Priors and decision thresholds in phase 2 and phase 3 randomized controlled trials evaluating drug efficacy using Bayesian methods: a systematic review.

Objective: To describe the priors and decision thresholds in phase 2 and 3 RCTs evaluating drug efficacy using Bayesian methods.

Study Design And Setting: A systematic review of phase 2 and 3 RCTs evaluating drug efficacy through Bayesian inference was conducted across the MEDLINE, EMBASE and Cochrane databases, with no date restrictions until September 2022. The type of prior used for the analysis of the primary endpoint and its characteristics (type and parameters of the distribution, justification, sensitivity analysis), the use of a posterior probability decision threshold defined a priori, and its value, were extracted.

[Construction of a methodology for clinical evaluation of medical devices using simulation tools and illustration through three studies].

Introduction: European regulations have recently moved towards more stringent requirements for demonstrating the safety and performance of medical devices (MDs).

Objective: To apply an innovative testing method using medical simulation to the evaluation of three medical devices at different stages of their life cycle.

Method: The methodology for evaluating DMs using simulation is based on seven stages: definition of the context, training, construction of a scenario to test the DM, validation of the scenario, realization of the scenario, evaluation of the scenario by the players and validation and exploitation of the results.

Very long-term risk of moderate-to-severe postthrombotic syndrome after deep vein thrombosis.

Background: Postthrombotic syndrome (PTS) refers to manifestations of chronic venous insufficiency after a deep vein thrombosis (DVT). The risk of developing moderate-to-severe PTS in the very long term is largely unknown and particularly in case of distal DVT. Furthermore, the impact of DVT vs other causes of chronic venous insufficiency on long-term manifestations of PTS is also unknown.

H inhalation therapy in patients with moderate COVID-19 (HCOVID): a prospective ascending-dose phase I clinical trial.

Unlabelled: The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has triggered a serious global health crisis, resulting in millions of reported deaths since its initial identification in China in November 2019. The global disparities in immunization access emphasize the urgent need for ongoing research into therapeutic interventions. This study focuses on the potential use of molecular dihydrogen (H2) inhalation as an adjunctive treatment for COVID-19.

Pilot Study: Safety and Performance Validation of an Ingestible Medical Device for Collecting Small Intestinal Liquid in Healthy Volunteers.

The connection between imbalances in the human gut microbiota, known as dysbiosis, and various diseases has been well established. Current techniques for sampling the small intestine are both invasive for patients and costly for healthcare facilities. Most studies on human gut microbiome are conducted using faecal samples, which do not accurately represent the microbiome in the upper intestinal tract.