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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: NCT06469541 Completed - Cataract Clinical Trials

Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL, Bi-Flex 877PAY With POB-MA Preloaded Injector

Start date: April 11, 2023
Phase:
Study type: Observational

The purpose of our investigation is to retrospectively assess visual outcomes, refractive stability, safety features of the lens and the incidence of developing PCO (posterior capsular opacification) in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal IOL, Bi-Flex 877PAY (Medicontur).

NCT ID: NCT06469138 Completed - COVID-19 Clinical Trials

A Phase 1 Study to Investigate 14C-bemcentinib Following Single Oral Administration in Healthy Male Subjects

8479217
Start date: August 2, 2022
Phase: Phase 1
Study type: Interventional

The aims of this Study are to determine: - How much of the Study Drug (bemcentinib) ends up in urine and faeces - How much of the Study Drug and its breakdown products get into the bloodstream - The breakdown products (metabolites) of the Study Drug - The safety of the Study Drug and any side effects that might be associated with it.

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: NCT06468501 Not yet recruiting - Eating Behavior Clinical Trials

SEP and the Impact of Price on Food Selection in a Simulated Food Delivery App

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this randomised controlled trial is to compare taxation with subsidies to encourage healthier food choices in the out-of-home food sector. Participants will be asked to make hypothetical food choices in an online simulation study of a delivery app. Participants will be randomised into four different intervention groups: 1. Price reduction (10%) on healthier foods 2. Price increase (10%) to less healthy foods 3. A combination of price reduction to healthier foods and price increase to less healthy foods 4. Existing price structure (i.e. control group) The investigators will further examine effectiveness of these fiscal policies on healthy eating by socioeconomic position to understand whether these policies are equitable.

NCT ID: NCT06466746 Not yet recruiting - Clinical trials for Anemia, Iron Deficiency

The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety

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

High levels of animal proteins (meat) in the diet are linked with a greater risk of developing heart disease and other long-term health conditions. Recently there has been a shift to plant-based diets including plant proteins such as pulses, defined as beans, peas, chickpeas and lentils. Pulses are a nutritious and sustainable form of plant protein which are rich in fibre and iron. Despite this, the UK population does not consume the recommended daily amount of pulses (80g/day equivalent to a large handful). In contrast, bread is commonly consumed but very little is known about how bread enriched with pulses influences the amount of iron that is digested and absorbed by the body as well as risk factors for developing heart disease and type 2 diabetes. The main purpose of this randomised controlled cross-over study is to determine how consuming bread enriched with pulses (in the form of faba bean flour at approximately 40% enrichment) compared with conventional white bread (100% wheat flour) influences the amount of iron absorbed in healthy males and females aged 18-50 years with low iron stores. Secondary aims are determining the effects on blood fats and sugar (glucose) and on feelings of fullness (also known as satiety) after eating the bread enriched in pulses and conventional white bread. Participants will be required: - To attend for seven study visits over a period of 60 days. - Consume a breakfast meal containing either the faba bean-enriched bread or conventional bread over two study periods, each consisting of one 7 hour study visit and two consecutive visits of 2 hours in duration. After 28 days, participants will return for the second study period as above, with a final study visit conducted 28 days later. - Give blood samples during 2 x 7 hour study visits - Complete visual analogue scales to rate appetite after consuming the faba bean-enriched and conventional white bread. - Record dietary intake prior to and during the study period.

NCT ID: NCT06466720 Not yet recruiting - Quality of Life Clinical Trials

Measuring and Mapping Cognitive Decline After Brain Radiosurgery

CoDeB-Rad
Start date: June 10, 2024
Phase:
Study type: Observational

Background Stereotactic Radiosurgery (SRS) is a localised radiotherapy treatment for patients with brain metastases or other benign tumours in the brain, like meningiomas. We do not currently know if, or how much, SRS affects brain function. Patients with brain tumours do not get tested routinely for their brain function. Understanding short- and long-term side-effects is important for SRS. Brain metastases patients have short life expectancies (6-months to 1-year). However, meningioma patients can live 10 years or more. SRS is used to treat both. We will use the Montreal Cognitive Assessment (MoCA) to test your brain function. We will use quality-of-life questionnaires QLQ-C30 and BN20. These are specific for patients with brain cancer. They include questions about physical and mental wellbeing. Why is it important This study aims to identify areas in the brain that relate to changes in brain function after SRS. These areas can then have the radiation dose reduced to them in future patients, hoping to minimise side-effects. Research Question Which regions of the brain contribute to a decline in brain function following SRS. Study Design This is a single centre observational study with prospective and retrospective collection of data. This study will look at two groups of patients: Group1: Patients will complete the MoCA and two quality-of-life questionnaires before your treatment and every 3 months for a year. Group2: Patients will complete the MoCA and two quality-of-life questionnaires once. We will use these tests, your MRI scans and your SRS treatment plan to identify areas of the brain that are responsible for any problems with your brain function. The participants for Group 1 will be recruited from the SRS Clinics, at City Campus, Nottingham University Hospitals NHS Trust. The participants for Group 2 will be identified through the Mosaiq Oncology Information System. This pilot study is funded by the Midlands Mental Health and Neurosciences Network.

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: NCT06464341 Active, not recruiting - Breast Cancer Clinical Trials

Nodal Burden and Nodal Recurrence in Patients With Isolated Tumor Cells After Neoadjuvant Chemotherapy Treated With Axillary Dissection or Nodal Radiation: the OPBC-05/EUBREAST-14R/ICARO Study

ICARO
Start date: May 4, 2023
Phase:
Study type: Observational

The purposes of this multicenter retrospective cohort study are to determine the residual nodal burden in patients with isolated tumor cells detected in the SLN or the clipped node after NAC and to determine oncologic outcomes in this group of patients after ALND or nodal RT or observation.