This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of pegozafermin for the treatment of Stage 2 or 3 liver fibrosis in adult subjects with NASH (Noncirrhotic Nonalcoholic Steatohepatitis). The study is designed to assess the efficacy and safety of 2 dose regimens of pegozafermin, administered either weekly (QW) or once every 2 weeks (Q2W) in subjects with biopsy-confirmed NASH (NAFLD activity score [NAS] ≥ 4, fibrosis stage F2 or F3 [NASH CRN system]). Approximately 840 subjects will be randomized 1:1:1 ...

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This is a multicenter evaluation of seladelpar, administered as a once-daily oral capsule, in a randomized, double-blind, placebo-controlled, parallel-group study in subjects with PBC. This fixed-duration study (156 weeks) will randomize approximately 192 subjects across approximately 150 sites worldwide. The population to be studied is patients with PBC and compensated cirrhosis restricted to Child-Pugh (CP)-A or CP-B.

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This is a multi-national, randomized, double-blinded study to evaluate the safety and effectiveness of AVIM therapy in patients with uncontrolled hypertension with a previously implanted Medtronic Astra/Azure pacemaker. Over 500 participants will be recruited across 100 sites in UK, Europe and US. AVIM is an investigational therapy that can be added to a pacemaker to allow for specific settings that may help with the treatment of hypertension. The study will be performed in three phases, Screening/Run-In, Randomised double-blind and Randomised ...

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This is a prospective, observational, non-interventional, multi-center, global clinical study of subjects with early to advanced stage STGD1 caused by bi-allelic likely pathogenic or pathogenic variants in the ABCA4 gene, confirmed genotypically by an accredited genotyping laboratory. The study will consist of 6 visits over a 96-week study period: Visit 1 (Screening Visit), Visit 2 (Week 16), Visit 3 (Week 32) Visit 4 (Week 48), Visit 5 (Week 72), and Visit 6 (Week 96). Subjects who discontinue the study early will ...

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Atrial Fibrillation (AF) is the most common cardiac arrhythmia and carries an increased risk of stroke. Stroke risk is commonly assessed using the CHA2DS2-VASC scoring system. To reduce stroke risk, guidelines advise AF patients with higher CHA2DS2-VASC scores be treated with oral anticoagulation (OAC), also known as blood thinning medication. OAC reduces the stroke risk, however it also increases the risk of bleeding episodes, which can be major and life-threatening. AF patterns can vary between patients. One patient may have only one ...

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Traumatic Brain Injury (TBI) is caused by a trauma to the head from a force outside the body, like an accident or fall. Around one million people visit Accident and Emergency each year following a head injury. Although many of these people will experience no lasting effects, others will be left with varying degrees of damage that can have devastating and lifelong consequences. Moderate head injury is defined as loss of consciousness between 15 minutes and six hours, or a ...

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Broken ankles in children often involve the area from which the bone grows – the growth plate. Following growth plate injuries, the growth of the main shin bone in the lower leg (the tibia) can be altered permanently, which can cause the bone to not grow at all, or to grow wonky. The younger the child at the time of injury (i.e. the more they have to grow) the worse the problem may get once the child has fully grown. ...

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Survivors of childhood cancer experience impaired health-related quality of life, psychological distress, and pain. A previously developed body mindset intervention has improved health-related quality of life and symptom distress in adult cancer patients. In the current research, we will examine whether a body mindset intervention can instil adaptive body mindsets, boost resilience, and improve physical and psychological functioning in survivors of childhood cancer. Survivors of childhood cancer will be randomised to the body mindset intervention or an active attention control group. ...

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Perianal fistula in Crohn's Disease (CD-pAF) is an abnormal tunnel that develops between the end of the bowel and the skin near the anus. It affects one third of Crohn's Disease (CD) patients causing significant morbidity and poor quality of life. Patients with CD-pAF are treated with several combined approaches involving medical and various surgical techniques with high failure rates (around 50%). The study will provide an evidence base to identify predictors of fistula healing, potentially modifiable factors, ...

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Crohn’s disease is a lifelong inflammatory illness that causes people to have severe stomach pains, chronic diarrhoea, and suffer weight loss. There is no cure. Crohn’s disease causes inflammation, ulceration, bleeding and narrowing of the digestive system. People can have periods of good health (“remission”) and times when symptoms are more active (“flare ups” or “relapses”). Medications can help keep it in remission, however one third of people will need surgery to remove/repair part of their diseased gut at some ...

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