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A randomised double-blind placebo-controlled multicentre Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
The 3 peroxisome proliferator-activated receptors (PPAR) isoforms play an important role in several components of NASH, from hepatic triglyceride accumulation to fibrosis. Lanifibranor, a pan-PPAR ...Phase
Interventional
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The HistoSonics Edison System for treatment of primary solid renal tumors using histotripsy (#HOPE4KIDNEY US)
This trial is a prospective, multi-center, single-arm pivotal trial designed to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of ...Phase
Interventional
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A Multicenter Randomized Double-blind Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of an SC treatment regimen of anifrolumab versus ...Phase
Interventional
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AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
The primary objective is to compare the PFS of patients with early-stage cHL treated through a response-adapted design with either standard therapy or with an ...Phase
Interventional
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Basis of sex-specific therapeutic responses to obstructive sleep apnea: Oxidative stress inflammation and vascular function
We will address the study aims using a single sample of middle-aged and older women and men (55–75 years). This is a descriptive evaluation ...Phase N/A
Non-Interventional
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Chiari Surgical Success Scale
A simple prognostic model that includes preoperative clinical and radiological variables predicts the likelihood of a successful outcome in surgery for Chiari malformation Type 1 ...Phase N/A Non-Interventional
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Lupus Omics Cutaneous Kidney Investigative Team: Skin Project 1 and Skin Project 2
Cutaneous lupus erythematosus (CLE) includes three main subsets: acute CLE (ACLE), subacute CLE (SCLE) and chronic CLE (CCLE), the latter including discoid lupus erythematosus (DLE ...Phase N/A Non-Interventional
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A 52-week Double-blind Placebo-controlled Randomized Phase 3 study Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of seladelpar in patients with PBC and ALP values greater than ULN but less than 1 ...Phase
Interventional
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A PHASE II RANDOMIZED OPEN LABEL MULTI-CENTER STUDY OF THE EFFECTS OF ELCTRONIC CIGARETTES ON SMOKING HARM REDUCTION IN CIGARETTE SMOKERS WITH SERIOUS MENTAL ILLNESS.
This study will compare the feasibility and preliminary efficacy of telehealth motivational counseling + e-cigarettes versus telehealth motivational counseling + combination Nicotine replacement therapy (NRT; patch and ...Phase
Interventional
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A Multi-Center Phase 2/3 Randomized Double-Blind Placebo-Controlled Parallel- Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare
This is a multi-center Phase 2/3 randomized, double-blind, placebo-controlled, parallel-group safety and efficacy study with a 7-day period of IMP treatment conducted in subjects ...Phase
Interventional
