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.
ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC. The first 2 modules will evaluate: i. safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd (Module 1) and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd (Module 0). The main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose (RP2D) of the combination containing HER3-DXd. The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate (ORR) at 6 months.
The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation.
Medical students have been shown to have a greater prevalence of poor sleep leading to poorer quality of life than other groups of students. Among medical students, poor sleep quality and insomnia have been associated with higher level of stress, as well as poorer academic performance. Our field surveys carried out in 2022 and 2023 at the Lyon Est medical school make the same alarming observation. They revealed that 53% of students had significant sleep problems.They also showed that students presented high levels of physical and mental fatigue. It is expected that these disorders will significantly degrade their quality of life as well as their health. Indeed, lack of sleep is associated with serious health problems such as illnesses cardiovascular or immune system deficiencies. The PROMESS - SLEEP project aims to offer solutions to students to improve their sleep during their medical studies. It responds to a demand expressed by students: our field study showed that 40% of 4th year students declared being "very interested and/or interested" in following an intervention that aimed at improving sleep. An early knowledge of sleep optimization tools would allow students to quickly acquire the tools necessary to cope with the difficult conditions encountered during their training and lives of future doctors.The objective of this study is to determine the influence of an intervention program based on sleep improvement and fatigue reduction among medical students.
This study aimed to assess the longitudinal changes in triceps surae muscle-tendon architecture to an ultra distance trail running. Experienced trail runners (N=55, 78% men, age: 45.2 [13.5] years) participated in a 156-km trail run (6000m climbing) consisting in six 26-km laps. The resting architectural properties of triceps surae muscle-tendon were measured using ultrasound imaging for Achille tendon cross-sectional area (AT CSA), medial gastrocnemius muscle pennation angle, thickness, length and fiber length. Measurements were performed the day before the race (Baseline), at 52-km (T1), at 104-km (T2), at 156-km (T3) and 12 hours after the race (H12).
Medical students are under great competitive pressure throughout their studies. Our field surveys conducted in 2022 and 2023 at the Lyon Est Faculty of Medicine revealed that 78% of 482 students showed an excessive sedentary lifestyle compared to the threshold set by WHO. It is expected that a low level of physical activity and/or too high a sedentary lifestyle deteriorates significantly their quality of life and their health. In 2014, a British survey of 356 students in Medicine showed that lack of physical activity was an major predictor of burnout symptoms. Numerous studies show that regular physical activity improves the mental health of students and their cognitive performance. The PROMESS - PHYSICAL ACTIVITY project aims to offer solutions to students to decrease their sedentary behavior and to improve their physical activity level during their medical studies through an intervention program. From a long term perspective, this intervention may also prevent disorders related to inadequate levels of physical activity and/or sedentary behavior. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested and/or interested" in following an intervention that aimed at improving physical activity. The objective of this study is to determine the influence of an intervention based on sedentary behavior reduction and physical activity promotion among medical students.
Young women represent a population at risk of psychiatric disorders, the first signs of which often appear between the ages of 15 and 25. Psychiatric disorders are a major source of disability and healthcare costs. The perinatal period is an additional period of psychological vulnerability, during which women are at increased risk of developing or worsening psychiatric disorders. Unfortunately, psychiatric disorders seem to be largely under-diagnosed during this period, and therefore under-treated. The goal of this Prospective multicenter study is to determine the prevalence of the presence of at least one characterized psychiatric disorder, as defined by the use of the Mini International Neuropsychiatric Interview (MINI), in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment. Participants will complete self-questionnaires and have a standardized psychiatric evaluation at T2 ultrasound and at 2 months postpartum.
Streptococcus pyogenes, commonly referred to as Group A Streptococcus (GAS), has the ability to induce a diverse range of illnesses. In several European countries and the United States, a notable surge in invasive GAS (iGAS) infections has been documented since mid-2022. This sharp increase contrasts with the gradual rise in iGAS incidence observed among children over the past three decades. As demonstrated for several viral infections, the recent upturn in iGAS infections is potentially linked to the relaxation of mitigation measures implemented during the COVID-19 pandemic, such as face mask usage and school closures. Since November 2022, concerns have been raised by French public health authorities regarding the rise in levels of iGAS infections, and an unexpected increase in pediatric severe GAS infections was reported in a French single-center study. However, this study ended in December 2022 and could only explore short-term trends. The Necker - Enfants malades Hospital in Paris, France, represents an excellent opportunity to examine the impact of the COVID-19 pandemic and the associated non-pharmaceutical interventions on the incidence of severe GAS infections, during, and after the pandemic. This study aims to investigate trends of severe GAS infection incidence in children in the Paris area over the course of the COVID-19 pandemic.
This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation.
Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it. The growing prevalence of this condition and the associated healthcare costs make it an important public health objective. Diagnostic criteria for Critical Limb Ischaemia differ between learned societies and countries. Its diagnosis is most frequently based on the combination of a clinical criterion (ischaemic decubitus pain and/or necrotic wounds, with a time to onset > 2 weeks) and a haemodynamic criterion (ankle systolic pressure (ASP) < 50mmHg or toe systolic pressure (TSP) < 30 mmHg or transcutaneous oxygen pressure (TCPO2) < 30 mmHg). Recent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs, both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries (dorsal artery of the foot and lateral plantar artery). The main aim of our study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible.
The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery.