title: Investigation of Cross-allergies Between Cefazolin and Amoxicillin With Skin Tests and Provocation Test

acronym: CEFAZOPE

summary:
Antibiotic prophylaxis in the operating room reduces the frequency of occurrence of surgical site infections (SSI) by preventing bacterial proliferation.

The main antibiotic used in all surgery is CEFAZOLINE. This antibiotic of the Beta-lactam family, and more precisely of the 1st generation cephalosporins, is active on a specific bacterial target, which is often the cause of surgical site infections. Patients known to be allergic to penicillin have a 50% higher risk of surgical site infection. The choice of antibiotic prophylaxis often comes up against the risk of allergy in anesthesia. In France in 2004, according to the INSERM database, 100 IgE-mediated immediate hypersensitivity reactions (IHR) were observed out of 1 million anesthesias. The attributable allergens in descending order were curares (60.6%), latex (5.2%) then antibiotics (18.2%), followed by dyes (3.5%), hypnotics, opioids, gelatins and local anesthetics were rarely found. Regarding allergy to antibiotics, the leading antibiotic for allergy in France is AMOXICILLIN, which accounts for 29% of drug-induced anaphylaxis. In view of the risk of cross-allergy, a history of allergy to AMOXICILLIN in the operating room is a contraindication to all beta-lactam antibiotics and therefore leads to an alternative choice to CEFAZOLINE when the latter was indicated for first-line antibiotic prophylaxis.

However, this choice of alternative antibiotic to CEFAZOLINE is not without consequences. First of all, the alternative antibiotics Vancomycin and Clindamycin have a narrower spectrum and therefore may not cover all germs found in SSI. They do not cover Gram-negative organisms for Vancomycin and Gram-negative aerobes for Clindamycin. Moreover, the use of these antibiotics exposes to undesirable effects. They can promote the occurrence of nosocomial infections such as Clostridium difficile colitis, infections with resistant germs such as methicillin-resistant Staphylococcus aureus (MRSA) or Vancomycin-resistant Enterococcus (VRE). Other adverse effects may occur such as Nephrotoxicity and Red Man Syndrome with Vancomycin. In addition, these antibiotics may be more difficult to handle, not allowing for the optimization of recommended delivery conditions. Secondly, the notion of the cost of these antibiotics must be taken into account.

Two elements could encourage investigators to use CEFAZOLINE despite a history of allergy to AMOXICILLIN.

1. Allergy declarations such as can be obtained in consultation correspond mainly to false positives. In fact, out of 10% of the world's population reporting an allergy to penicillins, only 1 to 2% of subjects have a proven allergy. In GHPSJ, among the patients consulting for a suspected allergy, the reintroduction test confirmed it in only 5.6% of them.
From a molecular point of view, there is a low rate of similarity between these two molecules. Contrary to popular belief, cephalosporin allergy is not mediated by the β-lactam core. The cross-allergy between cephalosporins and penicillin comes from the similarities of the R1 chain which is attached to the β-lactam nucleus at position 7 for cephalosporins, at position 6 for penicillins. This may therefore explain the lack of clinical cross-reactivity.

The primary objective is to evaluate the proportion of patients of allergies between CEFAZOLINE and AMOXICILLINE.

The secondary objectives are to evaluate the diagnostic value of skin tests to CEFAZOLINE and to describe the safety of protocol of reintroduction of CEFAZOLINE and AMOXICILLINE in the context of IgE-mediated cross-reactivity.

ReferenceCitation: Blumenthal KG, Ryan EE, Li Y, Lee H, Kuhlen JL, Shenoy ES. The Impact of a Reported Penicillin Allergy on Surgical Site Infection Risk. Clin Infect Dis. 2018 Jan 18;66(3):329-336. doi: 10.1093/cid/cix794.

ReferenceCitation: Tacquard C, Collange O, Gomis P, Malinovsky JM, Petitpain N, Demoly P, Nicoll S, Mertes PM. Anaesthetic hypersensitivity reactions in France between 2011 and 2012: the 10th GERAP epidemiologic survey. Acta Anaesthesiol Scand. 2017 Mar;61(3):290-299. doi: 10.1111/aas.12855.

ReferenceCitation: Blanca M, Torres MJ, García JJ, Romano A, Mayorga C, de Ramon E, Vega JM, Miranda A, Juarez C. Natural evolution of skin test sensitivity in patients allergic to beta-lactam antibiotics. J Allergy Clin Immunol. 1999 May;103(5 Pt 1):918-24.

ReferenceCitation: Vorobeichik L, Weber EA, Tarshis J. Misconceptions Surrounding Penicillin Allergy: Implications for Anesthesiologists. Anesth Analg. 2018 Sep;127(3):642-649. doi: 10.1213/ANE.0000000000003419. Review.

ReferenceCitation: Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists (ASHP); Infectious Diseases Society of America (IDSA); Surgical Infection Society (SIS); Society for Healthcare Epidemiology of America (SHEA). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013 Feb;14(1):73-156. doi: 10.1089/sur.2013.9999. Epub 2013 Mar 5.

ReferenceCitation: Pool C, Kass J, Spivack J, Nahumi N, Khan M, Babus L, Teng MS, Genden EM, Miles BA. Increased Surgical Site Infection Rates following Clindamycin Use in Head and Neck Free Tissue Transfer. Otolaryngol Head Neck Surg. 2016 Feb;154(2):272-8. doi: 10.1177/0194599815617129. Epub 2015 Nov 16.


title: Comparison Between Two Rehabilitation Programs (Conventional and Aquatic) After Cruciate Ligament Injury in Sportsmen

acronym: Thermasport

summary:
Knee cruciate ligament injury is a common injury (15 000 per year in France) which concerns young sportsmen. Consequences are limitation in physical and sporting activities and at work.

Main objective: to compare water and traditional rehabilitation after cruciate ligament injury reconstruction in terms of kinematics of recovery and of proprioceptive abilities development.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Peultier-Celli L, Mainard D, Wein F, Paris N, Boisseau P, Ferry A, Gueguen R, Chary-Valckenaere I, Paysant J, Perrin P. Comparison of an Innovative Rehabilitation, Combining Reduced Conventional Rehabilitation with Balneotherapy, and a Conventional Rehabilitation after Anterior Cruciate Ligament Reconstruction in Athletes. Front Surg. 2017 Nov 7;4:61. doi: 10.3389/fsurg.2017.00061. eCollection 2017.

lead_sponsor: Central Hospital, Nancy, France

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Pilot Study on Lung Cancer Screening Implementation Among Employees at Lyon Hospital

acronym: ILYAD

summary:
Several randomized studies have demonstrated the efficiency of lung cancer screening (LCS) on mortality rates. However, screening efficiency is related to the targeted population and the participation rate.

In France, the participation rate for breast and colon cancer screening programs is respectively 50% and 32%, which is low. Then, it appears very important to determine which factors are influencing the willingness to participate to these programs. Indeed, it will allow a better communication and we will be able to perform screening campaigns adapted to the eligible population.

The Lyon Hospital is the second university hospital in France. It is composed of 14 buildings and employed 23 000 persons. More than 160 occupations are represented. So, hospital employees look relevant to be studied for LCS program.

ILYAD was divided in 2 parts. The first one was completed in 2020 and goal to evaluate the number of eligible individuals among the hospital employees. About 800 persons would be eligible for LCS.

This second part of the study will evaluate the participation rate and the feasibility of the LCS program. The study will target the 800 individuals that were identified previously.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital de la Croix Rousse - Department of Pneumology

status_simplified: Ongoing


title: Coronavirus Disease 2019 (Covid-19) at the Regional Hospital Center Metz-Thionville: a Descriptive Study

summary:
France and especially the region "Grand Est" have been damaged by the COVID-19 pandemic. This pandemic resulted in a reorganization of the hospitalization sectors.

In order to better understand the disease, the investigators wish to carry out a descriptive analysis of hospitalized patient data. This study would notably allow us to identify some prognostic factors.

The main objective of this study is to identify individual factors that are associated with a poor prognosis (with ICU admission or death).

study_start_date_type: Actual

status: Recruiting

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Longitudinal Description of Hemorrhoidal Pathology

acronym: DeLPH

summary: Hemorrhoidal disease is a common cause of gastroenterology visits. In the United States, it is considered the 3rd most common gastrointestinal diagnosis with nearly 4 million scheduled or emergency visits. In France, self-reported questionnaires estimate that one person in five has suffered at least one hemorrhoidal attack in the past year.

status: Active, not recruiting

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


type: Other Identifier

title: Feasibility Study on the Medical and Economic Consequences of an Ambulatory Transient Ischemic Attack and Minor Stroke Management

acronym: MEDECO-AIT

summary:
The effectiveness of outpatient management of minor TIAs and strokes in the context of a dedicated outpatient pathway with specialized care has been demonstrated and has resulted in an 80% decrease in stroke in the year followed the AIT (EXPRESS and SOS-TIA studies) At the same time, few studies have been conducted on their economic interest and none in France.

