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.
Obtaining intravenous access is difficult in the pediatric population. Ultrasound-guidance allows real-time visualization of target veins which are invisible and impalpable. We hypothesize that the use of ultrasound by a trained nurse team would improve the success rate of peripheral intravenous catheter insertion in pediatric patients with difficult intravenous access, compared to palpation of the vein alone. For this study, when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient, state-certified nurse investigators, trained in ultrasound guidance, will be contacted. After verification of eligibility criteria and all informed consents obtained, one of the investigators will randomize the patient in one of the 2 treatment groups under study: peripheral intravenous catheterization by visualization and palpation of the vein alone (standard of care) or by ultrasound guidance performed by a trained nurse. Several outcomes will be measured and compared between the 2 groups (e.g. successful insertion of intravenous catheter, pain, adverse events).
The transition between adolescence and adulthood (generally defined as ages 18 to 25) is a key developmental window for narrative identity and psychotic disorders. Narrative identity is positively associated with mental health. This study will focus on the acquisition of narrative identity in First Episode Psychosis (FEP) and its impact on multidimensional subjective well-being. The study authors hypothesize that levels of the various components of narrative identity would be lower in the FEP group than in the "chronic" and control groups, and in the "chronic" group versus control group. Given the paucity contradictory nature of the published literature, no hypotheses have been formulated regarding these correlations and predictions. Instead, this study will remain an exploratory analysis in the different samples.
Brief Summary: * A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public. Limit: 5000 characters. Severe forms of sickle cell syndrome are characterized by the occurrence of repeated vaso-occlusive crises (CVO), early complications and a high morbidity and mortality in these patients. Intensified management is then required, with the introduction of hydroxyurea treatment and then, if it proves ineffective, a transfusion program or even a haematopoietic stem cell allograft. These latter treatments present significant risks of adverse effects for the patient (haemochromatosis, erythrocyte alloimmunisation for the transfusion program, risk of GVH, chemotherapy-related toxicity, MVO for the allograft). Hydroxyurea (HU) is the first treatment based on the specific pathophysiology of sickle cell disease. It is the first line of therapeutic intensification for adult patients and children (age ≥ 2 years) with major sickle cell disease. By mainly increasing the percentage of fetal haemoglobin (HbF), HU decreases the frequency of CVO, complications, hospitalizations and prolongs the life expectancy of patients. The initial dose of HU, recommended by the ANSM, is 15 mg/kg/d once daily. However, the optimal dose cannot be predicted at the start of treatment, which is why a dosage adjustment is essential. The usual dose is between 15 and 35 mg/kg per day. Typically, the dose is increased every 3 months until a mild myelosuppression tolerated by the patient is reached, indicating that the maximum tolerated dose (MTD) has been reached. When the dose of HU has reached the MTD, the ratio of clinical (reduced frequency of vaso-occlusive attacks) and biological (better % of HbF) benefits to risk (toxicity) is optimal for the patient. The disadvantages of this practice are that: - dose escalation can be long (9-12 months) - clinicians may be reluctant to escalate HU to MTD - patients are treated sub-optimally during the therapeutic adaptation period. Recent work has shown that it is beneficial for the patient to adjust the initial dose using a pharmacological therapeutic approach in addition to monitoring haematological tolerance. Thus, by customizing the dose of HU using an area under the curve (AUC) measurement at the initial intake of HU at a standardized dose (20 mg/kg/day), the MTD would be achieved in a faster time frame of 6-9 months. The primary objective of our trial is to identify the methodology that will most effectively decrease the time to reach the MTD (therapeutic target). The immediate benefit will be a reduction in CVO which is the major clinical problem and leads to a risk of complications in sickle cell disease.
Preeclampsia is a hypertensive disorder of pregnancy associated with important maternal and perinatal mortality. It complicates 2 to 5% of pregnancies and causes more than 70 000 maternal deaths each year worldwide. Although symptomatic management has improved there is currently no curative treatment, and only childbirth and delivery of the placenta, usually prematurely, alleviate the mother's symptoms. The management of extremely preterm infants is a major societal challenge in medical, ethical and economic terms. Placental insufficiency plays a central role in the pathophysiology of preeclampsia. Abnormal placentation during the first trimester leads to placental hypoperfusion, which induces trophoblast dysfunction and the release in maternal circulation of trophoblastic factors leading to the maternal symptoms. Among molecules that participate to the pathophysiology of preeclampsia, one of the most important players is soluble fms-like tyrosine kinase 1 (sFlt-1), which is a soluble form of the vascular endothelial growth factor (VEGF) and placenta growth factor (PlGF) receptor. sFlt-1 binds to free VEGF and PlGF in the maternal circulation, thus reducing their bioavailability for their membrane receptors. Targeting the sFlt-1 pathway is one of the most promising strategies for the development of new treatments for preeclampsia. As sFlt-1 results from alternative splicing, its peptide sequence is identical to that of the extracellular part of the membrane receptor. The development of drugs that act specifically on the soluble form and not on the membrane form is therefore particularly complex. The general objective of this research is to restore the angiogenic balance that maintains the physiological concentrations of free angiogenic factors in order to significantly prolong the pregnancy and diminish the consequences of the great prematurity. The precise objectives of the APHERESE 2 project are: 1. To transpose the proof of concept of the APHERESE1 project to the scale of a real apheresis column 2. To develop an innovative assay technology to determine the global circulating angiogenic balance for each patient
The purpose of this study is to determine if IN fentanyl (1.5 µg/kg) or IN ketamine (1 mg/kg) is more effective at 30 minutes than oral morphine (0.5 mg/kg) in reduction of moderate and severe pain associated with limb injuries in patients 2-17 years of age presenting to the ED.
Heart failure is a major cause of mortality and morbidity in children. Heart transplantation can significantly improve the prognosis of patients with severe heart failure, but access is limited by a shortage of transplants. Long-term mechanical circulatory support is a major advance in the management of heart failure and can provide haemodynamic support while awaiting myocardial recovery or heart transplantation. The Berlin Heart (BH) EXCOR is the only long-term support system available for children. Despite technical and medical advances in circulatory support, infection is a common complication and a major cause of morbidity and mortality in patients on BH. There are few studies on the management of infection with mechanical support. Current ISHLT (International Society for Heart and Lung Transplantation) recommendations are based on expert opinion and observational studies. Some experts recommend anti-infective therapy until transplantation for specific support infections or for support-associated infections with persistent bacteraemia.
Currently intravenous analgesics are used for postoperative analgesia. But the analgesia of these products is tempered by their adverse effects (sedation, confusion, nausea or vomiting, delayed transit, urinary retention and pruritus) which can slow down postoperative recovery. The aim of this study is to evaluate the effectiveness of the administration of local anesthetics via two catheters placed during surgery, but also to study their benefit on respiratory function and therefore on recovery time and morphine sparing.
The aim of the research is to analyze whether 18F-FDG PET helps in the diagnosis and therefore in the management of the patient.
Systemic SClerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to vasculopathy and/or fibrosis. The loss of self-tolerance is believed to be caused by the dysregulation of both innate and adaptive immune systems and may involve Reactive Oxygen Species (ROS). Neutrophils are potent producers of ROS and may play a role in endothelial cells and fibrobasts dysfunction, as in autoantibodies generation. However, their role in SSC pathogenesis remains to be determined. Recent studies discovered abnormal regulation of Neutrophil Extracellular Traps (NETs) in other auto-immune diseases such as Systemic Lupus Erythematosus (SLE). NETs are web-like structures composed of chromatin backbones and granular molecules. They are released by activated neutrophils through a process called "NETosis". Nets were first described in 2004 as a novel host defense mechanism to trap and kill foreign pathogens. Recent evidence shows that NETs also participate in the pathogenesis of a variety of inflammatory and autoimmune diseases, including SLE. The investigators recently highlighted this phenomenon in SSc, especially in patients with vascular complications and/or at a early stage of the disease. The investigators will now explore the factors implicated in this dysregulation of NETosis in SSc.
Impact of monocytes on Myeloproliferative Neoplasm hematopoietic stem cell growth and differentiation in vitro