title: Hepatitis B Virus Particles-bound Human Proteins : Identification in Clinical Samples and Implication in the Viral Life Cycle

summary:
The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough understanding of the biology of one of its major causative agents, the hepatitis B virus (HBV). HBV particles acquire via budding and encapsidation cellular proteins. There is mounting evidence on several viral species that virion-bound proteins are prone to be involved either at the replication, budding/egress or entry/release steps of the viral cycle.

Identifying such targets may yield ideal candidates for gaining insight on the dependence of HBV upon a restricted subset of host proteins, therefore providing refined sets of genetically stable targets for therapy. This project's goals are to set up adequate conditions for robust and reproducible purification of HBV virions in clinical samples, followed by the identification of their HBV-bound host proteins and the characterization of their functions. Proteomics profiling of HBV particles purified from clinical samples will be overlaid with proteins identified and characterized in cell culture grown HBV particles, using clinical biomarker discovery grade criteria. Targets identified in both samples sets will be subjected to in vitro investigations using HBV-replicating cells. Conventional biochemical and imaging methods will be used in order to: (i) ascertain their physical association with HBV virions; (ii) define the modalities of their interaction with HBV proteins; (iii) decipher the topology and subcellular localization of their association with HBV proteins and virions; (iv) quantitatively assess their functional involvement in particle budding, egress or secretion and infectivity. A candidate that yielded satisfactory results in these experiments will be disclosed and further investigated at the level of structural biology, in collaborative research programs.

location_facility: Service d'Hépato-Gastroentérologie, Hopital de la Croix-Rousse, Hospices Civils de Lyon


title: Thyroid Dysfunction and Obstetric Complications

acronym: TDOC

summary:
Obstetric complications are common and can be responsible for maternal and foetal morbidity and mortality. Thyroid dysfunction has been identified as a possible cause of obstetric complications.

Many studies have been conducted to estimate the prevalence and define the nature of obstetric complications observed in patients with thyroid dysfunction. However, women with obstetric complications are not systematically screened for thyroid dysfunction and no published study has evaluated the prevalence of thyroid dysfunction in women with an obstetric complication. As no consensus has been reached concerning systematic screening for thyroid dysfunction in pregnant women, the identification of new high-risk populations could possibly result in a change of clinical practice.

study_start_date_type: Actual

status: Withdrawn

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Unknown


title: Determination by a Noninvasive Method of the Geometric Dimensions of the Nasal Cavities of the Premature Newborn

acronym: MODERN

summary:
During the resuscitation of preterm infants, withdrawal of non-invasive ventilation is difficult. In a recent study in children gestational age <30 weeks of amenorrhea (SA), definitive withdrawal rate from the first attempt to stop the non-invasive ventilation was 32% . In the same study, the median number of attempts before achieving a final withdrawal was 3 for children born before 28 weeks. The reasons for weaning failure are multiple and little studied. It seems that the type of interface used, mask or cannula, having an influence on the effectiveness of non-invasive ventilation . The nasal lesions induced by non-invasive ventilation are not uncommon, regardless of the interface used . In a recent randomized trial, they ranged from 40% to 50% depending on the type of nasal cannula and non-invasive ventilation mode. It is in this case external damage. But we assume that the breakdown causes internal lesions dependent on the pressure, humidity and flow. These factors are likely to generate a nasal obstruction, source intervention nurses who aspire nasal passages more or less traumatic.

The nasal cavities are often abused and, because of their key role in breathing, could be involved in the withdrawal of ventilatory failure

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Intercommunal Creteil

intervention_type: Device


type: Other Identifier

title: Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease. A Randomized, Controlled Study.

acronym: ASYMOT

summary:
Parkinson's disease is a major source of handicap, for which physical treatments are often underutilized with respect to chemical or surgical treatments. Yet, dopaminergic treatments alone prove unable to stop or control the gradual worsening of motor disability after a few years.

The training program that this study sets out to evaluate aims to restore balance between agonist extensors and antagonist flexors in Parkinson's disease.

There is indeed in Parkinson's disease an imbalance between weak flexors and weaker extensors, with excessive predominance of the flexors. The hypothesis of the study is that a motor strengthening program targeting extensor muscles specifically will improve body posture and restore motor function better than a conventional physical therapy program, in mild to moderate Parkinson's disease.

This is a parallel-group, single blind, randomized trial (investigators will be kept unaware of the physical treatment followed by study subjects).

The duration of patient participation is 5 months: 2-month intervention and 3-month follow-up following the intervention.

status: Completed

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

status_simplified: Completed


title: Prevalence, Kinetic and Prognostic Value of XPO1 E571K Mutation Detection in Plasma Cell-free DNA From Patients Xith Classical Hodgkin Lymphoma

summary: The purpose of this study is to determine if the XPO1 E571K mutation could be used as molecular residual disease biomarker in classical Hodgkin's lymphoma. To determine the interest of the mutation assessment by digital Polymerase Chain Reaction, sensitivity and specificity after 2 courses of chemotherapy (C2) will be compared with the deltaSUVmax determined by Positron Emission Tomography after C2 and at end of treatment.

primary_purpose: Other

ReferenceType: derived

ReferenceCitation: Camus V, Viennot M, Lequesne J, Viailly PJ, Bohers E, Bessi L, Marcq B, Etancelin P, Dubois S, Picquenot JM, Veresezan EL, Cornic M, Burel L, Loret J, Becker S, Decazes P, Lenain P, Lepretre S, Lemasle E, Lanic H, Ménard AL, Contentin N, Tilly H, Stamatoullas A, Jardin F. Targeted genotyping of circulating tumor DNA for classical Hodgkin lymphoma monitoring: a prospective study. Haematologica. 2021 Jan 1;106(1):154-162. doi: 10.3324/haematol.2019.237719.

family: Camus

full_name: Vincent Camus

given: Vincent

sequence: first

family: Viennot

full_name: Mathieu Viennot

given: Mathieu

sequence: additional

family: Lequesne

full_name: Justine Lequesne

given: Justine

family: Viailly

full_name: Pierre-Julien Viailly

given: Pierre-Julien

family: Elodie Bohers

full_name: Elodie Bohers

family: Bessi

full_name: Lucile Bessi

given: Lucile

family: Marcq

full_name: Bénédicte Marcq

given: Bénédicte

family: Etancelin

full_name: Pascaline Etancelin

given: Pascaline

family: Dubois

full_name: Sydney Dubois

given: Sydney

family: Picquenot

full_name: Jean-Michel Picquenot

given: Jean-Michel

family: Veresezan

full_name: Elena-Liana Veresezan

given: Elena-Liana

family: Cornic

full_name: Marie Cornic

given: Marie

family: Burel

full_name: Lucie Burel

given: Lucie

family: Loret

full_name: Justine Loret

family: Becker

full_name: Stéphanie Becker

given: Stéphanie

family: Decazes

full_name: Pierre Decazes

given: Pierre

family: Lenain

full_name: Pascal Lenain

given: Pascal

family: Lepretre

full_name: Stéphane Lepretre

given: Stéphane

family: Lemasle

full_name: Emilie Lemasle

given: Emilie

family: Lanic

full_name: Hélène Lanic

given: Hélène

family: Ménard

full_name: Anne-Lise Ménard

given: Anne-Lise

family: Contentin

full_name: Nathalie Contentin

given: Nathalie

family: Tilly

full_name: Hervé Tilly

given: Hervé

family: Stamatoullas

full_name: Aspasia Stamatoullas

publisher: Ferrata Storti Foundation (Haematologica)


acronym: REVASC-TAVI

summary: Evaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure


title: Prevalence of S. Aureus Among Patients Presenting With Skin and Soft Tissue Infections: a Multi-centre Pilot Study in Europe

acronym: SSTIs

summary:
Methicillin-resistant Staphylococcus aureus (MRSA) is reported as one of the main causative pathogen of community acquired SSTIs. In the USA, high prevalence of MRSA among Skin and soft tissue infections (SSTIs) is known to be due to the spread of the USA300 clone [Moran et al. 2006]. Among S. aureus SSTIs infections in Europe, data regarding the prevalence of MRSA in SSTIs and the causative genotypes remain scarce. The paucity of literature on the prevalence of MSSA, MRSA and PVL-producing S. aureus strains in SSTI in Europe is probably due to the fact that culture and antimicrobial susceptibility testing is not a routine component of SSTI management.

Setting-up a prospective multi-centre study involving patients presenting to emergency departments with SSTIs in several European countries would allow drawing a picture on the role and the respective contribution of MSSA, MRSA and PVL-producing S. aureus strains as a cause of SSTIs. However, the roles of emergency rooms and local policies with regard to performing microbiological analysis after surgical drainage of SSTIs vary between countries.

In order to evaluate the feasibility of such multicenter European study, we aim at performing a pilot study based on few European clinical laboratories (five to seven) which will: i) evaluate the prevalence of MSSA, MRSA and S. aureus PVL-positive strains in community-acquired SSTIs; and ii) determine molecular characteristics of the isolated strains. The main objectives of this pilot study are to collect some preliminary information on the role of S. aureus in SSTIs and to determine factors that need to be harmonized or taken into consideration for the set-up a larger prospective cross-sectional study involving more European countries with several centers per country to cover different geographical areas per country.

ReferenceType: background

ReferenceCitation: Moran GJ, Krishnadasan A, Gorwitz RJ, Fosheim GE, McDougal LK, Carey RB, Talan DA; EMERGEncy ID Net Study Group. Methicillin-resistant S. aureus infections among patients in the emergency department. N Engl J Med. 2006 Aug 17;355(7):666-74.

lead_sponsor: Hospices Civils de Lyon

location_facility: National Reference Center for Staphylococci, 59 boulevard Pinel


title: ALDOsterone for Prediction of Post-Operative Atrial Fibrillation

acronym: ALDO-POAF

summary:
Post-operative atrial fibrillation (POAF) is a major and frequent complication occurring after cardiac surgery, contributing to prolonged intensive care and hospital stays and is associated with several cardiovascular complications. The exact mechanisms and signaling pathways involved in the development of POAF seem to be multifactorial and remain to date incompletely understood. β-blockers and amiodarone are the first line preventive drugs but are partially effective and near 30% of POAF resist to these strategies. In this context, there is some evidence indicating that renin-angiotensin-aldosterone system and Galectin-3 (Gal-3) share signaling pathways in the development of cardiac fibrosis and therefore could be very useful predictive biomarkers of POAF and potentially interesting therapeutic target to prevent POAF occurrence.

The investigators hypothesis is that preoperative plasma aldosterone levels and galectin-3 (Gal-3) expression (in plasma, right atrial appendage or epicardial fat) could be predictive of POAF in patients undergoing elective CABG surgery with preserved LVEF.

ReferenceCitation: Ollitrault P, Allouche S, Chequel M, Milliez P, Alexandre J. Plasma aldosterone and atrial mitochondrial functions of patients undergoing cardiac surgery. Future Cardiol. 2020 Jul;16(4):275-280. doi: 10.2217/fca-2019-0028. Epub 2020 Apr 14.

name: Department of Cardiology, Normandie Univ, Unicaen, F-14000 Caen, France

name: EA 4650 (Signalisation, électrophysiologie et imagerie des lesions d'ischémie-reperfusion myocardique), Normandie Univ, Unicaen, F-14000 Caen, France

family: Ollitrault

full_name: Pierre Ollitrault

name: Department of Biochemistry, Caen University Hospital, Normandie Univ, Unicaen, F-14000 Caen, France

family: Allouche

full_name: Stéphane Allouche

family: Chequel

full_name: Mathieu Chequel

given: Mathieu

family: Milliez

full_name: Paul Milliez

given: Paul

name: Department of Pharmacology, Normandie Univ, Unicaen, F-14000 Caen, France

family: Alexandre

full_name: Joachim Alexandre

given: Joachim

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Future Cardiology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ipd_sharing: Yes

lead_sponsor: University Hospital, Caen


title: Efficacy and Cost-effectiveness of Hospital Antimicrobial Stewardship Programs

acronym: CEFECA

summary: The main objective of the project is to evaluate the efficiency and cost-effectiveness of different strategies aiming at optimizing antibiotic prescribing in hospitals. In the first section of the project, the project team intend to map the different antimicrobial stewardship programs in French hospital, by investigating a sample of 30 healthcare facilities, and determine the strategies to be evaluated by the model. The investigators will also evaluate physicians' adherence to the intervention to promote better use of antibiotics and explore potential barriers and facilitators to the implementation of effective strategies.


intervention_type: Drug

status: Recruiting

acronym: PRISME

location_facility: Hématologie et thérapie cellulaire, Hôpital Saint Antoine

type: EudraCT Number

source: euctr

title: Clinical Phase II Trial Evaluating the Efficacy of Systemic Mesenchymal Stromal Cell (MSC) Injections for the Treatment of Severe and Chronic Radiotherapy-induced Abdomino-pelvic Complications (Pelvic Radiation Disease, PRD) Refractory to Standard Therapy

summary:
Patients receiving radiation therapy are still at risk for side effects due to off-target radiation damage of normal tissues The number of cancer patients is expected to increase from 14.1 million around the world in 2012 to 19.3 million in 2025. Up to ten percent will develop late severe gastrointestinal complications (i.e. Pelvic Radiation Disease - PRD). Symptoms are proctopathy (5-20%) and radiation-induced cystitis (3,5%) that affect quality of life. The treatment of PRD is limited to managing the symptoms; new alternatives should be proposed.

Clinical trials using MSCs to treat hemorrhagic cystitis, proctopathy have demonstrated the feasibility to used MSCs in these pathologies :

MSCs successfully repair hemorrhagic cystitis, and perforated colon in patients with hemorrhagic cystitis, perforated colon and peritonitis.
Six clinical trials are currently ongoing for proctopathy, 3 are phase III. Results suggest an inhibition of chronic inflammation and fistulization and interruption of hemorrhagic syndromes.
Clinical trials to evaluate the efficacy of MSCs to treat hemorrhagic cystitis is in progress.
A decrease in pain after the injection of MSCs was observed in patients treated by radiotherapy for breast cancer, radiation burns, and radiotherapy over-dosage.
Four patients, were treated with MSCs after receiving overdose pelvic irradiation for prostate cancer. A decrease in pain (EN score), bleeding and diarrhea was observed.

MSCs will represent a promising alternative strategy in the treatment of severe enteritis, rectitis and cystitis after radiotherapy, and may avoid surgical treatment and may diminish the adverse effect of PRD in terms of chronicity, morbidity, mortality and health costs.

status_simplified: Ongoing


title: Evaluation of the Effectiveness of Nutritional Practical Counseling for Elderly Patients at Risk of Malnutrition (and Their Caregivers) on Nutritional Status at Home

acronym: NutriPratiC

summary: At hospital, short term actions are used (adaptation of meals, oral supplementation…) to fight malnutrition. Oral supplementation can have a positive impact on weight gain. But actions should continue at home, particularly to maintain autonomy for elderly. The hypothesis is that practical workshop about enrichment and interest of foods can help malnourished patients to change their eating habits. The main goal of this study is to evaluate the effects of this workshop on improving nutritional status, measured by Mini Nutritional Assessment

status: Terminated

ReferenceCitation: Arnaud-Battandier F, Malvy D, Jeandel C, Schmitt C, Aussage P, Beaufrère B, Cynober L. Use of oral supplements in malnourished elderly patients living in the community: a pharmaco-economic study. Clin Nutr. 2004 Oct;23(5):1096-103.

ReferenceCitation: Boumendjel N, Herrmann F, Girod V, Sieber C, Rapin CH. Refrigerator content and hospital admission in old people. Lancet. 2000 Aug 12;356(9229):563.

ReferenceCitation: Correia MI, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr. 2003 Jun;22(3):235-9.

ReferenceCitation: McMurdo ME, Price RJ, Shields M, Potter J, Stott DJ. Should oral nutritional supplementation be given to undernourished older people upon hospital discharge? A controlled trial. J Am Geriatr Soc. 2009 Dec;57(12):2239-45. doi: 10.1111/j.1532-5415.2009.02568.x. Epub 2009 Nov 17.

ReferenceCitation: Persson M, Hytter-Landahl A, Brismar K, Cederholm T. Nutritional supplementation and dietary advice in geriatric patients at risk of malnutrition. Clin Nutr. 2007 Apr;26(2):216-24. Epub 2007 Feb 1.

ReferenceCitation: Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. J Clin Oncol. 2005 Mar 1;23(7):1431-8. Epub 2005 Jan 31.

lead_sponsor: University Hospital, Grenoble


title: Preferences and Representations Concerning High-throughput Sequencing Technologies in Medical Genetics. The Case of Development Anomalies.

summary:
After the use of DNA chips for diagnostic purposes, high-throughput sequencing (HTS) is transforming the field of developmental diseases, from fundamental research to care. Nonetheless, before HTS can be transferred to everyday clinical practice, in particular for expert diagnosis using exome HTS, it is necessary to anticipate the nature of the information to be given to patients and to parents in order to obtain consent for exome HTS.

The objective in terms of public health is to allow patients with rare diseases to benefit from innovative technologies in optimal conditions of information and accompaniment.

the objectives of this project are to

evaluate the preferences of families of patients with development disorders as regard to suspicious and incidental findings from HTS before its introduction for diagnostic purpose,
and then, following the exome analyses carried out for diagnostic purposes, describe, analyse and understand the experience, expectations and reactions of families and geneticists concerning the diagnostic trajectory in general and at the time the results of the HTS were announced in particular A methodology that associated quantitative and qualitative approaches was chosen so as to combine the advantages and overcome the shortcomings of each: a quantitative study to investigate a large number of patients, which would ensure a certain representativeness of the population and allow sub-groups analyses to study the upstream phase concerning indications for high-throughput sequencing; and a qualitative study, which though it allows only a small number of patients to be investigated, makes it possible to describe, analyze and understand in depth the complex downstream phenomena of high-throughput sequencing results

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Prospective and Monocentric Study of the Incidence of Venous Thromboembolic Disease (VTE) in Spinal Cord Injury (SCI) Patient Between 3 and 12 Months After SCI

acronym: IMATEM

summary:
Venous Thromboembolic Disease (VTE) in SCI patients is very common, its prevalence is 60 to 80% against 10-20% in the general population.

The risk of VTE is very important in the first weeks after spinal cord injury, and then declines with a prevalence of VTE slightly higher than the general population after 12 weeks. However there is no prospective study of incidence of VTE in SCI patients after 3 months. The investigators wish to conduct such a study during the year following spinal cord injury with performing venous Doppler ultrasound of the lower limbs 6, 9 and 12 months of the initial injuryassociated with a standardized clinical assessment, to know the incidence of VTE and determine prognostic factors for VTE.

lead_sponsor: Nantes University Hospital


title: Hepatic Steatosis and Pituitary Gland Failure, Evaluation by NMR Imaging

acronym: SHAH

summary: The investigator put forward the hypothesis that liver fat mass in patients with pituitary gland failure is greater than that in a control population. Failure of the anterior pituitary and more particularly impaired production of growth hormone (GH) could be the principal mechanism responsible for increased liver fat mass in these patients.


title: Multicentric Evaluation of in Utero Dexamethasone (DEX) on the Cognitive Development of Children at Risk of Congenital Adrenal Hyperplasia

acronym: Prenatal Dex

summary: The classic form of 21-hydroxylase deficiency (prevalence 1/15,000) is the most common cause of congenital adrenal hyperplasia (CAH). This autosomic recessive disease is responsible for virilization of the external genitalia in girls through androgen hypersecretion during fetal life. Since 1984, the Lyon Pediatric Endocrinology group has proposed prenatal dexamethasone (DEX) for all fetuses at risk of CAH With the aim of preventing fetal androgen hypersecretion in affected girls and avoiding poor long-term results from reconstructive surgery. Prenatal DEX was used in Europe and the USA but its use was recently suspended: in 2007, a Swedish study conducted on 26 children treated with DEX in utero for a short period of time reported cognitive impairments. These data were not confirmed by an American study on the short-term DEX use, which showed potential cognitive impairments in CAH children exposed to DEX for long periods of time. These confusing and controversial results have caused the scientific community to question its position and have resulted in the suspension of the use of prenatal DEX with drastic consequences for CAH girls (virilization; genital surgery etc.). In this context, an evaluation of neuropsychological development under in utero DEX is essential to validate its indication for use during the prenatal period. This study will evaluate outcomes using prospective cognitive and emotional assessments. It will first focus on the unaffected children previously treated in utero in order to assess the adverse effects of the drug. The study will then assess the children with CAH for whom DEX could have beneficial effects.

