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Hypersensitivity clinical trials

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NCT ID: NCT04770727 Completed - Clinical trials for Food Allergy in Children

CBT Group Intervention for Children With Food Allergy and Anxiety

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The research will design and evaluate a CBT based intervention to support children aged 11-17 with food allergies. The research on this population has shown that they can experience high levels of anxiety in management of their allergy which can have a significant impact on quality of life. However, the research exploring psychological interventions is limited. CBT has a wide evidence base from NHS settings delivering interventions to support those with various health conditions. In addition, CBT has been shown to be effective for supporting adolescents manage their health-related anxiety. The investigators are interested in the feasibility of designing and implementing a one day workshop aimed at adolescents with food allergy and self-reported anxiety. The group workshop will involve psychoeducation on anxiety, skills and techniques to manage anxiety, relaxation and how to set goals in relation to their food allergy. It will involve 2 'arms', one where participants will attend the group and the other 'control arm' where they will not attend the group but they will receive materials from the group once the evaluation is complete. All participants will be asked to complete questionnaires that measure level of anxiety, food allergy quality of life and coping skills at baseline, time of workshop, one month follow up and three month follow up. There will also be an opportunity for participants to volunteer to take part in a follow up interview to evaluate the workshop and also to contribute more to the research on what this population requires in terms of a psychological intervention.

NCT ID: NCT04769180 Completed - Clinical trials for Non-celiac Gluten Sensitivity

Extraintestinal Non Celiac Wheat Sensitivity

Start date: January 1, 2000
Phase:
Study type: Observational

Non Celiac Gluten Sensitivity (NCGS), or, better, Non Celiac Wheat Sensitivity (NCWS), since it is not known the real pathogenetic component(s) of grain, is a syndrome characterized by a cohort of symptoms, both gastrointestinal and extraintestinal, related to the ingestion of gluten/wheat-containing food in subjects who are not affected by celiac disease (CD) or wheat allergy. In particular, the possibility of extraintestinal manifestations in this condition has been suggested by some reports. In most cases, they are characterized by vague symptoms, such as headache, 'foggy mind', fatigue, joint and muscle pain, leg or arm numbness (i.e., fibromyalgia-like symptoms), even if more specific complaints have been described. A possible neurological involvement has been underlined by NCWS association with gluten encephalopathy, gluten ataxia, and gluten peripheric neuropathy. NCWS patients may show even psychiatric diseases, such as anxiety, depression, and psychosis. Other described extraintestinal manifestations are dermatitis, (eczema or skin rash), gynecological disorders, and anemia. In addition, the association of NCWS with autoimmune diseases, such as autoimmune thyroiditis, and presence of anti-nuclear or other autoantibodies has been demonstrated, suggesting that, similarly to CD, NCWS might be considered as an immune system-related disease, and this aspect should be of relevance. In conclusion, the novelty of this matter has generated an expansion of literature data about the clinical features of the disease, with the unavoidable consequence that some reports are often based on low levels of evidence. The aims of the present study were to: a) retrospectively evaluate the prevalence and kind of extraintestinal symptoms in a large cohort of NCWS patients; b) to research for a possible relationship between the clinical, serological, genetic and histological characteristics of the NCWS patients and the number and kind of extraintestinal manifestations. As control groups, the researchers used CD and Irritable Bowel Syndrome (IBS) patients unrelated to NCWS or other food allergies/intolerances.

NCT ID: NCT04763889 Completed - Anxiety Clinical Trials

Cognitive Behaviour Therapy for Adults With Allergy.

Start date: February 2, 2021
Phase: N/A
Study type: Interventional

People with severe allergy often experience distress but research exploring psychological interventions for them is limited. Cognitive Behaviour Therapy (CBT) is routinely used in NHS services. The research investigators would like to know whether a short term CBT group is feasible and acceptable for those with severe allergy who are also experiencing distress and/or anxiety. The research investigators will recruit people with allergy through support groups and social media. Those interested in the study will be invited to complete a screening interview. If the participants meet the inclusion criteria and consent to take part the participants will be randomly allocated into the CBT or a self-help group. Full written consent will be needed at the telephone screening session if participants are eligible for the study. Participants will be given time to complete this prior to the intervention. Participants will be able to withdraw at any point during the study. The self-help group will be sent self-help materials. The CBT group will attend a single session day workshop based on CBT (maximum 6 hours length). Due to the Covid-19 pandemic, the workshop may need to be delivered online. If delivered online, the workshop may be delivered over two three hour sessions. Participants will be asked to complete questionnaires at baseline, the day of the intervention, one month later and three months later. They will be asked to complete a feedback form about their experiences in the group and at three month follow up, a small subsample of participants will be invited to interview. Once the data is analysed it will be written up into a report for a clinical psychology doctoral qualification major research project. It may also be published in academic journals and presented at conferences. A possible outcome of the research is that people with allergy either do or do not find the workshops an acceptable and/or feasible intervention. It will identify the potential for this intervention to reduce distress and anxiety and to improve coping skills in adults with allergy. Those who take part are welcome to contact the researchers to find out the results of the study.

NCT ID: NCT04761822 Completed - COVID-19 Clinical Trials

COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations

SARS
Start date: April 7, 2021
Phase: Phase 2
Study type: Interventional

Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have been reported with either vaccine. This study is designed with two principal aims: - To estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a High-Allergy/Mast Cell Disorder (HA/MCD) population, and - If the risk in the HA/MCD is demonstrable, to determine whether the proportions are higher in the HA/MCD in comparison to a representative population without severe allergies or mast cell disorders

NCT ID: NCT04754763 Completed - Clinical trials for Dentine Hypersensitivity

A Comparative Study On The Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

Start date: June 1, 2018
Phase: Early Phase 1
Study type: Interventional

Background: Dentine hypersensitivity (DH) causes considerable pain and discomfort to an individual due to number of stimuli on exposed dentine. Different kinds of treatment strategies are used in the resolution of dentine hypersensitivity including the use of propolis and dentine bonding agent. No study had compared the efficacy of propolis and dentine bonding agent. Objective: The objective of the study was to find out whether there is a difference in the efficacy of Propolis and seventh generation dentine bonding agent in reducing the dentine hypersensitivity. Comparison within the groups and pairwise comparisons were also recorded in reducing dentine hypersensitivity. Methods: In this six month In- Vivo single blinded randomized clinical study, a total number of 52 patients with complain of dentine hypersensitivity were selected in two groups after taking informed consent. Group A and B received 30% ethanolic extract of propolis and dentine bonding agents respectively by a trained operator. Recordings of dentine hypersensitivity were obtained at Day 0, before and after the application of experimental agents, and also on Day 7, 15 and 30 by the principal investigator. Response was measured by Visual Analog Scale and Schiff Cold Air Sensitivity Scale. Statistical Package for the Social Sciences (SPSS) version 20 was used to analyze the data with level of significance set at p < 0.05. Friedman test was applied to see the comparison within groups and Wilcoxon Signed Rank test was used for Pairwise comparison. Mann Whitney U-Test was applied for comparison between groups.

NCT ID: NCT04750980 Completed - Allergy Clinical Trials

Microbiota and Allergy

MATFA I
Start date: June 1, 2017
Phase:
Study type: Observational

Food allergy derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for gut microbiota in oral tolerance development. An altered composition of gut microbiota results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. Preliminary results of MATFA study demonstrated gut microbiota in allergic children.These findings support the pivotal role of the gut microbiota in the pathogenesis of allergic diseases and may open new strategies in the development of innovative preventive and therapeutic approaches.

NCT ID: NCT04739332 Completed - Clinical trials for Mother-Infant Interaction

The Effect of the Newborn Behavioral Observations System on Maternal Sensitivity

Start date: July 1, 2016
Phase: N/A
Study type: Interventional

The study evaluates if the Newborn Behavioral Observation system, a relationship building tool, delivered to at risk mothers will have, on one site, an effect on maternal sensitivity and the other site on Childs responsiveness, measured by the Emotional Availability (EA) Scales at 4 months post partum.

NCT ID: NCT04738890 Completed - Clinical trials for The Quality of Life of Parents of Children With Food Allergy

Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies

Start date: March 2, 2021
Phase: N/A
Study type: Interventional

This study aims to conduct an initial evaluation of adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (MBCT-PCCFA).

NCT ID: NCT04712396 Completed - Clinical trials for Healthy Volunteers (Intended Indication: Metastatic Patients With Triple Negative or HR+ Breast Cancer, or Hormone Sensitive Prostate Cancer)

A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body

Start date: February 1, 2021
Phase: Phase 1
Study type: Interventional

This study will be an open-label, fixed sequence study in healthy subjects (vasectomized males and females of non-childbearing potential), performed at a single study centre.

NCT ID: NCT04700241 Completed - Vascular Function Clinical Trials

Nitrate and Brain Insulin-Sensitivity

NO-BRAINS
Start date: January 21, 2021
Phase: N/A
Study type: Interventional

Disturbances in brain insulin-sensitivity are not only observed in abdominal obesity and type 2 diabetes mellitus (T2D), but also during brain aging and in dementia. Inorganic nitrate may improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter cerebral blood flow (CBF) response to intranasally administered insulin, through beneficial effects on brain vascular function. Therefore, we now hypothesize that inorganic nitrate, which can be found in several vegetables such as beetroot, improves brain insulin-sensitivity, as assessed by the gray-matter CBF response to intranasally administered insulin, in abdominally obese men.