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[Rehabilitation after intercurrent morbid event of patients suffering from neurocognitive disorders in a pilot unit: management and outcomes].
Geriatr Psychol Neuropsychiatr Vieil
December 2024
Pôle recherche LNA Santé, Vertou, France.
People suffering from a neurodegenerative disease, at a stage still allowing physical activity, encounter more difficulties to access to re-education and rehabilitation care. A trial unit specialized in medical care and rehabilitation (SMR) was created to handle these patients, who suffered a morbid intercurrent event not related to the neurocognitive disorder. The trial unit was created thanks to a dedicated funding from the Brittany Health Regional Agency (ARS) following-up a call for projects in October 2021.
View Article and Find Full Text PDFLactic acidosis with metformin accumulation in the intensive care units of the Nord Pas de Calais region: A known serious adverse event that can be better prevented.
Therapie
December 2024
CHU Lille, University Lille, Intensive Médecine Reanimation, 59000 Lille, France.
Article Synopsis
- The study focused on identifying situations that lead to metformin-associated lactic acidosis (MALA) in ICU patients and evaluating its preventability.
- A total of 198 MALA cases were assessed, with 19.2% resulting in death; the majority of patients had acute events like dehydration or severe infections that contributed to the condition.
- The findings indicated that MALA is often preventable, highlighting the need for better physician and patient education regarding metformin use during high-risk medical situations.
Time to deterioration of patient-reported outcome endpoints in cancer clinical trials: targeted literature review and best practice recommendations.
J Patient Rep Outcomes
December 2024
Eli Lilly and Company, 639 S. Delaware St, Indianapolis, Indiana, 46285, USA.
Background: Time to deterioration (TTD) endpoints are often utilized in the analysis of patient-reported outcome (PRO) data in oncology clinical trials but different endpoint definitions and analysis frameworks exist that can impact result interpretation. This review examined the analysis, reporting and heterogeneity of TTD endpoints in the literature, the impact of analysis methods on results, and provides recommendations for future trials.
Methods: A targeted literature review of articles published between 2017 and 2022 was performed to collate TTD endpoints reported in oncology randomized controlled trials (RCTs).
[Preventive activities in women: PAPPS 2024 update].
Aten Primaria
November 2024
Medicina Familiar y Comunitaria, Centro de Salud Emisora, Pozuelo de Alarcón, Madrid, España.
Article Synopsis
- - The 2024 PAPPS update focuses on women's health preventive activities, excluding cancer prevention, and emphasizes the importance of contraception and informed decision-making about family planning.
- - General practitioners play a critical role in preconception and pregnancy care, emphasizing healthy lifestyle promotion and active monitoring during and after pregnancy.
- - The update also addresses menopause-related issues, including treatment for symptoms of estrogen deprivation and osteoporosis prevention, with a recommendation for bone density screening only for women at higher fracture risk.
Applying the estimand framework to clinical pharmacology trials with a case study in bioequivalence.
Br J Clin Pharmacol
November 2024
Statistical Innovation, Respiratory and Immunology Biometrics and Statistical Innovation, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use has published an addendum on estimands and sensitivity analysis in clinical trials along with related training materials. These define an estimand as a precise description of the treatment effect that reflects the scientific question of interest. In December 2022, the US Food and Drug Administration released draft guidance recommending estimands of interest be specified in bioequivalence trial protocols.
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