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NCT ID: NCT06469645 Recruiting - Clinical trials for Moderate Aortic Valve Stenosis

The Role of SGLT2i in Management of Moderate AS

Start date: May 30, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Background: The aortic valve is like a door in the heart that lets blood flow out to the body. Over time, this valve can get worn out and become too narrow, leading to a condition called aortic stenosis. When this happens, the heart has to work extra hard to push blood through the narrow valve to supply the body with what it needs. This extra effort can cause the heart muscle to become abnormally thick or to have fibrosis. For people with aortic stenosis, this can lead to more problems like feeling out of breath, chest pain, and even needing to go to the hospital. It also increases the risk of dying from heart issues. There is a type of medication called Sodium Glucose Cotransporter 2 (SGLT2) inhibitors, which has been studied in people with weak heart muscle. These medicines were found to help the heart work better and improve the pumping of blood around the body. This can be promising for patients with aortic stenosis because it might make the heart muscle stronger and protect it from damage. Aim of research study: The aim of this study is to investigate whether the use of the drug empagliflozin, an SGLT2 inhibitor, prevents the formation of fibrosis or the abnormal thickening of the heart muscle in patients with aortic stenosis. Using advanced imaging techniques (such as echocardiography and cardiovascular magnetic resonance), we intend to study their effect on the heart muscle of patients with aortic stenosis. Study design: Patients with moderate aortic stenosis will be invited for participation. Eligible consenting patients will have a baseline assessment with cardiac MRI scan, echocardiography, cardiopulmonary exercise test and validated quality of life questionnaires. They will then be randomised to receive either the SGLT2i for 6 months, or standard of care. All patients will undergo the same tests at 6 months. This way, we aim to investigate the potential changes in the heart muscle and whether the SGLT2 inhibitor prevents fibrosis or hypertrophy.

NCT ID: NCT06468527 Recruiting - Cystic Fibrosis Clinical Trials

Clinical Trial to Evaluate the Efficacy and Safety of Dirocaftor/Posenacaftor/Nesolicaftor in Adults With CF

CHOICES
Start date: June 3, 2024
Phase: Phase 2
Study type: Interventional

CF is caused by mutations in the gene that encodes the 'Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)' channel. To re-establish the function of this complex chloride channel, typically two to three drug modes of action are needed. To date, clinical studies of CFTR modulators have focused on patients carrying the F508del CFTR mutation, which is present in approximately 80% of CF patients, or gating mutations which are present in 5% of CF patients (gating mutations result in a reduced opening of the CFTR-channel at the cell surface which limits the flow of chloride ions through the CFTR channel). Although CF is a monogenetic disease, the 15% remaining patients represent more than 2000 different rare and mostly uncharacterized CFTR mutations. Multiple pharma companies have one or more CF drugs in their developmental pipeline. However, it is not known which patients may respond to the drugs in the pipeline. It is hypothesized that by using individual patient's intestinal organoids to screen for drug response, a subset of patients with rare CFTR mutations can be identified who will clinically respond to drugs in the developmental pipeline. The Human Individualized Therapy of CF (HIT-CF) project has been designed to further evaluate this hypothesis. The project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 755021. The core of the project consists of a two-step approach to identify patients outside the existing drug label who may also benefit from CFTR-modulator treatment. In the first step of the project (HIT-CF Organoid Study, NTR7520), novel CFTR modulators and their combinations were tested on organoids from over 500 European and Israeli CF patients with rare CFTR mutations to identify patients who are predicted to clinically benefit from these treatments. The second step will evaluate the predicted clinical effect of the CFTR modulators in subjects identified by their organoid response to investigational products. CFTR modulators from the HIT-CF participating pharmaceutical company, FAIR Therapeutics, will be evaluated in the CHOICES clinical study described in this protocol. Data from this clinical study will be compared with the HIT-CF Organoid Study results to validate the organoid model.

NCT ID: NCT06465277 Recruiting - Lung Cancer Clinical Trials

CMR Right Ventricular Contractile Reserve Following Lung Resection

Start date: July 21, 2023
Phase:
Study type: Observational

Feasibility study investigating CMR dobutamine stress testing before and after lung resection

NCT ID: NCT06465173 Recruiting - Dementia Clinical Trials

Self-compassion and Quality of Life After Dementia Diagnosis

Start date: March 18, 2024
Phase:
Study type: Observational

This study aims to investigate whether self-compassion is associated with older adult's quality of life after a diagnosis of dementia, and whether perceived threat posed by dementia mediates this relationship. Self-compassion has been found to be positive in supporting individuals in times of difficulty, in adjustment processes and older adults' wellbeing. While different factors have begun to be identified which are associated with individuals' psychological wellbeing and adjustment following a dementia diagnosis, little is known about the influence of self-compassion. Participants will be recruited via NHS memory clinics, Join Dementia Research and from the community via third-sector organisations. Individuals will be invited to attend a Microsoft Teams/telephone appointment in which informed consent and cognitive screening processes will take place at the start. Eligible participants will then be invited to continue to complete measures administered by a researcher and an interview question. Participants will be offered the opportunity to complete the measures in a second session (within 8 weeks) or using the online survey software, Qualtrics, if preferred. A small pilot study (n = 5) will take place prior to the main study.

