This is a Phase 2, global, multicenter, long-term safety study designed to assess the safety and tolerability of BHV-7000 in participants with focal refractory epilepsy. Approximately 660 eligible subjects will enter this study after completing the DBP of either the BHV7000-302 or BHV7000- 303 studies. In the opinion of the investigator, subjects must have tolerated BHV7000/placebo, during participation in the DBP of the parent studies, BHV7000-302 or BHV7000-303 to be eligible. Eligible subjects who completed the DBP of the BHV7000-302 study will ...

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This study is designed for the patients with coronary artery disease (CAD) who experience severe chest pain (refractory angina) despite taking the best available medications. These patients also have evidence of reversible Ischemia (reduced blood flow), but they are considered high-risk or unsuitable for heart surgery or other currently available medical procedures aimed at restoring blood flow (revascularization procedures). A heart team, including specialists such as cardiologists and surgeons, helps determine their eligibility for the study. Shockwave Medical, Inc. has developed ...

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Prospective cluster randomised cross-over trial We will conduct a prospective cluster randomised cross-over trial (ABAB/BABA) to assess the impact of an AI fracture detection tool in EDs and MIUs in the UK. The trial will involve installing a CE-approved AI algorithm at each site for six months. Sites will be randomly assigned to begin the trial with the AI algorithm either active ("On") or inactive ("Off") during the first month. Thereafter,the algorithm status will alternate each ...

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The 3P project is the foundational study of the TBI-REPORTER Experimental Medicine Network. It will establish the standardisation of protocols for collaborative research within TBI-REPORTER, and demonstrate the feasibility of recruitment and delivery across multiple TBI research centres. The data and samples that emerge in this protocol will allow us to carry out exploratory pilot analyses to allow the rational design of future interventional studies. Thus, the project has the potential to improve current health care and its delivery at ...

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Sepsis is a life-threatening emergency that happens when your body's response to an infection damages vital organs which can often lead to death. In the UK, there are about 245,000 sepsis cases leading to around 48,000 deaths each year, making it a leading cause of death in the UK. Despite considerable recent progress, detecting sepsis in the Emergency Department (ED) remains a challenge. Paramedics and ED doctors often miss signs of sepsis, with the current National Early Warning Score which is ...

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IMPEDE-PKD is a global trial evaluating the long-term efficacy of metformin therapy in slowing the rate of kidney function decline in metformin versus placebo treated Autosomal Dominant Polycystic Kidney Disease (ADPKD) subjects. The UK trial is assessing a primary outcome of change in pain severity from randomisation to 24 months measured using an 11 point numerical rating score (NRS) of average pain over the last 14 days in the ADPKD Pain Assessment Tool (APAT). It is a phase III,international,prospective,multicentre,double-blind,parallel group,placebo-controlled,randomised trial. Secondary ...

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The NHS bowel cancer screening check is offered to everyone over the age of 50. This is a home test kit, called a faecal immunochemical test (FIT). It is used to collect a small sample of stool (poo) which is sent to a lab to be checked for tiny amounts of blood. Your GP may also order a FIT if you have had a change in bowel habits or are experiencing abdominal (tummy) pain. In this study we will be ...

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Already existing and coded tumor biological material from the lymph node biopsy and personal health-related data of patients who have been diagnosed with NMZL will be collected retrospectively.The value of the expected results of the IELSG52 study are: (i) to inform on diagnosis and prognosis of NMZL; (ii) to allow selection of optimal therapy; and (iii) to provide a biology based framework on which to design and interpret clinical trials

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Hypothesis: Selected treatments that target key neurodegenerative / neuroprotective pathways in PD will slow disease progression compared to placebo. Aims: • To assess the clinical and cost-effectiveness of at least 3 potential disease modifying therapies (DMTs) compared with a shared placebo on the rate of progression of Parkinson's Disease (PD). • To establish sustainable infrastructure for the long-term evaluation of clinical and cost effectiveness of further potential DMTs in PD. • To recruit a representative study population. Methods: • We will recruit 1200 participants from 40 UK sites over ...

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This is a protocol to support primary research into the condition-specific needs of young adults in the UK who store ovarian or testicular tissue after childhood cancer, their parents and the healthcare professionals who provide reproductive survivorship care. This research will be used to help inform the development of a care support tool to help clinical teams look after young adults who store tissue after childhood cancer, and to support their parents/guardians. The tool will be developed and tested in ...

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