This is a post authorization safety study of patients treated with fenfluramine hydrochloride oral solution, conducted at centers prescribing fenfluramine in routine practice. This study will involve neuro-pediatrician's, pediatricians, or neurologists – with experience in the treatment of epilepsy in both European (Germany, Austria, Denmark, Italy, UK, Spain and France) and non-European countries (potentially including US and Japan). The study will last for 10years for first patient first visit with enrollment period spanning over 3years from registry start date. The maximum ...

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This is a phase 1 study exploring differences between the immunological responses to revaccination with intradermal-BCG and aerosol-inhaled BCG in healthy adults and those with pre-existing T2DM. There will be three study groups with twelve volunteers in each group (Table 2). Volunteers will be enrolled into groups based upon whether they have a diagnosis of T2DM. They will then be vaccinated with intradermal BCG (Groups A and C) or aerosolised BCG (Group B). Objectives: Co-Primary: To compare the immunological response of BCG ...

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This study will explore long-term effectiveness, safety, clinical insights, treatment patterns, and factors driving the treatment decisions among patients being treated with specified Roche ophthalmology products approved in retinal indications in real-world, routine clinical practice.

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As we get older, our bodies are less able to handle some medicines. Medicines that were once effective and safe may not have as much benefit and may have an increased chance of causing harm. Research shows that almost half of older people in hospital are prescribed a medication with a risk of harm, but these medicines are rarely stopped. In our previous research we asked older people and their carers about their thoughts on stopping these medicines. They told ...

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In patients with heart failure, serum hypomagnesaemia is common and attributed to increased renal magnesium (Mg2+) secretion and diuretic therapy. Serum hypomagnesemia is associated with increased heart failure presentations and hospitalisations in patients with heart failure with preserved ejection fraction (HFpEF). There is a poor correlation between serum Mg2+ (the compartment which can be measured) and intracellular Mg2+ concentrations9 (the compartment in which Mg2+ regulates cellular processes) with serum Mg2+ being a poor surrogate for total body Mg2+ content. Using ...

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Babies born prematurely can frequently experience periods where they stop breathing, known as apnoea. These events can be life threatening and may have long term effects on brain development, so it is essential to reduce the likelihood of occurrence. Caffeine citrate is given to babies born very prematurely as it can reduce apnoea. This treatment is usually given at a similar dose for all babies and is stopped when they reach approximately 34 weeks postmenstrual age. However, some babies experience ...

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ARTEMIS is a phase II,multi-centre,open-label,randomised controlled trial using IMRT/VMAT/TomoTherapy,comparing radiotherapy (SCRT/LCCRT) followed by chemotherapy (FOLFOX/CAPOX),with or without the addition of AN0025 throughout treatment. Eligible patients will have moderate to high-risk rectal cancer where pre-operative chemoradiotherapy (CRT) or total neoadjuvant treatment (TNT) are standard treatment options and who are interested in organ preservation. ARTEMIS uses the Sargent’s three-outcome two-stage comparative design,including an interim analysis for futility. The trial will randomise 140 patients,from 15-20 UK radiotherapy sites,with a 1:1 allocation ratio to receive ...

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Cirrhosis (scarring of the liver) can lead to varices (abnormally enlarged veins) developing in the lower gullet (food pipe) or stomach causing the varices to bleed. Variceal bleeding is a serious complication of liver cirrhosis. The currently accepted treatment for patients who bleed from varices is known as standard of care (SOC) and includes using an endoscope (a bendy tube incorporating light and a tiny video camera) to tie off an enlarged vein with a rubber ring (variceal banding) or ...

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A prospective,randomised,phase II platform trial for sequential evaluation of experimental treatments versus investigator choice standard therapy (ICT) for patients with relapsed or refractory follicular lymphoma (rrFL). There are three sequential treatment rounds; each has a control arm of ICT and an experimental novel treatment arm. Patients in Round 1 (R1) will be randomised using a 1:1 allocation ratio to receive either ICT or epcoritamab + lenalidomide (experimental treatment). Patients in Rounds 2 (R2) and 3 (R3) (experimental treatments yet to ...

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PROSpeCT is about improving recovery after surgery for carpal tunnel syndrome. Carpal tunnel syndrome is a hand disease, involving compression of the median nerve at the wrist. The median nerve controls the muscles of the thumb and feeling in much of the hand. Compression of the nerve leads to pain, tingling and weakness. Most people with CTS eventually need wrist surgery to decompress the nerve. However, as many as one in four people still get symptoms after their surgery. We ...

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