title: Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia : Prenatal Cephal

summary:
Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be present at birth. After birth, the diagnosis of retrognathia is based on the clinical examination. Cephalometry can be used to complete the diagnosis. Several authors have proposed the use of objective quantitative ultrasound parameters for the antenatal screening of PRS. In our study, the investigators evaluated fetal cephalometry.

The aim First, the investigators studied the inter- and intra-observer reproducibility of cephalometry. Second, the investigators established reference values for antenatal cephalometry in normal fetuses. Third, the investigators compared the diagnostic performance of cephalometry and the other angles described in the literature for the diagnosis of retrognathia.


type: Other Identifier

title: COLETTE : Study of the Pathophysiology of Status Epilepticus and Dysimmune Encephalitis and Identification of Valuable Biomarkers

acronym: COLETTE

summary: COLETTE is an interventional study for which blood, cerebrospinal fluid and post-mortem tissues are collected in patients with status epilepticus or epilepsy associated to dysimmune encephalitis as well as in control patients, to better understand the pathophysiology of these severe epileptic disorders.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders of People With Cognitive Disorders Hospitalized in Long-Term Care Units and in Reinforced Hosting Unit

acronym: TOVERTAFEL

summary:
The prevalence of behavioral disorders is high in patients living in an institutional environment or hospitalized in a long-term care unit. The consequences of these symptoms are not negligible with a faster cognitive decline and a significant impact on the life of the institution and of other patients when the disorders are pervasive and too difficult to manage for the healthcare teams.

Despite the daily attention paid to these disorders and their causes, especially the environmental ones, the teams are sometimes helpless, the teams are sometimes helpless today to fight against these symptoms, and their management thus constitutes a real challenge.

Non-drug interventions targeting this problem often require additional training, architectural installations (Snoezelen space) and / or are moderately effective. In order to offer a solution that can be used by everyone, that is transportable and based on new technologies, the TOVERTAFEL device was created.

These are interactive games projected onto a table using a ceiling projector. The light animations invite people to "play with the light" using arm or hand movements. These games stimulate residents' physical activity and encourage interactions between residents and with caregivers.

In this study, it is a question of evaluating the effectiveness of the TOVERTAFEL device on the frequent behavioral symptoms in dementia (agitation, ambulation, apathy, anxiety), the quality of life of the patients, as well as on psychotropic treatments.

study_start_date_type: Actual

status: Recruiting

primary_purpose: Supportive Care

lead_sponsor: Hospices Civils de Lyon

intervention_type: Behavioral


title: Drug Hypersensitivity Reactions To Cephalosporins

acronym: CephALL

summary:
Background :

Although the hypersensitivity reactions to cephalosporins have been recently a more focused subject, studies on the cephalosporin as an allergen are significantly less frequent that those regarding penicillins. Most of the available data regards cephalosporin sensitization in patients previously allergic to penicillin. Like penicillins, cephalosporins represent one of the most prescribed classes of antibiotics. The diagnosis of cephalosporin hypersensitivity is based mainly on clinical history, skin tests (ST) and drug provocation tests (DPT). This succession of tests, performed in specialized services, allows to eliminate responsibility for the drug in many cases (80-85%). The drug allergy work-up also allows to identify profiles of allergy to cephalosporins, with different patterns of cross-reactivity.

Objective: To analyse the characteristics of patients studied in our Unit for suspicion of cephalosporin hypersensitivity.

Methods: This retrospective study will comprise all the patients who attended the allergy service of the UH of Montpellier from 1997 till 2018 with a clinical history evocative of cephalosporin drug hypersensitivity reaction (DHR), who underwent a drug allergy work up and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy & Hypersensitivity Database (DAHD).

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


title: Supplementation of Rheumatoid Arthritis Patients With Dietary Fibre to Improve Their Gut Microbiota

acronym: SUPER-FIBRES

summary:
Design: Randomized, double-blind, placebo-controlled study with 4 weeks of treatment with either fiber supplements or placebo.

Primary outcome: variation in SCFA between baseline and week 4. Secondary outcomes : variations in gut microbiota, disease activity (DAS28, RAID), immune cells (regulatory T and B cells, Th17) and heart-rate variability.

Population: 29 patients with rheumatoid arthritis treated with only csDMARDs and a moderate disease activity will be recruited in each arm and 29 controls with mechanic disease (osteoarthritis, tendinitis).

Collection: Blood, feces, disease activity and heart rate variability will be collected at baseline and week 4.

design_allocation: Randomized

primary_purpose: Treatment

intervention_type: Drug


title: COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction

acronym: COLD-MI

summary: This study evaluates the benefit of colchicine on induced denervation after myocardial infarction. Patients who have suffered a documented De Novo myocardial infarction and completed a revascularization procedure will receive either colchicine on top of standard therapy, compared to standard therapy alone (1:1 allocation ratio). Colchicine 1mg (or 0.5mg) will be initiated within 48h after percutaneous revascularization and prescribed for one month.

status: Terminated

primary_purpose: Prevention

ipd_sharing: No

status_simplified: Unknown


title: Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis: a Randomised Placebo-controlled Trial

summary:
Chronic Rhinosinusitis (CRS) is a chronic condition with limited therapeutic options. Moreover, the pathophysiology is poorly understood. The aim of this study is to evaluate the efficacy of osteopathic manipulative treatment (OMT) in the course of this condition by applying several techniques supposed to be related to the autonomic nervous system. Our hypothesis is that these techniques could have beneficial effects on inflammation and head symptoms in CRS.

Methods:

A sample of 90 patients diagnosed by ENT specialist will be randomly assigned to the OMT group or the placebo group. The placebo procedure will consist in using light touch around the nose, on the throat and on the thorax. Treatment and placebo protocols are composed of two visits at day 0 and day 30.

A general practitioner will determine the eligibility for the study.

The outcomes include Peak Nasal Inspiratory Flow (PNIF) measured five times: at day 0, 30 (twice each, before and after treatment) and 180 (once). The two groups will be compared regarding short and long term evolution.

The evolution of symptoms will be assessed by the Sino-nasal Outcome Test (SNOT-22) seven times: at day 0, 30, 60, 90, 120, 150 and 180. This outcome will be analyzed using mixed effect modelling

A Qualitative study will be conducted in the two groups to understand the patients' experiences during care.

This protocol has been approved by a french ethic committee (Comité de Protection des Personnes Sud Ouest et Outre-Mer II, 2020.04.09).

status: Unknown status

lead_sponsor: Institut des Hautes Etudes Osteopathiques de Nantes

lead_sponsor_type: industriel


type: Registry Identifier

title: Study of the Contribution of Automatic Image Fusion of a Cone-beam CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors

acronym: IAT

summary: The automatic fusion of the ultrasound with a cone-beam CT volume will guide the positioning of the electrodes, despite the visibility of the tumor in ultrasound, in patients treated with irreversible electroporation in the interventional radiology room at Avicenna Hospital for hepatocellular carcinoma (HCC). The objective is to evaluate the primary success rate of the automatic cone-beam CT fusion procedure and ultrasound, regardless of the tumor's visibility status in ultrasound.

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Nault JC, Sutter O, Nahon P, Ganne-Carrié N, Séror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13. Review.

ReferenceCitation: Yu H, Burke CT. Comparison of percutaneous ablation technologies in the treatment of malignant liver tumors. Semin Intervent Radiol. 2014 Jun;31(2):129-37. doi: 10.1055/s-0034-1373788. Review.

ReferenceCitation: Monfardini L, Orsi F, Caserta R, Sallemi C, Della Vigna P, Bonomo G, Varano G, Solbiati L, Mauri G. Ultrasound and cone beam CT fusion for liver ablation: technical note. Int J Hyperthermia. 2018;35(1):500-504. doi: 10.1080/02656736.2018.1509237. Epub 2018 Sep 11.

ReferenceCitation: Lee LH, Hwang JI, Cheng YC, Wu CY, Lee SW, Yang SS, Yeh HZ, Chang CS, Lee TY. Comparable Outcomes of Ultrasound versus Computed Tomography in the Guidance of Radiofrequency Ablation for Hepatocellular Carcinoma. PLoS One. 2017 Jan 9;12(1):e0169655. doi: 10.1371/journal.pone.0169655. eCollection 2017.

ReferenceCitation: Cornelis FH, Korenbaum C, Ben Ammar M, Tavolaro S, Nouri-Neuville M, Lotz JP. Multimodal image-guided electrochemotherapy of unresectable liver metastasis from renal cell cancer. Diagn Interv Imaging. 2019 May;100(5):309-311. doi: 10.1016/j.diii.2019.01.001. Epub 2019 Jan 26.

intervention_type: Radiation


title: Colorectal Cancer Immunomodulation Combined to Radiofrequency ablatIon

acronym: ColIBRI

summary:
The primary objective of the study aims to compare soluble CD154 (CD40L) levels before and after radiofrequency ablation (RFA) in patients with colorectal cancer (CRC) liver metastases.

The secondary objectives aims:

to compare soluble CD154 (sCD40-L) levels before and after treatment by RFA or surgery alone in patients with CRC liver metastases;
to study the feasibility and reliability of soluble CD154 (sCD40-L) levels to detect and quantify the induction of immun response in CRC liver metastases patients after RFA;
to study the impact of surgery on plasma soluble CD154 levels;
to study association between CD154 expression level before and after RFA in CRC liver metastases patients and relapses rate at 1 year.

time_perspective: Prospective

ReferenceCitation: Lemdani K, Mignet N, Boudy V, Seguin J, Oujagir E, Bawa O, Peschaud F, Emile JF, Capron C, Malafosse R. Local immunomodulation combined to radiofrequency ablation results in a complete cure of local and distant colorectal carcinoma. Oncoimmunology. 2019 Jan 10;8(3):1550342. doi: 10.1080/2162402X.2018.1550342. eCollection 2019.

ReferenceCitation: Meier S, Stark R, Frentsch M, Thiel A. The influence of different stimulation conditions on the assessment of antigen-induced CD154 expression on CD4+ T cells. Cytometry A. 2008 Nov;73(11):1035-42. doi: 10.1002/cyto.a.20640.

ReferenceCitation: Dymicka-Piekarska V, Korniluk A, Gryko M, Siergiejko E, Kemona H. Potential role of soluble CD40 ligand as inflammatory biomarker in colorectal cancer patients. Int J Biol Markers. 2014 Sep 30;29(3):e261-7. doi: 10.5301/jbm.5000083.

ReferenceCitation: Tada N, Tsuno NH, Kawai K, Murono K, Nirei T, Ishihara S, Sunami E, Kitayama J, Watanabe T. Changes in the plasma levels of cytokines/chemokines for predicting the response to chemoradiation therapy in rectal cancer patients. Oncol Rep. 2014 Jan;31(1):463-71. doi: 10.3892/or.2013.2857. Epub 2013 Nov 19.

ReferenceCitation: Zhao P, Fang WJ, Chai L, Ruan J, Zheng Y, Jiang WQ, Lin S, Zhou SH, Zhang ZL. The prognostic value of plasma soluble CD40 ligand levels in patients with nasopharyngeal carcinoma. Clin Chim Acta. 2015 Jul 20;447:66-70. doi: 10.1016/j.cca.2015.05.015. Epub 2015 May 29.

ReferenceCitation: Allard MA, Bachet JB, Beauchet A, Julie C, Malafosse R, Penna C, Nordlinger B, Emile JF. Linear quantification of lymphoid infiltration of the tumor margin: a reproducible method, developed with colorectal cancer tissues, for assessing a highly variable prognostic factor. Diagn Pathol. 2012 Nov 13;7:156. doi: 10.1186/1746-1596-7-156.

location_facility: Department of digestive surgery, Ambroise Paré Hospital, APHP


title: 12-months of Treatment With Burosumab in Children and Adolescents With X-linked Hypophosphatemia: a Prospective Longitudinal Cohort Study

summary:
In this prospective longitudinal cohort study we studied the efficacy and safety of burosumab in real-clinical practice for <13- and >13-years old children affected with X-linked hypophosphatemia.

57 children with XLH were switched from conventional treatment to burosumab. After 12 months we assessed the efficacy and safety of treatment with burosumab on the whole cohort and separately on the cohort of >13-years old adolescents.

lead_sponsor: Bicetre Hospital


title: Design of a Mobility Protocol to Assess the Impact of Visual Pathologies in Daily Life Activities for Subjects With Advanced Visual Deficits

acronym: PROMA

summary:
Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors, responsible for a progressive and severe loss of vision.

People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily life, specifically for:

Visual research
Visuo-motor coordination in tasks requiring fine motor control
Visuo-motor coordination in mobility tasks

This study aims to assess the difficulties in the daily life of subjects with Retinitis Pigmentosa at a very advanced stage unsing, quaify of life questionnaires, simplified locomotion tasks in real situation and a posture task.

They are proposing a new test adapted and carried out in real situations, in binocular and monocular vision, making it possible to finely assess locomotion especially for "very low vision" patients.

This test will also ultimately make it possible to better evaluate the effectivements, that is to say to observe and quantify objectively by a score the performance progression obtained for locomotion tasks related to the visual recovery generated by the treatment.

primary_purpose: Other

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act

acronym: REV

summary:
The aim of the REV clinical trial is to evaluate the impact of a virtual reality exposure to decrease patient anxiety before chemotherapy or an invasive act. If positive, the access to virtual reality exposure is aimed to be used as standard of care at Lyon's hospital to improve cancer patient well-being in a drug-free manner.

The majority of cancer patients lives with high level of anxiety as soon as diagnosed. This level anxiety is particularly high before invasive acts but also before chemotherapy by side effects anticipation.

Hypnosis is a highly interesting drug-free approach to decrease patient's anxiety. It however requires on site specialists to be available whenever needed.

Virtual reality provides a distractive environment enabled to shift patient focus. It can support a switch of patient mindset by providing positive emotions.

Since 5 years, this disruptive technology is being more and more used as medical support thanks to a new generation of headsets enabling improved performance at cheaper prices.

Many publications have now demonstrated the positive impact of virtual reality to take in charge patients' pain or pre-operational anxiety.

location_facility: Service d'oncologie médicale, Institut de Cancérologie des Hospices Civils de Lyon, Hôpital Lyon sud


title: Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject, by a Threshold Inspiratory Load and During a Maximal Breath Holding.

acronym: Volatopnee

summary:
The dyspnea is a common symptom in patients with many respiratory diseases particularly chronic obstructive airway diseases, but also cardiovascular pathologies, obesity, or also in the deconditioned healthy subjects.

Called volatolom corresponds to the set of volatile organic compounds (VOCs) contained in exhaled air.

The analysis of volatolom can be done either by the methods based on mass spectrometry which allows the identification of each VOC in the exhaled air or by the use of electronic noses which are more simple to use, less specific and produce a quantitive signal change based on pattern recognition algorithms providing a global profile of the VOC without identifying them.

The aim of the study is to determine whether the analysis of VOCs in exhaled air would identify biomarkers related to the intensity and type of experimental dyspnea.

lead_sponsor: Hopital Foch


title: Septic Management and Outcome of Open Fracture : a 7 Years Retrospective Cohort Study

summary:
The aim is the study of the management and outcome of the open fractures.

Some open fractures will become pseudarthrosis. Thoses pseudarthrosis may be septic or not.

The management and evolution of all the open fractures will be described in order to identify the presence or not of a sepsis and then a development of a pseudarthrosis (septic or non septic).


title: Evolution of the Endonasal Microbiota After Endoscopic and Local Treatment or Local Treatment Alone in Patients With Chronic Rhinosinusitis

acronym: METEL-RC

summary:
Chronic rhinosinusitis (CRS) is defined according to the French society of otorhinolaryngology as chronic non-mechanical damage to the nasal structures, excluding infectious damage to the sinus structures. The duration of the chronic impairment must be at least 12 consecutive weeks. It causes many symptoms such as rhinorrhea, nasal blockage and anosmia. It is a poorly understood pathology that affects a large part of the population. Its prevalence has increased significantly over the past 30 years. It affects about 11% of the population in Europe. It has become one of ten high-cost medical conditions for employers. Initially, it was accepted that CRS was due to chronic nasal infection. It is very debilitating for patients leading to a major consultation with practitioners (general practitioners and ENT specialists). Many treatments are used such as nose washes, nasal or oral corticosteroids, antibiotic therapy or even surgical management is possible. Thèses treatments allow an improvement in the symptomatology but no treatment allows a stable result over time, making long-term treatments essential.

Today, it is recognized that CRS has a multifactorial etiology including inflammatory processes, hyperresponsiveness of the nasal mucosa and abnormalities in immune phenomena. The endonasal microbiota plays a role in these processes. Germs like Staphylococcus aureus and Pseudomonas aeruginosa were identified as pathogens in CRS in the first studies with bacterial cultures. Thanks to the 16S ribosomal RNA sequencing technique, recent studies have demonstrated a modification in the diversity and abundance of the microbiota in patients with CRS compared to healthy subjects, notably with a modification of the germs of the firmicutes group. .

Few studies have studied the modification of the microbiota with the treatment of CRS today. However, local treatments based on nosewashing with physiological saline associated with local corticosteroids and endoscopic treatments lead to an improvement in the symptomatology for patients suffering from CRS. This study will describe the modification of endonasal microbiota in différent conditions, such medical and surgical treatments, that usually improve patients symptomatology.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Prosthetic Arthroplasties in Weight-bearing Shoulders in Individuals With Long-term Wheelchair Use

summary: Repeated transfers and wheelchair propulsion in patients with neurological deficit of the lower limbs leads to a major mechanical overload of the upper limbs, especially on shoulders, the "weight-bearing" shoulder. Under these conditions, arthroplasty is subject to significant constraints; such an indication in this condition is always discussed. The objective of this study was to evaluate the medium-term clinical and functional outcomes of anatomical and reverse arthroplasty on the weight-bearing shoulder in individuals with long-term wheelchair use.

ipd_sharing_description: NC

intervention_type: Procedure


title: Interest of Individual Biomarkers From the Identification of Tumor Genotype in Plasma (ctDNA: Circulating Tumor DNA) by High-throughput Molecular Next Generation Techniques(CAPP Seq, PhAsE Seq, VIRCAPP-seq) in the Diagnosis and Personalized Management of Lymphomas in a Prospective Monocentric Cohort

summary:
Lymphomas are the most common haemopathic malignancy. The 3 most common types are diffuse large B-cell lymphoma (DLBCL), Hodgkin's lymphoma (HL) and follicular lymphoma (FL). In these three subtypes, the treatment strategy is most often curative. The therapeutic strategy is guided by PET (positron emission tomography), which optimises the risk-benefit balance between the efficacy and toxicity of the treatment and makes it possible to limit the intensity of treatment for good responders and to intensify the treatment of poor responders with a worse prognosis. PET therefore plays a central role in the pre-therapeutic evaluation of the disease and in the assessment of response to treatment. However, other complementary approaches could improve characterization prior to initiating lymphoma t-treatment and individual patient management during treatment and beyond. In DLBCL, it has been shown that the risk of relapse of good and bad responders is decreased by combining the PET response with a reduction in the amount of tumor DNA (ctDNA) in the blood, i.e. the genetic program of lymphoma cells that circulates freely in the blood. This evaluation of ctDNA has been made possible by the development of innovative techniques such as Next Generation Sequencing (NGS). In lymphomas, several approaches have been developed, the most sensitive and promising being CAPP-Seq (CAncer Personalized Profiling by deep Sequencing) developed at Stanford University.

It is therefore useful to study the description of ctDNA in the 3 types of lymphomas and to analyse the progression profiles under treatment by trying to establish the major potential usefulness of these techniques: modifying treatment in case of poor response based on ctDNA +/- and PET, detecting relapses earlier than at present in patients without any other sign of relapse (clinical, blood or PET).

The project presented here aims to build a collection of plasma samples taken before treatment, during treatment and during the first 2 years of follow-up in patients with one of the 3 most frequent types of lymphoma and undergoing curative treatment. The hypothesis is that sequential evaluation of ctDNA could improve the individualized management of future patients based on the results generated by the analyses of patients in this cohort.

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological


title: ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY: A FEASIBILITY STUDY (KNEE EMBOLISATION)

summary: Recent works in interventional radiology have shown interesting results in the treatment of musculoskeletal inflammatory sites by arterial embolization. Supra-selective arterial embolization has been successfully developed by Dr. Okuno (Japan) to manage moderate to severe knee osteoarthritis. Also, inflammation of the surgical site mediated via geniculate arteries is a major cause for persistent chronic post-operative gonalgia.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Caracteristics of the Patients Hospitalized With Unvonluntary Commitment Procedure, in Pandemic and Confinement Context

acronym: HoCoPsy

summary:
The actual worldwide context (disease outbreak, confinements instaured in many countries) is a stressful factor for many people. It can have consequences on mental health : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. Patients with mental disorders are especially vulnerable.

On march 17th, the french government ordonned a national confinement to slow the progression of the COVID-19 outbreak, for 15 days at first then renewed several times. This situation has led to a reorganization of care as requested on March 22nd, 2020 in the recommendations applicable to the organization of care in psychiatric services : priority to telephone contacts and teleconsultation by multiplying contacts and assessments.

By the time the reorganization of care became operational, the most vulnerable patients may have experienced a decompensation of their disease.

It is important to know if the COVID-19 outbreak combined with the confinement increased the number of unvoluntary commitment the month after the announce of the confinement.

This could help us understand which patients are more vulnerable is this context, and improve our organization (ambulatory and hospitalization care) if this situation occurs again.


title: Complications of Adenovirus Keratoconjunctivitis in Ophthalmologists and Orthoptists: Epidemiology and Risk Factor, a Retrospective Questionnaire Analysis

acronym: ADV-OPH

summary:
Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after infection.

The primary aim of the study is to investigate the prevalence of these sequelae in the at-risk population of ophthalmologists and orthoptist.

Secondary aim are to describe administrative procedures (occupational disease declaration and sick leave),infections characteristics; and risk factors.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Echocardiography in Critically-ill Patients With COVID-19 Pneumonia

acronym: ECHO-COVID

summary: Critical care echocardiography (CCE) has been widely used since the 10 last years. Covid outbreak leads that many patients with acute respiratory failure were admitted in the ICU. Many of these patients were ventilated and developed ARDS. Some of them developed deep vein thrombosis and pulmonary embolism. Nothing is already described about the cardiac function and the hemodynamics in these patients (how many RV failure, LV systolic dysfunction,...). The echo group of the cardiodynamix section of European society of intensive care medicien (ESICM) aims to promote CCE and evaluate its interest. The objective is to retrospectively enter in an international database all the echo studies done as usual care in these patients to evaluate (i) incidence of RV failure, (ii) incidence of LV systolic function, (iii) incidence of other patterns. Another objective will be to look for any association between some patterns and respiratory strategy, blood gas analysis, systemic hemodynamics. The echo studies were done and will be reported following one of the recent systematic review published by the same group (Huang S et al. AOIC 2020).

status: Enrolling by invitation

lead_sponsor: Hospital Ambroise Paré Paris


title: Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin

summary:
Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria.

Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide.

The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future


title: Immunomodulatory Profile of Dexmedetomidine Sedation in Patients Recovering After ARDS Covid-19

acronym: DEXDO-COVID

summary:
Covid-19 infection is due to SARS-CoV-2 member of the Coronavirus family represented by SARS- and MERS-CoVwith neuronal tropism capacity for the brainstem and thalami. Dexmedetomidine has(i) central antihypertensive (ii) sedative and (iii) neuroprotective properties and is often used during patient recovering after mechanical ventilation withdrawal.

Dexmedetomidine administration could change the immunomodulatory profile of Covid-19 patients and reduce inflammatory response.CAM-ICU scores and Blood samples from Covid-19 ICU patients will be collected at 4 different timepoints (before Dexmedetomidine administration, at D2, D7 and M6) to analyse the inflammatory profile with different approaches:i) chromatin accessibility, ii) transcriptome analysis, iii) inflammatory cytokines and chemokines levels.

location_facility: Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6


title: Study of the Efficiency and Security of NIVOLUMAB Therapy, Used in Immuno-stimulation, in Hospitalized Obese Individuals at Risk to Evolve Towards Severe Forms of COVID-19 Infection. Multicentric, Paralleled, Randomized, Controlled Trial

acronym: NIVISCO

summary:
Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus).

Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19.

In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production.

This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15

location_facility: Hôpital Lyon Sud Service Endocrinologie, Diabète et Nutrition


title: Cohort Study of Vasculitis Patients: Longitudinal Study for the Assessment of Presentation, Comorbidities, Management, Outcomes and Damage

acronym: VASCO

summary: VASCO is a prospective observational cohort study which aim to describe the presentation, comorbidities, management, outcomes and damage of vasculitis patients, from the analysis of the clinical, biological and immunological data.

ReferenceCitation: Leavitt RY, Fauci AS, Bloch DA, Michel BA, Hunder GG, Arend WP, Calabrese LH, Fries JF, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of Wegener's granulomatosis. Arthritis Rheum. 1990 Aug;33(8):1101-7.

ReferenceCitation: Lightfoot RW Jr, Michel BA, Bloch DA, Hunder GG, Zvaifler NJ, McShane DJ, Arend WP, Calabrese LH, Leavitt RY, Lie JT, et al. The American College of Rheumatology 1990 criteria for the classification of polyarteritis nodosa. Arthritis Rheum. 1990 Aug;33(8):1088-93.

ReferenceCitation: Masi AT, Hunder GG, Lie JT, Michel BA, Bloch DA, Arend WP, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, et al. The American College of Rheumatology 1990 criteria for the classification of Churg-Strauss syndrome (allergic granulomatosis and angiitis). Arthritis Rheum. 1990 Aug;33(8):1094-100.

ReferenceCitation: Jennette JC, Falk RJ, Andrassy K, Bacon PA, Churg J, Gross WL, Hagen EC, Hoffman GS, Hunder GG, Kallenberg CG, et al. Nomenclature of systemic vasculitides. Proposal of an international consensus conference. Arthritis Rheum. 1994 Feb;37(2):187-92. Review.

ReferenceCitation: Jennette JC, Falk RJ, Bacon PA, Basu N, Cid MC, Ferrario F, Flores-Suarez LF, Gross WL, Guillevin L, Hagen EC, Hoffman GS, Jayne DR, Kallenberg CG, Lamprecht P, Langford CA, Luqmani RA, Mahr AD, Matteson EL, Merkel PA, Ozen S, Pusey CD, Rasmussen N, Rees AJ, Scott DG, Specks U, Stone JH, Takahashi K, Watts RA. 2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheum. 2013 Jan;65(1):1-11. doi: 10.1002/art.37715.

ReferenceCitation: van der Woude FJ, Rasmussen N, Lobatto S, Wiik A, Permin H, van Es LA, van der Giessen M, van der Hem GK, The TH. Autoantibodies against neutrophils and monocytes: tool for diagnosis and marker of disease activity in Wegener's granulomatosis. Lancet. 1985 Feb 23;1(8426):425-9.

ReferenceCitation: Sablé-Fourtassou R, Cohen P, Mahr A, Pagnoux C, Mouthon L, Jayne D, Blockmans D, Cordier JF, Delaval P, Puechal X, Lauque D, Viallard JF, Zoulim A, Guillevin L; French Vasculitis Study Group. Antineutrophil cytoplasmic antibodies and the Churg-Strauss syndrome. Ann Intern Med. 2005 Nov 1;143(9):632-8.

ReferenceCitation: Bligny D, Mahr A, Toumelin PL, Mouthon L, Guillevin L. Predicting mortality in systemic Wegener's granulomatosis: a survival analysis based on 93 patients. Arthritis Rheum. 2004 Feb 15;51(1):83-91.

ipd_sharing_description: Undecided

location_facility: Service de médecine interne, Hôpital Cochin, AP-HP


title: A Cross-over Study to Compare Two Different Tracheal Cuff Pressure Monitoring Devices in a Pediatric Intensive Care Unit

summary: Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a continuous or intermittent technique, cuff underinflation and overinflation are common increasing the risk of microinhalation and tracheal ischemia. All these complications are associated with high morbidity and mortality in ICU.

intervention_type: Device


title: Importance of Ionized Magnesium Measurement for Monitoring of Continuous Venovenous Haemodialysis With Citrate Anticoagulation

acronym: MagiCC

summary: It has been reported in several studies that ionized hypomagnesemia is associated with higher morbidity and mortality rates. During continuous renal replacement therapy with regional citrate anticoagulation (CRRT-RCA), the loss of magnesium has been reported to not be covered by magnesium concentration in ordinary dialysis fluid. This may lead to ionized hypomagnesemia. However the incidence of ionized hypomagnesemia in patients requiring CRRT-RCA remains unclear and need to be estimated to determine if ionized magnesium monitoring could be of interest. This study aim to assess the incidence of ionized hypomagnesemia induced by CRRT-RCA.


title: Training of Persons With Complete Spinal Cord Injury for Pedaling on a Tricycle, Induced by Electrical Stimulation of the Paralysed Muscles: a Case Series

summary: The main objective of this study is to validate the effectivity of a simple home-based training for cycling with functional electrical stimulation (FES). The training is designed to progressively increase strength and endurance of the paralysed muscles of a person with complete spinal cord injury. After a limited period of only several months, performance will be assessed during FES-assisted cycling on a recumbent tricycle over flat ground. The outcomes of this study should provide evidence for the effectivity of FES-cycling as potential rehabilitation method.

ReferenceType: derived

ReferenceCitation: Fattal C, Schmoll M, Le Guillou R, Raoult B, Frey A, Carlier R, Azevedo-Coste C. Benefits of 1-Yr Home Training With Functional Electrical Stimulation Cycling in Paraplegia During COVID-19 Crisis. Am J Phys Med Rehabil. 2021 Dec 1;100(12):1148-1151. doi: 10.1097/PHM.0000000000001898.

lead_sponsor: Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie

location_facility: Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie


title: A Pilot Study to Assess the Concordance of Genomic Alterations Between Urine and Tissue to Develop Precision Medicine-Based Immunotherapy Approaches in High-Risk NMIBC Patients

acronym: ALU

summary:
The analysis of cell-free tumor DNA (cfDNA) in plasma has emerged as a clinically relevant predictive and prognostic biomarker in several metastatic solid malignancies, and even now represents standard-of-care for prescription of some targeted therapies in non-small cell lung cancer (blood-based T790M companion diagnostic test). cfDNA can be detected not only in plasma but also in urine, even in patients with non-invasive disease. Recent studies found that the detection of genomic alterations in plasma of urothelial bladder carcinoma patients was relatively uninformative in the localized setting. However, urine cfDNA has been shown to provide a promising resource for robust whole-genome tumor profiling in clinically localized Muscle invasive Bladder cancer (MIBC) and Non-Muscle Invasive Bladder Cancer (NMIBC). Genomic alterations using a targeted next-generation sequencing (NGS) panel have been recently documented in a series of treatment-naïve high-risk NMIBC.

The investigator's aim is to determine whether liquid biopsies can be used as a new diagnostic assay to guide immunotherapeutic approaches in patients with high-risk NMIBC. The ultimate goal is to develop a "testing decision tree" to segment patients for informing on therapeutic decision and customizing treatment.


title: Bayesian Network to Predict Transfer in Intensive Care Units or Death in Newly Covid-19 Hospitalized Patient

summary:
The project is a part of the "Protocol for a multicentre study of nosocomial SARS-CoV2 transmission: The NOSO-COR Project" registered in ClinicalTrials (NCT04290780).

In the current pandemic context, medical resources have often been exceeded. Developing, using artificial intelligence techniques, an algorithm capable of detecting patients at risk of acute respiratory distress following Sars-Cov2 infection could help physicians to optimize the treatment of patients and health decision-makers to optimize resources. Thus, the goal of this project is to create a prediction model using artificial intelligence to predict an unfavorable evolution of Covid-19 at the hospital admission of patients

location_facility: Hôpital E Herriot - Hospices Civils de LYON


title: Prospective and Retrospective Study Evaluating Epidemiological, Clinical, Molecular and Therapeutic Data of Prolymphocytic Leukemia T

acronym: T-PLL

summary:
Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an aggressive clinical course. It is a hemopathy exhibiting a post thymic T phenotype (Tdt-, CD1a-, CD5 +, CD2 + and CD7 +), generally CD4 + / CD8-, but also CD4 + / CD8 + or CD8 + / CD4-.

The main feature of T-PLL is the rearrangement of chromosome 14 involving genes encoding the T cell receptor complex (TCR) subunits, leading to overexpression of the proto-oncogene TCL1.

On the molecular level, the study of Prolymphocytic leukemia T shows a substantial mutational activation of the IL2RG-JAK1-JAK3-STAT5B axis.

Patients with Prolymphocytic leukemia T have a poor prognosis, due to a poor response to conventional chemotherapy. Treatment with the anti-CD52 monoclonal antibody: alemtuzumab has considerably improved the results, but the responses to treatment are transient; therefore, patients who obtain a response to alemtuzumab treatment are candidates for stem cell allograft (TSS) if they are eligible for this procedure. This combined approach extended the median survival to four years or more. However, new approaches using well-tolerated therapies that target signaling and survival pathways are necessary for most patients who are unable to receive intensive chemotherapy, such as JAK STAT axis inhibitors, anti-AKT, or anti BCL2 .

Main objective: Better manage prolymphocytic T leukemias.

Secondary objectives:

Molecular characterization of prolymphocytic leukemia T.
Study of the response to treatment, disease-free survival, overall survival.
Impact of prognostic factors on response to treatment, and survival.

lead_sponsor: French Innovative Leukemia Organisation


title: Fecal Incontinence Type Assessment Scale (FITAS): a New Tool to Distinguish Among Subgroups of Fecal Incontinence

summary:
Urge faecal incontinence (FI) and passive FI are the two subgroups of FI described by the International Continence Society. Urge FI is described as "the inability to defer defecation once the urge is perceived for long enough to reach a toilet" and passive FI as "the involuntary leakage of faeces without forewarning". If several validated questionnaires are available for FI, all of these questionnaires were developed to assess FI severity. In literature, there is only a small number of studies that investigated clinical and paraclinical characteristics of the different phenotype of FI. Moreover, there is an heterogenicity in the definitions used for both urge and passive FI among these studies. Lastly, patients with mixed FI were commonly excluded from these studies. It can be established that there is a lack of validate tools to distinguish patients between subgroups of FI.

The aim of the present study was to develop and to validate a new tool in order to investigate and classify patients among the different subgroups of FI (active, passive and mixed) defined by Rome IV criteria.

A monocentric prospective study was conducted in the Neuro-urology Department of a University Hospital. All consecutive patients presenting in the Department with FI between December 2019 and June 2020 were screened for inclusion in the present study. Criteria of inclusion were an age older than 18 years old and symptoms of FI according to Rome IV criteria. Exclusion criteria were anorectal fistula, active inflammatory bowel disease, anorectal malignant tumor not treated, rectal or hemorrhoidal prolapses and specific inability regarding the questionnaire (i.e. cognitive disorders, inability to read and to understand questions).

Phase 1: review of literature and qualitative interviews: To determine the dimensions of the different subgroups of faecal incontinence, a literature review was performed using Pubmed without date limitation until February 2020. The key words used were "active faecal incontinence", "active fecal incontinence", "passive faecal incontinence", "passive fecal incontinence", "urge faecal incontinence", "urge fecal incontinence", "questionnaire", "scale", "score" and "tool". In parallel to this literature review, semi-structured interviews were performed on 20 patients from December 2019 to February 2020. During this phase, a panel expert of 9 neuro-urologists and gastroenterologists was composed. At the term of all interviews, dimensions that were both the most used by patients and the most discriminative among subgroups of FI were included in the questionnaire. Redaction of questions was then performed by the panel expert.

Phase 2: feasibility study: The feasibility study was conducted from February to April 2020 on 30 patients. Each patient was asked to rate each version of the 2 questions with a four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding acceptance and comprehension of the questions.

Phase 3: validation study: To investigate the psychometric properties of the questionnaire, a validation study was performed from April to June 2020 on 100 consecutive patients. In order to evaluate the FITAS' test reproducibility, patients were asked to answer a second time the questionnaire by mail with a second evaluation from 7 days to 10 days after the first one. The "intra-class correlation coefficient" (ICC) was used to determine if these evaluations could lead to similar results for each question. An ICC > 0.70 was necessary to define reproducibility.

lead_sponsor: Gérard Amarenco


title: Evaluation of the Tolerance of Anti-MRSA Betalactamines (Ceftaroline / Ceftobiprole) in the Management of BJI / PJI: a Retrospective Study in a Reference Center

summary:
Staphyloccous aureus and coagulase negative staphylocci are responsible of a large marjority of PJI. Regarding the high rate of methicillin resistance, current guidelines recommend the use of a glycopeptide, and most frequently vancomycin, as the anti-gram positive agent in empirical therapy, while awaiting the microbiological results. Vancomycin is not considered as a safe antibiotic, and daptomycin is frequently an alternative option.

Ceftaroline and ceftobiprole are the only betalactam active on methicillin-resistant staphylococci. As some data report a synergistic activity with daptomycin, they could be an option in pandrug-resistant staphylococci BJI, but their use if off label in this indication.


title: Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks

summary: Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. The investigators described the different techniques of type 2 endovascular repair, and their efficacy at short and long term..

ipd_sharing_description:
All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes.

Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.

location_facility: Cardiovascular and thoracic surgery unit, CHU Dijon


title: Staphylococcus Lugdunensis Prosthetic Joint Infection: a Retrospective Cohort Study

summary: Staphylococcus lugdunensis is a coagulase-negative staphylococcus belonging to the human commensal cutaneous flora, and has been little studied in the field of prosthetic joint infections. However, it shares many virulence traits with Staphylococcus aureus, including many adhesins and its ability to form biofilm, and the few series of cases reports a significant failure rate.


title: Evaluation of the Efficacy of a Homeopathic Protocol to Reduce the Onset or Aggravation of Joint Pain or Stiffness Following the Taking of Anti-aromatases (AI) in Patients With Non-metastatic Breast Cancer

summary: Interventional, randomised, prospective, monocentric study

lead_sponsor: Institut Jean-Godinot


title: Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital

summary: Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic. Global mortality remains high even if it decreased last years. This is probably due to improvement of diagnostic techniques and the evolution of surgical practices. It is however important to have medical data and statistics obtained in past years in order to better understand the factors influencing peroperative mortality and thereby to continue this improvement.

ipd_sharing_description: All patients are informed before surgery that all the medical data included in the medical record could be used in cardiovascular monocentric retrospective study. No data shared.

lead_sponsor: Centre Hospitalier La Chartreuse

location_facility: Cardiovascular and thoracic surgery Unit - Dijon University Hopital


title: Descriptive Pilot Study of Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia

acronym: ANOSIRM

summary: To date there is no brain imaging and olfactory data available in COVID-19 positive patients with anosmia. By describing the pathophysiological characteristics underlying the olfactory symptoms and clinical characteristics of COVID-19 infection, the study investigators wish to compare the MRI aspects obtained in COVID-19 patients with and without anosmia, in the absence of other underlying neurological disorders.

status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Study of Retinal Vascular Parameters in Patients With Wilson's Disease

acronym: WILLY

summary:
The rare disease reference center " Wilson disease and other rare copper-related diseases" of the Rothschild Foundation follows a large number of patients with Wilson's with varying degrees of impairment and located at different times of their care.

Many people with Wilson's disease have a characteristic greenish-brown ring, known as Kayser-Fleischer, appearing at the periphery of the cornea due to a deposit of copper at the Descemet membrane. As a general rule, if the patient is compliant with his treatment, the ring usually disappears within a few years, although it may persist in some patients. However, apart from the stage of diagnosis, and the evolution of the ring, ophthalmological examinations are little used for the follow-up of these patients.

The objective of this study is to describe the retinal parameters, in particular vascular with two new retinal imaging technologies (OCT-A :Optical Coherence Tomography-Angiography , Adaptive optics) in patients with Wilson's disease and to correlate them with the parameters of the usual follow-up of these patients (hepatic assessment, exchangeable plasma copper, neurological scores, compliance, etc.).

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study

acronym: COVIDHomeless

summary:
COVID/Homeless is a prospective observational cohort study of homeless people to determine the impact of the SARS-CoV-2 epidemic on this population.

The cohort aims for exhaustiveness for the city of Marseille, being based on the active files of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams (including one specialized in psychiatry, three specialized in addictions, and three working in squats and shantytowns).

Aims of this cohort include to identify of the prognostic factors of morbi-mortality of homeless people by COVID-19, and therefore to propose appropriate management strategies.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Insuffisance Cardiaque Sous Carfilzomib: étude Prospective

acronym: ICARE

summary: Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib.

lead_sponsor: European Georges Pompidou Hospital

location_facility: Assistance Publique Hôpitaux de Paris - Centre Université de Paris


title: Etude de l'Incidence et Des Facteurs prédictifs de la Survenue de Fibrillation Atriale Sous Ibrutinib

acronym: FABRIC

summary: Ibrutinib (a tyrosine kinase inhibitor targeting Bruton) is a standard of treatment in haematology. According to retrospective data, atrial fibrillation and systemic hypertension are common ibrutinib-related advserse events. The investigators aim at prospectively establishing the incidence of thesedrug related advsere events through clinical monitoring and attempt at identifying populations at risk.


title: Cardio-Oncologie: étude Pilote évaluant la faisabilité, Utilité Concrète, Interdisciplinaire d'Une Unité Spécialisée

acronym: CONFUCIUS

summary:
Cardio-oncology is an emerging field. Most of the data available have been issued from either retrospective analysis, industry data or pharmacovigilance data. These data sources include a number of bias.

CONFUCIUS is a single tertiary centre prospective registry including all patients who have been referred for cardio-oncology assessemnt.

The objectives are to provide a comprehensive vue of cardoi-oncology, enable to detect early signals of cardiotoxicity and enhance ancillary projetcts aiming at specific populations (e.g., type of cancer) and/or drugs.


title: Impact of the Rheumatoid Factor on Serological Testing Performance for Covid-19 in Rheumatoid Arthritis Patients

acronym: COVID-SERA

summary: Due to the Covid-19 worldwide outbreak, fragile patients with immune diseases, notably rheumatoid arthritis (RA), have to be even more specifically and carefully followed-up. However, it has been shown that false postive serological results often occured while detecting antibodies directed against SARS-CoV-2 in patients with positive rheumatodoid factor (RF). The investigators propose here to investigated this issue. Therefore, the investigators will test three different immunoassays on this specific population. The investigators aim to establish these assays specificity and the levels of RF for which there is a risk of anti-SARS-CoV-2 false positivity and thus ensure a better follow-up of RA patients. The RF isotype will be analysed to determine whether there is a correlation and the impact of the presence of anti-CCP (citrullinated cyclic antipeptide antibodies) will be studied and assessed.

lead_sponsor: University Hospital, Montpellier


title: Evaluation of a Data Transmission Solution for Connected Nutrition Pump for Patients Treated by Home Parenteral Nutrition (HPN). Proof of Concept, Prospective, Monocentric, Non-randomized, and Open-label Study.

acronym: SERENE-eNUTRI

summary:
Patients requiring long-term home parenteral nutrition (HPN) suffer from chronic intestinal insufficiency. The causes of this syndrome can be either anatomical (extensive resection of the small bowel) or functional (occlusion, pseudo-occlusion, malabsorption). Consequences mean that patients are unable to cover their oral energy and / or hydroelectrolytic needs.

As a result, these patients survive only through a nutritional support by the venous route (parenteral nutrition). However, this lifesaving therapy requires complex technological nutritional support issues at home, which will influence the personal life of the patients.

At home, HPN therapy is performed by nutrition pumps providing a constant flow and able to detect anomalies.