NCT ID: NCT06461208 Recruiting - Liver Cirrhosis Clinical Trials

A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis

PROMISE
Start date: June 21, 2023
Phase: Phase 3
Study type: Interventional

A feasibility trial called PROFIT has previously shown that FMT administered endoscopically into the jejunum in patients with cirrhosis is safe and feasible and have identified some potential mechanisms of action that warrant further interrogation. The aim of the PROMISE Trial is to evaluate the efficacy and mechanisms of action of encapsulated FMT (versus placebo) to reduce infection and mortality in patients with alcohol-related and metabolic dysfunction-Associated Steatotic Liver (MASLD) cirrhosis.

NCT ID: NCT06460805 Recruiting - Inflammation Clinical Trials

axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis

axSEND
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

People with axial spondyloarthritis (axSpA) often have intestinal inflammation and intestinal microbiome dysbiosis, with some similarities to Crohn's-like inflammatory bowel disease (IBD) gut inflammation. However, research has not addressed whether Partial Enteral Nutrition (PEN), a diet formed of a liquid formula and some solid whole foods, which is effective at inducing remission in IBD, may influence the dysbiotic microbiome and inflamed, hyperpermeable intestine of axSpA patients, and whether these changes may be accompanied by alterations in systemic markers of inflammation. Thus, there is a need to determine the effects of PEN on these aspects in axSpA patients. In this study, the investigators intend to trial a 2-week course (with optional additional 2-week extension) of a PEN diet in people with active axSpA disease. A group of healthy volunteers following the same diet will act as a control.

NCT ID: NCT06459661 Recruiting - Dietary Exposure Clinical Trials

The Bowel Movement Monitoring (BoMoMo) Study

BoMoMo
Start date: May 1, 2024
Phase:
Study type: Observational

The link between what people eat and how it affects faecal output (poo) has been understudied. Most of the research that has looked at the link between diet, bowel movements and overall health has studied different types of fibre extracted from foods (e.g., fibre extracted from carrots), rather than foods in the form that they are consumed. It is necessary for scientists to investigate the relationship between food as people usual eat it (e.g., a carrot) and bowel movements, as this information is key to understanding the relationship between what people eat and overall health. The investigators would like to understand the relationship between intake of certain foods and faecal output. This will help to develop a chart, similar to the United Kingdom National Health Service urine colour hydration chart. The chart will allow people to know, by looking at their poo, whether they are eating enough of the foods that will keep them healthy. By monitoring and measuring participants' bowel movements, and providing information about diet, participants will provide the data we need for this research.

NCT ID: NCT06458270 Recruiting - Food Selection Clinical Trials

Salt Warning Label Restaurant Study

Start date: June 3, 2024
Phase: N/A
Study type: Interventional

This between-subjects randomised controlled trial aims to test the effect of a menu featuring salt warning labels on perceived message effectiveness relative to a menu with no labels in a real-world restaurant environment. The study will also act as a pilot experiment for examining the impact of the salt warning label on food choice and subsequent salt intake in real-world conditions. Primary objectives: - To measure the PME of a menu featuring salt warning labels relative to a menu with no labels - To measure label awareness, perceived knowledge gain, and perceived influence of the label on food choice Secondary objectives: - To identify whether there is an effect of the salt warning label on: - Food choice (label/no label) - Total salt selected - Total salt intake - To examine support for the introduction of a salt warning label policy in the UK

NCT ID: NCT06457815 Recruiting - Clinical trials for Acute Myocardial Infarction

Iron Deficiency in Acute Myocardial Infarction: Prevalence Pilot Study

IDAMI Pilot
Start date: April 29, 2024
Phase:
Study type: Observational

Acute Myocardial Infarction (heart attacks) affect about 86000 people each year in the UK. Given this large number of people, it is important that health teams look at ways to ensure the best care to improve outcomes after a heart attack. In related heart conditions, the role of iron is important, but there isn't much information about what effect iron levels have on patients following a heart attack. We want to plan a large scale study to look at this, but need some early data to understand how many patients have low iron levels. This small study will take part at one NHS Trust and will test for iron levels in all patients who provide consent (we expect up to 70 patients will take part). We will also collect data from medical notes for these patients and use all of this information together to understand more about iron and to plan a larger study.

NCT ID: NCT06455462 Recruiting - Severe Asthma Clinical Trials

Patient Characteristics, Treatment Patterns and Outcomes of Patients Enrolled in the Tezepelumab Patient Access Programme; a Retrospective, Observational Medical Chart Review Conducted in UK Severe Asthma Centres

TPAP
Start date: April 22, 2024
Phase:
Study type: Observational

This is a retrospective, observational chart review that will include patients with severe asthma (SA) who have participated in the tezepelumab patient access programme (TPAP). Electronic case report forms (eCRFs) will be used for data abstraction of clinical information from the health records of patients enrolled in the TPAP from eight NHS acute trusts. Approximately 200 patients with SA who took part in the TPAP with an index date (defined as the date of administration of the first dose of tezepelumab) between 1st January 2023 and 19th July 2023, and who meet the study eligibility criteria will be recruited to the study. Participation in the study does not affect the patients' treatment decisions since all data will be collected retrospectively from medical records. Key study definitions include: - Index date - the date of tezepelumab initiation (i.e., the date of first dose). - Pre-index period - defined as any time prior to tezepelumab initiation - Baseline period - defined as the 52 weeks prior to the index date - Outcomes period - defined as the 52 weeks post-index date. Patients will be followed up from their index date until the first of the following events (whichever is first): reach 52 weeks post-index, they switch to a different biologic treatment, die, or are otherwise lost to follow-up.