title: Comparison of Breathing Pattern During PSV and NAVA

summary: Comparison of Breathing pattern during mechanical ventilation. Two modes of mechanical ventilation are compared (Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist)

ReferenceCitation: Meric H, Calabrese P, Pradon D, Lejaille M, Lofaso F, Terzi N. Physiological comparison of breathing patterns with neurally adjusted ventilatory assist (NAVA) and pressure-support ventilation to improve NAVA settings. Respir Physiol Neurobiol. 2014 May 1;195:11-8. doi: 10.1016/j.resp.2014.01.021. Epub 2014 Feb 5.

family: Meric

full_name: Henri Meric

given: Henri

family: Calabrese

full_name: Pascale Calabrese

given: Pascale

family: Pradon

full_name: Didier Pradon

given: Didier

family: Lejaille

full_name: Michèle Lejaille

given: Michèle

family: Lofaso

full_name: Frédéric Lofaso

given: Frédéric

family: Terzi

full_name: Nicolas Terzi

given: Nicolas

journal_name: Respiratory Physiology & Neurobiology

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: A Phase I/II Trial to Compare the Immunogenicity and Safety of 3 DNA C Prime Followed by 1 NYVAC C Boost to 2 DNA C Prime Followed by 2 NYVAC C Boost

summary: The purpose of the trial is to evaluate the effect upon immune system of two regimens of preventive HIV vaccination in healthy adult volunteers. Volunteers will be vaccinated by DNA-C and NYVAC-C vaccines, and the immune changes will be assessed, as well as safety of the vaccines. Volunteers will be followed during 72 weeks.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

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

location_country: France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois CHUV

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Completed


title: LUMIERE on the PLACENTA : A Study on the Added Value of MRI

acronym: FETUS

summary: The frequency of IUGR is between 3 and 10% of births. The etiologies and mechanisms of IUGR are multiple. The placental insufficiency, that is the defect of perfusion, is, however, the principal mechanism, far in front of other maternal or fetal causes. This placental insufficiency is also now recognized as an essential risk factor for cardiovascular and metabolic diseases, such as diabetes, in adulthood. The interest in understanding in utero development is thus further increased by the short-, medium- and long-term consequences of placental dysfunction. However, there are few ways to evaluate uteroplacental vascularization in vivo. MRI is an imaging technique used routinely in the exploration of the fetus in addition to ultrasound. Its safety on the fetus and the mother is largely demonstrated at 1.5T. There are also MRI sequences used daily in the clinic to evaluate perfusion and organ structure in children and adults (brain, kidney, heart, etc.). Their application for evaluation of perfusion and placental structure, although still confined to research, is very promising. The investigator's team has extensive experience, in animals or in children, in the use of these sequences that could be used to evaluate placental function in vivo. The ASL (Arterial Spin Labeling) in particular is the most encouraging functional imaging technique because it allows today to measure an organ blood flow quantitatively and without injection of contrast medium.

study_start_date_type: Anticipated

status: Withdrawn

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

status_simplified: Unknown


intervention_type: Drug

status: Terminated

study_start_date_type: Actual

lead_sponsor: Fresenius Kabi

primary_purpose: Supportive Care

location_country: Germany France Poland

location_facility: SP ZOZ Wojewódzki Szpital Zespolony im. J. Śniadeckiego

location_facility: Klinikum rechts der Isar, Klinik für Anaesthesiologie

location_facility: Hôpital Saint-Antoine, Département d'Anesthésie-Réanimation

type: EudraCT Number

source: euctr

title: Reaching Protein Target With SmofKabiven® Extra Nitrogen Versus Olimel N9E: A Prospective, Randomised, Active-controlled, Patient-blinded, Multicentre Clinical Trial During the Early Phase of Acute Critical Illness

summary: The main focus of the study is to show that SmofKabiven® extra Nitrogen, in a realistic clinical setting, enables to meet high protein requirements in patients during the first week after onset of critical illness, without risk of overfeeding with energy.

lead_sponsor_type: industriel


title: Evaluation of the Prevalence of an Hyperactivation of NCC Cotransporter Three Months After Kidney Transplantation in Recipients Treated by Calcineurin Inhibitors

acronym: MANGUE

summary: Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. However, prevalence of NCC activation by CNI is unknown. Our objective is to determine the prevalence of NCC activation three months after transplantation in patient treated by CNI.

lead_sponsor: University Hospital, Bordeaux

location_country: France Réunion

location_facility: Hopital Felix Guyon - Service d'Explorations Fonctionnelles Rénales

location_facility: Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse


ReferenceType: background

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ReferenceCitation: Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d. Review.

ReferenceCitation: Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b. Review.

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ReferenceCitation: Vesikari T, Wysocki J, Chevallier B, Karvonen A, Czajka H, Arsène JP, Lommel P, Dieussaert I, Schuerman L. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S66-76. doi: 10.1097/INF.0b013e318199f8ef.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country: Finland France Poland

ipd_sharing: Yes

title: To Assess the Safety, Reactogenicity & Immunogenicity of a 4th Dose of GSK Biologicals' Pneumococcal Vaccine or Prevenar™ in Children (12-18 Months) Previously Vaccinated in the Primary Study NCT00307554 With Either Pneumococcal Vaccine or Prevenar™

summary:
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (NCT00307554). The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™.

The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.


title: Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role?

acronym: EXP DIAL

summary: This study aims at evaluating, in chronic kidney disease patients on dialysis, the effect of acute per- or pre-dialytic physical exercise on regional myocardial function and myocardial stunning, blood viscosity, arterial stiffness, variability of sinus rhythm, dialysis efficacy, inflammation, mineral and bone disorders, myokines and cardiac remodeling markers.

status: Not yet recruiting

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: University Hospital, Montpellier

location_facility: Lapeyronie Hospital clinical trials Department

intervention_type: Procedure

status_simplified: Ongoing


title: Genes Modulating the Severity of Aortic Aneurysms (MSF1-TGFBR2)

summary:
This project concerns a population at risk of sudden death by dissection of the thoracic aorta. Its interest is to make it possible to recognize the genes that protect or worsen the evolution of aneurysms, to better understand the mechanisms involved, to detect and treat aneurysms of the thoracic aorta, wich is a pathology that is completely silent clinically until life-threatening complications.

The variability in the severity of the disease within the same family is related to modifier genes.

