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.
Cognitive impairment and dementia are primarily due to a combination of vascular brain injury and neurodegenerative lesions. The vascular component is now recognized as a major contributor to the pathophysiology of dementia, with small vessel disease (SVD) being its most frequent substrate. This study aims to collect retinal microvascular markers as well as various parameters related to blood pressure and arterial stiffness, in a young adult population. The main objective is to explore the association between these parameters and structural changes on brain MRI. Results will allow to determine the most relevant biomarkers associated with very early brain imaging markers of SVD.
The impact of the inflammatory microenvironment in predicting the benefit of a CDK4/6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied. We propose a multicenter prospective study to confirm the prognostic value of pre-therapy NLR on progression-free survival of patients initiating treatment with a CDK4/6 inhibitor combined with hormonal therapy for locally advanced or metastatic HR-pos / HER2-neg breast cancer. We will also evaluate other markers of inflammation and their prognostic and predictive value for a better response to CDK4/6 inhibitor therapy in combination with hormone therapy in these patients. Specific blood tests (lymphocyte typing) will be performed during treatment with CDK4/6.
The use of a personalized 3D model of the breast in the management of breast cancer would be very useful to help the surgeon better understand the three-dimensional location of tumors in the operative position and thus better plan incisions and dissection of the breast tissue. This could be achieved with the help of a 3D biomechanical breast model that ideally should integrate the patient-specific mechanical properties of all breast tissue structures. The elasticity of the skin and especially the consideration of factors that can make it vary with age has been little studied. However, the integration of this parameter would clearly increase the robustness of the 3D model. Main objective: To perform a pilot evaluation of the performance of the biomechanical model by integrating the biomechanical characteristics of the skin and the collagenous architecture of the breast, during the transition from prone to supine or lateral position. Secondary Objectives: To describe the values of skin elasticity and thickness at different points of the breast, in women in the general population To search for clinical factors predictive of elasticity and skin thickness To carry out a pilot description of the collagen architecture of the breast Participation in this study will be offered to all patients consulting the gynecology-obstetrics department of the Montpellier University Hospital and meeting the inclusion criteria-Visit 1: Inclusion and measurement of skin thickness and elasticity: Inclusion will take place during the follow-up consultation in the obstetrics gynecology department of the Montpellier University Hospital. The patient's written consent will be obtained after a reflection period at the end of the consultation. Measurements of elasticity and thickness will then be performed for each of the 200 patients. Skin elasticity: The patient will be installed in dorsal decubitus position, with her arms at her sides on an examination table. Measurements will be performed at 3 sites on one of the two breasts: at the areola, above the areola and below. The measurements will be performed by a single gynecologist in the gynecology department using a cutometer provided by a laboratory of Grenoble. It has just been used by the Dutch Cancer Institute in Amsterdam to measure the elasticity of the tongue in a clinical study including 10 patients. Three measurements will be performed at each site. One measurement corresponds to a 10-second suction time (progressive rise of the depression) followed by 5 seconds of relaxation of the measurement site. The duration of these measurements will be approximately 15 minutes. Skin thickness: The measurement of skin thickness will be performed using an ultrasound device available in the obstetrics and gynecology consultation department. The measurement will be performed at 3 sites. The duration of the measurements will be of approximately 10 minutes. Adverse events will be collected at the end of the measurements. -Visit 2: Within 3 weeks after the first visit. Among the 200 patients, 10 patients who should benefit from a breast MRI as part of their follow-up, will have a breast MRI in 3 different positions: prone (standard protocol) and two additional acquisitions (as part of the research) in dorsal and right lateral decubitus. This examination will be scheduled in the Lapeyronie Hospital.
Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.
