title: Professional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work

acronym: VISIBILITE

summary:
The diagnosis of breast cancer and the treatments implemented have a significant impact on the professional situation.

Maintaining employment and/or reintegration into working life are therefore major issues for cancer patients.

This trial proposes to study the feasibility of a support/coaching program for a return to work in patients after breast cancer.

ReferenceCitation: Arfi A, Baffert S, Soilly AL, Huchon C, Reyal F, Asselain B, Neffati S, Rouzier R, Héquet D. Determinants of return at work of breast cancer patients: results from the OPTISOINS01 French prospective study. BMJ Open. 2018 May 18;8(5):e020276. doi: 10.1136/bmjopen-2017-020276.

ReferenceCitation: Banning M. Employment and breast cancer: a meta-ethnography. Eur J Cancer Care (Engl). 2011 Nov;20(6):708-19. doi: 10.1111/j.1365-2354.2011.01291.x. Epub 2011 Sep 20. Review.

ReferenceCitation: Barnes AJ, Robert N, Bradley CJ. Job attributes, job satisfaction and the return to health after breast cancer diagnosis and treatment. Psychooncology. 2014 Feb;23(2):158-64. doi: 10.1002/pon.3385. Epub 2013 Sep 3.

ReferenceCitation: de Boer AG, Verbeek JH, Spelten ER, Uitterhoeve AL, Ansink AC, de Reijke TM, Kammeijer M, Sprangers MA, van Dijk FJ. Work ability and return-to-work in cancer patients. Br J Cancer. 2008 Apr 22;98(8):1342-7. doi: 10.1038/sj.bjc.6604302. Epub 2008 Mar 18.

ReferenceCitation: Ekbladh E, Thorell LH, Haglund L. Perceptions of the work environment among people with experience of long term sick leave. Work. 2010;35(2):125-36. doi: 10.3233/WOR-2010-0964.


title: Effect of Prone Positioning on Mortality in Patients With Mild to Moderate Acute Respiratory Distress Syndrome.

acronym: PROMILD

summary:
Acute respiratory distress syndrome (ARDS) accounts for almost 10% of intensive care units (ICU) admissions. Three ARDS stages have been defined, based on the PaO2/FIO2 ratio measured with positive end-expiratory pressure (PEEP) ≥5 cmH2O: mild (201-300 mmHg), moderate (200-101 mmHg), and severe (≤100mmHg). They represent 30.0%, 46.6%, and 23.4% of ARDS, respectively.

Mechanical invasive ventilation (MV), the cornerstone of ARDS patient care, has a primary goal to protect the lung from ventilator-induced lung injury (VILI). Delivering MV in a prone position (PP) has been shown to improve oxygenation, protect the lung through a better homogenization of lung stress/strain, and stabilize hemodynamics.

A meta-analysis of four randomized controlled trials showed beneficial effect of PP vs. supine position (SP) in the most hypoxemic patients. A fifth randomized controlled trial further showed a significant reduction in mortality with PP in ARDS patients with PaO2/FIO2 <150 mmHg, when neuromuscular blockade and long prone positioning sessions were used. Therefore, PP has since been strongly recommended for ARDS patients with PaO2/FIO2 <150 mmHg. Yet, there is limited evidence in patients with mild to moderate ARDS.

There are, however, strong arguments supporting the need for a new trial in ARDS patients with PaO2/FIO2 in the range 150-300 mmHg:

There is no trial that has specifically tested PP in this ARDS subset;
PP is safe and has become a standard of care in ICU;
Should VILI prevention be a mechanism through which PP improves survival, this should be involved in all ARDS patients;
The mortality at hospital discharge in this subset of ARDS remains significant, amounting to 34.9% (95% confidence intervals 31.4-38.5%) in mild and 40.3% (37.4-43.3) in moderate stages;
Among 580 patients with mild ARDS at admission to the ICU, in-hospital mortality was 10%, 30%, and 37% for those who improved, persisted, and worsened ARDS, respectively.
Finally, PP has been shown to be cost-effective under commonly accepted thresholds.

The hypothesis is that in patients within the 150-300mmHg PaO2/FIO2 range at the time of ARDS diagnosis, PP can reduce mortality as compared to a similar group left in the SP.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: University Hospital, Grenoble

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: Nosocomial Outbreak of Monoclonal VIM Carbapenemase Producing Enterobacter Cloacae in an Intensive Care Unit During SARS-CoV-2 Pandemic

acronym: BHReICU

summary: Multidrug Resistant (MDR) bacteria have become a major worldwide public health challenge and hospitals are now increasingly faced with management of local outbreaks involving such pathogens. Especially, intensive care units (ICU) provide an ideal background for outbreaks caused by MDR bacteria among which carbapenemase-producing Enterobacteriaceae (CPE) can be found. Among CPE involved in ICU outbreaks, VIM producers have been reported worldwide, and described as especially difficult to control. The COVID-19 pandemic and all of the measures health workers have to implement to fight the spread of SARS-Cov-2 have also impacted the management of such outbreaks. In this retrospective study, the investigators aim to describe the management of an outbreak caused by a VIM-producing Enterobacter cloacae strain during the 2020 COVID-19 pandemic in an ICU, and show the importance of concerted measures and actions implemented at multiple levels to prevent the spread of this MDR strain.

study_type: Observational

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia

acronym: DEPRECOD

summary: Bronchopulmonary dysplasia is a complication of prematurity. Postnatal corticosteroid is used to treat the inflammatory part of this pathology, in particular to wean premature infants from the ventilator at the end of the first month of life. However, this therapy remains controversial because it may induce suboptimal neurocognitive development. Parents of infants who receive postnatal corticosteroid should be provided with information about the risks. The objective of our work was to evaluate the respiratory, neurodevelopmental and growth outcomes at 24 months corrected age of extremely preterm infants who received postnatal corticosteroid.

status: Completed

study_completion_date_type: Actual

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

intervention_type: Drug

status_simplified: Completed


title: Evaluation of the Effectiveness of the Therapeutic Education Program "Living Better With ADHD" in Improving the Quality of Life of Children With ADHD and Their Parents

summary:
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by attention deficit, impulsivity and hyperactivity. It's one of the most frequently encoutered disorder in child psychiatry. ADHD has a significant impact on the quality of life of children and their parents.

In the child psychiatry department of the MPEA Peyre Plantade, a Therapeutic Education program specific to ADHD has been set up for children and their parents. This program consists of different workshops whose aim is to reduce the ADHD repercussions on the daily life of children and their families and thus improve their quality of life.

The principal aim of our study is to evaluate the effectiveness of this program in improving the quality of life of children with ADHD and their parents.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Retrospective Study to Investigate Rotational Stability and Clinical Outcomes After Implantation of a Monofocal Toric Intraocular Lens (IOL)

summary:
This is a monocentric retrospective, open-label clinical study in patients after unilateral or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC and executed only with standard of care examinations.

The investigational device is CE approved. The investigational device and all study products, including the devices used for the study examinations, have been used within the intended use specifications from the manufacturer. In addition, there were no invasive or other burdening examinations.

The investigator is an accredited and experienced cataract surgeon and researcher.

The primary endpoint is to determine rotational stability in a minimum of 120 eyes of patients with PODEYE TORIC IOL implantation after cataract surgery. Patients will be enrolled for the documentation and evaluation of retrospective data up to 6 months postoperatively.

lead_sponsor: Beaver-Visitec International, Inc.

intervention_type: Device

lead_sponsor_type: industriel


type: Other Identifier

title: LIQUID BIOPSY IN Low-grade Glioma Patients

acronym: GLIOLIPSY

summary:
Diffuse low-grade gliomas (DLGG) (or WHO grade II gliomas) are rare tumors, with an incidence estimated at 1/105 person-year. DLGG are characterized by a continuous growth and an unavoidable anaplastic transformation. DLGG malignant progression is classically characterized by a continuum, from grade II to grade III or IV tumors.

To date, the histomolecular diagnosis of lower grade gliomas (that is, grade II and III gliomas) is achieved on tumor samples obtained from surgical resection or biopsy. Indeed, whereas brain MRI is often suggestive of DLGG, there is a need for a histological confirmation of diagnosis prior to any medical treatment. Moreover, MRI features to not always accurately predict the tumor grade, with grade II tumor presenting with contrast enhancement or non-enhancing authentic grade III tumors.

In this setting, the value of liquid biopsy (in blood or cerebrospinal fluid CSF) as a non-invasive, disease-associated biomarker has gained interest in the past decade, either at tumor diagnosis or to monitor tumor evolution in order to guide patient management and to detect changes of molecular features over time. While extracranial metastasis of glioma rarely occurs, recent reports suggest the possible presence of circulating tumor cells (CTCs) in blood of high-grade glioma patients. Beside CTCs, other circulating biomarkers have been recently investigated in glioma, including circulating tumor DNA, microRNA or tumor-educated platelet (TEP) RNA. Some of these techniques allow genome-wide characterization of RNA/DNA contents.

However, these studies are all small exploratory studies that have mainly included glioblastoma (grade IV glioma) patients rather than lower-grade gliomas, or glioma patients with no precision on tumor grade. Moreover, some of these studies analyzed samples performed after the patient received a medical oncological treatment (chemotherapy or radiation therapy). They advocate for the search of a circulating signature that would not be restricted to biomarkers directly derived from the tumor but include markers induced at a distance by the tumor. Indeed, slow-growing DLGG are likely to induce a systemic reaction to allow, for many years, an immuno-tolerance of the tumor. This reaction could have an impact on peripheral blood cells, including their RNA content.

