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.
Since the 2000s, endovascular procedures have been expanding rapidly in multiple disciplines: cardiology, radiology, interventional neuroradiology, and of course vascular surgery. Most procedures are performed by puncture of the common femoral artery with introducers ranging in size from 4F to 26F for aortic procedures. The most frequent complications of percutaneous punctures are false femoral aneurysms due to failure to close the arterial gap (up to 8% in some studies). A false aneurysm is a pocket of blood communicating with an artery and secondary to the rupture of the arterial wall. The blood is then contained by the adjacent structures and often a fibrous shell which distinguishes it from an aneurysm which retains the integrity of its wall. The management of false femoral aneurysms is variable. Below 2 cm, monitoring may be performed with or without manual or ultrasound-guided compression. In case of persistence of the false aneurysm and/or complication, open surgery can be performed. Endovascular treatment of false aneurysms was first proposed in 1986. Different endovascular techniques can be proposed to occlude false aneurysms such as the use of coils, biological glue, the use of arterial closure systems... Echoguided injection of thrombin to occlude the false aneurysm in a manner has been published since the late 1990s. The treatment is evaluated as reliable and safe. A recent article in the EJVES (6) investigates the value of low-dose thrombin for this indication, and the results appear to be very encouraging for low-dose thrombin in false femoral aneurysms. Thrombin injection for the treatment of iatrogenic false femoral aneurysms is the technique currently favoured by the vascular surgery team at the Paris Saint Joseph Hospital Group (GHPSJ). Open surgery is a second-line treatment and remains indicated in case of acute symptoms (radiculalgia, motor/sensory deficits; ischemia, skin necrosis), a false aneurysm that is too deep or without a neck, an infectious origin or a patient treated with dabigatran. Patients will be reviewed at 1 and 12 months according to the usual follow-up. In this work, investigators will study the efficacy of false aneurysm closure using human thrombin injection. This work is intended to confirm previous work. A socio-economic study may be conducted in parallel. Follow-up after the use of percutaneous closure systems and in the context of bypass surgery may also be of interest.
ICU Patients admitted after ARDS due to COVID infection should be weaned from invasive mechanical ventilation as quickly as possible. 60% of ARDS patient after COVID infection admitted in ICU developp a delirium during mechanical ventilation weaning, serious event that can lead to death or acute and late complications since 30% of patients who had a delirium in ICU develop cognitive sequelae. Based on epidemiological arguments and mouse models, severe neuroinflammation is considered to be one of the physiopathological mechanisms causing delirium during ventilatory weaning. In addition to its sedative properties, dexmedetomidine exhibits neuroprotective effects. In experimental models, dexmedetomidine reduces brain inflammation acting directly on the microglial phenotype. The role of this chronic neuroinflammatory condition on cognitive abilities and reserve begins to emerge in the literature no matter the initial stress is (surgery, head trauma, or Alzheimer's type dementia) and is therefore able to influence quality of life. The evaluation of this neuroinflammation by non-invasive tools appears essential in the management and follow-up of post-COVID cerebrolesed patients, as well as the potentially neuroprotective evaluation of dexmedetomidine.
The Nociception Level (NoL) is an index obtained via a non-invasive monitor, that is currently used to assess nociception in anesthetized adults. The NoL index varies from 0 to 100. It increases in response to nociceptive stimuli. The objective of this study was to investigate if the NoL index also indicates the level of nociception in anesthetized children. In children anesthetized according to standard practice, before surgical incision, three 5-seconds stimulations will be performed with different intensities (10, 30 and 60 milliamps). The order of the stimulations intensities will be randomized. The hypothesis of study is that the intensity of stimulation will influence the magnitude of NoL-index increase in response to the stimulation.
Hereditary dysfibrinogenemia results from monoallelic mutation in one of the fibrinogen genes (FGA, FGB, FGG). The spectrum of molecular abnormalities is broad, leading to several subtypes of coagulation disorders with specific biological and clinical features. The correlation between the genotype and the phenotype is poor, and the clinical course of patients, from major bleeding to recurrent thromboses, is unpredictable. Fibrin clot structure is a determinant of the risk of thrombosis in cardiovascular diseases. In all individuals, fibrin networks define the propensity of clot to be more resistant to removal or, on the contrary, susceptible to fragmentation leading to bleeding complications. Besides fibrinogen variants, other relatively common genetic polymorphisms in coagulation and fibrinolytic pathways may affect the fibrin clot structure and therefore act as modifiers of the blood clot function. In this proposal, the investigators will analyze properties (polymerization, fibrinolysis, viscoelastic properties, permeation) and ultrastructure (size, number, packaging, architecture of fibrin fiber by confocal microscopy and scanning electron microscopy) of plasma-based clots in relation to the presence of genetic modifiers (polymorphisms). Polymorphisms will be detected using a whole exome sequencing (WES) in a selected panel of genes of the coagulation and fibrinolytic pathways. The gene panel of 28 genes will include the three fibrinogen genes plus 25 potential modifier genes including F5, F2, PAI-1, PROCR and MTHFR. The overall clot phenotype will be correlated to the presence of prothrombotic polymorphisms and to the patient's clinical phenotype. The investigators plan to include about 100 patients with dysfibrinogenemia. The combination of integrative hemostasis models with genetic dataset will provide a global view of the patient's individual hemostatic profile. This may allow to better predict the clinical outcome and help provide a more personalized therapeutic strategy and precision medicine. In addition, the development of models allowing a reliable global assessment of fibrin clot architecture will be the basis for further research in other acquired diseases involving thrombotic or bleeding events.
Cerebral palsy (CP) is the leading cause of motor disability in children, affecting 125,000 people in France and with 1800 new cases per year. Prematurity remains a major risk factor, although children born at term represent 52% of children with cerebral palsy in France. Recent international and national (Haute Autorité de Santé, Troubles du neurodéveloppement - Repérage et orientation des enfants à risque, February 2020) recommendations emphasize the importance of continuous, early, and systematic management of infants at risk of cerebral palsy before 6 months of corrected age (CA), which is beneficial on the motor, cognitive, and social development of these children into preschool age. The principles of early identification and therapeutic intervention, which are at the core of multi-professional care, are becoming better known. The priorities of this care are: the identification of high-risk infants, the continuity of follow-up from the neonatal period and after the return home in order to detect motor developmental disorders as early as possible, with a the global approach centered on the family. From the neonatal period, parents have traumatic experiences and are subjected to sources of stress. A framework of trust must be established during hospitalization, and preventive, multidisciplinary post-hospitalization follow-up is necessary. Informing families about the risks of motor developmental disorders that may affect their child and about the necessary follow-up in the first months is essential to obtain their adherence to an early course of action. This should take place even before parents have noticed abnormalities, and without waiting for a proven disability. However, it is necessary to support parents in these difficult situations by trying to reduce stress and to preserve the role of the parent. Finally, the ESPaCe survey reveals several of the challenges faced by parents of children with CP: difficulty in finding trained therapists, low frequency of sessions, heterogeneity of rehabilitation techniques, and 75% of parents felt excluded from care and wish to be more involved. Fondation Motrice has therefore suggested developing recommendations for good clinical practice based on scientific evidence to address these difficulties. In this context, the physiotherapists of the CHU Dijon Bourgogne have implemented the recommended early identification tools in the traditional perinatal follow-up pathway by collaborating with the neonatologists and rehabilitation physicians of the CHU Dijon Bourgogne. After the child goes home from the hospital, professionals can ensure continuity and adapt developmental support care by continuing to accompany the families. The follow-up pathway currently offered to these high-risk children includes a motor assessment at 4, 9 and 24 months of corrected age, with an additional consultation at 18 months of corrected age depending on the child's neurodevelopment. However, the psychological impact of this type of pathway on the parents, their satisfaction and their level of adherence to this care pathway are currently unknown. Therefore, the objective of the DéStreSs study is to describe the level of parental stress and whether is varies over time, the consumption of care, parent satisfaction, and adherence to the follow-up program currently offered at the Dijon Bourgogne University Hospital.