design_allocation: Non-Randomized

location_facility: Groupement Hospitalier Est - Laboratoire d'endocrinologie moléculaire et maladies rares - Centre de biologie et de pathologie Est. 59 boulevard Pinel

intervention_type: Behavioral


type: Registry Identifier

title: Impact of Home-based Oxygen Therapy on Maternal and Fetal Complications, in Pregnant Women With Sickle Cell Disease. A Randomized Multi-center Trial.

summary: The purpose of this study is to assess the efficiency of the preventive oxygen therapy on the occurrence of vaso-occlusive complications, which last more than 24 hours and require hospitalisation, in women with sickle cell disease.

status: Active, not recruiting

primary_purpose: Prevention

location_facility: Hôpital Necker Enfants-Malades (Public Hospitals of Paris)


title: Assessment of the Effect of a Daily Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome

acronym: AAS-Lynch

summary: The proposed trial will evaluate the effect of aspirin 300 mg/d and 100 mg/d during 4 years vs placebo, in a 4 groups randomised parallel design in Lynch syndrome patients: patients with proven carriers of pathological mutations in mismatch repairs genes and patients with personal and family history characterizing Lynch syndrome according to modified Amsterdam criteria without proven mutation, aged more than 18 years with signed informed consent. The main hypothesis to be tested is that aspirin could decrease colorectal adenoma recurrence evaluated during high quality follow-up by colonic chromo-endoscopy in Lynch syndrome patients. The trial will also explore: (i) colorectal neoplasia recurrence according to different germline alteration in mismatch repair genes, (ii) observance to chemoprevention in Lynch syndrome patients, (iii) the burden of adverse events attributable to aspirin in Lynch syndrome patients, (iv) the dose-effect of aspirin on adenomatous polyp burden. All pathological samples will be reviewed using a centralized procedure. The INCA regional network organization and the HNPCC patient organization will allow the recruitment and the follow-up of a large number of patients with well characterised Lynch syndrome.

ReferenceCitation: Soualy A, Deutsch D, Benallaoua M, Ait-Omar A, Mary F, Helfen S, Boubaya M, Levy V, Benamouzig R; AAS-Lynch group. Effect of chemoprevention by low-dose aspirin of new or recurrent colorectal adenomas in patients with Lynch syndrome (AAS-Lynch): study protocol for a multicenter, double-blind, placebo-controlled randomized controlled trial. Trials. 2020 Sep 4;21(1):764. doi: 10.1186/s13063-020-04674-8.

family: Soualy

full_name: Adil Soualy

given: Adil

family: Deutsch

full_name: David Deutsch

given: David

family: Benallaoua

full_name: Mourad Benallaoua

given: Mourad

family: Ait-Omar

full_name: Amal Ait-Omar

given: Amal

family: Mary

full_name: Florence Mary

given: Florence

family: Helfen

full_name: Sabine Helfen

given: Sabine

family: Boubaya

full_name: Marouane Boubaya

given: Marouane

family: Levy

full_name: Vincent Levy

given: Vincent

family: Benamouzig

full_name: Robert Benamouzig

given: Robert

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: Impact of the Oxidative Stress on the Skeletal Muscle Dysfunction in Hemodialysis Patient

acronym: POPEYE

summary:
In hemodialysis patient (HD) a reduction of the skeletal muscle mass and strength has previously been reported. This muscle impairment constitutes an independent prognosis factor in HD patients. Oxidative stress and inflammation have been linked to the muscle impairment. The mitochondria is a classical producer and target of reactive oxygen species (ROS), and may thus constitute a central actor of the skeletal muscle impairment in HD patients. Therefore, the aim of the present study is to investigate the role of the muscle mitochondrial density on the muscle impairment in HD patients, in comparing the muscle mitochondrial density and oxidative stress in HD patients vs. healthy matched controls.

In order to assess the effect of the oxidative stress and inflammation on the muscle impairment in HD patients, muscle function assessements will be performed after renal transplantation (which lowers the oxidative stress and inflammation levels) in the HD patient group.

No therapeutic intervention will be tested in the present study.

primary_purpose: Basic Science

ReferenceCitation: Souweine JS, Gouzi F, Badia É, Pomies P, Garrigue V, Morena M, Hayot M, Mercier J, Ayoub B, Quintrec ML, Raynaud F, Cristol JP. Skeletal Muscle Phenotype in Patients Undergoing Long-Term Hemodialysis Awaiting Kidney Transplantation. Clin J Am Soc Nephrol. 2021 Nov;16(11):1676-1685. doi: 10.2215/CJN.02390221.

family: Souweine

full_name: Jean-Sébastien Souweine

given: Jean-Sébastien

family: Gouzi

full_name: Fares Gouzi

given: Fares

family: Badia

full_name: Éric Badia

given: Éric

family: Pomies

full_name: Pascal Pomies

given: Pascal

family: Garrigue

full_name: Valérie Garrigue

given: Valérie

family: Morena

full_name: Marion Morena

given: Marion

family: Hayot

full_name: Maurice Hayot

given: Maurice

family: Mercier

full_name: Jacques Mercier

given: Jacques

family: Ayoub

full_name: Bronia Ayoub

given: Bronia

family: Quintrec

full_name: Moglie Le Quintrec

given: Moglie Le

family: Raynaud

full_name: Fabrice Raynaud

given: Fabrice

family: Cristol

full_name: Jean-Paul Cristol

given: Jean-Paul

journal_name: Clinical Journal of the American Society of Nephrology

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

publisher_normalized: American Society of Nephrology


title: Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified Compared to a Usual Method

acronym: AirvoNEB

summary: The principal objective is to show noninferiority of nebulized salbutamol through the high flow nasal system moistened AIRVO ™ 2 in terms of reversibility of airflow obstruction compared to nebulization by the usual method (spray mask).

lead_sponsor: University Hospital, Tours


title: Self-defining Memories and Future Projections in Bipolar Disorder Patients

summary: Self-defining memories (SDMs) are memories that are still important today to understand who the investigators are and participate to the maintain of personal identity. SDMs are also linked to our capacity to project ourselves into the future. In bipolar disorder, life events play an important role in the course and outcome of the disease. the study is the first to investigate SDMs and self-defining future projections in a population of remitted patients with bipolar disorder.

lead_sponsor: CHU de Reims


title: Antimicrobial Peptides in Periodontitis : a Pilot Study

acronym: PAROPAM

summary: Periodontal diseases are complex chronic pathologies presenting a high prevalence worldwide. Etiopathological process involved in initiation and progression of these multifactorial diseases are not well understood, explaining the huge clinical forms variability and the complexity of the currently used classification of periodontal diseases. Recently, the implication of antimicrobial peptides (AMPs) have been suggested as potential track of explanation for periodontal diseases pathogeny. The here presented study explore the level of expression of genes coding those peptides by studying periodontal smears obtained from healthy and periodontitis patients.

primary_purpose: Diagnostic


title: Clinical Results After Medical Therapy Alone or Medical Therapy Associated With Lumbar Traction in the Treatment of Nerve Root Pain of Lumbar Disc Herniation With Disco-radicular Conflict

summary: The purpose of this study is to compare the clinical outcome of medical treatment associated with lumbar traction and medical treatment alone in the treatment of lumbar disk herniation.


title: Evaluation of Advanced Glycation End Products of Proteins as a Long-term Retrospective Markers of Glycemic Control in a Population of Non-complicated Type 1 Diabetic Children.

acronym: AGEDIA

summary: The objective of the study is to quantify the products of non-enzymatic glycation of proteins (called AGEs for advanced glycation end-products) in serum of type 1 diabetic patients without clinical complications in order to define the contribution of this markers in the long-term monitoring of glycemic control in these patients. The results will define the criteria for using these new markers in daily clinical practice for the monitoring of these patients


title: Evaluation of the Efficacy of Low-frequency rTMS on Craving in Smoking Dependence: Single-centre Randomized, Controlled Blinded Pilot Study

acronym: rTMS TABAC

summary:
The fight against smoking is a public health priority. Without help, fewer than 5% of des smokers are abstinent at 12 months after smoking cessation.

Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of success at 12 months in patients dependent on nicotine is only 18%. Moreover, other therapeutic strategies (acupuncture, hypnosis…) have not proved to be effective.

The investigators propose a new therapeutic strategy for smoking cessation, which is based on associating nicotine substitutes (to reduce physical symptoms of weaning from nicotine) with rTMS at 1 Hz to the right DorsoLateral PreFrontal Cortex (DLPFC) for 2 weeks (to diminish craving for tobacco). The principal objective is to improve the success rate for smoking cessation attempts in patients who are highly dependent on nicotine, and who have failed using usual smoking cessation strategies.


title: Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence? An Observational, Single-centre Pilot Study

summary: Dynamic indices of preload dependence (such as stroke volume variability -SVV , pulse pressure variability - PPV and plethysmograph variability index - PVI ) are reportedly predictive of the response to vascular filling in sedated, mechanically ventilated patients. However, the influence of the sedation depth on these dynamic indices has never been evaluated.


title: Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia? A Observational, Single-centre Study

summary: Monitoring the bispectral index (BIS) as a peri-operative hemodynamic tool appears to be justified by the agreement between various clinical situations in which BIS monitoring appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death , and the diagnosis of amniotic fluid embolism. The current controversy concerning the "triple low" state reinforces the need for an accurate study in this field. Furthermore, the recent review by Bidd argues in this sense.


title: Biological Phosphocalcic Metabolism and Coronary Artery Calcifications

acronym: BIOCAC

summary: Study a sample of patients in primary prevention, moderate cardiovascular risk (n = 83 patients), with normal, non-diabetic renal function. The investigators quantify the phophocalcic intake and excretion, realizing a food examination and a urine collection of 24 particular. The investigators will measure plasma levels of FGF23 serum calcium, phosphatemia, the investigators will calculate the tubular reabsorption of phosphate. The investigators will conduct a quantitative assessment of coronary calcification by a non-injected CT scan, measuring semi automated way Agatston calcium score. There will be an analysis of collinearity. An adjustment will be made for confounding variables in a generalized linear regression model.

lead_sponsor: French Cardiology Society

lead_sponsor_type: industriel


title: Effect of Hypnosis on Dyspnea

acronym: Hypnopnee

summary: The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: Service de Pneumologie et Réanimation Médicale


title: CODEX:Collection of Aflibercept Data in Routine Practice

acronym: CODEX

summary: The French CODEX study is designed as a national database to describe, in routine medical practice, functional and anatomical responses to intravitreal Aflibercept injection, in a large population of anti-VGEF-naïve patients presenting with wet Age-related Macular Degeneration (wAMD), Central Retinal Vein Occlusion (CRVO),Branch Retinal Vein Occlusion(BRVO), or Diabetic Macular Edema (DME). This national database will gather databases from French private and public ophthalmologic centers.

time_perspective: Retrospective

lead_sponsor: Bayer


title: Impact of Chyme Reinfusion Compared to Parenteral Nutrition on the Incidence of Complications in Patients With a Temporary High-output Double Enterostomy: a Multicentre Randomized Controlled Trial - FRY: efFiciency of Reinfusion of chYme - (FRY)

acronym: FRY

summary: In the case of intestinal failure with a high-output double enterostomy, the parenteral nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive continuity. PN has its own morbidity, and in the absence of expertise, the risks of infectious, mechanical, and metabolic complications are increased. Chyme reinfusion (CR) is an enteral nutritional technique which reestablishes the functional continuity of the anatomically present small bowel through an extracorporeal circulation of the chyme. In patients with intestinal failure with a temporary high-output double enterostomy, we hypothesize that CR, compared to PN will reduce post-operative complications after surgical reestablishment of digestive continuity, maintain the intestinal function including absorption, and reduce the complications during the transitional period pending the surgical reestablishment of digestive continuity.

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse


title: Change of Urinary Metabolic Profile Secondary to a Congenital Urine Flow Impairment (UFI) by Nuclear Magnetic Resonance (NMR) and Metabolomics Analysis

acronym: ACEU

summary:
For the new-born, diagnosis and prognosis of congenital urine flow impairment (UFI) are difficult to confirm only with morphological examination (ultrasonography, intravenous pyelography) and functional examination (dynamic renal scan MAG3). Only the test of time allows the post confirmation of a significant UFI requiring a surgery. This meant that the actual therapeutic indications are imperfect by the absence of an "absolute" endpoint for UFI.

The objective of the study is to characterize the urinary metabolomics profile of new born with renal pelvis and/or ureters tract dilatation (suspicion of pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux), detected by prenatal ultrasonography, by Nuclear Magnetic Resonance (NMR) and metabolomics analysis. This characterization will allow the identification of statistically significant metabolomics markers for the diagnosis and prognosis of a favourable evolution of the anomaly. The evolution with time of these metabolomics profiles will also considered.

location_facility: Hospices Civils de LYon - Hôpital Femme Mère Enfant


summary:
The ventilation of the patient under general anesthesia is an old problem and extensively studied, especially in visceral surgery, higher risk of postoperative complications. Studies have recently shown the impact of a lung-protective ventilation in visceral surgery, however obese patients are often excluded, and alveolar recruitment maneuver has never been studied independently.

The investigators are conducting a randomized controlled prospective study to investigate the clinical value to achieve alveolar recruitment maneuver routinely in patients undergoing bariatric surgery.

The objective is to show the reduction in dyspnea, oxygen dependency: reflection of atelectasis and the incidence of postoperative complications.

ReferenceCitation: Severac M, Chiali W, Severac F, Perus O, Orban JC, Iannelli A, Debs T, Gugenheim J, Raucoules-Aimé M. Alveolar recruitment manoeuvre results in improved pulmonary function in obese patients undergoing bariatric surgery: a randomised trial. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100775. doi: 10.1016/j.accpm.2020.09.011. Epub 2020 Nov 1.

family: Severac

full_name: Mathilde Severac

given: Mathilde

family: Chiali

full_name: Walid Chiali

given: Walid

full_name: François Severac

given: François

family: Perus

full_name: Olivier Perus

given: Olivier

family: Orban

full_name: Jean-Christophe Orban

given: Jean-Christophe

family: Iannelli

full_name: Antonio Iannelli

given: Antonio

family: Debs

full_name: Tarek Debs

given: Tarek

family: Gugenheim

full_name: Jean Gugenheim

given: Jean

family: Raucoules-Aimé

full_name: Marc Raucoules-Aimé

given: Marc

journal_name: Anaesthesia Critical Care & Pain Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis

acronym: QALCIMUM

summary:
The main objective of this study is to measure, in patients with MS or Chronic Inflammatory Arthritis (CIA), the correlation between two calcium intake assessment methods: A self assessment questionnaire of calcium intake (QALCIMUM®) versus a food survey serving as a reference (gold standard) and based on data from CIQUAL *.

* CIQUAL Data: Nutritional food composition table available on the website of the ANSES (National Agency for Sanitary Security of Food, Environment and Labour), published by the Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58 nutritional components. The data is integrated into the software (DATAMEAL) for calculating the ingesta parameters at the Nîmes University Hospital.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Non Invasive Methods for Differential Diagnosis Radionecrosis/Recurrence After Radiosurgery of Brain Metastases. CV-METANEC

acronym: CV-METANEC

summary:
The purpose of this multicenter study is to assess a diagnostic strategy concerning differential diagnosis between radiation necrosis and relapse in brain metastases treated with radiosurgery. Two non-invasive tests - positron emission tomography (PET) with 1F-fluoro-ethyl-tyrosine (FET) and magnetic resonance spectroscopy (MRS) - will be compared to histology in a cohort of patients presenting growing lesions 6 months after radiosurgical treatment.

The results of this study should help to earlier diagnosis of recurrences after radiosurgery and to perform an appropriate treatment for patients.

location_facility: CHU Pitié-Salpêtrière - Service de Neurochirurgie du Pr Philippe Cornu - Babinsky


title: Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis

summary:
Systemic Sclerosis (SSc) is an auto-immune systemic disease characterized by vascular damage, cutaneous and visceral fibrosis and a dysimmune condition.

Therapies in this disease remain insufficient and the complications resulting from organs involvement lead to strong morbi-mortality.The dermic infiltrate of the patients includes a strong proportion of Tcells. T cells and Natural Killer (NK) cells are potentially involved in the vascular damage of the SSc. However mechanisms at the onset of this endothelial cytotoxicity and its impact on the capacities of regeneration of the endothelial tissue remain poorly understood. Fractalkine is at the same time an endothelial membrane-bound adhesion molecule and a chemokine which is able to bind CX3CR1 expressed by the immune populations. The purpose of the project is to define the role displayed by cytotoxic, circulating immune populations of SSc patients in endothelial cytotoxicity as well as the role of the axis Fractalkine / CX3CR1 in mediating the interactions between the immune cytotoxic cells and the endothelium.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos

acronym: EMVOLS

summary: Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by decreasing the length of stay and the late complications: pain chronicles, quality of life, respiratory function

lead_sponsor: Poitiers University Hospital


title: Assessments and Recommendations for the Implementation of Advance Directives in Oncology

acronym: DA

summary: Legitimized by the Leonetti law of April 22, 2005, advance directives (AD) appear in various places of care that alongside the end of life, and even tend to be generalized to all areas related to health care in general. In this context, a prospective study to assess how the patient will seize the AD and identify the different problems writing these AD will be conducted. From this study, it will establish recommendations for the implementation of AD in the Multidisciplinary Oncology Department and Therapeutic Innovations service and in oncology in general. They will be asked patients if they choose to write their AD, complete and sign the AD pre-written in the book or not to draft their AD. The choice of the patients, but also the reasons they associate thereto and, where appropriate, their AD written will be collected. The patient will also inform its demographic and socio the case report (clinical data) should be completed by the investigator. During the first part of research, the use of AD by patients and will be assessed and analyzed in connection with the characteristics of these patients (history of the disease, course of care, socio-demographic) and the reasons they set out to explain their choice. For those who write their AD, they will, in a second step, subject to thematic content analysis to identify the main aspects that the subject convened to consider its end of life.This research therefore lead to the definition of the contours of a user device AD in oncology in general. This study was qualified biomedical research because of the sensitive nature of the study population and bring the patient to personal preoccupations when filling the questionnaire on the choice of directing advance directives and their contents.

primary_purpose: Health Services Research

location_facility: Assistance Publique Hôpitaux de Marseille


title: Interest of Preventive Personalized Treatment in Hemophilia A

acronym: OBTC

summary: The purpose of this study is to evaluate the implementation of pharmacokinetic (PK) driven prophylaxis in current clinical practice

primary_purpose: Supportive Care


acronym: Light-CARMIDO

summary: Hypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is observed within the left ventricle which is named left ventricular outflow tract obstruction (LVOTO). This phenomenon can occur at rest or during exercise and is associated with symptoms such as dyspnea, dizziness or chest pain that can significantly limit day life adaptation. To now, medical or interventional treatments such as betablocacker, calcium blockers or septal alcoholisation or surgery present with a limited efficiency. Recent studies from investigators group revealed new concepts about the role of venous return to the LVOTO. Therefore the investigators hypothesis that BX1514M generating a venous vascular constriction, could improve symptoms of HCM patients by reducing LVOTO.

lead_sponsor: University Hospital, Bordeaux


acronym: PREV-DEMALS

summary:
The project focuses on C9orf72, the most frequent genetic form of frontotemporal dementias (FTD, or frontotemporal lobar degeneration, FTLD) and amyotrophic lateral sclerosis (ALS). FTD is the second commonest cause of degenerative dementia in presenium after Alzheimer's disease. Behavioural and cognitive impairments progressively lead to dementia. ALS produces progressive muscle weakness leading to the death in 2 to 4 years. Since 2006, major discoveries have linked FTLD and ALS:

TDP-43 aggregates in neurons and
C9orf72 mutations is a major genetic cause in both disorders.

Two major pathological subtypes are now defined in FTD, FTD-TDP and FTD-TAU. C9orf72 mutations (associated to FTD-TDP) are the most frequent genetic causes of FTD (15%), FTD-ALS (65%) and ALS (40%).

FTD is difficult at an early stage; and no clinical, biological or imaging features can predict the underlying pathology in living patients. Therapeutic perspectives emerged against tau aggregation, progranulin deficit and C9orf72 expansion (antisense). Presymptomatic carriers of genetic FTD would benefit, before onset of symptoms, from these therapeutic that would delay or prevent the disease. At this step, it becomes crucial to develop markers to know how many years before symptoms, does the pathological progress begin, to treat the patients at the most early stage of the disease. Markers are also needed to predict the pathology (FTD-TDP/FTD-tau) in patients that will be eligible for trials targeting specific pathological lesion.

ReferenceCitation: Saracino D, Dorgham K, Camuzat A, Rinaldi D, Rametti-Lacroux A, Houot M, Clot F, Martin-Hardy P, Jornea L, Azuar C, Migliaccio R, Pasquier F, Couratier P, Auriacombe S, Sauvée M, Boutoleau-Bretonnière C, Pariente J, Didic M, Hannequin D, Wallon D; French Research Network on FTD/FTD-ALS; PREV-DEMALS and Predict-PGRN study groups, Colliot O, Dubois B, Brice A, Levy R, Forlani S, Le Ber I. Plasma NfL levels and longitudinal change rates in C9orf72 and GRN-associated diseases: from tailored references to clinical applications. J Neurol Neurosurg Psychiatry. 2021 Aug 4. pii: jnnp-2021-326914. doi: 10.1136/jnnp-2021-326914. [Epub ahead of print]

family: Saracino

full_name: Dario Saracino

given: Dario

family: Dorgham

full_name: Karim Dorgham

given: Karim

family: Camuzat

full_name: Agnès Camuzat

given: Agnès

family: Rinaldi

full_name: Daisy Rinaldi

given: Daisy

family: Rametti-Lacroux

full_name: Armelle Rametti-Lacroux

given: Armelle

family: Houot

full_name: Marion Houot

family: Clot

full_name: Fabienne Clot

given: Fabienne

family: Martin-Hardy

full_name: Philippe Martin-Hardy

given: Philippe

family: Jornea

full_name: Ludmila Jornea

given: Ludmila

family: Azuar

full_name: Carole Azuar

given: Carole

family: Migliaccio

full_name: Raffaella Migliaccio

given: Raffaella

family: Pasquier

full_name: Florence Pasquier

given: Florence

family: Couratier

full_name: Philippe Couratier

family: Auriacombe

full_name: Sophie Auriacombe

given: Sophie

family: Sauvée

full_name: Mathilde Sauvée

family: Boutoleau-Bretonnière

full_name: Claire Boutoleau-Bretonnière

given: Claire

family: Pariente

full_name: Jérémie Pariente

given: Jérémie

family: Didic

full_name: Mira Didic

given: Mira

family: Hannequin

full_name: Didier Hannequin

given: Didier

family: Wallon

full_name: David Wallon

given: David

family: Colliot

full_name: Olivier Colliot

family: Dubois

full_name: Bruno Dubois

given: Bruno

family: Brice

full_name: Alexis Brice

given: Alexis

name: the French Research Network on FTD/FTD-ALS

name: the PREV-DEMALS and Predict-PGRN study groups

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

ReferenceCitation: Kmetzsch V, Anquetil V, Saracino D, Rinaldi D, Camuzat A, Gareau T, Jornea L, Forlani S, Couratier P, Wallon D, Pasquier F, Robil N, de la Grange P, Moszer I, Le Ber I, Colliot O, Becker E; PREV-DEMALS study group. Plasma microRNA signature in presymptomatic and symptomatic subjects with C9orf72-associated frontotemporal dementia and amyotrophic lateral sclerosis. J Neurol Neurosurg Psychiatry. 2021 May;92(5):485-493. doi: 10.1136/jnnp-2020-324647. Epub 2020 Nov 25.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

ReferenceCitation: Querin G, Bede P, El Mendili MM, Li M, Pélégrini-Issac M, Rinaldi D, Catala M, Saracino D, Salachas F, Camuzat A, Marchand-Pauvert V, Cohen-Adad J, Colliot O, Le Ber I, Pradat PF; Predict to Prevent Frontotemporal Lobar Degeneration and Amyotrophic Lateral Sclerosis Study Group. Presymptomatic spinal cord pathology in c9orf72 mutation carriers: A longitudinal neuroimaging study. Ann Neurol. 2019 Aug;86(2):158-167. doi: 10.1002/ana.25520. Epub 2019 Jun 27.

name: Department of Neurology, SLA Reference CenterPitié‐Salpêtrière Hospital, Public Hospital Network of Paris Paris France

name: Laboratory of Biomedical Imaging, National Center for Scientific ResearchNational Institute of Health and Medical Research, Sorbonne University Paris France

name: Computational Neuroimaging Group, Academic Unit of NeurologyTrinity College Dublin Dublin Ireland

name: Department of NeurologyIcahn School of Medicine at Mount Sinai New York NY

name: Brain and Spinal Cord Institute, Sorbonne University, National Institute of Health and Medical Research U1127, National Center for Scientific Research Mixed Unit of Research 7225Pitié‐Salpêtrière Hospital Paris France

name: Reference Center for Rare or Early DementiaPitié‐Salpêtrière Hospital Paris France

name: Department of Neurology, Pitié‐Salpêtrière Hospital, Public Hospital Network of Paris, Sorbonne University, National Center for Scientific Research Mixed Unit of Research 7622National Institute of Health and Medical Research Accademic Research Unit 1156, Biology Institute Paris‐Seine Paris France

name: NeuroPoly Laboratory, Institute of Biomedical EngineeringPolytechnique Montreal Montreal Quebec Canada

name: Functional Neuroimaging Unit, Research Center of the University Institute of Geriatrics of MontrealUniversity of Montreal Montreal Quebec Canada

name: Aramis Project TeamInria Research Center of Paris Paris France

name: Center for Image Acquisition and ProcessingBrain and Spinal Cord Institute Paris France

name: Institute of Memory and Alzheimer's Disease, Center of Excellence of Neurodegenerative Disease, Department of Neurology, SLA Reference Center, Pitié‐Salpêtrière HospitalPublic Hospital Network of Paris Paris France

name: Northern Ireland Centre for Stratified Medicine, Biomedical Sciences Research Institute, Ulster University, Clinical‐Translational Research and Innovation CenterAltnagelvin Hospital Londonderry United Kingdom

name: for the Predict to Prevent Frontotemporal Lobar Degeneration and Amyotrophic Lateral Sclerosis Study Group

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

ReferenceCitation: Wen J, Zhang H, Alexander DC, Durrleman S, Routier A, Rinaldi D, Houot M, Couratier P, Hannequin D, Pasquier F, Zhang J, Colliot O, Le Ber I, Bertrand A; Predict to Prevent Frontotemporal Lobar Degeneration and Amyotrophic Lateral Sclerosis (PREV-DEMALS) Study Group. Neurite density is reduced in the presymptomatic phase of C9orf72 disease. J Neurol Neurosurg Psychiatry. 2019 Apr;90(4):387-394. doi: 10.1136/jnnp-2018-318994. Epub 2018 Oct 24.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

ReferenceCitation: Bertrand A, Wen J, Rinaldi D, Houot M, Sayah S, Camuzat A, Fournier C, Fontanella S, Routier A, Couratier P, Pasquier F, Habert MO, Hannequin D, Martinaud O, Caroppo P, Levy R, Dubois B, Brice A, Durrleman S, Colliot O, Le Ber I; Predict to Prevent Frontotemporal Lobar Degeneration and Amyotrophic Lateral Sclerosis (PREV-DEMALS) Study Group. Early Cognitive, Structural, and Microstructural Changes in Presymptomatic C9orf72 Carriers Younger Than 40 Years. JAMA Neurol. 2018 Feb 1;75(2):236-245. doi: 10.1001/jamaneurol.2017.4266. Erratum in: JAMA Neurol. 2019 May 13;:.

name: Sorbonne Universités, Université Pierre et Marie Curie Paris 06, Institut National de la Santé et de la Recherche Médicale, Centre National de la Recherche Scientifique, Institut du Cerveau et la Moelle, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Paris, France

name: Aramis Project Team, Inria Research Center of Paris, Paris, France

name: Department of Neuroradiology, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Paris, France

name: Department of Radiology, Hôpital Saint Antoine, Assistance Publique–Hôpitaux de Paris, Paris, France

name: Sorbonne Universités, Université Pierre et Marie Curie Paris 06, Institut National de la Santé et de la Recherche Médicale, Centre National de la Recherche Scientifique, Institut du Cerveau et la Moelle, Hôpital Pitié-Salpêtrière, Paris, France

name: Centre de Référence des Démences Rares ou Précoces, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Paris, France

name: Institute of Memory and Alzheimer’s Disease, Centre of Excellence of Neurodegenerative Disease, Department of Neurology, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Paris, France

name: Department of Neurology, Amyotrophic Lateral Sclerosis Center, Centre Hospitalier Universitaire de Limoges, Limoges, France

name: Limoges University, Institut d’Epidémiologie Neurologique et Neurologie Tropicale, Centre National de la Recherche Scientifique, Fédération de Recherche 3503, Institut Génomique, Environnement, Immunité, Santé et Thérapeutiques, Limoges, France

name: Neurology Department, National Reference Center for Young Onset Dementia, Centre Hospitalier Régional Universitaire de Lille, INSERM U1171, Lille, France

name: Equipe d’accueil 1046, Maladie d’Alzheimer et Pathologies Vasculaires, Lille University, Lille, France

name: Department of Nuclear Medicine, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Paris, France

name: Laboratoire d’Imagerie Biomédicale, Sorbonne Universités, Université Pierre et Marie Curie Paris 06, INSERM U1146, Centre National de la Recherche Scientifique, UMR 7371, Paris, France

name: Centre National de Référence pour les Malades Alzheimer Jeunes, Centre Hospitalier Universitaire de Rouen, INSERM 1245, Rouen, France

name: Department of Neurology, Centre Hospitalier Universitaire de Rouen, Rouen, France

name: Division of Neurology V and Neuropathology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Neurologico Carlo Besta, Milano, Italy

name: Centre pour l’Acquisition et le Traitement des Images, Institut du Cerveau et la Moelle, Paris, France

name: for the Predict to Prevent Frontotemporal Lobar Degeneration and Amyotrophic Lateral Sclerosis (PREV-DEMALS) Study Group

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Charles Foix


title: Poker, Skills and Associated Problems (PERHAPS). Controlled Experimental Single Centre Study of Poker Players: Study of the Cognitive Mechanisms Underlying Poker Skills and of the Specificity of Poker-related Problems

acronym: PERHAPS

summary: The PERHAPS project aims to fill two gaps in the scientific literature: on the one hand, studying the clinical and cognitive particularities of poker-related problems, and on the other hand, studying poker skill as a combination of multiple cognitive and emotional abilities. The underlying clinical aim is to develop a cognitive remediation therapy program dedicated to pathological gamblers.


title: Comparaison du Profil d'Absorption Des Acides aminés Entre Une Nutrition entérale Semi-élémentaire et Une Nutrition entérale polymérique

acronym: PEPS

summary: The purpose of this study is to evaluate amino acid absorption with two different type of proteins.

lead_sponsor: Nestlé

intervention_type: Dietary Supplement


title: Onset and Offset of Von Willebrand Factor Multimemirization Defects in Cardiovascular Disease: the Case of the Molecular Sensor of Blood Flow

acronym: WiTAVi

summary: The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand Factor-multimerizaton defects associated with devices in cardiovascular diseases.

