Clinical trials

Alcohol use disorders are a major public health problem in Europe. The average prevalence of Alcohol Use Disorders (AUD) in the general population is 7.5%, although there are large variations between countries. According to the literature, 20 to 30% of children have parents with problematic alcohol use. Public health authorities are alarmed by the precociousness of alcohol consumption in the youngest age and by the prevalence of alcohol consumption in adolescence. One of the well-established risk factors for alcohol use and abuse is having a parent with AUD. Compared with people growing up without any parent with AUD, the relative risk of suffering negative life events in childhood is 2 to 13 times higher if one or both parents have alcohol use disorders. A family history of Alcohol Use Disorders is predictive of earlier alcohol, tobacco, or cannabis use in adolescence, but it is also associated with a higher risk of developing substance use disorders.

The goal of this observational study is to explore the value of blood biomarkers for the purpose of predicting irAE development in cancer patients treated with immune checkpoint inihibitors (ICI) alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy). Data and blood samples will be collected from participants at different time points as part of routine follow-up visits. Data and blood samples will be analysed. Analysis will include the characterization of immune cells by mass and flow cytometry.

The goal of this prospective observational study is to evaluate changes in cognitive and behavioural markers associated with central sensitisation between the start and end of an exercise retraining programme on an exercise bike, in adult patients suffering from chronic lower back pain associated with an untreated degenerative spine, worth or without referred pain. The main changes it will evaluate are: \- Changes in cognitive and behavioural markers associated with central sensitisation between Day 0 and Day 40 during exercise retraining on an exercise bike as part of a rehabilitation programme for chronic low back pain Participants will undergo the followings: * A calibration test used to define moderate exertion on an ergocycle, corresponding to a perceived exertion of 4-5/10 on the modified Borg scale * Exercise-induced pain intensity assessment tests to detect changes in the intensity of pain during physical activity and the activity's potential to cause pain, realised on ergocyle * Exercise rehabilitation on an ergocycle * Final tests to assess cognitive and behavioural markers related to central sensitisation and pain intensity, as at baseline.

The goal of this clinical trial is to evaluate how bladder filling affects the uterine flexion angle in adult nulliparous women with a uterine flexion angle \<90° when the bladder is empty. The main questions it aims to answer are: How does the uterine flexion angle change as bladder volume increases? What bladder volume is needed to obtain a uterine flexion angle \>90°? Participants will: Drink 600 mL of water following a standardized protocol. Undergo repeated suprapubic ultrasound measurements of bladder volume and uterine flexion angle. Remain under observation until urination or for a maximum of 4 hours. No comparison group is included in this study.

Polymyalgia rheumatic (PMR) is an inflammatory rheumatic disease affecting the elderly. The diagnosis is based on established ACR/EULAR classification criteria. The activity of the disease is evaluated using the PMR-AS, a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment and pain assessment measured by the patient using VAS, and the C-reactive protein (CRP) level. The PMR-AS-CRP (PMR-AS) is considered as relevant to define disease activity (low activity \<7; moderate activity 7 to 17; high activity \>17), flare (\>10), remission (\<1.5), but also to decide if treatment has to be decreased, unchanged or increased (PMR-AS \<10: decrease, PMR-AS \>20 increase, 10≤ PMR-AS ≤20: stable dose) \[10-12\]. Long term low-dose glucocorticoid (GCs) (prednisone or prednisolone started at 12.5 to 25 mg/day progressively tapered) is the mainstay of the treatment. But comorbidities in PMR are due to GCs and 30% of the patients underwent a relapse when tapering GCs. Today, the physicians do not know what is the best duration and the best dosage of GCs. The international recommendation suggests to start prednisone at a dose between 12.5 to 25 mg, to be at 10 mg at 1 or 2 months, and then to decrease slowly. The treatment is generally ordered for 6-18 months but it is possible to try a shorter treatment duration when patients have been previously treated with GCs or in case of comorbidities. The TENOR study, a phase 2 study, demonstrated efficacy of tocilizumab as first line treatment in PMR and its ability to spare GCs. The Semaphore study confirmed the usefulness of tocilizumab in corticodependent forms and demonstrated its efficacy. Another IL-6 inhibitor, sarilumab was authorized for the treatment for polymyalgia rheumatic in adult patients with inadequate response to corticosteroid or relapsing disease but is not reimbursed in France. Baricitinib is an oral selective JAK inhibitor of JAK1 and JAK2 with a short half-life. There are two dosages available (i.e., 2-mg and 4-mg) which can help conduct a simple dose tapering. Administration of baricitinib resulted in a rapid dose dependent inhibition of IL-6 induced STAT3 phosphorylation. An evaluation could be made using the PMR-AS with and without imputation to minimize the effect of baricitinib on CRP by anti-IL-6 effect. Preliminary results of the BACHELOR study (34 patients treated with baricitinib or placebo) suggested a great efficacy of baricitinib in early PMR without steroids. It could be a treatment of PMR, with low dose or no steroids only during the first month, to minimize the adverse events of steroids. JAK inhibitors have been reevaluated by EMA, the Oral Surveillance study suggesting that tofacitinib (Xeljanz®) increases the risk of major cardiovascular problems, cancer, VTE, serious infections and death due to any cause when compared with medicines belonging to the class of TNF-alpha inhibitors. EMA has concluded that these safety findings apply to all approved uses of JAK inhibitors in chronic inflammatory disorders. Nevertheless, the risk was not increased during the first months of treatment in all studies and a short treatment could have lower risks than steroids. As no suitable treatment alternatives are available, excepted GCs which increase the vascular risk and osteoporosis, short treatment by jak inhibitor could be a relevant alternative treatment of PMR. Indeed, the physicians do not have any disease modifying drug (excepted anti IL6 off-label) in treatment of PMR. So, GCs are used for more than one year in the treatment of PMR. Baricitinib, used only 6 months demonstrated its ability to cure early PMR without steroids. It could be an alternative to steroid when physicians consider that ratio benefit/risk is better with a 6 months treatment by baricitininib than \>one year by steroids. Our goal is now to demonstrate in a large cohort the ability of a 6-month treatment with baricitinib in comparison to placebo to decrease glucocorticoids and then to maintain low disease activity without corticosteroids in PMR and a good safety profile. Due to the possible lower risk of 2 mg than 4 mg of baricitinib, but probably a lower efficacy, the investigators plan to compare both baricitinib (4 mg and 2 mg) to placebo. The study will be conducted in France.

Substance use disorders (SUD) and attention deficit disorder with or without hyperactivity (ADHD) are frequently co-morbid, particularly among people under court supervision. The coexistence of these disorders increases the social and legal vulnerability of individuals. Better identification of ADHD in vulnerable people with SUD is essential to improving their care. This project aims to provide appropriate support for this at-risk population.

This multicenter prospective observational study will evaluate the value of dynamic FDG-PET LAFOV imaging during the initial therapeutic assessment of a head and neck cancer 3 months after completion of curative radiotherapy.

Orofacial myofascial pain, most commonly represented by Temporomandibular Disorders (TMD) a significant public health, affecting approximately 12% to 14% of the general population. These disorders are characterized by musculoskeletal pain in the masticatory muscles and joints, leading to reduced productivity and high socio-economic costs. Pathophysiological mechanisms are largely central in origin, similar to other chronic pain syndromes like fibromyalgia. Beyond pain, TMD severely impacts oral health-related quality of life by disrupting vital functions such as mastication and swallowing, and is frequently associated with accelerated dental structure loss due to clenching or grinding. While aerobic exercise is a recommended frontline treatment for many chronic pain conditions due to its ability to induce short-term hypoalgesia and long-term neuroplastic adaptations, it remains critically underutilized in the management of orofacial pain. This controlled clinical study aims to compare a pain neuromodulation mechanism (Temporal Summation of Pain) among patients suffering from chronic orofacial myofascial pain, inactive healthy individuals, and healthy individuals practicing endurance sports. Furthermore, investigating Endogenous Pain Modulation (EPM) in pain-free populations allows for a better understanding of how physical activity modulates pain pathways by eliminating confounding factors associated with pre-existing painful conditions. This knowledge will help clarify how aerobic exercise can be utilized within preventive and therapeutic strategies for the management of orofacial myofascial pain. Moreover, it will facilitate the identification of efficacy markers for therapies such as exercise rehabilitation and physical activity.

The goal of this clinical trial is to validate the interest of a strategy adjusting the flow rate delivered under high-flow oxygen (HFO) therapy according to the lung volumes measured by a new technique, in intensive care patients with hypoxemic respiratory distress (HRD). The main question it aims to answer is: "The use of a technique of measurement of lung pulmonary with adjustement to the flow rate can make it possible to limite intubation in patients with HRD in intensive care?" The participants will be the patients admitted in intensive care for HRD with the need for treatment with HFO. This participants will be randomized in : * the arm control: treated by high flow oxygen therapy according to standard procedures. * or in the experimental arm : treated by high flow oxygen therapy with adjustement of ventilatory parametres based on lung volume measurements, obtained by the depth camera.

