Clinical trials

Intrapleural enzyme therapy (IET) is regarded by recent guidelines as a "rescue" therapy for managing complicated pleural infections; however, it is associated with significant side effects, including pleural bleeding, pain, and fever. Pleural irrigation with saline may serve as an alternative, yet evidence supporting its effectiveness is limited to a single small- scale, single-center randomized trial. The objective of the study is to compare the risk of treatment failure at 30 days (defined as a composite outcome that includes death, the need for thoracic surgery, or additional intrapleural enzyme therapy) between an early pleural irrigation strategy and standard care for complicated pleural infections.

As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the prototype during the weaning of the flap during surgery. Indeed, during weaning the investigators voluntarily interrupt the arterial and venous flow to transfer the flap to the breast. This weaning corresponds to a thrombosis model. The patients will benefit from an "improved" postoperative monitoring. Indeed, in addition to the classical clinical monitoring, they will benefit from an additional monitoring during 5 days thanks to the realization of an ultrasound of the flap which will be carried out every 6 hours the first 24 hours then every 12 hours. This protocol is therefore a feasibility study for the collection of data of interest.

Aortic stenosis is the most common valvulopathy in Western countries. Cardiac EchoDoppler is the reference method for assessment of aortic stenosis and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low flow and low gradient aortic retraction is discussed. The main objective of this work is to study the prognosis of asymptomatic and symptomatic aortic retraction.

Septic shock is one of the leading causes of death in patients admitted to the intensive care unit (ICU). Acute kidney injury (AKI) occurs in almost 50% of septic patients and is associated with significant mortality. Progression to the last stage (KDIGO stage 3) of AKI is an important step in the disease, as it usually requires initiation of RRT. Renal biomarkers are unable to accurately identify those patients who will progress to severe AKI (KDIGO 3). However, identification of patients at risk of progression to severe AKI could help the clinician to initiate optimal therapy including RRT. A new urine test, the Nephrocheck™ corresponding to the product of the urinary concentrations of 2 markers of renal tubule injury (TIMP2 and IGFBP7) has been validated. The Investigator have already performed two previous studies including septic shock patients (AKICHECK and BIOOCHECK). those previous datas will be reanalysed to examine whether the new urinary biomarkers TIMP2 and IGFBP7 can predict progression within 24 hours and 72 hours from mild and moderate (KDIGO 1 or 2) to severe AKI (KDIGO 3) in patients with septic shock. -All the datas required will be collected from two previous studies (AKICHECK and BIOCHECK) performed in 3 centers: Amiens medical ICU, Melun medico surgical ICU and Montpellier Medical ICU.

Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%). It is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE).

Velopharyngeal insufficiency is defined as the inability of the soft palate to isolate the nasopharynx from the oropharynx. It is a frequent sequela in patients with a velopalatine cleft despite anatomical restoration of the soft palate by intravelar veloplasty at 6 months. If rehabilitation by a speech therapist is not successful, a pharyngoplasty can be discussed. In the last ten years, MRI was used in dynamic and static way, to analyzed velopharyngeal muscles, in particular Levator Veli Palatini. MRI could be used to identify the etiology of VPI in those patients, and thus allow personalized rehabilitation and surgical management. The aim of this study is to examine the differences in velopharyngeal motricity as well as velar muscles morphology, positioning, and symmetry of children with repaired cleft palate with different degrees of severity of velopharyngeal insufficiency (VPI), and children with labial cleft (noncleft palate anatomy).

The benefits of breastfeeding no longer need to be proven. Many studies have shown its positives effects on both infants and mothers. Exclusive breastfeeding is thus recommended within the first six months of life. Excessive screen use has been shown to be harmful in many aspects of daily life. The impact upon the relation between mother and newborn infant is poorly studied. The study aims to evaluate the impact of the use of smartphones on the success and duration of breastfeeding.

Post-operative morbidity and mortality is related to many factors related to the patient's condition, the intra-operative period and the optimisation of intra-operative haemodynamic and respiratory parameters. Many studies have looked at the determinants and factors that increase postoperative complications. However, these have been randomised studies looking at one parameter in particular. This analysis would be the first to investigate the determinants of postoperative complications in a large population of patients undergoing major non-cardiac surgery. This is a post-hoc analysis of patients included in the OPHIQUE study, whose main objective was to evaluate intraoperative haemodynamic management guided by a marker of tissue hypoperfusion (the respiratory quotient).

Peripheral facial palsy affects 15 to 40 people per 100,000 inhabitants and induces important functional and social repercussions. Synkinesis is a frequent after-effect of facial palsy recovery, consisting of involuntary facial spasms that disturb the gestural harmony and can go as far as a painful hypertonic spasm. More than 55% of patients recovering from facial palsy will develop transient or permanent synkinesis. These facial hypertonias have two main causes: imperfect axonal regeneration, which is all the more important as the damage is proximal, and hyperexcitability of the facial nerve nucleus due to a lack of central control. Management is therefore essential for the functional restoration of the face, especially since synkinesis do not evolve spontaneously. The main treatments are currently botulinum toxin injection, acting on the motor plate, and functional rehabilitation, consisting on local muscle relaxation and central motor control work. In recent years, therapies based on biofeedback and acting on central motor control have shown interesting results, and technological advances in virtual reality have made it possible to deepen this treatment in patients suffering from stroke, limb trauma or Parkinson's disease. In this project, the investigators evaluate the contribution of virtual reality to the management of facial palsy, and hypothesize that self-rehabilitation using this technology will improve motor control of the skin muscles and reduce complications related to their hypertonia such as synkinesis.

In January 2020, researchers isolated and sequenced in China from patients with severe atypical pneumonia a novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 has rapidly spread throughout the world. SARS-CoV-2 may trigger hyperstimulation of immune system with an autoinflammatory response but also the development of an autoimmune process. These autoimmune responses may also develop through the molecular mimicry between virus and human-self components. Multiple autoantibodies have been described in COVID-19 patients. Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator has been identified as a new autoantigen in antiphospholipid syndrome. ANXA2 has been identified as candidate autoantigen recognized by SARS patient sera. ANXA2 contributes also to pulmonary microvascular integrity. These data lead to identify anti-ANXA2 antibodies in COVID-19 patient sera and to know if the presence of these antibodies is associated with pulmonary injury or thrombosis in COVID-19 and represents a marker of severity.

Clinician and the multidisciplinary team meeting in oncologic urology (MMO) play a key-role in the decision making. An unexplained surgeon attributable variance, probably linked to the subjective "eyeball test" effect, was identified as a strongest factor underlying non-compliance with guide line recommendations in the management of bladder cancer. So high-quality studies that identify barriers and modulators (such as comorbidities) of provider-level adoption of guidelines and how comorbidities are associated in making therapeutic choice and their impact in bladder cancer specific survival and overall survival, are crucial. To identify patients at high risk of early death, and to improve specific guideline for treatment might be decisive. In order to assess survival, where mortality events compete, it will be more appropriate to compute a Cumulative Incidence Function (namely CIF). The investigators will compare outcomes across patient populations to obtain information to improve clinical decision-making. Such learning will be done through the use of neural networks or by applying population-based approaches, such as Genetic Algorithms (GA), Ant Colony Systems (ACS) and Particle Swarm Optimization (PSO), using as a four-stage based approach. First, the investigators propose a "pretopology space" in order to study a dynamic phenomenon. Second, the investigators recall that the K-means approach remains one of the most used approaches for classifying a set of elements (patients / persons / others) into K (disjunctive) clusters. Third, the investigators propose a learning pretopology space for enhancing the clustering. Such an approach can be assimilated in spirit to one applied with high success on deep learning. Fourth and last, the investigators propose a reactive method that is able to include some new elements or remove some contained elements

In squamous cell carcinoma of the tongue, complete surgical resection of the tumor generally represents the primary treatment strategy. Among factors determining the disease prognostic, the surgical margins status is essential for the continued management of the patient, with or without complementary therapies. Generally, surgical margins are defined using visual and tactile elements. Unfortunately, in 15 to 30 percent of cases, they are defined as positive after histopathological examination, on average 5 to 7 days post-surgery. Techniques have recently been developed to analyze the cancerous and non-cancerous nature of tissues, using the spectral properties of tumor cells. SpiderMass™ is an instrument equipped with a probe for tissue micro-sampling and real-time molecular profile analysis. It is thus ultimately a tool for anatomopathological decision support, for diagnosis and prognosis of the disease. Used in the operating room, SpiderMass™ could also become an innovative surgical tool to precisely define cancerous areas in situ and the margins status in intraoperative conditions. Based on the principle of artificial intelligence, the SpiderMass™ machine must initially learn to recognize pathological tissues versus healthy. This project aims to accomplish this first phase of machine learning for squamous cell carcinoma of the tongue.

The French Society of Rheumatology cannot rule on the value of intra-articular injections of PRP due to the lack of hindsight and insufficient data. In fact, the injection protocols are very heterogeneous in terms of preparation method, the presence or not of leukocytes, the number of centrifugations, the volume injected, the ultrasound guidance, which makes it difficult to analyze the literature. The investigator objective is therefore to evaluate the effectiveness of combined injections of PRP and hyaluronic acid.

Although it is now established that calcification process result from the joint and coordinated action of different cell types, many areas of shadow remain regarding the spatio-temporal implementation of these events. Highlighting these processes requires additional research to consider new approaches to clinical management of patients with such conditions. It is in this context that the investigators need to use residual human tissue fragments resulting from surgery which are not intended to be used for clinical-biological management of patients. The use of these pseudonymised human tissues will allow the investigators to conduct in vitro cell culture experiences.

Obesity is in constant increase all over the world and affects 35% of the global population according to the World Health Organisation. It is associated with other cardiovascular risk factors (particularly hypertension and diabetes) and with high morbi-mortality. It is also responsible for an increase of the risk of developing chronic kidney diseases (CKD). In fact, obese patients represent 25% of the dialysis population and Picardy is one of the most affected areas. However, their access to kidney transplant is still restricted and the reasons are not completely understood.

Age-related macular degeneration (AMD) is the leading cause of blindness after 50 years in industrialized countries, compromising daily activities and reducing quality of life. And whose treatment is one of the first health expenditures. Since September 2015, Bevacizumab, which does not have marketing authorization in AMD, has been given a temporary recommendation for use. Studies in other countries have shown that bevacizumab is cost-effective in the treatment of AMD compared to other anti-VEGF therapies used.

The tricuspid valve : its evaluation is relatively difficult in echocardiography and the management of tricuspid valve diseases remains poorly codified.

Infectious endocarditis (IE) is the localization and proliferation of blood-borne germs in the endocardium. It remains a complicated disease to manage due to its low incidence, diagnostic difficulties, the change in epidemiology in recent decades and high mortality rates. The annual incidence is estimated at 3-10 cases per 100,000 people. The epidemiology of AR has changed significantly in recent years due to new risk factors. Indeed, the frequency of rheumatic heart disease, which was the first predisposing factor, decreased markedly in the industrialized countries, replaced by new predisposing factors: the presence of valvular prostheses or intracardiac materials (the risk of AR is multiplied by 50 Compared with the general population), hemodialysis, nosocomial infections, immunosuppression, increased use of injectable treatments and, above all, an aging population with an increase in degenerative diseases such as aortic stenosis and l Mitral insufficiency. The diagnosis of IA is based on DUKE criteria. But the clinical presentation is sometimes atypical especially in case of infection on prosthesis where the diagnosis is based mainly on the results of the blood cultures and the ultrasound data. The lesions visualized in ultrasound are: vegetations, abscesses, pseudo-aneurysms and fistulas constituting the degenerated abscess evolution, the perforation of the cusps of the native valve or the bioprosthesis giving rise to a jet of Eccentric regurgitation. The evolution of endocarditis and its prognosis vary according to many factors: the type of germ responsible, the precocity of the diagnosis, the existence of a complication, the site of occurrence. These complications of endocarditis are frequent, sometimes revealing. EI is complicated by heart failure, atrioventricular conduction disorders, peri-vascular abscesses, embolic, neurological, renal and septic complications. Despite improvements in diagnosis and therapeutic methods, diagnosis is sometimes difficult, management remains very complicated and morbidity and mortality remain high. Studies are still needed to study the prognosis and to determine the predictive factors for hospital mortality and long-term mortality.

The aortic valve bicuspidia (BVA) is a congenital condition corresponding to the presence of 2 sigmoids instead of 3. This is the most common cardiac congenital anomaly affecting 0.5 to 2% of the population The general rule. BVA may be associated with structural damage to the ascending aorta, which exposes BVA patients to a risk of developing ascending aortic aneurysm and acute aortic accidents. Recent data from the literature have revealed that the natural history of BVA is marked by a possible development towards significant valvulopathy and / or an ascending aortic aneurysm often requiring surgical treatment. However, the natural history of bicuspid disease remains poorly understood and the prognostic factors for progression to severe valvulopathy and / or aneurysmal dilatation of the ascending aorta remain to be determined.

The MEPI (Modified Elbow Performance Index) or MEPS (Modified Elbow Performance Score) is a multidimensional assessment scale for elbow pain and function. This score is widely used in scientific literature, particularly for post-traumatic and post-operative evaluation, including in many French-language studies. However, no French translation of this score has undergone quality criteria verification and validation in a pediatric population.

Implantation is a determining step in human reproduction which requires the transition from a pro-inflammatory state to an anti-inflammatory state allowing the implantation of a competent embryo within a receptive endometrium, and then the maternal immunotolerance towards the alloantigenic fetus. Repeat implantation failures (RIFs), that refers to the fail to achieve a clinical pregnancy after the transfer of at least 3-4 good quality embryos or two blastocysts, and unexplained recurrent spontaneous miscarriage (RM) (≥2-3) could be related in some patients to immune imbalances characterized by an excessive and prolonged inflammatory response and/or a defect of anti-inflammatory regulation. In this context, several therapies have been evaluated in patients with RIFs or RMs in order to restore the immune balance, with heterogeneous results. No serum biomarker assay has been routinely approved to identify patients with immune imbalances that may explain repeated pregnancy failures and to predict the success of the subsequent IVF/ICSI cycle. The immunological analysis on peripheral blood will be based on the determination of the proportions of immune subpopulations (e.g. CD4+ et CD8+, TH1, TH2, TH17, Treg, ILC 1, ILC2, and ILC3) on the one hand and the circulating level of plasma cytokines on the other hand.

Various treatment options are available for brain metastases, depending on factors such as lesion site or number lesions. Radiotherapy is a commonly used treatment. Following stereotactic radiotherapy for brain metastases, a potential complication, namely brain radionecrosis, can occur subsequently. It is essential to differentiate between this radionecrosis and lesion recurrence in order to determine the appropriate treatment approach. Contrast-enhanced magnetic resonance imaging (MRI) is the most widely used technique for monitoring brain metastases. Therefore, patients undergo routine MRI at 3 months and during subsequent follow-ups, but if the lesion evolve and if distinguishing between recurrence and radionecrosis is challenging, an \[18F\]-FDG PET scan is then prescribed by oncologists or radiotherapists during follow-up consultations. As part of the standard patient management protocol, a 10-minute image acquisition begins after a 45-60 minutes wait following the radiotracer injection. A second image acquisition is then conducted 3-4 hours later. For both acquisitions, a low-dose X-ray scanner is synchronously coupled to allow attenuation correction of the PET images. Patient for whom a \[18F\]-FDG PET cerebral examination has been prescribed as part of the usual management of brain metastases will be eligible to the protocol. If the patient agrees to participate, an early imaging session is initiated immediately upon radiotracer injection, lasting 15 minutes in addition to the standard acquisition protocol.

Cardiac surgery is a high-risk surgery and is associated with a rate of postoperative adverse outcomes. Like many others major surgery, cardiac surgery procedures induce a proinflammatory phase usually counterbalanced with an immunosuppressive phase so the immune response remained balanced. In some cases, the immune response might be dysregulated with a more pronounced pro inflammatory state that compromises organ perfusion and with the occurrence of organ failure. From a mechanistic approach, the relationship between organ failure is complex and multifactorial with a high level of proinflammatory cytokines, a decrease in microcirculation, an endothelial dysfunction and an activation of coagulation and over. The clinical expression is an increase in vasopressor exposure and dose, an increase in mortality and in adverse outcomes with a predominance of acute kidney injury. Various therapies have been assessed to manage cardiac surgery related sepsis including glucocorticoid therapy. Briefly, two major randomized trials assessed glucocorticoid therapy solely in scheduled cardiac surgery with cardiopulmonary bypass. No clinical benefit was demonstrated in term of reduction in postoperative mortality or adverse outcomes. Since, data support that the selection of patients at risk is crucial to demonstrate such a strategy. Indeed, data support that surprisingly some patients will have a very light immune response reflected by a low pro inflammatory cytokine. The hypothesis is that the combination glucocorticoid and fludrocortisone could decrease adverse outcomes in selected patients.

Narcolepsy is a chronic disabling neurologic disorder mainly characterised by excessive daytime sleepiness. Type 1 narcolepsy is associated with a deficit of hypocretin in the cerebrospinal fluid responsible for the cataplexy symptom while type 2 shows a normal hypocretin level and no cataplexy. While the development of narcolepsy is independent of parental social level, narcolepsy has a significant influence on educational level, grading, social outcome, and welfare consequences. Several studies assessed global cognition efficiency, mood, and attention in narcoleptic patients but only a few specifically measured social cognition and mostly without a control group. In a population of narcoleptics children, a severe impairment in social cognition is described for 20% of the group, contrary to 2 % for the control group. The literature also depicts some impairments in decision making, somatic and cognitive emotions responses but the emotion recognition seems to be preserved. A better understanding of the social and cognitive aspects of narcolepsy could lead to a better treatment of the disease in its entirety, including if relevant specific cognitive behavioural therapy. The protocol consists in a psychometric evaluation including several questionnaires in order to assess social cognition. It will be proposed to patients with type 1 or type 2 narcolepsy and patients with idiopathic hypersomnia.

The incidence of postoperative atrial fibrillation (POAF) after cardiac surgery is around 30%. POAF increases the risk of developing permanent atrial fibrillation and raises the risk of cardiac decompensation, stroke, acute myocardial infarction, and death. While the role of the left atrium (LAF) in the pathophysiology of POAF is now well-established, the part of the right atrium (RA) remains poorly understood. Recent studies suggest a correlation between RA function and POAF. RA function can be assessed by transthoracic echocardiography (TTE) with dedicated software for measuring the RA strain (RAS). RA function is thus divided into three phases: reservoir (RASr), conduit, and contraction. Numerous studies have demonstrated that a significant alteration in RAS predicts POAF in various clinical contexts. Therefore, it is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery. It is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery.