Clinical trials

The aim of this study is to measure FMD (flow-mediated dilation) in healthy volunteers aged over 50 in order to establish reference values for women aged over 50.

Periodontitis is a chronic inflammatory disease affecting the supporting tissues of the teeth and may negatively affect patients' oral health-related quality of life. Although periodontal treatment is expected to improve periodontal health, its impact on patients' perceived oral quality of life has been less extensively studied. The PAROQoL CROC study is a prospective and monocentric study designed to evaluate changes in oral health-related quality of life in patients with periodontitis undergoing periodontal treatment. Oral quality of life will be assessed using two validated questionnaires, the OHIP-14 and the GOHAI, before treatment and during follow-up. Clinical periodontal parameters, including probing pocket depth, bleeding on probing, plaque levels and clinical attachment loss, will also be collected. The study will investigate the relationship between changes in oral quality of life and clinical periodontal outcomes, as well as the potential influence of patient characteristics and oral hygiene habits. A total of 100 adult patients with periodontitis requiring periodontal treatment will be included.

Self-medication is an increasingly common practice that carries risks. When a patient requests self-medication, the community pharmacist intervenes in the identification, prevention and resolution of medication-related problems. Previous work led to the validation of a reporting grid for pharmaceutical interventions and to the creation of a database of several thousand pharmaceutical interventions in self-medication. Thirty per cent of these are associated with a complaint of pain. Recording these interventions and following up on their outcomes, particularly when the community pharmacist is at the limit of their advisory role and referral to another healthcare professional is required, would help promote coordinated practice among primary care professionals and could even inform public health policy. The AUTOMED'IP-DOL study will test the introduction of a liaison form and a brief pharmaceutical follow-up interview for pharmaceutical interventions arising from a spontaneous request in a context of pain and leading to the patient being referred to a consultation with a healthcare professional. The aim is to compare the value of such a practice with usual care in the pharmacy, by assessing patients' pain levels, quality of life and satisfaction.

Heart failure affects 2.3% of the adult French population. Readmission within 30 days doubles the risk of early death within the following 30 to 60 days, as well as the risk of rehospitalization over the subsequent two years. Incorporating nurse-led discharge education can significantly reduce readmissions for heart failure as well as all-cause readmissions. Drawing on practices from English-speaking countries and Switzerland regarding patient discharge education at hospital, we propose to evaluate a discharge education program in the French hospital setting for patients with heart failure. The objective of this multicenter before-and-after study is to evaluate the impact of a nurse-led discharge education delivered at hospital on the quality of the care pathway for patients with heart failure, assessed 30 days after hospital discharge. The primary outcome is the reduction in 30-day unplanned all-cause hospital readmissions, including emergency department visits. An informal (non-professional) caregiver may also be enrolled in the study if identified by the patient and present during the hospitalization. Patients enrolled before implementation of the discharge education will constitute the control group (standard therapeutic patient education group). They will receive usual hospital care, including educational sessions throughout hospitalization covering the disease, treatments, and self-care, as well as a follow-up consultation with a nurse 30 days after hospital discharge. This usual care is referred to as standard therapeutic patient education and does not include a structured therapeutic patient education intervention at hospital discharge. Patients receiving the discharge education will constitute the intervention group (standard therapeutic patient education with discharge education group). They will receive the same usual care (i.e., standard therapeutic patient education and the 30-day post-discharge nurse follow-up consultation), supplemented by the nurse-led discharge education intervention during their hospitalization. To minimize the risk of contamination (diffusion bias), the control group will be enrolled and complete follow-up before nurses receive training in the discharge education intervention.

Ulcerative colitis (UC) is a chronic bowel disease. It causes inflammation of the rectum and sometimes the colon. This disease can also affect other parts of the body. It can be very difficult to live with on a daily basis. People with UC may experience frequent diarrhea, rectal bleeding, urgency to defecate, and even incontinence. All of this can significantly reduce their quality of life. The goal of treatment is twofold: * To eliminate or reduce symptoms (this is clinical remission), * To allow the bowel to heal. When these two goals are achieved, the risk of relapse, hospitalization, surgery, or colorectal cancer decreases. To monitor the progression of the disease, gastroenterologists use a test called fecal calprotectin: this is a protein measured in stool that helps detect intestinal inflammation. When conventional treatments like corticosteroids or immunosuppressants are ineffective or poorly tolerated, the investigators use more targeted therapies. For a long time, doctors have used drugs called anti-TNFs. They block a protein responsible for inflammation (TNF-alpha). These treatments are often injected under the skin, which is generally well-tolerated by patients. A drug called infliximab, now available as a subcutaneous injection, could be used as a first-line treatment for ulcerative colitis because it appears to be more effective than other injectable anti-TNFs. Another drug, vedolizumab, works differently from anti-TNFs and can also be used as a first-line treatment. More recently, new classes of drugs have shown promise: * JAK inhibitors (such as filgotinib), * interleukin-12 and interleukin-23 inhibitors (such as ustekinumab). These new treatments have advantages, such as the oral administration method for filgotinib and the fact that they can be used alone, without any other associated medication, which could simplify patients' lives and improve their quality of life. Today, there are increasingly more different treatments for ulcerative colitis, and the investigators still don't know clearly what the best strategy is: Is it better to start with one type of medication rather than another? Does the order in which the investigators try treatments lead to different results? This is an important question for gastroenterologists, as their goal is to choose the most appropriate treatment for each patient from the outset. The main objective of this research is to compare four strategies, corresponding to four treatment arms, starting with the use of infliximab, filgotinib, vedolizumab, or ustekinumab, to maintain remission in patients with ulcerative colitis. The following four arms are therefore proposed: * Based on efficacy: infliximab - filgotinib - ustekinumab - vedolizumab * Based on safety: ustekinumab - vedolizumab - infliximab - filgotinib * Based on current practice: vedolizumab - infliximab - filgotinib - ustekinumab * Based on convenience and route of administration: filgotinib - ustekinumab - vedolizumab - infliximab This study will also allow for a comparison of the efficacy, safety, participant acceptability, and quality of life of the four treatment regimens. This study is intended for adult patients (aged 18 to 65), male or female, with moderate or severe ulcerative colitis (UC) for at least 3 months. Treatment for these patients must require biologic therapy, as determined by the investigator. Participants must be able to provide informed consent to participate in the research and must be covered by a national health insurance plan. Women of childbearing age must be using active contraception for at least the duration of the study (2 years). Patients will be followed for two years. They will be seen at the initial visit, then every two months during the first year, and then every three months during the second year. At each visit, they will be required to undergo blood and stool tests and complete a questionnaire. Endoscopies will be scheduled for weeks 16, 52, and 104. Patient treatments can be optimized once, and based on the endoscopic score, patients may change treatments according to a predefined sequence.

Although advances in treatment and patient management have considerably improved post-infarction prognosis, the risk of sudden cardiac death remains a major concern. Sudden cardiac death (SCD) is defined as an unexpected death occurring within one hour of the onset of symptoms, often of arrhythmic origin. In patients who have survived a myocardial infarction, sudden death represents a persistent threat. This risk is often associated with complications such as left ventricular dysfunction, malignant ventricular arrhythmias, and structural alterations of the myocardium, all of which can favor the development of fatal cardiac events. Among the risk factors identified, reduced left ventricular ejection fraction, a history of ventricular arrhythmias and the presence of extensive scarring of the myocardium are particularly significant. Assessing the risk of SCD in post-infarction patients is crucial to determining appropriate prevention strategies, such as implanting automatic implantable defibrillators (ICDs). Assessment tools are varied, but currently only left ventricular ejection fraction (LVEF) \< 35% is identified and validated. However, this risk stratification is unsatisfactory, particularly in view of SCD in patients with a history of myocardial infarction and a moderately impaired LVEF (between 35 and 50%). Although the initial treatment of myocardial infarction is essential for the patient's immediate survival, managing the risk of sudden death in the long term remains a major clinical challenge. A multiparametric approach is needed to optimize prognosis and prevent premature death in these patients.