The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)

The objective of this study is to analyse the positioning of the scapula in standing position and compared to the supine position (CT scan) in 3 dimensions (3 rotations of the scapula) using a non-radiant, portable system, combining an ultrasound probe with marker and a camera integrated into a Tablet for the three-dimensional location of the marker (probe).

Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term. The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits. This study concerns patients with a diagnosis of one or more chronic respiratory diseases. It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms: * a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group) * a control group receiving only usual care

Systemic lupus erythematosus is a complex systemicautoimmune disease that can affect most organs of the human body. Although they are many recommendations on the diagnosis and managment of SLE, diagnosis and therapeutic managment is still challenging. A pluridisciplinary consultation grouping rheumatologist, nephrologist, dermatologist, gynecologist, internist and immunologists has been set up in 2009 at the university hospital of Brest. The investigators would like to identify in a longitudinal cohort the occurrence of the different clinico-biological and immunological patterns of systemic lupus erythematosus patients during our multidisciplinary consultation. It is now crucial to organize a standardized data collection of these patients in order to evaluate our pratices, to be able to study the epidemiology of SLE in our city, and to promote this initiative at national and international level.

France has one million people with heart failure (HF). Exercise intolerance, characterised by dyspnoea, is the main clinical symptom in HF patients and a key determinant of reduced quality of life. In addition to drug and surgical treatments, cardiac rehabilitation programmes have shown benefits in heart failure patients. Lasting at least 3 weeks, these programmes improve physical abilities, quality of life and reduce the risk of hospitalisation for heart failure patients. To date, the real challenge is no longer to prove the benefits of cardiac rehabilitation, but to find solutions to maintain its long-term effects. The transition between the end of the supervised programmes in the centre and the return home is a difficult phase for the majority of patients who do not continue regular physical activity and thus quickly lose the benefits of the programme. To help maintain the benefits of cardiac rehabilitation, some centres offer patients programmes to continue physical activity during phase III. Although these options are often beneficial in the first few months after the end of rehabilitation compared to control groups, the long-term results are mixed. These results imply that one of these maintenance options may not be suitable for all patients. It is therefore important to propose a personalised post-rehabilitation follow-up involving the patient in the choice of physical activities to optimise the maintenance of long-term benefits. We hypothesise that patients who receive personalised support from a sport and health professional following rehabilitation maintain long-term benefits compared to a control group who do not receive this support.

Very little is currently known about the pathophysiology of pruritus sine materia according to the etiology. The creation of this cohort should make it possible to improve our clinical and biological knowledge according to the etiology, by collecting blood, skin, feces, and clinical data.

This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis. It will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota analysis.

Chronic subdural hematomas (CSH) are collections of blood in the subdural space. CSH are becoming the most common cranial neurosurgical condition among adults, and a significant public health problem, due to an increasing use of anticoagulant and antiplatelet medication in an ageing population. Symptomatic CSH, or CSH with a significant mass effect, are treated surgically. However, recurrences are common (10 to 20%). Conservative management (medical) is used in patients who are asymptomatic or have minor symptoms. However, therapeutic failures, requiring surgical treatment, are common. The pathophysiology of CSH involves inflammation, angiogenesis, and clotting dysfunction. Self-perpetuation and rebleeding is thought to be caused by neo-membranes from the inflammatory remodeling of the dura-mater mainly fed by the distal branches of the middle meningeal artery (MMA). There are 13 ongoing registered RCTs in CSH, with the most common covering application of steroids, surgical techniques and tranexamic acid. Further to this, there are trials running on other pharmacological agents, and peri-operative management. Some industrial or academic trials are or will enroll in France in the next year in France. But to our best knowledge, none of these trials will the eventual benefits of the MMA embolization in both cases of medical and/or surgical management, and none will focus on the use of cyanoacrylates (CYA) for this purpose. Preliminary case series and nonrandomized retrospective studies have suggested that MMA embolization alone or as adjuvant therapy to surgery can decrease recurrences. The investigators hypothesize that in both conditions of conservative or surgical managements, endovascular embolization of patients with CSH significantly reduces the risk of recurrence of CSH. The investigators choose the CYA as liquid embolic agent because of the pain and cost of the use of Ethylen Vinyl alcohol copolymer (EVOH) agents and its simplicity to be used.

As rare disease, vasculitis affects a small number of patients, the cohorts available in the literature are few and the pathophysiological mechanisms remain to be elucidated. The collection of standardized data within a patientheque as part of a multi-year follow-up will facilitate the study of the characteristics of these diseases. This may, in particular, address the main objective of identifying predictors of relapse, as well as secondary objectives for predictive factors of mortality, infectious, cardiovascular or neoplastic complications that affect the prognosis of vasculitis in order to establish a more appropriate management of the patients concerned.

Establishment of a patient library for patients who have had a first psychotic episode and who have an "at risk" status for psychotic disorder (GRD, APS, BLIPS group) or a psychosis threshold during CAARMS administration. Samples are taken on inclusion, at 2 years, and if relapse or significant clinical event within 5 years of inclusion, on 250 patients for 10 years.

The aim of this study is to determine the expression of STIM1 in the plasma membrane of lymphocytes from patients suffering from different autoimmune diseases in order to identify new pathologies of interest presenting an over-expression of STIM1PM. This would allow to initiate, following this study, research and development programs on the use of anti-STIM1 antibodies in these identified autoimmune diseases of interest.

Myelodysplastic syndromes (MDS) are chronic myeloid hemopathies characterized by ineffective hematopoiesis (with peripheral cytopenias) and which contrast with a marrow of normal richness. MDS is considered one of the four most common blood diseases. The incidence is estimated at 4,059 cases / year in 2012 with an average age of 78 years in men and 81 years in women (INCA report, Cancers in France in 2015). The incidence increases with lengthening of the lifespan. The main risk of MDS is transformation to acute leukemia in 30 to 40% of cases. Treatment options depend on clinical, hematologic and chromosomal abnormalities. The prognosis is considered to be at low or high risk of developing acute leukemia. This distinction will therefore have an impact on the therapeutic solution (s). MDS exhibit clinical, morphological and genetic heterogeneity. It is therefore necessary to form subgroups of patients to better understand the physiopathogenesis of this pathology. The constitution of a biocollection will make it possible to search for clinical and biological prognostic markers in order to identify patients progressing to acute myeloid leukemia.

This study corresponds to a monocentric prospective cohort of adult patients presenting a suspicion of idiopathic inflammatory myopathy. It will allows the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood sample, urine, stool and muscle specimen.

Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as compared to term born infants. These neurodevelopmental disorders include difficulties with self-regulation, tone, posture or poor quality movements as well as inadequate responses to sensory simulation. Post-hospital discharge follow-up and interventionsof children born very preterm ares very heterogeneous in France. They are mainly carried out in a rehabilitation center, based on caregivers whereas IBAIP is carried out at home and family centered. Early interventions during hospitalization or after discharge appear potentially of great interest in improving the neurodevelopemental outcome of the very preterm infants. Several early interventions have been developed and evaluated in other countries. These interventions are designed to be used early in life, mainly during the first 3 years of life, and are based on brain plasticity and intense synaptogenesis during this period of life. The IBAIP (Infant Behavior Assessment and Intervention Program) was developed on the same theoretical foundations as the NIDCAP (Neonatal Individualized Development Care and Assessment Program). IBAIP consists of providing the child and his family with an intervention, at home, starting just before hospital discharge up to a 6 months corrected age. .The aim of IBAIP is to support developmental functions including infant's self-regulation and focus on improving the responsiveness of parents' infant interactions.

Cerebral palsy (CP) is the most common cause of child disability. Nearly 40% of PC children suffer from sleep disorders, which are not routinely screened. The neuro-cognitive, physical and environmental morbidity of sleep disorders should require their diagnosis and management. Limited access to the reference exam (polysomnography or PSG) delays the diagnosis and only allows screening of these disorders for a limited number of PC children. The hypothesis of our study is that connected technologies could optimize screening for sleep disorders in PC children by selecting children requiring PSG exploration and specific management.

Sensitive skin is defined as a syndrome manifested by the occurrence of unpleasant sensations (tingling, burning, pain, pins and needles) in response to stimuli that should not normally cause them. These unpleasant sensations cannot be explained by lesions attributable to a specific skin disease. Sensitive skin can affect different parts of the body. The scalp is a site that is often affected, with specificity linked in particular to the presence of hair and different triggering factors (styling habits, wearing of head coverings, application of cosmetics to the scalp, etc.). Sensitive scalp affects around half the population, and can have an impact on the quality of life of sufferers, particularly those whose symptoms are very intense. Women are more likely than men to have a sensitive scalp, so in order to have a more homogenous study population, we chose to include 40 women. The pathophysiology of sensitive skin is imperfectly understood, and studies specific to the sensitive scalp are very rare. However, the pathophysiology of the sensitive scalp could be different because it is a hairy area, more innervated, and less exposed to environmental factors.