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NCT ID: NCT04659889 Completed - Covid19 Clinical Trials

Clinical and Haematological Phenotypes in Long COVID

Start date: December 1, 2020
Phase:
Study type: Observational

Analysis of the relationship between clinical characteristics and haematological parameters in long COVID. The novel coronavirus (Covid19) pandemic declared by the World Health Organisation in March 2020 has had an enormous huge impact upon health, health systems and society. Early research has focused on the acute illness caused by the virus. It is now clear that significant numbers of patients infected with Covid19 continue to suffer with multiple, often severe, unexplained symptoms for months after initial infection, so-called long-Covid. Long-Covid symptoms are typically multi-system in their presentation comprising constitutional changes (e.g. fever and fatigue), neuropsychiatric disturbance (e.g. anxiety, insomnia and brain fog), neurosensory symptoms (e.g. headaches and pins and needles), cardiorespiratory effects (e.g. breathlessness and chest pain), gastrointestinal dysfunction (e.g. diarrhoea and food intolerances) and dermatological changes (e.g. rashes and vascular changes). The objectives of this observational, cross-sectional, case-control study are to describe long-Covid clinical phenotypes and to explore whether clinical symptom presentations correlate with haematological and other inflammatory blood abnormalities that might shed insight into underlying pathogenic mechanisms. The study will require the participation of long-Covid patients, seen in an outpatient setting at The Physicians' Clinic, and will correlate clinical symptom phenotypes with laboratory parameters we believe might be relevant to long-Covid. Recruitment of asymptomatic patients, who have recovered from Covid19 infection, will provide a control patient group. Eligible patients will be sent a patient information sheet, describing the study objectives and protocol, inviting them to participate in the study and seeking consent for their participation, which will require analysis of their [anonymised] clinical and laboratory data. Clinical information will be retrieved from patient case records and patients will be asked to complete a symptom questionnaire. All patients will require one blood sample to be taken which will typically form part of their clinical care. Recruitment will occur over a 6 month period.

NCT ID: NCT04659590 Completed - Bowel Disease Clinical Trials

Exploratory Study of Rectal Mucus for Diagnosing Disease

ORI-EGI-02
Start date: November 6, 2020
Phase:
Study type: Observational

The identification of patients with colorectal cancer is challenging as they present with a variable symptom profile and require invasive tests (colonoscopy) for diagnosis (through histological analysis of biopsies) and complimented by cross-sectional radiology, prior to commencement of treatment. The biopsy forms the basis of the diagnosis and management planning for a patient with colorectal cancer through the multidisciplinary team. The biggest challenge currently faced in the management of colorectal cancer is the accurate identification of patients who present with various symptoms none of which are specific for bowel cancer. Currently the NICE referral guidelines are used to determine the appropriateness of referral pathway, i.e. Fast-Track/Two-Week Wait referral. A recent review of over 10000 referrals revealed a colorectal cancer diagnosis in 4.1% of referrals. Previous literature reports rates as high as 8%, but in series of cases with only 72-89% adherence to the referral guidance leading to at best 40% of all colorectal cases being diagnosed through this route. The remainder of colorectal cancers being diagnosed through the bowel cancer screening programme (NBCSP), non-two-week wait referrals and other processes such as emergency admissions. Inherently the Two-Week Wait pathway refers a large volume of "symptomatic patients" and it has become a "cancer exclusion pathway." Once cancer has been excluded, patients are often discharged back to General Practice, yet the patients often still have symptoms. The current Covid-19 pandemic has had a significant impact on the already pressed Two-Week pathway impacting on the reduction of endoscopic and radiological appointments available leading to delays in treatment. Each test performed in the diagnostic pathway has a significant financial, personal, and institutional resource profile. It is our aim to develop a novel diagnostic device based upon the identification of genetic mutations and genomic alterations from material trapped in the rectal mucous layer allowing focused endoscopic assessment, confirmation/exclusion of cancer diagnosis from cross-sectional imaging in those unfit for endoscopic examination and identification of high-risk lesions (dysplasia). This would allow a greater triage, and focus colonoscopic services onto therapeutic procedures, improving overall care.

