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Hypersensitivity clinical trials

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NCT ID: NCT02609919 Completed - Clinical trials for Adverse Reaction to Drug

Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age

Start date: January 2016
Phase:
Study type: Observational

Our primary outcome is to assess the safety of Dotarem in children <2 years old up to 24 hours after Dotarem injection. Patients will be monitored for any adverse events that occur for 2 hours following the completion of the MRI exam. The type of event, time of onset, duration of symptoms, intensity of the reaction (mild, moderate, severe), causality (not related, probably related, related, definitely related, unclassifiable), and subsequent outcome (required treatment, favorable outcome, recovery with sequela, or death) will be documented. Parents will be given instruction sheets on who and when to call should any adverse event occur after discharge. Parents will be called by the radiology department the next day to identify any adverse events that occurred during the first 24 hours after discharge from the hospital. Our secondary outcome is to assess image quality of the exam. The pre-contrast images will be compared to the combined pre- and post-contrast images following administration of Dotarem by radiologists who are blinded to the patients' clinical information to assess for improvement of image quality and delineation of structures with contrast.

NCT ID: NCT02606721 Completed - Clinical trials for Food Hypersensitivity

Food Allergy Challenge Diagnostic Study

Start date: March 2016
Phase:
Study type: Observational

The objective of this study is to correlate various diagnostic measurements taken during an escalating dose oral food challenge to the subject's response. This study will investigate whether non invasive objective biomarkers can indicate a positive response to an escalating dose OFC before a systemic reaction occurs.

NCT ID: NCT02601690 Terminated - Allergy Clinical Trials

Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America

Start date: October 2015
Phase:
Study type: Observational

This is a research study intending to look at the response of a specific type of allergy cells in the blood (called T cells) to a a type of immunotherapy product known as SPIREs (Synthetic Peptide Immuno-Regulatory Epitopes), across a broad range of subjects. This is a non-interventional study in which no investigational product will be administered to any subject.

NCT ID: NCT02595684 Completed - Obesity Clinical Trials

Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.

Start date: August 2015
Phase: Phase 4
Study type: Interventional

Obesity is a chronic disease of multifactorial etiology that develops from the interaction of the influence of nutritive , metabolic , cellular and molecular psychological factors. Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile dysfunction, and recently approved for the treatment of pulmonary hypertension , it is innovative because of its longer life means, provides efficacy after 36 hours and the highest selectivity. The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and insulin secretion in obese men. The investigators hypothesis is that the administration of tadalafil improve the insulin sensitivity and insulin secretion in obese men.

NCT ID: NCT02588326 Completed - Hypersensitivity Clinical Trials

Sensitivity of Pharmacokinetics to Differences in Particle Size Distribution of Suspension-based Nasal Sprays

Start date: September 21, 2018
Phase: Phase 1
Study type: Interventional

Currently FDA does not accept pharmacokinetic studies to show bioequivalence of locally-acting nasal suspension formulations. However, bioequivalence is defined as the absence of significant differences in pharmacokinetics of therapeutically equivalent drug products compared to the matching originally invented drug formulation. These there-called "generic drugs" are then interchangeable. Drug companies have to show that their generic version has the same active ingredient, the same label, is intended to be used for the same conditions or diseases and works at the same rate in the body. The aim of the study is to determine if pharmacokinetics is sensitive to differences in the particle size distribution of two different nasal suspension formulations of mometasone furoate during charcoal block. The result from this study will aid the FDA in finding methods to ensure that generic products are the same as the trade name drugs.

NCT ID: NCT02586168 Completed - Insulin Sensitivity Clinical Trials

The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

Start date: July 2001
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.

NCT ID: NCT02580513 Completed - Clinical trials for Diabetes Mellitus, Type 2

Circadian Misalignment and Insulin Sensitivity

Start date: January 2016
Phase: N/A
Study type: Interventional

This study will evaluate the effect of circadian misalignment on insulin sensitivity in healthy lean subjects in a randomized cross-over design. Subjects will be admitted to the research facility for two study periods of 3 and 3.5 days. In one of the study periods, the behavioral cycle will be shifted by 12 hours. Insulin sensitivity will be measured with a hyperinsulinemic euglycemic clamp.

NCT ID: NCT02578914 Completed - Clinical trials for Allergic Conjunctivitis

A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis

Start date: August 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, parallel, single center, double masked, vehicle controlled study. The purpose of this study is to determine the activity and safety of NS2 in patients with grass, tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized 1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle (0.0%). Free aldehydes are thought to be related to inflammatory conditions such as allergic conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether it may decrease inflammation by lowering aldehyde levels.

NCT ID: NCT02575053 Completed - Latex Allergy Clinical Trials

Safety of a Powder-free Latex Allergy Protocol in the Operating Theatre: A Prospective, Observational Cohort Study

Start date: October 2015
Phase: N/A
Study type: Observational

Study objectives Primary objective: This study wants to evaluate the safety of a latex safe protocol as proposed by the Australasian Society of Clinical Immunology and Allergy. In other words,the investigators hope to demonstrate that patients with known latex allergy or latex sensitisation can be treated safely in operating theatres without special requirements towards scheduling provided that all powdered latex gloves are removed from the OR environment( preparation rooms, theatres, recovery room and surroundings). In contrast, earlier guidelines require the theatre to be left unused during at least 3 hours before a patient with suspected latex allergy can be operated on in this theatre. Secondary objectives: - The investigators want to evaluate to what extend patients who report a latex allergy show risk factors of latex allergy. - To investigate to what extend latex allergy was proven by laboratory testing or skin testing in patients who report a latex allergy. - Type of latex allergic reaction when patients report a latex allergy. - The level of satisfaction of surgeons and OR scheduling staff with the new latex safe protocol and with the switching to powder free latex gloves.

NCT ID: NCT02569840 Completed - Clinical trials for Milk Hypersensitivity

Amino Acid Feed Children's Study

Start date: November 2015
Phase: N/A
Study type: Interventional

This study of the tolerance and acceptability of an amino acid based feed will assess gastrointestinal (GI) tolerance, product intake and acceptability in relation to taste, smell, texture in 20 patients between 1-10 years currently using or requiring an amino acid based feed for the dietary management of Cows' Milk Allergy and food-allergy-associated conditions, over 4 weeks.