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A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Novel H1N1 Influenzal Acute Respiratory Infection > 18years Suspected or confirmed influenza (Appendix A) Requirement for ICU admission due to respiratory distress or critical illness defined as one of:a) Inspired oxygen need of >50% for at least 4 hours (For FiO2 for non-intubated patients see Appendix B) b) mechanical ventilation c) Patient is receiving inotrope or vasopressor Age less than 18 years | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia Severe community acquired pneumonia treated with azithromycin age over 18 years Azithromycin initiated before hospitalization technically undecipherable ECG Permanent pacemaker | 1 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia, Bacterial New diagnosis of pneumonia Patient in medical or surgical intensive care unit Age greater or equal than 18 years old Neutropenia Recipient of a solid organ or bone marrow transplant Bacteremia Presence of Acinetobacter baumannii or Stenotrophomonas maltophilia from a respiratory tract culture Presence of a second infection requiring antibiotic therapy Pregnancy Enrollment in another clinical study Patient or surrogate unable to provide informed consent Attending intensive care unit physician declined enrollment in the study | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 20.0-999.0, Pneumonia Males and non-pregnant, non-lactating females with written informed consent, 20 years of age or older Within 48 hours prior to the first study drug administration, all patients should have the pathogens identified with appropriate specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage [BAL], protected brushing specimen [PBS]), or should have appropriate specimens highly likely to identify the pathogens sampled. (However, the patients with Legionellosis is enrolled when the test of Legionella antigen is positive.) The following severe bacterial pneumonia meeting the diagnostic of pneumonia or secondary infection of chronic respiratory disease Severe pneumonia Community-acquired pneumonia: PORT score III, IV or V Hospital-acquired pneumonia [HAP]-Group B and with a low risk for multidrug-resistant pathogens Patients with [HAP]-Group A whose pathogen is suspected to be Pseudomonas aeruginosa Hospitalized patients with bacterial pneumonia with a poor response to other antimicrobials Note: The patients should be limited to CAP patients with PORT score III, IV or V and HAP patients with-Group A or B who don't respond to or have a poor response to other antimicrobials over 3day's treatment.2 Secondary infection of chronic respiratory disease Patients who are hospitalized for the treatment of secondary infection of chronic respiratory disease Creatinine clearance (Ccr) ≤ 30 mL/min or nephrotic syndrome Patient with chronic treatment of immunosuppressive drug Decompensated congestive heart failure Subject who received more than 24 hours of an antibacterial drug for the current infection Patient who requires Intensive Care Unit (ICU) management [In case subjects who don't correspond to the severity for ICU management need to be admitted to ICU due to a circumstance of the site (e.g. shortage of hospital beds), those subjects shall not be excluded] Patients with infections other than pneumonia or secondary infection of chronic pulmonary disease Lung abscess, or empyema Viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis Known or suspected bacteremia secondary to Staphylococcus aureus Known causative microorganisms other than indication (microorganisms) of the study drug, or positive in urinary antigen test of Streptococcus pneumonia | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Bacterial Pneumonia Written informed consent by the subject/subject's LAR Hospitalized males or females ≥ 18 yrs with respiratory failure requiring mechanical ventilation and clinical suspicion of HABP, HCAP or VABP Onset or exacerbation of pneumonia at least 48 hours after admission to any patient health care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility Women of childbearing potential if their pregnancy test is negative Subjects who have received previous antibacterial therapy within 14 days of pre-treatment bronchoscopy entry may be entered only if the subject has not responded clinically.). While less than 24 hours of pre-treatment antibiotics is preferential, recovery of >104 CFU/ml in the quantitative Bronchoscopic BAL will be seen as primary evidence that the prior therapy was not efficacious and enrollment will be allowed.) Patients should have clinical findings that support a diagnosis of HABP/VABP/HCAP Within 48 hours before starting empiric therapy a subject's chest radiograph should show the presence of a NEW or progressive infiltrate, cavitation, or effusion suggestive of pneumonia Within 36 hours before the start of empiric study therapy, a quantitative culture of Bronchoscopic BAL fluid must be obtained Patients with VABP should have a Clinical Pulmonary Infection Score of >/= 5 Subjects with pneumonia caused by pathogens resistant to meropenem (MIC greater than or equal to 16µg/ml) or a prior meropenem therapy failure Subjects with contra-indications to ANY study medication, in particular with known or suspected allergy or hypersensitivity Women who are pregnant or lactating Subjects taking anticonvulsant medications for a known seizure disorder.Patients with a history of seizures, AND who are stabilized on anti-seizure medication, may be enrolled into the study at the discretion of the site investigator Subjects with known or suspected community acquired bacterial pneumonia (CABP) or viral pneumonia; or Subjects with acute exacerbation of chronic bronchitis without evidence of pneumonia Subjects with primary lung cancer or another malignancy metastatic to the lungs Subjects who were previously enrolled in this study Subjects who have had an investigational drug or have used an investigational device within 30 days prior to entering the study Subjects with another focus of infection requiring concurrent antibiotics that would interfere with evaluation of the response to study drug Subjects with cystic fibrosis, AIDS with a CD4 lymphocyte count <200 cells/µl, neutropenia (absolute neutrophil count <500 cells/ml), known or suspected active tuberculosis | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | 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 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 2.0-18.0, Community-acquired Pneumonia Children hospitalized for community-acquired pneumonia 18 years old Pulmonary chronic disease (including asthma) Immunodeficiency Diseases wich requires corticosteroids therapy (i.e. rheumatic diseases) Wheezing in current disease Previous hospitalization (14 days prior to admission) Pleural effusion on admission Malnutrition | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Community Acquired Pneumonia or older admitted with CAP will be included sequentially. Pneumonia is defined as pulmonary infiltrate shown in a thoracic X-ray not known to be old patients with human immunodeficiency virus infection immunosupressed patients (with a solid organ transplant, spelenectomy, treated with a prednisone dose of 10 mg/day or equivalent for longer than 30 days or with other immunodepressors, with neutropenia) those hospitalized in the 14 days prior and those living in assisted care facilities pneumonia cases caused by infrequent agents (i.e. P. aerouginosa, S. Aureus) will also be excluded, as well as infectious processes requiring an extended treatment with antibiotocs (i.e. bacterial endocarditis, abscesses) pneumonia cases with pleural effusion requiring a drainage tube patients who were deceased or admitted to ICU before randomization and those not giving their informed consent | 1 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Community-acquired Pneumonia ● Adult patients greater than age 17 years who are initially evaluated in the ED with symptoms of CAP. This includes those who will be treated as outpatients and those admitted to the hospital (both ward and ICU) The definition of CAP is as follows Presence of pulmonary infiltrates on chest radiography. (Initial reading may be performed by the ED physician but has to be confirmed by board certified radiologist for in the study) At least 2 of the following: new onset of cough, productive sputum, shortness of breath, chest pain, fever > 380C, abnormal chest auscultation, WBC > 12,000 cells/mL Able to provide informed consent Read, signed, and dated informed consent document Available for follow-up for the planned duration of the study Patients with underlying immunosuppressive illness (HIV, neutropenia, asplenia, transplant recipient, cystic fibrosis, receipt of immunosuppressive medications including corticosteroids, (equivalent of prednisone > 10 mg) cancer chemotherapy, or anti-tumor necrosis factor agents Patients residing in long-term care facilities | 1 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-75.0, Healthy Volunteers and Asthma Understanding of the study and a signed informed consent form before any study-related procedures Willing and able to adhere to the restrictions specified in the protocol Results of the following laboratory tests within the following limits: serum alanine aminotransferase (ALT) levels ≤2 x ULN; serum aspartate aminotransferase (AST) levels ≤2 x ULN Part 1 (healthy participants) a). Body weight in the range of 40 to 125 kg, inclusive. Have a body mass index (BMI) of 19 to 32 kg/m2, inclusive b). Healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, coagulation and urinalysis, measurement of vital signs, and 12-lead electrocardiogram (ECG) performed at Screening Visit 2 Part 2 a). (BMI) of 19 to 40 kg/m2, inclusive; have a physician-documented diagnosis of asthma for at least 6 months prior to Screening Visit 2; have stable asthma based on physician assessment at Screening Visit 2 b). Have an Asthma Control Questionnaire (ACQ) symptom score less than (<)2.5 at Screening Visit 2 c). Have a prebronchodilator forced expiratory volume in the first second (FEV1) greater than or equal to (>=) 65 percent of predicted normal value at Screening Visit 2 Part 1 (healthy participants): Has any condition that in the opinion of the investigators, would constitute a risk or a contraindication for participating in the study, prevent the participant from meeting or performing study requirements, or could interfere with the study objectives, conduct, or evaluation At Screening Visit 1 and throughout the study, works with (or lives with a family member who cares for) the elderly, (eg, nursing home), or lives with someone who may be at risk from transmission of the human rhinovirus type 16 (HRV-16) challenge agent, including, but not limited to, individuals with chronic lung disease (including asthma), a premature infant, or an immunocompromised individual Has had any acute illness, including a common cold, within 4 weeks prior to Screening Visit 1, or has had a major illness or hospitalization within 6 months prior to Screening Visit 1 Has active allergic rhinitis or perennial allergy symptoms (eg, due to ragweed) at Screening Visit 2 or expects to have active allergic rhinitis or perennial allergy symptoms during the study Has a current infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized and/or received antimicrobials for a serious infection during the 6 months prior to Screening Visit 1 Part 2 (asthmatic patients): Has a history of any other chronic lung disease, including chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease, liver or renal insufficiency; significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, or other body system disorders that are clinically significant in the opinion of the investigator Has ever had an episode of life-threatening asthma defined as respiratory arrest or requiring intubation for asthma Has been hospitalized (for greater than 24 hours) due to asthma in the 5 years prior to Screening Visit 1 Has experienced an asthma exacerbation in the 12 weeks prior to Screening Visit 1 requiring management with systemic steroids Is receiving a high-dose inhaled corticosteroid (ICS) (>500 µg/day to fluticasone or equivalent). Use of low or medium dose ICS (≤500 µg/day fluticasone or equivalent) with or without permitted controller medications, eg, long-acting Beta2 agonists (LABA), leukotriene receptor antagonists (LTRA), is allowed | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 1.0-10.0, Pneumonia children aged 1-10 y presenting to the emergency department must fulfil definition of 'pneumonia', ie any one of fever in the ED a recorded fever at home in the 48h prior to presentation, or WBC > 12 or WBC < 5 in the ED any one of tachypnoea on exam cough on exam or by history increased work of breathing on exam; or or more episodes of emesis in the emergency history of CF, anatomic lung disease, bronchiectasis, congenital heart disease, repeated aspirations, malignancy, immune suppression, recent prolonged admission to hospital, pneumonia diagnosed within the last month, lung abscess within the past six months, > 24 hours of beta-lactam antibiotic therapy prior to presentation, allergy to penicillin, allergy to food colouring evidence of empyaema or necrotizing pneumonia on chest radiograph | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia, Bacterial Nosocomial Infection Intraabdominal Infections Urinary Tract Infection Patients who are diagnosed with nosocomial pneumonia including ventilator-associated pneumonia, complicated intra-abdominal infections or complicated urinary tract infection Patients who are eligible for doripenem treatment Pregnant or lactating females Patients with hypersensitivity to doripenem and/or its derivatives Known at study entry to have an infection caused by pathogen(s) resistant to doripenem Patients taking probenecid History of severe allergies to certain antibiotics such as penicillins, cephalosporins, and carbapenems Severe impairment of renal function including a calculated creatinine clearance of less than 10 mL per minute, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (less than 20 mL urine output per hour over 24 hours) | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-45.0, Neonatal Infection Pregnant women (aged 18 to 45 years) in labour attending a health centre in western Gambia for delivery Known HIV infection Any chronic or acute conditions of the women that might interfere with the study as judged by the research clinician Planned travelling out of the catchment area during the following 2 months (follow-up period) Planned caesarean section Known required referral Known multiple pregnancy Known severe congenital malformation Intrauterine death confirmed before randomization Known allergy to macrolides Consumption of antibiotic within the week before randomisation | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Lung Transplant Infection Lower Respiratory Tract Infection. Post bilateral sequential lung transplant Capable of performing airway clearance techniques / nebulisers Pulmonary exacerbation as defined by Fuchs et al Must be productive of sputum Able to provide informed consent within 48 hours of presentation *Fuchs Scale(8): Treatment with / without parenteral antibiotics for 4/12 signs and symptoms Change in sputum New or increased haemoptysis Increased cough Increased dyspnoea Paediatric transplant <18yrs Single lung transplant native lung physiology may confound outcome measures Interstate unable to complete follow up Unable to perform lung function testing Unable to complete subjective outcome measures unable to read English fluently Critically unwell / ICU / ventilator dependent Within 2 months of transplant date *Cystic Fibrosis will be stratified | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.0-5.0, Pneumonia Bronchiolitis Asthma All children below 5 exceeding WHO age-dependent tachypnea criteria | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 40.0-999.0, Idiopathic Pulmonary Fibrosis Males/females aged 40 years and over, at the time of signing the informed consent A female patient is eligible to participate if she is of: Non child-bearing potential, where females are post-menopausal, defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milliinternational units per milliliter (MlU/mL) and estradiol < 40 picograms per mililiter (pg/mL) (<147 pmol/L) is confirmatory. Peri-menopausal or pre-menopausal, and have a negative pregnancy test as determined by serum or urine human chorionic gonadotropin (hCG) test, confirmed at screening, and then at each subsequent clinic visit before the CT scanning is conducted BMI within the range 18 kilogram per meter^2 (kg/m^2) (inclusive) Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Patients will have a diagnosis of IPF as determined by a responsible and experienced Respiratory physician and based on established defined by the American Thoracic Society/European Respiratory Society: American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias Patient's lung function measurements of Forced vital capacity (FVC) and Diffusing capacity of the Lung for Carbon Monoxide (DLCO) at screening must fall within the category below to be included in this study: FVC >=40 % predicted and DLCO >=30 % predicted Patients with a current Idiopathic Pulmonary Fibrosis (IPF) exacerbation Patients with a known underlying cause of pulmonary fibrosis Patients that have both IPF and Chronic obstructive pulmonary disease (COPD) that requires therapy with more than an intermittent bronchodilator or a long acting muscarinic antagonist, or where the Forced Expiratory Volume in One Second (FEV1)/ Forced vital capacity (FVC) ratio is <0.65 Patients with an upper or lower respiratory tract infection within four weeks of Visit 1 Patients with a recognised co-existing respiratory disorder other than usual interstitial pneumonia (UIP) (e.g. significant COPD, asthma, sarcoid, lung carcinoma) that in the opinion of the investigator would confound the study outcomes Patients with poorly controlled left ventricular heart failure Serious or uncontrolled medical, surgical or psychiatric disease that in the opinion of the investigator would compromise patient safety or confound the study data (e.g. congestive cardiac failure [CCF], asthma, angina, neurological disease, liver dysfunction and blood dyscrasia) Patients found to have clinically significant anaemia until adequately treated Patients that have a history of alcohol abuse Patients who are currently taking Pirfenidone for IPF or who have received Pirfenidone within the previous 30 days prior to Visit 1 | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia Be 18 years of age Having the diagnosis of ventilator-associated pneumonia Be under 18 years of age | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Community Acquired Pneumonia Pleuritis Pulmonary Embolism Lung Cancer patient aged 18 years and older patient affected by thoracic pleuritic pain patient affected by a chronic condition causing thoracic pain patient affected by acute cardiovascular diseases (e.g. acute coronary syndrome) | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.0-21.0, Community Acquired Pneumonia All intubated pediatric patients Age 1 day to 21 years Admitted to the LLUCH PICU with suspected pneumonia for the next 6 months Have received antibiotics for less than 12 hours Have been intubated for less than 24 hours Patients must be English or Spanish speaking for consent purposes Patients who have received antibiotics for greater than 12 hours Patients who have been intubated for greater than 24 hours Patients who are unable to tolerate non-bronchoscopic bronchoalveolar lavage | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia Streptococcus Pneumoniae Immune Response Patients who participated in the Ovidius or Triple-P study (2004-2009) Diagnosis in these studies with pneumococcal pneumonia or pneumonia due another identified organism Age ≥ 18 years Signing of informed consent Diagnosis of pneumonia without an identified causative organism Fever at time of vaccination Previous/known allergic reaction to any of the components of the vaccine given Mentally incompetent Previous pneumococcal conjugate vaccination Pneumococcal polysaccharide vaccination within 6 months prior to inclusion Clinical pneumonia within 1 month prior to inclusion | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Ventilator-Associated Pneumonia Mechanical ventilation for at least 48 hours New or evolving infiltrate on chest radiograph (CXR) or computed tomography (CT), and A minimum of two of the following clinical Body temperature ≥ 38.5° C (101° F) or < 36° C (97° F) White blood cell count > 10,000/ml or < 4,000/ml or > 10% immature cells Partial pressure of oxygen in arterial blood < 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio < 300 Purulent respiratory secretions Known ongoing pneumonia Patient younger than 18 years old Mechanical ventilation <48 hours Contraindication to bronchoscopy | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.25-4.917, Pneumonia Children admitted with severe pneumonia as defined by the presence of all the following as defined as below months to 59 months old History of cough and/or shortness of breath Unwell for <= 7 days -Increased respiratory rate ( ≥ 50/min if ≤12 months old, ≥ 40/min) or retractions,- Any of the following signs/symptoms are present at examination that would necessitate admission: chest retractions, cyanosis, saturation< 92% on air, poor feeding or lethargy Documented fever (axillary /central temp ≥ 38/38.5°C) within 24 hrs of admission Abnormal CXR with presence of alveolar infiltrates Responds to IV antibiotics by the first 72 hrs and able to go home with oral antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute illness ( ie >7 days) (f) unable to come for follow-up (g) not community acquired pneumonia e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation (j)significant comorbidities that can increase the risk of having a complicated pneumonia (k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics (o) underlying illness that can predispose to recurrent pneumonia | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia have a positive Febrile Respiratory Illness (FRI) screen on admission to hospital (http://www.health.gov.on.ca/fr/public/programs/emu/sars/reports/dir_122303_acute_care_nonoutbreak.pdf) diagnosed with pneumonia by the admitting physician (Acute exacerbations of chronic obstructive lung disease are considered within the definition of pneumonia for the purposes of this study as they are commonly treated with the same antimicrobial regimens as patients with pneumonia) admitted to a medical ward hospitalized for ≥ 48 consecutive hours in the preceding 3 months receiving immunosuppressants [defined as ≥ 40 mg prednisone daily (or steroid equivalent) for ≥ 2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection] neutropenic [defined as a polymorphonuclear count ≤ 0.5 x 109 cells/L] from any cause immunocompromised [defined as having leukemia, lymphoma, HIV with CD4 cell count ≤ 200, splenectomy or on cytotoxic chemotherapy] admitted to high acuity units such as intensive care units require mechanical ventilation, either non-invasive or invasive have a life expectancy of ≤ 3 months (palliative) | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia Community-acquired pneumonia Immunocompetent Age > 18 years Admitted to an intensive care unit or high intensity unit Requiring invasive or non-invasive ventilation Life expectancy less than 3 months Hospitalization within the previous 3 months for at least 48 consecutive hours Immunocompromised defined as defined as having leukemia, lymphoma, HIV with CD4 count <=200, splenectomy or on cytotoxic chemotherapy Neutropenic [defined as a PMN count<=0.5x109 cells/L] from any cause Receiving immunosuppressants [defined as >=40 mg prednisone daily (or steroid equivalent) for >=2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Coughing Cough is the main or only clinical symptom and was persistent for 3-8 weeks Chest X-ray reveals no noticeable pathological changes ≥18 year old, regardless of gender and ethical background Not taking angiotensin-converting enzyme inhibitor Patients must join the programme voluntarily and are able to attend examination and follow-up sessions Patients diagnosed with rhinallergosis, chronic nasosinusitis or bacterial respiratory tract infections Patients diagnosed with severe reportorial disease of other severe systemic disease Patients who are allergic to any drugs to be tested Patients who are non-cooperative during examination sessions or other steps of the trial Patients who are not able to or refuse to sign consent | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Cough Cough is the main or only clinical symptom and was persistent for 3-8 weeks Chest X-ray reveals no noticeable pathological changes year old, regardless of gender and ethical background Not taking angiotensin-converting enzyme inhibitor Patients must join the programme voluntarily and are able to attend examination and follow-up sessions Patients diagnosed with allergic rhinitis, chronic nasosinusitis or bacterial respiratory tract infections Patients diagnosed with severe reportorial disease of other severe systemic disease Patients who are allergic to any drugs to be tested Patients who are non-cooperative during examination sessions or other steps of the trial Patients who are not able to or refuse to sign consent | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.167-4.917, Pneumonia Tachypnea History of cough or difficult breathing < 14 days (observed or reported) AND Respiratory rate ≥ 50 breaths per minute in children 2 to <12 months (on two consecutive readings by independent physicians) OR respiratory rate ≥ 40 breaths per minute in children12 months (on two consecutive readings by independent physicians) AND Written informed consent by a legal guardian Previously enrolled in study Pedal edema History of hospitalization in last two weeks With severe lower chest wall in-drawing Known asthmatics,TB or other severe illness Antibiotics taken in last 48 hours Bulging fontanel Congenital heart disease Any surgical condition requiring hospitalization Out of catchment area | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 21.0-59.0, Respiratory Failure Healthy male or female volunteers in the age group Any acute or chronic cardiopulmonary disorder including a simple common cold | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.083-2.0, Bronchiolitis Patients admitted to the pediatric intensive care unit or pediatric nursing unit. Which they are diagnostic of acute viral bronchiolitis (AVB) Presence of cyanotic congenital heart disease no longer for comparing the constants Relative or absolute contraindication CPT techniques included in the protocol Patients diagnosed with moderate or severe gastroesophageal reflux since the PSE gastroesophageal reflux can accentuate a previously exist Patients with laryngeal diseases caused because the cough is a technique that is applied directly to the tracheal wall and can affect the larynx Absence of cough reflects and presence of laryngeal stridor is a contraindication to chest physiotherapy in general Systematic presence of gag reflex as the aspiration of secretions and coughing caused nasobucales stimulate this reflex | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 65.0-999.0, Pneumonia Patients above 65 years old AND at least one infectious sign: T° >38°C or <35°C; C-reactive protein (CRP) >10 mg/L; leucocytes >10,000/mL with >85% polynuclear neutrophils or left deviation AND at least one respiratory sign: cough; purulent sputum; chest pain; localized crackles; recently appeared dyspnea; oxygen saturation (SpO2) <90%; respiratory frequency >20/min AND who will be prescribed antimicrobial therapy for suspicion of low respiratory tract infection AND who will give consent himself or through his support person Diagnosis of pneumonia in the previous six months AND/OR more than 48h of antimicrobial treatment given before hospitalization AND/OR thoracic CT scan performed before hospitalization or of the patient Each patient will be included only once | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 14.0-999.0, Community Acquired Pneumonia Patients > or = 14 years of age Patient meets the of community acquired pneumonia Patient meets the of healthcare-associated pneumonia Patients <14 years of age Patient meets the of hospital acquired pneumonia Known active tuberculosis or current treatment for tuberculosis Non-infectious pulmonary diseases HIV positive | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 14.0-999.0, Community Acquired Pneumonia Patients > or = 14 years of age Patient meets the of community acquired pneumonia Patient meets the of healthcare-associated pneumonia Informed consent to participate in the study is provided Patients participating in a clinical trial or other intervention studies Patients <14 years of age Patient meets the of hospital acquired pneumonia Known active tuberculosis or current treatment for tuberculosis Non-infectious pulmonary diseases （e.g. pulmonary embolism, pulmonary edema, pulmonary vasculitis, interstitial pneumonia） HIV positive | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Community Acquired Pneumonia Be male or female at least 18 years of age Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions Have an acute illness (7 days duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening) Dyspnea New or increased cough Purulent sputum production Chest pain due to pneumonia Have at least 2 of the following vital sign abnormalities Fever (body temperature >38.0°C (100.4°F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature <35.0°C (95.0°F) measured orally or equivalent temperature from an alternate body site) Hypotension (systolic blood pressure <90 mmHg) Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 24 hours before randomization Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms. NOTE: Residence in an independent living facility is permitted Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs (e.g., Pseudomonas aeruginosa, any pathogen of the Enterobacteriaceae Family) or attributable to etiologies other than community acquired bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other fungal pneumonia, viral or mycobacterial infection of the lung) Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis) Have confirmed or suspected pleural empyema (does not sterile parapneumonic effusions) Require mechanical ventilation | 1 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 17.0-70.0, Cough chronic cough group cough lasting ≥ 8 weeks,characterized by irritating dry cough sensitive to fumes，dust,the odorous and cold air with normal chest x-rays. 4.17-70 years old without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result chronic cough group and healty controls group with respiratory tract infection within 8 weeks with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week women during pregnancy or lactation patients with malignant tumours | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.5-3.0, Acute Otitis Media Male or female aged < 407 days or less than/equal to 36 months old and meets recurrent acute otitis media Child has received full ( 3 dose ) infant series of Prevnar 13 Parent/guardian willing to bring to all study visits Any major illness/condition that in investigator opinion would put subject at risk during study Participation in another investigational/interventional trial within 28 days prior or during study. ( Observational study is permitted ) Direct descendant of study site personnel | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 0.0-999.0, Kidney Cancer Sarcoma Diagnosis of peripheral primitive neuroectodermal tumor, including peripheral neuroepithelioma or Askin tumor OR Diagnosis of localized or metastatic Ewing's sarcoma, including the following: Unresectable or metastatic small cell osteosarcoma Unresectable or metastatic other nonrhabdomyosarcomatous soft-tissue sarcomas Unresectable or metastatic other non-osteosarcomatous bone sarcomas Desmoplastic small round-cell tumor Metastatic or non-metastatic Wilms' tumor Immunocytochemistry, electron microscopy, and/or chromosomal analysis may be required to rule out other small round cell neoplasms Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR Not specified | 1 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 0.0-999.0, Neuroblastoma Sarcoma Histologically confirmed GD2 positive tumors which High risk neuroblastoma (stage IV, or N-myc amplified, or localized neuroblastoma multiply recurrent) Recurrent or metastatic osteosarcoma Recurrent or metastatic GD2 positive sarcomas If free of disease, patient must be fully recovered from toxic effects or complications of prior treatments (chemotherapy or surgery) No greater than 6 months since last chemotherapy or surgery before first injection of A1G4 Age Any age Performance status Not specified | 1 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 0.0-999.0, Sarcoma Histologically confirmed recurrent osteosarcoma after initial systemic therapy with doxorubicin Measurable disease Immunohistochemical evidence of 2+ overexpression of HER2 Age Any age Performance status Karnofsky 80-100% Life expectancy Not specified Hematopoietic | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 16.0-999.0, Lung Cancer Adult Soft Tissue Sarcoma Colorectal Cancer Bone Cancer Ovarian Sarcoma Melanoma Colon Cancer Rectal Cancer Breast Cancer Eye Cancer Uterine Sarcoma ENTRY --Disease Characteristics- Histologically documented metastatic cancer of one of the following types: Cutaneous melanoma Ocular melanoma Colorectal carcinoma Non-small cell lung cancer Breast carcinoma Sarcoma HLA-Cw*0702 positive MAGE-12 expression by RT-PCR amplified tissue analysis Failed prior standard therapy Measurable or evaluable disease No renal carcinoma Hormone receptor status: Not specified --Prior/Concurrent Therapy- Biologic therapy: At least 3 weeks since prior biologic therapy for cancer No other concurrent biologic therapy for cancer Chemotherapy: At least 3 weeks since prior chemotherapy for cancer and recovered No concurrent chemotherapy for cancer Endocrine therapy: At least 3 weeks since prior hormonal therapy for cancer No concurrent hormonal therapy for cancer No concurrent steroids Radiotherapy: At least 3 weeks since prior radiotherapy for cancer and recovered No concurrent radiotherapy for cancer Surgery: Prior surgery for cancer allowed --Patient Characteristics- Age: 16 and over Sex: Male or female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 Hepatic: Bilirubin no greater than 1.6 mg/dL AST/ALT less than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No cardiac ischemia, myocardial infarction, or cardiac arrhythmias (if receiving interleukin-2 (IL-2) therapy) Pulmonary: No obstructive or restrictive pulmonary disease (if receiving IL-2 therapy) Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active systemic infections No autoimmune disease, known immunodeficiency disease, or active primary or secondary immunodeficiency Hepatitis B surface antigen negative HIV negative No other active major medical illnesses (if receiving IL-2 therapy) | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 2.0-21.0, Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Kidney Cancer Leukemia Liver Cancer Neuroblastoma Ovarian Cancer Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific Meets 1 of the following Histologically confirmed solid tumor (closed to accrual as of 10/4/2007) that relapsed after or failed to respond to front-line curative therapy and for which no other potentially curative treatment options exist Curative therapy may surgery, radiotherapy, chemotherapy, or any combination of these modalities Eligible tumor types but are not limited to, the following Rhabdomyosarcoma Other soft tissue sarcomas Ewing's sarcoma family of tumors Osteosarcoma Neuroblastoma Wilms' tumor | 1 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-999.0, Arthritis Septic Patients with acute onset of symptoms of less than or equal to two weeks' duration Patients with infection of only the following joints: ankle, knee, hip, wrist, elbow, or shoulder Patients with proven bacterial infection by positive gram stain or culture of synovial fluid and with white blood cell count in synovial flood consistent with infection (75,000 000 cells/mm3.) Cases with negative synovial fluid cultures if positive blood cultures are present and associated with typical inflammatory synovial fluid changes without other identifiable sources of infection and if antibiotic therapy had been initiated earlier to explain negative synovial fluid cultures Monoarticular arthritis Gonococcal infections Infected prosthetic joints Adjacent osteomyelitis preceding joint infection Septic arthritis occurring as an incidental event late in the course of otherwise fatal illness Patients that are 17 years old or less Polyarticular arthritis | 1 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-75.0, Thromboembolism Knee Replacement Hip Replacement Patients undergoing either an elective major hip or knee replacement or revision Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child History of serious active bleeding in last 3 month Concurrent or history of thrombocytopenia ( Platelet< 100x109/L) History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product Acute bacterial endocarditis Congenital or acquired bleeding disease in last 3 months Concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia Concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye Conditions need to leave a tubule in intradural or extradural Contraindication to anticoagulant or condition required to take long term oral anticoagulant Abnormality in hepatic (>1.5x UNL), renal (Clcr < 30ml/min) or cardiac function, uncontrolled hypertension or tumor Concurrent disorder of blood vessel in lower limb | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 50.0-999.0, Knee Osteoarthritis Aged 50 years or over of either gender Radiographic tibiofemoral OA grade 2 or higher, unilateral or bilateral Demonstrated knee OA related dysfunction per WOMAC score Not engaged in a regular exercise program for minimum of 6 months Inability to obtain physician release for exercise High risk health status e.g., uncontrolled medical conditions such as hypertension, diabetes, heart disease, pulmonary disease, high cholesterol, anginal type pain, dizziness or syncope, orthopnea or paroxysmal nocturnal dyspnea, ankle edema, heart palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue or shortness of breath with usual activities Unresolved balance disorder Unresolved neurological disorder History of knee surgery or major knee trauma injury Hip or ankle instability, excessive weakness, surgery or major trauma injury Intra-articular joint injection within 4 weeks of the study | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 16.0-999.0, Edema knee replacement surgery pacemaker cardiac defibrillator other metallic implant than knee arthroplasty | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-45.0, Familial Mediterranean Fever Fulfilling the Tel Hashomer for the diagnosis of FMF [5] Suffering from episodes of exertional leg pain and or exertional ankle edema 18-45 years old On a stable (≥ 2 weeks) dose of oral colchicine therapy Non-smokers with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia) Suffering from muscular or neurological diseases not related to FMF With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-80.0, Osteoarthritis Male or female subjects aged between 18 and 80 years inclusive Subjects who require a primary total knee replacement and are considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol Subjects who are able to give and have given voluntary, written informed consent to participate in this clinical investigation Subjects who have given consent to the transfer of his/her information to DePuy Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups Subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis Subjects who have a fixed flexion contracture of greater than 10º Subjects who are clinically obese i.e. BMI ≥30 Subjects who have, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study Female subjects who are pregnant or lactating Subjects who are known drug or alcohol abusers or have a psychological disorder that could affect follow-up care or treatment outcomes Subjects who have participated in a clinical investigation with an investigational product in the last 3 months Subjects currently involved in any personal injury litigation, medical-legal or worker's compensations claims Subjects who have previously had a prosthetic knee replacement device (any type) of the affected knee Subjects who present with ankylosis of the hip joint on the side to be treated or previous ipsilateral Upper Tibial Osteotomy/High Tibial Osteotomy | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 0.0-21.0, Neuroblastoma Melanoma Osteosarcoma Ewing Sarcoma Diagnosis Part A: Recurrent or refractory neuroblastoma or melanoma Part B: Recurrent or refractory neuroblastoma or melanoma Part C: Recurrent or refractory osteosarcoma and Ewing sarcoma Age: ≤ 21 years of age at the time of enrollment (i.e. participants are eligible until they reach their 22nd birthday) Does not have a clinically significant neurologic deficit or objective peripheral neuropathy (greater than or equal to grade 2). Peripheral (sensory or motor) neuropathy related to limb sparing procedure or amputation is allowed Life expectancy: at least 8 weeks Organ Function: Must have adequate organ and marrow function Performance status: Karnofsky ≥ 50 for > 10 years of age; Lansky ≥ 50 for children < 10 years of age Prior Therapy: Patient must have fully recovered from the acute toxic effects of all prior therapy prior to enrolling on study Prior monoclonal antibody: Participants having received in vivo monoclonal antibodies for biologic therapy or for tumor imaging are eligible provided they did not experience a severe allergic reaction with the antibody Pregnancy or Breast Feeding: Study participants who are pregnant are not eligible for this study. Pregnancy tests must be obtained in girls who are > 10 years of age or post-menarchal within 7 days prior to study enrollment. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during participation in the trial. Breast feeding should be discontinued if a mother wishes to participate in this study Allergy: known hypersensitivity to other recombinant human antibodies An uncontrolled infection | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-90.0, Reduced Knee Flexion Reduced flexibility in AROM of knee extension Pain that is worsened by bending over while legs are straight Impaired gait pattern Ability to understand informed consent and experiment responsibilities Fractures Knee sepsis Osteomyelitis or any orthopedic infection Extensor mechanism dysfunction Psoriasis Knee joint neuropathy Previous Stroke or Brain Injury | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-999.0, Total Knee Arthroplasty Knee Pain Primary, bilateral TKA Age 18 years or older Postoperative analgesic pain includes bilateral continuous femoral nerve blocks Chronic, high-dose opioid use History of opioid abuse Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles Pregnancy Incarceration | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 1.0-50.0, Osteosarcoma Age > 1 year and < 50 years First osteosarcoma relapse, either local or metastatic, or second relapse after exclusive surgery NB: Whenever possible, only patients with histological evidence of relapse will be included Indication for chemotherapy confirmed by a multidisciplinary committee Surgical resection of all tumor sites must be possible, either as first-line therapy or after chemotherapy Lansky score ≥ 60%, or ECOG Performance Status ≤ 2 ≥ 21-day interval after first-line chemotherapy Blood tests, renal and liver functions within the normal range for age with, in particular, 7 days prior to study entry, blood or serum values as follows blood: neutrophil count > 1 G/L; platelets >100 G/L renal: serum creatinine ≤ 1.5 x ULN depending on age; patients with serum creatinine values > 1.5 x ULN are eligible if creatinine clearance is > 70 mL/min/1.73 m² liver: total bilirubin < 2 x ULN; ASAT and ALAT ≤ 5 x ULN Patients with multiple relapses for whom surgical resection seems impossible, even after chemotherapy Patients already treated with high-dose chemotherapy regimens Patients with a contra-indication to the treatment proposed Patients not eligible for leukapheresis Two-year follow-up impossible due to social, family, geographic or psychological reasons Patient included in another protocol of clinical research Pregnant or lactating women | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 40.0-76.0, Osteoarthritis of the Knee Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to entry into the Screening Period (Day -3) Subject has OA pain of the Target Knee with a WOMAC Pain Subscale baseline value of > 9 at the Baseline/Randomization Period (Maximum score is 20 for 5 questions with 0 = none; 4 = extreme Subject must have a Functional Capacity Classification of I-III Subject has taken a stable dose of NSAIDs or COX-2 inhibitor agents for OA pain for at least 22 of the previous 28 days and for each of the 2 days prior to the Screening Period (Day -3) and for at least each of the 2 days prior to the Baseline/Randomization Period (Day 1). Subject must also, agree and be expected to remain on this stable daily dose throughout the study Subject is between 40-75 years of age Diagnosis of OA is present for at least 6 months according to the ACR for OA of the knee Radiographic evidence of OA of the Target Knee (within the last 3 years) with a Kellgren-Lawrence scale of 2 or 3 Subject is generally in good health Subject is expected to be compliant with study procedures Females of child-bearing potential must have a negative urine pregnancy test at Screening Presence of tendonitis, bursitis, partial or complete joint replacement of Target