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 impact of deploying artificial intelligence (AI) in healthcare settings in unclear, in particular with regards to how it will influence human decision makers. Previous research demonstrated that AI alerts were frequently ignored (Kamal et al., 2020 ) or could lead to unexpected behaviour with worsening of patient outcomes (Wilson et al., 2021 ). On the other hand, excessive confidence and trust placed in the AI could have several adverse consequences including ability to detect harmful AI decisions, leading to patient harm as well as human deskilling. Some of these aspects relate to automation bias. In this simulation study, the investigators intend to measure whether medical decisions in areas of high clinical uncertainty are modified by the use of an AI-based clinical decision support tool. How the dose of intravenous fluids (IVF) and vasopressors administered by doctors in adult patients with sepsis (severe infection with organ failure) in the ICU), changes as a result of disclosing the doses suggested by a hypothetical AI will be measured. The area of sepsis resuscitation is poorly codified, with high uncertainty leading to high variability in practice. This study will not specifically mention the AI Clinician (Komorowski et al., 2018). Instead, the investigators will describe a hypothetical AI for which there is some evidence of effectiveness on retrospective data in another clinical setting (e.g. a model that was retrospectively validated using data from a different country than the source data used for model training) but no prospective evidence of effectiveness or safety. As such, it is possible for this hypothetical AI to provide unsafe suggestions. The investigators will intentionally introduce unsafe AI suggestions (in random order), to measure the sensitivity of our participants at detecting these.
The primary objective is to describe the real-world clinical effectiveness of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) or metastatic cutaneous squamous cell carcinoma (mCSCC) treated in routine clinical practice.
Background Medication errors are the leading cause of preventable harm in healthcare settings worldwide. An estimated 237 million medication errors occur in England alone every year, with 66 million considered clinically significant. There is an estimated cost to the NHS from definitely avoidable adverse drug reactions as a result of these errors of £98.5 million per year, consuming 181,626 bed-days and causing to 712 deaths. Medication related clinical decision support systems, often integrated with electronic prescribing systems, are rapidly increasing in number over the last few decades, ranging from drug-drug interaction alerts to allergy checks and formulary support. A recent systematic review summarised that these systems are still relatively immature, with limited use of patient-specific input or human factors research used to develop them. There is an opportunity to improve these systems significantly for the benefit of the user and for patient safety. The World Health Organization propose that interventions to reduce medication error should include the development of technologies that are well understood and designed for the systems and practice they are applied to. Human factors and usability engineering is an integral part of developing medical devices, such as clinical decision support (CDS) systems, to ensure that such devices are easy to use and can be used safely as intended. User testing / usability testing, which may incorporate several methods, should be conductive throughout the development process (at formative, summative assessment, and during post-market surveillance). These methods are now becoming more common place in healthcare technology research and should continue to support the development of new technologies. RxConnect RxConnect, a newly registered UKCA marked medical device, is an on-demand clinical decision support tool that receives medication and patient inputs and uses them to filter an underlying formulary, such as the BNF, and perform dosing calculations, as needed, to return patient-specific dosing recommendations. RxConnect does not have a user interface and relies on an integration with third-party systems, such as electronic prescribing systems, to deliver CDS services to clinical end users. For this study a prototype user interface for RxConnect that emulates a typical electronic prescribing system will be used. The study team hypothesise that use of RxConnect as a digital prescribing aid is quicker, easier, and as safe to use as currently available prescribing aids. This study aims to utilise user testing to prove or disprove the above hypothesis and to generate quantitative and qualitative outputs to support the continued development of RxConnect prior to clinical deployment.
The purpose of this study is to a) assess how coronavirus 2019 (COVID-19) affects cardiac function in middle age and older adults and b) assess if a physical activity intervention (increased daily step count by 2,000) can affect cardiac function in a population with a history of COVID-19.
KiCS1 study : Digital health for current hospital- based Cardiac rehabilitation programmes to increase effectiveness and patient outcomes.
