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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: NCT06462157 Not yet recruiting - Menopause Clinical Trials

Group Compassionate Mind Training for Adults Experiencing the Menopause Transition

Start date: June 10, 2024
Phase: N/A
Study type: Interventional

Menopause transition occurs naturally for women aged 45-55. In addition to the hormone changes, there are often changes in other areas of life including low mood, anxiety, 'brain fog' and embarrassment. Some people may not be eligible for or want to receive hormone replacement therapy, therefore psychological treatments for menopause have been investigated. There is growing evidence for the use of Compassionate Mind Training (CMT). CMT aims to reduce feelings of self-criticism and shame which are commonly reported by adults experiencing the menopause, by helping individuals to take better care of themselves, known as self-compassion. Findings show menopausal individuals who are more self-critical may be more vulnerable to difficulties during menopause. Therefore, CMT could help manage this. CMT improves self-compassion and reduces depressive symptoms, with group formats found to be more effective than individual or self-help. A previous study of online self-help CMT for the menopause received positive feedback for the therapy and people improved in several areas including self-compassion. Clearly, there could be benefits to offering CMT as a treatment for menopause. Given that group CMT is effective in other populations and groups are more economical and practical for the NHS, this study is interested in looking at the impact of group CMT on menopause. This study aims to find out how practical and suitable group CMT is for improving the wellbeing of adults experiencing the menopause, and what their views are on the therapy and taking part in the study. To measure the aims, we will look at the ease of recruiting people to the study, whether they are happy to be randomly allocated to receive the therapy or not, whether they stay in the study, the number of completed questionnaires and feedback from participants. It will also look at whether there have been any changes in different domains e.g. anxiety and self-compassion. This will be done through a variety of quantitative and qualitative outcomes.

NCT ID: NCT06461715 Not yet recruiting - Heart Failure Clinical Trials

Left Bundle Branch Area Pacing 3D Guidance System

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

The investigator's project proposes the development of a 3D hybrid guidance system which has the aim of avoidance of scar and septal perforation through targeted lead deployment via a personalised septal real time image overlay onto x-ray fluoroscopy imaging during left bundle branch pacing. The investigators hypothesise that the use of cardiac anatomy and myocardial scar distribution derived from cardiac magnetic resonance imaging (MRI) as well as 3D position of the pacing lead, may improve LBBAP lead deployment success and improve clinical outcomes by guiding the physician towards optimal lead positioning.

NCT ID: NCT06459999 Not yet recruiting - Heart Failure Clinical Trials

Biomarkers for the Assessment of Congestion in Patients With Ambulatory and Hospitalised Heart Failure

BIO-CONGEST
Start date: June 2024
Phase:
Study type: Observational

The goal of this study is to test the accuracy of new blood and urine tests in people with heart failure. The main question it aims to answer is: - Do new blood and urine tests correlate with fluid status? This will be determined by comparison to routine and gold-standard tests in a range of patients with heart failure.

NCT ID: NCT06457126 Not yet recruiting - Stroke Clinical Trials

Piloting the Attention Training Technique for Post-Stroke Emotionalism

Start date: June 24, 2024
Phase: N/A
Study type: Interventional

The aim of this mutli-phasic systematic case series is to explore if the Attention Training Technique (ATT) can improve symptoms of Post Stroke Emotionalism. It will teach the ATT to at least three people who have had a stroke at least six months ago, have PSE and are currently receiving support from a Community Neurorehabilitation service in the North West of England. Stroke survivors will also require the support of a carer/loved to record their symptoms on a daily basis. Stroke survivors will attend weekly appointments either at the community service site or via video-call for up to 15 weeks. There is also the option to complete an interview to discuss their experiences of learning the ATT. This study hopes to be the first step in establishing evidence in support of a novel psychological intervention to help improve PSE symptoms. Phase 1 of the study aims to explore the effects associated with the ATT on PSE symptoms. The primary research questions are: 1a. Is the ATT associated with an improvement of PSE symptoms? 1b. Does this replicate across individual cases? If these are not initially supported, the ATT delivery will be extended, addressing: 1. c. Is the ATT associated with an improvement of PSE symptoms when some parameters (e.g., frequency and dose) are modified? Only if a clear association between ATT and symptom change is demonstrated, will Phase 2 begin. Phase 2 aims to understand the relative mechanisms underlying any treatment effect. The primary research question for Phase 2 is: 2. a. Is the ATT associated with a greater change in PSE symptoms than a comparator passive listening intervention (controlling for non-specific factors, (e.g., provision of a credible intervention, task practice and therapist involvement))? The comparator intervention will be a passive version of the ATT whereby participants are instructed to not follow the instructions on the audio-recording. Secondary research questions throughout Phase 1 and 2 will address: 1. Is the active ATT (and passive ATT) associated with an improvement in executive functioning, attention, mood and quality of life and is there any difference between the two interventions?

NCT ID: NCT06455449 Not yet recruiting - Clinical trials for Polymyositis, Dermatomyositis

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

JASMINE
Start date: June 27, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.

NCT ID: NCT06453785 Not yet recruiting - Prostate Cancer Clinical Trials

Comparing pOrtable MRI and TRUS-Fusion Prostate Biopsy to Assess aCcuracy of Prostate Cancer Detection

IP10-COMPACT
Start date: March 2025
Phase: N/A
Study type: Interventional

Currently, patients suspected of having prostate cancer undergo an MRI followed by targeted biopsies of any suspicious lesions under trans-rectal ultrasound (TRUS) guidance. This pathway is labour, time, and cost-intensive. Additionally, TRUS-MRI-Fusion devices are needed, which overlay the MRI scan onto the TRUS used for biopsies. This can lead to targeting errors due to mismatched images. Although biopsies can be performed in the MRI scanner to reduce these errors, it requires a significant amount of time within an expensive MRI scanner in the radiology department, along with special MRI-compatible equipment. Portable MRI technology has the potential to reduce these errors and streamline the diagnostic pathway to one visit. The Promaxo portable MRI is an FDA-cleared MRI device for MR-guided procedures. It uses a novel "truly" open MRI with an unobstructed field of view and a central aperture for robotic-guided intervention and has a limited footprint, allowing it to be placed in a standard operating theatre or large clinic room. The strength of the magnet is also low enough that special precautions and equipment are not needed to take biopsies. The intention is to conduct a study that answers the following research question: How does the accuracy of targeted biopsies of the prostate performed under the guidance of a portable MRI scanner compare to TRUS-MRI-fusion biopsies? Design: A single-arm, single-center IDEAL stage 2a study (n=85 patients) of patients undergoing prostate biopsy for suspected prostate cancer, where each patient would undergo both a portable MRI-registered biopsy and a TRUS-image-fusion biopsy. To reduce the risk of bias between the two modalities, the order of the modality will be randomized 1:1. There will be no blinding of the surgeon. The primary outcome will be the technical feasibility of performing portable MRI and portable MRI-targeted biopsies and estimates on cancer detection.

NCT ID: NCT06453733 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Crainio Non-invasive ICP Monitor for TBI

Start date: September 15, 2024
Phase: N/A
Study type: Interventional

The clinical investigation aims to advance the Crainio device, designed for non-invasive intracranial pressure (ICP) monitoring. This feasibility study involves 54 participants over a 12-month period and seeks to collect cerebral photoplethysmogram signals alongside concurrent invasive ICP measurements in patients with traumatic brain injury. The primary objective is to establish the diagnostic accuracy of the Crainio device, aiming for at least 90% sensitivity and specificity in detecting raised ICP (above 20 mmHg). Secondary objectives include evaluating patient-related factors such as skin tone, skull thickness, and skull density, as well as the tolerability and acceptance of the device by both patients and healthcare professionals.