Not everything is known about a medicine when it receives its licence for marketing. The merits of a new drug, balancing its beneficial and its untoward effects, become only established after sufficient experience has been gained from its use in real practice. Part of the reason for this is that our extensive phase III clinical trials fail to detect some side-effects. Why is this so? Three groups of reasons may be envisaged, namely (1) our trials lack the power to detect rare side-effects; (2) some side-effects do not occur in the context of clinical trials; (3) some side-effects, though common enough, fully or partly escape detection due to lack of suitable detection techniques. The following presents a closer look at these three mechanisms.
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http://dx.doi.org/10.1002/(SICI)1099-1557(199901/02)8:1<61::AID-PDS395>3.0.CO;2-A | DOI Listing |
Fam Process
March 2025
Unit of Psychiatry, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Borderline personality disorder (BPD) has a strong impact not only on patients' lives but also on their families. The presence of an invalidating environment is one of the key factors in the etiology of BPD. This study evaluated the impact of the Family connections (FC) program on burden, grief, and other clinical variables in 202 caregivers and identified the profiles of participants who improved/deteriorated their levels of burden and grief.
View Article and Find Full Text PDFJ Cachexia Sarcopenia Muscle
February 2025
Aging and Metabolism Research Group, Korea Food Research Institute, Wanju-gun, Jeollabuk-do, Republic of Korea.
Background: Sarcopenia, characterized by a gradual decline in skeletal muscle mass and function with age, significantly impacts both quality of life and mortality. Autophagy plays a crucial role in maintaining muscle health. There is growing interest in leveraging autophagy to mitigate muscle ageing effects.
View Article and Find Full Text PDFJ Dent Sci
January 2025
School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan.
Background/purpose: Salivary microbiome has become a surrogate indicator of oral disease due to its collective reservoirs and convenience in sampling. However, failed clinical trials often lead to wastes of resources, indicating a need for preclinical models. In this pilot study, we aimed to compare the salivary microbiome by metagenomics analysis before and after lysogeny broth culture for prospective translational studies.
View Article and Find Full Text PDFFront Neurosci
January 2025
HealthPartners Institute, Neuroscience Research, HealthPartners Neuroscience Center, Saint Paul, MN, United States.
Introduction: Intranasal (IN) deferoxamine (DFO) has emerged over the past decade as a promising therapeutic in preclinical experiments across neurodegenerative and neurovascular diseases. As an antioxidant iron chelator, its mechanisms are multimodal, involving the binding of brain iron and the consequent engagement of several pathways to counter pathogenesis across multiple diseases. We and other research groups have shown that IN DFO rescues cognitive impairment in several rodent models of Alzheimer Disease (AD).
View Article and Find Full Text PDFJ Orthop
August 2025
Instituto de Ortopedia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Introduction: This study aimed to evaluate the effectiveness and safety of intra-articular vancomycin powder in reducing prosthetic joint infections (PJIs) in primary hip and knee arthroplasty through a meta-analysis of randomized controlled trials (RCTs).
Methods: A research in Pubmed, Embase and Cochrane databases was performed to identify randomized clinical trials comparing intra-articular vancomycin use to conventional antibiotic prophylaxis in total hip or knee arthroplasty patients, assessing postoperative infection rates, adverse drug reactions, and venous thrombotic events. Statistical analysis was performed using R (RStudio 2024.
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