The investigators propose to evaluate a new protocol-based intervention that is informed by Dialectical Behaviour Therapy (DBT), known as a DBT-informed intervention, delivered in routine mental health settings within South London and Maudsley NHS foundation trust. The intervention is delivered to a group of transdiagnostic service users with a severe mental illness (SMI). It is delivered by a junior workforce who will be referred to as Protocol-Based Intervention Facilitators (P-BIFs). Successful delivery by a less expert workforce has potential to increase routine implementation, compared to delivery by expert staff, where costs of both salary and training are higher. Dialectical Behaviour Therapy (DBT) is a type of psychological treatment recommended for people with a diagnosis of emotionally unstable personality disorder (EUPD). Individuals with a diagnosis of EUPD commonly experience difficulties with managing and responding to their emotions. This is known as emotion dysregulation. Difficulties with emotion dysregulation are thought to play a role in many mental health difficulties. The evidence base for using interventions that are informed by DBT, known of as DBT informed interventions with other mental health diagnoses, is emerging. The current research aims to investigate whether it is possible (feasible) to conduct a randomised control trial evaluating the transdiagnostic DBT-informed skills group for individuals representative of SMI presentations seen within community mental health settings. The study will also examine whether it is possible for junior staff to deliver the manualised group intervention. Service user participants will be randomised to either a 10-week DBT-informed intervention delivered by the P-BIFs, or a waitlist. Those on the waitlist will access the intervention once their involvement in the study has ended. The study will last for up to 1 year. The maximum duration to complete trial participation from consent to completion will be 18 weeks. It is hypothesized that the DBT informed intervention, delivered by junior staff, will be feasible and acceptable with this client population.
Severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) (COVID19) is a readily transmissible virus that has a wide ranging incubation period of 2-14 days. The symptoms include fever, cough and loss of taste and smell. Symptoms range from mild to severe. Pre-existing potential drug therapies are under investigation, but so far few have demonstrated any benefit and only in patients with severe symptoms. There is a scarcity of other pre-existing drug treatments that change the outcomes/symptoms in non-hospitalised patients with COVID-19. Prophylaxis and prevention is currently dependent on social distancing and isolating with vaccines remaining in development, potentially not for mass use in the near future. Sambucus extract has well documented anti-viral properties both in vitro and in clinical trials of influenza, it has a low side effect profile so may be effective in reducing duration of symptoms and progression to more severe disease in patients with mild/ moderate COVID19. Black Elderberry Original Liquid (Sambucus nigra) (Sambucol®) is sold as a food supplement in heath food shops and supermarkets, does not require a prescription and has no known side effects, meaning it would be a well-tolerated treatment in early disease in comparison with other potential medications. The study will be conducted at East Kent Hospitals. Potential participants with mild or moderate confirmed COVID19 infection will be identified from the drive-through hospital test centre and accident and emergency. Following an eligibility check and consenting they would be randomised to placebo or Sambucol® Black Elderberry (Sambucus nigra) 15ml four times daily for 14 days which they will take at home. Telephone consultations with the research team and patient daily diaries will used to document symptoms on days 1,3,7,10,14 and a follow up on day 28. Time to clinical improvement will be compared between the 2 groups.
To demonstrate the reduction of Biomarkers of Exposure (BoExp) to selected harmful and potentially harmful constituents (HPHC) in smokers switching from cigarette (CIG) to P4M3, an Electronic Nicotine Delivery System (ENDS), compared to continuing cigarette smoking for 5 days.
A multi-centre, randomised, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks, consisting of four site visits and two 4-week test periods at home. Visits 0 and 1 could be performed on the same day. For visit 2 and 3, catheterisations were performed in a hospital setting for bladder emptying assessment and collection of urine samples (the latter only in Denmark). Visit 1 and 2 were followed by a home-use test period, followed by visit 3 which terminated the study.
The principal aim of this study is to obtain safety and tolerability data when AQ280 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients.