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.
Fibrosis is a dynamic process resulting from the balance of fibrogenesis and fibrolysis, mainly secondary to chronic necro-inflammation related to regular alcohol consumption, metabolic syndrome (NASH) or viral hepatitis. The liver has the property of allowing the reversion of fibrosis / cirrhosis when the necrotic-inflammatory activity is controlled. The balance between fibrosis / fibrolysis and its inhibition depends on many pathways and the hypothesis of the efficacy of a single treatment remains uncertain. Molecular factors in the progression of liver fibrosis should be determined. It is necessary to control the liver fibrosis and thus reduce the risk of carcinoma in this population. The anti-fibrotic drugs are being developed, but so far only alpha-tocopherol and obeticholic acid have been shown to have a significant anti-fibrotic effect in humans. Several new drugs are currently being evaluated in ongoing Phase 2 and 3 randomized clinical trials, but most of them have intrinsic limitations: (i) they take a long time for evaluation (> 3 years), ( ii) they generally require an histopathological evaluation by serial liver biopsies that are invasive and unpopular with patients who are aware of noninvasive tests for fibrosis assessment and (iii) treatment is often a single treatment versus a placebo group with the uncertainty that at 1 or 3 years, serial liver biopsies results are convincing.
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
This study aims to explore learning process in a role play for undergraduate students working on psychiatric interview. This study is one of the 3 studies included in a PhD on learning process during simulation training in psychiatry. The results of this 3 studies will aim at building a formative and summative assessment tool of competences specific to this pedagogic context Methodology: Mixed method study with: - Quantitative features: - Self-reported questionnaries : " Learning Effectiveness Inventory Scale " - Sociodemographical data and others questions - Qualitative : Grounded Theory - Semi-structured interview of learners and teachers - Record of simulation and audio-record and briefing and debriefing (supplemented by quotation with conversational analysis (Rotterdam Interaction Analysis System, RIAS) for video)
Biomarker series can indicate disease progression and predict clinical endpoints. When a treatment is prescribed depending on the biomarker, confounding by indication might be introduced if the treatment modifies the marker profile and risk of failure. The two-stage model fitted within a Bayesian Markov Chain Monte Carlo framework is particularly flexible to account for such data. Prostate-specific antigens in prostate cancer patients treated with external beam radiation therapy can be monitored. In the presence of rising prostate-specific antigens after external beam radiation therapy, salvage hormone therapy can be prescribed to reduce both the prostate-specific antigens concentration and the risk of clinical failure, an illustration of confounding by indication. The prognostic value of hormone therapy and prostate-specific antigens trajectory on the risk of failure based on a two-stage model within a Bayesian framework to assess the role of the prostate-specific antigens profile on clinical failure while accounting for a secondary treatment prescribed by indication. the aim of this research is to model prostate specific antigens using a hierarchical piecewise linear trajectory with a random changepoint. Residual prostate-specific antigens variability can be expressed as a function of prostate-specific antigens concentration. Covariates in the survival model can include : hormone therapy, baseline characteristics, and individual predictions of the prostate-specific antigens nadir and timing and prostate-specific antigens slopes before and after the nadir as provided by the longitudinal process.
Surgery of large cerebellopontine angle (CPA) tumors (>2 x 2 cm diameter), with compression of the pons exposes the patient to inadvertent parasympathetic nerve stimulation (IPNS) leading to bradycardia and asystole. The analgesia nociception index (ANI) monitor assesses the balance between analgesia and nociception through the detection of parasympathetic tone. ANI >80 generally denotes excessive analgesia (EA). The main objective of this study was to determine whether ANI values for IPNS are different or the same as ANI values for EA. This study also aims at calculating the number of patients with IPNS and EA during surgery of large CPA tumours.
Secondary mitral insufficiency is a common complication of heart failure, aggravating symptoms and prognosis, and may be responsible for worsening dyspnea, pulmonary edema, and excess mortality. It is essentially a ventricular rather than a valvular disease, whose origin may be ischemic or not. It is induced by a geometrical and contractile modification of the left ventricle which causes an imbalance between the tensile and the closing forces of the mitral valve thus causing a defect of coaptation and the increase of the surface between the mitral leaves and the ring in systole (tenting). Dynamic mitral insufficiency is defined by changes in the degree of severity of regurgitation as a function of hemodynamic conditions. During exercise, the course of mitral insufficiency is variable and is not predicted by the degree of regurgitation at rest. The worsening of the leak is also well correlated with the onset of dyspnea on exertion in patients with left Ventricular Ejection Fraction heart failure (LVEF reduced). Nevertheless, there is little data available in the literature on the factors predisposing to the development of stress-related mitral insufficiency, as well as its clinical and echocardiographic impact in the cardiac insufficiency patient, particularly in the case of preserved LVEF (6.7%). The identification of echocardiographic data at rest to predict and anticipate the behavior of mitral insufficiency in the effort (aggravation or stability / disappearance), would allow a simplified evaluation and a better management in this population of patients for which the evaluation in echography of effort can be technically complex and limited (difficulty of quantification of the mitral leak, time of effort sometimes too short ...).
The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.
The objective of this study is to assess the effectiveness of naps under different environmental conditions and a rest without nap, on driving, alertness and psychomotor performance. This study also aims to record during nap time, sleep, body temperature and heart rate.
The hospitalization of a child for cardiac surgery is a major event in a family's life. Some factors induced by surgery can have serious psychological consequences and cause high stress and anxiety in the child but also in the parents. Many interventions have been tested to reduce this anxiety generated by apprehension of the surgical procedure, but there is no evidence to date that would allow health care services to effectively prepare these families for surgery. The authors encourage researchers to continue research on this subject in order to confirm or refute their results.
Brain tumors are the most common solid tumors in children and are the second most common cause of cancer-related death among this population. Posterior brain fossa tumors represent about 50% of children brain tumors. Recently, knowledge in molecular biology has permitted to identify different tumors subgroups of very different prognosis. Today, surgery removal of the tumor is the mandatory. Neuro-oncological treatment differs depending on the histological and molecular subgroup. With classical Magnetic Resonance Imaging (cMRI), distinction between different types of posterior fossa tumors remains difficult. Positron Emission Tomography combined with MRI (PET/MRI) has proven its benefits for the management of brain tumors. The direct spatiotemporal correlation makes possible the assessment of metabolic, anatomical and functional information. PET/MRI would provide precisions on the pre-therapeutic characterization of tumors, which could permit to modify the patients' care. L- [methyl-11C] methionine (11C-MET) is currently the gold-standard tracer used in neuro-oncology, but few data exists in children. 11C-MET PET/MRI assessment seems promising, but has not been studied enough. To the best of our knowledge, there is no specific study on primary brain tumors of the posterior fossa in children using 11C-MET PET/MRI. The primary objectives of this first pilot study is to evaluate the practical feasibility of 11C-MET PET/MRI imaging (machine accessibility and imaging interpretability) before surgery in a population of children older than 5 years old with posterior fossa tumors. The secondary objectives aim to describe : - the PET/MRI parameters of the different tumors studied, - and the patient's participation acceptation. This feasibility study will allow us to standardize the PET/MRI measurements; this could allow us to discriminate, in a larger study, the different tumor subgroups before surgery.