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 study of circulating tumoral DNA makes it possible to study, without invasive procedures or pathological studies, the tumoral DNA circulating in the blood of a patient and its various alterations. In patients with colon-rectal cancer with resected tumor, circulating tumor DNA can be used as a predictive biomarker of metastatic relapse of cancer. However, the routine extension of circulating tumoral DNA remains limited due to several difficulties. One of the pifalls that circulating tumor DNA is greatly diluted by healthy circulating DNA from non-tumor cells. The amount of healthy circulating DNA has been described as being influenced by certain physiological parameters. The aim of the study is to increase knowledge on the influence of physiological factors associated with sports activity and meal on the release kinetics of circulating DNA.
In this proposal, investigators seek to address conclusively two knowledge gaps: 1) the lack of data on the impact of a schedule including a day off clinic before night shift on performances of residents in anesthesia or critical care medicine and 2) the lack of data on the relationship between resident sleep deprivation and their non technical skills impairment. Investigators designed a prospective, randomized, blinded in cross over evaluation of medical pratices. Investigators will compare resident's performance during a high fidelity simulation session, on crisis managment in intensive care unit, after a night shift in intensive care unit, of residents who work on an intervention schedule with no clinical activity before night shift, with resident's performance of residents who had a traditionnal schedule including an usual clinical day before night shift. Investigators also assess cognitive performances, sleepiness and self esteem before and after night shift. Investigators specific aims will be: To test the hypothesis that residents working on an intervention schedule will have non technical skills, assessed by Ottawa GRS global score, significantly less impaired after a night shift, than those on traditionnal schedule To test the hypothesis that residents working on an interveniton schedule will have cognitive performances, sleepiness and self esteem less impaired after night shift than those on a traditionnal schedule
In kidney transplantation, donor selection is based in part on the assessment of the functional capacity of the kidneys. For this purpose, it is recommended to measure the glomerular filtration rate (GFR) by a reference technique. To estimate GFR, several approaches are possible depending on the type of measurement (urinary or plasma) and the marker (exogenous or endogenous) used. Among these methods, the measurement of inulin clearance has long been considered the reference method. The occurrence of anaphylactic reactions led to its withdrawal from the market. Iohexol, an iodinated contrast agent, has characteristics similar to inulin. It is eliminated by glomerular filtration and its biological determination is simple. Nevertheless, the techniques currently used to calculate plasma clearance of Iohexol have been imperfectly validated and are not always easy to implement in practice. the investigators propose to develop a Bayesian estimator for estimating Iohexol clearance applied to a population of healthy subjects, representative of potential kidney donors.
"Nasal polyposis is a chronic inflammation of the sinonasal mucosa which is characterized by the development of polyps in the sinonasal cavities. In the general population, its prevalence is 4% with a clear increase from the age of 50 years. When drug treatment is not effective, and the patient's quality of life is impaired, surgery is proposed. It allows to widen the nasal cavities with aerodynamic and acoustics effects on speech. There are few studies, that have focused on the impact of NP and its treatment on speech. Yet there is a real demand from patients to obtain answers related to the impact of this surgery on their voice. Preoperatively and postoperatively, the resonance will be disturbed: polyps will impacted the quality of the nasal sounds. And after surgery, the new anatomical shape can create an excessive resonance in the nasal cavities. Indeed, there is a diversity of acoustic effects that differ according to the sinuses involved, the nature and type of surgery and the anatomical and physiological specificities of the patient. The impairment of acoustic properties after surgery is diverse and little known. The surgery improves the communication between sinuses and nasal cavities but the real impact on nasal resonance still unknown. The particularity of this pathology stands in the obstruction of the sinonasal cavity by polyps. On this study, it represents a model of nasality disturbance/impairment ? Indeed, all aspects of nasality will be altered : the articulation by the obstruction of the sino-nasal cavities, the aerodynamic by a disturbance of the circulation of the airflow within the nasal cavity, acoustics by an alteration of the resonance of this flow, and finally the perception of speech by others where the comprehension of speech is difficult. Thus, the investigators wish to observe this dysfunction in a multipara metric way in order to have an accurate approach. This population is therefore ideal. In preoperative, it will allow to measure by aerodynamic, articulatory, acoustic, and perceptive data taking this dysfunction, to give precise answers. Then, postoperatively, these measurements will be repeated to observe a return to the expected functioning of the nasal cavity. Indeed, the cavities being no longer congested, a greater flow of nasal air would be expected, which would have acoustic consequences on the resonance of nasal sounds. This could be accentuated because of the new anatomical configuration due to the surgery. Perceptually, the voice after surgery should no longer be considered as pathological. In addition to the linguistics aspect, this population has the particularity of having a strongly impacted quality of life. The investigators would therefore like to measure this impact on quality of life before and after surgery. For this study, the main objective is to measure the articulatory, aerodynamics, acoustics and perceptive impact of the nasal polyposis on speech before and after surgery. the secondaries objectives are to: - Compare the differences in aerodynamic, acoustic, articulatory and perceptual changes between the ""presence of polyps in the nasal and sinus cavities"" group and the ""presence of polyps in the sinus cavities"" group - Compare the modifications on the speech of the pathology before and after surgical treatment - Identify the elements related to the quality of life impacted by this pathology. - Identify the glottic compensation strategies induced by the pathology - Compare preoperative and postoperative nasal resonance and the relationship between nasal and sinus cavities using 3D models - Validate the adequacy of the nasality-speech questionnaire for patients with sinonasal polyposis"
Context: Until 70% of thrombotic event are reported during Sars-CoV2 infection. Antiphospholipid antibodies (aPL) tests are often positive. We aim to determine if aPL positivity is involved in thrombose of Sars-CoV2 infection investigating the effect of aPL on thrombin generation (TG) and leucocyte pathway activation (neutrophils extracellular traps (NETs) and activation of triggering receptor expressed on myeloid cells 1 (TREM-1)). Method: We will compare plasma from five groups of subjects: patients with antiphospholipid syndrome (APS) and patients hospitalized for Sars-CoV-2 infection with or without aPL, and as control, patients with acute venous thromboembolism event and healthy volunteers. For each subject, we will analyze aPL, activated protein C (APC) resistance measured by TG and leukocytes markers as circulating neutrophils extracellular traps (NETs) and soluble triggering receptor expressed on myeloid cells one (sTREM-1). We will control aPL test at three month and analyze their persistent positivity and association with thrombotic event. Results: we hypothesize that patients with COVID-19 and aPL will have a similar aPL and level of APS resistance that patients with APS. Also, we think that circulating NETs and sTREM-1 levels will be more important in patients with COVID-19 with aPL than patients without aPL and similar in patients with COVID-19 and aPL and patients with APS. Conclusion: our study will be the first to analyze the potential role of aPL on APC resistance measured by TG and neutrophil activation in COVID-19.
Rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. This means that it is difficult to provide adequate information to families at diagnosis and during follow-up. Prognostic factors are also important for management as they can have an impact on the patient's outcome (time to intervention, choice of one molecule over another, etc.). Finally, few treatments are currently available for these epilepsies. One of the limitations to the development of treatments is the lack of real life data as it is difficult to create reliable primary endpoints such as the rate of patients becoming seizure free naturally compared to a therapeutic intervention. The aim of this real-life study is to evaluate the response to treatment as well as to see the evolution of cognitive and psychiatric comorbidities. As explained above, there are very few randomised trials except for 3 rare epilepsies (infantile spasm syndrome, Dravet syndrome, Lennox-Gastaut syndrome). This has led to the virtual absence of management recommendations, including for the three syndromes mentioned above, where attempts at treatment algorithms have been proposed, although these have not been able to be considered as evidence-based recommendations. As a result, there is some diversity in the management of rare epilepsies from one centre to another. However, this diversity in management can be an asset in a real-life study. This will make it possible to compare different management methods, both in terms of seizure control and medium-term outcome.
Anti-cancer immunotherapy, one of the therapeutic revolutions of recent years. It is based on the use of antibodies that block immune system checkpoints that have been hijacked by cancer cells to benefit themselves. Blocking these checkpoints, such as PD-1, unleashes the action of anti-cancer T cells that can then destroy the tumor. The efficacy of these targeted therapies is significant, with an average 40% response rate in patients with metastatic cancers.Immune checkpoint inhibitors (ICIs) are becoming a 1st line therapy in many oncology indications due to their therapeutic line in many oncology indications due to their favorable effect on the prognosis of various prognosis of various cancers Since checkpoints play a key role in controlling the intensity and duration of an immune response, their immune response, therefore, their inhibition exposes to adverse inflammatory or autoimmune effects inflammatory or autoimmune adverse effects that can be severe and sometimes lethal.Most side effects of ICIs occur within the first few months after initiation of treatment. The toxicity of immunotherapy is immunological, all organs including the heart can be including the heart, can be affected. Cardiac autoimmune involvement in ICIs can involve the myocardium, pericardium, and/or vascular endothelium. These entities may be interrelated or, on the contrary, isolated. In the last 5 years, the number of described cases of myocarditis associated with ICIstreatment has increased. Their incidence remains low, estimated between 0.5 and 2%. This probably represents the most serious cardiovascular complication, as the mortality attributed to it reaches almost 50%. In recent years MRI has become very important in the noninvasive diagnosis of acute myocarditis. The latest update of the Lake Louise criteria in 2018 has thus confirmed cardiac MRI in its first place among noninvasive examinations for the diagnosis of myocarditis with a sensitivity of 87.5%, a specificity of 96.2%, and a positive predictive value of 97.2%.
Genetic diagnostic testing becomes increasingly important for enhancing our understanding of the disease notably the genetics and providing the best care to the patients, and several initiatives seek to gather more data in order to better understand and treat those diseases. Within this context, Novartis and SENSGENE/Strasbourg University Hospitals (HUS) want to set up, through a research collaboration, a non-interventional study in France to better understand the epidemiology of IRDs, particularly the distribution of pathogenic variants in patients. This study aims to serve as a starter study to implement an IRD national registry led by SENSGENE/Strasbourg University Hospitals (HUS). The data collected might also be used to populate global European registries. The primary objective has been defined in a sufficient broad way to address this perspective of registries. As IRDs can present from birth to late middle age, this study will include both children and adult patients regardless of age, sex, and the type of IRD.
Pulmonary Langerhans cell histiocytosis (PLCH) is a rare disease, of unknown etiology, that occurs almost exclusively in smokers.The clinical experience suggests a high prevalence of anxiety symptoms and an addictive profile. However, no study to date has precisely investigated the prevalence of co-morbid psychiatric disorders in this population.The aim of the study is to evaluate the prevalence of co-morbid psychiatric disorders in adult PLCH patients. This study should allow: - to assess the prevalence of psychiatric disorders co-morbid in PLCH patients - a targeted and more effective management of patients - a better response rate to smoking and cannabis weaning, that represents a major goal for these patients.
The study aims is to evaluate the efficacy of intravenous iron supplementation on celiac disease remission (total intestinal mucosal recovery). This randomized multicenter trial compare the administration of intravenous iron by infusion (Ferinject©: 15 mg/kg in NaCl solution in 30 min) and oral iron in combination; to patients receive only oral iron as standard care. The first benefit with IV Iron supplementation is to correct iron deficiency more rapidly than oral iron alone because of trouble of absorption in case of intestinal villous atrophy.