Eosinophilic Esophagitis

Researchers are developing and validating a wearable sensor designed to help patients with Parkinsons Disease PD who have swallowing difficulties and drooling problems. This study focuses on improving the devices battery life and size, assessing usability with patient feedback, and testing its ability to detect and encourage swallowing in PD patients. The aim is to provide a digital therapeutic platform that can support swallowing function in this population. The wearable device, called the Aria sensor, is a patch that monitors physiological signals continuously and provides vibratory haptic cues to increase how often participants swallow. Participants will use the sensor for three weeks, with the device actively providing haptic cues only during the second week. This single-arm study tracks how the sensor performs in real-life conditions without randomization or blinding. Participants will be involved for three weeks, during which researchers will measure swallow frequency changes, participant adherence to using the haptic cues, and changes in clinical scales related to drooling and swallowing. Assessments include comparing sensor data to a gold standard and evaluating symptom severity before and after the intervention. The study also includes focus groups to gather patient feedback on usability, and safety monitoring is conducted throughout the study period.

Eosinophils are a type of white blood cell that can cause damage to the heart, nerves, and other organs when their levels are elevated, as seen in hypereosinophilic syndrome HES. Some people have a hereditary form called familial eosinophilia FE. This research aims to study FE, its genetic causes, damage mechanisms, and disease markers to better understand the disease and support the development of less toxic treatments. Approximately 50 adults and children from a family with FE will be enrolled in this long-term study. Participants will undergo yearly clinical exams including medical history, physical exams, blood tests, EKG, echocardiograms, and pulmonary function tests. Adult participants will also donate bone marrow initially, and some will undergo leukapheresis sessions where blood is processed and returned. Both affected and unaffected family members will provide blood and tissue samples for research to help identify genetic and immunologic factors involved in FE. Throughout the study, participants will be regularly evaluated to monitor the natural history of FE and to identify early signs of disease progression. Researchers will measure immunologic and molecular mechanisms, clinical markers, and any organ damage caused by eosinophilia. Medical care for any needed treatment will be provided by clinical services or local doctors. The study is indefinite in duration, with yearly assessments and additional tests as needed.

Researchers are conducting a non-interventional, observational study to understand patients in Germany receiving dupilumab for eosinophilic esophagitis EoE. The study focuses on patients medical history, socio-demographic and disease characteristics, other related conditions, concurrent therapies, and prior EoE treatments. It also aims to evaluate the long-term effects of dupilumab on disease symptoms and patients quality of life over a two-year period. Participants in this study are those already prescribed dupilumab by their treating physicians in routine clinical practice no treatments are administered by the study itself. The study observes dupilumab use patterns, safety, and effectiveness during the two years of follow-up. Patients will be followed for approximately 24 months after starting dupilumab treatment with assessments at multiple timepoints to track changes in symptoms, biopsy results, and quality of life measures. During the study, participants will undergo evaluations including medical history review, clinical symptom assessment, endoscopic scoring, esophageal biopsies, and questionnaires on anxiety, depression, and quality of life. Researchers will also collect data on hospitalizations and sick leave related to EoE. Safety will be monitored throughout, and the total participation time for each person is about two years, within a four-year overall study timeline.

The FARE Patient Registry is a prospective observational study focused on collecting detailed health and basic information about individuals living with food allergies. Its purpose is to encourage open sharing of de-identified data and to support participation in clinical trials, ultimately aiming to advance scientific discoveries related to food allergy causes and contributing factors. This registry does not involve any treatment or interventions but gathers real-world experiences from participants with food allergies. It serves as a platform for the food allergy community to contribute data that can help researchers understand the extent and etiology of food allergies. Participants provide their health information and experiences, which are stored in the registry for ongoing research use. The main outcome measured is the creation of a registry that characterizes food allergies and factors influencing their development. The study is observational, with no interventions, and participation can continue until the study end date in August 2027.

Researchers are evaluating the safety, effectiveness, and how the body processes EP-104GI, an extended-release fluticasone propionate injectable suspension, in adults with eosinophilic esophagitis EoE. This Phase 1b2 study aims to understand the local effects of EP-104GI on disease activity using endoscopic and tissue assessments. About 160 participants will be enrolled across dose escalation and randomized dose optimization phases to identify recommended doses and assess outcomes. Participants will receive EP-104GI or a matching vehicle control through submucosal injections during an esophagogastroduodenoscopy EGD procedure at the baseline dosing visit. The dose escalation phase will enroll 27 to 33 participants in different dose cohorts, while the randomized phase will assign about 120 participants to one of two dose levels or vehicle control. Those on vehicle control may switch to EP-104GI after 24 weeks if eligible. Additional substudies may include extended pharmacokinetic follow-up. During the study, participants will attend 8 to 10 visits over approximately 52 weeks, with some having up to 4 extra visits extending to 108 weeks. They will undergo 3 to 5 EGD procedures with biopsies to monitor disease changes and safety. Blood and urine samples will be collected for laboratory tests and drug level measurement. Questionnaires will track symptoms like difficulty swallowing and pain when swallowing. Safety and physical health will be regularly assessed throughout the trial.

