The EXPERTS-ALS platform is designed as a randomised,open-label,multi-arm trial with a biomarker-based endpoint. It aims to prioritise drugs for further testing based on their ability to lower NFL levels and to also identify drug-specific adverse events.The EXPERTS-ALS protocol describes an overarching trial design to evaluate the effect of candidate drugs on blood NFL levels in patients with ALS receiving usual standard of care. The protocol is deliberately flexible,allowing: as broad a range of ALS patients to be recruited; participant randomisation ...

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This extension trial, 1305-0031, is aimed to assess the tolerability, long-term safety, and efficacy of BI 1015550 in patients with IPF and PPF over a longer duration of treatment. This will also fulfil a commitment to patients and the medical community to continue to provide a (potentially) beneficial treatment to trial participants after the end of their involvement in pivotal trials 1305-0014 and 1305-0023, which is important considering the progressive nature of IPF and PPF and the continuing unmet medical ...

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This study will evaluate long-term safety and efficacy in approximately 400 subjects who were dosed with SRP-9001 in a previous clinical study. The study will consist of 2 periods as follows: • An Eligibility Confirmation Visit of up to 2 days in length, during which eligibility confirmation, informed consent, disease characteristics, and current therapy/ concomitant medication data will be collected. • A Long-Term Follow-Up Period that will begin the day eligibility is confirmed and continue for at least 5 years post-infusion of ...

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The purpose of this study is to investigate if it is worthwhile prescribing medicines to reduce blood clots after varicose vein procedures. People enrolled in the study will undergo an assessment to make sure that they don’t have the most important risk factors for clots. Those most at risk would not be included in the trial. People enrolled in the study will be over 18 years of age and would receive compression stockings along with one of the following three ...

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BACKGROUND Venous thromboembolism (VTE) is a major global health burden. Many people who survive VTE suffer from longer term physical complications or psychological sequelae. Temporary lower limb immobilisation (plaster cast,walking boot or rigid splint) and injury are combined risk factors for VTE. Approximately 70,000 people are immobilised after injury every year in the UK. VTE in this setting is potentially preventable through early prophylaxis with anticoagulant medication. However,baseline VTE risk varies widely across the population and there are multiple drugs for ...

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This is a multicenter RWE study to evaluate the efficacy of etrasimod daily dose of 2 mg in patients with moderately to severely active UC. The study consists of a 52-Week treatment period, and a 28-day safety follow-up period. This prospective, international, non-interventional primary data collection study will be conducted in countries across the world. Countries will be divided into study regions. A country can be a study region on its own. Each study region will start with patient recruitment as soon ...

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Overview and Purpose: Preterm birth (PTB) is defined as the occurrence of live birth before 37 weeks of pregnancy. Although PTB affects 10% of pregnancies worldwide and is a major global health concern, its aetiology is not fully understood. Recent studies indicate specific genetic factors are related to PTB. This nationwide multicentre cohort study aims to explore the genetic factors linked to spontaneous preterm birth (sPTB) using Whole Genome Sequencing (WGS) across diverse populations in England. The study may help ...

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What is the problem? Skin cancers are common and the number of people who are developing them is increasing. They are usually split into two groups: melanomas are less common but more serious and keratinocyte skin cancers are more common but less serious. Most need to be cut out. Keratinocyte skin cancers on the leg often cannot be closed with stitches and the wounds are left open to heal by themselves (known as secondary intention wound healing). When left open, they ...

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The overall aim of this research is utilise blood donated from patients on warfarin therapy to aid the development and optimisation of Microvisk’s second generation Prothrombin/International Normalized Ratio (PT/INR) Test System. The donated blood will be used on ongoing development, validation, verification, and calibration projects. Microvisk has developed a small hand-held device which will measure PT/INR from a low volume capillary blood sample. The device is intended for use by both healthcare professionals and for self-testing by the patient. Consenting patients of ...

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Allogeneic hematopoietic cell transplantation (alloHCT) is a well-established therapy for different lifethreatening hematologic malignancies. The use of alloHCT is constantly increasing, with nearly 20 000 transplantations reported to the European Society for Blood and Marrow Transplantation (EBMT) per year. However, this treatment is limited by high morbidity and mortality, mainly related to relapse, infection, graft-versus-host disease (GvHD), and conditioning-related toxicity. Therefore, overall survival (OS) and GvHD-free, relapse-free survival (GRFS) after alloHCT, remain low, around 60% and 30% at one year. Over ...

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