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.
Introduction In 2019, France was the 4th highest consumer of antibiotics in Europe. Among the interventions proposed to reduce antibiotic prescribing, delayed prescribing deserves particular attention. The effectiveness of delayed antibiotic prescription in reducing antibiotic consumption remains poorly studied in the literature, and no study has yet been conducted in France. The main objective of our study is to investigate the factors associated with the choice of antibiotic strategy(immediate or deferred). The secondary objectives are to study the frequency and factors associated with antibiotic consumption according to the initial prescription, and to determine the typical profiles of patients, in the context of a delayed prescription, who consume the antibiotic outside the GP's recommendations. Method 330 general practitioners in Ile-de-France will recruit 2800 patients older than 6 months with acute otitis media between September 2022 and March 2023. GPs will be recruited via the CNGE investigator network, the colleges of general medicine in Ile-de-France, the Sentinelles network, the French Medical Association and the regional unions of health professionals. Initial medical data will be collected by the physicians. Patients will fill in daily data for 2 weeks to monitor their disease. They will also fill in social data, and questionnaires assessing their level of health literacy, confidence and satisfaction with the general practitioner consulted. Factors associated with the physician's choice of antibiotic therapy and the patients' consumption of antibiotics will be analyzed via mixed models. Consumption rates will be expressed as percentages with their confidence intervals. Conclusion This work will allow a better understanding of the elements that guide physicians towards delayed prescription. It can help physicians to better assess patients who are likely to be non-compliant with delayed prescription in order to avoid this type of prescription for them.
With the increasing shortage of available donor organs, liver transplantation from donation after circulatory death (DCD) has been established in many countries to offer a therapeutic strategy for patients with end-stage liver disease beyond standard donation after brain death (DBD). In France, a controlled DCD (cDCD) program based on the use of normothermic regional perfusion (NRP) during organ procurement has been successfully implemented since 2015. This program has since shown excellent post-transplant outcomes with one-year patient and graft survival rates >90%. However, owing to very strict donor and graft selection criteria nearly one third of all potential liver grafts were not transplanted because of presumed poor quality. Furthermore, survival in cDCD liver transplantation which did not adhere to the current selection criteria was significantly lower (68% vs 94%) compared to the highly selected population. Thus, to further expand selection criteria and reduce discard rates without compromising outcomes, there is an urgent need for novel objective methods to assess graft quality prior to transplantation. Graft quality assessment prior to transplantation has been a key challenge in liver transplantation for decades and still today the decision to accept or decline a graft before transplantation relies for the most part on ''gut feeling" of the procurement or transplant team. Currently, selection criteria for cDCD in France are based on donor data, liver biopsy results and hepatocyte injury markers AST and ALT. While donor data are only indirect indicators of graft quality, liver graft biopsy are highly pathologist dependant and do not provide a dynamic assessment. Hepatocyte injury markers during normothermic perfusion have been shown to only have limited value in predicting post-transplant graft function. In addition, several recent studies have suggested a superior predictive value of specific biomarkers in the liver through metabolomics. There is growing evidence that dynamic graft preservation such as NRP may even allow a direct analysis of key injury metabolites within solid organ grafts. During cDCD procurement, liver grafts are exposed to donor warm ischemia which in combination with static cold storage causes ischemia-reperfusion injury (IRI) of the graft during implantation in the recipient. IRI is directly correlated to detrimental post-transplant complications such as primary non function and ischemic cholangiopathy or even recipient death. Studies in animal models have revealed that mitochondria play a major role in IR injury and several mitochondrial signature metabolites for example succinate have been identified in various solid organ grafts such as livers, hearts and kidneys. Based on these results, our team and others have recently identified the release of a small auto fluorescent molecular compound of the mitochondrial respiratory chain, Flavin Mononucleotide (FMN), during the early phase of hepatic I/R injury. Furthermore, FMN has been shown to serve as a surrogate marker for impaired cellular energy production of the liver graft prior to transplantation and enable accurate prediction of post-transplant liver graft viability. Given the natural fluorescence of FMN, a real time quantification method has been established allowing to rapidly assess viability of human liver grafts during the procurement process. Of note, a team from the United Kingdom has validated this real-time FMN quantification during NRP of cDCD liver grafts. Interestingly, since mitochondrial injury is a universal signature of graft injury during the transplant process, FMN has the potential to serve as viability marker in other solid organs such as hearts, lungs and kidneys. In addition, metabolomics approach allow the identification and quantification of many metabolites in a biological system through the use of high-throughput analytical technologies. It can give valuable information about what has, is and will occured in a specific tissu. In Liver transplantation, efforts have focused on studying early event of IR which are known to influence long term outcomes. It is however a complex pathway involving numerous metabolites. Metabolomic is therefore gaining interst in field of LT because it can enlight underlying metabolic process occurring during organ preservation and can lead the way toward a better evaluation of graft quality. Thus, this study aims at developing a robust bio-clinical prediction model of liver graft viability during NRP using in depth metabolomics of perfusate and tissue in combination with available donor and graft characteristics
The purpose of this study is to determine the efects of prone positioning on the recruitment- to-inflation ratio in COVID-19 patients with acute respiratory distress syndrome.
