Clinical trials

This pilot study evaluates video therapy for lower limb motor recovery after stroke, an approach remains insufficiently documented. This single-center pilot study uses a Single-Case Experimental Design (SCED) to evaluate the effects of intensive video therapy combined with conventional rehabilitation in patients with subacute or chronic post-stroke hemiparesis. Twelve participants will be included and allocated to different baseline durations according to a multiple-baseline SCED design. The primary outcome is functional mobility, assessed using the Timed Up and Go (TUG) test, measured repeatedly throughout baseline, intervention, and follow-up phases.

This cross-sectional proof-of-concept study aims to investigate the relationship between chronic kidney disease (CKD) severity and circulating FGF23 cleavage intensity estimated by the iFGF23/cFGF23 ratio. Eighty male patients aged 55-75 years with CKD stages 3a to 5 will be included (20 per stage). Blood samples obtained during routine nephrology care will be supplemented by two additional tubes to measure iFGF23, cFGF23, hepcidin, erythropoietin, 1,25-vitamin D and TRAP5b. The primary endpoint is the iFGF23/cFGF23 ratio. Secondary analyses will evaluate the associations between FGF23 forms and renal, hematological, iron metabolism and mineral bone parameters. This study will provide the first human data on FGF23 cleavage alterations across CKD stages and may identify novel biomarkers for anemia and cardiovascular complications.

In France today, it is estimated that one in 850 people aged between 20 and 45 has been cured of cancer in childhood. Some descriptive studies have established that cancer diagnosis and treatment can affect psychological health, with an increased risk of depression, post-traumatic stress, anxiety and suicidal risk. A French study published by our team in 2015 and 2020 also showed that, as adults, 40% of former pediatric cancer patients experienced symptoms of anxiety, a rate significantly higher than that of the general French population (25%). While it is well established that it is essential to detect the onset of anxiety-depressive disorders and, if necessary, to set up conventional psychological treatment (CPT), few studies have sought to show the benefit of complementing this conventional CPT with mind-body therapies (MBT) in the post-cancer pediatric setting. This project aims to determine the benefit of mind-body therapies (hypnosis and relaxation) as a complement to conventional psychological treatment (CPT) in the management of anxiety in children, adolescents and young adults in remission from pediatric cancer or leukemia.

Open surgery (laparotomy) has long been the gold standard for pediatric surgery. The development of laparoscopy in the 1980s reduced post-operative pain. Since the 2000s, robotic surgery has been on the rise. The most commonly used robotic system is the Xi robotic system (Intuitive Surgical), which allows instruments to be inserted through three or four trocars and replicates the movements of the surgeon's hands as they sit at a control console a few meters away from the patient.The Single Port (SP) robotic system is a new development in this technology. It allows the same procedures to be performed using a single trocar instead of four. CE marking was obtained in 2024 for abdominal surgery, but without provision for use in children. The pediatric surgery team at Saint-Etienne University Hospital has been performing robotic surgery using the Xi (Intuitive) system since January 2020. Between January 2020 and April 2025, 150 patients underwent surgery, including 49 pyeloplasties, 42 ureterovesical reimplantations, and 23 gastroesophageal reflux treatments. No conversions were necessary, and there were no complications related to the use of the robotic system. The Saint-Etienne University Hospital was the first institution in France to acquire the SP robotic system.

The BELAMI trial is an open label, multicenter, phase 2 study for patients with MM who relapsed following BCMA-directed CAR-T cells or bispecific antibodies with a Phase Ib Safety run-in. The primary hypothesis of this study is that a combination of ADC targeting BCMA and CELMoD will be efficient for these patients.

Sensory neuronopathies (SN) are a group of rare neuropathies characterized by selective destruction of sensory neurons located in the dorsal root ganglia. SN may result from a wide range of etiologies, particularly paraneoplastic, autoimmune, toxic, and genetic causes. The functional prognosis of patients with SN is generally poor: in a recent study, two-thirds of patients had a modified Rankin Scale (mRS) score ≥3 and nearly half had an mRS ≥4. The absence of reliable biomarkers in neuropathies justifies the use of clinical scales as indicators of disease severity, disability, and treatment response. However, none of the currently available "general neuropathy" scales have been specifically designed or validated for SN. The only scale developed specifically for SN is the SEARS (Sensory Ataxia Rating Scale), proposed in 2019, but it has not been widely used nor validated in large populations. As a result, the absence of a clinical scale specifically designed for patients with SN makes longitudinal follow-up more challenging, particularly when assessing the response to immunomodulatory or immunosuppressive treatments when these therapies are indicated.

To diagnose sleep disorders, practitioners primarily use polysomnography (PSG), a precise but costly, cumbersome method that is limited to a single observation. This does not allow for longitudinal monitoring of sleep habits in real-world conditions. An alternative is offered with the C. Santé software receiving information from sensors installed on medical bed. This software analyzes cardiorespiratory parameters and sleep phases without disturbing the patient, enabling continuous and comfortable monitoring. A preliminary study aims to validate the reliability of the C. Santé software analysis, by comparing it to the PSG analysis, considered the gold standard.

A prevalence of urinary incontinence ranging from 5.7% to 80% has been observed in young nulliparous athletes during their activity. The usual recommendations for managing adult women do not seem to be transferable. Young nulliparous athletes need specific educational and behavioral interventions and an alternative to pelvic floor muscle strengthening. A multimodal and multidimensional intervention for athletes and coaches combining specific pelvic health education and strengthening of lumbopelvic-abdominal stability appears to be an innovative and optimal solution for reducing the symptoms of urinary incontinence in young nulliparous women who participate in athletics.

The WHO and our governance advocate that health professionals should organize care around the patient, considering his or her values, needs and preferences, and enabling the patient to develop the capacity to self-manage the chronic health problems he or she faces. Chronic disease is an ongoing dynamic process and adaptation to this process is complicated by the interaction of several determinants: self-management capacity, level of health literacy, quality of life and experience of care. To best support chronic disease, the recommendation is to adopt a management strategy that allows chronic patients to play an active role in the management of their condition and in the day-to-day decision-making process. The management of chronic pathologies is one of the specialties in which Advanced Practice Nurses are positioned, in primary care, outside hospital. Nursing care benefits from care models that allow for more adapted responses, regarding particular care situations, or certain patient typologies. The Humanistic Partnership Health Care Model (MPHS) implement in current Advanced Practice Nurse (APN) practice.

Rheumatoid arthritis affects 0.5% of the population, often leading to foot deformities and pain that are difficult to treat. Management is based on controlling inflammation, adapting footwear and using custom-made insoles, all of which have proven effective. The aim of this research is to build a digital model of plantar pressures based on CT scans, in order to optimize orthopedic insoles. The study will analyze the gait of patients with and without standard insoles to identify mechanical criteria correlated with pain. The ultimate aim is to design optimized insoles, validated by a new gait analysis.

In France, over 1.5 million people suffer from mild cognitive impairment, often a precursor to Alzheimer's disease (AD), whose global prevalence could reach 153 million by 2050. With no curative treatment available, maintaining patients' autonomy at home is essential to mitigate the negative effects of institutionalization and reduce economic costs. Non-pharmacological approaches, such as cognitive training, have shown potential in stabilizing cognitive functions. Research suggests that motor networks and procedural memory remain relatively preserved in early AD, and bodily engagement during encoding enhances memory. For patients with motor impairments, motor imagery (MI) activates these networks without actual movement. Additionally, dynamic visual cues, like videos, reduce cognitive load compared to static images. This project aims to combine real action, MI, and dynamic visual supports to optimize memory. By validating 120 videos of daily activities, it will assess the impact of action on recall, evaluate MI's effectiveness for patients with mobility limitations, and confirm the superiority of videos over static images. The results could support the development of digital tools, such as serious games, to enhance patients' autonomy and address aging-related challenges.

Dry eye syndrome is a multifactorial pathology of the ocular surface. Epidemiological studies report a prevalence of 15% in adults aged between 50 and 95. Depending on the severity of the disease, different treatment strategies may be proposed. The use of autologous serum eye drops (AS) represents an interesting therapeutic alternative for the most severe forms of the disease, due to the serum's composition, which is similar to that of tears. The mechanism of action of AS is still controversial, but is probably multifactorial and seems to be based on growth factors, vitamin factors and anti-inflammatory factors. The clinical response of patients could be dependent on the protein composition of the eye drops. The investigators are aiming to highlight a difference in serum protein composition that could explain the differences in clinical response between patients treated with autologous serum eye drops and to identify the proteins that would be involved in a clinical response or non-response.

We hypothesize, based on field and scientific data, that setting a very ambitious goal such as completing a mountain ultra-marathon could motivate sedentary and inactive individuals not only to begin training but also to follow a progressive yet extremely ambitious program that has not yet been studied comprehensively. Indeed, the effects of intense and prolonged endurance training (18 months) on the health and performance of completely sedentary individuals have never been investigated exhaustively.

This pilot study evaluates video therapy for lower limb motor recovery after stroke, an approach remains insufficiently documented. This single-center pilot study uses a Single-Case Experimental Design (SCED) to evaluate the effects of intensive video therapy combined with conventional rehabilitation in patients with subacute or chronic post-stroke hemiparesis. Twelve participants will be included and allocated to different baseline durations according to a multiple-baseline SCED design. The primary outcome is functional mobility, assessed using the Timed Up and Go (TUG) test, measured repeatedly throughout baseline, intervention, and follow-up phases.

Modern lifestyles are marked by a prevalence of sedentary behaviors and physical inactivity, which have been linked to numerous adverse health effects. While regular physical exercise is a well-established countermeasure, exercising in the late afternoon may paradoxically disrupt deep sleep due to increased core body temperature. Inactive and sedentary individuals, who often have impaired autonomic function compared to endurance-trained athletes, may be particularly susceptible to these negative effects, potentially resulting in compromised thermoregulation and exacerbated disruptions to deep sleep, a critical stage of sleep essential for overall recovery. Therefore, this study aims to investigate the impact of aerobic exercise performed in the late afternoon versus morning on: 1) deep sleep and sleep onset latency; and 2) core body temperature and its autonomic regulatory mechanisms on endurance-trained and inactive-sedentary people.

immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity. In this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus Erythematosus) and very low priced. One randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group). Considering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study.

Muscle deconditioning, characterized by a loss of muscle mass and strength, is a frequent consequence of prolonged lower limb unloading. Beyond muscle mass loss, reduced neural drive contributes significantly to strength decline, highlighting the need for interventions targeting neuromuscular function during immobilization. Focal muscle vibration (FMV) has shown promise in modulating neuromuscular excitability by activating muscle spindle afferents and inducing cortical adaptations. Chronic use of FMV has been associated with significant strength gains and improved neural command. This makes FMV an effective rehabilitation tool. Its simplicity and non-invasiveness further make it a practical countermeasure.

Fuchs endothelial corneal dystrophy (FECD) is the leading indication for corneal transplantation worldwide. It is characterized by the accumulation of guttae and progressive loss of corneal endothelial cells, leading to corneal edema and visual impairment. Endothelial keratoplasty remains the standard treatment; however, graft shortages have driven the development of cell-based therapies involving the injection of cultured endothelial cells. A key unresolved issue is whether removal of the pathological endothelium prior to injection improves cell adhesion. Clinical data are limited and sometimes contradictory, particularly regarding endothelial polishing. The actual effectiveness of this procedure in removing guttae and enhancing the survival of injected cells remains uncertain. Therefore, an in vivo clinical evaluation is required to assess its impact on guttae removal.

Systemic sclerosis (SSc) is an autoimmune disease characterized by skin fibrosis, which clinically manifests as thickening, hardening, and loss of elasticity of the skin. Patients are typically classified as having diffuse cutaneous SSc (dcSSc) or limited cutaneous SSc (lcSSc) depending on the extent of skin fibrosis. The standard assessment of cutaneous sclerosis is based on the modified Rodnan skin score (mRSS), which consists of clinical palpation of 17 areas of the body, scored from 0 (normal) to 3 (severe sclerosis) for each area, with a total of 51 points. However, the mRSS has several limitations, including high inter- and intra-observer variability, particularly depending on the clinician's experience, subjectivity of palpation with difficulties in quantifying subtle changes in firmness or elasticity, and limited sensitivity to small changes or in areas that are not severely affected. The assessment of skin fibrosis therefore faces a lack of objective, quantitative tools that are easy to use in routine clinical practice. Certain alternatives have been evaluated (durometer, ultrasound, elastography, etc.), but none has yet been fully adopted or validated for measuring firmness, elasticity, and adhesion at different depths of the skin with good accuracy and reproducibility. ADHELASKIN° technology (by Tactinnov, LTDS / École Centrale de Lyon) enables objective, highly sensitive measurement of rigidity, firmness and elasticity using an indentation method with a ruby ball sensor. The objective of our study is to assess whether the ADHELASKIN device can differentiate between the biomechanical properties of healthy patients and those of patients with SSc.

