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.
No SFORL recommendation for adult ambulatory tonsillectomy. This study would allow the establishment of an ambulatory management during an adult tonsillectomy. This would allow a return home from J0 for the patient and therefore would improve the comfort of the patients and reduce the cost associated with a conventional hospitalization over several days.
Study of sexual health by repeated anonymous self-administered questionnaires in patients treated for non-metastatic breast cancer and referred to Jeanne de Flandre hospital for possible preservation of their fertility. Sexual health is affected by treatments and improves after the treatments. Sexual health is influenced by multiple factors : oncology treatments received, self-esteem, body image, anxiety, depression, professional activity
Vaccination remains the main promising measure to fight against the COVID-19 pandemic. The presumed efficacy of the vaccines is quite remarkable since it varies between 62 and 95%. There is increasing evidence that sex-specific effects may lead to different outcomes of vaccine safety and efficacy. However, sex-disaggregated data after COVID-19 vaccine are lacking. The first purpose of the study is to determine antibody titers against SARS-CoV-2 spike after COVID-19 vaccination. The secondary purpose is to identify predictor factors of immune response including age, gender and biological factors.
Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in December 2019 in Wuhan, China. Infection with this new coronavirus called SARS-CoV-2 can lead to fatal pneumonia associated with high rates of hospitalization in intensive care units (ICU). Hospitalized patients with hematologic malignancies have a higher mortality rate than patients without hematologic malignancies (62% vs. 8%). The severity of Covid-19 may be related to their treatment, in particular anti-CD20 used in B lymphoid hemopathies. In fact, anti-CD20 antibodies induce rapid and prolonged depletion of B cells, but they are necessary for development. humoral immune responses. But currently, no immunogenicity data are known for patients with hemopathy or in those on anti-lymphocyte immunochemotherapy.
In December 2019, infection with a new coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged in China and has since spread throughout the world. Forms of varying severity of COVID-19, a disease induced by this emerging virus, have been described in pregnant women. In addition to the direct effects of the virus on the pregnant woman and the fetus, the pandemic context itself is likely to act as a psychological risk factor and to alter the protective factors for mental disorders. This pandemic context is in itself anxiety-provoking, even traumatogenic, particularly because of the potentially lethal infectious risk that it conveys, all the more so in psychologically vulnerable populations. In addition to the fear of viral contamination, the fear of childbirth and the postpartum period, which includes a more or less important part of anxiety-provoking uncertainty, is added to the fear of viral contamination in the perinatal period. This addition of stress factors is likely to increase the prevalence of perinatal depressive disorders and anxiety disorders, particularly the psychotraumatic experience of childbirth. Sanitary and social measures, such as quarantine, restriction of access of accompanying persons to maternity unit, or contagious isolation of mothers suspected of being infected or infected, which may furthermore impose a separation of mother and child, are also likely to have psychopathological consequences. In this context, three maternity wards of the PREMA University Hospital Federation (UHF PREMA) : Groupe hospitalier Paris Saint-Joseph (GHPSJ), Louis Mourier Hospital (APHP) and Port-Royal Hospital (APHP), in partnership with the "Centre de Psychopathologie du Boulevard Brune (CPBB)" and the psychiatry department of the Louis Mourier Hospital have set up a care protocol consisting of a systematic screening offered to women following childbirth on the first day of their pregnancy, aimed at identifying those with perinatal anxiety and depressive symptoms. Women presenting symptoms are then treated according to the modalities adapted to the organization of each of these three centers.
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia. Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography. Subsequent examinations (24-hour external loop recording, exercise electrocardiogram, cardiac Magnetic Resonance Imaging) and a close follow-up can be proposed to the patient depending on its condition. More recently, detection of myocardial fibrosis and a mitral ring disjunction among patients with MVP were associated with the occurrence of severe ventricular arrhythmia. The investigators hypothesize that ventricular remodeling over time is mediated by the progression of mitral insufficiency severity from myocardial fibrosis secondary to MVP and possibly promoted by other mitral valve abnormalities. This remodeling, characterized by circulating biomarkers and imaging (MRI and echocardiography), could allow the identification of patients with a higher risk of severe ventricular arrhythmia. The main objective of this study is to identify prognostic factors for unfavorable evolution (ventricular remodeling or a rhythm disorder event) at 3 years from initial assessments in MVP patients.