In this context, the development of connected systems that allow informations transmission could help patient's caregiving by the different persons involved in his follow-up (prescribing physicians, home support nurses, patients and relatives, manufacturers).

The main objective of this study is to evaluate the performance of an end-to-end data transmission chain which integrates a nutrition pump connected to a medical IoT module (developped by Maatel) able to send information to an applicative layer (software interface PatHView2, developped by Orange Labs) via different transmission modes : LoRaWAN (Long Range Wide-area network), BLE (Bluetooth Low Energy), GSM LTE-M (Global System for Mobile Communications, Long Term Evolution - Machine Type Communication).

primary_purpose: Device Feasibility

ReferenceCitation: Pironi L, Miglioli M, Ruggeri E, Longo N, Suriani U, Maselli S, Gnudi S, Barbara L. Home parenteral nutrition for the management of chronic intestinal failure: a 34 patient-year experience. Ital J Gastroenterol. 1993 Oct;25(8):411-8.

ReferenceCitation: Detsky AS, McLaughlin JR, Abrams HB, L'Abbe KA, Whitwell J, Bombardier C, Jeejeebhoy KN. Quality of life of patients on long-term total parenteral nutrition at home. J Gen Intern Med. 1986 Jan-Feb;1(1):26-33.

lead_sponsor: University Hospital, Grenoble


title: Social Cognition in Patients With Amyotrophic Lateral Sclerosis

acronym: COSISLA

summary:
Amyotrophic Lateral Sclerosis, also known as Charcot disease, is a neurodegenerative disease evidenced by gradual paralysis of the muscles involved in voluntary motor function. The clinical hallmark of Amyotrophic Lateral Sclerosis is the combination of upper and lower motor neuron signs and symptoms. The most recent studies suggest that up to 50% of Amyotrophic Lateral Sclerosis patients demonstrate mild to moderate cognitive disturbance. Impaired social cognition, including a deficit in the recognition of facial emotions and the identification of vocal prosody, is recognized as a part of the cognitive phenotype of Amyotrophic Lateral Sclerosis, with crucial implications for patients' and caregivers' training. However, studies remain scarce and the data acquired must be supported. The evolution of these manifestations during the disease is still poorly understood.

In this study the investigators aim to assess the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to healthy matched control subjects.

lead_sponsor: University Hospital, Angers


title: Reorganization of the Healthcare System During COVID-19 Pandemic: Impact on Management of Patients With Exocrine Pancreatic Cancer

summary:
Pancreatic adenocarcinoma will be the 2nd cause of death by cancer in Europe in 2030. Pancreatic adenocarcinoma has poor prognosis with an all-stages combined 5-year survival rate below 8%.

Since December 2019, a new coronavirus (Severe Acute Respiratory Syndrome Corona Virus 2, SARS-CoV-2) is responsible of COVID-19 infection with potentially severe respiratory syndrome or even multi-organ failure. An increased risk of severe COVID-19 infection in cancer patients is suggested in several Chinese series. Cancer care structures quickly reorganized to limit high-risk situations (diagnostic procedure, major surgery, cytotoxic poly-chemotherapy) and use alternatives such as on-hold chemotherapy. These reorganizations could be associated with a loss of chance for pancreatic adenocarcinoma.

ReferenceCitation: Brugel M, Letrillart L, Evrard C, Thierry A, Tougeron D, El Amrani M, Piessen G, Truant S, Turpin A, d'Engremont C, Roth G, Hautefeuille V, Regimbeau JM, Williet N, Schwarz L, Di Fiore F, Borg C, Doussot A, Lambert A, Moulin V, Trelohan H, Bolliet M, Topolscki A, Ayav A, Lopez A, Botsen D, Piardi T, Carlier C, Bouché O. Impact of the COVID-19 pandemic on disease stage and treatment for patients with pancreatic adenocarcinoma: A French comprehensive multicentre ambispective observational cohort study (CAPANCOVID). Eur J Cancer. 2022 May;166:8-20. doi: 10.1016/j.ejca.2022.01.040. Epub 2022 Feb 10.

lead_sponsor: CHU de Reims


title: Psychological Impact of the Health Measures Generated by the SarsCov-2 Pandemic in Adolescents (COVADO)

acronym: COVADO

summary: The lockdown of the French population is a health measure put in place in response to the pandemic linked to a new coronavirus, SARS-CoV-2 (Covid-19). After a health campaign to recommend hygienic "barrier gestures" and social distancing, the decision to confine the population at the national level was decided by the executive from Monday 16 March to Monday 11 May 2020. The national confinement implies the restriction of movement to the strict necessary, outings near the home and the closure of schools and communities. These decisions have led to an unprecedented state of stress for the entire French population, the consequences of which are unknown in the short, medium or long term. The objectives of this study are to evaluate the psychological impact of the confinement on adolescents with or without chronic disease and also the difficulties and fears engendered by deconfinement .

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Confinement Effect on Low Back Pain Intensity in Chronic Low Back Pain Patients

acronym: CONFI-LOMB

summary:
The current situation, linked to the pandemic of the new coronavirus SARS-CoV-2 generates health concerns, but is also accompanied by many other psychological, social, economic, professional, etc. consequences as well as numerous changes in behavior and lifestyles, notably due to confinement.

While the prevention of chronic low back pain and its management are primarily based on the practice of regular physical and sports activity, other psychological factors (stress, anxiety, depression), socioeconomic (low level of education, resources), professionals (physical workload, job dissatisfaction), etc. also have a major role in the onset and the persitence of low back pain.

Thus, it is to be supposed that the current context, and more particularly the confinement to which the population has been constrained for almost 2 months, have and will have notable consequences on the evolution of lumbar symptoms in chronic low back pain patients. However, the entanglement of different factors related to containment will potentially have different consequences depending on the individual. It therefore seems difficult to predict how the lumbar symptoms will develop in this population. Indeed, if it can imagined that the decrease in regular physical activity and the increase in anxiety in this context of insecurity could lead to an increase in pain, it could just as well consider that the decrease in stress work, strenuous physical work or travel time from work to home can, on the contrary, have a favorable effect.

The objective of this study is to assess the confinement effect on low back pain intensity in chronic low back pain patients.

This is an observational, descriptive, transversal and pluricentric study conducted by a single questionnaire.

time_perspective: Cross-Sectional


title: Endovascular Thrombectomy in COVID-19 Infected Patients: Intrahospital and Peri-operative Outcomes

summary:
About 5% of COVID-19 patients may present symptoms related to acute ischemic stroke (AIS). Treatment-management and outcomes related to mechanical thrombectomy (MT) for COVID-19 infected patients harboring large vessel occlusion is largely unknown.

This multicentric study aims to investigate morbidity, mortality and neurological outcomes after MT performed in patients with COVID-19 infection.

ReferenceCitation: Cagnazzo F, Piotin M, Escalard S, Maier B, Ribo M, Requena M, Pop R, Hasiu A, Gasparotti R, Mardighian D, Piano M, Cervo A, Eker OF, Durous V, Sourour NA, Elhorany M, Zini A, Simonetti L, Marcheselli S, Paolo NN, Houdart E, Guédon A, Ligot N, Mine B, Consoli A, Lapergue B, Cordona Portela P, Urra X, Rodriguez A, Bolognini F, Lebedinsky PA, Pasco-Papon A, Godard S, Marnat G, Sibon I, Limbucci N, Nencini P, Nappini S, Saia V, Caldiera V, Romano D, Frauenfelder G, Gallesio I, Gola G, Menozzi R, Genovese A, Terrana A, Giorgianni A, Cappellari M, Augelli R, Invernizzi P, Pavia M, Lafe E, Cavallini A, Giossi A, Besana M, Valvassori L, Macera A, Castellan L, Salsano G, Di Caterino F, Biondi A, Arquizan C, Lebreuche J, Galvano G, Cannella A, Cosottini M, Lazzarotti G, Guizzardi G, Stecco A, Tassi R, Bracco S, Bianchini E, Micieli C, Pascarella R, Napoli M, Causin F, Desal H, Cotton F, Costalat V; ET-COVID-19 Study Group*. European Multicenter Study of ET-COVID-19. Stroke. 2021 Jan;52(1):31-39. doi: 10.1161/STROKEAHA.120.031514. Epub 2020 Nov 23.


title: Exploring Brain Damages After COVID-19 Infection

acronym: BRAINCOV

summary: Although direct evidence is currently lacking, the high identity between SARS-CoV-1 and SARS-CoV-2 suggests, that the latter viral strain could also infect the Central Nervous System (CNS). Indeed, some cases of SARS-COV2 encephalitis begin to be described and CNS damages are increasingly highlighted in the literature, but still not objectified by imaging and do not allow to explain the entire clinical patterns. We hypothesise that these CNS damages are not always objectified by Magnetic Resonance Imaging (MRI) but could be indirectly observed by a physiological dysfunction of neural conduction in the brainstem. We will explore brainstem disruption through an electrophysiological approach.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Bordeaux


title: CACOLAC : Randomized Trial of Citrulline Administration in the Hospital Patient in Intensive Care for COVID-19 Acute Respiratory Distress Syndrome

acronym: CACOLAC

summary:
Respiratory involvement of SARS-CoV2 leads to acute respiratory distress syndrome (ARDS) and significant immunosuppression (lymphopenia) exposing patients to long ventilation duration and late mortality linked to the acquisition of nosocomial infections.

