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 electroencephalogram or EEG is a painless and non-invasive exploratory examination routinely performed in clinical and experimental medicine and has various applications. It is therefore relevant to develop application-specific EEG measurement devices. The clinical development of therapies based on brain control has led to the emergence of numerous EEG devices that aim to allow mobile, autonomous, and easy use for users. Data from the literature have proven the ability of neurofeedback (a form of biofeedback in which subjects respond to a display of their own brainwaves in order to improve their health or performance) to improve brain function in healthy or pathological subjects. These therapeutic applications are offered in hospital settings with conventional systems and in the presence of a therapist. The EEG measurement device URGOnight was developed with the aim of offering autonomous neurofeedback exercises at home. URGOnight is a portable device. It uses passive electrodes (which do not send an electric current) and so-called dry electrodes, i.e. no gel or conductive paste is required. Therefore, the SIGMA study aims to evaluate the quality of the EEG signal collected by URGOnight and compare it with an electroencephalography device commonly used in clinical and research settings. We will also evaluate the quality of the brain wave measurement usually retained in comparative studies of EEG systems.
Coronary calcified lesions will have an increasing impact in the daily practice of coronary angioplasty, considering the epidemiological explosion of factors favoring coronary calcifications, first of all diabetes. Moreover, calcified lesions are underestimated in angiography and associated with an increase in angiographic complications, as well as with a worse clinical prognosis. The usual techniques for the preparation of calcified plaque, in particular rotary atherectomy, have a low penetration rate in France (3% of procedures) and are associated with an increase in per-procedural complications without clinical evidence of effectiveness4. A new device has been developed by Schockwave Medical Inc. for the treatment of calcified lesions to facilitate stent delivery: the C2 Shockwave Medical® Coronary Lithotripsy System (IVL), Inc. This system uses the principle of lithotripsy to induce microfractures in the calcified plaque prior to low-pressure balloon dilatation. The objective of the study is to evaluate the safety and performance of the C2 Shockwave Medical® (IVL), Inc. coronary lithotripsy system in coronary angioplasty in the general population in France.
Percutaneous ablation (PA) is the only non-surgical curative treatment of hepatocellular carcinoma (HCC). Due to its excellent tolerance, particularly in patients with portal hypertension or bearing comorbidities, it now represents in France nearly 70% of the first-line curative treatment of "in Milan" tumours. For HCC less than 3 cm, ideal indication for percutaneous ablations, results of monopolar radiofrequency ablation (mRFA), are excellent with only 5% of reported non-tumoral control after a first procedure. In addition to mRFA the arsenal of ablations has grown considerably with the emergence of new techniques which allow the expansion of indications for PA, especially in patients with poor prognostic tumors or relatively advanced beyond the Milan criteria. In this setting, multibipolar mode using no touch technique (mbpRFAnt) increases the tumour volume than can be ablated, allowing the removal of large tumors> 5 cm. Inadequate tumour control is then de facto greater in these situations, around 20%. Difficult-to-access tumors can furthermore be treated by percutaneous irreversible electrotroporation (IRE). Despite a tumor burden accessible for curative ablation, a phenotype of "aggressive" HCC characterized by high rates of local recurrences is yet to be defined. Up to now, several characteristics might define this subtype with a poor-prognosis and include 1) high serum alpha-foetoprotein (AFP) levels, 2) radiological infiltrative form, and 3) histological macrotrabecular subtype. Based on these characteristics, median recurrence-free survival of these patients is usually below 10 months. High serum AFP level is a well-known predictor of HCC recurrence following curative procedure. In patients treated by percutaneous ablation, regardless of the technique used and irrespective of tumor burden, high baseline serum AFP level has tenaciously been reported as an independent predictor or recurrence.. More recently, the radiological description of infiltrative HCC (as opposed to mass-forming) has been identified as an aggressive from of HCC with a poor prognosis even when eligible for ablation. This aspect is often associated with infra-clinical invasion of the portal veins (PV), leading to poor prognosis. Finally, a "massive macrotrabecular" (MTM) histological subtype of HCC associated with specific molecular features has recently been described. This MTM-HCC subtype, reliably observed in 12% of patients eligible for curative treatment, represents an aggressive form of HCC is an independent predictor of early and overall recurrence following PA, which is retained even after patient stratification according to common clinical, biological, and pathological features of aggressiveness. The idea of optimizing HCC curative treatments using adjuvant biotherapy, particularly in patients with poor-prognosis tumors in curative intent, is particularly attractive. One trial in adjuvant setting was conducted, the STORM trial, that tested the benefit of sorafenib in curative intent of in Milan HCC. This negative trial included patients within Milan HCC, with an expected low rate of recurrence with only few patients treated by PA. Lenvatinib is a multikinase inhibitor which has been recently approved as firs-line therapy for advanced HCC. The investigators assume that lenvatinib could have also a synergistic local action with PA in two ways. First, given as neoadjuvant regimen, lenvatinib by reducing tumor and liver perfusion could decrease the global heat sink effect associated with loco-regional blood microcirculation during PA. Second, by carrying on in adjuvant treatment, lenvatinib could decrease the magnitude of non-specific inflammatory angiogenesis around the treatment zone, therefore reducing the risk of locoregional (intrasegmental) cells tumor spreading or promotion. Given the dismall prognosis of the aforementioned poor-prognosis HCC eligible for PA with an overall median recurrence-free survival below 10 months, the investigators hypothesis is that addition of Lenvatinib as neo- and adjuvant therapy might increase tumour control in these difficult-to-treat patients. Patients combining either high serum AFP levels, infiltrative form or MTM-HCC histological subtype represent 30% of BCLC A stage HCC patients in expert centers, and are the ideal candidates for such trials. Therefore, the first aim of this proposal is to assess the benefit of lenvatinib in neo- and adjuvant setting combined with curative percutaneous ablation for BCLC A HCC patients considered at high risk of local recurrence (high AFP or infiltrative form or macrotrabecular massive subtype).
There are no approved treatments for pSS and the clinical endpoints currently used in clinical trials are inadequate to capture all aspects of the disease that should be evaluated in clinical trials. The newly developed composite endpoint: Sjögren's Tool for Assessing Response to treatment (STAR) will allow a more specific and meaningful assessment of treatment efficacy in pSS. Because of the heterogeneity of the disease and of the central role of the interplay between B- and T-cells in the pathogenesis, it is worth to evaluate combination of conventional synthetic immunomodulatory drugs targeting both B- and T-cells.
Kidney transplantation is the treatment of choice for patients with end stage renal disease. One of the major challenges is to better diagnose the attacks undergone by the kidney transplant in order to increase its longevity. Multiple attacks are caused by non-immune and immune mechanisms, first and foremost the acute rejection of the transplant. Biopsy, an invasive method, remains the "Gold Standard" for diagnosing rejection and other pathologies affecting the kidney transplant. The invasive nature of these biopsies limits their use and alternative biomarkers have been evaluated in order to diagnose kidney transplant pathologies in a non-invasive manner. It is in this context that the nephrology and renal transplantation department of the Necker hospital and Inserm U1151 have carried out several studies leading to the identification of the diagnostic and prognostic potential of acute rejection, by the determination of urinary concentrations of two chemokines, CXCL9 and CXCL10. The most recent study conducted within these teams demonstrated that the diagnostic potential of urinary chemokines could be improved by taking into account standard clinicobiological parameters in multiparametric models. The main objective of the study is to develop, train and validate artificial intelligence models including urinary chemokines, efficient, robust, explainable and interpretable for the diagnosis and non-invasive prognosis of acute renal transplant rejection, trained on a data set made up of clinical and biological parameters.
The spectrum of pathologies accompanied by tissue mineral deposits is wide. In dermatology, several pathologies are associated with calcium mineral deposits, such as calciphylaxis and pseudoxanthoma elasticum (PXE). However, few studies have been carried out on the chemical characteristics of these deposits, their implication on the pathophysiology and their consequences. This motivated our two previous studies on the characterization of skin mineral deposits during calciphylaxis and sarcoidosis. We have shown that these deposits were most often composed of carbapatite and preferentially localized to elastic fibers. Most calcifying dermatoses are preceded by an inflammatory skin condition. Some authors suspect the digestion of elastin by metalloproteinase (MMP) of the extracellular matrix, thus creating nucleation nuclei favoring phosphocalcic deposits. We thus wish to study the structural alteration of dermal elastic fibers during calcifying dermatoses using multiphoton microscopy, a tool available at the Laboratoire d'Optique et Biosciences (LOB) at the Ecole Polytechnique. Multiphoton microscopy presents several contrast modes that can be used in parallel and without marking. This makes it possible to identify constituent elements of tissues without the use of artificially added fluorescent dyes or proteins, for example fibrillar collagen by the so-called "SHG" contrast and elastin by its intrinsic fluorescence. It is then possible to deeply image an intact tissue, without staining, by specifically visualizing its various components. Used in several studies on the skin, including the LOB, multiphoton microscopy has shown its interest in the characterization of dermal fibers, in particular elastin and collagen fibers, but also in the structural study of these and of their possible alteration. It has thus been applied to the study of skin aging, but also of pathologies leading to degeneration of elastic fibers (PXE) or collagen (Marfan syndrome). The main objective of our project is to characterize the structural alterations of elastic fibers during calcifying dermatoses. The secondary objectives are to study the consequences of skin inflammatory phenomena on the deterioration of elastic fibers and to identify a possible nucleus of phospho-calcium deposits within elastic dermal and vascular fibers. We will thus study human skin biopsies already carried out in the context of the diagnosis of these calcifying dermatoses, skin biopsies from the murine model of PXE and in control, human biopsies of healthy skin from patients of different ages (excision margin of skin tumors). This project should provide a better understanding of the genesis of skin phosphocalcic deposits and provide therapeutic avenues for treating them and limiting their occurrence.
Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, especially among children. The diagnosis can be difficult, and recommendations for follow up and prescription for an emergency kit are rarely provided after emergency visit. The Investigators will evaluate the management of pediatric anaphylaxis and clinical signs of allergy in the pediatric emergency department of Montpellier University Hospital
International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.
Stroke is a major cause of disability over the world. While acute therapies have made huge progresses, the number of survivors leaving with clinical consequences of stroke is increasing. Beyond stroke itself, secondary neurodegeneration of disconnected areas, especially of central hubs such as the substantia nigra or the thalamus, could significantly impact the overall outcome of the patients. Data have identified iron accumulation within the disconnected areas as potentially accelerating neurodegeneration. In this research, the main objective is test whether long-term chelation through Deferiprone (Ferrirpox®, Chiesi) administered daily from 3-to-5 days following stroke to 6 months could avoid iron accumulation as measured with Magnetic resonance imaging (MRI) within disconnected areas (substantia nigra). MRI imaging methods such as the quantification of the transverse relaxation rate R2* provide highly correlated information to the histologically measured iron load
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.