In this study, the investigators aim at conducting an exploratory study in DLGG patients to explore the value of several blood-based biomarkers for the disease diagnosis and/or monitoring.

design_allocation: Non-Randomized

primary_purpose: Other

intervention_type: Biological


title: Percutaneous Edge To Edge Repair for the Treatment of Severe Tricuspid Valve Regurgitation in High-surgical Risk Patients With Systemic Right Ventricle : a Multicentric French Cohort.

acronym: PETER-TRESRIV

summary:
Our study is about to follow adult congenital patients, known with systemic right ventricle (mostly correct transposition of the great arteries ou congenitally corrected transposition fo the great arteries) and systemic valve severe regurgitation which was treated with a Mitraclip device on this tricuspid valve.

It's an observationnal study with a 2 years follow up with clinical (symptoms, complications, VO2 exercice test) echographic and MRI outcomes

.

lead_sponsor: University of Bordeaux


title: A Prospective Observational Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response

acronym: OPALE

summary: The aim of the study is to describe the real-world profile of patients treated with adalimumab FK in gastroenterology, dermatology or rheumatology in order to evaluate in this population the predictive factors of therapeutic response (in particular nutritional status) and generate hypothesis between nutritional status and therapeutic response.

lead_sponsor: Fresenius Kabi


title: Nasality Evolution in a Nasal Polyposis Context: Multiparametric Evaluation: Articulatory (Imaging), Aerodynamics, Acoustics and Perception

acronym: MultiNas

summary:
"Nasal polyposis is a chronic inflammation of the sinonasal mucosa which is characterized by the development of polyps in the sinonasal cavities. In the general population, its prevalence is 4% with a clear increase from the age of 50 years.

When drug treatment is not effective, and the patient's quality of life is impaired, surgery is proposed. It allows to widen the nasal cavities with aerodynamic and acoustics effects on speech. There are few studies, that have focused on the impact of NP and its treatment on speech. Yet there is a real demand from patients to obtain answers related to the impact of this surgery on their voice.

Preoperatively and postoperatively, the resonance will be disturbed: polyps will impacted the quality of the nasal sounds. And after surgery, the new anatomical shape can create an excessive resonance in the nasal cavities.

Indeed, there is a diversity of acoustic effects that differ according to the sinuses involved, the nature and type of surgery and the anatomical and physiological specificities of the patient.

The impairment of acoustic properties after surgery is diverse and little known.

The surgery improves the communication between sinuses and nasal cavities but the real impact on nasal resonance still unknown.

The particularity of this pathology stands in the obstruction of the sinonasal cavity by polyps. On this study, it represents a model of nasality disturbance/impairment ? Indeed, all aspects of nasality will be altered : the articulation by the obstruction of the sino-nasal cavities, the aerodynamic by a disturbance of the circulation of the airflow within the nasal cavity, acoustics by an alteration of the resonance of this flow, and finally the perception of speech by others where the comprehension of speech is difficult. Thus, the investigators wish to observe this dysfunction in a multipara metric way in order to have an accurate approach.

This population is therefore ideal. In preoperative, it will allow to measure by aerodynamic, articulatory, acoustic, and perceptive data taking this dysfunction, to give precise answers. Then, postoperatively, these measurements will be repeated to observe a return to the expected functioning of the nasal cavity. Indeed, the cavities being no longer congested, a greater flow of nasal air would be expected, which would have acoustic consequences on the resonance of nasal sounds. This could be accentuated because of the new anatomical configuration due to the surgery. Perceptually, the voice after surgery should no longer be considered as pathological.

In addition to the linguistics aspect, this population has the particularity of having a strongly impacted quality of life. The investigators would therefore like to measure this impact on quality of life before and after surgery.

For this study, the main objective is to measure the articulatory, aerodynamics, acoustics and perceptive impact of the nasal polyposis on speech before and after surgery.

the secondaries objectives are to:

Compare the differences in aerodynamic, acoustic, articulatory and perceptual changes between the ""presence of polyps in the nasal and sinus cavities"" group and the ""presence of polyps in the sinus cavities"" group
Compare the modifications on the speech of the pathology before and after surgical treatment
Identify the elements related to the quality of life impacted by this pathology.
Identify the glottic compensation strategies induced by the pathology
Compare preoperative and postoperative nasal resonance and the relationship between nasal and sinus cavities using 3D models
Validate the adequacy of the nasality-speech questionnaire for patients with sinonasal polyposis"

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Using the Superb Microvascular Imaging Method in the Diagnosis of Intraocular Tumors (SMITIS)

acronym: SMITIS

summary:
The diagnosis and monitoring of intraocular tumors are based on multimodal imaging in addition to the clinical examination (ultra-widefield retinal imaging, echography, angiography). Nevertheless, it may be difficult in cases of retinal hemorrhage, small tumor size or atypical presentation. The study of microvascular flow (Superb Microvascular Imaging, SMI) of intraocular tumors could improve the confidence of differential diagnosis when evaluating these suspicious lesions, or even determine whether a lesion is benign or malignant by describing the vascularization of the lesion.

The investigators propose to study the microvascular flow patterns of intraocular tumors prior to proton therapy.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Diagnostic Test


title: Ability of Peripheral Venous Pressure Variation to Predict Fluid Responsiveness During an Alveolar Recruitment Maneuver in Patients Undergoing Non Cardiac Surgery

summary:
The decision to give fluids or not should not be taken lightly. Indeed, excessive or insufficient fluid administration is associated with increased morbidity and mortality. Prediction of fluid responsiveness relies on the use of a hemodynamic variable to determine how likely a patient is going to respond to a fluid bolus with a significant increase in their cardiac output or stroke volume. Depending on the response to fluids, patients are either responders or non-responders.

Today, we have many techniques to predict fluid responsiveness. However, almost all require the use of an advanced hemodynamic monitoring device.

lead_sponsor: Erasme University Hospital


title: Assessment in Patients With Essential Trigeminal Neuralgia of Nerve Involvement by MRI in DTI and Functional Connectivity in "Resting State"

acronym: SENSE

summary:
Essential trigeminal neuralgia is the most common facial pain. In forms resistant to drug and disabling treatments, surgical treatment may be offered to the patient. The type of intervention will be conditioned by the presence or absence of a vasculo-nervous conflict objectified by MRI(Magnetic resonance imaging) Morphological MRI with contrast injection does not always allow an accurate assessment of trigeminal nerve damage in patients with essential facial neuralgia. Despite advances in the anatomical definition of high-resolution MRI, the correlation between a vascular conflict visible on MRI and present during surgery and prolonged postoperative clinical improvement remains insufficient These data raise the question of additional imaging sequences to assess the distressing characteristics of NT in addition to the usual anatomical criteria for compression By performing during morphological MRI two additional sequences, one in diffusion tensor (DTI) and one in resting state (fMRI), we could better characterize the achievement of NT

The contribution of new imaging sequences in the context of essential trigeminal neuralgia treated with microvascular decompression (MVD) would:

1/improve the diagnostic criteria for suffering and compression of the NT (trigeminal nerve) 2 / define objective prognostic criteria for the effectiveness of surgery, particularly in the context of unusual clinical symptoms or moderate conflict on MRI (Magnetic resonance imaging) 3 / to analyze more precisely the causes of recurrence at a distance from surgery and help in the decision of re-intervention Our main hypothesis: the addition of a diffusion tensor sequence and sequences (allowing functional brain analysis) in addition to standard anatomical MRI in the assessment of a vasculo-nervous conflict would allow us to better characterize involvement of the trigeminal nerve in essential facial neuralgia. It also helps guide therapeutic management and surgical indications.

This is a prospective, monocentric cohort study. It will be offered to patients referred to neurosurgery or to the pain assessment and treatment center for assessment and management of a neuralgia of the essential trijumeau unilateral.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat)

acronym: DyScapLat

summary: The aim of this study is to assess the influence of anterior abutment surgery using the Latarjet method on the kinematics of the scapula. The sub-objectives will be to show that Latarjet-type surgery does not lead to scapular dyskinesia and modification of muscle activity compared to a control group that has not undergone an operation.

lead_sponsor: Ramsay Générale de Santé

intervention_type: Other


title: Observational Study Evaluating Safety and Performance of Dental Implant Systems (5 Implant Ranges: IDAll, IDBio, IDCam, IDMax, ID3; 3 Types of Prosthetic Parts: Sealed, Screw-retained and Removable) in Subjects Followed During 18 Month

summary: Post-Market Clinical Follow-Up to evaluate the safety and performance of IDI dental implant systems : confirmation of osseointegration of the different implants at the loading visit (between 2 and 6 months after surgery).

lead_sponsor: Implants Diffusion International


title: Randomized Controlled Trial Evaluating the Efficacy of Venous Sinus Stenting Versus Neurosurgical Internal Ventricular Shunt on Papillary Edema in the Management of Idiopathic Intracranial Hypertension

acronym: HYDROPTIC

summary:
Idiopathic intracranial hypertension (HTICi) is a pathology, affecting young adults with a predominance of women, due to an increase in intracranial pressure, which may be associated with stenosis of the cerebral venous sinuses and whose origin remains unknown.

This hypertension can lead to papillary edema (OP) which can lead to a narrowing of the visual field and progress to blindness. Along with weight reduction, acetazolamide, which reduces the production of cerebrospinal fluid (CSF), is prescribed as a first-line treatment. Its efficacy is inconsistent in resolving papillary edema and there are many side effects.

In the event of ineffectiveness or dependence on acetazolamide associated with hygiene and dietetic rules, a second line of therapy is then considered: neurosurgical (internal shunt of the LCS) or endovascular (venous stenting) treatment.

These invasive techniques have each proven their effectiveness in the rapid and permanent resorption of OP, allowing improvement or preservation of visual function. In terms of induced morbidity, the superiority of one technique over the other, if it exists, has not been established.

