View clinical trials related to Hypersensitivity.
Filter by:When a drug company first develops a drug, the company has to show the Food and Drug Administration (FDA) that the drug is safe and effective. If FDA concludes that the drug is safe and effective, FDA approves the drug. The company can then sell the drug, which the company does using "trade name." Only the drug company that developed the "trade name" drug is allowed to sell it. However, other drug companies can create their own version of the "trade name" drug, which usually happens after the patents for the "trade name" product run out. These drugs, often called "generic drugs," potentially will be less expensive for the patient. In order to sell generic drugs, drug companies must show that their generic version is the same as the "trade name" drug in a number of ways. For example, they generally have to show that their product is intended to be used to treat the same diseases or conditions, that it has the same label, and that the product has the same active ingredient as the "trade name" drug. The generic company also has to show that generic product is "bioequivalent" to the trade name drug, meaning that the generic product gets to the part of the body where the drug works at the same rate that the trade name drug does. How to show how much drug gets to the part of the body where it works, and how fast, depends on the type of product the drug is. The primary aim of this research study is to aid the FDA in finding methods to ensure that the versions of generic drugs that are inhaled (for example, drugs used to treat asthma) are bioequivalent to the trade name drug. As a part of the research study, pharmacokinetic (PK) studies (studies measuring drug levels in the blood over time after inhalation) will be done using three different versions of fluticasone propionate (FP, a drug routinely used in asthmatic patients) administered using a dry powder inhaler (DPI, an inhalation device that delivers the drug as a dry powder). The results from this study will help FDA ensure that generic products are the same as the trade name drugs.
Child food allergy represent 6 to 8% of child in industrialised country. Within this allergy, peanuts and egg allergy are one of the most common. Actually when there is a suspicion of food allergy, the OPT is the gold standard for the diagnosis. During the OPT we give increasing doses of the allergen to the patient and evaluate threshold causing a clinical reaction. This test is associated with a risk of strong allergic reaction and need a medical supervision. Standard allergy test, like skin test or specific IgE test, can't be use for the diagnosis of these allergy. Some publications demonstrate that these tests lack sensibility and specificity for child food allergy diagnosis. New tests have to be develop to diagnosis child food allergy without risks. The BAT is a cellular test able to evaluate the basophiles activation by specific allergen in vitro. This test allow us to evaluate more physiologically the sensitization of patients to an allergen. It is already used in drug allergy and it has been evaluated in infant milk allergy in an other clinical trial. In this study we want to evaluate the sensitivity of BAT to the diagnosis of child food allergy compare to the gold standard test OPT. We will evaluate the BAT on 140 children with food allergy and compare this results with the OPT at the same time. If the BAT results can predict the sensitivity of children to food allergen, it could limit the use of the OPT and reduce the risk of this test.
The calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2 days after the first bleaching session without increasing the bleaching-induced tooth sensitivity
Food allergy is on the rise within the pediatric population. Having a food allergy can cause medical, nutritional and psychological issues in those who suffer with it. Although making the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy has been a challenge. Skin prick testing and food-specific immunoglobulin-e (IgE) testing of the blood can give positive results that are false. Currently, Oral Food Challenges are the best way to diagnose a food allergy. Unfortunately, Oral Food Challenges are time consuming and may not be readily available to suspected food allergy sufferers. This study is designed to examine the effectiveness of an allergy-detecting blood test called ImmunoCAP manufactured by the company, ThermoFisher. Soybean is one of the eight allergy-inducing foods that are responsible for 90% of all food allergies. A part of the study is to allow the study Sponsor to use some of the blood sample collected from you to test if genetically-changed soy has more or less allergy producing factors. This is important to the Sponsor to test the safety of their genetically modified soy.
Food allergy is on the rise within the pediatric population. Having food allergy can cause medical, nutritional and psychological issues in those who suffer with it. Although making the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy has been a challenge. Skin prick testing and food-specific IgE testing of the blood can give positive results that are false. Currently, Oral Food Challenges are the best way to diagnose a food allergy. Unfortunately, Oral Food Challenges are time consuming and may not be readily available to suspected food allergy sufferers. This study is designed to examine the effectiveness of an allergy-detecting blood test called IMMULITE 2000 manufactured by the study sponsor, Siemens.
The purpose of this study is to determine if a special coating, applied to the surface of glasses can reduce the frequency and severity of migraine headaches in children and adolescents. This study is being conducted by researchers at Primary Children's Medical Center, The John Moran Eye Center, and the University of Utah Department of Electrical Engineering. The investigators have determined that a specific frequency of light is particularly bothersome to migraine patients. The coating they've developed is designed to block this frequency of light. Very few treatments are approved for the treatment of childhood migraine. The investigators hope that these glasses will provide a safe way to improve headaches in children.
The purpose of this study is to determine a well-tolerated dose of Carfilzomib in combination with Irinotecan (Phase 1b portion of the study) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers and to assess the 6 month survival of relapsed small cell lung cancer patients treated with this combination therapy. **The Phase 1b portion of the study is now complete**. Phase 2 portion of the study. The safest, maximally tolerated dose established as established in Phase 1 for Phase 2 is as follows -- Carfilzomib will be provided at 20/36 mg/m^2 with Irinotecan dosed at 125 mg/m^2. The purpose of the Phase 2 portion of the study is to assess 6 month survival of relapsed small cell lung cancer ins subjects treated with this combination therapy.
The isolated response of the carotid bodies to local stimulation with adenosine has not been researched in humans. There are single reports indicating that intravenous administration of adenosine causes hyperventilation through activating the carotid bodies. Adenosine will be injected intraarterially during invasive treatment (percutaneous carotid artery stenting, CAS) or diagnostic (arteriography) procedures and their conduct will only slightly influence the standard scheme of the procedure.
The aim of this trial is to evaluate the effects of dairy product consumption on insulin sensitivity and pancreatic β-cell function in men and women at risk for the development of type 2 diabetes mellitus (T2DM) who habitually consume beverages high in sugar (non-diet sodas and fruit juice cocktails).
The purpose of this research study is to learn about the medical effects, safety, and how the Walnut Oral Immunotherapy (OIT) treatment affects your body (immune system). This type of immunotherapy involves giving increasing doses of walnut allergen to gradually build up a person's tolerance to walnut and at least one other tree nut. The goal of the study is to determine whether participants can tolerate (eat) walnuts and at least one other tree nut in their diet after stopping the study therapy.