AICA-Ribosiduria due to ATIC deficiency is a rare genetic metabolic disease that affects less than 10 patients (PMID: 32557644). It results in severe polyhandicap linked to neurodevelopmental disorders, visual impairment, growth retardation, severe spinal deformities and scoliosis, and often early-onset epilepsy. The disease is caused by dysfunction of the ATIC enzyme, which is involved in de novo purine biosynthesis. A recent study (PMID: 38244287) reported a decrease in disease biomarkers in a single patient after 3 months on a purine-rich diet, which persisted for at least 1 year. The investigators propose to replicate this study on several patients to investigate the potential of this treatment for this severe orphan disease.

Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disease caused by the degeneration of motor neurons in the anterior horn of the spinal cord, due to the absence of the SMN1 gene and the resulting lack of SMN protein. Some patients with particularly severe forms (types 0 or 1) die before the age of 2 in the absence of treatment, while others retain autonomous walking throughout their lives, with no reduction in life expectancy. Three treatments aimed at restoring SMN (TRS) protein expression have recently been approved by the US Food and Drug Administration and the European Medicines Agency (i.e. Nusinersen / Onasemnogene Abeparvovec / Risdiplam). Patients treated with TRS after the onset of symptoms (symptomatic patients) may show significant motor improvement, but retain difficulties such as muscle weakness and fatigue leading to limitations in activities of daily living. The aim of this study is to adapt a fatigability test, widely validated in its original version in different populations (QIF test), but adapted in this protocol to the motor level and low abilities of certain SMA patients. Our objectives are to determine whether these assessments are feasible in SMA patients, reproducible, and relevant for monitoring this population, either routinely or for future clinical trials.

Papillomaviruses are responsible for almost all cervical cancers. In France, there are more than 3000 new cases of cervical cancer each year and nearly 1000 deaths. One of the ways to prevent this cancer is screening by PCR on cervical sample for which national coverage rate remains very insufficient (\<60%). The invasive and uncomfortable nature of cervical sampling has been identified as a major obstacle to screening. In this context, an alternative sample, such as the first-void urine, seems to be judicious. Nevertheless, some studies have shown a lack of sensitivity of the HPV PCR test on urine. As underlined by the French National Authority for Health (HAS), this is mainly due to a lack of standardization of urine collection. In this study, the investigators therefore propose to evaluate the performance of the HPV PCR test on first-void urine using a standardized protocol. Through a questionnaire, they will also evaluate the acceptability of the first void urine collection device.

Chronic fatigue is enhanced by adapted physical activity (APA) programs. Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid benefit from a 4-6 week APA program, with 2 sessions per week. While most patients are improved by these exercise-training programs, for some the benefits remain very modest, and patients describe persistent fatigue. The literature unanimously describes the necessity of longer APA protocols (8-12 weeks, 2-3 sessions/week) for fatigue reduction in fibromyalgia and long Covid. However, it seems difficult to adhere to an optimal program as described in the literature for these fatigued patients. The investigators want to test a device that would both reduce fatigue and improve recovery between APA sessions, in order to gradually reach the recommendations for APA practice. Transcutaneous vagal nerve stimulation (tVNS) seems to be a promising approach. Thus, combining an APA intervention with a tVNS protocol could potentiate the expected and now well-known effect of exercise.

The pathophysiology of the most common corneal endothelial dystrophies (Fuchs' Corneal Endothelial Dystrophy, FECD) is beginning to be dismembered. There is a significant heterogeneity in the clinical forms and the investigators have just highlighted a great diversity of histological forms that seem to define distinct groups.

Venous thromboembolism (VTE) and atherosclerotic cardiovascular disease share common risk factors and frequently coexist in the same patients. Their management requires use of antithrombotic agents: anticoagulant therapy (AC) for secondary prevention of VTE recurrence, antiplatelet (AP) for secondary prevention of major adverse ischemic cardiovascular and cerebrovascular event (MACCE) in patients with atherosclerotic cardiovascular disease (coronary artery disease, atherosclerotic cerebrovascular disease, lower extremity peripheral arterial disease). Side effects of antithrombotic drugs are the 1st cause of emergency admission and hospitalization for an adverse drug reaction (mainly bleeding), and the combination of AC with AP strongly increases this risk.