The level of expression of HPV16 early transcripts is not associated with the natural history of cervical lesions.

The natural history of cervical cancer is closely linked to that of high-risk human papillomaviruses (HPV) infection. It is recognized that upon HPV DNA integration, partial or complete loss of the E2 open reading frame precludes expression of the corresponding protein, resulting in upregulation of the E6 and E7 viral oncoproteins. To better characterize HPV16 infection at the cervical level, viral load, viral DNA integration, and viral early transcript expression (E2, E5, and E6) were analyzed in a series of 158 cervical specimens representative of the full spectrum of cervical disease. Overall, the frequency of early transcript detection varied from 45% to 90% and tended to increase with lesion severity. In addition, the levels of E2, E5, and E6 transcript expression were slightly higher in high-grade lesions than in cervical specimens without abnormalities. Notably, early transcript expression was clearly associated with viral load, and no inverse correlation was found between the expression of E2 and E6 transcripts. No clear association was found between early transcript expression and HPV16 DNA integration, with the exception that samples with a fully integrated HPV16 genome did not harbor E2 or E5 transcripts. In conclusion, early HPV16 transcript expression appears to be associated with viral load rather than lesion grade. From a practical point of view, quantification of HPV16 early transcripts is difficult to translate into a relevant biomarker for cervical cancer screening.

Simple Aspiration versus Drainage for Complete Pneumothorax: A Randomized Noninferiority Trial.

Rationale: Management of first episodes of primary spontaneous pneumothorax remains the subject of debate. Objectives: To determine whether first-line simple aspiration is noninferior to first-line chest tube drainage for lung expansion in patients with complete primary spontaneous pneumothorax. Methods: We conducted a prospective, open-label, randomized noninferiority trial. Adults aged 18-50 years with complete primary spontaneous pneumothorax (total separation of the lung from the chest wall), recruited at 31 French hospitals from 2009 to 2015, received simple aspiration (n = 200) or chest tube drainage (n = 202) as first-line treatment. The primary outcome was pulmonary expansion 24 hours after the procedure. Secondary outcomes were tolerance of treatment, occurrence of adverse events, and recurrence of pneumothorax within 1 year. Substantial discordance in the numerical inputs used for trial planning and the actual trial rates of the primary outcome resulted in a reevaluation of the trial analysis plan. Measurement and Main Results: Treatment failure occurred in 29% in the aspiration group and 18% in the chest tube drainage group (difference in failure rate, 0.113; 95% confidence interval [CI], 0.026-0.200). The aspiration group experienced less pain overall (mean difference, -1.4; 95% CI, -1.89, -0.91), less pain limiting breathing (frequency difference, -0.18; 95% CI, -0.27, -0.09), and less kinking of the device (frequency difference, -0.05; 95% CI, -0.09, -0.01). Recurrence of pneumothorax was 20% in this group versus 27% in the drainage group (frequency difference, -0.07; 95% CI, -0.16, +0.02). Conclusions: First-line management of complete primary spontaneous pneumothorax with simple aspiration had a higher failure rate than chest tube drainage but was better tolerated with fewer adverse events. Clinical trial registered with www.clinicaltrials.gov (NCT01008228).

Liberal or Conservative Oxygen Therapy for Acute Respiratory Distress Syndrome.

BACKGROUND: In patients with acute respiratory distress syndrome (ARDS), the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network recommends a target partial pressure of arterial oxygen (Pao2) between 55 and 80 mm Hg. Prospective validation of this range in patients with ARDS is lacking. We hypothesized that targeting the lower limit of this range would improve outcomes in patients with ARDS. METHODS: In this multicenter, randomized trial, we assigned patients with ARDS to receive either conservative oxygen therapy (target Pao2, 55 to 70 mm Hg; oxygen saturation as measured by pulse oximetry [Spo2], 88 to 92%) or liberal oxygen therapy (target Pao2, 90 to 105 mm Hg; Spo2, ≥96%) for 7 days. The same mechanical-ventilation strategies were used in both groups. The primary outcome was death from any cause at 28 days. RESULTS: After the enrollment of 205 patients, the trial was prematurely stopped by the data and safety monitoring board because of safety concerns and a low likelihood of a significant difference between the two groups in the primary outcome. Four patients who did not meet the eligibility criteria were excluded. At day 28, a total of 34 of 99 patients (34.3%) in the conservative-oxygen group and 27 of 102 patients (26.5%) in the liberal-oxygen group had died (difference, 7.8 percentage points; 95% confidence interval [CI], -4.8 to 20.6). At day 90, 44.4% of the patients in the conservative-oxygen group and 30.4% of the patients in the liberal-oxygen group had died (difference, 14.0 percentage points; 95% CI, 0.7 to 27.2). Five mesenteric ischemic events occurred in the conservative-oxygen group. CONCLUSIONS: Among patients with ARDS, early exposure to a conservative-oxygenation strategy with a Pao2 between 55 and 70 mm Hg did not increase survival at 28 days. (Funded by the French Ministry of Health; LOCO2 ClinicalTrials.gov number, NCT02713451.).

Trajectories of cough without a cold in early childhood and associations with atopic diseases.

BACKGROUND: Although children can frequently experience a cough that affects their quality of life, few epidemiological studies have explored cough without a cold during childhood. OBJECTIVES: The objective of the study was to describe the latent class trajectories of cough from one to 10 years old and analyse their association with wheezing, atopy and allergic diseases. METHODS: Questions about cough, wheeze and allergic diseases were asked at 1, 1.5, 2, 3, 4, 5, 6 and 10 years of age in the European prospective cohort of Protection against Allergy: STUdy in Rural Environment (PASTURE). Specific IgE assays were performed at 10 years of age. Questions regarding a cough without a cold were used to build a latent class model of cough over time. RESULTS: Among the 961 children included in the study, apart from the never/infrequent trajectory (59.9%), eight trajectories of cough without a cold were identified: five grouped acute transient classes (24.1%), moderate transient (6.8%), late persistent (4.8%) and early persistent (4.4%). Compared with the never/infrequent trajectory, the other trajectories were significantly associated with wheezing, asthma and allergic rhinitis. For asthma, the strongest association was with the early persistent trajectory (ORa  = 31.00 [14.03-68.51]), which was inversely associated with farm environment (ORa  = 0.39 [0.19-0.77]) and had a high prevalence of cough triggers and unremitting wheeze. Late and early persistent trajectories were also associated with food allergy. Atopic sensitization was only associated with the late persistent trajectory. CONCLUSION: Late and early persistent coughs without a cold are positively associated with atopic respiratory diseases and food allergy. Children having recurrent cough without a cold with night cough and triggers would benefit from an asthma and allergy assessment. Growing up on a farm is associated with reduced early persistent cough.

The association between real-life markers of phone use and cognitive performance, health-related quality of life and sleep.

INTRODUCTION: The real-life short-term implications of electromagnetic fields (RF-EMF) on cognitive performance and health-related quality of life have not been well studied. The SPUTNIC study (Study Panel on Upcoming Technologies to study Non-Ionizing radiation and Cognition) aimed to investigate possible correlations between mobile phone radiation and human health, including cognition, health-related quality of life and sleep. METHODS: Adult participants tracked various daily markers of RF-EMF exposures (cordless calls, mobile calls, and mobile screen time 4 h prior to each assessment) as well as three health outcomes over ten study days: 1) cognitive performance, 2) health-related quality of life (HRQoL), and 3) sleep duration and quality. Cognitive performance was measured through six "game-like" tests, assessing verbal and visuo-spatial performance repeatedly. HRQoL was assessed as fatigue, mood and stress on a Likert-scale (1-10). Sleep duration and efficiency was measured using activity trackers. We fitted mixed models with random intercepts per participant on cognitive, HRQoL and sleep scores. Possible time-varying confounders were assessed at daily intervals by questionnaire and used for model adjustment. RESULTS: A total of 121 participants ultimately took part in the SPUTNIC study, including 63 from Besancon and 58 from Basel. Self-reported wireless phone use and screen time were sporadically associated with visuo-spatial and verbal cognitive performance, compatible with chance findings. We found a small but robust significant increase in stress 0.03 (0.00-0.06; on a 1-10 Likert-scale) in relation to a 10-min increase in mobile phone screen time. Sleep duration and quality were not associated with either cordless or mobile phone calls, or with screen time. DISCUSSION: The study did not find associations between short-term RF-EMF markers and cognitive performance, HRQoL, or sleep duration and quality. The most consistent finding was increased stress in relation to more screen time, but no association with cordless or mobile phone call time.

Improvement of downscaled ozone concentrations from the transnational scale to the kilometric scale: Need, interest and new insights.

BACKGROUND: Ground-level ozone is a major public health issue worldwide. An accurate assessment of ozone exposure is necessary. Modeling tools have been developed to tackle this issue in large areas. However, these models could present inaccuracies at the local scale. OBJECTIVES: The objective of this study was i) to assess whether O3 concentrations estimated by transnational modeling at the kilometric scale (9 km2) could be improved, ii) to propose a potential correction of these downscaled ozone concentrations and iii) to evaluate the efficiency and applicability of such a correction. METHOD: The present work was carried out in three phases. First, the performance of a transnational modeling platform (PREV'EST) was assessed at 6 geographic points by comparison with data from 6 air quality monitoring stations. Performance indicators were used for this purpose (MBE (mean bias error), MAE (mean absolute error), RMSE (root mean square error), r (Pearson correlation coefficient), and target plots). Second, several corrections were developed using MARS (multivariate adaptive regression splines) and integrating different sets of variables (mean temperature, relative humidity, rainfall amount, wind speed, elevation, and date). Their performance was evaluated. Third, external validation of the corrections was conducted using the data from six additional air quality monitoring stations. RESULTS: The uncorrected PREV'EST model presented a lack of exactitude and precision. These concentrations did not reproduce the interday variability of the measurements, leading to a lack of temporal contrast in exposure data. For the best performance enhancement, the correction applied improved MBE, MAE, RMSE and r from 14.67, 19.23, 23.18 and 0.67 to 0.00, 8.00, 10.19 and 0.91, respectively. External validation confirmed the efficiency of the corrections at the regional scale. CONCLUSIONS: We propose a validated and efficient methodology integrating local environmental variables. The methodology is adaptable according to the context, needs and data available.

Impact of a visual indicator on the noise level in an emergency medical dispatch centre - a pilot study.

BACKGROUND: Noise levels are monitored in call centres. A maximum of 52 to 55 dB(A) is recommended in order to prevent adverse events. We aimed at assessing the noise level and the impact of a visual noise indicator on the ambient noise level in a French Regional Emergency Medical Dispatch Centre (EMDC). METHODS: We conducted an observational study in the EMDC of the SAMU25 (University Hospital of Besancon). We measured the noise level using a SoundEarII® noise indicator (Dräger Medical SAS, France). The measurement took place in two phases on three consecutive days from 00:00 to 11:59 PM. At baseline, phase 1, the device recorded the average ambient noise for each minute without visual indication. Secondly, phase 2 included a sensor mounted with a light that would turn on green if noise was below 65 dB(A), orange if noise ever exceeded 65 and red if it exceeded 75 dB(A). RESULTS: In the presence of the visual noise indicator, the LAeq was significantly lower than in the absence of visual noise indicator (a mean difference of - 4.19 dB; P < 10-3). It was higher than 55 dB(A) in 84.9 and 43.9% of the time in phases 1 and 2, respectively. CONCLUSIONS: The noise levels were frequently higher than the standards, and sometimes close to recommended limits, requiring preventive measures. The noise indicator had a positive effect on the ambient noise level. This work will allow the implementation of effective prevention solutions and, based on future assessments, could improve operators' well-being and better care for patient.