In case of acute portal vein thrombosis (PVT) prothrombotic factors are identified in about 60% of cases, while a local condition is present in 30% of cases. Prothrombotic factors may indicate a long term anticoagulant therapy whereas the risk of recurrence seems low when a local condition is isolated (cholecystitis, angiocholitis, liver abces, diverticulitis, appendicitis, acute/chronic pancreatitis, chronic bowel inflammatory disease, acute hepatitis due to cytomegalovirus, bacteroïdes pylephlebitis, abdominal neoplasia such as adenocarcinoma of the colon, abdominal traumatism or surgery such as cholecystectomy, bariatric surgery or splenectomy). To date the impact of prothrombotic factors associated with local conditions responsible for acute PVT has not been well studied except for acute or chronic pancreatitis. No significant association has been pointed out in this pathology. The aim is to determine what are the risk factors of thrombotic recurrence or extension associated with local conditions responsible for acute non cirrhotic PVT, and to evaluate the rate of secondary long term anticoagulant therapy.
CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events.
Record the ENMG data carried out systematically in patients treated by rehabilitation for thoracic outlet syndrome in order to assess their characteristics and judge the relevance of these data in the context of the diagnosis and their possible modifications following the rehabilitation treatment.
Primary Objective: To describe the lung, spleen and liver outcomes of olipudase alfa Secondary Objectives: - To describe the patient's characteristics - To describe conditions of olipudase alfa use - To describe safety data related to the use of olipudase alfa - To describe complementary effectiveness outcomes parameters
The primary goal of this study is to evaluate the safety and pharmacodynamic effects of PTC518 compared with placebo in participants with HD.
Amyotrophic lateral sclerosis (ALS) is a relentlessly progressive neurodegenerative disorder with no effective disease-modifying therapies at present. The disease is sporadic in 90 % of the ALS patients. Up to 40 % familial ALS cases and up to 25% of familial frontotemporal dementia (FTD) are caused by autosomal dominant GGGGCC hexanucleotide repeat expansions in the C9orf72 gene. The presymptomatic phase of the disease represents a unique opportunity to evaluate mechanisms of disease propagation, characterise patterns of anatomical spread, validate staging systems and appraise the comparative sensitivity profile of emerging imaging modalities. Very few spinal cord imaging studies currently exist in ALS despite their potential to characterise both the lower and upper motor neuron components of the disease. This prospective longitudinal study of asymptomatic and symptomatic c9orf72 hexanucleotide carriers will use a purpose-designed spinal and brain imaging protocol and comprehensive clinical, genetic, electrophysiological and neuropsychological profiling. Newly developed imaging techniques such as spinal cord NODDI, spinal fMRI, quantitative thoracic cord imaging will be implemented in addition to established spinal cord and brain imaging techniques.
The mechanical ventilation weaning must begin as early as possible to limit its complications and requires a spontaneous breathing trial (SBT) before the separation from the ventilator to the patient. However, some patients fail this test and cannot be extubated. The main causes are pulmonary edema and diaphragmatic dysfunction. Predicting the risk of failure before carrying out the SBT makes it possible to anticipate a failure of the extubation and to adapt the therapies as well as possible. To assess the risk of pulmonary edema, cardiac preload, which corresponds to the end-diastolic filling volume of the ventricle, can be estimated using simple tests as the passive leg raising test before an SBT. However, this test requires tilting the patient's trunk and raising the lower limbs to 45°, and is not practical, especially in intensive care. The Müller maneuver, which allows maximum inspiratory pressure measurement via a one-way valve connected to the intubation tube, is currently used in routine care for diaphragmatic assessment. The endothoracic depression induced by this test is likely increasing venous return and cardiac output in patients with a reserve of preload, i.e. in preload-dependent patients. This test would be an easy alternative to the passive leg raising test used in current practice. The objectif is to assess whether the presence of an independant prelaod state, as detected by the absence of increased cardiac output during the Müller maneuver, is associated with the occurence of pulmonary edema during weaning from mechanical ventilation. The study consist in the measurement of cardiac output before and after the passive leg raising test and the Müller maneuver, then measurement of cardiac output before and after an SBT. A transthoracic ultrasound and a blood sample with dosage of proteins and hemoglobin will be carried out initially and then at the end of the SBT as part of routine care. The investigators hypothesize: - The Müller maneuver induces a greater increase in cardiac output in patients in a state of preload dependancy than in patients in a state of preload independancy. - The absence of documented preload dependancy during a Müller maneuver is associated with the occurrence of pulmonary edema during an SBT. The investigators included patients : - > 18 years old, conscious patient, with health insurance, placed under mechanical ventilation for at least 24 hours ; - In whom it was decided to perform a passive leg raising test and an SBT. The investigators excluded pregnancy, patient with chest tube, particpation in another interventional study, tracheostomy, patient under legal protection.