There are about 25435 clinical studies being (or have been) conducted in United Kingdom. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The goal of this observational study is to determine if a COPD exacerbation can be detected early in its onset. The main questions it aims to answer are: - Can an exacerbation be detected before the person recognizes they are unwell? - What are the biological signals which provide the best indication of decompensation? - How does this indication of decompensation compare to a daily CAT? Participants will be asked to place a device, DistaSense, on top of their mattress and then sleep as normal. In addition, they will be asked to complete a daily CAT.
This is a seamless Phase 1/2 study consisting of two components. Phase 1 component is a dose-escalation, single arm, open label study in 10 patients to evaluate the safety and tolerability of KRC 01. Phase 2 component is a randomized, open label, controlled, multi-center study in 60 patients to evaluate the preliminary antitumor effect of KRC-01 in combination with CRT.
Point-of-care ultrasound (PoCUS) is a rapidly evolving method of clinical assessment within the intensive care unit (ICU) with training predominantly aimed at physicians. Routine whole-body PoCUS (lungs, heart, abdomen and blood vessels) when conducted by physicians benefits patient care and outcomes including reducing the risk of prolonged ICU stay (>7 days) and mechanical ventilation as well as reducing utilisation of other diagnostic tests. However, physician-only use of PoCUS does not allow for use as a routine assessment method in the ICU due to the low physician to patient ratio and poor ultrasound accreditation rate. Providing other healthcare professionals such as Advanced Critical Care Practitioners (ACCPs), ICU nurses and physiotherapists with PoCUS skills increases the proportion of trained staff to perform routine PoCUS in the ICU. This could aid earlier identification of abnormal pathology, earlier treatment, and prevent patient deterioration. The advancement of handheld PoCUS technology is making ultrasound more portable, cheaper and easier to use. The increased accessibility of PoCUS combined with growing evidence of its diagnostic accuracy compared to other modes of imaging means PoCUS use is gaining traction globally. However, little to no research exists investigating the feasibility of implementing scheduled interprofessional PoCUS in the ICU and its impact on patient outcomes. This study aims to evaluate the acceptability and feasibility of a quick and simple whole body ultrasound scan performed by trained ACCPs, ICU nurses, physiotherapists, and doctors at set time points throughout the patients ICU stay. The investigators want to find out the most common barriers and facilitators to intervention implementation and to explore the key clinical outcomes for use in a future definitive RCT.
Around 3500 children including 1,000 babies a year in the UK require heart surgery. Open-heart repairs involve the heart being stopped, while blood is pumped around the body using a cardiopulmonary bypass machine. Following complex operations, the patient may temporarily develop poor heart function, leading to reduced organ blood supply. Low heart output leads to post-operative complications or even death. The current methods to assess cardiac output and to see if vital organs, especially the brain, are receiving enough blood flow, are indirect and can be inaccurate. If we find a better way to detect and then avert or ameliorate periods of poor cardiac output and / or reduced brain perfusion, then this would be helpful for clinicians and could lead to better outcomes for children. We believe that optical coherence tomography angiography (OCTA), a non-invasive way to image the blood vessels in the retina at the back of the eye, could help us to assess cardiac output and brain perfusion. The OCTA machine was approved for use in humans in 2019 and given a CE Marking, but it has previously been used mainly in the management of eye diseases. There is a small amount of experience with its use in critically ill adults. We plan a pilot study to see if it is possible to use the OCTA machine at key time points, before, during and after children's heart operations, in 30 patients. We will study the images taken with OCTA machine to see if they are of good quality and we will analyze the images to see whether or not the expected changes in cardiac output and brain perfusion that occur with heart surgery can be detected as changes in blood flow in the back of the eye. Depending on the success of this pilot, we will plan further studies.
