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.
Since the start of 2020, the new SARS-CoV-2 coronavirus is causing a real global health crisis. In France, nasopharyngeal swabs are used to obtain the sample needed for respiratory infection screening. There are three major difficulties with this type of sampling: I) It is really unpleasant for the patient because the device has to be pushed into the nostril to reach the nasopharynx. It causes some patients to bleed or even feel uncomfortable. II) It is not easily accepted by children. III) It is dependent on the availability of swabs. Faced with these difficulties linked to the initial sampling, new methods are being studied to enable a rapid and non-invasive diagnosis of COVID-19 based on the instantaneous identification of metabolites or volatile organic compounds (VOCs). Due to their sensitivity and the wealth of information that can be provided, the most promising techniques are based on mass spectrometry coupled with a soft ionisation system. For example, on-line exhaled air analysis is capable of detecting a very large number of VOCs. Various tests on metabolites in the exhaled air have already been carried out without being totally conclusive because the existing instruments suffer from various limitations: I) poor repeatability/accuracy in the chemical characterisation of exhaled air ; II) too high specificity (detection of only part of the emitted compounds); III) too limited sensitivity; IV) and poor adaptation to be deployed in a clinic. In order to overcome these various limitations, we propose the use of a new generation of mass spectrometer: Vocus PTR-TOF. The Vocus PTR-TOF is a Proton Transfer Mass Spectrometer (PTR-MS) developed for the detection, in real time, of trace VOCs in industrial environments, laboratories or directly in the environment. This new generation of instrument offers the following advantages: I) unequalled sensitivity : II) a robust ionisation system not affected by environmental conditions (relative humidity...) ; III) a high mass resolution allowing precise identification of compounds ; IV) a compact and durable architecture allowing deployment in a constrained environment such as hospital, airport… The sensitivity and speed of measurement allow the expiration process to be monitored in real time, bringing an additional dimension to the measurement and the chances of success.
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which four additional 20-minute sequences will be added. MRI of routine care in the context of MS includes at least the following sequences: - 3D T1 TFE (2 minutes) - T2 TSE (2 minutes) - 3D FLAIR (3 minutes) - SWI EPI 0.6 iso (7 minutes) The sequences added by the search are: - SWI non EPI QSM 6 echo (10 minutes) - SWI EPI in resolution equivalent to non-EPI SWI (3 minutes) - SWI EPI to TR equivalent to SWI non EPI (6 minutes) These sequences will be acquired before or after the injection of gadolinium (if present in the examination of routine care). For examinations carried out with injection, the order of carrying out the 4 post-injection SWI sequences will be random.
Umbrella study structure to independently and simultaneously assess the effects of the association of durvalumab and tazemetostat in multiple solid tumors.
Sense of smell disorders are common and are said to affect up to 20% of the general population. They are often disabling and have a real impact on the quality of life. Smell disorders are most often assessed using a visual analogue scale and more rarely with objective tests (Sniffing Stick Test). Many ENT units do not have these objective tests because they are time-consuming and are not covered by health insurance. Some teams, such as that of Dr Thomas Hummel of the Carl Gustav Carus University Clinic in Dresden Germany, have developed self-assessment questionnaires for the sense of smell in order to improve the overall care of patients with olfactory disorders. Two of these self-questionnaires seem to us to be particularly relevant for use in everyday practice. Since then, these questionnaires have already been validated in different languages (English, Chinese, Korean...), but have never been translated and validated in French. Translating and validating these questionnaires into French would make it possible to improve the management and follow-up of French patients with olfactory disorders and to assess the impact of loss of smell on their quality of life.
Combined use of inhaled corticosteroids and long-acting β-agonists (LABAs) as the controller and the quick relief therapy termed single maintenance and reliever therapy (SMART) is a potential therapeutic regimen for the management of persistent asthma. A recent systematic review supports the combined use of inhaled corticosteroids and LABA as both the controller and quick relief therapy (SMART) among patients aged 12 years. In Emergency room (ER), Meta-analysis showed that using salbutamol (or albuterol) by meter doses inhaler (MDI) with a valved holding chamber (VHC) in children with moderate-severe acute asthma exacerbation was more effective, that is, fewer hospital admissions, more clinical improvement, and had fewer adverse effects (tremor and tachycardia) than salbutamol by nebulizer. Therefore, several international guidelines recommend the use of salbutamol by MDI rather than by nebulizer for moderate-severe asthma exacerbations. In children older than 8 years old, dry-powder inhaler (DPI), a device that delivers medication to the lungs in the form of a dry powder is currently used for maintenance and reliever therapy rather than MDI. In this context, we aim to assess the use of combined inhaled corticosteroids and long-acting β-agonists (LABAs) as a quick relief therapy in children older than 8 years old presenting at the ER with moderate asthma exacerbation. Acute asthma patients who had severe exacerbation were excluded from this study (these patients receiving systematically continuous nebulized salbutamol and/or intravenous salbutamol upon their arrival)
The study will be conducted over a 6 months period. For the first three months, the child will be accompagned with a connected companion. After this period, the companion will be removed for three months in oder to prove this companion could improve treatment adherence for children suffering from cytolisis fibrosis. This study will be conducted at the University Hospital Center of Rennes and Hospital Center of Saint-Brieuc.
Merkel cell carcinoma (MCC) is a rare aggressive skin carcinoma. Approximately 80% of MCC are related to the Merkel Cell Polyomavirus (MCPyV). Although rates of relapse are high, the follow-up strategy lacks consensus. Patients are usually assessed clinically every 3 to 6 months for the first 2-3 years, and every 6 to 12 months thereafter. In the European guidelines, patients with early stages are monitored with clinical examination and ultrasonography of lymph nodes, while whole-body imaging is optional in patients with stage III disease, on a yearly basis for 5 years. Such strategy may prevent the diagnosis of infra-clinical recurrences, whereas patients could still be treated with surgery or radiation therapy. Until 2017, patients with advanced disease were treated with chemotherapies, with no long-term benefit. Immunotherapies with PD-1/PD-L1 inhibitors currently allow durable responses in 50% of such patients. This major change in the management of MCC patients argues for a follow-up strategy that would allow early diagnosis of infra-clinical metastases, when tumoral burden is still low. Given that all patients cannot be monitored by systematic regular imaging, additional non-invasive tools are needed. Blood-based biomarkers as a surrogate of tumor burden are advantageous as they can be repeated over time, providing guidance on when imaging is necessary. The study aims to assess two blood biomarkers, MCPyV T-Ag antibodies and cell-free miR-375, in a prospective fashion from baseline diagnosis, in a cohort of 150 European MCC patients
Excessive weight gain during pregnancy can promote subsequent obesity or increase pre-existing maternal obesity, lead to complications during pregnancy, such as gestational diabetes, hypertension and pre-pregnancy eclampsia, which affect fetal growth. What are the determinants of excessive weight gain? The first determinant of excessive weight gain is related to healthy living place and physical activity, noted as "PA". Many meta-analyses have demonstrated the role of PA in gestational weight gain. The main objective is to study the role of the living environment in the PA practice of pregnant women and to identify the socio-environmental construction contributing to the disparities in the practice of PA in women during their pregnancy. This thesis is based on an innovative approach in France, combining both epidemiology and geography approaches to meet priority research objectives in a public health context. With regard to the general issue "What are the contextual determinants of pregnant women's PA practice beyond their individual characteristics that could explain the disparities in practice according to their socio-economic position?" This question underlies the following assumptions: i) In addition to their individual characteristics, women with low PA and who have reduced PA during pregnancy reside in a more socio-economically deprived neighborhood. ii)Beyond the socio-economic dimension, the physical characteristic of the residential place influences the level of PA practice of pregnant women. iii) The combination of the socio-economic, physical and psychosocial environment contributes to reducing the level of PA among pregnant women. iv) Pregnant women with an unfavourable living environment and low PA have adverse pregnancy outcomes.
Pain is one of the non-motor symptoms of Parkinson's disease still poorly known and misdiagnosed and its management is complex. This encourage to explore new non-drug therapeutic paths, such as foot reflexology (FR). the present study proposed a comparison of the evolution of different parameters, quantitative and qualitative, to identify biomarkers and highlight the specific effect of FR on pain, compared to sham massage.
This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy.