mteb/BIRCO-ClinicalTrial-Test huggingface dataset:
The overall goal of this retrospective registry study is to investigate the burden-of illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect information on the diseases epidemiology including incidence and prevalence of AF and stroke as well as a stroke risk stratification of the Danish AF-population, the clinical and economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients, healthcare providers / healthcare system and society as well as describing treatment patterns with anticoagulant agents and their consequences in terms of stroke, bleeds, death and according cost in a real-life setting.
This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma. BACKGROUND: Asthma is an increasingly serious cause of morbidity and mortality in the United States. There are approximately 12 million asthmatics, and the disease affects both sexes and impacts all racial and ethnic groups. It is now recognized that asthma is a complex disease of varied etiology, which is triggered by a number of factors (e.g., allergens, drugs, chemicals, exercise, cold air, infections, and emotions), making asthma therapy difficult and sometimes complicated. Multiple drugs, including medications to treat and control symptoms (bronchodilator agents such as beta-adrenergic agonists, theophylline, and anticholinergics) and medications thought to control underlying airway inflammation (e.g., inhaled and systemic corticosteroids, cromolyn sodium, and nedocromil), are often required. Despite major advances in the understanding of the etiology and pathophysiology of asthma and the development of new therapeutic modalities, the prevalence, severity, and mortality from asthma in all age groups have increased over the past decade. Mortality rates are disproportionately high in urban and rural minority populations. Hospitalizations for asthma have doubled in adults and increased five-fold for children over the past 20 years. Asthma continues to place a heavy burden on patients and their families, the health care system, and society as a whole.
Sickle cell anemia is the most common genetic disease affecting African-Americans. About 1 in every 1000 African-Americans has the disease and 1 in every 12 carry the genes that could be passed on to their children. People with sickle cell anemia have abnormal hemoglobin, the molecules responsible for carrying oxygen in the blood. The abnormal hemoglobin can cause damage to the red blood cells. The damaged red blood cell may then stick in the blood vessels and cause pain and injury to organs. Some of the complications caused by the sticking of blood cells are called acute pain crisis and acute chest syndrome (ACS). Nitric oxide (NO) is a gas that has been proposed as a possible therapy for the ACS complication of sickle cell anemia. Studies have shown that NO may favorably affect sickle cell hemoglobin molecules, thereby improving blood flow through small vessels. This study is designed to evaluate the effects of NO, when taken in combination with a drug called nitroglycerin on patients with sickle cell anemia and normal volunteers. The effects of these two drugs only last while the patient is receiving them. Researchers hope the information learned from this study will help to develop new therapies for sickle cell anemia. Sickle cell anemia is an autosomal recessive disorder and the most common genetic disease affecting African-Americans. Approximately 0.15% of African-Americans are homozygous for sickle cell disease, and 8% have sickle cell trait.
This study will evaluate magnetic resonance imaging (MRI ) methods for measuring changes in the brain's blood flow during hypercapnia (a condition of excess carbon dioxide in the blood). MRI is a diagnostic tool that uses a large magnet and radio waves to produce images of the body without X-rays. Healthy normal volunteers in this study may have as many as six MRI scans over a 2-year period. For this procedure, the person lies on a stretcher placed in a strong magnetic field produced by the MRI machine. During the scan, the person's blood carbon dioxide (CO2 ) levels will be increased either by: 1) breathing air mixtures containing up to 5% CO2; or 2) receiving an intravenous (I.V.) injection of a drug called acetazolamide. Persons who breathe CO2 will have their heart rate, blood pressure and oxygen levels monitored throughout the procedure. Those receiving acetazolamide will have the drug injected intravenously (I.V.) into an arm vein. If the volunteer experiences any unpleasant side effects from the CO2 or acetazolamide, the study will be stopped. The information gained from this study will be used to develop better ways to study brain function, possibly leading to better diagnostic and treatment methods. Advances in MR perfusion imaging have provided clinical researchers with the opportunity to quantitate regional increases in cerebral blood flow.
This study will use magnetic resonance imaging (MRI) to examine the role of prostaglandins-a type of fatty acid with hormone-like actions-in the regulation of brain blood flow. The results will provide information on how to better use this technique to study brain function, which, in turn, may lead to a better understanding of certain illnesses and more effective treatments. Healthy normal volunteers 18 years of age and older may be eligible for this study. Participants will fill out a health questionnaire and undergo a history, physical examination and MRI studies. MRI is a diagnostic tool that uses a strong magnetic field and radio waves instead of X-rays to show structural and chemical changes in tissues. During the scanning, the subject lies on a table in a narrow cylinder containing a magnetic field. An intercom system allows the subject to speak with the staff member performing the study at all times during the procedure. Four separate studies will be done-two carbon dioxide inhalation studies and two functional activation studies-as follows: Carbon dioxide inhalation (indomethacin): This study is done in two parts. In both parts, an MRI brain scan is done. During the scan, the subject inhales an air mixture containing 6% carbon dioxide through a facemask or mouthpiece. Blood pressure and heart rate are monitored during inhalation of the mixture. For the second part of the study, indomethacin-a non-steroidal anti-inflammatory drug-is injected through a catheter (thin flexible tube) in an arm vein.
Asthma currently affects an estimated 15 million Americans. A number of studies have found an association between low dietary magnesium (Mg) intake and increased asthma incidence and severity of symptoms. However, clinical intervention trials are necessary to directly assess whether there is a true protective or preventative causal relationship between low Mg and asthma. In our study, we will assess the effects of 6 1/2 months of oral Mg supplements or placebo on clinical markers of asthma control, indirect biomarkers of inflammation, bronchial hyperresponsiveness, and indices of oxidative defense and damage in subjects with mild to moderate persistent asthma. Over the past twenty years a number of studies of acute bronchial asthma have shown that i.v. or nebulized MgS04 may improve symptoms over a course of hours. With respect to dietary supplementation, short term (3 wk) oral Mg has been associated with a significant decrease in symptoms but no significant effect on measurements like FEV1 or bronchial hyperreactivity by methacholine challenge. Although a large number of studies have attempted to address this issue, we believe that major gaps still exist. One of the gaps is in the comparison of large numbers of asthmatics and non-asthmatics, with regard to dietary intake, and a variety of measures of Mg status. We will evaluate baseline Mg intake (diet, tap and bottled drinking water, vitamin-mineral supplements, laxatives, and antacids), and multiple measures of Mg status, such as total and free serum Mg, total erythrocyte Mg, and Mg retention after an IV Mg load in subjects with and without asthma.
The purpose of this study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma. The duration of treatment is 2 weeks.
The purpose is to find out if Icleen IQAir, HEPA-filter air cleaners with high capacity and pre-set speed functions, have a beneficial effect on patients with asthma and allergy to dogs. Air cleaners will be installed in the bedrooms and living rooms in the homes of children and adolescents aged 8-17 years at the study entry, with allergy to dogs, but not to house dust mites. The investigators will look upon the significance of this study, and of a previous study with a similar design and the same main parameters to find out if this trial supports the results of the first trial by the same project leader, or makes it likely that the seemingly beneficial effects of the first study occurred by chance. Main parameters: - hyperventilation cold air challenge test Supportive parameters: - serum ECP - symptom scores The trial will be a parallel, double blind placebo controlled one. Project leader: Leif Bjarte Rolfsjord, M.D., section leader, Paediatric Department Sykehuset Innlandet HF Elverum-Hamar; Ragnhild Halvorsen, M.D. Ph.D., Voksentoppen, Paediatric Clinic, Rikshospitalet; Leiv Sandvik, Ph.D. professor, research leader statistics, Competence Centre for Clinical Research, Ullevaal University Hospital AIM: To examine if powerful air cleaners with HEPA-filters and a pre-set speed function making it possible to run the air cleaners at a high, but noisy speed at acceptable times, and , if wanted, at a lower, but less noisy speed at other times, (Icleen IQAir®) , have a favourable effect on asthma in children and adolescents aged 8-17 years, who are allergic to dogs, but not to house dust mite.
