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A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-50.0, Pulmonary Disease, Chronic Obstructive Healthy adult male or female aged between 18 and 50 years Body mass index within the range 19-29.9 kilograms/metre2 Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7 The subject has an increase in sGAW of >% over pre-dose baseline within 2 h of administration of 400 ug salbutamol by MDI inhaler at screening or in the 3 months before screening Subject has an increase in sGaw of 25% over pre-dose baseline within 2 h following 40 ug ipratropium bromide at screening or in the 3 months before screening Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years A past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject History of respiratory disease Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec Supine mean heart rate outside the range 45-90 beats per minute (bpm) at screening Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort) Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 1 month Infected with the Hepatitis B, Hepatitis C, or HIV virus Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 6.0-17.0, Allergic Rhinitis Patients Patients between 6 and 17 years old Patients with allergic rhinitis Witness Patients between 6 and 17 years old Patients without allergic rhinitis and asthma Rhino-bronchitis infection dated from less than 15 days Patients younger than 6 or older than 17 years | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 5.0-12.0, Asthma Physician diagnosis of asthma for at least a year At least one acute exacerbation of asthma in past 12 months that required a visit to the emergency department, hospitalization or an unscheduled office visit for acute care and/or a course of oral steroids Taking daily controller medications or symptoms consistent with persistent asthma No phone Unable to speak English Child has another disease that requires regular monitoring by pediatrician A sibling is already enrolled in the study Child's primary asthma provider is an asthma specialist | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 12.0-999.0, Allergic Asthma Allergic Rhinitis Allergic asthma or allergic rhinitis age 12+ smokers | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 1.0-45.0, Respiratory Sounds Patient and/or parents/guardian signed informed consent Patients with cough or shortness of breath Chest tubes Skin lesions precluding attachment of sensors Respiratory distress Pregnant women | 2 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 0.25-2.0, Asthma age 3-23 months be delivered at >=37 weeks first wheezing episode written informed consent from guardian chronic illness other than atopy previous systemic or inhaled corticosteroid treatment participation to another study varicella contact if previously intact need for intensive care unit treatment, or poor understanding of Finnish | 2 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 0.5-16.0, Aspirated Foreign Body of Lower Respiratory Tract age between 6 months and 16 years suspicion of a foreign body aspiration health care assurance information of parents emergency situation certainly of foreign body presence delay for CT Scan realization longer than 24 hours no speaking French parents parents refusal | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 6.0-12.0, Rhinitis, Allergic, Seasonal Asthma Children must be >= 6 to < 12 years of age of either sex and any race Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent Children must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations Children's parent(s) or legal representative(s) must understand and be able to adhere to dosing and visit schedules, agree to report concomitant medications and adverse events to the Investigator or designee The diagnosis of seasonal allergic rhinitis with or without intermittent asthma will be assessed by Clinical history of sneezing, rhinorrhea (nasal discharge/running nose or post-nasal drip), nasal stuffiness/congestion and nasal itching and non-nasal symptoms (eye symptoms) as itching, burning, tearing and redness, during the previous pollen season Ascertained skin prick positivity (or RAST positivity) to one of the following: grasses, parietaria, birch, hazelnut (the skin test has to be performed within the last year) Children must be clinically symptomatic with SAR at Visit 1 (day 1): the total (nasal + non nasal) symptoms score must be >= 8 with a nasal congestion score of >= 2, and the non-nasal symptoms severity score must be >= 2 Asthma symptoms (wheezing, cough, difficulty breathing, chest tightness) will be evaluated at visit 1 (day 1) and graded only for child with concomitant asthma Children who have not observed the designated washout periods for any of the prohibited medications Children with persistent asthma (mild, moderate or severe) or perennial allergic rhinitis (PAR) Children with rhinitis medicamentosa Children who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (day 1), or children who have had a viral upper respiratory infection within 7 days prior to Visit 1 (day 1) Children who have nasal structural abnormalities, including nasal polyps and marked septal deviation, that significantly interfere with nasal airflow Children who, in the opinion of the Investigator, are dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids Children with a history of hypersensitivity to desloratadine or any of its excipients Children who have any current clinically significant metabolic, cardiovascular, hepatic, renal, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular or respiratory disease, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect subject safety A known lack of response to H1-antihistamines | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-50.0, Asthma Hypersensitivity for healthy controls Normal lung function, defined as (Knudson 1976/1984 predicted set) FVC of > 80 % of that predicted for gender, ethnicity, age and height FEV1 of > 80 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > .75 Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 Diastolic between 90-60 mm Hg) Symptom Score no greater than 6 (out of a possible 24) for total symptom score with a value no greater than 2 for any one score Negative methacholine inhalation challenge as performed in the screening protocol. (Less than a 20% decrease in FEV1 at a maximum methacholine concentration of 10 mg/ml) --Negative pregnancy test for females Negative allergy skin test (AST) for allergic asthmatics also Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician Use of inhaled steroids, cromolyn or leukotriene inhibitors (montelukast or zafirlukast) except for use of cromolyn exclusively prior to exercise Use of daily theophylline within the past month Use of tricyclics and MAO inhibitors Pregnancy or nursing a baby Cigarette smoking > 1 pack per month Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma | 1 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 3.0-10.0, Asthma All 6 must be met Physician-diagnosed asthma (based on caregiver report with validation from the child's physician) > 2 ED visits or > 1 hospitalization for asthma within past 12 months Mild persistent to severe persistent asthma based on NHLBI guidelines (7-9) having any 1 of the following An average of > 2 days per week of asthma symptoms > 2 days per week with rescue medication use (albuterol, xopenex) OR > 2 days per month of nighttime symptoms Age > 3 and < 10 years Reside in Baltimore Metropolitan area Not currently participating in another asthma study or sibling enrolled in PAAL study Inability to speak and understand English No access to a working phone or alternate phone for follow-up surveys Co-morbid respiratory condition including cystic fibrosis, chronic lung disease (BPD), lung cancer, tracheostomy that could interfere with the assessment of asthma-related outcome measures Children residing in foster care or where consent cannot be obtained from a legal guardian | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-39.0, Asthma Personal history of asthma, eczema, allergic rhinitis or a history of asthma, eczema, allergic rhinitis in the biological father of the child Gestational age between 10 and 18 weeks at the time of randomization Maternal age between 18 and 39 years Not a current smoker English or Spanish speaking Intent to participate for the full 4 years (through Pregnancy and then until the 3rd birthday of the child) Not meeting Gestational age greater than 18 weeks Presence of chronic medical conditions Taking vitamin D supplements containing more than 2000 IU/day of vitamin D3 Multiple gestation pregnancy (twins, triplets) Pregnancy achieved by assisted reproduction techniques (e.g., IUI, IVF) | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 6.0-9.0, Bronchial Asthma Clinical diagnosis of bronchial asthma Must be able to swallow tablets Steroid inhalation or ingestion | 1 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-999.0, Avian Influenza Virus Diseases Be at least 18 years old Be willing to participate by signing a consent form, completing the study questionnaire, and providing a blood sample Less than 18 years old Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy. (Note that we have chosen to such populations because of their increased risk of acquiring infections, they are relatively few, and are not representative of a national sample) Any individual with unknown poultry exposure status, or who was exposed to poultry more than 5 years ago | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 6.0-14.0, Asthma Allergic Rhinitis children with intermittent asthma and allergic rhinitis children with acute respiratory symptoms in the last 4 weeks children with nasal polyposis or bronchial or respiratory tract infections children with a severe exacerbation of asthma resulting in hospitalization during the last month | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 3.0-10.0, Asthma (all 4 must be met) Physician-diagnosed asthma (based on parent report) Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following An average of >2 days per week with asthma symptoms >2 days per week with rescue medication use >2 days per month with nighttime symptoms ≥2 episodes of asthma during the past year that have required systemic corticosteroids Age ≥3 and ≤10 years Attending school in participating Rochester City School District preschools or elementary schools Inability to speak and understand English. (*Parents unable to read will be eligible, and all instruments will be given verbally.) No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number) Family planning to leave the school district within fewer than 6 months The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures Children in foster care or other situations in which consent cannot be obtained from a guardian | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-999.0, Allergic Asthma Allergic Rhinitis Subjects over 18 years old with allergic asthma and/or allergic rhinitis who are beginning allergen desensitization Smokers Subjects of dimished capacity | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-65.0, Asthma male or female to 65 years of age non smoker beta agonist naive for at least 14 days baseline FEV1 at least 70% predicted no respiratory tract infection or allergen exposure (if atopic) within 4 weeks of visit 1 poorly controlled asthma pregnant or lactating women | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-60.0, Asthma Male or female subjects with history of mild atopic asthma between 18 and 60 years-of-age Body mass index (BMI) between 18 and 35 kg/m2 Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes history of mild atopic asthma Used only inhaled short-acting β2-agonists infrequently to treat asthma No current exposure to allergens to which subject experiences asthmatic responses No other lung disease, exacerbations of asthma or lower respiratory tract infections for at least 6 weeks prior to screening Positive skin prick test to common aeroallergens at screening Additional apply History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion History or current medical conditions that are contraindicated for methacholine challenge, such as myocardial infarction or stroke within previous 3 months, known cardiac disease, uncontrolled hypertension and aortic or cerebral aneurysm Evidence of active or suspected bacterial, viral, fungal or parasitic infections within past 6 weeks Subject has know type I/II diabetes History of residential exposure to tuberculosis or has a positive PPD or QuantiFERON test within 4 weeks before randomization Subject who has history of malignancy of any type within 5 years prior to enrollment Subjects tested positive for drugs/alcohol or nicotine use at screening Subjects tested positive for HIV, Hep B or Hep C Additional apply | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 6.0-11.0, Asthma Subjects will females (6 to 9 years of age) and males (6 to 11 years of age) All subjects must have a history of physician diagnosed mild intermittent or mild persistent asthma as documented by PCP medical record or detailed history by study investigator All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination Subjects may be on current treatment with montelukast as this drug does not affect growth. If a subject is on montelukast at screening/baseline, they will remain on a stable dose throughout the study Subjects must be willing to comply with study requirements Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days Subjects will be excluded if they had more than one burst of systemic steroids within the past year Subjects will be excluded if their baseline FEV1 is < 80% predicted Subjects will be excluded if they have any other serious systemic disease other than asthma Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days Subjects will be excluded if they have a history of allergy to any of the study medications, milk protein or lactose Subjects will be excluded if they have active chickenpox or measles or recent exposure to chickenpox or measles Subjects will be excluded if they have any history of tuberculosis of the respiratory tract Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic infections | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-999.0, Asthma Subjects eligible for enrolment in the study must meet all of the following Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated Type of subject: Subjects with documented GP diagnosis of asthma as their primary respiratory disease Current Anti-Asthma Therapy: All subjects must be prescribed maintenance therapy and receiving ICS with or without LABA (either a fixed combination or via separate inhalers), and for at least 4 weeks prior to Visit 2 Other background asthma medication such as anti-leukotrienes are permitted All subjects on ICS monotherapy or ICS/LABA combination (this can be a fixed dose combination or an ICS alone or LABA alone in separate inhalers) must have had symptoms in the past week prior to Visit 2. Symptoms are defined by daytime symptoms more than twice per week, use of short-acting beta2-agonist bronchodilator more than twice per week, any limitation of activities, or any nocturnal symptoms/awakening. (The symptoms are based on subject's recall and are consistent with the GINA and in principal with the BTS/SIGN guidelines) Subject questionnaires: Subjects must be able to complete the electronic subject questionnaires as well as those questionnaires that are completed by phone or provide a proxy e.g. a partner/relative/a friend who can do so on their behalf Gender and Age: Male or female subjects aged ≥18 years of age at Visit 1. A female is eligible to enter and participate in the study if she is of Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH > 40MIU/ml and estradiol <40pg/ml (<147 pmol/L) is confirmatory OR Child bearing potential has a negative urine pregnancy test at Visit 2, and agrees to one of the highly effective and acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study Subjects meeting any of the following must not be enrolled in the study Recent history of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months COPD Respiratory Disease: A subject must not have current evidence or GP diagnosis of chronic obstructive pulmonary disease Other diseases/abnormalities: Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the GP/ Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta2-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the GP/ Investigator, contraindicates the subject's participation will also be excluded Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 2 or within five half-lives (t½) of the prior investigational study (whichever is longer of the two), (if unsure discuss with the medical monitor prior to screening) Chronic user of systemic corticosteroids: A subject who, in the opinion of the GP/Investigator, is considered to be a chronic user of systemic corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening) Subjects who are using LABA without an ICS as asthma maintenance therapy Subjects who plan to move away from the geographical area where the study is being conducted during the study period and/or if subjects have not consented to their medical records being part of the electronic medical records database that is operational in the Salford area | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 12.0-65.0, Asthma Written informed consent Adolescents aged 12-17 years & adults aged 18-65 years (both inclusive) Documented clinical history of severe asthma requiring prednisone/prednisolone therapy, high-intensity treatment ICS, OCS, LABA Stable OCS dose for ≥7 days before Screening Visit & during Screening Period At least 80% compliant w/regular asthma medication per investigator at end of Screening Period Documented asthma reversibility within 5 yrs prior to/during Screening Period, or diagnosis of asthma that is incontrovertible per investigator Ability to use nDPI correctly, per investigator's review of completed inhaler operation checklist Ability to use eDiary correctly, assessed by investigator at end of Screening Period Ability to comply w/study procedures, including blood sampling Ability to perform technically satisfactory pulmonary function tests | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-999.0, CHRONIC OBSTRUCTIVE PULMONARY DISEASE ASTHMA HEALTHY SUBJECTS COPD patients, either male or female, over the age of 40 with a clinical diagnosis of COPD with airflow obstruction(FEV1/FVC<0.7) and post-bronchodilator FEV1>50% predicted, gas trapping (on lung volume testing), and decreased carbon monoxide transfer factor Healthy subjects will be nonsmokers(or exsmokers stopped 5 years ago), will have no respiratory disease, normal spirometry and be age-matched to the COPD patients Asthmatic subjects, either male or female, over the age of 18 with a clinical diagnosis of Asthma with airflow obstruction (FEV1/FVC<0.7) All patients should be capable of giving informed consent Oral corticosteroids taken within last month Current involvement (or involvement in the last 4 weeks)in clinical trials assessing investigational medicinal products Previous adverse reaction to short or long acting β2 agonist Any subject with a contraindication to taking inhaled beta2-adrenoceptor agonists (especially salbutamol) as listed in the British National Formulary will not be entered into this study Those who have experienced an acute respiratory exacerbation requiring emergency room treatment and/ or hospitalisation within four weeks of visit 1 (screening visit) Pregnant or breastfeeding women Subjects unable to give Informed Consent | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 0.5-15.0, Croup Pediatric population: 6 