration of study Life expectancy >12 months Patients should not enter the study if any of the following are fulfilled Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) Previous randomization in the present study Patients who have been randomized in a clinical study and received an investigational product within 30 days of Visit 1 (participation is defined as the completion of a treatment related visit) Current diagnosis of asthma Known history of drug or alcohol abuse which, in the opinion of the Investigator, may interfere with subject's ability to participate or comply with the study An acute exacerbation of COPD that required hospitalization or emergency room visit or treatment with systemic steroids and/or antibiotics during the 28 days before Visit 1. Patients who had a COPD exacerbation within 28 days of Visit 1 can be re-screened once. Re-screening can occur no earlier than 28 days from the last dose of systemic steroids and/or antibiotics and/or hospitalization, whichever is later Enrolled patients that have a COPD exacerbation during the run-in period, defined as worsening symptoms which in the judgment of the Investigator requires treatment with systemic steroids and/or antibiotics and/or hospitalization. Patients who had a COPD exacerbation during the run-in period can be re-screened once. Re-screening can occur no earlier than 28 days from the last dose of systemic steroid and/or antibiotics and/or hospitalization, whichever is later Any hospital admissions due to ischemic heart disease or heart failure within 3 months of study enrollment
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Asthma Pulmonary Disease, Chronic Obstructive Airway Disease (Asthma and COPD) 1. Participant is willing and able to give informed consent for participation in the study. 2. Male or Female, aged 18 years or above. 3. Participants diagnosed with Asthma or COPD with airflow limitation (FEV1% predicted < 80%) with no exacerbations for at least 4 weeks prior to study entry. 4. Participant has no clinical contraindication for CMR scan. 5. Able (in the Investigators opinion) and willing to comply with all study requirements. 6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. Healthy Volunteers 1. Participant is willing and able to give informed consent for participation in the study. 2. Male or Female, aged 18 years or above. 3. Healthy participant in good health with no past history of cardiovascular or respiratory disease. 4. Participant has no clinical contraindication for CMR scan. 5. Able (in the Investigators opinion) and willing to comply with all study requirements. 6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study Airway Disease (Asthma and COPD) The participant may not enter the study if ANY of the following apply: 1. Female participants who are pregnant, lactating or planning pregnancy during the course of the study. 2. Severe renal impairment eGFR < 30 ml/min. 3. Contraindication for undergoing CMR scan including permanent pacemaker and surgical procedure within last 6 weeks. 4. Unable to understand / read English 5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. Healthy Volunteers The participant may not enter the study if ANY of the following apply: 1. Female participants who are pregnant, lactating or planning pregnancy during the course of the study. 2. Severe renal impairment eGFR < 30 ml/min. 3. Contraindication for undergoing CMR scan including permanent pacemaker and surgical procedure within last 6 weeks. 4. Unable to understand / read English 5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, COPD (Chronic Obstructive Pulmonary Disease) Subject must be able to understand and provide informed consent 2. Age 40-80 3. ≥10 pack-year smoking history 4. Post-bronchodilator FEV1/FVC ratio ≥0.70 5. Baseline CAT≥10 Inability or unwillingness of a participant to give written informed consent or comply with study protocol. 2. Subject is pregnant, breast-feeding, or plans to become pregnant. 3. Active pulmonary infection or prior pulmonary infection where antibiotic and/or steroid treatment was completed ≤4 weeks prior to enrollment. 4. Post-BD FVC < 70% predicted 5. A primary diagnosis of asthma established by each study investigator based on ATS/ERS as previously implemented in the MACRO clinical trial. 6. Known concomitant lung disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), or clinically significant bronchiectasis. 7. History (or family history) of long QT syndrome. 8. History of paroxysmal (intermittent) atrial fibrillation will be considered an exclusion. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, heart rate at enrollment must be < 100/min. 9. Patients with BMI < 15 or more than 40 kg/m2. 10. Patients with diabetes Type I or uncontrolled diabetes Type II. 11. Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) significant renal disease, psychiatric disease, gastrointestinal disease, unstable ischemic heart disease, arrhythmia (excluding chronic stable atrial fibrillation), uncontrolled hypertension or any other condition which in the opinion of investigator might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study. 12. Patients with any history of lung cancer. 13. Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or severe renal impairment or urinary retention. Benign Prostatic Hyperplasia (BPH) patients who are stable on treatment can be considered. 14. Any other past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 15. Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar chemical classification, including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof. 16. Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements. 17. Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer. 18. Patients receiving any protocol-specified prohibited medications.. 19. Patients receiving any protocol-specified prohibited COPD related medications (will be required to undergo a required washout period prior to enrollment)
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 50.0-75.0, Chronic Obstructive Pulmonary Disease patients with FEV1 / FVC <70% beta blocker supraventricular rhythm disorder previous history of respiratory disease other than COPD diabetes autonomic dysfunction dysautonomia renal failure long-term oxygen therapy history of psychiatric illness
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, Patients With Asthma-COPD Overlap Syndrome (ACOS) All patients with confirmed diagnosis of COPD {post-bronchodilator FEV1/FVC<0.7 (FEV1 forced expiratory volume at one second, FVC forced vital capacity) based on the medical records} Aged >40 years old at time of diagnosis Seen at out-patient clinic Patients currently with acute exacerbation of COPD by GOLD definition (any worsening of a patient's respiratory symptoms that is beyond normal day-to-day variations and requires a change in medication) Patients with respiratory diseases that can show similar symptoms to chronic airway diseases such as bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma, endobronchial TB, and lung cancer, or those who have history of these diseases based on physician's judgment Patients currently diagnosed with pneumonia and acute bronchitis Patients currently randomized in other clinical studies
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 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 any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-75.0, Asthma Healthy For all subjects Men/Women, ages 18-75, with or without current asthma, are eligible to be screened Cigarette smoking history of >30 total pack-years Current use of other smoked products or recreational drugs (e.g. pipes, cigars, e-cigarettes, other illicit drugs) History of lung disease other than asthma Recent upper respiratory tract infection treated with antibiotics within 8 weeks of visit 1 Recent antibiotic use (except topical or ocular) within 8 weeks of visit 1 (chronic antibiotic use for asthma management allowed) Currently pregnant or breast-feeding Other medical conditions or treatments that may increase subject risk or affect study results, based on study physician judgment. These the following: significant cardiovascular disease(+/ active symptoms), arrhythmia, or stroke, active cancer, post-organ transplant Any other condition for which subject is taking immunosuppressive therapies (except steroids for asthma) History of allergy to albuterol or methacholine 2. For asthma subjects only: Note: Enrollment target is for 90 asthmatics already taking inhaled corticosteroids prescribed by their physician (any formulation and dose) and 60 subjects who are not currently using inhaled corticosteroid. Additional
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-80.0, Chronic Obstructive Pulmonary Disease COPD patients Gold B or C Regular smokers with no desire to quit their habit Severe cardiovascular diseases Chronic inflammatory diseases Active oncologic diseases Treatment with corticosteroids or other antiinflammatory drugs Acute exacerbation of COPD in the last 12 weeks previous to their in the study
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Antibiotic Resistant Infection Critical Illness SIRS Sepsis age > 18 years critically ill adult patients sepsis SIRS initiation of antibiotic treatment patients < 48 hours after admission on ICU multiple admissions on ICU, (>1 in last 2 weeks period) leukopenia < 1 G/l and thrombocytopenia rhG-CSF or IFN-gamma therapy up to 1 week before participation in another study receiving drugs or biological within the preceeding 30 days recent longterm corticosteroid treatment HIV patients after organ transplantation treated with immunomodulating drugs pregnant patients or after delivery life expectancy < 24 hours
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Male, 45 years or older Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia refractory to medical therapy for at least 6 months IPSS score at initial evaluation should be greater than 12, and uroflowmetry (Qmax) of <15mL/s (milliliters per second) All prostate volumes will be > 40gm PSA which meets one of the following criteria:Baseline PSA ≤ 2.5ng/mL, Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required);Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Negative prostate biopsy (minimum 12 cores within 12 months) if abnormal digital rectal examination Patients with active urinary tract infections or recurrent urinary tract infections (> 2/year), prostatitis, or interstitial cystitis Cases of biopsy proven prostate, bladder, or urethral cancer Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy who are unwilling to stop therapy for 2 months prior to the study Use of anithistamines, anti-convulsants, and antispasmodics within one week of treatment unless they have been treated with the same drug (at the same dosage) for at least 6 months and has an associated stable voiding pattern Patients who are classified as New York Heart Association Class III (Moderate), or higher, have cardiac arrhythmias, have uncontrolled diabetes, or are known to be immunosuppressed Hypersensitivity reactions to contrast material not manageable with prophylaxis Patients with glomerular filtration rates less than 40 who are not already on dialysis Prostate volume <40 mL Patients with bilateral internal iliac arterial occlusion Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc)
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, COPD Emphysema Adults over 18 with a predominant diagnosis of COPD Ability to understand spoken English Attending PR assessment/ enrolled in Pulmonary Rehabilitation (PR) or maintenance therapy Ability and capacity to make their own decision and consent freely No clear COPD diagnosis Inability to consent
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 45.0-999.0, Prostatic Hyperplasia Benign Prostatic Hyperplasia Adenoma, Prostatic Prostatic Adenoma Prostatic Hyperplasia, Benign Prostatic Hypertrophy Prostatic Hypertrophy, Benign Rezum Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention. 2. IPSS score of ≥ 15. 3. Qmax: Peak flow rate ≤ 15 ml/sec. 4. Post-void residual (PVR) < 300 ml. 5. Prostate transverse diameter > 30 mm. 6. Prostate volume between 20 to 120 gm. 7. Voided volume ≥ 125 mL 8. Subject able to complete the study protocol in the opinion of the investigator. 9. Life expectancy of at least one year History of any illness or surgery that may confound the results of the study or have risk to subject. 2. Presence of a penile implant. 3. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH. 4. Currently enrolled or has been enrolled in another trial in the past 30 days. 5. Confirmed or suspected malignancy of prostate or bladder 6. Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease. 7. Previous pelvic irradiation or radical pelvic surgery. 8. Documented active urinary tract infection by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catherization specimen) 9. Neurogenic bladder or sphincter abnormalities. 10. Urethral strictures, bladder neck contracture or muscle spasms. 11. Bleeding disorder or is currently on coumadin. (Note that use of anti-platelet medication is not an ) 12. Subjects interested in maintaining fertility. 13. Use of concomitant medications to the following: 1. Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes). 2. Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment. 3. Use of 5-alpha reductase inhibitor within the last 6 months 4. Use of antidepressants, anticholinergics, anticonvulsants, and beta blockers unless there is documented evidence of stable dosing 14. Subject is unable or unwilling to go through the "washout" period prior to treatment. 15. Subject has chronic urinary retention. 16. Post-void residual volume > 300 ml. 17. Significant urge incontinence. 18. Poor detrusor muscle function. 19. Neurological disorders which might affect bladder or sphincter function. 20. Urinary sphincter abnormalities. 21. Bladder stones. 22. Evidence of bacterial prostatitis or symptoms of epididymitis 23. Renal impairment or serum creatinine > 2.0 mg/dl 24. In the physician's opinion, subject cannot tolerate a cystoscopy procedure well. 25. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements. 26. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study. 27. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum). 28. Biopsy of prostate within 30 days of procedure
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Prostatic Hyperplasia males, over forty years, with clinical diagnosis or imaging diagnosis of benign prostate hyperplasia (ultrasonography, computed tomography, magnetic resonance imaging) with stable low urinary tract symptoms and International Prostate Symptom Score lower or equal to 25 points followed at tertiary care clinic low urinary tract symptoms and International Prostate Symptom Score over to 25 points, inadequate clinical treatment response, surgical treatment indication, suspicion of prostate malignancy or urethra stricture or neurogenic bladder and illiterates
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Cystic Fibrosis Willing and able to comply with scheduled visits, treatment pan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures Body weight ≥35 kg Sweat chloride value ≥ 60 mmol/L from test results obtained during screening Subjects must have an eligible CFTR genotype Cohorts 1A, 1B, 1C: Heterozygous for F508del and a minimal function mutation known or predicted not to respond to TEZ and/or IVA Cohorts 2A, 2B: Homozygous for F508del Subjects must have an FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height at the Screening Visit Stable CF disease as judged by the investigator Willing to remain on a stable CF medication regimen through the planned end of treatment or if applicable the Safety Follow-up Visit History of any comorbidity that in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject History of cirrhosis with portal hypertension Risk factors for Torsade de Pointes History of hemolysis Glucose-6-phosphate dehydrogenase (G6PD) deficiency assessed at Screening Clinically significant abnormal laboratory values at screening An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before the first dose of study drug Lung infection with organisms associated with a more rapid decline in pulmonary status An acute illness not related to CF within 14 days before the first dose of study drug A standard digital ECG demonstrating QTc >450 msec at screening
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-65.0, Asthma for people with asthma: 1. Physician diagnosis of asthma 2. PC20 to methacholine < 16 mg/ml 3. Asthma diagnosis age >= 18 years 4. IgE < 100 IU/ml 5. Ages 18-65 years 6. BMI >=30 kg/m2 for controls: 1. No physician diagnosis of asthma 2. PC20 to methacholine > 16 mg/ml 3. IgE < 100 IU/ml 4. Ages 18-65 years 5. BMI >=30 kg/m2 FEV1 < 60 % predicted 2. Other significant disease that in the opinion of the investigator would interfere with study. 3. Inability to perform required testing. 4. Smoking within last 6 months. 5. ≥ 20 pack year smoking history 6. Inability to provide informed consent 7. Pregnancy 8. Known obstructive sleep apnea/ high likelihood of obstructive sleep apnea 9. Asthma exacerbation in the prior 6 weeks 10. Stoke or heart attack in the prior 3 months 11. Known aortic aneurysm 12. Renal failure 13. A known severe heart, vascular, liver, renal, or hematological disease 14. Active allergic rhinitis 15. Recent eye surgery (within the last month)
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Diabetes Mellitus Chronic Disease self-identified African-American adults diagnosis of uncontrolled diabetes (HbA1C > 8) have at least one other of 13 chronic health conditions (hypertension, congestive heart failure, coronary artery disease, cardiac arrhythmias, hyperlipidemia, stroke, arthritis, asthma, cancer, chronic kidney disease, chronic obstructive pulmonary disease, depression, and osteoporosis and excluding dementia)) using the CMS ICD-9-CM-based definitions is receiving or will receive care at one of our identified clinical sites has a cell phone or smart phone with texting and voicemail capabilities is not planning to move from the area in the next year is able to provide informed consent is English speaking completes a two-week run-in period for text message and voice message use inability to understand consent procedures Pregnant presence of an unstable psychiatric condition or dementia perceived unwillingness or inability to participate inability to successfully complete the text message and voice message screening test Plans to move from the area and change primary care physicians in the next year Diagnosis of severe depression in the last six months Individuals with cognitive impairment will be excluded if they experience difficulty either understanding, following directions, or communicating clearly with program staff. Individuals will be excluded if they exhibit uncontrolled psychiatric symptoms and/or behaviors that may present a danger to program staff or to the study participants themselves
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-80.0, Chronic Obstructive Pulmonary Disease (COPD) Main diagnosis for the Pulmonary Rehabilitation is an International Classification of Diseases-Code J44 (Other chronic obstructive pulmonary disease) at all 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Classifications A-D and stages 1-4 Considerably reduced health status (severe concomitant disease, which will affect the results of the outcome parameters, for example, cancer or severe cardiac, neurological or orthopaedic comorbidities) Considerable reduction of sight and hearing Severe psychiatric condition as secondary diagnosis Lack of ability to speak German
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease COPD Patient who provided of informed consent prior to any study-specific procedures 2. Male or female 40 to 80 years of age (both inclusive) at Screening (Visit 1). A female is eligible to enter and participate in the study if she is of non-childbearing potential. Note: A female is considered to be of non-childbearing potential if she meets one of the following 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. 3. Male patient 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 investigational product (IP) until 3 months after the last administration of the IP. 4. COPD Diagnosis: Patient with an established clinical history of COPD for more than 1 year at Screening, according to the Global Initiative for Chronic Obstructive Lung Disease 2016 COPD guidelines. 5. Tobacco Use: Patient is a current or former smoker with a history of ≥10 pack-years of cigarette smoking. A former smoker is defined as one who has stopped smoking for at least 6 months prior to Screening. 6. Patient with post-bronchodilator FEV1/FVC (Forced vital capacity) 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. 7. Patient with post-bronchodilator FEV1 that must be ≥40% and <80% predicted normal value and must also be >750 mL at Visit 2. If criterion is not met, the test can be repeated at the latest, up to Day 14. 8. Patient who fulfils reversibility to salbutamol at Visit 2. Reversibility is defined as ≥12% and ≥200 mL increase in FEV1 after inhalation of 4 puffs of salbutamol. (400 µg). If criterion is not met, the test can be repeated at the latest, up to Day 14. 9. 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 Four times a day (if needed, during run-in and wash-out periods) with or without Inhaled corticosteroid for maintenance therapy of COPD and as needed rescue salbutamol from Visit 1 up Visit 11. 10. Patient is free from any clinically active disease other than COPD that may impact study outcome, as determined by medical history, physical examination, laboratory testing, and 12-lead ECG findings, at Screening. 11. Patient is willing to remain at the study centre as required per protocol to complete all visit assessments. 12. Patient with body mass index (BMI) <40 kg/m2 at the time of screening Patient previously enrolled in the present study. 2. Patient has significant diseases other than COPD, ie, disease or condition or an abnormality in laboratory, ECG, medical history or physical examination 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'spatient's ability to participate in the study. 3. Childbearing potential female, pregnant or lactating. 4. Patient who, in the opinion of the Investigator, has a current diagnosis of asthma. 5. Patient has alpha-1 antitrypsin deficiency as the cause of COPD. 6. Patient has other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnoea. Allergic rhinitis is not exclusionary. 7. 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). 8. 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. 9. Patient has been hospitalised due to poorly controlled COPD within 3 months of Screening. 10. Patient has acute worsening of COPD that requires treatment with corticosteroids or antibiotics in the 6 week interval prior to Screening (Visit 1), or during the Screening Period (between Visits 1 and 3). 11. Patient has had lower respiratory tract infections that required antibiotics within 6 weeks prior to Screening. 12. Patient cannot perform acceptable spirometry, ie, meet American Thoracic Society (ATS)/European Respiratory Society (ERS) acceptability criteria. 13. Patient has changed their smoking status (ie, start or stop smoking) or initiation of a smoking cessation program within 6 weeks prior to Screening. 14. 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. 15. Cardiac disease: Subject with significant cardiovascular disease cardiovascular instability. Patient with heart rate <50 beats per minute. Patient has clinically significant uncontrolled hypertension as assessed by the investigator. 16. Neurological: Patient with seizures or history of seizures requiring anticonvulsants within 12 months prior to Screening. 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. 17. Renal: Patient with symptomatic bladder neck obstruction, acute urinary retention or symptomatic non-stable prostate hypertrophy. 35.23. Patient with a serum potassium value <3.5 mmol/L at Screening and on repeat testing. Note: however potassium replacement and rescreening is allowed if serum potassium concentration was < 3.5mmol/l at screening. 18. Others Any laboratory abnormality or suspicion of any clinically relevant disease or disorder (on history or examination), including uncontrolled hypertension or uncontrolled diabetes, 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 History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin Patient with known narrow-angle glaucoma Patient has a history of hypersensitivity to β2-agonists, muscarinic anticholinergics or lactose/milk protein. Lactose intolerance is not an criterion The patient has a known or suspected history of alcohol or drug of abuse within the past 2-year period years or consuming more than 14 (female subjects) or 21 (male subjects) units of alcohol a week, or shows positive for drugs of abuse and alcohol tests at screening and prior to randomization Patient who, in the opinion of the Investigator, would be unable to abstain from protocol-defined prohibited medications during the study Patient who received a live attenuated vaccination within 30 days prior to Screening Patient involved in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) Patient treated with investigational drug or device in another clinical trial within the last 30 days or five half-lives (whichever is longer) prior to Screening
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-75.0, Chronic Obstructive Pulmonary Disease Asthma for all subjects: 1. Subject's written informed consent obtained prior to any study-related procedure 2. Body mass index (BMI) between 18 and 32 kg/m2 3. Ability to understand the study procedures and the risks involved and ability to be trained to use the devices correctly at screening and pre-dose. 4. Normal vital signs (Diastolic BP 60-90 mmHg, Systolic BP 90-140 mmHg or 90-150 if >45 yrs) at screening and pre-dose. 5. 12-lead digitalised ECG considered as normal: 60 ≤ heart rate ≤ 100 bpm, 120 ms ≤ PR ≤210 ms, QRS ≤ 120 ms, QTcF ≤ 450 ms (male) and ≤ 470 ms (female) at screening and pre-dose 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. Female patients 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) Additional for Healthy /volunteers and Asthmatic patients: 9. Males and females aged 18-55 10. Non or Ex-smokers who smoked < 5 pack years (pack-years = number of cigarette packs per day times the number of years) and stopped smoking > 1 year Additional only for Healthy volunteers: 11. Lung function within normal limits: FEV1 ≥ 80% of predicted (according to the Global Lung Function Initiative, ERS Task Force Lung Function Reference Vales) and FEV1/FVC ratio > 0.70 at screening Additional only for Asthmatic patients: 12. Pre-bronchodilator 60% ≤ FEV1 ≤ 80% of predicted (according to the Global Lung Function Initiative, ERS Task Force Lung Function Reference Vales) and FEV1/FVC ratio > 0.70 at screening. If this criterion is not met at Screening, the test can be repeated once before Day -1. 13. Positive reversibility test as defined by an increase in FEV1 ≥ 12% and at least 200 ml compared to the initial value 20-30 minutes after inhalation of 400 μg Salbutamol at screening. If this criterion is not met at Screening, the test can be repeated once before Day -1. Additional only for COPD patients: 14. Males and females aged 40-75 15. Current or ex smokers (stopped smoking > 1 year ) minimum smoking history of 10 pack-years (packyears = number of cigarette packs per day times the number of years) 16. 30% ≤ FEV1 < 50% of predicted and FEV1/FVC < 0.70 after inhalation of 400 μg Salbutamol. If this criterion is not met at Screening, the test can be repeated once before Day -1 for all subjects: 1. Pregnant or lactating women 2. Documented history of drug abuse (within 12 months before screening) and/or positive urine drug test at screening and/or at treatment period 3. History of hypersensitivity to M3 Antagonists, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial; 4. Any clinically relevant abnormal laboratory value at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the subject or the evaluation of the result of the study according to the investigator's judgment 5. Clinically relevant and uncontrolled hepatic, gastrointestinal, renal, genitourinary, endocrine, metabolic neurologic, or psychiatric disorder that may interfere with successful completion of this protocol 6. Serology at the screening positive to HIV1 or HIV2 and positive results for Hepatitis which indicates acute or chronic Hepatitis B (i.e. positive HB surface antigen HBsAg positive and/or positive HB core antibody anti-HBc) or Hepatitis C (HCV antibody); 7. Subjects with history of sustained and non-sustained cardiac arrhythmias (ECG demonstrated) and subjects with a family history of sudden cardiac death 8. 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 9. Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic agents" 10. Significant blood loss ≥ 400 ml within 3 months prior screening and between screening and Day 1; 11. Participation in another clinical trial with an investigational drug in the previous 3 months before the administration of the study drug; a longer and more appropriate time could be considered by the principal investigator based on the elimination of the half-life and/or long term toxicity of the previous investigational drug; 12. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study. 13. Unsuitable veins for repeated venipuncture 14. Any not allowed concomitant medication Additional for Healthy volunteers and Asthmatic patients: 15. Current use of any nicotine or nicotine replacement product Additional for Asthmatic and COPD patients: 16. Use of systemic steroids in the 4 weeks prior to screening and between screening and Day 1 (injectable depot steroids 6 weeks) 17. Life-threatening/unstable respiratory status including upper or lower respiratory tract infection, within the previous 30 days before screening and between screening and Day 1 18. Requirement for continuous oxygen therapy (supplemental oxygen not exceeding 2 l/min, at night only and/or during exercise is allowed) Additional only for asthmatic patients: 19. Change in dose or type of any medications for asthma within 4 weeks prior to the screening visit 20. Asthma exacerbation within the 4 weeks prior screening and between screening and Day 1 21. History of COPD or any chronic respiratory disease other than Asthma Additional only for COPD patients: 22. Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit 23. COPD exacerbation within the 4 weeks prior screening and between screening and Day 1 24. History of asthma or any chronic respiratory disease other than COPD
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 45.0-80.0, Benign Prostatic Hypertrophy With Outflow Obstruction Benign Prostatic Hyperplasia years of age or older Clinically diagnosed with mild to moderate BPH Prostatic volume ≥ 30 ml determined by transrectal ultrasound Maximum flow rate (Qmax) < 15 ml/sec for a voided volume 150-500 ml Participants must not have severe BPH (IPSS symptom score >21) Participants should not be currently undergoing any other form of medical therapy for BPH (5-PDE inhibitors, mepartricine, plant extracts such as Saw Palmetto, vitamin E, and quercetin) Patients must not have undergone prior transurethral resection of the prostate (TURP) Post void residual (PVD) > 200 ml Previous urological history including urethral stricture disease and/or bladder neck disease, urinary retention, bladder stone, chronic prostatitis, bladder cancer, interstitial cystitis, active upper tract stone disease causing symptoms, insulin-dependent diabetes mellitus and non-controlled non-insulin-dependent diabetes mellitus, chronic renal failure