ReferenceCitation: Van Belle E, Rauch A, Vincentelli A, Jeanpierre E, Legendre P, Juthier F, Hurt C, Banfi C, Rousse N, Godier A, Caron C, Elkalioubie A, Corseaux D, Dupont A, Zawadzki C, Delhaye C, Mouquet F, Schurtz G, Deplanque D, Chinetti G, Staels B, Goudemand J, Jude B, Lenting PJ, Susen S. Von Willebrand factor as a biological sensor of blood flow to monitor percutaneous aortic valve interventions. Circ Res. 2015 Mar 27;116(7):1193-201. doi: 10.1161/CIRCRESAHA.116.305046. Epub 2015 Feb 10.

ReferenceCitation: Vincent F, Spillemaeker H, Kyheng M, Belin-Vincent C, Delhaye C, Piérache A, Denimal T, Verdier B, Debry N, Moussa M, Schurtz G, Porouchani S, Cosenza A, Juthier F, Pamart T, Richardson M, Coisne A, Hertault A, Sobocinski J, Modine T, Pontana F, Duhamel A, Labreuche J, Van Belle E. Ultrasound Guidance to Reduce Vascular and Bleeding Complications of Percutaneous Transfemoral Transcatheter Aortic Valve Replacement: A Propensity Score-Matched Comparison. J Am Heart Assoc. 2020 Mar 17;9(6):e014916. doi: 10.1161/JAHA.119.014916. Epub 2020 Mar 16.

name: Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France

name: Inserm U1011 Institut Pasteur de Lille EGID Lille France

family: Vincent

full_name: Flavien Vincent

given: Flavien

family: Spillemaeker

full_name: Hugues Spillemaeker

given: Hugues

name: EA 2694–Santé Publique: Épidémiologie et Qualité des Soins CHU Lille University of Lille France

family: Kyheng

full_name: Maéva Kyheng

given: Maéva

family: Belin‐Vincent

full_name: Cassandre Belin‐Vincent

given: Cassandre

family: Delhaye

full_name: Cédric Delhaye

given: Cédric

family: Piérache

full_name: Adeline Piérache

given: Adeline

family: Denimal

full_name: Tom Denimal

given: Tom

family: Verdier

full_name: Basile Verdier

given: Basile

family: Debry

full_name: Nicolas Debry

given: Nicolas

name: Anesthésie et Réanimation Cardio‐Vasculaire CHU Lille Lille France

family: Moussa

full_name: Mouhamed Moussa

given: Mouhamed

family: Schurtz

full_name: Guillaume Schurtz

given: Guillaume

family: Porouchani

full_name: Sina Porouchani

given: Sina

family: Cosenza

full_name: Alessandro Cosenza

given: Alessandro

name: Chirurgie Cardiaque CHU Lille Lille France

family: Juthier

full_name: Francis Juthier

given: Francis

family: Pamart

full_name: Thibault Pamart

given: Thibault

family: Richardson

full_name: Marjorie Richardson

given: Marjorie

family: Coisne

full_name: Augustin Coisne

given: Augustin

name: Chirurgie Vasculaire CHU Lille Lille France

family: Hertault

full_name: Adrien Hertault

given: Adrien

family: Sobocinski

full_name: Jonathan Sobocinski

given: Jonathan

family: Modine

full_name: Thomas Modine

given: Thomas

name: Radiologie Cardiovasculaire CHU Lille Lille France

family: Pontana

full_name: François Pontana

given: François

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Labreuche

full_name: Julien Labreuche

given: Julien

journal_name: Journal of the American Heart Association

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Ultrasound Guidance to Reduce Vascular and Bleeding Complications of Percutaneous Transfemoral Transcatheter Aortic Valve Replacement: A Propensity Score–Matched Comparison

ReferenceCitation: Van Belle E, Rauch A, Vincent F, Robin E, Kibler M, Labreuche J, Jeanpierre E, Levade M, Hurt C, Rousse N, Dally JB, Debry N, Dallongeville J, Vincentelli A, Delhaye C, Auffray JL, Juthier F, Schurtz G, Lemesle G, Caspar T, Morel O, Dumonteil N, Duhamel A, Paris C, Dupont-Prado A, Legendre P, Mouquet F, Marchant B, Hermoire S, Corseaux D, Moussa K, Manchuelle A, Bauchart JJ, Loobuyck V, Caron C, Zawadzki C, Leroy F, Bodart JC, Staels B, Goudemand J, Lenting PJ, Susen S. Von Willebrand Factor Multimers during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2016 Jul 28;375(4):335-44. doi: 10.1056/NEJMoa1505643.


title: Comprehensive Analysis of HIV Reservoirs in Chronically Infected HIV-1 Treated Patients With a Low Total Cell-associated Blood HIV-DNA

acronym: RESACHRON

summary:
HIV infection can be efficiently controlled by antiretroviral therapy (ART), with in 2013 nearly 85 % of patients having a suppressed viremia, but HIV cannot, however, be eradicated with ART alone [1]. Overall, HIV has moved from a fatal to a chronic disease provided treatment is maintained life-long. Despite major improvement in antiretroviral drugs in terms of efficacy, tolerability and simplicity, life-long therapy is still associated with drug toxicity. Several drugs or drug classes, which have historically saved lives since 1996 and are currently widely used such as protease inhibitors and nucleosides analogues, are associated with long-term toxicities and increased incidence of comorbidities.

Currently, worldwide there is an approximated 10 millions of HIV infected patients under cART. This number should increase in the next years, as most recent guidelines recommend earlier therapy given the benefits in terms of disease progression and prevention of transmission. Because of the increasing number of patients who will be under cART in the future, the cumulative ART toxicity, the difficulties to access ART in some areas of the world, the fatigue expressed by patients about ART and the cost issues, there is an urgent need to search for HIV CURE. To date, only two cases of sterilizing HIV cure were reported so far: the famous "Berlin Patient" after two homozygous Delta32-CCR5 bone-marrow grafts for an acute leukemia [2], and the Mississipi baby after very early initiation of cART 31 hours after delivery [3]. However those cases of sterilizing HIV cure remain exceptional and the alternative objective of a functional HIV cure appears to be more realistic, though still described in rare groups of patients like Elite controllers (EC) and post treatment controllers (PTC) patients. In addition new and complex therapeutic strategies are currently proposed to try purging the HIV reservoirs, but none of them proved so far able to reach this goal.

Therefore the objective of finding a Cure to HIV [4] requires first to better understand the basic mechanisms of the persistence of HIV reservoirs in the population of chronically-infected fully-suppressed HIV+ patients in order to define future therapeutic strategies.

time_perspective: Cross-Sectional

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

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales


title: Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

acronym: PRONOCELDIAB

summary:
Islet transplantation for type 1 diabetes results are still improving, and actually Insulin-independence with normal HbA1c is obtained in 50% of patients after 5 years, 80% of c-peptide positive patients. In addition to the need of 2 or 3 surgical or radiological interventions to inject islets, an immunosuppressive regimen is needed, which can be deleterious, particularly on kidneys. Moreover, long term beneficial effects of islet transplantation on stabilization or prevention of macro and micro vascular complications of diabetes has not been evaluated. In a preliminary work, it was observed a stabilisation or improvement of microvascular complications when compared to pre-transplant data.

The aim of this study is to compare the evolution of diabetes complications, especially nephrologic, 10 years after islet transplantation and to compare it to patients with a brittle diabetes, 10 years after evaluation for islet transplantation, finally not performed.

This case-control study will evaluate nephrologic parameters (creatinine, MDRD creatinine clearance, microalbuminuria, proteinuria) and other micro and macro-vascular complications of type 1 diabetes) before islet transplantation and 10 years after the transplantation or after the first evaluation in patients who finally did not underwent islet transplantation for various non nephrologic reasons

lead_sponsor: University Hospital, Lille


title: The Effect and Tolerance of a Ketamine Subcutaneous Bolus, During Painful Care of Refractory Bed Sores, Ulcers and Vascular Wounds in a Palliative Care Unit

acronym: KETAREF

summary:
Pain is one of the major symptoms in palliative care units and often is very difficult to treat, being considered as a refractory pain.

There are different causes of refractory pain: pain due to bed sores and ulcer bandages, carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, pain due to traumatological injuries, pain associated with a long-term bed confinement, etc.

The investigators propose a prospective study to estimate the effect and the tolerance to a subcutaneous bolus of ketamine administered for the treatment of refractory pain due to the care of bedsores, ulcers and vascular wounds in patients hospitalized in palliative care units.

lead_sponsor: Lille Catholic University


title: Pilot Phase II, Randomized , and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment With ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering From Symptomatic Endometriosis

acronym: FRA-IIT-UPA

summary: Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prospective Multicenter Randomized Open-label Controlled Trial Assessing Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia

acronym: DAPS-ITP

summary:
Due to its expected efficacy based on the retrospective data available in ITP, its relatively good safety profile and its very low cost , dapsone could be a good steroid-sparing second-line option for adults with ITP.

This study is a phase III prospective multicenter randomized open trial comparing two treatment strategies:

Arm A (experimental arm): prednisone at 1 mg/kg for 3 weeks + dapsone at 100 mg per day up to week 52 if an initial response is achieved.
Arm B (control arm): prednisone alone at 1 mg/kg for 3 weeks followed by monitoring and "standard of care" The aim of the study is to demonstrate the efficacy of dapsone based on the overall response rate (including response and complete response) as a second-line treatment for adults with newly-diagnosed persistent or chronic (modified by amendment 08/11/2016) ITP not achieving a durable response with corticosteroids. The primary endpoint will be the overall response-rate (response or complete response according to standard definitions) in both arms at week 52 (1 year).

The secondary endpoints are the following :

To assess the safety of dapsone over the study period and especially the incidence of cutaneous reactions.
To analyze the overall response rate (platelet count > 30 x 109/L with at least a doubling of the pre-treatment count in the absence of any other ITP treatment) in both treatment arms at week 24.
To compare the rate of complete response and failure in both arms at 24 and 52 weeks.
To compare time to treatment failure (TTF) in both arms
To investigate the mechanisms of action of dapsone in ITP in a subgroup of patients (ancillary study)

ReferenceCitation: Durand JM, Lefèvre P, Hovette P, Mongin M, Soubeyrand J. Dapsone for idiopathic autoimmune thrombocytopenic purpura in elderly patients. Br J Haematol. 1991 Jul;78(3):459-60.

ReferenceCitation: Godeau B, Oksenhendler E, Bierling P. Dapsone for autoimmune thrombocytopenic purpura. Am J Hematol. 1993 Sep;44(1):70-2.

ReferenceCitation: Hernández F, Linares M, Colomina P, Pastor E, Cerveró A, Pérez A, Perella M. Dapsone for refractory chronic idiopathic thrombocytopenic purpura. Br J Haematol. 1995 Jun;90(2):473-5.

ReferenceCitation: Godeau B, Durand JM, Roudot-Thoraval F, Tennezé A, Oksenhendler E, Kaplanski G, Schaeffer A, Bierling P. Dapsone for chronic autoimmune thrombocytopenic purpura: a report of 66 cases. Br J Haematol. 1997 May;97(2):336-9.

ReferenceCitation: Damodar S, Viswabandya A, George B, Mathews V, Chandy M, Srivastava A. Dapsone for chronic idiopathic thrombocytopenic purpura in children and adults--a report on 90 patients. Eur J Haematol. 2005 Oct;75(4):328-31.


title: Study of the Genetic and Environmental Factors of Vulnerability in Bipolar Disorders

acronym: GAN

summary:
Bipolar disorder is a complex, multifactorial disorder with the intervention of genetic vulnerability factors. To help the identification of these genetic factors and to improve genotype-phenotype correlation, the identification of endophenotype through the exploration of vulnerability characteristics in unaffected first degree relatives have been recommended. For this purpose, the investigator include bipolar patients, unaffected first degree relatives and control subjects to perform genetic association studies and subphenotype analyses. In this study the investigator will focus on subgroups defined according to the existence of abnormal circadian rhythm (a major indicator of bipolar vulnerability).

Lithium is the leading treatment of bipolar disorders but prophylactic lithium response is highly variable and difficult to predict due to lack of biomarkers of response. To explore lithium response variability and to identify biomarkers of response, the investigator characterise lithium response using "ALDA" scale to conduct pharmacogenetic studies and pharmacokinetic studies of lithium extended release, in the subpopulation of patients treated with lithium. As lithium is a circadian agent, the investigator will also explore the links between lithium response and circadian phenotypes. Finally, using Li7 magnetic spectroscopy, the investigator will compare lithium brain distribution in a small sample of good and partial responders to lithium.

ReferenceCitation: Loftus J, Scott J, Vorspan F, Icick R, Henry C, Gard S, Kahn JP, Leboyer M, Bellivier F, Etain B. Psychiatric comorbidities in bipolar disorders: An examination of the prevalence and chronology of onset according to sex and bipolar subtype. J Affect Disord. 2020 Apr 15;267:258-263. doi: 10.1016/j.jad.2020.02.035. Epub 2020 Feb 19.

family: Loftus

full_name: J. Loftus

given: J.

family: Scott

full_name: J. Scott

family: Vorspan

full_name: F. Vorspan

given: F.

family: Icick

full_name: R. Icick

given: R.

family: Henry

full_name: C. Henry

given: C.

family: Gard

full_name: S. Gard

given: S.

family: Kahn

full_name: J.P. Kahn

family: Leboyer

full_name: M. Leboyer

given: M.

family: Bellivier

full_name: F. Bellivier

family: Etain

full_name: B. Etain

given: B.

journal_name: Journal of Affective Disorders

ReferenceCitation: Geoffroy PA, Micoulaud Franchi JA, Maruani J, Philip P, Boudebesse C, Benizri C, Yeim S, Benard V, Brochard H, Leboyer M, Bellivier F, Etain B. Clinical characteristics of obstructive sleep apnea in bipolar disorders. J Affect Disord. 2019 Feb 15;245:1-7. doi: 10.1016/j.jad.2018.10.096. Epub 2018 Oct 9.

family: Geoffroy

full_name: Pierre A. Geoffroy

given: Pierre A.

family: Micoulaud Franchi

full_name: Jean-Arthur Micoulaud Franchi

given: Jean-Arthur

family: Maruani

full_name: Julia Maruani

given: Julia

family: Philip

full_name: Pierre Philip

given: Pierre

family: Boudebesse

full_name: Carole Boudebesse

given: Carole

family: Benizri

full_name: Chloé Benizri

given: Chloé

family: Yeim

full_name: Sunthavy Yeim

given: Sunthavy

family: Benard

full_name: Victoire Benard

given: Victoire

family: Brochard

full_name: Helena Brochard

given: Helena

full_name: Marion Leboyer

given: Marion

full_name: Frank Bellivier

given: Frank

ReferenceCitation: Richard-Lepouriel H, Kung AL, Hasler R, Bellivier F, Prada P, Gard S, Ardu S, Kahn JP, Dayer A, Henry C, Aubry JM, Leboyer M, Perroud N, Etain B. Impulsivity and its association with childhood trauma experiences across bipolar disorder, attention deficit hyperactivity disorder and borderline personality disorder. J Affect Disord. 2019 Feb 1;244:33-41. doi: 10.1016/j.jad.2018.07.060. Epub 2018 Aug 6.

repository_institution: University of Geneva - Archive ouverte UNIGE


title: Early Surgery for Patients With Asymptomatic Aortic Stenosis

acronym: ESTIMATE

summary: Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS) saves lives. However there is currently no direct evidence for this and most recommendations from the ESC/ EACTS or ACC/ AHA in this field are supported by Level-B or C evidence. Therefore, the investigators designed a randomized controlled trial to demonstrate whether early surgery improves mortality and morbidity of patients with asymptomatic severe AS and low operative risk.

ReferenceCitation: Monin JL, Lancellotti P, Monchi M, Lim P, Weiss E, Piérard L, Guéret P. Risk score for predicting outcome in patients with asymptomatic aortic stenosis. Circulation. 2009 Jul 7;120(1):69-75. doi: 10.1161/CIRCULATIONAHA.108.808857. Epub 2009 Jun 22.

ReferenceCitation: Farré N, Gómez M, Molina L, Cladellas M, Blé M, Roqueta C, Ascoeta MS, Comin-Colet J, Vila J, Bruguera J. Prognostic value of NT-proBNP and an adapted monin score in patients with asymptomatic aortic stenosis. Rev Esp Cardiol (Engl Ed). 2014 Jan;67(1):52-7. doi: 10.1016/j.rec.2013.06.020. Epub 2013 Oct 20.

ReferenceCitation: Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Epub 2014 Mar 3. Erratum in: J Am Coll Cardiol. 2014 Jun 10;63(22):2489. Dosage error in article text.

ReferenceCitation: Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS), Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schäfers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012 Oct;33(19):2451-96. doi: 10.1093/eurheartj/ehs109. Epub 2012 Aug 24.

ReferenceCitation: Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999 Jul 15;341(3):142-7.


title: Endoscopic Submucosal Dissection for the Treatment of Early Barrett's Neoplasia

acronym: ESTEBAN

summary: This study assesses the quality of the resection of early neoplasia arinsing in Barrett's esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection.

lead_sponsor: Hôpital Cochin


title: ADIposity and Bone Metabolism: Effects of eXercise-induced Weight Loss in Obese Adolescents

acronym: ADIBOX

summary:
The present protocol is mainly involved in the understanding of the local interaction between the released products by fat tissue and hormones production of bone tissue. These complex interactions between adipocyte and osteocyte activities could explain the mechanisms of the body responses to the strategies of weight loss that include diet and/or physical activity program, as well as the side effects encountered by these interventions.

Adolescence is a period of development characterized by many metabolic and somatic changes that may influence weight. Weights bearing physical activities are a key factor allowing body composition changes (i.e. fat and bone tissue). The difficulties of managing weight and the onset of overweight and obesity during this very important growth spurt lead to various hormonal dysregulation. The specific mechanisms of the evolution and interactions between these two parameters (fat and bone tissue) are not yet elucidated; therefore our aim is to analyze the possible connections between fat tissue and the quality of the skeleton in order to reduce related risks of the consequence of weight loss in obese individuals.

ReferenceCitation: Chaplais E, Dutheil F, Naughton G, Greene D, Pereira B, Thivel D, Courteix D. Cross-sectional and longitudinal study protocols of the 'ADIposity and BOne metabolism: effects of eXercise-induced weight loss in obese adolescents' (ADIBOX) project. BMJ Open. 2016 Oct 18;6(10):e011407. doi: 10.1136/bmjopen-2016-011407.

family: Chaplais

full_name: Elodie Chaplais

given: Elodie

family: Dutheil

full_name: Frédéric Dutheil

given: Frédéric

family: Naughton

full_name: Geraldine Naughton

given: Geraldine

family: Greene

full_name: David Greene

given: David

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Thivel

full_name: David Thivel

family: Courteix

full_name: Daniel Courteix

given: Daniel

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: Australian Catholic University - Research Bank

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Cross-sectional and longitudinal study protocols of the ‘ADIposity and BOne metabolism: effects of eXercise-induced weight loss in obese adolescents’ (ADIBOX) project

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Radiation


title: Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis

acronym: PERFECT

summary: The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to validate the accuracy of this technique with metabolic intestinal cells changes.

ReferenceCitation: Diana M, Noll E, Diemunsch P, Dallemagne B, Benahmed MA, Agnus V, Soler L, Barry B, Namer IJ, Demartines N, Charles AL, Geny B, Marescaux J. Enhanced-reality video fluorescence: a real-time assessment of intestinal viability. Ann Surg. 2014 Apr;259(4):700-7. doi: 10.1097/SLA.0b013e31828d4ab3.

ReferenceCitation: Diana M, Halvax P, Dallemagne B, Nagao Y, Diemunsch P, Charles AL, Agnus V, Soler L, Demartines N, Lindner V, Geny B, Marescaux J. Real-time navigation by fluorescence-based enhanced reality for precise estimation of future anastomotic site in digestive surgery. Surg Endosc. 2014 Nov;28(11):3108-18. doi: 10.1007/s00464-014-3592-9. Epub 2014 Jun 10.

ReferenceCitation: Diana M, Dallemagne B, Chung H, Nagao Y, Halvax P, Agnus V, Soler L, Lindner V, Demartines N, Diemunsch P, Geny B, Swanström L, Marescaux J. Probe-based confocal laser endomicroscopy and fluorescence-based enhanced reality for real-time assessment of intestinal microcirculation in a porcine model of sigmoid ischemia. Surg Endosc. 2014 Nov;28(11):3224-33. doi: 10.1007/s00464-014-3595-6. Epub 2014 Jun 17.

ReferenceCitation: Diana M, Agnus V, Halvax P, Liu YY, Dallemagne B, Schlagowski AI, Geny B, Diemunsch P, Lindner V, Marescaux J. Intraoperative fluorescence-based enhanced reality laparoscopic real-time imaging to assess bowel perfusion at the anastomotic site in an experimental model. Br J Surg. 2015 Jan;102(2):e169-76. doi: 10.1002/bjs.9725.

ReferenceCitation: Boni L, David G, Mangano A, Dionigi G, Rausei S, Spampatti S, Cassinotti E, Fingerhut A. Clinical applications of indocyanine green (ICG) enhanced fluorescence in laparoscopic surgery. Surg Endosc. 2015 Jul;29(7):2046-55. doi: 10.1007/s00464-014-3895-x. Epub 2014 Oct 11.

ReferenceCitation: D'Urso A, Agnus V, Barberio M, Seeliger B, Marchegiani F, Charles AL, Geny B, Marescaux J, Mutter D, Diana M. Computer-assisted quantification and visualization of bowel perfusion using fluorescence-based enhanced reality in left-sided colonic resections. Surg Endosc. 2021 Aug;35(8):4321-4331. doi: 10.1007/s00464-020-07922-9. Epub 2020 Aug 27.

family: D’Urso

full_name: Antonio D’Urso

given: Antonio

family: Agnus

full_name: Vincent Agnus

given: Vincent

family: Barberio

full_name: Manuel Barberio

given: Manuel

family: Seeliger

full_name: Barbara Seeliger

given: Barbara

family: Marchegiani

full_name: Francesco Marchegiani

given: Francesco

family: Charles

full_name: Anne-Laure Charles

given: Anne-Laure

family: Geny

full_name: Bernard Geny

given: Bernard

family: Marescaux

full_name: Jacques Marescaux

given: Jacques

family: Mutter

full_name: Didier Mutter

given: Didier

family: Diana

full_name: Michele Diana

given: Michele

journal_name: Surgical Endoscopy

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil


title: Study by Magnetic Resonance Imaging of the Modifications of the Vasoreactivity and Cerebral Connectivity in the Progressive Forms of Multiple Sclerosis

acronym: VASOSEP

summary: The goal of this study is to show pattern differences of vasoreactivity and connectivity between Progressive Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, by the use of methods of advanced brain MRIs and the Diffusion Tensor Imaging , and correlate these differences with Clinical disability and cognitive disorder results.

lead_sponsor: University Hospital, Montpellier

location_facility: Hopital Gui de Chauliac -Service de Neurologie


title: Prognostic Value of Myocardial Perfusion Heterogeneity in Normal Dual Isotope High Speed Myocardial Perfusion Imaging With a Semi Conductor Gamma Camera.

acronym: PROMETHE

summary:
Myocardial perfusion imaging is an efficient tool to assess the risk of major cardiac events for patients with known or suspected coronary artery disease. If the test is normal, or if the abnormalities of perfusion represent less than 10% of the left ventricle myocardium, the patient is considered at low risk and should be managed with optimal medical treatment only.

Recently, new gamma cameras using semi-conductor detectors have been developed. Their diagnostic performances have been demonstrated and confronted with various anatomical and functional reference techniques, such as coronary angiography and FFR. The prognostic value of a normal SPECT MPI has not been specifically assessed yet.

Coronary microvascular dysfunction (CMVD) has been demonstrated to be an early marker of coronary artery disease (CAD). Preliminary data suggest that myocardial perfusion heterogeneity (a potential surrogate marker of endothelial dysfunction) can be assessed on conventional MP-SPECT, but its additive and independent prognostic value over the presence of myocardial ischemia remain unknown.

Accordingly, the purpose of this study is :

To assess the prognostic value of a normal myocardial perfusion stress imaging using a semiconductor gamma camera with a dual isotope high speed protocol,
To evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new automatized image processing method, in normal SPECT MPIs.

The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD.

ReferenceCitation: Verma S, Buchanan MR, Anderson TJ. Endothelial function testing as a biomarker of vascular disease. Circulation. 2003 Oct 28;108(17):2054-9. Review.

ReferenceCitation: Schindler TH, Nitzsche EU, Schelbert HR, Olschewski M, Sayre J, Mix M, Brink I, Zhang XL, Kreissl M, Magosaki N, Just H, Solzbach U. Positron emission tomography-measured abnormal responses of myocardial blood flow to sympathetic stimulation are associated with the risk of developing cardiovascular events. J Am Coll Cardiol. 2005 May 3;45(9):1505-12.

ReferenceCitation: Johnson NP, Gould KL. Clinical evaluation of a new concept: resting myocardial perfusion heterogeneity quantified by markovian analysis of PET identifies coronary microvascular dysfunction and early atherosclerosis in 1,034 subjects. J Nucl Med. 2005 Sep;46(9):1427-37.

ReferenceCitation: Hachamovitch R, Hayes SW, Friedman JD, Cohen I, Berman DS. Comparison of the short-term survival benefit associated with revascularization compared with medical therapy in patients with no prior coronary artery disease undergoing stress myocardial perfusion single photon emission computed tomography. Circulation. 2003 Jun 17;107(23):2900-7. Epub 2003 May 27.

ReferenceCitation: Barone-Rochette G, Leclere M, Calizzano A, Vautrin E, Céline GC, Broisat A, Ghezzi C, Baguet JP, Machecourt J, Vanzetto G, Fagret D. Stress thallium-201/rest technetium-99m sequential dual-isotope high-speed myocardial perfusion imaging validation versus invasive coronary angiography. J Nucl Cardiol. 2015 Jun;22(3):513-22. doi: 10.1007/s12350-014-0016-0. Epub 2014 Nov 8.

family: Barone-Rochette

full_name: Gilles Barone-Rochette

given: Gilles

family: Leclere

full_name: Mélanie Leclere

given: Mélanie

family: Calizzano

full_name: Alex Calizzano

given: Alex

family: Vautrin

full_name: Estelle Vautrin

given: Estelle

family: Céline

full_name: Gallazzini-Crepin Céline

given: Gallazzini-Crepin

family: Broisat

full_name: Alexis Broisat

given: Alexis

family: Ghezzi

full_name: Catherine Ghezzi

given: Catherine

family: Baguet

full_name: Jean Philippe Baguet

given: Jean Philippe

family: Machecourt

full_name: Jacques Machecourt

family: Vanzetto

full_name: Gérald Vanzetto

given: Gérald

family: Fagret

full_name: Daniel Fagret

journal_name: Journal of Nuclear Cardiology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: University Hospital, Grenoble


title: Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption

summary: The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.

lead_sponsor: Pr Isabelle CONSTANT

location_facility: Departement d'anesthesie Hopital Armand Trousseau


title: Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial

acronym: MEMBO

summary: This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

location_facility: Service de Chirurgie Colorectale - Hôpital Beaujon


title: Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy

summary:
The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.

The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.

On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.

lead_sponsor: Centre Leon Berard


title: Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children

acronym: TAPPS

summary: Single-center prospective study to assess the clinical course of group A streptococcal blistering distal dactylitis in children after antibiotic treatment.

lead_sponsor: Camille JUNG


acronym: VINTAGE VHC

summary: The study consists to Identify viral variants involved in the transmission of hepatitis C and characterize the antigenic and functional properties of their envelope glycoproteins at very early stage of infection (before seroconversion).

lead_sponsor: University Hospital, Tours


title: Characterization of Ascending and Descending Auditory Processing Involved in the Encoding of Speech Sounds in Adult and Children: Variability Related to Changes in Sensory Input or a Neurodevelopmental Disorder or Targeted Remediation

acronym: PRODIPRICIDE

summary: The ability to encode the speech signal is determined by ascending and descending auditory processing. Difficulties in processing these speech signals are well described at the behavioral level in a specific language disorder. However, little is known about the underlying pathophysiological mechanisms. The assumption is that we should observe a degradation of the signal provided by the ear in the deaf subject while in case of specific language impairment it would be a phonemic disorder (possibly linked to a processing disorder auditory). The two population groups should therefore have different abnormalities of their central auditory process - which could be modified by the target remediation for each group.

lead_sponsor: Hospices Civils de Lyon

location_facility: Sercive d'Audiologie et d'Exploration Orofaciales, Hôpital Edouard Herriot, Hospices Civils de Lyon