Clinical trials

ECUM-RUN is a randomized, double-blind, placebo-controlled phase 3 trial evaluating whether a 30-day oral supplementation with curcumin, ginger, and piperine (9-5-1 formulation) reduces exercise-induced joint pain and inflammatory markers in 82 ultra-trail runners competing in the Diagonale des Fous (175 km). The primary endpoint is the change in knee pain (VAS score) between end of supplementation and race finish, compared between intervention and placebo groups.

The goal of this study is to assess the discriminatory power of a previously developed tool for detecting decompensated heart failure-which includes, in particular, clinical signs-in a population of patients hospitalized in cardiology units in Réunion. The main question it aims to answer is : Would a simple and rapid screening tool for decompensated heart failure help identify a high probability of this condition in a population hospitalized in a cardiology unit in Réunion? This study includes patients aged 55 and older, who reside in Réunion, who were admitted on an unscheduled basis to the cardiology department at the Réunion University Hospital or the Ouest Réunion Hospital, for any reason (whether as an inpatient or in the intensive care unit) The study is conducted in two phases: Phase 1: Development of the new e-DELPHI consensus-based screening tool Phase 2: Administration of the Déspist'IC-Run early detection tool for decompensated heart failure and performance of the gold standard cardiology examination (RIPH3)

The goal of this clinical trial is to evaluate whether participation in 12 Qi Gong sessions (intervention group), compared with usual care without Qi Gong (control group), reduces dissociative symptoms, as measured by the Dissociative Experience Scale-II (DES-II), between T0 and T1, in outpatients hospitalized for psychiatric disorders related to aversive experiences during childhood. The main questions it aims to answer are: \- a) To assess whether participation in the Qi Gong program leads to a reduction in symptoms related to complex trauma, b) To assess whether participation in the Qi Gong program leads to an increase in the level of mindfulness c) To explore whether the effect of the Qi Gong program on reducing dissociative symptoms varies according to participants' baseline level of dissociation (Dissociative Experiences Scale-II ) d) To explore whether the effect of the Qi Gong program on reducing dissociative symptoms is sustained over time e) To explore the experiences of patients who participated in the Qi Gong sessions following the intervention. This is a randomized controlled trial with parallel groups: * Intervention group: participation in 12 Qi Gong sessions led by a trained professional, in addition to standard care * Control group: standard care, without access to Qi Gong sessions during the study period. Participants will be required to: * complete 3 questionnaires (DES-II, ITQ, MAAS) * attend one Qi Gong session per week for 12 weeks (including a group debriefing) or receive standard care at a medical-psychological center (without Qi Gong) * complete the same questionnaires (DES-II, ITQ, MAAS) after the 12 weeks * complete the DES-II questionnaire 2 months later

The goal of this clinical trial is to learn if administration of plasma, from a whole blood donation from an individual who has declared a Chikungunya infection for less than 6 months , to a newborn, whose mother has a peripartum chikungunya infection, will have an impact on the proportion of newborns surviving without encephalitis/encephalopathy (EE) within the first 5 days of life. Researchers will compare results to an observational study of 30 newborns who couldn't have been proposed to participate at the clinical trial, because of delay of diagnosis or delay of transfer to hospital which doesn't allow transfusion or parents not accepting plasma transfusion to the newborn. Participants of the clinical trial will: * receive a transfusion, * visit the clinic and undergo biological tests every day until day 7 and once between 1 and 3 months. Participant of observational study as part of their regular medical care, and biological data will be reused for the research from the mother's diagnosis until the newborn reaches 3 months of age

The goal of this interventionnal study is to demonstrate that sending SMS messages with advice on physical activity or nutrition, in addition to a program of hygienic-dietary management, significantly increases weight loss in subjects with prediabetes in La Réunion. Indeed, type 2 diabetes is a priority health problem on Reunion Island: 10% of the population are treated for type 2 diabetes, twice as many as in France. International studies have demonstrated the value of modifying dietary and physical activity habits to reduce the risk of transition to diabetes in patients with prediabetes Against this backdrop, a Regional Nutrition Diabetes Program (PRND) 2020-2023 was launched by Réunion's Regional Health Agency (ARS) in 2020. Studies have also demonstrated the effectiveness of using SMS to encourage and support weight loss interventions. So, the main question it aims to answer are: • Does the addition of 72 SMS of physical activity and nutriton advice, to the "FindRisc Péi-CPTS" program, significantly increase weight loss by 3% after 6 months of starting the program. FindRiscPei-CPTS program includes sports sessions, dietary consultations and therapeutic education. The 300 participants will be randomized into two arms * 150 participants will take part in the FindRiscPei-CPTS program + receive SMS messages * 150 participants will only take part in the FindRiscPei-CPTS program (no SMS) All participants will follow procedures below: * Inclusion: assessment of weight and waist circumference, Lifestyle Questionnaire and Socio-Efficacy Questionnaire. * Participation in Findrisk program for 3 to 9 months (+ SMS for experimental group) * 3 follow-up visits: 3 months, 6 months and 9 months after starting the program: weight and waist measurement, self-efficacy questionnaire.

A randomized pilot study which proposes to patients having suffered a traumatic event to have either only the standard care or the standard care associated with adaptated psychotrauma watch and prevention system.

The goal of this study is to develop a new scale for assessing prolonged pain, dedicated to extremely premature infants born before 27 weeks of gestation, adapted to their particular ways of expressing pain and discomfort, which will be called the EDEX (Extremely Premature Infant Pain Assessment Scale). This scale will take into account the level of development of extremely premature infants, recognizing that the perception and manifestations of pain vary according to gestational age. It was chosen to develop a specific pain assessment scale for preterm infants born before 27 weeks of gestation, in line with their level of development and their relatively homogeneous manifestations in this population. This population, which is the most immature, is particularly fragile and sensitive to its environment and the care provided. Pain manifestations are the most subtle, vegetative reactions are very present, and the motor system is still underdeveloped, linked to low muscle tone. It is with this category of patients that the nursing staff encounter the most difficulty in assessing pain and discomfort based on the EDIN scale. After creating the new EDEX scale during the first phase of the DOU-PREMA study, both scales (EDIN and EDEX) will be administered to the same pool of extremely premature infants during the second phase of the DOU-PRÉMA study in order to assess the correlation between the two scales. The main hypothesis is that EDIN and EDEX scores will not be correlated, as the EDIN does not appear to be suitable for extremely premature infants in routine practice. if the hypothesis is confirmed, a multicenter psychometric validation of the EDEX scale will then be considered in a future study. The study is a monocentric, non-interventional observational study conducted in the neonatal intensive care unit (NICU) of the University Hospital of Reunion Island (Site Nord). It is designed as a preliminary step toward the psychometric validation of a newly developed behavioral pain and discomfort assessment scale for extremely preterm infants (\<27 weeks' gestational age), named EDEX. The study includes two sequential phases: 1. a developmental phase dedicated to the creation of the EDEX scale : This stage is based on the production of videos of premature extreme in order to ajust the provisional scale define during a multidisciplinary meeting. 2. a cross-sectional observational phase comparing EDEX with the EDIN scale in the same population. The second phase of the project will evaluate the correlation between EDIN and EDEX scores. This protocol follows the SPIRIT recommendations for study protocols involving human participants.

The Mini-Mental State Examination (MMSE) is the most widely used cognitive screening and monitoring test for neurocognitive disorders in current clinical practice. Its French version was published in 1998 by the GRECO group (MMSE-GRECO). However, some items of this French version are not adapted to local Reunionese particularities. The main objective is to propose and validate the psychometric properties of an adapted version of the MMSE, to the Reunionese culture (MMSE-RUN) in a healthy population and in a sick population (Alzheimer's Disease and Vascular Cognitive Disorder), and to compare its performance with the MMSE-GRECO.

DOREVI is a monocentric randomized controlled study that will evaluate the efficacy of virtual reality helmets for pain prevention during invasive care on 78 oncologic pediatric patients. Two groups of children (between 6 and 11 and between 12 and 18 years old) will be randomized to use helmet plus standard care or standard care alone during invasive procedures (central venous catheter puncture, lumbar puncture, or bone marrow aspiration). The pain intensity will be evaluated using a visual analogic scale during three invasive procedures, and results will be compared between the patients with or without virtual reality.

ThThe aim of this study is to determinate the potential benefits of a respiratory training program (cardiac coherence, CC) in patients suffering from acute stress disorder, after a potentially traumatic event. Using this method is supposed to prevent the onset of chronic post traumatic stress disorder after 3 months. This pilot study will help to determinate the need of developing this kind of complementary and alternative program, and will also provide knowledge about the feasibiility and acceptability of this program for the patients.

Comunity health actions are set up in populations of women aged 30 to 65 in vulnerable situations living in the outlying areas of Reunion Island. The idea is to evaluate those action on health

We propose the following hypotheses: * The use of herbal medicine is common among patients with chronic kidney disease in Réunion island. * This use could influence the progression of kidney disease in these patients. To assess the primary inclusion criterion, patients will be easily identified by nephrologists through existing follow-up. The questionnaires will be administered after this early identification by the investigators at each center. The primary evaluation criterion is straightforward: it aims to establish an overview of the use of herbal medicine in our patient population. This information is currently unavailable and remains crucial for measuring the extent of the issue. Our secondary criteria will involve more in-depth analysis of this use and an attempt to correlate the use of certain herbs with the rate of progression of kidney disease at one year. We targeted patients with moderate to end-stage chronic kidney disease (KDIGO classification 3 to 5), which are the stages typically included in kidney disease studies. Furthermore, these patients are the most likely to experience a greater annual progression of their kidney disease, and the effect of herbs on this progression could be investigated. Transplant patients were not included because they are more aware of the risks of not using herbal medicine due to their use of immunosuppressants.

Multi-professional primary care practices (Maisons de Santé Pluriprofessionnelles, MSP) have expanded widely in France over the last decade to respond to increasing healthcare needs, uneven distribution of physicians, and deteriorating working conditions, which were further exacerbated by the COVID-19 pandemic. MSPs are expected to offer more collaborative and coordinated care, and to provide a more attractive work environment, particularly for younger healthcare professionals seeking less isolation and better work-life balance. Well-being at work for healthcare professionals is now recognised as a key determinant of quality and safety of care. Studies have shown links between staff satisfaction, burnout, and patient outcomes, including communication quality, error rates and staff retention. However, research specifically focused on collective well-being or "shared happiness" within multi-professional primary care teams remains limited. Existing work in French MSPs (notably qualitative studies by F. Burté and O. Caillaud) has identified relevant dimensions of "shared happiness" and led to the preliminary construction of a questionnaire named the Shared Happiness Index (Indice de Bonheur Partagé, IBP). To date, no validated, standardised instrument exists to measure this collective well-being in MSPs. The Be\_aPi study aims to validate the IBP questionnaire among healthcare professionals working in MSPs. The study is observational, descriptive and cross-sectional, conducted in several French regions covered by the GIRCI (Groupement Interrégional de Recherche Clinique et Innovation) SOHO (Sud-Ouest Outre-Mer Hospitalier) network (Nouvelle-Aquitaine, Occitanie, Réunion and Mayotte). It comprises three main steps. First, a content validation phase will be carried out with two independent panels of experts. One panel, including psychometrics, methodology and linguistics experts and MSP representatives, will assess face validity by examining each item in relation to the concept of shared happiness in multi-professional primary care. A second panel will be involved in an e-Delphi process to establish consensus validity on the relevance and clarity of items, using Likert-type ratings and iterative feedback. Second, the psychometric validation phase will recruit approximately 350 professionals from over 100 MSPs. Eligible participants include medical and paramedical professionals, medical-social staff, medical assistants, coordinators, health mediators, adapted physical activity instructors and psychologists, working in MSPs that have been operating for at least one year, with at least one year of seniority in their current MSP. Participants will complete an online survey including the IBP questionnaire and three reference instruments: the Maslach Burnout Inventory (MBI), the General Health Questionnaire-12 (GHQ-12) and the Short Form-12 (SF-12). Internal consistency of the IBP will be assessed using Cronbach's alpha, and construct validity will be examined with exploratory factor analysis and correlation patterns with the reference scales, according to a multi-trait multi-method approach. Third, to evaluate test-retest reliability, participants who completed the initial IBP will be invited to fill in the same questionnaire again after a delay of approximately one month. The stability of scores over time will be assessed using intraclass correlation coefficients. Ceiling and floor effects, as well as the distribution of scores across professional categories and organisational characteristics of MSPs (e.g. single-site vs multi-site, role in the organisation, membership in interprofessional associations), will also be analysed. The expected outcome of Be\_aPi is a valid, reliable and transferable Shared Happiness Index specifically tailored to multi-professional primary care practices. This tool should enable regular monitoring of collective well-being, support targeted quality-of-work-life interventions, and ultimately contribute to improving quality and safety of care, staff retention and the long-term sustainability of MSPs. In the longer term, the IBP could inform policy instruments and financing schemes that aim to "take care of those who care," in line with national quality and safety strategies.

This study aims to compare the accuracy of two different blood sampling methods from a central venous catheter (CVC) for measuring anti-Xa activity in children receiving unfractionated heparin (UFH) from this CVC. The results will be compared to a "gold standard" sample taken from an arterial catheter (KTA) whithout UFH. The objective is to identify a more reliable method for monitoring UFH, thereby reducing the risk of bleeding or thrombosis in these patients.

The goal of this clinical trial is to evaluate the feasibility of the study, measured by the acceptability rate of patients to be recruited in a study proposing temperature monitoring at home, by a remote monitoring device or by the visit of an IDE at home (in association with the usual educational sessions), to children at risk of febrile neutropenia, from families with psycho-social vulnerabilities. The main questions it aims to answer are: * Will participants adhere to the telemonitoring system? * Is the intervention feasible, in terms of the device's failure to record temperature data? * Will parents behave appropriately when using the device? * How satisfied will parents and caregivers be? * What will be the physical tolerance of the device? * On an exploratory basis, will the remote monitoring system be effective for months? Researchers will compare : * patients using the telemonitoring device for continuous temperature monitoring at home, in combination with education sessions on temperature monitoring and the device * with patient with temperature monitoring at home by a nurse, 2 times a day, in combination with education sessions on temperature monitoring (without the telemonitoring device at home)

The goal of this clinal trial is to compare the effectiveness of nurse-led teleconsultation with usual care (intervention group) on psychological distress in patients with primary malignant tumors of the central nervous system between diagnosis and first anti-cancer treatment, versus usual care alone (control group). Participants will be randomized into two groups : * group A) intervention: usual care + nurse teleconsultation for psychological support * group B) control: usual care alone Enrolment = Day0 (D0) Participants will : * groups A and B: D0: complete 4 questionnaires (Quality of Life, Screening for Distress, Screening for Anxiety and Depression, Social Support Questionnaire) * Group A : D0+2/4 das : nursing teleconsultation for psychological support * Groups A and B: D0+10days : telephone call to complete the same 4 questionnaires as at inclusion * Group A : D0+15days: semi-directive interview, at home, for voluntary patients.

Anal canal cancers are on the increase in France, with around 2,000 new cases per year. These lesions can be detected by directed biopsies or smear tests. The incidence rate of anal cancer is 30 times higher in people living with HIV than in the general population. According to a recent study, the risk of anal cancer is highest in this population, but is also high in heterosexual men over 30 and women over 30. However, the proposal of a proctological examination in this population is not systematic. In France, there is no HPV screening for people living with HIV, but there is a recommendation for proctology consultation in certain cases, notably for men who have sex with men (MSM) or for women with vaginal cervical lesions. Several oncogenic HPV serotypes have been identified in the genesis of anal cancer. The serotype identified as the most carcinogenic is HPV-16 (89%). This study will look at anal HPV screening in people over 30 living with HIV, thus including a population for which no screening is currently offered (heterosexual men living with HIV and women living with HIV without vaginal cervical lesions), and will assess the concordance and acceptability of self-screening versus screening by a healthcare professional as part of a comprehensive anal cancer screening strategy in this population.

Atopic dermatitis (AD) is a chronic inflammatory dermatosis, common in children. It causes pruritus and skin lesions that can have a significant impact on patients' quality of life. AD can be difficult to treat because of its chronicity, demanding local care, corticophobia and the financial cost of non-reimbursed products. Patients are often looking for therapeutic alternatives. Medical hypnosis is a therapeutic alternative via hypnoanalgesia induced by direct suggestions of comfort and skin soothing and via anxiolysis, by working on stress management and self-esteem reinforcement. Four studies are interested in its action in AD and seem to show a reduction in pruritus, skin pain, an improvement in the intensity of atopic dermatitis, sleep, mood and for some a cure of AD. These results are encouraging but limited by the absence of a control group or by the small population included. Therefore, we propose in a first step to evaluate the feasibility of an hypnosis program through a pilot study, designed in the miniature format of a future, larger scale, randomized controlled trial.

Arboviroses, such as dengue, chikungunya and the Zika virus, represent a growing threat to public health in the Indian Ocean, but also in Europe and the rest of the world. Réunion has experienced several major epidemics, notably chikungunya in 2005-2006 and dengue since 2018, with a current resurgence of chikungunya. Mayotte was hit by a dengue epidemic in 2019, followed by a few cases of Rift Valley fever. The development of Zika could also affect this region. Arboviruses, transmitted by hematophagous arthropods, require the coexistence of a reservoir and a vector. Dengue fever, transmitted by Aedes mosquitoes, is caused by four serotypes of dengue virus (DENV) from the orthoflavivirus family. Primary infection with one serotype confers lasting specific immunity, but only transient protection against the other serotypes. Chikungunya, caused by an alphavirus, now causes epidemics in major tropical areas. It is also transmitted by Aedes mosquitoes. Arboviruses present four main clinical forms: algoeruptive, hemorrhagic, neurological and arthritic. Dengue fever is 75% asymptomatic, but can progress to a severe form, dengue hemorrhagic fever, characterized by increased vascular permeability and potentially fatal complications. Chikungunya causes a sudden onset of fever, polyarthralgia and maculopapular rash, with possible complications in newborns, the elderly and pregnant women. Understanding the factors associated with hospitalization and the severity of these infections is crucial to improving patient management and optimizing medical resources. This cohort study aims to identify the clinical, demographic and environmental determinants influencing the severity of arbovirosis. By analyzing data from patients who have used a healthcare facility, we hope to establish risk profiles and severity criteria that may or may not be specific to each infection. The results will enable us to better understand the pathophysiology of these viruses, develop targeted prevention strategies and improve treatment protocols, thereby helping to reduce the morbidity and mortality associated with arboviroses in this region. Due to the current chikungunya epidemic in La Réunion, this study will focus on the inclusion of patients affected by this arbovirosis as early as 2025. Its openness over the coming years will allow sufficient reactivity to include any arbovirosis on the territories of Mayotte and La Réunion.

Against the backdrop of a growing chikungunya epidemic in La Réunion, this prospective study will assess the real-life efficacy, safety and immunogenicity of IXCHIQ® vaccine in vulnerable individuals (seniors, comorbid patients), defined by the French Health Autority (HAS) as at risk of severe or complicated forms and/or chronic disabling forms (chronic arthritis, chronic fatigue phenotypes). This study will also provide input for the preparation of a cluster randomized trial on a population scale.

In view of the new priority given to diabetes in Réunion and the implementation of an ambitious plan to combat the disease at regional level, which includes the identification and management of pre-diabetes, the need for up-to-date data on the extent of these 2 diseases (diabetes and pre-diabetes) has become essential. These two diseases have known risk factors: age, overweight, obesity, high waist circumference, family history, hypertension, eating habits and physical activity, all of which form part of a risk score for developing diabetes: the Findrisk recommended by the Haute Autorité de Santé for identifying people at risk of diabetes. Given the specific population characteristics of Réunion compared with Finland, where this score has been validated, it would seem important to be able to measure these risk indicators in the population as a function of carbohydrate status in order to check that the proposed thresholds are appropriate for the population of Réunion. Finally, cardiovascular risk has been described as early as the pre-diabetes stage. Given the young age of onset of diabetes in Réunion and the high proportion of diagnoses of diabetes made following the occurrence of a cardiovascular complication, the study of the prognosis of carbohydrate status on the occurrence of complications using the social security information system will be offered on a voluntary basis to study subjects (via a probabilistic social security link).

The goal of this observational study is to identify the health literacy profile of diabetic patients in Reunion Island and France in order to obtain information to improve access to information, therapeutic education and to health service. The main question\[s\] it aims to answer \[is/are\]: Participants will complete the Health Literacy Questionnaire (HLQ) once.

Despite the controversy, on October 6, 2021, the World Health Organization (WHO) recognized Long Coronavirus disease (COVID) by officially defining it: " symptoms appeared 3 months after the onset of the primary infection by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), persisting for at least 2 months and which cannot be explained by any other condition ". Long COVID can affects any type of patient and has polymorphic and fluctuating symptoms over time. The Reunion Island is a French overseas department located in the Indian Ocean accounting more than 860,000 inhabitants. It has recorded since March 11, 2020, nearly 491,825 cases of COVID-19 and 961 deaths of hospitalized patients. Reunion's population is multi-ethnic and younger than the metropolitan France's one. It also has a higher prevalence of obesity and type 2 diabetes, two serious form factors of COVID-19. This specific context makes this island a particular study site for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Long COVID. In addition, some studies have confirmed the involvement of the autonomic nervous system (ANS) in the symptomatology of Long COVID and demonstrated that patients with a Long COVID present a dysfunction of their ANS which is objectified by a reduced Heart Rate Variability (HRV). The regulation of heart rate by the ANS is strongly favored by respiration. A regular slow and deep breathing training helps to adjust the baroreflex, which connect heart rate, breathing and blood pressure. The result of this training is an induced state called "cardiac coherence" (CC). The investigator therefore hypothesize that respiratory training to CC could "re-educate" the ANS and durably improve the symptomatology of patients with Long COVID.

This study compares the efficacy of music therapy associated with standard care versus the standard care alone on the psychological pain in suicidal patients.

Beach tennis, a fast-growing sport since its creation in Italy in the 1970s, has rapidly gained in popularity, particularly in La Réunion sisland since 2000. However, despite its development, studies on beach tennis-specific injuries are rare, based on cross-sectional studies and therefore limited by temporal or memory bias. The need for prospective research is crucial if we are to gain a better understanding of the epidemiology of injuries and improve prevention and medical management. The aim will be to determine the risk of injury among beach tennis players within a one-year national prospective cohort.