A novel design of a Phase III trial of isradipine in early Parkinson disease (STEADY-PD III).

Objective: To describe the rationale for a novel study design and baseline characteristics of a disease-modifying trial of isradipine 10 mg daily in early Parkinson disease (PD).

Methods: STEADY-PDIII is a 36-month, Phase 3, parallel group, placebo-controlled study of the efficacy of isradipine 10 mg daily in 336 participants with early PD as measured by the change in the Unified Parkinson Disease Rating Scale (UPDRS) Part I-III score in the practically defined ON state. measures include clinically meaningful measures of disability progression in early PD: (1) Time to initiation and utilization of dopaminergic therapy; (2) Time to onset of motor complications; (3) Change in nonmotor disability.

The nature and management of labor pain: executive summary.

This report describes the background and process for a rigorous project to improve understanding of labor pain and its management, and summarizes the main results and their implications. Labor pain and methods to relieve it are major concerns of childbearing women, with considerable implications for the course, quality, outcome, and cost of intrapartum care. Although these issues affect many women and families and have major consequences for health care systems, both professional and public discourse reveal considerable uncertainty about many questions, including major areas of disagreement.