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Hypersensitivity clinical trials

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NCT ID: NCT04872218 Active, not recruiting - Peanut Allergy Clinical Trials

Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

ATARI
Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

This is a phase 2a, multi-center, randomized and double-blind placebo-controlled trial comparing 24 weeks of abatacept versus placebo used as adjuvant to oral immunotherapy to induce remission in adolescents and adults with persistent severe peanut allergy. This is a proof-of-concept trial in which the primary outcome will be the suppression of the initial peanut specific IgE surge during OIT, which is used as a proxy outcome of peanut allergy remission. Adolescents and adults with persistent severe peanut allergy (n=14) will be randomized to either abatacept or placebo at a ratio 1:1 for a total period of 24 weeks. Peanut oral immunotherapy will be initiated the day following the first administration of the investigational product. Sustained tolerance to peanut will be assessed at 36 weeks.

NCT ID: NCT04801823 Active, not recruiting - Clinical trials for Food Allergy in Infants

The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants With Peanut Allergy

TreEat
Start date: June 1, 2021
Phase: Phase 3
Study type: Interventional

Early and regular ingestion of the common allergens, peanut and egg has been shown to be an effective allergy prevention strategy. It is not clear whether this is also true of tree nut allergy. Current practice in many Australian allergy clinics for children with peanut allergy (high risk of tree nut allergy), is to advise families to introduce each individual tree nut into their child's diet via a cautious home introduction protocol without prior allergy testing (screening). The safety and effectiveness of an early and regular ingestion strategy for the prevention of tree nut allergy has not been formally evaluated and it is known that around a third of children with peanut allergy develop one or more other nut allergies. This trial is a 2-armed, open-label, randomized, controlled trial (RCT) to assess the safety and efficacy of a supervised hospital based multi-tree nut (almond, cashew, hazelnut and walnut) oral food challenge (OFC) + then home introduction of the remaining tree nuts versus standard care (home introduction of all 8 tree nuts) in infants with peanut allergy to reduce the risk of developing tree nut allergy.

NCT ID: NCT04736199 Active, not recruiting - Prostatic Neoplasms Clinical Trials

Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

ARANOTE
Start date: February 23, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.

NCT ID: NCT04677790 Active, not recruiting - Clinical trials for Egg Hypersensitivity

Gradual Egg-tolerance Induction in Hen's Egg Allergic Children Who Tolerate Baked Egg (TETI-II Study)

TETI-II
Start date: December 9, 2020
Phase: N/A
Study type: Interventional

The investigators want to test the hypothesis that a total period of 12 months of stepwise open egg introduction is not inferior when compared to a total period of 20 months gradual open egg introduction of a certain egg product with regard to full egg tolerance induction.

NCT ID: NCT04675047 Active, not recruiting - Healthy Clinical Trials

Multimodal Brain Decoding of Pain Sensitivity

Start date: September 10, 2019
Phase:
Study type: Observational

Pain is the leading cause of disability worldwide. However, the pain sensitivity of individuals varies to a large extent, which often results in the mismatch between clinical diagnosis or treatment and individual's actual needs. There are still no established objective indicators for comparisons between individuals. This integrated pilot project is the first large-scale, multi-modal brain decoding study for pain sensitivity. We will explore the brain network signature of pain sensitivity by analyzing electroencephalogram (EEG) signals and magnetic resonance imaging (MRI.) Meanwhile, we will integrate the innate, environmental, and humanity factors with aforementioned brain network signatures to establish multi- modal objective model of pain sensitivity using machine learning. This research team is composed of more than 30 physicians, scientists, and IT experts, along with international collaborators with expertise in the fields of neuroscience, medical imaging, and human philosophy. The five elite groups constitute this international research team and establish five multi-disciplinary sub-projects: Sub-project A: Pain sensitivity and associated innate and environmental factors Sub-project B: Electrophysiological brain signatures of pain sensitivity Sub-project C: MRI brain signatures of pain sensitivity Sub-project D: Innovative brain computer interface (BCI) technology in pain sensitivity measurement and prediction Sub-project E: Pain and Art: neuro-mental mechanisms and potential applications There are three key features of this integrated project: scientific novelty, technology and humanity. In terms of scientific novelty, in addition to machine learning and big data applications, we will focus on the deep brain structure such as brainstem, in which the image acquisition has been difficult in the past. We will develop an MRI sequence and EEG protocol optimized for brainstem. In terms of technology, we will develop a wearable EEG cap implanted with algorithm chip for clinical measurement to decode the pain sensitivity real time. In terms of humanity, we will combine music and painting appreciation to explore their impact on brain signatures related to pain sensitivity. Furthermore, we will develop potential applications of art intervention in pain modulation. We expect this pilot project to achieve the four following goals: 1. To establish a Taiwan database of pain sensitivity. Meanwhile, to clarify the interactions between the innate and environmental factors of the individual and the brain network, and to identify brain signatures related to pain sensitivity. (sub- projects A, B, C) 2. To confirm the brain signatures for predicting the pain sensitivity using machine learning. In addition, to develop wearable devices such as EEG cap for large sample screening by combining the brain-computer interface through the industry-university cooperation (sub-projects B, C, D) 3. To explore the plasticity of brain signatures related to pain sensitivity by sensory modulation such as music, painting appreciation or transcutaneous electrical nerve stimulation, and to explore the application potential for pain modulation (sub-projects B, C, D, E) 4. Based on the cooperation model of this international research team, we will cultivate young researchers, and promote academic interactions among different team members, and improve the international visibility and competitiveness of Taiwan (sub-projects A, B, C, D, E)