For the last twenty years, the proportion of patients aged 80 years and more, hospitalized in intensive care (ICU) has been increasing. The question of the admission of an elderly patient in intensive care raises many medico-socio-economic questions. The general objective of geriatric management is to improve the survival of the patient by maintaining his autonomy. Before an invasive management, it is therefore important to assess which patients are capable of surviving in good conditions. Moreover, as intensive care resources are not extensible, it is important to rationalise the use of this type of care. To date, there are no reliable criteria for predicting which patients will benefit from ICU care. The use of a predictive biomarker, in addition to the existing scores which are not very effective in this population, could guide the intensive care physician in his decision which is generally made in the emergency. The hypothesis of the study is that neopterin measured on admission of the elderly patient to the ICU may improve prediction of survival without major loss of autonomy at 3 months. Acute stress induced by a serious pathology has a profound impact on the immune system via the activation of the neuroendocrine system and the production of endogenous cortisol. Usually, cortisol inhibits the production of pro-inflammatory cytokines such as interferon gamma (IFNg). Sometimes this inhibition is ineffective and leads to an intense pro-inflammatory state that is harmful to the body. Neopterin is produced by monocytes/macrophages under the influence of IFNg. It is associated with a poor prognosis in many diseases such as sepsis or cancer. In the comorbid elderly patient with an upper femoral fracture, the pre-operative neopterin level is predictive of one-year mortality and functional recovery. The hypothesis of the study is that neopterin measured on admission of the elderly patient to the ICU may improve prediction of survival without major loss of autonomy at 3 months. Each patient will be included on admission to the intensive care unit within a maximum of 24 hours (D0). Demographic data (age, sex), severity (IGSIII), comorbidity (CIRS), autonomy (ADL and IADL) and frailty (CFS) scores will be collected as well as the diagnosis at admission. Two additional tubes will be collected during the entry assessment (performed as part of usual care) at inclusion (D0) for neopterin and other biomarkers (4 ml dry tube and 10 ml lithium heparin tube). The blood tubes will be transferred to the research laboratory within 48 hours after sampling. The determination of neopterin, cytokines and oxidative stress biomarkers will be performed by an enzyme-linked immunosorbent assay (Neopterin ELISA Kit CE-IVD, Tecan laboratory) at the Centre d'Immunologie et des Maladies Infectieuses (CIMI-Paris). The assays will be performed at the end of the study, blinded to the patient's outcome, and the follow-up of the patients will be performed blinded to the results of the neopterin assay and the other markers. Patients will be followed up at 3 months from inclusion (M3). The follow-up data will be collected during a routine geriatric consultation. During this consultation, the scores of comorbidities (CIRS), autonomy (ADL and IADL) and frailty (CFS) will be collected. An assessment of physical performance will be carried out by measuring the Short Physical Performance Battery (SPPBS) and the "Handgrip". If it is impossible to carry out the consultation (patient unable to move), the follow-up data (CIRS, ADL and CFS) will be collected from the patient or his relatives during a phone interview conducted by a clinical research technician.
Drug-induced acute interstitial nephritis (DAIN) is a rare entity characterized by acute renal failure linked to inflammation of the renal parenchyma secondary to allergenic drug exposure. Treatment is based primarily on the precise identification of the causative drug and its final elimination. Currently, the identification of the causative drug is based on clinical presumption. There is no test to formally identify the causative drug. On the other hand, in-vitro allergological tests (lymphocyte transformation test in particular) have been developed in the course of immuno-allergic drug toxiderma linked to delayed type IV hypersensitivity to identify the causal drug. These tests have not been studied during DAIN, but their value in drug-induced eruption is indisputable. The objective of our study is to determine whether in vitro allergy tests can identify the causative drug during DAIN. If the in vitro tests fail, they will be supplemented by allergological skin tests.
A Prospective, multicenter, randomized (two arms, parallel groups); double-blind, placebo-controlled in order to assess the ability of preoperative levosimendan to prevent post-operative low cardiac output in high-risk patients referred to cardiac surgery for correcting functional tricuspid regurgitation. The primary end point is a composite element that includes peri-operative mortality and low cardiac output syndrome at day-90: 1) catecholamine infusion persisting beyond 48 hours after cardiac surgery, 2) the need for circulatory mechanical assist devices in the postoperative period, 3) or the need for renal replacement therapy at any time during intensive care unit stay. If a patient had at least 1 of these criteria, he or she was considered as meeting the primary end point.The secondary end points were 1) each component of the primary end point, and 2) the study drug safety defined as refractory hypotension.
Many studies have shown Childhood Cancer Survivors (CCS) are ill-informed about long-term follow-up (LTFU). Massive open online courses (MOOCs) could easily allow a deployment at an international level and make reliable information available for all CCS, wherever they live. The MOOC team (specialists of LTFU care, communication professionals and CCS associations), bringing together nearly 130 people, designed a MOOC named "Childhood Cancer, Living Well, After" including three modules addressing transversal issues (lifestyle, psychological support, fertility problems) and eight modules covering organ-specific problems.
The primary objective of the study focuses on the kinetics of plasma CRP measured during the overall management (before the angioplasty procedure until the discharge of hospitalization) of patients with ST+ ACS requiring emergency transluminal angioplasty.