Comparison between type A and type B early adiposity rebound in predicting overweight and obesity in children: a longitudinal study.

Early adiposity rebound (EAR) predicts paediatric overweight/obesity, but current approaches do not consider both the starting point of EAR and the BMI trajectory. We compared the clinical characteristics at birth, age 3-5 and 6-8 years of children, according to the EAR and to its type (type A/type B-EAR). We assessed the children's odds of being classified as overweight/obese at age 6-8 years, according to the type of EAR as defined at age 3-5 years. As part of this two-wave observational study, 1055 children were recruited and examined at age 3-5 years. Antenatal and postnatal information was collected through interviews with parents, and weight and height from the health records. Type A and type B-EAR were defined in wave 1 according to the BMI nadir and the variation of BMI z-score between the starting point of the adiposity rebound and the last point on the curve. At 6-8 years (wave 2), 867 children were followed up; 426 (40·4 %) children demonstrated EAR. Among them, 172 had type A-EAR, higher rates of parental obesity (P < 0·05) and greater birth weight compared with other children (P < 0·001). Odds for overweight/obesity at 6-8 years, when adjusting for antenatal and postnatal factors, was 21·35 (95 % CI 10·94, 41·66) in type A-EAR children and not significant in type B-EAR children (OR 1·76; 95 % CI 0·84, 3·68) compared with children without EAR. Classification of EAR into two subtypes provides physicians with a reliable approach to identify children at risk for overweight/obesity before the age of 5 years.

The score of integrated disease surveillance and response adequacy (SIA): a pragmatic score for comparing weekly reported diseases based on a systematic review.

BACKGROUND: The Integrated Disease Surveillance and Response (IDSR) strategy implemented by the World Health Organization (WHO) in Africa has produced a large amount of data on participating countries, and in particular on the Democratic Republic of Congo (DRC). These data are increasingly considered as unevaluable and, therefore, as requiring a rigorous process of validation before they can be used for research or public health purposes. The aim of this study was to propose a method to assess the level of adequacy of IDSR morbidity data in reflecting actual morbidity. METHODS: A systematic search of English- and French-language articles was performed in Scopus, Medline, Science Direct, Springer Link, Cochrane, Cairn, Persée, and Erudit databases. Other types of documents were identified through manual searches. Selected articles focused on the determinants of the discrepancies (differences) between reported morbidity and actual morbidity. An adequacy score was constructed using some of the identified determinants. This score was applied to the 15 weekly reported diseases monitored by IDSR surveillance in the DRC. A classification was established using the Jenks method and a sensitivity analysis was performed. Twenty-three classes of determinants were identified in 35 IDSR technical guides and reports of outbreak investigations and in 71 out of 2254 researched articles. For each of the 15 weekly reported diseases, the SIA was composed of 12 items grouped in 6 dimensions. RESULTS: The SIA classified the 15 weekly reported diseases into 3 categories or types: high score or good adequacy (value > = 14), moderate score or fair adequacy (value > = 8 and < 14), and low score or low or non-adequacy (value < 8). Regardless of the criteria used in the sensitivity analysis, there was no notable variation in SIA values or categories for any of the 15 weekly reported diseases. CONCLUSION: In a context of sparse health information in low- and middle-income countries, this study developed a score to help classify IDSR morbidity data as usable, usable after adjustment, or unusable. This score can serve to prioritize, optimize, and interpret data analyses for epidemiological research or public health purposes.

High Prevalence of Anal Canal High-Risk Human Papillomavirus Infection in Patients With Crohn's Disease.

BACKGROUND & AIMS: The increasing incidence of anal canal carcinomas requires better knowledge on anal human papillomavirus (HPV) infection. We aimed to assess anal canal HPV infection prevalence and risk factors among patients seen at a gastroenterology department in France. METHODS: We analyzed anal tissue samples collected from 469 consecutive patients (median age 54 years, 52% women), including 112 who received immunosuppressant therapies and 101 with inflammatory bowel disease (70 with Crohn's disease), who underwent colonoscopy examinations from April 1, 2012 to April 30, 2015. HPV was detected and genotyped using the INNO-LiPA assay, and we collected medical and demographic data from all subjects. Risk factors for any HPV, high-risk HPV (HR-HPV) and HPV16 infection were assessed by bivariate and multivariate analysis. The primary outcomes association of HR-HPV or HPV16 with medical and demographic features. RESULTS: We detected HPV DNA in anal tissues from 34% of the subjects and HR-HPV in 18%. HPV16 was the most prevalent genotype (detected in 7%), followed by HPV51, HPV52, and HPV39. HR-HPV was detected in a significantly higher proportion of samples from women (23.1%) than men (12.8%) (P = .0035); HR-HPV and HPV16 were detected in a significantly higher proportion of patients with Crohn's disease (30.0%) than without (18.1%) (P = .005). Female sex, history of sexually transmitted disease, lifetime and past year-number of sexual partners, active smoking, and immunosuppressive therapies were independent risk factors for anal HR-HPV infection in multivariate analysis. CONCLUSION: One third of patients who underwent colonoscopy at a gastroenterology department were found to have anal canal HPV infection. We detected HR-HPV infection in almost 20% of patients and in a significantly higher proportion of patients with Crohn's disease than without. Increasing our knowledge of HPV infection of anal tissues could help physicians identify populations at risk and promote prophylaxis with vaccination and adequate screening.

Clinical Effectiveness of Intravenous Exenatide Infusion in Perioperative Glycemic Control after Coronary Artery Bypass Graft Surgery: A Phase II/III Randomized Trial.

BACKGROUND: We aimed to assess the clinical effectiveness of intravenous exenatide compared to insulin in perioperative blood glucose control in coronary artery bypass grafting surgery patients. METHODS: Patients more than 18 yr old admitted for elective coronary artery bypass grafting were included in a phase II/III nonblinded randomized superiority trial. Current insulin use and creatinine clearance of less than 60 ml/min were exclusion criteria. Two groups were compared: the exenatide group, receiving exenatide (1-h bolus of 0.05 µg/min followed by a constant infusion of 0.025 µg/min), and the control group, receiving insulin therapy. The blood glucose target range was 100 to 139 mg/dl. The primary outcome was the proportion of patients who spent at least 50% of the study period within the target range. The consumption of insulin (Cinsulin) and the time to start insulin (Tinsulin) were compared between the two groups. RESULTS: In total, 53 and 51 patients were included and analyzed in the exenatide and control groups, respectively (age: 70 ± 9 vs. 68 ± 11 yr; diabetes mellitus: 12 [23%] vs. 10 [20%]). The primary outcome was observed in 38 (72%) patients in the exenatide group and in 41 (80%) patients in the control group (odds ratio [95% CI] = 0.85 [0.34 to 2.11]; P = 0.30). Cinsulin was significantly lower (60 [40 to 80] vs. 92 [63 to 121] U, P < 0.001), and Tinsulin was significantly longer (12 [7 to 16] vs. 7 [5 to 10] h, P = 0.02) in the exenatide group. CONCLUSIONS: Exenatide alone at the dose used was not enough to achieve adequate blood glucose control in coronary artery bypass grafting patients, but it reduces overall consumption of insulin and increases the time to initiation of insulin.

The RAPID Neuropsychological Test Battery for Subjects Aged 50-89: From Norms to Cognitive Profile.

