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 DaRe2 approach (healthcare Data for pragmatic clinical Research in the NHS - primary 2 secondary) is designed to operationalise efficient, nationwide, primary care approaches for randomised trials embedded within the UK National Health Service (NHS), providing automated screening, targeted patient enrolment and 'no-visit' follow-up through innovations in big data and technology solutions. DaRe2THINK will be the first exemplar of this system, and is appropriately focused on the intersection of key national priorities for healthcare; atrial fibrillation (a heart rhythm condition that will double in prevalence in the next few decades) and the impact this condition has on stroke, thromboembolic events, cognitive impairment and vascular dementia. The trial will test the hypothesis that direct oral anticoagulants (DOACs), now commonly used in older patients with atrial fibrillation (AF), are effective and cost-effective at reducing major adverse clinical events in younger patients at low or intermediate risk of stroke, and can reduce the high rate of cognitive decline. The health technology innovations noted above will allow the investigators to answer this important clinical question, as well as demonstrate the capacity and potential of this system for future, large-scale healthcare-embedded clinical trials for patient benefit.
CO2 data, serving as a proxy marker for tidal volume, might enable titration of tidal volume/pressure thereby providing optimal ventilation during neonatal resuscitation. Currently there is insufficient data on Co2 levels for preterm babies requiring resuscitation. This study involves monitoring of CO2 during preterm stabilisation.
Bowel cancer is the third most common cancer occurring in the UK. Treatment usually involves surgery, often with chemotherapy or radiotherapy. In some cases radiotherapy can be used instead of surgery, especially if surgery may cause a higher risk of symptoms or a colostomy bag. Currently, the medical team collects information on patients' symptoms before and after treatment by direct questions in a clinic setting. It's recognised that patient-reported symptoms often differ from doctor-documented symptoms. This leads to inaccuracies in doctors' descriptions of the effects of cancer or treatment to patients. Patients told us an accurate description of expected symptoms is important when they are choosing their treatment. Patient-Reported outcomes measures (PROMs) may help us identify what affects the QoL after treatment and develop ways to improve it. The primary aim of the trial is to evaluate whether patients find it acceptable to use electronic data collection to assess their symptoms. Many bowel cancer patients are elderly and they may find electronic data system collection more challenging. The secondary aim is to identify which symptoms impact QoL. This will lead to the development of treatments to manage these symptoms which will be assessed in CITRuS2. All patients diagnosed with bowel cancer are entered into the colorectal database to determine the effectiveness of cancer treatments and outcomes. Participants will electronically answer questionnaires at study entry and during follow up. The questions are related to health and well-being with a holistic approach. The questions will take approximately 45 minutes to answer the first time and then 15 minutes thereafter. Following consent, participants gain access to their clinical details on the database. Then they can use a computer, laptop, tablet or smart phone to access a webpage and answer questions at monthly intervals over a 2 year period. Email reminders will be sent to prompt log on. This may help discover how bowel cancer and its treatment affect patients and their lives. This may help doctors describe the effects of treatment more accurately to future patients. It may also help doctors identify which patients need extra help or support through their treatment. Electronic data may allow patterns to be identified that may not be seen by doctors until a later stage. This may enable earlier treatment resulting in less time with symptoms, which could be physically and economically beneficial.
Craniosynostosis is a condition where infants are born with or subsequently develop an abnormally shaped skull. The skull develops from plates of bone separated from each other by growth lines (sutures). Craniosynostosis refers to early fusion of one or more of these sutures. Whilst in many cases the abnormal head shape provides doctors with the underlying diagnosis, it is necessary to confirm this using imaging. A CT scan involves using multiple x-rays to build a picture of the part of the body being examined. X-rays are associated with potential long term harm, particularly in young children who have longer to incur those risks. MRI uses magnets and radiowaves to create images of the body, and therefore a radiation-free method of imaging. The investigators have previously shown in a pilot group that a specific MRI technique ("Black Bone") can distinguish between normal and prematurely fused cranial sutures, and that the images can be reconstructed in 3D in the same way as CT. The investigators now need to confirm the findings in a larger patient group, and develop automated methods of creating 3D images of the bone. Children in whom there is clinical suspicion of craniosynostosis will be recruited for MRI examination. In children who are already undergoing MRI examination of the head (for any indication), the investigators will add on bone specific sequences. There are no known long term risks associated with MRI, and no contrast medium is required. Anonymised MRI data will be used to further develop our 3D techniques.
People living with dementia (PLWD) often struggle to access services and treatment which may benefit their emotional and cognitive wellbeing, as well as disease progression. Transport provision; hospital access and restricted mobility are barriers that often deny people the opportunity to receive treatment in-line with NICE guidelines. Considering the current Covid-19 pandemic, hospital access and face-to-face treatment is even more limited at present; with services across the UK unable to offer their usual levels of care and support. This is particularly the case for people in vulnerable groups. Therefore, many services have been considering the potential of remote-access therapy, specifically the use of video-conferencing apps. During the covid-19 crisis and beyond, it is of urgent and practical need that we develop more accessible, innovative home-based group interventions to people with dementia that can be delivered remotely. A group at The University of Hong Kong, are undertaking a study entitled 'FaceCog' which involves the delivery of Cognitive Stimulation Therapy (CST) via the video-conferencing application 'Zoom'. CST is an established, evidence-based group intervention shown to improve quality of life and slow down cognitive deterioration in PLWD. In collaboration with the Hong Kong 'FaceCog' team, we propose to deliver a culturally adapted version of their Zoom-CST protocol in the UK in a proof of concept study during the current Covid-19 pandemic. The facecog Zoom-CST protocol is the first virtual CST protocol of its kind that we are aware of. It closely follows the original, evidence-based CST manual that was developed in the UK. It has been slightly adapted to make it useable on a virtual platform and to be culturally sensitive for use in Hong Kong. It incorporates all key elements and principles that have been evidenced to make the treatment effective. As we are delivering it in the UK, we will be using activities from the original manual, in place of the activities that have been adapted for the Hong Kong protocol. For example, we will use British phrases in the word games session rather than Chinese proverbs. Data on recruitment, attrition, attendance data, focus groups, participant-completed session feedback forms and qualitative post-session interviews, will offer us the opportunity to assess intervention acceptability. Outcomes related to cognition, quality of life and mood will allow us to make inferences about the potential for clinical impacts of such an intervention. Engagement analysis will allow us to explore the potential barriers and facilitators to virtual-delivered CST for this population and highlight any potential adaptations to intervention which may be needed. This project is intended as a preliminary exploration which will pave the way for future intervention-modifications and pilot-studies which can evaluate the potential benefits of 'virtually'-delivered CST. This research aims to: - Modify a pre-existing Zoom-CST protocol (FaceCog HK) to be culturally relevant and deliverable remotely within the UK. - Modify and develop resources for the groups, along with dementia-friendly 'how to' guides on using the chosen video-conferencing application. - Consult with stakeholders (including staff working within dementia care - clinical staff, charity organisations, and PLWD and their carers) about the potential foreseen barriers and facilitators to successful implementation of virtual-CST. Two remote, 'virtual' focus groups are proposed, one for professionals, and one for PLWD and/or informal carers. - Asses virtual CST's feasibility as guided by Orsmond and Cohn's (2015) discussion article on this topic, which identifies objectives of feasibility studies as, an evaluation of recruitment capability and sample characteristics, data collection procedures and outcome measures, the acceptability and suitability of the intervention and study procedures, the resources and ability to manage and implement the study and intervention, participants' responses to the intervention.
Background/scope There is growing recognition that family caregiving is a serious public health issue requiring supportive interventions. Family caregivers play an essential role in sustaining a stable environment enabling individuals with motor neurone disease (MND) that are technology dependent to live at home. The family caregivers can experi¬ence exceptional burden and significant decline in psychological wellbeing due to MND's rapid and pro¬gressive nature with profoundly debilitating effects and intensive support needs. Dependence on assistive technology adds an additional level of complexity to family caregiving due to the need to learn how to operate and troubleshoot medical devices, train other caregivers, and negotiate appointments with new specialties within the healthcare system. Despite the recognized impact of caregiving for individuals with MND, data are scarce as to effective interventions that provide direct practical and psychosocial supports. Difficulty accessing support may increase psychological distress. As the burden of caring increases due to disease progression and increasing technology dependence, access to existing informal support networks may diminish. Online peer support using virtual modalities is a flexible and low cost form of support. Peers, people who have experienced the same health problem and have similar characteristics as support recipients, can be a key source of emotional, informational, and affirmational support. Peer support improves psychological well-being of caregivers of people with conditions such as dementia, cancer, and brain injury. Although peer support programmes for family caregivers of people with MND exist, data as to their efficacy are limited. Therefore, we have developed an online peer support programme, completed beta and usability testing and now propose to test the effect on caregiver psychological wellbeing and caregiver burden. Aim/research question(s) Overall aim: to determine the efficacy of a 12-week online peer support programme on family caregiver psychological health and caregiver burden. Primary research question: What is the effect of the online peer support programme on psychological distress measured using the Hospital Anxiety and Depression Scale (HADS)? Secondary research questions: 1. What is the effect on positive affect, caregiver burden, caregiving mastery, caregiving personal gain, and coping? 2. How do participants use the programme (fidelity and reach)? 3. What is the perceived usability and acceptability? Methods The investigators will conduct a parallel group randomised controlled trial with participants allocated to 12-week access to the online peer support programme or a usual care control group. The investigators will enrol family caregivers of an individual with MND who is referred for consideration or receiving any of the following 1. assisted ventilation 2. cough assist 3. gastroscopy and enteral feeding i.e., entering King's clinical staging Stage 4A: nutritional support; or Stage 4B: respiratory support [51]: The 12-week peer-to-peer support programme entails: 1. audio, video, or text private messaging; 2. synchronous weekly chat; 3. asynchronous discussion forum; and 4. informational resources. The investigators will collect demographic and caregiving data including the Caregiver Assistance Scale and Caregiving Impact Scale, and caregiver measures (HADS, Positive and Negative Affect Schedule, Zarit Burden Interview, Pearlin Mastery Scale, Personal Gain Scale, Brief COPE) at baseline and programme completion. The investigators will download use of online peer support programme features, assess usability, and conduct semi-structured interviews to explore acceptability using the Theoretical Framework of Acceptability. To test for a medium size effect (d=0.5), at 5% level of significance (2-sided) with power 80%, 64 participants are required in each arm (128 total). Adjusting for 20% attrition requires 154 participants. Proposed findings The proposed study will demonstrate the effect of a online peer support programme on psychological distress, positive affect, caregiving burden, mastery, personal gain and coping. Data on programme fidelity will enable the investigators to objectively assess acceptability and interpret study results. Data on usability and acceptability will inform future scalability of the online peer support programme outside of the trial both nationally and internationally, and to other family caregiver populations.
MS is a chronic inflammatory and degenerative disease of the central nervous system (CNS) affecting more than 120,000 people in the UK.and 2.5 million people worldwide. Without disease modifying treatment (DMT),the majority of people with MS (pwMS) will develop significant disability within 10 years of onset, and 50% will require wheelchair assistance within 20 years. convenient, highly effective and CNS penetrant DMT for patients with relapsing multiple sclerosis (pwRMS) administered in short (8-10 days/year over 2 years) treatment courses. It effectively depletes B cells, particularly Memory B cells, a likely key mechanism of disease control in MS. Cladribine is the investigational product in this study as it not currently used to treat patients with an EDSS of 6.5 - 8.5. This is a multi-centre, randomised double-blind placebo-controlled phase IIb to test cladribine tablets (MAVENCLAD®) (3.5mg/kg over 24 months) for safety, efficacy, and cost effectiveness, and to advance mechanistic understanding of its action in people with advanced MS (pwAMS).
The study aims to validate neutrophil function, immature granulocyte and plasma free DNA levels as predictive diagnostic biomarkers of sepsis in burn patients. Inclusion criteria includes healthy volunteers, patients aged 5-15 years old with burns affecting 20% or less Total Body Surface Area (TBSA) and patients aged 16 or above with burns affecting >15% TBSA. The study involves taking blood, tissue and urine samples.
The study's purpose its to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)
To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2).