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NCT ID: NCT05098522 Completed - Clinical trials for Seasonal Allergic Rhinitis

Allergen Challenge Trial of IRL201104 in Seasonal Allergic Rhinitis

Start date: November 4, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this allergen challenge study is to assess the efficacy of IRL201104 compared with placebo in adult participants with seasonal allergic rhinitis.

NCT ID: NCT05098223 Completed - Healthy Diet Clinical Trials

Price Promotions on Purchases of Snacks

WoodsTRP
Start date: October 29, 2021
Phase: N/A
Study type: Interventional

Study Design: Randomised controlled trial Study Participants: Healthy volunteers from the UK Planned Sample Size: 500 Planned Study Period: June - December 2021 Objectives and Outcome Measures: 1. Primary - Objective: To investigate the effect of promotions on the total number of calories selected - Measure: Difference in the absolute energy (kcal) of the final basket between the two groups 2. Secondary Objectives: - To investigate the effect of promotions on the nutritional content of the items selected overall, and across the individual target food categories - To explore the impact of removing promotions by socioeconomic status Measures: - Difference in the absolute sugar (g, kcal, %E), salt (g), and saturated fat (g, kcal, %E) of the final basket between the two groups - Difference in the absolute energy (kcal), sugar (g, kcal, %E), salt (g), and saturated fat (g, kcal, %E) between the two groups across the individual target food categories - Analyses of the primary and secondary outcomes specified above by gender, age group, ethnic group (White vs Non-White), BMI stratified into <30 and ≥30kg/m2 groups, education level (lower vs. higher), and household income (lower vs. higher) 3. Exploratory outcomes: - Objective: To investigate the acceptability of the intervention - Measures: Rating scores and open-ended answers from the follow-up questionnaire

NCT ID: NCT05098041 Completed - Healthy Volunteers Clinical Trials

A Study of Soticlestat and Rifampin in Healthy Adults

Start date: November 22, 2021
Phase: Phase 1
Study type: Interventional

The main aim of this study is to check how rifampin affects the way soticlestat is processed by the body. Participants will be required to stay at the study clinic for 18 consecutive days. On the first full day and 15th day, participants will take a single dose of soticlestat. Rifampin will be taken each day starting on the 5th day for 13 consecutive days. Clinic staff will follow up with each participant about 15 days after the last soticlestat dose to check for any side effects.

NCT ID: NCT05097703 Completed - Sleep Hygiene Clinical Trials

Sleep Resource for Carers of Pre-school Aged Children; a Development and Pilot Study

SLEEPY
Start date: November 29, 2021
Phase: N/A
Study type: Interventional

Evidence suggests sleep difficulties in pre-school children (aged 3-6 years) are highly prevalent and that carer knowledge of good sleep hygiene practices and the importance of them is relatively poor. Establishing a regular bedtime routine, involving activities shown to induce relaxation and prepare the child for sleep, is important in promoting optimal sleep duration and quality. However, there appears to be a lack of evidence-based resources that are empirically evaluated for carers to use with children within the family home. This study proposes to co-develop and pilot a new sleep resource. This will be an interactive storybook which guides children and their carers through a number of activities, designed to increase relaxation and prepare the child for sleep. A randomised control trial (RCT) design will be used, with an intervention group and a waitlist control group who will receive the resource at the end of the intervention period. Both groups will be asked to complete pre-intervention, post-intervention and follow-up measures; as well as keep sleep diaries for their children for the duration of the intervention period. The intervention group will also be asked to keep a diary of resource use and then to complete a feedback survey post-intervention. They will be asked to use the resource for a minimum of three days a week for a one-month period. This pilot aims to assess the acceptability of the resource and provide initial findings in terms of its efficacy on a range of sleep related outcomes.

NCT ID: NCT05096988 Completed - Phenylketonurias Clinical Trials

Evaluation of PKU Sphere Liquid

Start date: November 23, 2021
Phase: N/A
Study type: Interventional

PKU Sphere Liquid is a prospective, open-label, acceptability study to evaluate PKU sphere liquid in up to 15 participants aged 3 and above for the dietary management of PKU over 31 days.

NCT ID: NCT05096819 Completed - Clinical trials for Pulmonary Hypertension

Evaluation of the Usefulness of Adopting Remote, Mobile-based 6MWT Among Hospital Outpatients (the 6-APPnow), Within the Constraints Imposed by the SARS-COV2 Pandemic

6-APPnow
Start date: September 1, 2021
Phase:
Study type: Observational

The six-minute walk test (6MWT) is a standard method for measuring exercise capacity in patients with cardiopulmonary disease such as pulmonary hypertension (PAH) and measures how far a patient can walk in 6 minutes. The test is usually performed in the hospital, by walking along a hospital corridor. Since the outbreak of SARS-CoV-2, there has been a need to minimise patient contact with hospitals and their staff to reduce transmission of the virus. In a previous research project called 6APP, the investigators designed, developed and evaluated a mobile phone app, to allow them to perform the 6MWT in the community. Given the current circumstances, cardiovascular outpatients including patients in the PAH clinic at Oxford University Hospitals are being recommended to use an app derived from that project to provide their 6MWT distance to the clinical team for assessment, in addition to their symptoms and general well-being. This is felt to be more appealing to the patients, and would reduce the time spent in hospital on the day of their outpatient appointment. The investigators plan to measure the usefulness of adopting remote, mobile-based 6MWT among hospital outpatients, within the constraints imposed by the SARS-COV2 pandemic.

NCT ID: NCT05093790 Completed - Clinical trials for Coronary Artery Disease

A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy Participants

Start date: March 25, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effectiveness, safety and tolerability of BMS-986141 added on to aspirin or ticagrelor or the combination on thrombus formation in both healthy participants and participants with stable coronary artery disease.

NCT ID: NCT05093530 Completed - Clinical trials for Viral Respiratory Tract Infection

Safety and Tolerability of Single and Multiple Doses of Neumifil

Start date: October 12, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of Neumifil, administered intranasally.

NCT ID: NCT05093426 Completed - Breast Cancer Clinical Trials

PERSONAL - Sleep In Breast Cancer

Start date: January 15, 2022
Phase:
Study type: Observational

Sleep is essential for human function, immunity, and well-being. In the general population, sleep disturbance and insomnia cause significant health problems and impact on the quality of life of many individuals. The incidence of insomnia in cancer patients is disproportionality higher, with breast cancer patients experiencing prevalence rates ranging from 19% to 69%. The impact of insomnia on cancer patients' lives can be significant and is associated with depression, cancer-related fatigue, increased pain, reduced quality of life, decreased immunity, disease progression, and survival. To date, breast cancer studies show large variation in reported insomnia prevalence rates, and the severity of sleep complaints in these patients have been difficult to assess. Thus, these issues require further investigation using standardised and validated measures. In this observational study, we aim to investigate the prevalence and severity of insomnia in a cohort of breast cancer patients at the Christie Hospital using the Insomnia Severity Index (ISI), a validated measure for insomnia. This study will consist of two stages. In Stage 1, patients aged 18 and over, who provide informed consent and have a diagnosis of Stage I, II or III breast cancer in the previous 12 months will be asked to complete the validated ISI. Using the ISI, participants identified as having sleeping difficulties and/or insomnia will be invited to Stage 2 of the study. In this stage, participants will be asked to track their sleep each morning for 3 weeks using a digital sleep diary downloaded onto their own smartphone. They will also be asked to complete a series of questionnaires gathering information regarding their quality of life, well-being, and health. This research will provide a better understanding of sleeping patterns, sleeping difficulties and insomnia in patients with breast cancer, and in the long-term, help us design better treatments for patients with sleeping problems.

NCT ID: NCT05093348 Completed - Enucleated; Eye Clinical Trials

Click2Print Artificial Eyes

Click2Print
Start date: November 25, 2021
Phase: N/A
Study type: Interventional

To undertake a randomised crossover trial in human subjects the Click2Print ocular prosthesis versus an analogue ocular prosthesis demonstrating non-inferiority in the assessment of ocular prosthesis motility, cosmesis, fit and function, comfort, mucous discharge and benefits of use in daily life in 40 data subjects (Crossover Trial).