NCT ID: NCT04658940 Completed - Clinical trials for Typical Atrial Flutter

AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)

AcQForce AFL
Start date: March 25, 2021
Phase: N/A
Study type: Interventional

The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.

NCT ID: NCT04658797 Completed - Myopia Clinical Trials

Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

The aim of this study was to explore satisfaction with vision correction and ease of use of PFM (Personal Face Masks) in a group of spectacle wearers who were randomised to continue wearing spectacles or be fitted with daily disposable contact lenses.

NCT ID: NCT04657939 Completed - Clinical trials for Diabetes Mellitus, Type 2

Targeting Beta-cell Failure in Lean Patients With Type 2 Diabetes

Lean-DM
Start date: December 1, 2020
Phase: Phase 4
Study type: Interventional

The majority of people with type 2 diabetes (T2D) are overweight, and while weight gain is a major contributor to diabetes, a minority of patients with T2D are not overweight or obese. The reasons why lean or normal body weight individuals develop T2D (lean-T2D) are not yet understood. T2D occurs when the body does not produce enough insulin, or becomes less sensitive to its effects. Insulin acts like a key to allow sugar into cells and if someone is overweight that key works less well. Recent research suggests that T2D in lean people should be considered a different disease from the diabetes associated with obesity and the main problem in lean-T2D patients may be a reduced capacity of insulin secretion. However, some researchers argue that many seemingly thin people carry more fat than muscle, making them trim on the outside, but fat on the inside, and they are in fact not truly lean. This implies that just like overweight diabetics, lean diabetics also have high resistance to insulin. The main aim of this research is to better understand the main driver of T2D in lean individuals, as this will determine how best to treat these individuals. There are many different types of drugs for treating T2D. Liraglutide improves insulin secretion capacity of the pancreas. Pioglitazone reduces resistance to insulin action. The investigators will compare the actions of these diabetes drugs on the blood supply and the heart's energy levels in lean-T2D and obese-T2D patients. This will allow the investigators to determine the ideal treatment strategies for improving cardiovascular health in lean-T2D patients, and better understand the role of impaired insulin secretory capacity, insulin resistance and excess fat deposition specifically in this group.

NCT ID: NCT04657900 Completed - Atrial Fibrillation Clinical Trials

Predicting Patient-level New Onset Atrial Fibrillation

Start date: November 2, 2020
Phase:
Study type: Observational

Atrial fibrillation (AF) is a major cardiovascular health problem: it is common, chronic and incurs substantial health-care expenditure as a result of stroke, sudden death, heart failure and unplanned hospitalisation. There is a compelling argument for the early diagnosis of AF, before the first complication occurs, but population-based screening is not recommended. Strategies to identify individuals at higher risk of new onset AF are required. previous risk scores have been limited by data and methodology. The investigators will use routinely collected hospital-linked primary care data and focus on the use of artificial intelligence methods to develop and validate a model for the prediction of incident AF. Specifically, the investigators will investigate how population-based data may be used for precision medicine using a deep neural networks learning model. Using clinical factors readily accessible in primary care, the investigators will provide a method for the identification of individuals in the community who are at risk of AF, as well as when incident AF will occur in those at risk, thus accelerating research assessing technologies for the improvement of risk prediction, and the targeting of high-risk individuals for preventive measures and screening.

NCT ID: NCT04657627 Completed - Physical Activity Clinical Trials

FOODS: Food shOppers' sOcial meDia Study

FOODS
Start date: January 6, 2021
Phase: N/A
Study type: Interventional

This study aims to assess the effects of a new approach to food labelling called physical activity calorie equivalent (PACE) labelling. PACE food labelling provides the public with information about how many minutes (or miles/kilometres) of physical activity (e.g. walking or running) are equivalent to the calories contained in foods.

NCT ID: NCT04656275 Completed - Clinical trials for Non-cystic Fibrosis Bronchiectasis

A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation

Start date: March 4, 2021
Phase: Phase 1
Study type: Interventional

This study is open to adults with non-cystic fibrosis bronchiectasis. The main purpose of this study is to find out how a medicine called BI 1323495 is tolerated by people with non-cystic bronchiectasis. The study tests 2 different doses of BI 1323495. Some of the participants get placebo. It is decided by chance who gets BI 1323495 and who gets placebo. Participants take BI 1323495 or placebo as tablets twice a day for 3 months. Placebo tablets look like BI 1323495 tablets but do not contain any medicine. Participants can also continue taking standard medicines for noncystic bronchiectasis throughout the study. Participants are in the study for about 4 months. During this time, the participants visit the study site about 11 times and get about 2 phone calls. At the visits, doctors check the health of the participants and note any health problems that could have been caused by BI 1323495.

