5 results
Primary Safety Endpoint:Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device…
The main purpose of this pilot study is to investigate the feasibility of fluorescence imaging using cetuximab-IRDye800CW for intraoperative margin assessment in patients with cutaneous squamous cell carcinoma.
Primary Objective: Therapeutic effect of electrical stimulation. Secondary Objective(s): (i) Side effects of electrical stimulation(ii) Effect on quality of life (iii) Effect of electrical stimulation on inflammatory and histologic parameters.
Primary Objectives: Safety Assessments: Effect of Administration of Relacorilant on: • Incidence of TEAEs (assessed monthly): TEAEs, SAEs, treatment-related TEAEs, TEAEs leading to early discontinuation of study treatment• Clinical laboratory tests…
Primary • To assess the efficacy of relacorilant for the treatment of endogenous Cushing syndrome based on BP control at Week 12 of the Randomized- Withdrawal (RW) phase compared with placebo• To assess the safety of relacorilant for the treatment…