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.
Despite a decrease in voltage amplitude in post-infarction scar areas, greater voltage amplitudes are sometimes observed at the time of local extrasystoles mechanically induced by catheters. However, no study has investigated whether these electrical changes are associated with mechanical changes in local contractility. However, the voltage is closely correlated to the local contractile function as evidenced by the use of the NOGA system.
Aim of the study : To evaluate postoperative outcomes of all surgical approach for retrorectal tumors. Methods : From 2005 to 2020, all consecutive patients who underwent surgery for a retrorectal tumor in two referral tertiary center were prospectively collected. Considering our exlusion criterias, data from XX patients were analyzed. The cohort was separated into 2 groups according to tumor localization regarding the third sacral vertebra. Short and longterm outcomes were compared between the two groups. Primary outcome : 90 days postoperative morbidity rate
The purpose of this study is to evaluate the benefits of an exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns. For that, we use of a specific neonatal device "Calinange" able to record maternal voice and heartbeats and to restore it with a sound level control. We hypothesize an improvement of the well being of the newborn under Calinange exposition.
The primary objective of this study is to establish scores of Cognitive impairment (CI) of the 3 DigiCog [Brief Computerized Cognitive Assessment for Multiple Sclerosis (BCCAMS) app] tests [Computerized Speed Cognitive Test (CSCT), Computerized Episodic Visual Memory Test (CEVMT) and the French Learning Test (FLT), a verbal memory test similar to the CVLT], using a tablet application in a sample of healthy participants matched to persons with MS (PwMS). The secondary objectives of this study are to determine the ability of the DigiCog app to detect cognitive impairment (CI) compared to the classical Brief International Cognitive Assessment for MS (BICAMS) in PwMS; to determine the relationship between depressive symptoms and cognitive performance in Multiple Sclerosis (MS) sample; to determine the relationship between subjective perception of CI and cognitive performance ; to evaluate the reliability of Konectom™ digital outcome assessments (DOAs) in healthy subjects (HS) and PwMS; to evaluate the convergent validity of Konectom™ digital outcome assessments (DOAs) against in-clinic conventional disability outcome assessments in PwMS; to evaluate differences in Konectom™ DOAs [self administered at home and in-clinic] between PwMS and HS; to evaluate the variability of Konectom™ DOAs self-administered at home in free-living environment in HS and PwMS; to compare Konectom™ DOAs between in-clinic supervised administration versus self-assessments in free-living environment in HS and PwMS; to evaluate the clinical meaningfulness of Konectom™ DOAs against Patient-Reported Outcomes (PRO) in PwMS.
The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants with lymphopenia. The secondary objectives of the study are characterization of lymphopenia in overall population; characterization of lymphopenia in participant with DMF discontinuation ; description of the evolution of ALC during DMF treatment; description of the time to reach a discontinuation of DMF treatment; exploration of the time to reach clinical outcomes (Expanded Disability Status Scale [EDSS] and relapse) according to lymphopenia; description of the event rate of the serious or opportunistic infections in overall population from DMF initiation and according to DMF discontinuation and lymphopenia; description of the event rate of serious and opportunistic infections in overall population from DMF initiation and according to lymphopenia; estimation of the associations between the baseline demographic and clinical characteristics and the risk to reach a lymphopenia; estimation of the associations between the baseline demographics and clinical characteristics and the risk to reach an ALC reconstitution after DMF discontinuation in participants with lymphopenia; and investigation of the changes of absolute cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) count in overall population on DMF if available.
European countries faced another wave of the SARS-CoV2 pandemic, which has led to a second lockdown in France in November 2020 in order to avoid overwhelming health services. To prevent or reduce another wave, the strategy calls for vaccination, maintaining barrier measures and testing and isolating infected persons in order to break the cycles of infection. The latter objective is made difficult by the existence of asymptomatic carriers or symptomatic carriers that have very few symptoms and that aren't tested. Identification of these carriers in the general population is usually based on a search for close contact persons from those who were tested positive or from identified clusters. Experiments of mass testing are being carried out or were carried out, for example in Liverpool or Slovakia but, in order for them to be effective, they must be repeated, which limits feasibility. Another strategy of wide screening in the general population to identify asymptomatic persons is to offer a systematic screening during medical consultations and particularly in the emergency departments (ED). This strategy grants access to the entire population attending health facilities, including persons with lower income. This strategy can be conducted continuously in order to: 1) contribute to controlling the epidemic by identifying and isolating asymptomatic persons and their close contacts; 2) provide an observatory on the evolution of viral circulation in the general population. To the best the knowledge, this strategy has not been evaluated and will be tested it in 18 emergency departments in the Paris Metropolitan area, one of the most SARS-CoV2 affected regions. The aim is to evaluate the benefit of a systematic offer of SARS-Cov2 screening by rapid testing (molecular multiplex PCR/ RT-LAMP) to identify infected persons, associated with the usual practice of the EDs (intervention strategy) compared to a period based on usual practice of the EDs (control strategy) The strategies will be compared during two periods following a cluster-randomized two-period crossover design. During intervention periods, nurses will suggest performing a SARS-CoV2 test to patients using a PCR multiplex for symptomatic patients and a RT-LAMP for asymptomatic patients.
The management of pain in the emergency department is a major issue, especially for sickle cell patients who regularly consult for vaso-occlusive seizure (VOS). The place of virtual reality remains to be defined in a busy environment, in which the permanence of care generates a significant turn over of medical and paramedical personnel. With Its immersive nature, allowing the patient to detach from his immediate environment, wich is often stressful for patients, we can hope that in multimodal management, Virtual Reality (VR) can contribute to a faster reduction in pain with lower doses of morphine, but so far we have no data. Our pilot study aims to assess the effectiveness, feasibility and tolerance of adding virtual reality to the management of VOS in sickle cell patients in the ER.
To demonstrate the superiority of square lumbar block to ropivacaine compared to intrathecal morphine in the efficacy of postoperative analgesia following scheduled caesarean.
Acute kidney injury (AKI) is a frequently encountered complication in the intensive care unit (ICU), affecting on average 25 to 35% of patients. It is associated with an increased mortality, proportional to AKI severity. RRT induces important shifts of water and electrolytes. Thus, significant amount of chloride might unintentionally be transferred to patients. Chloride is the main anion of the organism. It is involved in the regulation of numerous physiological processes. Thus, significant and rapid modification of chloride amount contained in the organism (as might be induced by renal replacement therapy) may be responsible for important, and potentially deleterious, consequences to critically ill patients. Studies have shown that the administration of high amounts of chloride rich solutions (such as sodium chloride (NaCl) 0,9%) was associated with the development of hyperchloremic acidosis in a dose-dependent manner. This hyperchloremic acidosis could also be theoretically associated with deleterious physiological effects. However, the true clinical consequences of administration of high amounts of chloride rich solutions remains unclear. Their effect on mortality remains a matter of debate, the results of studies being very conflicting in that respect. Nevertheless, hyperchloremia itself and/or the rise of chloremia in the intensive care unit seems to be associated with increased mortality. Moreover, the impact of those chloride rich solutions on the development of acute kidney injury is also a subject of controversy, data from the literature being here again very conflicting. A recent study already showed that continuous RRT (CRRT) techniques induce a significant transfer of sodium to patients benefiting from those techniques. In that study, the amount of sodium transferred depended mainly on the difference between patient's natremia and sodium concentration in dialysate and/or replacement fluid (usually higher than patient's natremia) used. By analogy, it is likely that an occult transfer of chloride also happens during RRT, given the high chloride concentration of dialysate fluids (in continuous veno-venous dialysis, CVVD) and replacement fluids (in continuous veno-venous hemofiltration, CVVH), or when these 2 modalities are combined (continuous veno-venous hemodiafiltration, CVVHDF). Finally, the investigators suspect, although it remains undemonstrated so far, that the RRT technique (convective vs. diffusive) may influence this transfer, to an unknown extent. Nevertheless, this transfer and its potential determinants have never been studied yet. If chloride overload (and its potential clinical consequences) induced by the administration of solutions such as NaCl 0,9% is being extensively studied, no study has ever focused on chloride transfer that may result from the use of renal replacement therapy. However, as mentioned above, it is very likely that such a chloride transfer to patients happens, and that its magnitude depends on different parameters such as RRT modality, RRT fluids characteristics, or patient's chloremia at the start of RRT. The investigators conduct the present study to describe and compare the intensity of chloride transfer during the first 24 hours of renal replacement therapy by continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVD),or continuous veno-venous hemodiafiltration (CVVHDF), and to determine if that transfer is more important with one or the other of those two techniques, in ICU patients affected with severe AKI requiring RRT. Secondary aims are to describe and compare the effects of chloride transfer under 3 RRT modalities (CVVD, CVVH and CVVHDF) on patient's outcome, organ failures, electrolyte and acid-base balance, fluid balance and hemodynamics. Finally, the investigators aim to develop a pharmacokinetic compartment model of chloride transfer during different modalities of RRT.
The first-line treatment of anaplastic oligodendrogliomas, radiotherapy exclusive or combined with PCV, will be defined by the pending results of phase III of the EORTC. If the phase II study proposed here achieves its objective, it may help define a new treatment regimen that will be compared to the standard arm from phase III of the EORTC. In addition, this study, by prospectively testing the predictive value of 1p and 19q deletions and of REGF amplification, may allow characterization of patients using these markers. If validated, this characterization can constitute a key element in any therapeutic evaluation (patient stratification), and potentially a major tool for medical decision support in these tumors.