Validated physical activity questionnaires are often long and time-consuming, particularly when assessing both leisure-time and occupational physical activity and sedentary behavior. The ACTIWORK study aims to validate a short questionnaire assessing physical activity at work and during leisure time, as well as sedentary behavior, by comparison with the reference Recent Physical Activity Questionnaire (RPAQ). Participants will complete the study questionnaires twice, approximately one week apart, to assess the consistency of their responses over time.

Embryo selection is one of the major challenges in Assisted Reproductive Technology (ART) in order to continuously improve clinical pregnancy rates. Morphological evaluation of embryos is the standard method used to assess embryo quality and to select the embryo to be transferred. However, this observational method has limitations: it can be subjective and may lead to inter- and intra-observer variability. To increase pregnancy rates, the transfer of two embryos may be proposed, which can result in high-risk multiple pregnancies. Despite the introduction of time-lapse systems and embryo selection algorithms aimed at increasing live birth rates, outcomes in ART remain suboptimal and can still be improved. The use of artificial intelligence (AI) is expanding in the medical field and is increasingly being applied in ART laboratories to optimize outcomes while avoiding multiple pregnancies. EMA™ is a secure artificial intelligence software platform developed by the company AiVF. The use of this software could allow a standardized and reproducible evaluation of embryo development up to the fifth day of embryonic culture. Through the application of an algorithm, the software may enable the selection of the embryo with the highest potential for achieving pregnancy. The primary objective of this study is to evaluate the use of the EMA™ artificial intelligence system in embryo selection for embryos cultured up to day 5, in comparison with the morphokinetic criteria currently used in the laboratory for the first fresh transfer of a day-5 embryo. The secondary objectives are to assess whether artificial intelligence (1) reduces the time to achieve pregnancy (defined as pregnancy achieved or not after the first transfer of a day-5 embryo) and (2) affects the miscarriage rate among patients treated in the ART CECOS unit. A medico-economic analysis will be conducted to evaluate the number of new patients undergoing an additional treatment attempt and to determine whether there is a correlated reduction in time to pregnancy by assessing the number of pregnancies achieved after the first transfer in patients already under treatment. A cost-effectiveness analysis will also be performed, comparing the cost-effectiveness ratios between the two study arms.

Preventive practices among physicians remain insufficiently studied, particularly in situations for which recommendations are limited or unavailable. The PREVMED study aims to describe physicians' preventive practices and to investigate the sociodemographic, occupational, and lifestyle factors that may influence these practices.

Fibroblast growth factor 23 (FGF23) is the principal hormone regulating serum phosphate homeostasis. Secreted by osteocytes, it promotes renal phosphate excretion and suppresses the synthesis of 1,25-dihydroxyvitamin D. Measurement of FGF23 has become a key tool in the evaluation of hypophosphatemia, allowing distinction between FGF23-dependent forms (such as X-linked hypophosphatemic rickets, tumor-induced osteomalacia, and intravenous iron-induced hypophosphatemia) and FGF23-independent forms (including renal, gastrointestinal, nutritional, or drug-related causes). In healthy adults, several studies have demonstrated that FGF23 levels vary according to phosphate intake, decreasing during dietary restriction and increasing following phosphate loading. In hypophosphatemic conditions, however, available data are limited to X-linked hypophosphatemic rickets, where prolonged supplementation with phosphate and calcitriol leads to increased FGF23 levels, consistent with the underlying pathophysiology. Based on these observations, it is currently recommended, as a precaution, to measure FGF23 at least 15 days after discontinuation of phosphate supplementation in order to avoid transient elevations that may confound interpretation. In practice, however, this recommendation is difficult to implement, as most patients are already receiving phosphate supplementation at the time of evaluation. To date, no study has specifically assessed the effect of phosphate supplementation in patients with FGF23-independent hypophosphatemia, a condition characterized by appropriately low FGF23 levels. It therefore remains unclear whether supplementation could induce a transient rise in circulating FGF23, potentially leading to misclassification as FGF23-dependent hypophosphatemia (FGF23 \> 95 ng/L). This uncertainty provides a strong rationale for conducting the present study.

