FIRE Stones: impact of forced diuresis on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser-protocol for a randomized controlled two-parallel group multicenter trial with blinding evaluation.

Background: Lithiasis is a common and recurrent disease. Flexible ureteroscopy (fURS) is the cornerstone of laser treatment of kidney stones. Kidney stones destruction requires its laser pulverization into small fragments in order to remove them through the ureter or improve their spontaneous expulsion along the urinary tract.

Rituximab and mycophenolate mofetil combination in patients with interstitial lung disease (EVER-ILD): a double-blind, randomised, placebo-controlled trial.

Background: Standard of care for interstitial lung disease (ILD) with a nonspecific interstitial pneumonia (NSIP) pattern proposes mycophenolate mofetil (MMF) as one of the first-step therapies while rituximab is used as rescue therapy.

Methods: In a randomised, double-blind, two-parallel group, placebo-controlled trial (NCT02990286), patients with connective tissue disease-associated ILD or idiopathic interstitial pneumonia (with or without autoimmune features) and a NSIP pattern (defined on NSIP pathological pattern or on integration of clinicobiological data and a NSIP-like high-resolution computed tomography pattern) were randomly assigned in a 1:1 ratio to receive rituximab (1000 mg) or placebo on day 1 and day 15 in addition to MMF (2 g daily) for 6 months. The primary end-point was the change in percent predicted forced vital capacity (FVC) from baseline to 6 months analysed by a linear mixed model for repeated measures analysis.

Peripheral facial palsy post SARS-CoV-2 vaccine: A regional pharmacovigilance cases series.

Peripheral facial palsy (PFP) is a rare adverse reaction identified from clinical trials of coronavirus disease 2019 (COVID-19) vaccines (messenger ribonucleic acid [mRNA] and viral vector). Few data are available on their onset patterns and risk of recurrence after re-injection of a COVID-19 vaccine; the objective of this study was to describe PFP cases attributed to COVID-19 vaccines. All cases of facial paralysis reported to the Regional Pharmacovigilance Center of Centre-Val de Loire area between January and October 2021, in which the role of a COVID-19 vaccine was suspected, were selected.

Adverse effect of Pneumocystis Jirovecii infection associated with rituximab therapy for autoimmune disease are more frequently reported in older vs. younger patient.

Introduction: Rituximab is a chimeric anti-CD20 antibody commonly used to treat patients with autoimmune diseases. Such diseases mainly affect young people, but older patients may also be concerned. So far, very little data exist concerning the safety of rituximab in older patients with autoimmune diseases.

Study of Influence of Atmospheric Conditions on the Thermal Properties of Sleeping Bags.

The thermal properties of clothing products are influenced by external environmental parameters, such as temperature, humidity, air flow and parameters related to the user's body, which mainly include temperature and humidity. Depending on the type of raw material, its thickness and the material manufacturing technique, clothing products are characterised by certain insulating properties to protect the human body from external factors. A multilayer system made of different material groups can change the thermal insulating capacity significantly, which cannot be determined by the testing of individual layers used in the production.

Specific features of amoxicillin-associated Drug Reaction with Eosinophilia and Systemic Symptoms syndrome: a nationwide study.

Background: Growing evidence indicates that amoxicillin induces herpesvirus replication in vitro. As these play a central pathophysiological role in Drug Reaction with Eosinophilia and Systemic Symptoms syndrome (DRESS), amoxicillin could present with specific DRESS features.

Objective: To characterize the onset patterns of amoxicillin-associated DRESS.

Bullous haemorrhagic dermatitis induced by heparins and other anticoagulants: 94 cases from French pharmacovigilance centres and a literature review.

Background: Bullous haemorrhagic dermatitis (BHD) is an uncommon and highly particular side effect of various forms of heparins.

Methods: To better characterise the disease, we collected all cases from French Pharmacovigilance centres recorded over a 20-year period (37 cases) and performed a Medline literature search up to June 2020 (57 cases).

Results: In all, 94 patients were identified (male/female ratio: 2.

Transient major hypothermia associated with acetaminophen: A pediatric case report and literature review.

We report the case of a 4-month-old baby boy who presented hypothermia (rectal temperature 36°C) after acetaminophen intake for post-vaccination fever. A recurrence of the hypothermia was observed after acetaminophen rechallenge for fever. We reviewed 14 other pediatric cases of hypothermia secondary to therapeutic doses of acetaminophen.

Rituximab-induced serum sickness is more frequent in autoimmune diseases as compared to hematological malignancies: A French nationwide study.

Introduction: Rituximab induced serum sickness (RISS) is a rare delayed hypersensitivity reaction. The aim of this study was to describe the epidemiological and clinical characteristics of the RISS cases reported in France.

Method: Serum sickness cases involving rituximab were identified from the French PharmacoVigilance Database from 1998 to 2016.

Pregnancy outcome following in utero exposure to azathioprine: A French comparative observational study.

Aim Of The Study: To evaluate whether azathioprine exposure during pregnancy increases the risk of birth defects and prematurity.

Method: Prospective comparative observational study using the French pregnancy database TERAPPEL. To evaluate birth defects, outcomes of pregnancies exposed to azathioprine during the 1st trimester were prospectively assessed and compared to that of pregnancies exposed to another drug used for the same indications.

[Post-licensure safety surveillance for Prevenar 13 in France].

Objective: To describe the profile and the incidence of adverse events (AEs) reported with Prevenar 13 since its commercialization.

Method: Analysis of all adverse events reported with Prevenar 13 in France between 1st July 2010 and 31 October 2014.

Results: In 4 years and 4 months, 376 AEs, including 252 severe (67%), were recorded, 83 of which occurred following an injection of Prevenar 13 alone: 39 cutaneous AEs, 16 neurological AEs, four cases of collapse or shock, nine cases of fever, and one of thrombocytopenia.

[Safety profile of etonogestrel contraceptive implant (Nexplanon and Implanon) reported in France].

Objectives: The aim of the study was to assess the incidence of adverse effects (AE) reported with etonogestrel contraceptive implant in France (Implanon and Nexplanon).

Materials And Methods: All cases of AE or unintended pregnancies reported to health authorities or to the firm were analyzed.

Results: During 10 years, 5433 AE and 789 unintended pregnancies were reported.