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NCT ID: NCT05943730 Recruiting - Preoperative Care Clinical Trials

Validity of Measuring Preoperative Fitness Using Seismofit

Start date: August 31, 2023
Phase: N/A
Study type: Interventional

Physical fitness levels of people waiting for a planned operation are often measured using an exercise test. This is because fitness levels help doctors make a plan to improve each person's chances of a successful recovery after their planned operation. The exercise test requires skilled staff, expensive equipment, a 1 hour appointment, and the patient to exercise heavily during the test. Ventriject, a small to medium sized enterprise, have designed a device called Seismofit that estimates fitness levels of people from a measurement taken whilst laying down. It measures the vibrations of the chest wall caused by the beating heart and uses this information with additional information, such as height, weight and sex, to estimate fitness. The measurement takes around 5 minutes to perform, does not require heavy exercise, expensive equipment or skilled staff. The Seismofit device was shown to be accurate in young fairly fit people. It has not been tested in people who undergo an exercise test before an operation, who are less fit on average compared to the people that the device was originally tested on. It is likely that the calculations used to estimate fitness levels with the Seismofit device will need to be adjusted for people waiting for an operation. There are two parts to this study. The first part aims to estimate up to 50 people's fitness with the Seismofit device and use directly measured fitness from their standard exercise test before their operation to adjust the calculations for estimating fitness. The second part of this study aims to have a further 50 people undergo the Seismofit device measurement and compare the estimated fitness level with the results from the standard exercise test before an operation. This is to see if the Seismofit device is valid at estimating fitness in people awaiting surgery.

NCT ID: NCT05943366 Recruiting - Malnutrition Clinical Trials

Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults

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

Trial Design: This is a feasibility randomised controlled trial. Aim: The study aims to assess the feasibility of conducting a randomised controlled trial using a digital health tool (Keep-On-Keep-Up Nutrition, KOKU-Nut) to improve dietary intake in community-dwelling older adults. Objectives: 1. Is it feasible and practical to run KOKU-Nut study as a powered randomised controlled trial. 2. Adherence to the intervention, motivations, barriers and facilitators of engaging with KOKU-Nut Study population: Community-dwelling adults aged 65 and older Intervention: Participants in the intervention group will be asked to engage with KOKU-Nut at least 3 times a week throughout the 12-week period. A crib sheet and contact details for the research team will be available if participants require additional support to help with technical issues. Control: Participants will continue with usual care and receive a leaflet developed by Age UK about the importance of a healthy lifestyle. Timing and duration 3 month intervention with interviews carried out approximately one week after the intervention period

NCT ID: NCT05943249 Recruiting - Healthy Clinical Trials

Development of Novel MR Techniques Using Volunteer Participants

Start date: June 4, 2007
Phase:
Study type: Observational

Using magnetic resonance (MR) imaging or spectroscopy as part of clinical research typically involves developing new MR protocols. Although some of this work is done by scanning artificial 'phantoms', volunteer studies are normally needed to configure and validate new protocols appropriately. Developing new MR protocols and techniques is also useful in its own right. The volunteer scanning described in this application will provide data to support this type of methodological research into new scanning and image processing techniques: improving the speed, quality, and range of measurements possible with the scanner. With proper safety and screening procedures, MR has no known side-effects, and has been performed on millions of human subjects worldwide without ill effect. There are well-established contraindications for MRI, and screening procedures are already in place in the MR unit at UCLH to exclude such subjects and ensure the safety of subjects. With these, and the MR scanner's built in safety mechanisms, residual risk is low. Many other trusts with active MR research have previously made similar applications to this related to volunteer MR scanning for pilot work and methodological research Although scans may obtained as part of several research projects, in each case it is only the scanning technique (the programmed sequence of data acquisition and processing steps) which will vary, along with the body region to be imaged. The volunteer experience will be very similar, and all ethical issues, including the information sheet and consent form, will be identical. These scans are for methodological research on the MR techniques themselves, and will be never form part of the volunteer's own healthcare. Separate ethical permission is sought for any study which does not match the above criteria.

NCT ID: NCT05942859 Enrolling by invitation - Clinical trials for Pulmonary Hypertension (Diagnosis)

Applying Artificial Intelligence to the 12 Lead ECG for the Diagnosis of Pulmonary Hypertension: an Observational Study

Start date: October 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to apply Artificial Intelligence (AI) and machine learning technology to the resting 12-lead electrocardiogram (ECG) and assess whether it can assist doctors in the early diagnosis of Pulmonary Hypertension (PH). Early and accurate diagnosis is an important step for patients with PH. It helps provide effective treatments early which improve prognosis and quality of life. The main questions our study aims to answer are: 1. Can AI technology in the 12-lead ECG accurately predict the presence of PH? 2. Can AI technology in the 12-lead ECG identify specific sub-types of PH? 3. Can AI technology in the 12-lead ECG predict mortality in patients with PH? In this study, the investigators will recruit 12-lead ECGs from consenting participants who have undergone Right heart Catheterisation (RHC) as part of their routine clinical care. AI technology will be applied to these ECGs to assess whether automated technology can predict the presence of PH and it's associated sub-types.