The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD). The hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.

Metabolic diseases, including childhood obesity, represent a major public health challenge. Studies in mice have identified transcriptomic markers in adipose tissue capable of predicting a predisposition to obesity prior to any weight gain. The MARIOBE project aims to translate this approach to young children (≤ 4 years old) in order to identify individual vulnerability to obesity at an early stage.

Our main objective is to evaluate the intervention that best enables women's adherence to physical activity (PA). Our hypothesis is that identifying types of interventions suitable for pregnant women (in-person PA sessions, videoconferences or mixed format) could help improve their PA level and simultaneously reduce their sedentary behavior (SB).

Urinary bladder tumors with a frequency of 13000 new cases a year, have a heterogeneity in terms of survival according to the stage of local flooding. This is an aggressive tumor because of the potential muscular infiltration. It seems important in this case (muscular invasion), to increase the global survival. The anatomopathological analysis of the TURB (biopsy byTrans-Urethral Resection of the Bladder) is actually the gold standard for the pathology of bladder tumor. No need an imaging to discuss about the small and non muscular invasive tumor. But in most cases, the use is to perform at last an ultrasound or a CT-Scan, specially for the invasive tumor. A lot of studies show that CT SCAN. is not the best way of investigation for the bladder muscle invasion. However, as in the prostate cancer with the PIRADS Score, the MRI can be useful for the bladder, thanks to the sequence improvement to the machine. The study from Panebianco 2018, starts to talk about the MRI in the urinary bladder cancer with new radiological terms. It creates a new score called VIRADS score (as the PIRADS score already used for the prostate cancer). But it is never compared with the results of the TURB. Our study compares the results of the MRI pre operative versus the pathology results on prospective analysis. Main objective : T tumoral score in urinary bladder tumor : MRI versus pathology results. Secondary objectives : the contribution of diffusion weighted MRI in the bladder neoplasm. Type of study : interventional study, prospective, mono centric, single arm, intent-to-treat

Diabetic retinopathy is a complication of diabetes that can affect vision. Early detection and appropriate management can help prevent or delay vision loss. However, some people with diabetes do not receive the recommended regular eye examinations. The RETINOMED study is a pilot study designed to evaluate the feasibility of offering diabetic retinopathy screening to workers with diabetes through an Occupational Health service. Participants will attend a single study visit at the Occupational Health Department of Clermont-Ferrand University Hospital. During this visit, retinal photographs will be taken using a non-mydriatic retinal camera, which does not require pupil dilation. Participants will also complete a questionnaire about their sociodemographic and occupational characteristics, lifestyle, and diabetes. The study will assess the acceptability of this screening program among eligible workers. It will also estimate the prevalence of diabetic retinopathy among screened workers and explore participant characteristics that may be associated with diabetic retinopathy.

Current pharmacological treatments have not demonstrated significant improvement in cognitive impairment in Parkinson's disease (PD). Given the high prevalence and serious impact of cognitive impairment in PD, there is a pressing need for non-pharmacological interventions with demonstrated functional benefits. Cognitive rehabilitation is a structured program designed to help improve or compensate for patients' cognitive abilities by providing an approach tailored to each patient's individual needs and goals. Neuropsychologists from French Parkinson's Disease expert centers have developed a new cognitive rehabilitation program called LifeCOG-PD, for PD patients with a subjective cognitive complaint or a mild cognitive impairment (MCI), delivered at the hospital in seven 90-minute sessions conducted in groups of 3-4 participants. This program, combining psychoeducation, practical strategies, and personalized goal setting, aims to maintain patients' daily autonomy, enhance quality of life, and delay the cognitive impact of the disease. By evaluating feasibility, acceptability and functional outcomes, this study will contribute critical data to inform future PD management guidelines to help support autonomy and cognitive resilience in PD.

The purpose of the study is to study changes in sedentary behavior following a behavioral intervention (sit-and-stand desk, and cycloergometer)

The goal of this clinical trial is to learn what is the best anesthetic management in participants with severe stroke that require a medical intervention called mechanical thrombectomy (MT) done to open the occluded brain vessel. The main question it aims to answer is: • Is general anesthesia (GA) better than procedural sedation (PS) for improving functional performance and decrease dependance in daily life 3 months after stroke? GA (a non-arousable state induced by anesthetic medications that require respiratory assistance) or PS (a state of reduced arousal induced by lesser dose of anesthetic medications that do not require respiratory assistance) are both used for MT. GA enables strict immobility that could facilitate the conduct of MT but lessen blood pressure and blood flow in the brain. PS provides less drop in blood pressure but MT could be more difficult due to possible movement and breathing may be decreased. Researchers will compare GA with PS to see which one is better for MT success and for the functional consequences of stroke. Participants will be treated with GA or PS for the intervention of MT and will be followed by researchers during their hospital stay and asked by a telephone interview how is their functional status 3 months after stroke.

Acute ischemic stroke due to large vessel occlusion is responsible of cerebral blood flow impairment with a progressive and extensive ischemic process. Cerebral collateral circulation may preserve an ischemic penumbra that could recover providing timely reperfusion of the occluded vessel. Mechanical thrombectomy is the standard of care for anterior circulation large vessel reperfusion. Strategy to promote cerebral blood flow in collateral circulation before reperfusion is scarce and rely mainly on blood pressure maintenance. Carbon dioxide is a potent cerebral vasodilator that could enhance collateral circulation blood flow and cerebral protection before reperfusion. General anesthesia with endotracheal mechanical ventilation could be used for thrombectomy and give the opportunity to modulate and control carbon dioxide tension in the blood. This study will test the effect of moderate hypercapnia on penumbral collateral circulation before reperfusion during mechanical thrombectomy for anterior circulation acute ischemic stroke under general anesthesia.

We spend a third of our life at work. Psychosocial risks (PSR) are a major issue in occupational health 1. Approaching the different dimensions of PSR calls on a dozen essential components: workload, autonomy, social support, burnout, anxiety, efforts made, rewards, work addiction, investment, etc. a specific questionnaire which usually contains 20 to 30 questions, so that having an overall view of PSR using the current reference questionnaires (Karasek, Siegrist, etc.) represents a total of more than 300 questions. The response time is thus incompatible with current medical practice (passage in the waiting room before the occupational health medical examination) and leads to a majority of non-responses during anonymous questionnaires on the Internet. On the other hand, these validated questionnaires were carried out by different people and are very heterogeneous between them, including in their formulation, so that the respondents have the impression of disorganization and anarchy. There is therefore a need for short, quick and uniform questionnaires. EVAs offer the incredible advantage of meeting these criteria: speed, uniformity, precision. From a data analysis point of view, EVAs also have the advantage of offering a continuous quantitative response, allowing the use of all statistical approaches. If some questionnaires have already been validated in the form of EVA, such as the EVA stress versus the " Perceived Stress Scale " questionnaire (PSS), the EVA workload and EVA autonomy at work versus the Karasek questionnaire, the other reference questionnaires are not yet validated in EVA (burnout, anxiety, efforts / rewards, work addiction, etc.).

The objective of this study is to conduct post-marketing clinical follow-up of four products: HMG, PHN, PHR, and TUR. This follow-up will consist of collecting clinical data in real-life conditions to confirm the tolerance, safety, and efficacy of medical devices used in the treatment of sore throats related to acute pharyngitis and/or viral-origin tonsillitis, while also assessing the benefit/risk ratio of the products.

France is among the countries with one of the highest suicide rates in the world, far above those of its neighboring countries \[Wasserman et al., 2012\]. Suicide is the second leading cause of death among 15-24-year-olds, just after road traffic accidents, and the leading cause of death among 25-34-year-olds. Current models emphasize the variability of suicidal trajectories and the possible fluctuation in the duration of suicidal crises: for some individuals, the crisis evolves rapidly and explosively (brief), whereas for others, distress becomes more chronic, often in connection with underlying psychiatric disorders \[Stanley, Brodsky, and Monahan, 2023\]. In this context, the concept of a 'brief suicidal crisis' is an emerging one in psychiatry. It is characterized by an acute phase of psychological vulnerability, during which the main risk is progression to suicidal behavior, but it remains a temporary and reversible psychic crisis (lasting less than 24 hours). The crisis state is marked by a sudden inability to mobilize one's usual coping resources in the face of difficulties, making the individual highly vulnerable. Nevertheless, this concept has been little described, and a better assessment seems desirable, particularly in populations consulting a psychiatrist. Indeed, around 25% of people who die by suicide had consulted a psychiatrist in the month before their death \[Luoma et al., 2002\], yet few data are available on this topic. Primary objective is to assess the prevalence of brief suicidal crisis episodes (lasting less than 24 hours) over the past 12 months among patients attending outpatient psychiatric care and within a sample of patients from a population catchment area in the Clermont-Ferrand region.

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can significantly impair patients' quality of life. Due to its transmural nature (affecting the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula), requiring intestinal resection in approximately half of patients during follow-up. The long-term goal for patients is to maintain a normal life, i.e., without symptoms and without intestinal destruction. To this end, short- and medium-term therapeutic goals have evolved in recent years. Clinical remission is not a sufficient goal, as it has not changed the natural history of the disease. The current goal is to achieve a combination of clinical remission and endoscopic mucosal healing, as this is associated with a reduced risk of adverse outcomes (recurrence of symptoms, hospitalization, intestinal resection). Transmural healing assessed by MRI is also a promising goal associated with a reduced risk of adverse outcomes (recurrence of symptoms, hospitalization, intestinal resection). Furthermore, it is associated with a lower risk of progression to intestinal destruction, unlike endoscopic remission. In this context, transmural healing could soon become the benchmark in terms of therapeutic objectives for Crohn's disease, particularly in the ileum. Although enteric MRI is better accepted than colonoscopy by patients with Crohn's disease, in the ACCEPT1 study, nearly half of patients (48.6%) reported the need to use an intestinal distension product (PEG, mannitol, etc.) as a significant obstacle to repeating entero-MRI, while more than a third complained of vomiting (33.7%) or severe diarrhea (35.0%) induced by these same products. Being able to do without the use of distension products would significantly improve the acceptability of entero-MRI. The investigators hypothesize that an enteric MRI without distension would lead to poorer ileal distension but would allow inflammatory activity scores to be assessed on MRI in a manner similar to an examination with distension, and thus would not impact the need for therapeutic intensification.

CARDIAUVERGNE is a heart failure telemonitoring system at Clermont-Ferrand's hospital. The aim of this study is to analyze the prognosis and evolution of patients after exclusion of telemonitoring. The patients were included from 1st January 2023 to 31st December 2024 and the monitoring was terminated for end of eligibility according to the French health authority criteria.

Multidisciplinary management of amyotrophic lateral sclerosis (ALS) can significantly increase survival but also improve the quality of life of patients. The evaluation of cortical-spinal motor neuron damage is currently based only on the assessment of clinical data. However, the alteration of the central motor pathway and conduction can be identified and quantified by different techniques using motor-evoked potentials (MEP). The combined quadriceps test (QCT) has been developed to assess central and peripheral motor pathway conduction. This test allows to quantify central and peripheral part of a mixed disorder, and to detect physiological hyporeflexia or hyperreflexia which, in the case of suspected ALS, can lead to interpretation problems. The evolution of the QCT parameters during the course of pathology will lead to determine the preponderance of an initial central involvement, but also its extension throughout the pathology. The study of these parameters as well as the clinical course of the disease could reveal a correlation between peripheral and central involvement. This link would provide arguments in favor of pathophysiological hypotheses of disease onset and progression. From a prognostic point of view and depending on the quantification of central and peripheral involvement, the QCT would make it possible to characterize the different ALS phenotypes. This phenotypic characterization would help identify prognostic factors at diagnosis. The investigators propose a cohort study with the exploration of central motor neuron damage by QCT during the course of ALS in order to provide arguments for a better mechanistic understanding and follow-up of this disease with a poor prognosis.