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.
For the clinical component: Describe the young people hospitalised in residential care at the FSEF, in particular through vulnerability factors and their psychosocial repercussions (school level, repetition, intensity of symptoms, irritability, nervousness, substance use (cannabis, alcohol, tobacco), social relationships, family relationships, well-being, level of health literacy, learning disorders)) and to compare them with young people from the general school population. For the epidemiological aspect: To study the construct validity of the EnCLASS questions aiming to characterize handicap situations in the general school population in both a population in situation of psychic handicap and of somatic handicap.
Background: Physical activity (PA) has beneficial effects on health, physical condition, and the maintenance of autonomy and independence at all ages of life. It also has numerous benefits during pregnancy: maintenance or improvement of physical condition, prevention of excessive weight gain, aid in postpartum weight loss, prevention of gestational hypertension, reduction in number of macrosomic infants at birth, reduction in lower back and pelvic pain, and prevention and improvement of postpartum depressive symptoms. A recent systematic review of the literature concluded that interventions to increase PA levels among pregnant women have a positive effect on this level. The studies included in the review also showed that these interventions have a positive effect on these women's well-being and their mental and physical health. Nonetheless, no study has examined this subject in France. Moreover, to our knowledge, no study in the international literature has looked at online interactive video sessions of PA during pregnancy. Overall, few studies allow an assessment of the effect of sedentary behavior and inadequate PA during pregnancy on maternal, neonatal, or infant outcomes. This is equally true for the health of adults whose mothers were physically active during pregnancy. Moreover, we do not know the actual level of PA of women in France. Finally, we do not know what types of intervention described in the literature would enable the best adherence by French women to their initiation or maintenance of an adequate PA level. Study hypothesis: Our hypothesis is that setting up a free program of physical and sports activity session for pregnant women will enable them to meet the guidelines for PA practice during this period and to reduce their sedentary behavior. Objectives: 1.1. Principal objective To study the feasibility of setting up physical activity (PA) sessions for pregnant women during their prenatal care, by assessing its acceptability, the perceived difficulty of the sessions, and their satisfaction with these sessions. 1.2. Secondary objectives - To evaluate the effect of these sessions: - on the PA level and sedentary behavior of pregnant women, - on their quality of life (QoL). - The feasibility and impact of the sessions will be studied according to their PA level at inclusion: active or inactive. - To identify the facilitators of and obstacles to the acceptability of these sessions, other than those studied in the objectives above. - To measure the willingness to pay of pregnant women so that we can quantify how much they would be willing to pay for such a program, were it were not free. Willingness to pay (measured in €) makes it possible to measure indirectly the acceptability of the program to the participants and the monetary value they attribute to it.
Swallowing disorders are a common consequence of stroke. After stroke, some patients retain a dysphagia responsible for an alteration of the quality of life, respiratory diseases and a degradation of the general health status. The oral phase of the swallowing involves a significant control of the various intraoral organs. These allow the formation of the bolus, its propulsion, and the emptying of the oral cavity after swallowing. Precise and coordinated mobility of the tongue, lips and mandible is essential during this time. During the speech therapy after a stroke, targeted analytical training, coupled with passive stimulations of the swallowing reflex, is typically used. Previous studies have shown a functional link between fine manual motor skills and oral motor skills, particularly during child development. Little data are available for adult subjects. A pilot study is therefore needed before a larger scale comparative study can be considered. Our hypothesis is that there is a functional link between digital and oral motor areas that could, through co-activation during rehabilitation sessions, promote the recovery of swallowing disorders after stroke.
When a patient presents with a fetus in PS after 36+0SA, after acceptance of participation in the study, pelvimetry with evaluation of the height of the fetal presentation by EOS® system in the upright and sitting position will be performed. CT pelvimetry will not be performed. The patient may then be offered an attempt at VME, with clear, fair and appropriate information, after being informed of the data from the right standing EOS® pelvimetry (report and images). VME will be performed according to the recommendations and practice of the department. In the event of failure with a fetus that remains in PS, the choice of delivery route will be decided in consultation with the patient after clear, fair and appropriate information. If the patient wishes to have a vaginal delivery, the pregnancy will be continued without intervention until spontaneous labour or induction in case of indication (premature rupture of membranes (PMR), over term, or intercurrent maternal or fetal pathology). The modalities of the delivery route and/or a possible induction will be discussed between the obstetric team and the patient. If the patient wishes a caesarean delivery in case of persistent PS, the delivery will be scheduled after 39+0SA or earlier if indicated (RPM, intercurrent maternal or fetal pathology). In the case of a successful VME with a fetus that remains in cephalic presentation until labour, management will follow current recommendations. The characteristics of the dimensions and angles of the obstetric pelvis and the height of the fetal presentation in the standing and sitting positions, the performance and success of MEC, the choice of delivery route, and the final delivery route will be recorded.
Following an acute COVID-19 infection, many patients suffer from long lasting physical symptoms that may greatly impair quality of life. Persisting dyspnea and other functional respiratory complaints could evoke Hyperventilation Syndrome (HVS) as a putative contributor of the long-COVID presentation in COVID-19 survivors. We aimed to assess the possible relationship between a HVS and previous acute SARS-CoV-2 infection.
Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. While this train of four ratio threshold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 Hz stimulation showed a marked fade. This result has been observed in absence of reversal agent administration. Therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 Hz and tetanus 100 Hz stimulation in patient receiving rocuronium during general anesthesia and reversed by an anticholinesterase agent (neostigmine). Neostigmine will be injected once four muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (40 µg/kg) in accordance with the clinical practice worldwide admitted. Two questions have to be investigated. First, is this dose of neostigmine sufficient to allow a complete recovery of tetanus stimulations ? Second, due to the pharmacological properties of neostigmine, does a recurarisation phenomenon occur following repeated tetanus stimulations ? The attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.
In civilian practice, the incidence of firearm violence depends on the country. In high income countries, most cases are reported in the USA or South Africa. In these countries, gunshot wounds (GSW) represent 20% of death cases in trauma centers, more than motor vehicle collisions. The mortality in civilian practice occurs during the first 24 hours following GSW, mainly due to hemorrhage and traumatic brain injury, though long term effects on physical and psychological outcomes have also been shown. Some factors of mortality specific to GSW have been established: multiples wounds, homicide vs suicide attempt, impact zone, or firearm caliber. Few specific guidelines have been published concerning civilian GSW management. These cases are mostly treated in standard guidelines, such as hemorrhagic shock or traumatic brain injury guidelines. As in other trauma mechanisms, the "platinum ten minutes and golden hour" concept is applicable. In Europe, the incidence of civilian GSW is much lower and few European studies have been published recently. Penetrating injuries in Europe are less likely to be GSW, and are more often self-inflicted than in the USA. In addition, European studies are heterogeneous, due to the difference in populations, healthcare systems and GSW being grouped with stabbing wounds under the label "penetrating trauma". However, there is a global concern in Europe regarding a potential rise of GSW, with higher severity score than conventional trauma patients and often necessitate ICU admission. Studies analyzing data from different European countries show significantly different ICU admission rates for overall GSW, ranging from 17% up to 30%. Therefore, the investigators conducted a multicenter, retrospective study on four French University Hospitals aiming to describe the epidemiology (mortality and type of organ damage) and identify prognosis factors of civilian GSW admitted in ICU.
Phase 1-2 study including a dose escalation safety and proof of concept phase (Stage 1, open label), followed by a double-blind, randomized, placebo-controlled confirmatory phase (Stage 2)
Acute respiratory distress syndrome accounts for 23% of mechanically ventilated patients and is associated with high mortality rate. Although life-saving, mechanical ventilation may worsen lung injury through two main mechanisms: lung overdistension and atelectrauma. Indeed, the cyclic opening and closure of airways during tidal ventilation may cause lung and bronchial injuries as suggested by animal models and autopsy findings. Complete airways closure has recently been described in 40% of patients with acute respiratory distress syndrome, and setting positive end-expiratory pressure above the airway opening pressure may limit atelectrauma. However, animal and mathematical models suggest that above the airway opening pressure, more distal airways open unevenly according to their own opening pressure, resulting in an "avalanche"-like phenomenon during lung inflation. This phenomenon has never been described in humans. A better understanding of the opening of airways in acute respiratory distress syndrome may help to limit ventilation-induced lung injury and to improve outcomes.
Lower limb amputation has a definitive impact on a person's locomotor abilities, considerably reducing his or her autonomy in everyday life. 50% of lower limb amputees in France are trans-femoral. The femoral prosthesis must be adapted to allow the amputee to walk in everyday situations and to make the range of activities practiced by non-amputees accessible to them. Sitting posture, which represents an important part of a day, must also be comfortable. Comfort will be closely linked to the socket, which ensures the transmission of the mechanical actions of the prosthesis to the body of the amputee through the residual limb. This must be done without damaging the integrity of the biological tissues at the interface. The challenge is therefore to transmit the mechanical actions inherent to the use of the prosthesis while being as comfortable as possible. The most common form of femoral socket is the one with included ishions, which by its structure limits the rotation of the socket around the residual limb. However, it limits hip joint amplitudes, which significantly impacts comfort during walking, especially when the individual must evolve in constraining environments (irregular terrain, slopes, uphill, downhill). Comfort is also limited when putting the prosthesis in place and when sitting, because of the limits of the socket that go up into the groin and the buttock. Discomfort can also be induced by contact and clamping surfaces. Only 42% of amputees are satisfied with their sockets. An uncomfortable or wound-inducing brace will not be worn or will be worn only a little, which can increase the risk of comorbidities. One solution to the comfort issue could be the Access Socket (AS) soft socket, which is exactly the same shape and manufacturing principles as the Rigid Included Carbon Socket (ER), but combines a rigid structure with soft areas. These soft areas allow pressure to be distributed within the socket, allowing for some deformation, while maintaining the mechanical properties necessary for walking. The objective of this study is to compare the comfort perceived by amputees when wearing an AS soft socket versus their RE, both sockets being mounted identically on the patients' usual medical devices. The hypothesize is that scores on the various comfort, satisfaction, and mobility scales should be better when patients wear the soft socket compared to the rigid socket. In this multicenter, randomized, cross-over study, patients will wear the rigid socket and then the access-socket (or vice versa), over a 4-week period for each socket. The two sockets will have an identical shape and will be mounted in the same way on the patients' medical device. At the end of each 4-week period, patients will fill out self-questionnaires (PEQ, SCS, PLUS-M, ESAT and SF-36) to evaluate their comfort, satisfaction and ambulation.