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 purpose of this study was to demonstrate similarity of NI-071 (proposed biosimilar to infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in participants with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).
Cognitive impairments, especially deficits of executive function, have been well documented as a core and early feature in Huntington's disease (HD). Cognitive impairments can be considerably burdensome and devastating for people and families affected by HD. Computerised cognitive training interventions that focus on improving executive function present a potentially exciting non-pharmacological treatment option. Novel work conducted in mouse models of HD, has demonstrated that cognitive training, administered from an early stage in the disease, can improve motor performance at an older age, even in the absence of further training in the intervening time. This represents proof of principle in an animal model of HD that cognitive training can improve HD disease symptoms. Improvements associated with executive function training have also been reported in a clinical setting in a variety of neurodegenerative diseases. For example, cognitive training, can improve executive function as people age, and training specifically focused on tasks of executive function has been shown to improve both cognitive and motor outcomes in neurodegenerative diseases such as Parkinson's disease (PD) and Alzheimer's disease (AD). Therefore, this study is a feasibility study which aims to establish proof of principle for using computerised cognitive training in people with HD. The investigators propose to determine the feasibility, acceptability and gather preliminary evidence of the effectiveness of a cognitive training intervention programme, targeted for people with HD. The investigators will also aim to investigate the most appropriate outcome measures to use in this study and gather feedback on the cognitive training intervention. The investigators will also establish proof of concept via the study of brain structure and function, using MRI scanning techniques. The computerised cognitive training software and the associated outcome measures will be investigated, taking into account the views of people and families who are affected by HD. A randomised feasibility study of computerised cognitive training for people with HD will then be conducted. Participants who are randomised to the cognitive training intervention group will be asked to complete a cognitive training intervention utilising "HAPPYneuron" software. Participants in the intervention group will be asked to complete the cognitive training programme for a minimum of 30 minutes, 3 times a week for the 12 week study duration. Participants in the control group will not receive any cognitive training and will be asked to continue as normal, however they will have home visits to control for the confounding effect of social interaction. Additional monitoring and prompting for the intervention group, will be conducted via email, text or telephone reminders (as preferred by the participant) and home visits. The motor and cognitive function of participants will be assessed at the beginning and end of the study, using a range of motor and cognitive assessments. Additional cognitive measurements will be recorded as part of the HAPPYneuron programme throughout the cognitive training intervention, such as accuracy and response time measures of particular computer games. MRI scans (optional) will be conducted at the beginning and end of the study to identify any structural changes in the brain that may be associated with the cognitive training intervention. As part of the feasibility and acceptability assessment, participants, family members and carers will be invited to complete a semi-structured interview at the end of the study, if consent is obtained, focusing on using this type of software as a home based therapeutic intervention.
Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM). Secondary Objectives: - To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm. - To compare the Overall Survival (OS) between the two arms. - To evaluate the Time To Progression (TTP) in each arm. - To evaluate the PFS in high risk cytogenetic population in each arm. - To evaluate the Duration of Response (DOR) in each arm. - To evaluate the safety in both treatment arms. - To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide. - To evaluate the immunogenicity of isatuximab. - To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.
Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Participants, all personnel involved in the evaluation of participants' response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Participants are required to have a histologically-confirmed diagnosis of isocitrate dehydrogenase-1 (IDH1) gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment. IDH1 mutation testing will be performed at participating investigative sites. Participants must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All participants must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen.
Patients with kidney, or renal, failure require life-saving treatment with regular dialysis. Dialysis is a form of treatment that simulates some kidney functions; to remove harmful waste products and extra water from the blood. Almost one-third of people with kidney failure also have diabetes, as diabetes is one of the leading causes of kidney disease in the United Kingdom, usually due to poor blood sugar control over a long period of time. Malnutrition is common in patients needing dialysis due to kidney failure causing fatigue, taste changes and a build up of waste products, which can reduce appetite. Treatment of malnutrition involves increasing both the energy and protein intake from food and drinks, and milk-drink style specialist nutrition drinks are often given to dialysis patients due to their specific dietary needs. These nutrition drinks can increase blood sugar levels and optimal control for diabetes may be difficult. This research study aims to measure the blood sugar response to a "slow-release" sugar nutrition drink specifically designed for dialysis patients, which may result in a lower blood sugar level, compared to standard nutrition drinks, consumed during a dialysis session. 28 patients with diabetes and having regular dialysis treatment will enrol in the study. Patients will be asked to drink 1 of 3 different nutrition drinks, once a week for 3 weeks during their regular dialysis treatment. Blood sugar levels will be measured from the blood samples taken from the patient's circulation directly before it enters the dialysis machine over 3 hours and the maximum blood sugar reading and total blood sugar response will be measured. Differences between the 3 drinks will be tested statistically. The results will help to advise patients with diabetes and kidney failure on the most suitable type of nutrition drink to consume during dialysis.
Acute stress induced (Tako-tsubo) cardiomyopathy (TTC) or broken heart syndrome, a condition typically occurring after acute stress has a death rate similar to heart attacks and is frequently associated with long-term symptoms (fatigue and exercise limitation). There are no effective therapies. The investigators have recently showed that there is a profound shortage of energy in the hearts of Tako Tsubo Cardiomyopathy patients in the days after acute presentation with only partial recovery by four months. The investigators would now like to establish whether this recovers after at least one year, or persists, and also to investigate the mechanisms responsible for exercise limitation after recovery from the acute phase.
Some women experience the pain of miscarriage on numerous occasions. Studies show that these women experience feelings of anxiety and distress during the early stages of a new pregnancy as they worry another miscarriage will occur. This study will investigate whether a coping strategy, developed for a similar group of women, would be acceptable and useful to women suffering recurrent miscarriage, and reduce the anxiety and worry they experience. A secondary aim of the study is to develop a deeper understanding of the experiences and feelings of women in the early stages of a new pregnancy, following multiple miscarriages.
The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors
To determine whether PET-MRI can obtain comparable images to PET-CT in those with coronary artery disease.
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.