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.
Dyspnea, more commonly known as breathlessness, is a symptom found in the majority of patients with chronic obstructive pulmonary disease (COPD), with a major impact on quality of life and mortality. COPD is a chronic inflammatory disease of the bronchi, affecting 8% of the French population (more than 3 million people). By 2030, it will be the third leading cause of death worldwide. Effective management of dyspnea in these patients is a priority. In patients with severe COPD, physical exertion increases the workload of breathing, leading to dyspnea. At the same time, the respiratory muscles and fatty cells release cytokines, myokines and adipokines - a group of proteins involved in the inflammatory response. In addition, 15% of COPD patients suffer from sarcopenia (loss of muscle mass and strength) which increases respiratory effort and dyspnea. Our research project aims to study the effect of dyspnea relief in COPD patients on cytokine, myokine and adipokine levels, taking into account the presence of sarcopenia. Indeed, it is possible to alleviate the workload of the respiratory muscles during exercise by means of respiratory assistance. The ultimate goal is a better understanding of dyspnea mechanisms, to enable the development of cytokine-targeted therapies and improve quality of life and survival in these patients.
The management of lung cancer is a major public health challenge. Molecular anomaly testing is recommended from the early stages for optimal and personalized care of all lung adenocarcinomas and non-smoker lung cancers. The search for these anomalies relies on increasingly advanced and sensitive analysis techniques, particularly Next-Generation Sequencing (NGS), which can simultaneously detect various molecular abnormalities in both DNA and RNA, including point mutations, complex mutations, rearrangements, and amplifications. These techniques are predominantly performed on biopsy specimens embedded in paraffin. However, these biopsies may require invasive and sometimes iatrogenic procedures, and their feasibility, quantity, and quality of the samples can be limited. The turnaround time for analysis results from the time of biopsy is typically around 2 to 3 weeks. In recent years, alongside the improvement in the sensitivity of molecular analysis techniques, liquid biopsy has emerged as a valuable approach, particularly in the analysis of circulating tumor DNA (ctDNA). ctDNA is a non-invasive diagnostic biomarker that has been validated for detecting targetable molecular anomalies similar to those detected by "conventional" biopsies. ctDNA can be detected in plasma through a simple blood draw, as well as in cerebrospinal fluid, urine, saliva, or any other "liquid" sample from the patient. The concordance between mutations identified in the tumor and those detected in the blood exceeds 90% specificity in numerous studies. However, the sensitivity of ctDNA detection varies depending on the stage of the disease and the sensitivity of the detection technique used. The utility of bronchial ctDNA is currently underexplored. However, there is a rationale for investigating ctDNA as close as possible to the cancerous lesion at the bronchial level. Bronchial ctDNA could play a role in molecular diagnosis for distal lesions not visible through endoscopy and could also help reduce costs and turnaround time for molecular diagnosis in larger tumors. The objective of this study is to evaluate the utility of liquid biopsy (ctDNA and ctRNA) during bronchoscopy in the molecular diagnosis and management of bronchial carcinomas. This is a prospective multicenter French study that will include 50 patients.
Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease characterized by chronic inflammation of the colon. Composition of gut microbiota of UC patients is abnormal (dysbiosis). Ulcerative Colitis patients have an increased risk of Clostridioides difficile infection (CDI) and CDI complications (colectomy, death, recurrence). The reason for this increased risk in IBD patients is not fully understood. The decrease in the proportion of secondary bile acids, induced by microbiota dysbiosis in patients with UC could favor C. difficile infection. The main objective of the study is to describe the composition of bile acids (primary and secondary) in children followed for UC during relapse with or without CDI and to compare it to children with UC in remission and healthy controls. The composition of fecal microbiota will be also describe to correlate dysbiosis and bile acid abnormalities. And finally some fecal biomarkers will be study : short chain fatty acids, metabolic pathway of Tryptophan, and fecal Calprotectin.
Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises. The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.
Gender-based or sexual violence, or violence against women (VAW), is a global public health problem affecting around 30% of women over the age of 15, with significant consequences for physical and mental health, including depression and post-traumatic stress disorder (PTSD). In 2019, the French National Authority for Health (HAS) published recommendations in two parts, one for identifying women who are victims of domestic violence, and the other for dealing with a woman who has been exposed to such violence. But violence against women is not limited to the marital sphere. VAW can simply be detected in a consultation using a translated version of the Abuse Assessment Screen (AAS) questionnaire. Women who are victims of VAW have specific needs linked to the often repeated nature of the violence they experience, and the complex trauma that can ensue. They also tend to combine other risk factors for poor mental health, such as economic insecurity and social isolation. In France, dealing with the specific medical, psychosocial and legal needs of victims-survivors of VAW has come up against a number of obstacles, including a lack of dedicated care facilities, a lack of trained professionals and a lack of coordination between the various parties. Health professionals rarely receive the training they need to deal with VAW-related issues with confidence and professionalism, and often lack the resources to refer female victims to appropriate care. "La Maison des Femmes" (MdF) was set up in 2016 in Saint-Denis, located in a department where a quarter of the women who consult a family planning centre (FPC) has suffered from VAW. It is a hospital service specifically dedicated to the individualised, multidisciplinary care of victims-survivors of VAW, offering health, social and legal support within the same facility. The MdF comprises 4 units: a FPC, a violence management unit (involving doctors, midwives, psychologists, social workers, lawyers, police officers and support groups), a female genital mutilation management unit (surgeons and sexologists) and a 24/7 reception unit for victims of sexual violence. Several MdF-inspired care structures have been set up in France. The service provided by these facilities needs to be evaluated, particularly in terms of their ability to improve the physical and mental health, including post-traumatic stress, of women who have been victims of VAW.
