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.
Toxoplasmosis is a benign disease in healthy adults, but can be serious in the case of contamination during pregnancy: the parasite can pass through the placental barrier and infect the foetus. The severity of congenital infection varies, but in France, where maternal seroconversions during pregnancy are treated, the manifestations of the disease are often infraclinical at birth and only appear during the first years of life in the form of retinochoroiditis. In order to prevent long-term sequellae, children with confirmed congenital toxoplasmosis (TC) are treated with pyrimethamine combined with either sulfadiazine or sulfadoxine (Fansidar®). The relative efficacy of these two combinations has not yet been evaluated. Moreover, there is no consensus about the duration of the treatment, which varies, in France, from 12 to 24 months depending on the centre. Compared with the duration of parasitaemia in non-treated children, which can persist for up to 4 weeks, these treatments are very long. They are also far longer than the 3 months of treatment, which is in accordance with the World Health Organization (WHO) recommendations, given in Denmark to infants identified as being infected with the parasite during neonatal screening. A one-year treatment was developed in the United States, but it mainly concerns only symptomatic children, given the absence of generalised screening in the United States of America (USA). We have no arguments to justify the use of treatments lasting one year or more in children with asymptomatic or mildly-symptomatic TC. As these treatments carry certain risks, which may be severe, notably with regard to haematological or skin conditions, they have to be supervised closely with biological tests, which adds further constraints for both the children and their parents and increases the cost to health care systems.
This was a multi-center, parallel, active comparator controlled, open-label, randomized (1:1) phase III study of single agent ofatumumab compared to single agent rituximab in subjects with rituximab-sensitive indolent B-cell non hodgkin lymphoma that has relapsed at least 6 months after completing treatment with single agent rituximab or a rituximab-containing regimen. Subjects must have attained a Complete Response or Partial Response to their last prior rituximab containing therapy lasting at least six months beyond the end of rituximab therapy. Subjects were to receive four weekly doses of single agent ofatumumab (1000 mg) or rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2 months for four additional doses. Therefore, subjects were to receive a total of eight doses of anti-CD20 antibody over 9 months. Subjects were evaluated for response after completion of the first four doses of therapy, after six doses of therapy, and after completion of study therapy. Subjects were to be followed until the end of the designated follow-up period (total study duration of 200 weeks) or until they meet the withdrawal criteria. The primary objective of the study OMB157D 2303 was to demonstrate the efficacy of Arzerra based on the primary endpoint (Progression-free survival (PFS) as assessed by the IRC) in patients with Indolent B-cell Non-Hodgkin's Lymphoma Relapsed After Rituximab-Containing Regimen. The Independent Data Monitoring Committee (IDMC) met on November 22, 2015 and recommended the termination of the study due to futility (cut-off date = 12Jun2015). The IDMC reviewed analyses results for progression free survival (PFS), overall response rate (ORR), and overall survival (OS). Novartis accepted this recommendation and the study was closed. Final analysis was performed (cut-off date =19 Dec 2016). As the study was stopped for futility, the primary objective was not met and some secondary endpoints, supportive of primary objective (Duration of Response (DOR), time to next therapy, and pharmacokinetics) were removed as secondary end points.
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.
This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.
Several technological challenges exist to apply Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for treatment of liver or kidney in particular challenges related to the motion of these organs. This study tests a new software to improve thermometry accuracy in mobile organs in patients with liver or kidney tumors. In the same time, the trajectory of the target in 3D is analyzed.
The main objective of this study is to evaluate the decrease of inflammation of adipose tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by continuous positive airway pressure (cPAP). An interim analysis will be performed when 40 patients will be included.
The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function, before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a cardiovascular surgery, by an observational physiological study. An interim analysis will be performed when 100 patients will be included.
The objectives of this study are to assess and compare bilateral uncorrected distance visual acuity and distance spectacle independence post bilateral implantation of AcrySof Toric Intraocular Lenses (IOLs) and monofocal IOLs. Secondary outcomes will include cost of eyeglass purchased and patient vision-related quality of life.
REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma. PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma.