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.
Sacrospinofixation is one of the reference techniques for the treatment of vaginal prolapse. It consists of fixing a non-absorbable thread on the sacrosciatic ligament unilaterally or bilaterally to correct a urogenital prolapse. The technical difficulty is linked to the fact that the approach to the sacrosciatic ligament is palpatory without visual control. However, if the thread is not well fixed in the ligament, there is a risk of this suture coming loose and therefore of recurrence of the prolapse. On the other hand, due to the vascular and nervous proximity (pudendal nerve), vascular complications such as hemorrhage and/or hematoma have been described by vascular lesion during the passage of the needle through this ligament. Nervous complications due to pinning of the pudendal nerve or its nerve branches have also been described, which can cause after-effects of pain or even chronic dyspareunia. Clearly and precisely visualizing the sacrosciatic ligament and the vascular and nervous structures with a microcamera could make it possible to better correct the prolapse and limit recurrences, but also to avoid these serious and disabling complications. The Nanoscope system, which can be used in routine practice as part of sacrospinofixation, could make it possible to obtain visibility of tissues under vision control. Thus the precise visualization of the sacrospinous ligament would allow an easier approach and therefore more precise surgical procedures.
Fibrous dysplasia of bone /McCune Albright syndrome (FD/MAS) is a rare bone disease caused by somatic mutations in GNAS gene. This GNAS mutation predisposes to cancers, including breast cancer, thyroid cancer, chondrosarcoma and osteosarcoma, as well as biliary tract anomalies, liver-tumors or pancreatic tumors - IPMNs. Intraductal papillary and mucinous neoplasms of the pancreas (IPMN) are cystic intraepithelial ductal lesions developed at the expense of pancreatic ducts. They are pre-cancerous lesions, requiring monitoring and, in case of progression or malignant degeneration, surgical resection. Pancreatic MRI screening of patients with polyostotic FD and MAS is recommended. The aim of this study is to investigate the epidemiology and characteristics of these hepato-pancreato-biliary abnormalities (prevalence, age of onset, degeneration), based on magnetic resonance imaging (MRI) realized during the follow-up of patients with FD/MAS treated in a French FD expert center. A better understanding of these IPMNs and other digestive abnormalities will enable clinicians to improve the management and monitoring in this high-risk population.
Allergic contact dermatitis (ACD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries. ACD typically presents as a severe skin inflammation with redness, edema, oozing and crusting. It is characterized by a delayed type IV hypersensitivity response mediated by allergen-specific T cells in sensitized individuals. Current diagnosis relies on clinical investigations by diagnostic patch testing with suspected allergenic chemicals. The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. This is a time consuming and costly process. It requires experienced medical staff to read the reaction, and is only performed by a limited number of expert dermato-allergologists across Europe (which limits the accessibility of suspected ACD patients to diagnosis). Finally, if the robustness of the patch-test method is undisputable, it cannot be neglected that patch-test results are sometimes false positive or non-relevant, which leads to non-appropriate disease management. Therefore, there is today an urgent need for the availability of new ex vivo/in vitro tools based on the modern understanding of the immune mechanisms of ACD to enhance the current diagnostic procedure, and open new avenues for a personalized diagnosis of skin ACD. In this context, the team "Epidermal Immunity and Allergy" (CIRI, Inserm U1111) recently characterized the molecular signatures of ACD (using microarrays), based on positive patch-test reactions to reference chemical allergens or non-allergenic irritants. It was shown that there are unique molecular profiles and signaling pathways characterizing each inflammation. Machine learning methods were then developed to identify and validate classification algorithms based on the expression levels of a minimum set of biomarkers (n=12), enabling very good discrimination between allergen-induced and irritant-induced patch-test inflammation (which was confirmed by complementary quantitative RT-PCR analyses). Finally, some patients with weak positive patch-test reactions to allergens show no/low marks of allergy molecular signature, questioning about the reliability/relevance of their patch-tests results. Our results therefore stress the value of molecular profiling of patch-test reactions to improve/reinforce clinical ACD diagnosis, and to help the dermatologist to discriminate true versus false positive patch test reactions. Importantly, those results also open new avenues for the development of a future point care diagnosis. Indeed, it is currently is estimated that only 20% of patients being sent for allergology work-ups suffer from true skin allergy (i.e. patients with positive patch-tests, combined with relevant clinical history and confirmatory use tests). Most of the patients (80%) are in fact suffering from skin irritation. Therefore, the detection of ACD biomarkers in active eczema lesions could provide the dermatologist with major information to improve and accelerate its clinical diagnosis. This could also prevent numerous patients (negative for ACD biomarkers) being sent for unnecessary allergology work-ups. However, to date, it remains to be demonstrated that (i) the same panel of ACD biomarkers is expressed both in acute eczema lesions and positive patch-test reactions, and that (ii) the detection of these biomarkers allows for a sensitive and reliable diagnosis of skin allergy. The main objective of the study will be to make the proof of concept that the expression of allergy biomarkers correlates with patients suffering from true ACD (i.e. patients with high biomarker expression in acute lesions, positive patch-tests and relevant clinical history), versus those developing skin irritation (no/low biomarker expression in acute lesions, negative patch-tests, and lack of clinical history).
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of faricimab in patients with myopic choroidal neovascularization (CNV). This non-inferiority study will compare 6.0 mg faricimab versus 0.5 mg ranibizumab administered at a pro-re-nata (PRN) dosing regimen after an initial active IVT treatment administration at randomization (Day 1).
Pneumothorax is characterized by an abnormal presence of air in the pleural cavity, that is to say between the two layers of the pleura, the membrane that surrounds the lungs and lines the rib cage. "The patient is usually seized with sudden chest pain and difficulty in breathing. In this retrospective research, the investigators wish to carry out an inventory of the management of spontaneous pneumothorax in adolescents within the University Hospitals of Strasbourg
This is a phase II study, preceded by a safety run-in, with two independent cohorts (cohort A in early Triple Negative Breast Cancer (TNBC) patients and cohort B in late in metastatic TNBC patients) designed to evaluate the efficacy of atezolizumab, tiragolumab and chemotherapy.
Resuscitation patients are monitored for various physiological parameters. When these parameters exceed abnormal thresholds, an audible alarm is triggered. Given the complexity of physiological situations and the number of monitored parameters, the number of alarms within an intensive care unit is significant. In the literature, the number ranges from 100 to 350 alarms per patient per day. Among these alarms, 74 to 99% are deemed irrelevant as they provide false or insignificant information. This study will enable to assess the efficacy of a restrictive protocol for managing alarms as a means of rationalizing their use.
This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).
R-CPD syndrome (Retrograde Cricopharyngeal Dysfunction syndrome) is an inability to burp. It is a syndrome whose diagnosis is clinical, and for which there is effective treatment. Recently treated in the United States (first publication in 2019), this syndrome affects many patients in France and is currently unknown. This study concerns a series of patients treated at the University Hospitals of Strasbourg for a syndrome of retrograde dysfunction of the cricopharyngeus muscle having been treated by injection of botulinum toxin into the cricopharyngeus muscle.
Age-related macular degeneration (AMD) is the 1st cause of visual impairment after the age of 50. Its most aggressive form, wet AMD, requires regular intravitreal injections (IVI) spaced 4 to 8 weeks apart usually depending on the treatment regimen and the patient's response. The IVI procedure requires a double disinfection with periocular and conjunctival cutaneous povidone-iodine. Antiseptic agents such as povidone iodine are a highly likely factor in the development of dry eye syndrome. Clinical data have demonstrated the abrasive and toxic effects of their use on the ocular surface, especially with repeated exposure (Saedon H, Nosek J, Phillips J. Ocular surface effects of repeated application of povisoden-iodine in patients receiving frequent intravitreal injections. Cutaneous and Ocular Toxicology. 2017;36(4):343-6.). The IVIS study coordinated by Prof. Dot reported impaired ocular surface and quality of life immediately after IVI. The authors suggest 3 levels of action to improve immediate tolerance: (i) improve the basal status of the ocular surface, (ii) reduce the contact time with povidone-iodine which could be toxic to the ocular surface and (iii) improve immediate post-IVI treatment. (Verrecchia S et al. A prospective multicentre study of intravitreal injections and ocular surface in 219 patients: IVIS study. Acta Ophthalmol. 2021 Mar 18). This study is part of the extension of the IVIS study. IVIs are effective and do not currently present a therapeutic alternative. However, their role in the development or exacerbation of dry eye is still poorly evaluated although millions of IVIs are performed each year worldwide (1.3 million in France in 2019). In addition, discomfort after injection is one of the factors that limit adherence to long-term IVI treatment, some patients fearing this repeated act. We propose in this bicentric, prospective, randomized, parallel group study, to evaluate in this context the impact of the continuous consideration of the risk of dry eye. The expected results are the objective improvement of dry eye indicators, comfort and quality of life of patients, all aimed at optimizing the adherence of our patients to their AMD treatment.