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NCT ID: NCT06245291 Recruiting - Clinical trials for Hepatitis B, Chronic

Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection

Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

This is a phase 2a, open-label, multicenter study investigating the safety, tolerability, and antiviral activity of durvalumab administered at targeted times during a 48-week treatment period of imdusiran in virologically-suppressed CHB subjects

NCT ID: NCT06244966 Not yet recruiting - HIV Infections Clinical Trials

GUM Remote Testing v4.0

Start date: May 2024
Phase: N/A
Study type: Interventional

Capillary blood sample results are compared to venous blood results

NCT ID: NCT06243549 Recruiting - Low Back Pain Clinical Trials

Personalisation of Prosthetic Care for Lower- Limb Amputees

Start date: September 1, 2023
Phase:
Study type: Observational

The global rise in lower-limb amputations is mainly due to diabetes and vascular complications. Amputations cause serious physical and psycho-social disabilities which impair locomotion and compromise patients quality of life. Biopsychosocial factors such as altered gait parameters, poor prosthetic fit, depression, fear avoidance behaviours and stigma increase the risk of individuals incurring lower back pain; the leading cause of secondary disability amongst persons with lower-limb amputation. Exploring the potential mechanistic pathways of lower back pain development is important to inform timely patient-centred programmes of care. Currently, limited information exists to inform the design of such programmes. Thus, there is a pressing need to understand the bio-behavioural, psychological, and social features of individuals with lower-limb amputation in the presence of lower back pain.

NCT ID: NCT06243029 Recruiting - Clinical trials for Acute Decompensated Heart Failure

A Study to Assess Multidomain Endpoints of an ECG Patch

Start date: January 8, 2024
Phase:
Study type: Observational

This study aims to evaluate the utility of a wearable heart monitoring patch that can be worn on the body to collect various measurements related to heart failure and develop a concept to potentially be used as a new measurement. It is crucial to test out new ways that make it easier to do research for new drugs and increase our chances of knowing how well they will work early on in the development process. Results from this study will be useful in planning future development programs for drugs aimed at treating patients with heart disease. This study will be conducted in a single hospital, it is non-randomised (not chosen by chance), exploratory, study in the United Kingdom (University Hospitals of Leicester NHS Trust). It aims to involve up to 80 men and women recently admitted due to sudden, severe heart failure symptoms. Participants will be part of the study for about two months, with one hospital visit after discharge, as commonly done in heart failure centres. - Visit 1 (Pre-Screening/Screening/Enrolment) will assess the participant's eligibility for participating in the study and for collecting data following hospitalisation for acute decompensated heart failure (ADHF). Participants will be trained and receive an ECG patch to wear from that moment onwards at home for a period of 4 to 7 days. - Visit 2 (Follow-up visit) will be conducted approximately 6-8 weeks post Visit 1 and this will be the final study-related site visit. Participants will receive an ECG patch to wear at home for a second time for a period of 4 to 7 days. - Visit 3 (Review of Medical Records). It is a review of the health status using medical records by the study team. The participant is not expected to attend the hospital for any appointments

NCT ID: NCT06242990 Recruiting - Physical Inactivity Clinical Trials

The Youth - Physical Activity Towards Health Intervention in Northern Ireland

Y-PATH NI
Start date: February 23, 2024
Phase: N/A
Study type: Interventional

The Y-PATH programme is an evidence-based intervention programme that has been found to be successful at increasing levels of physical activity in school children in the Republic of Ireland. The Irish Heart Foundation collaborated with Dublin City University and University College Cork to disseminate the programme nationally. The intervention programme aims to improve physical activity levels of adolescents through education about the importance of physical activity for health and the development of fundamental movement skills, which are basic movements associated with physical activity, such as, catching, throwing, and running. The main aims of the Y-PATH NI study are: - To explore Y-PATH as an intervention 'template', to lead the development of a research-informed model suitable for feasibility testing in a Northern Ireland context (Y-PATH NI). - To undertake feasibility testing of the Y-PATH NI multi-component intervention aimed at increasing moderate-to-vigorous physical activity in 11-14 year olds. - To conduct a process evaluation to determine primarily fidelity, but also acceptance and sustainability of the Y-PATH NI intervention.

NCT ID: NCT06241976 Recruiting - Clinical trials for Hyperglycemia, Postprandial

Diabetes Risk in East London and Its Association With Vitamin D by Ethnic Group (DELVE)

DELVE
Start date: December 12, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to investigate the relationship between vitamin D status and a diabetes risk factor, postprandial glycaemic response in White, South Asian and Black African Caribbean populations in East London. The main question[s] it aims to answer are: - Are there differences in postprandial glycaemic response to a sugar water drink or orange juice between White, South Asian and Black African Caribbean people in East London? - Is there a relationship plasma 25(OH)D and the postprandial glycaemic response to a sugar water drink or orange juice consumption? - What are the knowledge and perceptions of vitamin D intake between White, South Asian and Black African Caribbean people in East London? - Is there a difference in dietary vitamin D intake between the three ethnic groups? Participants will make two visits to the lab, approximately 2.5 hours each. The order of the two drinks will be randomized via Excel Random function. For each visit, the blood sugar levels will be measured at fasting (0) and every 30 minutes up to 2 hours postprandially (5 times total) using a finger prick. At baseline only (visit 1), participants will fill out a knowledge and perception survey, provide a 4-day estimated food diary, provide a 7 ml blood sample via phlebotomy, and have their height, weight and body fat percentage measured.

NCT ID: NCT06241313 Recruiting - Migraine Clinical Trials

Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

ECLIPSE
Start date: March 25, 2024
Phase: Phase 3
Study type: Interventional

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly. Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world. All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24). There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.

NCT ID: NCT06241287 Recruiting - Dementia Clinical Trials

BELIDE: Better Living With Non-memory-led Dementia

BELIDE
Start date: January 29, 2024
Phase: N/A
Study type: Interventional

Around 48 million people worldwide 1 live with dementia, of whom 3.9 million start with symptoms before the age of 65 (young-onset dementia). Most of the people presenting with young-onset dementia and some people with later onset dementia develop non-memory led dementias such as the atypical forms of Alzheimer ́s disease (AD)or frontotemporal dementia (FTD). Despite the proven benefits of educational programmes and skill training for caregivers, families of people with non-memory led dementias encounter fewer opportunities to receive this type of support. This is a significant gap in care considering that many people with young-onset non-memory led dementia are in their 50s or early 60s, which carries additional challenges about employment, financial stability, and childcare responsibilities. Finding suitable information and resources is less likely due to the lower prevalence of these phenotypes, their consequent geographical spread, and their atypical symptoms. Caregivers demands for more phenotype-specific support suggest that tailored provision of education and training is a gap in the provision of care in these types of dementia. The aim of this study is to: 1. Determine the effectiveness of the Better Living with Non-memory Dementia educational programme for caregivers in improving psychological outcomes [WS1]; and 2. Conduct a mixed methods process analysis to elucidate mechanisms of change, barriers and facilitators to access and implementation as well as perceived benefits and costs [WS2]. The design is a randomised waiting list control trial with an 8-week intervention and 6-month follow-up comparing intervention to standard care with embedded process analysis. The intervention comprises a virtual onboarding session with a facilitator, 6 learning modules (including module-end real-life tasks to put skills into practice) and up to two further virtual check-in sessions with the facilitator. Intervention adaptation, adaptation to design and selection of primary outcome measures was based on feasibility work.

NCT ID: NCT06241118 Recruiting - Dermatitis Atopic Clinical Trials

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

AQUA
Start date: February 29, 2024
Phase: Phase 3
Study type: Interventional

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 [RIVER-AD] study).

NCT ID: NCT06240663 Completed - Insulin Resistance Clinical Trials

Walking Before or After Breakfast - Which is Better to Improve Health in Overweight Individuals?

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effectiveness of a home-based walking-based exercise intervention undertaken in the fed or fasted state to improve glycaemic control in overweight and obese individuals. This study will evaluate the adherence and compliance to this "real-world" exercise programme that requires no face-to-face contact with the research team. It is also hypothesised that individuals who exercise before breakfast (fasted) will see greater improvements in glycaemic control than those who exercise after breakfast.