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.
During a space mission the crew has to perform a wide variety of tasks under different acceleration conditions. For handling of displays and control items during a mission, the astronaut's performance is strong depended on an intuitive usability. Currently investigators are exploring and developing different Augmented Reality interfaces for the International Standard Payload Rack (ISPR) Biolab that is installed in the International Space Station (ISS) module Columbus. Augmented reality (AR) is a live, direct or indirect, view of a physical, real-world environment whose elements are augmented by computer-generated sensory input such as sound, video, graphics or GPS data. Using AR technologies provides user-oriented support for working procedures in development, production, and operating of complex technical products and systems. It is conceivable that in future manned missions such interfaces will be applied to space operations, where the astronaut will handle virtual information that enriches the physical reality. To improve the support for the operational ground team and the space crew by performing service and maintenance tasks at the Columbus space laboratory Biolab, investigators explore innovative tridimensional (3D) interaction techniques that allow an intuitive way to interact with the virtual content. The developed AR interfaces for the ISPR Biolab ought to offer support while handling standardize service and maintenance procedures. This research is primarily focused on supporting the ground team during their work at the engineering model of Biolab that is located in Cologne at the Institute of Aerospace Medicine. Applying these interfaces subsequently to space operations requires previous exploration regarding the influence of different acceleration conditions that ought to be considered at the investigators' current stage of designing and development. Thereby one important aspect is focused on the correct placement of virtual user interfaces while interacting with it. To explore human adaption of handling and controlling virtual AR interfaces, this experiment denotes a usability study that will supply findings about human mental workload and sensorimotor coordination while performing the experimentation task under different accelerations of gravity. The proposed experiment will supply essential information about understanding the adequate quality characteristics concerning placement of virtual interfaces in physical reality and identify disturbing factors while applying in hyper-g and micro-g conditions.
In preschool aged children, the most suitable techniques to assess airway obstruction is debit interruption technic (Rint) and plethysmographic measure of specific airway resistance (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems to be better for discriminating airway obstruction. These two techniques will be compared in terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.
In the general population, age of puberty, and age of menarche in girls, are closely correlated with those of their mother. The severity of chronic disease has an impact on the stature, the weight gain and the onset of puberty: age of menarche is even later that chronic illness is serious. Cystic fibrosis is one of the major chronic diseases of children. Neonatal screening is organized since 2002, most girls with cystic fibrosis therefore currently have a very specialized and early care. Older patients were diagnosed during childhood. The optimization of the nutritional and respiratory management has allowed over the past two decades a significant improvement in the survival of these patients. Most young people reach adulthood, puberty and reproductive desire are a crucial issue in the care of these young adults. In literature, it is often noted an age of menarche delayed an average of 2 years compared to the general population, but correlated with the age of menstruation from the mothers. The factors involved in the conduct of cycles in the girl followed for cystic fibrosis are poorly known and there are few data on the characteristics of cycles. The menstrual irregularity and amenorrhoea episodes concern nearly half of women. On the pathophysiological level, studies in animals show that there is a direct effect of CFTR (Cystic Fibrosis Transmembrane Regulator) on the hypothalamic pituitary gonadal and reproductive capacity in mice. The literature data on the pubertal development, fertility and hormonal profile of these girls are for studies with low numbers and are very old. There is to date no French cohort study on this topic. The study is a multicenter cross-sectional descriptive study for pubertal and gynecological characteristics in girls followed annually in the reference centers Cystic Fibrosis two inter-region.
This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.
Intensive care unit acquired muscle weakness (ICUAW) is a common disease. After 7 days of mechanical ventilation, a quarter of patients develop an ICUAW responsible of a 15-20% of muscle loss. This is a serious pathology associated with high morbidity and mortality. Clinical diagnosis of ICUAW is difficult and need a patient awoken. CT scan and Magnetic Resonance Imaging (MRI) are considered as "gold standards" to quantify and monitor changes in muscle mass. But these tools are not adapted to ICU patients. Ultrasound (US) is an easy access tool at the bedside to assess muscle mass and does not expose the patient to additional radiation. The objective of this study is to evaluate the correlation between US and CT scan to measure quadriceps muscle thickness of ICU patients.
The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and trastuzumab-based therapy. In addition, pharmacokinetic data on the combination of T-DM1 and liposomal doxorubicin will be obtained.
Achieving gastro-jejunal or duodenal anastomosis (GJA ) by exclusive endoscopically is a real goal for many years in the development and research of the transluminal endoscopic surgery (N.O.T.E.S). Endoscopic treatment, including palliative antro duodenal stenosis by metallic stent, although minimally invasive, causes problems in long-term secondary obstruction and migration. Surgical treatment of these strictures is associated with significant morbidity and mortality . The complication rate and severity of post-operative surgery after gastric bypass Roux-en-Y anastomosis or gastroduodenal fistulas remain close to 5% with a mortality of 1%. After 3 years of experimental research on porcine model, our team has developed a procedure of gastro duodenal anastomosis using transgastric endoscopic minimally invasive surgical technique (or NOTES) - LBA UMRT24 CERC laboratory , Aix-Marseille University , Faculty of Medicine North, with the aim to offer a credible alternative to conventional surgery. Thus the investigators propose to conduct a pilot prospective intervenionnal study. The investigators hypothetized that this technique would reduce morbidity and mortality clinical but also economic consequences of surgery while making it possible to obtain excellent results permeability and long-term functionality. This method uses a new concept of tissue apposition with a fully covered metallic stent to create the anastomosis under endoscopy exclusively. Ten patients with antro duodenal obstructions requiring surgical or endoscopic bypass will be included as part of an interventional biomedical research that will be conducted in one expert center. The duration of the inclusions will be 18 months. Then, the stent will be removed three months after insertion, at the end of the healing process, and each patient will be followed for one year. The primary endpoint will be the assessment of the feasibility of the procedure for gastro duodenal anastomosis using tissue apposition stenting and NOTES in human being. The secondary endpoints will be the clinical efficacy, the long term (1 year) patency of the anastomosis, the procedure duration, adverse events, morbidity and mortality, the quality of life and the length of stay. In case of failure of the NOTES procedure, the patient will be treated either by surgery or by conventional endoscopy according to the usual techniques without loss of chance. The risk / benefit ratio appears positive and a safety report will be issued after the first 4 inclusions. There will be no supplementary examination in patient follow-up in this study for which a CT iconography and biology are enough. The material used in the context of this work is consistent with the legislation on medical devices and has received CE Mark (tissue apposition fully covered stent Axios ®).
It is a study of basic research with mechanistically objectives and including clinical biological samples.
An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance. There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2 max). This injury is a new follow-up parameter of cardiac function for the adult. The nature of damage (vascular or membrane) can be determined by the measure of double pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO). Today, in chronic heart failure consecutive to a congenital heart disease, there is no data on evolution of membrane and capillar factors.It is impossible to predict if membrane damage will be the best factor correlated to the VO2max in patients suffering from complex congenital heart disease. Assessing these parameters could be an comparative evaluation of heart-rate exercise tolerance test with VO2max and an early control of his damage without risks related to heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart disease.These results would have an early prognostic value that would permit to refine the follow-up and the treatment. The main objective of this trial is to assess the statistic correlation between the membrane injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in children and adults suffering from complex congenital heart disease.
Patients who are overweight or obese, diabetic or not, share with those who are suffering from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney ammoniogenesis default. This results in an overly acidic urine pH which is directly pathogenic in people predisposed to develop uric stones because the precipitation of urate soluble uric acid is accelerated in acid medium. Excess visceral fat, particularly perirenal, this defect may promote formation of renal ammonium. Indeed, the perirenal fat is adjacent to the renal cortex and shares with it a common arterial supply via the plexus Turner. Adipokines and fatty acids of the perirenal fat are predisposed to gain the renal cortex, seat of the ammoniogenesis. In humans the pathogenic role of the perirenal fat is demonstrated in chronic kidney disease and essential hypertension. However, the amount of fat and perirenal that of intra-abdominal fat are positively correlated. Investigators hypothesis is that the perirenal fat also exert a pathogenic role in uric because of anatomical links between kidney stones and greasy environment and because excess fatty acids reaching the renal cortex decreases ammoniogenesis in an animal model metabolic syndrome. For the test, the investigators will compare the amount of fat and perirenal renal ability to form ammonium in patients with uric or calcium lithiasis taking into account the amount of intra-abdominal fat.