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.
After cardiac surgery, there is a high prevalence of postoperative atrial fibrillation (POAF). However, its diagnostic and therapeutic management is poorly codified. This pathology is caused by atrial abnormalities which form the concept of atrial cardiomyopathy. New tools affording to itemize the atrial cardiomyopathy are needed. Indeed, current tools, as echocardiography and electrocardiogram are relevant but only lead to a raw evaluation of the atrial cardiomyopathy. MRI, because of the assessment of the atrial fibrosis by late gadolinium assessment (LGE) and 4D flow magnetic resonance imaging (MRI) could be relevant to specify the atrial cardiomyopathy.
First Episode Psychosis (FEP) includes perceptual distortions, delusions and cognitive impairment with severe consequences, such as suicidal behaviour. It affects 3% of the population, mainly adolescents and young adults, the majority of with progress to a psychotic disorder. The early stages of psychotic disorders, from the first full blown symptoms to the next two to five years, represent an opportunity to targeted care and prevention. Indeed, it is a critical period with a worsened clinical prognostic when intervention is delayed, increasing the duration of untreated psychosis (DUP). Also, it is a key period to reduce mortality, as it is characterized by elevated risks of suicide and low physical health outcomes. Besides the symptomatic components, this period is also critical for self-building on educational, professional and emotional levels. Early intervention programmes involve multi-disciplinary teams, including a care coordination function, embodied by a "case manager". His missions include assessing the patient's needs, developing a care plan to meet the latter, organising access to the different components of the care plan, monitoring and evaluating care, and providing clinical follow-up. Engagement in the care process is fragile in psychotic disorders, particularly in the context of first episode psychosis with a high risk of care disengagement, often associated with a relapse. It is therefore essential that case-managers involved in FEP services have access to tools designed according to the patient needs and not solely to symptoms, in a "recovery oriented" approach, to foster the feeling of commitment of patients in their care process. The use of mobile applications for smartphones represents an interesting perspective to improve the engagement of patients with FEP in care. However, the use of an application focused on recovery is feasible and acceptable in patients with first episode psychosis enrolled in a specialised outpatient department (FEP-type service) and allows improvement on clinical criteria, such as psychotic symptoms or mood. User-centred design methods including identification of users and an inventory of their needs, prototyping with rapid iterations, is a simplification of the procedure and exploitation of existing constraints to increase the rate of use. Moreover, it has recently been shown that such a methodology is feasible in populations with a first episode of psychosis. Our hypothesis is that the use of a mobile case-management application for planning and monitoring individualised care objectives, co-designed with patients, their careers, and health professionals, improves the functioning of patients managed for a first psychotic episode, compared to usual case management practices. The originality of our project is built up on two pillars : - the use of a a mobile monitoring application, which will be used jointly by patients and case-managers, - the methodological innovation also lies in the collaborative and patient-centred design of the application The originality of our project concerns on the one hand the intervention, an application mobile follow-up, which will be used jointly by patients and case managers. The innovative character also lies at the methodological level in the collaborative and patient-centered design of the application ('user-centered design' approach).
Inflammatory bowel diseases (IBDs), including Crohn's disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U), are characterised by chronic inflammation of the gastrointestinal tract. Over the past 50 years, the incidence of IBD has increased globally, with the highest increase in industrialised countries. During the last 25 years, the incidence of IBD has increased dramatically among teenagers in northern France, with an increase of 126% and 156% for CD and UC, respectively. Physical fitness is a set of attributes related to a person's ability to perform physical activities that require aerobic capacity, endurance, strength or flexibility and is determined by a combination of regular physical activity and genetically inherited ability. Physical fitness, widely recognised as an important health determinant, plays an important role in growth and development. Due to the evidence-based importance of physical fitness for young people's health status, attention should be paid to the assessment of physical fitness at these ages and whatever the health status. At this time, there is no study on the assessment of physical fitness in IBD pediatric patient.
Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the treatment of HER2-positive breast cancer. EMA's approvals were obtained on phase I pharmacokinetic equivalence trials and phase III clinical trials based on efficacy primary endpoints in the neoadjuvant setting and on Overall Response Rate in metastatic setting. Safety was a secondary endpoints in these trials. Phase III pivotal trials compared trastuzumab biosimilars to Herceptin® in combination with chemotherapy in the neoadjuvant setting and in the metastatic setting. The trials were designed before the approval of pertuzumab (in the neoadjuvant and metastatic settings). Thus, there is no available prospective data on the safety and efficacy of trastuzumab biosimilars in combination with pertuzumab. A biosimilar compound can obtain an extrapolation of its indications to those of the reference biological product since bio-similarity has been demonstrated (ie pharmacokinetic equivalence and clinical studies in the most "sensitive" indications). To date, the use of trastuzumab biosimilar in combination with pertuzumab is allowed, but this combination is not supported by neither scientific evidence nor clinical guidelines. PETRA aims at evaluate the efficacy and safety of the combination of pertuzumab and a trastuzumab biosimilar in real life.
The Motor Function Measure (MFM), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in France in many teams. It can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. Two versions of the MFM exist, one composed of 32 items validated for patients from 6 years old (MFM-32) and a shorter version composed of 20 items validated for patients between 2 and 6 years old (MFM-20). In order to show the possible use of MFM-20 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with Nusinersen, we propose in this project to study the sensitivity to treatment-induced change of MFM-20 and the validity of the scale in this population.
Overweight or obese patients are particularly exposed to severe forms of COVID-19. Few data suggest that adipose tissue infected with SARS-CoV-2 could be involved in the onset of the cytokine storm seen in severe forms of COVID-19. The aim of this study is to determine the pathogenesis of SARS-CoV-2-infection of adipose tissue. In particular the investigators will study how this virus enters the adipocyte and how it modulates metabolism and inflammation in the adipose tissue. From these data, the investigators hope to determine at the adipose tissue level, original therapeutic targets to modulate the effects of SARS-CoV-2 at the systemic level.
The wide uptake of "liquid biopsy" diagnostics in the care of advanced cancer patients highlights the desire for improved access to tumor allowing accurate tumor genotyping (1). Genotyping of plasma cfDNA is now routine for detection of EGFR driver mutations at diagnosis of NSCLC, or for detection of the EGFR T790M mutation after TKI resistance, and is an emerging approach for the detection of other drivers (HER2 or BRAF mutations, ALK or ROS1 fusions…) (2) or the estimation of tumor mutation burden (TMB) (3). However, the most sensitive plasma genotyping platforms still have a sensitivity of only 70%-80%, such that a negative result requires tissue biopsy confirmation.
Constipation is a frequent symptom that is reported by more than 10% of the general population. In a few case, constipation is resistant to medical standard care, including osmotic and stimulant laxatives. The diagnosis of colonic inertia may be suspected in these patients although diagnostic criteria for colonic inertia may vary from one country to another. In France, the diagnosis of colonic inertia is based on manometric study of the colorectal contractile activity using manometric probe. Using conventional manometric catheters, severe alteration of the colorectal motility is found in a very small subset of patients, who may later benefit from surgery. The recent use of high resolution manometric probe allowed to map more precisely colorectal motility, but whether these new parameters are relevant remains to be assessed. The aim of this study is to assess the diagnostic performance of a new high resolution manometric probe by comparing healthy volunteers to patients suspected of colonic inertia.
Our goal is to perform a first evaluation of the capabilities of a new generation of non-invasive magnetoencephalography sensors (OPM He4) to record brain magnetic activities. The investigator will record 1) normal subjects stimulated with visual, auditory, somesthesic and motor stimuli and 2) epileptic patient. The investigator will compare the signal to noise ratio of the normal or pathological activities between classical MEG sensors and our OPM He4 prototype.
Introduction. Although ageing is a general phenomenon, a great inter individual variability on the quality of ageing can be observed. This substantial heterogeneity may be partly explained by extrinsic factors such as lifestyle, habits, physical activity, diet, which may play an important role in the age-associated declines. The concept of frailty was introduced to account for variability in the aging process. This clinical and biological syndrome reflects a decrease in the physiological reserve, and leads to an insidious, precarious equilibrium that can break down during a stressful life event. In older adults, frailty is known to be associated with an increased risk of adverse outcomes, such as falls, fractures, unplanned hospitalizations, and death. Several frailty domains may only be slightly altered, so that early-stage frailty is not necessarily clinically visible. The most commonly used operational definitions of frailty are based on two different conceptual frameworks. Fried's rules-based criteria correspond to a physical phenotype, whereas the "Rockwood accumulative model" defines frailty as the accumulation of multiple deficits. These tools were built for individuals aged 65 and over. However, frailty can also be found in younger adults. Although the early detection of frailty is potentially important (since the condition might be reversible in its early stages), frailty has not been extensively investigated among middle-aged individuals. Indeed, most of the literature studies have focused on older adults or on a small number of frailty parameters the investigators hypothesized that the factors determining the main ageing-related adverse events are already present in middle age. The main objectives of the SUCCEED cohort are therefore to 1/investigate the prevalence of frailty parameters in community-dwelling individuals aged 50 and over, 2/ assess the parameters' prognostic value for future adverse health events, 3/ investigate frailty classifications in this population and assess the evolution of profiles over time Method. The SUCCEED survey is a French retrospective and prospective cohort that includes community-dwelling individuals aged 50 years or over consecutively attending an outpatient clinic ("successful ageing") in a geriatric teaching hospital in the Paris area, France. Baseline parameters are collected using a self-administered questionnaire followed by an interview, physical measurements, and performance tests conducted by trained nurses, and then a standardized clinical evaluation by a geriatrician. This clinical assessment includes evaluation of autonomy, cognition, mood, balance, mobility, muscle strength, nutrition, comorbidities, continence, sensory functions, bone density, sleeping disorders. Patients who have attended the outpatient clinic from the 01/01/2010 to 14/01/2020 are retrospectively included in the cohort, the other ones are prospectively included.