Clinical trials

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.

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can dramatically affect the quality of life of patients. Due to its transmural nature (involvement of the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula) which requires intestinal resection in approximately half of patients during their follow-up. The long-term goal for patients is to maintain a normal life, that is, without symptoms and without intestinal destruction. For this, the short and medium term therapeutic objectives have evolved in recent years. Clinical remission is not a sufficient goal since it has failed to alter the natural history of the disease. The current objective to be achieved is the combination of clinical remission and endoscopic mucosal healing since it is associated with a reduced risk of progression (reappearance of symptoms, hospitalization, intestinal resection). Fecal calprotectin, better accepted than colonoscopy, is a non-invasive biomarker of endoscopic inflammatory activity in CD. The CALM study recently showed that close follow-up with clinical and biological evaluation (assays of CRP and fecal calprotectin), called "tight control", associated with therapeutic intensification in the absence of clinical or biological remission, was associated with a better rate of endoscopic mucosal healing at 1 year than follow-up based solely on symptoms. Thus, the "CALM" strategy is considered to be the current benchmark. Transmural healing evaluated by MRI is also a promising objective associated with a reduced risk of progression (reappearance of symptoms, hospitalization, bowel resection). In addition, it could prevent intestinal destruction. A recent study by our team suggested that calprotectin (mucosal assessment) and MRI (transmural assessment) may be complementary and be a better therapeutic goal. We hypothesize that a "CALM + MRI" strategy concomitantly targeting transmural healing would be superior to the "CALM" strategy alone in maintaining clinical remission without corticosteroids in patients with CD treated with biotherapies.

This study aims to investigate the underlying mechanisms of speech-in-noise difficulties in patients with normal conventional pure-tone and speech audiometry. Participants presenting with complaints of impaired speech understanding in noisy environments will undergo a comprehensive audiological assessment, including extended high-frequency audiometry, electrocochleography (EcoG), distortion product otoacoustic emissions (DPOAEs), auditory brainstem responses (ABR), and central auditory processing evaluation. The study seeks to identify cochlear, neural, and central auditory abnormalities that may contribute to hidden hearing loss and improve its clinical characterization.

Dental caries is the most common chronic disease in children, and its early form-Early Childhood Caries (ECC)-which particularly affects children under the age of six, represents a major public health problem worldwide. This disease has a negative impact on the quality of life of affected children and their families, and leads to significant functional and developmental consequences. Moreover, due to their young age, these children require specialized care and adapted treatment procedures, particularly the use of general anesthesia (GA) for comprehensive oral rehabilitation. This conservative therapeutic approach improves the quality of life and orofacial functions of the children concerned, particularly their masticatory ability. However, there remains a significant rate of caries recurrence within the year following treatment. This is largely due to the difficulty families face in changing the dietary habits that contribute to the disease, such as the frequent consumption of sugar-rich foods in all their forms. These families are often bio-psycho-socially vulnerable and have a low level of oral health literacy. They also tend to show lower adherence to preventive measures (oral hygiene practices and regular dental check-ups for children) as well as to the health education and therapeutic interventions proposed to them. In order to stabilize dental caries in these children, prevent repeated procedures due to recurrent caries, and offer interventions tailored to their needs, it is essential to better understand why oral health behaviors are so difficult to change within these families. This study aims to adopt a qualitative approach to explore the obstacles and barriers to modifying etiological behaviors, particularly dietary behaviors, in families of young children with severe ECC treated under general anesthesia in the specialized care unit of Handiconsult ARA Ouest (CHU Estaing Clermont-Ferrand - CH Riom). Semi-structured, face-to-face interviews conducted with one or both parents will investigate the different dimensions of this issue. A subgroup analysis will compare the factors influencing the adoption of oral health-promoting habits in families of children with and without associated developmental disorders.

The goal of this observational study is to compare the intensity of pain experienced by children (aged 6 to 15) during local anaesthesia with that perceived by the parent accompanying them. The main question it aims to answer is: Can a parent help assess their child's pain when the child is unable to assess it themselves? A preliminary study carried out in the dentistry department of Clermont-Ferrand University Hospital in 2019 showed that parents could be effective external assessors in distinguishing between pain and anxiety in their own children, whom they know well, and were better at this than dentists, who are more prone to errors of judgement.13 This pilot study covered several dental procedures, including pulpotomy, extraction of a primary tooth, curettage of a carious lesion and dental anaesthesia. The study yielded interesting results but also contained some biases, so the investigators would like to improve upon it. To do so, the focus here is on a single therapeutic procedure: local anaesthesia, which is one of the procedures most feared by children and, very often, by the parents accompanying them as well. Once consent has been obtained from both parents (or legal guardians), two questionnaires will be used. The first will consist of simple questions and will be aimed at the children (9 items). The second (20 items) will be for parents and will provide additional information on the child's state of health and on the parents' anxiety regarding their own dental care and that provided to their child. The main aim of both questionnaires will be to assess the intensity of pain perceived by the child during the administration of local anaesthesia, with the child self-reporting their pain and the parent providing an external assessment. These questionnaires will be completed every Wednesday, which allows a child (requiring multiple treatments) to complete the questionnaires several times, thereby enabling us to observe changes in the pain perceived by the child and their accompanying parent over the course of successive anaesthetic procedures.

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.

Among the different types of pain observed in Parkinson's disease, primary parkinsonian pain (PPP) is the most severe, the most difficult to treat, but also the least well characterized and the hardest to describe, not only by patients but also by neurologists. Consequently, PPP remains difficult to identify, even for clinicians with expertise in Parkinson's disease. Nevertheless, patients with Parkinson's disease who experience PPP appear to exhibit certain demographic and clinical characteristics that may help distinguish them from other patients, including a poorer motor response to levodopa, a stronger association with sleep disturbances, and cognitive and behavioral features such as impulse control disorders (ICDs). PPP may therefore be associated with a specific disease phenotype supported by distinct pathophysiological mechanisms. Recently, a disease progression model proposed the existence of a "Brain-First" subtype (characterized by disease onset in the brainstem) and a "Body-First" subtype (characterized by disease onset in the gastrointestinal system). Several clinical markers appear to distinguish these subtypes, notably the presence of REM sleep behavior disorder (RBD), which has been associated with the Body-First phenotype. The association between PPP and RBD, as well as between PPP and the Body-First subtype, has never been investigated. We hypothesize that PPP may be associated with several clinical markers of the Body-First phenotype. Identifying such associations could facilitate the routine clinical diagnosis of PPP and, consequently, improve its management, which remains inadequate at present. The primary objective is to assess the proportion of patients with primary parkinsonian pain according to the presence of probable RBD in Parkinson's disease. This prospective, cross-sectional, non-interventional category 3 study (RIPH 3) will be conducted in 300 patients. Patients contacted through the France Parkinson Association and interested in participating in the study will be able to access the online questionnaire via a QR code or a web link. Completion of the questionnaire is expected to take no more than 15 minutes. This self-administered questionnaire will include collection of general data (age, sex, disease duration, initial motor symptoms, side of symptom onset predominance, and comorbidities), assessments of pain, migraine, sleep, constipation, olfaction, anxiety and depression and impulse control disorders.

The goal of this clinical trial is to evaluate in real life, in patients with Hereditary Hemorrhagic Telangiectasia (HHT), the tolerance of the strategy of use of anticoagulant and/or antiplatelet, by comparing a new exposure period (first trimester of treatment) to a period of reference non-exposure (last trimester before start of treatment).

Impulse control disorders (ICDs) are frequently observed in Parkinson's disease (PD) and can have a major functional impact on the quality of life of both the patient and their entourage. The primary risk factor for the emergence of ICDs in PD is long-term dopaminergic treatment, but other risk factors, such as rapid eye movement sleep behavior disorder (RBD), have recently been identified. The mechanisms leading to ICDs in PD remain debated, but it has been shown that the dopaminergic mesocorticolimbic pathways play a key role in reward, learning, and reinforcement processes, as well as in the regulation of impulsivity. PET studies using \[11C\]raclopride, a tracer that allows evaluation of the postsynaptic availability of dopamine D2/D3 receptors, have demonstrated abnormal sensitization of the mesocorticolimbic dopaminergic system (the reward system), particularly in the ventral striatum, in Parkinson's patients with ICDs when presented with appetitive stimuli or during gambling tasks. However, this has never been studied in patients with and without RBD. Parkinson's patients with RBD may present greater impairment of mesocorticolimbic pathways than those without RBD, particularly abnormal sensitization and postsynaptic modifications of the dopaminergic system, which could predispose patients to the emergence of ICDs when exposed to dopaminergic agonists. Confirming a particular pattern of denervation in Parkinson's patients with RBD that may favor the emergence of ICDs constitutes a personalized medicine approach with a readily identifiable risk marker in routine clinical practice and offers the possibility of adapting the management of these patients. The main objective of this study is to investigate the availability of D2 dopaminergic receptors in subcortical structures (particularly the mesocorticolimbic system) in patients with idiopathic Parkinson's disease, depending on the presence or absence of RBD

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

This is a follow-up study of masticatory function, orofacial functions, and quality of life in patients with a history of upper aerodigestive tract cancer who have undergone rehabilitation with maxillofacial prostheses. The main objective of this study is to evaluate changes in masticatory function during a prosthetic rehabilitation program in patients with a history of upper aerodigestive tract cancer.

Osteoporotic vertebral fractures may lead to chronic pain with a neuropathic component, which is often underdiagnosed and undertreated in older adults. This proof-of-concept randomized controlled trial aims to evaluate whether early application of a 5% lidocaine plaster can prevent the development of neuropathic pain following an osteoporotic vertebral fracture. Participants will be randomized in a 2:1 ratio to receive either a daily 5% lidocaine plaster plus standard care or standard care alone for 2 months. The primary outcome is the proportion of participants who develop neuropathic pain at 2 months, assessed using the PainDETECT questionnaire.

Migrants living with HIV - whether the infection was diagnosed in their country of origin or in France- frequently experience vulnerabilities related to their migration trajectories and often face socioeconomic and administrative instability upon arrival . The primary outcome of this study is to compare the immunovirological efficacy of antiretroviral therapy among migrants living with HIV patients according to their social and administrative status.

The objective of this observational study is to assess the correlation between the severity of periodontal involvement and masticatory performance in patients with periodontitis. The secondary objectives are to identify periodontal parameters that may be associated with a reduction in masticatory performance. This study includes a single group. Participants will be asked to perform a masticatory performance test consisting of chewing a piece of gum for 20 cycles.

The objective of this single-center prospective study is to evaluate the impact of periodontal treatment on masticatory performance in patients with periodontitis. Participants will be asked to complete several questionnaires related to their oral health and quality of life. Functional masticatory tests and salivary flow measurements will also be performed.

This randomized, controlled, two-arm clinical study aims to determine how increasing the proportion of plant-based foods in the diet affects skeletal muscle strength, mass and function, protein metabolism, microbiota and key metabolic markers in healthy older men and women. We hypothesize that diets enriched with animal-based foods will maintain maximal quadriceps strength-the primary outcome of the study-more effectively after the 3-month nutritional intervention than plant-based diets. Proteomic analyses will be performed to identify molecular mechanisms and potential muscle biomarkers reflecting metabolic adaptations of skeletal muscle to plant-enriched diets. In addition, metabolic health markers and micronutrient status will be evaluated to better understand the overall health effects of dietary plant-based transition in older adults.

Restless Legs Syndrome (RLS) is a neurological disorder affecting between 4% and 29% of adults. It is characterized by an urge to move the legs or other parts of the body, often accompanied by unpleasant and sometimes painful sensations. The pathophysiology of RLS, whether associated with pain or not, remains poorly understood, and only a limited number of studies have specifically investigated this aspect. The aim of this study is to determine the prevalence of the painful component of symptoms in a large cohort of patients with RLS, to further characterize its clinical features, and to assess its impact on patients' quality of life. This work could improve the identification of patients experiencing pain, enhance our understanding of pain characteristics in RLS, and help optimize patient management. Furthermore, in the context of emerging therapeutic approaches such as neuromodulation, a better characterization of pain in RLS may contribute to the development and evaluation of new treatment strategies. This is particularly relevant given the high prevalence of RLS and its substantial impact on patients' quality of life. Participants will be recruited either through their neurologist during routine follow-up visits at the Neurology Department of Clermont-Ferrand University Hospital or through the France Ekbom Association. Individuals interested in participating will be provided with access to the online questionnaire via a QR code or a dedicated web link. One thousand patients will be include in this study (RIPH type 3). The online questionnaire is expected to take approximately 30 minutes to complete. It includes the collection of demographic data (age, sex, lifestyle factors, weight, height, employment status, comorbidities, and dietary habits), as well as questions regarding the patient's medical history and sleep habits. The questionnaire also includes validated instruments assessing sleep, pain, RLS severity, anxiety and depression, and quality of life. At the end of the questionnaire, participants will be invited to take part in an optional ancillary study aimed at validating the French translation of the Restless Legs Syndrome Quality of Life questionnaire (RLS-QOL). Participants who agree to participate will complete the questionnaire once at baseline and will subsequently receive an email reminder to complete it a second time two weeks later. This test-retest procedure will be used to assess the reproducibility of the French-adapted version of the questionnaire.

Patients undergoing interventional radiology procedures frequently experience significant anxiety and procedural pain despite standard care. Virtual reality (VR) has emerged as a promising non-pharmacological tool for anxiety and pain reduction in various medical settings. The HYPNO-VR study is a prospective randomized controlled trial designed to evaluate the effect of immersive virtual reality during interventional radiology procedures. Participants will be randomized in a 1:1 ratio to either a virtual reality group or a standard care control group. The primary objective is to assess the impact of VR on procedural anxiety and pain using validated anxiety questionnaires (State-Trait Anxiety Inventory, STAI) and a numerical pain rating scale. Secondary and exploratory objectives include assessment of patient satisfaction, operator experience, procedural duration, analgesic use, and feasibility of VR integration in interventional radiology practice.

The medical and surgical treatment of hidradenitis suppurativa (HS) remains difficult to date. The search for new therapies for HS is a major challenge. The pathophysiology of HS, the similarities with Crohn's disease and the data in the literature suggest a role for the digestive flora in HS. The role of the intestinal microbiota has now been clearly demonstrated in the pathophysiology of chronic inflammatory bowel disease (IBD), and is suspected in many other diseases. Fecal microbiota transplantation (FMT) is the gold-standard treatment for recurrent Clostridioides Difficile infection, and is being investigated in a wide range of conditions. Our hypothesis is that FMT would improve inflammatory lesions of HS by modifying patients' digestive microbiota. Translated with DeepL.com (free version)

Some people with knee osteoarthritis (gonarthrosis) experience pain differently. In some, the pain is described as "nociceptive" (directly related to the joint), while in others it has "neuropathic" characteristics (related to nerve function). The goal of this multicenter, cross-sectional and comparative study is to compare resting brain activity in a brain region called the anterior insula among female patients with painful knee osteoarthritis who experience nociceptive pain compared to those with neuropathic pain. Researchers will compare brain activity at rest between these two types of pain in women over 40 with painful knee osteoarthritis. A better understanding could help improve pain management in the future. Participants will be asked to : * complete questionnaires during the inclusion visit and on the day of the scan, * undergo a clinical examination and a blood test at the inclusion visit, * undergo a functional MRI (fMRI), an imaging test that allows observation of brain activity at rest. Paticipants in the study does not involve any additional treatment. the fMRI scan is non-invasive and does not require any injections.