Evidence-Based Strategies to Minimize Unnecessary Primary Cesarean Sections: A Comprehensive Review.

The increase in cesarean section (CS) rates, whether they are classified as unnecessary or elective, has globally raised significant concerns due to the associated risks involving maternal and neonatal outcomes. Although CS can be a lifesaving operation in specific medical cases, its overuse is exposing mothers and neonates to complications like hemorrhage, infections, and long-term consequences such as uterine scarring, infertility, and future pregnancy problems. The contributing factors include maternal preferences for convenience, fear of labor, and financial incentives within the healthcare systems that favor surgical interventions.

Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints.

For rare serious and life-threatening disorders, there is a tremendous challenge of transforming scientific discoveries into new drug treatments. This challenge has been recognized by all stakeholders who endorse the need for flexibility in the regulatory review process for novel therapeutics to treat rare diseases. In the United States, the best expression of this flexibility was the creation of the Accelerated Approval (AA) pathway.

Raising orphans: how clinical development programs of drugs for rare and common diseases are different.

We compared clinical trials described in package inserts from noncancer orphan and nonorphan drugs from 1 January 2001 to 31 December 2011. Among the 37 orphan and 58 nonorphan drugs approved by the US Food and Drug Administration (US FDA) during this period, orphans had fewer clinical trials (2.8 vs.

Occult lumbosacral dysraphism in children and young adults: diagnostic performance of fast screening and conventional MR imaging.

Purpose: To compare fast screening and conventional magnetic resonance (MR) imaging for the detection of occult dysraphic myelodysplasias in children and young adults.

Materials And Methods: A retrospective case-control study included 101 patients (mean age, 4.9 years; range, 1 day to 26 years) suspected of having occult lumbosacral dysraphism.