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, COPD Patients aged ≥40 years with COPD diagnosis according to the current GOLD (The Global Initiative for Chronic Obstructive Lung Disease) strategy Patients who have symptomatic stable moderate to severe COPD diagnosis with post-bronchodilator FEV1/FVC ratio <0.70, and FEV1 <80% of predicted normal at screening visit Current smokers or ex-smokers with a smoking history of at least 10 pack-years Patients who have no exacerbation within last 4 weeks Female patients with childbearing potential using effective birth control method Patients who signed written informed consent prior to participation Patients who accept to comply with the requirements of the protocol Patients who have a capability of communicate with investigator History of hypersensitivity to drugs contains anticholinergics, beta-adrenergic, lactose Diagnosis of asthma Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to screening visit or during run-in period Patients who have a history of myocardial infarction, hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks Patients who have lung cancer Patients with active tuberculosis Patients who use oxygen therapy Patients who have common interstitial lung diseases like cystic fibrosis, bronchiolitis obliterans Patients with serious liver or renal disease that leads to organ failure
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, COPD Patient diagnosed with COPD. The patient must be referred to PR from his/her physician with spirometry results confirming that he/she has chronic obstructive pulmonary disease (defined as post-bronchodilator FEV1/VC <0.70 and a compatible exposure history) Ability to exercise Neuromuscular diagnosis Patient involved in any ongoing drug intervention study
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Emphysema Age 40 or older 2. Diagnosis of severe COPD 3. Stopped smoking for at least 6 months prior to entering the study. 4. Completed a pulmonary rehabilitation program within 12 months prior to treatment and/or regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 12 months prior to baseline testing. 5. Received Influenza vaccination consistent with local recommendations and/or policy. 6. Read, understood and signed the Informed Consent form. 7. Dyspnea scoring ≥2 on mMRC scale of 0-4. 8. FEV1%pred <45% and FEV1/FVC <60%. 9. TLC%pred >100% AND RV%pred >175%. 10. RV/TLC >55% 11. CT thorax must demonstrate heterogeneous emphysema and a disrupted interlobar fissure (75-90% intact) in the treatment lobe. Scans will be analysed using in-house software to calculate a heterogeneity score and percentage fissure integrity. 12. Chartis balloon catheter assessment confirms the presence of collateral ventilation in the target lobe Patient unable to provide informed consent. 2. Subject has a history of recurrent clinically significant respiratory infections, defined as 3 or more hospitalizations for respiratory infection during the year prior to enrolment. 3. Subject has clinically significant bronchiectasis. 4. Alpha-1 AT deficiency. 5. Medical history of asthma. 6. Subject has co-morbidities that may significantly reduce ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnoea. 7. Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study. 8. Subject is pregnant or lactating, or plans to become pregnant within the study timeframe. 9. Subject has an inability to tolerate bronchoscopy under conscious sedation or general anaesthesia. 10. Subject has severe gas exchange abnormalities as defined by: PaCO2 >8.0 kPa and/or PaO2 < 6.0 kPa (on room air). 11. FEV1 <15% predicted and Total lung CO uptake (TLCO) <20% predicted. 12. Subject has an inability to walk >140 meters in 6 minutes. 13. Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >45 mm Hg measured on transthoracic echocardiogram. 14. Subject has giant bullae >1/3 lung volume. 15. Lung nodule requiring surgery. 16. Subject has had previous LVR surgery, lung transplantation or lobectomy. 17. Subject has been involved in pulmonary drug or device studies within 30 days prior to this study. 18. Subject is taking >10 mg prednisone (or equivalent dose of a similar steroid) daily. 19. Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder. 20. Subject is on an antiplatelet (such as Plavix) or anticoagulant therapy (such as Warfarin or NOAC) which cannot be stopped prior to the procedure. 21. Subject has a known sensitivity or allergy to Nickel. 22. Subject has a known sensitivity to drugs required to perform bronchoscopy. 23. Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Adult patients with frequent exacerbations of COPD (clinically dominant COPD in the case of multiple co-morbidities eg. bronchiectasis, interstitial lung disease, congestive heart failure) Confirmed diagnosis of COPD (bronchodilator FEV1/FVC ratio <0.7 on spirometry within previous 12 months) Age >40 years >10 pack year smoking history Frequent COPD exacerbations in the previous 12 months before enrollment, defined by one or both of the following Treatment as an outpatient with antibiotics or prednisone (physician diagnosed COPD exacerbation) on 2 previous occasions OR One hospitalization for COPD exacerbation (as defined by 2/3 of increased dyspnea, sputum volume, or sputum purulence in patients with known airflow limitation) Expected to live > 12 months Known severe hypersensitivity to immunoglobulin or its components (anaphylaxis) Active or metastatic malignancy (including chronic lymphocytic leukemia) excluding local skin cancers History of hematopoietic stem cell transplant or solid organ transplant Current treatment with a biological therapy for other conditions Concomitant significant immunodeficiency or use of immunosuppressive treatment (other than for COPD) Alpha-1 antitrypsin deficiency (based on enzyme level from bloodwork) Significant proteinuria (dipstick proteinuria ≥ 3+ AND known urinary protein loss ≥ 2 g/day or nephrotic syndrome) and/or has a history of acute renal failure and/or severe renal impairment (creatinine more than 2.5 times the upper limit of normal and/or on dialysis) IgA deficiency (IgA <0.1 g/L) Immunoglobulin therapy in the last 12 months or on current Ig therapy or have a clinical indication for Ig replacement therapy (www.nacblood.ca/resources/guidelines/IVIG.html) Pregnancy
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 35.0-999.0, Pulmonary Disease, Chronic Obstructive Adult >= 35 years old At least one of the following risk factors for COPD: • being a current smoker (who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes) or past smoker (who has smoked at least 100 cigarettes in his or her lifetime but who had quit smoking at the time of interview); Current or past exposure to biomass smoke, such as wood or coal, for cooking or heating (exposure >=100 hours/year Capable of giving signed informed consent Physical or mental disability to complete the study procedures Heart above 120 beats per minute Participants under treatment for tuberculosis Participant in current clinical trial Pregnancy Patients with one of the following contraindications to spirometry: chest surgery in the last month; abdominal surgery within the past three months; neuromuscular disease, acute coronary syndrome; retinal detachment; hospitalization for any cardiac problem in the prior 3 months
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 45.0-80.0, Copd Age 45 to 80 years Smoking history >10 pack-year Mild COPD subjects: Male or female individuals; post-bronchodilator forced expiratory volume in 1 s (FEV1) ≥80% of predicted normal and post-bronchodilator FEV1/forced vital capacity (FVC) ratio <0.70 Non-COPD subjects: Male or female individuals; post-bronchodilator FEV1 ≥80% of predicted normal and post-bronchodilator FEV1/FVC ratio ≥0.70 Unable to tolerate study procedures Unable to walk or cycle without assistance Dementia or cognitive disorder, which would prevent the participant from consenting the study or completing study procedures Major depressive disorder Locomotor disease that seriously limits exercise tolerance Untreated symptomatic peripheral artery disease Body Mass Index >40 kg/m2 Non-COPD significant pulmonary disease such as asthma; interstitial lung disease; sarcoidosis; tuberculosis; cystic fibrosis; diffuse bronchiectasis; and others Primary pulmonary hypertension Current lung cancer
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Copd Patients aged ≥40 years with newly or formerly diagnosed moderate to severe COPD (Patients with postbronchodilator FEV1/FVC ratio <0.70, and FEV1 <80% of predicted normal. Patients have chronic cough or chronic productive cough with breathlessness even walking slowly along flat ground.) Current smokers or exsmokers with a smoking history of at least 10 pack-years Patients who have no exacerbation within last 4 weeks Females patients with childbearing potential using effective birth control method Patients who has a capability of communicate with investigator Patients who accept to comply with the requirements of the protocol Patients who signed written informed consent prior to participation Patients who have history of hypersensitivity to drugs contains long-acting beta2-agonist or corticosteroids Patients who have abnormal blood glucose level ((≥140 mg/dl) Patients who have unregulated diabetes mellitus Patients who have a serum potassium level of ≤3.5 mEq/L or >5.5mEq/L Patients who have asthma Patients who have a history of myocardial infarction, severe hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks Patients who have lung cancer Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to screening visit or during run-in period Women who are pregnant or nursing
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 45.0-999.0, Chronic Obstructive Pulmonary Disease Moderate Obesity non obese no history of respiratory disease non smokers self declared sedentary Forced expiratory volume at first second (FEV1) equal or higher than 80% of predicted Forced Vital capacity (FVC) equal or higher than 80% of predicted FEV1/FVC higher than 70% of predicted BMI lower than 30 kg/m2 obese no history of respiratory disease non smokers Difficulty to understand verbal commands exacerbations during the study period
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive Participants must be aged between 40 to 80 years of age inclusive, at the time of signing the informed consent Participants who have COPD (post bronchodilator FEV1/FVC ratio <0.7 and FEV1% predicted >=40%) based on American Thoracic Society (ATS)/European Respiratory Society (ERS) current guidelines. Participants with a historical diagnosis of asthma may be included so long as they have a current diagnosis of COPD History of respiratory symptoms including chronic cough, mucus hypersecretion, and dyspnea on most days for at least the previous 3 months prior to screening Participants with a documented history of COPD exacerbation(s) in the 12 months prior to study participation (screening) meeting at least one of the following >=2 COPD exacerbations resulting in prescription for antibiotics and/or oral corticosteroids or hospitalization or extended observation in a hospital emergency room or outpatient center; 1 COPD exacerbation resulting in prescription for antibiotics and/or oral corticosteroids of hospitalization or extended observation in a hospital emergency room or outpatient center and a plasma fibrinogen concentration at screening >=3 grams/liter (300 milligram/deciliter) Current and former smokers with a cigarette smoking history of >=10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent). Current smokers are defined as those who are currently smoking cigarettes (i.e. have smoked at least one cigarette daily or most days for the month prior to Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1 Participants must have the ability and willingness to use an electronic diary (log pad) on a daily basis Body weight >=45 kilogram (kg) Male or female: A male participant must agree to use contraception during the treatment period and for at least 60 hours after the last dose of study treatment, corresponding to approximately 6 half-lives (which is the time needed to eliminate any teratogenic study treatment) and to refrain from donating sperm during this period; A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 60 hours after the last dose of study treatment Capable of giving signed informed consent Diagnosis of other clinically relevant lung diseases (other than COPD), e.g. sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis or lung cancer Alpha-1-antitrypsin deficiency as the underlying cause of COPD Pulse oximetry <88% at rest at screening. Participants should be tested while breathing room air. However, participants living at high altitudes (above 5000 feet or 1500 meters above sea level) who are receiving supplemental oxygen can be included provided they are receiving the equivalent of <4 liter per minute (L/min) and screening pulse oximetry is measured while on their usual oxygen settings Less than 14 days have elapsed from the completion of a course of antibiotics or oral corticosteroids for a recent COPD exacerbation A peripheral blood neutrophil count <1.5 x 10^9/L Diagnosis of pneumonia (chest X-ray or CT confirmed) within the 3 months prior to screening Chest x-ray (posterior-anterior with lateral) or CT scan reveals evidence of a clinically significant abnormality not believed to be due to the presence of COPD (historic results up to 1 year prior to screening may be used). For sites in Germany: If a chest x-ray (or CT scan) within 1 year prior to screening is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office of Radiation Protection (BfS) History or current evidence of other clinically significant medical condition that is uncontrolled on permitted therapies. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through study participation, or that would affect the safety analysis or other analysis if the disease/condition worsened during the study Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) Abnormal and clinically significant 12-lead ECG finding. The investigator will determine the clinical significance of each abnormal ECG finding in relation to the participant's medical history and participants who would be at undue risk by participating in the study. An abnormal and clinically significant finding that would preclude a participant from entering the study is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: atrial fibrillation with rapid ventricular rate >120 beats per minute (bpm); sustained or non-sustained ventricular tachycardia; second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator has been implanted); Corrected QT Interval using Fridericia formula (QTcF) >=500 millisecond (msec) in participants with QRS <120 msec and QTcF >=530 msec in participants with QRS >=120 msec
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Shoulder Dislocation Brachial Plexus Block Patients (ASA SCORE I-III) without acute cardio-pulmonary decompensation, who arrive to the ER with shoulder dislocation for reduction maneuver Unconscious patient 2. Patient refusal/unable to give informed consent 3. Patients with acute cardio-pulmonary decompensation 4. Patients with known allergy to medications which will be included in the study 5. Patients who suffer additional injuries and need to be hospitalized for further treatment 6. Patients who received narcotic/sedative premedication before the procedure
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 50.0-68.0, Chronic Obstructive Pulmonary Disease Emphysema Chronic Bronchitis Airway Obstruction Smoking, Tobacco Gender Spirometry of postbronchodilator forced expiratory volume in 1 second (FEV1) >50% of predicted level for all groups Spirometry of postbronchodilator FEV1 >80% of predicted level and FEV1/FVC ratio >0.70 for Healthy control groups Spirometry of postbronchodilator FEV1/FVC ratio <0.70 for COPD groups Smoking (for never-smoker groups) Other lung diseases Received antibiotics in the 3 months prior to study entry Treatment with oral or inhaled glucocorticoids within past 3 months prior to study entry
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 30.0-80.0, Ischemic Heart Disease Coronary Artery Disease Ischemic Reperfusion Injury CABG ischemic heart disease valve disease diabetes millitus
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, Osteoarthritis, Knee Previously treated with intra-articular Aquamid Reconstruction in the knee for knee osteoarthritis and referred to our clinic for evaluatino of possible adverse device events There are no
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Heart Arrest, Out-Of-Hospital Intubated and comatose adult (>18 yo) resuscitated from out-of-hospital cardiac arrest (OHCA)* *Cardiac arrest within an emergency department or outpatient medical center will be included). OHCA includes Emergency Medical Service (EMS) witnessed cardiac arrest Return of spontaneous circulation (ROSC) within 40 min of CPR initiation Full Outline of Unresponsiveness (FOUR) Brainstem score ≥ 2 (i.e. patient must have pupil OR corneal reflex at the time of ED presentation or within 1h if sedation/neuromuscular blockade clouds the picture) Traumatic etiology of OHCA Prisoner Known pregnancy (beta-human chorionic gonadotropin screening is NOT for enrollment in women of appropriate age) Hemodynamic instability defined as >1 recurrent arrest prior to enrollment OR inability to maintain mean arterial blood pressure (MAP) > 65 using vasopressors and inotropes (ie actively up titrating medications or giving fluid bolus) Head CT grey-white ratio < 1.2; Head CT is NOT prior to enrollment Fixed and dilated pupils without another explanation Known intracranial hemorrhage or acute cerebral infarction; Head CT is NOT prior to enrollment Malignant EEG upon presentation defined as: myoclonic status epilepticus, non-convulsive status epilepticus, generalized periodic epileptiform discharges. EEG screening is NOT prior to enrollment ROSC >3h from time of ED arrival (treatment allocation must be within 4h so anything that will prevent this is reason for exclusion) Alert and interactive patient with minimal evidence of neurologic injury
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-70.0, Crohn Disease Ulcerative Colitis Intestinal Helminthiasis The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his in the study was that he was healthy
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, Hepatitis B， Chronic Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months) Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV) History of liver transplantation History of hepatocellular carcinoma (HCC)
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease Diastolic Dysfunction Patients age 18 and older Patients admitted to the general medicine or pulmonary floors, or the medical intensive care unit with a primary diagnosis of acute exacerbation of COPD will be eligible for the study Patients with a secondary diagnosis of congestive heart failure and other respiratory conditions that the investigator's deem could confound the diagnosis including but not limited to pneumonia, bronchiectasis and lung cancer will be excluded Pregnant or breastfeeding women will be excluded Patients with conditions that preclude an adequate echocardiogram such as hemodynamically significant arrhythmias will also be excluded
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-65.0, Hepatitis B HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT <40 IU/ml No Advanced fibrosis[LSM <14 KPa] TDF/ETV >1 year Clinical Relapse after stopping NA will be defined as HBV DNA>2000IU/ml and ALT > 80IU HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM >14 Co-infection HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin>2mg/dl Patient having neutropenia
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Venous Thromboembolism Acutely ill medical patients admitted to medical wards Indication for therapeutic anticoagulation or ongoing therapeutic anticoagulant treatment
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Asthma for Cases The subject has given his/her informed consent and signed the consent form The subject is affiliated with or beneficiary of a medical insurance system The subject has had asthma for over a year The following are present in the patient's medical file: (i) a positive methacholine test (PC20 < 16 mg/ml) OR (ii) reversibility > 200 ml and 12% of the FEV1 after inhaling 400 µg or less of a short acting bronchodilator Treatment with >= 1000 µg inhaled beclometasone equivalents for Cases The subject is pregnant The subject is breastfeeding The subject is participating in another interventional study The subject has participated in another study in the 3 months preceding The subject is in an period determined by a previous study The subject is under judicial protection or is an adult under any kind of guardianship The subject refuses to sign the consent It is impossible to correctly inform the subject The subject cannot fluently read French
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-85.0, COPD Pulmonary Hypertension Chronic Obstructive Pulmonary Disease Male or female patient 2. A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) 3. Pulmonary hypertension will be defined as sPAP ≥ 38 mmHg as determined by echocardiogram (not obtained within ± 7 days of an exacerbation) within the past 12 months. 4. Current or former smokers with at least 10 pack-years of tobacco cigarette smoking before study entry 5. Age ≥ 40 years, ≤ 85 years 6. A post-bronchodilatory FEV1/FVC < 0.7 and a FEV1 < 60% predicted (values obtained within 6 months prior to screening can be used unless obtained within ± 7 days of an exacerbation; otherwise, the test must be performed during screening) 7. Receiving LTOT for ≥ 3 months and ≥ 10 hours per day as determined by history 8. Females of childbearing potential must have a negative pre-scan urine pregnancy test 9. Signed informed consent prior to the initiation of any study mandated procedures or Assessments Males who have the intention to father a child during the study. 2. A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator 3. Lack of patency of nares upon physical examination 4. Experienced during the last month an exacerbation requiring: 1. start of or increase in systemic oral corticosteroid therapy and/or 2. hospitalization 5. Left ventricular dysfunction as measured by: 1. Screening echocardiographic evidence of left ventricular systolic dysfunction (left ventricular ejection fraction [LVEF] < 40%), or 2. Screening echocardiographic evidence of left ventricular diastolic dysfunction >moderate (i.e., > Grade 3), or 3. Any history of pulmonary capillary wedge pressure (PCWP), left atrial pressure (LAP) or left ventricular end diastolic pressure (LVEDP) > 18 mmHg as measured during cardiac catheterization within the past 6 months unless documented to have resolved by a subsequent cardiac catheterization 6. Renal impairment (i.e., an estimated GFR CKD-EPI < 30 ml/min/1.73 m2) or history of renal failure using the equation: Men: crs< 0.9 mg/dL: eGFRCKD-EPI = 141 × (crs /0.9)-0.411 × 0.993Age crs≥ 0.9 mg/dL: eGFRCKD-EPI = 141 × (crs /0.9)-1.209 × 0.993Age Woman: crs< 0.7 mg/dL: eGFRCKD-EPI = 144 × (crs /0.7)-0.329 × 0.993Age crs≥ 0.7 mg/dL: eGFRCKD-EPI = 144 × (crs /0.7)-1.209 × 0.993Age where crs= Normal and elevated serum creatinine Subjects with possible compromised kidney function (i.e., Glomerular Filtration Rate estimated using the Modification of Diet in Renal Disease equation [eGFR CKD-EPI] between 30 and 60 ml/min/1.73 m2) may be enrolled provided the Radiology Department and Principal Investigator review the medical records of subjects with an eGFR CKD-EPI between 30 and 60 ml/min/1.73 m2 in order to confirm the contrast agent can be safely administered to these subjects and approval by both the Radiology Department and Principal Investigator must be obtained before enrolling these subjects. 7. Known allergy to contrast media. 8. Clinically significant valvular heart disease that may contribute to PH, including mild or greater aortic valvular disease (aortic stenosis or regurgitation) and/or moderate or greater mitral valve disease (mitral stenosis or regurgitation), or status post mitral valve replacement 9. Use within 30 days of screening or current use of approved PH medications such as sildenafil or bosentan (use of Cialis® or Viagra® for erectile dysfunction is permitted) 10. Use of investigational drugs or devices within 30 days prior to enrollment into the study 11. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, COPD Pulmonary Vascular Disorder Right Ventricular Dysfunction stable COPD patients patents with other respiratory diseases and pulmonary hypertension other than group 3 PH psychopath, addict or patients not able to coordinate patients in pregnancy or breastfeeding patients with limited life expectancy patients with contraindiction for MRI or PET patients having cerebrovascular events in 3 months unstable COPD patients
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 2.0-999.0, Respiratory Tract Infection Acute Transcriptome Virus Disease Bacterial Infections A. Age 24 months or older B. Acute respiratory illness of less than 28 days in duration. C. Acute respiratory illness will be defined by at least two qualifying symptoms OR one qualifying symptom and at least 1 qualifying vital sign abnormality Qualifying symptoms:Headache, rhinorrhea, nasal congestion, sneezing, sore throat, itchy or watery eyes, conjunctivitis, cough, shortness of breath, sputum production, chest pain, wheezing Qualifying Vital Signs: Age greater than or equal to 2 and less than 6:Tachycardia (HR greater than or equal to 110), Tachynpnea (RR greater than or equal to 20),Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius. Age greater than or equal to 6: Tachycardia(HR greater than or equal to 90), Tachynpnea (RR greater than or equal to 20), Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius. D. Ability of the subject or legally authorized representative/parent to understand study procedures, and willing and able to comply with all required A. Known or suspected infection at any other anatomic site requiring antibacterial therapy. B. Any specific condition that in the judgment of the referring provider or the site investigator precludes participation because it could affect subject safety or ability of subject to participate in this trial
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Pulmonary Disease, Chronic Obstructive, Severe Early-Onset Episodes of patients with exacerbation of chronic obstructive pulmonary disease (COPD). Those patients can be admitted with 2 presentations: A) known case of COPD: episodes of patients with a previous diagnosis of COPD (FEV1/FVC<70%) who have an exacerbation of COPD. The exacerbation of COPD is defined as an acute worsening of symptoms in relation to the baseline situation and beyond the patient's daily variability. In addition, the exacerbation makes necessary to make changes in the patient's usual medication. The most frequently reported symptoms are dyspnea, cough, increased the sputum's production, and changes in the sputum's color. B) New case of COPD: episodes in which COPD is suspected because of the medical history and anamnesis (smokers or ex-smorkers of more than 15 pack/year, with basal dyspnea, cough, and expectoration for more than three months per year) and it is compatible with an exacerbation. The diagnosis will be confirmed at respiratory outpatient clinic within two months after discharge, by performing a spirometry when the patient is stable. If COPD is not confirmed in this consultation, the patient would be excluded from the study Patients who sign informed consent Patients admitted with obstructive or restrictive ventilatory failure due to another disease (asthma, consequences of tuberculosis, pachypleuritis, restrictive diseases) All COPD patients finally admitted for any other cause, other than exacerbation or complicated COPD Patients with severe physical or psychopathological disease, cognitive deterioration, any neurologic disease, that prevented them from properly completing the questionnaires Patients who do not understand the Spanish language to complete properly the questionnaires Patients that do not want to participate or do not sign the inform consent. For re-admissions Those who are programmed admissions or those for another cause not in relation with CMS algorithms
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive Hypercapnic Respiratory Failure years old < age < 80 years old COPD diagnosis was made according to GOLD guidelines The subjects with chronic type II respiratory failure The subjects with structural lung disease The subjects signed informed consent The subjects suffering from COPD acute exacerbation The subjects currently participating in other related products The subjects with organ dysfunction because of liver,kidney, hematopoietic system and serious metabolic disease endocrine system The subjects with poor compliance The subjects refused to sign the informed consent
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease Age > 18years Chronic obstructive pulmonary disease stade III to IV Referred for pulmonary rehabilitation. Non Pregnancy or likely to be History of psychiatric, neuro-vascular, cognitive disease or cranial trauma Active alcoholism Guardianship Hospitalisation for acute exacerbation of chronic obstructive pulmonary disease in the previous 4 weeks Interruption of the pulmonary rehabilitation program > 15 days Disruption of the training before the 18th session Less than 18 sessions in four month
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Gastrostomy Head and Neck Neoplasms Malignant Neoplasm Surgical risk ASA I-III, Karnofsky Performance Status >70, acceptance and comprehension of the orientations and after-care, adequate social a familiar support, easy access to the hospital patients who live more than one hour away from the hospital, coagulopathies, refuse to join the protocol
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-80.0, Heart Rate Determination Age 18-80 Scheduled for surgery under general anesthesia requiring invasive blood pressure monitoring Heart Rate other than sinus Cardiac Pacemaker Status Transplanted Heart
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-75.0, Respiratory Failure Respiratory rate >30 per minute 2. Arterial blood gas analysis showing a PaCO2 >45 mmHg and pH <7.35 3. PaO2/FiO2 ratio < 300 4. Use of accessory muscles of respiration or paradoxical respiration Age <18 years or >75 years 2. Pregnancy 3. PaO2/FiO2 ratio ≤100 4. Hypotension (systolic blood pressure <90 mmHg) 5. Severe impairment of consciousness (Glasgow coma scale score <8) 6. Inability to clear respiratory secretions (Airway care score [ACS] ≥12)(27) 7. Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality) 8. Subjects who have an artificial airway like tracheostomy tube or T-tube 9. Contraindications for insertion of naso-/orogastric feeding tube (facial/nasal trauma, recent upper airway surgery, esophageal surgery, esophageal varices, upper gastrointestinal bleeding) 10. More than two organ failures 11. Unwillingness to undergo placement of nasogastric catheter 12. Known phrenic nerve lesions 13. Suspected diaphragmatic weakness 14. Patient already on home NIV therapy for chronic respiratory failure 15. Application of NIV for more than one hour for the current illness 16. Failure to provide informed consent
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, COPD Asthma Subjects must fulfil all of the following All patients with confirmed diagnosis of COPD (post-bronchodilator FEV1/FVC<0.7 based on the medical records) 1 or asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 400 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable) 6 Aged >40 years old Signed written informed consent to participate in the study Patients currently with acute exacerbation of COPD by GOLD definition (any worsening of a patient's respiratory symptoms that is beyond normal day-to-day variations and requires a change in medication) 1 or acute exacerbation of asthma by GINA guideline. 6 Patients with respiratory diseases that can show similar symptoms to chronic airway diseases such as bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma, endobronchial TB, and lung cancer, or those who have history of these diseases based on physician's judgment Patients currently diagnosed with pneumonia and acute bronchitis Patients currently randomized in other clinical studies
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 19.0-999.0, Cardiovascular Diseases Neuro-Degenerative Disease Cancer Pregnancy Men and women Older than 18 years Cardiovascular disease neurodegenerative disease Cancer Pregnancy Inability to understand and to want Refusal to sign the informed consent
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease Participants with a clinical diagnosis of COPD and who meet the following are eligible: 1. Recommended for Pulmonary Rehabilitation and minimum mMRC2 level of dyspnea 2. Motivated for participating in the project (and acceptance of randomization) 3. Sufficient mobility to attend PR Certain comorbidities (e.g. unstable coronary complications) 2. Severe cognitive disabilities (e.g. dementia) 3. Inability to speak or understand Danish No previous singing experience or musical competence is required
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease COPD Copd Exacerbation Acute COPD Exacerbation Admission with acute exacerbation of COPD within 24 hours of presentation to hospital Age >40 Confirmed COPD diagnosis (FEV1/FVC <0.70 on spirometry) Willing to participate in the study and provide informed consent Admission for reason other than COPD exacerbation e.g. Heart Failure Acute confusion as per clinical team Allergy or contraindication to combined bronchodilator medication Severe respiratory sepsis as evident by temperature >38 degrees and/or lobar pneumonia on Chest Radiograph Sustained tachycardia >120bpm Patients with very advanced COPD, admitted for palliative or long term care Patients re-admitted within 90 days who have already been enrolled in the study
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, COPD known or first diagnosis of COPD lung function testing consistent with hyperinflation or peripheral obstruction emphysema in imaging symptoms (dyspnea, cough, sputum) and risk factors (>= 10 pack years) indication for bronchodilator therapy GOLD stages 3 and 4 (spirometric) indication for dual bronchodilator therapy, triple therapy or inhaled steroid contraindication for cardiopulmonary exercise testing unwilling to participate
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, Sleep one patient not relevant - one patient not relevant
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 22.0-999.0, Uncontrolled Hypertension English-speaking adults less than 60 years of age with BP measurements of ≥140/ ≥90 mm Hg years of age or older with BP measurements of ≥150/ ≥90 mm Hg diagnosed with diabetes with BP measurements of ≥140/ ≥90 mm Hg Patients with BP measurements of <180/ <110 mm Hg without hypertensive urgency symptoms comorbidities of COPD, renal disease or chronic alcoholism -
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Sepsis Septic Shock Critical Illness Fluid Overload Diagnosis of severe sepsis or septic shock within 12 hours of admission in our Intensive Care Unit (ICU) Informed consent Age < 18 years Pregnancy Do Not Resuscitate (DNR/DNI) with limitations of care Patients with fatal underlying disease who are unlikely to survive to hospital discharge (e.g.: disseminated malignant disease) Patients primarily admitted for acute coronary syndromes, acute cerebrovascular incidents or active gastrointestinal (GI) bleeds Patients that need immediate surgical treatment Patients with HIV and a cell count of cluster of differentiation 4 (CD4) cells < 50 mm2 Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency Patients with severe sepsis/septic shock transferred from another hospital Patients with features of sepsis/septic shock > 24 hours
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Cystic Fibrosis subject has confirmed diagnosis of cystic fibrosis (sweat chloride >60mmol/l and/or 2 mutations in the cftr gene known to cause cystic fibrosis) subject is able to perform informed consent inability to give informed consent antibiotic therapy in the last 4 weeks prior to study start (exception: long term azithromycin therapy, long term antistaphylococcal therapy, long term inhaled antibiotics)
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Asthma Aged 18 years or older at the time of consent History of airflow obstruction as indicated by a pre-bronchodilator forced expiratory volume in one second (FEV1) <80 percent predicted recorded in the previous 12 months Documented evidence of a reversibility assessment within the previous 12 months, which demonstrated a post-bronchodilator increase in FEV1 of >=12 percent and >= 200 milliliters (mL) Diagnosed with moderate or severe asthma as defined by a stable maintenance inhaled corticosteroid (ICS) dose for at least 12 weeks prior to screening of; moderate: medium ICS dose > 250 and <=500 micrograms per day (mcg/day) fluticasone propionate (or equivalent) based on the total daily maintenance treatment dose; Severe: high ICS dose > 500 mcg/day fluticasone propionate (or equivalent) based on the total daily maintenance treatment dose Documented control status defined using the asthma control questionnaire (ACQ-6) items (ACQ-6) obtained at the time of screening Able to understand, read and speak English or Spanish sufficiently to complete all assessments Willing and able to take part in a telephone interview session Willing and able to provide written informed consent Is a current smoker Has any medical condition that would preclude participation in this study, including the presence of emphysema or chronic bronchitis (COPD other than asthma) or a clinically important lung condition other than asthma such as current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis or diagnoses of an eosinophilic disorder such as eosinophilic esophagitis or a history of lung cancer Participated in an interventional study within the past 30 days
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive to 80 years of age, inclusive, at Screening (Visit 1) An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [ global initiative for chronic obstructive lung disease (GOLD), 2017] as follows: "Chronic obstructive pulmonary disease is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases." Current or former cigarette smoker with a history of cigarette smoking of >=10 pack-years. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening (Visit 1). Number of pack years = (number of cigarettes per day / 20) x number of years smoked) Acute exacerbation of COPD requiring an escalation in therapy to oral/systemic corticosteroid(s) (prednisone 40 mg/day or equivalent) for 5 days and antibiotic(s) for 7 days; the dose and/or duration of prednisone (40 mg/day or equivalent) and/or the antibiotic can be modified according to the Investigator's/medically qualified designee's judgment or according to local country/institution practice. Acute exacerbation to be confirmed by an experienced physician and to represent a recent worsening of at least two major and one minor symptoms, one major and two minor symptoms, or all 3 major symptoms. Major symptoms subjective increase in dyspnea, increase in sputum volume or change in sputum color. Minor symptoms increased cough, increased wheeze, sore throat, colds or fever (oral temperature >37.5 degree Celsius) without other cause Body weight >=45 kilogram (kg) and body mass index (BMI) within the range 16 kg per meter square (kg/m^2) (inclusive) Male and female subjects are eligible to participate in the study. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the 12-Week Double-Blind Treatment Period and for at least 5 half-lives (10 days) after the last of double-blind study treatment Capable of giving signed informed consent Current diagnosis of asthma, according to the Global Initiative for Asthma (GINA, 2017). Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD Potential of hydrogen (pH) < 7.30 or the need for invasive mechanical ventilation Moderate/severe exacerbation of COPD for which SoC was started >48 hours since diagnosis A chest X-ray [or computed tomography (CT) scan] that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray (or CT scan) must be taken at Screening (Visit 1). For sites in Germany: if a chest X-ray (or CT scan) within 1 year of Screening (Visit 1) is not available, approval to conduct a diagnostic chest X-ray (CT scan) will need to be obtained from the Federal Office for Radiation Protection (BfS) Clinically significant pneumonia, identified by chest X-ray (CT scan) at Screening A diagnosis of alpha 1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, clinically overt bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), primary pulmonary hypertension, interstitial lung diseases,or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the subject or affect the interpretation of the results A history or current evidence of clinically significant and unstable disease such as cardiovascular (e.g., subjects requiring implanted cardioverter defibrillator [ICD], pacemaker requiring a rate set >60 beats per minute (bpm), uncontrolled hypertension, New Your Heart Association Class IV [NYHA, 1994], known left ventricular ejection fraction <30 percent) neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or hematological abnormalities. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. (Note: subjects with adequately treated and well controlled concurrent medical conditions (e.g. hypertension or noninsulin-dependent diabetes mellitus [NIDDM]) are permitted to be entered into the study) Having undergone lung volume reduction surgery or lung resection for any other reason e.g. lung carcinoma Liver diseases including ALT>2x upper limit of normal (ULN); Total bilirubin >1.5xULN (Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent); current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); Presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to first dose of study treatment; Positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study treatment Positive hepatitis C ribonucleic acid (RNA) test result at Screening or within 3 months prior to first dose of study treatment
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-75.0, Late-onset Pompe Disease Subject has a diagnosis of Pompe disease based on documented deficiency of GAA activity and a documented GAA mutation. 2. Male and female subjects between 18 years and 75 years, inclusive and ≥ 50 kg. 3. Subject must be currently receiving standard-of-care ERT (alglucosidase alfa) at a dose of 20 mg/kg dose every other week. 4. Subject must have been on ERT for the preceding 2 years or more. 5. Subject must have an upright forced vital capacity (FVC) within 35 to 90% of predicted normal (NHANES III reference values), based on the higher of the screening or baseline value, if their 6 minute walk distance (6MWD) is > 200 m. Subject must have an upright FVC within 40 to 90% of predicted normal (NHANES III reference values), based on the higher of the screening or baseline value, if their 6MWD is ≤ 200 m. If FVC is between 80 and 90% of predicted normal, the subject may enter the study if the percent predicted FVC value drops by 10% predicted or more in supine position 6. Subject is able to walk at least 100 m in the 6MWT and the assessment is noted as valid Subject has received any investigational therapy or pharmacological treatment for Pompe disease, other than alglucosidase alfa within 30 days or 5 half lives, whichever is shorter, prior to the Baseline Visit or is anticipated to do so during the course of the study 2. Subject is on any of the following prohibited medications within 30 days of baseline miglitol (eg, Glyset) miglustat (eg, Zavesca) acarbose (eg, Precose, Glucobay) voglibose (eg, Volix, Vocarb, Volibo) 3. Subject requires use of invasive or non-invasive ventilatory support for > 6 hours a day while awake. 4. Subject has a medical or any other extenuating condition or circumstance that may, in the opinion of the investigator, pose an undue safety risk to the subject or compromise his/her ability to comply with protocol requirements. This includes clinical depression (as diagnosed by a psychiatrist or other mental health professional) with uncontrolled or poorly controlled symptoms. 5. Subject is breastfeeding, or is pregnant or planning to become pregnant within the next 2 years. 6. Other according to the Lumizyme/Myozyme instructions for use
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, COPD Dyspnea Age ≥ 40 Ability to provide consent COPD diagnosis Forced Expiratory Volume in one second (FEV1) <55 and ≥ 25 percent of predicted value Perceived Shortness of Breath via the Modified Medical Research Counsel Dyspnea questionnaire (rating of 2 or greater) (Appendix B) Able to follow directions Able to tolerate mild physical activity Pursed Lip Breathing as standard of care No evidence of bullous lung disease (with any bullae greater than 3cm in diameter) as confirmed by a CT scan within the past one year Subjects who are acutely ill, medically complicated or who are medically unstable as determined by the investigator Suffering from COPD exacerbation at time of enrollment or 60 days prior Subjects who are not currently prescribed oxygen and manifest oxygen desaturation below 88% on the screening 6MWT Subjects with heart disease or neuromuscular disease Subjects who are not prescribed short-acting bronchodilator medication Patients who have experienced recent barotrauma or pneumothorax Unstable angina or Myocardial Infarction during past month Uncontrolled Hypertension (systolic blood pressure of >180mmHg (millimeters of Mercury) and a diastolic >100mmHg) Heart Rate >120 at rest Subjects who have trouble coordinating their breathing with the device during the device training, or cannot tolerate the device mouthpiece resulting in leaks from the nasal cavity
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-75.0, Asthma Chronic Obstructive Pulmonary Disease Part 1 male subjects aged 18-55 years inclusive healthy subjects based on medical evaluation including medical history,physical examination, laboratory tests and cardiac testing Body Mass Index (BMI) between 18.5 and 32.0 kg/m2 extremes inclusive 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 > 1 year Good physical and mental status, determined on the basis of the medical history and a general clinical examination Lung function equal to or more than 80% of predicted normal value and FEV1/FVC ratio > 0.70; Part 2 Adult male and female subjects aged 18 to 75 years Clinical diagnosis of mild persistent asthma Part1 Any clinically relevant abnormabilites and/or uncontrolled diseases Abnormal laboratory values Recent respiratory tract infection Hypersensitivity to the drug excipients Positive serology results Positive cotinine, alcohol, drug of abuse tests Part 2 Pregnant and/or breast-feeding women Subjects with a medical history or current diagnosis of COPD or any other pulmonary disease other than asthma Subjects who have cardiovascular condition
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, COPD Tobacco Use At least 10 pack year smoking history Daily use of at least 5 cigarettes No plan to quit cigarettes in the next 30 days Willing to use e-cigarettes Diagnosis of COPD (FEV1/forced vital capacity [FVC] <0.70) with mild (FEV1 >80% predicted) or moderate (FEV1 <80% but >50% predicted) airflow limitation (post-bronchodilator); confirmed by spirometry English-speaking Past 30-day use of nicotine-containing products (cigars, cigarillos, hookah, electronic cigarettes, smokeless tobacco, nicotine replacement therapy) Past 30 day use of inhaled drugs (marijuana, crack) Pregnant or breastfeeding Planning to become pregnant within the next 3 months or unable to agree to use appropriate contraception during study Pulmonary disease other than COPD or asthma Ever requiring mechanical ventilation or more hospitalizations for COPD in the past 12 months Cardiac hospitalization in the past 6 months Active chest pain or palpitations Uncontrolled hypertension (blood pressure >160/100)
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Small Cell Lung Cancer Subject has provided informed consent prior to initiation of any study-specific activities/procedures Age ≥ 18 years old at the time of signing the informed consent Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 At least 2 measurable lesions as defined per modified 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment. Subjects with 1 measurable lesion may be considered upon agreement with Sponsor Subjects with treated brain metastases are eligible provided they meet the following Definitive therapy was completed at least 2 weeks prior to enrollment No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days Adequate organ function History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for ≥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma History of organ transplant Major surgery within 28 days of enrollment Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment Untreated or symptomatic brain metastases and leptomeningeal disease Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor Known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine) Evidence of a bleeding diathesis Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. ≥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, Chronic Stroke more than 3 months post-stroke ischemic or hemorrhagic stroke a person who understands the experiment and has a willingness to participate and signs the agreement User of artificial heartbeat Patients with claustrophobia Patients with metal implants Patients who are contraindicated for other common MRI
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-100.0, Pulmonary Disease, Chronic Obstructive COPD diagnosis aged 40 years or older (to minimise the likelihood of including individuals who have asthma only) New user of olodaterol or a new user of indacaterol, salmeterol, or formoterol (not in fixed-dose combination with an inhaled corticosteroid) and have no dispensing of any LABA in the 6 months before the index date at least 1 year of enrolment in the electronic database before their first LABA dispensing (defined as the index LABA) Complete data on sex none
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-75.0, Hypertension Between 18 and 75 years old with HTN (ICD-10 code I10) Has had at least two office visits at Penn Family Care (PFC) within the past 12 months (at time of chart review), with at least two of the visits with BP readings exceeding HTN guidelines, including the last visit (150/90 or 140/90 if ages 21-59 yrs with CKD or diabetes) Must have a cellular phone with texting capabilities Must be prescribed at least one medication for hypertension Has metastatic (Stage IV) blood or solid tumor cancer Has end stage renal disease Has congestive heart failure Has dementia Has liver cirrhosis
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, COPD Exacerbation COPD patient who have FEV1/FVC < 70% by spirometry and those who have not been admitted for acute exacerbation in recent 3 monthes Those who does not consent or those who have drug addiction, psychosocially or medically not feasble to this study
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-65.0, Chronic Obstructive Pulmonary Disease (COPD) Written informed consent must be obtained before any assessment is performed 2. Male or female adults aged 18-65 years 3. Diagnosed with COPD according to GOLD 2016 (The ratio of post-bronchodilator forced expiratory volume in 1 second (FEV1) to force vital capacity (FVC)<0.70 with the use of salbutamol 400ug) 4. Moderate to very severe airflow limitation (post-bronchodilator FEV1 < 80% of the predicted normal value) 5. A documented history of at least 2 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticoids and/or antibiotics, or at least 1 exacerbation in the previous 12 months that requires hospitalization. 6. In the stable stage of COPD Patients who have clinically significant and chronic hepatic, renal, cardiovascular and gastrointestinal abnormalities or malignant tumor (except for lung cancer) which could interfere with the assessment of the efficacy and safety of the study treatment 2. Patients who are in critical conditions 3. Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids or an acute exacerbation of any other diseases in the 4 weeks prior to screening 4. Patients with concomitant pulmonary disease (including but not limited to bronchiectasis, interstitial lung disease, asthma) 5. Patients who are highly likely to be lost during the 3-month treatment and the 1-year follow up 6. Pregnant or nursing (lactating) women 7. Patients who have been vaccinated against influenza in the current year, or against Streptococcus pneumoniae within five years, or have vaccination contraindications 8. Patients who are allergic to amikacin or other aminoglycosides 9. Patients who have participated in any interventional clinical trials in the three months prior to screening 10. Patients with mental diseases or cognitive disorders which could interfere with treatment and follow-up
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Clinical diagnosis of Chronic obstructive pulmonary disease aged >= 40 years spirometry can not be completed because of various reasons asthma pulmonary embolism lung cancer sequelae of tuberculosis extensive bronchiectasis interstitial lung disease left cardiac insufficiency
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-90.0, COPD Patients diagnosed with any severity of COPD (according to British Thoracic Society i.e. >10 pack year smoking history and post bronchodilator spirometry FEV1/FVC ratio <0.70 and FEV<80%) Previously enrolled on pulmonary rehabilitation providing at least one sample for the trial Any unstable ongoing cardiovascular events Other active inflammatory conditions (e.g. rheumatoid arthritis, cancer) Known asthma, allergic rhinitis or other respiratory disease (bronchiectasis, pulmonary fibrosis)
|
1
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.