NCT ID: NCT04666129 Active, not recruiting - Clinical trials for Metastatic Castration-Resistant Prostate Cancer

Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Start date: February 18, 2021
Phase: Phase 1
Study type: Interventional

This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).

NCT ID: NCT04636489 Active, not recruiting - Hyperglycemia Clinical Trials

Effect of Prebiotics on Blood Glucose Management

Start date: November 30, 2020
Phase: N/A
Study type: Interventional

This survey is designed to investigate the effect of highland barley β-glucan supplementation on the regulatory of blood glucose, gut microbiota and cardiovascular risk fators in subjects with hyperglycemia.

NCT ID: NCT04619017 Active, not recruiting - Allergic Rhinitis Clinical Trials

Airway Immune Response to Allergens (Use Lay Language Here)

Start date: October 28, 2021
Phase: Phase 1
Study type: Interventional

Most asthma is allergic in origin. The purpose of this study is to better understand the airway immune response to inhaled allergens in order to identify factors that promote asthma.

NCT ID: NCT04601779 Active, not recruiting - Parenting Clinical Trials

INFANT HEALTH- Promoting Mental Health and Healthy Weight in Infancy Through Sensitive Parenting

Start date: August 16, 2021
Phase: N/A
Study type: Interventional

Mental health problems and overweight often co-occur, they have their origin in early childhood and new research evidence suggest a key role of cognitive, emotional and behavioral regulation in the early developmental trajectories and points to the benefits of intervention in infancy that builds on strategies of sensitive parenting. The research group behind this project has developed the PUF program (PUF: In Danish: 'Psykisk Udvikling og Funktion') to target infants' mental health and development within the settings of community health nurses. Still, measures are lacking that address the infants most vulnerable regarding the development and progression of mental health problems and overweight. In this project, we develop and test a new intensified intervention to address major cognitive and regulatory vulnerabilities identified at child age 9-10 months and adapted to the settings of community health nurses. The intervention is created as an add-on to the PUF-program, using an evidence-based method to promote sensitive parenting, the Video-based Intervention to Promote Positive Parenting (VIPP). The new intervention VIPP-PUF comprises six therapeutic sessions delivered by the community health nurse during home visits over a three months period. The intervention builds on teaching the health nurses to promote parents' sensitivity to meet the infants' cognitive and regulatory vulnerabilities, and it takes in account the needs of psycho-socially disadvantaged families. The Infant Health project is conducted in sixteen municipalities across Denmark. We use the Intervention Mapping approach as the study frame and integrate the best practice of community health nurses. The efficacy of the VIPP-PUF intervention is examined in a randomized controlled step-wedge design, in which approximately 1.000 children are followed up to the age of 24 months. The VIPP-PUF intervention is hypothesized to reduce mental health problems at ages 24 months among infants with high levels of cognitive and regulatory problems at age 9-10 months, (primary outcome). Also, it is hypothesized that among children with high levels of cognitive and regulatory vulnerabilities at age 9-10 months, adding the VIPP-PUF intervention to treatment as usual at age 9-10 months, will reduce infants' cognitive and regulatory problems; promote healthy weight development; reduce parents' experiences of stress; promote sensitive parenting and promote parents' feeling of competence and relatedness.

NCT ID: NCT04552522 Active, not recruiting - Immunotherapy Clinical Trials

Immunological Response After Shrimp Oral Immunotherapy Treatment

Start date: August 28, 2020
Phase: N/A
Study type: Interventional

Oral immunotherapy is effective in desensitized food allergy. Shrimp allergy is increasing in Thailand. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to shrimp, Immunoglobulin G4 and immunoblot analysis in shrimp allergy patients after shrimp oral immunotherapy.