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Influence of an Alternative Diagnosis on the Diagnosis of Pulmonary Thromboembolism.
Healthcare (Basel)
November 2024
Department of Internal Medicine Hospital HM Sanchinarro, HM Hospitales, Avenida/Montepríncipe 26, 28260 Madrid, Spain.
Background: The diagnosis of pulmonary embolism (PE) is based on the application of a priori probability scales such as the Wells scale or PERC. However, the clinical heterogeneity of this pathology results in the absence of a target population to apply these algorithms. The Wells score does consider the possibility of an alternative diagnosis, awarding an additional point if no other diagnosis is likely, yet the presence of objective alternative diagnoses can still complicate clinical assessment and lead to unnecessary testing or missed diagnoses.
View Article and Find Full Text PDFExpediting treatments in the 21st century: orphan drugs and accelerated approvals.
Orphanet J Rare Dis
November 2024
EveryLife Foundation for Rare Diseases, Washington, DC, USA.
Background: In response to activated patient communities' catalyzation, two significant efforts by the FDA to expedite treatments have now been in place for multiple decades. In 1983, the United States Congress passed the Orphan Drug Act to provide financial incentives for development of drugs for rare diseases. In 1992, partly in response to the HIV epidemic, the FDA implemented Accelerated Approval (AA) to expedite access to promising new therapies to treat serious conditions with unmet medical need based on surrogate marker efficacy while additional clinical data is confirmed.
View Article and Find Full Text PDFNavigating the orphan medicinal product designation: Evidence requirements for gene therapies in Europe.
Mol Ther
October 2024
Orphan Medicines Office, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands. Electronic address:
To provide insight into regulatory decision-making at the time of granting initial orphan designation by the Committee for Orphan Medicinal Products, we have conducted a retrospective analysis for viral vector-mediated gene therapies in rare non-oncological conditions with respect to the data provided to support the criteria to be met in successful applications. We found that a high proportion of non-clinical in vivo data was used for gene therapies, indicating earlier submissions of products that are at the stage of preclinical research and not in clinical development. Clinical data were submitted in only 13% of the applications, containing preliminary results derived from early-stage clinical trials in few patients.
View Article and Find Full Text PDFCurrent status, evolution, and future perspectives in robotic platform systems for prostate cancer treatment: a narrative review.
Chin Clin Oncol
October 2024
Department of Oral and Medical Sciences, University "G. D'Annunzio" of Chieti, Chieti, Italy; Department of Urology, ASL02 Abruzzo, Chieti, Italy.
Article Synopsis
- Robotic surgery has shifted urology towards minimally invasive techniques, significantly benefiting procedures like radical prostatectomy.
- A review of literature on robotic platforms reveals that while the DaVinci system is predominant, new alternatives are emerging, but comprehensive comparisons are rare.
- The role of artificial intelligence in robotic surgery is growing, suggesting that more research is needed to fully understand its impact and future developments in urology.
Recent advancements in new tracers from first-in-human studies.
Ann Nucl Med
November 2024
Division of Fundamental Technology Development, Near InfraRed Photo-ImmunoTherapy Research Institute at Kansai Medical University, 2-5-1, Shin-Machi, Hirakata, 573-1010, Japan.
Article Synopsis
- - Recent advancements in positron emission tomography (PET) tracers have improved our ability to image brain inflammation and neurotransmitter systems, aiding in the treatment of neurodegenerative and psychiatric disorders.
- - Innovative tracers in cancer research allow for detailed imaging of tumors’ metabolic and molecular features, essential for personalized therapies and monitoring treatment responses like radiotherapy.
- - New tracers have been created not just for neurological and oncological uses, but also for other medical applications such as adrenal imaging, amyloidosis detection, and HIV infection assessment.
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