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.
Dementia with Lewy body disease (DLB) is the second leading cause of degenerative cognitive disorder after Alzheimer's disease (AD). Its variable clinical expression makes diagnosis difficult. To date, there is no validated DLB diagnostic biomarker, despite several biomarkers in development (EEG, MRI, biology). Studies have shown that an improvement in diagnostic performance could be obtained by combining different modalities biomarkers using machine learning. The aim of this research is to identify the best combination of multimodal biomarkers for the diagnosis of DLB (EEG, MRI, biology, cognitive scores), using a machine learning approach applied to a clinical cohort.
Vitiligo affects 0.5 to 2% of worldwide population and has a demonstrated impact on the quality of life. Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), but also to induce the differentiation of melanocyte stem cells (to induce repigmentation). There is a well demonstrated discrepancy in the repigmentation response between anatomical areas of the body. Face and neck are the best responder with complete or almost complete repigmentation achieved in most cases under treatment. Trunk and limbs could have a complete or almost complete repigmentation in approximately half of the cases. The repigmentation is much more difficult in wrists, elbows, knees, proximal part of the hands. Finally, some areas such as the extremities of hands and feet, palms, soles, are almost impossible to repigment. The investigator hypothesize that there are some factors that are produced in the skin that prevent (or at least decrease) the differentiation but also probably the migration and proliferation of melanocytes. Primary objective To compare the mRNA expression of each types of cells in the skin of vitiligo patients compared to healthy volunteers according to body locations
This is a retrospective study assessing the effectiveness of endoscopic pyloromyotomy in patients suffering from gastroparesis and/or symptoms of delayed gastric emptying after esophagectomy with gastric pull-through. Several, mainly European, centres which perform G-POEM on a routine basis will be asked to participate. The main reason to assess the effectiveness of G-POEM in this specific subgroup of patients is the fact this specific subgroup of patients is often being excluded from trials assessing efficacy and safety of G-POEM. The participating centres will be asked to report appropriate patients among those who have undergone G-POEM since 2015 till December 2023. Patients fulfilling inclusion and not having exclusion criteria will be included into the analysis; the minimum follow-up is set to 6 months after G-POEM. The main outcome is the symptomatic response at 6, 12 and 24 months (measured by GCSI score). Other endpoints will be change in other symptoms not covered by GCSI, change in gastric emptying rate and safety of the procedure. For each enrolled patient a case report form (CRF) will be filled in and delivered to the leading centre via an online database or in other forms if preferred by the respective centres. The leading centre will be responsible for data collection and analysis.
The goal of this observational study is to use the International Organization for Standardization (ISO) 24442:2011 in vivo method for assessment of the Ultraviolet A Protection Factor (UVAPF) of topical sunscreen products in healthy adults. The main question it aims to answer is to determine the degree of UVA-protection against UVA radiation. An area of each subject's skin is exposed to UVA light without any protection and another (different) area is exposed after application of the sunscreen product under test. One further area is exposed after application of a reference UVA sunscreen formulation (S2), which is used to validate the procedure.
Augmented Reality is a technology that allows surgeons to superimpose virtual images from preoperative imaging onto the endoscopic vision system intraoperatively. The goal of this clinical trial is to demonstrate that the use of augmented reality during laparoscopic gynecological surgery with a dedicated device could provide assistance to the surgeon, in terms of technical comfort and better visualization of the benign tumor to be resected on a mobile organ.
According to the Centers for Disease Control and Prevention (CDC), a surgical site infection (SSI) is an infection that occurs after surgery at the site where the surgery was performed. The prevalence of SSIs is difficult to obtain and is probably underestimated, as many SSIs occur after the patient has been discharged from hospital and are not taken into account. SSIs are responsible for an increase in length of stay, mortality and costs. Their prevention is therefore essential in the operating theater, and has been the subject of recommendations recently updated by the CDC. The first line of prevention is the administration of prophylaxis antibiotic adapted to the surgical procedure, administered within a specific timeframe in order to achieve an effective bactericidal concentration in the tissues at the time of the surgical incision. In France, in the United States and for the WHO, the recommended first line of antibiotic prophylaxis is most often an agent from the beta-lactam family, a penicillin or a cephalosporin, with the exception of ophthalmological surgery. No strategy is described for the management of patients with a reported allergy to penicillin, apart from the recommendation of therapeutic alternatives. The use of a decision-making strategy in the operating theater for patients with a reported allergy to penicillin therefore appears necessary and is recommended by experts. In the intraoperative context, the application of a strategy would make it possible to guide the use of cephalosporins, without removing the "penicillin allergy" label from the patient, but by proposing an alternative via the use of a cephalosporin depending on the probability of the risk of a real allergy to penicillin, according to the description of the former reaction.
In view of the known link between pre-eclampsia, overweight/obesity and chronic kidney disease, the aim is to offer for obese and overweight patients to reduce their BMI without reducing lean body mass. The POPADIPE project will make it possible to limit overweight or obesity by means of nutritional management chosen by the patient (hypocaloric or a dissociated diet). The latter has been the subject of little scientific investigation, particularly in relation to the management of post-pre-eclampsia.
The control of antibiotic resistance requires a reduction in inappropriate prescriptions of broad-spectrum antibiotics (amoxillin-clavulanate (AMC), fluoroquinolones (FQ), third-generation cephalosporins (C3G)), particularly for urinary tract infections treated in primary care. Several studies have reported the positive impact of antibiotic susceptibility testing performed on urine cultures on the appropriate use of antibiotics. The "selective reporting for antibiotic susceptibility testing ", defined as the restriction of the list of antibiotics mentioned in the report according to the antibiotic resistance profile, would allow, according to observational studies, a reduction of 25 to 70% of the initial prescriptions of broad-spectrum antibiotics and a 20% rate of antibiotic de-escalation (=reduction of the antibacterial spectrum of an antibiotic treatment after re-evaluation). The objective is to assess the impact of disseminating a selective reporting for antibiotic susceptibility testing on the dispensing of broad-spectrum antibiotics prescribed by general practitioners (GPs) for E. coli positive urine cultures in adult women, compared to the dissemination of a standard antibiotic susceptibility testing.
Neoadjuvant treatment is an important part of the treatment strategy for locally advanced TNBC having established a positive and significant correlation of pathologic Complete Response (pCR) with long-term clinical benefit such as Event-Free Survival (EFS) and Overall Survival (OS) as shown via large meta-analysis. Much effort has been made to identify novel agents and new drug combinations that can improve pCR rates in this specific clinical setting, which is the leading rationale to evaluate RP1 oncolytic immunotherapy in combination with Atezolizumab.
During their lifetime, 15 to 25% of patients with diabetes mellitus will develop a Diabetic Foot Ulcer (DFU) related to neuropathy and/or peripheral arterial disease. DFU is the leading cause of non-traumatic lower-extremity amputation worldwide. Diabetic foot osteomyelitis (DFO), which complicates up to 60% of DFU, is a major trigger of amputation in over 80% of persons with diabetes resulting in subsequent loss of quality of life. It has been shown that medical treatment of DFO may prevent amputations with early diagnosis of osteomyelitis and appropriate use of antibiotics. Empirical antimicrobial treatment is not recommended for DFO as for other chronic infections. Surgically or radiologically acquired bone sample for culture is the reference standard recommended by the International Working Group of Diabetic Foot (IWGDF) to diagnose DFO and to determine the causative bacteria and their susceptibility. However, defining appropriate antimicrobial therapy directed to the causative bacteria in DFO is challenging since it requires bone biopsy (BB) procedures which are underused in clinical practice for various reasons: lack of availability, cost, and delay. Some clinicians also find bone biopsy cumbersome or too invasive. To overcome these barriers, we have set up for a few years a bedside blind BB procedure performed by diabetologists at the bedside in the clinical ward. Since then, this method has been used in more than 200 patients with DFO in the diabetology departments of Lariboisiere Hospital and Bichat Hospital (Paris). We have recently published our observational data of 79 patients showing that bedside BB is a simple, safe and efficient procedure for the diagnosis of DFO with a similar rate of complete healing at 12 months compared to conventional surgical or radiological bone biopsies. In order to extend and confirm these preliminary and observational results, the aim of this study is to compare the efficiency and safety of bedside BB versus conventional bone biopsy in a randomized controlled trial (RCT) of patients with DFO. Our hypothesis is that bedside BB is non-inferior to conventional bone biopsy in DFO and can be used as a simpler alternative procedure to document DFO