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Orally dissolving pilocarpine tablets for xerostomia in advanced cancer: A pilot N-of-1 feasibility study.
Palliat Med
December 2024
Palliative and Supportive Care, Mater Misericordiae Ltd., South Brisbane, QLD, Australia.
Background: Xerostomia is a common and difficult symptom experienced by patients with cancer. Pilocarpine is a cholinergic agent that stimulates salivation.
Aim: To assess the feasibility of conducting a N-of-1 trial to determine the efficacy of pilocarpine orally dissolving tablets in patients with xerostomia.
Specifications and functional impact of a self-triggered grasp neuroprosthesis developed to restore prehension in hemiparetic post-stroke subjects.
Biomed Eng Online
December 2024
Department of Clinical Physiology, Motion Analysis Center, University Hospital of Toulouse, Hôpital de Purpan, Toulouse, France.
Background: Stroke is the leading cause of acquired motor deficiencies in adults. Restoring prehension abilities is challenging for individuals who have not recovered active hand opening capacities after their rehabilitation. Self-triggered functional electrical stimulation applied to finger extensor muscles to restore grasping abilities in daily life is called grasp neuroprosthesis (GNP) and remains poorly accessible to the post-stroke population.
View Article and Find Full Text PDF[Statistical design and application of clinical trials with small sample sizes for rare diseases].
Zhonghua Liu Xing Bing Xue Za Zhi
December 2024
Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing211166, China.
Due to the limited number of cases, conducting large-scale clinical trials for rare diseases is challenging. This review introduces several small sample statistical designs tailored for rare diseases, including crossover design, -of-1 design, randomized placebo-phase design, randomized withdrawal design, group sequential design, and adaptive design. It discusses the advantages, disadvantages, and application scenarios of these designs.
View Article and Find Full Text PDFDiet-gut microbiome interaction and its impact on host blood glucose homeostasis: a series of nutritional n-of-1 trials.
EBioMedicine
December 2024
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, China; Zhejiang Key Laboratory of Multi-Omics in Infection and Immunity, School of Medicine and School of Life Sciences, Westlake University, Hangzhou, China; Westlake Center for Intelligent Proteomics, Westlake Laboratory of Life Sciences and Biomedicine, Hangzhou, China; Institute of Basic Medical Sciences, Westlake Institute for Advanced Study, Hangzhou, China. Electronic address:
Background: The interplay between diet and gut microbiome substantially influences host metabolism, but uncertainties remain regarding their relationships tailored for each subject given the huge inter-individual variability. Here we aim to investigate diet-gut microbiome interaction at single-subject resolution and explore its effects on blood glucose homeostasis.
Methods: We conducted a series of nutritional n-of-1 trials (NCT04125602), in which 30 participants were assigned high-carbohydrate (HC) and low-carbohydrate (LC) diets in a randomized sequence across 3 pair of cross-over periods lasting 72 days.
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