Clinical Research Directory

Induced Tolerogenic Dendritic Cells as Modulators of Allergic Asthma

Despite advances in medications, allergic diseases, including allergic asthma continue to rise in prevalence. For this reason, there is a need for a better understanding of the mechanisms of allergic diseases and novel insights into modulating allergic inflammation. The investigators hypothesize that much remains to be learned about the behavior of T effector and T regulatory cells in allergic disease. Furthermore, the investigators hypothesize that novel mechanisms of allergic tolerance may exist, and elucidation of these mechanisms may provide insights into novel therapeutic strategies to control allergic diseases. The investigators will investigate the capacity for T cell tolerance induction in allergic subjects by a novel type of immune tolerizing dendritic cell (it-DC). The investigators will assess whether in vitro generated it-DCs have the capacity to induce antigen-specific T regulatory cells and suppress allergen-specific T effector cell function in vitro. Standardized Cat Allergen extract and Dust Mite Allergens will be used to generate changes in the airways that occur during exposure to allergen. For this investigation, the route of administration will be topical application of the titrated allergen to a bronchoscopically isolated subsegment of one lobe of one lung. The dose of biologic will be determined from prior skin-prick testing.

Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD

This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies. Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.

Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring

Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.

Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention

The goal of this randomized controlled trial is to evaluate the impacts of an attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood illnesses, body mass index, and sleep) in low-income Latino children (N=260; 9 months at enrollment). It is hypothesized that children randomized to ABC will have better health outcomes in comparison to the HBOW control group.

Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study

Apple-birch pollen-food allergy syndrome is particularly common in Northern and Central Europe (70% of patients allergic to birch pollen), and classically induces an oral syndrome that impairs patients' quality of life. Current treatment is based on food avoidance. However, evidence of the efficacy of this treatment is limited (small numbers, lack of validation with a control group, absence of double-blind evaluation of the primary endpoint in a challenge test against placebo). The aim of oral immunotherapy with raw apple is to improve the management of allergic patients by enabling them to acquire tolerance to raw apple and other rosacea.

Improved Child Nutrition and Development Through Social Transfers

The goal of this clinical trial is to learn if a conditional social transfer works to improve rates of complementary breastfeeding. It will also learn about the impacts of social transfers on maternal and child health and development. The main questions it aims to answer are: * Does the social transfer increase complementary breastfeeding rates at 24-months postpartum? * Does the social transfer increase complementary breastfeeding duration? * Does the social transfer impact child health and development? * Does the social transfer impact maternal physical and mental health? Researchers will compare a conditional social transfer to a control group that only receives education about breastfeeding recommendations to see if a conditional social transfers works to increase complementary breastfeeding. Participants will: Receive a pamphlet explaining the current recommendations of breastfeeding Receive instructions that if they meet the recommendation to breastfeed until 24-months postpartum they receive a social transfer or receive no additional information Complete home visits at 12- and 24-months postpartum Complete detailed questionnaire

Elemental 028 Extra Case Studies

Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to support patients with severe impairment of the gastrointestinal tract who may require an elemental diet. An upgraded formulation of Elemental 028 Extra with an increased energy, protein content micronutrient profile has been developed to better meet the nutritional requirements of patients. This series of case-studies aims to evaluate the acceptability, compliance, and gastrointestinal tolerance of the upgraded formulation of Elemental 028 Extra, in 30 adult and paediatric patients (15 powder and 15 liquid), with conditions where there is a severe impairment of the gastrointestinal tract, such as inflammatory bowel disease, short bowel syndrome, intractable malabsorption, allergic disease, and neurodegenerative diseases, and an elemental feed is required. The case study will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple centres in the UK, to meet the UK ACBS and GMS requirements for acceptability studies.

Omalizumab Weight-Based Dosing Efficacy Trial

This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.

Healthspan Connect Programme of Research

Healthspan Connect is a new research programme designed to understand what helps people stay healthy as they age. The programme will explore how lifestyle, environment, genetics, and social factors influence healthy ageing and overall wellbeing. The programme will recruit participants aged 12 years and older across the UK. By including adolescents, the programme aims to understand how early life behaviours and experiences shape long-term health. There is no upper age limit, and people from all backgrounds are encouraged to participate. Special pathways ensure that young participants provide consent in an age-appropriate way. Healthspan Connect is a digital and home-based study, meaning participants can take part from home using smartphones, computers, and online surveys. Participants may also be asked to collect samples such as blood, saliva, stool, urine, or other biological specimens at home using easy-to-use kits. In some sub-studies, participants may be invited to attend research visits for additional tests, scans, or clinical assessments. Family members and close contacts may also be invited to participate in some studies. Through Healthspan Connect, researchers aim to: * Identify the biological, environmental, and social factors that help people live longer, healthier lives. * Understand how different groups, including those historically underrepresented in research, experience ageing. * Explore ways to support behaviour changes that improve health over the lifespan. * Provide near real-time information to inform health policies and interventions. Participants may also be asked for permission to link their information with health records, education records, and environmental data to better understand health outcomes over time. This programme will serve as a flexible platform for multiple sub-studies, allowing participants to contribute to a wide range of research questions related to healthy ageing, resilience, and long-term health. All data and biological samples will be stored securely and used to advance scientific knowledge, with participant privacy carefully protected.

Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives

To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.