BACKGROUND/AIMS: It is well established that healthy adults obtain low performances when simultaneously interpreting the results of multiple tests. The aim of this study was to estimate the proportion of French-speaking healthy older adults with low scores for the RAPID (Réseau d'Aide au diagnostic et à la PrIse en charge des Détériorations cognitives et de maladies neurologiques chroniques en Franche-Comté et au niveau national) battery test and consider different combinations of test scores within a specific domain and across different domains. METHODS: The prevalence of low scores (i.e., ≤5th percentile) on the 14 RAPID primary measures was calculated from the RAPID normative sample (n = 476), based on 4 ages (50-89 years) and 3 levels of education. RESULTS: A high percentage (40.1%) of the normative sample obtained at least one or more low scores (i.e., false positives). In contrast, the risk of having low scores was much less important (<2%) when considering the combinations of 2 test-scores. CONCLUSION: Low scores are very common in healthy older subjects and are thus not necessarily pathological or indicative of truly impaired functioning. The information derived from a cognitive profile may provide a greater clinical relevance in an individual, since very few of the healthy older adults obtained low scores on combinations of 2 test-scores.

Prevalence and risk factors for COPD in farmers: a cross-sectional controlled study.

There are conflicting data regarding the magnitude and determinants of chronic obstructive pulmonary disease (COPD) risk in farmers.In a cross-sectional study of 917 nonfarming working controls and 3787 farmers aged 40-75 years, we assessed respiratory symptoms, tobacco exposure, job history (without direct exposure measurement) and lung function. COPD was defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criterion (post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) <0.70) and by the Quanjer reference equation (post-bronchodilator FEV1/FVC

Obesity is Not an Independent Factor for Adverse Outcome after Abdominal Aortic Aneurysm Repair.

BACKGROUND: The prevalence of obesity is increasing, and its impact on the outcome of open and endovascular abdominal aortic aneurysm (AAA) repair remains unclear, particularly in the European population. We herein assessed the impact of obesity on the postoperative course for both techniques. METHODS: From a database that consecutively collects all patients undergoing AAA repair; we selected all patients undergoing elective surgery for open or endovascular AAA repair, between January 2003 and December 2011. We considered obese patients (body mass index >30 kg/m(2)), overweight (25.1-30 kg/m(2)), and normal-weight patients (18.7-25 kg/m(2)), and compared mortality and/or severe complications at 30 days between obese and nonobese patients (overweight and normal weight) separately for each type of surgery by logistic regression analysis. We analyzed wound complications in the 2 groups. RESULTS: We included 748 patients, 174 obese, and 574 nonobese patients. Obese patients were younger (P < 0.001) and were less likely to have renal failure (P < 0.001) in both techniques. Obese patients in the open repair (OR) group showed a trend toward lower mortality and/or complication rates than in nonobese patients (4.8% vs. 7.5%, P = 0.34). In contrast, in the endovascular aortic aneurysm repair (EVAR) group, obese patients showed a trend toward higher mortality and/or complication rates than nonobese patients (7.1% vs. 3.2%, P = 0.17). In multivariate analysis, obesity was not an independent predictor of outcomes in OR (P = 0.18) or in EVAR (P = 0.20). Wound complications were not higher in obese patients in OR and in EVAR. CONCLUSIONS: Obesity should not be considered an independent risk factor of death and severe complications at 30 days in either open or endovascular AAA repair. Therefore, obesity should not systematically lead to the decision to use EVAR.

Association between ambient noise exposure and school performance of children living in an urban area: a cross-sectional population-based study.