NCT ID: NCT04655937 Completed - Stroke Clinical Trials

Wellbeing After Stroke (WAterS): Supporting Adjustment and Wellbeing After Stroke

WAterS
Start date: January 5, 2021
Phase: Phase 1
Study type: Interventional

Stroke survivors face a range of mental health challenges adjusting post-stroke. There is a lack of treatment options and clinical psychologist workforce to deliver support. Acceptance and Commitment Therapy (ACT) has been used successfully in clinical services to improve wellbeing. The investigators worked with stroke survivors, health care professionals and researchers to co-develop group ACT therapy, specifically for stroke survivors, to be delivered using video calling (Zoom). Staff training and supervision programmes were also developed to equip Stroke Association workforce (paraprofessionals) to deliver ACT. The current study will recruit and train up to 10 professionals with some experience of supporting stroke survivors but no experience of ACT. We then aim to recruit up to 30 stroke survivors in the community who are at least 4 months post-stroke and experiencing distress adjusting to their stroke. The investigators aimed to make everything accessible for people with mild/moderate difficulties with thinking and communicating. Recruitment took place across England, over a 6 month period. The study will test how feasible and acceptable it is to deliver the co-developed, remote ACT intervention to stroke survivors, as well as the feasibility of collecting outcomes data: 1. Participants will be invited to consent to complete online measures of well-being every 3 months for up to 12 months (taking around 20 minutes), with the option to participate in group intervention. Those who don't opt for groups will not be treated but will be followed up about their wellbeing, if they agree. 2. Those who opt to attend groups will be randomly assigned into intervention groups A, B, or C and receive the ACT intervention, involving 9 weekly sessions and homework. Data will be collected on how successfully the groups are delivered and how acceptable they are / how to improve them, through online surveys, feedback questionnaires and interviews. UPDATE May 2023: The investigators had initially intended to run an active comparator arm of social support and randomly allocated people to arms *and* groups. However, the design changed after the COVID-19 pandemic, meaning that the planning phases took longer than expected in order to pivot all study components to be deliverable online. *Please see references section for our findings and publications

NCT ID: NCT04655456 Completed - Sarcopenia Clinical Trials

Feasibility of Estimating the Prevalence of Malnutrition, Frailty and Sarcopenia in Older People in UK Biobank, Cross-sectional Study: A Study Protocol

Start date: April 1, 2007
Phase:
Study type: Observational [Patient Registry]

Background: measuring the prevalence of malnutrition, frailty and sarcopenia in same group of older adults is effective in understanding the relation between these conditions. This could support diagnosing, treatment and prevention in future practice. The research is aiming to measure the estimate prevalence of malnutrition, frailty, sarcopenia and their overlap in older adults, using the UK Biobank. In addition, it will aim to compare the two models of frailty the phenotype and deficit accumulation using the UK Biobank database, as data comparing these models is limited. Methods/design: This is a cross-sectional study design that will use the UK Biobank database, which includes 381,000 participants males and females, aged 50 years and above, who completed the UK Biobank baseline assessments were included that is a subset from the main sample size from the UK Biobank. For baseline, details of participant's characteristics will be included. All three conditions will be identified as malnutrition by using GLIM criteria, while frailty by using two models; the first model will be the 36 deficits model and phenotype model. Finally, sarcopenia condition will be judge according to EWGSOP standard. All these models will be determining the feasibility to apply it using the available database in the UK Biobank. Discussion: This proposed study will help in understanding the relation between malnutrition, frailty and sarcopenia. As in worldwide, there is little published research on the overlap between malnutrition, frailty and sarcopenia. Despite definitions and diagnostic criteria were developed for these conditions. There is conflict extend to the definitions and identification criteria's. This study will use UK Biobank database to measuring the estimate prevalence in older people and determine the overlap between three conditions.