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.
This is an open-label Phase 1/2a study which will enroll patients that have relapsed or relapsed-refractory multiple myeloma to combination regimens of melflufen with currently approved agents. Patients will receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab.
Medically intractable pain caused by occipital neuralgia can be very difficult to control with traditional pain management. Peripheral nerve stimulation which is used in migraines and cluster headache can be an alternative for these patients with occipital neuralgias when medical treatment and traditional pain management have failed (drugs for neuropathic pain, infiltrations, psychobehavioral approaches and multidisciplinary approach in a pain center). Occipital nerve stimulation consists to put a lead subcutaneously in front of the occipital nerve and to connect the lead to a pulse generator. A retrospective study of 60 patients was conducted in Nantes University Hospital. The results were good with the Visual Analog Scale (VAS) decreased from 8.4 preoperatively to 2.85 postoperatively. The medical quantification scale (MQS) was reduced to about 50% (18 preoperatively versus 9.9 postoperatively). Stimulation was quiet stable over time with a mean follow-up of 24 months (range 6 to 72 months). The aim of StimO is to confirm this result through a national controlled randomized multicenter study where occipital nerve stimulation will be compared to the optimal medical management.
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation. Our Hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.
Systemic amyloidoses are rare diseases affecting approximately 1 in 100,000 persons each year. In systemic amyloidoses abnormal proteins deposit in bodily organs and severely impair their function, causing death if not treated effectively. Light chain (AL) amyloidosis is caused by a usually small population of plasma cells (the cells that produce antibodies). These cells produce part of antibodies, the light chains (LC) that form amyloid deposits. Almost every organ, with the exception of the brain, can be affected by AL amyloidosis. The heart is involved in three fourths of patients and is responsible for almost all the deaths occurring in the first 6 months after diagnosis. Current therapy of AL amyloidosis is based on drugs targeting the plasma cells producing the amyloid-forming LC. At present, most patients receive a powerful anti-plasma cell drug, bortezomib, as part of their initial treatment. However, bortezomib-based therapy, can improve heart involvement only in less than one third of patients with AL amyloidosis, and many patients (approximately one third) still die within 12 months from diagnosis. Early cardiac deaths remain an acute unmet need and the major determinant of overall outcome in this disease. Thus, there is the need of alternative means to treat heart involvement in AL amyloidosis. Doxycycline is a widely used, well tolerated, antibiotic that has been marketed for decades and used to treat a number of different infectious diseases caused by bacteria. This molecule has been extensively studied in the laboratory, in animal models and, more recently, in small studies involving patients, for its potential of improving cardiac damage in amyloidosis. These studies showed that doxycycline disrupts amyloid deposits, reduces the amyloid load in a mouse model, and counteracts the toxicity exerted by amyloid-forming LCs on C. elegans, a worm whose pharynx is used as a model resembling human heart. In a small clinical study, doxycycline was given to patients with cardiac AL amyloidosis during treatment for their underlying plasma cell disease. This resulted in a remarkable improvement of survival compared to "matched historical controls" (i.e. similar patients who had received only anti-plasma cell therapy without doxycycline in the past). Based on these promising preliminary results, we designed the present clinical trial to assess whether the addition of doxycycline to anti-plasma cell therapy can improve survival in patients with cardiac AL amyloidosis who were not previously treated. The rate of survival at 12 months will be compared in patients receiving doxycycline and in controls receiving standard antibiotic therapy, together with anti-plasma cell therapy. Patients will be assessed for parameters of plasma cell disease, heart involvement and possible involvement of other organs, as well as for quality of life. To make sure that patients who will receive doxycycline and those who will not have comparable severity of cardiac disease, patients will be stratified according to the stage of cardiac involvement. Patients with very advanced heart dysfunction will not be enrolled in the trial, because preliminary data indicate that doxycycline is of little or no benefit in these subjects. Patients will be randomized to receive doxycycline or standard antibiotics in combination with anti-plasma cell therapy. Bortezomib-based treatment directed against plasma cells will be delivered according to each participating institutions' guidelines. Doxycycline will be administered at a dosage of 100 mg two times a day, which is usual in the treatment of bacterial diseases. Standard antibiotics will be delivered according to each participating institutions' guidelines (provided that drugs of the same class as doxycycline are not administered) in the control arm. Patients will be provided a diary to record possible adverse events and will be instructed accordingly. Patients will be evaluated at trial centers every 2 months for treatment efficacy and toxicity. In case of unsatisfactory response second-line therapy will be initiated. In the absence of unacceptable toxicity, doxycycline administration will be continued for the entire duration of follow-up (12 months).
Patients undergoing suspension laryngoscopy under general anaesthesia have oxygen delivered to their lungs through different methods. Inserting a tube in the trachea is the best means for oxygen delivery. However, it does not allow for optimal visibility of the operated area. Other techniques can be used but have disadvantages with some being associated with serious complications. No consensus exists regarding the best airway management technique for this intervention. The aim of the study is to investigate a new device that delivers oxygen at very high flow through a nasal cannula in patients undergoing suspension laryngoscopy under general anaesthesia. This technique allows the surgeon to have a perfect visualisation of the laryngeal structures while allowing the delivery of oxygen for the lungs. After informed consent, adult patients undergoing suspension laryngoscopy under general anaesthesia in two French hospitals will receive high flow oxygen throughout the procedure. At the end of surgery or, whenever applicable, at the time of technique failure (with a decrease in blood oxygen saturation to less than 92%), blood will be drawn for analysis. All patients will have a thin security catheter inserted in their trachea (the currently used technique in both participating hospitals), allowing for rescue high frequency ventilation if ever the study technique fails. The safety of the device will also be assessed by analysing the blood samples for signs of carbon dioxide accumulation and by collecting any intra or post-operative complications. If the device shows to be effective at maintaining blood oxygenation without significant associated risks, it could be used for other surgical situations where airway management is expected to be difficult.
Microparticles have recently emerged as a thrombotic risk marker with a potential role in determining which patients are at greatest risk for developing thrombosis. Available data show an increase in the level of microparticles in cancer patients who are undergoing chemotherapy for solid tumors with a possible link to their thrombogenic state. Our study focuses on the kinetics of microparticles under chemotherapy in patients with pancreatic or gastric cancer by serial measurements of microparticles procoagulant activity. Detailed Description: The impact of chemotherapy on microparticles expression will be assessed by measuring their procoagulant activity on blood samples taken during the course of chemotherapy. The thrombotic risk will be evaluated by the score of Khorana in parallel. Microparticles expression in patients with thrombosis will be compared to that in other patients.
Colonic microbiota changes may play a key role in the pathogenesis of acute diverticulitis. A previous proof-of-concept study suggests that rifaximin, a low-absorbable oral antibiotic, may be beneficial for prevention of acute diverticulitis recurrence by modulating the gut microflora. The main objective of this study is to evaluate the safety and efficacy of two different doses of a delayed release formulation of rifaximin, versus placebo, for the prevention of recurrence of acute diverticulitis and diverticular complications in patients with a recent episode of acute diverticulitis.
The main objective of the BALISTIC research program is to characterize COPD related to organic particles (of which the model is agricultural COPD) in comparison with tobacco-related COPD, at the clinical, functional (at rest and exercise), inflammatory and physiopathological level. The cross-sectional step BALISTIC 1 made it possible to include 400 patients between 2011 and 2015, and to identify approximately 100 dairy farmers COPD and 100 non-dairy farmers COPD (tobacco COPD). Preliminary results, as well as those of an ancillary study that included a group of subjects exposed to mineral dust and fumes, suggest that agricultural COPD is a predominantly non-emphysematous or essentially bronchial disease with IgE-mediated allergic mechanisms. The current project BALISTIC 2 proposes to conduct a comparative study at + 6 years on average of the two groups of COPD subjects identified in BALISTIC 1 in order to specify the phenotype of COPD in dairy farmers by, in particular, the study of the rate of decline of resting and exercise respiratory function parameters, its computed tomography presentation and its genetic and epigenetic profile. The prospects of this work are to improve the management of COPD in any cause by setting up preventive and curative therapeutic approaches in order to provide answers to the progression of a disease that makes part of the few major public health problems of the 21st century.
Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs) and/or biologically active doses.
The primary objective of the trial was to investigate the effect of the use of inhaled colistimethate sodium (CMS), administered twice a day (b.i.d.) via a specific nebulizer for 12 months, compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with P. aeruginosa on the annualised frequency of pulmonary exacerbations.