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A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 0.25-16.0, Dengue Disease Progression Age >3 months and <16 years Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) Not a prisoner or ward of the state Parents able and willing to give consent. Children older then 7 able and willing to give assent Allergic to Ultrasound gel Prisoners or wards of the state Unstable patients Known pleural effusion, ascites, or gallbladder wall thickening | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 5.0-18.0, Suppurative Appendicitis Pediatric patients aged 5-18 Diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800 Intraoperative findings of suppurative appendicitis Pregnancy Complex medical history not appropriate for same day discharge | 1 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-999.0, Appendicitis patients in emergency department with right lower quadrant pain patients under 18 years old pregnant women | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 8.0-17.0, Appendicitis English and non-English speaking patients Age : 8-17 years US or CT confirmed early appendicitis with US showing hyperemia, ≤ 1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon or CT showing hyperemia, fat stranding, ≤ 1.1 cm in diameter, no abscess, no fecalith, no phlegmon White Blood Cell count > 5,000/µL and ≤ 18,000/µL Abdominal pain ≤ 48hours prior to receiving antibiotics History of chronic intermittent abdominal pain Pain > 48 hours prior to first antibiotic dose Diffuse peritonitis Positive urine pregnancy test White Blood Cell ≤ 5,000/µL or ≥ 18,000/µL Presence of a fecalith on imaging Evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon Communication difficulties (e.g. severe developmental delay) | 1 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-80.0, Cholelithiasis age higher than 18 and lower than 80 American Society of Anesthesiologists class (ASA) I-II absence of any previous anesthetic complication accompaniment by a responsible adult during 24 hours symptomatic gallstones candidate to cholecystectomy and a signed informed consent a Body Mass Index (BMI) higher than 35 any laparoscopic contraindication acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy anti-inflammatory allergy psychiatric history that could hinder ambulatory procedure | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-80.0, Cancer Pancreas Patients of locally advanced pancreatic cancer with Major venous infiltration / thrombosis of the portal vein or superior mesenteric vein extending for several centimeters Tumor encasement (≥180°) of the superior mesentric artery or proximal hepatic artery Tumor abutment (<180°) of the celiac trunk Tumor invasion of the aorta Presence of metastasis to lymph nodes beyond the field of resection Histopathologically proven ductal adenocarcinoma of the pancreas (biopsy /cytology) Eastern Cooperative Oncology Group (ECOG) performance scale 0 and 1 Age: 18 to 80 years At least one of the diameters of the primary tumor or regional lymph node or both should be greater than 4 cm, as confirmed on contrast-enhanced computed tomography (CECT) Histopathology other than ductal adenocarcinoma pancreas Prior radiotherapy to the site of treatment Patients with unequivocal distant metastasis including liver Patients with gross peritoneal carcinomatosis on laparoscopy No prior or concurrent malignancies other than surgically treated squamous cell or basal cell carcinoma of the skin No serious medical illness which would prevent informed consent or limit survival to less than 2 years Active uncontrolled bacterial, viral or fungal infections until these conditions are corrected or controlled Psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements Patients having metal implants, pacemakers or clustered markers Metallic endobiliary stenting would be a contraindication, hence plastic stents may be used if biliary drainage is indicated | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 5.0-999.0, Acute Uncomplicated Appendicitis Adult or child ages ≥5 years Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and Negative pregnancy test for subjects who are women of childbearing potential instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol | 2 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-999.0, Gallstones Patients referred to the radiology department for an abdominal ultrasound Age > 18 years Inability to communicate with the examiner Referral for intervention Metastasis screening Referrals concerning contrast enhanced examinations | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 0.0-18.0, Appendicitis Potential subjects must be 0-18 years of age, presenting to the pediatric emergency department for evaluation of right lower abdominal pain and suspected appendicitis The clinical diagnostic plan before subject enrollment must abdominal ultrasound and/or abdominal CT Because ultrasound does not involve the use of ionizing radiation or contrast agents, it is not contraindicated in any patients, although image quality may be nondiagnostic in obese patients. The focus of this study is on acquisition of research 3D POC US images to determine feasibility of use in pediatric patients with suspected appendicitis Patients with BMI >30 or mass >70kg, as these patients are anticipated to have nondiagnostic ultrasound images Ultrasound also requires a gel material be applied to the skin surface as an acoustic transmission medium. Allergy to such gel will be an criterion | 2 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 1.0-12.0, Periodic Fever Aphthous Stomatitis Pharyngitis Cervical Adenitis diagnosis or confirmation of diagnosis of PFAPA from Dr. Bennett based on clinical or laboratory data is or will be undergoing treatment for PFAPA at CCMC agrees to the consent and, if necessary, assent forms is between 1 and 12 years of age is currently taking another probiotic regularly (>=2 times/ week) is allergic to ingredients in the probiotic or placebo may react adversely to the probiotic due to any form of immune deficiency or chronic disease including pulmonary, renal, cardiac disorders including underlying structural heart disease, gastrointestinal disease, or diabetes is not a proficient English speaker does not agree to the consent and/or assent forms patients who use antibiotics or have used them within a month of the study start | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 15.0-999.0, Wound Infection Complication Scar patients with a clinical diagnosis of acute appendicitis children under 14 are not included | 2 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 7.0-18.0, Appendicitis Children and adolescents aged 7-18 years old ASA Score I (American Society of Anesthesiologists classification) [Appendix 1]: a normal healthy patient ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease Patients scheduled for laparoscopic appendectomy surgery Uncomplicated appendicitis Hemodynamically stable patient No evidence of appendiceal perforation based on preoperative clinical and imaging assessment Diagnosed to have simple acute appendicitis by intraoperative laparoscopy Patients who have provided a written informed assent Caregivers who have provided a written informed consent ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation Hemodynamically unstable patient Evidence of appendiceal perforation on based on preoperative clinical and imaging assessment Perforated or gangrenous appendicitis diagnosed during laparoscopic surgery Postoperative admission in an intensive care unit with sedation or ventilatory assistance Cognitive impairment or mental retardation Progressive degenerative diseases of the CNS Seizures or chronic therapy with antiepileptic drugs | 1 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 5.0-19.0, Appendicitis children and adolescents ages 5-19 years with abdominal pain internal med, family med, or emergency med trained providers at participating EDs select comorbid conditions previous abdominal surgery treated for select comorbid conditions | 2 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Chronic Obstructive Lung Disease Age greater than or equal to 40 years Cigarette smoking greater than or equal to 30 pack years Obstructive Spirometry First degree relative with smoking history willing to participate | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Methicillin Resistant Staphylococcus Aureus (MRSA) Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding) Subjects with severe neutropenia (<500 cells/mm3) Subjects with hypersensitivity to oxazolidinones or vancomycin | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease, COPD Main Written informed consent Patients with a history of chronic obstructive pulmonary disease for at least 12 months as defined by the GOLD (Global Initiative on Obstructive Lung Diseases) (2003) Age ≥ 40 years FEV1/FVC ratio (post-bronchodilator) ≤ 70% FEV1 (post-bronchodilator) ≤ 65% of predicted FRC (post-bronchodilator) ≤ 120% of predicted Clinically stable COPD within 4 weeks prior to baseline visit (B0) Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit (B0) or a willingness to have a chest x-ray performed at visit (B0) Main COPD exacerbation indicated by a treatment with systemic glucocorticosteroids not stopped at least 4 weeks prior to the baseline visit (B0) Non smoker, current smoker or ex-smoker (smoking cessation at least one year ago) with a smoking history of < 10 pack years Suffering from any concomitant disease that might interfere with study procedures or evaluation Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit (B0) Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis) Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 2 months preceding the baseline visit (B0) Known alpha-1-antitrypsin deficiency Need for long term oxygen therapy defined as ≥ 15 hours/day Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator) Known infection with HIV, active hepatitis and/or liver insufficiency | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 0.167-1.0, Bronchiolitis Any child 2-12 months old seen in the emergency department A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS) Diagnostic of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions No child will be excluded based on race or gender Patients under the age of 2 months or greater than 12 months Patients with cyanotic heart disease Patients with lobar pneumonia, defined by results of chest radiographs