Patient's typology (younger patient, no sequel, no disability) with Transient ischemic attack (TIA) and minor stroke (MS) makes them compatible with ambulatory management.

lead_sponsor: University Hospital, Toulouse


title: SENOMETRY : Big Data and Text-mining Technologies Applied for Breast Cancer Medical Data Analysis

acronym: SENOMETRY

summary:
Primary purpose :

To develop a method to automatically extract and structure the information included in numerous medical records from breast cancer patients.

Secondary purpose :

With this procedure we can analyze the content of ten thousand anonymized textual medical records.

This information should enable us to explore many subjects, such as:

The impact of certain therapeutic procedures
The characteristics of sub-groups of patients
Pregnancy associated breast cancers
Risk factors

lead_sponsor: University Hospital, Strasbourg, France


type: EudraCT Number

title: Phone-based Safety Monitoring of the First Year of Baclofen Treatment for Alcohol Use Disorder: the BACLOPHONE Cohort Study

acronym: BACLOPHONE

summary:
BACLOPHONE is a prospective multicenter cohort study, conducted in two nearby French regions (Hauts-de-France and Normandie). BACLOPHONE consists of the monthly phone-based monitoring of 792 patients during their first year of baclofen prescription for alcohol use disorder.

The main objective of the study is to determine the rate of patients who stop baclofen due to an adverse event (AE) in the first year of treatment.The BACLOPHONE study also aims to determine which types of AEs and serious AEs are actually liable to baclofen, and which other types are more likely the consequence of confounding factors, e.g., concomitant alcohol, psychotropic medications or substance uses, and comorbidities.

primary_purpose: Other

lead_sponsor: University Hospital, Lille

location_facility: Etablissement Public de Santé Mentale (EPSM)

location_facility: Centres de Soins, d'Accompagnement et de Prévention en Addictologie (CSAPA) Le Cèdre Bleu

location_facility: Service d'Aide aux Toxicomanes (SATO-Picardie)

intervention_type: Drug


title: Etude Des Facteurs prédictifs de l'Apparition et de l'évolution de la Maladie de Parkinson

acronym: ICEBERG

summary:
Observational, prospective, monocentric study to assess clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients and rate of progression compared to healthy controls (HC) and subjects at risk to develop PD.

The primary objective of this study is to identify clinical, imaging and biologic markers of PD onset and progression for use in clinical trials of disease-modifying therapies.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France


status: Completed

primary_purpose: Basic Science

acronym: IDA-Adult

intervention_type: Biological

title: Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol

study_completion_date_type: Actual

source: euctr

location_facility: Unité de Recherche Clinique et Immunologique

summary:
Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent, and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a temporary immunosuppression; furthermore, an improvement of AD has been observed during measles infection.

This trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms.

30 adult patients of both sexes with moderate to severe AD will be randomly assigned to measles vaccine (ROUVAX ®), or placebo (vehicle) and follow-up for 45 days.

The primary outcome is the effect of anti-measles vaccination on the T cell responses in patients; Other outcomes include: clinical evolution of AD, as measured by the SCORAD, the evolution of blood level of measles specific IgE and antibodies; evolution of other biomarkers and phenotypic characteristics of T lymphocytes.

status_simplified: Completed


title: Hepatitis B Cohort: Predictive Factors of the Outcome of Chronic Hepatitis B Virus Infection

summary: It is estimated that 350-400 million people worldwide are chronically infected with hepatitis B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV infection and are responsible of about 500,000 deaths each year. Although some predictive factors of the outcome of chronic HBV infection were reported, it remains needed to more precisely determine the factors which are associated with the outcome in non-selected patients. Indeed, these factors should help to identify patients who are likely to have a better or worse evolution of their chronic HBV infection over time and thus, to adapt their clinical management and monitoring.Therefore, our purpose is to constitute a "real-life" cohort of non-selected patients to create a database of epidemiological, clinical, biological, virological and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.


title: Impact of Parent's Presence in Neonatology

summary:
Every year 75000 new-born babies are hospitalized in neonatology yard in France with about 60000 born prematurely.

Studies showed that parents presence is good for the baby development , decrease the stress due to hospitalization.It's also efficient for the attachment between the baby and parents.

Although the team try to settle a good atmosphere to establish this link and let parents take their position,it seems that the time taken to stay with the baby is less moreover the night.

The aim of the study is to evaluate the time of presence to find tools to increase this time in the neonatotology yard


title: Assessment of the Safety and Feasibility of a High-intensity Interval Training Program in Adult CF Patients: a Randomized Bicentric Pilot Study

acronym: ITHI

summary:
This study compare an usual training program (in continuous endurance) with an ITHI program over a period of 3 weeks, in France. The aim is to evaluate the safety and feasibility of this type of program in CF adults, and also more specifically, in subgroups:

patients divided according to the severity of their FEV1 ; patients treated with modulating CFTR canal therapy ; diabetic patients on insulin ; undernourished patients.

lead_sponsor: Fondation Ildys

location_facility: CF Center of Giens - Hospices Civils de Lyon Hôpital Renée Sabran

location_facility: CF Center - Fondation Ildys Site de Perharidy

lead_sponsor_type: industriel


title: Evaluation of the Respiratory Function in Renal Transplanted Children : a Prospective, Multicenter French Study

acronym: SPIROKID

summary:
Objectives:

While a respiratory abnormality was found in 50% of pediatric renal transplant recipients in a study conducted in Belgium and the Netherlands in 2008, the respiratory status of transplanted children in France remains unknown. The primary objective of this study is to assess the prevalence of respiratory impairment and its characteristics in children with renal transplant. The secondary objective is to study its association with some potential risk factors such as immunosuppressive therapy or humoral immunodeficiency.

Methodology:

This interventional study aims to recruit the 385 children currently being followed by 5 French pediatric renal transplant centers between June 2018 and November 2019. A clinical and functional respiratory assessment will be carried out during the routine annual follow-up of the transplant recipient. Children with clinical signs of concern or abnormal spirometry will be referred to a respiratory specialist. Pharmacokinetic assays of immunosuppressant therapy and the exploration of humoral function will also be performed. The prevalence and type of respiratory abnormalities will be described. Logistic regression will be used to explore the association between potential risk factors and impaired respiratory function.

Expected results:

This study will be the first to evaluate the respiratory status of children with renal transplants in France. The prospective, multi- centered nature of the study, in addition to the large cohort size (which represents two thirds of children with renal transplants in France) will guarantee current, reliable, and representative data for the target population. We will provide new knowledge by precisely characterizing the type of lung injury and looking for potential risk factors. If our study confirms the high prevalence of pulmonary impairment in children with renal transplants, systematic monitoring of respiratory function may be recommended to enable early diagnosis and management. The expected individual and public health benefits would be significant by limiting the appearance of long-term, irreversible sequelae (such as non-cystic-fibrosis bronchiectasis) and improving the quality of life of these patients.

lead_sponsor: Nantes University Hospital

location_facility: Hôpital Universitaire Necker Enfants Malades


title: Immediate Effect of Cervical Posterior Muscles' and Gluteus Medius Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia

acronym: VIBR-AVC

summary:
Balance disorders are very common after strokes and often last for long periods of time. Their origin is multifactorial and their impact on the daily lives of patients are particularly important, especially on gait.

The vibration technology for rehabilitation was already studied in static posture with force plats but their impact on gait have yet to be evaluated.

This present study aims at investigating the effects of vibrations applied by an approved medical device to the posterior neck muscles and the gluteus medius - major actors of proprioception and posture mechanisms - on gait disorders in patients with hemiplegia during the chronic phase after stroke.

lead_sponsor: Rennes University Hospital


title: The Issue of Late Recourse to HIV Testing. A Study of the Psychosocial Factors at Play Within Men Who Have Sex With Men in France.

acronym: ReTarD

summary:
The present study will try to investigate and analyze the psycho-social hindrances and levers concerning the recourse to late HIV testing among the MSM population.

This study is divided in two parts. The first one will consist of individual and groups interviews. Then, depending on the items that will rise from the first part of the study, groups interview will take place based on theses items. Finally, a questionnaire build from the collected information will be sent to MSM community in order to obtain quantitative results.

ipd_sharing: Undecided

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility:
Hôpital Bichat Claude-Bernard
Le 190
Hôpital Pitié-Salpêtrière
Hopital Saint-Antoine

intervention_type: Behavioral


type: Registry Identifier

title: Multidomain Intervention to Prevent Disability in Elders

acronym: MINDED

summary: Prevention of physical disability represents a major priority for the public health system. Physical disability is the final result of a complex cascade of negative events occurring at different levels (i.e., environmental, social, biological, and clinical). The heterogeneity of the underlying mechanisms responsible for the onset of physical disability may require the adoption of preventive interventions affecting multiple domains. Although several studies suggest that single or different combinations of preventive interventions (in particular, physical activity, cognitive training, and healthy diet) might provide beneficial effects in preventing functional loss (and its related features, such as pain or reduced quality of life), very limited evidence coming from clinical trials is currently available on the topic. Intervention trials are usually designed to test the effect of a specific monodimensional intervention on a very selected population, so to reduce the risk of biased results. This approach, although legitimate and methodologically correct, may 1) be insufficient to target the multiple and heterogeneous physiopathological mechanisms underlying the onset of physical disability, and 2) cause a population selection bias leading to difficulties in implementing the study results to the overall older population (thus, determining the "evidence-based medicine" issue in the elderly). To our knowledge, there are no available data from clinical trials evaluating the effects of a multidomain intervention based on lifestyle modifications (e.g., physical activity, cognitive training, nutritional modification) for preventing mobility disability (a very early phase of the disabling process) in community-dwelling older persons. In the present project (Multidomain Intervention to preveNt Disability in ElDers, MINDED), we propose to conduct a pilot study aimed at estimating the effects of a multidomain person-tailored preventive intervention (based on physical activity, cognitive training, and nutritional modifications) on frailty status, physical performance, cognitive function, nutritional status, health-related quality of life, and use of health care services. In addition, we will perform cost-effectiveness analyses of the proposed intervention. The project will yield the necessary preliminary data to design a definitive full-scale Phase 3 randomized clinical trial. By providing a conclusive answer about the effectiveness of a multidimensional preventive program in the primary prevention of major health-related outcomes, the results of the full-scale trial will have relevant clinical and public health implications, and will promote the practicing of a truly evidence-based geriatric medicine.

primary_purpose: Prevention

location_facility: Centre de Rééducation Fonctionnelle "La Roseraie"


title: Effect of Weight Loss Induced Either by Gastric Bypass or Lifestyle Intervention on the Peripheral Activity of the Endocannabinoid System

acronym: CCENDO

summary: The aim of the study is to precise the effect of a large amount of weight loss induced by gastric bypass on the endocannabinoid system (plasma and adipose tissue) of morbidly obese patients and to determine the influence of a gastric bypass surgery compared to a lifestyle intervention with equivalent weight loss on the endocannabinoid system

ReferenceType: background

ReferenceCitation: Di Marzo V, Matias I. Endocannabinoid control of food intake and energy balance. Nat Neurosci. 2005 May;8(5):585-9. Review.

ReferenceCitation: Cota D. CB1 receptors: emerging evidence for central and peripheral mechanisms that regulate energy balance, metabolism, and cardiovascular health. Diabetes Metab Res Rev. 2007 Oct;23(7):507-17. Review.

ReferenceCitation: Engeli S, Böhnke J, Feldpausch M, Gorzelniak K, Janke J, Bátkai S, Pacher P, Harvey-White J, Luft FC, Sharma AM, Jordan J. Activation of the peripheral endocannabinoid system in human obesity. Diabetes. 2005 Oct;54(10):2838-43.

ReferenceCitation: Blüher M, Engeli S, Klöting N, Berndt J, Fasshauer M, Bátkai S, Pacher P, Schön MR, Jordan J, Stumvoll M. Dysregulation of the peripheral and adipose tissue endocannabinoid system in human abdominal obesity. Diabetes. 2006 Nov;55(11):3053-60.

ReferenceCitation: Sjöström L, Narbro K, Sjöström CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lönroth H, Näslund I, Olbers T, Stenlöf K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52.

lead_sponsor: University Hospital, Bordeaux

location_facility: Haut Lévêque Hospital, Endocrine department


title: Antioxidant Signature in Adult Patients With Phenylketonuria (PKU) and Healthy Volunteers : Relationship With Metabolic Disturbances

acronym: StressOX-PCU

summary: To date, oxidative stress in PKU has been evaluated only with fragmented approaches.The aim of the present study is to investigate oxidative stress in PKU with more comprehensive methods.The relationship between oxidative stress and metabolic disturbances (hyperPhenylalaninemia) will also be studied.

lead_sponsor: University Hospital, Tours


title: Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes

acronym: CERADIAB

summary: Sphingolipids are associated with metabolic diseases. Distribution of plasma sphingolipids in type 1 and type 2 diabetes has never been studied. The objective of the CERADIAB study is to compare plasma sphingoliplids concentrations in type 1 and type 2 diabetic patients.

time_perspective: Cross-Sectional

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: Effects of Levosimendan Pretreatment in Patients With Low Ejection Fraction (40 % or Less) Undergoing CABG: a Randomised, Double Blind, Multicenter Trial

acronym: LICORN

summary: The investigators want to test the hypothesis that an infusion of levosimendan started prior to CABG surgery can reduce incidence and severity of low cardiac output syndrome in patients with poor LV function (EF 40% or less).

ReferenceCitation: Levin R, Degrange M, Del Mazo C, Tanus E, Porcile R. Preoperative levosimendan decreases mortality and the development of low cardiac output in high-risk patients with severe left ventricular dysfunction undergoing coronary artery bypass grafting with cardiopulmonary bypass. Exp Clin Cardiol. 2012 Sep;17(3):125-30.

ReferenceCitation: De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. Erratum in: Anesth Analg. 2007 Jun;104(6):1544. Dosage error in article text.

ReferenceCitation: Tritapepe L, De Santis V, Vitale D, Santulli M, Morelli A, Nofroni I, Puddu PE, Singer M, Pietropaoli P. Preconditioning effects of levosimendan in coronary artery bypass grafting--a pilot study. Br J Anaesth. 2006 Jun;96(6):694-700. Epub 2006 Apr 4.

ReferenceCitation: Cholley B, Caruba T, Grosjean S, Amour J, Ouattara A, Villacorta J, Miguet B, Guinet P, Lévy F, Squara P, Aït Hamou N, Carillion A, Boyer J, Boughenou MF, Rosier S, Robin E, Radutoiu M, Durand M, Guidon C, Desebbe O, Charles-Nelson A, Menasché P, Rozec B, Girard C, Fellahi JL, Pirracchio R, Chatellier G; -. Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):548-556. doi: 10.1001/jama.2017.9973.

ReferenceCitation: Caruba T, Hourton D, Sabatier B, Rousseau D, Tibi A, Hoffart-Jourdain C, Souag A, Freitas N, Yjjou M, Almeida C, Gomes N, Aucouturier P, Djadi-Prat J, Menasché P, Chatellier G, Cholley B. Rationale and design of the multicenter randomized trial investigating the effects of levosimendan pretreatment in patients with low ejection fraction (≤40 %) undergoing CABG with cardiopulmonary bypass (LICORN study). J Cardiothorac Surg. 2016 Aug 5;11(1):127. doi: 10.1186/s13019-016-0530-z.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, France


title: Testing the Effect of Raltegravir on Persistent de Novo HIV Infection in Virologic Responders to Antiretroviral Therapy ( RALNOVO )

acronym: RALNOVO

summary:
There is a theoretical possibility of a complete suppression of HIV viral replication, subject to the use of highly active associations of more than 25 antiretroviral drugs currently available and good treatment adherence. But a key question remains: whether it can persist viral replication low noise HAART, since several arguments suggest a subclinical escape of the virus to HAART at least in some individuals. The technique proposed in this research consists of the detection and quantification of the linear viral cDNA intra cytoplasmic, as persistent novo infection marker in order to highlight the subclinical replication active in treatment of HIV-1 and consider an optimized therapeutic management of patients.

Main objective : Comparing the frequency of patients infected with HIV and treated effectively (HIV viral load undetectable plasma with conventional methods) having the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood, as cellular infection marker novo persistent, among patients with a therapeutic regimen contains or not the viral integrase inhibitor raltegravir.

Secondary objectives

To evaluate the frequency of patients infected with HIV and treated effectively with the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood
Evaluate the causes of persistent infection in de novo virological responders to treatment with ART: presence of the HIV genome encoding strains resistant to treatment ART ongoing noncompliance to treatment, type of antiretroviral therapy, CD4 nadir , pretreatment level of plasma HIV RNA, total duration of ART
Assess the impact of persistent novo infection virological responders: cell activation CD4 + and CD8 +, lack of immunological treatment response, changes in lymphocyte ratio T naïve / memory cells cells, the presence of transient increase viremia, residual viremia levels
Identify virological responders may benefit from treatment intensification

lead_sponsor: University Hospital, Montpellier


title: French Study on COgnitive Enhancement and Consumption of Psychoactive Substances Among Youth Students (Enquête Nationale Sur le Dopage Intellectuel et Les Consommations de Substances Psychoactives Chez Les Jeunes étudiants)

acronym: ENQUETE-COSYS

summary: This descriptive and declarative study will help to find out consumption rates, all psychoactive substances taken together, among 18-25 year olds. More specifically, it will allow assessment of the extent of the cognitive enhancement phenomenon among students in France (including study of misuse of methylphenidate (MPH) and modafinil in improvement of cognitive performance).

