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Hypersensitivity clinical trials

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NCT ID: NCT02152826 Completed - Dentin Sensitivity Clinical Trials

Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Dental Hypersensitivity

Start date: March 2014
Phase: N/A
Study type: Interventional

This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.

NCT ID: NCT02152059 Withdrawn - Clinical trials for Small Cell Lung Cancer

A Study to Evaluate the Good and Bad Effects of BIBF1120 in Small Cell Lung Cancer Patients Who Have Previously Benefited From First-line Platinum-based Chemotherapy

Start date: July 2014
Phase: Phase 2
Study type: Interventional

This study is being done to evaluate the good and bad effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients and to see if BIBF1120 may or may not be more effective and better tolerated than standard therapy. The purpose of this study is to: - Find out the proportion of patients with their small small cell lung cancer controlled for at least 90 days after treatment with BIBF1120 - Compare the response rate, survival and side effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients - Identify a group of patients who will benefit the most from BIBF1120 In this study, patients will receive BIBF1120 at 200 mg twice daily continuously. A cycle will be 21 days. During treatment, the dose of BIBF1120 will be held or reduced to lower doses if patients do not tolerate it well or if the doctors are concerned about the side effects of BIBF1120 on individual patients.

NCT ID: NCT02149719 Completed - Clinical trials for IgE Mediated Peanut Allergy

Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study

BOPI-1
Start date: May 2015
Phase: N/A
Study type: Interventional

Peanut allergy is increasingly common, especially in countries such as UK and Australia. There is currently no accepted routine clinical therapy to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. Although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects during protocol, resulting in a significant rate of drop-outs. Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may therefore provide a safer way of inducing desensitisation in patients who are allergic to roasted peanut, by first inducing tolerance to boiled peanut. Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted peanut, in peanut-allergic individuals.

NCT ID: NCT02149134 Recruiting - Cow's Milk Allergy Clinical Trials

Evaluation of the Efficacy of a New Infant Formula in Subjects With Cow's Milk Allergy

Start date: October 2013
Phase: Phase 2
Study type: Interventional

Cow's milk protein allergy is defined as an immunological reaction to one or more milk proteins. A variety of symptoms can be suggestive for cow's milk protein allergy . Cow's milk protein allergy is suspected clinically in 5-15% of infants, while most estimates of prevalence of cow's milk protein allergy vary from only 2 to 5 %. Confusion regarding cow's milk protein allergy prevalence is often due to differences in study populations, study design and a lack of defined diagnostic criteria. The importance of defined diagnostic criteria needs to be emphasised. It precludes infants from an unnecessary diet and avoids delay in diagnosis, which can lead to malnutrition. There are two clinical types of cow's milk protein allergy: the immediate and the delayed type. The immediate type usually presents within minutes after the ingestion of cow's milk protein with urticaria, angio-oedema, vomiting or an acute flare of atopic dermatitis and is present in slightly more than half of the patients with cow's milk protein allergy. Delayed reactions such as atopic dermatitis or gastrointestinal symptoms like proctocolitis or enteropathy usually present after hours or days. Immunologically, cow's milk protein allergy can be IgE or non-IgE mediated. IgE mediated reactions are often of the immediate type. Non-IgE mediated reactions are often cell mediated or mixed cell and IgE mediated and are more difficult to prove by specific testing. The immunological reaction differentiates cow's milk protein allergy from other milk induced pathology such as lactose intolerance. A variety of symptoms can be suggestive for cow's milk protein allergy although none of them is diagnostic. A good medical history remains the cornerstone for the diagnosis. The treatment of cow's milk protein allergy is the dietary elimination of cow's milk proteins. In non-breastfed infants and children less than 2 years of age, a substitute formula is mandatory as prescribed by several international scientific societies. Extensively hydrolyzed formulas are used as therapeutic formulas. An extensively hydrolysed formula is often a whey or casein based formula in which the protein has been chopped up in smaller pieces that are less allergenic. Because of high cross-reactivity (up to 80%) and nutritional inadequacy, the use of any other animal milk or soy-based formula is precluded.The infant should be maintained on an elimination diet until the child is between 9-12 months of age or at least for 6 months, whichever occurs first. In most cases, symptoms will improve substantially within 2-4 weeks if diagnosis is correct. According to consensus in literature, a therapeutic formula is a formula tolerated by at least 90% (with 95% confidence) of cow's milk protein allergy infants. The aim of the investigators study is to show the efficacy, tolerance and nutritional adequacy of a newly developed thickened extensively hydrolyzed formula in infants with a proven cow's milk protein allergy. In all included patients, cow's milk protein allergy will have been diagnosed based on a double blind placebo controlled food challenge, considered as golden standard in cow's milk protein allergy diagnosis. To evaluate efficacy of the formula, the formula has to be tolerated by at least 90% (with 95% confidence) of cow's milk protein allergy infants following literature consensus. A symptom diary will be filled out for this purpose by the patients' parents or legal guardians and the patient will be followed clinically by his doctor several times during the study period. Nutritional adequacy of the formula will be evaluated clinically by following growth and weight several times during the study period and by comparing it to the standard WHO growth curves, based on breastfed infants.

NCT ID: NCT02144428 Recruiting - Cow's Milk Allergy Clinical Trials

Hypoallergenicity To Substitutive Formulas In Children With Cow's Milk Allergy

Start date: April 2011
Phase: N/A
Study type: Observational

The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. In the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. These formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. In these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.

NCT ID: NCT02136576 Completed - Hypersensitivity Clinical Trials

Caries Prevention Products & Dentinal Hypersensitivity

Start date: May 2014
Phase: N/A
Study type: Interventional

The aim of this pilot research project is to compare the clinical effect on dentinal hypersensitivity of three products: Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) paste with fluoride, 5000 Sodium Fluoride (NaF) dentifrice containing Tri-Calcium Phosphate (TCP), and a dentifrice containing Potassium Nitrate. The hypothesis of this study is that CPP-ACP with fluoride and 5000ppm NaF with TCP will exhibit a greater reduction in dentinal hypersensitivity compared to the control (dentifrice containing Potassium Nitrate). The results of this pilot study will validate or negate the need for a larger clinical study that may provide generalizable results for using caries-prevention products with the additional benefit of minimizing dentinal hypersensitivity.

NCT ID: NCT02128633 Completed - Dentin Sensitivity Clinical Trials

Effectiveness of a Homecare Dentin Hypersensitivity Gel

ECR
Start date: November 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Aim: To evaluate the effectiveness of a desensitizing gel for topical and home use in the treatment of dentin hypersensitivity (DH) through a randomized clinical trial, double-blind, with three parallel treatment. Methods: 126 subjects were divided into three groups: placebo gel (PG), test gel (TG) (5% sodium fluoride, potassium oxalate 5%, strontium chloride 10%) and sodium fluoride gel (2% FG ). The measurement of DH was performed by a single examiner blinded by the visual analog scale (VAS) after tactile, thermal and osmotic stimuli in the Baseline, 7, 15 and 30 days.

NCT ID: NCT02114892 Completed - Clinical trials for Metabolic Syndrome X

Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight. The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion. The investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

NCT ID: NCT02113241 Completed - Clinical trials for Metabolic Syndrome X

Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion

Start date: April 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have benefits on blood pressure, triglycerides levels and help to raise the levels of high density lipoproteins cholesterol (c-HDL). The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome, insulin sensitivity and insulin secretion. The investigators hypothesis is that the administration of dapagliflozin modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

NCT ID: NCT02112734 Active, not recruiting - Food Allergy Clinical Trials

Can Vitamin D Supplementation in the First Year of Life Prevent Food Allergy in Infants? The VITALITY Trial: Parts 1&2

VITALITY
Start date: December 2014
Phase: Phase 4
Study type: Interventional

We report that Australia has the highest prevalence of Immunoglobulin(Ig)E-mediated food allergy in the world, with 10% of infants having challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital admissions for life-threatening anaphylaxis. These changes are most pronounced in children less than 5 years, suggesting a causal role for early life determinants. We have primary data to inform hypotheses for the rise in food allergy, which appears to result from potentially modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency (VDI). We propose an intervention study to assess if infant Vitamin D supplementation during the first year of life significantly decreases the risk of early-onset food allergy and other allergic disease at 12 months (part 1) and 6 years of age (part 2). Australia is ideally placed to answer this important question since, unlike the USA, Canada and Europe, there are no population recommendations for routine infant supplementation with Vitamin D and we are one of the few developed countries that do not supplement the food chain supply with Vitamin D.