Routine clinical and radiological assessment of response of patients with rectum cancer to neoadjuvant chemoradiotherapy does not allow accurate identification of complete pathological response, and leads to frequent false positive and negative results. Molecular markers reflecting the initial and post-nCRT status of the tumor would be ideal to select patients eligible for organ preservation. This project will test the detection of tumor extracellular vesicles (EVs) in liquid biopsy as a reliable marker for the identification of poor versus good responders to nCRT.
Context : Ventricular tachycardia (VT) are serious heart rhythm disorders which can lead to sudden death. A curative treatment for these abnormalities in the cardiac electrical conduction system is possible through an interventional electrophysiology procedure. A catheter is inserted, generally via a femoral access, and is introduced in the heart ventricles in order to collect various 3D electro-anatomical maps. The pace-mapping technique developed in Nancy (de Chillou et al, Heart Rhythm 2014) allows the reentrant circuit underlying the VT to be identified, as well as a definition of the target zones to be ablated, using radiofrequency energy with the catheter. The pace-mapping technique consists of stimulating the ventricle from various sites within its internal surface, in order to generate different activation pathways of the myocardium. When an activation pathway is similar to the VT pathway, this means that the stimulation site is located near the pathologic zone to be ablated. The surface electrocardiogram (ECG) is used to compare activation pathways. A 3D correlation ma is then generated: the zones with high correlation (>90%) indicated the exit of the reentrant circuit, while rapid transition zones (several %/mm) indicate the entrance of the VT circuit. The pace-mapping technique has several limitations: (i) it requires an ECG recording of the clinical VT of the patient (spontaneous or induced at the beginning of the procedure), however it is not always possible to induce it; (ii) sometimes several VT circuits may be present, rendering the procedure of identification and ablation non-exhaustive. The aim of this study is to analyze retrospectively electroanatomical data collected during the intervention, in order to develop a new method for identifying target zones to be ablated, and to compare the results with the conventionally used method. Hypothesis : The investigators hypothesize that alternative methods to analyze electroanatomical data (surface ECG and spatial coordinates of the pacing sites) could provide information equivalent to conventional methods (e.g. VT correlation map, VT activation maps etc…) without the need for a reference recording of the clinical VT of the patient.
ST+ Acute Coronary Syndrome (ACS) is a major cause of mortality, morbidity and healthcare costs in Europe and France. Emergency trans-luminal angioplasty (TLA), the gold standard treatment, is the major determinant of vital prognosis and functional recovery of patients with ST+ ACS. However, data from surveys and French practice registers highlight frequent deviations from the recommendations at different stages of the procedure; in the pre-hospital phase these malfunctions result in longer delays. Improving the quality of care for patients with ST+ ACS, and in particular improving compliance with recommended delays in the acute phase, is a public health priority in France. Feedback has been identified as one of the most effective interventions to improve practices and organisations in healthcare institutions. Feedbacks are defined as "any summary of a care performance over a given period of time that can be transmitted a posteriori to the health professional in any form, whether written, oral or by computer (in this case called e-feedbacks)". Feedbacks, by objectifying the level of individual and collective performance, encourage recipients to modify their practices and organisations to improve their performance. It also acts as a social pressure mechanism. While the minimum elements of feedback have been identified in the literature, there is a lack of information about the optimal operational modalities for their deployment, which limits the system's capacity to implement them. To overcome this lack of information, there is a consensus in the scientific community that research on feedback should focus not only on analysing its effectiveness, but above all on the determinants of its effectiveness. With regard to the quality of management of patients with ST+ ACS, only four trials were found in the literature that studied the effectiveness of feedbacks; none of them defined the optimal intervention for deploying feedbacks in the emergency department setting. Practice registers, particularly in the cardiovascular field, have shown their effectiveness in improving practices, particularly through the implementation of feedback to practitioners, who produce data. In 2012, the ARS Aquitaine set up two regional cardiovascular registers constituting permanent, nominative, continuous and exhaustive records of the management of patients suffering from coronary pathologies: the Aquitaine Interventional Cardiology Register (ACIRA) and the Aquitaine Register of Initial Management of Myocardial Infarction (REANIM). The cross-referencing of the REANIM and ACIRA registers constitutes an exhaustive cohort of patients with ST+ ACS containing information on the management of the entire care pathway, from the onset of symptoms to the end of the hospitalization for the management of the acute episode. This cohort, which is unique in France in the field of coronary pathologies, makes it possible to produce unprecedented and highly accurate information, particularly concerning the time taken to provide care. Wishing to actively engage in a process of changing practices, the Aquitaine Cardiovascular Registries team has developed an e-feedback tool for emergency, EMS and cardiology teams. This tool alone cannot contribute to effectively improving patient care. It is necessary to build an intervention for the deployment of this tool that takes into account the scientific data and the organisational constraints of care. Secondly, the evaluation of the effectiveness and economic impact of this e-feedbacks tool deployment intervention will allow us to know its real added value on practices, organisations and health care expenditure.
Neuropathic pain is described as a "pain initiated or caused by a primary lesion or dysfunction in the nervous system". It is thus often a chronic affection, as a difficult-to-treat condition. As such, there is growing proportion of patients with inefficient pain relief. The prevalence of chronic neuropathic pain has been estimated from 6.9 to 10% in the general population and represents a heavy financial burden for the health care systems. Spinal Cord Stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain (SCS is a reversible treatment option which leads to improve pain relief and quality of life Using conventional SCS, the prerequisite to target any pain relief is to obtain an appropriate coverage of the painful area with induced paresthesia. Despite its effectiveness, conventional SCS has some limitations (Selectivity, Energy consumption …) and in order to address these limitations and challenges, medical devices and neuromodulation industries have developed the Dorsal Root Ganglion (DRG) stimulation. DRG stimulation appears to be a promising technology that can be proposed to patients with chronic neuropathic pain for several reasons: DRG stimulation has shown promising results in pathologies generating focal pain with more selectively than SCS, lead localization appeared to be less discriminative than SCS. Consequently, DRG seems more stable and efficient to relief pain with lower energy consumption than SCS (therapy can be delivered with very low amplitude compared to SCS). Last but not least, Abbott technology has moved forward to Burst stimulation a couple of years ago and validated this new way of delivering electrical stimulation through several major publications. To our knowledge, applying new waveforms to DRG has not been yet validated. This will represent a fantastic opportunity to refine the design of the next generation of Internal Pulse Generators (IPGs). To date, the baseline study comparing DRG stimulation to SCS is the ACCURATE study. This is a high quality prospective, multicenter, randomized comparative trial conducted in 152 patients implanted with either SCS or DRG stimulation system. Although ACCURATE study is well designed, it has some limitations. To bridge this gap, the investigators propose to conduct a randomized controlled trial (RCT) with a crossover design, where SCS and DRG stimulation will be used within patient in three conditions: (i) SCS alone, (ii) DRG stimulation alone (DRGS), (iii) combination of SCS and DRGS (DUAL). Our goal will be to compare SCS vs DRGS vs DUAL therapies in order to establish the superiority of DRG stimulation over SCS in a crossover design, assess the added value of hybrid stimulation (DUAL) over the separate standalone stimulation types, compare the different cortical pathways involved in both techniques, by functional imaging, incl. MRI, analyze energy consumption by optimizing neural targeting. assess the added value of applying Burst on these different targets, after a 3-month follow-up and to reinforce the perception of neurostimulation techniques through the pain community, as the investigators will demonstrate their benefits on pain relief, functional capacity and quality of life, with objectives measures and a randomized design. This study represents a unique opportunity to boost the rationale of SCS/DRGS since each arm of treatment will be blinded for the patient and the implanter.