Knee Presence of active skin disease, erythema, infection, wound or irritation near the treatment area of the Target Knee Subject has history of frequent headache or other painful conditions (other than OA) that is expected to require any use of systemic opiates or derivatives, or more than twice a week additional administration of different oral NSAIDs or COX-2 inhibitors (see Section 6.1, Table 2) Subject experiences regular significant pain due to osteoarthritis or other conditions in the non-target knee or other joints while on stable doses of their current analgesic therapy Subject has an anticipated need for any surgical or other invasive procedure that will be performed on the Target Knee or other part of the body during the course of the study OA secondary to local joint disorders (e.g., mechanical disorder, internal derangement of the knee), systemic metabolic disease, endocrine disorders, bony dysplasia, calcium crystal deposition disease, neuropathic arthropathy, frostbite, congenital abnormalities Subject has history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory OA, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease Subject has active (redness, swelling, fever, etc.) gout/pseudogout within 6 months prior to screening Subject has Type I or Type II diabetes with peripheral neuropathies Subject is extremely obese with BMI ≥ 39 | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 21.0-999.0, Dengue Fever Age ≥ 21years Probable or confirmed dengue a) Confirmed dengue: laboratory confirmation of acute dengue by either i) positive polymerase chain reaction (PCR) for viral ribonucleic acid (RNA), or ii)positive NS1 antigen test with a compatible clinical syndrome b) Probable dengue: Positive acute dengue serology and clinical presentation fulfilling either WHO 1997 or 2009 for probable dengue i) 1997 Acute febrile illness and two or more of the following headache retro-orbital pain myalgia arthralgia rash hemorrhagic manifestations | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-999.0, Urinary Incontinence Subject is a male IC user able to self-catheterise Subject has used hydrophilic-coated ICs for at least 1 month Subject is at least 18 years old Subject has provided informed consent Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease) Subject has known abnormalities in the lower urinary tract | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 0.0-999.0, Sarcoma Diagnosis of localized or metastatic osteosarcoma Banked snap-frozen tumor tissue samples and paired blood DNA samples available Not specified Not specified | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-75.0, Healthy Healthy males or females Abdominal surgery other than appendectomy, laparoscopic cholecystectomy, cesarean section, vaginal or laparoscopic hysterectomy or tubal ligation A history of chronic gastrointestinal or systemic illnesses that could affect gastrointestinal motility Any history of hypertension Use of medications that may alter gastrointestinal motility or interact with the study medications Use of any of the study medications within the past 30 days Pregnancy Chronic renal insufficiency (serum creatinine >1.5 mg/dL) Psychiatric or psychologic dysfunction | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-999.0, Joint Disease Patient is of legal age and skeletally mature Patient requires primary total knee arthroplasty due to non inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, a vascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., Rheumatoid arthritis) Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk The patient will be available for follow up throughout the duration of the study Patient is unable to have an MRI scan due to the following conditions Cardiac pacemaker Surgical clips in head (aneurysm clips) Some artificial heart valves Electronic inner ear implants Metal fragments in eyes Electronic stimulators Implanted pumps Patient has active infection or sepsis (treated or untreated) Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 15.0-30.0, Knee Instability The anterior drawer laxity of the knee joint in this study was defined as anterior displacement over 3 mm discrepancy between bilateral knee joints by a KT-2000 test under 20-pound force anterior displacement less than 3 mm discrepancy between bilateral knee joints by a KT-2000 test under 20-pound force | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-999.0, Osteoarticular Infections Patient are more than 18 years old Patient who do not declined to have his medical records reviewed for research Spondylodiscitis (S) group Patients suspected of Discitis and/or Vertebral Osteomyelitis is defined by the need of spinal biopsy in infectious context. Spinal biopsies will be justified by one or more clinical or imaging findings Clinical presentation Spinal pain unrelieved by rest Localized tenderness, Neurological deficits or limited range of motion Fever > 38°C Imaging findings (plain radiographs, MRI or CT) Erosions of end plates on adjacent vertebral bodies Patients already include Patient without health insurance Antibiotic treatment before sampling does not constitute an criterion for control groups Patient with one or more Suspicion of concomitant infection defined by a fever >38°C and CRP > 10mg/l Arthrosis treated by infiltration in the 6 months which preceding Rapidly progressive arthrosis Prosthesis loosening or bone necrosis presumed to be aseptic Patients with prior spinal instrumentation or surgery | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-999.0, Overactive Bladder Women >18 years of age A score of > 4 on the OAB-q short form for urgency (question 1) Average urinary frequency > 10 times in one 24 hour day based on a 3-day voiding diary Self-reported bladder symptoms present > 3 months Self-reported failed conservative care (e.g., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.) or use of antimuscarinics Off all anti-muscarinics for at least 2 weeks prior to enrollment Capable of giving informed consent Ambulatory and able to use a toilet independently, without difficulty Capable and willing to follow all study-related procedures The patient is pregnant or intends to become pregnant during the course of the study. (Patients becoming pregnant during the course of the study will immediately be terminated from the study.) The patient has an active urinary tract infection Neurogenic bladder Botox use in bladder or pelvic floor muscles in the past year Pacemakers or implantable defibrillators Primary complaint of stress urinary incontinence Current vaginal infection Current use of InterStim Current use of Bion Current use of TENS in the pelvic region, back or leg | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 2.0-35.0, Osteosarcoma Lung Metastases Must be between 2 and 35 years of age at time of diagnosis Must have biopsy-proven, high-grade osteosarcoma Patients with metastases are eligible as long as the lung is the only site of metastatic disease The primary tumor and all pulmonary metastases must be deemed to be potentially resectable. There must be a commitment by the surgical team to resect the primary tumor at week 12, and pulmonary nodules at any point, unless the clinical situation indicates these interventions are not in the patient's best interest Patients must have normal laboratory values and cardiac function as defined below Creatinine clearance or radioisotope GFR of > or equal to 70ml/min/1.73 m2 OR A serum creatinine based on age/gender as follows Age Maximum Serum Creatinine (mg/dL) Male Female month to < 6 months 0.4 0.4 6 months to < 1 year 0.5 0.5 to < 2 years 0.6 0.6 Patients with any low-grade osteosarcoma, post-radiation osteosarcoma, and osteosarcoma associated with Paget's disease are not eligible Patients with metastases other than lung metastases are not eligible Patients may not have received prior chemotherapy | 1 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 45.0-79.0, Knee Osteoarthritis A female is eligible if she is of Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post menopausal Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly Pregnancy test result of negative at screening Primary Knee OA(Osteoarthritis) on medial femorotibial compartment based on ACR(American College Rheumatology) Criteria ACR : With Knee pain and satisfied at least 1 of 3 (① age > 50 years, morning stiffness < 30 minute, ③ Presence of Crepitus and Osteophytes on motion) Appropriately signed and dated informed consent has been obtained Rheumatoid arthritis or inflammatory arthritis Bilateral total knee replacement already treated, or planning for the procedure Knee prosthesis already implanted, or foreseen within the next year Clinically significant hip osteoarthritis Severe renal insufficiency defined as creatinine clearance < 30ml/mln(Cockcroft formula) Clinically significant pulmonary, hepatic, renal or heart disorder or diagnosis crucial disease by investigator ( Glycosuria(Diabetes mellitus) or asthma patients are excluded from this clinical study and the patients who has a clinically significant disease are also excluded.) MRI contraindications : overweight, inferior limb diameter non-fitting the knee antenna, inserted pace-maker, metallic prosthesis( if known to interfere with MRI procedure or if known to be unsafe for MRI), metallic clips, insulin pump, cytostatic pump, hearing aid, essential tremor, claustrophobia, etc Allergic reaction to Clinical trial medication Other clinical trial drugs during the 1 month prior to the screening visit | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 0.0-999.0, Arthrogryposis Craniofacial Abnormalities Syndrome Group Freeman-Sheldon syndrome Sheldon-Hall syndrome Distal arthrogryposis type 1, or Distal arthrogryposis type 3 Deceased patients with enough clinical information available to satisfy study requirements Syndrome Group Individuals not confirmed to have a condition under study Deceased patients without enough clinical information available to satisfy study requirements Patients with other anomalies, not having one of the above syndromes Patients or parents of minor children not willing to give consent Mature female patients who are pregnant or breast-feeding will be reassessed for consideration for enrolment Mature female patients who are currently experiencing menses will be reassessed for consideration for enrolment Patients with active, acute comorbid illness will be reassessed for consideration for enrolment Control Group Subjects must be healthy and free of active disease Subject or parent of minor child must be willing to give consent | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-999.0, Linear or Emi-linear Incisions Total Hip Arthroplasty Total Knee Arthroplasty Subject must be ≥ 18 years of age Subject must, at the treating physician's determination and definition, be an appropriate Candidate for primary total hip or knee arthroplasty Subjects who undergo primary total knee or hip arthroplasty must have a linear or semi-linear incision whose length and curvature should fit within the dimensions bound by the polyurethane foam (10 inches in length by 2.5 inches in width) Subject is able and willing to provide written informed consent and comply with visit schedule Subject must agree to avoid application of tanning lotions or exposure of ultraviolet radiation from sun or artificial sources such as a tanning bed on operative area for the duration of study participation Subject must not be pregnant if of child-bearing potential, or otherwise must be surgically sterilized or unable to conceive. All females, regardless of child-bearing potential, will receive a urine hCG test 2 weeks prior to surgery and the test result must be negative for pregnancy Subjects who are of child-bearing potential must be utilizing an acceptable method of birth control (eg, birth control pills, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch, etc) and be willing to continue birth control for duration of study participation. If birth control method is the form of birth control pills, shots, implants skin patches, or IUD, the method must have been utilized for at least 30 days prior to study participation Subject must be willing to wear loose fitting clothing for duration of treatment period Subject must be willing to comply with visit schedule for the duration of the study Positive pregnancy test confirmed by hCG in urine Current or past (30 days prior to surgery) within time of screening attempts to become pregnant Current local or systemic infection (eg, skin infections, sinus infections, urinary tract infection, sepsis, etc) Current or past (14 days prior to surgery) within time of screening topical treatments on operative area (eg, laser hair or tattoo removal, sunless tanning lotions) Current or past (14 days prior to surgery) steroid topical therapies on operative area Current or past (30 days prior to surgery) use of oral steroids (NOTE: Use of non-topical, ophthalmic or aerosol types of steroids (ie, inhaled corticosteroids) are permitted at screening and throughout the clinical trial) Current or past (72 hours prior to surgery) within surgery use of antihistamines Current or past (30 days prior to surgery) within time of screening use of oral Tetracycline or AcutaneTM or topical Tetracycline or AcutaneTM on the operative area Presence of skin lesions or abnormalities on operative area Current or past malignancy requiring immunosuppressant therapy or chemotherapy within 5 years within time of screening | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-75.0, Arthroscopic Meniscal Surgery Male and female patients between 18 and 75 years of age Good general health condition Signed written informed consent Patients with necessity for arthroscopic meniscal surgery Ensured compliance of subject over the whole study period Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion Knee joint arthroscopy in study relevant joint within 6 months prior to study inclusion Patients with known hypersensitivity to the investigational device (i.e. active compound and excipients) or any component or procedure used in the study Contraindication for the use of the investigational product or for the scheduled arthroscopy, used anesthesia and post-surgical treatment Concomitant disease of sufficient severity (e.g. uncontrolled diabetes mellitus, carcinoma, etc.), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study Concomitant disease of sufficient severity at study relevant joint (e.g. known or suspected infection, peripheral neuropathy or presence of hemarthros) List of concomitant medications not allowed which interfere with the functional assessments of this study Use of medication contraindicated for arthroscopic surgery Intra-articular treatment with a sodium hyaluronate-based product within the last 6 months or use of corticosteroid containing substance within the last 3 months at study relevant joint Recent history of drug and/or alcohol abuse (within the last 6 months) or patients with severe mental illness or suicidal tendency | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-99.0, Urinary Incontinence includes English-speaking women over the age of 18 who have been admitted to the Rehabilitation Institute of Chicago with reports of urinary incontinence in the past 3 months. Those who report "yes" to the screening questions who fit the above will be screened by the principal investigator to ensure they fall into the criteria Non-English speaking women under the age of 18, or those that do not give consent to participate in the study will not be enrolled. Also excluded will be any woman who has any chance of being pregnant or having an active urinary tract infection. No women with active infection lesions, unknown vaginal bleeding or those who have never had any kind of pelvic examination will be included in the study. Other women with a neurogenic bladder or admission FIM scores on sections Comprehension and Memory of below 4. Women with reports of significant pelvic pain or recent pelvic surgery or radiation or post-partum in last 6 months will be excluded | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 2.0-4.917, Influenza Healthy male or female child at least 24 months of age and no older than 59 months of age at the time of study vaccination A child whose parent or guardian's primary residence, at the time of study vaccinations, is within the Kamalapur surveillance site catchment area and who intends to be present in the area for the duration of the trial A child whose parent or legal guardian is willing to provide written informed consent prior to the participant's study vaccination Has any serious chronic disease including progressive neurologic disease, tuberculosis, Down's syndrome or other cytogenetic disorder, or known or suspected disease of the immune system Is receiving immunosuppressive agents including systemic corticosteroids during the two weeks prior to study vaccination Has a history of documented hypersensitivity to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with life-threatening reactions to previous influenza vaccinations Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks before Lives in household with somebody currently participating in a respiratory vaccination or antiviral study Has current or past participation (within 2 months of trial enrollment visit) in any clinical trial involving a drug or biologic with activity against respiratory disease Has any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the child | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-75.0, Irritable Bowel Syndrome Age 18-75 years Positive for IBS symptoms by Rome III No prior abdominal surgery (except appendectomy or cholecystectomy Score of 10 or less on either Anxiety or Depression on the Hospital Anxiety/Depression Inventory Patients with significant depression (score of greater than 10 on Hospital Depression Inventory Patients with anxiety (score of greater than 10 on Hospital Anxiety Inventory. However, patients on stable doses of selective serotonin inhibitors (SSRIs) or low dose of tricyclic antidepressants will be eligible | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 0.0-39.0, Localized Osteosarcoma Metastatic Osteosarcoma Recurrent Osteosarcoma Tissue samples from patients with osteosarcomas obtained from the CHTN P9754 clinical trial for patients with non-metastatic osteosarcoma AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 0.0-999.0, Osteosarcoma Samples from the COG tissue repository | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 0.0-999.0, Sarcomas Procurement Diagnosis of refractory or metastatic GD2-positive sarcoma not responsive to standard treatment. Patients with osteosarcoma do not require GD2 testing of their tumor as osteosarcomas are uniformly GD2 positive Either previously infected with varicella zoster virus(VZV; chicken pox) or previously vaccinated with VZV vaccine Karnofsky/Lansky score of greater than or equal to 50 Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent Treatment Diagnosis of refractory or metastatic GD2-positive sarcoma not responsive to standard treatment. Patients with osteosarcoma do not require GD2 testing of their tumors as osteosarcomas are uniformly GD2 positive Recovered from the acute toxic effects of all prior chemotherapy Karnofsky/Lansky score of greater than or equal to 50 Bilirubin less than or equal to 3x upper limit of normal, AST less than or equal to 5x upper limit of normal, Serum creatinine less than or equal to 2x upper limit of normal, Hgb greater than or equal to 9.0 g/dl, ANC>500/uL, platelets > 50,000/uL Procurement • Known primary immune deficiency or HIV positivity Treatment Severe intercurrent infection Known primary immune deficiency or HIV positivity Pregnant or lactating History of hypersensitivity reactions to murine protein-containing products Known allergy to VZV vaccine | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-30.0, Hyperalgesia Asymptomatic subjects who met the criterion of being between 18 and 30 years old rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment development of systemic or degenerative diseases subjects with symptoms of depression according Beck's questionnaire pain in any area between the lower back and head in the last 9 months traumatic event in the past 12 months history of neck or face pain in the last 6 months | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-999.0, Septic Arthritis Major patients hospitalized in Rheumatology, Infectiology, Orthopedy Department (hospital of Nantes, of La Roche sur Yon and of Saint-Nazaire) with a septic arthritis of shoulder, or elbow, or wrist , or hip, or knee, or ankle on native joint, with positive microbiologic culture joint fluid or positive hemoculture; the diagnosis was based on positive histology or imagery with an inflammatory joint fluid if the microbiologic cultures (hemoculture or joint effusion) were negative Presence of material on the targeted joint Age < 18 years old Patients under guardianship Pregnancy | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 50.0-999.0, Total Knee Arthroplasty Pain Nerve Blocks Age > 50 years Patients set to cemented Total knee arthroplasty in spinal block Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully Illness score 1-3 Patients who can not cooperate with the investigation Patients who do not understand or speak Danish Patients receiving immunosuppressive therapy Patients with a treatment-dependent diabetes mellitus Patients with known neuropathy in the lower limbs Allergy to those drugs used in the study Alcohol and / or drug abuse the investigator's opinion Patients who can not tolerate Non steroid analgesic drugs Use of strong opioid several times a day (morphine, ketogan, Oxynorm, methadone, fentanyl) | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 45.0-80.0, Osteoarthritis Pain Age 45 to 80 years old, inclusive Clinical diagnosis of osteoarthritis in one target knee based on the following American College of Rheumatology (ACR) Knee Pain At least 1 of 3 Age > 50 years Morning stiffness lasting < 30 minutes Crepitus on motion Osteophytes on radiograph Symptoms associated with osteoarthritis of the knee (including pain) for ≥ 6 months prior to Screening Knee pain associated with osteoarthritis, which required NSAID or other therapy for ≥ 15 days during the preceding month General Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential may not be entered into the study if They are or intend to become pregnant (including use of fertility drugs) during the study They are nursing They are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit and maintained at the same dosing level throughout the 9-week clinical trial.) Body Mass Index (BMI) over 40 A history of osteoarthritis symptoms that are completely non-responsive to non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator Planned change (increase or decrease) in subject's level of physical activity (e.g., aerobic or anaerobic exercise) during the 6-week Treatment Period following randomization Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01 or OLT1177-02 | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 1.0-35.0, Sarcoma Osteosarcoma Neuroblastoma Melanoma Diagnosis (a) Osteosarcoma, neuroblastoma and melanoma that have been treated with standard frontline therapy and are judged to be incurable with standard therapy, based upon the fact that they are unresectable, metastatic, progressive/persistent or recurrent Evaluable disease must be present i) For all histologies except osteosarcoma and neuroblastoma, pathologic review of frozen tissue must document GD2+ expression. Positive expression is defined as at least 2+ expression (0-4+ scale) in > 50 percent of the tumor cells using anti-GD2 mAb 14G2a. If adequate archived frozen tissue is available, this may be utilized, or if not, patients may undergo biopsy following enrollment to obtain tissue to assess GD2 expression, with the following restrictions ii) Patients with histologies other than osteosarcoma or neuroblastoma must have adequate accessible tumor for biopsy (at least 1 cm diameter) iii) Procedures employed to acquire biopsies for tumor lysates will be limited to percutaneous needle or core biopsies, thoracoscopic excision or open biopsies of readily accessible lesions. Pulmonary lesions may be biopsied but extensive surgery such as thoracotomy or laparotomy should not be employed iv) Patients who will require biopsy should not be enrolled if in the opinion of the principal investigator, the tumor site places the patient at substantial risk from the biopsy procedure Weight greater than or equal to 15 kg Age less than or equal to 35 years old at the time of enrollment Prior Therapy Concurrent Illnesses Clinically significant systemic illness (e.g. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgment of the PI would compromise the patient s ability to tolerate protocol therapy or significantly increase the risk of complications Peripheral nerve symptoms from prior therapies or from tumor compression > grade 1 Untreated CNS metastasis Extradural masses that have not invaded the brain parenchyma or parameningeal tumors without evidence for leptomeningeal spread will not render the patient ineligible. Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible Prior Therapy Previous treatment with genetically engineered GD2-CAR T cells. Previous vaccine therapy, anti-GD2 mAb therapy or therapy with other genetically engineered T cells is not an Lactating or pregnant females (due to risk to fetus or newborn) Active HIV, HBV or HCV infection Immune Therapies | 1 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 5.0-12.0, Cerebral Palsy age 5 to12 years inclusive assessed as GMFCS Levels II or III able to follow testing instructions, and participate in a minimum of 30 minutes of active PT able to reliably signal pain, fear and discomfort have passive range of motion (ROM) of hips and knees within minimum range requirement for Lokomat (hip and knee flexion contracture < 10 degrees, and knee valgus < 40 degrees) client of Child Development Program at Holland Bloorview able to commit to attendance of twice weekly for eight weeks (to support the primary efficacy analysis) a fixed knee contracture > 10 degrees, knee valgus >40 degrees such that robotic leg orthosis will not be adaptable to lower limbs hip instability/subluxation > 45% orthopaedic surgery within the last 9 months (muscle) or 12 months (bone) Botulinum toxin-A (BTX-A) injections to lower limb in the last 4 months inability to discontinue BTX-A for period of 6 months (during trial) due to concerns about ROM or pain severe spasticity may be a contraindication any weightbearing restrictions seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months) open skin lesions or vascular disorder of lower extremities not able to co-operate or be positioned adequately within the Lokomat as shown during the two Lokomat fitting/acclimatisation sessions | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-65.0, TBI Traumatic Brain Injury Age > 18 years Brain injured patients with a diagnosis of NHO around the hip and/ or knee for a period of greater than one year Patients who are able, or legal guardians who are willing, to provide informed consent after both oral and written information Pregnancy Rheumatoid arthritis, ankylosing spondylitis, or femoral neck fractures Elevated serum alkaline phosphatase (SAP) levels and/or evidence of active bone remodelling in bone scan | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 16.0-65.0, Osteochondral Lesion of Talus Degenerative Lesion of Articular Cartilage of Knee single osteochondral lesion in knee/ankle (2-4 sq cm) multiple osteochondral lesions pre-existing injuries/arthropathies | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 50.0-100.0, Peripheral Nerve Block Pain Age> 50 years Patients set to cemented Total knee arthroplasty in spinal block ASA 1-3 Patients who can not cooperate with the investigation Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully Patients who do not understand or speak Danish Patients receiving immunosuppressive therapy Patients receiving glucocorticoid daily Patients with a treatment-dependent diabetes mellitus Patients with known neuropathy in the lower limbs Allergy to those used in the study drugs Alcohol and / or drug abuse the investigator's opinion | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-999.0, Osteoarthritis of Hip Osteoarthritis, Knee Planned primary unilateral THA or TKA Patients (male/female) ≥ 18 år Patients giving written informed consent and authority Patients receiving spinal anaesthesia Patients with intolerance to trial medications Rejection of or contraindicated spinal anaesthesia Patients with rheumatoid arthritis Patients with Body Mass Index (BMI) ≥ 35 Patients that do not read or write Danish | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 16.0-40.0, Primary Hypertrophic Osteoarthropathy diagnosed with primary hypertrophic osteoarthropathy clinically over 16 years old no other medication intake informed consent signed below 16 years old active gastric ulcer inflammatory bowel disease New York Heart Association classification（NYHA） II to IV liver or renal failure allergic to nonsteroid anti-inflammatory drugs not willing to participate | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 1.0-49.0, Recurrent Osteosarcoma Patients must have had histologic verification of osteosarcoma at original diagnosis or relapse Patients must have measurable disease according to 1.1, and have relapsed or become refractory to conventional therapy Patient must have archival tumor specimen available for submission Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea) Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation Monoclonal antibodies: must not have received any monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks, prior to study enrollment Must not have received other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study enrollment Patients with > grade 2 neuropathy according to the Modified ("Balis") Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery Patients who have previously received glembatumumab vedotin (CR011-vcMMAE; CDX-011) or other monomethyl auristatin E (MMAE)-containing agents Patients with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin; compounds of similar composition auristatin PHE as an anti-fungal agent, auristatin PE (TZT-1027, Soblidotin, NSC-654663) as an anti-tumor agent and symplostatin 1 as an anti-tumor agent Female patients who are pregnant are ineligible Lactating females are not eligible unless they have agreed not to breastfeed their infants Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met | 1 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 1.0-6.0, Caudal Block Patients aged 1-6 years, classified as American Society of Anesthesiologist (ASA) 1 and 11 who are undergoing herniotomy and whose parents or legal guardian has duly signed an informed consent form Patients with hypersensitivity to any local anesthetics Children with Bleeding diathesis Presence of Infections at puncture sites Preexisting neurological disease Patients with diabetes mellitus Failure to consent by parents | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 1.083-40.0, Recurrent Osteosarcoma Patients must have recurrent high-grade OS verified by histopathology review by MSKCC's Department of Pathology Patients must be in a ≥2nd complete remission as indicated by appropriate radiologic evaluations at the time of study entry Patients must be older than 1 year of age and less than or equal to 40 years of age Prior therapy: ≥3 weeks should have elapsed since last cytotoxic therapy, immunotherapy or radiation therapy. More than one week should have elapsed since major surgery Adequate hematopoietic function defined as Absolute neutrophil count ≥ 500/ul Absolute lymphocyte count ≥ 500/ul Platelet count ≥ 50,000/ul (transfusion independent) Adequate hepatic function as defined by Total bilirubin of ≤ 1.5 times upper limit of normal (exception is made for patients with Gilbert's syndrome who may be considered eligible if total bilirubin is ≤ 3 times upper limit of normal) Patients with OS in first complete remission Presence of overt metastatic disease at any site Active life-threatening infection Pregnant women or women who are breast-feeding Inability to comply with protocol requirements | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 0.0-999.0, Infection Immune Deficiency Hypogammaglobulinemia Septic Arthritis Mycoplasma Hominis Adult with decision making capacity afflicted with chronic mycoplasma hominis septic arthritis despite standard treatments | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 18.0-999.0, Periprosthetic Joint Infection Septic Arthritis adult of 18 or more years written consent to participate in study suspicion of septic arthritis or periprosthetic joint infection joint aspirate minimum of 5 ml is not able to understand the aim or purpose of this study empty joint aspirate | 0 |
A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion. | eligible ages (years): 0.0-999.0, Childhood Solid Tumor for the safety and feasibility testing of AV0113 Male and female patients with a malignant neoplasia shall be eligible for this protocol provided they have no more "conventional" treatment options and have measurable disease. There is no age limit for participation in this study provided that the tumour is typical for the group of refractory solid neoplasias of childhood Patients must not be HIV-positive Patients must have primary tumour tissue or cells available at sufficient number to allow treatment according to the protocol Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form for patients included in the long-term follow up and comparison with historic controls Patients suffering from bone or soft tissue sarcoma that received treatment with AV0113 or are documented in the database of the Medical University Vienna's Department of Orthopaedics At least one disease recurrence after first CR or worse disease condition (e.g.: never reached CR) Diagnosis between 1992-2003 and/or "inclusion time point" during the years 2000-2004 Availability of date of death or of confirmation that patient is still alive (for the currentness of confirmation that patients are still alive only the time span from 1 April 2014 to 1 April 2015 is accepted) for the safety and feasibility testing of AV0113 Any of the not met Any condition which, in the investigator's opinion, may pose a risk to the patient or will interfere with the study objectives for patients included in the long-term follow up and comparison with historic controls Date of "inclusion time point" and death or confirmation that patient is still alive at time of evaluation not available | 1 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 0.0-999.0, Ectopic Pregnancy Confirmed diagnosis of ectopic pregnancy via D&E without products of conception identified on frozen pathology or VABRA without products of conception identified with pathologic evaluation or Ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole the subject is hemodynamically stable without signs of hemoperitoneum laparoscopy has not been performed the subject is able to return for frequent follow-up care normal renal and liver function have been documented within 2 days normal white blood count and platelet count have been documented as per laboratory standard normal chest x-ray was obtained if the subject has a history of pulmonary disease breastfeeding laboratory evidence of immunodeficiency alcoholism or chronic liver disease the concomitant use of non-steroidal anti-inflammatory drugs blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia active pulmonary disease hepatic, renal, or hematological dysfunction adnexal mass > or = 3.5 cm presence of fetal cardiac motion active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction | 1 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 21.0-40.0, Infertility Female partner age 21 up to 40th birthday, at the time of recruitment. Infertility is defined as failure to conceive a recognized pregnancy after one year (or 12 menstrual cycles) of unprotected intercourse Male partner has a normal semen analysis with a sperm concentration of >15 million total motile sperm, >1% normal forms by strict or >5 million total motile sperm on IUI prep Female patient has at least one ovary and at least one ipsilateral patent fallopian tube confirmed by HSG or laparoscopy; pelvic pathology amenable to operative laparoscopy (pelvis restored to functional). The open tube cannot have had a previous ectopic (tubal) pregnancy and the closed tube cannot be a hydrosalpinx (a tube that is blocked at the end and filled with fluid), unless a tubal ligation has been performed at the junction of the uterus and fallopian tube Patients with surgically corrected stages I and II endometriosis will be included Normal uterine cavity demonstrated by HSG, Sonohysterogram (SHG), or hysteroscopy; pathologies of uterine cavity amenable to operative hysteroscopy (cavity restored to normal and demonstrated by post operative study) Anovulatory patients who did not conceive after a minimum of three ovulatory cycles with any medications, not including gonadotropin therapy. Anovulatory patients unable to achieve ovulation at dosages up to 150 mg of clomiphene or standard dosages of other ovulation inducing medications (i.e. bromocriptine). Hypoestrogenic hypothalamic amenorrhea patients will qualify immediately for prior to any gonadotropin therapy Normal ovarian reserve demonstrated in all patients i.e., cycle day 3 FSH/E2 values of <15 mIU/mL and <100 pg/mL, respectively. Normal TSH and prolactin Female body mass index ≤ 38 Previous tubal reconstructive surgery in which the pelvis was not restored to functional Unilateral or bilateral hydrosalpinx (a tube that is blocked at the end and filled with fluid) that has not had a tubal ligation performed at the junction of the uterus and fallopian tubes A laparoscopy that demonstrated pelvic adhesions or endometriosis for which the pelvis could not be restored to normal by surgery or endometriosis was not ablated or excised. All patients with stages III and IV endometriosis One or more prior ectopic pregnancies in which one or both tubes were rendered nonfunctional; two or more ectopic pregnancies, even if tubes are patent Severe male factor (i.e.; semen analysis with a sperm concentration of <15 million total motile sperm, <1% normal forms by strict or <5 million total motile sperm on IUI prep). Couples using donor semen will be excluded Previous treatment with IUI or IVF. Previous treatment of normal ovulation patients with gonadotropins Inadequate ovarian reserve demonstrating FSH >15 mIU/mL or estradiol > 100 pg/mL Patients requiring gamete intrafallopian tube transfer (GIFT), zygote intrafallopian tube transfer (ZIFT), or tubal embryo transfer (TET) Female body mass index > 38 | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-80.0, Elective Laproscopic Bilateral Inguinal Hernia Elective Laproscopic Cholecystectomy Local ethic committee approval Written informed consent ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic BIH Difficulty in communication Allergy to oxycodone and/or morphine Allergy to local anesthetic History of alcohol and substance abuse Treated depression Chronic use of opioid or tramadol or Pregnancy Obstructive sleep apnea Anticipated fiber optic intubation Severe hepatic or renal impairment | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-45.0, Bilateral Ovarian Disease Female patients aged 18-45 years at screening Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease Pregnant (including ectopic pregnancy) or breastfeeding patient Patients with a documented diagnosis of cancer Patients with a lymphatic, hematologic or coagulation disorder Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™ Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants Patients who have participated in another clinical study within 30 days of enrolment Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 11.0-21.0, CHLAMYDIA INFECTIONS Female to 21 years of age at the time of enrollment Positive for Chlamydia infections by urine or cervical PCR h Chlamydia-negative subject who fits all other Negative pregnancy test Written informed consent provided Signed a HIPAA authorization form Willingness to comply with all the requirements of the protocol Positive pregnancy test Negative for Chlamydia, unless 5th negative subject to be in the control group Any condition that in the opinion of the investigator would interfere with the ability of the potential subject to complete the study or would result in significant risk to the subject | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 21.0-24.0, Chlamydia Trachomatis Infertility Ectopic Pregnancy born in 1974, 1974 or 1976 AND living in Aarhus County October 1007 | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-45.0, Ovarian Cysts Endometriosis Adhesions Female patients aged 18-45 years at screening Patients undergoing elective laparoscopic surgery involving at least one adnexa Pregnant (including ectopic pregnancy) or breastfeeding patient Patients with a documented diagnosis of cancer Patients with a lymphatic, hematologic or coagulation disorder Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™ Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants Patients who have participated in another clinical study within 30 days of enrolment Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 20.0-90.0, Adhesive Capsulitis shoulder discomfort for at least one month limited range of motion of the glenohumeral joint in at least two directions systemic inflammatory joint disease radiological evidence of bony abnormality of the shoulder full-thickness rotator cuff tear acute systemic medical illness history of major trauma or surgery involving the shoulder contraindication to intra-articular, local anesthestic injection | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 21.0-45.0, Unplanned Pregnancy Currently pregnant with a single gestation of at least 27 completed weeks estimated gestational age, with no complications of pregnancy including, but not limited to, preeclampsia, non-gestational diabetes, anemia Desires to use intrauterine contraception (IUD) after delivery Anticipates having a vaginal delivery No intention to leave the area 7 months after enrollment Able to consent to participate in the study in English Has no known uterine anomalies Has no allergies to any components of the intrauterine contraception Prior cesarean delivery Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy Allergic to betadine Allergy to lidocaine Medical or personal conditions which in the judgment of study staff contradict participation in the study Any contraindications to use of the levonorgestrel-releasing intrauterine contraceptive system which includes: known or suspected breast carcinoma, acute liver disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in situ After enrollment, and after delivery of the infant but before IUD insertion subjects will be excluded by checking with the attending obstetric physician and/or obstetric medical chart for the following Endometritis or chorioamnionitis during the intrapartum period Membranes ruptured for greater than 24 hours prior to delivery Fever greater than or equal to 38C | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-60.0, Clinically Severe Obesity Gastroesophageal Reflux Disease Status post, either open or laparoscopic, primary Nissen fundoplication with all the following requirements Met NIH for bariatric surgery With functional or failed antireflux surgery (Nissen fundoplication) Laparoscopic approach for revisional surgery Any other type of revisional bariatric procedure Nonstandard revisional RYGB surgery Open approach for revision surgery Missing records and/or unreachable patients with scant information for analysis | 1 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-999.0, Morbid Obesity The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic sleeve gastrectomy The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic gastric bypass Subjects having any other obesity surgical procedure | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-45.0, Contraception Intrauterine Devices Pilot Study Africa Primary Ages 18-45 attending prenatal care Greater than 34 weeks estimated gestational age Desire to use the CuT380A-IUCD for contraception postpartum Plan to stay in the area for at least 5 months postpartum If HIV+ the women must be WHO Clinical Stage 1 or 2, or known to be clinically well on antiretroviral therapy as documented in their health passport No prior cesarean delivery No treatment for pelvic inflammatory disease within 3 months prior to pregnancy No known uterine anomalies No known pelvic tuberculosis prior cesarean section fever during labor and delivery AIDS, not well on antiretroviral therapy genital tuberculosis known uterine abnormalities or genital tract cancer history of ectopic pregnancy within 3 months of current pregnancy | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-60.0, Morbid Obesity Age: 18 years BMI 35-39.9 kg/m2 with one or more severe co-morbid conditions or BMI 40-55 kg/m2 Willingness to comply with dietary restrictions required by the protocol History of obesity for at least 5 years History of at least 6 months of documented failures with traditional non-surgical weight loss methods Willingness to follow protocol requirements which signing the informed consent form, completing routine follow-up visits for the study duration, and completing all pre and post-operative laboratory and diagnostics tests in addition to the quality of life questionnaire If female with childbearing potential, using an appropriate form of contraception Age less than 18, age greater than 60 Pregnancy History of major depressive disorder or psychosis Previous bariatric surgery or previous gastric surgery Presence of achalasia Any condition that, in the judgment of the investigator, would place a subject at undue risk, or could potentially compromise the results or interpretation of the study | 0 |
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