CUPCAKE is a randomized, non-comparative, multicenter, proof-of-concept phase II trial, using the Trials within Cohorts concept(1) to assess the clinical utility of ctDNA monitoring combined with 68Ga-FAPI-46-PET-CT imaging upon ctDNA detection for the surveillance of patients with a non-metastatic TNBC at high risk of relapse. The study has two steps. In Step 1, patients who have completed the treatments for a localized TNBC will undergo ctDNA monitoring every ~3 months (± 2 weeks). In Step 2, patients for whom ctDNA will be detected will then be randomized between an observation arm, in which monitoring will continue until the detection of a clinical relapse, and an experimental arm, in which the ctDNA detection will be revealed to both the patient and the clinician: patients will then undergo a 18F-FDG PET-CT and a 68Ga-FAPI-46-PET-CT, in addition to whatever workup the investigator will deem necessary.
The goal of this observational study is to estimate the frequency of neuropathic pain and migraines in a group of patients with osteoarthritis of the knees, hips, hands, spine or other joints. In addition to their usual care for osteoarthritis, participants will complete questionnaires to define migraine and neuropathic pain.
Ibrutinib, an oral inhibitor of Bruton tyrosine kinase (BTK), has recently revolutionized the treatment of various chronic B-cell malignancies and particularly chronic lymphocytic leukemia (CLL). Atrial fibrillation (AF) has early emerged as a cardiovascular adverse effect (CVAE) of ibrutinib but underlying mechanisms of IRAF are not fully understood. While a dose-reduction or an interruption of ibrutinib is mentioned in the summary of product characteristics of ibrutinib, any beneficial effect on IRAF management of such a management is unclear. The main aim of this study is to determine if IRAF is a dose-dependent CVAE in chronic B-cell malignancies patients by studying the association between ibrutinib dose and IRAF reporting in Vigibase®, the World Health Organization (WHO) pharmacovigilance database.
In France, 10% of the population suffers from chronic kidney disease (CKD). CKD is classified into five stages, described from the least severe (stage 1) to the most severe (stage 5). Every year, in the PACA region, around 1,000 new patients present with end-stage CKD (5D), necessitating the introduction of suppletive therapy, whether hemodialysis, peritoneal dialysis or kidney transplantation. In CKD stages 4 and 5, a hypo-protein diet can be proposed to delay dialysis initiation (Garneata et al. 2016). To introduce a low-protein diet, the dietician first assesses protein intake. This can be done by : - Measuring 24-hour urine urea. This is the reference method for assessing the amount of protein consumed over the last 24 hours. However, it cannot be used to determine the patient's dietary habits, and therefore cannot be used to suggest modifications with a view to introducing a low-protein diet. - A detailed dietary record. The 3-day dietary record currently in use (a tool for recording dietary habits defined by the HAS) provides a reliable assessment of protein intake. However, this tool takes up a lot of dietetic time, limiting the time available for nutrition education and the number of patients who can benefit from a dietetic consultation. MS-Nutrition is a start-up that has developed a web application that can be used by patients themselves to assess nutritional intakes, incorporating a food frequency questionnaire (known as the FFQ questionnaire) used to obtain information on the frequency of foods and drinks consumed over a period of time (1 week, 1 month...). For the general population (without CKD), there is good agreement between the FFQ questionnaire and a conventional ingesta assessment (3-day dietary record as currently practiced or 24h recall, another collection based on the previous day's consumption) (Affret et al., 2018; Deschamps et al., 2009). These studies on healthy adults do not take into account the reference method (urinary urea) for assessing protein intake. Only one study in the CKD population evaluates the concordance of the assessment of protein intakes (as well as calcium, phosphorus, potassium and sodium intakes) between an FFQ questionnaire and a dietary record (24-hour recall) (Affret et al. 2017). This study shows an acceptable correlation between the FFQ and the dietary record (correlation coefficient between 0.05 and 0.79, with a median of 0.40), yet this study was carried out without dietary intervention and using a different type of dietary record. As in studies on a population of healthy adults, protein intakes assessed by any type of dietary questionnaire are not compared with a more reliable assessment of these same intakes (24-hour urine urea). The proposed study will compare the concordance of dietary intake assessment between each of the 2 types of dietary collection (FFQ and a 3-day dietary collection) and 24-hour urine urea, which limits the biases inherent in dietary collection.
This trial is a translational, open-label, monocentric prospective study of 80 patients aiming to study resistance mechanisms as well as biomarkers of resistance or sensitivity to TTFields. The study will be conducted on a population of patients with newly diagnosed glioblastoma treated with radio-chemotherapy followed by TTFields in the context of either routine care or a clinical trial. In this study, the Optune® system (battery operated device which delivers TTFields to the brain) will not be under investigation. For each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months during TTFields treatment. Additional blood samples will be scheduled at recurrence (if applicable). Moreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case of recurrence, and if a second surgery is possible, tumor samples will also be collected. Tumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure. No additional biopsies will be performed for the study. Patients will be followed-up for time to progression and overall survival for a maximum duration of 24 months from the TTFields initiation. MRI performed by patients during the course of the study will be collected by the sponsor for additional future research purposes.