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.
This phase I/II open-label, dose-finding, multi-center study will assess safety and primary efficacy of Onureg and Venetoclax combination, to define the optimal biological dose and optimal treatment duration of Onureg to be used along with Venetoclax for further studies in previously untreated patients with higher-risk myelodysplastic syndromes (HR-MDS) not eligible to transplant.
The aim of this study is to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.
The prevalence of Sjogren's syndrome (SS) in rheumatoid arthritis (RA) patients varies from 3.5 to 31%. Between 30% and 90% of patients with (RA) have dry eye and/or mouth syndrome. To date, no studies have assessed whether RA patients have echostructural changes in their salivary glands suggestive of SS and the factors associated with these changes.The aim of this study is to investigate if there are changes in the echostructure of the salivary glands of RA patients, especially in patients with dry syndrome.
Longitudinal analysis of myocardial function using "Speckle Tracking Echocardiography" STE analysis and prediction of delayed toxic induced cardiomyopathy in young patients who received anthracycline therapy in childhood.
This is an open-label, randomized, non-comparative, multicentre, phase II study in which NSCLC patients who have progressed following chemotherapy and immunoptherapy are randomized to receive treatment with either paclitaxel and bevacizumab (Arm A), or paclitaxel, bevacizumab and atezolizumab (Arm B). An estimated 156 patients (52 in Arm A, 104 in Arm B) will be enrolled at approximately 40 centres. Patients will be treated until disease progression, unacceptable toxicity, withdrawal of consent or another discontinuation criterion is met. For patients in Arm B, continuation of atezolizumab beyond progression is permitted, at the investigator's discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 6 months ≤ 50% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 66% or more of patients in Arm B would achieve progression free survival at 6 months.
Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology. Multicentric, controlled, randomized and double-blind label study.
This study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (SCA) and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (SCD) complications, 2-lipids profile evolution during and after prospective acute complications (vasoocclusive crises (VOC) and priapism), 3-lipids profile variation (inter /intra individuals) during 4 prospective years, 4- Genetic primary modulators of SCD complications, 5- insulin resistance (HOMA), free fatty acids and glycerol dosages, 6- lipids enzymes, lipidome and functionality of HDL in sub-groups of SCD population.
The WHO and our governance advocate that health professionals should organize care around the patient, considering his or her values, needs and preferences, and enabling the patient to develop the capacity to self-manage the chronic health problems he or she faces. Chronic disease is an ongoing dynamic process and adaptation to this process is complicated by the interaction of several determinants: self-management capacity, level of health literacy, quality of life and experience of care. To best support chronic disease, the recommendation is to adopt a management strategy that allows chronic patients to play an active role in the management of their condition and in the day-to-day decision-making process. The management of chronic pathologies is one of the specialties in which Advanced Practice Nurses are positioned, in primary care, outside hospital. Nursing care benefits from care models that allow for more adapted responses, regarding particular care situations, or certain patient typologies. The Humanistic Partnership Health Care Model (MPHS) implement in current Advanced Practice Nurse (APN) practice.
Routine revascularization of asymptomatic carotid stenosis is questionable as optimal medical therapy has significantly reduced the risk of stroke. Therefore, it is crucial to identify high-risk patients who may still benefit from carotid revascularization. In 2017, the ESC guidelines clarified the criteria associated with a high risk of stroke despite optimal treatment to consider a revascularization procedure, including altered cerebral vasoreactivity. However, cerebral vasoreactivity using transcranial Doppler ultrasound is reserved for qualified centers. It requires a technical platform and trained personnel, is time-consuming and generally not readily available. A simpler test is therefore necessary. The goal is to quickly and easily detect patients with normal vasoreactivity who do not benefit from the cerebral vasoreactivity test (reference standard) and to reserve the time-consuming cerebral vasoreactivity test for patients likely to have altered vasoreactivity. The hypothesis of the study is that on a routine measure in transcranial echo-Doppler, the resistance index (RI), can predict the response to the cerebral vasoreactivity test. With this new test, it will be possible to select patients who do not benefit from pharmacological cerebral vasoreactivity testing ("true negatives"). Thus, the time-consuming cerebral vasoreactivity test will be reserved only for patients with a possibility of impaired vasoreactivity.
Medical condition and pathology studied skin pigmentation. Justification / rationale for the study UV are both the physiological stimulus for skin pigmentation and the main etiological factor in melanoma. Recently, visible (blue) light has also been described to induce skin pigmentation, without any obvious pro-carcinogenic effect. Studies have been carried out to identify genes induced by UV in melanocytes and to understand the mechanisms responsible for photo-induced skin pigmentation. However, the rarity of these cells in the epidermis (3% of cells) has so far been an insurmountable obstacle to achieving this goal. The same is true for visible light, for which the data is even more patchy. The advent of transcriptome analysis techniques at the single cell or single nucleus level will allow us to overcome this obstacle and identify the transcriptional effects of UV and blue light in melanocytes in-situ, as well as in other skin cells (keratinocytes, fibroblasts). Understanding the molecular mechanisms regulated by UV and blue light in melanocytes and other cells will reveal new key steps in skin pigmentation. The data from our study will be used to develop new photoprotective agents as well as new treatments for pigmentary pathologies. Primary objective Describe the variations in gene expression induced by solar ultraviolet (UV) radiation or blue light in human melanocytes in vivo. Secondary objectives Describe the variations in gene expression induced by ultraviolet (UV) radiation sunlight or blue light in other skin cells. Evaluation criteria Single cell transcriptome analysis Immunolabelling on skin sections Population and number of inclusions Healthy male volunteers, phototype III on the Fitzpatrick scale, age 25 + 5 years and of similar corpulence (body mass index between 20 and 28). 2 inclusions Duration of the study Total duration of the study: 12 months Duration of the inclusion phase: 1 month Duration of participation for a patient: 11 days Methodology Two healthy volunteers will be exposed to UV or visible light in the forearm region. Suction blisters, and skin biopsies will be performed in the test areas, suction bubbles for transcriptome, biopsies for immunohistochemistry. The study of gene expression in the different cell types will be done by RNA-Seq on single cells, using the 10X genomics approach. Finally a validation of the results will be carried out by immunostaining with specific antibodies or RNA-Scope. Course of the study - Day 1: The study begins with the determination of the Minimum Erythemal Dose (MED) for each subject in the region of the forearms. This determination will be carried out by means of the administration of six different doses in increasing stages of 25% of UVB + UVA rays (simulated solar ultraviolet spectrum) on six selected test areas (each 1.3 cm²). Exposed areas will be assessed 24 + 2 hours after exposure on Day 2, erythema will be assessed Day 2: Reading of the DEM, and irradiations on two zones in the region of the forearms with respectively a dose of 2 DEM UV, and 48J/cm2 in visible light. A third non-irradiated area will serve as a control. Day 3: A skin blister and biopsy will be performed on each of the three test areas. Cells collected in the blister fluid will be used for the transcriptome and biopsies for validation by immunohistochemistry. Day 11: The subjects will be seen again eight days after the day of sampling, i.e. on Day 11 for removal of sutures and monitoring of healing. On the same day, an evaluation of the level of UV pigmentation induced on each test area will be carried out visually and by colorimetry.