This research aims to understand how eosinophils, a type of white blood cell, become activated and their role in immune responses. Eosinophil counts often increase due to allergies, asthma, parasitic infections, autoimmune conditions, or rarely, tumors. Elevated eosinophil levels, called eosinophilia, usually cause no symptoms but can sometimes lead to swelling, itching, allergic lung problems, heart disease, or nerve damage. Participants with eosinophil counts over 750ml or abnormal eosinophil buildup in skin or tissues, aged 1 to 100 years, will undergo clinical evaluations including medical history, exams, and blood tests. Additional testing may include studies of eyes, lungs, skin, bone marrow, nerves, or heart depending on symptoms and age. This is an observational study without experimental treatments patients needing therapy will get standard care. Some participants may also undergo bone marrow biopsy, genetic testing, or leukapheresis for adults for research purposes. During the study, participants will donate blood samples for laboratory studies and may have annual follow-ups with exams and blood tests to track eosinophil levels and condition changes. Researchers will collect samples like blood, bone marrow, tissue, and body fluids to study disease mechanisms, biomarkers, and treatment responses. The study will monitor clinical and immunological responses to therapy and evaluate family members to explore genetic causes of eosinophilia. The main goal is to better understand eosinophilic disorders and improve diagnosis and treatment options.

Researchers are evaluating a new approach to treating patients with squamous cell carcinoma of the oropharynx who have larger primary tumors stage T3-T4. This phase II randomized trial compares the current standard chemoradiation treatment with a new method that adapts radiotherapy based on MRI scans taken mid-treatment. The goal is to see if adjusting radiation therapy according to tumor shrinkage seen on MRI can reduce swallowing difficulties measured six months after treatment. Participants will be randomly assigned to one of two groups. The standard care group receives radiotherapy planned at the start of treatment, with adjustments only if major anatomical changes occur. The experimental group receives systematic radiation plan changes guided by mid-treatment MRI scans to target the shrinking tumor. Both groups may also receive chemotherapy as part of their treatment. This study uses advanced MR-Linac technology to enable detailed imaging during therapy. During the study, patients will undergo assessments including patient-reported swallowing function measured six months after treatment using the MD Anderson Dysphagia Inventory. Researchers will also monitor acute and late side effects for up to five years after chemoradiation. The trial includes safety monitoring and statistical review of interim data to ensure appropriate sample size. Participation involves regular clinical visits, imaging, and questionnaires to track treatment effects and quality of life.

This research aims to understand how co-existing health conditions, medical history, and allergy tests affect the results of allergen provocation tests in children. The study includes children from birth up to 18 years old who are being investigated for allergies to foods or antibiotics. It is a prospective observational study conducted at the Hans Christian Andersen Childrens Hospital. Participants undergo oral provocation tests where small, increasing amounts of allergens are given to assess allergic reactions. The allergens studied include antibiotics and a variety of common food allergens such as milk, egg, peanut, hazelnut, sesame, wheat, various nuts, soy, fish, shellfish, and poppy seed. Each child is assigned to a group based on the specific allergen they are being tested for. During the study, data on demographics, co-existing conditions, symptoms, skin prick tests, specific IgE levels, and details from the provocation tests are collected and entered into a database. Researchers will assess the relationship between allergy test results and provocation outcomes over a five-year period. Children will be monitored through these evaluations to better understand allergy responses and test effectiveness.

Researchers are studying individuals of all ages with suspected or known inherited genetic diseases related to allergic inflammation and immune dysregulation. This research aims to better understand genetic and immune system factors involved in conditions such as atopic dermatitis, asthma, autoimmune diseases, anaphylaxis, and immunodeficiency. The study includes both affected patients and their family members to explore the underlying causes and mechanisms of these disorders. Participants include patients and their blood relatives who may have disorders affecting allergic inflammation or immune system regulation. The study involves collecting various biological samples such as blood, saliva, hair, fingernail clippings, cord blood, bone marrow, tissue biopsies, and buccal swabs. Researchers may also obtain outside medical records and conduct patient evaluations to support laboratory research into genetic and immunopathogenic factors. During the study, participants provide consent for sample collection and storage for future immune system research. Researchers will analyze these samples alongside clinical data to identify susceptibility traits related to these diseases over a period of up to one year. The study may involve ongoing monitoring, review of medical histories, and correlating clinical findings with laboratory results to improve diagnosis and management of allergic and immune dysregulatory disorders.

Researchers are evaluating the effects of additional education combined with more frequent follow-up visits and patient reminders on how well adults with eosinophilic esophagitis stick to their long-term treatment plans. This trial focuses on improving treatment adherence, which is often challenging for patients with chronic conditions, including eosinophilic esophagitis. The study is led by the Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA. Participants are randomly assigned to one of two groups one group receives a behavioral intervention that includes extra education, frequent follow-ups, and reminders, while the control group receives no additional intervention. The study is single-blind and monitors treatment adherence over several time points, including 12 weeks, 6 months, and 12 months. During the study, participants will be assessed for treatment adherence using various self-report questionnaires and clinical symptom changes evaluated through specific symptom questionnaires. The primary outcome is treatment adherence at 12 weeks. Secondary outcomes include adherence and symptom changes at 6 and 12 months. Participants involvement includes regular follow-ups and completing questionnaires to track adherence and symptoms throughout the study period, which lasts up to one year.