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 a multicenter, interventional, prospective study among breast cancer patients with a suspicion of metastatic meningitis. The current study aims to assess the use of proteomic profile issued from cerebrospinal fluid microvesicles for diagnosis of leptomeningeal metastases.
Some patients with antibody-mediated autoimmune hematological diseases (warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (cAIHA) and immune thrombocytopenia (ITP)) shows no or only minor and transient response to therapy despite several treatment-lines. Such patients are more likely to have a severe disease, with a higher morbidity and mortality. Hypothesis Effective depletion of autoreactive plasma cells might be the key for a curative approach of these diseases. Therefore, there is a rationale for using proteasome inhibitors (PIs) in these refractory patients. The rationale is that non-tumoral autoreactive plasma cells are rapidly targeted by proteasome inhibitors. It led us to propose a short course of dexamethasone and ixazomib (5 cycles), to evaluate the safety/efficacy of this innovative strategy of treatment. Method Prospective interventional uncontrolled single arm open study evaluating the rate of patients achieving 5 cycles of ixazomib and dexamethasone without severe toxicity and response on therapy.
The main objective of this study is to compare the protein composition of simultaneously collected undiluted pulmonary edema fluid and AnaConDa-S ® fluid from patients with ARDS. In a previous pilot randomized controlled trial, in patients with moderate-severe acute respiratory distress syndrome (ARDS), the use of inhaled sevoflurane improved oxygenation and decreased levels of a marker of lung epithelial injury (soluble receptor for advanced glycation end-products, sRAGE) and of some inflammatory markers (interleukin (IL)-1β, IL-6, IL-8 and tumor necrosis factor (TNF)-α), compared to intravenous midazolam. These results reinforce those from previously published preclinical studies as they suggest a protective effect of sevoflurane from alveolar/systemic inflammation and from reduced epithelial injury and/or improved alveolar fluid clearance, as assessed by plasma soluble receptor for advanced glycation end-products (sRAGE). The results from available studies support the safe use of sevoflurane inhalation through dedicated device is well tolerated, with no major adverse effect, e.g. on renal function or respiratory mechanics, in critically ill patients admitted to the intensive care unit (ICU), including those with ARDS. Because the investigators group frequently uses sevoflurane in patients with ARDS and are interested in developing further research on the effects of inhaled sedation in ARDS, the current study has been designed to verify whether the same concept could be applied to the filter the investigators use to vaporize sevoflurane in their ICUs.
Gut-derived endotoxaemia, microbial imbalance and bacterial translocation play an increasingly recognized role in the progression from non-alcoholic fatty liver disease (NAFLD) to its more advanced state, NASH (non-alcoholic steatohepatitis). Animal model studies confirmed that Yaq-001 reduces liver injury and prevents steatosis in these models which leads to the theoretical potential of Yaq-001 altering the microbiome and gut permeability in patients with NASH. The purpose of this clinical trial is to study the safety and tolerability of Yaq-001 in patients with NASH. Results from this study will lead to the design of future pivotal performance and safety trials for registration purposes. Candidate patients must be between 18-70 years old and have a clinical diagnosis of NASH, determined histologically or phenotypically, as well as meeting other clinical inclusion/exclusion criteria. Eligible patients will be randomly assigned to receive standard of care treatment plus Yaq-001, or standard of care treatment plus placebo). The treatment lasts for 48 weeks. During treatment, the patient will have 6 study visits. At all the visits, the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital. On two occasions the patient will have a liver Multiscan and on three occasions the patient will have a liver Fibroscan. 70 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.
Prospective, monocentric, randomized phase II study evaluating Low-Level Laser Therapy (LLLT) as a treatment for the pain due to grade 2 oral mucositis in patients with upper aero-digestive tract cancer treated by radiotherapy or chemoradiotherapy. Patients with upper aero-digestive tract cancer receiving their first cervicofacial radiotherapy or chemoradiotherapy will be included in this study if they suffer from oral mucositis due to their treatment. The study procedure will consist in 5 applications of the LLLT that will be performed at three days intervals for a maximum duration of 15 days. Each patient will be followed until 3 days after the end of the study treatment, for a total duration of the study of 18 days.
This trial is a prospective, monocentric study aiming to evaluate an adaptive radiotherapy method (automatic deformable recontouring on the daily MVCT (MegaVoltage Computerized Tomography)) using the Precise ART™ software in patients with head and neck cancer. Patients will receive helical intensity-modulated radiotherapy (IMRT) according to the standard recommendations (35 fractions during 7 weeks). Radiotherapy will include daily repositioning MVCT. For the study, patients will undergo 4 intermediate re-planning CT-scan (without injection of intravenous contrast agent) at week 3, week 4, week 5 and week 6 of treatment. 3 recontouring modalities will be evaluated for the study: - Manuel recontouring (standard method) - Precise ART™ deformed contours - Precise RTX™ deformed contours The total duration of the study for each patient will be 7 weeks.
