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Safety outcome trials in four mainline medical journals 30 years apart: a narrative review and the need for the transparency of informed consents.
Trials
January 2025
Internal Medicine (Rheumatology), Academic Hospital, Istanbul, Turkey.
Background: It was our impression that safety outcome trials were getting more frequent, raising ethical issues mainly related to patient autonomy. We and others had also proposed this autonomy would be best served if wording of the informed consents would be in the public domain.
Methods: Initially two observers and an arbiter tabulated the main aims of randomized controlled trials (RCTs) published in 1990-1991 vs.
Propolis mouthwashes efficacy in managing gingivitis and periodontitis: a systematic review of the latest findings.
BDJ Open
January 2025
Department of Orthodontics, Institute of Dentistry, Medical Faculty, Jagiellonian University, Kraków, Poland.
Background And Objectives: Gingivitis and periodontitis are common periodontal diseases that can significantly harm overall oral health, affecting the teeth and their supporting tissues, along with the surrounding anatomical structures, and if left untreated, leading to the total destruction of the alveolar bone and the connective tissues, tooth loss, and other more serious systemic health issues. Numerous studies have shown that propolis can help reduce gum inflammation, inhibit the growth of pathogenic bacteria, and promote tissue regeneration, but with varying degrees of success reported. For this reason, this comprehensive systematic review aims at finding out the truth concerning the efficacy of propolis mouthwashes in treating gingivitis and periodontitis, as its main objective.
View Article and Find Full Text PDFImpella versus Non-Impella for Non-emergent High-Risk Percutaneous Coronary Intervention: Impella vs. Non-Impella for HR-PCI.
Am J Cardiol
January 2025
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address:
Background: The benefit of mechanical circulatory support (MCS) with Impella (Abiomed, Inc, Danvers, MA) for patients undergoing non-emergent, high-risk percutaneous coronary intervention (HR-PCI) is unclear and currently the subject of a large randomized clinical trial (RCT), PROTECT IV. While contemporary registry data from PROTECT III demonstrated improvement of outcomes with Impella when compared with historical data (PROTECT II), there is lack of direct comparison to the HR-PCI cohort that did not receive Impella support.
Methods: We retrospectively identified patients from our institution meeting PROTECT III inclusion criteria (left ventricular ejection fraction [LVEF] <35% with unprotected left main or last remaining vessel or LVEF <30% undergoing multivessel PCI), and compared this group (NonIMP) to the published outcomes data from the PROTECT III registry (IMP).
Risks associated with opioid prescriptions for headache in the emergency department.
Am J Emerg Med
January 2025
Departments of Emergency Medicine (EM) and Community Health Sciences, University of Calgary, Canada.
Study Hypothesis: Use of opioids for treatment of headache in the emergency department (ED) is associated with an increased 1-year risk of opioid-related adverse events.
Objective: To assess the safety and efficacy of opioid prescribing for ED patients with headache.
Methods: We performed a multicenter observational cohort study using linked administrative data.
Ensuring Medical Device Safety: The Role of Standards Organizations and Regulatory Bodies.
J Med Syst
January 2025
Advancing a Healthier Wisconsin Endowment, Medical College of Wisconsin, Milwaukee, WI, USA.
Medical devices significantly enhance healthcare by integrating advanced technology to improve patient outcomes. Ensuring their safety and reliability requires a delicate balance between innovation and rigorous oversight, managed through the collaborative efforts of standards development organizations, standards accrediting organizations, and regulatory agencies such as the U.S.
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