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.
Despite significant advances in patient blood management, cardiac surgery remains a surgical procedure at high risk for bleeding. Numerous perioperative blood conservation strategies have been developed for limiting the use of blood products. Among them, the processing of shed blood and residual cardiopulmonary bypass circuit volume with autotransfusion device is routinely used. Conventional centrifugation-based autotransfusion devices actually available only recover red blood cells while platelets and coagulation factors are almost totally lost. Consequently, large amounts of intraoperative cell salvage could significantly alter perioperative haemostasis. The SAME autotransfusion device (i-SEP, France) is a new and innovative filtration-based autotransfusion device able to recover erythrocytes, leukocytes but also platelets. By offering the opportunity to re-infuse to patients their own platelets in addition red blood cells, significantly improve perioperative haemostasis with this new device is expected. The purpose of the COLTRANE trial is to compare the quality of the perioperative haemostasis in cardiac surgical patients for whom intraoperative cell salvage will be performed using either the SAME autotransfusion device or conventional centrifugation-based device. Because allogenic transfusion of blood products as well as surgical re-exploration for excessive bleeding are associated with poor outcomes and prolonged length of stay, the use of filtration-based SAME device by maintaining perioperative haemostasis could improve outcomes and reduce length of stay of high risk patients. The fact that patients receive their own platelets should also limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection.
In France, undernutrition affects almost three million people, a third of whom are over 70 (Diagnosing undernutrition earlier in the elderly aged 70 and over, n.d.). In fact, 30 to 70% of hospitalized elderly patients suffer from protein-energy undernutrition (denutrition_personne_agee_2007_-_recommandations.pdf, n.d.). The Nutricancer 2 study published in 2014, demonstrated that undernutrition is common among cancer patients. Indeed, 39% of patients suffer from undernutrition and its prevalence depends on the type of cancer, with a predominance of esophagus, stomach and pancreas (60% to 66%), colon/rectum, ovary/uterus and lung (39% to 45%), hematological malignancies (34%), as well as prostate and breast (13% to 20%) (Hébuterne et al., 2014). Moreover, over the past 30 years, undernutrition has been observed in 30% to 50% of the population at the time of diagnosis and before the start of cancer treatment (Boranian et al., n. d.). Undernutrition is often associated with several terms such as malnutrition, anorexia, sarcopenia or cachexia, which refer to geriatric or metabolic syndromes of multifactorial origin that sometimes overlap, and are often observed in cancer patients. Cancer cachexia is a metabolic syndrome associated with undernutrition of multifactorial origin (Boranian et al., n.d.). Its prevalence is around 50% to 80% in cancer patients and is an independent indicator of morbidity and mortality in this population (Nicolini et al., 2013). Undernutrition is a major health issue in elderly cancer patients. It is therefore crucial to diagnose it early, given its high prevalence in this population and the serious complications it can lead to. In 2021, the HAS updated its recommendations on the diagnosis of undernutrition in the elderly. The diagnosis of severe undernutrition is based on several criteria, including serum albumin levels. This is a commonly used marker of nutritional status, especially in patients with involuntary weight loss. However, it is important to note that hypoalbuminemia can be observed in many pathological conditions, including inflammatory syndromes common in cancer. Therefore, interpretation of albuminemia results must take into account the patient's inflammatory status, assessed by C-reactive protein. This analysis makes it possible to distinguish undernutrition due to insufficient food intake from that associated with an inflammatory syndrome and hypercatabolism (Patry & Raynaud-Simon, 2010).
The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).
Macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy. A monocentric ancillary study of the EarlyDry randomized controlled trial.
Campylobacter bacteria, a Gram-negative bacillus commensal in the digestive tract of many animals and mainly responsible for human infections with digestive origins, has been little studied in the field of osteoarticular infections (OAI). Campylobacter spp. are, however, well described, mainly for C. fetus, and pose a dual therapeutic problem: i) a capacity for persistence due to the capacity of most strains to form biofilm; and ii) potential resistance to many antibiotics. The management of IOA caused by Campylobacter spp. is not codified, and is based on small series of cases reported in the literature.
The goal of this project is to describe somatic mutations of healthy oral mucosa from patients with oral squamous cell carcinoma (OSCC).
The main objective is to evaluate the impact of a Regorafenib combined with metronomic chemotherapy (capecitabine and cyclophosphamide) and low-dose aspirin compared to standard Regorafenib treatment in patients with metastatic colorectal cancer by assessing progression-free survival.