Immunoscore Colon Test (ICT) will be applied on tumor samples from curative surgery. In the Multidisciplinary Meeting (MM) evaluating the participant adjuvant strategy, a first decision will be taken, based on the participant medical record only. ICT will then be disclosed and the MM will take a second decision. The aim of the study is to observe if the ICT result modifies the treatment decision.
Investigators aimed to estimate the effect of showing and handling a three-dimensional modelization of a patient's kidney presenting with tumor the day before his nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the STAI score. 2 types kidney models (virtual and printed) will be evaluated as compared to usual information, using a randomization.
Even if squamous cell carcinoma of the anal canal (SCCA) is a rare disease, its incidence increases worldwide. SCCA is mostly induced by Human papillomavirus (HPV) infections and HPV-related oncoproteins (E6 and E7) are expressed in more than 90% of SCCA. T stage and N stage are recognized prognostic factors for local and/or distant recurrence in SCCA patients treated by chemoradiotherapy. In fact, ≥T3 or ≥N1 anal cancers are associated with as high as 50% of disease recurrence rate at 2 years. The University Hospital of Besançon with the Gercor conducted a prospective clinical trial (Epitopes HPV02 study) including 69 advanced SCCA patients and established a new standard of care based on Docetaxel, Cisplatin and 5-FU (5-FluoroUracil) chemotherapy (DCF). Among 69 patients treated with DCF regimen, 66 patients were evaluable for efficacy end-points. The objective response rate was 86% including 44% of complete response, and 47% of patients were progression-free at 12 months of follow-up from the first cycle of DCF treatment. Thus, the "Epitopes-HPV02" trial has demonstrated a high response rate of the DCF regimen with a higher than expected 12 months progression-free survival rate.These results raised the hypothesis of DCF being an immunogenic chemotherapy and in that demonstrating a possibly new role of taxane-based chemotherapy in SCCA patients. More than 50% of patients in complete remission had a detectable immunological response against peptides derived from HPV oncoproteins (E6 or E7) or from the telomerase antigen (which is transactivated by E6). LAND study will enroll patients with locally advanced SCCA enrolled in OPTIMANAL clinical trial. OPTIMANAL study will assess the feasibility and efficacy to combine nivolumab to mDCF chemotherapy, followed by the standard chemo-radiotherapy, in high risk locally advanced SCCA patients with T3/T4 N1a or N1b/N1c disease. LAND study is an exploratory translational study, which will analyze the biological mechanisms of action and our ability to track the immune responses against HPV and telomerase. The investigator group will take advantage of the presence of HPV antigens in most patients to set up a specific immunomonitoring program based on tumor samples and blood-derived lymphocytes to better understand the potential synergisms between immunogenic chemotherapy and anti-PD1 (Programmed Death-1), and to identify valuable biomarkers of treatment efficacy.
Adenomyosis is a benign condition defined as the invasion of ectopic endometrium into the myometrium, resulting in smooth muscle hyperplasia and endometrial inflammation, commonly associated with endometriosis and uterine fibroids. Heterogeneity among studies regarding diagnostic criteria and therapeutic management has fed the debate surrounding the impact of adenomyosis on assisted reproductive therapy outcomes. Nevertheless, recent data support that adenomyosis impairs reproductive outcomes associated with in vitro fertilization (IVF). According to several experimental data, prolonged exposure to gonadotropin releasing hormone (GnRH) agonists may overcome part of the detrimental impact of adenomyosis on fertility outcome. Overall, GnRH agonist treatment resulted in decreased local production of cytochrome P450 aromatase, decreased intrauterine concentration of free radicals and reduced inflammatory response and angiogenesis in endometrium, myometrium and adenomyosis lesions. At the same time, GnRH agonists affect neither endometrial capacity to support invasion nor invasive potential of the blastocyst in the early stages of implantation. For IVF, 2 main protocols based on GnRH agonist pituitary down-regulation are available: - the long protocol involving a 15 days pituitary down-regulation; - the ultra-long protocol involving a 3 months pituitary down-regulation. Most studies using ultra-long protocol reported similar IVF outcomes in adenomyosis patients and control groups. Conversely, studies involving long or GnRH antagonist protocols demonstrated a significant reduction in clinical and ongoing pregnancy rates in adenomyosis patients compared to control subjects. Thus supporting that ultra-long protocol may be beneficial to improve IVF outcomes in the setting of adenomyosis.This is what investigators would like to demonstrate in this study