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NCT ID: NCT05299242 Completed - Frozen Shoulder Clinical Trials

The Anti-Freaze-F Study- "Anti-TNF for Treatment of Frozen Shoulder - a Feasibility Study"

Anti-FreazeF
Start date: July 21, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Frozen shoulder is a common condition affecting approximately 9% of people aged 25-64 years. During the early phase the pain is usually unbearable and the later restriction in movement is severely limiting. It occurs when the flexible tissue (capsule) that surrounds the shoulder joint becomes inflamed, thickened and tight. The pain can be very severe and lasts 3-9 months, followed by a 4-12 month period of increasing stiffness, after which the condition usually improves. Frozen shoulder often affects a person's ability to sleep, carry out everyday activities, and work. Current treatments include rest, painkillers, anti-inflammatories, physiotherapy and steroid injections. If stiffness persists, surgery is sometimes recommended. However, there is no evidence that any of these treatments lead to significant benefit in the long term, with many being ineffective. The aim of this study is to find out if it is possible to run a larger trial to test whether an injection of adalimumab can reduce pain and prevent the disease from getting worse, if given during the early painful phase of frozen shoulder. The investigators need to conduct this smaller study first to be sure it's possible to identify and treat people with early stage frozen shoulder, before they conduct a much larger trial to find out if this treatment works. In this study the investigators will include 84 adults from 5 sites with painful early stage frozen shoulder who have not yet received treatment. People will be randomised to receive either an injection of the drug adalimumab or a dummy injection of saline (placebo) directly into the shoulder joint, both guided by ultrasound. All participants will also receive standardized advice on how to manage their shoulder pain. The investigators will assess participants before treatment and three months later. Adalimumab has been used very successfully to treat other inflammatory diseases such as rheumatoid arthritis. This study has been funded by the NIHR RfPB programme and 180 Life Sciences.

NCT ID: NCT05298735 Completed - Type 1 Diabetes Clinical Trials

Pancreatic Calcium Handling in Islet Beta Cells in Patients With Type 1 Diabetes Mellitus

Pancreas MEMRI
Start date: March 1, 2021
Phase:
Study type: Observational

Approximately 400,000 people are living with type 1 diabetes mellitus (T1DM) in the United Kingdom: one of the highest rates in the world. It is characterised by autoimmune loss of pancreatic beta cell mass leading to metabolic dysregulation, requiring lifelong insulin therapy. It is now recognised that there are micro-secretors of insulin and that preservation of insulin secretion in these cases is associated with decreased complications. Therefore, recent research has focussed on using immunomodulation to preserve pancreatic beta cell mass. Evaluation of novel therapies for T1DM requires reliable methods to measure beta-cell function, which is unattainable using traditional non-invasive imaging techniques. A new approach is manganese-enhanced magnetic resonance imaging (MEMRI). This proof-of-concept study was designed to investigate whether MEMRI can be used as a measure of beta-cell function in people with T1DM.

NCT ID: NCT05298553 Completed - Atrial Fibrillation Clinical Trials

Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias

WEAR-TECH ECG
Start date: April 18, 2022
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is the most common arrhythmia (irregular heart rhythm), affecting 1-2 million people in the UK. AF significantly increases the risk of an AF-related stroke, heart failure and dementia. A significant proportion of people will have no symptoms, and they may only be found to have AF after suffering an AF-related stroke. An electrocardiogram (ECG) uses sensors placed on the skin to record the heart's electrical activity. A 12-lead ECG uses 10 sensors and is the gold-standard (best available test) to detect any abnormal heart rhythm disturbances. Until recently, a 12-lead ECG showing an irregular heart rhythm was required to make a diagnosis of AF but as AF episodes are often short and unpredictable it may be missed. Therefore, a small device that continuously records heartbeat and heart rhythm could make the diagnosis of arrhythmias and AF much quicker and easier. Accessories such as watches or rings - referred to as wearable devices - have extremely good sensors that measure pulse rate by detecting small changes in skin colour during each heartbeat and can perform a single-lead ECG. Algorithms built in the wearable devices can identify irregular heart rhythms, such as atrial fibrillation. The purpose of this study is to test two new wearable devices - the Skylabs CART-I ring and the Apple Watch - in detecting abnormal heart rhythm recording and recording ECGs. The investigators plan to recruit 500 patients attending Cardiology Departments in several hospitals in the UK and will ask them to wear the Apple Watch and the CART-I and perform 12-lead ECG with each device (two in total). No extra follow-up visits are required. At the end of the study, the investigators will compare interpretation by two cardiologists of the wearable devices' ECGs and the 12-lead ECGs and look at their ability to automatically detect abnormal rhythms.

NCT ID: NCT05298540 Completed - Clinical trials for Postoperative Cognitive Dysfunction

Feasibility and Acceptability of Home-based Computerised Cognitive Training After Cardiac Surgery

FACCT
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The aims of this study are to (1) evaluate the feasibility and acceptability of a home-based computerised cognitive training programme in the postoperative cardiac surgical population, and (2) estimate measures of precision about the mean and variance of cognitive outcome to inform sample size calculations for a subsequent efficacy study.

NCT ID: NCT05298462 Completed - COVID-19 Clinical Trials

Clinical Evaluation of Rapid Antibody Test for Covid-19

CERAbTc-19
Start date: May 17, 2020
Phase: N/A
Study type: Interventional

Rapid, accurate diagnosis of Covid-19 would greatly help to improve clinical management of patients presenting with symptoms of possible Covid-19. Currently results of the standard test for the virus take 2-3 days to be reported. Watford General Hospital has imported rapid antibody tests manufactured by Zuhai Livzon Diagnostics Inc in China and our team would like to evaluate their accuracy and clinical usefulness. The test involves taking a drop of blood from the patient (either from a venous blood sample taken for other blood tests, or from a fingerprick). This is applied to a test strip (similar to a pregnancy test) and two drops of diluent are added. If the patient has antibodies to Covid-19, two lines appear on the test strip (like a positive pregnancy test) whereas if the patient has no antibodies, only one line appears (like a negative pregnancy test). There are two different types of antibody: IgM is produced early in the course of the illness (day 7-14) and then IgG is produced later and continues to be present, probably for months or years. There are two test strips, one for each of these types of antibody. In this study we aim to evaluate the accuracy of this new test, in three groups of patients. Firstly those with proven Covid-19 and at least 7 days after the onset of their illness. We aim to recruit 200 patients in total: at least 138 patients with 10 or more days of symptoms, plus a subgroup of up to 62 patients with 7-9 days of symptoms (to explore the usefulness of the test earlier in the course of illness). The second group of 250 patients will be those hospital staff who report symptoms possibly caused by Covid-19 and are receiving a standard antibody test. The third group of patients will be those followed up in a "virtual hospital" for clinically suspected Covid-19 who had never been tested with a standard PCR test. As we are not sure of the accuracy of the new test, its results will not be used to make decisions about treatment for the patient. This study will enable us to discover rapidly whether the new test is accurate, and if so we will conduct further studies to assess how it can help to improve management of patients with suspected Covid-19.

NCT ID: NCT05297565 Completed - Melanoma Clinical Trials

A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

CheckMate-6GE
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.

NCT ID: NCT05296538 Completed - Suicidal Ideation Clinical Trials

The Mental Imagery for Suicidality in Students Trial (MISST)

MISST
Start date: February 21, 2022
Phase: N/A
Study type: Interventional

In the UK, suicide is the leading cause of death in young people and have increased in recent years. Areas in the North of England appear particularly at risk. University students represent one vulnerable group. 42% of students contemplate suicide in any one-year period. Suicidal thinking is an important indicator of distress and clinical need, which predicts subsequent suicidal experiences and worse mental health. It is therefore an important target for clinical treatment and early intervention. However, evidenced based interventions for targeting suicidal thinking in students are lacking. This project will evaluate the feasibility of a novel psychological intervention, called the Broad Minded Affective Coping (BMAC) intervention. The BMAC aims to increase peoples' access to positive thoughts and emotions to help them to break out of cycles of negative mood and suicidal thinking. It is targeted, protocolised, and deliverable by a range of professional groups. Our existing co-development work with young people has suggested that it is acceptable and helpful to University students. This randomised controlled feasibility trial of the BMAC intervention for suicidal thinking in university students. Participants will be randomised to either a risk assessment and signposting plus the BMAC (n = 33), or risk assessment and signposting alone (n = 33). The study will assess outcomes at baseline and after eight weeks, 16 weeks, and 24 weeks. The study will explore the safety, feasibility and acceptability of delivering the intervention and trial procedures. Embedded qualitative interviews with staff and participants, and field notes, will help us to understand the potential factors affecting acceptability and delivery of the BMAC intervention and conduct of the trial, and the proposed underlying mechanisms of change. The project will be a crucial step in evaluating the BMAC for suicidal students, paving the way for a larger trial of clinical effectiveness.

NCT ID: NCT05294458 Completed - Clinical trials for Chronic Kidney Disease

A Randomised, Open-Label Study to Evaluate the Relative and Absolute Bioavailability of Cotadutide in Healthy Subjects

Start date: March 28, 2022
Phase: Phase 1
Study type: Interventional

The Sponsor is developing the test medicine, cotadutide, for the potential treatment of non-alcoholic steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM) with chronic kidney disease. This healthy volunteer study will try to identify how two different concentrations of cotadutide are taken up by the body when dosed under the skin (subcutaneous injection). The study will also try to identify the absolute bioavailability of cotadutide (amount taken up by the body when dosed under the skin compared to an injection directly into the vein (intravenous)). This is a single-part, three-period study taking place at one non-NHS site in the UK and will involve 12 male and female (non-pregnant/non-lactating) volunteers aged 18-55. For each study period, on Day 1 volunteers will receive cotadutide as either a subcutaneous injection (into the stomach) or an intravenous injection following an overnight fast of at least 10 hours. The subcutaneous injections will be given as either a 1 mg/ml or 5 mg/ml concentration. The intravenous injection will be given as a 0.1 mg/ml concentration. Volunteers will be discharged on Day 4 and there will be a washout period of 7 days between dosing. Blood samples will be taken at regular intervals for pharmacokinetics and safety assessments from Day -1 to discharge. Volunteers will need to return for a follow up visit 28 (±2) days post-first dose for provisional of an anti-drug antibody sample and to ensure wellbeing

NCT ID: NCT05294419 Completed - Clinical trials for Cardiovascular Diseases

The Healthcare Evaluation of Absolute Risk Testing Study

HEART
Start date: November 4, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to demonstrate the integration and use of cardiovascular disease (CVD) integrated risk tool (IRT) in an environment as close to real-world as possible. This study will recruit participants of both biological sexes and any ancestry or background who require and are eligible for a CVD risk assessment as part of the NHS Health Check. Those aged 45-64 years are most likely to benefit from CVD IRT and will be included in the study, as they are more likely to be asymptomatic but also derive most benefit from preventative measures. The study will be conducted in GP surgeries as the CVD IRT will have its greatest impact if incorporated into primary care practice for early identification of patients at highest risk. This study is a device performance evaluation.

NCT ID: NCT05292690 Completed - Stroke Clinical Trials

An Assistive Powered Wheelchair: Stage 2 Trial

EDUCAT
Start date: March 29, 2021
Phase:
Study type: Observational

Preliminary evaluation of an obstacle alerting system to enhance the user's independent mobility by improving their confidence to drive and their safety in driving a powered wheelchair.