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 hypothesis of the study is that Bone Marrow Tryptase (MT) level is a diagnostic marker of Systemic Mastocytosis (SM). Determination of the bone marrow tryptase in Bone Marrow Aspirate (BMA) could be a new diagnostic criteria for systemic mastocytosis with sensitivity close to 100% and a low false negative rate. This new test could be useful to improve the ability to diagnose accurately systemic mastocytosis (in particular the indolent forms). Because of its limited invasiveness compared to bone marrow biopsy, it could also be considered as a test performed before bone marrow biopsy. Only patients with high bone marrow tryptase would then undergo bone marrow biopsy. In the future and if validated by this study, bone marrow tryptase could be a useful marker of mast cell load and help to monitor the efficacy of treatment in systemic mastocytosis.
Type 2 diabetes is the chronic disease with the most important development in France, and particularly in the Saint-Etienne area due to his specific population. Different studies showed the interest of screening targeted on high risk population to reduce cardiovascular risks and mortality. The current screening recommandation is an opportunist targeted screening on population older than 45 years with risk factors by a fasting glucose every 3 years, and a communautaire screening targeted on population older than 45 years suffering precarity with or without risk factors by capillary blood glucose or fasting glucose. The objective of the Sainté Diabete network is to optimize the screening of diabetics, their follow-up and their treatments. Using a self-administered questionnaire during a medical visit could be a simple, cheap and efficient tool to detect diabetics as soon as possible.
Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has been implicated in large outbreaks with increased severity, frequent recurrence, and significant mortality. The host immune responses can influence the severity of CDI and play crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of antibodies directed against the toxins A&B of C. difficile have been associated with a higher risk of recurrence. However, there are conflicting reports.
This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes will be performed at 1 month, 3 months, 6 months and 9 months. This observational study is non-interventional, it does not change the usual care of patients who underwent a bariatric surgery. Data collection will be carried out during routine visits planned in the post-operation usual follow-up. The blood tests are part of the patient's usual care for his bariatric surgery. Surgeons will include patients for whom they have freely decided to use the dietary supplement Refill under the care of the treatment of obesity. The motivation of the patient and his commitment to the project is evaluated by the surgeon. The main objective is to evaluate the efficacy of the dietary supplement Refill. The primary endpoint is the reduction of iron deficiency.
Multiple myeloma (MM) is an incurable disease that is characterized by the accumulation of clonal plasma cells in the bone marrow. While MM patients with relapsed disease may achieve responses to subsequent antimyeloma therapies, the duration of response decreases with successive relapses until resistant disease develops. Until recently, the median survival following relapse after induction therapy was approximately one year. The relatively recent US Food and Drug Administration (FDA) approvals of bortezomib (2003) and combination lenalidomide plus dexamethasone (2006) therapies for the treatment of previously treated MM has provided effective therapeutic options that give patients with relapsed or refractory MM the prospect for a prolongation of overall and progression-free survival times. However, MM remains an incurable disease. A clear unmet medical need still exists for additional novel therapeutic options for the treatment of previously treated MM. Plerixafor reversibly inhibits CXCR4 binding to stromal cell derived factor (SDF)-1alpha and was recently discovered to be an effective agent to mobilize CD34+ cells into the peripheral blood. In normal volunteers, administering Plerixafor after 4-5 days of G-CSF resulted in a 3-3.5 fold increase in circulating CD34+ cells. Two phases 3 studies demonstrated that the combination of G-CSF and Plerixafor is superior to G-CSF alone for mobilizing hematopoietic progenitor cells in front-line or as salvage therapy in patients with multiple myeloma. Nevertheless, almost all patients ultimately relapse, and no plateau is observed in the survival curves. At the time of disease recurrence, there is not one standard salvage approach, but instead, various therapeutic options are available, including novel agents-based therapy, administered for a fixed duration of time or until progression. In the pivotal trial for the approval of bortezomib as monotherapy in relapsed and refractory MM, the median PFS was 7 months, whereas in the pivotal trials for the approval of lenalidomide in combination with dexamethasone in the same group of patients, the median time to progression was approximately 11 months. A more recent prospective, randomized, phase 3 study has shown that a triplet combination of bortezomib, thalidomide and dexamethasone (VTD) achieved superior results compared to thalidomide dexamethasone (TD) alone in patients relapsing following ASCT, with a median time to progression of 19.5 versus 13.8 months, respectively. This study suggests that combinations consisting of both an IMiD and a proteasome inhibitor are a valuable option at the time of relapse. However, when a frozen graft is available, it is also possible to repeat high-dose therapy in patients who previously responded to the frontline application of high-dose melphalan and ASCT. Over time, several reports have demonstrated the feasibility of this salvage strategy. The majority of data are available from retrospective studies and are based on single-centre experiences with small numbers of selected patients. In this setting, PFS has been shown to range from 7 to 22 months, and the treatment-related mortality (TRM) was acceptable, ranging from 0 to 8%. Various prognostic factors for prolonged PFS have been described, such as the duration of response to the first high-dose therapy, or the number of lines of therapy prior to salvage ASCT. With this background, this prospective non-interventional multicentre study will aim to collect data on the feasibility of salvage ASCT using a Plerixafor-based stem cell mobilization in relapsed MM, according to Plerixafor label in France. This is a non-interventional study; visit will be performed as usual, according to each center practices. No additional visits will be requested for the study purpose. The date for each visit and any data generated must be recorded on the appropriate eCRF. The study will consist of 3 periods: - An early screening period - Autologous stem cell mobilization period - High dose melphalan therapy and autologous graft infusion and follow-up for12 months after salvage ASCT Inclusion visit This visit may occur up to 28 days before Mozobil® administration. This visit will be performed during the visit of pre-transplant assessment. For the pre-transplant assessment, the procedures are performed routinely before ASCT even if the patient is not included in the study: Stem cell mobilization phase The stem cell mobilization phase is performed according to standard practice of each participating centre. Follow-up visits High dose melphalan administration and autologous graft infusion will be performed according to each centre standard practice. Patients will be followed according to each center practices. The follow-up of this non-interventional study will end 12 months after ASCT. Subjects will be enrolled over a 2 years period. The total duration of the study will be 36 months
Coronary artery disease is a common and serious disease, the leading cause of death worldwide. Obstructive sleep apnea syndrome (OSAS) is common and often under-diagnosed in coronary artery disease where it could be involved in the pathophysiology and perhaps prognosis. The entanglement of the two pathologies is actually quite well known, in particular the consequences of one over the other just beginning to be studied. Understanding the pathophysiology through new imaging modalities should improve the management of patients to propose new approaches. "SAS-IDM" is an interventional and prospective study conducted at the University Hospital of Montpellier. Patients will be divided in three groups depending of the results of the polysomnography: 1/ AHI < 5/h: normal, without OSA ; 2/ 5/h ≤ AHI < 30/h: mild or moderate OSA ; 3/ IAH ≥ 30/h: severe OSA. A treatment by CPAP will be proposed to patients of the group "severe OSA".
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.
Ultrasound guidance can reduce the required local anesthetic volume for successful peripheral nerve block. The aim of the study is to determine the minimum volume of local anesthetic to achieve an ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.
The purpose of the study is to evaluate the performances of Soluble Fibrin for diagnosing Pulmonary Embolism. Secondary objective is to compare the diagnostic performances of the Soluble Fibrin Assay and the D-Dimer test.
Neuroplasticity is supposed to be altered in patients suffering from a Major Depressive Disorder (MDD). Transcranial Magnetic Stimulation is a medical device which measures cerebral plasticity. Several parameters of cortical excitability are available for that purpose. These parameters are altered on patients wth MDD and these modifications are corrected after treatment. Therefore results in the studies are very heterogeneous. Theta Burst Stimulation (TBS) is a type a Transcranial Magnetic Stimulation (TMS) protocol and can induce cerebral plasticity. The cerebral plasticity induced by TBS was measured on a group of patients suffering from Asperger's disease (ASD) versus a control group. The plasticity was significantly different in patients with ASD. The aim of our study is to study the neuroplasticity induced by TBS on a patients with MDD.