The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not patients Patients with croup Patients with foreign body aspiration Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease Patients with liver or renal disease Patients with sickle cell anemia | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 45.0-999.0, Chronic Obstructive Pulmonary Disease Acute exacerbation of COPD type I or II according to GOLD Ability to perform lung function tests Ability to take oral medication Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation Progression or new radiographic abnormalities on the chest X-ray Severe exacerbation that required mechanical ventilation History of bronchiectasis Recent or unresolved lung malignancy Other disease likely to require antibiotic therapy Significant gastrointestinal or other conditions that may affect study drug absorption Class III or IV congestive heart failure or stroke | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Asthma Chronic Obstructive Pulmonary Disease Physician-diagnosis of asthma, COPD exacerbation, or undifferentiated asthma/COPD exacerbation Admitted to the inpatient medical service at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center Evidence of airflow obstruction on spirometry (FEV1/FVC<70%) Age 18 years or older History of allergy or other contraindication to macrolides (azithromycin, erythromycin, clarithromycin) Treatment with any macrolide in the 4 weeks prior to study entry Elevated AST or ALT (2 or more times the upper limit of normal) on current admission Elevated alkaline phosphatase (>1.25 times the upper limit of normal) on current admission Elevated total serum bilirubin (more than upper limit of normal) on current admission Previous participation in this study Patients prescribed digoxin (azithromycin may increase digoxin levels) Patients prescribed warfarin (azithromycin may increase INR in patients on warfarin) Patients prescribed pimozide (azithromycin may increase risk of arrhythmias) Patient unable to provide consent (e.g., language difficulty or history of dementia) | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Asthma Chronic Obstructive Pulmonary Disease (COPD) Undifferentiated Asthma/COPD Age 18 years and older Admission to the inpatient medical service Physician-diagnosed asthma or asthma/COPD or COPD exacerbation Evidence of airflow obstruction on spirometry More than 24 hours since admission to the inpatient medical service Admission to an intensive care unit Hospital discharge planned within the next 24 hours Other chronic respiratory disease (e.g., sarcoidosis, idiopathic pulmonary fibrosis) Chest wall abnormalities (e.g., severe kyphoscoliosis) that precludes using the vest Chest wall or abdominal trauma/surgery in the past 6 weeks that precludes using the vest Physician declines to provide consent Patient unable (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent Previous participant in this study Corticosteroid therapy (prednisone >0 mg/d equivalent) for >1 week prior to admission | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-70.0, Chronic Obstructive Lung Disease (COLD) Patients included are those with documented or suspected COLD, exclusive of other bronchial or lung disease, and admitted for acute exacerbation, in the absence of overt sepsis or broncho-pneumonia, and having no other organ Patients recently hospitalised, having received antibiotics since more than 24h, or on long-term steroids will not be included | 2 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, COPD clinical COPD smoking age > 40 years age < 40 years use of antibiotics, corticosteroids or beta-agonists | 2 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-80.0, COPD Acute Exacerbation COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded | 2 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Smoker or ex smoker of at least 10 pack years Age 40 or above Prior and current use of inhaled corticosteroids for at least 6 months duration (Used for at least 75% of time on direct questioning) FEV1 <80% of predicted, FEV1/FVC ratio <70% Less than 15% change and <200 mls change in FEV1 20 minutes after 5 mg nebulised salbutamol patients to be included in trial of which 196 must have had a precious exacerbation of COPD in the last year Clear history of asthma, bronchiectasis, carcinoma of bronchus or other significant respiratory disease Inability to give informed consent (severe mental illness, mental handicap or brain damage) Recorded exacerbation within last month that has required antibiotics or steroids (delayed randomisation) Classification as a never smoker Strongly positive skin allergy result (>10mm skin weal greater then negative control) to house dust mite, grass, tree, aspergillus, cat, dog or weed (irrespective of asthma/atopy status) | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 6.0-12.0, Attention Deficit Disorder With Hyperactivity Tourette Syndrome Diagnosis of ADHD or ADHD plus Tourette syndrome Determined to be dangerous to self or others Scores less than 70 on an IQ test Any seizure disorder, major organic brain dysfunction, major medical illness, major mood disorder, psychosis, pervasive developmental disorder, or peripheral sensory loss Any condition that may make use of methylphenidate unsafe | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 0.167-4.917, Severe Pneumonia Age: 2 to 59 months Sex: Both boys and girls Severe pneumonia according to WHO (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate ≥ 50 breaths per minute for children aged 2-11 months and ≥ 40 breaths per minute for children aged 12-59 months) Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) Written informed consent by respective parents/guardians Very severe and non-severe pneumonia Nosocomial pneumonia History of taking antibiotics for pneumonia within 48 hour prior to enrollment Chronic illnesses like tuberculosis, cystic fibrosis Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease Immunodeficiency Trauma/burn Bronchiolitis Bronchial asthma Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site) | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 45.0-70.0, Quality of Life Exercise Moderate COPD (GOLD classification) , AGE 45-70, both sexes Treated with inhaled steroids and long acting beta agonists Active ischemic heart disease, heart failure, orthopedic problems that preclude ergometric bicycle activity | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-80.0, Asthma COPD Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects between 18 years Any severity of exacerbation of obstructive airway disease attending the outpatient clinic History of at least two exacerbations in the past 12 months prior to recruitment that required a course of prednisone or antibiotic or long acting bronchodilator or inhaled corticosteroid, in addition to the daily maintenance therapy Signed written informed consent to participate in the protocol and ability to return to the outpatient clinic for repeated clinic visits If the exacerbation is severe enough to warrant hospitalization Active malignancy Significant gastrointestinal, hematological, cardiovascular or cerebrovascular disorder that would affect compliance with follow up visits Recent (within the past 2 months) or planned (within the study period) lung surgery Psychosis, alcoholism, active substance abuse or any personality disorder that would make compliance with the follow up visits problematic Pregnant or nursing females, as this could affect the compliance during the trial Any other medical or social condition, which in the opinion of the investigator could confound the interpretation of the data derived from this study | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Asthma Pulmonary Disease, Chronic Obstructive No change from the MIA and LEUKO trials No change from the MIA and LEUKO trials | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-80.0, COPD Patients admitted with COPD exacerbation | 2 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 35.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. age >35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following Current smoking Suffering from COPD according to the GP's diagnosis In command of the Dutch language Too ill Under control of a chest physician Serious physical or psychological comorbidity | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Phase 1 & Gene Expression: --Current hospitalization for COPD exacerbation Phase 1 & 2: COPD & ONE of the following History of hospitalization for COPD exacerbation, OR Currently on supplemental oxygen, OR History of evaluation for lung transplant or LVRS, OR >/= 6 months post-LVRS Phase 1 or 2 Current or former smoker, >/= 20 pack-yr. smoking history FEV1 </= 70%; FEV1/FVC </= 70% Life expectancy of > 6 months < 20 pack-yr. smoking history Diagnosis of pulmonary fibrosis, bronchiectasis, mediastinal mass, or presence of a pulmonary mass Asthma FEV1 > 70% or FEV1/FVC >70% | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Current or former smokers with a diagnosis of COPD Having impaired lung function as measured by spirometry History of asthma or nasal symptoms caused by hayfever No telephone Inability to record symptoms in an electronic diary (PDA) | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease Sepsis Antibiotics All patients having a COPD (according to the definition of the American Thoracic Society) and having an acute exacerbation leading to an acute respiratory failure requiring the admission to ICU and mechanical ventilation The acute exacerbation of COPD is defined by increase in the frequency of cough, the volume and the purulence of expectoration and increase of baseline dyspnea. To be included, patients must have respiratory rate >30 cycles/min and one of the following blood gas (with blood gases performed right before the initiation of mechanical ventilation): PaC02 > 6kPa and arterial pH <7.30 Pneumonia documented with chest radiography Antibiotic treatment in the ten previous days of ICU admission Former in the study History of allergy to the quinolones and/or to trimethoprim sulfamethoxazole Pregnancy or breast feeding Severe chronic disease: heart, liver, kidney Known immunodeficiency (malignant hemopathy, AIDS...) Digestive disease which could affect the absorption of the drugs Concomitant infection which requires systemic antibiotic treatment | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-75.0, Chronic Obstructive Pulmonary Disease Age 18-75 years Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 