ReferenceCitation: Batisse A, Leger S, Vicaut E, Gerbaud L, Djezzar S. COgnitive enhancement and consumption of psychoactive Substances among Youth Students (COSYS): a cross-sectional study in France. Public Health. 2021 May;194:75-78. doi: 10.1016/j.puhe.2021.02.036. Epub 2021 Apr 14.

location_facility: CHU Clermont-Ferrand - service de santé publique


title: Contribution of Body Composition Monitor (BCM) Among Patients Using Daily Home Dialysis With Low Dialysate Flow : French Study Cohort

acronym: VOLODIA

summary:
The fluid overload measured by the Body Composition Monitor (BCM Fresenius Medical Care) is a new independent risk factor of mortality.

This risk has already been described in intermittent hemodialysis patients and peritoneal dialysis patients but never evaluated in Daily Home Dialysis with low dialysate flow.

The investigator propose a first study measuring the state of hydration by impedancemetry (BCM) in this population.

The aim of this work is to to analyze hydration status in a representative sample of prevalent Daily Home Dialysis with low-flow Dialysate patients.

Secondary objectives are to identify associations between hydration status and patient characteristics and treatment practice in order to find out which conditions should alert the clinician to potential fluid overload, to compare these results with the peritoneal dialysis population and in center hemodialysis population, to evaluate the correlation between impedancemetry and blood pressure in this population, to assess the nutritional status and evaluation of a new method of measurement of kt / V based on impedancemetry, without recourse to a blood test.

ReferenceCitation: FHN Trial Group, Chertow GM, Levin NW, Beck GJ, Depner TA, Eggers PW, Gassman JJ, Gorodetskaya I, Greene T, James S, Larive B, Lindsay RM, Mehta RL, Miller B, Ornt DB, Rajagopalan S, Rastogi A, Rocco MV, Schiller B, Sergeyeva O, Schulman G, Ting GO, Unruh ML, Star RA, Kliger AS. In-center hemodialysis six times per week versus three times per week. N Engl J Med. 2010 Dec 9;363(24):2287-300. doi: 10.1056/NEJMoa1001593. Epub 2010 Nov 20. Erratum in: N Engl J Med. 2011 Jan 6;364(1):93.

ReferenceCitation: Chertow GM, Levin NW, Beck GJ, Daugirdas JT, Eggers PW, Kliger AS, Larive B, Rocco MV, Greene T; Frequent Hemodialysis Network (FHN) Trials Group. Long-Term Effects of Frequent In-Center Hemodialysis. J Am Soc Nephrol. 2016 Jun;27(6):1830-6. doi: 10.1681/ASN.2015040426. Epub 2015 Oct 14.

ReferenceCitation: Mathew A, McLeggon JA, Mehta N, Leung S, Barta V, McGinn T, Nesrallah G. Mortality and Hospitalizations in Intensive Dialysis: A Systematic Review and Meta-Analysis. Can J Kidney Health Dis. 2018 Jan 10;5:2054358117749531. doi: 10.1177/2054358117749531. eCollection 2018.

ReferenceCitation: Kjellstrand CM, Buoncristiani U, Ting G, Traeger J, Piccoli GB, Sibai-Galland R, Young BA, Blagg CR. Short daily haemodialysis: survival in 415 patients treated for 1006 patient-years. Nephrol Dial Transplant. 2008 Oct;23(10):3283-9. doi: 10.1093/ndt/gfn210. Epub 2008 May 5.

ReferenceCitation: Weinhandl ED, Liu J, Gilbertson DT, Arneson TJ, Collins AJ. Survival in daily home hemodialysis and matched thrice-weekly in-center hemodialysis patients. J Am Soc Nephrol. 2012 May;23(5):895-904. doi: 10.1681/ASN.2011080761. Epub 2012 Feb 23.

ReferenceCitation: Raimann JG, Chan CT, Daugirdas JT, Depner T, Gotch FA, Greene T, Kaysen GA, Kliger AS, Kotanko P, Larive B, Lindsay R, Rocco MV, Chertow GM, Levin NW; Frequent Hemodialysis Network (FHN) Trial Group. The Effect of Increased Frequency of Hemodialysis on Volume-Related Outcomes: A Secondary Analysis of the Frequent Hemodialysis Network Trials. Blood Purif. 2016;41(4):277-86. doi: 10.1159/000441966. Epub 2016 Jan 21.

ReferenceCitation: Kaysen GA, Greene T, Larive B, Mehta RL, Lindsay RM, Depner TA, Hall YN, Daugirdas JT, Chertow GM; FHN Trial Group. The effect of frequent hemodialysis on nutrition and body composition: frequent Hemodialysis Network Trial. Kidney Int. 2012 Jul;82(1):90-9. doi: 10.1038/ki.2012.75. Epub 2012 Mar 28.

ReferenceCitation: Ipema KJ, Struijk S, van der Velden A, Westerhuis R, van der Schans CP, Gaillard CA, Krijnen WP, Franssen CF. Nutritional Status in Nocturnal Hemodialysis Patients - A Systematic Review with Meta-Analysis. PLoS One. 2016 Jun 20;11(6):e0157621. doi: 10.1371/journal.pone.0157621. eCollection 2016. Review.

ReferenceCitation: Weinhandl ED, Nieman KM, Gilbertson DT, Collins AJ. Hospitalization in daily home hemodialysis and matched thrice-weekly in-center hemodialysis patients. Am J Kidney Dis. 2015 Jan;65(1):98-108. doi: 10.1053/j.ajkd.2014.06.015. Epub 2014 Jul 29.

ReferenceCitation: Suri RS, Li L, Nesrallah GE. The risk of hospitalization and modality failure with home dialysis. Kidney Int. 2015 Aug;88(2):360-8. doi: 10.1038/ki.2015.68. Epub 2015 Mar 18.

ReferenceCitation: Finkelstein FO, Schiller B, Daoui R, Gehr TW, Kraus MA, Lea J, Lee Y, Miller BW, Sinsakul M, Jaber BL. At-home short daily hemodialysis improves the long-term health-related quality of life. Kidney Int. 2012 Sep;82(5):561-9. doi: 10.1038/ki.2012.168. Epub 2012 May 23.

ReferenceCitation: Jaber BL, Schiller B, Burkart JM, Daoui R, Kraus MA, Lee Y, Miller BW, Teitelbaum I, Williams AW, Finkelstein FO; FREEDOM Study Group. Impact of short daily hemodialysis on restless legs symptoms and sleep disturbances. Clin J Am Soc Nephrol. 2011 May;6(5):1049-56. doi: 10.2215/CJN.10451110. Epub 2011 Mar 17.

ReferenceCitation: Jaber BL, Lee Y, Collins AJ, Hull AR, Kraus MA, McCarthy J, Miller BW, Spry L, Finkelstein FO; FREEDOM Study Group. Effect of daily hemodialysis on depressive symptoms and postdialysis recovery time: interim report from the FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study. Am J Kidney Dis. 2010 Sep;56(3):531-9. doi: 10.1053/j.ajkd.2010.04.019. Epub 2010 Jul 29.

ReferenceCitation: Cornelis T, Usvyat LA, Tordoir JH, Wang Y, Wong M, Leunissen KM, van der Sande FM, Kotanko P, Kooman JP. Vascular access vulnerability in intensive hemodialysis: a significant Achilles' heel? Blood Purif. 2014;37(3):222-8. doi: 10.1159/000362106. Epub 2014 Jun 5. Review.

ReferenceCitation: Daugirdas JT, Greene T, Rocco MV, Kaysen GA, Depner TA, Levin NW, Chertow GM, Ornt DB, Raimann JG, Larive B, Kliger AS; FHN Trial Group. Effect of frequent hemodialysis on residual kidney function. Kidney Int. 2013 May;83(5):949-58. doi: 10.1038/ki.2012.457. Epub 2013 Jan 23.

ReferenceCitation: Wabel P, Moissl U, Chamney P, Jirka T, Machek P, Ponce P, Taborsky P, Tetta C, Velasco N, Vlasak J, Zaluska W, Wizemann V. Towards improved cardiovascular management: the necessity of combining blood pressure and fluid overload. Nephrol Dial Transplant. 2008 Sep;23(9):2965-71. doi: 10.1093/ndt/gfn228. Epub 2008 May 5.

ReferenceCitation: Wieskotten S, Heinke S, Wabel P, Moissl U, Becker J, Pirlich M, Keymling M, Isermann R. Bioimpedance-based identification of malnutrition using fuzzy logic. Physiol Meas. 2008 May;29(5):639-54. doi: 10.1088/0967-3334/29/5/009. Epub 2008 May 7.

