View clinical trials related to Hypersensitivity.
Filter by:B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
This study will be conducted in 2 cohorts. In Cohort A, approximately 40 subjects will participate in a single-center, open-label, non-randomized, parallel-group trial to investigate the molecular mechanisms involved in delayed-type hypersensitivity (DTH) to various antigens and assess the most appropriate skin challenge antigen to study the effect of systemic treatments on T cells. Following evaluation of the results in Cohort A, approximately 20 healthy volunteers will be enrolled in Cohort B. This cohort will be a single-center, double-blind, randomized, two-arm, placebo-controlled study to evaluate the effect of corticosteroid treatment on the molecular and cellular phenotype of delayed hypersensitivity response to one if the antigens previously studied in Cohort A.
Penicillin antibiotics are safe and inexpensive, and target selected bacteria rather than killing a broad range. Unfortunately, around 10% of the population are labelled as 'penicillin allergic'. This is often based on side effects such as rash and diarrhoea, and 90-95% of people with the label are not actually allergic to the drug. The label leads to the use of alternative antibiotics, which tend to more toxic, and less specific about which bacteria they kill; this increases the risk of infections with so-called 'super-bugs', compared to patients without the label. People with the label also have an increased length of hospital stay and rates of readmission. These are significant problems for individuals, as well as wider society. Where the diagnosis is in doubt, the gold standard test for allergy is an oral challenge. Patients undergo skin +/- blood tests prior to a challenge, as these can help make the diagnosis. This combined pathway is expensive and time consuming, so testing cannot be offered routinely to all patients. However in patients with 'historic' reactions (many years previously), skin and blood tests become much less useful; in one study, 100% of patients who skin tested positive for amoxycillin allergy, tested negative 5 years later. Patients with historic reactions can therefore proceed directly to an oral challenge without prior skin or blood testing, since these offer little help in making the diagnosis. This streamlines the pathway, making it quick, non-invasive and cheap. Already established practice in several centres in Europe and beyond, this abbreviated pathway is offered on an ad-hoc basis in some centres in the UK. The aim is to demonstrate that this pathway offers a safe and effective way to perform large-scale delabelling of elective surgical patients, who might not otherwise meet NICE criteria for testing.
Background Type 1 diabetes mellitus is a chronic metabolic disorder that presents a significant set of challenges to the patient, their family and the physician. Near normoglycemia is associated with a reduced risk of microvascular and macrovascular complications in type 1 diabetes mellitus but is difficult to achieve despite considerable effort from patients and healthcare providers . Furthermore, episodes of hypoglycemia are frequent and may endanger life acutely. Subcutaneous glucose monitoring systems (CGMS), also called sensors that continuously measure interstitial fluid glucose levels have become available recently, and approved for use in children. CGMS has made it possible to assess the patterns and trends of blood glucose and the substantial variability in glucose excursions in the population of type 1 diabetes, and to prevent severe hypoglycemic episodes. The benefits of this technology are most apparent with near continuous wear of the sensors and is incorporated into the day to day management of the individual's diabetes . These devices provide patients with information regarding postprandial and overnight glucose profiles that are rarely, if ever, obtained with conventional self monitoring of blood glucose using home glucose meters . Skin reactions CGM systems measure the glucose content of interstitial fluid , using an electrochemical enzymatic sensor, which is accessed by a needle sensor inserted subcutaneously. The CGMS is compromised of a disposable subcutaneous glucose-sensing catheter connected by a cable to a pager sized glucose monitor . Problems related associated to skin irritation and sensor adhesiveness in these young children presents challenges to daily use of the CGMS. In the study conducted by Englert et al, for the Diabetes Research in Children (Directnet) Study Group - three primary factors that contributed to reduced CGM use were identified: the limited body surface area in smaller children, ambient temperature and humidity, as well as the type and duration of physical activity. A study conducted in Israel, by our group, demonstrated only 30% consistant use of the system, partly due to skin reactions . In our cohort, thirty participants of the CGMS group (36.1 %) had signs of local reaction to the RT-CGMS insertion. Mild-to severe local redness was reported in 19 % of patients and hyperpigmentation in 17 %. Skin reactions were among the reasons for discontinuation of CGMS (2/51 participants, 3.9 %). The use of Local Fluticasone for dermatological use Fluticasone propionate - the first carbothioate corticosteroid - has been classified as a potent anti-inflammatory drug for dermatological use. It is available as cream and ointment formulations for the acute and maintenance treatment of patients with dermatological disorders such as atopic dermatitis, psoriasis and vitiligo. This glucocorticoid is characterized by high lipophilicity, high glucocorticoid receptor binding and activation, and a rapid metabolic turnover in skin. Several clinical trials demonstrate a low potential for cutaneous and systemic side-effects . Even among paediatric patients with atopic dermatitis, fluticasone propionate proved to be safe and effective. These pharmacological and clinical properties are reflected by the high therapeutic index of this glucocorticoid. The same drug is also available as a nasal spray ,for cases of allergic rhinitis. The use of fluticasone in spray, sprayed on the location of CGMS insertion, prior to insertion to prevent adverse skin reactions in patients with type 1 DM using CGMS devices has not been addressed in the literature. Hypothesis : Minimizing skin irritation may significantly improve duration of use and tolerability of CGM devices by young children, as well a in young adults. The Investigators assumed that the simple use of a spray, which will not decrease the adhesiveness of the sensor, may improve use . Methods Children whose parents had difficulty with CGMS due to irritation, redness were offered to use Flixonase (FLUTICASONE PROPIONATE), with an approval form 29ג, indicating it is not approved for this specific diagnosis . The investigators followed those patients for improvement and possible local side effects. Study population Every patient, treated by the pediatric and adolescents diabetes mellitus interdisciplinary service , Assaf Haroffe Medical Center , who experienced local reaction at the site of CGMS was offered this medical option . Charts were reviewed for response . total participants - 15
Cow's milk (CM) allergy is the most frequent food allergy in the first years of life, with prevalence rates estimated in the range of 2-3%. The elimination of CM is the mainstay of treatment, but accidental exposure to CM proteins is not uncommon, with a considerable risk of severe allergic reactions. Recent evidence suggests that early oral exposure in young children may protect to the development of allergy. On the same way, strategies have been developed for the use of oral exposure as immunotherapy for the treatment of children with established food allergy even if available data on the use of oral immunotherapy in infants with food allergy are very limited. The aim of this study is to evaluate the feasibility of an oral immunotherapy protocol, started in the first year of life, in children with CM allergy.
The present study aims to investigate the effect of fat level and fat type of a snack on self-reported satiety and associated biomarkers. The relevant individual differences will also be investigated.
The objective of this study was to determine how metabolic and inflammatory effects of physical exercise in overweight individuals are altered when sugar-sweetened beverages (SSB) are consumed after physical exercise. A randomized, controlled crossover trial was performed in which participants performed exercise with and without the ingestions of SSB during exercise or a non-exercise control condition to evaluate metabolic and inflammatory responses one day after the exercise and or SSB treatment.
This study aims to compare the sensitivity of detecting Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium by real-time multiplex PCR in a pooled analysis (i.e. gathering pharyngeal, anorectal and urinary samples) versus the standard of care (where a real-time multiplex PCR is made in each of the three samples).
This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).
Atopic Dermatitis (AD), also known as eczema, is a common skin disease characterized by itchy lesions. The prevalence of AD has increased over the past few decades, with 15-30% of children and 2-10%of adults being affected. The lesions of AD patients are very inflamed, with an increased number of inflammatory cells in the skin. There are not many medications available that are fully effective and can be used long-term for treatment of atopic dermatitis. Benralizumab is a monoclonal antibody used for treatment of a type of asthma called "eosinophilic asthma". Atopic dermatitis is also associated with elevated levels of eosinophils, and we would like to determine if benralizumab is effective in patients with atopic dermatitis. This is a randomized, double-blind, parallel group, placebo-controlled study will evaluate the effect of 3 doses of a fixed 30 mg dose of benralizumab administered subcutaneously (SC) every 4 weeks to patients with moderate-to-severe atopic dermatitis, on the severity of atopic dermatitis, and the cellular inflammation of skin lesions in these patients. Anti-inflammatory properties of benralizumab when a skin flare is induced in a controlled laboratory setting, in addition to the effects of benralizumab on skin that is already inflamed will be examined.It is hypothesized that benralizumab will attenuate eosinophilic inflammation in the skin.