This study is a proof-of-concept trial of vonafexor safety, its effects on kidney function in subjects with at risk of progression Alport syndrome.
Background. Cardiovascular diseases (CVDs) are the leading cause of premature mortality and disability accounting for one third of all deaths worldwide with considerable impacts on economics and on quality of life. Recent studies suggest that a lifestyle intervention might have a role in the reduction of CDV risk. Lifestyle intervention programs typically combine physical activity, diet and behavior modification components. Poor sleep health is highly prevalent in the general population and contributes to increased risk of several noncommunicable diseases. However, sleep is rarely addressed in lifestyle intervention programs in primary prevention. Given the high prevalence of poor sleep health in people without a diagnosed sleep disorder, and the associated health consequences, there is a clear need for broad-reaching, effective interventions to improve sleep quality in subclinical populations. Aims. The main objective of this study is to compare a lifestyle intervention program including a sleep intervention compared to a lifestyle intervention program alone on the health-related quality of life (measured by the EQ-5D-5L) and physical activity levels of non-exercising adults. Methods. Non-exercising adults (n=201) will be recruited in the community via advertisement or their primary care doctor and then randomized to one of the following 3 groups : lifestyle intervention, lifestyle and sleep intervention or standard care. The lifestyle intervention includes a physical activity component (physical activity initiation visit and 6 months of supervised physical activity, once weekly), a diet component (consultation with a dietician and 3 group sessions). The sleep intervention includes individualized face-to-face sessions aimed at improving and optimizing sleep hygiene. At baseline and after 6 and 12 months, quality of life, physical activity levels, cardiovascular and metabolic risk factors will be evaluated. Perspectives. This study should determine whether adding a sleep intervention dimension to a lifestyle intervention program provides significant benefits in terms of quality of life and physical activity levels. Based on this study, the modalities of real-life lifestyle intervention programs could be reconsidered in order to provide optimal primary prevention.
Non-Hodgkin lymphomas (NHLs) constitute a heterogeneous group of malignant neoplasms, with diverse clinical behaviors and distinct pathologic and molecular characteristics. Among these lymphomas, follicular lymphomas (FLs), marginal zone lymphomas (MZLs) and diffuse large B-cell lymphomas (DLBCLs) emerge as the most prevalent entities. While FL and MZL are representative of indolent B-cell lymphomas, characterized by a slow progression of the disease and favorable clinical outcomes, DLBCL stands out as an aggressive lymphoma, often occuring from the transformation of a pre-existing indolent lymphoma. Chromosome translocations are a hallmark of some NHL subtypes, offering insights into their molecular pathogenesis. For instance, the conventional FL is genetically characterized by the t(14;18) chromosomal translocation, found in 85-90% of cases, resulting in sustained elevation of the antiapoptotic protein B-cell lymphoma 2 (BCL2). However, certain FL cases lack BCL2 translocations and exhibit distinct clinical, morphological and phenotypical features with genetic heterogeneity. A subset of BCL2-negative FLs displays rearrangements within chromosomal region 3q27, inducing abnormal modulation of B-cell lymphoma 6 (BCL6) expression. The BCL6 gene plays a critical role in germinal center development and B-cell differentiation. Previous investigations indicate that BCL6 rearrangements (BCL6-R) manifest distinct pathological and genetic features, diverging from classical FL presentations. FLs carrying BCL6-R commonly share a specific CD10- Bcl-2- Bcl-6+ phenotype, often accompanied by a monocytoid component and increased frequency of diffuse architectural patterns. Patients with BCL6-R tend to exhibit advanced clinical stages and complex genetic profiles. MZLs present differential diagnostic challenges due to shared monocytoid components, phenotypes traits, and common genetic features. The similarities observed between BCL6-R FL and MZL suggest a convergence in both morphological and genetic aspects, leading to intricate differentiation. Traditionally, these indolent NHLs with BCL6-R were categorized as FL and incorporated into the FL category in the WHO classification. However, few studies highlight the occurrence of BCL6-R in MZLs. This observation gives rise to the hypothesis that indolent NHLs exhibiting BCL6-R might correspond to a continuum comprising both FL and MZL. Additionally, BCL6-R has been frequently documented in DLBCL cases with residual MZL component. These DLBCL cases might display a mutational profile reminiscent of MZL. This suggests a plausible origin of BCL6-R DLBCL from indolent BCL6-R MZLs or BCL6-R FLs cases.