ReferenceCitation: Wizemann V, Wabel P, Chamney P, Zaluska W, Moissl U, Rode C, Malecka-Masalska T, Marcelli D. The mortality risk of overhydration in haemodialysis patients. Nephrol Dial Transplant. 2009 May;24(5):1574-9. doi: 10.1093/ndt/gfn707. Epub 2009 Jan 7.

ReferenceCitation: Zoccali C, Moissl U, Chazot C, Mallamaci F, Tripepi G, Arkossy O, Wabel P, Stuard S. Chronic Fluid Overload and Mortality in ESRD. J Am Soc Nephrol. 2017 Aug;28(8):2491-2497. doi: 10.1681/ASN.2016121341. Epub 2017 May 4.

ReferenceCitation: Hecking M, Moissl U, Genser B, Rayner H, Dasgupta I, Stuard S, Stopper A, Chazot C, Maddux FW, Canaud B, Port FK, Zoccali C, Wabel P. Greater fluid overload and lower interdialytic weight gain are independently associated with mortality in a large international hemodialysis population. Nephrol Dial Transplant. 2018 Oct 1;33(10):1832-1842. doi: 10.1093/ndt/gfy083.

ReferenceCitation: Jotterand Drepper V, Kihm LP, Kälble F, Diekmann C, Seckinger J, Sommerer C, Zeier M, Schwenger V. Overhydration Is a Strong Predictor of Mortality in Peritoneal Dialysis Patients - Independently of Cardiac Failure. PLoS One. 2016 Jul 14;11(7):e0158741. doi: 10.1371/journal.pone.0158741. eCollection 2016.

ReferenceCitation: Takahashi S. Future home hemodialysis - advantages of the NxStage System One. Contrib Nephrol. 2012;177:117-126. doi: 10.1159/000336944. Epub 2012 May 8.

ReferenceCitation: Benabed A, Henri P, Lobbedez T, Goffin E, Baluta S, Benziane A, Rachi A, van der Pijl JW, Bechade C, Ficheux M. [Low flux dialysate daily home hemodialysis: A result for the 62 first French and Belgian patients]. Nephrol Ther. 2017 Feb;13(1):18-25. doi: 10.1016/j.nephro.2016.06.007. Epub 2016 Nov 18. French.

ReferenceCitation: Daugirdas JT. Second generation logarithmic estimates of single-pool variable volume Kt/V: an analysis of error. J Am Soc Nephrol. 1993 Nov;4(5):1205-13.

ReferenceCitation: Wabel P, Chamney P, Moissl U, Jirka T. Importance of whole-body bioimpedance spectroscopy for the management of fluid balance. Blood Purif. 2009;27(1):75-80. doi: 10.1159/000167013. Epub 2009 Jan 23.

ReferenceCitation: Leypoldt JK, Kamerath CD, Gilson JF, Friederichs G. Dialyzer clearances and mass transfer-area coefficients for small solutes at low dialysate flow rates. ASAIO J. 2006 Jul-Aug;52(4):404-9.

ReferenceCitation: National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015. Review. Erratum in: Am J Kidney Dis. 2016 Mar;67(3):534.

ReferenceCitation: Wabel P, Chamney P, Moissl U (2007) Reproducibility of bioimpedance spectroscopy for the assessment of body composition and dry weight. J Am Soc Nephrol 18: A255

ReferenceCitation: Cole, K. S., & Cole, R. H. (1941). Dispersion and absorption in dielectrics I. Alternating current characteristics. The Journal of chemical physics, 9(4), 341-351.

ReferenceCitation: Moissl UM, Wabel P, Chamney PW, Bosaeus I, Levin NW, Bosy-Westphal A, Korth O, Müller MJ, Ellegård L, Malmros V, Kaitwatcharachai C, Kuhlmann MK, Zhu F, Fuller NJ. Body fluid volume determination via body composition spectroscopy in health and disease. Physiol Meas. 2006 Sep;27(9):921-33. Epub 2006 Jul 25.

ReferenceCitation: Chamney PW, Wabel P, Moissl UM, Müller MJ, Bosy-Westphal A, Korth O, Fuller NJ. A whole-body model to distinguish excess fluid from the hydration of major body tissues. Am J Clin Nutr. 2007 Jan;85(1):80-9.

lead_sponsor: University Hospital, Caen


title: A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care

summary: The purpose of this study is to evaluate the feasibility and the effectiveness of sleep apnea screening program for patients at risk in community pharmacies.

primary_purpose: Screening


title: French National Registry of Bone Marrow Failures: Prospective and Retrospective Database Associated to a Collection of Biological Samples: RIME Project

acronym: RIME

summary:
This is a unique clinical and biological database that collects standardized clinical information during the management of all patients with bone marrow failure syndromes (BMF) in France (multicenter registry), from diagnosis and throughout follow-up during the natural history of the disease, treated or not. In parallel, biological samples (blood and/or bone marrow and/or skin) are collected during clinical care and are biobanked in Saint-Louis Hospital (Hematology laboratory) in order to be used in translational research related to bone marrow failure diseases.

This registry has two main objectives:

Public health care evaluation and improvement: to assess the medical and social needs inherent to the management of these rare diseases; to precisely assess the level of diagnosis and management of bone marrow failure syndromes in France; to evaluate the impact and guidance of the French reference center guidelines for diagnosis and treatment; to evaluate the real-life efficacy and tolerance of any given specific treatments; to analyze treatment's cost-effectiveness according to each situation.

Research:

Epidemiology: to determine the incidence, prevalence, and distribution of different bone marrow failure syndromes at the national level;
Biology: to better understand the pathophysiology of BMF; to identify and to study complications within each entity, such as mechanisms underlying clonal evolution, new forms of inherited BMF and acute myeloid leukemia (AML)/MDS-predisposition syndromes, and to better and deeper characterize known entities;
Treatment: to identify prognostic factors and predictors of response; to identify side effects and impact of treatment on others organs and natural functions; to assess patients' quality of life as early as possible since diagnosis and throughout follow-up.


title: Restoring Vision With the Intelligent Retinal Implant System (IRIS V1)in Patients With Retinal Dystrophy (Title in France: Compensation of Vision With the Intelligent Retinal Implant System (IRIS V1) in Patients With Retinal Dystrophy)

summary: This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V1)

lead_sponsor: Pixium Vision SA

location_country: Austria Germany France

location_facility: Clinique Ophtalmologique du CHU de Nantes

location_facility: Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf

location_facility: Dept. of Ophthalmology, University of Bonn

location_facility: Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild

intervention_type: Device


title: A Prospective Observational Autopsy Study of Neuropathology in Adults Intensive Care Unit Patients With COVID 19

summary: This is a single center observational autopsy study, conducted during the first wave of the coronavirus disease (COVID-19) pandemic in France. The main objective is to evaluate brain damages in patients who died from COVID-19 to inform the cause of death. Investigations include macroscopic and histology examinations, and virology analyses.

ipd_sharing_description: all individual patient data will be available upon request to the study official and after signing a data sharing agreement immediately after publication in a peer-reviewed journal

lead_sponsor: University of Versailles

intervention_type: Procedure


title: Prospective Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital

acronym: DIDTGENOU

summary:
Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for CA. Currently 71.8% of knee arthroscopy are made in this context. However ligamentoplasties anterior cruciate are still carried out predominantly in conventional hospitalization (HC) with a median of 3 to 5.5 days of stay.

Two recent prospective studies French single-operator shows the feasibility of reconstruction of the anterior cruciate ligament (ACL) in ambulatory: no serious events were recorded, the risks are comparable to those of a HC.

However, this support requires a structure and a coordinated network between different medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor, physiotherapist).

The objective of the study is to evaluate (i.e. EPP or "feasibility") ACL reconstruction in CA in hospitals, multi-operator.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Evaluation of the Performance and Tolerance of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Patients Suffering From Lung Cancer: Multicenter, Post CE-mark Study

acronym: LUCIOLA

summary:
Following CE certification, this Post Market Clinical Follow-up investigates the performance and safety of using the new fiducial marker, NOVATECH® LUCIOLA™ EB, in the lung airways to monitor in real-time tumor location during radiotherapy.

At the time of insertion near the tumor, the Luciola's 3 fiducial marker arms are deployed simultaneously. Optimal detection of the fiducial marker is considered during the radiotherapy treatment.

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility: Centre de radiothérapie Francois Baclesse


title: Factors Associated With Gynecological Consultation by General Practitioner

acronym: Gyn-MG

summary:
Because of the shortage of doctors in France, notably gynaecologist, general practitioners are definitely an essential partner women's health. However, few of them regularly practice gynecological acts.

A lot of studies have studied why general doctors not practice gynecological acts but it would necessary to include the women's perspective.

lead_sponsor: Université de Reims Champagne-Ardenne


title: Using the Immersive Virtual Reality for the Management of Anxiety and Pain in Orthopedic Surgery

acronym: IVR-Ortho

summary:
Interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines.

The prosthetic knee surgeries are painful and anxiety-provoking acts. At the hospital of Montauban, to relieve patients' pain, we offer them a therapeutic regimen with regional anesthesia (spinal anesthesia). We also use accompaniment hypnotic virtual reality to the management of anxiety and pain patients.

primary_purpose: Supportive Care

ReferenceCitation: Askay SW, Patterson DR, Sharar SR. VIRTUAL REALITY HYPNOSIS. Contemp Hypn. 2009 Mar;26(1):40-47.

ReferenceCitation: Benhaiem JM, Attal N, Chauvin M, Brasseur L, Bouhassira D. Local and remote effects of hypnotic suggestions of analgesia. Pain. 2001 Jan;89(2-3):167-73.

ReferenceCitation: Sharar SR, Miller W, Teeley A, Soltani M, Hoffman HG, Jensen MP, Patterson DR. Applications of virtual reality for pain management in burn-injured patients. Expert Rev Neurother. 2008 Nov;8(11):1667-74. doi: 10.1586/14737175.8.11.1667. Review.

ReferenceCitation: Hoffman HG, Patterson DR, Soltani M, Teeley A, Miller W, Sharar SR. Virtual reality pain control during physical therapy range of motion exercises for a patient with multiple blunt force trauma injuries. Cyberpsychol Behav. 2009 Feb;12(1):47-9. doi: 10.1089/cpb.2008.0056.

ReferenceCitation: Borteyrou X, Bruchon-Schweitzer M, Spielberger CD. [The French adaptation of the STAXI-2, C.D. Spielberger's State-trait anger expression inventory]. Encephale. 2008 Jun;34(3):249-55. doi: 10.1016/j.encep.2007.06.001. Epub 2007 Oct 10. French.

ReferenceCitation: Spielberger CD, Auerbach SM, Wadsworth AP, Dunn TM, Taulbee ES. Emotional reactions to surgery. J Consult Clin Psychol. 1973 Feb;40(1):33-8.

ReferenceCitation: Hodgues WF, Spielberger CD. An indicant of trait or state anxiety? J Consult Clin Psychol. 1969 Aug;33(4):430-4.

ReferenceCitation: Williamson A. What is hypnosis and how might it work? Palliat Care. 2019 Jan 31;12:1178224219826581. doi: 10.1177/1178224219826581. eCollection 2019.

ReferenceCitation: Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12. Review.

ReferenceCitation: Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, Lam C, Liu L, Foster S, Sambell R, Jeyachanthiran K, Crock C, Stock A, Hopper SM, Cohen S, Davidson A, Plummer K, Mills E, Craig SS, Deng G, Leong P. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. J Pediatr. 2019 Jun;209:160-167.e4. doi: 10.1016/j.jpeds.2019.02.034. Epub 2019 Apr 29.

ReferenceCitation: Spiegel B, Fuller G, Lopez M, Dupuy T, Noah B, Howard A, Albert M, Tashjian V, Lam R, Ahn J, Dailey F, Rosen BT, Vrahas M, Little M, Garlich J, Dzubur E, IsHak W, Danovitch I. Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial. PLoS One. 2019 Aug 14;14(8):e0219115. doi: 10.1371/journal.pone.0219115. eCollection 2019.

ReferenceCitation: Carl E, Stein AT, Levihn-Coon A, Pogue JR, Rothbaum B, Emmelkamp P, Asmundson GJG, Carlbring P, Powers MB. Virtual reality exposure therapy for anxiety and related disorders: A meta-analysis of randomized controlled trials. J Anxiety Disord. 2019 Jan;61:27-36. doi: 10.1016/j.janxdis.2018.08.003. Epub 2018 Aug 10.

ReferenceCitation: Bani Mohammad E, Ahmad M. Virtual reality as a distraction technique for pain and anxiety among patients with breast cancer: A randomized control trial. Palliat Support Care. 2019 Feb;17(1):29-34. doi: 10.1017/S1478951518000639. Epub 2018 Sep 10.

ReferenceCitation: Smith V, Warty RR, Sursas JA, Payne O, Nair A, Krishnan S, da Silva Costa F, Wallace EM, Vollenhoven B. The Effectiveness of Virtual Reality in Managing Acute Pain and Anxiety for Medical Inpatients: Systematic Review. J Med Internet Res. 2020 Nov 2;22(11):e17980. doi: 10.2196/17980.

ReferenceCitation: Anderson PL, Molloy A. Maximizing the impact of virtual reality exposure therapy for anxiety disorders. Curr Opin Psychol. 2020 Dec;36:153-157. doi: 10.1016/j.copsyc.2020.10.001. Epub 2020 Oct 15. Review.

ReferenceCitation: Gumaa M, Rehan Youssef A. Is Virtual Reality Effective in Orthopedic Rehabilitation? A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1304-1325. doi: 10.1093/ptj/pzz093.

ReferenceCitation: Negrillo-Cardenas J, Jimenez-Perez JR, Feito FR. The role of virtual and augmented reality in orthopedic trauma surgery: From diagnosis to rehabilitation. Comput Methods Programs Biomed. 2020 Jul;191:105407. doi: 10.1016/j.cmpb.2020.105407. Epub 2020 Feb 21.

lead_sponsor: Centre Hospitalier de Montauban


title: Study Evaluating Near-infrared Imaging Coupled With Indocyanin Green for Intraoperative Control of Resection Margins in ENT Surgery

acronym: MAGNOLIA

summary: Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancers

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush Study

summary: The object of this study is to determine the benefit of follicular flushing with a double channel needle in a poor responder population for a maximum number of oocytes to be retrieved. The investigators compare two methods of oocyte retrieval with or without flushing. 220 patients undergoing an in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) have to be included. All patients with less than 5 follicles of 14 mm and more the day of ovulation induction will be included, following a randomized protocol in two groups, Group A: Oocyte retrieval is performed with a single lumen aspiration needle 17G. Group B: Oocyte retrieval is performed with a double lumen aspiration needle 17G. all follicles are flushed with flushing solution in addition to direct aspiration of the follicular fluid, 20CC of flushing medium is provided for all the procedure and flushing medium is collected separately from direct fluid aspiration in order to follow up each oocyte one by one. First criterion of our comparison is the number of oocyte retrieved. Second criteria are: oocyte quality, fertilization rate, number and quality of embryos obtained, clinical pregnancy rate. In Group B the investigators will compare two subgroups: oocytes collected in flush medium and oocytes from direct follicle fluid. Then the investigators will know the capability of oocyte collected after follicular flushing to be fertilized and to increase the success chance of pregnancy for poor responder patients.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Centre d'Assistance Médicale à la Procréation, CMCO-SIHCUS


title: OBESITY, PHYSICAL INACTIVITY OR DIETARY FAT ? Role of Physical Activity in the Trafficking of Dietary Fatty Acids Varying in Length and Saturation Degree.

summary: Obesity is the consequence of a chronic disequilibrium of fat balance. Genetic factors determine predisposition to obesity, but the most often mentioned idea is that environmental factors, such as a high-fat diet and a sedentary lifestyle, join to favour weight gain and explain the increased prevalence of obesity in our westernized societies. Since lipogenesis is negligible in humans, obesity represents the consequence of altered fat partitioning between oxidation and storage, likely due to a preferential directing of dietary fat towards adipose tissue and away from muscle. Interventions that favour partitioning of dietary fat towards muscle for oxidation might thus protect against weight gain. Exercise may be one kind of such intervention but the scant data on dietary fat metabolism does not allow clear conclusions, in particular in obese subjects. One question concerns the impact of the type of fat eaten: the effects of physical inactivity may vary according to the length and saturation degree of the fatty acids. We hypothesize that 1) physical activity of moderate intensity, independently of its effect on energy balance, will favor a preferential trafficking towards adipose tissue, will modify the expression of genes implicated in fat oxidation and storage and partly correct the abnormalities observed in obese subjects, 2) effects of physical activity vary according to the saturation degree of fat. Twelve obese subjects, aged 18 to 55, will undergo tests before and after 2 months of training at current recommendations to ascertain dietary fat partitioning using stable isotopes and to determine changes in gene expression with muscle and adipose tissue microbiopsies.

design_allocation: Non-Randomized

location_facility: Service de Médecine Interne et de Nutrition - Hôpital de Hautepierre

location_facility: Service des Explorations Fonctionelles Respiratoires et de l'Exercice - Hôpital Civil


title: A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection in France and Belgium

summary: Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/ kg twice a week for two weeks on immune reconstitution of lymphopenic COVID-19 patients.

status: Terminated

ReferenceCitation: Francois B, Jeannet R, Daix T, Walton AH, Shotwell MS, Unsinger J, Monneret G, Rimmelé T, Blood T, Morre M, Gregoire A, Mayo GA, Blood J, Durum SK, Sherwood ER, Hotchkiss RS. Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial. JCI Insight. 2018 Mar 8;3(5). pii: 98960. doi: 10.1172/jci.insight.98960.

ReferenceCitation: Venet F, Foray AP, Villars-Méchin A, Malcus C, Poitevin-Later F, Lepape A, Monneret G. IL-7 restores lymphocyte functions in septic patients. J Immunol. 2012 Nov 15;189(10):5073-81. doi: 10.4049/jimmunol.1202062. Epub 2012 Oct 10.

ReferenceType: result

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113.

ipd_sharing_description: publication

lead_sponsor: Revimmune

location_facility:
hopital COCHIN
Hôpital Edouard Herriot
Chr Orleans La Source
hopital Edouard Herriot
Chru Tours
University Hospital of Limoges


title: ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS

acronym: PADAONCODERM

summary:
The law about advance directives is evolving but, in France, few people write it.

Te main endpoint of this research is to estimate the proportion of patients who have written their advance directives or considering doing so in onco-dermatologic population. If this rate remains low, some insights on the reasons will be able to be advanced looking at the point of view and opinion of patients about this topic.

Seconds endpoints are :

For patients against or not planning to write it, understand their reasons

Estimate the proportion of patients requesting information and understand how they would like to receive it.

Investigate a possible association between the stage of the oncological disease and the positioning of the patient concerning advance directives.

lead_sponsor: Central Hospital, Nancy, France


title: Epidemiological Study on Mental Health of Migrant Population in the Retention Center of Geispolsheim

summary:
In 2019, the lack of studies about mental health of the detained population at retention centers in France is pointed out by the report of Controller-General for Places of Deprivation of Liberty. The aim of this study is to contribute to this relatively untouched field by describing which psychiatric pathologies are encountered in this population who went through migration and retention. Having a clearer picture of the situation can help to provide a more adapted psychiatric care in retention centers.

The results are expected to show a higher rate of psychiatric disease than in the general population including addiction to substance, anxiety disorder and post-traumatic stress disorder (PTSD).

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Ependymomics: Multiomic Approach to Radioresistance of Ependymomas in Children and Adolescents

acronym: EPENDYMOMICS

summary:
Treatment of childhood ependymoma, the second most frequent pediatric brain tumor, is based on surgery and radiation therapy. However, 50% relapse, mainly locally. Progress in imaging, molecular biology and radiotherapy ballistics has led us to propose the EPENDYMOMICS project, a multi-omics approach using artificial intelligence to detect the predictive characteristics of relapse, and to define innovative radiotherapy targets using multimodal imaging. We previously reported that the relapse sites are mainly located in the high-dose radiotherapy zone and that there appear to be prognostic factors for relapse based on anatomical and functional MRI abnormalities by diffusion and perfusion. In addition, recent studies in molecular biology have identified significant prognostic factors. The challenge now is to use and correlate all these findings in larger cohorts to tackle the radio-resistance of this disease.

Our objective is to collate in a single database called NETSPARE (Network to Structure and Share Pediatric data to Accelerate Research on Ependymoma) the clinical, histological, biological, imaging and radiotherapy data from two consecutive studies that included 370 children and adolescents with ependymoma since 2000 in France. The EPENDYMOMICS project will comprise a clinical research team, three imaging research teams, two histopathology teams, and a biostatistics team working on NETSPARE. Our goal is to obtain a radiogenomic signature of our data, which will be validated with the English external cohort of 200 patients that is currently being analyzed. The perspective is to optimize the indications and volumes of irradiation that could in the future be used in a European translational research trial to tackle radioresistance.

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ReferenceCitation: Ducassou A, Padovani L, Chaltiel L, Bolle S, Habrand JL, Claude L, Carrie C, Muracciole X, Coche-Dequeant B, Alapetite C, Supiot S, Demoor-Goldschmidt C, Bernier-Chastagner V, Huchet A, Leseur J, Le Prise E, Kerr C, Truc G, Nguyen TD, Bertozzi AI, Frappaz D, Boetto S, Sevely A, Tensaouti F, Laprie A; Pediatric French Radiation Oncologist Group (GFRP) and the French Society of Children With Cancer (SFCE). Pediatric Localized Intracranial Ependymomas: A Multicenter Analysis of the Société Française de lutte contre les Cancers de l'Enfant (SFCE) from 2000 to 2013. Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):166-173. doi: 10.1016/j.ijrobp.2018.05.036. Epub 2018 May 24.

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ReferenceCitation: Tensaouti F, Ducassou A, Chaltiel L, Sevely A, Bolle S, Padovani L, Jouin A, Alapetite C, Supiot S, Huchet A, Bernier V, Claude L, Kerr C, Le Prisé E, Bertozzi-Salamon AI, Liceaga S, Lotterie JA, Péran P, Laprie A; French Society for Childhood Cancer (SFCE). Imaging biomarkers of outcome after radiotherapy for pediatric ependymoma. Radiother Oncol. 2018 Apr;127(1):103-107. doi: 10.1016/j.radonc.2018.02.008. Epub 2018 Mar 2.

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lead_sponsor: Institut Claudius Regaud


title: Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. (CoV-CONTACT-SERO)

summary:
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.

Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.

Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.

Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.

In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers.

The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition.

This include both children and adult subjects, subject without social security, and healthcare workers.

status: Suspended

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_country:
French Guiana
France

location_facility: Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon

location_facility: Département maladie infectieux CHU Saint Etienne

location_facility: Centre d'Investigation Clinique 1403 -CHU Lille

location_facility: Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau

location_facility: Centre d'Investigation Clinique Hôpital Saint Louis

location_facility: Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord

location_facility: Centre d'investigation clinique 1406 CHU Grenoble

location_facility: Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard

location_facility: Hôpital Cochin CIC 1417 Bâtiment Lavoisier

location_facility: Centre d'Investigation Clinique Ile de la Réunion CHU sud

location_facility: Centre Investigation Clinique 1433 CHRU de NANCY

location_facility: Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne

location_facility: Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou

location_facility: Service de Maladies infectieuses et tropicales Centre hospitalier

location_facility: Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand

location_facility: Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin

intervention_type: Diagnostic Test


title: Nutritional Care Influences Head Growth at Discharge in Extremely Low Birth Weight Infants.

acronym: KARLY

summary:
As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units. A retrospective study included extremely low birth weight infants born in Lyon, France or in Stockholm, Sweden. Data on morbidity, treatments, care practices, macro-nutrient intakes and postnatal growth were collected to determine risk factors of extra uterine growth restriction at discharge.

By comparing postnatal growth in ELBW infants hospitalized in two European neonatal intensive care units with different nutritional and extra nutritional care,our objective was to evaluate the role of nutrition in this population of preterm infants.

lead_sponsor: Hôpital de la Croix-Rousse


title: E-Compared: Comparative Effectiveness Research on Internet Based Depression Treatment- French Trial

acronym: E-COMPARED

summary: To compare the clinical impact and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU). Within the French context the TAU is considered as the traditional face to face CBT.

ReferenceCitation: van Genugten CR, Schuurmans J, Hoogendoorn AW, Araya R, Andersson G, Baños R, Botella C, Cerga Pashoja A, Cieslak R, Ebert DD, García-Palacios A, Hazo JB, Herrero R, Holtzmann J, Kemmeren L, Kleiboer A, Krieger T, Smoktunowicz E, Titzler I, Topooco N, Urech A, Smit JH, Riper H. Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study. JMIR Ment Health. 2021 Dec 6;8(12):e32007. doi: 10.2196/32007.

ReferenceCitation: Kleiboer A, Smit J, Bosmans J, Ruwaard J, Andersson G, Topooco N, Berger T, Krieger T, Botella C, Baños R, Chevreul K, Araya R, Cerga-Pashoja A, Cieślak R, Rogala A, Vis C, Draisma S, van Schaik A, Kemmeren L, Ebert D, Berking M, Funk B, Cuijpers P, Riper H. European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries. Trials. 2016 Aug 3;17(1):387. doi: 10.1186/s13063-016-1511-1.

location_facility: Hôpital de la conception Pôle Psychiatrie Centre


title: Evaluation of METAglut1 Diagnostic Test Performances in Patients With a Clinical Suspicion of GLUT1 Deficiency Syndrome

summary:
The study aims at validating the diagnostic performances of the METAglut1, a blood in vitro diagnostic test, for the simple and early diagnosis of the Glut1 deficiency syndrome (Glut1DS, or De Vivo disease).

The blood test will be carried out prospectively on patients presenting with a clinical suspicion of Glut1DS, blindly from the reference strategy, which consists in a lumbar puncture for glycorrhachia measurement, completed by a molecular analysis.

The study will be conducted in more than 40 centers in France on up to 3,000 patients for 2 years.

ReferenceCitation: Gras D, Cousin C, Kappeler C, Fung CW, Auvin S, Essid N, Chung BH, Da Costa L, Hainque E, Luton MP, Petit V, Vuillaumier-Barrot S, Boespflug-Tanguy O, Roze E, Mochel F. A simple blood test expedites the diagnosis of glucose transporter type 1 deficiency syndrome. Ann Neurol. 2017 Jul;82(1):133-138. doi: 10.1002/ana.24970.

lead_sponsor: METAFORA biosystems

location_facility: Hôpital Gui de Chauliac- CHU Montpellier

location_facility: Hôpital de la mère et de l'enfant- CHU Limoges

location_facility: Centre hospitalier Pellegrin_ CHU Bordeaux


title: Randomized, Double-blinded, Placebo Controlled Study to Assess Efficacy of Oral 35 mg Per Week Risedronate in Preventing Bone Loss in Postmenopausal Women With Aromatase Inhibitor Therapy for Breast Cancer.

acronym: RISAROS

summary:
Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures.

This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot


title: Role of Mitochondrial Dysfunction in the Occurrence of Acute Kidney Injury(AKI) in Postoperative Cardiac Surgery

acronym: MIT-CEC

summary:
Cardiac Surgery and Acute Kidney Failure (AKI) post Surgery:

AKI is a frequent complication in the immediate aftermath of cardiac surgery with an incidence varying from 5 to 40%. KDIGO criteria (Kidney Disease: Improving Global Outcomes) are used to define the AKI in cardiac surgery because of their validated prognostic value in this patient population. The occurrence of a postoperative AKI, even of low severity, is accompanied by a significant increase in the duration of hospitalization and mortality. The AKI risk factors in cardiac surgery are related to the precarious clinical conditions of the patient before the surgery, to the complex surgical context, to the surgical procedures particularly the duration of extracorporeal circulation (ECC) greater than 120 min and the occurrence of a postoperative circulatory insufficiency.

AKI and inflammatory response:

The mechanisms involved in postoperative AKI in cardiac surgery, are low cardiac output, ischemia reperfusion injury (IRI), mechanical intravascular hemolysis, hypothermia, and activation of the neuroendocrine system by the ECC.

In addition, ECC triggers a secondary inflammatory response to blood contact with the ECC circuit and membranes. The secondary stimulation of immunocompetent cells accompanies secretion of many cytokines and proinflammatory mediators via the activation of nuclear transcription factors as the NFκB factor.

Of the 50 000 ECC performed per year in France, about 25% of the patients develop a Systemic Inflammatory Response Syndrome (SIRS). Although most often transient, SIRS can intensify and lead to a multi-visceral failure and to death, especially if the patient presents medical history of type 2 diabete. Increase of postoperative plasma cytokine levels has a positive predictive value on the occurrence of AKI and the risk of death.

Priming of the NLRP3 inflammasome and post ECC inflammatory response:

In addition to activation by nuclear transcription factors (NFκB), the inflammatory syndrome may develop secondarily to the activation of multi-protein platforms, called inflammasomes.

The activation of the NLRP3 inflammasome has been particularly studied in humans because of its association with multiple chronic inflammatory pathologies, infectious and cardio-metabolic diseases. Its activation is the combination of intracellular receptors like NOD-like receptors (NLR) types, ASC-like adapter proteins and pro caspase-1.

This assembly activates inflammatory caspases (caspase-1, in particular) responsible for the cleavage of pro-interleukins IL-1β and IL-18 in mature pro-inflammatory cytokines that participate in the orchestration of the inflammatory response.

Activation of the NLRP3 inflammasome requires prior priming which allows increase of NLRP3 and pro-cytokines IL1β and IL18 expressions. This priming is particularly intense in the presence of a mitochondrial dysfunction and of an increase in reactive oxygen species (ROS). Next, the activation of the NLRP3 inflammasome may be secondary to the presence of danger signals from cellular damages, such as cellular and mitochondrial debris (including mitochondrial DNA) recognized by NLRP3 receptors. Thus, preoperative mitochondrial dysfunction and its postoperative aggravation by ECC due to IRI induced by ECC represents powerful signals ,of the NLRP3 inflammasome activation.

Research hypothesis:

The hypothesis is that the preoperative priming of the NLRP3 inflammasome by a preoperative mitochondrial dysfunction is a factor favoring the occurrence of postoperative AKI after cardiac surgery with ECC.

For type 2 diabetic patients, the investigators think that preoperative mitochondrial dysfunction (mitochondrial respiration abnormalities and hyperpermeability of mitochondrial membranes) is accentuated worsening IRI induced by the ECC.

This increases postoperative release of cells and mitochondrial debris that maintain the activation of the NLRP3 inflammasome, exacerbating the inflammatory response and favoring the occurrence of AKI.

ReferenceCitation: Zakkar M, Ascione R, James AF, Angelini GD, Suleiman MS. Inflammation, oxidative stress and postoperative atrial fibrillation in cardiac surgery. Pharmacol Ther. 2015 Oct;154:13-20. doi: 10.1016/j.pharmthera.2015.06.009. Epub 2015 Jun 24. Review.

ReferenceCitation: Corral-Velez V, Lopez-Delgado JC, Betancur-Zambrano NL, Lopez-Suñe N, Rojas-Lora M, Torrado H, Ballus J. The inflammatory response in cardiac surgery: an overview of the pathophysiology and clinical implications. Inflamm Allergy Drug Targets. 2015;13(6):367-70. Review.

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lead_sponsor: University Hospital Center of Martinique


title: Proof-of-concept Study for a New Intraocular Lens, MODEL C0001

summary:
This study is a 12-month, prospective, 2-arm (1 test & 1 control), randomized (1 test:1 control), bilateral, subject/evaluator-masked clinical investigation of the EPV IOL versus the standard TECNIS monofocal control IOL.

The study will be conducted at a minimum of one to a maximum of five sites in France, with a total of 40 evaluable subjects for the investigational lens group and 40 evaluable subjects for the control lens group participating in the sub-study. The peripheral and functional testing will be conducted on a sub-group of subjects who achieve binocular uncorrected distance visual acuity (UCDVA) of 0.2 logMAR or better and/or are able to perform the driving simulator-sickness testing as determined by patient response to the SSQ (Appendix D) at the first 1-month visit.

The eye implanted first will be considered the primary study eye (first eye). Subjects will be randomized to either the investigational IOL Model C0001 or the control IOL Model ZCB00 in both eyes.

ipd_sharing: Yes

ipd_sharing_description: Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu

lead_sponsor: Johnson & Johnson Surgical Vision, Inc.

location_facility: Centre Hospitalier National d'Ophtalmologie


title: A Transversal Study for the French Validation of Two Assessment Tools of Gambling Related Cognitions.

summary: This study is divided into two stages. In the first stage, students from the University of Nantes completed the two assessment tools of gambling related cognitions (GABS : Gambling Attitudes and Beliefs Survey ; GRCS : Gambling Related Cognitions Scale), and a reference tool for gambling problem severity (SOGS : South Oaks Gambling Screen). In the second stage, consecutive pathological gamblers seeking treatment at the University Hospital of Nantes completed the three questionnaires. Only questionnaires from participants who reported gambling at least one time in the past year were kept for analyses.Responses of students gamblers and pathological gamblers presenting for treatment have been compiled for analysis.The main objective of the study is to validate the French adaptations of the GABS and the GRCS, and to explore their psychometric properties and structures.

lead_sponsor: Nantes University Hospital


title: Nervous System Infections Among Patients With Febrile Seizure : Retrospective Cohort Review of Consecutive Patients Admitted in 7 Pediatric Emergency Departments in Ile-de-France Between 2007 and 2011

summary:
Few studies dealing with the risk of infectious of nervous system and the utility of lumbar puncture and of emergent neuroimaging among patients with simple febrile seizure between 3 and 11 months age and with complex seizure has been reported. None of these studies was multicentric. Recommendations about management of these children are heterogeneous.

The investigators aim to study by an observational retrospective multicentric study the rate of infectious of central nervous system among patients with a complex febrile seizure and among patients between 3 and 11 months age with simple febrile seizure.

lead_sponsor: Hôpital Armand Trousseau

location_facility: Centre hospitalier intercommunal de Poissy

location_facility: Centre hospitalier Lagny-Marne la Vallée

location_facility: Centre hospitalier intercommunal de creteil


acronym: VIDADO

title: Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents: Prospective, Randomized, Controlled Trial

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

ReferenceCitation: Vinet A, Morrissey C, Perez-Martin A, Goncalves A, Raverdy C, Masson D, Gayrard S, Carrere M, Landrier JF, Amiot MJ. Effect of vitamin D supplementation on microvascular reactivity in obese adolescents: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2021 Jul 22;31(8):2474-2483. doi: 10.1016/j.numecd.2021.04.025. Epub 2021 May 10.

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

summary: The main objective of this study is to analyze in a population of obese adolescents, the effect of vitamin D3 supplementation in addition to lifestyle and dietary management on vascular function assessed by the change between M0 and M3 of endothelium-dependent vasorelaxation measured at the brachial artery (Flow-Mediated Dilation).