BEACON is a UK based,multicentre,1 year,assessor-blind,parallel group,superiority,randomised controlled trial. The primary aim of the trial is to determine the effectiveness of methotrexate and dupilumab compared with ciclosporin. The primary endpoint is change in objective disease severity at 6 months,presented as mean absolute change from baseline,using the Eczema Area Severity Index (EASI,blinded assessment). Patients will be randomised 1:1:1 to methotrexate,dupilumab or ciclosporin for 6 months (optional dose increase at 3 months for those on methotrexate or ciclosporin as per clinical practice). ...

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Previous studies have shown that Continuous Glucose Monitoring (CGM) improves maternal glucose, reduces neonatal admissions and is clinically and cost-effective in type 1 diabetes (T1D) pregnancy, and as a result CGM is now standard care in T1D pregnancy. However, there are no well-designed adequately powered trials to compare CGM and standard care monitoring of blood glucose in type 2 diabetes (T2D) pregnancy. The purpose of this study is to examine whether using CGM improves glucose levels in pregnant women with ...

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This is a seamless, Phase 1b/2 Multiple Ascending Dose (MAD)/Proof of Concept (POC) Study (hereafter referred to as Phase 2 Program) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary involvement. The study is comprised of two parts: Part A is an open label multiple dose-escalating study, and Part B is a randomized double-blind placebo-controlled POC study. The primary objective of Part A is to evaluate the safety and tolerability of MAD of XTMAB-16, and to determine the recommended ...

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Leiomyosarcoma (LMS) is a type of rare cancer that grows in the smooth muscle tissue. The prognosis for patients with metastatic LMS (cancer that has spread to other parts of the body) is poor, and there are few effective treatments available. In previous clinical studies, LMS patients were treated with lurbinectedin in combination with doxorubicin. Lurbinectedin is an experimental medication that has been shown to kill cancer cells and modify the environment around the tumour to block growth. Doxorubicin is an ...

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In this study,a new drug will be used,durvalumab,to try and block this signal to increase the immune response,in combination with standard of care cisplatin/gemcitabine chemotherapy. Durvalumab is an antibody (a protein produced by the body’s defense system) and it is hoped that by blocking this signal,the immune cells will once again be able to prevent or slow down cancer growth. This drug combination has been shown in a large clinical trial to increase survival in patients with BTC where surgery ...

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The primary objectives for this trial are related to each of the trial questions. For the chemotherapy questions,the objectives are to determine: • whether outcome in newly diagnosed metastatic ES patients can be improved with the addition of regorafenib to the standard backbone chemotherapy VDC/IE when compared with VDC/IE alone (Randomisation A) •whether the addition of 6 cycles of maintenance chemotherapy of vinorelbine and cyclophosphamide improves the outcome for patients. (Randomisation C) For the radiotherapy questions,the objectives are to determine: • whether dose escalation of radiotherapy improves ...

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Background: It is common for children who learn to walk to walk on their tiptoes to help with their balance. However, approximately 7% of children will continue to walk on their toes past the age of three, with no established diagnosis to explain why. This is defined as idiopathic toe walking (ITW) and can cause problems with balance, pain and participating in sports. For children with ITW who cannot touch their heels to the floor in standing, surgery is ...

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This is a randomized, active-controlled, parallel-group, multi-site, open-label study of nemtabrutinib in participants with CLL/SLL who have not received any prior therapy. After providing documented informed consent, suitable candidates will be screened to assess whether they meet all study eligibility criteria. The study will be conducted in conformance with GCP. Approximately 1200 eligible participants will be enrolled and randomly assigned in a 1:1 ratio to 1 of the 2 treatment groups: • Experimental Group – nemtabrutinib • Comparator Group – investigator’s choice ...

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Management of a strict, gluten-free diet is essential for children and young people (CYP) with coeliac disease, but this can negatively impact psychological wellbeing and quality of life. Despite calls from families, clinicians and researchers, psychological support is not routinely available for these families. This is surprising, given the mounting evidence for self-help psychological resources (e.g. guided self-help books, websites) in supporting the self-management, and wellbeing, of a range of long-term conditions. This project proposes to adapt existing psychological interventions, ...

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Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D). HFpEF occurs when the heart muscle is unable to relax sufficiently to pump the blood around the body. This leads to fluid build-up, breathlessness and inability to tolerate physical exertion. People who develop HFpEF do less well because treatment options are limited. Pilot data using low energy diets in patients with obesity and diabetes and a small number of patients ...

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