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.
The purpose of this study is to determine whether reading of low-dose thoracic CT scans can be done by a single general radiologist who has been trained to lung cancer screening, and will evaluate the performance in comparison with double reading by experts. The study will enroll women between 50 and 74 years old, at risk for lung cancer due to their smoking history.
Actually no treatment exists to prevent the loss of diaphragmatic function induced by mechanical ventilation during an intensive care unit stay. The consequence is a growing number of survivors with moderate to severe chronic respiratory disease so called Ventilation-Induced Diaphragmatic Dysfunction (VIDD). This study complements the BOTAN study (IRB Accreditation number: 198711, NCT02900300) on 24/11/2021 under number 2021_IRB-MTP_08-37), which aim was the constitution of a biological bank of diaphragmatic tissue in order to be able to propose an innovative tool for the in vitro screening of bioactive molecules of interest in human, to improve the regenerative capacity of this main and essential muscle for breathing. In this present study, in order to offer this evaluation tool in the screening of bioactive molecules of interest, without the need of the diaphragm biopsy, but simply of the quadriceps, the investigators propose, by adding a quadriceps muscular biopsy to patients already included in BOTAN study, to compare the regenerative capacity of quadriceps and diaphragmatic muscle in the same individual. Thus, this study is the first, which will propose a new minimally invasive tool for the evaluation and optimization of future pharmacological treatments targeted to limit the impact of VIDD. Thus our main objective of thus study is to compare in the same patient the regenerative capacity of the muscular fiber of the quadriceps to that of the diaphragm in order to set up an in vitro model allowing to test in humans future pharmacological treatment devoted to limit the incidence of VIDD. In this study will be recruited 10 patients treated surgically for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm and who have agreed to participate in the BOTAN study. This resection to be complete (R0) must pass within the diaphragmatic muscle allowing us to obtain without any constraint for the patient, diaphragmatic tissue. During this surgery, for the purposes of the present study, the investigators will perform a quadriceps biopsy. Quadriceps biopsies are widely used in biomedical research and no deleterious effects have been described. The surgical team is fully qualified for this type of sampling and all experiments necessary to compare regenerative capacity of quadriceps and diaphragmatic muscular fiber use laboratory techniques perfectly mastered by our research team. For each patients, this study will be performed over two visits. The first, during a consultation will allow the inclusion of the patient, as well as the collection of clinical data and a second during the scheduled surgical intervention where quadriceps biopsy will be realised. The expected duration of inclusions will be one year. No immediate individual benefit is expected for the patient. This study aims to improve, in the future, therapies that reduce the incidence of diaphragmatic dysfunction induced by mechanical ventilation. In fact, diaphragmatic dysfunction induced by ventilation is observed in at least 50% of patients in intensive care; this dysfunction has been implicated in the significant lengthening of the hospital stay, the difficulties in weaning from mechanical ventilation and in the increased risk of co-morbidity and mortality. The validation of the first in vitro model in humans of this dysfunction, from quadriceps biopsy, will allow us to pre-select antioxidant molecules and the most effective concentrations to use for a future therapeutic trial aimed at limiting the deleterious effects of mechanical ventilation on the diaphragm in humans.
Several epidemiologic studies have clearly shown that sleep complaints are very common in the general population. It involves a predominant complaint of a nonrestorative sleep or dissatisfaction with sleep quality or duration and it is accompanied by difficulties in initiating sleep at bedtime, frequent or prolonged awakenings, or early-morning awakening with an inability to return to sleep. Lavender oil as well as valerian officinalis are benefiting from a long traditional use in sleep and these products have moderate sedative effects compared to classical hypnotic compounds. This study is proposed to assess the efficacy and the safety of this combination in subjects with slight to moderate sleep complaints.
Most studies use static visual percepts that are less representative of joint attention versus an ecological environment. This has the consequence of decreasing the perception of an interaction with a social partner, which is an essential step in achieving joint attention. The originality of this study is to improve the design of visual percepts (in the form of video) in order to mimic an ecological environment as much as possible by using MRI-ET coupling. The second originality of this study is the longitudinal exploration of the neurodevelopment of social cognition in autistic children. Studies by the Redcay and Oberwelland teams observe different activations at different ages. The hypothesis is that the perception of joint attention varies over time in people with ASD. To date, there are no studies to determine the influence of childhood neurodevelopment in autistic people on the perception of joint attention. It would be unprecedented to use the MRI-ET pairing as a tool for assessing social cognition as a function of the development of children with ASD.
ABSTRACT Background and Aims: To determine the diagnostic performance of the epilepsy and intellectual disability panel used in the pediatric population, starting in June 2019, at the Regional University Hospital Center of Nancy, France. Design: An observational and retrospective study, at the Regional University Hospital Center of Nancy, France. Materials and Methods: Pediatric patients who underwent genetic analysis with the epilepsy-intellectual disability gene panel. All of these patients were either epileptic or had intellectual disability, or both, of undetermined etiology. Results: We included 69 patients in this study. We identified causative mutations in 46.4% (32 of 69 patients) of this cohort after the gene panel and 52.2% (36 patients) including positive results after realization of the Clinical Exome Solution.
This is a monocentric, open and randomized study. The purpose is to evaluate the cutaneous tolerance of three medical masks (class I medical device) after 3 consecutive days of use on a population with normal or sensitive skin.
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies and accumulation of immune complexes resulting in systemic inflammatory response and tissue damage. Dysfunction of proteins initially known to initiate the classical pathway for complement activation (C1q and C1s), and their functional interference with the multifunctional protein HMGB1 (High-Mobility Group Box 1), appears to be associated with SLE. On the other hand, C1s, HMGB1 and C1q can be targeted by anti-C1s, anti-HMGB1 and anti-C1q autoantibodies from lupus patients, whose functional impact remains to be explored, in particular for non-canonical functions, independent of the complement activation cascade. Studies are needed to investigate the pathogenic role of these autoantibodies in SLE, including possible interference with the inactivation of HMGB1. This project plans to investigate the role of anti-C1s, anti-HMGB1 and anti-C1q autoantibodies in the pathogenesis of Systemic Lupus Erythematosus. This pilot study will be performed for 30 patients with active SLE on serum, realized for routine patient care. The investigators will identify the molecular targets recognized by anti-C1s, anti-HMGB1 and anti-C1q autoantibodies purified from the SLE patients' serum. The investigators will also explore the functional role of these purified autoantibodies.
Few data are available on the management of critically ill pregnant women with pneumonia related to SARS-CoV-2. In the absence of clear recommendations for the management of delivery, clinicians are faced with the risk of pregnancy continuation against the risk of premature birth. In these multicenter retrospective study, the investigators want to describe clinicians attitude on delivery management in pregnant women requiring invasive mechanical ventilation for acute respiratory distress syndrome related to SARS-CoV-2. Two strategies will be compared on maternal, obstetric and neonatal outcomes: - Wait strategy defined by no extraction within 24 hours of invasive venting - Early strategy defined by extraction within 24 hours of invasive ventin
Gilteritinib is available in early access in France through Temporary Authorisation of Use (or ATU program) since March 2019. The ATU program reflects a real-life treatment situation and the related clinical data would help to better understand the benefit/risk profile of gilteritinib and to better document gilteritinib efficacy and safety in patients who received midostaurine in First Line (1L) setting. The main objective is to describe gilteritinib effectiveness in FLT3 (Fms Related Tyrosine Kinase 3) -mutated AML patients in Refractory/Relapsed(R/R) situation treated in the context of early access program to gilteritinib in France through Temporary Authorisation of Use, the so-called ATU program, and the post ATU period from marketing authorisation to launch when reimbursement and price are published.
The literature describes recurrent nerve damage during thoracic surgery as a fairly complication (5 to 31% of patients). This nerve damage leads to paresis or paralysis of the ipsilateral vocal cord. This cord dysfunction no longer ensures the protective role of the airways during swallowing. This postoperative dysphagia is associated with complications such as aspiration pneumonia, the use of nasogastric tube feeding (adding difficulty to swallowing), delayed oral refeeding (risk of undernutrition, dehydration, decrease in the quality of life), and an increase in the length of hospitalization and mortality. Identifying these patients at risk is essential to limit complications (pneumonia, reintubation, inadequate refeeding, etc.). The benchmark test to objectify vocal cord palsy is to perform a nasofibroscopy requiring equipment and the intervention of an ENT doctor or thoracic surgeon. A physiotherapist can also perform a preliminary swallowing test by evaluating several criteria. The aim of this study is to compare the concordance of results between nasofibroscopy and that by preliminary swallowing test, two procedures performed in the screening of vocal cord paralysis in a surgical intensive care unit and a thoracic surgery ward. Patients will be included before the surgery. During this inclusion visit, we will perform a preoperative swallowing test. Immediately after surgery (H2-H24 after extubation), we will perform a preliminary swallowing test, an ultrasound examination of the vocal cords and a nasofibroscopy to determine the mobility of the vocal cords. A physiotherapist will carry out the first two assessments. An ENT physician will perform the nasofibroscopy. The ENT physician performing the nasofibroscopy will not know the conclusions of the tests carried out by the physiotherapist immediately after the operation. At last, on day 4 after extubation, we will repeat the preliminary swallowing test and the ultrasound examination to measure the evolution of cord mobility. Initial evaluation and secondary evaluation (day 4) will be performed by two different physiotherapists in order to allow blinding between the two stages of the procedure. 45 days after the surgery, we will realize a follow-up on medical file and mark the end of the research. We want to include 72 patients over an 18 months period.