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 was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.
This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine.
The primary objective is to evaluate neonatal characteristics, and biological and clinical investigations as predictive factors of death, or of severe and moderate neurodevelopmental disability at 3 years, in a large population-based cohort of full-term and late preterm neonates with moderate or severe HIE. Contrary to most previous studies which have often analyzed the accuracy of one factor among all other clinical investigations, the investigators objective's is to seek a relevant combination of several factors among the following list: - Neonatal characteristics: gestational age and birthweight, maternal disease, acute intrapartum event, delivery mode, acidosis, neurological examination, place of birth and neonatal transfer - Laboratory investigations: pH, lactates and new biological markers as detailed below - Clinical investigations: aEEG, EEG, MRI, diffusion-weighted MRI
The study aims to define and compare the immunological characteristics (lymphocyte subpopulations, specific immunity against HIV, lymphocyte activation, inflammatory parameters) and the virological characteristics (study of viral reservoir) between 2 groups of vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before 6 months-of-age ("early treatment" group) or after 24 months-of-age ("late treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia. Moreover, the viral reservoir will be deeply characterized in 10 children (5 patients in each group) with sustained control of the HIV-1 viremia under cART (≥ 90% of HIV-1 RNA measures <400 copies /mL): quantification of the reservoir in the lymphocyte subpopulations and study of the inductibility of the viral reservoir.
Experimental data suggest that GLP-1 promote endothelial cell growth and angiogenesis which may have beneficial effects on the cardiovascular system but harmful effects on the retina . This project investigate the possible link between incretin therapy and Severe Diabetic Retinopathy. The prevalence of severe DR in patients exposed to incretin therapy (GLP-1 analogs or DPP4 inhibitors) is compared to that in non-exposed patients to these antidiabetic classes.
This is a prospective, multi-center, single-arm study to evaluate the VenTouch System for treatment of moderate to moderate-severe functional mitral valve regurgitation [FMR].
This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pharmacokinetic (PK), pharmacodynamics, and immunogenicity of durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in adult participants with selected advanced solid tumors and the combination of durvalumab and monalizumab (IPH2201) standard of care systemic therapy with or without biological agent and monalizumab (IPH2201) with biological agent administered to participants with recurrent or metastatic colorectal cancer (CRC).
Background : About 25% of adnexal masses remain indeterminate after transvaginal ultrasonography, as evidenced by the published literature. According to a multicenter study conducted in France by Huchon et al., surgery is mainly indicated based on tumor size and ultrasonographic appearances and a high rate of benignity is finally found at pathology (83.3%). MRI is the most accurate second-line imaging technique for characterizing adnexal masses with an accuracy>95%. However, among physicians, a debate exists on the relevance of MR imaging to characterize adnexal masses possibly due to the absence of standardization of the MR report. In 2013, the first MR scoring system for adnexal masses named "ADNEXMR score" was developed and found to be accurate, with an AUROC>0.94 to distinguish benign from malignant adnexal masses. Indeed, our hypothesis is that ADNEXMR score that relays the radiologist's suspicion of malignancy to clinician has the potential aim of improving patient management, in particular by limiting the number of patients undergoing inappropriate surgery. Main objective: To compare the rate of inappropriate surgery that occurs when patients are managed according to the therapeutic strategy based on ADNEXMR score with the therapeutic strategy performed in clinical routine. Primary endpoint: The rate of inappropriate surgical intervention during the two first months after MR imaging (i.e. unnecessary diagnostic surgery for benign lesions and incomplete staging for borderline or invasive cancer). Study design: - The study is a prospective multicenter randomized diagnostic study. 606 patients will be included by 9 hospitals (17 centers). - Total duration of the study is 56 months with 32 months for patient inclusions. - At D0, following informed written consent, patients will be randomized in one of two groups (intervention group or control group). In the intervention group, patients will undergo a pelvic MR imaging (1.5T or 3T) as routinely performed, including morphological sequences (T2, T1 with and without fat suppression and T1 after dynamic gadolinium injection) and functional sequences (perfusion and diffusion-weighted sequences). Prospectively, a senior radiologist analyzes the different MR criteria to characterize adnexal masses. The reader will classify the mass using ADNEXMR SCORING system and the patient will be managed according to the score. In control group, the complex adnexal mass will be managed according to the standard strategy and treatment plan routinely used by the multidisciplinary team. Clinical, biological, ultrasonographic and/or MR data and the type of treatment will be recorded. If a surgery is required, surgical procedure will be performed within the two months after initial diagnostic imaging (as routinely recommended). At M6/M12, follow-up will be performed. If the lesion has increased or changed with suspicious criteria, surgery will be performed as routinely recommended in both groups. At M24, adnexal masses status will be recorded by clinical and imaging follow up.
ABACUS is an open-label, international, multi-centre, window of opportunity phase II trial for patients with histologically confirmed (T2-T4a) transitional cell carcinoma of the bladder. The trial aims to test the efficacy of preoperative MPDL3280A and will include extensive biomarker work on samples from these patients. Eligible patients will receive two 3-weekly cycles of MPDL3280A pre-cystectomy. Following cystectomy, patients will be followed up for safety, survival, and disease data.
This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.