5 groups described above Able to stop smoking for 10 days and start smoking 3-4 cigarettes within 1 hour Physically and mentally able to undergo the total study protocol Written informed consent Participation in another study Alpha-1-antitrypsin deficiency Selected grade 1-3 co-morbidity listed in the ACE-27 Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, metotrexate, azathioprine,Acenocoumarol | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-50.0, Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Asthma Specific allergy to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .75 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma History of nasal allergy, including episodic, perennial, or seasonal sneezing, nasal congestion or cough, or such symptoms associated with specific exposures (such as cat or dog) for classification as having asthma with allergic rhinitis vs. allergic rhinitis alone History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma Provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used (see below) Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable Use of daily theophylline within the past month Pregnancy or nursing a baby Cigarette smoking > 1 pack per month Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to prophylactic use of albuterol prior to exercise) | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, COPD FEV1/FVC < 70% FEV1 % predicted > 60% Other major disease Asthma Currently taking inhaled corticosteroids oral corticosteroids in the last 3 month significant cardiovascular disease pregnancy/breast feeding current use of salmeterol or other long acting bronchodilator | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-90.0, Chronic Obstructive Pulmonary Disease COPD patients All COPD patients who seek medical assistance at the clinic during the study period will be asked about COPD exacerbation related symptoms-medical history and then they will be included in the study if they satisfied all the following COPD diagnosis according to the GOLD Consensus Statement initiation of symptoms diagnostic for COPD exacerbation in the past 72 hours abstention from any new therapeutic intervention absence of any signs suggestive of severe exacerbation requiring hospitalization Control subjects Subjects who seek medical assistance at respiratory clinic for symptoms suggesting acute bronchitis (dyspnea, sputum production, purulence, wheeze, cough) medical history free of COPD, Asthma, pneumonia, other chronic respiratory disease or congestive cardiac failure initiation of symptoms in the past 72 hours Patients with Asthma or other respiratory disease will be excluded from this study | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 45.0-75.0, COPD stable stage II and III (GOLD) COPD, diagnosed 2 years ago and up Heart failure Malignancy Immune suppressed | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Smoking Smoking Cessation Chronic Bronchitis Emphysema Group A Healthy nonsmokers Enrolled in the "Normal" protocol #0005004439 "Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy" Healthy according to the "Normal" protocol #0005004439 Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies Male and Female subject ≥18 years of age smoked < 100 cigarettes per lifetime and whose urine nicotine <2 ng/mL and urine cotinine <5 ng/mL, at entry into the study Group B Healthy current smokers Enrolled in the "Normal" protocol #0005004439 Groups A Unable to provide proper informed consent Drug and/or alcohol abuse within the past six months Individuals with asthma and with recurrent or recent (within three months) and/or acute pulmonary infection Allergy to lidocaine Significant kidney disease or subjects on dialysis Females who are pregnant or lactating or intending to become pregnant in the next 12 months Major depression or other significant psychiatric disorder HIV+ Subjects that have unstable coronary artery disease as evidenced by unstable angina, >Class II NYHA cardiac status, history of congestive heart failure or MI within the last 12 months | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Cardiovascular Disease Smoking Bronchodilation COPD Gold stage II-III (FEV1/FVC<0,70 and FEV1 30-80% of predicted value) Current cigarette smoking (at the time of performing the study) Willing to provide written informed consent Refrain from smoking and bronchodilators > 8 hours (depends on treatment) before the test Registered in one of the recruitment institutes COPD gold stage I or IV Asthmatic component: History of asthma, present asthma by complaints, eosinophilia or reversibility ≥ 10% of predicted Unable to communicate Physically unable to perform any of the tests Non-COPD respiratory disorders Previous lung-volume reduction surgery and/or lung transplantation Evidence of alcohol, drug or solvent abuse Known α-1 antitrypsin deficiency | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, COPD Diagnosis of COPD according to GOLD (FEV1/FVC<70%), classification into GOLD I (FEV1 70-100% predicted), GOLD II (FEV1 50-70% predicted), GOLD III (FEV1 30 predicted) or GOLD IV (FEV1 ≤ 30% predicted) Age ≥ 18 years Three or more exacerbations of COPD in one year for which a course of prednisone and/or antibiotic therapy was started Clinically stable during 1 month. Patients have to be free of COPD exacerbation or respiratory tract infection within a month prior to involvement in the study and they should not have received a high dose of systemic glucocorticoids or antibiotics in this period Informed consent Use of antibiotics or high dose of systemic steroids within a month prior to involvement in the study Addition of inhalation steroids to the patient's therapy regimen, shortly before entering the study Pregnant or lactating women Allergy to macrolides Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal) Asthma, defined as episodic symptoms of airflow obstruction which is reversible with bronchodilators, assessed with lung function testing Presence of a malignancy which is clinically active Bronchiectasis Malignancy of any kind for which the subject is under treatment or is being monitored as part of follow up after treatment Heart failure | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-90.0, Chronic Obstructive Pulmonary Disease COPD diagnosis according to GOLD guidelines Hospitalization for any acute exacerbation of chronic obstructive pulmonary disease Failure of outpatient treatment Increasing of dyspnea in the last days Comorbidity that causes detriment of respiratory function Life expectancy of less than 6 months Mechanical Ventilation Cardiovascular condition that causes exacerbation Immunosuppression Pulmonary infiltrates that suggest pneumonia Antibiotic treatment in the last month Pregnancy ECG with a large QT segment Hypokalemia Hepatic failure or renal failure | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 50.0-80.0, Chronic Obstructive Pulmonary Disease Sixty stable moderate COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2) requiring regular treatment with long-acting bronchodilators, according to international guidelines GOLD stage 2 COPD patients will be enrolled providing they were steroid-free for the last 4 months Atopy Asthma Concomitant lung diseases (e.g. lung cancer) Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, COPD Exacerbation Bronchitis Sputum C-Reactive Protein Age 40 or over. No upper age limit will be employed Written informed consent obtained according to the GOLD guideline. An exacerbation of COPD is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD for hospital admission according to the GOLD: marked increase in symptoms (i.e. resting dyspnoea), severe underlying COPD, onset of new physical signs (cyanosis, edema), failure to respond to initial medical management, significant co morbidities, frequent exacerbations, newly occurring arrhythmias, diagnostic uncertainty Former of current smoker with a minimum smoking history of 10 pack years Patients have to be capable of ingesting oral medication Patients have to be mentally capable of participating in the study (able to complete questionnaires and perform lung function tests) Life expectancy ≥ 30 days Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception Pretreatment with corticosteroids (cumulative dose >210 mg) for the present exacerbation Progression or new radiographic abnormalities on the chest X-ray or CT scan compatible with pneumonia bronchiectasis (HRCT confirmed) Cystic fibrosis Tuberculosis Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc., and the use of immunosuppressive drugs (>30 mg prednisolone/day maintenance dose or equivalent for more than 4 weeks) Recent or unresolved lung malignancy Other disease likely to require antibiotic therapy, such as recurrent sinusitis or urinary tract infection Significant gastrointestinal or other conditions that may affect study drug absorption | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, COPD Signed informed consent Age ≥ 40 years Patients fulfilling for COPD according to the Global initiative for chronic obstructive pulmonary disease (GOLD) stage I or higher Smokers or ex-smokers of at least 10 pack-years Patients suffering an either Admitted to hospital due to (severe exacerbation) or Confirmed at GP (general practitioner) setting (moderate exacerbation) Definition Increase in respiratory symptoms requiring treatment with oral corticosteroids, antibiotics or both Patients who have never smoked Patients with active long-term respiratory disease (e.g. bronchial asthma, cystic fibrosis, severe bronchiectasis, malignancy, restrictive lung diseases etc.) Exacerbation of COPD due to other causes such as pneumothorax and acute decompensated congestive heart failure Difficulties in communication (cognitive deterioration, sensorial disability, language barriers) Severe disease with poor vital prognosis (life length expectancy less than one year) | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Chronic Cough Male and female subjects, age 18 years and over History of cough for more than 8 weeks Normal chest x ray Chronic idiopathic cough or chronic cough resistant to treatment of specific triggers Smoking status Current smokers Ex smokers with history of smoking > 20 pack years or those who have given up < 6 months ago Prohibited medications Use of medications likely to suppress / affect cough including codeine, morphine, pregabalin, gabapentin, amitriptylline, angiotensin converting enzyme inhibitors (type 1) and baclofen