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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: NCT06239558 Recruiting - Clinical trials for Cardiac Rehabilitation

Cardiac Rehabilitation Participation and South Asian Service Users

Start date: February 29, 2024
Phase:
Study type: Observational

The goal of this qualitative study is to learn about the barriers and enablers to cardiac rehabilitation, experience by South Asian service users based in the UK who have experienced an acute cardiac event and been referred for CR. This may allow NHS programmes to make adaptations to their services to enhance uptake, adherence and completion for this ethnic population. The main questions it aims to answer are: - What are the barriers and enablers to uptake, adherence or completion of CR experienced by service users with South Asian heritage? - What adaptations to the CR service could be implemented to overcome identified barriers, enhance enablers and result in increased uptake, adherence or completion to CR? Participants will be invited to participate in a semi-structured interview and/or a focus group to explore lived experiences that can answer the research questions.

NCT ID: NCT06238817 Recruiting - Atopic Dermatitis Clinical Trials

A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis

TRuE-AD4
Start date: April 26, 2024
Phase: Phase 3
Study type: Interventional

This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.

NCT ID: NCT06238089 Recruiting - Clinical trials for Intellectual Disability

Anti-psychotic Drug Prescribing Patterns Within Specialist Adult ID Services in England and Wales

APHID
Start date: December 19, 2023
Phase:
Study type: Observational

The overall aim of this observational study is to establish the anti-psychotic prescribing patterns across specialist intellectual disability (ID) services in England and Wales by collecting cross-sectional retrospective data at 7 annual time-points (1st July) from 2017 to 2023.

NCT ID: NCT06237660 Recruiting - Wheezing Clinical Trials

Longitudinal Preschool Wheeze Biomarker Study

Start date: February 1, 2024
Phase:
Study type: Observational

Preschool children (aged 1-5 years) account for 75% of all UK childhood wheezing hospitalisations. This has not changed over 20 years, meaning current treatments are not working and a new approach is needed. Currently, all preschool wheezers are treated with inhaled steroids. However, only about 25% of patients, with allergies, respond well to inhaled steroids; for the other 75%, they are ineffective. This research group has found that some preschool wheezers may have other causes but there are no specific, non-invasive tests to match the right treatment to each child. The goal of this observational study is to test various bedside tests for this purpose in preschool children with wheeze, to see if they are feasible, accurate and acceptable in this age group. The research team would like to investigate the following aims: Aim 1 - To test the proposed panel of simple bedside tests below, to see how accurately they corelate with lower airway infection or inflammation. Aim 2 - To test the acceptability of these bedside tests are to parents and children, and if they reflect the child's symptoms, symptoms control and medication use. Aim 3- A small proof-of -concept study, to test if these simple bedside tests, can be used to determine treatment for each individual child. The panel of simple non-invasive tests that the research team are proposing are: 1. Skin prick tests to common allergies (house dust mite, cat, dog, grass, tree pollen, mixed moulds) 2. Finger prick blood test 3. Phlegm test for bacteria 4. Nose and throat swab for bacteria 5. Lung function test called forced oscillation technique (FOT)

NCT ID: NCT06236880 Recruiting - Clinical trials for Major Depressive Disorder

A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD

Start date: January 31, 2024
Phase: Phase 2
Study type: Interventional

The aim of this Phase 2a study in patients with MDD is to assess safety and tolerability and preliminary antidepressant efficacy.

NCT ID: NCT06236321 Recruiting - Colorectal Cancer Clinical Trials

The Microbrect-FFC Study

Start date: November 4, 2022
Phase: N/A
Study type: Interventional

This study will focus on two points: 1. To determine if response to neoadjuvant chemoradiotherapy treatment in rectal cancer can be predicted by analysing data from Fast Field Cycling imaging (FFC), a novel type of MRI technique. 2. To determine if there is evidence that the bacteria living in our mouth and in our large bowel influence the way our body responds to cancer treatment. Rectal cancer which is locally advanced is often managed with pre-operative chemoradiotherapy. The idea is to reduce the size of the cancer and increase the chance of a complete resection at the time of an operation. Interestingly, in approximately 20% of patients a complete response (with no evidence of residual tumour) occurs. As yet, there is no mechanism to predict for complete response before treatment. In this study we seek to assess whether FFC or the microbiota can correlate with response. In this study 60 patients with rectal cancer requiring chemoradiotherapy before surgery will be asked to take part. Each patient will have up to three FFC scans. One scan will be done prior to commencement of neoadjuvant chemoradiotherapy, the second will be arranged for seven to eight weeks after the patient has completed the preoperative treatment and the third will be done before any subsequent surgery (if required). Participants will also be asked to give saliva and bowel motions samples before chemoradiotherapy, and after eight weeks. These samples will have the type and number of bacteria analysed, as well as levels of key products of these bacteria. The FFC imaging scans and the microbiota of the saliva and faecal samples will be analysed and results compared to the response to chemoradiotherapy using standard criteria agreed upon at the regional colorectal cancer Multidisciplinary clinical team meeting.

NCT ID: NCT06236048 Recruiting - Schizophrenia Clinical Trials

Energetics and Glutamate in Schizophrenia

EAGLES
Start date: March 1, 2024
Phase:
Study type: Observational

The goal of this case-control study is to compare brain glutamate, glucose utilisation, lactate production and brain activity in healthy volunteers and people with a diagnosis of schizophrenia. It investigates the following main questions: Whether, compared to healthy volunteers, participants with schizophrenia show: 1. reduction in brain glucose utilisation 2. increased brain lactate 3. greater variability in brain glutamate Participants will be asked to have a screening visit, a MRI brain scan and a PET-MRI brain scan.

NCT ID: NCT06235736 Recruiting - ACL Tear Clinical Trials

Do Patients With ACL Tears Demonstrate Weakness of the Soleus Muscle?

ACL
Start date: January 17, 2024
Phase:
Study type: Observational

The goal of this prospective, cross-sectional study is to test the strength of the soleus muscle in participants who have a ACL tear confirmed by MRI. Previous studies have shown that the soleus muscle, which one of the muscles situated in the calf, decreases mechanical loading on the ACL. Therefore, we aim to test soleus muscle strength using a seated plantar flexor test. The main questions we aim to answer are: - Do patients with ACL tears demonstrate inter-limb soleus strength asymmetry (>10%) - Do patients with ACL tears have soleus muscle weakness compared with uninjured (normative) participants? - Do changes in soleus strength values correlate with patient reported outcomes and stability, as measured by the IKDC questionnaire? To achieve this the VALD force frame will be used as the testing device for plantar flexor strength testing. This device records the force generated by the movement. This will be repeated three times on each leg as part of the testing procedure. Furthermore, as part of the testing procedure participants will be required to fill out an IKDC form to assess their knee stability. Interrater reliability of the force frame will be investigated. Further data from participants without ACL tears will be used to compare results. Thus allowing us to see if people with ACL tears have a weakness in the soleus muscle.