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 purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis (CF).
Clinical presentation of patients after severe injury such as a severe infection, trauma or extensive burns is characterized by the simultaneous occurrence of dysregulation of the initial inflammatory response and immunosuppression associating quantitative and functional alterations of innate and adaptive immune cells. These acquired immune dysfunctions have been associated with an increased susceptibility to nosocomial infections, foremost among which are ventilator-associated pneumonia (VAP). Despite the implementation of a set of preventive measures, the incidence of these VAP remains high in intensive care, with rates in Europe of 1.5% per day of ventilation. Post-aggressive immunosuppression is characterized by the decrease in the expression of HLA-DR (belonging to the type II major histocompatibility complex, MHC-II) on the surface of monocytes (mHLA-DR). The administration of interferon gamma (IFNγ) can restore the level of mHLA-DR and may possibly improve the prognosis as an adjuvant therapy associated to antibiotics. However, the level of proof of this therapeutic strategy is low, limited to small cohorts of patients, or clinical studies without prior immunodepression assessment. The objective of this study is to conduct a randomized, double-blind, placebo-controlled superiority trial to assess the effect of IFNγ administration on the duration of mechanical ventilation following the first episode of VAP in patients having an HLA-DR < 8000 AB/C All reported data about recombinant human IFNγ 1b for the control of secondary infections in patients with septic shock used the dose of 100 micrograms per day by subcutaneous route for 3 to 5 days . At this dose, no retrospective study has reported any serious adverse effects and recombinant human IFNγ 1b allows an increase in monocyte membrane expression of mHLA-DR.
Obesity and metabolic associated diseases such as type 2 diabetes, NASH, cardiovascular diseases, are the dysregulation of energy homeostasis associated with an imbalance between different types of adipose tissues (ATs). White AT (WAT) which stores energy and functions as a fat storage depot, is fibrotic whith chronic inflammation and is found in excess. On the other hand, brown and beige ATs (BATs), considered as the good ATs because they regulate energy expenditure, are almost undetectable in individuals with obesity. In addition, BAT and WAT produce different hormones that are involved in the control of energy homeostasis via central and peripheral actions. A promising emerging therapeutic approach is to restore BAT in patients with severe obesity in two ways, i) by stimulating BAT in individuals with obesity by pharmacological treatment, ii) by injecting BAT into individuals with obesity using a cell-based therapy approach. However, the development of these two proposals is limited both by the lack of in vitro preclinical BAT models relevant for the screening and validation stages of drug candidates, and by the lack of physiologically functional BAT compatible with tissue graft. The bottleneck is the absence of an unlimited source of human BAT. The ExAdEX technology makes possible in vitro to turn WAT derived from lean donors into BAT. This new technology offers the possibility of having in vitro predictive human 3D models suitable for the identification and characterization of compounds affecting AT biology, and paves the way for the production of BAT for cell-based therapy of obesity and associated metabolic diseases. The Primary objective of the study is addressed the effectiveness of the ExAdEx process to induce, ex vivo, the conversion of WAT from obese patients into TAB. The secondary objectives are 1) to compare the efficacy for conversion into BAT when WAT derived from either from visceral or from subcutaneous AT; 2) to investigate the capacity of the ExAdEX-BAT to produce the FGF21 and adiponectin batokines and to respond to insulin.
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 3 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib based on their disease activity and their original treatment assignment in Study 1 or 2. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
This study aims to define individual profiles of treatment resistants in order to find indicators and predictors of the therapeutic response.
Adverse Childhood Experiences (ACEs) have long been linked to mental health problems in adulthood. In the case of cancer, no study has considered that such an anteriority could make patients more vulnerable emotionally, even though the presence of reactionary disorders such as stress, anxiety or depression are characteristic of such a pathology. Activated during periods of stress and therefore during the illness, even the attachment system is mobilized and must be considered to allow more understanding of the illness experience. The attachment style can be seen here as an individual dimension that plays a role in the emotional regulation and resilience of patients. It is also particularly solicited during the remission phase, a complex and singular period of cancer disease that confronts patients with an ambivalence of hope and fear. The fear of recurrence is a concern that the cancer may return or progress in the same organ or in another part of the body. This is a determining factor in the occurrence of anxiety-depressive disorders. Finally, several studies have shown a strong association between depression/anxiety and Cancer-Related Fatigue (CRF) after treatment, especially during the remission phase. ACEs leave physiological and epigenetic impact that can nowadays be easily evaluated, thus providing additional evidence between adversity, physiological and epigenetic vulnerability and the ability to adapt to life's challenges such as cancer. Life history changes are mediated by changes in cellular mechanisms affecting genome expression. It is currently widely demonstrated that ACEs increases epigenetic modifications. The interest of this project is therefore to highlight the psychological consequences related to the occurrence of cancer in the developmental history (in terms of adversities) of patients who have completed adjuvant chemotherapy for breast cancer, taking into account the patients' previous attachments, resilience, fear of recurrence and perceived fatigue in order to consider their interactions and their effects on their psychological health and ultimately on their quality of life.
The pediatric orthopaedic surgeon treats idiopathic scoliosis in children and adolescents using the posterior vertebral arthrodesis technique. This surgery is considered "heavy" by the child and families while it is intended for a healthy population. Through this study to take stock of the measures governing idiopathic scoliosis surgery (pre-operative, intra-operative and post-operative) within the various pediatric orthopedic surgery departments on the French national territory.
This research promoted by the AP-HP (DRCI) is financed by the Agence de la biomédecine (ABM) and the Fondation Maladie Rare (FMR) and received a favourable opinion from the CPP on 8/12/2020. It aims to describe the decision-making process of couples faced with the discovery of an isolated corpus callosum anomaly in their fetus during pregnancy. Indeed, the anomaly of the corpus callosum in antenatal represents a paradigmatic situation of the clinic of uncertainty for couples and teams, because the prognosis is variable, in 80% of the cases it is favourable and in 20% it is associated with an intellectual deficiency. This study will use a mixed methodology, combining quantitative data (STAI A and B anxiety scale, BDI-II depression scale, PCL-5 post-traumatic stress scale, DAS-16 marital relationship dynamics scale, experimental emotional self-evaluation scales adapted to each member of the couple, R/S scale) and qualitative data (through a research interview of the couple conducted by a research psychologist). In the course of the study, 50 couples will be interviewed between 3 months and 5 years after the pregnancy (post-medical termination of pregnancy and post-delivery), with 25 couples who will have continued the pregnancy and 25 couples who will have terminated the pregnancy. Statistical and qualitative analysis of the data using NVivo software will be performed. The aim is to better understand the factors that lead couples to decide to continue or terminate a pregnancy in a situation of extreme prognostic uncertainty, their experience of their decision and to improve the care pathway currently offered to these couples faced with this type of situation.
Crohn's disease is a multifactorial complex disease resulting in a between microbiota and immune system. Indeed, GWAS (Genome-Wide Association Studies) association study pinpointed polymorphisms as genes susceptibility on more than 200 loci. Among them genes coding for proteins involved in autophagy machinery (i.e: ATG16L1, IRGM et NDP52). Autophagy is a ubiquitous intracellular mechanism mandatory for protein and microorganism recycling. So far, the role of autophagy in gut inflammation and intestinal homeostasis in Crohn's disease patients is partially understand. Then, investigators plan to evaluate, on native cells, the autophagic flux in pediatric patients suffering of a Crohn's disease compare to controls.
The aim of this non-interventional secondary use of data study is to evaluate hematological response in patients with paroxysmal nocturnal hemoglobinuria and anemia in the 6-month period after initiation of anti-C5 antibody treatment using real-world data obtained from multiple datasets. The results will be used to contextualize results from the APPOINT-PNH (NCT04820530) trial with iptacopan.