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Demonstration of Major Therapeutic Advantage From a Review of EU Conditional Marketing Authorizations in Oncology and Hematology.
Clin Pharmacol Ther
January 2025
European Medicines Agency, Amsterdam, The Netherlands.
In the EU, conditional marketing authorization is a pragmatic tool for early approval of a medicine that fulfills an unmet medical need. In the pharmaceutical legislation, an unmet medical need means that a condition lacks a satisfactory method for diagnosis, prevention, or treatment. If such satisfactory methods exist, the new medicinal product must hold a major therapeutic advantage for those affected, meaning that it must demonstrate an improvement in efficacy or safety over existing methods or, in exceptional cases, a major improvement in patient care.
View Article and Find Full Text PDFBenefits of Intensive Rehabilitation Programs Using Physiotherapeutic Scoliosis-Specific Exercises in Adolescent Idiopathic Scoliosis.
Cureus
December 2024
Research, SMR pédiatrique Marc Sautelet - APF France Handicap, Villeneuve d'Ascq, FRA.
Purpose Adolescent Idiopathic Scoliosis (AIS) affects 3% of adolescents. Physiotherapeutic Scoliosis Specific Exercises (PSSE) are recommended to limit AIS progression, especially within intensive multidisciplinary programs. Our study evaluated the efficiency of these programs in AIS cases with a high progression risk.
View Article and Find Full Text PDFA 10-Year Single Center Analysis: Is There a Need to Reconsider Our Approach to the Management of Neonatal Testicular Torsion?
Cureus
November 2024
Pediatric Surgery, Royal Hospital for Children, Glasgow, GBR.
The management of neonatal testicular torsion lacks consensus. Arguments in favor of emergency bilateral exploration and fixation include a salvage rate and the incidence of bilateral torsion. We performed a retrospective single-center analysis of all cases of neonatal torsion in our unit between 2012 and 2022 to assess whether our data supports this approach and to publish further data on a disease on which there remains a paucity.
View Article and Find Full Text PDFEXPRESS: Deliberate Search for Analogous Cases Aids the Retrieval and Transfer of Suboptimally-Encoded Memory Items.
Q J Exp Psychol (Hove)
December 2024
Psychology Department, University of Comahue.
Even though spontaneous retrieval of analogous cases lacking surface similarity with a target situation typically requires achieving an abstract representation of the target situation, recent studies on analogical argumentation suggest that the deliberate disposition to search for analogous cases in long-term memory (LTM) suffices to increase cross-domain retrieval significantly. However, a limitation of these studies concerns the impossibility to determine whether the analogous situations reported were invented rather than retrieved, and whether there were instances of analogical retrieval that were not reflected in participants' arguments. To overcome these shortcomings, Experiment 1 resorted to a traditional transfer paradigm where a base analog is learned prior to the presentation of the target situation during a contextually-separated phase.
View Article and Find Full Text PDFA Study on Deliberate Self-Harm by Poisoning and Associated Risk Factors at Batticaloa Teaching Hospital.
Cureus
November 2024
University Medical Unit, Batticaloa Teaching Hospital, Batticaloa, LKA.
Background: Deliberate self-harm (DSH) by poisoning is a significant public health concern worldwide. This study aimed to analyze the demographic, socioeconomic, and psychological factors contributing to self-harm by poisoning in patients admitted to a tertiary care hospital in Sri Lanka.
Methods: A cross-sectional study was conducted on 101 patients admitted to the hospital for poisoning-related self-harm.
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