To compare the bronchodilator efficacy of ipratropium plus salbutamol (Combivent) with salbutamol alone given every 20 minutes for three doses in asthmatic children with severe acute exacerbation A Comparison of Ipratropium 500mcg and salbutamol 2.5mg (Combivent UDV) and salbutamol UDV alone (2.5mg) in a Double-blind, Efficacy and Safety Study in Asthmatic Children with Severe Acute Exacerbation Study Hypothesis: Several studies, including a study conducted in an emergency room setting, demonstrated that the addition of ipratropium bromide, an anticholinergic drug, to standard salbutamol therapy significantly improves pulmonary function as compared to salbutamol alone. Comparison(s): Ipratropium bromide 500 mcg plus salbutamol 2.5mg (Combivent) vs salbutamol (2.5mg) alone given every 20 minutes for 3 doses
Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However, in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic allergic response, known as "IgE-induced airway inflammation" is what causes the increased inflammation in response to ozone. To do this we will examine the response to ozone in a group of asthmatics treated with omalizumab, a medicine available and approved for use in people with asthma, or a placebo control. The placebo for this study is inert physiologic saline ("salt water") which contains no omalizumab. Both the omalizumab and the placebo will be administered as an injection under the skin. Omalizumab, also called Xolair, is a humanized monoclonal antibody, which means that it originally was produced in mice, then genetically engineered to look more like human than mouse antibody. Omalizumab inactivates IgE, a protein our own immune systems make as part of allergic reactions. The purpose of this study is to test the hypothesis that omalizumab, by blocking this aspect of allergic reactions, will decrease the number of inflammatory cells in the airway after ozone challenge. We also hypothesize that omalizumab will decrease the effects of ozone on changes in lung function, mucociliary clearance (a measure of how quickly mucus clears form the airway) and airway reactivity. Airway reactivity is a measure of how sensitive the airways are to a medication used to diagnose asthma, called methacholine.
From a previous community needs survey, we determined that asthma was a particular problem in our community-based research network of child care centers. This study will examine whether a moderate intervention can help these centers improve their "asthma-friendly" rating as per NHLBI guidelines. We will both center directors and parents to establish baseline data on child health and the "asthma-friendliness" of each center. We will use a wait-list control, with all centers eventually receiving the intervention. Asthma is the most common chronic health problem affecting children in the U.S., and it is getting worse. Children under the age of 18 years account for one third of the nation's asthma sufferers. The percent of children with asthma has increased from 3% in 1981 to 6% in 2003. Asthma is a leading reason for hospitalizations of children under the age of 15 years and causes 14 million days of missed school each year. Previous studies suggest particularly high asthma rates among Hispanic and African-American populations. Poverty, increased exposure to indoor allergens, low education level, poor access to healthcare, and failure to take prescribed medicines increase the likelihood of having a severe asthma attack, or dying of asthma. According to the results of HealthSpark I, children in the target communities have rates of asthma that are more than three times the national average. 29.3% of HealthSpark families with children ages 3 to 5 years responded "yes" to the question, "Did a doctor ever tell you that your child has asthma?"
The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease. Researchers suspect that allergies to common inhaled allergens (such as house dust mite, cat dander, and grass pollens) are a major cause of childhood asthma. Recent evidence suggests that if allergies to inhaled allergens are prevented, this can cause changes in the immune system that may inhibit the development of asthma. Although strategies to prevent allergies generally focus on avoiding the allergen, complete avoidance of the common allergens linked to asthma would require extreme measures and is impractical. Oral mucosal immunoprophylaxis (OMIP) therapy is an allergy treatment that can induce long-lasting immune tolerance in people already suffering from allergies. By exposing the patient to small, repeated, but increasing doses of the problem allergen over a long period of time, the patient's immune system is eventually desensitized to that particular allergen. OMIP therapy has been shown to be safe in children as young as 2 years old. This study will evaluate if OMIP therapy against common inhaled allergens is safe and effective in preventing the development of asthma in children at high risk for developing the disease. Children enrolled in this study have been diagnosed with eczema or food allergies and have a family history of eczema, allergic rhinitis, or asthma.
Asthma is a respiratory condition that affects millions of children. It can be controlled, however, with the proper medications and treatment. AsthmaNet, an internet-based asthma management system, aims to improve the asthma care of children by providing their parents and doctors with appropriate tools and feedback related to asthma management. The purpose of this study is to evaluate the effectiveness of AsthmaNet at improving quality of care and controlling asthma symptoms in children. In the United States, almost 9 million children have been diagnosed with asthma. It is a leading cause of hospitalization, chronic disease, and school absenteeism. With the proper treatment, most children with asthma are able to lead a normal life. However, if asthma is not adequately controlled, it can be a life-threatening disease. It is important for parents to work with their child's doctor to develop a comprehensive treatment plan that minimizes asthma symptoms. AsthmaNet, an interactive web-based system, aims to improve the quality of care for children with asthma by enhancing parents' asthma care skills and encouraging parents to discuss their child's asthma care with their doctor. AsthmaNet provides evidence-based guidelines, asthma management tools, and individually tailored feedback to both parents and physicians to improve communication and enhance asthma management skills and behaviors. The goal of this study is to evaluate the effectiveness of AsthmaNet at increasing medication and treatment adherence in children with asthma.
This study will examine whether exposure to the increased levels of mold and other allergens in New Orleans post-Hurricane Katrina affect symptoms in children with asthma. It will also determine if having an asthma counselor (AC) can reduce a child s asthma symptoms in this setting. An AC helps the families in the study obtain appropriate health care, medicines and social services for their asthmatic child and instructs them about avoiding allergens and ridding allergens from the home. Children between 4 and 12 years of age living in Orleans Parish or surrounding areas impacted by flooding who have moderate to severe asthma may be eligible for this study. Parents provide a family medical history and information about the child s asthma symptoms, medications and medical history. The children undergo the following procedures: - Medical examination and blood tests - Spirometry (for children 6 and older) or peak flow (for children under 6) test: For spirometry, the child wears a nose clip and breathes into a mouthpiece attached to a machine that measures how fast air moves out of the child s lungs. For the peak flow meter test, the child blows into a plastic tube after taking a deep breath. - Allergy skin testing: 24 common allergens are applied to the arm by little pricks or scratches and the skin is observed for reactions to the allergens. Study staff visit the participants homes three times during the 1-year study to test for moisture, mold and other allergens.
This study will determine risk factors of human infection with avian influenza A virus, also known as bird flu virus. Certain risk factors such as exposure to poultry, travel history, health status, and other factors may affect one's risk of getting bird flu. Study participants will include individuals, older than age 1, that tested positive for influenza A (H5N1) in a previous surveillance program and controls (individuals that have not tested positive for avian influenza A (H5N1) and have no fever or respiratory symptoms). There will be 1 study visit during which volunteers will be asked detailed questions about their health, work, and travel habits. Study participants will be asked to donate a blood sample to test for antibodies, the part of the blood that fights infection. This study is a matched case-control study of risk factors for human infection with avian influenza A (H5N1) virus in China. The primary study objective is to determine the risk factors for avian influenza A (H5N1) virus infection in humans, in China, whether or not the subject was symptomatic. The confirmed case-patients and confirmed antibody positive avian influenza A (H5N1) persons (asymptomatic or sub-clinical) identified by the previously done National Surveillance Program will be included in this study as cases. Controls will be identified from population registries in villages with rural cases and in the adjacent apartment buildings of the urban cases' residences.
A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma.
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
Optimising the propranolol block model The bronchodilatory effects of inhaled beta2 agonists and anti-muscarinic drugs are the mainstay of symptomatic treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). A new approach is to combine both pharmacological approaches in a single molecule - ie a dual pharmacophore. It will be necessary to explore the relative contribution of the beta2 agonist versus anti-muscarinic bronchodilator properties of such a molecule. One way to do that is to block one of the components. Inhibition of beta2 agonist-mediated bronchodilatation by the non-selective beta-blocker propranolol is an established experimental method. Therefore this method may be useful in exploring the pharmacology of a dual pharmacophore. Published studies have generally looked at the effect of a single dose of propranolol on a beta2 agonist over a relatively short period of time (a few hours). There is a desire to develop long acting bronchodilators that require once daily dosing only. Thus any dual pharmacophore developed is likely to have 24 hour duration of action after a single dose. Therefore to use this method of beta blockade to inhibit beta2 agonist mediated bronchodilation, it is necessary to confirm a dosing regimen of propranolol that has acceptable tolerability and is effective in blocking the effects of a beta2 agonist over 24 hours. That is the main purpose of this study. It is also important to confirm that the bronchodilator effect of an antimuscarinic is unaffected by beta blockade.
Using a human pangenomic microarray, the researchers established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct groups: 1. allergic rhinitis to dust mite (AR) isolated (n=12), 2. AR associated with bronchial hyperreactivity (n=12), 3. AR associated with asthma (n=14), 4. control (n=14). Context: Asthma is the most frequent chronic disease in childhood. Allergic rhinitis has been described as a risk factor to develop asthma. The objective of the study was to evaluate the contribution of the respiratory epithelium to development of allergic rhinitis and asthma and to identify the molecular mechanisms driving rhinitis toward asthma. Methods: Using a human pangenomic microarray, we established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct children 2 to 18 years of age groups: 1. allergic rhinitis to dust mite (AR) isolated (n=12), 2. AR associated with bronchial hyperreactivity (n=12), 3. AR associated with asthma (n=14), 4. control (n=14).
Asthma is the most common chronic disease of childhood and a major cause of morbidity in the United States. If asthma symptoms are controlled, a child with asthma can stay well and lead a normal life. Daily use of inhaled steroids controls symptoms and reduces morbidity and emergent health care utilization in children with persistent asthma, and is safe for long-term use. However, inhaled steroids are underused in community asthma care. The Telephone Asthma Program (TAP) is a series of brief, telephone calls with a trained coach to help the parent manage the child's asthma care. The coach will teach self-management skills, help the parent to use the child's asthma medicines effectively, provide support and remind the parent to go for follow-up care with the pediatrician. We hypothesized that the Telephone Asthma Program will reduce the incidence of acute exacerbations of asthma that require emergent care, improve the quality of life of children with asthma and their parents, and increase the daily use of inhaled steroids in children with persistent asthma. We evaluated the Telephone Asthma Program in a randomized controlled trial involving 362 children aged 5 to 12 years old cared for by community pediatricians. Eligible children were randomized to the TAP program or usual care by their pediatrician. Asthma morbidity is largely preventable with effective maintenance care. National guidelines recommend 1) daily treatment with inhaled corticosteroids (ICS) to prevent asthma symptoms and activity limitations, minimize acute exacerbations and maintain normal lung function; 2) early intervention guided by a written Asthma Action Plan for worsening symptoms;3) a partnership between the primary care provider, the patient and their family to develop shared treatment goals, select an appropriate treatment plan, resolve asthma-related concerns, and provide support for day-to-day care, and 4) periodic assessments (every 1 to 6 months) by the physician to monitor asthma control and assess if the goals of therapy are being met, with asthma self-management education provided at diagnosis and reinforced at every opportunity.
Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood. This blood will be used to be stimulated with to whatever the patient allergic. In the laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and IL-3. These are chemicals responsible for allergy symptoms.
The purpose of this study is to study prospectively the early clinical and immunological events in children susceptible to rhinovirus induced early wheezing (i.e., recently found highest risk factor for recurrent wheezing/asthma) and the efficacy of systemic corticosteroid to modify these events. Up to 50% of children suffer from acute wheezing before school-age. The prevalence of childhood asthma is 5-7%. Although pediatric asthma is mainly allergic, the exacerbations are associated with respiratory viral infections in 95% of cases. The means to predict asthma from environmental factors have been limited mainly to sensitization to aeroallergens (3-fold risk), which start to develop usually at 2-3 years of age. VINKU 1-study (orig. VINKU-study) discovered simultaneously with two other groups, that early wheezing associated with rhinovirus, the "common cold" virus, is the strongest predictor of recurrent wheezing/asthma (up to 10-fold risky). Noteworthily, viral infections work as risk markers already during infancy, a lot earlier than the sensitization to aeroallergens. The investigators also found retrospectively that early wheezers affected by rhinovirus responded to 3 day course of oral prednisolone (inexpensive and widely available treatment): recurrent wheezing decreased by 50% during following 12 months and the difference appeared to continue. VINKU 5V-study is currently investigating the clinical history, prevalence of asthma and airway hyperreactivity of these same children at school-age. The mechanism of rhinovirus associated risk or why they respond to prednisolone are largely unknown.
To access CT Scan as a diagnostic tool for foreign bodies aspiration. Comparison with gold standard diagnostic tool, the endoscopy
The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with hayfever with or without asthma. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. The doctor also rated how much relief the patient got from treatment and recorded any side effects.
Young inner-city children with asthma have the highest emergency department (ED) visit rates. Relying on the emergency department for asthma care can be a dangerous sign of poorly controlled asthma. This research will focus on whether having a specialized asthma nurse join the family at a child's doctor visit after an ED visit for asthma to make sure the child and parent keep the follow-up appointment and have the nurse remind the child's doctor to prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention) will result in young children with asthma having fewer days with wheezing and cough. The investigators hypothesize that: 1. Significantly more children receiving the PAAL intervention will attend greater than 2 non-urgent visits and greater than 6 refills for the child's anti-inflammatory medications over 12 months when compared to children in the control or standard asthma education group. 2. Children in the PAAL intervention group will experience less morbidity and caregivers will experience increased quality of life compared to children in the control of standard asthma education group. Asthma is the number one cause of pediatric emergency department (ED) visits in young children and results in a significant economic impact on society and use of health resources. Reliance on the ED for asthma care is not only costly but it is also a dangerous index of poorly controlled asthma. Recent updated national asthma guidelines recommend daily inhaled corticosteroids (ICS) as the cornerstone of treatment for patients with persistent asthma.
Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children. Asthma is one of the leading causes of morbidity in children with 60% of all cases diagnosed by age 3. Thus, finding factors that can lead to prevention of this disease would be of great public health importance. Vitamin D deficiency is highly prevalent among pregnant women, and thus, represents a potentially modifiable factor for the prevention of disease. Due to the effect of vitamin D in modulating immune responses, we believe that vitamin D deficiency in pregnant mothers leads to faulty immune system development in the neonate, predisposing them to asthma and allergy. We have observational data from two independent birth cohort studies that higher maternal intakes of vitamin D during pregnancy are each independently associated with a 50% reduction in risk for recurrent wheezing and asthma in 3- and 5-yr old children. However, in order to recommend this as a universal treatment to prevent asthma, a randomized, controlled, clinical trial is necessary. Therefore, we propose a two arm, double-blind, placebo controlled, randomized, clinical trial of Vitamin D, to determine whether higher vitamin D intake and levels in the pregnant mother will prevent asthma and allergy in the child at age 3. We will identify pregnant women who have asthma or allergies or whose partner has asthma or allergies, from obstetric clinics in the three clinical centers participating in this trial.
Childhood Asthma and Schooling: The Truth Unveiled. Children with mild persistent asthma still performed worse than normal healthy children in school. The aim of the study was to evaluate school performance of children with mild persistent asthma in comparison with normal healthy children.
The highly pathogenic avian influenza (HPAI) H5N1 virus arrived in the Middle East in 2005 and has since established itself in local domestic birds and is now considered endemic in several Middle Eastern countries.Few studies indicate the presence of low pathogenicity avian influenza (LPAI) viruses of the H9 type among Lebanese poultry and wild birds. These studies also provide some evidence suggesting that humans exposed to these sick birds are showing elevated antibody titers against these LPAI H9 viruses. This study will focus on the following objectives: - To determine the seroprevalence of AI in poultry-exposed and non-exposed human populations. - To identify risk factors associated with AI infections in occupationally-exposed poultry workers. - To conduct nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks. This study will examine the sera of 200 poultry-exposed adults and 50 adult controls and administer questionnaires to identify risk factors for AI infections in human beings.Study volunteers will be interviewed regarding their exposures, medical history, and behaviors using a close-ended questionnaire specifically tailored for this study. A blood sample will be collected from every participant to verify presence of antibodies against the viruses under study. All study materials are in English and Arabic. Along side the human aspect of the study, specimens will be collected from the birds that the individual handles. This study hypothesizes that they will find evidence of previous infection with these viruses among poultry workers.
Although it is well known that the presence of uncontrolled inflammation in upper airways may compromise the control of asthma and may favor the progression of asthma toward more severe grades of disease, few studies addressed whether therapies aimed to control both upper and lower airway inflammation may be more effective in controlling asthma. Markers of oxidative stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a facial mask (for treating both upper and lower airways) will be able to reduce the production of oxidants as well as of IL5 in both districts thus promoting clinical and functional improvements in mild intermittent asthmatic children. The results provided by this study will contribute to further clarify the relationship between nasal and bronchial inflammation.
The goal of this new translational project is to test the feasibility and effectiveness of implementing school-based directly observed therapy of preventive asthma medications in a real-world setting, using state-of-the-art web-based technology for systematic screening, electronic report generation, and communication between nurses, caregivers, and primary care providers. With the use of a novel method to improve adherence and subsequently reduce morbidity, the investigators hypothesize that this novel adaptation of school-based asthma care will; 1) be feasible and acceptable among this population and among school and community stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). The investigators anticipate that enhancing preventive healthcare for young urban children with asthma through partnerships with the schools using a novel technology will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs.
This study will evaluate whether exhaled nitric oxide levels are affected by allergen immunotherapy ("allergy shots"). The investigators' hypothesis is that successful allergen immunotherapy may be accompanied by decreased exhaled nitric oxide levels.
Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The onset of tolerance to salbutamol is not known.
