This is a global open-label, randomized, multicenter, interventional study in pregnant participants with a prior FNAIT-affected pregnancy to assess the efficacy, safety, tolerability, PK, PD, and immunogenicity of nipocalimab or IVIG. ‘IVIG’ throughout the protocol will be referring to the IVIG with or without prednisone regimen adapted from Bussel et al (Bussel 2021). The studywill target participants whose current pregnancies are affected by HPA-1a and/or HPA-5b incompatibility. Maternal participants with alloantibodies against both HPA-1a and HPA-5b will be categorized under HPA-1a ...

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Each year in the UK, around 37,000 patients have radiotherapy for breast cancer. Radiotherapy uses radiation to kill cancer cells. Radiotherapy is given to the breast and, if needed, to the lymph node regions in daily doses. Until recently most patients needed at least 15 daily treatments of radiotherapy. In addition, around 10,000 women per year in the UK needed up to 8 extra radiation treatments to the part of the breast where the cancer was, resulting in a total ...

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Children and young people (CYP) with problems with sore joints called Juvenile idiopathic Arthritis (JIA) or problems with their immune system (rheumatological issues) have a range of complaints, such as painful, stiff joints. These problems come and go and can stop CYP attending school. In adulthood, symptoms may affect what job they are able to do. CYP often need to take medications with severe side effects. CYP are usually watched closely to ensure that their medications are working and side ...

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Basal thumb osteoarthritis (BTOA) is a common condition that affects 21% of the population by the age of 40 and 45% by the age of 80. BTOA causes significant problems in this large population with symptoms including pain, tenderness and stiffness. There are a variety of non-surgical and surgical treatments available for BTOA. If non-surgical treatment fails then surgical options can be offered (trapeziectomy and carpometacarpal joint replacement (CMCJR)). However there is a lack of high quality evidence comparing these ...

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Ketone bodies are fat-derived fuels used by tissues for energy when glucose availability is limited, such as during fasting. In people with diabetes, various factors can trigger a build-up of ketones in the blood (ketosis), including inadequate insulin administration, infection, continuous subcutaneous insulin infusion pump failure, and certain medications. This can lead to a life-threatening medical emergency called Diabetic Ketoacidosis (DKA). Patients with heart failure or chronic kidney disease also have an increased risk of ketosis due to the use ...

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Focal cortical dysplasia (FCD) is a malformation of brain development, the most common cause of drug-resistant epilepsy and often caused by mutations in mammalian target of rapamycin (mTOR) pathway genes. Patients with FCD develop drug-resistant seizures. Our study will look at FCD tissue removed during epilepsy surgery and aims to detect mutations in mTOR pathway genes in brain cells. Secondly, we will establish if evidence of mutations found in brain cells can also be detected as circulating free DNA (cfDNA) ...

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Head and neck cancer affects the mouth, throat, salivary glands, voice box, nose or sinuses. Every year over 12,000 people get head and neck cancer. It is the 8th most common form of cancer. Over recent years many more people, particularly young people, have developed head and neck cancers. Many of these cancers are removed surgically. Some people also need radiotherapy or chemotherapy. Treatments are improving and better at getting rid of these cancers. Neck dissection is a common operation ...

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We are conducting a study to gather more information on the safety and effectiveness of Xromi (hydroxyurea), a liquid medicine licensed to treat sickle cell disease (SCD) in children from 9 months of age. We aim to understand its safety profile and efficacy in preventing serious SCD complications (e.g., pain crises, acute chest syndromes, stroke) in children under 2 years when used in standard care. We will compare medical information collected during routine clinical appointments of children under 2 years who ...

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As people live longer, understanding how cognitive abilities change with age is increasingly important. Cognitive abilities generally decline slowly as we age, but in some cases, this decline can be more pronounced. Mild Cognitive Impairment (MCI) is a condition where cognitive decline is greater than expected for someone's age but does not severely impact daily activities. This differentiates MCI from Alzheimer's dementia, a more serious condition involving significant brain cell death parallelled by cognitive and behavioural dysfunction. While distinct, MCI ...

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Despite the lack of evidence on safety or efficacy, many clinicians offer whole body therapeutic hypothermia to infants with mild hypoxic ischaemic encephalopathy, and even to those without any encephalopathy. Such a wide variation in clinical practice within the NHS not only leads to poorer outcomes and may harm infants who would have otherwise done well, but masks improvements in obstetric care and increase litigations. The COMET trial will establish the safety and efficacy of whole-body hypothermia for mild hypoxic ischaemic ...

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