months to 15 years of age or more episodes of croup in 12 month period croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress Grade 3 or 4 subglottic stenosis Subglottic hemangioma Posterior laryngeal cleft Recurrent respiratory papillomatosis External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc) Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease Other medical conditions necessitating chronic steroid utilization | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 5.75-6.5, Focus of Study: Association of Blood DHA and Lutein With Cognition in Children full-term single birth (no multiple births) no major illness or surgery requiring hospitalization likely to impact the outcomes no metabolic, congenital or allergic disease that impact food intakes parents have sufficient command of English language to complete the informed consent and study documents The specific enrollment for Group 1: children consuming <25 mg/day DHA and < 400 μg/day lutein, n=24; Group 2: children consuming >150 mg/day DHA and >1,200 μg/day lutein, n=24; Group 3: children consuming >150 mg/day DHA and <400 μg/day lutein, n=10 children of mothers enrolled in studies by our group that involved randomization to supplemental DHA during pregnancy children for whom blood, diet records or developmental tests at 5 years and 9 months of age are incomplete children consuming 25-150 mg/day DHA or 400-1200 μg/day lutein children of mothers who do not sign the informed consent any children having a cardiac pacemaker, aneurysm clip, cochlear implant of possible metallic foreign bodies in the eyes or other contraindication as detailed in the C&W MRI Patient Screening Form will be excluded from this study | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 50.0-90.0, Pulmonary Disease COPD patients (Global Initiative of Chronic Lung Disease (GOLD) definition COPD stage II, III, IV Patients who are followed in Outpatients' Unit Patients >50 years of age Patients who accept PIF to be measured using the In-Check Inhaler Patients who have signed the Informed Consent Patients who will comply with study demands and procedures COPD stage I patients Patients who are hospitalized Patients <50 years of age Patients who do not accept PIF to be measured using the In-Check Inhaler Patients who have not signed the Informed Consent Patients who face problems in order to comply with study demands and procedures | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 0.167-4.917, Bacterial Pneumonia Viral Pneumonia Acute Asthma children aged 2 to 59 months with cough and or difficult breathing Presence of a serious concurrent illness such as meningitis, Children with congenital or acquired heart disease Severe anaemia Measles pneumonia Foreign body inhalation A confirmed diagnosis of pulmonary tuberculosis | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 1.0-17.0, Asthma Child presented to study institution emergency department during study period Child was 1 years-old Child has physician-diagnosed asthma by parent report Attending physician for child believed emergency department visit was due to asthma Attending physician for child completed informed consent and was randomized to PACCI-ED or control group at beginning of study Child has major pulmonary or cardiac co-morbid illness Family of child was non-English speaking Child was triaged to the med-trauma bay for severe respiratory distress | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-40.0, Memory Functions Healthy, male and female, aged between 18 and 40, BMI be-tween 19 and 27 kg/m2, normotensive (BP between 90/60 mmHg and 140/90 mmHg), native or fluent German-speaking, caucasian (European ancestry), able and willing to give written informed consent and comply with the requirements of the study protocol, willing to donate saliva sample for DNA-analysis - Acute or chronic psychiatric or somatic disorder, tachycardia at rest (> 100 bpm), known hypersensitivity to salbutamol, pathological ECG, pregnancy, breast-feeding, long-term medication within last 3 months (oral contraceptives are disregarded) smoking (>3 cigarettes per day), concurrent participation in another study, participation in one of our previous studies using the same memory tests, inability to read and understand the participant's information. - | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 0.0-72.0, Asthma Parent(s) must speak English Moms age 14 and older (will sign Informed Consent Statement (ICS), not an assent) Mother of child enrolled must have a physician diagnosis of asthma or being treated for asthma Must live within a reasonable distance to the Indianapolis area Child must be between 0-72 hours of age Signed informed consent from parent or legal guardian Must consent to all procedures Child has a history of wheezing or underlying lung disease Prior use of antibiotics Respiratory complications at birth (airway support higher then nasal cannula) Not be able to comply with research procedures or be available for long term follow up as determined by the site investigator Born earlier then 37 weeks gestation Congenital heart defects (not including Patent Ductus Arteriosus (PDA), hemodynamically insignificant Ventricular Septal Defect (VSD) or Atrial Septal Defect (ASD) Underlying neuromuscular disease Severe upper airway obstruction, sleep apnea, tracheomalacia, or laryngomalacia Hydrocephalus History of seizures | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-65.0, Asthma Male/females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent Body weight >=50 kg and body mass index within the range 19.0 0 kilogram per square meter (inclusive) A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study as obtained via a verbal interview with the subject or from the subject's medical records; or postmenopausal defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international units per milliliter (MlU/mL) and estradiol < 40 picograms per milliliter (pg/mL) (<147 picomole per liter) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in listed in protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at screening or urine hCG prior to dosing AND; Agrees to use one of the contraception methods listed in protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until follow-up; OR has only same-sex partners, when this is her preferred and usual lifestyle Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the or outside the reference range for the population being studied may be included only if the Investigator agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures Alanine transaminase, alkaline phosphatase and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) Based on single or averaged corrected QT interval (QTc) values of triplicate ECGs obtained over a brief recording period: QTcF <450 milliseconds Current non-smokers who have not used any tobacco containing products within 3 months of screening and with a total pack year history of <=10 pack years [number of pack years = (number of cigarettes per day / 20) x number of years smoked] Able to use all medical device products included in the study adequately after training Part B Able to tolerate the charcoal block at screening Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) History of sensitivity to any of the study medications, or components thereof (including milk protein allergy) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-999.0, Pulmonary Hypertension All cases referred to the clinic for assessment for possible pulmonary hypertension patients with a cardiac pacemaker or retained temporary pacing wire patients with aneurysm clip non MRI compatible heart valve prosthesis intra orbital metalic foreign body pregnancy metal prosthesis/spinal rods retained shrapnel cochlear implants/bladder stimulator | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-50.0, Mild, Allergic Asthma Age 18-50 of both genders Negative pregnancy test for females who are not s/p hysterectomy with oopherectomy History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine) by the method used in a separate screening protocol FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours or long acting beta agonists for 24 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response Symptom Score (this will be submitted as an attachment) no greater than 16 (out of a possible 24) for total symptom score with a value no greater than 3 for any one score. No more than one score may be greater or equal than 3 subjects must be willing to avoid caffeine for 12 hours prior to all visits Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, history of tuberculosis Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Moderate or Severe asthma Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to prophylactic use of albuterol prior to exercise) Viral upper respiratory tract infection within 2 weeks of challenge Any acute infection requiring antibiotics within 2 weeks of exposure or fever of unknown origin within 2 weeks of challenge Severe asthma Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements Medications which may impact the results of the CCRE exposure, interfere with any other medications potentially used in the study (to steroids, beta antagonists, non-steroidal anti-inflammatory agents) | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 0.5-4.0, Asthma The written informed consent must be obtained from his/her parent or legally acceptable representative. If the investigator can get the oral consent from the patient, the investigator should record so in the informed consent which is signed by his/her parent or legally acceptable representative Ethnic origin is Japanese Aged >=6 months and <=4 years at Visit 1 Male and pre-menarchial female. Pre-menarchial females are defined as any female who has yet to begin menses Patient: outpatient Diagnosis as a pediatric asthma has been made by reference to JPGL 2012 and the document which is of help as evidence should be kept as source document. As for <2 years old, children are going to be diagnosed according to an instruction as follows in JPGL2012 as a reference. There are 3 or more episodes of marked expiratory wheezing, regardless of the presence of respiratory tract infection. It is also needed to confirm that there is asymptomatic period for about a week between each episode. In addition to this finding, if there is at least one of following findings, it is more helpful to diagnose infantile asthma: At least one of parents is diagnosed with bronchial asthma by a physician (including past history); Specific immunoglobulin E (IgE) antibody for inhalation antigen is detected in at least one of parents; Diseased child is diagnosed with atopic dermatitis by a physician (including past history); Specific IgE antibody for inhalation antigen is detected in diseased child; High serum IgE level in diseased child or his/her family (serum IgE level should be determined by considering age); Eosinophils and creola bodies found in sputum (examine nasal discharge eosinophilia and peripheral blood eosinophilia); Expiratory wheezing occurs when there is no airway infection; Expiratory wheezing and labored respiration or oxygen saturation are improved after beta-2 stimulant inhalation A patient who needs to be treated with Inhaled corticosteroid (ICS)/ Long-acting beta 2 agonist (LABA) and fulfill following all conditions: At least one documented exacerbation in that the patient treated with systemic glucocorticosteroids, aminophylline dose intravenous(d.i.v) or continuous isoproterenol inhalation in the 12 months prior to Visit 1. Or a well-documented regular treatment with ICS (FP 200-400 mcg daily or equivalent) continuous use in the 12 months prior to Visit 1; The patient has not received systemic glucocorticosteroids, aminophylline d.i.v., ICS (FP>200 mcg daily or equivalent) or continuous isoproterenol inhalation within 4 weeks prior to Visit 1 A patient who has suffered from upper and lower respiratory tract infection and then received medication within 2 weeks prior to Visit 1 A patient who is diagnosed upper and lower respiratory tract infection at Visit 1. Or a patient who has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available. Or a patient who is suspected to have respiratory syncytial (RS) virus infection and cannot be identified to be negative for RS virus antigen A patient who has respiratory disorder other than bronchial asthma, and the investigator judges the respiratory disorder affect the assessment of efficacy in this study A patient who has unstable liver disease or chronic stable hepatitis B receiving significant immunosuppressive agents due to risk of hepatitis B reactivation A patient who has malformation/foreign particle lodged in an airway. Or subjects who have known, pre-existing, clinically significant gastroesophageal reflux disease , endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment A patient who has or is suspected to have hypersensitivity to study medications, the rescue medication or any ingredients of them A patient who has been treated with another investigational product within 1 months prior to Visit 1 or within five half-lives (t-half) of the prior investigational study (whichever is the longer of the two) As for the patients who has evaluable ECG data at Visit 1, QT interval corrected (Fridericia) for heart rate (QTc[F])>=450 milliseconds (msec). The QT interval corrected for heart rate (QTc) should be based on averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period. As for the patients who don't has evaluable ECG data at Visit 1, if the patient has known prolonged QTc>=450 msec (any correction is valid), the patient will be excluded A patient who is child in care (including foster parent system), or whom the investigator judges inappropriate for the study Randomization Criterion | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-999.0, Asthma Male or female patients aged >=18 years Uncontrolled asthma on medium doses of ICS+LABA with ACQ >=1.5 Pre-bronchodilator FEV1 ≥40% and <80% of their predicted normal value Pregnant or lactating women Diagnosis of COPD Patients treated for asthma exacerbations in the 4 weeks prior to study entry Patients who are in therapy for gastroesophageal reflux disease Patients who have a clinically significant cardiovascular condition | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 7.0-12.0, Asthma Male or female patients with a diagnosis of asthma according to the American Thoracic Society Patients aged 7 to 12 years inclusive Patients able to perform spirometry Patients with FEV1 (forced expiratory volume in the first second) ≥ 80% of predicted normal value after saline Patients with PD20 (provocative dose that reduces FEV1 by 20 %) metacholine lower than 8 mg/ml Patients or responsible relatives willing and able to sign an informed consent form Patients on treatment for or suspected as having glaucoma Patients with known allergy of contra-indications to either salbutamol, ipratropium or their excipients Patients suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum Patients with a history of chest surgery Patients with other respiratory conditions if diagnosed. These pulmonary fibrosis, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary tuberculosis, pulmonary complications of AIDS Patients requiring drugs for the treatment of the acute asthma attack other than the study drugs or oxygen Patients who have been previously recruited into this study Patients with myocardiopathy, pulmonary edema or other life threatening diseases, which in the judgement of the pediatrician precludes their entry into the study Patients with obvious or previously diagnosed serious hepatic or renal disease Patients who have been under the following drugs within the specified periods of time prior to determination of Baseline FEV1 or metacholine challenge | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Male and female patients with moderate to severe stable COPD Patients with a diagnosis of chronic bronchitis and/or emphysema FEV1 <65% of predicted value without regard to prior treatment Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial Patient aged ≥40 years Patients with a smoking history of ≥15 pack-years Patients must have given informed consent to participate in the trial Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans Patients with any of the following untreated angle closure glaucoma hypertrophic obstructive cardiomyopathy tachyarrhythmia recent myocardial infarction (within six months of screening visit) severe organic cardiac or vascular disorder untreated hyperthyroidism diabetes mellitus (after approval of Protocol Amendment 1, the of well controlled diabetic patients was allowed) Patients who are pregnant, or who are planning a pregnancy, and nursing mothers | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 3.0-6.0, Asthma Boys or girls between 3 and 6 years old Presenting to emergency departments with an acute asthmatic attack Requiring nebulised bronchodilator therapy Rint increased by 200 % compared to theoretical Rint Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH) Ipratropium bromide received within four hours before admission First acute asthmatic attack Hospital admission to intensive care with asthma within six months before Hospital admission for asthma during the month prior to Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy Concomitant cardiac disease Life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients Renal or hepatic insufficiency Poorly controlled diabetes | 2 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 0.25-1.0, Behavior infants less than 12 month are permanent residents in the area have no plan to move away during the intervention period are willing to adopt the agriculture activities; and have adequate place and time to adopt developed gardens & backyard poultry production infants with severe acute malnutrition warranting referral to nutrition rehabilitation program with Ready-To-Use Therapeutic foods severely ill infants with clinical complications warranting hospital referral; and infants with obvious congenital or chronic abnormalities that impair feeding or physical growth measurements | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 3.0-17.0, Asthma caretaker is age 18 or older and child is age 3-17 have not controlled as thma residence in King County spoken language is English or Spanish Child is enrolled in a Medicaid managed care health plan offered by Community Health Plan of Washington (CHPW) or Molina Health Plan of Washington, Inc (Molina) Parent/guardian plans to move out of King County within the next year or lacks permanent housing Parent/guardian has a mental or physical disability making it impossible to participate in the protocols The household appears to be unsafe for visitation by the CHW The child has other serious chronic medical conditions (e.g. poorly controlled sickle cell disease, cystic fibrosis) that cause sufficient limitation in functional status so that that asthma control is not a priority The family is enrolled in another asthma research study within the past three years. This is to avoid the potential confounding effect from other studies The child is in foster care or group care settings | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-999.0, Cough Dyspnea Wheezing Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) Referred for CXR and/or CT scan Life threatening medical condition requiring immediate treatment Unable to sit up for a chest ultrasound Unable to consent Pregnant Unable to speak, read and write in English | 2 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-75.0, Asthma History of asthma ≥ 5 years and diagnosed before 40 years old Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) ≥1.5 Pre-bronchodilator FEV1 ≥40% and <90% of their predicted normal value Positive reversibility test Pregnant or lactating women Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Patients treated for asthma exacerbation in the 4 weeks prior to study entry Patients who are in therapy for gastroesophageal reflux disease Patients who have a clinically significant cardiovascular condition | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 12.0-999.0, Asthma Subjects must give their signed and dated written informed consent to participate prior to commencing any study related activities Subjects must be outpatients >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health, for at least 12 weeks prior to Visit 1 (Note: Countries with local restrictions prohibiting enrollment of adolescents will enroll subjects >=18 years of age only) Subjects may be male or an eligible female. An eligible female is defined as having non-childbearing potential or having childbearing potential and a negative urine pregnancy test at Screening and agrees to use an acceptable method of birth control consistently and correctly Subjects must have a FEV1 of >=80% of the predicted normal value Subjects are eligible if they have received mid dose ICS plus LABA (equivalent to FP/salmeterol 250/50 twice daily or an equivalent combination via separate inhalers) for at least the 12 weeks immediately preceding Visit 1 All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use, as needed, for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits If in the opinion of the investigator the subject's asthma is well controlled History of Life-Threatening Asthma, defined for this protocol as an asthma episode that required intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or in the opinion of the Investigator, expected to affect the subject's asthma status or the subject's ability to participate in the study Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or resulting in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1 A subject must not have current evidence of Atlectasis, Bronchopulmonary dysplasia, Chronic bronchitis, Chronic obstructive pulmonary disease, Pneumonia, Pneumothorax, Interstitial lung disease, or any evidence of concurrent respiratory disease other than asthma A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study, whichever is longer of the two Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of inhaler, inhaler or FP 250 History of severe milk protein allergy Administration of prescription or non-prescription medication that would significantly affect the course of asthma, or interact with study drug A subject must not be using or require the use of immunosuppressive medications during the study | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 6.0-15.0, Rhinitis Asthma Inflammation Hypersensitivity Clinical diagnosis of allergic rhinitis and/or asthma Sensitized to more than 1 common aeroallergens Respiratory infection 2 weeks prior to initial visit Children with nasal polyposis History of immunotherapy Unable to complete the test or had limited understanding Use of systemic corticosteroids 4 weeks prior to initial visit Nasal and inhaled corticosteroids 2 weeks prior to initial visit Leukotriene receptor antagonists 2 weeks prior to initial visit | 2 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 14.0-17.0, Allergic Rhinitis Asthma Clinical cases n°: 600 adolescents affected by allergic rhinitis with/without asthma, from 14 to 17 years age Controls n°: 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology Subjects that have not allergic rhinitis with/without asthma diagnosis or are <14 years old or >17 years old | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-999.0, Allergic Rhinitis persistent allergic rhinitis the presence of asthma or nasal polyps acute and chronic upper respiratory infections administration of intranasal or systemic corticosteroids or H1 antihistamines in the past 30 days | 2 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 40.0-70.0, Chronic Obstructive Pulmonary Disease Provide informed consent Males not donating sperm and using adequate contraception or females who are surgically sterile or postmenopausal lead ECG showing:Heart rate 45 to 90 bpm, QTcF≤450 msec, QRS ≤120 msec, PR interval ≤220 msec, no clinically significant abnormality Capable of complying with all study restrictions and procedures including ability to use the study nebuliser correctly BMI 18 to 33 kg/m2 with a minimum weight of 45 kg COPD diagnosis for at least 1 year and clinically stable COPD in previous 4 weeks Demonstrates reversibility to bronchodilator (two puffs of salbutamol followed by two puffs of ipratropium) via spirometry Post-bronchodilator FEV1/forced vital capacity (FVC) ratio of ≤0.70 Post-bronchodilator FEV1 ≥40 % and ≤80% of predicted normal ≥150 mL increase from pre-bronchodilator FEV1 History of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation COPD exacerbation requiring oral steroids in the previous 3 months History of one or more hospitalisations for COPD in the previous 12 months Respiratory tract infection (both upper and lower) treated with antibiotics in previous 12 weeks Evidence of cor pulmonale or clinically significant pulmonary hypertension Other respiratory disorders Previous lung resection or lung reduction surgery Oral therapies for COPD in the previous 3 months and throughout the study Drug or alcohol abuse in the past 3 years Received an experimental drug within 3 months or five half lives, whichever is longer | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 0.5-999.0, Healthy Volunteers Only All children between the ages of 6 months to 12 years of age who are typically developing and born of a full term pregnancy if under 24 months of age, healthy, and English speaking are eligible for in the study. Typically developing children would not have any diagnosed congenital conditions, developmental delay or disability, dyslexia, PDD, ADD, ADHD, or ASD. In addition, we will only enroll subjects if they are from a racial and ethnic group that is still needed to ensure the diversity and representative nature of our sample as set forth in the Planned Enrollment Form. These are the initial screening that will be used Children outside of the 6 month-12 year age range: These years cover early life and are the ages of interest for children s play and are of central significance to the Consumer Product Safety Commission s goals Families not fluent in English: Fluency in English is essential for parents to be able to fill out surveys. Families also need to be fluent in English so that they can comprehend verbal directions given by the experimenter during the testing session. If we included people who were not fluent in English, we would need many additional staff members who speak the multitude of languages of the diverse population of the Washington, D.C metro area to work with participants during the testing session and code the videos after the testing session is complete Children who are sick, not typically developing, born premature (if they are under 24 months of age), blind, or deaf: We must recruit a healthy sample of typically developing children born in a full term pregnancy (if they are under 24 months of age) who are not blind or deaf for this project to remove any potential confounds that atypical conditions may have on children s play. Typically developing children would not have any diagnosed congenital conditions, developmental delay or disability, dyslexia, PDD, ADD, ADHD, or ASD. Including other populations such as deaf or blind children would require a different experimental set up, stimulus toys, and resources (i.e., someone who could convert our surveys to American Sign Language or Braille and could code the videos for the parent child behaviors during those sessions) Children who are not adding to the ethnic and racial diversity of the sample: The goal of our study is to recruit a sample of subjects who are racially and ethnically diverse. By making this diverse sample a priority, we hope that our results will be applicable to the diverse populations residing within the United States. To keep with this goal of a diverse and representative sample of children, we may have to some families if we have already reached the quota of families from that particular racial or ethnic group | 2 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 12.0-999.0, Allergic Rhinitis Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen A previous specific immunotherapy finished at least five years ago had to be successful Contraindications according to the patient information leaflet | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-999.0, Chronic Hepatitis C ≥18 years of age 2 consecutive positive HCV RNA tests at least 6 months after estimated date of infection HCV genotype 1 HCV RNA <6 million copies by Roche TaqMan Assay No evidence of hepatic cirrhosis (as determined by two indices: Fib4<3.25—an accurate test for detecting cirrhosis based on age, AST, ALT and platelets [sensitivity/specificity 76-100/82-91%], confirmed by the fibrosis-cirrhosis index (FCI)<1.25 based on ALT, bilirubin, albumin and platelets [sensitivity/specificity 86/100%]) Drug injection in past 30 days by self-report and physical exam evidence of injection drug use (e.g. track marks) injected with others in past 12 months by self-report Lab values within acceptable range (platelets>50,000, creatinine clearance by Cockroft-Gault>30mL/min, hemoglobin >10g/dL, INR<1.5 x upper limit of normal (ULN) unless stable on anticoagulant regimen or known hemophilia, AST/ALT<10 x ULN) Able to speak English No plans to leave San Francisco area for at least 9 months and either lives or works in San Francisco, or travels to San Francisco at least weekly HIV+ by rapid test or pooled viral load HBV surface antigen + Non-definitive HCV genotype results Previously received treatment for HCV (interferon, ribavirin, or DAA) Taking medications that affect pharmacokinetics of LDV-SOF (proton-pump inhibitors, anticonvulsants [phenobarbital, phenytoin, carbamazepine, oxcarbazepine], rifamycins, rosuvastatin, herbs [St. John's wort, silymarin, echinacea]) History of any of the following Current gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug History of hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage) History of solid organ or bone marrow transplantation Current treatment for cancer | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 16.0-23.0, Cervical Cancer Genital Warts Female with an intact uterus with lifetime history of 0-4 sexual partners Prior Human Papillomavirus (HPV) vaccination Prior abnormal paps History of genital warts | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-70.0, Cervix Neoplasms Women with ONLY the following results on a routine Pap smear Low grade epithelial abnormality Minor changes in squamous cell Minor changes in squamous cells with appearances consistent with Papillomavirus Women aged between 18-70 years Women who are pregnant or planning to become pregnant in the next 12 months Women with previous Pap smear abnormality for 2 years | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 20.0-30.0, Papillomavirus Infection Participated in study 580299/001 and received all three doses of vaccine/placebo Written informed consent obtained from the subject prior to enrollment Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001 | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 15.0-25.0, Infections, Papillomavirus A woman whom the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) A woman between, and including, 15 and 25 years of age at the time of the first vaccination Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent) Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study Subject must have a negative urine pregnancy test Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements Subject must have intact cervix Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8) Previous administration of components of the investigational vaccine Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window Previous vaccination against human papillomavirus (HPV) History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 26.0-999.0, Infections, Papillomavirus A woman who the investigator believes that she can and will comply with the requirements of the protocol A women of at least 26 years of age at the time of the first vaccination Written informed consent obtained from the subject prior to enrolment Free of obvious health problems as established by medical history and clinical examination before entering into the study Subject must have intact cervix Subject must have a negative urine pregnancy test. This test is not applicable to women of non-childbearing potential Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study) A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose (Month 0 Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 84) Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0 the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window Previous administration of components of the investigational vaccine Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period History of HPV infection/treatment or planned treatment to evaluate an abnormal cervical cytology (Pap smear) test, e.g. colposcopy Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 20.0-25.0, Human Papillomavirus (HPV) Infection Papillomavirus Vaccines Cervical Neoplasia Subjects who the investigator/co-investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study A Japanese female subject between, and including, 20 and 25 years of age at the time of the first vaccination Written informed consent obtained from the subject prior to enrolment Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study Subjects must have a negative urine pregnancy test Subjects must be of non-childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series Subject must have an intact cervix Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/control within 30 days preceding the first dose of study vaccine/control, or planned use during the study period Pregnant or breastfeeding women. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to 2 months after the last vaccine dose previous administration of components of the investigational vaccine Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Routine vaccines may be allowed up to 8 days before the first dose of study vaccine Previous vaccination against HPV History of vaccination against hepatitis A or a known clinical history of hepatitis A disease Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-999.0, Papillomavirus Infections HIV Infections HIV-infected men who have sex with men | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 21.0-100.0, Cervical Neoplasia Women in KPNC aged 25 years or older who tested positive for HPV Will also a random sample of women who tested negative for HPV Male Children under 18 | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 26.0-65.0, Cervical Intraepithelial Neoplasia Five-hundred women attending colposcopy and 500 women receiving cytology screening, including 250 unscreened women, will be recruited for the study. Non-pregnant, non-hysterectomized women aged 26-65 will be recruited Women under 26 or over 65 years of age Pregnant women or women having given birth to a child in the past 8 weeks. To insure women included in the study are not pregnant, we will ask women during the consenting process if they are pregnant. Women who answer yes for either query will be excluded. Participants will also receive a reminder call for their 2-week self-collection. At that time, women again will be asked if they are pregnant. If any woman answers yes, she will be instructed to not self-collect Women who have had a total hysterectomy Women who have an overt cancerous lesion visible upon exam by the clinician Other reasons to women the inability to speak English, the appearance of mental incompetence, or refusal to participate or sign the informed consent form | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-999.0, Cervical Cancer Precancerous Condition Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or invasive cervical cancer (ICC), meeting any of the following CIN grade 2-3 or higher Repeated CIN1 (times 6) Abnormal Pap smear (atypical squamous cells of undetermined significance [ASCUS] or worse) HIV seropositive Negative cytology but positive for high-risk human papillomavirus (HPV) Negative cytology and negative HPV HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73) >= 18 years of age < 18 years of age Pregnant at screening Cervix not intact not able to provide informed consent | 2 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 25.0-65.0, Cervical Cancer Screening Women from 25 to 65 years of age, registered with the Medical Services Plain in BC attending a collaborating healthcare provider for routine cervical screening in Metro Vancouver or Greater Victoria pregnant history of invasive cervical cancer no cervix HIV positive or on immunosuppressive treatments unable or unwilling to give informed consent Treatment of moderate or greater dysplasia within last 5 years | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-26.0, Papillomavirus Infections Women between 18 and 26 years of age Women able to consent for themselves Referring Pap smear was ASCUS, + HPV or LGSIL Women who decide they wish to get the Gardasil vaccination series Women who have had previous cryotherapy of the cervix, LEEP or cervical conization Women who had their first Gardasil injection prior to their referring Pap smear Women under the age of 18 Women unable to consent for themselves Women who are pregnant currently trying to conceive Women in an immunocompromised state (diabetes, HIV, on chronic immunosuppressants or steroids, etc) Women who do not want the Gardasil vaccination series | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 15.0-25.0, Infections, Papillomavirus Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study Subjects who participated in study 580299-007 Written informed consent obtained from the subject prior to enrollment Use or planned use of any investigational or non-registered product other than the study vaccine Decoding of the subject's 580299-001 treatment allocation to either the subject or the investigator Administration or planned administration of any other HPV vaccine, other than the vaccine administered in study 580299-001 | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-45.0, Papanicolaou Smear female, between 18 and 45 years of age and must have recently experienced an abnormal pap results within the past 3 months has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives has other concurrent/active STD's has a history of known prior vaccination with an HPV vaccine has a history of recent (within 1 year from date of enrollment) or ongoing alcohol abuse or other drug abuse | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 25.0-55.0, Patient With Invasive Cervical Carcinoma Patient With CIN Lesion Patient With HPV Infected Patients Without Histopathologic Lesion Normal Populations. Healthy volunteers People infected with HPV type 16 but without CIN lesions Patients with CIN lesions Patients with cervical cancer from National Taiwan University Hospital Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-24.0, Cervical Cancer Precancerous Condition Currently enrolled in a college, university, or community college in the Greater Cleveland metropolitan area Currently single and never married Not specified Not specified | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-999.0, Cervical Cancer years and older Ability to speak and clearly understand English Female patients No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.) Women who have had Pap smears within the previous 10 months Women under the age of 18 Women who are pregnant Inability to give informed consent in English | 2 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 25.0-80.0, Cervical Cancer Healthy volunteers People infected with HPV type 16 but without CIN lesions Patients with CIN lesions Patients with cervical cancer from National Taiwan University Hospital Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-26.0, Human Papillomavirus Infection Between the age of 18 and 26 years Registered female sex worker living in Lima Healthy with no known immune deficiency Willing to participate in a study of HPV vaccine including a Pap smear, three pregnancy tests, blood draws, and three vaccine administrations over 7 months Willing to provide informed consent Currently pregnant or planning to get pregnant in the next six months Known immune deficiency disorder Current receipt of immunosuppressive drugs Allergy to yeast or known contraindication to HPV vaccine Women who have had their cervix removed Previous HPV vaccination Current fever over 100 degrees Fahrenheit | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 9.0-26.0, Inflammatory Bowel Disease Uterine Cervical Dysplasia Women 9-26 years of age Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis) Pregnancy Taking corticosteroids Allergy to yeast aluminum component of the HPV vaccine Positive for all HPV types in the Gardasil vaccine—6, 11, 16, 18 | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 21.0-30.0, Cervical Neoplasia HPV Infections To be eligible to receive crossover vaccination, participants must fulfill all of the following Participation Status: Women previously randomized into the HPV-16/18 vaccine trial 04-C-N191, also known as the Costa Rica Vaccine Trial Planned Residence: Residents of Guanacaste or Puntarenas Province or willingness to visit one of the study clinics for participation Consent: Written informed consent obtained prior to enrollment into the crossover protocol The following will be checked for all potential participants at the time of enrollment. If any apply, the participant will not be included in the study History of (a) allergic reaction (e.g., difficulty breathing) after receipt of any vaccine, (b) hypersensitivity to latex History of vaccine related adverse events during the vaccination phase that, at the discretion of the investigators, preclude vaccination during the crossover phase Are receiving vaccination with Cervarix , are sexually experienced and of childbearing potential (i.e., not surgically sterilized), and are unwilling to use an effective method of birth control for 30 days before vaccination until 60 days after the last Cervarix vaccination (approximately 9 months). Acceptable forms of birth control abstinence, surgical sterilization, hormonal contraceptives (e.g., oral, injectable, implant, and patch), intrauterine devices, and diaphragm or condom History of chronic condition that per attending doctor opinion precludes her from receiving vaccination (e.g., no proper treatment available or participant is unwilling to stay under proper treatment) The participant has a diagnosed autoimmune illness (per the specific requirement of the IRB) The vaccine or vaccines the participant is interested in receiving are contraindicated in her case | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-65.0, HPV-related Cytological Abnormalities on PAP Smear (LSIL) women with a new LSIL diagnosis an HPV positivity on PAP smear women over 65 immunocompromised patients (because of disease or drugs) | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-999.0, Cervical Intraepithelial Neoplasia Cervical Smears HPV DNA Probes Diagnosis of ASCUS or LSIL years or older Able to give informed consent with reasonable likelihood of follow-up Previous Hysterectomy History of excisional or ablative treatment of cervix, such as laser treatment, radiation therapy, cauterization (burning), freezing or surgery such as cone biopsy or LEEP Already known to be pregnant Already known to be HIV positive (HIV may negatively affect the clinical history of HPV, making triage less appropriate | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-999.0, Human Papillomavirus Infection Women >= 18 years of age attending a clinic for gynaecological examination Women who agree to provide a cervical sample for human papillomavirus testing Written informed consent obtained from the subject Referral for abnormal cervical sample at the current visit Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed History of hysterectomy Known diagnosis of immunosuppression, or patient on immunosuppressives Pregnant women Having received one or more doses of HPV vaccine prior to participating in the study | 2 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 0.0-999.0, Genital Warts Human Papilloma Virus All female patients with genital warts Patients who are pregnant, too frail or ill for gynaeoclogical examination and refusal to participate | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 21.0-999.0, Infections, Papillomavirus Cervical Cancer A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date Written or oral-witnessed informed consent obtained from the subject prior to any study procedure No prior chemo or radiotherapy for cervical cancer | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 15.0-999.0, Infections, Papillomavirus Cervical Cancer Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study Women >=15 years of age attending a clinic for routine cervical screening Written informed consent obtained from the subject and/or subject's parent/guardian Referral for abnormal cervical sample at the current visit Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed No cervical sample provided History of hysterectomy Known diagnosis of immunosuppression, or patient on immunosuppressives Pregnant female >=25 years of age | 2 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 25.0-65.0, DNA Probes E6 Protein Uterine Cervical Neoplasms HPV have not been previously diagnosed with cervical cancer have a cervix are not pregnant are physically able to undergo routine cervical cancer screening 5) are able to provide informed consent We will not women if they have had previous cervical cancer screening because we assume that even if a few women have been screened for cervical cancer, the quality of cytology screening was very poor are not married AND report never having had sexual intercourse 2) have had a total hysterectomy have a history of cervical cancer are physically or mentally unable to undergo routine cervical cancer screening or unable to provide informed consent are pregnant or have been pregnant in the last month -Women who are currently menstruating at the time of enrollment will be deferred from participating, and will become eligible to participate 7-14 days after menstruation has ended. The menstruating women will be advised to return for the screening 7 to 14 days after their menstrual period has concluded | 2 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-999.0, Human Papillomavirus Infection • the subject attended a colposcopy visit, and the referral Pap sample had a valid HPV Assay result, and the sample had an HPV Assay positive result, or the sample had an HPV Assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (CIN) grade 2 [CIN2] or more severe (eg, CIN2, CIN grade 3 [CIN3], or cervical cancer; "CIN2+"), or the sample had an HPV Assay negative result and the subject had a consensus histology result of normal or CIN grade 1 (<CIN2) and was randomly selected for inclusion. the referral Pap sample had a valid HPV Assay result, and the sample had an HPV Assay positive result, or the sample had an HPV Assay negative result and the subject had a consensus histology result of CIN2+, or the sample had an HPV Assay negative result and the subject had a consensus histology result of <CIN2 and was randomly selected for inclusion Samples from evaluable subjects meeting the sample will not be tested with the AHPV-GT Assay if there is insufficient volume for AHPV-GT Assay testing or the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions) | 2 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-999.0, Human Papilloma Virus Infection the sample had an aliquot with a valid positive or negative HPV Assay System result (from testing under protocol 2007HPVASCUS30) an aliquot is available and suitable for testing, and the sample was randomly selected for inclusion sample integrity was compromised (eg, stored under unacceptable conditions) | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 13.0-27.0, HPV HIV For both HIV-infected and healthy subjects Subjects aged 13-27 years, females and males Written informed consent from parent or guardian if applicable (age<18 years) For HIV-infected subjects HIV-positive Asymptomatic subjects (generalized lymphadenopathy is accepted) Lymphocyte CD4+ count > or equal to 350 cells/mm3 For subjects receiving HAART Good compliance to therapy At least two suppressed viral loads HIV-RNA (<37copies/ml9 during 6 months prior to enrollment For female subjects (both HIV-infected and healthy) Pregnancy or breastfeeding Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded For both females and males (HIV-infected and healthy) Prior vaccination with quadrivalent HPV vaccine Gardasil before study entry History of severe allergic reaction after previous vaccination or hypersensitivity to any vaccine component Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator Acute infection requiring therapy or fever at time of enrollment Chronic autoimmune or oncologic disease receiving chemotherapy Concomitant therapies (other than HAART) | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 0.0-999.0, Cervical Cancer Squamous Cell Human Papilloma Virus Infection Human Papilloma Virus-Related Carcinoma Prevention Any women who come to do the Papanicolaou test at the Barretos Cancer Hospital and in the mobile units on the remote Brazilian areas | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 21.0-999.0, Atypical Squamous Cells of Undetermined Significance Cervical Cancer Cervical Intraepithelial Neoplasia Grade 1 Cervical Intraepithelial Neoplasia Grade 2 Cervical Intraepithelial Neoplasia Grade 3 Health Status Unknown Human Papilloma Virus Infection Stage 0 Cervical Cancer Able to provide informed consent in English Have had hysterectomy Currently pregnant Received treatment of cervical dysplasia with loop electrosurgical excision procedure (LEEP), cone biopsy, laser procedure or cryotherapy within THREE years Received colposcopy of cervix within TWO years Received Pap test within ONE year Immunocompromised (positive human immunodeficiency virus [HIV] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs) Decisionally impaired adults requiring a legally authorized representative | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-90.0, Anal Intraepithelial Neoplasia MSM with HIV negative MSM with HIV positive | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 0.0-999.0, Uterine Cervical Neoplasms Referred to follow up due to one or more abnormal Pap or an HPV infection Subjects who have provided informed consent Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines Known to be pregnant With prior complete or partial hysterectomy involving removal of cervix Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry this includes acetic acid, iodine, spermicide, douche, anti-fungal meds Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed | 2 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-40.0, Human Papillomavirus Infection Couple must have been in a new relationship that started no more than six months prior to study entry Both partners plan on remaining in Montreal for at least 1 year Plan on having continued sexual contact with partner Be willing to comply with study procedures Volunteers must not have been vaccinated against HPV (both partners) Any history of cervical, penile, oral or anal cancers Being pregnant or plan on immediately becoming pregnant | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 30.0-65.0, HPV Infection Age 30 to 65 years of age the sex life of female patients , liquid-based cytology (TCT) check no intraepithelial lesions and malignant cells , HPV DNA typing test for high-risk HPV positive (including a single high-risk type positive, and more high-risk type of positive and high-and low-risk hybrid positive) kinds of high-risk types, including HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68 (1) cervical intraepithelial neoplasia (CIN); (2), combined with a severe fungal, trichomonas vaginitis; (3), severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; (4), allergies or allergy to the drug known ingredients. (5), within 30 days to accept other clinical trials of drugs or are participating in clinical trials; (6), pregnant and lactating women and to be pregnant women; (7), the researchers do not consider it appropriate clinical trials | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 20.0-49.0, Cervical Intraepithelial Neoplasia Fertile women between age of 20 and 49 Patients with cervical intraepithelial neoplasia 1(CIN1) HPV(Human Papilloma Virus) positive(+) White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 10^6/L AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray Be informed of the nature of the study and will give written informed consent Malignant tumor in any organ other than cervical intraepithelial neoplasia Active liver disease, immune disorder and severe renal failure Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded) Diagnosed diabetes Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc) Pregnancy and breastfeeding Registered in other clinical trials Patients whom the investigator considers inappropriate to participate in the study | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 30.0-64.0, CIN3 CIN2 Cervical Cancer Aged 30-64 years Mentally competent to be able to understand the consent form Able to communicate with study staff Physically able to have a pelvic exam Reporting no previous sexual activity History of cervical cancer Previous treatment for cervical pre-cancer in the last six months Hysterectomy Plans to move out of the study area in the next 12 months Screened for cervical cancer in the last 12 months (depending on local regulations) | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 40.0-999.0, High Grade Cervical Dysplasia Cervical Cancer Women ≥ 40 years old Previous or current high grade cervical dysplasia or cervical cancer Women ≥ 40 years old because the median time between the diagnosis of anal cancer and previous cervical cancer is approximately 20 years chemotherapy or radiation therapy within the last 6 months | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 18.0-999.0, Cervical Abnormality Female years or older Able to give informed consent Intact cervix No prior history of invasive cervical cancer English speaking Willing to have biological specimens stored for future studies Resident of Appalachian Ohio Pregnant Medical or psychiatric illness that precludes research project requirements, ability to give informed consent, or protocol compliance Smokers (will be contacted by study team to see if they are eligible/willing to participate in CARE: Project 2 | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 25.0-69.0, Cancer of the Cervix Cervical Intraepithelial Neoplasia Australian female residents aged 25-69 years who are attending for routine cervical screening Participants may have been previously enrolled in the Compass Pilot but must have been discharged to routine screening. Women may also be in follow-up management for a previous abnormality or unsatisfactory cytology Previous total hysterectomy (uterus and cervix) The presence of symptoms or signs for which cervical cancer must be excluded Currently undergoing treatment for cervical cancer Currently enrolled in the Compass Pilot Study | 1 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 25.0-59.0, Compliance Cervical Cancer Women between 25-59 years-old Not pregnant Had held their last Pap smear for over a year Could read Women with previous hysterectomy History of cervical cancer or its precursors Bearers of some state of chronic immunosuppression (such as HIV ou autoimmune diseases) Those who underwent self-collection of their specimen during menstrual period | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 30.0-999.0, Patient Adherence Women 30 years and older living in a household visited by Community Health Workers (CHWs) Women with a previous HPV test Women with precancerous lesion or cervical cancer Current pregnancy Women with Mental disability | 0 |
A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive. | eligible ages (years): 30.0-60.0, Human Papilloma Virus Infection Women aged 30 years Women attending gynaecological practices for routine screening Women who gave informed consent to participation in the study Women with hysterectomy or known destructive therapy to the cervix Women who are pregnant Women with an abnormal cytology result during the previous 6 months Women with known HIV infection or history of transplants Women vaccinated against HPV Women participating in another research protocol | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Cardiovascular Diseases Heart Diseases Heart Failure, Congestive Heart Failure Men and women, ages 18 and over. Patients had compensated congestive heart failure due to idiopathic dilated cardiomyopathy or coronary disease with ejection fraction less than or equal to 0.35, were in the New York Heart Association functional class III or IV, and were taking an angiotensin-converting enzyme inhibitor, digitalis, and if needed, a diuretic. Patients with a specific indication for, or contraindication to, beta-blockade were excluded | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Atherosclerosis Heart Failure, Congestive Hypertension Myocardial Infarction Patients over 18 years with endothelial dysfunction requiring diagnostic cardiac catheterization Normal volunteers or patients undergoing catheterization who have normal coronary arteries without risk factors for atherosclerosis will be used as controls No unstable angina No significant left main disease (greater than 50% stenosis) No recent myocardial infarction (less than 1 month) No pregnancy, lactation No allergy to losartan No renal failure (creatinine greater than 2.5 mg/dl) Ability to withdraw ACE inhibitors | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Atherosclerosis Heart Failure, Congestive Hypertension Myocardial Infarction Patient must be over 18 years of age requiring diagnostic cardiac catheterization will participate Women on chronic estrogen therapy are eligible for the study Patients investigated for chest pain syndrome with normal coronary arteries with and without risk factors for atherosclerosis, patients with coronary artery disease, and patients with heart failure No patients with unstable angina; significant left main disease (greater than 50% stenosis); Recent myocardial infarction (less than 1 month); Pregnancy, lactation; Allergy to losartan; Renal failure (creatinine greater than 2.5 mg/dl); Inability to withdraw ACE inhibitors | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 35.0-84.0, Cardiovascular Diseases Heart Diseases Atherosclerosis Coronary Disease Hypertension Cerebrovascular Disorders African American | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Cardiovascular Diseases Heart Diseases Heart Failure, Congestive Heart Failure | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Chronic Heart Failure CHF diagnosis, NY stage 2 or 3 | 2 |
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