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.
Evaluation of practices: retrospective and prospective monocentric survey on the satisfaction of patients undergoing Cardiac Surgery who were able to benefit from additional management by Ericksonian Medical Hypnosis during their stay.
Pre-eclampsia is a disease characterized by placental damage leading to a cascade of complications during pregnancy. It is initially manifested by high blood pressure and the presence of albumin in the urine. It can lead to emergency hospitalization in severe cases and cause major complications or even death in the mother and the fetus. Several studies observing the outcome of patients with pre-eclampsia have shown an increased long-term cardiovascular risk in these patients, justifying regular medical follow-up with the treating physician and specialists, mainly cardiologists. The main objective of this research is to describe the cardiovascular risk assessment actions implemented by the treating general practitioner in the year following pre-eclampsia (blood pressure measurement in the office, self-measurement of blood pressure, ABPM, cardiological consultation, biological monitoring of blood (creatininemia, LDL, fasting glycemia) or urine (albuminurie/creatininurie ratio), and screening and management of possible smoking).
Idiopathic intracranial hypertension (IIH) is a condition characterized by an increase in intracranial pressure (ICP), papilledema with a risk of permanent visual loss, and severe headaches that profoundly affect quality of life. To date the exact pathophysiology of IIH remains unknown. IIH is considered a complex neurometabolic and neuroendocrine disorder, favored by female gender, and obesity. In the majority of patients (80% of the cases) IIH is associated with obstruction of cerebral venous drainage with stenosis of the transverse sinus. This stenosis may be the main underlying cause in the so-called "venogenic" form of IIH. Equally, in the absence of a stenosis, obstruction may occur when otherwise normal venous sinuses are compressed by the increased ICP, the so-called "non-venogenic" form of IIH. An innovative treatment of IIH with associated venous stenosis includes stenting of the transverse sinus stenosis. This strategy may allow resolution of papilledema and ICP reduction rates up to 80%. Although the pathogenesis of IIH is still poorly understood, inflammatory mechanisms, autoimmune reactions, and hormonal abnormalities of notably androgens, have been proposed to contribute to its pathophysiology. The function of the blood-brain barrier (BBB) has been studied by determining the prevalence of extravasation of endogenous proteins such as fibrinogen. A growing body of the literature shows a correlation between increased ICP and metabolic/hormonal changes. The improvement of IIH treated with acetazolamide and/or stenting appears to correlate with the reduction of ICP. Yet the association of this reduction with metabolic changes at the peripheral and central blood level as well as the CSF remains unclear. The search for specific inflammatory, immunological and hormonal biomarkers in patients with IIH and their variation in relation to the ICP should provide a better understanding of its etiology.
This phase II study will evaluate dostarlimab with a watch-and-wait approach for patients with localized mismatch repair deficiency (dMMR)/microsatellite instability (MSI) gastric or oeso-gastric junction adenocarcinoma. The goal of the study is to determine whether the surgery could be avoided in patients with localized dMMR/MSI-H gastric/OGJ adenocarcinoma with complete response at endoscopy and biopsies free of tumoral cells after treatment with dostarlimab, with a watch-and-wait approaches.
Chronic inflammatory rheumatism (CIR) is a group of inflammatory diseases that affect the joints and spine and are related to an abnormal immune response. CIR includes many different forms of arthritis that manifest as painful and swollen joints, stiffness, especially in the morning and persisting even after exercise, and limited joint mobility. CIR can also affect bones, cartilage, ligaments, tendons and muscles. Some may affect other organs. These symptoms can lead to a reduced quality of life, limited physical activity and progressive structural and functional deterioration of the joints. Current treatment for CIR is aimed at reducing inflammation and relieving pain. Anti-inflammatory medications such as corticosteroids and non-steroidal anti-inflammatory drugs can be used to relieve pain and inflammation. Biotherapies can also be used to modify the progression of the disease. On the other hand, regular exercise can help strengthen the muscles that support the affected joints and improve mobility. Physical therapies, such as physical and occupational therapy, can also help improve mobility and relieve pain. Although there is no definitive cure for CIR early and appropriate treatment can help reduce symptoms and improve quality of life, as well as avoid the risk of developing complications such as lung, cardiovascular, kidney, ophthalmic, liver and other diseases. It is in this context, in order to better understand CIR to improve the global management of patients, and to analyze the evolution of CIR over time in relation to the different treatments proposed, that the interest in creating a database of patients with CIR arises.
To meet adolescents' needs regarding mental health vulnerability, this study aims to propose and evaluate three original school-based preventive interventions delivered to French 13y-adolescents, with respect to their effects on mental health outcomes, as well as users' experiences of intervention, evaluated through questionnaires. Based on cognitive-behavioral therapies (CBT) techniques, these interventions target three strategic process areas: reactive adaptation, proactive adaptation, and interpersonal adaptation. Their effectiveness will be evaluated through a four-arm randomized controlled trial, conducted in an ecological context. Intra-group and inter-group comparisons will be carried out for our different variables of interest, namely targeted psychological processes, levels of distress, functional impairment, and well-being, and user experience indicators of acceptability, utility, and usability.
This study is an open label Phase I/II study conducted according to a Fleming design, investigating the safety and the efficacy of 4 IV injections of 177Lu-PSMA-1 in patients with metastatic clear cell renal cancer. This trial is divided in 2 parts: - A safety run-in part aiming to assess the safety of 177Lu-PSMA-1 (with 6 patients treated at the starting activity = 7.4 GBq of 177Lu-PSMA-1, every 6 weeks (Q6W) for 4 administrations). If more than one patient experiences a ST during the first cycle of therapy (6 weeks), then a lower activity of 177Lu-PSMA-1 will be evaluated in an additional cohort of 6 patients (5.9 GBq). The 6 patients from this safety run-in step, treated at the activity selected for phase II, will be included in the evaluation of Phase II part. - A Phase II part aiming to assess the clinical activity of 177Lu-PSMA-1
Duodenal injuries remain rare among abdominal trauma, concerning less than 5 % of cases. However, due to its central location, it is most commonly associated with multiple organs lesions, with the main three organs being the liver, the colon and the pancreas. Additionally, the penetrating mechanism is four times more common than blunt trauma and the most common duodenal site of injury is the second portion (36 %), the least being the first duodenum (13 %). These particularities generate a high morbidity, ranging from 22 to 27.1 %, and a mortality still as high as 5.3 to 30 % today. When facing it, surgeons are usually challenged in their strategy. Indeed, when surgery is required, different options can be chosen depending on the grade of the lesion and the involvement of the papilla and/or other organs. Primary repairs, duodenal diverticulization, pyloric exclusion, gastrojejunostomy, retrograde duodenostomy, distal feeding tube, or even resection and Whipple procedures, have all been described. Since the classification of the American Association for the surgery of trauma (AAST), most studies stratified their management as such: drainage only or primary repair for grade 1 and 2, jejunostomy and/or pyloric exclusion for grade 3, Whipple for grade 4 or 5. However, reviews of the literature aren't clear if this decisional tree is in correlation with lower morbidities, and often different procedures have been reported for the same grade. The escalation of technical exclusions among severe grades became controversial. As an example, pyloric exclusion has been criticized in its preventive role of protecting the suture, being useless at least, or even worse at times. Thus, in the recent years, the management has been focused towards minimization. Indeed, in the retrospective review of the Pan-American trauma society primary repair alone was performed in 80 % of cases, all grades comprised. Although mortality was high, duodenal suture line leak was statistically lower among survivors over every grade. To clear the situation, prospective studies are difficult if not impossible in such context. Thus, The investigators propose this national benchmark, to retrospectively review in France the management of duodenal trauma, depending on the grade, and its associated morbidity.
This research proposes to investigate physiological and cognitive markers of locus coeruleus (LC) neuronal integrity and function in cognitively-healthy participants over 60 years old. The locus coeruleus is a brainstem nucleus, sole source of noradrenaline for the brain. Tau pathology appears in neurons of this nucleus, which may induce initial cognitive changes. The study aims at relating locus coeruleus markers, assessed with MRI and eye-tracking techniques, with cognitive function.
Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments). Despite its high prevalence, a reliable diagnostic remains difficult. Currently, nonspecific clinical signs that might be related to other neonatal conditions such as prematurity and birth defects, are used to determine the diagnosis of LOS. Laboratory results of biological markers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT) are often delayed in comparison with LOS onset. Blood culture results are too late and lack sensitivity. This explains why excessive antibiotic use is observed in a large proportion of NICU hospitalized newborns. This results in an increased antibiotic resistance, microbiota modification, neonatal complications (pulmonary, ophthalmologic and neurologic) and mortality. A previous study (EMERAUDE) aimed to identify new biomarkers to early exclude the diagnosis of LOS, in order to limit antibiotic overuse. This study including 230 neonates revealed high performances of IL6, IL10, NGAL and combinations of PCT/IL10 and PTX3/NGAL. The main objective of the present study will be to validate the performances of these biomarkers in another cohort. The secondary objectives will be to explore transcriptomic biomarkers and salivary biomarkers.