There are about 36633 clinical studies being (or have been) conducted in France. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The incidence in pediatrics is very low (about 3.5 per million per year according to a 2015 study) and therefore the data on the pathology very poor, especially on the therapeutic level. Without appropriate treatment, the disabling sequelae, even involving the vital prognosis, are significant. However, in paediatrics, therapeutic habits have been extrapolated from adult data and lack precision. Existing treatments are almost composed of immunomodulatory and/or immunosuppressive treatments. Different therapeutic lines have been introduced over the years and a better understanding of the pathology. More recently, biotherapies have been introduced in this pathology, but data on their effectiveness remain limited. Data on the evolution under therapy in children are thus still poor. Complications related to the pathology that can jeopardize the vital prognosis and the response to treatment for this pathology deserve to be studied in order to be known and if possible avoided. The aim of the study is to describe French practices and compare the lines of treatment proposed for juvenile atrophic polychondritis.
GenoMed4All 'Genomics and Personalized Medicine for all though Artificial Intelligence in Haematological Diseases' aims to advance on individual SCD patients' disease characterisation and to improve the monitoring of patients' health status, optimise clinical therapy guidance and ultimately improved health outcomes by the identification of biomarkers and the development of individual (risk) models in SCD. Genomed4All supports the pooling of genomic, clinical data and other "-omics" health through a secure and privacy respectful data sharing platform based on the novel Federated Learning scheme, to advance research in personalised medicine in haematological diseases thanks to advanced Artificial Intelligence (AI) models and standardised interoperable sharing of cross-border data, without needing to directly share any sensitive clinical patients' data. The SCD Use case will gather multi-modal clinical and -OMICs data from 1,000 SCD patients in 4 EU-MS: France, Italy, Spain and The Netherlands. In close collaboration with the European Reference Network on Rare Hematological Diseases (ERN-EuroBloodNet, GA101157011), GENOMED4ALL involves multiple clinical partners from the network, while leveraging on healthcare information and repositories that will be gathered incorporating interoperability standards as promoted by ERN-EuroBloodNet central registry, the European Rare Blood Disorders Platform.
Heart failure (HF) is a chronic disease that has a strong impact on quality of life and is often accompanied by anxiety and depression symptoms that can contribute to poor treatment compliance. The overall management of heart failure is currently part of the recommendations and, alongside drug therapy and electrical devices that can be proposed, lifestyle changes (diet, physical activity) can help improve well-being. and perhaps patient prognosis. Yoga is an ancient practice, known to improve the emotional and physical well-being of individuals. There is no formal medical contraindication to this practice, which can be perfectly adapted to the patient's condition. However, very few patients with heart failure practice yoga. A few randomized trials with small numbers as well as the combined analysis of several studies have shown the benefit of yoga in heart failure. The main objective of the research is to demonstrate the improvement in the quality of life induced by the regular practice of yoga in the management of stabilized chronic heart failure patients. Secondly, we will evaluate the effectiveness of regular yoga practice on improving the clinical condition of chronic heart failure patients.
Post-operative ileus is a temporary stoppage of bowel function following surgery. Indeed it can occur in 20% of cases during post-operative follow-up of bowel surgery. The absence of resumption of transit can lead to the implementation of specific treatments such as the placement of a nasogastric tube and drug treatments. To date, the definition of this event is not accepted by everyone and is not based on reproducible evaluation criteria. The main objective of this study is to evaluate a score used to date to define postoperative ileus, the IFEED score, and to compare it to the length of postoperative stay.
Creatine transport deficiency (CTD) is a rare genetic disorder related to pathogenic variants in the SLC6A8 gene, located on chromosome Xq28. Clinical diagnosis of CTD is based on clinical presentation, an increased urinary creatine/creatinine ratio and a severe decreased creatine peak on 1H-MRS magnetic resonance spectroscopy. A retrospective study with questionnaires identified that most CTD patients had moderate to severe intellectual disability. Less than one third of patients were able to speak in sentences. Seizures were present in 59% of the patients. 41% had autistic features. Motor dysfunction was mentioned in 58%, and gastrointestinal symptoms were reported in 35% of the patients. Several new therapeutic avenues are currently emerging in this disease for which no treatment has been available until now : cyclocreatine (interesting but unfortunately with very little clinical applicability due to its toxicity; dodecyl creatine ester incorporated into lipid nanocapsules with intranasal administration; pharmaco-chaperoning (for the folding-deficient creatine transporter variants, Ultragenyx pharmaceuticals new prodrug designed to deliver creatine to the brain (UX068). These new pharmacological treatment options may offer future opportunities to improve cognition in CTD patients. A key issue is to determine outcome measures that are accessible to these patients, despite the importance of their cognitive deficit. In a preliminary study (on 31 CTD patients), investigators showed for example, that 75% of patients were unable to perform a Wechsler scale, which is one of the most used neuropsychological test to determine patient IQ (intelligence quotient). Most of the existing cognitive tests were developed to distinguish typically developing persons and ID (intellectual disability) patients, leading to a floor effect in the latter who systematically fail these tests. Therefore, these tests are not adapted to capture the potential effect of a drug in ID patient group. The identification of reliable and sensitive outcome measures for use in clinical trials in ID patients was recognized as a priority in a meeting convened by the NIH. N-of-1 trials (also called Single-Case Experimental Designs or SCEDs) appear of great interest for rare diseases, statistical power coming from the number of repeated measures, which leads to choose outcome measures that can be repeated multiple times. This innovative study will allow to efficiently preparing future therapeutic trials, by specifying the phenotype of the patients, and by determining the most adapted outcome measures taking into account their cognitive deficiency and the type of experimental design to be used in the context of rare diseases.
Primary Objective: - To describe dupilumab health-related quality of life (HRQoL) effectiveness at 52 weeks compared to baseline. Secondary Objectives: - To describe dupilumab HRQoL effectiveness at 12 and 24 weeks compared to baseline. - To assess the safety during the year of treatment in a real-world setting.
The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry [IHC]2+/in situ hybridization [ISH]- and IHC 1+) population.
The aim of this study is to evaluate the correlation between the fat infiltration of the lumbar multifidus muscle and several parameters including the severity of the lumbar foraminal stenosis. The investigators will analyse lumbar MRI of patients previously included in a database of patients suffering from low back pain. Foraminal stenosis, muscle fat infiltration and other imaging lumbar parameters will be studied by 2D and 3D manuel segmentation, semi-automatic segmentation. Correlations between factors influencing the muscle fat infiltration will be studied by univariate and multivariate statistical analysis.
Acute coronary syndrome (ACS) encompasses a continuum of clinical situations secondary to acute myocardial ischemia. In France, it is a major health problem and represented 60,000 to 65,000 hospitalizations in 2010. In 2015, a diagnosis of ACS was made in 15 to 25% of patients consulting for chest pain in emergency medicine. The incidence of ACS is estimated between 80,000 and 100,000 new cases per year. At the University Hospital Center (CHU) of Réunion, acute chest pain is the leading cause of discharges from the Mobile Emergency and Resuscitation Service (SMUR). In 2019, it represented 23% of exits, 8.5% of which concerned SCAs. The SCA can be anxiety-provoking due to its unexpected and brutal nature. Pain related to myocardial ischemia generates anxiety. This increases when patients associate these pains with death. This anxiety is exacerbated by waiting times for care, especially for patients living in rural areas. In addition, conditions relating to medical care such as noise and the pre-hospital medical environment are perceived as influencing anxiety by patients. The prevalence of anxiety is high, ranging from 30 to 48.5%, in patients with chest pain and/or ACS. A 2020 meta-analysis revealed that anxious patients at the start of their ACS treatment had an increased risk of death, non-fatal myocardial infarction, rehospitalization, recurrence of ACS and the need for coronary revascularization repeated. Overall, ACS patients with anxiety have a 21% increased risk of mortality and 47% increased risk of adverse cardiovascular events compared to those without anxiety. Pre-hospital anxiolytic treatment is therefore essential and consists above all in reassuring the patient with ACS. Medicated anxiolytics are often combined with analgesics and recommended in front of a picture of agitation due to anxiety. However, negative effects may interfere, making clinical monitoring of these patients unsuitable. At the same time, several studies note that anxiety is underdiagnosed and undertreated in the care of these patients. In reducing the anxiety of patients with ACS, unconventional care techniques such as aromatherapy or touch massage have demonstrated their effectiveness. Music therapy is recognized in reducing the anxiety of patients in intensive care or Cardiology. To the knowledge, in France, the effect of a musical intervention on patients with pre-hospital ACS has not yet been studied. It is in this context that the MuSCA study takes place.
Fighter pilots have to perform tasks requiring high mental workload during moderate-intensity acceleration phases (2 to 3G) that can last several minutes. When these accelerations are performed in the body axis (+Gz), they induce a redistribution of blood flow in the lower limbs associated with a decrease in cerebral blood flow, partially compensated by activation of the sympathetic nervous system (baroreflex). The main hypothesis is that the effects of these prolonged accelerations, even of moderate intensity (<+4Gz), could impair pilots' ability to perform complex cognitive tasks, with potential consequences for flight safety and mission conduct. Moreover, flight missions are often performed after sleep debt, which is known to induce cardiovascular responses, sympathetic nervous system activation and impaired mental performance. The secondary hypothesis is that sleep debt (3h of time spent in bed) may increase the impairment of cognitive performance during prolonged acceleration.