Most of the studies investigating the effects of the external noise on children's school performance have concerned pupils in schools exposed to high levels due to aircraft or freeway traffic noise. However, little is known about the consequences of the chronic ambient noise exposure at a level commonly encountered in residential urban areas. This study aimed to assess the relationship between the school performance of 8- to 9-year-old-children living in an urban environment and their chronic ambient noise exposure at home and at school. The children's school performances on the national standardized assessment test in French and mathematics were compared with the environmental noise levels. Children's exposure to ambient noise was calculated in front of their bedrooms (Lden) and schools (LAeq,day) using noise prediction modeling. Questionnaires were distributed to the families to collect potential confounding factors. Among the 746 respondent children, 586 were included in multilevel analyses. On average, the LAeq,day at school was 51.5 dB (SD= 4.5 dB; range = 38-58 dB) and the outdoor Lden at home was 56.4 dB (SD= 4.4 dB; range = 44-69 dB). LAeq,day at school was associated with impaired mathematics score (p = 0.02) or impaired French score (p = 0.01). For a + 10 dB gap, the French and mathematics scores were on average lower by about 5.5 points. Lden at home was significantly associated with impaired French performance when considered alone (p < 10(-3)) and was borderline significant when the combined home-school exposure was considered (p = 0.06). The magnitude of the observed effect on school performance may appear modest, but should be considered in light of the number of people who are potentially chronically exposed to similar environmental noise levels.

Efficacy of high-flow nasal oxygen therapy started in the emergency room versus conventional oxygen therapy in patients with acute hypoxaemic respiratory distress: protocol for a French multicentric, prospective, open and randomised superiority study protocol (HIFLOWED).

INTRODUCTION: Acute respiratory failure is a life-threatening condition frequently found in the emergency department. High-flow nasal oxygen (HFNO) is increasingly used in emergency departments for patients with hypoxaemic acute respiratory failure. However, despite the increasing number of studies, its potential advantages regarding the need for therapeutic escalation and mortality have not been precisely evaluated. Our objective is to compare conventional oxygen therapy to HFNO when they are initiated during the first hour following the patient's arrival at the emergency department, with the hypothesis that HFNO would reduce the need for ventilatory therapy escalation. METHODS AND ANALYSIS: This is a multicentric, prospective, open and randomised superiority study. 500 inpatients will be randomised (1:1) to receive conventional oxygen therapy or HNFO. The primary outcome is a failure in the oxygen therapy defined as the need for a therapeutic escalation within 4 hours after therapy initiation. ETHICS AND DISSEMINATION: The study has been submitted and approved by the Comité de Protection des Personnes Nord Ouest IV (20 October 2020). As required, a notification was sent to the Agence nationale de sécurité du médicament et des produits de santé (22 October 2020). The research results will be published in peer-reviewed publications and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT04607967.

Analysis of the transplacental transmission of SARS CoV-2 virus and antibody transfer according to the gestational age at maternal infection.

To quantify transplacental transmission of SARS-CoV-2 virus and antibody transfer in pregnant women and their newborns according to the gestational age at maternal infection. A prospective observational multicenter study including pregnant women with a positive RT-PCR or a positive serology for SARS-CoV-2 and compatible symptoms, from April to December 2020, in 11 French maternities. The study was designed to obtain a systematic collection of mother-infant dyad's samples at birth. SARS-CoV-2 viral load was measured by RT-PCR. IgG and IgM antibodies against the SARS-CoV-2 spike protein were measured by enzyme-linked immunosorbent assay. Antibody concentrations and transplacental transfer ratios were analyzed according to the gestational age at maternal infection. The primary outcome was the rate of SARS CoV-2 materno-fetal transmission at birth. The secondary outcome was the quantification of materno-fetal antibody transfer. Maternal and neonatal outcomes at birth were additionally assessed. Among 165 dyads enrolled, one congenital infection was confirmed {n = 1 (0.63%) IC95% [0.02%; 3.48%]}. The average placental IgG antibody transfer ratio was 1.27 (IC 95% [0.69-2.89]). The transfer ratio increased with increasing time between the onset of maternal infection and delivery (P Value = 0.0001). Maternal and neonatal outcomes were reassuring. We confirmed the very low rate of SARS-CoV-2 transplacental transmission (< 1%). Maternal antibody transfer to the fetus was more efficient when the infection occurred during the first and second trimester of pregnancy.

Spatialized temporal dynamics of daily ozone concentrations: Identification of the main spatial differences.

Ground-level ozone (O3) is one of the most worrisome air pollutants regarding environmental and health impacts. There is a need for a deeper understanding of its spatial and temporal dynamics. Models are needed to provide continuous temporal and spatial coverage in ozone concentration data with a fine resolution. However, the simultaneous influence of each determinant of ozone dynamics, their spatial and temporal variations, and their interaction make the resulting dynamics of O3 concentrations difficult to understand. This study aimed to i) identify different classes of temporal dynamics of O3 at daily and 9 km2 resolution over a long-term period of 12 years, ii) identify the potential determinants of these dynamics and, iii) explore the spatial distribution of the potential classes of temporal dynamics on a spatial continuum and over about 1000 km2. Thus, 126 time series of 12-year daily ozone concentrations were classified using dynamic time warping (DTW) and hierarchical clustering (study area centered on Besançon, eastern France). The different temporal dynamics obtained differed on elevation, ozone levels, proportions of urbanized and vegetated surfaces. We identified different daily ozone temporal dynamics, spatially structured, that overlapped areas called urban, suburban and rural. Urbanization, elevation and vegetation acted as determinants simultaneously. Individually, elevation and vegetated surface were positively correlated with O3 concentrations (r = 0.84 and r = 0.41, respectively), while the proportion of urbanized area was negatively correlated with O3 (r = -0.39). An increasing ozone concentration gradient was observed from urban to rural areas and was reinforced by the elevation gradient. Rural areas were both subject to higher ozone levels (p < 0.001), least monitoring and lower predictability. We identified main determinants of the temporal dynamics of ozone concentrations. The joint influence of determinants was also synthesized. This study proposed a systematic, and reproducible way to build exposure area mapping.

ATHLETIQUE: interest of an adapted physical activity program in patients with juvenile idiopathic arthritis: a feasibility and preliminary effectiveness study.

Background: Juvenile Idiopathic Arthritis (JIA) is associated with joint inflammation, pain and limited joint mobility, impacting the practice of physical activities. Adapted Physical Activities (APA) are an increasingly used method of rehabilitation, but additional studies are needed to define the nature of the most appropriate physical activity for patients with JIA. The "ATHLETIQUE" project aims to evaluate the impact of a program integrating APA sessions with use of a pedometer watch, on disease activity in patients with JIA. Methods: This study will be a randomized, multicenter, open-label, controlled clinical trial with 2 parallel arms. The patients included in this study will be children and adolescents with JIA, aged 6 to 17 years. The experimental group (30 patients) will participate in an APA program for 3 months and will use a pedometer watch for one year. We will evaluate and compare the change in disease activity measurements (primary objective), fatigue, pain, quality of life, level of physical activity, functional capacities, and muscle strength (secondary objectives) after 14, 26 and 50 weeks. The control group (10 patients) will undergo the same evaluations as the experimental group but will not participate in the APA program and will not wear the pedometer watch. Expected results: The APA program may help to promote an active lifestyle with regular physical activity, preventing comorbidities and motor disability. Promising results on disease activity, functional capacities and quality of life would enable us to envisage a larger research program with a view to optimizing and assessing APA for children with JIA. Discussion: This study will be conducted in the short and medium-term, with one-year follow-up, including 3 months of APA sessions for the experimental group. The sessions proposed during the APA program will mainly be aerobic and bodyweight exercises. Furthermore, in contrast to previous studies on this topic, our study will integrate a novel element, namely the use of a pedometer watch. This watch will help to implement strategies to address motivation. This study aims to improve physical and mental well-being, provide a basis for the design of a larger study, and propose recommendations adapted to children with JIA. Trial registration: Registered with ClinicalTrials.gov under the number NCT05572424.