There are about 31483 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.
Objective: Analgesic Opioids misuse among patients with chronic pain ranges from 0% to 50%. The general practitioner is the first prescriber of opioid analgesics Our objective was to validate in primary care the POMI (Prescription Opioid Misuse Index) to identify the misuse of AOs. Study Setting: Patients with chronic pain, taking AOs for at least 3 months, and followed in general practice. Study design: Psychometric study Data Collection/Extraction methods: Eligible patients followed in general practice responded to the POMI: Test phase. They then responded after 2 weeks: the retest. The gold standard used was the DSM-V.
The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.
Chronic athletic pubalgia is a frequent sport condition in which the effectiveness of medical treatment has not been proven. Intra-muscular injection of botulinum toxin A may have positive effects on pain in some chronic tendinitis. The investigators hypothesized that similar analgesic effect of intra-muscular botulinum toxin A may be observed in individuals with chronic AP. In the present study, the investigators aimed to describe the short-term evolution of pain and of activity limitations and quality of life, after an injection of the adductor longus with botulinum toxin A, in individuals with chronic AP, for whom medical and/or surgical treatments have failed.
The increase of cardiac output resulting from increased blood volume (systolic ejection volume) during intravenous fluid administration defines a state of fluid responsiveness. Fluid responsiveness in intensive care patients with circulatory failure (shock) needs to be carefully evaluated because only half of the patients are fluid responsive and excessive fluid administration is harmful. To reliably assess this state, it is currently necessary to perform either invasive cardiac output monitoring or ultrasound evaluation before and after a fluid administration (called fluid challenge). It is either an invasive procedure or a time-consuming technique (that might depend on operator experience and patient echogenicity). The investigators foresee a potential benefit for an objective quick-answering screening tool that does not require additional monitoring. Instantaneous CO2 production rate (VCO2) calculated automatically by the most recent ventilators (Hamilton C5-C6) via the analysis of exhaled gases. There is an established physiological link between cardiac output, arterial oxygen transport to cells and CO2 production by cell metabolism. The variation in End-Tidal CO2 (another parameter derived from exhaled CO2) is conventionally monitored in the operating room; it can show sudden changes in cardiac output. In intensive care, the EtCO2 variation is probably less sensitive than the variation in VCO2 to detect changes in cardiac output. The aim of this study is to show that the variation in VCO2 as shown on ventilators during a fluid challenge test has satisfactory diagnostic performance in the detection of fluid responsiveness in patients with circulatory failure in intensive care.
A multicentre, prospective, open-label, single arm study for 2 months, involving adult patients under poorly tolerated Home Enteral Nutrition (HEN). The study aims to analyse the evolution of tolerance and quality of life of HEN patients after switching from a High Protein High Energy (HPHE) polymeric Enteral Nutrition (EN) formula with or without fibre to Sondalis® HP 2kcal, with or without fibre. Eligible patients will give their written consent to participate before being included into the study.
Prospective multicentric study including women aged 18 to 35 and men aged 18 to 45 during their visit to centers for the study and storage of human sperm and eggs (CECOS). Subjects will be included before adjuvant treatment initiation (T0) and immediately after treatment (approximately 1 year after initiation, T1), and, in late post treatment (1 year after treatment cessation, T2). Expected results: This study will evaluate the evolution of AMH, AFC, and semen parameters in our cohort of melanoma patients treated with anti-PD-1 and targeted therapy in an adjuvant settings.
The aim of this study is to investigate the differences in brain activation in healthy subjects during motor tasks, depending on the laterality of the subject, the laterality of the task and the complexity of the task. It seems that the laterality of activation is less marked in left-handed people, when using the non-dominant hand and when performing a complex task. The objective of this study is to highlight profiles of subject and modality of use of the hand with a specific lateralization of cerebral activation.
Renal failure is present in 40% of heart failure patients, and is one of the main comorbidities of heart failure. Follow-up with pulmonary artery pressure (PAP) monitoring has shown a reduction in mortality and frequency of hospitalization in patients with heart failure alone in the CHAMPION trial. Patients with New York Heart Association class III heart failure and a hospitalization in the previous 12 months were included in that study. They benefited from the "CardioMEMS™ HF" device with a sensor implanted in the pulmonary artery to measure PAP. According to that study, the information led to more precise and early adaptation of therapy by avoiding the onset of heart failure symptoms and reducing the number of hospitalizations. However, in that study, patients with impaired renal function (Glomerular Filtration Rate<25 mL/min/1.73m2) were excluded, limiting the indication for treatment in those patients, and the evolution of renal function during the study was not reported. Patients with heart failure AND advanced renal failure are defined as having a cardio-renal syndrome, with strong interaction between these 2 organs. In the event of predominant right heart failure, they may require treatment by renal replacement or dialysis. There seems to be a link between high venous pressure, renal repercussions and the need for dialysis. Additional follow-up data in this clinical situation are needed to confirm this link and to suggest the interest of continuous PAP monitoring to improve the management of these patients with cardio-renal syndrome with severe renal impairment defined by a Glomerular Filtration Rate< 30 ml/min/1.73m2 (KDIGO Cardio-renal 2019). This pilot study aims to evaluate how tolerable the "CARDIOMEMS™ HF" device in patients with cardio-renal syndrome and obtain the first information on the relationship between cardiac hemodynamics and renal function in this population.
In order to propose the best therapeutic option to relapsed MN patients with strong activation of the Th17 pathway, the investigators propose to study in vitro the effect of different immunomodulators on the Th17/Treg balance, assessed by cytokine profile and lymphocyte phenotyping using flow cytometry.
In rheumatoid arthritis (RA), the consensual 1st line conventional synthetic disease modifying antirheumatic drugs (csDMARD) of RA is methotrexate (MTX). In case of contra-indication or intolerance to MTX, leflunomide is an alternative. If the treatment target is not achieved with csDMARD strategy, addition of a biological DMARD (TNF inhibitors, anti-Interleukin 6 (anti-IL6)), abatacept, or rituximab) or a targeted synthetic (ts) DMARD (JAK inhibitors) is considered. Current practice is to start a bDMARD (biologic Disease Modifying Antirheumatic Drugs) and especially TNF inhibitors (etanercept or monoclonal anti-TNF antibodies) with the benefit of hindsight. However, abatacept and TNF inhibitors have demonstrated similar efficacy in patients with insufficient response to csDMARD (AMPLE trial). Although abatacept has shown a very good tolerance profile that might be superior to other bDMARDs rheumatologists might be reluctant to use it as a first line bDMARD as there is a belief of a slower efficacy compared to other bDMARDs or JAK inhibitors. Indeed, in real world study, compared to TNF inhibitors it seems that discontinuation of abatacept is more related to lack of effectiveness than safety issues. Investigators have hypothesized that first rapidly controlling the inflammation phase, using TNF inhibitors followed by abatacept to induce an immunological remission would optimize response and tolerance of ACPA positive patients with RA. To demonstrate our hypothesis, the investigaors propose a randomized controlled trial with one arm receiving an induction therapy for three months with a TNF inhibitor followed by a cell-targeted bDMARD (abatacept) and the other arm, receiving TNF inhibitors.