Clinical trials

Maternal mental health in the postpartum period is a major public health issue in France. The 2021 National Perinatal Survey highlights high prevalence rates of mental health disorders among mothers, with 27.6% experiencing anxiety disorders, 16.7% experiencing depressive disorders and 5.4% having suicidal thoughts. Between 2016 and 2018, suicide was also the leading cause of maternal mortality in the year following childbirth, underscoring the severity and frequency of these disorders. In response, international guidelines, notably those of the World health Organisation (WHO), as well as national policies such as the 'First 1,000 Days' strategy, emphasise the importance of early, enhanced and individualised postnatal support. In France, this postpartum care tends to be structured around the Early Postnatal Interview and the recommended use of validated screening tools such as the Edinburgh Postnatal Depression Scale (EPDS). However, the quality of postpartum care depends not only on screening and clinical follow-up, but also on organisational and environmental factors. Among these, the arrangements for maternity ward visits constitute a potential determinant of patients' experiences, likely to influence both their mental state, their rest, the establishment of breastfeeding and, indirectly, the health of the newborn. The exceptional measures implemented during the Covid-19 pandemic, notably the restriction of visits, have shown generally favourable effects, with improved satisfaction among patients and healthcare staff, better conditions for rest, facilitation of breastfeeding and a perceived improvement in working conditions. However, these data were collected in an exceptional health context, which may introduce biases linked to the social, emotional and organisational constraints specific to this period. Their extrapolation to routine practice therefore remains uncertain. Furthermore, in the absence of specific national guidelines governing maternity ward visits, the current regulatory framework remains unclear and practices vary between institutions, often relying on local decisions that have not been scientifically evaluated. Against this backdrop, the VISIMAT study aims to characterise maternity ward visiting arrangements outside of any exceptional circumstances and to assess their impact on the health of mothers and newborns, as well as on healthcare workers' working conditions. Its aim is to provide a scientific basis to inform the development of standardised recommendations and prevention messages.

The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is To develop and validate a clinical-biological score (VISCOTHEM score) incorporating viscoelastometric tests parameters; based on an association study, and to establish a threshold that enables the prediction of the immediate risk of bleeding in haematology patients with severe thrombocytopenia (\<20 G/L); with a view to selecting a population with a residual risk of bleeding of zero (NPV ≥ 95%, to achieve a residual probability of bleeding \< 5%). The score may incorporate variables identified in the literature as having a plausible causal relationship with the occurrence of bleeding (14,15), as well as viscoelastometric tests parameters, conventional haemostasis parameters and relevant clinical parameters. . Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 21.1 mL. The following analyses will be performed: Quantra®, Rotem®, blood count, platelets, immature platelet count, plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen, urea, creatinin, albumin.

Hemodialysis is a vital replacement therapy for patients with end-stage chronic kidney disease, but it imposes a heavy, demanding, and prolonged management, associated with a significant deterioration in quality of life. Hemodialysis patients are exposed to numerous physical, organizational, and social constraints, including repeated and prolonged sessions at the center, dietary and fluid restrictions, chronic fatigue, and frequent comorbidities. Therefore, depressive disorders in hemodialysis patients represent a major public health issue. The literature reports a high prevalence of depressive symptoms among hemodialysis patients, ranging from 22% to 60%, significantly higher than that observed in the general population. These disorders are associated with a significant deterioration in quality of life, increased hospitalizations, lower therapeutic adherence, an increased risk of suicide, and excess mortality. Despite these important clinical consequences, depressive disorders often remain underdiagnosed in hemodialysis. Current guidelines, including those from the Haute Autorité de Santé (HAS), emphasize the importance of regular quality of life assessments in patients with chronic kidney disease and recommend the use of validated questionnaires. However, they do not formalize a specific operational strategy for screening depressive disorders in routine hemodialysis practice, contributing to their under-evaluation. The gold standard diagnosis of depressive disorders relies on a structured psychiatric interview, which is difficult to reconcile with the organizational constraints of dialysis centers. Standardized self-assessment tools, such as the Hospital Anxiety and Depression Scale (HADS), particularly its depression subscale (HADS-D), have been widely used. The HADS-D has the advantage of excluding somatic symptoms and has been validated in hemodialysis patients. However, self-assessment relies on the patient's ability to express their subjective experience. Thus, the self-administration of standardized questionnaires in these patients is often challenging due to their age, comorbidities, fatigue, and functional limitations, often necessitating the intervention of healthcare staff. In contrast, registered nurses (IDE) working in hemodialysis possess longitudinal clinical knowledge of patients, acquired over repeated sessions, which can serve as a relevant lever for rapid and standardized screening of depressive symptoms. To date, the diagnostic performance of structured nursing hetero-evaluation remains poorly documented. The IDE-3D study aims to evaluate the ability of nurses to identify depressive symptoms in hemodialysis patients using structured tools, comparing the nursing hetero-evaluation of the HADS-D with the self-assessment conducted by the patient. It is part of a pragmatic approach aimed at improving the screening of depressive disorders in hemodialysis, structuring the care pathway, and enhancing the integration of mental health into the overall management of hemodialysis patients.

RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months. Most people with RSV infection get better by themselves but babies and younger children can become very poorly. About 1 in 15 infants with confirmed RSV within the first 12 months of life will be hospitalised, and a very small proportion will be seriously ill and may die. Currently there are two different prevention options that can be used to prevent RSV infection in babies. One is a vaccine given to the mother during pregnancy, and the other is a monoclonal antibody given by injection to the baby. Although both prevention options work well on their own and are safe, neither provides 100% protection to the infant. It is not known whether giving both medicines, one to the mother in pregnancy and one to the infant, would provide better protection than giving only one medicine - this is what the PIPELINE-RSV study will look at. PIPELINE-RSV-France will recruit about 1000 pregnant women in France. A parallel trial, running across Europe (PIPELINE-RSV-International) will recruit about 1500 pregnant women in UK, Switzerland, the Netherlands and Belgium. The protocols will align on key aspects and the data will be analysed together. The study will include two study groups with different prevention options used in each: (1) an injection given to the baby at the beginning of RSV season, or (2) both a vaccine given to the mother in pregnancy and an injection given to the baby at around 4 months of age. Each mother-baby pair will be randomly allocated to group by a computer. The numbers of babies in each of these groups who acquire RSV will be compared. In some countries participating to the International trial, an other study groups may be available : (3) a vaccine given to the mother in pregnancy. Pregnant women and their babies will be followed until the baby reaches 12 months of age. Information will be collected about medically-important side effects either the mother or the baby had from their medicine(s) and any symptoms of RSV the baby had. Visits with the mother and baby will occur at birth and 12 months later. The mother will complete questionnaires via a Web-based platform to report any non-routine in-person visits, once in pregnancy and after the baby is born twice a month or monthly (more often in the winter), to also report baby's symptoms, to report their trial experience when the baby is 4 and 12 months' old, and to provide their views on vaccination at birth, and when the baby is 4 and 12 months' old. If the baby develops symptoms that might be RSV, their mother or another caregiver will be asked to take a sample using a swab from the baby's nose or mouth, and to send it by post for testing to find out if the baby has RSV. As well as the main research study, there are also some substudies. A questionnaire will be given to women who consent to take part, to find out their motivations for joining the study and how they prefer to receive information about taking part in studies. A small number of women will be asked to take part in a study to look at how mothers' and babies' immune systems respond to the two different study prevention options , and to investigate different ways of collecting samples from their babies. In addition, researchers will use data from the study to see whether giving both medicines is cost-effective compared with giving just one medicine.

During the winter of 2022/23, a standardized protocol for managing fever in children aged 3 months to 10 years was implemented at Annecy Genevois Hospital for a period of one month. This protocol included advice given by the regulator and sending a text message to parents after the call. A total of 182 calls were handled in one month: 95 during a 15-day period before the intervention was rolled out and 87 during a 15-day period during the intervention (43 with unread text messages and 44 with read text messages). All parents who read the text message understood it. The rate of compliance with advice was improved by the intervention when the text message was read (p \< 0.01), in terms of increased paracetamol intake, avoidance of cold baths, undressing the child, and administering fluids. When the text message was read, the rate of calls to the 15 emergency center fell from 13% before the intervention to 2% when the text message was read (p = 0.04). A downward trend in emergency room visits was also observed, from 13% before the intervention to 5% when the text message was read and 19% when the text message was not read (p = 0.13). These encouraging data suggest that a randomized study would demonstrate the value of this approach in routine practice. Even if the effect of such protocols is moderate, the target audience is such that their impact on the use of unscheduled care and on the healthcare system could be significant, at a low implementation cost. The use of a standardized protocol involving the sending of text messages in cases of uncomplicated fever in children makes it possible to: * standardize the advice given by call center doctors, * ensure the traceability of advice, * help parents monitor their children. The objective of this study is to determine, in a randomized trial, whether the combined use of standardized advice for children with fever and text messages sent to parents by the emergency medical service (EMS) can: i) reduce the use of unscheduled medical care; ii) improve compliance with advice; iii) reduce the rate of callbacks to the emergency medical service; iv) improve parent satisfaction.

Orthognathic surgery consists of rebalancing the position of the jaws, taking into account functional criteria (tooth engagement, tooth/lip ratio, breathing, etc.) and aesthetic criteria. It has become much more accurate in recent years thanks to the advent of osteosynthesis plates and the contribution of three-dimensional imaging. Three-dimensional imaging makes it possible to simulate fairly accurately the surgical procedures and bone displacements required. However, the effect of these bone displacements on the soft tissues (skin, subcutaneous tissue, muscles) does not make it possible, with today's digital tools, to simulate the final aesthetic result and in particular to anticipate the sometimes significant postoperative changes to the face. Many patients are worried about these post-operative morphological changes and would like to have a precise idea of how they will look after surgery. Being able to offer them, before surgery, a visual solution simulating the final aesthetic appearance would be essential in this respect. The aim of the study is to validate the predictions provided by the digital face model on a series of patients scheduled for orthognathic surgery by comparing the simulation of the morphological result of the operation, provided by our algorithm (SPOC), with the actual result assessed on a scan taken 6 months after the operation.

Prospective multicenter cohort to determine patient profiles (associated factors, including allodynia) with a better response to pain desensitization by capsaicin delivered in the form of a high concentration patch (8%), in a population of patients with peripheral neuropathic pain and followed up in a pain consultation in the Auvergne Rhône Alpes region.