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Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)
Expand descriptionThe purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.
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AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
Expand descriptionThe AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.
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A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Expand descriptionThe objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris
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Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Expand descriptionProspective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.
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Clinical Study to Investigate Visual Performance of IOL: FineVision HP
Expand descriptionThis is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.
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Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring ECMO
Expand descriptionThe purpose of this study is to describe the changes in quadriceps muscle size and quality over the first 10 days on extracorporeal membrane oxygenation (ECMO) using ultrasound imaging. This study will also examine the relationship between those changes and muscle strength and level of physical function at day 10 and day 20 after ECMO commencement.
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Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults
Expand descriptionThis is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300 eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions of subjects in various strata will not be pre-specified and the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the treatment groups. Serology measures consistent with the study outcomes will be reported.
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A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis
Expand descriptionThis is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
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Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
Expand descriptionThe primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).
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A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy
Expand descriptionThis is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.