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Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)
Expand descriptionThe QuickStart study aims to assess the impact of three models of HCV care on HCV treatment uptake and cure among people who inject drugs. Rapid point-of-care (POC) HCV testing and test-and-treat strategies will be utilised in primary health care settings across Australia.
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Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
Expand descriptionThis study aimed to evaluate the safety and effectiveness of ociperlimab combined with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone, in participants with non-small cell lung cancer (NSCLC) that was locally advanced, could not be removed by surgery, or had spread to other parts of the body.
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A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
Expand descriptionThe primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).
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A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
Expand descriptionThe purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986166 and of branebrutinib, each versus placebo, for the treatment of participants with moderate to severe atopic dermatitis.
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A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006)
Expand descriptionThe purpose of this study is to assess the safety and efficacy of tulisokibart (MK-7240) in participants with moderately to severely active Crohn's Disease. After the completion of the 12-week Induction Period, eligible participants have the option to enter an Open-label Extension (OLE) Period for up to 170 weeks.
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Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)
Expand descriptionACTION Teens is a multinational cross-sectional survey-based study. The study consists of a quantitative online survey to be conducted among three groups of respondents in ten countries worldwide. The respondent population will include Adolescents Living with Obesity (ALwO), Caregivers of ALwO, and HCPs treating adolescents who have obesity. The goal of this study is to provide insights to drive awareness around the needs of adolescents living with obesity and their caregivers, as well as to identify key areas of misalignment between adolescents, their caregivers and the HCPs involved in obesity treatment and management. ACTION Teens is designed to generate evidence to identify and address these challenges on both a global and local level, extending the insights from the previously conducted ACTION-IO study.
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Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies
Expand descriptionThe purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C) PET/CT can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors to immuno-oncology therapy.
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An add-on Study to the FIGARO-DKD Study Called FIGARO-BM to Learn About the Link Between Biomarkers (Substances in the Blood Used as Indicators of Biological Processes, Disease Processes or Responses to Medication) and Finerenone in FIGARO-DKD Participants
Expand descriptionResearchers are looking for a better way to treat people who have chronic kidney disease (CKD), a long-term, progressive decrease in the kidneys' ability to work properly. When CKD happens in people with type 2 diabetes mellitus, a condition characterized by high blood sugar levels, CKD is also referred to as diabetic kidney disease (DKD). FIGARO-BM is an add-on study in which blood draws that were collected in the FIGARO-DKD study are further analyzed. No additional blood draws (also referred to as biological samples) or data will be obtained from the participants, nor will any additional or new study intervention be introduced. No visit or patient contact other than for obtaining the agreement by the patients (also called informed consent) will be required. Inflammation and scarring are both seen as responsible for worsening of chronic kidney disease. There is much information from animal studies that the study treatment finerenone (BAY94-8862) works against inflammation and against scarring (also called fibrosis) in organs such as the kidney. In this exploratory study researchers want to learn more about the study treatment finerenone (BAY94-8862). To find this out, this study will examine substances called biomarkers in blood draws from participants in the FIGARO-DKD study. Biomarkers are used as indicators of biological processes, disease processes or responses to medication. The biomarkers that will be examined stand for inflammation, organ scarring (also called fibrosis), blood vessel function and congestion. The main question of this study is whether there are differences between these biomarkers in the group of participants who received finerenone and the group of participants who received a placebo in the FIGARO-DKD study. A placebo looks like a treatment but does not have any medicine in it. To answer this question, the researchers will compare the levels of these biomarkers between the two groups at different time points after starting the study treatment. Blood samples for this study will be obtained from FIGARO-DKD study sites with a high number of participants who had been treated with finerenone or placebo for at least 24 months. This information will be combined with other information from biomarker examinations already available in the FIGARO-DKD study.
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FTIH Study of ECC0509 in Healthy Volunteers
Expand descriptionA Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study to Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC0509 in Healthy Volunteers.
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An Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of Oral NNZ-2591 in Angelman Syndrome
Expand descriptionA study of the safety, tolerability and pharmacokinetics of NNZ-2591 and measures of efficacy in children and adolescents with Angelman syndrome