General Design and Methodology Sample Clauses

General Design and Methodology. This is a randomized, double-blind, placebo-controlled, dose ranging study to explore the safety and efficacy of TRV027 in patients with ADHF. [*] A total of 500 patients are expected to be randomized. [*] Study drug (TRV027 or placebo) will be administered [*] [*] · Efficacy Variables and Endpoints: · Primary Efficacy Variable and Endpoint: The primary clinical endpoint will be [*] · Secondary Efficacy Variable and Endpoint: [*] · Exploratory endpoints [*] · Safety Measures The incidence of the following events will be collected: [*]

General Design and Methodology. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a 200-mcg dose of IPP-201101 plus standard of care (SOC) compared with placebo plus SOC in patients with active SLE. The study consists of a 2-week screening period (visit 1), a 48-week treatment period beginning with a baseline visit in which randomization will be completed and study drug treatment will start (visit 2 and visits 4 through 14), and a final assessment 4 weeks after the last dose of study drug (visit 16 [week 52]). NOTE: If needed during the screening period, up to 14 additional days are permitted to confirm eligibility (eg, BILAG-2004, SLEDAI-2K, and PhGA central system assessment, laboratory results ….). In addition to the typical assessments obtained at the screening visit, such as obtaining medical, psychiatric, and medication history (medication history to be obtained from start of screening) and performing a physical examination and tests to determine the patients’ health status and eligibility for participation in the study, procedures will include assessment of disease activity using the SLEDAI-2K and BILAG-2004 disease activity indices and the SFI, and disease marker testing (ie, at screening, anti-dsDNA Ab, C3, C4, and XXX only]). Eligibility will be confirmed by using a central system to validate the BILAG-2004, SLEDAI-2K, and PhGA assessments. Eligible patients will return to the study center at baseline and will be randomly assigned (stratified by region, SLEDAI-2K screening total score [6 to 9 or

General Design and Methodology. This is a single center, prospective, non-randomized cohort study to assess clinical outcomes following the use of the MvIGS spine navigation system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine. There will be separate study arms for cases utilizing the three-dimensional (3D) MvIGS spine navigation system and cases that utilize conventional two-dimensional (2D) fluoroscopy. Study Arm 1: One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance. Study Arm 2: One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy.