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NCT ID: NCT05701358 Recruiting - Clinical trials for Coronary Artery Disease

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

COMPLETE-2
Start date: June 22, 2023
Phase: N/A
Study type: Interventional

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

NCT ID: NCT05701202 Completed - Sarcopenia Clinical Trials

Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis

ARLA-WHEY
Start date: June 15, 2021
Phase: N/A
Study type: Interventional

Skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. Undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many diseases and scenarios including ageing, bed rest/immobilisation, cancer and physical inactivity. Despite the exact mechanisms causing muscle atrophy being not yet fully understood, "anabolic resistance" (reduced muscle building in response to protein feeding and exercise) is thought to be key, especially for age-related skeletal muscle losses (known as sarcopenia). As such, the search for optimal strategies (e.g., exercise and/ or nutritional interventions) to combat this anabolic blunting remains a hot-topic in scientific research. Leucine, an essential and branched chain amino acid (EAA/BCAA), is thought to be the most potent AA for stimulating muscle protein synthesis (MPS; the muscle building process). Although, as a stand-alone supplement, leucine is unlikely to provoke a robust and prolonged state of MPS, low doses of leucine-enriched mixed-EAAs can elicit similar increases in MPS as compared to a large dose of whey protein. As reduced appetite and increased satiety (feeling fuller) are common with advancing age, supplementation of a low-dose protein (i.e., leucine-enriched) that can adequately stimulate MPS may contribute to muscle health maintenance in older adults and reduce satiation following a meal. This study aims to examine whether a novel whey protein with greater leucine content ("super-whey") has superior muscle building properties compared to a regular whey protein, at rest and after a single bout of exercise, in both young and older adults

NCT ID: NCT05701033 Recruiting - Clinical trials for Mental Health Wellness 1

Does Engagement With Heritage Sites Have the Potential to Improve Sub-clinical Levels of Low Wellbeing in NHS Staff: A Feasibility Study. The HerWellNHS Study

HerWellNHS
Start date: March 6, 2023
Phase:
Study type: Observational

This feasibility study will focus on assessing and identifying the wellbeing effects of self-directed (unmediated) visits to heritage sites for a high-risk population, specifically NHS staff at PHU self-reporting sub-clinical levels of low wellbeing. In particular, it seeks to understand whether wellbeing effects can be derived from unmediated visits to heritage sites, how much exposure to heritage is necessary to experience wellbeing effects, whether and how benefits may be accumulated, how long wellbeing effects may last following visits, and the nature of these wellbeing effects. In addition, it will establish appropriate psychological measures (qualitative and quantitative), test a web-based data collection interface, examine participant choices and their characteristics, and assess participant adherence and response rates prior to developing a clinical trial.

NCT ID: NCT05700851 Completed - Clinical trials for Chronic Kidney Disease Requiring Chronic Dialysis

Immuno-nutrition Supplementation in Haemodialysis

Start date: September 27, 2022
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to test if an "immuno-nutrition" supplement can decrease inflammation in people on haemodialysis. This immuno-nutrition supplement is high in calories and protein like other common nutritional supplements, but also contains a unique combination of ingredients that have been shown to reduce inflammation (a problem which is caused by the body's defence [immune] system communicating that something is wrong) and improve the immune system in people with cancer. The research team hopes that this small study will help with gaining a good understanding of the effect of immuno-nutrition on inflammation in people on haemodialysis, which will guide and allow the research team to do a larger research study in the future.