The purpose of this study is to assess the late asthmatic response, safety and tolerability of AMG 157 following multiple intravenous (IV) dose administration in subjects with mild atopic asthma.
Children with mild persistent asthma that have asthma symptoms once or twice a week and use a daily controller, while children with mild intermittent asthma rarely have asthma symptoms and do not use a daily controller. Inhaled corticosteroids are the standard treatment for mild peristent asthma. The purpose of this study is to measure children rate of growth while on different inhaled corticosteroids. A randomized, cross over study evaluating the effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on short term growth in pediatric subjects with asthma. Objectives: 1. The primary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus Pulmicort Flexhaler 180 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma. 2. The secondary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus QVAR 80 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma. Aims: 1. The primary aim is to show that there is a growth suppressive effect of Pulmicort Flexhaler 180 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma. 2. The secondary aim to show that there is a growth suppressive effect of QVAR 80 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma.
This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period. This is a Phase III multi-centre, randomised open label study performed in subjects followed in primary care who have a diagnosis of and receive regular treatment for asthma in a localised geographical region of the UK
To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines 2011.
Patients with chronic obstructive pulmonary disease (COPD) experience breathing difficulties because the airways deep in their lungs become narrowed. COPD patients use inhaler drugs to provide relief from breathlessness. However, current inhalers are inefficient as they deliver a 'coarse-mist' of drug-droplets that do not reach the deep airways. In our study, we will use an inhaler of 'fine-mist' drug-droplets, tagged with a radioactive tracer to track them. We will take images of the lungs to see if the fine-mist droplets reach the deep airways, and assess if this improves the breathing capacity in our patients. Our research may allow the development of new, more efficient inhalers to improve treatment for patients with COPD. PURPOSE: The purpose of the research (or "knowledge gap" this research is designed to fill) is to understand the fate of inhaled drug within the lungs of COPD patients. Current inhalers in use were developed to treat asthma, which is predominantly a disease of the large airways, and these inhalers may not be optimal in treating COPD patients (which is predominantly a disease of the small airways). Poor delivery of inhaled bronchodilators to the peripheral deep airways may be a major factor limiting the clinical benefit provided by existing devices. The key to successful treatment could be to accurately target inhaled drug to the diseased lung sites, which is the hypothesis that this protocol will test.
Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of our study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.
Studies suggest that lutein and n-3 fatty acids may influence the development of a child's brain and may be related to how well children learn. Both lutein and the n-3 fats (also known as omega-3 fats) are not made by the body and must be obtained in the diet. The investigators are interested to understand the importance of n-3 fats and lutein to child brain development. Functional magnetic resonance imaging (fMRI) will make it possible to look into the brain from the outside and see which parts of the brain are being used as children complete working memory tasks. The investigators will study brain function using fMRI among children with different intakes of n-3 fats and lutein. Hypothesis: 1. Children 6 years of age consuming < 25 mg/day DHA and < 400 μg lutein/day will show poorer activation of brain areas on fMRI than children consuming > 150 mg/day DHA and > 1,200 μg/day lutein. 2. Children consuming < 400 μg lutein/day and > 150 mg/day DHA will also show differences in fMRI results when compared to children consuming > 150 mg/day DHA and > 1,200 μg/day lutein.
Peak Inspiratory Flow Rate (PIFR) is defined by the fastest flow rate noted during the inspiratory cycle. Inhaled medication plays an important role in the treatment of chronic obstructive pulmonary disease (COPD), with dry powder inhalers (DPIs) increasingly replacing metered dose inhalers (MDIs). DPIs are interesting as they do not require the need for coordinate actuation of the MDI device with inhalation or the use of a large spacer device 1-3. Several DPIs are available for the administration of inhaled corticosteroids, as well as bronchodilators, with each of them corresponding to a different type of inhaler (e.g. Diskus®, Turbuhaler®, Aeroliser®, etc.). During the inspiratory effort the patient generates a pressure drop with a consequent airflow across the DPI. This inspiratory flow has to be high enough to disaggregate and adequately disperse the drug powder into an aerosol cloud of drug particles and to guarantee an optimal deposition of the medication in the lung. Such peak inspiratory flows (PIFs) are not only dependent on a patient's inhalation effort but also on the internal resistance of the device. It has been shown that optimal deposition of medication with DPIs is not achieved in some patients with low inspiratory flow rates, such as children or patients with COPD, especially during acute exacerbations. In such conditions the use of a DPI with low internal resistance has been suggested, ensuring an optimal deposition despite the lower flow rate.
The purpose of this study is to find out whether adjunct treatment with inhaled corticosteroids lead to faster improvement and reduce mortality of children under 5 years of age admitted to hospital with ALRI. Pneumonia is one of the common causes of serious illness in children under 5 years of age. It is one of the common causes of admission to hospital and the commonest cause of death in Ugandan children under 5 years of age. The signs of pneumonia also occur in children with asthma making it difficult to differentiate the two. Other researchers have found that one of two children under five years of age with pneumonia have asthma. Wheeze which is regarded as a sign of asthma is heard in only one of three children with asthma, implying that many children with asthma especially in the first few years of life are less likely to be diagnosed. They are also less likely to receive inhaled steroids, the recommended treatment for asthma. Failure to administer asthma medicines may contribute to delayed improvement and increase the risk of death. The study hypothesizes that use of inhaled corticosteroids in addition to standard treatment in children hospitalized with ALRI will be associated with reduced morbidity and mortality and that the improvement will be more marked in children diagnosed with asthma posthoc. Outcomes: Reduction in case fatality, Time to normalization of respiratory rate, Time to normalization of oxygen saturation, Duration of hospitalisation.
This study examined whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency department accurately assess a child's asthma control. This study involved an intervention with the doctors in the emergency department of an urban pediatric hospital. The intervention was done when one of the doctors involved in the study treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED results and half were not. The two groups of doctors were compared on their ability to correctly identify asthma control categories, whether a child's asthma was worsening or improving, whether the family was administering controller medications as often as they should, and how much burden the child's asthma was for the family.
Aim is to investigate the effect of beta2 adrenergic stimulant salbutamol on emotional and cognitive functions in healthy humans.
This study tests the hypothesis that an increase in pathogenic bacteria within the infant airway leads to increased airway inflammation, decreased airway function and ultimately airway obstruction throughout the first two years of life. With the prevalence of asthma increasing each decade, our focus has shifted from treatment to understanding the pathogenesis of asthma so we may develop methods of prevention. With the advent of new bacterial detection techniques, we have the opportunity to examine the infant microbiome (collection of genetic information from organisms that live on humans and pose no threat) prior to the development of wheezing and subsequent asthma. Based on our knowledge that certain bacteria are associated with recurrent wheezing, we believe that an increase in pathogenic bacteria alters the airway epithelium resulting in airway inflammation. This chronic inflammation leads to airway obstruction, resulting in recurrent wheezing. By prospectively following children over two years we have the opportunity to determine if changes seen in early infancy are established early and persist until 2 years of age. In addition, we propose to determine if the microbiome contributes to airway obstruction and episodes of wheezing with respiratory illness. This study tests the hypothesis that an increase in pathogenic bacteria within the infant airway leads to increased airway inflammation, decreased airway function and ultimately airway obstruction throughout the first two years of life. Once enrolled, study procedures will consist of non-sedated passive pulmonary function test or Respiratory Inductive Plethysmography (RIP) test at enrollment; nasal swabs and stool specimens collected at enrollment, 3-5 months, and 22-24 months; blood draw at 3-5 months; spirometry will be performed through infant pulmonary function tests at 3-5 months and repeated at 22-24 months of age; and finally surveys completed every three months starting after the 4-6 month time point and ending before the 22-24 month time point.
This is an open-label, two part, six period- cross over, randomised, single dose, single centre study in healthy subjects. This is the first clinical study for the UD-DPI. This study is divided into two parts. Part A will ascertain whether the pharmacokinetic (PK) of salbutamol delivered via the UD-DPI is comparable to the salbutamol delivered via the Diskus or MDI. For this reason four treatment doses consisting of three dose strength and two percentage blends will be assessed in Part A delivered via UD-DPI. Part A will also provide preliminary PK variability estimates to allow for better sample size/precision calculations for Part B. Part B will explore whether the UD-DPI has a pharmacokinetic exposure profile that is comparable to either Diskus or MDI in the presence of the charcoal block.
The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At present cardiac catheterisation is the cornerstone investigation in these patients where it is used to establish disease severity and estimate prognosis. It is an invasive procedure which is expensive and not without risk to the patient. Despite the multitude of tests performed, identifying those patients with PH who have a poor diagnosis can be difficult. The aim of this study is to improve the assessment of patients with PH using novel magnetic resonance techniques.