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Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022.
Clin Trials
January 2025
Rare Diseases Team, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Background/aims: Rare disease drug development faces unique challenges, such as genotypic and phenotypic heterogeneity within small patient populations and a lack of established outcome measures for conditions without previously successful drug development programs. These challenges complicate the process of selecting the appropriate trial endpoints and conducting clinical trials in rare diseases. In this descriptive study, we examined novel drug approvals for non-oncologic rare diseases by the U.
View Article and Find Full Text PDFReal-World 12-Month Outcomes with Sirolimus-Coated Balloon Angioplasty for Complex Femoropopliteal Disease.
J Clin Med
January 2025
Department of Vascular and Endovascular Surgery, Rhein Main Vascular Center, Asklepios Clinics Langen, Paulinen Wiesbaden, 63225 Langen, Germany.
: Sirolimus-coated balloons (SCBs) have emerged as a promising alternative to paclitaxel-coated devices for the treatment of femoropopliteal lesions. However, real-world data on SCB performance in also complex peripheral arterial disease remains unknown. We sought to evaluate the safety and 12-month clinical outcomes of the Selution SLR™ balloon angioplasty in a challenging real-world patient cohort.
View Article and Find Full Text PDFComparison of Functional Outcomes of Superficial Palmar Branch of Radial Artery (SPBRA) and Free Venous Flap (FVF) Techniques for Finger Tissue Defects.
J Clin Med
January 2025
Department of Hand Surgery, Private Clinic, Gaziantep 27060, Turkey.
: This study aimed to compare two surgical techniques-the free flap of the superficial palmar branch of the radial artery (SPBRA) and the free venous flap (FVF)-to evaluate their efficacy and aesthetic outcomes in repairing finger tissue defects. The goal was to determine which procedure offers faster healing curves and better overall patient outcomes, ultimately improving the quality of life for individuals undergoing these surgeries. : A retrospective study was conducted using the clinical database of Sanliurfa Mehmet Akif Inan Education and Research Hospital, University of Health Sciences, from 1 January 2019 to 1 January 2022.
View Article and Find Full Text PDFSuperparamagnetic Iron Oxide Nanoparticles as a Tracer for Sentinel Lymph Node Mapping in Endometrial Cancer.
Int J Mol Sci
January 2025
Department of Oncology, Wroclaw Medical University, 50-367 Wroclaw, Poland.
Sentinel lymph node (SLN) detection has been widely investigated in recent years as a part of the surgical staging of women with endometrial cancer (EC), gradually overtaking lymphadenectomy (LND) in this respect. In this study, thirty EC patients, assumed as stage I, were investigated using superparamagnetic iron oxide (SPIO) as a tracer for SLN detection followed by LND. The endpoints of this research were the proportion of successful SLN detection, the average number of SLNs per patient, the percentage of bilaterally detected SLNs, and the proportion of metastatic SLNs.
View Article and Find Full Text PDFImpact of Sex-Related Differences in Infrarenal Aortic Neck Morphology on Outcomes of Endovascular Aneurysm Repair for Similar-Sized Aortic Aneurysm.
Diagnostics (Basel)
January 2025
Vascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I-"La Sapienza" University of Rome, Viale del Policlinico, 00161 Rome, Italy.
: This study aimed to evaluate whether gender-related anatomical differences in proximal aortic neck morphology affect the feasibility and outcomes of endovascular aortic aneurysm repair (EVAR) in women with abdominal aortic aneurysms (AAA). : This study performed a retrospective analysis of patients electively treated by EVAR for infrarenal AAA between January 2019 and December 2023. Demographics, anatomical characteristics, and stent graft details were analyzed.
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