Parkinson's disease is the world's fastest-growing neurological condition. It is a progressive neurodegenerative disorder that causes a wide range of movement-related (motor) problems (slowness, stiffness, tremor, balance difficulties) and non-motor problems (disturbances of thinking, memory, perception, mood, bladder, bowels, blood pressure). Even before the pandemic, NHS services were struggling to meet the demand for care. To address this need for support, the investigators have co-designed an innovative digital care pathway, Home Based Care (HBC), with people with Parkinson's (PwP) and care partners (CP) to deliver self-management support and clinical expertise to the patient's home. This pathway is supported by remote monitoring with a wrist-worn sensor and questionnaires. In this study, the investigators will be digitising this pathway so that data from a variety of sources (including the sensor, questionnaires, and patients' health records) can be combined in one place to enable more personalised care and to provide advice to support self-management of symptoms by patients. After the investigators have set up the digitised pathway, its implementation will be evaluated with a group of 120 people with Parkinson's and their care partners and associated healthcare providers through the Plymouth Parkinson's Service. The investigators will examine participants' adoption of and engagement with the patient-facing digital platform over the course of 3 months and gather their feedback about its usability and acceptability. A smaller group of the participants will discuss their experiences in more detail to help pinpoint aspects that work well and those needing adjustment and development. The investigators anticipate that this system will result in improved quality of life and care and increased knowledge and confidence for self-managing symptoms. The results of the study will be used to improve the digitised Home Based Care pathway. People with Parkinson's and care partners involved in the project will help guide the sharing of these results with healthcare providers and the general public.
Depression is a leading cause of disability worldwide and poses a large economic burden in the UK. There is evidence that exercise is beneficial in the management of depression and NICE now recommends group exercise programs as a treatment for people with mild and moderate-severe depression. Research shows that patients with severe depression are less likely to engage in exercise than patients with mild to moderate depression. There is little evidence, however, on the barriers and drivers to participation in such programs experienced by patients with depression; leading to uncertainty in the most effective way to implement these programs. We aim to analyse accounts of patients who have been referred to or participated in the Exercise Recovery Group (ERG), a group exercise program at the Nottingham Specialist Depression Service (NSDS). The NSDS is a tertiary unit where referred patients have suffered moderate-severe, persistent clinical depression. Eligible participants will be patients with persistent major depression who have agreed to referral to the ERG at the NSDS and who are able to provide informed consent. Participants will undergo a one-off 60 minute meeting via MS Teams, including an in-depth semi-structured interview on their experience as well as self-completion questionnaires assessing demographics, depression, anxiety and shame. Transcripts of the interviews will be subject to qualitative thematic analysis addressing questions on barriers and drivers of exercise treatment in depression; and the perceived impact of an exercise group on the individual participating. Themes will be developed to give an account of these questions, supported by anonymised quotes from the transcripts. The questionnaire data (on demographics, depression, anxiety, shame) will be used to characterise the group, in order to help assess directness of the evidence provided for other clinical populations; ultimately helping clinicians to implement exercise groups for depression that are acceptable for patients.
In an aging population, cataract and presbyopia become increasingly common. A cataract develops when the natural crystalline lens inside a person's eye, becomes cloudy over time, causing reduction of vision. Presbyopia is an age related condition resulting in loss of reading/near vision and requiring reading glasses. Cataract surgery is the most common elective surgery in the world for patients over 65. It is composed of removal the cataract and insertion of a new intraocular lens (IOL). Currently only monofocal IOLs are available on the NHS (National Health Service, United Kingdom) - meaning they give good distance or near vision. The majority of patients opt for good distance vision with glasses to read. The investigators are trialling insertion of a new Extended Depth of Focus (enhanced aspheric) IOL (EDoF IOL), which treats both cataract and presbyopia. All patients attending St Thomas' hospital for treatment of cataracts will be considered for invitation to the study. Patients who participate in the study will be randomly selected to receive either the new Extended Depth of Focus IOL - the TECNIS Eyhance ICB00 IOL, or a well-established monofocal (non-EDoF) IOL the Alcon Acrysof IQ SN60WF IOL during cataract surgery. Insertion of the Alcon Acrysof IQ SN60WF IOL is known to treat cataract but not presbyopia. Patients will be assessed and have their surgery performed at St Thomas' Hospital London. They will have 7 appointments over 12 months, plus surgery. The investigators hope to demonstrate better distance, intermediate and near vision and increased spectacle independence in the TECNIS Eyhance ICB00 IOL group. EDoF IOLs have the potential to improve cataract surgery outcomes for patients in the NHS.
Older adults have very specific food and nutrient requirements and often struggle to meet these needs due to poor appetite, reduced functionality and dexterity. Protein (both quality and quantity) is an important macronutrient in maintaining muscle in older adults which can help prevent falls, delay disease onset and help individuals maintain independence. Fortifying regular/ everyday foods with additional protein is one strategy to help older adults meet these increased protein needs. However, it is well established that protein is the most satiating of the nutrients we eat, yet less is known about how this is impacted by age and protein type. This study aims to test 2 protein fortified porridge recipes in older adults (and a control recipe) with outcomes focused on protein bioavailability, appetite and satiety responses.
In an aging population, cataract and presbyopia become increasingly common. A cataract is the opacification of the natural crystalline lens inside a person's eye, causing reduction of vision. Presbyopia is an age related condition resulting in loss of reading/near vision which results in requiring reading glasses. Astigmatism is a common condition characterized by an abnormal cornea (the clear tissue at the front of the eye) which results in blurred distance and near vision, again requiring glasses. Cataract surgery is the most common elective surgery worldwide for patients over 65. It is composed of removal the cataract and insertion of a new intraocular lens (IOL). Currently only monofocal IOLs are available on the National Health Service (United Kingdom) - meaning they give good distance or near vision. The majority of patients opt for good distance vision with glasses to read. The investigators are trialling insertion of a new Extended Depth of Focus (enhanced aspheric) Toric IOL (EDoF Toric IOL), which treats all 3 conditions - cataract, presbyopia and astigmatism. All patients attending St Thomas' hospital for treatment of cataracts, who have presbyopia and astigmatism will be considered for invitation to the study. Patients who participate in the study will be randomly selected to receive either the new IOL - the TECNIS Eyhance Toric II IOL, or a well-established IOL the Alcon Acrysof IQ Toric IOL during cataract surgery. Insertion of the Alcon Acrysof IQ Toric IOL is known to treat cataract and astigmatism but not presbyopia. Patients will be assessed and have their surgery performed at St Thomas' Hospital London. They will have 7 appointments over 12 months, plus surgery. The investigators hope to demonstrate better distance, intermediate and near vision and increased spectacle independence in the TECNIS Eyhance Toric II IOL group. EDoF Toric IOLs have the potential to transform cataract surgery outcomes for patients in the NHS.
Chronic low water intake may raise the risk of morbidity and mortality by influencing key water regulating hormones (e.g., AVP), which are known to modulate glucoregulation and renal function. For example, AVP stimulates the HPA axis to release the glucocorticoid stress hormone cortisol with potentially far-reaching effects on metabolism, immunity and inflammation. One study observed elevated blood cortisol in a group of low water drinkers, albeit cortisol was measured at one time of day only. However, in the field of psychobiology, researchers have traditionally related more dynamic assessments of cortisol with health outcomes; by evoking cortisol responses to acute standardised laboratory stressors, such as The Trier social stress test. More recently, researchers have appreciated the importance of circadian variability in cortisol levels, by examining influences on, and consequences of individual differences in the diurnal variation of cortisol. The major measurable parameters of the diurnal variation are; the cortisol awakening response (CAR), which is the rise in cortisol during the first 30-45 minutes following awakening, and the diurnal cortisol slope, which is the rate of decline in cortisol levels across the day, from morning to evening. These parameters are considered to reflect different aspects of HPA axis function; with the CAR best reflecting the adrenal capacity to respond to stress and awakening and diurnal slope more indicative of daily cortisol exposure. Although distinct, both blunted CAR and a flattened diurnal cortisol slope appear to be consistent markers of HPA axis dysfunction and related to a variety of poor health outcomes. Therefore, it has been recommended that contemporary research should simultaneously estimate an individual's awakening cortisol responsiveness, and diurnal slope, thereby capturing distinct and important components of HPA axis function. The shared pathways that regulate body water, diurnal variation in cortisol and our response to stress underpin the broad aim of this research programme: to investigate the influence of low and high fluid intake on diurnal cortisol variation and the cortisol response to acute stress. The aims of this study are to investigate: 1. The influence of a change in water intake behaviour on diurnal saliva cortisol variation as assessed by the CAR (primary outcome) 2. The influence of a change in water intake behaviour on biomarkers of hydration and thirst as assessed by urine osmolality, urine colour and thirst sensation. 3. The influence of habitual low and high total fluid intake on saliva cortisol response to an acute psychological stress (secondary outcome) 4. Investigate the influence of a change in water intake behaviour on plasma biomarkers of hydration as assessed by plasma osmolality and plasma copeptin (exploratory outcome)