NCT ID: NCT05942599 Recruiting - Clinical trials for Relapsed Acute Myeloid Leukaemia

Base Edited CAR T Cells Against AML: Deep Conditioning Ahead of Allogeneic Stem Cell Transplantation

CARAML
Start date: July 21, 2023
Phase: Phase 1
Study type: Interventional

In this phase 1 clinical trial, the investigators are testing an experimental medicine in children aged 6 months up to 16 years with acute myeloid leukaemia (AML), which has come back (relapsed). The new product is made from white blood cells (T cells) collected from a healthy donor and changed so they can kill leukaemia cells. These 'ready-made' CAR T cells have been made using a new technique called Base Editing to modify their DNA code and have been given the code name 'BE CAR-33'. This technique allows them to work after chemotherapy and also disarms them to prevent effects against normal cells. The main purpose of this study is to assess the safety of the 'BE CAR-33' therapy and to see if ready-made CAR T cells can get rid of Acute Myeloid Leukaemia ahead of a planned bone marrow transplant that will hopefully prevent the leukaemia from returning.

NCT ID: NCT05942287 Recruiting - Obesity Clinical Trials

The Effect of Obesity and Weight Loss in Heart Failure With Reduced Ejection Fraction.

SLEnDR
Start date: May 24, 2023
Phase: N/A
Study type: Interventional

This study looks at the effects of weight loss in people who have heart failure with reduced ejection fraction (HFpEF) and are overweight or obese. The main questions it aims to answer are whether weight loss in this group of people improves: - The heart's shape and how well it pumps blood - The person's quality of life and how much they can exercise Participants will attend 2 study visits, separated by 3-6 months. The intervention period takes place in between the 2 study visits. Each study visit may involve measurements including: Symptom and quality of life questionnaires Body measurements such as height and weight Blood tests Ultrasound scans of the heart (echocardiogram) Magnetic Resonance Imaging (MRI) scans of the heart 6 minute walk test Participants are randomly allocated (in other words, by lottery) to either 'diet' or 'control' groups. The control group will continue standard care. The diet group will be enrolled in a weight loss program supervised by the study team. Participants in the diet group will replace their usual meals with meal replacement products specifically designed to deliver a low calorie diet for weight loss. The products will consist of formula soups, shakes and porridges. This diet would last 8 weeks, followed by a guided period of food reintroduction and maintenance.

NCT ID: NCT05941832 Recruiting - Cystic Fibrosis Clinical Trials

ANNE Sensor Monitoring in Cystic Fibrosis

ASM in CF
Start date: July 3, 2023
Phase:
Study type: Observational

The ANNE sensor is a small, wire free device that is placed on the chest with a removable adhesive patch. It measures things like temperature, heart rate and breathing rate without the need for wires and large machines that are needed currently. The aim is to trial this sensor in a small group of participants to see how well it is tolerated and how well it measures. The aim is to see if the sensor could provide additional information to help the medical team detect when a participant is becoming unwell with less need for the participant to perform repeated tests. Participants will wear the sensor for 6 weeks continuously (apart from when it is charged for 4-6 hours each day). Participants can perform their usual activities whilst wearing the sensor but should not submerse the sensor in water for long periods of time.

NCT ID: NCT05941702 Active, not recruiting - Clinical trials for Functional Neurological Disorder

Body Signal Integration Training: A Case Series

Start date: September 19, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about an intervention package in individuals with Functional Neurological Disorder (FND). The main questions it aims to answer are: - Is the intervention package acceptable to and feasible to deliver to individuals with FND? - Does the intervention package improve symptoms of FND? Participants will be asked to engage in 8 weekly sessions of an intervention aimed to improve the perception of signals coming from the body (interoception). Participants will be asked to complete tasks between session practising tuning into signals from the body. Participants will also be asked to complete questionnaires measuring their psychological wellbeing, FND symptoms and interoception.

NCT ID: NCT05940922 Not yet recruiting - Clinical trials for Guillain-Barre Syndrome

RWE-based Treatment Patterns and Outcomes in CIDP

Start date: August 17, 2023
Phase:
Study type: Observational

To describe the demographics, clinical characteristics, treatment patterns and clinical outcomes of chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barre Syndrome (GBS), and heredofamilial amyloidosis (hATTR) adult patients at a single U.K. centre.

NCT ID: NCT05939544 Recruiting - Clinical trials for Cardiovascular Diseases

Impact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health

Start date: July 10, 2023
Phase: N/A
Study type: Interventional

In a randomised, controlled cross-over manner, this trial aims to determine how short-term daily supplementation with a milk fat globule membrane-enriched ingredient impacts on cardiometabolic health and cognitive outcomes.