FARGO is a randomised,phase IIa,multi-centre,placebo-controlled,single-blind,parallel group trial investigating the activity of FMT in the treatment of patients with PSC. The primary objective is to determine the effect of FMT,administered via colonoscopy (single dose) and via enema (once weekly for seven weeks),on circulating ALP values measured at 48 weeks.

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Part 1a will consist of dose escalation using a statistical hybrid design to identify the MTD and/or RDE(s) of INCA033989 monotherapy in participants with MF or revised IPSET-thrombosis high-risk ET (TGA). After initial characterization of safety, PK, and pharmacodynamic effects of INCA033989 as monotherapy in TGA, dose escalation will start in TGB-MF SubOpt R, which encompasses participants with MF exhibiting suboptimal response to ruxolitinib. Participants enrolled in TGB-MF SubOpt R must be on a stable dose of ruxolitinib for at least 8 ...

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This is a non-interventional Post-authorisation Safety Study (PASS) that will collect data from 2 groups of patients: those treated with avacopan for active ANCA-associated vasculitis (AAV), and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active AAV. The study will be conducted in Germany and United Kingdom. Additional countries may be considered according to availability of avacopan and suitability for the study. The overall study duration is anticipated to be up to 7 years. The ...

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Head and neck squamous cell carcinoma (H&N SCC) incorporate tumours of varying areas of the upper aerodigestive tract,including the larynx,hypopharynx,nasopharynx,and oropharynx. H&N cancer is increasingly common in the UK,with rates increasing by 34% since the early 1990s. The rising prevalence of H&N cancer has been attributed to a rising rate in women,and the prevalence of the Human papilloma virus (HPV) in oropharyngeal cancer,which can account for up to 70% of cases. The survival in H&N cancer is highly variable,ranging from over ...

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Primary biliary cholangitis (PBC) is a rare liver disease. A number of treatments exist,which slow the rate that liver disease gets worse. However,at the moment,doctors have to wait for one treatment to fail before adding in a second. As a result,many people with PBC develop symptoms and some go on to need a liver transplant. The aim of the OPERA trial is to see if people who are newly/recently diagnosed with PBC have a better outcome if they receive two medicines ...

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AGCT1531 is the first international Phase 3 randomised controlled trial for low and standard risk extra-cranial germ cell tumours (GCT) in children, teenagers and young adults (TYA). Many cancers predominantly affecting TYA patients are considered rare because the incidence is low during early childhood and in older patients. However, GCTs are the third most common cancer diagnosed in the TYA population. Most patients with a GCT can expect cure, however, TYA outcomes are much worse than in children and adults. The trial ...

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GT005, a recombinant adeno-associated viral serotype 2 (AAV2) vector encoding for human complement factor I, is currently being developed as a potential gene therapy for GA secondary to AMD. Current regulatory guidelines [EMA 2009; EMA 2018; FDA 2020] recommend that participants enrolled in gene therapy clinical trials with viral vectors that are non-replicating, non-integrating, and have no known potential for latency and re-activation should be followed for approximately 5 years post-treatment. The aim of this study (GT-ORACLE) is to evaluate ...

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Surgery remains the best option for the cure of patients with lung cancer. Around 7000 people in the UK undergo lung surgery each year, but up to 45% of patients developed post-operative complications leading to readmission to hospital and potentially poorer quality of life. National and international cancer, surgery and nutrition guidelines recommend a combination of exercise and nutritional support before and after surgery to help reduce post-operative complications. However it is not clear what is the best way to ...

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Breast cancer is the most common cancer worldwide and a leading cause of cancer-related death. Despite improvements in survival rates, a significant number of patients eventually develop distant metastasis after initial treatment. Metastatic breast cancer is difficult to diagnose and current tests including CT, MRIs, and PET scans are expensive and have low throughput. Biomarkers for metastatic cancer require specialised laboratory equipment, yet, their clinical utility is limited. This study aims to investigate the use of a point-of-care test LIT ...

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This study is looking at the best way to confirm the presence of an eye condition known as neovascular age-related macular degeneration (nAMD), a common condition that affects vision. nAMD usually affects people in their 50s and 60s, and diagnosis is confirmed by examining the back of the eye. There are a number of ways of doing this, the most common being Fluorescein Angiography (FA) where any leakage of a fluorescent dye over several minutes is detected by a special ...

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