BI 690517 is an aldosterone synthase inhibitor and participants will be randomised 1:1 (using a minimisation algorithm) to active of placebo BI 690517 in addition to study supplied empagliflozin 10mg daily.

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This protocol includes 2 independent, multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (Study 1 and Study 2) to assess the efficacy and safety of MK 7240 in participants of any sex/gender aged 16 to 75 (inclusive) with moderately to severely active CD. While this “master” protocol includes common operational elements for both Study 1 and Study 2, randomization, data collection, statistical analyses, and data reporting will be conducted for each study independently. Each study has its own objectives and ...

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This is a global, multicenter, randomized, open-label, Phase 2/3 study in subjects with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received at least 1 and no more than 3 prior systemic lines of anticancer therapy. In this operationally seamless design, data from Phase 2 will not be utilized for the primary analysis in Phase 3 to strictly control the type I error in Phase 3. Phase 2 Study Design The Phase 2 part of this study is designed ...

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Behçet's disease (BD) is an inflammatory condition that causes damages of the blood vessels affecting many parts of the body. The disease is characterized by intermittent symptoms of varying severity across almost all organ systems and oral ulcers, considered the most common sign at the onset of BD and are observed in nearly every patient The treatment of BD is generally based on experience, and the drug of choice is based on specific clinical signs and symptoms in each patient. The ...

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This is a multicentre, prospective, non-interventional observational cohort study of patients who are planned to receive, or already receiving Epidyolex under real-world conditions of clinical care. This study is designed to address a Pharmacovigilance Risk Assessment Committee (PRAC) request to conduct a Category 3 Post-Authorisation Safety Study (PASS), as requested in the Risk Management Plan (RMP) at the time of approval. While 12 safety concerns were noted in the RMP, PRAC emphasis was on the need to further characterize the ...

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The study hypothesis is that a strategy of universal primary prevention of anaemia during pregnancy with oral iron supplementation will impact the composite primary outcome of pre-term birth,stillbirth,neonatal death and small for gestational age (SGA).

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RATiFY is a non-randomised,multicentre,phase II trial. Eighty patients will be recruited and,following initial treatment with 3 cycles of tislelizumab and PET-CT with ceCT scan,will be assigned to 1 of 5 treatment groups (Groups A to E) based on disease stage,risk,and response. Patients with early stage lymphoma showing good response (Group A) will receive radiotherapy and further tislelizumab for up to 2 years,but no chemotherapy. All other patients (Groups B-E) will receive further tislelizumab with AVD chemotherapy for between 2 and ...

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PEARLS is a 2-arm,parallel-group,individually randomised,open label assessor-blinded,multicentre,superiority trial with an internal pilot phase. It is a pragmatic trial and the trial participants in both intervention and comparator group will receive commonly prescribed topical corticosteroids (TCSs),which is tailored for the participant. The only difference between the treatment groups is the treatment regimen/strategy. There are number of TCS products available on the market and all available brands and forms can be prescribed to participants. Participants will be randomised to one of ...

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Every year more than 700,000 women give birth in the United Kingdom. Of these at least 8700 nearly die – called a “near-miss”, and 70 die. Many more women suffer harm, often with effects lasting for life. Women from less wealthy areas and particular ethnic groups are more likely to come to harm. "Vital signs" include measurements of blood pressure, heart and breathing rates. Doctors and midwives use tools that score vital signs to spot women becoming unwell. These tools are ...

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ADVANCE is a longitudinal cohort study supporting scientific research by members of the 'NASH Disease Translational Accelerator' (NASH-DTA) Consortium. The overarching aim is to leverage a greater understanding of disease pathophysiology to develop robust methods for diagnosis, risk stratification and therapy for patients with Non-Alcoholic Fatty Liver Disease related advanced liver fibrosis/cirrhosis (“compensated advanced chronic liver disease, cACLD”). To achieve this we will assemble a longitudinal observational cohort of well-characterised patients with Non-Alcoholic Fatty Liver Disease (NAFLD) related advanced liver ...

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