Aulnay Sous Bois

Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. Prevalence of FPIES is unknown. In 2011, Katz published cumulative incidence of cow 'milk FPIES of 3 per 1000 new-borns, from prospective birth cohort in Israel. The offending food depend on the country, probably in relation to eating habits. Cow's milk (CM) is most commonly incriminated and can lead to a chronic digestive disease or in its acute form with potentially life-threatening vomiting/diarrhoea/dehydration, confusing with anaphylaxis. Rice and oat in US, or fish and egg in France are the solid food most often implicated. This disease is usually unknown by clinicians. Its diagnostic is based on clinical history, and differential diagnosis elimination. In 2017, an international workgroup of American Academy of Allergy, Asthma and Immunology published clinical criteria to specify the diagnosis and management. According to this last definition (JACI 2017), patient have to meet the major criterion and at least 3 minor criteria. Major criterion is vomiting in the 1- to 4-h period after ingestion of the suspect food and absence of classic IgE-mediated allergic skin or respiratory symptoms. Minor criteria are : 1. A second (or more) episode of repetitive vomiting after eating the same suspect food, 2. Repetitive vomiting episode 1-4 h after eating a different food 3. Extreme lethargy with any suspected reaction 4. Marked pallor with any suspected reaction 5. Need for emergency department visit with any suspected reaction 6. Need for intravenous fluid support with any suspected reaction 7. Diarrhea in 24 h (usually 5-10 h) 8. Hypotension 9. Hypothermia Skin prick test et IgE antibody are negative except atypical FPIES. Acute management begins with clinical evaluation, then administer normal saline bolus quickly. Parenteral ondansetron can be used to stop vomiting. Nutritional management implicate elimination of the offending foods. Only the oral food challenge in hospital can be done to determine resolution of FPIES after a long time of no symptom. The age of tolerance, depend of the food. The average age of acquiring tolerance for cow's milk changes in the literature, around 8-10 months in Korea, around 1 year in Israel, around 5 years in the United States. There is no data in France on the recovery age of CM-FPIES. However, there is a lack of information in literature for describe the evolution and atypical phenotypes. In addition, no prospective French series has been published to date. Our work is a national prospective study, which will collect news cases of acute FPIES diagnosis in sixteen French centres. Main objective: To determine the rate of acquisition of tolerance by food at 1 year, 2 years, 3 years post inclusion. Secondary objectives: * Description of a population of children with newly diagnosed FPIES. 2. Describe the rate of patients with FPIES progressing to IgE sensitization whatever the food at 1 year, 2 years, 3 years post inclusion. 3\. Determine per food the rate of FPIES patients evolving towards IgE sensitization at 1 year, 2 years, 3 years post inclusion. 4\. Describe the rate of patients with FPIES progressing to clinical symptoms of IgE-mediated allergy, whatever the food, at 1 year, 2 years, 3 years post inclusion. 5\. Determine, by food, the rate of FPIES evolving towards clinical symptoms of IgE-mediated allergy at 1 year, 2 years, 3 years post inclusion. 6\. Describe the rate of patients with multiple FPIES at each time point of the study. 7\. Describe at each time the rates of patients with personal atopic comorbidities. The inclusion period will last three years, and the follow up of each patient will last three years. Allergologist will see the patient at inclusion visit, then one time a year. If the patient does not acquire tolerance, an oral food challenge (OFC) in hospital will lead to answer. The aim of our work will help allergologist to manage FPIES children, with French specificities in offending food, and tolerance.

Currently, managing children with ASD emphasizes compensating for communication and social interaction disabilities. Communication tools like PECS or Makaton and social skills groups have shown effectiveness but have limitations, particularly not addressing sensory atypicalities seen in children with ASD. These sensory atypicalities are evident when children watch videos on screens. The idea is to use video to understand the sensory experiences of children with ASD and help them move away from an isolated relationship with screens. New technologies can further isolate children with ASD in their autistic sphere. The hypothesis is that observing these children with screens will provide better understanding of their sensory experiences and improve therapeutic support towards play and interaction with others

For patients successfully resuscitated who got restoration of spontaneous circulation (ROSC) after cardiopulmonary resuscitation (CPR), the course is usually marked by a post-resuscitation syndrome including multiple organ failures of various intensity and anoxic brain damage. The cardiocirculatory failure usually dominates the clinical picture, and it often leads to multiorgan failure. This hemodynamic failure is multifactorial, including at various levels vasoplegia, myocardial dysfunction, endotoxin release and adrenal dysfunction and is at least partly related to a hormonal defect that could be counteracted by hormonal supplementation. Such a substitutive opotherapy by hydrocortisone and AVP could improve hemodynamic failure and decrease overall mortality in this setting. This trial is a superiority multicentric trial and patients will be randomized in a 1:1:1:1 ratio using an electronic CRF. Investigational medicinal products: \- Arginin-vasopressin or AVP (REVERPLEG) The solution for infusion is prepared by diluting 40 I.U. REVERPLEG® with sodium chloride 9 mg/ml (0.9%) solution. The total volume after dilution should be 50 ml (equivalent to 0.8 I.U. AVP per ml). AVP will be administered according to mean arterial pressure to target a 65mmHg blood pressure for max 3 days. \- HYDROCORTISONE HEMISUCCINATE Vials with lyophilisate (100mg hydrocortisone) are provided by SERB laboratory. Hydrocortisone hemisuccinate will be administered as a 50mg intravenous bolus every 6 hours after an initial dose of 100mg, for 7 consecutive days. Stop of treatment by hydrocortisone will be performed without tapering. Comparator treatment: placebos. 17 ICU centers in France will participate to this study targetting 380 patient's enrollment in the study.

Major surgery induces traumatic stress due to the surgical aggression which could lead to major postoperative complications and death when the patient organism is not ready or prepared to support this intense stress. Malnutrition can be caused by chronic starvation, chronic inflammatory disease and acute injury (stress, acute inflammation). Therefore, nutritional supplements are indicated for patients who do not meet their energy needs through oral food ingestion. Immune-modulating nutrient-enriched products containing arginine, Omega-3 polyunsaturated fatty acids (PUFAs), nucleic acids, vitamins and antioxidants (selenium) like ORAL IMPACT (Nestlé) can modulate immune and inflammatory processes in burn, trauma, major surgery and improving clinical outcomes. These immune-modulating nutrient-enriched products have shown their ability to decrease postoperative complications up to 50% in patients undergoing non-gastrointestinal major surgery and length of hospital and ICU stay (Jie B 2012, Drover 2011). Mortality benefits have been demonstrated in one study focused on Neck and Head surgery. (Buijs N, 2010) Before 2019, in our urology surgery setting, it seemed that the postoperative complications rate was clinically increasing despite reliable surgeons and excellent surgery techniques and procedures. It appeared that the sources of these complications might be the weakness of the patients against major surgical stress. Patients might have been malnourished. The nutritional status had been omitted from our preoperative anesthesia assessment and no perioperative nutritional rehabilitation had been performed. The effect of immune-modulating nutrient-enriched products had been demonstrated mostly in gastrointestinal surgery but also in non-gastrointestinal surgeries such as neck and head cancer surgery, gynecologic cancer surgery and cardiac surgery. There are not studies conducted in urologic major surgery. Reducing the number of post-operative complications is a major challenge in surgery because they cause an increase in the length of stay, which translates into higher hospital costs for the community. Surgery generates major metabolic stress that the human body must manage. This metabolic stress will manifest itself in an increase in catabolism and a decrease in anabolism, resulting in protein-energy malnutrition in the patient if they are insufficiently prepared. Preoperative undernutrition is one of the risk factors for major postoperative complications. Moreover, postoperative infection can occur despite the Oral Impact treatment and associated iron and protein-caloric rehabilitation. It is linked to postoperative hypoalbuminemia. The antimicrobial role of albumin in the body is significant due to its antioxidant power. Reduced, non-oxidized albumin is the primary antioxidant in the body. Postoperative