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 twin pregnancies monochorionic are specifically explained to two main types of complications: the anomalies of the embryo affecting a symmetry and in particular the median line on one hand and malformative sequences of vascular origin on the other hand. This last category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a division of the foeto-placentary circulation between both twins through the pooling of certain placentary cotyledons. The latter are then vascularized by an arterial and venous foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results from it an imbalance moderate but very early hemodynamic which is going to return a hypovolume twin (the donor) and its plethoric co-twin (the recipient). These anomalies in utero could not only have consequences during the fetal life, on the born weight and the later development of newborns, but also on the organization and the functioning of a whole series of physiological systems. So these anomalies of the pregnancy could have also consequences which exceed by very far from the perinatal period, by favoring the development of the atheroma, the high blood pressure, the resistance in the insulin, and many other metabolic and endocrine functions were known for their importance in human pathology. For these reasons the investigators suggest estimating the tensional, cardiac and metabolic status of children ex-transfusers and of children ex-transfused in 2 different age classes: between 4 and 8 years then when these children will have between 12 and 16 years. There are also some evaluation clinical and biological of the puberty (only at the age of 12-16) To understand a possible effect of the prenatal status of these children on the endocrinology of the puberty, the measures and the following dosages will be realized: - Test in the GnRH (T0, T30, T60, T90): dosages of LH and FSH (relationship of peaks to determine the puberty evolution), - Dosages of the sexual steroids, the oestradiol for the girl and the testosterone for the boy, - Clinical examination looking for the signs of puberty This if study leans on the big originality of the physiopathological model of TTTS in which the children present the peculiarity to have an identical genetic and postnatal status and a different prenatal environment. The follow-up of these children should allow: - To understand better the postnatal impact anomalies on these children in the course of pregnancy - To anticipate and thus to improve their care in case of appearance of biological or clinical signs
The purpose of this multicenter double blind study is to assess efficacy and safety of Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.
The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of Amivantamab as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD) (combination therapy), and to determine recommended Phase 2 Dose (RP2q3W) with combination chemotherapy (Amivantamab in combination with standard of care carboplatin and pemetrexed) in 21 day treatment cycle for participants with advanced non-small cell lung cancer (NSCLC).
In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left ventricular (LV) ejection fraction is well known. Consequently, there is class I indication for surgery in these patients when LV ejection fraction <50%. However, there is growing evidences suggesting that subclinical LV dysfunction, and more particularly longitudinal myocardial dysfunction, may be a powerful early predictor of outcome, even when LV ejection is still preserved. In asymptomatic AS patients with LV ejection fraction >50%, a reduced LV global longitudinal strain, as assessed using speckle tracking imaging with transthoracic echocardiography, may be an accurate marker to identify early subclinical LV dysfunction and thus, to improve the risk stratification, the management and the timing of surgery. Several mono-centric observational small studies recently reported results emphasizing the role of LV global longitudinal strain in AS patients. Therefore, a meta-analysis may be conducted and may provide meaningful data. The investigators hypothesized that LV global longitudinal strain is a determinant of outcome in asymptomatic patients with AS and preserved LV ejection fraction.
Premature birth deprives infants of sensory stimulation. Tactile stimulation such as massage pressure with kinesthetic movement significantly increases the weight, bone density and shorten the duration of stay of premature babies who benefits. Studies using vegetable oils show an increase in the effect on weight gain by cutaneous absorption. The mechanism is probably vagal (stimulation of baroreceptors and skin mechanoreceptors) since it is found in children stimulated an increase in the vagal activity, acceleration of gastric emptying and an increase in the secretion of insulin and IGF1. Few studies have evaluated the effects of massage on the medium-term neurological development in preterm infants and the effect of the essential oils in the effectiveness of touching the short and medium term massage. The aim of the investigators study is to evaluate the neurological development in the short and medium term in premature newborns and biological effects of massage with essential use of vegetable oil. Methodology and possible collaborations This is a monocentric, randomized, controlled, in a neonatal intensive care unit. It concerns 60 children born between 26 and 30 weeks of amenorrhea. Each child receives massage randomized with or without oil ISIO 4. The treatment is administered 10 minutes twice a day for 10 consecutive days watching for signs of intolerance. The quality of the spontaneous motility between 12 and 20 weeks of age corrected is used as the first neurological assessment criterion. The questionnaire (ASQ) Bricker and Squires (translated into French by Martha Bonin et al.) is used to 6, 12, 24 months corrected age and completed by the parents as a second neurological endpoint. A lipid chromatography is performed at the beginning and at the end of the massage time and at the deliverance from NICU for comparing the profile of children's fatty acids. Expected results Show that there is an improvement in the neurological development in children who received massage with vegetable oil ISIO 4. Show that there is a skin absorption of essential fatty acids that can substitute for a known major deficiency in premature even in infants fed breast milk.
The purpose of this study is to determine the outcomes of severe osteoporotic fractures hospitalized in France, the risk of incident severe fracture at 2 years and 5 years and the risk of mortality over 2 and 5 years.
This study will assess the efficacy of mirabegron, a new beta3-adrenergic receptor in the prevention of heart failure. This is a two armed, prospective, randomized, placebo-controlled, multi-centric european phase IIb trial with placebo and mirabegron distributed in a 1:1 fashion. The patients enrolled will have cardiac structural remodeling with or without symptoms of heart failure (maximum NYHA II). Patients will be monitored for change in left ventricular mass (assessed by cardiac MRI) and/or changes in diastolic function (assessed by echocardiography) after 12 months of treatment.
The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Part 1 of the study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Part 2 of the study. An Extension Phase has been included to allow continued treatment for those subjects who are benefitting from imetelstat and to continue to evaluate the long-term safety, overall survival (OS), and disease progression, including progression to acute myeloid leukemia (AML) in transfusion-dependent participants with low or immediate-1 risk MDS that is relapsed/refractory to ESA treatment.
The aim of this study is to evaluate the sentinel node policy in early stage endometrial carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node policy to current initial staging protocols).
This is a multicentric randomized parallel group open trial comparing 5-year survival of chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients with confirmed unresectable liver-only metastases, well controlled by chemotherapy (no progression) and extensively explored by modern imaging techniques. The primary objective of the trial is to validate in a large multicentric cohort of selected patients the possibility to obtain at least 50% 5-years survival with LT combined to chemotherapy compared to around 10% with chemotherapy alone.