IELSG48 is a Phase III,interventional,multicenter,open label,randomized study to evaluate whether treatment with zanubrutinib in combination with rituximab will result in an improvement in PFS compared to treatment with rituximab in patients with previously untreated SMZL. Approximately 120 subjects will be randomized in a 1:1 ratio to receive zanubrutinib and rituximab Treatment Arm A) or rituximab (Treatment Arm B). The study will include a Screening Phase,a Treatment Phase,and a Follow-Up Phase. Subjects with investigator-confirmed progressive disease according to the Lugano 2014 criteria ...

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Follicular lymphoma is a common mature B cell malignancy with a UK incidence of 3.3/100,000 people per year1. Most patients have advanced stage disease that follows a protracted and incurable disease course leading to a high overall disease prevalence. Despite advances in front line management, treatment of relapsed and refractory (r/r) FL has not been standardised and data on treatment patterns and clinical outcomes are lacking, presenting significant challenges for therapy selection and novel drug development to optimise clinical outcomes. ...

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Clavicle (collar bone) fractures make up around 5% of all bone fractures. Usually, people fracture the middle part of their collarbone but sometimes the outer part on top of the shoulder breaks and separates. This is called a “displaced distal clavicle fracture”. These fractures can be very painful, make it hard to move your arm, disturb sleep and affect the appearance of your shoulder. Patients either undergo surgery to repair the collarbone with plates and screws or they wear a ...

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Sodium bicarbonate is widely,but not universally,used to treat metabolic acidosis in very preterm babies but the evidence underpinning its use is poor. The BASE trial aims to answer the question,‘In very preterm babies with metabolic acidosis,does giving them sodium bicarbonate or not impact on their health and development in the short and long term?’ The primary objective of the BASE trial is to evaluate the effect of sodium bicarbonate on survival to discharge from neonatal care without major morbidity. In this randomised ...

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REGN4018 and cemiplimab are the study drugs under investigation for the treatment of ovarian cancer. They are both investigational drugs, meaning they have not received approval from health authorities for the treatment of ovarian cancer. The purpose of this study is to learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or with cemiplimab to patients with ovarian cancer, without causing too many side effects. The study will also look at ...

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In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects. The underdevelopment can occur gradually during fetal growth caused by a narrowing of the aortic valve. At some international centers, such fetuses are treated with a balloon dilation of the narrowed valve, but there is no scientifically sound evidence that this treatment is effective. The aim of this study is: 1/ ...

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The Meniscus is an important structure within the knee. One of its key roles is to cushion impact and protect the gliding surface of the joint from wear. Patients that have damaged their meniscus, and had a removal of the meniscus (a total meniscectomy), are more likely to develop persistent pain after this resulting in years of disability. At present, there are several treatment options ranging from knee therapy (physiotherapy) to a replacement meniscus also known as a ‘meniscal transplant’. Mensical transplant is thought ...

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Type 1 diabetes (T1D) is a chronic condition of childhood, affecting 1 in 490 children under the age of 15 years. It is caused by the immune system damaging the pancreas, the organ which makes insulin, and impacts every aspect of a person’s life. T1D has recognised stages before symptoms develop, providing an opportunity for early diagnosis, education and treatment which may delay the onset of symptoms. Early diagnosis often relies on a test called the oral glucose tolerance test ...

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MYTX-011 is a cMET-targeted val-cit-monomethyl auristatin E (vcMMAE) antibody-drug conjugate (ADC) with a fully humanized immunoglobulin (Ig)G1. The drug-to-antibody ratio (DAR) for MYTX-011 is 2:1. MYTX-011 binds to cMET with high affinity and specificity. MYTX-011 has been engineered to have pH dependent binding, which results in higher internalization and payload delivery to cMET+ tumor cells. This is manifested as increased internalization in cMET+ tumor cells in vitro compared to a non-engineered parent ADC and greater in vivo efficacy in murine ...

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Glioblastoma multiforme is a type of brain tumour. When it is first diagnosed,patients are usually treated with surgery and then a combination of radiotherapy and chemotherapy with temozolomide. Unfortunately,although this often slows or stops the disease from growing for a period of time,in most cases,usually a few months after the end of the original treatment,the tumour starts to grow again. This can be detected by an MRI scan. When this happens patients may experience new symptoms or a repeat of ...

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