inflammation consumes reduced albumin, thereby diminishing the body's antioxidant capacity and exposing it to complications and nosocomial infections. The exogenous supply of reduced albumin is therefore indispensable. The liver's albumin synthesis yield is too low in this inflammatory context, amounting to approximately one vial of 20% albumin per day. Preoperatively, the correction of any hypoalbuminemia is anticipated through the nutritional rehabilitation implemented with the dietitian team. The timing of the surgery does not always allow the body to correct this hypoalbuminemia on its own. It is also essential to correct it postoperatively, in case of complications if necessary, through the exogenous supply of 20% reduced albumin. Numerous studies have shown the benefit of perioperative Oral Impact immunomodulation in gastrointestinal surgery, ear, nose and throat surgery, gynecological and cardiac surgery. No studies have been done in major Urological surgery The proposed study will be the first formal evaluation of the benefits and risks of using ORAL IMPACT in the preoperative period of urological surgery. The choice of this clinical project for this research question is justified by the proven benefit of this food substitute perioperatively in gastrointestinal, ear, nose and throat, gynecological and cardiac surgery. We hypothesize that Oral Impact will protect against major postoperative complications and prolonged hospital stay for patients undergoing urological surgery. There are no current guidelines recommending or discouraging the prescription of ORAL IMPACT in urological surgery patients.

Background In 2023, with 61,214 new cases diagnosed in France, breast cancer accounts for 33% of women's cancers and is the most common cancer in women. With an estimated prevalence in 2017 of 913089 people, studies also suggest an increase in the standardized incidence rate for several years, from 72.8 per 100,000 in 1990 to 99.2 per 100,000 in 2023. This increase is partly explained by the implementation of screening campaigns that promote the early detection of new cases, but also by the presence of risk factors that are responsible for a large proportion of breast cancers. Studies on social inequalities in the face of breast cancer highlight several realities. Indeed, while breast cancer is considered one of the cancers with a better prognostic life due to the net survival rate of 88% observed five years after diagnosis, studies show that these rates vary by age and that women from lower social classes have a higher risk of death than women from privileged social classes. In addition, although immigrant women, especially those from sub-Saharan Africa, face several health problems and often live in precarious situations in France, few studies have documented the situation of these women with breast cancer compared to women born in France. The few studies carried out highlight inequalities in access to breast cancer screening and a life after breast cancer marked by significant social and administrative precariousness. Thus, it is possible to think that, in the face of breast cancer, the trajectories of women born in sub-Saharan Africa could be different from those of women born in France. For example, it is possible that immigrant women have a different age of cancer onset than non-immigrant women or that they encounter greater difficulties in accessing care. The SENOVIE France project was designed to fill this knowledge gap. It aims to better understand the impact of breast cancer on the life trajectories of women born in France and women born in sub-Saharan Africa. Objectives The SENOVIE France survey aims: * To understand how breast cancer (diagnosis, treatment, and breast reconstruction) impacts women's lives that are already affected by migration in many spheres (i.e., social consequences of breast cancer on spheres like family or occupation/financial situation). * To study the therapeutic itineraries (including self- reconstruction) of immigrant women living with breast cancer in the greater Paris area and understand their social determinants. * To observe how gender can shape women's medical and social outcomes in a migration context. Methodology The SENOVIE France survey is a mixed-methods survey with two components: a quantitative component and a qualitative component. Quantitative component The quantitative component is based on a life event survey, a methodology successfully used in the field of HIV/Hepatitis B among immigrants in the greater Paris area by several members of this research. This innovative methodology has the great advantage of collecting longitudinal data while avoiding attrition which is very frequent in prospective cohorts among disadvantaged populations: women are surveyed one time and are asked retrospectively about their past trajectories. A close-ended question CAPI questionnaire and a biographical grid paper where the interviewer reports key elements and dates will be used for data collection. The biographical grid paper was shown to help to minimise memory biases because the interviewees can use both dates and age to remember the order of events and can place elements in perspective with one another (for example, a woman can ignore at what date she had access to medical insurance, but she would remember it occurred during her second pregnancy). This methodology has shown robustness in tracing back life and health trajectories. This survey aims to recruit about 1000 women, including 500 women born in France and 500 women born in sub-Saharan Africa. During the twelve months of the data collection, a CAPI patient questionnaire, a biographical grid paper (completed by interviewers recruited and trained by INED) and a medical questionnaire (completed by clinical researchers from partner hospitals) will be used to collect the following data: The patient questionnaire and the biographical grid include the following modules: 1. retrospective on the whole life (residential history, professional history), 2. history of relationships and children, 3. nationality, arrival in France and stay (for immigrant women), 4. health coverage, 5. violences, 6. breast cancer (diagnosis, treatment, and impact on women's life), 7. Covid period, 8. economic consequences, 9. health, sexuality and well-being. The collection will be carried out in the context of a face-to-face interview. Within each health services, eligible patients will be identified by the healthcare professional during (or before) the consultation. The survey will be offered by the healthcare professional to all eligible patients. Patients who will agree to participate will be referred to the interviewers. Patients will be able to agree to participate in the survey immediately after their consultation or agree to participate by appointment. Those who will agree to participate by appointment will agree on a date for taking the questionnaire with the interviewers. In both cases, the questionnaire will be administered in the premises of the project's hospital partners (Saint-Louis University Hospital AP-HP ; Delafontaine Hospital Saint-Denis ; Robert Ballanger Hospital Aulnay-sous-Bois) in offices that guarantee the confidentiality of the interview. The individual questionnaires will be entered in real time on an INED secure LimeSurvey server. The biographical grids will be collected on paper before being entered by a dedicated operator on the same LimeSurvey server. The medical questionnaire contains questions about the characteristics of the cancer and the treatments followed by women. It will be supplemented by hospital staff from partner centres. The entry will be done on the IRD's REDCap secure server. In terms of statistical analysis, descriptive statistics will be used to precisely describe the medical status, social characteristics, and living conditions of women born in France and women born in Sub-Saharan Africa living with breast cancer in the greater Paris area. These statistics may also be age-standardized if, as expected, women from sub-Saharan Africa are younger than their native-French counterparts. To measure the social consequences of breast cancer diagnosis and treatments, specific statistical methods for longitudinal data (sequence analysis, Cox models, discreet-time logistic regressions) that allow to take different temporalities into account (time since migration, since diagnosis, since treatment, etc.) will be used. A specific attention will be paid to how healthcare trajectories may have been impacted between 2020 and 2021 by the sanitary crisis, and also to examine whether all women were affected in the same way (missing medical follow-ups, delayed surgeries). Special attention will also be paid to the social determinants and social impacts of breast reconstruction. Qualitative component The objective of this qualitative component is to describe in depth the way in which women's health, social and migratory trajectories are articulated, and their involvement in the care of women born in Sub-Saharan Africa in French health services. This section aims to answer the following questions: which immigrant women circulate and under what conditions? What are the challenges and obstacles participants face? What are the administrative, material and social difficulties participants face? What levers can be activated ? To remove these obstacles, which actors can immigrant women rely on? What are the professional, family, conjugal, emotional and physical experiences of these women? To answer these questions, qualitative interviews will be conducted with women born in sub-Saharan Africa. The goal is to carry out about forty interviews in the greater Paris area. The exact number may vary depending on the principle of data saturation. The interviews will be recorded, pseudonymized and transcribed. They will be stored on a secure NextCloud server at Ceped. The interviews will be analyzed with a comprehensive approach that aims to analyze the experiences as they were lived by the participants. Perspectives and expected results This research will document the social and health trajectories of women with breast cancer and followed in certain hospitals in the greater Paris area with a comparative aim. It will provide scientific knowledge on the circumstances of cancer diagnosis in women born in France and those born in sub-Saharan Africa, on the experience of the disease and its consequences on different aspects of women's lives (economic, entourage, sexuality, couples, etc.). This research will raise the awareness of patients' associations and perhaps help them to develop specific lines of action for immigrant women and to lobby political decision-makers to promote their access to care. These results could thus contribute to the improvement of medical and psychosocial care for women living with breast cancer.