Lymphopenia characteristic of severe forms of ARDS secondary to SARS-CoV2 infection may be linked to expansion of MDSCs and arginine depletion of lymphocytes.

Severe forms of COVID-19 pneumonitis are marked by persistent ARDS with acquisition of nosocomial infections as well as by prolonged lymphocytic dysfunction associated with the emergence of MDSC.

It has been found in intensive care patients hypoargininaemia, associated with the persistence of organ dysfunction (evaluated by the SOFA score), the occurrence of nosocomial infections and mortality. Also, it has been demonstrated that in these patients, the enteral administration of ARG was not deleterious and increased the synthesis of ornithine, suggesting a preferential use of ARG by the arginase route, without significant increase in argininaemia nor effect on immune functions. L-citrulline (CIT), an endogenous precursor of ARG, is an interesting alternative to increase the availability of ARG. Recent data demonstrate that the administration of CIT in intensive care is not deleterious and that it very significantly reduces mortality in an animal model of sepsis, corrects hypoargininemia, with convincing data on immunological parameters such as lymphopenia, which is associated with mortality, organ dysfunction and the occurrence of nosocomial infections. The availability of ARG directly impacts the mitochondrial metabolism of T lymphocytes and their function. The hypothesis is therefore that CIT supplementation is more effective than the administration of ARG to correct hypoargininaemia, decrease lymphocyte dysfunction, correct immunosuppression and organ dysfunction in septic patients admitted to intensive care.

The main objective is to show that, in patients hospitalized in intensive care for ARDS secondary to COVID-19 pneumonia, the group of patients receiving L-citrulline for 7 days, compared to the group receiving placebo, has a score of organ failure decreased on D7 (evaluated by the SOFA score) or by the last known SOFA score if the patient has died or been resuscitated.

lead_sponsor: Rennes University Hospital

intervention_type: Dietary Supplement


type: EudraCT Number

title: Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency

acronym: HORNbILL

summary: The study aims at assessing the efficacy and the safety of hydrocortisone combined with fludrocortisone compared to placebo in ICU adults with critical illness related corticosteroid insufficiency.

ReferenceCitation: Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21. Erratum in: Intensive Care Med. 2018 Feb 23;:.

ReferenceCitation: Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, François B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohé J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: General Intensive care Unit, Raymond Poincaré Hospital, APHP


acronym: LOVIT ARDS

title: A Multicentre Concealed-Allocation Parallel-Group Blinded Randomized Controlled Trial to Ascertain the Effect of High-Dose Intravenous Vitamin C Compared to Placebo on Mortality or Persistent Organ Dysfunction at 28 Days in Septic Intensive Care Unit Patients

source: euctr

location_facility: Department Intensive Care Unit, Hospital Raymond Poincaré - APHP

summary:
The primary objective of the study aims to compare the effect of high-dose intravenous vitamin C vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 28 days on intensive care unit (ICU) patients.

As secondary objectives, the study aims:

To compare the effect of high-dose intravenous vitamin C vs. placebo on:

6-month mortality;
6-month HRQoL;
organ function (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU);
global tissue dysoxia (at baseline);
oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU, and if still intubated);
occurrence of stage 3 acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global Outcomes) criteria20;

acute hemolysis as defined by:

clinician judgment of hemolysis, as recorded in the chart, or

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.

Severe hemolysis:

- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells;

hypoglycemia as defined as core lab-validated glucose levels of less than < 3.8 mmol/L.
To assess baseline vitamin C levels in study participants (before the first dose of investigational product).


title: "STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE" GERONIMO 19

acronym: GERONIMO 19

summary:
According to recent data, death rate is more than 20% for 75 years old hospitalized patients and older.

In case of aggravation, according to the latest observations, if they are refused for mechanical ventilation in intensive care, their death rate could reach 60% even for patients without comorbidity.

Apart from an increase in oxygen therapy, no specific treatment is currently proposed.

The control of the inflammatory component seems to be a key element to be able to influence the patients' health evolution.

Polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties with a favorable safety profile for these elderly patients and several clinical cases lead to positive impact in the caring for Covid patients.

This study objective is evaluation of the efficacy of polyvalent IVIg in combination with the standard management of patients aged 75 and over with SARSCov2 infection with acute respiratory failure (saturation ≤ 95%) requiring oxygen therapy> 5 L / min (i.e. patients considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02≤200) and disqualified from a care in the ICU.

lead_sponsor: Versailles Hospital


title: Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 During Pregnancy

acronym: TRANSCOVID

summary: The study evaluates the distribution of immunological and virological profiles of newborns patients. Mothers of these children have a proven infection to SARS Cov-2 during pregnancy.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Diagnostic Test


title: Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.

acronym: COVID-PSL

summary:
COVID-19 is an infection linked to a new coronavirus: SARS-CoV-2, which appeared in Wuhan in China at the end of 2019, and which has since spread around the world, responsible for a new major pandemic, which is upsetting the whole world.

If severe respiratory disease is the form that constitutes the extreme gravity of the disease (mortality, with more than 170,000 deaths worldwide to date).

However, there is a great heterogeneity of clinical forms with asymptomatic or symptomatic pauci forms, moderate forms, up to severe forms.

Different symptoms may appear: fever, cough, asthenia, dyspnea, gastrointestinal forms, anosmia and / or ageusia, skin involvement, etc.

Given the novelty of this infection, several questions remain:

What are all the symptoms that can be contracted by a COVID-19 patient?
Are there clinical forms not described?
What is the evolutionary profile, the healing time of this disease in patients treated on an outpatient basis?
What are the factors associated with a prolonged form of COVID-19 disease, including on an outpatient basis?

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida


title: DERMACLIC : Study on Skin Toxicities Induced by Cancer Treatments

acronym: DERMACLIC

summary: The skin toxicities will be evaluated on patient (male or female) with an indication of cancer treatment in the case of solid tumor of the breast, lung, digestive system or ENT (Ear, nose and throat).

lead_sponsor: Institut Curie


title: Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis

acronym: CannabisRIC

summary:
Patients with inflammatory rheumatism very often have residual pain that is not easily relieved by conventional treatments. They can then use non-drug methods, such as physiotherapy, hypnosis or even cannabis.

The aim of this study is to assess the percentage of patients who use cannabis to better relieve their pain or anxiety in chronic inflammatory rheumatism.

time_perspective: Other

lead_sponsor: University Hospital, Clermont-Ferrand


title: Psychometric Properties of a Mobile Application in Pressure Ulcers for Patients With Spinal Cord Injuries (SCI)

acronym: IMITO

summary:
Current methods to assess superficial size and area of pressure ulcers are either time-consuming (using Transparency Tracings techniques), costly (computers, softwares), or necessitating to touch the patient's skin (using commun rulers).

A free smartphone application (for IOS or Android) has recently been developed to measures skin lesions. It is called imitoMeasure. It does not require any contact with the patient. A photograph is taken with the smartphone, the limits of the lesion is then drawn with the health carers' finger on the phone's screen. The application computes the length, width and surface of the ulcer.

This technique has not yet been validated, although it has been used to measure various types of skin lesions.

The objective of this study is to validate this measurement technique on a sample of pressure ulcer in a population of patients with spinal cord injury (SCI). Reliability is assessed by comparison to the currently most frequently used techniques (Transparency Tracings and ruler-based), and fiability is assessed by intra-rater and inter-rater correlations.

imitoMeasure is a new smartphone application to measure wounds size. The present study assesses validity of the measure against common measures (ruler-based and transparency tracings), and the inter- and intra-rater reliability.

ReferenceCitation: Do Khac A, Jourdan C, Fazilleau S, Palayer C, Laffont I, Dupeyron A, Verdun S, Gelis A. mHealth App for Pressure Ulcer Wound Assessment in Patients With Spinal Cord Injury: Clinical Validation Study. JMIR Mhealth Uhealth. 2021 Feb 23;9(2):e26443. doi: 10.2196/26443.


title: Study KBP-2020-CPHG Documenting New Cases of Primary Lung Cancer (PLC) Diagnosed in Respiratory Medicine Departments and Lung Cancer Units at General Hospitals From January 1st to December 31st 2020

summary:
Twenty years after KBP-2000-CPHG study and ten years after KBP-2010-CPHG study, the CPHG proposes to conduct a new epidemiological study on primary PLC in order to evaluate and analyze the changes that have occurred over the last decade.

Primary endpoint:

Estimate 1-year- and 5-year-mortality rates in patients with PLC.

Secondary endpoints:

Describe PLC patient population managed by pulmonologists at French General Hospitals in 2020
Describe PLC diagnostic and therapeutic management by pulmonologists at French General Hospitals in 2020 and compare them to KBP-2000-CPHG and KBP-2010-CPHG studies
Estimate prognostic factors
Compare patient and tumor characteristics to those observed for KBP-2010-CPHG and KBP-2000-CPHG studies
Compare observed survival rates to those reported for KBP-2000-CPHG and KBP-2010-CPHG studies

location_facility: Collège des Pneumologues des Hôpitaux Généraux (CPHG) (General Hospital Pulmonologists College)


title: Multiparametric Evaluation of One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia After Intensive Care Unit

acronym: CO-Qo-ICU

summary:
Many of the patients hospitalized for a severe form of SARSCoV-2 respiratory impairment require prolonged intensive care that can be complicated in the short term, In the medium and long term, physical and psychological sequelae can affect patients' quality of life and prevent a return to normal working life.

To date, there is little data on the fate of patients treated in Resuscitation for a severe form of COVID-19, both in terms of respiratory sequelae, as well as in terms of psychological sequelae and their quality of life. The objective of this study is to be able to describe and evaluate the possible physical and psychological sequelae and quality of life of patients hospitalized in Resuscitation for a severe form of COVID-19 in the short (3 and 6 months), medium (1 year) and long (5 years) End of their stay in ICU. To do this, we want to carry out a prospective, observational and monocentric study in the consultation department of the Nice CHU. All patients admitted to Resuscitation for a severe form of COVID-19 who have accepted the longitudinal medical follow-up proposed by the Nice CHU will be included in the study and data from the computerized medical record will be analyzed.

ipd_sharing_description: No Data sharing plan has been established

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder

acronym: COVID-TRAUMA

summary:
The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. The study's primary objective is to measure the presence of a potential post-traumatic stress disorder in cancer patients, and to assess the associated factors. The secondary objectives are to measure patients' anxiety, as well as their perception of both the management of their cancer care, and their fear of a cancer recurrence.

It is a prospective, multi-centric study using self-assessing survey offered to cancer patients currently under ongoing care or treatment. The surveys will be sent by post at the beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000 patients will be contacted, over a period of 3 months, in order to receive 1600 responses, and 640 responses 6 months later.

Researching the factors associated with the appearance of post-traumatic stress could lead to better screening of patient disorders in highly anxiety-provoking crisis situations. As a result, it would lead to an improvement of their care, healthcare organization, and their follow-up in the case of a new epidemic or any other stressful event of this magnitude. Furthermore, promoting the patient's expression capabilities favors their implication in their care, and facilitates the development of health democracy.

lead_sponsor: Institut Paoli-Calmettes


title: Evaluation of the Natural History of Alcoholic Liver Disease According to Baseline Severity

acronym: SALVE

summary:
Alcohol-induced liver injury is made up of fatty liver, fibrosis and alcoholic hepatitis (AH), elementary lesions that may occur separately, simultaneously or sequentially in a same patient. Among these histological features, alcoholic hepatitis, a necro-inflammatory process is associated with the fastest fibrosis progression leading to cirrhosis in 40% of cases and a pivotal lesion driving increased risk of liver decompensation.

The non-invasive methods for the diagnosis of fibrosis open new perspectives for a better understanding of the natural history of disease-progression from early injury to the cirrhotic stage, for the identification of subgroup patients at risk of developing cirrhosis at medium term and for proposing a strategy of screening of patients with extensive cirrhosis at risk of liver-threatening events. There is an urgent need to perform studies in asymptomatic heavy drinkers in order to identify cut-offs associated with significant risk of development of cirrhosis at medium term. Such objectives require large-scale screening of heavy drinkers. Each of non-invasive methods have been tested to predict with of extensive fibrosis with a high predictive performance as shown below.

A screening policy cannot be accepted without answering the following questions: a) are the requirements of public health screening fulfilled? b) Is the group of patients undergoing screening defined? c) is there a reliable method for of testing? Indeed, the detection of a disease is subject to certain public health requirements and may be proposed to health authorities only if it modifies the management of subjects screened. In the specific case of mass screening of liver fibrosis in heavy drinkers, only the detection of extensive fibrosis could fulfill this criterion because of the potential survival benefit resulting from the screening of hepatocellular carcinoma (HCC) in patients with extensive fibrosis. Indeed, recent studies have found that the probability of receiving curative treatment of HCC was significantly higher in patients who received a six-month surveillance ultrasound. Therefore, the detection of extensive fibrosis seems reasonable in the light of these studies when considering that the yearly risk of development of HCC in the subgroup of heavy drinkers with extensive fibrosis is approximately 3%.

Taking into account the above scientific arguments, the most recent EASL clinical practical guidelines on ALD recommend longitudinal studies using non-invasive tools to evaluate screening of extensive fibrosis and disease progression in heavy drinkers.

lead_sponsor: University Hospital, Lille


acronym: IMPALA

title: Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy Followed by Anti-PD-1 NIVOLUMAB in Patients With Malignant Pleural Mesothelioma - a Pilot Study

summary: Pilot study of the feasibility of an innovative multimodal treatment combining intrapleural photodynamic therapy with videothoracoscopy followed by adjuvant immunotherapy with anti-PD-1 Nivolumab antibodies in patients with malignant pleural mesothelioma


title: Ex Vivo Study of Drugs Transfer Across the Placenta

acronym: DRUGS-PTP

summary: Drug prescriptions are usual during pregnancy however women and their fetuses still remain an orphan population with regard to drugs efficacy and safety clinical studies. Most xenobiotics diffuse through the placenta and some of them can alter fetus development resulting in structural abnormalities, growth or functional deficiencies. The aim of the study is to study the drug transfer using human placenta after delivery.

ReferenceCitation: Schneider H, Panigel M, Dancis J. Transfer across the perfused human placenta of antipyrine, sodium and leucine. Am J Obstet Gynecol. 1972 Nov 15;114(6):822-8.

ReferenceCitation: Hutson JR, Garcia-Bournissen F, Davis A, Koren G. The human placental perfusion model: a systematic review and development of a model to predict in vivo transfer of therapeutic drugs. Clin Pharmacol Ther. 2011 Jul;90(1):67-76. doi: 10.1038/clpt.2011.66. Epub 2011 May 11. Review. Erratum in: Clin Pharmacol Ther. 2011 Sep;90(3):479.


title: Feasibility Study of the ETOILE Program, a Therapeutic Education Program in Pediatric Hematology About Acute Lymphoblastic Leukemia and Allogenic Hematopoietic Steam Cells Transplantation, for Patient and Caregivers

acronym: ETOILE

summary: Feasibility study of a therapeutic education program for the patient and his carers, intended for children suffering from acute lymphoblastic leukemia or having received an allograft of hematopoietic stem cells in the pediatric hematology department of Robert Debré hospital ( Paris, APHP). In addition to feasibility, the intermediate effectiveness of the program will be assessed.


title: Impact of Hypnosis During Invasive Procedure in Intensive Care Unit

acronym: HYPNOICU

summary: Pain during ICU stay remains one of the major complaints for patients. Beside pain intensity, well described by patients' self reports, pain distress, which is an emotional experience, cannot be treated with usual analgesia. The aim of the study is to analyze the impact of hypnosis on pain intensity and distress on short and long term outcomes in non-sedated ICU patients.


title: Highlighting the Medico-economic Interest of an Adapted Physical Activity for Haemodialysis Patients

acronym: NEPHRACTIVE

summary:
Chronic hemodialysis is often associated with a reduction in the quality of life of patients and a reduction in physical activity, due to the repeated frequency of sessions.

Various studies conducted in hemodialysis patients have shown the beneficial effects of physical exercise during hemodialysis sessions on reducing cardiovascular risk, the number of hospitalizations and improving quality of life. It also contributes to improved patient adherence to care.

Finally, it has been shown that exercise during the hemodialysis session is safe for the patient and does not disrupt dialysis parameters.

Nevertheless, there are no data on the medico-economic impact of such a program.

Based on the investigators' experience, the investigators have developed a specific protocol linking the different types of physical activity that have provided evidence of their efficiency and used in standard practice in the investigators' institutions. From tests and questionnaires assessing the physical abilities of patients have already validated for this population in this pathology.

The objective of this project is to show the medico-economic interest of an adapted physical activity program for hemodialysis patients.

lead_sponsor: Clinique Néphrologique Saint-Exupéry

location_facility: Clinique Néphrologique Saint Saint-Exupéry


title: End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room: Prospective Randomized Clinical Trial Comparing Two Occlusion Tests (EXPIRE)

acronym: EXPIRE

summary: The purpose of the study is to evaluate the influence of different durations of the end-expiratory occlusion test to predict fluid responsiveness in mechanically ventilated patients in the operating room.