Our objective is to compare the efficacy, safety, and safety of LCS bypass surgery versus venous sinus stenting in HTICi with moderate to severe visual impairment after failure of medical treatment defined by the absence of resorption of the OP after several months


title: Descriptive Bicentric Study of Moya Moya Syndrome and Disease in Sickle Cell Disease Patients and Not Sickle Cell Disease

acronym: BMM-ScD

summary:
Moya Moya disease or syndrome ar characterized by a progressive or occlusion of the intracranial carotid arteries and their mainproximal branches, followed by the development of fragile neovessels at the base of the skull, leding to a high risk of both ischemic and hemorragic stroke over time. Moya Moya syndrome are associated to a variety of disease, which main frequent is sickle cell disease (SCD).

Among patients with SCD who had suffered from at least one ischemic stroke, the prevalence of moya moya syndrome was estimated up to 43%. In general, therapeutic strategies in Moya Moya to prevent first ever ou recurrent stroke can be divided into conservative medical treatment and surgical revascularisation (direct bypass, indirect bypass or combined bypass).

The aim of this study is to compare prognosis of patients with Moya Moya syndrome associated with sickle cell disease or not. The investigators retrospectiveluy analysed medical chart from 2010 to 2021 of patients with Moya Moya disease or syndrome at two French university hospitals (including a center of the french West Indies where prevalence of sickle cell disease is high). The diagnosis was based on angiography or MRI records showing uni- or bilateral stenosis of distal intracranial internal carotide arteries or middle cerebral arteries associated wirh classic collateral network.

Main endpoint will be comparison of a composite outcome defined as time from Moya Moya diagnosis to first or recurrent stroke or bad prognosis achivement (defined by modified Rankin score >2)


title: Cognitive Disorders and Brain Pulse

acronym: COG-PULCE

summary: Following an initial consultation with a memory, resources and research centre (MRRC) doctor, a day hospital may be prescribed to carry out an assessment of cognitive disorders. Patients are then usually followed up in consultation at least once a year, in the framework of a new day hospital and/or consultations with a MRRC doctor.

lead_sponsor: University Hospital, Tours


title: m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome. Prospective, Randomized, Controlled, Multicenter Study

acronym: mRehabOSA

summary: Obstructive sleep apnea syndrome (OSA) is a common condition associated with major repercussions such as excessive daytime sleepiness and impaired quality of life as well as metabolic and cardiovascular complications. Continuous positive airway pressure (CPAP) remains the treatment of choice but its effectiveness remains limited, especially in reducing cardio-metabolic risk. Interventions to modify the lifestyle are therefore recommended in the management of OSA. The emergence of information and communication technologies is an opportunity for patients to have tools that promote self-management and behavioral changes. The recent development of telerehabilitation (TR) is a promising approach that has only been the subject of pilot studies. In a randomized, controlled and multicenter study, we propose to test the hypothesis according to which the use of a mobile TR solution, associated with continuous positive airway pressure (CPAP), will allow obese patients to adopt behavioral modifications to improve markers of severity of OSA. The analysis of big data (data-mining) will allow a better understanding of the motivational obstacles and levers.


type: Registry Identifier

title: Prevalence of Renal Disease in Children With Celiac Disease

acronym: COELIGAN

summary: To assess the prevalence of renal disease in a pediatric population of patients with celiac disease by looking for the presence of hematuria and/or proteinuria.


title: Observation of Platelets in Primary and Secondary Tumors of the Central Nervous System and Association With Survival: a Prospective Cohort Study

acronym: Platon

summary:
Platelets are primarily known for their central role in primary hemostasis. However, they are increasingly recognized for their participation in various non-hemostatic processes, such as cancer progression and clinical expression. Experimental and clinical data indicate that the involvement of platelets in the pathophysiology of cancer goes far beyond the realm of cancer-associated thrombosis.

Several experimental studies have shown that platelets can promote the metastatic process by various mechanisms. However, while it has been shown in vitro that direct contact with platelets initiates tumor cells for metastasis, it remains unclear whether such contacts occur in solid tumors. In addition to their ability to promote metastasis, platelets have been shown to stimulate angiogenesis and play a crucial role in lymphangiogenesis.

Considering that blood vessels, lymphatics and immune cells are major components of the tumor ecosystem, our hypothesis is that platelets contribute to the development and / or regulation of the tumor microenvironment. This is because platelets stabilize tumor blood vessels by permanently repairing vascular damage caused by immune cells infiltrating tumors. Targeting platelets destabilizes tumor vessels, causing intra-tumor hemorrhage, which allows intra-tumor accumulation of intravenously administered anti-tumor drugs such as paclitaxel and improves their efficacy.

Studies have also reported the role of platelets in several pathogenic mechanisms of cancer: thrombocytosis is a paraneoplastic syndrome which suggests a poor prognosis in patients with solid tumors; a negative correlation between the platelet count and the response to chemotherapy has been reported in several types of cancer; histological analyzes of esophageal cancer suggested a possible association between the presence of platelets in the tumor stroma and the level of tumor lymphangiogenesis and lymphovascular invasion; finally, a recent study reported the expression of one of the main targets of immunotherapies, PD-L1, on the platelets of patients suffering from different types of solid cancers.

All of these data support our hypothesis that platelets are components and / or regulators of the tumor microenvironment and therefore potential targets for the improvement of anti-tumor therapies. In this context, the objectives of our project are to determine whether platelets are components of the microenvironment of tumors of the central nervous system, and to study the possible correlations between the intratumoral presence of platelets and the evolution of patients with central nervous system tumors


title: Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly

acronym: HYPOXAGE

summary: In line with the ever-growing aging of Western populations, the development of preventive strategies to slow down the effects of aging on cardiovascular health represents a major challenge in order to preserve functional capacities and a sufficient quality of life in the elderly. The alteration of vascular function (at the cerebral and systemic level) with aging is an important feature in the clinical picture including a decrease in physical and cognitive capacities. Although physical activity is recognized as an essential means of combating the effects of aging, optimizing its effects by defining the most effective strategies of practice remains a key objective. Offering alternative interventions to exercise training is also necessary for people who are unwilling or unable to engage in a physical activity program. In this context, hypoxic conditioning, alone or in conjunction with rehabilitative exercise training, is a new therapeutic modality with strong preclinical validity, in particular from a cardiovascular standpoint, and used in other pathologies to improve cardiovascular function and exercise performance and quality of life. Our aim is, therefore, to investigate the effect of hypoxic conditioning (alone or in conjunction with exercise training) on cerebrovascular health in the elderly.

primary_purpose: Prevention

ipd_sharing_description: No plan at this point in time.


title: Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study

acronym: PIRAT

summary: ICU patients frequently face complicated recovery processes, including long-term anxiety disorders. Lung transplantation (LTx) offers people with terminal respiratory conditions both the hope of prolonged survival and a better quality of life related to health. Among the disorders usually encountered in the postoperative period of LTx are anxio-depressive disorders. These anxiety disorders affect the quality of life related to health and compromise the follow-up of the patient by phenomenon of psychological disinvestment. Other psychological disorders are also anchored in the patient's experience of this post-surgical ICU period (ie, depressive episodes and/or, at a distance, post-traumatic stress disorder (PTSD). Various models of management of anxio-depressive disorders and PTSD are proposed in the literature. To our knowledge, while many of them have shown their efficiency in the curative management of disorders, few have demonstrated their effectiveness in preventing them. Exposure therapies using virtual reality (ETVR) have in the past demonstrated their effectiveness in many areas of psychiatry. In our study, experimental arm patients will be offered ETRV support with a virtual reality headset. A scenario with progressively increasing stress levels linked to the ICU environment and different situational contexts (alarms, etc.) will be presented to patients. This habituation to the potentially anxiety context of ICU will reduce the occurrence of psycho-cognitive disorders by progressive extinction phenomenon.

primary_purpose: Supportive Care

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hôpitaux de Marseille

intervention_type: Behavioral


title: Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care

acronym: ASPIC

summary:
Increasing emergence of multidrug resistant (MDR) bacteria worldwide is now considered one of the most urgent threats to global health. The association between increase of antibiotics consumption and resistance emergence has been well documented for all patients admitted to the Intensive care unit (ICU) who received antibiotic treatment and for patients treated for ventilator associated pneumonia (VAP).

Reduction of use of antibiotics is a major point in the war against antimicrobial resistance. VAP is the first cause of healthcare-associated infections in ICU and more than half of antibiotics prescriptions in ICU are due to VAP.

Once the diagnosis of pneumonia under MV has been made, initiation of antibiotic treatment must be prompt but there is no clear consensus on its duration. In the case of a good clinical response to treatment, it has been shown in some situations that short course antibiotics can be effective without side effects and antimicrobial stewardship initiatives can be applied successfully and effectively to the management of Community Acquired Pneumonia (CAP).

The hypothesis is that an antimicrobial stewardship is possible in the treatment of VAP with no increase in the rate of all-cause mortality, treatment failure or occurrence of new episode of pneumonia.

The objective is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia.

This study will be a prospective, national multicenter (24 centers), phase III, comparative randomized (1:1), single-blinded clinical trial comparing two management strategies of treatment of pneumonia on the basis of two parallel arms:

Experimental group: Antimicrobial stewardship based on daily clinical assessment of clinical cure.

Control group: standard management: duration of appropriate antibiotic therapy for confirmed VAP according to guidelines.

primary_purpose: Health Services Research


title: An Open-label, Non-randomized, Biopsy-based Mechanistic Study on Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ianalumab in Patients With Sjögren's Syndrome

summary: This study aims at elucidating the mechanism of action of ianalumab in salivary glands and explore relationships with clinical assessments

ipd_sharing: Yes

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals


title: Pathological Results After Downstaging of Agressive Hepatocellular Carcinoma Using 90Y-SIRT With Personalized Dosimetry

acronym: PAHCHS

summary:
The aim of our study is to analyze pathological analysis of surgically treated aggressive hepatocellular carcinomas after radio-embolization.

The investigators aim to demonstrate that a higher dose results in better tumor response while respecting safety conditions, that is, no radiologically induced liver disease.


title: Prospective Evaluation of Transplacental Transmission of SARS-COV-2 (COVID-19) in a Cohort of 10 Mother/Child Dyads

summary:
SARS-CoV-2, the agent responsible for pandemic COVID-19 infection, is transmitted mainly by respiratory droplets. Regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of placental contamination, trans-cervical or by environmental exposure. .

The case described by J. Vivanti of a newborn with neonatal neurological involvement and whose mother had been infected during the last trimester of pregnancy reports possible transplacental transmission in a context of positive and elevated viremia in the mother and positive viremia in the newborn.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Safety and Efficacy of a Strategy Extending Duration of Prone Position in COVID-19-related ARDS Patients. a Retrospective Monocentric Observational Study

summary: Prone position (PP) is standard of care for mechanically ventilated patients with severe acute respiratory distress syndrome in the intensive care unit (ICU). Recommendations suggest PP durations of at least 16 hours. In 2020, COVID-19 pandemic led to a great number of patients requiring mechanical ventilation and PP in the ICU. Risk of ICU staff viral contamination and work overload led to prolongation of PP duration up to 48 hours. Here investigators report outcomes of prolonged PP sessions in terms of skin complications (pression injuries) and ventilatory improvement.

ReferenceType: background

ReferenceCitation: Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

ReferenceCitation: Papazian L, Aubron C, Brochard L, Chiche JD, Combes A, Dreyfuss D, Forel JM, Guérin C, Jaber S, Mekontso-Dessap A, Mercat A, Richard JC, Roux D, Vieillard-Baron A, Faure H. Formal guidelines: management of acute respiratory distress syndrome. Ann Intensive Care. 2019 Jun 13;9(1):69. doi: 10.1186/s13613-019-0540-9. Review.

ReferenceCitation: Nasa P, Azoulay E, Khanna AK, Jain R, Gupta S, Javeri Y, Juneja D, Rangappa P, Sundararajan K, Alhazzani W, Antonelli M, Arabi YM, Bakker J, Brochard LJ, Deane AM, Du B, Einav S, Esteban A, Gajic O, Galvagno SM Jr, Guérin C, Jaber S, Khilnani GC, Koh Y, Lascarrou JB, Machado FR, Malbrain MLNG, Mancebo J, McCurdy MT, McGrath BA, Mehta S, Mekontso-Dessap A, Mer M, Nurok M, Park PK, Pelosi P, Peter JV, Phua J, Pilcher DV, Piquilloud L, Schellongowski P, Schultz MJ, Shankar-Hari M, Singh S, Sorbello M, Tiruvoipati R, Udy AA, Welte T, Myatra SN. Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method. Crit Care. 2021 Mar 16;25(1):106. doi: 10.1186/s13054-021-03491-y.

ReferenceCitation: Sud S, Friedrich JO, Adhikari NK, Taccone P, Mancebo J, Polli F, Latini R, Pesenti A, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L, Guérin C. Effect of prone positioning during mechanical ventilation on mortality among patients with acute respiratory distress syndrome: a systematic review and meta-analysis. CMAJ. 2014 Jul 8;186(10):E381-90. doi: 10.1503/cmaj.140081. Epub 2014 May 26. Review.

ReferenceCitation: Labeau SO, Afonso E, Benbenishty J, Blackwood B, Boulanger C, Brett SJ, Calvino-Gunther S, Chaboyer W, Coyer F, Deschepper M, François G, Honore PM, Jankovic R, Khanna AK, Llaurado-Serra M, Lin F, Rose L, Rubulotta F, Saager L, Williams G, Blot SI; DecubICUs Study Team; European Society of Intensive Care Medicine (ESICM) Trials Group Collaborators. Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study. Intensive Care Med. 2021 Feb;47(2):160-169. doi: 10.1007/s00134-020-06234-9. Epub 2020 Oct 9. Erratum in: Intensive Care Med. 2021 Apr;47(4):503-520.

ReferenceCitation: Gaudry S, Tuffet S, Lukaszewicz AC, Laplace C, Zucman N, Pocard M, Costaglioli B, Msika S, Duranteau J, Payen D, Dreyfuss D, Hajage D, Ricard JD. Prone positioning in acute respiratory distress syndrome after abdominal surgery: a multicenter retrospective study : SAPRONADONF (Study of Ards and PRONe position After abDOmiNal surgery in France). Ann Intensive Care. 2017 Dec;7(1):21. doi: 10.1186/s13613-017-0235-z. Epub 2017 Feb 24.

ReferenceType: derived

ReferenceCitation: Walter T, Zucman N, Mullaert J, Thiry I, Gernez C, Roux D, Ricard JD. Extended prone positioning duration for COVID-19-related ARDS: benefits and detriments. Crit Care. 2022 Jul 8;26(1):208. doi: 10.1186/s13054-022-04081-2.

lead_sponsor: Hôpital Louis Mourier

location_facility: Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris


title: Preliminary Study Evaluating Feasibility and Acceptability of a Psychological Management Program Focused on Body Dissatisfaction in Eating Disorders. SABG : Secondary Alveolar Bone Grafting

summary:
The cognitive model of Eating Disorders (ED) highlights dysfunctional cognitive patterns common to the different subtypes. Body dissatisfaction, which can be defined as the negative and subjective evaluation of one's body shape, i.e., negative thoughts and emotions concerning one's body image and the origin of pathological behaviours with the aim of modifying one's weight and body shape, thus appears to be a central transdiagnostic concept in the ED. It is, moreover, described as a major factor in the development, maintenance and relapse of the various types of ED.

It is suggested that Acceptance and Commitment Therapy (ACT) may be beneficial in treating body dissatisfaction insofar as body image inflexibility appears to influence the relationship between body image appraisal and coping strategies. ACT, which aims to develop psychological flexibility, appeared to us as a promising tool to manage body dissatisfaction in ED.

The investigators therefore aim to evaluate the feasibility and acceptability of a psychological management group for body dissatisfaction (9 or 10 weekly group session), based on ACT therapy, in patients suffering from an ED.


title: DENTAL CARE OF PATIENTS LIVING WITH HIV, OR COINFECTED HIV / HBV OR HIV / HCV, FOLLOWED IN THE INFECTIOUS DISEASES DEPARTMENT OF CHU CLERMONT-FERRAND

acronym: DENTA-VIH

summary: This study is perform to identify oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Risk of Osteoarthritis of the Knee at Least 5 Years After ACL Reconstruction: Comparative Study Between an Isolated ACL Reconstruction and a Reconstruction Combining ACL and ALL

summary: The main objective of this study is to compare, with a minimum follow-up of 5 years, the prevalence of femoro-tibial osteoarthritis after an isolated ACL ligamentoplasty or after an ACL ligamentoplasty combining ACL and ALL.

primary_purpose: Screening


title: Distribution of Knee Isokinetic Angle-specific Moments and Ratios: Searching for Normative Values in Healthy Subjects

acronym: MOMANGLE

summary: The quantification of the strength-producing capacity of the knee joint muscles by isokinetic measurement is one of the most widely used tools for monitoring and deciding whether to return to sport after ACL reconstruction. However, the isokinetic evaluation performed in current practice does not exploit all the measures offered by this exploration technique, which can lead to errors in analysis and interpretation of the results and underestimate its ability to predict a return to sport under optimal conditions. Recently, more complete analysis models than those currently in use and integrating the moment-angle relationship have thus proposed the use of functional ratios sweeping the whole amplitude of the knee joint. Baumgart proposed an analysis of the variation of isokinetic force moments at each angle after ligamentoplasty. This approach seems to be the future of isokinetic performance analyses, but for the moment this has only been used in pathological populations and on small numbers of patients (less than 40). There are therefore no reference values in healthy subjects.

primary_purpose: Basic Science

ReferenceCitation: Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25. Review.

ReferenceCitation: Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16.

ReferenceCitation: Baumgart C, Welling W, Hoppe MW, Freiwald J, Gokeler A. Angle-specific analysis of isokinetic quadriceps and hamstring torques and ratios in patients after ACL-reconstruction. BMC Sports Sci Med Rehabil. 2018 Dec 6;10:23. doi: 10.1186/s13102-018-0112-6. eCollection 2018.

lead_sponsor: University Hospital, Toulouse


title: Clinical Signs and Activity Limitations Associated With Dural Ectasia in Patients With Marfan Disease: Cross-sectional Case-control Study.

acronym: MARFANLOMB

summary:
Primary outcome is to compare the frequency and clinical features of spinal symptoms between Marfan patients with dural ectasia (cases) and those without (controls).

/ Frequency of orthostatic headaches
/ Frequency of low back pain due to orthostasis
/ Frequency of low back pain during Vasalva maneuvers
/ Frequency of lumbar claudication
/ Frequency of root claudication

Secondary outcomes are to compare activity limitations, quality of life and intensity of low back and radicular pain between Marfan patients with dural sac ectasia (cases) and those without (controls).

/ Average intensity of back pain measured on a self-administered digital scale (0 = no pain and 100 = maximum pain)
/ Average intensity of radicular pain measured on a self-administered digital scale (0 = no pain and 100 = maximum pain)
/ Activity limitations specific to the lumbar spine measured using the self-administered Oswestry Disability Index questionnaire (ODI, 0 = no limitations and 100 = maximum limitations)
/ Physical component of quality of life measured using the physical component of the self-administered questionnaire 12-Item Short Form Health Survey (SF-12, 9.95 = worst quality of life imaginable, 70.02 = worst quality of life imaginable )
/ Mental component of the quality of life measured using the mental component of the SF-12 self-administered questionnaire (5.89 = worst quality of life imaginable, 71.97 = worst quality of life imaginable)

time_perspective: Cross-Sectional

ReferenceCitation: Böker T, Vanem TT, Pripp AH, Rand-Hendriksen S, Paus B, Smith HJ, Lundby R. Dural ectasia in Marfan syndrome and other hereditary connective tissue disorders: a 10-year follow-up study. Spine J. 2019 Aug;19(8):1412-1421. doi: 10.1016/j.spinee.2019.04.010. Epub 2019 Apr 15.

ReferenceCitation: Chuzel Q, Dupuis-Girod S, Rousset M, Decharry C, Decullier E, Pialat JB. Assessment of Dural Ectasia Using Computed Tomodensitometry as a Criterion in Marfan Syndrome. J Comput Assist Tomogr. 2019 Mar/Apr;43(2):282-287. doi: 10.1097/RCT.0000000000000822.

ReferenceCitation: Foran JR, Pyeritz RE, Dietz HC, Sponseller PD. Characterization of the symptoms associated with dural ectasia in the Marfan patient. Am J Med Genet A. 2005 Apr 1;134A(1):58-65.

ReferenceCitation: Nguyen C, Papelard A, Schnitzler A, Mangione P, Poiraudeau S, Rannou F. Congenital lumbar spinal stenosis associated with Marfan syndrome. Joint Bone Spine. 2012 Mar;79(2):199-200. doi: 10.1016/j.jbspin.2011.07.007. Epub 2011 Oct 1.


title: Evaluation of the Impact of the Administration of Single Dose of Ivermectin in the Early Phase of COVID-19 on the Time to Negativation of the SARS-COV-2 Viral Load Determinated by RT-PCR

acronym: IVERCoV

summary:
The action of ivermectin in vitro on the viral replication of SARS-CoV-2 was demonstrated and published by an Australian team in June 2020. On the other hand, the doses to be administered in vivo to reach the concentrations described in vitro would lead to toxicities especially neurological, in treated patients, . However, some trials and studies, such as the ICON3 study, demonstrate the clinical efficacy of ivermectin administered at lower doses (200 µg / kg) in hospitalized patients with COVID-19.

The use of ivermectin in the early stages of the disease has not yet been studied. The administration of the maximum authorized dose (MA) of ivermectin could at least slow down the replication of the virus in vivo before the inflammatory phase of COVID-19, and reduce the duration of symptoms as well as the risk of hospitalization of patients, especially in critical care.

Unlike other studies conducted so far on COVID-19, IVERCoV will target the "viral" phase of the disease by screening patients in the city. In addition, home visits (symptom recording +/- PCR) will make it easier to monitor patients during the study.

status: Active, not recruiting

lead_sponsor: Raincy Montfermeil Hospital Group


title: EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial.

acronym: AXIOS-CPRE

summary: The main objective is to compare the EUS-BD with the insertion of a LAMS vs. traditional ERCP to restore biliary patency. Although ERCP has been the primary treatment for many years, it is associated with a significant risk of procedural complications and possible stent blockage. EUS-BD has been shown to be potentially safer and is associated with a lower risk of stent blockage. We seek with our study to determine whether EUS-BD may be the most effective treatment modality.


title: Constitutive Study of a Serum Bank and Plasma Bank of Healthy Subjects Comparators to Dialysis Subjects (SPSSCD)

acronym: SPSSCD

summary: To be able to evaluate the predictive value of glycosylated ferritin as a predictive marker of hepatic iron stock in dialysis patients, we need to validate these results with a cohort of healthy volunteers.


title: Skin Preparation of Patients Before Orthopedic Surgery : A Randomized Controlled Study on the Efficacy of Chlorhexidine Cloths Versus Chlorhexidine Soaps

acronym: POL

summary: Surgical site infections (SSI) in orthopedic surgery are rare events but associated with great morbidity as well as a significant additional cost. The World Health Organization (WHO) recently carried out meta-analyzes on all the existing prophylactic measures and could not rule on the use of chlorhexidine (CHX) cloths due to the low number of studies available. CHX cloths could actually benefit patients for whom preoperative showering is not possible, whether in emergency or trauma settings due to pain-induced functional impotence. A randomized controlled clinical study aimed at evaluating the in vivo microbiological efficacy of CHX cloths in a population of orthopedic surgery patients while evaluating the psycho-social determinants of adherence to a new preoperative preparation technique seems essential.

lead_sponsor: University Hospital, Grenoble


title: EEG Encephalopathy Patterns in Immune Effectors Cells-associated Neurotoxicity Syndrome : a Prospective Observational Study

summary:
Immune effectors cells-associated neurotoxicity syndrome (ICANS) is one of the most clearly defined acute toxicities after CAR-T cells infusion.

The investigators conducted a prospective cohort study of all patients who received CAR T cell infusions on the hematology department from Montpellier University Medical Center.

Each patient was assessed between the 6th and 8th day after infusion by a neurological clinical examination, an electroencephalogram, and a brain MRI.

The aim of the studies is to describe the EEG pattern associated with ICANS.

lead_sponsor: University Hospital, Montpellier


title: A Comparative Study Between Malone Procedure and Percutaneaous Endoscopic Caecostomy in Patients Treated With Antegrade Colonic Enema for Severe Anal Incontinence and/or Constipation

acronym: MAPEC

summary:
Background: Antegrade colonic enema (ACE) is a second intent treatment of severe constipation and/or fecal incontinence following the failure of medical treatment. ACE is classically administered through a percutaneous access to the caecum performed surgically according to the Malone procedure (MP). Recently, a novel endoscopic approach named Percutaneous Endoscopic Caecostomy (PEC) has been proposed to perform the percutaneous access to the caecum. PEC has never been compared to the traditional MP in terms of postoperative quality of life and functional outcomes.

Objective: The aim of the study is to compare postoperative quality of life between MP and PEC in patients treated with ACE for severe constipation and/or fecal incontinence.

Hypothesis: MP and PEC achieve similar quality of life outcomes. Methods: All patients from two prospective databases who underwent MP or PEC for severe constipation and/or fecal incontinence between 2006 and 2016 will be included. They will be contacted to answer questionnaires about quality of life (GIQLI) and functional outcomes including constipation, fecal incontinence and body image assessment (KESS, Wexner and BIQ scores respectively). The main measured outcome will be GIQLI score.

Results: The results of this comparative study will determine if the endoscopic and the surgical approaches are similar in terms of quality of life, or if one of them is better than the other. This study will clarify the optimal protocol to perform a caecal percutaneous access before ACE administration in patients suffering from severe constipation and/or fecal incontinence.

lead_sponsor: Nantes University Hospital


title: Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma: a Double Blind Prospective Randomzed Study

acronym: Kligman

summary: Kligman's trio remains the gold standard treatment for melasma. It contain hydroquinone which is an effective anti-melanogenic compound but that has poor tolerance and numerous side-effects. Thiamidol has been proven to be at least as effective as hydroquinone and has a very good safety profile. The objective of this study is to compare the Kligman's trio to the same preparation in which hydroquinone is replaced by thiamidol.


title: Efficacy at One Year of Combined Injections of Plasma Rich in Platelets and Hyaluronic Acid in Knee Osteoarthritis

acronym: ISPAG

summary: 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.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: A Double-blind, Placebo-controlled Pilot Trial of BP1.4979 for the Treatment of Binge Eating Disorder

lead_sponsor: Bioprojet

type: EudraCT Number

source: euctr

location_facility: Nutrition Department, La Pitié Salpêtrière Hospital

summary: This pilot study is to assess the efficacy and safety of BP1.4979 15 mg BID in female patients with moderate to severe binge eating disorder (BED), as defined according to DSM-5 guidelines.


title: Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle: A Cross-sectional Observational Multicenter Prospective Study

summary:
Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Among CHD, univentricular heart disease or "single ventricle" is rare and complex. As a result of the improved patient care over the last decades, the number of children and adults with single ventricle is increasing significantly. Today, the main challenge is to ensure an optimal follow-up of these new patients in order to improve their life expenctancy as well as their quality of life (QoL). Currently, echocardiography and cardiopulmonary exercice test (CPET) are central in management of patients with single ventricle as part of good clinical practice guidelines.

Single ventricle volumes and function are very difficult to asses with conventional echocardiography because of their complex geometry. Indeed, single ventricle size and morphology vary depending on the patient characteristics and on the initial CHD (before surgical repair). That's why conventional 2D echocardiographic parameters are not reliable for single ventricle assessment.

Magnetic resonance imaging (MRI) is more effective in assessing single ventricle volumes and function. Nevertheless, MRI is not universally available, is not practical in many situations, is expensive, and is a relative contraindication in patients with pacemakers.

Over the past decade, the use of the 3D echocardiography has increased. This is an available tool that can assess ventricular function and volumes in few seconds. Recent studies shown a good correlation between 3D echocardiography and MRI for assessment of ventricular volumes and function in patient with CHD and especially in those with single ventricle.

Moreover, according to some authors, CPET parameters are strongly correlated with risk of hospitalization, risk of death, physical activity and quality of life, especially in patients with single ventricle.

To date, there is no study performed about the relationship between 3D echocardiography and CPET parameters in patients with single ventricle.


title: Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms: a Patient-derived Tumoroids Prospective Collection From Systemic Treatment Naive Tumors

acronym: CRC-ORGA 2

summary: Colorectal cancer is the third most common cancer worldwide and its progression-free survival is still low, around 10 months. Thirthy to 50% of patients do not respond to chemotherapy upon initiation of treatment, suggesting that early development of chemoresistance mechanisms remains a major challenge. In order to better characterize these mechanisms, we aim to develop a model of tumoroids derived from patients with a colorectal tumors prior to any systemic anti cancer treatment. This project will both allow us to study the role of the immunological microenvironment in chemoresistance and identify new predictive markers of tumor response. It will then serve to develop innovative personalized medicine strategies by targeting the newly identified mechanisms. This study should in fine help to improve the cancer patient's care.


title: Evaluation of Pétale® (Small Hearing Test Equipment for Children) for the Screening of Hearing Disorders in Children From 9 Months to 3 Years Old by the General Practitioner or Pediatrician

acronym: PETALE

summary: The aim of this study is to confirm the value of this new version of Pétale® ((small equipment for testing the child's hearing) in the daily practice of general practitioners or pediatricians for the screening of hearing disorders in very young children.


title: The Effect of the Consumption of 4 Botanical Extracts (Acerola, Panax Ginseng, Echinacea, Quillaja) on the Innate and Adaptive Immune Response in Healthy Adults: a Pilot Randomized Placebo-controlled Clinical Trial

summary: This study will evaluate the capacity of botanical extracts to modulate immune mechanisms compared to a placebo group in healthy volunteers.

lead_sponsor: Naturex SA

intervention_type: Dietary Supplement


title: Single-center Retrospective Study of the Long-term Results of the Stapled TransAnal Rectal Resection (STARR) Operation Proposed in the Treatment of a Rectocele in Consecutive Patients

acronym: STARRLOC

summary: Rectal static disorders, including the rectocele, represent a frequent functional pathology which affects the quality of life of affected patients. Among vaginal treatments, the STARR technique corresponds to rectal resection by transanal approach using a stapler. The American Gastroenterology Association (AGA) has concluded that service to patients is insufficient. The technical and functional results published are mostly short-term studies. The investigators seek to assess the technical and functional results of Operation STARR, based on a series of consecutive expert center cases, to confirm or refute the conclusions of the AGA recommendations.

time_perspective: Other

ReferenceCitation: Lehur PA, Stuto A, Fantoli M, Villani RD, Queralto M, Lazorthes F, Hershman M, Carriero A, Pigot F, Meurette G, Narisetty P, Villet R; ODS II Study Group. Outcomes of stapled transanal rectal resection vs. biofeedback for the treatment of outlet obstruction associated with rectal intussusception and rectocele: a multicenter, randomized, controlled trial. Dis Colon Rectum. 2008 Nov;51(11):1611-8. doi: 10.1007/s10350-008-9378-1. Epub 2008 Jul 19. Erratum In: Dis Colon Rectum. 2008 Nov;51(11):1739. Narisetty, Prashanty [corrected to Narisetty, Prashanthi].

ReferenceCitation: Slim K, Mezoughi S, Launay-Savary MV, Tuech JJ, Michot F, Sielezneff I, Sastre B, Pigot F, Juguet F, Faucheron JL, Voirin D, Chipponi J. [Repair of rectocele using the Stapled TransAnal Rectal Resection (STARR) technique: intermediate results from a multicenter French study]. J Chir (Paris). 2008 Jan-Feb;145(1):27-31. doi: 10.1016/s0021-7697(08)70298-9. French.

ReferenceCitation: Gagliardi G, Pescatori M, Altomare DF, Binda GA, Bottini C, Dodi G, Filingeri V, Milito G, Rinaldi M, Romano G, Spazzafumo L, Trompetto M; Italian Society of Colo-Rectal Surgery (SICCR). Results, outcome predictors, and complications after stapled transanal rectal resection for obstructed defecation. Dis Colon Rectum. 2008 Feb;51(2):186-95; discussion 195. doi: 10.1007/s10350-007-9096-0. Epub 2007 Dec 22.

ReferenceCitation: Liu WC, Wan SL, Yaseen SM, Ren XH, Tian CP, Ding Z, Zheng KY, Wu YH, Jiang CQ, Qian Q. Transanal surgery for obstructed defecation syndrome: Literature review and a single-center experience. World J Gastroenterol. 2016 Sep 21;22(35):7983-98. doi: 10.3748/wjg.v22.i35.7983.

location_facility: CHU Grenoble Alpes, Service de chirurgie digestive et de l'urgence


title: Measure of Stress After the First Wave of Covid 19 Within Hospital Workers

summary:
As of December 2019, the global pandemic of COVID-19 has spread rapidly throughout the world, putting healthcare staff at the frontline.

In this context, several factors leading to the appearance of psychiatric symptoms have emerged : work overload, fear of being infected or of infecting, exhaustion… (The Lancet, 2020)

Indeed, post-traumatic stress disorder (PTSD), depressive symptoms, anxiety symptoms, insomnia and increased stress have been reported (Rossi et al., 2020).

Furthermore, the increased anxiety and depression symptoms and stress associated with the COVID-19 pandemic may increase the risk of suicide in this already high-risk population. For example, suicidal ideation has been reported in up to 5% of healthcare workers in the United States (Young et al., 2021).

It is therefore essential to evaluate the incidence of psychiatric disorders (e.g. PTSD, depression, suicide) and their associated risk factors among the hospital staff.

To do so, Montpellier University Hospital healthcare staff was asked their mental state during the first wave of COVID-19.


title: Analysis of Emergency Department Visits and Activity in Montpellier Dental University Hospital : Study Protocol

acronym: EOTDES

summary: The main objective will be to evaluate the type of care performed and the main reasons for consulting patients for an odontological emergency in order to better adapt to the flow and expectations of patients.


title: HIV and Inflammatory or Autoimmune Disease: Rare Patients, Many Questions (MAIVIH)

acronym: MAIVIH

summary: Follow-up registry of patients living with HIV who also have various inflammatory and autoimmune pathologies that may require immunosuppressive treatment.

lead_sponsor: Tourcoing Hospital


title: Genetic Study of Idiopathic Scoliosis in a Cohort of Families

acronym: SCOGEN

summary: This study will focus on a large cohort of multiplex families, to precisely identify candidate genes. The fact of have a large database (fifty families, collected by the principal investigator for more than two decades), will contribute to the discovery of genes of interest. It will also allow testing for the presence or absence of mutations found in other cohorts in previous studies. The main objective of this study is to identify genetic abnormalities associated with the presence and severity of idiopathic scoliosis, in families of scoliosis.

lead_sponsor: Ramsay Générale de Santé


title: Development of MRI Protocols and Associated Neuro-physiological Explorations in Healthy and Pathological Subjects

acronym: MAP-IRMaGE

summary: IRMaGe is a Joint Service Unit (UMS) which provides users of brain exploration equipment (clinical MRI and preclinical, TMS, EEG, NIRS and metabolomics). The methods available on this equipment are intended to evolve according to the most recent discoveries and this protocol aims to frame the developments necessary around clinical MRI for IRMaGe can continue to offer tools at the cutting edge of technology.


title: Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis: an Exploratory Study

acronym: PsyHistio

summary:
Pulmonary Langerhans cell histiocytosis (PLCH) is a rare disease, of unknown etiology, that occurs almost exclusively in smokers.The clinical experience suggests a high prevalence of anxiety symptoms and an addictive profile. However, no study to date has precisely investigated the prevalence of co-morbid psychiatric disorders in this population.The aim of the study is to evaluate the prevalence of co-morbid psychiatric disorders in adult PLCH patients.

This study should allow:

to assess the prevalence of psychiatric disorders co-morbid in PLCH patients
a targeted and more effective management of patients
a better response rate to smoking and cannabis weaning, that represents a major goal for these patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Saint-Louis, Centre de référence national des histiocytoses, Service de Pneumologie


title: Peripheral Artery Disease (PAD) : Its Effects on Bone

acronym: AMICOS

summary:
Prevalence of PAD and osteoporosis (OP) both get higher with age. Clinical and epidemiologic evidence have showed an increased cardiovascular risk in OP and bone loss and fragility fractures in patient with cardiovascular disease.

This study will examine the relationship between vascular disease in legs and sBMD and vBMD at trabecular and cortical sites and bone microarchitecture.

ReferenceCitation: Bréban S, Benhamou CL, Chappard C. Dual-energy X-ray absorptiometry assessment of tibial mid-third bone mineral density in young athletes. J Clin Densitom. 2009 Jan-Mar;12(1):22-7. doi: 10.1016/j.jocd.2008.10.009. Epub 2008 Dec 25.

ReferenceCitation: Collins TC, Ewing SK, Diem SJ, Taylor BC, Orwoll ES, Cummings SR, Strotmeyer ES, Ensrud KE; Osteoporotic Fractures in Men (MrOS) Study Group. Peripheral arterial disease is associated with higher rates of hip bone loss and increased fracture risk in older men. Circulation. 2009 May 5;119(17):2305-12. doi: 10.1161/CIRCULATIONAHA.108.820993. Epub 2009 Apr 20.

ReferenceCitation: Fehérvári M, Sarkadi H, Krepuska M, Sótonyi P, Acsády G, Entz L, Lakatos P, Szeberin Z. Bone mineral density is associated with site-specific atherosclerosis in patients with severe peripheral artery disease. Calcif Tissue Int. 2013 Jul;93(1):55-61. doi: 10.1007/s00223-013-9727-5. Epub 2013 Apr 6.

ReferenceCitation: Gaudio A, Muratore F, Fiore V, Rapisarda R, Signorelli SS, Fiore CE. Decreased bone cortical density at the forearm in subjects with subclinical peripheral arterial disease. Osteoporos Int. 2015 Jun;26(6):1747-53. doi: 10.1007/s00198-015-3057-6. Epub 2015 Feb 12.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: LIPId Profile Changes in Inflammatory Conditions Induced by SARS-CORoronavirus-2 : LIPICOR Study

acronym: LIPICOR

summary:
In late 2019, a new coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the cause of COVID-19 (COronaVIrus Disease-2019) in Hubei Province, China. COVID-19 has become a pandemic with approximately 4.1 million confirmed cases as of May 2020 resulting in 280,000 deaths worldwide. Between 5 and 20% of patients hospitalized with SARS-CoV-2 infection are admitted to the ICU with a mortality ranging from 25 to 60% depending on the series. At present, there is no effective targeted therapy against this viral infection.

