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Hypersensitivity clinical trials

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NCT ID: NCT02316912 Completed - Allergy Clinical Trials

First in Man Evaluation of Single and Multiple Doses of Oral ATX2417

Start date: February 2015
Phase: Phase 1
Study type: Interventional

First in man evaluation of single and multiple doses of compound ATX2417 in healthy male volunteers. A double blind placebo controlled parallel group ascending dose design; up to five dose levels for the single dose and up to two dose levels for the multiple dose (8 days of dosing). Subjects will be screened to assure normal health prior to inclusion in the trial and will be monitored for safety (adverse events, vital signs, ECGs, safety labs) and pharmacokinetic profile. A fasted/fed comparison will also be included in the single ascending dose part of the trial.

NCT ID: NCT02316080 Completed - Clinical trials for Dentin Hypersensitivity

The Effect of Desensitizing Agents in In-home or In-office Dental Bleaching

Start date: July 2011
Phase: Phase 4
Study type: Interventional

The aim of this project is to evaluate in vitro and in vivo the effect of dental bleaching agents, carbamide peroxide 16% (T1) and hydrogen peroxide 35% (T2) together with desensitizers/remineralizer agents, Sensodyne® dentifrice (D1); experimental dentifrice with 7,5% of Biosilicate micro-particles (D2); Odontis RX® dentifrice (D3); Sorriso® dentifrice (D4); Biosilicate micro-particles paste, 1:1 (D5), Desensebilize Nano P (D6), bioglass type 45S5 paste, 1:1 (D7); GC= distilled water, in the experimental groups: T1/D1; T1/D2; T1/D3; T1/D4; T1/D5; T1/D6; T1/D7; T1/GC e T2/D1; T2/D2; T2/D3; T2/D4; T2/D5; T2/D6; T2/D7; T2/GC. In the in vitro study, microhardness and roughness measurements, and images using scanning electron microscopy (SEM) will be made on samples of bovine dental enamel and dentin (4x4x3mm; n=10 per group) before and after the treatment with the bleaching gels (T1= 14 days/ 04 hours/day; T2=single session) and the desensitizers/remineralizer agents. In the clinical study, the volunteers (n=10 per group) will be evaluated regarding dentin hypersensitivity (DH), using visual analogue scale, before the beginning of the treatments (T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days) in which the desensitizers/remineralizer agents (there´s no control group in the clinical experiments) will be applying. Data will be analysed intra and inter-group, statistically.

NCT ID: NCT02311413 Completed - Cat Allergy Clinical Trials

A Randomized Prospective Clinical Trial of Fel d 1 Peptide Immunotherapy

Start date: March 9, 2015
Phase: Phase 2
Study type: Interventional

The goal of this study is to identify changes in cells that are related to the treatment with Cat-PAD (ToleroMune Cat).

NCT ID: NCT02304991 Completed - Food Allergy Clinical Trials

FARE Peanut SLIT and Early Tolerance Induction

FARE/SLIT
Start date: January 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. [Time Frame: Baseline, 36 months] Secondary Objectives: A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance). To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. [Time Frame: Baseline, 39 months]

NCT ID: NCT02295488 Completed - Hymenoptera Allergy Clinical Trials

Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy

MAISAVEN
Start date: March 23, 2015
Phase: N/A
Study type: Interventional

Currently, most of the protocols used for desensitization to Hymenoptera venoms consist of a very rapid increase in doses of venom extracts administered during the SIT in a day without systemic reaction of the patient which is not yet explained. The hypothesis is that this good tolerance is due to a rapid decrease in the response of mast cells and basophils to the allergen.. The main objective is to study basophil activation in response to the allergen during the first day of desensitization, measured by basophil activation test. The initiation of desensitization follow a protocol of rapid growth rates. The basophil activation level in the course of desensitization will be analyzed by flow cytometry after in vitro stimulation by allergen. Changes in T cell polarization is also analyzed by flow cytometry. Evolution of the expression of different proteins in blood basophils will be studied by measuring their messenger RNAs

NCT ID: NCT02295397 Completed - Food Allergy Clinical Trials

Integrated Approaches to Food Allergen and Allergy Risk Management

iFAAM
Start date: November 2014
Phase: N/A
Study type: Interventional

Patients with history of a food allergy to hazelnut, walnut or celeriac will undergo food provocation with a dose of the allergenic food to which 5% of the respective food allergic population (ED05) has been calculated to respond with allergic reactions (single shot study). In patients with a hazelnut or peanut allergy a double-blind placebo controlled food challenge with cookies containing either placebo or hazelnut and peanut respectively will be performed to determine threshold levels eliciting an allergic reaction. The results for threshold levels determined by cookie matrix will be compared to the results gained from the EuroPrevall project (matrix comparison study). In patients with a walnut allergy double-blind placebo controlled provocation with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on the threshold level and on the clinical manifestation.

NCT ID: NCT02293044 Completed - Dentin Sensitivity Clinical Trials

A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity

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

This study will compare the safety and effectiveness of a potassium oxalate desensitizer on adjacent teeth with dentinal hypersensitivity.

NCT ID: NCT02290106 Completed - Obesity Clinical Trials

Effects of Pitavastatin on Insulin Sensitivity and Liver Fat

Start date: March 2, 2015
Phase: N/A
Study type: Interventional

HMG co-A reductase inhibitors, commonly called statins, are an effective treatment for dyslipidemia and atherosclerotic heart disease with proven mortality benefit. While the lipid-lowering effects of statins are well-known, other metabolic effects, including effects on glucose tolerance and ectopic fat distribution, are less completely understood. Recent studies have shown that some statins may increase the risk of diabetes. Further, research has suggested that statins may have some benefit in nonalcoholic fatty liver disease (NAFLD), a condition associated with obesity that includes increased fat in the liver (steatosis) and, in some cases, inflammation and hepatocellular damage (steatohepatitis). Pitavastatin, approved by the United States Food and Drug Administration (FDA) in 2009, is the most recent statin to enter the market. Unlike most statins, pitavastatin is not primarily metabolized through cytochrome P450 (CYP450), and thus has reduced potential for interactions with other medications that are metabolized by CYP450. Previous studies have suggested that pitavastatin may be neutral to glucose homeostasis and may improve hepatic lipid. Neither of these effects has been proven definitively, however, and the current proposal aims to characterize in detail the effects of pitavastatin on glucose homeostasis, hepatic steatosis, and steatohepatitis.

NCT ID: NCT02289950 Completed - Clinical trials for Platinum-Sensitive Ovarian Cancer in First Relapse

A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer

Start date: March 19, 2015
Phase: Phase 2
Study type: Interventional

MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in subjects with low cancer antigen 125 (CA125) platinum-sensitive ovarian cancer in first relapse.

NCT ID: NCT02271776 Completed - Obesity Clinical Trials

GOS and Insulin Sensitivity

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

Based on our hypothesis that orally administered GOS will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective: To investigate the effects of a 12-week supplementation of GOS on peripheral insulin sensitivity and body weight control in obese adults with impaired glucose homeostasis.