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 the present study is to evaluate the effect of emotional prosody on the perception of emotional discourse in the schizophrenic spectrum. The investigators hypothesize that participant may use emotional prosody as an emotional cue to understand the emotional content of discourse.
This is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three cohorts will enroll independently.
The investigators believe that the initial cerebral connectivity as well as its evolution immediate post-stroke could be correlated to the amount of motor recovery. Therefore a cohort of 21 people early post-stroke, and 6 weeks post standard routine rehabilitation will be analyzed. Clinical, kinematic and imaging (MRI) data will be compared with 12 healthy controls. Kinematic movement information has been collected within the fMRI. By integrating multi-modal clinical, kinematic and MRI, the study aims to identify biomarkers of recovery to improve patient specific evaluation post-stroke in order to adapt rehabilitation protocols accordingly and to improve functional gain.
Brain is composed of several anatomical compartments separated by physiological barriers allowing the maintenance of homeostasis. Furthermore, brain-barriers restrain the diffusion of some drugs in cerebro spinal fluid (CSF) and in extracellular fluid (ECF) of brain tissue, making the development and optimization of dosing regimen of new drugs difficult. Most dosing regimen are determined from the plasma concentration because target site concentrations are difficult to obtain in the brain, hence making the prediction of the therapeutic effect, the adverse effect and the toxicity of a brain- diffused drug difficult. Although quantitative and qualitative differences exist in the processes governing pharmacokinetic (PK) in CSF and brain tissue, CSF is considered as the best surrogate of drugs penetration in the human brain. A study previously published has evaluated in rats the cerebral distribution of paracetamol, used as a marker of passive diffusion in the ECF by microdialysis in the striatum and in the CSF by microdialysis in the ventricular lateralis and the cistern magna. Authors chose paracetamol, as it has the property to diffuse passively and rapidly in the central nervous system allowing the exclusive description of the relationship between the different compartments of the brain. This study has first revealed an unexpected important difference between the distribution profiles obtained in ECF and CSF. Based on these results, authors developed a physiologically based PK model (PBPK) to describe their results and thereby offering the possibility to perform interspecies simulations to predict central nervous system (CNS) distribution of paracetamol in human. In this study, authors used this model to perform pharmaceutical extrapolations between species converting data from animal to human by replacing obtained data from clinical past studies describing paracetamol distribution in the CSF and in plasma. Microdialysis allows determination of free extracellular concentrations of drug in different tissues and also in brain. Our research team, INSERM U1070, has several past experiences with studies involving micro-dialysis to study the distribution of antibiotic in tissue in both animal and human including cerebral tissue in rat and human. Recommendation from the scholar society suggests that brain injured patients should benefit from a multimodal monitoring to optimize their care and brain perfusion. This invasive multimodal monitoring consists of measuring the intracranial pressure, the oxygen tissue-pressure, the estimation of the cerebral blood flow-rate by cranial Doppler as well as the monitoring of cerebral ischemic parameters by microdialysis. We also prevent systemic cerebral aggression among which, hyperthermia, explaining the prescription of paracetamol among a large number of brain injured patients. Furthermore setting up of an external ventricular draining (EVD) to treat an intra cranial hypertension is usually necessary to allow the continuous flow of the excess of CSF in the brain ventricle. Few studies carried on human has aimed at comparing the distribution of drugs in both the CSF and the brain extracellular fluid though it is established that the brain barriers differ in their permeability as well as the drug's concentrations are different between brain compartments. Thus by mean of monitoring through microdialysis and/or through therapeutic EVD, required by brain-injured patients, we aim in our study to explore the pharmacokinetic of paracetamol in the brain ECF, the CSF and the plasma and to validate in man the PBPK developed in rat.
The aim of this randomized study is to develop a new motor assessment of space exploration in a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3 until 16 years old.
In vaccination centers, venipunctures and vaccinations are sources of pain and anxiety in pediatric patients. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses. The topical anesthetic cream (lidocaine, prilocaine) and the non-pharmacological (distraction and relaxation) interventions which are usually used for prevention of procedural pain impose certain constraints on families and on vaccination centers. A distraction and local anesthesia (cold and vibration) based medical device (Buzzy®) could overcome these constraints and could be an interesting alternative for healthcare management in vaccination centers and, in a broader perspective, in other medical services. Research on this device has been scarce to date. Three of them have shown an efficacy of Buzzy® in comparison to the absence of prevention of vaccination and venipuncture induced pain. An ongoing study will assess the Buzzy® device in comparison to a topical anesthetic cream, but will be set in an emergency department context. To date, no study has compared Buzzy® to topical anesthetic cream on healthy children in a vaccination center. The research team has formulated the following hypothesis: the Buzzy® device will allow to get a not lower or an equivalent level of pain compared to the level of pain obtained with the usual topical anesthetic cream. The aim of this study is to evaluate the efficacy of the device Buzzy® on vaccination and venipuncture induced pain in a vaccination center.
The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.
Severity of allergic reactions are highly variable from one individual to another, they can range from absent to life threatening. Allergic manifestations and specifically those of anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells and/or basophils followed by the release of histamine. Recently however evidence accumulated that other pathways might similarly contribute or even trigger anaphylaxis. Moreover, while the variance in human populations is an important subject to scientific research, medical practices and public health policies typically take a 'one for all' approach to disease management and drug development. Indeed, individual heterogeneity in the immune response can have a big impact on the likelihood to respond to therapy. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that define the immune system of allergic patients and its natural occurring variability. Thanks to the efforts that have been made in the framework of the Labex "Milieu Intérieur" study genetic, immunological and environmental factors have been identified that can be linked to the heterogeneity of immune responses in healthy individuals. By comparing these already available data from healthy individuals to a novel cohort of patients with defined severe allergic manifestations, we will be able to identify for the first time immunological and environmental parameters that are common to patients with severe allergies and identify those parameters that distinguish allergic patients from the healthy donor cohort. This analysis will thus open new perspectives on deregulated immune pathways in allergic patients allowing to orient future treatment approaches. Furthermore, comparing immune responses before and after allergen-specific immunotherapy will help understanding, which changes in immune responses are causal to a successful treatment. Importantly, this analysis will shed light on the individual differences that may predict the outcome of treatment approaches and propose novel markers of its success.
This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect. Patients who sign up for this trial must also fall into one of these categories: - Patients have already received treatment with platinum-containing chemotherapy - Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.
The purpose is to determine in a case-control study if an association exist between bone marrow adiposity and fragility fractures in post-menopausal women.