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 primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).
Therapeutic patient education (TPE) is one of the approaches used to manage chronic diseases. It aims to make the patient an active participant in his or her own care and to establish an effective partnership with the carer, thereby also responding to the need to control health expenditures. However, the contribution of TPE has revolutionised healthcare professions, in particular by profoundly changing the carer-patient relationship and certain aspects of their professional culture. a recent action-research study conducted in partnership with Crf-Cnam in Paris showed that although the training of professionals appears to be a major issue, the integration of TPE forces the involved parties to question their practices. TPE imposes a change in the understanding that carers have of their usefulness in accompanying patients and in their perception of education and care. It also changes their relationship to the involvement of patients in maintaining their health. The implementation of educational approaches in Mental Health is also at the origin of many questions. In a study of patients suffering from schizophrenia, discrepancies appeared amongst the carers, whose outlooks seemed to be correlated with their experience in TPE. The carer-caregiver relationship was evoked with a feeling of lack of exchange, and a feeling of infantilization for certain carers. This study highlights the misconception that some psychiatric caregivers have of TPE in somatic care, and the idea that TPE is limited to drug treatments. Therapeutic education is of particular importance as it is a determinant of the schizophrenic patient's adherence to therapeutic principles. However, it must be based on an appropriate strategy that facilitates communication and the exchange of knowledge with patients suffering from severe and persistent psychological disorders. During the implementation of two ongoing TPE programs initiated with schizophrenic patients, we were able to observe that despite the knowledge of the TPE caregivers, there were still difficulties in its implementation: lack of recruitment, organizational difficulties, loss of motivation... In the same prism as the development of new care strategies by the Ministère des solidarités et de la santé, we asked ourselves questions about strengthening the training of paramedical staff, such as: how can health literacy be enriched in mental health training programs? But the trainig of individuals in the field seems to be only one of the components. This care project raises questions about values systems and the mechanisms for legitimizing power, and requires consent and commitment from the various actors. The hypothesis formulated is that one of the keys to better patient adherence and better appropriation of a TPE programme in mental health would be to take into account the representations of the carers dispensing these programmes. This investigation will be based on TPE programs dispensed to schizophrenic patients at La Chartreuse Psychiatric Hospital in Dijon, France.
Tracheal intubation (TI) is associated with a high risk of adverse events in critically ill patients and peri-intubation hemodynamic collapse is the most commonly observed. The primary aim of the PREVENTION trial is to compare the effect of the pre-emptive use of noradrenaline versus no peri-intubation use of noradrenaline on incidence of cardiovascular collapse following TI in adult critically ill patients. Patients with absolute indication or contraindication to vasopressor support will be excluded from this trial. Patients will be randomized 1:1 to a continuous infusion of noradrenaline started before induction titrated according to baseline mean arterial pressure. The primary outcome will be the incidence of cardiovascular collapse. Secondary outcomes will include lowest systolic blood pressure and cardiac arrest within 30 minutes from intubation.
The purpose of this study is to determine the effect of JNJ-64251330 in participants with Familial Adenomatous Polyposis (FAP) on colorectal polyp burden (sum of the polyp diameters).
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
Evaluate the effectiveness of an intervention including the clinical assessment carried out with the (Multidimensional Inventory of Development, Sex, and Aggression) MIDSA and the review of the results with the professional in charge of the subject on the adherence and commitment to the care of the sexual offenders.
The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Crohn's Disease. After the completion of the 12-week induction period, all participants have the option to continue in the open-label extension for another 38 weeks.
Primary Objectives: Part 1 (Dose Escalation) - To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for intravenous (IV) and subcutaneous (SC) administration in the dose escalation part. - To determine the safety of SAR443216 after intravenous (IV) and subcutaneous (SC) administration. Part 2 (Dose expansion) • To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Secondary Objectives: Part 1 • To assess preliminary clinical activity of single agent SAR443216 after IV and SC administration at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Part 2 • To determine the safety of SAR443216. Part 1 and 2 - To characterize the pharmacokinetic (PK) profile of SAR443216 when administered as a single agent after IV and SC (Part 1 only) administration. - To evaluate the immunogenicity of SAR443216 after IV and SC administration. - To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
Increasing knowledge on rectal motility and bladder-rectum cross-talk has been published in recent years. However, whether bladder filling factors during multichannel urodynamic studies affect rectal contraction (RC) parameters has not been studied. The primary aim of this study is to assess the impact of bladder filling and desire to void on rectal contraction amplitude or frequency. Secondary objectives are to determine any significant change in rectal parameters depending on clinical and urodynamic factors or treatment. All patients referred for urodynamic assessment and with studies positive for rectal contractions as defined by the international continence society (ICS) will be included. Abdominal pressure will be measured using a T-doc air charged abdominal catheter inserted 10 cm from the anal margin. Standardized urodynamic evaluation will be conducted following ICS guidelines. Mean amplitude, maximal amplitude (cmH20) and mean frequency of rectal contractions on all urodynamic studies will be visually measured on the recording software and compared depending on bladder sensation (First Desire to void (FDV), Strong Desire to Void (SDV) and filling volume (200ml, 400ml). Demographic data (age, sex, BMI), underlying neurological disease, clinical symptoms, and scores (Neurogenic Bladder Symptom Score, Bristol Score, Cleveland Score), urodynamic parameters and treatments will be collected. Time since last defecation and meal will also be collected. This prospective observational study will be conducted in a Neuro-Urology department of a French university hospital. All the patients included are referred for multichannel urodynamic assessment.
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries. Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.