NCT ID: NCT05700110 Recruiting - Pancreatic Cancer Clinical Trials

Porto-Venous Radiomics in Pancreatic Cancer

Start date: May 5, 2022
Phase:
Study type: Observational

Multi-centre Retrospective Observational Cohort study of patients who underwent pancreaticoduodenectomy from 01/01/2005 to 01/02/2022 with histologically confirmed pancreatic head malignancy

NCT ID: NCT05700058 Recruiting - Sarcopenia Clinical Trials

Assessing the Dose-response of Muscle Protein Synthesis to "Super-whey" in Older Adults

ARLA-WHEY
Start date: January 2023
Phase: N/A
Study type: Interventional

Skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. Undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many diseases and scenarios including ageing, bed rest/immobilisation, cancer and physical inactivity. Despite the exact mechanisms causing muscle atrophy being not yet fully understood, "anabolic resistance" (reduced muscle building in response to protein feeding and exercise) is thought to be key, especially for age-related skeletal muscle losses (known as sarcopenia). As such, the search for optimal strategies (e.g., exercise and/ or nutritional interventions) to combat this anabolic blunting remains a hot-topic in scientific research. Leucine, an essential and branched chain amino acid (EAA/BCAA), is thought to be the most potent AA for stimulating muscle protein synthesis (MPS; the muscle building process). Although, as a stand-alone supplement, leucine is unlikely to provoke a robust and prolonged state of MPS, low doses of leucine-enriched mixed-EAAs can elicit similar increases in MPS as compared to a large dose of whey protein. As reduced appetite and increased satiety (feeling fuller) are common with advancing age, supplementation of a low-dose protein (i.e., leucine-enriched) that can adequately stimulate MPS may contribute to muscle health maintenance in older adults and reduce satiation following a meal. This study aims to examine which of three doses of a novel leucine-enriched whey protein ("super-whey") best stimulates muscle building in older adults

NCT ID: NCT05699837 Recruiting - Pain, Chronic Clinical Trials

Alpha Entrainment for Pain and Sleep (Extension)

Start date: September 19, 2022
Phase: N/A
Study type: Interventional

Long-term pain affects one-third of the United Kingdom population and can be very disabling. People experiencing long-term pain often suffer from disturbed sleep because of their pain symptoms, and disturbed sleep can then make their pain symptoms worse. Managing long-term pain is also very costly to the National Health Service. The most common treatment is prescribed medicines, but these do not always work and can have serious side-effects for some patients. The investigators have been developing an alternative approach for treating long-term pain. This approach uses simple non-invasive tools to promote some kinds of brain activity over others. It involves patients using headphones to listen to some specific sounds, or a headset with lights flashing at particular frequencies. The studies undertaken so far seem to show that doing this can change how the brain responds to pain. It potentially offers an inexpensive yet effective way of reducing pain and improving sleep for patients with long-term pain. There are a few small studies that support this approach and more work is needed. In a recent study the investigators found that these tools can be reliably used in home settings and there were some indications that they improved symptoms. However, sleep was only measured with sleep diary and movement detection, there was no direct measurement of whether the stimulation frequencies were resulting in the desired brainwave changes. Finally, the benefit to symptoms may have been the result of other factors, such as the passage of time or placebo effect. Therefore this study extends the experiment, adding more accurate sleep monitoring which includes monitoring electrical activity in the brain (EEG), as well as providing rhythmic and non-rhythmic stimulation in a randomised order. The aim is to further test the effect of these home-based tools with individuals with long-term pain, in a more rigorous way. Up to 30 participants with long-term pain and pain-related sleep disturbance will use the tools for 30 minutes at bed time every day for 4 weeks (2 weeks with one type of stimulation, 2 weeks with another type). The changes in participants' pain, sleep, brainwave frequencies, fatigue and mood will be measured. These findings will inform the planning and design of a future much larger study to test this technology, if this is justified by the results.

NCT ID: NCT05699148 Active, not recruiting - Cystic Fibrosis Clinical Trials

Gut Imaging for Function and Transit in Cystic Fibrosis 3 Junior

GIFT-CFJunior
Start date: April 1, 2022
Phase:
Study type: Observational

Recently trial data has shown that the medicine KaftrioTM (Elexacaftor/ Tezacaftor/ Ivacaftor) improves lung function in children aged 6 to 11 years who have cystic fibrosis (CF). This has led to it being licensed for use in the UK in 2022 and is now being prescribed in this age group. There is little information in trials however that shows the effect KaftrioTM (ETI) has on the gut or liver in this age group. Previous studies in the GIFT-CF series (NCT 03566550, NCT04006873 and NCT04618185) has found differences in the functioning of the gut between adults with CF and healthy controls but it is not known whether these differences are present in those aged 6 to 11 years. This study is a significant amendment of the GIFT-CF3 protocol (NCT04618185) that aims to measure gut function using magnetic resonance imaging (MRI) in children with CF before and after starting ETI. This study also aims to opportunistically measure lung function and structure using MRI and explore how the liver can be measured using MRI in this age group. The study is split into 2 stages. The first is a pilot stage using the modified GIFT-CF protocol recruiting 3 children with CF before starting ETI and 3 healthy volunteers. This is to determine we are able to successfully perform these scans in these age groups. If successful, the second stage will recruit a further 12 children with CF before they start ETI. This will take our cohort up to 15 children with CF. This cohort will then be rescanned 6 months after starting ETI using the same scan protocol.

NCT ID: NCT05698875 Completed - type1diabetes Clinical Trials

The Breakfast Rise, Education and Knowledge Study

BREAK
Start date: February 14, 2023
Phase: N/A
Study type: Interventional

The study proposes to recruit 90 children and young people who have type 1 diabetes (T1D) and who regularly use Dexcom continuous glucose monitoring (CGM). The participants will be recruited from National Health Service (NHS) sites in the United Kingdom (UK) via their managing dietitian. The dietitian will be asked to provide baseline information about the participants which will include demographic data and information on clinical data, treatment and anthropometrics. Participants will be asked to provide access to Dexcom CGM data throughout the period of recording. Participants will be asked to test three breakfast meals (high glycaemic load, high glycaemic with 10g added protein and medium glycaemic load) plus a control meal (usual breakfast), repeating each meal twice in a randomized order using a Latin square randomisation. The dietitian will be asked to optimise the participants insulin doses prior to commencing test meals. Participants will be asked to complete a questionnaire for each of the postprandial test and control meal periods. This will include questions about their diabetes management, food and fluid intake in addition to questions on activities all of which took place during the three-hour postprandial period. The glycaemic response to the test and control meals will be analysed using the CGM data and the results statistically described using univariate, bivariate and multivariate analysis.

NCT ID: NCT05698862 Recruiting - Healthy Clinical Trials

Mapping the Impact of Gut Microbiota on Brain and Behavior Through the Lens of GABA

GutBrainGABA
Start date: May 21, 2022
Phase: N/A
Study type: Interventional

Gut microbiota produce different metabolites within the human body, which include neurotransmitters. Animal studies have demonstrated a critical role for the gut microbiota in various aspects of brain and behavioural function, and a smaller number of studies in humans have shown differences of gut microbiota composition in psychiatric conditions. However, almost nothing is known about the impact of neurotransmitters produced by the gut microbiota on human brain and behaviour. The way in which differences in brain, behaviour and personality traits are associated with the gut microbiota, and how they are influenced by a probiotic will be explored, with a special focus on GABA (Gamma Amino Butyric Acid). Abnormalities of microbiota composition have been identified in metabolic disorders, such as inflammatory bowel disease and obesity, and psychiatric conditions, such as depression and anxiety. The aim of this intervention trial will be to answer the following fundamental questions: 1. Does the population of gut bacteria capable of producing GABA modulate brain-based measures of GABA? 2. Does the population of gut bacteria capable of producing GABA influence performance in behavioural tasks known to depend on GABA-ergic function? The impact of a GABA producing probiotic on the measures of GABA in the brain and serum, relevant metabolites in blood, faecal and urine samples and performance in GABA dependent behavioural tasks will be investigated in this trial.