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 First In Human (FIH) study is a prospective, open-label, multicenter, Phase 1 study, with a dose escalation design, followed by an optimized design. It will consist in a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part followed by a "Regimen optimization" part with an extension cohort.
High Flow Nasal Oxygen Therapy (HFNO) is a new oxygenation tool that is becoming increasingly widespread in perioperative anaesthesia. The benefits of this oxygenation tool are based on different physiological principles. These include the reduction of dead space by "flushing" the nasopharyngeal cavities, positive airway pressure and the warming and humidification of inspired air. In addition, the high flow rates used ensure that the patient's inspiratory demand is covered, allowing for the delivery of oxygen-enriched and controlled air. It is simple to use, with the only parameters to be set being gas flow and FiO2. The use of HFNO appears to allow a prolongation of apnoea time without desaturation in apneic ventilation. Mainly studied in ENT surgery because of the interest that this oxygenation strategy presents with the absence of recourse to oro-tracheal intubation (OTI), several authors will use it in the framework of micro-laryngoscopy surgery in suspension. However, its use as an oxygenation strategy during panendoscopy has been little explored. Panendoscopy is a common procedure that requires deep and short anesthesia. The main challenge is the sharing of the airway between the anesthesia team and the surgical team. Learning to use this new method or the impact of operator experience has never been explored.
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger & lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. The evidence on redo-TAVI (where a transcatheter heart valve [THV] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations. Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year.
Low back pain (LBP) is a common condition worldwide as the lifetime prevalence is up to 80%. It is defined as pain in the lumbosacral region in which the etiological causes are most often mechanical, and it is therefore defined as "non-specific LBP". Lumbar belts are used in the treatment and secondary prevention of LBP. They are supposed to reduce the intensity of pain by improving the functional capacities of daily activities and thus preventing the risk of chronicity related to immobility (HAS). Despite some proof of their efficiency in the literature, it is still not clear how the pressure applied by the belt and the immobilization constraints on the trunk improve the patient mobility. Considering that LBP causes movement limitation, and that the lumbar belt contributes to initially decrease the pain intensity, as well as to improve the mobility and the functional capacities of the patient, we propose to evaluate the clinical and biomechanical effects of the lumbar belt during different trunk movements in subjects with and without LBP. This is a clinical investigation on a CE marked medical device, used in accordance with its intended purpose, in the context of a post-marketing clinical follow-up with additional non-invasive procedures (IC SCAC: case 4.1 of the medical device regulation 2017/745).This is a prospective, monocentric, comparative and open clinical investigation. The objective is to evaluate the clinical and functional effects related to spinal movements in 2 conditions, with and without the wearing of a lumbar belt. The study will be carried out with two groups of subjects: one group of subjects presenting an episode of LBP (NS>4) (subjects considered to have subacute or chronic nonspecific LBP according to the classification of LBP) and another group of control subjects with no spinal symptoms and no pain that could limit movement (healthy subjects). Each group will undergo 2 visits on 2 separate days with a 30-day delay for the LBP subjects and a 7-day delay for the healthy subjects - a first visit (V1) for inclusion, familiarization with a clinical and functional test, and an external measurement of spinal mobility during movements; - a second visit (V2) for a clinical and functional evaluation, external measurements of spinal mobility and biomechanical measurements.
This study is being conducted to provide updated clinical data on safety and performance (demonstrated previously for CE marking under the Medical Devices Directive) Cooper Aqueous Eosin 2%. This is an observational study conducted under real-life conditions and as part of post-marketing surveillance activity for a device that has been on the market for a long time and a well-established technology, in accordance with the Medical Devices Regulations 2017 /745 (MDR) and MDCG 2020-6 guidelines. The study will be a multicenter, national, observational, prospective study, with a 7-day follow-up (+/- 2 day). 60 patients are scheduled.
In localized intermediate- and high-risk prostate cancers (according to the NCCN classification), external radiotherapy delivering a "high" dose (dose equivalent 78-80Gy EQD2, α/ß=1.5) to the entire prostate volume combined with hormonal treatment, if necessary, has shown its benefit in terms of recurrence-free survival and is considered a standard treatment for this indication. Two fractionation modalities (number of sessions) are considered as therapeutic standards, conventional fractionation (39 to 40 sessions of 2 Gy in 8 weeks) and moderate hypo-fractionation (20 sessions of 3 Gy). More recently, phase II and two phase III studies have shown equivalence in terms of safety and efficacy of "extreme hypofractionation" (5 or 6 sessions) for these localized cancers, using stereotactic-type techniques. In view of the current data, this fractionation is considered a therapeutic standard in some countries (notably the USA) and an option in France. Delivering higher doses, beyond 80 GyEQD2 would improve tumor control, as demonstrated by randomized studies using brachytherapy, but at the cost of an increased risk of urinary toxicity. As an alternative to this combination of external radiotherapy and brachytherapy, an innovative approach of external radiotherapy has been developed to increase the therapeutic ratio of patients with localized prostate cancer, based on an escalation of the radiation dose (> 95 GyEQD2) focused on the macroscopic tumor or "dominant intra-prostatic lesion" (DIPL), the area most at risk of local recurrence after conventional dose radiotherapy (3). This external radiotherapy technique consists in performing a conventional dose irradiation on the whole prostate, with at the same time (at each session) a higher dose ("Boost") on the DIPL. This is a modality known as "simultaneous integrated boost" (SIB). The feasibility of simultaneous integrated boost (SIB) on the DIPL has been proven in external radiotherapy using conventional fractionation in the phase III FLAME study and the results in terms of long-term tumor control of this study showed a benefit in terms of biological recurrence-free survival. Feasibility in terms of tolerance has also been established for very hypofractionated regimens (5 sessions), in particular in the HypoFLAME study that followed the above-mentioned study . Multiparametric MRI (mpMRI) is used to identify and delineate the "dominant intra-prostatic lesion" (DIPL), and is the most commonly used modality in clinical studies that have evaluated SIB techniques. However, several studies show that PET imaging, particularly 68Ga-PSMA PET, significantly improves the correlation between the image-defined DIPL and histological data and may improve the likelihood of tumor control. A dosimetric simulation study also showed that dose escalation based on 68Ga-PSMA PET could improve local tumor control with an acceptable level of toxicity . Moreover, 68Ga-PSMA PET could be used to select the patients who could benefit most from this dose escalation, by excluding patients with lymph node or distant metastases.
Creation of a patient library in Medically Assisted Procreation to allow the implementation of further research with the following objectives: - To identify new relevant biomarkers in patients who will carry a pregnancy to term - To better specify or identify new infertility risk factors - To identify new relevant biomarkers in patients with reduced ovarian reserve Four consultations are planned with biological et clinical collection.
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
The MISTIK project aims at clinically validating the technique of oral anticancer drugs determination by volumetric absorptive micro-sampling and at comparing the results to measurements performed on venous samples.
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.