4 results
Establish the technical feasibility and safety of implantation of the investigational device, adjustment of the investigational device post-implantation and the ability of the investigational device to reduce mitral valve regurgitation.
The primary objective of this clinical trial is to evaluate the safety and effectiveness of the AltaSeal® implants to provide bilateral mechanical occlusion of the fallopian tubes resulting prevention of pregnancy.
Primary Objectives:Part 1- Estimate the relative bioavailability of the tablet formulation of TAK-931 in reference to the PIC formulation.Part 2- Assess the effect of a high-fat meal on the single dose PK of TAK-931 administered as the tablet…
The purpose of this study is to compare the effectiveness of treatment Arm A and Arm B by measuring the event free survival (EFS) and pathological complete response (pCR). EFS is defined as the time from the first treatment dose that the patient…