Use of any anti-arrhythmic medication Use of cimetidine, beta blockers, or diuretics Cardiovascular conditions Sinoatrial disease, bradycardia or all types of heart blocks History of ischaemic heart disease or heart failure | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Type of subject: Outpatients Informed consent: Subjects must give their signed and dated written informed consent to participate Gender: Male or Female Age: 40 years of age or older at Visit 1 COPD diagnosis: Documented diagnosis of COPD at least 6 months prior to Visit 1 in accordance with the following definition by the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guideline: Post bronchodilator FEV1/FVC < 0.7 History of exacerbations: At least one COPD exacerbation which required the use of any additional treatment in the last 12 months prior to Visit 1 For subjects who were diagnosed between 6 to 12 months prior to Visit 1, they should have at least one COPD exacerbation that required the use of any additional treatment since diagnosis Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis Non-compliance: Subjects unable to comply with any aspect of this study protocol or scheduled visits to the study centre | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 12.0-65.0, Asthma Male or female patients, age 12 through 65 years at the time of screening Written informed consent obtained from the patient prior to beginning study procedures Documented clinical history of chronic persistent asthma requiring controller therapy Able to complete the study period, including follow-up period, of up to approximately 2 years; and Willing to forego other forms of experimental treatment and study procedures during the study and for 30 days after the follow-up period is completed History of any disease, evidence of any current disease (other than asthma), any finding upon physical examination, or any laboratory abnormality, that, in the opinion of the investigator, may compromise the safety of the patient in the study or confound the analysis of the study Lung disease other than asthma (e.g., chronic obstructive pulmonary disease, cystic fibrosis) Any disease or illness, other than asthma, that is likely to require the use of systemic corticosteroids during the study period Current acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (100.5°F) within 4 weeks of enrollment Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives prior to screening, except omalizumab for asthma Pregnancy at enrollment Breastfeeding or lactating females Elective major surgery planned from screening through study completion History of cancer other than basal cell carcinoma of the skin or cervical carcinoma-in-situ treated with apparent success with curative therapy more than 1 year prior to enrollment History of primary immunodeficiency | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-75.0, Chronic Obstructive Airway Disease Asthma Chronic Cough General Adult subjects aged 18 years and over Meet for subject groups as outlined below (1) Healthy volunteers Non-smokers No history of respiratory disease (2) Healthy smokers Current smokers with smoking history of ≥10 pack years Spirometry within normal limits i.e. FEV1>80% predicted and FEV1/FVC ratio >75% predicted (3) Asthma Symptoms of upper respiratory tract infection within the last 6 weeks 2) Participation in another clinical trial of an investigational drug within the last 4 weeks 3) Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate, 4) Patients with severe respiratory disease i.e. FEV1 < 1 litre, 5) Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease age 40-80 years old cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment non-smoking controls: no COPD (spirometry based) + < 1 pack year Respiratory disorder other than COPD α1-antitrypsin deficiency Known history of significant inflammatory disease other than COPD COPD exacerbation within 4 weeks prior to study Lung surgery Recent diagnosis of cancer Therapy with oral corticosteroids in the last 6 weeks Significant cardiovascular comorbidity Significant orthopedic/musculoskeletal problems | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Diagnosis of COPD in any field in the pre-index period and 60 days after the index date Diagnosis of depression/anxiety in any field and a medication for treating depression/anxiety in the pre-index period and 60 days after the index date Index date occurs during identification period Patients must be continuously eligible during 1-year pre and 1-year post-index date and be of at least 40 years of age comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis) during the 1 year pre or post-index periods No other maintenance medications other than the index medication on or 60 days after the index date | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 60.0-999.0, Lung Cancer Tobacco Use Disorder Patients over 60 seeing a participating General Practitioner Currently smokes 10 or more pack years, meeting at least one of the following New or altered cough of any duration reported to primary care Increased breathlessness or wheezing (with or without purulent sputum) Do not qualify for an urgent referral for a chest x-ray under the National Institute for Health and Clinical Excellence (NICE) guidelines (i.e., hemoptysis or unexplained or persistent [lasting > 3 weeks] signs or symptoms), including having any of the following Cough Chest/shoulder pain Dyspnea Weight loss Chest signs | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-65.0, Chronic Obstructive Pulmonary Disease no previously vaccination with PPSV23 a clinical diagnosis of severe COPD which is defined according to the GOLD 2006 guideline (11): FEV1/FVC < 70%, FEV1 reversibility test < 200 ml, and FEV1 < 50% of predicted current or past exposure of smoking no exacerbation in the month prior to enrollment age < 65 years using high daily dose of ICS (budesonide > 800-1600 mcg/day or fluticasone > 500-1000 mcg/day) providing written informed consent Patients are excluded from the study if they are pregnant, or have immunosuppressed status (known current neoplasm, renal insufficiency in dialysis, human immunodeficiency virus (HIV) infection, severe hepatic impairment, hypogammaglobulinemia, anatomical or functional asplenia) Asthma, cystic fibrosis, bronchiectasis, and severe sequelae of pulmonary tuberculosis are also excluded by pulmonary function study and chest imaging before patient's enrollment | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive minimum age 40 years at index continuously enrolled in health plan diagnosis of COPD (ICD-9 codes of 491, 492, 496) at least one moderate exacerbation event as defined previously Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, or sarcoidosis Patients excluded if they did not receive treatment within the treatment assessment period following moderate exacerbation Receipt of maintenance medication in the pre-period Presence of treatment switch, discontinuation of index drug, or any COPD-related exacerbation during the treatment assessment period | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 0.083-16.0, Community-Acquired Infections Respiratory Tract Infections Sepsis Urinary Tract Infections Meningitis Gastroenteritis Children aged 1 month to 16 years Acute illness episode of maximum 5 days recent trauma neurological conditions intoxication psychiatric of behavioural disorders without a somatic cause acute exacerbation of a chronic condition (asthma, known immunodeficiency, diabetes, cystic fibrosis, etc) | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive at least 40 years of age continuously enrolled for medical and pharmacy benefits during their pre and post-period diagnosis of COPD (ICD 491.xx, 492.xx, 496.xx) Patients were excluded if they had MTx in the pre-index period (to ensure of MTx-naïve patients) or if they received their first MTx during 181 to 365 days of the post-period (as dispensing of MTx unlikely to be related to the index exacerbation) Additionally, patients were excluded if they had any of the following comorbid conditions anytime during the study period: respiratory cancer, cystic fibrosis, fibrosis due to, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, or sarcoidosis, and also if they had other doses (unapproved in the US) of fluticasone propionate-salmeterol xinafoate combination (100/50 mcg or 500/50 mcg) or budesonide dipropionate-formoterol fumarate fixed dose combination (any dose) | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Inflammatory Disease Endothelial Dysfunction presence of COPD according to standard acute exacerbation of COPD according to recommended international over 40 years of age history of at least 10 py pneumonia history or signs of congestive heart failure acute myocardial infarction thoracotomy incl. resection of lungtissue interstitial lung disease acute or chronic renal failure active malignancy autoimmune disease | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 4.0-21.0, Sickle Cell Anemia Acute Chest Syndrome Hemoglobin SS, SC, SB0thal or SBthal Ages ≥ 4-21 years old Patients are admitted to the hematology oncology inpatient service and have been enrolled and consented in the study Meet clinical for ACS an infiltrate on Chest X-ray and one of the following Respiratory symptoms/signs (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline, tachypnea, cough, and increased work of breathing) Fever Chest pain AND Patients' eligible for a simple transfusion based on one of the following Hypoxemia (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline) Hemoglobin < 5 gm/dl Increased work of breathing Patient requires exchange transfusion within first 24 hours of admission Patient requires PCCU transfer within first 24 hours of admission Hemoglobin > 9gm/dl secondary to these patients requiring an exchange transfusion | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 19.0-92.0, COPD Men of ages 18 and 30 (Dates of birth 1973-1985) or 55-92 years old (Dates of birth 1911-1948) Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at least 10 years and consumption were no more than 10 pack years Agrees to volunteers for the study and willing to sign the informed consent form There were negative/normal screening tests for the following Responses to the questionnaire deny current and prior respiratory diseases (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any cardiac medications or admit to a physician-diagnosed cardiac condition "Normal" spirometry measurements with FEV1 & FVC greater than 75% predicted and FEV1/FVC more than 69% Impedance oscillometry were within normal limits "Negative" physical examination of the chest with absence of wheezing and crackles on auscultation of the chest Exhaled nitric oxide concentration is less than 35 ppb for younger and less than 65 ppb for older groups men of: ages < 18, 31-54 and >92 years old current cigarette smokers or exsmokers who have smoked within the past 10 years and/or smoked more than 10 pack/years refusal to volunteer for the study and not willing to sign the informed consent form screening test not considered "normal" by physician/PI and showing one or more of the following one or more positive response to the questionnaire(e.g., current or past respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung disease; and/or; current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or; admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac condition (e.g., coronary heart disease, angina, myocardial infarction, valvular heart disease, cardiomyopathy, etc.) Abnormal spirometry measurements (FEV1 &/or FVC <75% predicted and FEV1/FVC <69%) "Positive" physical examination (performed by Physician/PI) with presence of wheezing and/or crackles on auscultation of the chest Impulse oscillometry >4 times normal limits Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. - | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 8.0-999.0, Cystic Fibrosis Diagnosis of cystic fibrosis 8 years of age or greater Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds Pulmonary exacerbation as defined by Fuchs et al Admission for greater than 48 hours prior to enrollment Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months Current treatment for allergic bronchopulmonary aspergillosis Pregnant or breast feeding History of solid organ transplantation Renal impairment at time of randomization (< 40 mL/min as calculated by the Cockcroft-Gault equation24 ¬for adults or the Schwartz equation45 for those < 18 years of age) or receipt of hemodialysis Allergy to study medication | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-85.0, Chronic Obstructive Pulmonary Disease (COPD) Subjects who the investigator believes can and will comply with the requirements of the protocol Written informed consent obtained from the subject Male or female subjects between, and including, 40 and 85 years of age, at the time of consent Subjects with confirmed diagnosis of COPD (based on postbronchodilator spirometry). [GOLD, 2009] with FEV1 of >80% (mild COPD) or >50% but ≤80% (moderate COPD) of predicted normal and FEV1/FVC<0.7 Subjects have mild or moderate COPD, according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging [GOLD, 2009] Subjects have a current or prior history of ≥10 pack years of cigarette smoking. Former smokers are defined as those who have stopped smoking for at least 6 months. Number of pack years = (number of cigarettes per day/20) x number of years smoked Subjects with recent COPD exacerbations, in stable condition, and having stopped antibiotics, can be enrolled one month post exacerbation Subject also has a confirmed diagnosis of asthma (as only cause of obstructive respiratory disorder), cystic fibrosis, pneumonia risk factors (e.g., HIV, Lupus, Parkinson's, Myasthenia Gravis) or other respiratory disorders (e.g., tuberculosis, lung cancer) Subjects having undergone lung surgery Subject has a α1-antitrypsin deficiency as underlying cause of COPD Subject who experienced a moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids (subjects can be enrolled when their acute or pneumonia has resolved) Subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit Subject has other conditions that the principal investigator judges may interfere with the study findings, such as Subject at risk of noncompliance, or unable to comply with the study procedures Evidence of alcohol or drug abuse Others, as per clinical judgement Women who are pregnant or lactating or are planning on becoming pregnant during the study **If subject has any ONE of the above they cannot be enrolled into the study** | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 60.0-999.0, COPD Exacerbation Presence of purulent sputum documented by colorimetric assay (Allegra et al., Resp Med 2005), plus at least two of the following signs-symptoms Increased cough Increased dyspnea Increase in sputum volume appeared at least 3 days previous antibiotic treatment with any medication (eg, amoxicillin, amoxicillin / clavulanate, cephalosporins or macrolides) with the exception of quinolones, conducted for at least 3 days with persistence or worsening of symptoms and subsequent use of hospital ≥ 60 years FEV1 <80% and ≥ 30% and ratio FEV 1 / FVC <70% chest x-ray negative for inflammatory infiltrates informed consent asthma pulmonary neoplasms a history of allergy or hypersensitivity to quinolones impracticability in oral antibiotic and / or altered ability to absorption by the gastrointestinal system a history of epilepsy, seizures, cerebral vascular disease (stroke cerebri within 6 months) history of tendinopathy note or severe renal impairment creatinine> than twice the upper limit of the normal range or hepatic impairment (AST and / or ALT> twice the upper limit of the normal range) patients with sepsis, tuberculosis or other infections in other organs or systems cystic fibrosis patients with inherited tolerance to intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, or deficiency of the enzyme glucose-6-phosphate dehydrogenase | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, COPD i. Patients with a diagnosis of COPD, emphysema, or chronic bronchitis ii. Age ≥ 40 years-old iii. Smoking history ≥ 10 pack-years iv. Presentation to the emergency room with increased dyspnea, increased sputum, or increased cough v. Admission to the hospital i. Alternative diagnosis for cause of dyspnea, increased sputum or cough ii. Patients who requires intubation at time of recruitment iii. Patients who are unable to give consent iv. Patients who are pregnant or could be pregnant or are currently breast-feeding v. Women of child-bearing age who cannot use methods of contraception as described in the consent, including condoms, female condoms, cervical caps, diaphragms, and intra uterine devices vi. Patients who were previously entered into the trial and are re-admitted to the hospital with a new COPD exacerbation | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Diabetes Chronic Obstructive Pulmonary Disease Diabetic patients with COPD exacerbation Patients treated with steroids during the previous 3 months | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-80.0, Bronchiectasis Age ≥ 18 years HRCT-diagnosed Bronchiectasis Capable of providing written informed consent Patient judged to have poor compliance Cystic fibrosis bronchiectasis | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 17.0-999.0, Cystic Fibrosis Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels Chronic infection with Pseudomonas aeruginosa Patients able to produce daily sputum samples Current history of at least two pulmonary infective exacerbations in the past 12 months Able to give written informed consent Unable to provide written informed consent Patients unable to produce daily sputum samples Fewer than two infective pulmonary exacerbations in 12 months | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Adults, either sex, older or equal than 40 years of age For female patients, the following conditions are to be met has been postmenopausal for at least 1 year, or is surgically incapable of bearing children, or is of childbearing potential, and the following conditions are met has a negative pregnancy test (urine or serum-based) immediately before study entry (i.e., before the start of treatment or any other study procedure that could potentially harm the fetus), and one or more of following must agree to abstinence or use an accepted method of contraception. The subject must agree to continue with the same method throughout the study having only female sexual partners sexual relationship with sterile male partners only Severe exacerbation: defined by need for ventilatory support (indicated by severe dyspnea with failure to respond to emergency treatment and/or persistent hypoxemia (PaO2 <50 mm Hg despite O2 administration and / or respiratory acidosis (pH <7.35 and PaCO2> 45mmHg)) or mental confusion or circulatory insufficiency (need of vasopressors) Fever (>38.5°C) Known impaired hepatic or renal function Active or suspected tuberculosis infection of the respiratory tract Acute exacerbation of asthma Suspected or known hypersensitivity to, or suspected serious adverse reaction to sultamicillin; suspected or known hypersensitivity to penicillins or cephalosporins Immunosuppression or Immunosuppressive therapy (cytostatic chemotherapy within last 28 days or neutropenia (neutrophils < 1000/µ)l; systemic corticosteroids (≥20 mg prednisolon equivalent/day > 14 days; HIV-infection; immunosuppression after organ or bone marrow transplant) Patients with metastatic or hematological malignancy, splenectomized patients or patients with known hyposplenia or asplenia Oral/parenteral antibiotic use within 30 days prior to randomization (a singular administration of antibiotics prior to randomization is allowed) | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Chronic Obstructive Lung Disease 3. and Recruitment Doctors in Pulmonary Medicine Department, Bispebjerg Hospital, which is involved directly in the treatment of patients who are potential candidates can be created as "investigator" after proper information and training. Then, these doctors patients. is based on the following in-and and after oral and written participant information The following must all be met for the patient can be First The patient must have confirmed / suspected COPD, and must be hospitalized with COPD exacerbation Second The patient must be an adult (more than 18 years) and age. 3rd There must be a signed informed consent 4th Patients included only on weekdays Exclusions: The following should NOT be satisfied that the patient can be First The patient can not understand or relate to the oral or written information Second The patient has previously been involved in the study | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 0.0-5.0, Pneumonia Bronchiolitis Asthma All children below 5 exceeding WHO age-dependent tachypnea criteria | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-85.0, Chronic Obstructive Pulmonary Disease Endothelial Dysfunction COPD patients in stable condition ( without exacerbation min 1 months ago) Over 40 years History of at least 10 py acute exacerbation of COPD active malignancy autoimmune disease acute myocardial infarction diabetes mellitus with late complications congestive heart failure women of childbearing potential | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, COPD Chronic Obstructive Pulmonary Disease Diagnosis of stable COPD years or older Smoking history of at least 10 pack-years Forced Expiratory Volume in one second (FEV1) ≤ 70 % of predicted value and FEV1 / Forced Vital Capacity (FVC) < 0.70 Dyspnea ≥ 2 on the Medical Research Council (MRC) scale At least 2 exacerbations requiring prednisone treatment in the past 3 years Using a written action plan and having demonstrated adequate use of the self-administered antibiotic & prednisone (adequate use defined as prednisone started by the patient within 72 hours of symptom worsening and patient called the case-manager as recommended for following the response) Already on Advair BID (twice a day) as a maintenance therapy or able to switch over to Advair if already taking another combination medication (Symbicort) as maintenance therapy for COPD History of asthma or allergic rhinitis before the age of 40 Regular use of oxygen, oral corticosteroids, antibiotics Unstable or life threatening co-morbid condition Medical conditions or taking medications known to affect tremor and/or heart rate (HR) Pre-existing medical conditions or on concomitant medications contraindicated with salmeterol or fluticasone propionate (e.g. monoamine oxidase inhibitors and tricyclic antidepressants, beta-adrenergic receptor blocking agents, non potassium-sparing diuretics, inhibitors of cytochrome P450 (ritonavir, ketoconazole)) On theophyllines Colonized with pseudomonas aeruginosa | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 50.0-85.0, Chronic Obstructive Pulmonary Disease Signature of informed consent COPD patients with age raging from 50 to 85 years old Patients with at least a history of COPD of one year COPD patients clinically stable in the last three months COPD subjects with Forced Expiratory Volume at one second (FEV1)<50% of predicted value COPD subjects with Residual Volume (RV) >125% predicted value FEV1/Forced Vital Capacity (FVC) <88% (males) or <89% (females) of Low Levels of Normality (LLN) COPD former or active smokers with at least a smoking history of 20 pack year Acute Bronchial Exacerbation at recruitment Fertile women with age between 18 and 50 years old or with active period Pregnancy Subjects enrolled in other clinical trials or that have taken part in one of them in the month preceding the enrollment FEV1/FVC more than 70% of predicted value in basal conditions FEV1 more than 70% of predicted value in basal conditions Known deficit of alpha 1 antitrypsin Subjects that underwent a Lung Volume Reduction Surgery (LVRS) Subjects with known positivity to Human Immunodeficiency Virus (HIV) Misuse of alcool or drugs | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 58.0-72.0, Chronic Obstructive Pulmonary Disease ex-smokers (> 10 packets-year) with moderate-severe COPD patients | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease Age≥ 40years old The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease Chest radiography shows congestive heart failure Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases Serious cardiac failure, renal insufficiency or hepatic dysfunction | 2 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-75.0, Chronic Obstructive Pulmonary Disease Post bronchodilator forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio less than 0.7 Stable phase of COPD History of exposure to respirable silica dust, nonsmokers with absence of passive exposure to tobacco smoke or history of exposure to polycyclic aromatic hydrocarbons exhaust, nonsmokers with absence of passive exposure to tobacco smoke or current tobacco smokers without history of occupational exposure COPD risk factor exposure (occupational or tobacco smoke) duration not less than 12 months Male Caucasian Age of 40 years old Control group history of biomass smoke exposure age less than 40 and above 75 years old current COPD exacerbation concomitant asthma tuberculosis and other pulmonary diseases allergic and autoimmune disorders active infections immunodeficiency, including HIV infection parasitological diseases malignancies | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-85.0, COPD Exacerbation clinical and spirometric diagnosis of COPD for study group: clinical symptoms of exacerbation and infection of low airway Signed informed consent No acceptance of informed consent The STUDY GROUP: treatment with antibiotic more tan 2 days before consultation Another entity known pulmonology other than COPD (non-obstructive disorders, bronchiectasis, interstitial lung disease patients, severe pulmonary hypertension, hypoventilation) Chronic treatment with oral corticosteroids or immunosuppressive drug severe organ comorbidity such as cancer in advanced or terminal phase, pulmonary tuberculosis with important involvement, severe pneumoconiosis Severe alteration of nutritional status Heart disease evolved Limitation for understanding the study (including psychiatric disorder, language problem, social or cultural differences, etc.) | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-85.0, Community Acquired Pneumonia Adults aged 18 to 85, inclusive Has given written, informed consent Has acute illness with onset within previous 7 days Has at least 2 of the following symptoms Difficulty breathing or shortness of breath Cough Production of purulent sputum Pleuritic chest pain Has at least 2 vital sign abnormalities Fever (> 38°C or < 35°C) Contra-indication to the administration of any of the study treatments, such as hypersensitivity to any of the glycopeptide agents, beta-lactam agents, linezolid or macrolide antibiotics, or current or recent (within 2 weeks) use of MAO inhibitors or serotonergic antidepressants (within 5 weeks for fluoxetine) (see Section 5.5.1) Has received antibiotic therapy in the 4 days prior to screening, with the following exception: up to 25% of patients may have received a single dose of a short acting (half life < 8 hours) antibiotic Has aspiration pneumonia Has hospital acquired or ventilator associated pneumonia, or healthcare associated pneumonia, or 2 or more days in hospital in the previous 90 days Has cystic fibrosis or known or suspected Pneumocystis pneumonia or known or suspected active tuberculosis Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant Has primary or metastatic lung cancer Has known bronchial obstruction or a history of post-obstructive pneumonia Requires admission to ICU at baseline Has empyema requiring drainage | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 50.0-75.0, Chronic Obstructive Pulmonary Disease male and female COPD with an FEV1 of under 60% of predicted non-smoker between 50 and 75 years old experiencing an acute exacerbation of COPD (24-48 hours, before treatment) all inflammatory disease (HIV, cancer, renal and cardiac deficiency) hormonal dysregulation inferior limb pathology neuromuscular pathology history of tobacco or alcool abuse oxygen dependent | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-75.0, Chronic Obstructive Pulmonary Disease Post bronchodilator forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio less than 0.7 Stable phase of COPD History of exposure to respirable silica dust, nonsmokers with no of passive exposure of tobacco smoke or history of exposure to aromatic hydrocarbons, nonsmokers with no of passive exposure of tobacco smoke or current tobacco smokers without history of occupational exposure COPD risk factor exposure (occupational or tobacco smoke) duration not less than 12 months Male Caucasian Age of 40 years old history of biomass smoke exposure age less than 40 and above 75 years old current COPD exacerbation concomitant asthma tuberculosis and other pulmonary diseases allergic and autoimmune disorders active infections immunodeficiency, including HIV infection parasitological diseases malignancies | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive COPD diagnosis and severity: Participants with a clinical history of COPD (established by a physician) in accordance with the following definition by the American Thoracic Society/European Respiratory Society, for at least 6 months prior to enrolment. Participants must have evidence of airflow obstruction, defined as post-bronchodilator FEV1 equal to or less than 80% of predicted normal value calculated using "Third National Health and Nutrition Examination Survey" (NHANES III) reference equation at Visit 1 and a FEV1 / FVC ratio <=70% at Screening (Visit 1). Note: Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the participants has self-administered 4 inhalations (i.e., total 400/360 [microgram] mcg) of salbutamol/albuterol via a Metered Dose Inhaler (MDI) (use of spacer will be optional). The study-provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values Exacerbation History: A documented history (e.g., medical record verification) in the 12 months prior to Visit 1 of >=2 COPD exacerbations resulting in prescription for antibiotics and/or oral corticosteroids or hospitalisation or extended observation in a hospital emergency room or outpatient centre. Note: Prior use of antibiotics alone does not qualify as a moderate exacerbation unless the use was specifically for the treatment of worsening symptoms of COPD Existing COPD maintenance treatment: Participants must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Notes: Participants receiving only "pro re nata" or as needed (PRN) COPD medications are not eligible for in the study. All participants will continue on their current Standard of Care (SoC) COPD medications throughout the entire duration of the study Tobacco use: Participants with a current or prior history of >=10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. One pack year =20 cigarettes smoked per day for 1 year or the equivalent. Number of pack years=(number of cigarettes per day/20) x number of years smoked Sex: Male or female participants aged >=40 years at Screening (Visit 1). A female participant is eligible to participate if she is of non-child bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international unit/milliliter (MIU/mL) and estradiol <40 picogram/milliliter (pg/mL) (<140 [Picomoles per liter] pmol/L) is confirmatory] or if of child-bearing potential is using a highly effective method for avoidance of pregnancy from 30 days before the first dose, for the duration of dosing and until 2 weeks post last-dose Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Corrected ECG QT interval (QTc)<450 milliseconds(msec) or QTc<480 msec for participants with bundle branch block. The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or manual over-read. For and withdrawal, ideally the same QT correction formula will be used for all participants. However, because this is not always possible, the same QT correction formula will be used for each individual participant to determine for and withdrawal from the study. The QTc will be based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period Eosinophils: >2.0% blood eosinophils at Screening (Visit 1) Concomitant medication: COPD Medication: Participants currently on chronic treatment with macrolides or Roflumilast; Long term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen PRN use (i.e. <=12 hours per day) is not exclusionary. Multidrug and toxin extrusion (MATE) transporter 1 (MATE1) inhibitors: cimetidine, pyrimethamine, trimethoprim (short course treatment with trimethoprim is allowed). Other medications: Chronic maintenance therapy with anti-Tumor Necrosis Factor (anti-TNF), anti-Interleukin-1 (anti-IL1), phosphodiesterase type 4 (PDE4) inhibitors, or any other immunosuppressive therapy (not including steroids) within 60 days prior to dosing. Any other investigational drug within 30 days or 5 half lives, whichever is longer prior to Screening Visit Other respiratory disorders: Participants with asthma (as primary diagnosis) lung cancer, bronchiectasis, active sarcoidosis, active lung fibrosis, cystic fibrosis, idiopathic pulmonary hypertension, active interstitial lung diseases or other active pulmonary diseases. Participants with alpha-1-antitrypsin deficiency as the underlying cause of COPD Participants with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device Participants who require a non-invasive positive pressure ventilation (NIPPV) device (Note: Use of non invasive ventilation (NIV) in hospital as part of the medical management of an acute exacerbation is permitted.) Lung resection: Participants who have undergone previous lung reduction surgery (e.g. lobectomy, pneumonectomy, or lung volume reduction) COPD stability: Less than 30 days prior to Visit 1 have elapsed from completion of a course of antibiotics or oral corticosteroids for a recent COPD exacerbation Evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD on chest X-ray (posteroanterior with lateral) or computerised tomography (CT) scan (historic data up to 1 year may be used) Pulmonary rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Participants who are in the maintenance phase of a pulmonary rehabilitation program are not excluded Alanine aminotransferase (ALT) >2x Upper limits of normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-85.0, COPD, HEAD&NECK CANCER,SCREENING group of adult COPD patients Adult patients with smoking history and no clinical manifestation of COPD who will be recruited form the institute of pulmonary medicine and the otolaryngology outpatient clinic Adult patients with lung disease unrelated to smoking, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine Patients with an acute disease or COPD exacerbation Pregnant patients Patients who were intubated ≤3 months prior to Patients with a medical history of surgical intervention in the upper airway Patients with a medical history of malignant disease in the upper airway Patients who underwent radiotherapy of head and neck | 2 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Adverse Effect of Glucocorticoids and Synthetic Analogues Disease Exacerbation Informed Consent as documented by signature Age ≥40 years History of ≥10 pack-years of smoking (past or present smokers) Airway obstruction, defined as FEV1/FVC≤70% Current acute exacerbation of COPD by clinical defined by the presence of at least two of the following Change of baseline dyspnea Change of cough Change of sputum quantity or purulence Diagnosis of asthma Initial necessity of hospitalization Women who are pregnant or breast feeding Premenopausal women with insufficient contraception and anamnestic risk for pregnancy Severe coexisting disease with life expectancy <6 months Diagnosis of tuberculosis Known severe immunosuppression or immunosuppression after solid organ or stem cell transplantation Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia, etc. of the participant Participation in another study involving an investigational drug Previous enrolment into the current study | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-75.0, COPD Asthma for Healthy Smoking Subjects Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Be between 18 and 75 years of age, inclusive, at informed consent Healthy as determined by a physician, based on medical history and physical examination Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of ≥ 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked) for All COPD Subjects Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Aged between 40 and 75 years of age inclusive, at the time of signing the informed consent COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli, 2004). Symptoms must be compatible with COPD for at least 1 year prior to screening and post-bronchodilator spirometry readings at screening Post-bronchodilator FEV1/FVC ratio of <0.7 for Healthy Smoking Subjects Any potential subject who meets any of the following will be excluded from the participating study Upper or lower respiratory tract infection within 4 weeks of the screening visit Positive test for alcohol at screening Taking prescription medication in the 14 days before screening Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded but are not limited to pipes, cigars and e-cigarettes Subjects who are unable to produce a total weight of at least 0.1 grams (g) of selected sputum at screening Urinary cotinine levels at screening < 30 ng/ml Subject is mentally or legally incapacitated Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO Any other reason that the Investigator considers makes the subject unsuitable to participate | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Pulmonary Disease, Chronic Obstructive Patients Male of Female, aged 18 years or above Attended the clinic as a patient Participant is willing and able to give informed consent for participation in the study Patients The patient is unable or unwilling to give consent Health Care Professionals Male or Female, aged 18 or above Attended the clinic as a health care professional Participant is willing and able to give informed consent for participation in the study Health Care Professionals The health care professional is unable or unwilling to give consent | 2 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 0.167-17.0, Community-acquired Bacterial Pneumonia History of and/or documented fever (rectal, ear, or oral temperature ≥38°C or axillary temperature ≥37.5°C) or hypothermia (rectal, ear, or oral temperature <35°C or axillary temperature <34.5°C) Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia caused by atypical bacterial agents); if a subject is outpatient and starting on oral therapy, a radiograph is not required Presence of at least 2 of the following signs or symptoms Cough Difficulty breathing Production of purulent sputum Chest pain Grunting Hypotension Tachycardia, defined as follows Ventilator-associated or hospital-acquired pneumonia >48 hours of systemic antibacterial therapy confirmed or suspected bacterial meningitis breast-feeding females positive pregnancy test | 0 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Peptic Ulcer Pulmonary Disease, Chronic Obstructive Dental Plaque COPD arm COPD Gold standard 2-4 Peptic ulcer arm H.pylori positive peptic ulcer Physically unable to make it to the dental clinic | 1 |
A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation. | eligible ages (years): 18.0-999.0, Multiple Sclerosis, Relapsing-Remitting Male or Female ≥ 18 years of age Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald (2010 revision) Patient with an acute MS exacerbation as determined by their treating clinician Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation Patient capable of providing informed consent Patients with a diagnosis of Progressive MS Patients that require concomitant corticosteroid therapy Patients receiving experimental drug therapy Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex, or cancer within prior 5 years Patients who had recent surgery or have a history of or the presence of a peptic ulcer within 6 months prior to study entry, congestive heart failure, or sensitivity to proteins of porcine origin If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 18.0-999.0, Normal PBPC Donors Eligible to be PBPC donor for allogeneic transplantation as determined by local institution History of splenectomy Previous PBPC mobilization attempts Previous treatment with GCSF or GMCSF | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 18.0-85.0, Pulmonary Embolism age between 18 and 85 symptomatic PE confirmed by: high probability lung scan, or intermediate probability lung scan and objectively confirmed deep vein thrombosis, or spiral CT-scan or pulmonary angiography or TE echocardiography normal blood pressure (SBP >100mmHg) RVD at echocardiography (see criteria) written informed consent absence of RVD at echocardiography shock or hypotension (SBP < 100 mmHg) therapeutic heparin (UFH or LMWH) treatment for more than 48 hours prior to randomization administration of thrombolytic agents within the previous 4 days vena cava filter insertion or pulmonary thrombectomy within the previous 4 days chronic pulmonary hypertension or severe COPD hypertension defined as blood pressure >180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on a single, reliable measurement during current admission at enrolling site prior to randomisation use of GP IIb/IIIa antagonists within the preceding 7 days significant bleeding disorders either at present or within the past 6 months active peptic ulceration | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 16.0-999.0, Abdominal Injuries Thoracic Injuries Patients with life threatening vital problems: respiratory, circulatory (pulse > 120/min, blood pressure < 100 mmHg, refill > 4 sec, exterior blood loss > 500 ml) or neurologically (Glasgow Coma Score < 14, abnormal pupils) compromised patients Patients with a revised trauma score under 12 Patients with signs of fractures from at least two long bones Patients with clinical signs of flail chest/multiple rib fractures Patients with a clinically evident pelvic rim fracture Patients with signs of unstable vertebral fractures or signs of neural cord compression Patients involved in a high-energy injury mechanism Fall from height (> 3 m) As declared by prehospital emergency medical services Patients suffering from a shock Class IIIB/IV Patients who need immediate neurosurgical intervention Pregnant patients Patients referred from other hospitals Patients who die at the emergency department | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 18.0-999.0, Immune Thrombocytopenia (ITP) ITP with platelet count <30 x 109 /l after 2 weeks of treatment with prednisolon or during prednisolon tapering period i.e. from week three of prednisolon initiation. Patients with platelet count between 30 -50 are eligible if a higher platelet count is considered necessary, because of : concomitant medical illness predisposing to bleeding (hypertension, GI bleeding, bleeding diathesis, previous history of bleeding) concomitant medical condition requiring platelet blocking agents/ anticoagulation, persistent bleeding despite platelets > 30 x 109 /l, prior to surgery, or because of other patient related factors necessitating higher platelet count as occupation, hobby, psychological intolerability Subject is >18 years Subject has signed and dated written informed consent Subject is able to understand and comply with protocol requirements and instructions, and intends to complete the study as planned Females in fertile age should express willingness for use of contraceptive means for 6 months following the administration of the study drugs Previous splenectomy, chemotherapy, treatment with anti-D Ig, rituximab, or immune-suppressive treatments other than corticosteroids, Dapsone or Danazol Underlying malignancy or previous history of malignancy in the past 5 years (except skin carcinoma) Pregnancy and lactation Not willing to participate in the study Expected survival of < 2 years Known intolerance to murine antibodies Females in child-bearing age not willing to use contraception for 6 months HIV-positive/AIDS-, Hepatitis -B virus positive or Hepatitis -C virus positive Patients with a definite Systemic Lupus Erythematosus (SLE) (> 4 of the American College of Rheumatology Criteria) | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 0.083-15.0, Injuries and Wounds All asymptomatic trauma patients from 0 to 15 years old Any pediatric trauma patients with clinical indications for CT scan | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 18.0-60.0, Pain Adult ASA 1-2 Cardiovascular disease Former smoker Pregnant Nursing Asthma | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 35.0-999.0, Pancreatic Cancer Persons 50 years or older with recently diagnosed diabetes (within 2 years), with at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum CA 19-9, or those undergoing EUS with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening ; OR Persons 35 years old or older with familial pancreatic cancer with 2 or more first degree relatives with pancreatic cancer; OR Persons 35 years old or older with Peutz-Jeghers syndrome; OR Persons 35 years old or older with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks Persons with contraindication to iodinated contrast Allergy to iodinated contrast Renal insufficiency (serum creatinine > 1.5 mg/dl) Patients with contraindication to ionizing radiation Pregnancy Patients with previous pancreatic surgery Contraindication to secretin Allergy to secretin Acute pancreatitis | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 18.0-70.0, Hernia, Ventral Body Image Respiratory Function Tests Quality of Life Laparoscopy Informed consent Age 18 years or older Diagnosis of reducible incisional hernias up to 200 cm² Medically fit for general anesthesia Comprehension and use of French language Installed in the geographical region without foreseeable move for two years Incarcerated hernia Ongoing chronic pain syndrome, other than hernia origin Coagulation disorders, prophylactic or therapeutic anticoagulation, unable to stop platelet antiaggregation therapy 10 days before surgery American Society of Anesthesiology Class 4 and 5 patients Emergency surgery, peritonitis, bowel obstruction, strangulation, perforation Mentally ill patients Presence of local or systemic infection Life expectancy < 2 years Any cognitive impairment (Psychiatric disorder, Alzheimer's disease etc.) Morbid obesity (BMI over 40) | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 18.0-999.0, Peritoneal Cavity Cancer Patients must have histologic proof of peritoneal metastases (includes adenomucinosis) Complete tumor resection possible (may liver metastasis if treatable by resection or radiofrequency ablation) Patients may have received previous chemotherapy (except peritoneal) and/or immunotherapy. If previous chemotherapy, at least 4 weeks must have passed since last dose Patients may have received previous radiation therapy, however radiation to the large bowel, small bowel and/or stomach will make the patient ineligible for this study Patients must have a Karnofsky performance score of ≥ 80% Adequate hematologic, renal and hepatic function within 14 days of registration defined as White blood count (WBC) ≥ 3,000 platelet count ≥ 70,000 serum bilirubin ≤ 2.0 mg/dL serum creatinine ≤ 1.5 mg/dL Metastatic disease is present outside the peritoneal cavity Diagnosis of mesothelioma Grade 2 or higher sensory neuropathy at time of study enrollment History of allergic reaction to platinum compounds Pregnant or lactating women. Pregnancy is a contraindication for receiving therapy, thus where relevant, patients will be required to use effective birth control. The agents used in this study those which are pregnancy category D clear evidence of risk in pregnancy. There is no information on the excretion of agents into breast milk therefore patients must refrain from breastfeeding while receiving study therapy Previous peritoneal chemotherapy Patients with uncontrolled concurrent medical problems (i.e. diabetes mellitus) or history of uncontrolled cardiovascular disease (no history of hospitalization for acute myocardial infarction or congestive heart failure (CHF) within 3 months prior to registration) Patients have psychiatric or addictive disorders that preclude obtaining informed consent | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 18.0-999.0, Intra-Abdominal Infection Adult patients ( > 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity) Acute appendicitis: Ruptured or perforated with abscess Acute diverticulitis with perforation and/or abscess Acute cholecystitis (including gangrenous) with either rupture or perforation Acute gastric and duodenal ( > 24 hours) perforation Traumatic (> 12 hours) perforation of the intestines Secondary peritonitis due to perforated viscus Intra-abdominal abscess (including of liver and spleen) Traumatic bowel perforation requiring surgery within 12 hours Perforation of gastroduodenal ulcers requiring surgery within 24 hours other intra-abdominal processes in which the primary etiology was unlikely to be infectious Patients lactating or pregnant Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics Patients with rapidly progressive or terminal illness Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance < 0.5 ml/min/1.73 m2) Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 18.0-75.0, Thrombotic Microangiopathy Thrombotic Thrombocytopenic Purpura Male or female ≥18 to ≤75 years of age Diagnosis of TMA based on presence of Thrombocytopenia, defined as a platelet count <100 x 109 per liter Microangiopathic hemolytic anemia, defined by negative findings on direct antiglobulin test, and evidence of accelerated red blood cell (RBC) production and destruction); AND Absence of a clinically apparent alternative explanation for thrombocytopenia and anemia, e.g., disseminated intravascular coagulation (DIC), eclampsia, HELLP syndrome, Evans syndrome Females: non-pregnant and commit to use of effective, redundant methods of contraception (i.e., for both self and male partner) throughout the study and for at least 30 days after discontinuation of study drug treatment Males: commit to use of a medically acceptable contraceptive (abstinence or use of a condom with spermicide) throughout the study and for at least 30 days after discontinuation of study drug treatment Not received an unlicensed investigational agent (drug, device, or blood-derived product) within 30 days prior to randomization, and may not receive such an investigational agent in the 30 days post-randomization (note: investigational use for treatment of TMA of a licensed immunomodulator, e.g., rituximab, is permitted at any time relative to randomization) Capable of understanding and complying with the protocol, and he/she (or a legal representative) must have signed the informed consent document prior to performance of any study-related procedures Females: pregnant or <24 hours post-partum, or breastfeeding History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days Disseminated malignancy or other co-morbid illness limiting life expectancy to ≤3 months independent of the TMA disorder Diagnosis other than TMA which can account for the findings of thrombocytopenia and hemolytic anemia (e.g., DIC, HELLP syndrome, Evans syndrome) Diagnosis of DIC verified by laboratory values for D-dimer, fibrinogen, prothrombin time (PT), and activated partial thromboplastin time (aPTT) Patients who have again become acutely ill following recent treatment and achievement of a brief remission of acute TMA may not be enrolled in the study if ANY of the following conditions are met The last plasma exchange of the patient's preceding course of treatment occurred less than 7 days prior The patient underwent splenectomy during the preceding course of treatment The new course of plasma exchange has been ongoing for more than 3 days | 0 |
A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. | eligible ages (years): 0.0-999.0, Postoperative Pain Splenomegaly 15 cm or longer spleens Patient confirmation to join the study Normal sized spleens Patient denial | 0 |
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