High-density lipoproteins (HDL) are nanoparticles made up of apolipoproteins, mainly apoA1, associated with phospholipids whose main function is the reverse transport of cholesterol from peripheral tissues to the liver. This property gives HDL a major cardiovascular protective effect. In addition to this effect, studies have highlighted a number of properties such as anti-inflammatory, anti-apoptotic, anti-thrombotic and anti-oxidant effects of these particles. Furthermore, it has been shown that HDL is able to bind and neutralize bacterial lipopolysaccharides (LPS), promoting their elimination.

During bacterial sepsis, a rapid decrease in plasma HDL cholesterol (HDL-C) concentration has been demonstrated, but also an inverse correlation between mortality and HDL-C concentration. In addition to the quantitative decrease in HDL during sepsis, dysfunctions of these particles have been described, such as major differences in size, or a notable alteration in protein composition with, in particular, more pro-inflammatory proteins. In this context of both quantitative and qualitative alteration of HDL, authors have tested the efficacy of injection of either reconstituted HDL (apoA1 + phosphatidylcholines) or peptides structurally similar to ApoA1 in animal models of sepsis and have demonstrated a protective effect on morbidity and mortality, with in particular a decrease in the inflammatory state induced by sepsis.

Low-density lipoproteins (LDL) can also neutralize LPS and observational studies have shown a decrease in the concentration of LDL cholesterol (LDL-C) during sepsis. The authors also showed that low LDL-C was associated with a poor prognosis in patients with sepsis.

During COVID-19-induced sepsis, a few studies have demonstrated a decrease in lipoprotein (HDL and LDL) concentration. More specifically, some authors have found an association between low lipoprotein concentrations and increased disease severity. To the best of the knowledge of the investigators, no study has specifically investigated particulate dysfunction of lipoproteins and in particular HDL during severe COVID-19 infections. On the other hand, as it has been described that lipoproteins and particularly HDL can bind bacterial components (LPS or LTA) favoring their clearance, it can be envisaged that these particles can also bind SARS-CoV-2 components, and this, in a more or less strong way depending on the virus strain.

The preliminary results of the investigators show that in sepsis, serum amyloid A (SAA) protein tends to replace apolipoprotein A1, making HDL dysfunctional. In addition, paraoxonase-1, an antioxidant enzyme mainly carried by HDL, is almost absent or degraded in septic patients. The SAA/PON-1 ratio could allow to assess the severity of COVID-19 damage and to reinforce a possible therapeutic strategy based on the supplementation of severe patients with apolipoprotein A1 and PON-1 rich HDL nanoparticles.

Main objective: To evaluate the functionality of HDL as a prognostic marker of mortality in COVID-19 patients in ICU. To do so, a quantification of the SAA/PON-1 ratio at plasma level and on isolated lipoproteins will be performed by ELISA.


title: Treatment of Hyperlactatemia in Acute Circulatory Failure Based on Analysis of CO2: a Prospective Randomized Superiority Study (The LACTEL Study)

acronym: LACTEL

summary:
The management of a patient with shock is based on improving tissue oxygenation through hemodynamic optimization. Lactate is a marker of tissue hypoperfusion commonly used in the ICU. In principle, hyperlactatemia can be caused by either increased tissue production (tissue hypoperfusion: type A), decreased lactate uptake (type B), or a combination of both mechanisms. It is important to correctly determine the cause(s) of hyperlactatemia, as this determines the treatment (expanders, inotrope, vasopressor, blood derivative transfusion), and the patient's morbidity and mortality. A classic example of this concept is volume expanders, which are frequently used to correct hyperlactatemia secondary to tissue hypoperfusion, but are associated with mortality if used excessively (fluid overload). In clinical practice, it is difficult to differentiate the exact causes of hyperlactatemia (type A and type B). From work carried out over the last 20 years in septic shock and then in other states of shock and in the operating theatre, it has been shown that the arteriovenous CO2 gradient (pCO2gap) measured from arterial and venous blood gases is a marker of tissue hypoperfusion with better predictive ability than the usual markers (clinical examination, SVO2....). Furthermore, when we relate pCO2gap to the arteriovenous O2 difference (pCO2gap /C(a-v)O2), this ratio allows us to distinguish with greater accuracy between states of acute circulatory failure associated with anaerobiosis (tissue hypoperfusion, type A) and those related to the underlying disease.

Also, several studies have demonstrated a strong ability of the pCO2gap and the pCO2gap/CavO2 ratio to predict the severity of shock, mortality of the shock patient, hyperlactatemia, and correction of hyperlactatemia with hemodynamic treatment. As a result, many authors have proposed algorithms for the management of shock patients based on the measurement of these CO2-derived indexes.

The hypothesis of this study is that the use of an algorithm based on CO2gap and the CO2gap/CavO2 ratio is superior in terms of correction of hyperlactatemia to usual practice based on clinical and macro-hemodynamics.

ReferenceCitation: Caruso V, Besch G, Nguyen M, Pili-Floury S, Bouhemad B, Guinot PG; Lactel Study Group. Treatment of Hyperlactatemia in Acute Circulatory Failure Based on CO(2)-O(2)-Derived Indices: Study Protocol for a Prospective, Multicentric, Single, Blind, Randomized, Superiority Study (The LACTEL Study). Front Cardiovasc Med. 2022 Jun 23;9:898406. doi: 10.3389/fcvm.2022.898406. eCollection 2022.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: NEw Clinical Endpoints in Patients With Primary Sjögren's Syndrome (pSS): an Interventional Trial Based on stratifYing Patients

acronym: NECESSITY

summary:
There are no approved treatments for pSS and the clinical endpoints currently used in clinical trials are inadequate to capture all aspects of the disease that should be evaluated in clinical trials. The newly developed composite endpoint: Sjögren's Tool for Assessing Response to treatment (STAR) will allow a more specific and meaningful assessment of treatment efficacy in pSS.

Because of the heterogeneity of the disease and of the central role of the interplay between B- and T-cells in the pathogenesis, it is worth to evaluate combination of conventional synthetic immunomodulatory drugs targeting both B- and T-cells.


title: Norepinephrine Load and Relationship With Prognosis in Critically Patients With Circulatory Shock

summary:
Norepinephrine is recommended as first-line vasopressor in critically ill patients, regardless of shock etiology. Its advantages over dopamine and/or epinephrine have been demonstrated, especially by reducing tachycardia events. The current guidelines recommend a mean arterial pressure of at least 65 mmHg that in the resuscitation from sepsis-induced hypoperfusion. Some study reported that delay in initiation of vasopressor therapy was associated with an increase mortality risk in patient with septic shock .The recent experts' opinion suggest that " vasopressors should be started early, before (complete) completion of fluid ressuscitation ".

In the event of refractory septic shock, high-dose vasopressors may be used. The precise maximal dose of norepinephrine associated with mortality excess has been poorly studied. High doses have been defined by a cutoff value ranging from 0.5 μg/kg/min to 2 μg/kg/min and recently by 1 μg/kg/min for mortality at 90% and by 0,75 μg/kg/min for mortality at 60%. Furthermore, an increasing vasopressor dosing intensity during the first 24 hours after shock septic was associated with increased mortality depending of fluid administration. If a threshold value of norepinephrine score can be obtained, it could indicate the association with another vasopressor such as vasopressin or surrogates.

The primary aim of the present study aimed to confirm if a given norepinephrine dose is associated with mortality. The secondary aims were the link between mortality and norepinephrine duration, cumulative dose in order to build a score that predicts a futility of increasing norepinephrine dose.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Altération Des Fibres élastiques Dermiques au Cours Des Dermatoses Calcifiantes : étude Structurelle en Microscopie Multiphoton

acronym: Calciphoton

summary: The spectrum of pathologies accompanied by tissue mineral deposits is wide. In dermatology, several pathologies are associated with calcium mineral deposits, such as calciphylaxis and pseudoxanthoma elasticum (PXE). However, few studies have been carried out on the chemical characteristics of these deposits, their implication on the pathophysiology and their consequences. This motivated our two previous studies on the characterization of skin mineral deposits during calciphylaxis and sarcoidosis. We have shown that these deposits were most often composed of carbapatite and preferentially localized to elastic fibers. Most calcifying dermatoses are preceded by an inflammatory skin condition. Some authors suspect the digestion of elastin by metalloproteinase (MMP) of the extracellular matrix, thus creating nucleation nuclei favoring phosphocalcic deposits. We thus wish to study the structural alteration of dermal elastic fibers during calcifying dermatoses using multiphoton microscopy, a tool available at the Laboratoire d'Optique et Biosciences (LOB) at the Ecole Polytechnique. Multiphoton microscopy presents several contrast modes that can be used in parallel and without marking. This makes it possible to identify constituent elements of tissues without the use of artificially added fluorescent dyes or proteins, for example fibrillar collagen by the so-called "SHG" contrast and elastin by its intrinsic fluorescence. It is then possible to deeply image an intact tissue, without staining, by specifically visualizing its various components. Used in several studies on the skin, including the LOB, multiphoton microscopy has shown its interest in the characterization of dermal fibers, in particular elastin and collagen fibers, but also in the structural study of these and of their possible alteration. It has thus been applied to the study of skin aging, but also of pathologies leading to degeneration of elastic fibers (PXE) or collagen (Marfan syndrome). The main objective of our project is to characterize the structural alterations of elastic fibers during calcifying dermatoses. The secondary objectives are to study the consequences of skin inflammatory phenomena on the deterioration of elastic fibers and to identify a possible nucleus of phospho-calcium deposits within elastic dermal and vascular fibers. We will thus study human skin biopsies already carried out in the context of the diagnosis of these calcifying dermatoses, skin biopsies from the murine model of PXE and in control, human biopsies of healthy skin from patients of different ages (excision margin of skin tumors). This project should provide a better understanding of the genesis of skin phosphocalcic deposits and provide therapeutic avenues for treating them and limiting their occurrence.

location_facility: Service de gériatrie plaies et cicatrisation


title: Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery

acronym: AGORA

summary: Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Health-related Quality of Life (HRQoL) and Physical, Psychological and Cognitive Impairments After Intensive Care Unit (ICU)Discharge A Longitudinal Cohort Study

summary:
Diagnostic and therapeutic progress of the last twenty years has been accompanied by an evolution in the morbidity and mortality of intensive care unit (ICU) patients. While there has been an overall decrease in mortality in the ICU, nearly 20% of patients die within one year after ICU discharge and survivors are marked by an increase in morbidity.

Indeed, independently of the initial disease, it is currently recognized that an admission to the ICU can be experienced as a traumatic situation, with potential physical, psychological and cognitive impairments that can be described by the term "post-intensive care syndrome" (PICS). This results in a decrease in quality of life compared to the general population.

Health-related quality of life (HRQoL)has received increasing attention in the literature. Thus, many studies have been interested in its evaluation, in particular in certain pathologies such as acute respiratory distress syndrome (ARDS), sepsis, cardiac arrest or in patients with onco-hematological diseases.

Paradoxically, few studies have described the HRQoL and the elements of the PICS in the overall population of patients admitted to the ICU. However, a better understanding of these elements could allow us to propose improvement strategies to facilitate the rehabilitation of these patients.

lead_sponsor: Versailles Hospital


title: Analysis of the Kinematics of the Shoulder Complex in Sports "Overhead" Gestures Such as Kayaking Polo Throwing (Overhead)

acronym: Overhead

summary: The objective of this study is to analyze the throwing gesture specific to the kayak polo. A throw in a seated position with fixation of the pelvis (by the seat) and antepulsion of the hip ipsilateral to the throwing shoulder.


title: Securing the Immediate Perioperative Walk: Creating and Validating a Score.

acronym: Déambu

summary: The aim of this study is to set up a pre and postoperative ambulation score on a population of adult patients and undergoing outpatient surgery operated under locoregional anesthesia and sedation.


title: Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)

acronym: VOC-BPCO

summary: This is a prospective interventional study to determine whether the profile of volatile organic compounds (VOCs) present in exhaled air (VOLATOLOM) is reproducible in stable severe COPD (Chronic Obstructive Pulmonary Disease) patients.

lead_sponsor: Hopital Foch


title: Pursuit of Vaccination in Anaphylactic Reaction to COVID19 Vaccines

acronym: COVALL

summary:
Prospective monocentric study designed firstly to estimate the proportion of patients who tolerated the continuation of the COVID-19 2nd injection (absence of anaphylactic manifestations).

secondly, to know the proportion of definite anaphylactic reactions in cases of suspected anaphylaxis after the first administration of a COVID-19 vaccine the very complete allergological explorations with both the clinical side, skin tests and biological tests will allow us to highlight the responsibility or not of the components of the vaccine,in particular of the excipients (PEG2000, PS80 and tromethamine) in anaphylactic reactions to COVID-19 vaccines A biological collection will be set up during this clinical study in order to study the immunological mechanisms; the effector cells and the signalling pathways involved in these reactions.

location_facility: Tenon Hospital APHP dermatology and allergology department


title: Monitoring of Progesterone Administered in Infertile Patients During a Cycle of Frozen Embryo Transfer: a Population Pharmacokinetic Study.

acronym: PEKAPROGE

summary: During an In Vitro Fertilization (IVF) attempt, several embryos are obtained but not all of them can be transferred to the uterus in the same cycle due to the risk of multiple pregnancies. Thus, it is very common for these couples to benefit from cryopreservation. Patients scheduled for frozen embryo transfer (TEC) receive estrogen and progesterone replacement therapy to prepare the endometrium for implantation. Data from the literature recently showed that low progesterone on the day of embryo transfer was responsible for a significantly higher rate of implantation failure and miscarriage.

lead_sponsor: University Hospital, Toulouse


title: Exploring the Psycho-traumatic Impact of a Violent Act Commited - Study Among Inmates of the Bordeaux-Gradignan Penitentiary Center

acronym: IPTAVC

summary: The study will seek to explore the possibility of developing post-traumatic stress disorder following a violent offense commited, among the population of prisoners of the Bordeaux-Gradignan penitentiary center.

ReferenceCitation: Koenen KC, Ratanatharathorn A, Ng L, McLaughlin KA, Bromet EJ, Stein DJ, Karam EG, Meron Ruscio A, Benjet C, Scott K, Atwoli L, Petukhova M, Lim CCW, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Bunting B, Ciutan M, de Girolamo G, Degenhardt L, Gureje O, Haro JM, Huang Y, Kawakami N, Lee S, Navarro-Mateu F, Pennell BE, Piazza M, Sampson N, Ten Have M, Torres Y, Viana MC, Williams D, Xavier M, Kessler RC. Posttraumatic stress disorder in the World Mental Health Surveys. Psychol Med. 2017 Oct;47(13):2260-2274. doi: 10.1017/S0033291717000708. Epub 2017 Apr 7.

ReferenceCitation: Baranyi G, Cassidy M, Fazel S, Priebe S, Mundt AP. Prevalence of Posttraumatic Stress Disorder in Prisoners. Epidemiol Rev. 2018 Jun 1;40(1):134-145. doi: 10.1093/epirev/mxx015. Erratum in: Epidemiol Rev. 2018 Jun 1;40(1):166.

ReferenceCitation: Ashbaugh AR, Houle-Johnson S, Herbert C, El-Hage W, Brunet A. Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). PLoS One. 2016 Oct 10;11(10):e0161645. doi: 10.1371/journal.pone.0161645. eCollection 2016.

ReferenceCitation: Jakobowitz S, Bebbington P, McKenzie N, Iveson R, Duffield G, Kerr M, Killaspy H. Assessing needs for psychiatric treatment in prisoners: 2. Met and unmet need. Soc Psychiatry Psychiatr Epidemiol. 2017 Feb;52(2):231-240. doi: 10.1007/s00127-016-1313-5. Epub 2016 Nov 22.

ReferenceCitation: Vaiva G, Jehel L, Cottencin O, Ducrocq F, Duchet C, Omnes C, Genest P, Rouillon F, Roelandt JL. [Prevalence of trauma-related disorders in the French WHO study: Santé mentale en population générale (SMPG)]. Encephale. 2008 Dec;34(6):577-83. doi: 10.1016/j.encep.2007.11.006. Epub 2008 Apr 2. French.

ipd_sharing_description: no IPD sharing plan

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux


title: Psychogenic and Neurogenic Components in Patients With Psychogenic or Neuropathic Pruritus : PRURINEURO, a Pilot Study

acronym: PRURINEURO

summary:
Scientific research on pruritus is in intensive development, with significant advances in understanding its pathophysiology. The causes of pruritus are very huge; they can be classified into different categories; we can find dermatological causes, systemic causes, neuropathic or neurological causes, psychogenic or even idiopathic causes.

The diagnosis of psychogenic pruritus is often over stated, when no cause is found; therefore, it is important to see what is really relieving from psychic so as not to over-diagnose and adopt a therapy more in line with the real problem of the patient. In daily practice, it seems to have a tendency to separate psychogenic and neurogenic etiologies in the diagnosis of neuropathic or psychogenic pruritus.

In the case of patients with psychogenic pruritus and neuropathic pruritus, no study has attempted to study the respective part of psychogenic and neurogenic components. Consequently, it would therefore be interesting to assess the areas of superposition and distinction of neuropathic and psychogenic pruritus.

The aim of this pilot study is to assess the psychogenic and neurogenic components of psychogenic pruritus and neuropathic pruritus in order to improve understanding of the mechanism and therefore their management.

The main objective of this study is to highlight the differences and the potential common characteristics between psychogenic and neuropathic pruritus in order to improve the differential diagnosis between these two pathologies.

The secondary objective of this study is to describe the psychogenic and neurogenic characteristics of psychogenic and neuropathic pruritus.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)

summary: Prospective, nonrandomized, single-center, comparative study to define if right ventricular (RV) contractile reserve assessed by exercise CMR helps to improve the differential diagnosis between pathological and physiological remodeling of the RV; ie. arrhythmogenic right ventricular cardiomyopathy (ARVC) and athlete's heart.

lead_sponsor: Rennes University Hospital


title: OSV-IRM - Volunteer MRI Sequence Optimization

acronym: OSV-IRM

summary:
Optimization of magnetic resonance imaging (MRI) protocols on healthy volunteers and voluntary patients.

In MRI, a large number of technical parameters (sequence, parameters in sequence, antenna, reconstruction method, etc.) can be changed to optimize the diagnostic quality of the exam. Some optimizations can be performed on participants healthy volunteers, others need to be carried out on images pathological and acquired in voluntary patients.


title: Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

acronym: iGRAISSE

summary:
The goal is to have a small spectrometer (pocket size) , reliable and rapid tool that can be used during liver harvesting, which enables macrosteatosis to be evaluated reproducibly and selectively, at any time.

This tool must be minimally invasive, inexpensive and without significantly impacting the general organization of multi-organ harvesting.

In the operating room, the surgeon will perform an intraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta. The surgeon will not be informed of the results of the spectrometer, and will carry out (or not) the biopsy. The spectrometers' results will be compared with definitive histological findings.

location_facility: Centre Hépato Biliaire de l'hopital Paul Brousse