This is a randomized, double-blind and vehicle-controlled Phase III study to evaluate the safety and efficacy of topical TMB-001 0.05% ointment for the treatment of CI in subjects with either the RXLI or ARCI subtypes. In addition, a subset of preselected centers will recruit subjects in parallel with either the RXLI or ARCI subtypes for enrollment into an Optional Maximal Use arm for evaluation of the systemic exposure and safety of topical TMB-001 0.05% ointment for the treatment of CI. The Phase III Study is designed in three periods: • Period 1 - Induction (3 weeks): At the beginning of the 3-week Induction Period, eligible subjects will be randomized (2:1 ratio) to either TMB-001 0.05% once-a-day (QD) or Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™) provided by the Sponsor. • Period 2 - Treatment (9 weeks): The dosing frequency in the 9-week treatment period will be increased in each treatment group to TMB-001 0.05% BID or Vehicle BID. Mandatory bland emollient will be discontinued. • Period 3 - Maintenance (12 weeks): At Week 12, eligible subjects in the TMB-001 treatment group will be randomized (1:1 ratio) to an open-label treatment with TMB-001 0.05% BID or TMB-001 0.05% QD. To be eligible, subjects must have achieved a ≥1-point reduction in IGA score from Baseline. Subjects with less than a 1-point reduction in IGA score from Baseline will be discontinued from the study. Vehicle-treated subjects who achieved <1-point reduction in IGA score from Baseline are eligible to cross over to the TMB-001 0.05% BID treatment group. Subjects with a ≥1-point reduction in IGA score from Baseline will be discontinued from the study. Subjects at the end of the study or subjects discontinued from the study at any time will be followed-up for additional 2 weeks for AEs.
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
This study is open to children and adolescents with interstitial lung disease (ILD) that causes lung fibrosis. This is a study for people who took part in a previous study (study 1199-0337, InPedILD™) and for people who are between 6 and 17 years old and have fibrosing ILD. This study tests a medicine called nintedanib. Nintedanib is already used to treat different types of lung fibrosis in adults. The purpose of the study is to find out how well long-term treatment with nintedanib is tolerated in children and adolescents. All participants take nintedanib capsules twice a day. Participants are in the study for at least 1 year and 5 months or until nintedanib or other treatment options become available outside of this study. During the first 3 years, they visit the study site about 15 times. Afterwards, they visit the study site every 3 months. The doctors collect information on any health problems of the participants.
A French Survey on patients' practices, knowledge and beliefs about diet in chronic inflammatory rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, spondylarthritis) Use of a questionnaire about what patients have heard concerning diet and rheumatism, what kind of diet they tried eventually and how it affected their health and disease
This study is an analytical observational retrospective cohort study. It is a single-center study conducted in the Nancy University Hospital. End stage renal disease is the ultimate stage of the chronic kidney disease. Patients need extra-renal replacement techniques. Kidney transplantation is the most effective option for survival, quality of life and costs. Then long-term immunosuppressive agents are required to prevent allograft rejection and improve graft survival. The number of patients who return in dialysis after graft loss is increasing and accounts for 10% of incident dialysis patients and 14% of patients on the kidney transplant waiting list registered in 2019. This population may develop complications induced by end-stage renal disease and adverse events related to prolonged exposure to immunosuppressive agents. There are currently no formal guidelines on the management of immunosuppressive agents when patients return to dialysis. Reduction or discontinuation of therapy appears to decrease cardiovascular, infectious, and neoplastic complications. However, continuing these treatments may limit anti-HLA sensitization which may access to retransplantation. Only a few low-powered cohort studies have evaluated the impact of the management of immunosuppressive therapy on the HLA-sensitization. The hypothesis of our study is that the continuation of immunosuppressive agents when patients return in dialysis may limit anti-HLA sensitization. Therefore, access to retransplantation could be facilitated. The main objective is to compare the evolution of anti-HLA sensitization according to the management of immunosuppressive treatment after the return in dialysis (maintenance, reduction, cessation). Secondary objectives are time to re-transplantation for patients on the transplant waiting list, survival of the new graft, patient survival, and dialysis complications (cardiovascular, infectious and neoplastic complications).
This 2-part study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Extensive-stage Small Cell Lung Cancer (ES-SCLC) who received at least 1 prior line of platinum-based chemotherapy and a maximum of 3 prior lines of therapy (Part 1) and a minimum of two previous lines of systemic therapy (Part 2). This study will also investigate I-DXd anti-tumor activity in this population.