Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial

BackgroundWe evaluated the safety and immunogenicity of NVX-CoV2373, a recombinant SARS-CoV-2 nanoparticle vaccine, in healthy Japanese participants.MethodsThis phase 1/2, randomized, observer-blind, placebo-controlled trial conducted in Japan (two sites), enrolled healthy Japanese adults aged ≥ 20 years with no history/risk of SARS-CoV-2 infection and no prior exposure to other approved/investigational SARS-CoV-2 vaccines or treatments. Participants were stratified by age (< 65 or ≥ 65 years) and randomized to receive two doses of either NVX-CoV2373 (5 μg SARS-CoV-2 rS; 50 μg Matrix-M1) or placebo, 21 days apart. Primary outcomes were safety and immunogenicity assessed by serum IgG antibody levels against SARS-CoV-2 rS protein on day 36. Herein, we report the primary data analysis at 4 weeks after the second dose, ahead of 12-month follow-up completion (data cut-off: 8 May 2021).ResultsBetween 12 February 2021 and 17 March 2021, 326 subjects were screened, and 200 participants enrolled and randomized: NVX-CoV2373, n = 150; placebo, n = 50. Solicited adverse events (AEs) through 7 days after each injection occurred in 121/150 (80.7%) and 11/50 (22.0%) participants in the NVX-CoV2373 and placebo arms, respectively. In the NVX-CoV2373 arm, tenderness and injection site pain were the most frequently reported solicited AEs after each vaccination, irrespective of age. Robust immune responses occurred with NVX-CoV2373 (n = 150) by day 36: IgG geometric mean fold rise (95% confidence interval) 259 (219, 306); seroconversion rate 100% (97.6, 100). No such response occurred with placebo (n = 49).ConclusionTwo doses of NVX-CoV2373 given with a 21-day interval demonstrated acceptable safety and induced robust anti-SARS-CoV-2 immune responses in healthy Japanese adults. Funding: Takeda Pharmaceutical Company Limited and Japan Agency for Medical Research and Development (AMED). ClinicalTrials.gov identifier: NCT04712110.     

Síntomas de tramo urinario inferior y síndrome de apnea obstructiva del sueño: evolución urodinámica antes y después de un año de tratamiento con presión continua positiva de la vía aérea

ObjectiveTo report the clinical evolution and the urodynamic behaviour of several lower tract urinary symptoms in patients with obstructive sleep apnea syndrome before and after the treatment with continuous positive airway pressure (CPAP) devices.MethodsA prospective study was performed; patients with recent diagnosis of sleep apnea confirmed by nocturnal sleep polygraphy and absence of medical urological past history. In order to discard important lower urinary tract conditions, urological examinations were previously performed. Urinary symptoms were evaluated using the IPSS and OAB-V8 validated questionnaires, three-day Bladder Diary and invasive urodynamic examinations with a gap of one year before and one year after using the CPAP.Results84 urodynamic studies were carried out in 43 patients. The IPSS score decreased by 3.58 points. The OAB-V8 score decreased by 2.87 points. Nocturia episodes decreased to one per night. The percentage of patients with nocturnal polyuria went down to 26%. The bladder compliance significantly increased (97.39 vs 200.40 ml/cm H2O). The presence of detrusor overactivity decreased from 11 (before CPAP) to 5 patients (after CPAP).ConclusionThe proper treatment with CPAP showed a statistical and clinical improvement of several LUTS with limited urodynamic modifications.     

Substernal Chest Pain and Dyspnea in a Female Patient

A 76-year-old female patient presented to the emergency department with substernal chest pain and dyspnea symptoms. She reported that the symptoms started 2 days earlier. These symptoms can arise from both cardiac and noncardiac conditions. It is difficult to ascribe chest pain and dyspnea symptoms to a single cause. Recognizing these symptoms is critical for inpatient cardiac and primary care nurse practitioners to choose the correct diagnosis and facilitate more effective treatment planning.     

Guidelines of the French Society of Otorhinolaryngology. Role of the ENT specialist in the diagnosis of childhood obstructive sleep apnea-hypopnea syndrome (OSAHS). Part 1: Interview and physical examination

ObjectivesTo present the 2017 Clinical Practice Guidelines of the French Society of Otorhinolaryngology concerning the role of the ENT specialist in the diagnosis of pediatric obstructive sleep apnea-hypopnea syndrome. This article focuses specifically on medical history and physical examination.MethodsA multidisciplinary work-group drew up a first version of the guidelines, graded according to level of evidence following the GRADE grading system. The final version was obtained by including the suggestions and comments from the editorial group.ResultsAt the end of the process, guidelines were established and graded regarding the following points: interview and analysis of the various interview scores recommended in the literature; clinical examination with awake upper-airway endoscopy; and indications for referral to non-ENT specialists.     

Impact of Venous Collaterals on Clinical Outcomes in Paget–Schroetter Syndrome

Purpose

To characterize the degree of venous collateralization before and after endovascular therapy and determine the effect of collateralization on success of thrombolysis and rate of repeat intervention in patients with Paget–Schroetter syndrome.

Leukaemic variants of cutaneous T-cell lymphoma: Erythrodermic mycosis fungoides and Sézary syndrome

Mycosis fungoides (MF) and Sézary syndrome (SS) are the most common types of cutaneous lymphoma, accounting for approximately 60% of cutaneous T-cell lymphomas. Diagnosis requires correlation of clinical, histologic, and molecular features. A multitude of factors have been linked to the aetiopathogenesis, however, none have been definitively proven. Erythrodermic MF (E-MF) and SS share overlapping clinical features, such as erythroderma, but are differentiated on the degree of malignant blood involvement. While related, they are considered to be two distinct entities originating from different memory T cell subsets. Differential expression of PD-1 and KIR3DL2 may represent a tool for distinguishing MF and SS, as well as a means of monitoring treatment response. Treatment of E-MF/SS is guided by disease burden, patients’ ages and comorbidities, and effect on quality of life. Current treatment options include biologic, targeted, immunologic, and investigational therapies that can provide long term response with minimal side effects. Currently, allogeneic stem cell transplantation is the only potential curative treatment.     

Dietary fat intake and metabolic syndrome in adults: A systematic review

Background and aimsThe metabolic syndrome (MetS) is a cluster of coexisting cardiovascular risk factors. The role of specific dietary fats was reemphasized by dietary recommendations. This systematic review aims to assess evidence for the effect of dietary fat intake on MetS occurrence and reversion in adults.Methods and ResultsThe MEDLINE database was used to search the existing literature. We included observational studies that analyzed dietary fat intake in adults with MetS and clinical trials that compared the effects of different dietary fat diets on MetS and/or its components. Thirty articles were selected (14 observational and 16 clinical trials), and we included information of dietary fat and fatty acids as well as MetS, body mass index, cholesterol, hypertension, and diabetes in adults. SFA intake was found to be positively associated with MetS components. Most of the observational reviewed studies found beneficial associations between MUFA and PUFA (including n-3 and n-6 subtypes) intake and MetS components. Clinical trials also supported the benefits of MUFA- or PUFA-enriched diets (including low-fat diets) in reducing MetS.ConclusionsThe effects of dietary SFAs on MetS will be influenced by other specific nutrients. Replacement of SFA by MUFA and PUFA has been associated with a decrease in MetS. Dietary recommendations should emphasize on different qualities of fat intake, not only to reduce total fat intake, to obtain health benefits in adults.