The objective is to find the modifying factors that account for the variability in the severity of the progression of aneurysms of the thoracic aorta.

lead_sponsor: French Cardiology Society


type: Other Identifier

title: Cell Signaling, Reinnervation and Metabolism in Kennedy Disease and Amyotrophic Lateral Sclerosis (ALS)

acronym: CERMALS

summary:
Amyotrophic lateral sclerosis (ALS), is a rapidly progressive neurodegenerative disorder, usually leading to death from respiratory failure in 3-5 years. Riluzole, the only drug currently available, only modestly prolongs survival and does not improve muscle strength or function. In ALS, loss of functional motor neurons is initially compensated for by collateral reinnervation and strength is preserved. In the majority of ALS patients, as the disease progresses, compensation fails leading to progressive muscle weakness. Conversely, in long-term ALS survivors, slow functional decline is correlated with their ability to maintain a successful compensatory response to denervation over time. Compensatory collateral reinnervation is thus essential for functional motor preservation and survival, and elucidation of the molecular mechanisms involved is crucial to help identify new therapeutic targets. Energy metabolism and glucose homeostasis modifications also influence disease clinical course but the mechanisms by which they contribute to the progression of ALS are unknown. Weight loss is an independent negative prognostic factor for survival and, by contrast, ALS risk and progression are decreased in individuals with high body mass index and non-insulin-dependent diabetes mellitus. Insulin shares many common steps in its signaling pathways with insulin-like growth factor 1 (IGF-1), and is thus at the interface between glucose homeostasis regulation and maintenance of muscle mass. However, the contribution of insulin signaling to preservation of muscle innervation and function in ALS has never been investigated.

With this study, we aim to determine the role of insulin signaling pathways in maintenance of collateral reinnervation and muscle function in ALS. We will also investigate the link with the disease-modifying effect of metabolic and glucose homeostasis perturbations, by identifying the contribution of metabolic profiles to preservation of skeletal muscle innervation and motor function in patients with ALS. For this purpose, we will determine the whole-body and skeletal muscle metabolic profiles of 20 patients with ALS and correlate these results to collateral reinnervation ability quantified on muscle biopsy specimens. For each patient, we will use both clinical and electrophysiological methods to evaluate motor function and motor neuron loss over time. Body composition, insulin secretion, insulin resistance level and serum concentrations of IGF-1 axis components will be determined. A motor point muscle biopsy will be performed for morphological analysis of neuromuscular junctions and quantification of innervation by confocal microscopy. Activation of insulin/IGF-1 canonical signaling pathways and metabolic pathways of glucose homeostasis will be quantified in muscle specimens. Skeletal muscle and whole-body metabolic parameters will be analyzed together and correlated with clinical assessment of motor function, electrophysiological data, and innervation quantification results. For comparison, 10 healthy subjects of similar age and 10 patients with spinal and bulbar muscular atrophy - a slowly progressive motor neuron disorder with maintenance of effective collateral reinnervation - will be used as controls. This study will be the first to address the question of the contribution of insulin signaling pathways and metabolic profiles in maintenance of muscle reinnervation and function in ALS patients. The molecular mechanisms identified will be new targets for future treatments promoting compensatory reinnervation and slowing disease progression in ALS. Ultimately, this translational project could have a significant therapeutic impact in disorders with muscle denervation and collateral reinnervation as a compensatory mechanism, such as spinal muscle atrophy or peripheral neuropathies.


title: Effects of Fluid Therapy on Peripheral TIssue Perfusion During Septic Shock

acronym: REPTILOS

summary: Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1

time_perspective: Cross-Sectional

ipd_sharing: Undecided

location_facility: Intensive care department, Hôpital Saint Antoine


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status: Recruiting

primary_purpose: Treatment

acronym: MIRACLE

location_facility: Gastroenterology Department of Saint Antoine Hospital

title: Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal

summary:
Crohn's disease (CD) is a chronic inflammatory bowel disease. CD pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota in predisposed hosts.

The purpose of this study is to evaluate de clinical efficacy of the fecal microbiota transplantation (FMT) as a maintenance treatment following anti-TNF agent withdrawal in CD's patient.


title: Non-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis

acronym: PROSTA-PAP

summary: The purpose of this study is to isolate and characterize tumor cells non-invasively from biological samples in patients with prostate cancer and demonstrate the ability to identify the presence and number of tumor cells before prostate biopsy.


acronym: REMOMEPO

title: Airway Remodeling Changes Induced by Mepolizumab in Severe Eosinophil Asthma

summary: Chronic airway changes, such as smooth muscle hypertrophy/hyperplasia, reticular basement membrane (RBM) thickening, goblet cells hyperplasia characterize severe asthma. Chronic inflammation, and especially eosinophilia and T2 cytokines are involved in these structural changes. The aim of this prospective observational study is to assess airway changes, assessed by bronchial biopsies before treatment, then after 6 months and 12 months, induced by mepolizumab in 40 severe asthma patients who will receive the treatment as part of their standard care. Changes in RBM thickening, in airway smooth muscle (ASM) area, in the number of PGP9 sections will be assessed on bronchial biopsies after 6 months and 12 months of mepolizumab treatment. Bronchoalveolar lavage (BAL) levels of inflammatory and remodeling mediators and of extra-cellular matrix (ECM) components will be measured after 6 months and 12 months of mepolizumab treatment. Relationship between clinical response to mepolizumab and remodeling changes after 6 months and 12 months will be assessed.


title: An Interventional, Phase II, Non Randomized, Mono-centric Study on the Clinical Efficacy and Safety of the Medical Device PAGETEX® as a Photodynamic Therapy Device in the Treatment of Extra-Mammary Paget's Disease of the Vulva (EMPV)

acronym: PAGETEX

summary:
Vulvar Paget's disease is a rare skin tumour which affect Caucasian post-menopausal women. The disease is revealed by erythematous, eczematous, pruritus and vulvar burns. The diagnosis is often late (from a few months to several years) because the symptoms are neglected by patients or misinterpreted by doctors. The reference treatment is based on surgical excision but unfortunately local recurrences are very frequent (17 to 38% of cases).

Photodynamic therapy (PDT) is already used in some dermatological pathologies and could therefore be an alternative treatment.

The objective of this study is to assess the efficacy and evaluate the safety of the new PDT device "PAGETEX" for the treatment of vulvar Paget's disease.

ReferenceType: derived

ReferenceCitation: Lecomte F, Thecua E, Ziane L, Deleporte P, Duhamel A, Maire C, Staumont-Salle D, Mordon S, Mortier L. Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study): Protocol for an Interventional Efficacy and Safety Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e15026. doi: 10.2196/15026.

apc_source: openAPC

family: Lecomte

full_name: Fabienne Lecomte

given: Fabienne

sequence: first

family: Thecua

full_name: Elise Thecua

given: Elise

sequence: additional

family: Ziane

full_name: Laurine Ziane

given: Laurine

family: Deleporte

full_name: Pascal Deleporte

given: Pascal

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Maire

full_name: Cyril Maire

given: Cyril

family: Staumont-Salle

full_name: Delphine Staumont-Salle

given: Delphine

family: Mordon

full_name: Serge Mordon

given: Serge

family: Mortier

full_name: Laurent Mortier

given: Laurent

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JMIR Research Protocols

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 OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

lead_sponsor: University Hospital, Lille

intervention_type: Device


title: Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial

acronym: REBALANCE-UC

summary:
Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease. UC pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota (called dysbiosis) in predisposed hosts.

The purpose of this study is to determine the effect of the fecal microbiota transplantation on UC.

ReferenceCitation: Ananthakrishnan AN. Epidemiology and risk factors for IBD. Nat Rev Gastroenterol Hepatol. 2015 Apr;12(4):205-17. doi: 10.1038/nrgastro.2015.34. Epub 2015 Mar 3. Review.

ReferenceCitation: Angelberger S, Reinisch W, Makristathis A, Lichtenberger C, Dejaco C, Papay P, Novacek G, Trauner M, Loy A, Berry D. Temporal bacterial community dynamics vary among ulcerative colitis patients after fecal microbiota transplantation. Am J Gastroenterol. 2013 Oct;108(10):1620-30. doi: 10.1038/ajg.2013.257. Epub 2013 Sep 24.

ReferenceCitation: Beaugerie L, Itzkowitz SH. Cancers Complicating Inflammatory Bowel Disease. N Engl J Med. 2015 Jul 9;373(2):195. doi: 10.1056/NEJMc1505689.

ReferenceCitation: Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology. 1976 Mar;70(3):439-44.

ReferenceCitation: Borody T, Fischer M, Mitchell S, Campbell J. Fecal microbiota transplantation in gastrointestinal disease: 2015 update and the road ahead. Expert Rev Gastroenterol Hepatol. 2015;9(11):1379-91. doi: 10.1586/17474124.2015.1086267. Epub 2015 Sep 28. Review.

ReferenceCitation: Colman RJ, Rubin DT. Fecal microbiota transplantation as therapy for inflammatory bowel disease: a systematic review and meta-analysis. J Crohns Colitis. 2014 Dec;8(12):1569-81. doi: 10.1016/j.crohns.2014.08.006. Epub 2014 Sep 13. Review.

ReferenceCitation: Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.

ReferenceCitation: D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lémann M, Marteau P, Rutgeerts P, Schölmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. Epub 2006 Dec 20. Review.

ReferenceCitation: Debast SB, Bauer MP, Kuijper EJ; European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014 Mar;20 Suppl 2:1-26. doi: 10.1111/1469-0691.12418.

ReferenceCitation: Grinspan AM, Kelly CR. Fecal Microbiota Transplantation for Ulcerative Colitis: Not Just Yet. Gastroenterology. 2015 Jul;149(1):15-8. doi: 10.1053/j.gastro.2015.05.030. Epub 2015 May 27.

ReferenceCitation: Kelly CR, Ihunnah C, Fischer M, Khoruts A, Surawicz C, Afzali A, Aroniadis O, Barto A, Borody T, Giovanelli A, Gordon S, Gluck M, Hohmann EL, Kao D, Kao JY, McQuillen DP, Mellow M, Rank KM, Rao K, Ray A, Schwartz MA, Singh N, Stollman N, Suskind DL, Vindigni SM, Youngster I, Brandt L. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol. 2014 Jul;109(7):1065-71. doi: 10.1038/ajg.2014.133. Epub 2014 Jun 3.

ReferenceCitation: Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G. Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook. Gastroenterology. 2015 Jul;149(1):223-37. doi: 10.1053/j.gastro.2015.05.008. Epub 2015 May 15. Review.

ReferenceCitation: Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):307-17. doi: 10.1038/nature10209. Review.

ReferenceCitation: Lamas B, Richard ML, Leducq V, Pham HP, Michel ML, Da Costa G, Bridonneau C, Jegou S, Hoffmann TW, Natividad JM, Brot L, Taleb S, Couturier-Maillard A, Nion-Larmurier I, Merabtene F, Seksik P, Bourrier A, Cosnes J, Ryffel B, Beaugerie L, Launay JM, Langella P, Xavier RJ, Sokol H. CARD9 impacts colitis by altering gut microbiota metabolism of tryptophan into aryl hydrocarbon receptor ligands. Nat Med. 2016 Jun;22(6):598-605. doi: 10.1038/nm.4102. Epub 2016 May 9.

ReferenceCitation: Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jørgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clément K, Doré J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium, Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.

ReferenceCitation: Lee CH, Steiner T, Petrof EO, Smieja M, Roscoe D, Nematallah A, Weese JS, Collins S, Moayyedi P, Crowther M, Ropeleski MJ, Jayaratne P, Higgins D, Li Y, Rau NV, Kim PT. Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):142-9. doi: 10.1001/jama.2015.18098.

location_facility: Service de Gastroentérologie et Nutrition Hôpital Saint Antoine


title: Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient

acronym: VASCIP

summary: Paraplegic patients have defective wound healing for sore below the level of spinal lesion. Defect of vascularization of the healing zone certainly participate to this effect. Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. the pressure between the patient body and the surface he/she is lying on) to assess the correlation between mechanical stress in term of pressure applied over time and tissue oxygenation which represent micro-vascular function. The aim of this clinical trial is to correlate the variations of pressure intensities and changes in micro-vascularization. The measure are recorded when paraplegic patient came into the hospital for pressure ulcer related surgery. The patient is laying on his/her mattress on top of a flexible pressure mapping device. The micro-vascularization parameters are measured at the area displaying the peak pressure a few minutes after the beginning of the pressure interface recording and one hour later at the same area. The data generated during this monocentric study will help to achieve a better understanding of the relation between pressure and micro-vascularization. In the mid term, it will provide a better and more patient adapted pressure ulcer prevention.

primary_purpose: Basic Science


title: Modulation of Lactase Expression by a New Synthetic PPARgamma Ligand in Ex-vivo Cultures of Duodenal Biopsies

summary: This study is designed to assess the effect of a new PPARgamma modulator on the expression and activity of the lactase enzyme in human intestinal epithelial cells. Based on their previous experimental results, the investigators hypothesized that modulating intestinal PPARgamma activity is a new pharmacological mechanism allowing the control of lactase expression and activity in the gut


title: DNA Methylation and Lung Disease in Cystic Fibrosis

acronym: METHYLCF

summary: Lung disease progression is variable among cystic fibrosis (CF) patients and depends on DNA mutations in the CFTR gene, polymorphic variations in disease-modifier genes and environmental exposure. The contribution of genetic factors has been extensively investigated, whereas the mechanism whereby environmental factors modulate the lung disease is unknown. Because these factors can affect the epigenome, investigators hypothesized that DNA methylation variations at disease-modifier genes modulate the lung function in CF patients.

ReferenceCitation: Magalhães M, Tost J, Pineau F, Rivals I, Busato F, Alary N, Mely L, Leroy S, Murris M, Caimmi D, Claustres M, Chiron R, De Sario A. Dynamic changes of DNA methylation and lung disease in cystic fibrosis: lessons from a monogenic disease. Epigenomics. 2018 Aug;10(8):1131-1145. doi: 10.2217/epi-2018-0005. Epub 2018 Jul 27.

name: Laboratoire de Génétique de Maladies Rares – EA7402 Montpellier University – Montpellier – France

name: Laboratory of Biological System Modeling – INCT/IDN, CDTS – Rio de Janeiro – Brazil

family: Magalhães

full_name: Milena Magalhães

given: Milena

name: Laboratory for Epigenetics & Environment – Centre National de Recherche en Génomique Humaine – CEA – Institut de Biologie François Jacob – Evry – France

family: Tost

full_name: Jörg Tost

given: Jörg

family: Pineau

full_name: Fanny Pineau

given: Fanny

name: Equipe de Statistique Appliquée – ESPCI Paris – PSL Research University – UMRS1158 – Paris – France

family: Rivals

full_name: Isabelle Rivals

given: Isabelle

family: Busato

full_name: Florence Busato

given: Florence

family: Alary

full_name: Nathan Alary

given: Nathan

name: CRCM, Renée Sabran Hospital – CHU Lyon – Hyères – France

family: Mely

full_name: Laurent Mely

name: CRCM, Pasteur Hospital – CHU Nice – Nice – France

family: Leroy

full_name: Sylvie Leroy

given: Sylvie

name: CRCM, Larrey Hospital – CHU Toulouse – Toulouse – France

family: Murris

full_name: Marlène Murris

given: Marlène

name: CRCM, Arnaud de Villeneuve Hospital – CHU Montpellier – Montpellier – France

family: Caimmi

full_name: Davide Caimmi

given: Davide

name: Laboratoire de Génétique Moléculaire – CHU Montpellier – Montpellier – France

family: Claustres

full_name: Mireille Claustres

given: Mireille

family: Chiron

full_name: Raphaël Chiron

given: Raphaël

family: De Sario

full_name: Albertina De Sario

given: Albertina

journal_name: Epigenomics

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd


title: Diagnostic Accuracy of Lung MRI to Detect Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis

acronym: MRAB

summary: In this diagnostic study, the aim is at evaluating the diagnostic accuracy of MRI (Magnetic Resonance Imaging) to detect allergic broncho-pulmonary aspergillosis in patients with cystic fibrosis.

lead_sponsor: Hôpital Haut Lévêque


title: Multicentric Observational National Analysis of Listeriosis and Listeria : Evaluation of the Neurological Consequences of Perinatal Listeriosis Infection

acronym: MONALISABABY

summary: The purpose of the study is to determine whether perinatal listeriosis is associated with long-term neurological consequences, and to evaluate the respective contribution of perinatal sepsis, of prematurity and of the known neurological tropism of the involved pathogen, Listeria monocytogenes.

design_allocation: Non-Randomized

primary_purpose: Diagnostic


title: Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis

acronym: TRANSTEATOSE

summary:
Hypothesis of this study is the existence of a relation between parameters measured by FibroScan® FS 502 according to our non invasive method and liver steatosis condition.

This proof of concept validation is made up of two steps:

Step 1: feasibility study of the method on 10 healthy volunteers
Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25 between 40-65 years-old) and on 25 patients whom cares including an liver biopsy et whom the histological answer is clean steatosis (NAFLD).

Experimental procedures consist in:

Fibroscan measure, preceded by tracking ultrasonography.
liver MRI (for substudy about MRI comparison, in step 2)
a blood test for biological assessment of liver functions

status: Unknown status

lead_sponsor: University Hospital, Tours


title: Genetic and Environmental Risk Factors of Type 1 Autoimmune Diabetes and Its Early Complications. French Multicentric Cohort of Diabetic Patients.

acronym: ISIS-DIAB

summary:
The aim of this study is to complete the identification of genetic factors (G) and to undertake the search of environmental factors (E) predisposing to type 1 diabetes (T1D) by constituting a cohort of 3500 T1D patients and a control cohort. We will use the base of G analysis (whole genome genotyping done once a patient using methods conually updated at Centre National de Genotype) and innovative E analysis to develop the following long term objectives :

Identify G and E factors influencing the process of remaining beta cells' destruction during the first 3 years after diagnosis (subgroup of T1D patients with a 0-3 years diabetes duration);
Identify G factors (pharmacogenomics) of the individual response to insulin using the effective insulin dose as a phenotype over a period of 2 years (subgroup of T1D patients with negative C-peptide and well managed diabetes);
Undertake a prospective research of G and E risk factors of "death in bed" syndrome in diabetic adolescents;
Undertake a prospective research of G and E risk factors of incipient glomerular microangiopathy (regule measurement of microalbuminuria).

ReferenceCitation: Balazard F, Le Fur S, Valtat S, Valleron AJ, Bougnères P; Isis-Diab collaborative group, Thevenieau D, Chatel CF, Desailloud R, Bony-Trifunovic H, Ducluzeau PH, Coutant R, Caudrelier S, Pambou A, Dubosclard E, Joubert F, Jan P, Marcoux E, Bertrand AM, Mignot B, Penformis A, Stuckens C, Piquemal R, Barat P, Rigalleau V, Stheneur C, Fournier S, Kerlan V, Metz C, Fargeot-Espaliat A, Reznic Y, Olivier F, Gueorguieva I, Monier A, Radet C, Gajdos V, Terral D, Vervel C, Bendifallah D, Signor CB, Dervaux D, Benmahammed A, Loeuille GA, Popelard F, Guillou A, Benhamou PY, Khoury J, Brossier JP, Bassil J, Clavel S, Le Luyer B, Bougnères P, Labay F, Guemas I, Weill J, Cappoen JP, Nadalon S, Lienhardt-Roussie A, Paoli A, Kerouedan C, Yollin E, Nicolino M, Simonin G, Cohen J, Atlan C, Tamboura A, Dubourg H, Pignol ML, Talon P, Jellimann S, Chaillous L, Baron S, Bortoluzzi MN, Baechler E, Salet R, Zelinsky-Gurung A, Dallavale F, Larger E, Laloi-Michelin M, Gautier JF, Guérin B, Oilleau L, Pantalone L, Lukas C, Guilhem I, De Kerdanet M, Wielickzo MC, Priou-Guesdon M, Richard O, Kurtz F, Laisney N, Ancelle D, Parlier G, Boniface C, Bockel DP, Dufillot D, Razafimahefa B, Gourdy P, Lecomte P, Pepin-Donat M, Combes-Moukhovsky ME, Zymmermann B, Raoulx M, Dumont AG. Association of environmental markers with childhood type 1 diabetes mellitus revealed by a long questionnaire on early life exposures and lifestyle in a case-control study. BMC Public Health. 2016 Sep 29;16(1):1021.


title: Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

acronym: TEDECAD

summary:
Explorative study on a medical device with two steps. The first pilot step will be on 8 patients (4 with lymphedema and 4 with venous insufficiency). The main objective is to assess the feasibility of measures by high resolution transient elastography on these pathologic skins, and to define 3 areas for measures.

The second step will be on 136 participants (48 healthy volunteers, 48 with venous insufficiency and 40 with unilateral lymphedema of a limb). The main objective is to quantify, by high resolution transient elastography, the dermal and hypodermal cutaneous fibrosis in limbs with lymphedema and venous insufficiency, and to compare it to healthy skin.


title: Differential Study of Muscle Transcriptome in Patients With Neuromuscular Disease and Control Subjects

acronym: TRANE

summary: To isolate biomarkers of ALS in muscle

location_facility: Centre d'évaluation Thérapeutique, Dr LACOMBLEZ


title: Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

summary: To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related hemorrhage).We hypothesize that patients with lobar hemorrhage (probably related to Cerebral Amyloid Angiopathy) will have a greater AV45 cortical binding than patients with deep hemorrhage (probably related to hypertension).

ReferenceCitation: Planton M, Pariente J, Nemmi F, Albucher JF, Calviere L, Viguier A, Olivot JM, Salabert AS, Payoux P, Peran P, Raposo N. Interhemispheric distribution of amyloid and small vessel disease burden in cerebral amyloid angiopathy-related intracerebral hemorrhage. Eur J Neurol. 2020 Aug;27(8):1664-1671. doi: 10.1111/ene.14301. Epub 2020 May 31.

name: Department of Neurology Toulouse University Hospital Toulouse France

name: Toulouse NeuroImaging Center Université de Toulouse Inserm, UPS Toulouse France

family: Planton

full_name: M. Planton

given: M.

family: Pariente

full_name: J. Pariente

given: J.

family: Nemmi

full_name: F. Nemmi

given: F.

family: Albucher

full_name: J‐F. Albucher

given: J‐F.

family: Calviere

full_name: L. Calviere

given: L.

family: Viguier

full_name: A. Viguier

given: A.

family: Olivot

full_name: J‐M. Olivot

given: J‐M.

name: Department of Nuclear Medicine Imaging Center Toulouse University Hospital Toulouse France

family: Salabert

full_name: A‐S. Salabert

given: A‐S.

family: Payoux

full_name: P. Payoux

given: P.

family: Peran

full_name: P. Peran

family: Raposo

full_name: N. Raposo

given: N.

journal_name: European Journal of Neurology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Interhemispheric distribution of amyloid and small vessel disease burden in cerebral amyloid angiopathy‐related intracerebral hemorrhage

ReferenceCitation: Planton M, Saint-Aubert L, Raposo N, Branchu L, Lyoubi A, Bonneville F, Albucher JF, Olivot JM, Péran P, Pariente J. High prevalence of cognitive impairment after intracerebral hemorrhage. PLoS One. 2017 Jun 1;12(6):e0178886. doi: 10.1371/journal.pone.0178886. eCollection 2017.

full_name: Mélanie Planton

given: Mélanie

family: Saint-Aubert

full_name: Laure Saint-Aubert

given: Laure

full_name: Nicolas Raposo

given: Nicolas

family: Branchu

full_name: Laura Branchu

given: Laura

family: Lyoubi

full_name: Aicha Lyoubi

given: Aicha

family: Bonneville

full_name: Fabrice Bonneville

given: Fabrice

full_name: Jean-François Albucher

given: Jean-François

full_name: Jean-Marc Olivot

given: Jean-Marc

family: Péran

full_name: Patrice Péran

given: Patrice


title: Neuro Anatomic Basis of Psychic Pain in Depression and Suicidal Behaviour

summary: Suicidal behaviour (SB) represents a major public health problem, costing life in more that one million people every year worldwide. Even if SB is considered as a consequence of social adversity and depression, these stress factors are often necessary but not sufficient to explain the occurrence of a suicidal act. A preliminary study suggests that an increased perception of psychic pain during a major depressive disorder increases the risk of suicide behaviour. The investigators aimed to investigate the relationship between social exclusion (a classic trigger of psychic pain) and SB and improve our knowledge about the physiopathology of this domain.


title: Selections of Subjects With Dramatic Changes in Their Cardiac Repolarization Parameters After a Pharmacologic Stimulus Aiming to Collect Their Skin Biopsy and Blood Cells

acronym: iQTEST

summary: The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.

ReferenceCitation: Stillitano F, Hansen J, Kong CW, Karakikes I, Funck-Brentano C, Geng L, Scott S, Reynier S, Wu M, Valogne Y, Desseaux C, Salem JE, Jeziorowska D, Zahr N, Li R, Iyengar R, Hajjar RJ, Hulot JS. Modeling susceptibility to drug-induced long QT with a panel of subject-specific induced pluripotent stem cells. Elife. 2017 Jan 30;6. pii: e19406. doi: 10.7554/eLife.19406.

name: Cardiovascular Research Center, Icahn School of Medicine at Mount Sinai, New York, United States

family: Stillitano

full_name: Francesca Stillitano

given: Francesca

name: Department of Pharmacology and Systems Therapeutics, Systems Biology Center, Icahn School of Medicine at Mount Sinai, New York, United States

family: Hansen

full_name: Jens Hansen

given: Jens

family: Kong

full_name: Chi-Wing Kong

given: Chi-Wing

family: Karakikes

full_name: Ioannis Karakikes

given: Ioannis

name: Sorbonne Universités, UPMC Univ Paris 06, AP-HP, INSERM, CIC-1421, Institute of Cardiometabolism and Nutrition, Paris, France

family: Funck-Brentano

full_name: Christian Funck-Brentano

given: Christian

family: Geng

full_name: Lin Geng

given: Lin

name: Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, United States

family: Scott

full_name: Stuart Scott

given: Stuart

family: Reynier

full_name: Stephan Reynier

given: Stephan

family: Wu

full_name: Ma Wu

given: Ma

family: Valogne

full_name: Yannick Valogne

given: Yannick

family: Desseaux

full_name: Carole Desseaux

given: Carole

family: Salem

full_name: Joe-Elie Salem

given: Joe-Elie

family: Jeziorowska

full_name: Dorota Jeziorowska

given: Dorota

family: Zahr

full_name: Noël Zahr

given: Noël

name: Ming Wai Lau Centre for Reparative Medicine, Karolinska Institutet, Stockholm, Sweden

name: Dr. Li Dak-Sum Centre, The University of Hong Kong – Karolinska Institutet Collaboration in Regenerative Medicine, Pokfulam, Hong Kong

family: Li

full_name: Ronald Li

given: Ronald

family: Iyengar

full_name: Ravi Iyengar

given: Ravi

family: Hajjar

full_name: Roger J Hajjar

given: Roger J

family: Hulot

full_name: Jean-Sébastien Hulot

given: Jean-Sébastien

bso_classification: Biology (fond.)

journal_name: eLife

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


type: Other Grant/Funding Number

title: Impact of a Proactive Strategy of Communication With Patients Hospitalized in ICU and Their Families With the Aim of Reducing Their Anxious and Depressive Symptoms and Their Post Traumatic Stress Symptoms

acronym: FAMIREAXV

summary: The investigators propose an interventional multicentric (23 ICUs) study measuring the impact of a consultation at the end of ICU stay for the patients and his/her families on the prevalence of symptoms of PTSD and anxiety or depression 3 months and one year after discharge. Patients will be randomly assigned to a intervention or control group. In the intervention group, the patient and his/her family will benefit from an conference by the intensivist at the end of the ICU stay, regarding information about the progress of his stay in ICU, his orientation after discharge, the possibility of consulting a GP, etc. Patients and proxies will be interviewed by phone three months and one year after discharge from ICU. Main instruments are Hospital Anxiety and Depression Scale, and Impact of Events Scale Revised.

intervention_type: Behavioral


title: Prospective Pilot Study Assessing Safety and Efficacy of Single Pass Albumin Dialysis in Patients With Acute on Chronic Liver Failure

acronym: DACAR

summary: The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.


title: Dosing of Antibiotics (Serum and Periprosthetic Tissues) During Reimplantation of Infected Knee and Hip Prostheses

acronym: DOSOS

summary: The purpose of the study is to evaluate the concentrations of antibiotics used as empirical treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee prostheses

lead_sponsor: Tourcoing Hospital

location_facility:
Dron Hospital
CHU
CHRU


title: Assessment of the Efficacy and Tolerance, and Health Economic Study of a Single Administration of Pegfilgrastim in Lymphoma or Myeloma Patients Treated With Intensive Chemotherapy and Autologous Peripheral Stem Cell Transplantation

acronym: PALM

summary:
The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred.

Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months.

The number of patients required in this multicentric and prospective study is 150 (13 participating centers).

This is a phase II, controlled, randomized, non comparative and open-label multicentric study.

lead_sponsor: Centre Leon Berard

location_facility:
CHU Angers
Centre Hospitalier Lyon Sud
CHU Tours - Hôpital Bretonneau
Hopital Edouard Herriot
CHU Toulouse - Hôpital Purpam
Hôpital Lapeyronnie
CHU Nantes
Centre Leon Berard
Centre Henri Becquerel
CHU Brest
Institut Gustave Roussy


title: Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.

summary: The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.

ReferenceCitation: Bartelmaos T, Chabanel A, Léger J, Villalon L, Gillon MC, Rouget C, Gomola A, Denninger MH, Tardivel R, Naegelen C, Courtois F, Bardiaux L, Giraudeau B, Ozier Y. Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas. Transfusion. 2013 Jun;53(6):1335-45. doi: 10.1111/j.1537-2995.2012.03895.x. Epub 2012 Sep 24.

family: Bartelmaos

full_name: Tonine Bartelmaos

given: Tonine

family: Chabanel

full_name: Anne Chabanel

given: Anne

family: Léger

full_name: Julie Léger

given: Julie

family: Villalon

full_name: Loïc Villalon

given: Loïc

family: Gillon

full_name: Marie Christine Gillon

given: Marie Christine

family: Rouget

full_name: Claude Rouget

given: Claude

family: Gomola

full_name: Alexandra Gomola

given: Alexandra

family: Denninger

full_name: Marie Hélène Denninger

given: Marie Hélène

family: Tardivel

full_name: René Tardivel

given: René

family: Naegelen

full_name: Christian Naegelen

family: Courtois

full_name: Françoise Courtois

given: Françoise

family: Bardiaux

full_name: Laurent Bardiaux

given: Laurent

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

family: Ozier

full_name: Yves Ozier

given: Yves

journal_name: Transfusion

lead_sponsor: Etablissement Français du Sang


title: Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker

acronym: DREAM

summary: The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.

lead_sponsor: LivaNova

location_country: France Spain


title: Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease

summary: This study evaluates the efficacity of Erickson hypnosis in the treatment of chronic pain in patients with Parkinson's disease. Half of participants will follow a 2-month Erickson hypnosis protocole, while the other half will benefit from the usual care.

location_facility:
Hôpital Roger Salengro, CHRU de Lille
Hopital Purpan Chu Toulouse
Hopital Charles Nicolle Chu Rouen
Chu Cote de Nacre


title: Segmentation of Structural Abnormalities in Chronic Lung Diseases

summary: Lung structural abnormalities are complex, time-consuming, and may lack reproducibility to evaluate visually on CT scans. The study's aim is to perform automated recognition of structural abnormalities in CT scans of patients with chronic lung diseases by using dedicated software.

status: Active, not recruiting

time_perspective: Other

ipd_sharing_description: Automated software measurements


title: Clinical Trial Comparing Neurologic Development of Temporal Voice Area in Cochlear Implanted Deaf Infant and in Normally Hearing Infant.

acronym: Implaneuro

summary:
Hypothesis At 12 months of age, the neurologic development of TVA of a non cochlear implanted profound congenital deaf infant would be different to the development of a normally hearing infant.

At 24 months of age, the neurologic development of TVA of deaf infant implanted before the age of 18 months would be similar to the development of a normally hearing infant.

Main aim The main aim of the research is to study, by means of functional near infrared spectroscopy (fNIRS), the neurologic development of the TVA at 24 months of age (+/- 1 month) in a group (n=40) of normally hearing infant and in a group (n=40) of profound congenital deaf children implanted before the age of 18 months.

Main outcome Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type. Comparison of the results between groups at 24 months of age +/- 1 month allows to analyse eventual differences.

Secondary aims and outcomes To study by means of functional near infrared spectroscopy the neurologic development of the temporal voice area at 12 months of age (+/- 1 month) in a group of normally hearing infant and in a group of profound congenital deaf infant wearing a standard hearing device between the age of 11 and 13 months and who will receive a cochlear implant between 12 and 18 months of age.

To study the association between fNIRS data and clinical data of the evaluation of comprehension of the spoken language at 24 months of age.

Methods Two groups of 40 infants matching in age will be constituted. Less than 13 months old children will be included during a medical consultation in the ENT department of Necker hospital after complete information of both parents. Written consent of both parents will be required. An audiophonological checking will be done.

Then a fNIRS examination will be programmed at the maternity of the Robert Debré hospital and done at the age of 12 months (+/- 1 month) and 24 months (+/-1 month). A fNIRS examination will be programmed at 36 months of age (+/- 1 month) for patinets included in the first year of the study.

This fNIRS examination measures the modifications in brain blood flow during the listening of human voice sound and environmental sound.

location_facility: Hôpital Necker Enfants malades Service d'ORL


title: Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

summary: The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.

ReferenceCitation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. Erratum in: Eur Heart J. 2016 Dec 30;:.

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

family: Voors

full_name: Adriaan A. Voors

given: Adriaan A.

family: Anker

full_name: Stefan D. Anker

given: Stefan D.

family: Bueno

full_name: Héctor Bueno

given: Héctor

family: Cleland

full_name: John G. F. Cleland

given: John G. F.

family: Coats

full_name: Andrew J. S. Coats

given: Andrew J. S.

family: Falk

full_name: Volkmar Falk

given: Volkmar

family: González-Juanatey

full_name: José Ramón González-Juanatey

given: José Ramón

family: Harjola

full_name: Veli-Pekka Harjola

given: Veli-Pekka

family: Jankowska

full_name: Ewa A. Jankowska

given: Ewa A.

family: Jessup

full_name: Mariell Jessup

given: Mariell

family: Linde

full_name: Cecilia Linde

given: Cecilia

family: Nihoyannopoulos

full_name: Petros Nihoyannopoulos

given: Petros

family: Parissis

full_name: John T. Parissis

given: John T.

family: Pieske

full_name: Burkert Pieske

given: Burkert

family: Riley

full_name: Jillian P. Riley

given: Jillian P.

family: Rosano

full_name: Giuseppe M. C. Rosano

given: Giuseppe M. C.

family: Ruilope

full_name: Luis M. Ruilope

given: Luis M.

family: Ruschitzka

full_name: Frank Ruschitzka

given: Frank

family: Rutten

full_name: Frans H. Rutten

given: Frans H.

family: van der Meer

full_name: Peter van der Meer

given: Peter

journal_name: European Heart Journal

oa_colors: green hybrid

evidence: open (via free pdf)

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. Epub 2005 Mar 7.

ReferenceCitation: Linde C, Abraham WT, Gold MR, St John Sutton M, Ghio S, Daubert C; REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008 Dec 2;52(23):1834-1843. doi: 10.1016/j.jacc.2008.08.027. Epub 2008 Nov 7.

journal_name: Journal of the American College of Cardiology

title: Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms

ReferenceCitation: Zeitler EP, Friedman DJ, Daubert JP, Al-Khatib SM, Solomon SD, Biton Y, McNitt S, Zareba W, Moss AJ, Kutyifa V. Multiple Comorbidities and Response to Cardiac Resynchronization Therapy: MADIT-CRT Long-Term Follow-Up. J Am Coll Cardiol. 2017 May 16;69(19):2369-2379. doi: 10.1016/j.jacc.2017.03.531.

ReferenceCitation: Healey JS, Hohnloser SH, Exner DV, Birnie DH, Parkash R, Connolly SJ, Krahn AD, Simpson CS, Thibault B, Basta M, Philippon F, Dorian P, Nair GM, Sivakumaran S, Yetisir E, Wells GA, Tang AS; RAFT Investigators. Cardiac resynchronization therapy in patients with permanent atrial fibrillation: results from the Resynchronization for Ambulatory Heart Failure Trial (RAFT). Circ Heart Fail. 2012 Sep 1;5(5):566-70. Epub 2012 Aug 14.

ReferenceCitation: Daubert C, Behar N, Martins RP, Mabo P, Leclercq C. Avoiding non-responders to cardiac resynchronization therapy: a practical guide. Eur Heart J. 2017 May 14;38(19):1463-1472. doi: 10.1093/eurheartj/ehw270. Review.

ReferenceCitation: Okamura H. Up-to-date cardiac resynchronization therapy. J Gen Fam Med. 2017 May 17;18(5):195-199. doi: 10.1002/jgf2.24. eCollection 2017 Oct. Review.

ReferenceCitation: Macías A, Gavira JJ, Alegría E, Azcárate PM, Barba J, García-Bolao I. [Effect of the left ventricular pacing site on echocardiographic parameters of ventricular dyssynchrony in patients receiving cardiac resynchronization therapy]. Rev Esp Cardiol. 2004 Feb;57(2):138-45. Spanish.

ReferenceCitation: Butter C, Auricchio A, Stellbrink C, Fleck E, Ding J, Yu Y, Huvelle E, Spinelli J; Pacing Therapy for Chronic Heart Failure II Study Group. Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients. Circulation. 2001 Dec 18;104(25):3026-9.

ReferenceCitation: Umar F, Taylor RJ, Stegemann B, Marshall H, Flannigan S, Lencioni M, De Bono J, Griffith M, Leyva F. Haemodynamic effects of cardiac resynchronization therapy using single-vein, three-pole, multipoint left ventricular pacing in patients with ischaemic cardiomyopathy and a left ventricular free wall scar: the MAESTRO study. Europace. 2016 Aug;18(8):1227-34. doi: 10.1093/europace/euv396. Epub 2015 Dec 30.

ReferenceCitation: Bonadei I, Vizzardi E, Gorga E, Carubelli V, Pagnoni M, Sciatti E, Raweh A, Cerini M, Bontempi L, Curnis A, Metra M. Role of the old and new echocardiographic technologies in cardiac resynchronization therapy. Minerva Cardioangiol. 2016 Oct;64(5):572-80. Epub 2015 Jun 23. Review.

ReferenceCitation: O'Brien T, Park MS, Youn JC, Chung ES. The Past, Present and Future of Cardiac Resynchronization Therapy. Korean Circ J. 2019 May;49(5):384-399. doi: 10.4070/kcj.2019.0114. Review.

ReferenceCitation: Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Calò L, Vicentini A, Concha JF, Thibault B. Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I. Eur Heart J. 2019 Sep 14;40(35):2979-2987. doi: 10.1093/eurheartj/ehz109.

name: Université de Rennes I, CICIT 804, Rennes, CHU Pontchaillou, Rennes, France

name: University of Geneva, Geneva, Switzerland

name: Università degli Studi di Brescia, Brescia, Italy

name: Isala Klinieken, Zwolle, The Netherlands

name: Hospital Universitario Infanta Cristina, Spain

name: Université de Montréal, Montreal, Canada

ReferenceCitation: Auricchio A, Heggermont WA. Technology Advances to Improve Response to Cardiac Resynchronization Therapy: What Clinicians Should Know. Rev Esp Cardiol (Engl Ed). 2018 Jun;71(6):477-484. doi: 10.1016/j.rec.2018.01.006. Epub 2018 Feb 14. Review. English, Spanish.

ReferenceCitation: Antoniadis AP, Behar JM, Sieniewicz B, Gould J, Niederer S, Rinaldi CA. A comparison of the different features of quadripolar left ventricular pacing leads to deliver cardiac resynchronization therapy. Expert Rev Med Devices. 2017 Sep;14(9):697-706. doi: 10.1080/17434440.2017.1369404. Epub 2017 Aug 23. Review.

ReferenceCitation: Tomassoni G, Baker J, Corbisiero R, Love C, Martin D, Niazi I, Sheppard R, Worley S, Beau S, Greer GS, Aryana A, Cao M, Harbert N, Zhang S; Promote® Q CRT-D and Quartet® Left Ventricular Heart Lead Study Group. Postoperative performance of the Quartet® left ventricular heart lead. J Cardiovasc Electrophysiol. 2013 Apr;24(4):449-56. doi: 10.1111/jce.12065. Epub 2013 Jan 22.

ReferenceCitation: Crossley GH, Biffi M, Johnson B, Lin A, Gras D, Hussin A, Cuffio A, Collier JL, El-Chami M, Li S, Holloman K, Exner DV. Performance of a novel left ventricular lead with short bipolar spacing for cardiac resynchronization therapy: primary results of the Attain Performa quadripolar left ventricular lead study. Heart Rhythm. 2015 Apr;12(4):751-8. doi: 10.1016/j.hrthm.2014.12.019. Epub 2014 Dec 19.

ReferenceCitation: Mittal S, Nair D, Padanilam BJ, Ciuffo A, Gupta N, Gallagher P, Goldner B, Hammill EF, Wold N, Stein K, Burke M. Performance of Anatomically Designed Quadripolar Left Ventricular Leads: Results from the NAVIGATE X4 Clinical Trial. J Cardiovasc Electrophysiol. 2016 Oct;27(10):1199-1205. doi: 10.1111/jce.13044. Epub 2016 Aug 19.

location_facility:
CHRU Hopital Trousseau
CHU de Clermont-Ferrand
CHU Pontchaillou
CHRU de Lille - Hôpital Cardiologique
CHU de Rouen


acronym: ENDEAVOR II

summary: To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in diameter.

ReferenceType: result

ReferenceCitation: Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Münzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8):798-806. Epub 2006 Aug 14.

ReferenceCitation: Mauri L, Massaro JM, Jiang S, Meredith I, Wijns W, Fajadet J, Kandzari DE, Leon MB, Cutlip DE, Thompson KP. Long-term clinical outcomes with zotarolimus-eluting versus bare-metal coronary stents. JACC Cardiovasc Interv. 2010 Dec;3(12):1240-9. doi: 10.1016/j.jcin.2010.08.021. Erratum in: JACC Cardiovasc Interv. 2011 Feb;4(2):260.

family: Mauri

full_name: Laura Mauri

given: Laura

family: Massaro

full_name: Joseph M. Massaro

given: Joseph M.

family: Jiang

full_name: Songtao Jiang

given: Songtao

family: Meredith

full_name: Ian Meredith

given: Ian

family: Wijns

full_name: William Wijns

given: William

family: Fajadet

full_name: Jean Fajadet

given: Jean

family: Kandzari

full_name: David E. Kandzari

given: David E.

family: Leon

full_name: Martin B. Leon

given: Martin B.

family: Cutlip

full_name: Donald E. Cutlip

given: Donald E.

family: Thompson

full_name: Kweli P. Thompson

given: Kweli P.

journal_name: JACC: Cardiovascular Interventions

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Long-Term Clinical Outcomes With Zotarolimus-Eluting Versus Bare-Metal Coronary Stents

ReferenceCitation: Remak E, Manson S, Hutton J, Brasseur P, Olivier E, Gershlick A. Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data. EuroIntervention. 2010 Feb;5(7):826-32.

ReferenceCitation: Eisenstein EL, Wijns W, Fajadet J, Mauri L, Edwards R, Cowper PA, Kong DF, Anstrom KJ. Long-term clinical and economic analysis of the Endeavor drug-eluting stent versus the Driver bare-metal stent: 4-year results from the ENDEAVOR II trial (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2009 Dec;2(12):1178-87. doi: 10.1016/j.jcin.2009.10.011.

family: Eisenstein

full_name: Eric L. Eisenstein

given: Eric L.

family: Edwards

full_name: Rex Edwards

given: Rex

family: Cowper

full_name: Patricia A. Cowper

given: Patricia A.

family: Kong

full_name: David F. Kong

given: David F.

family: Anstrom

full_name: Kevin J. Anstrom

given: Kevin J.

title: Long-Term Clinical and Economic Analysis of the Endeavor Drug-Eluting Stent Versus the Driver Bare-Metal Stent


title: Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Anti-Retroviral TX in HIV Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm(3) Who Have Received Anti-Retroviral TX

acronym: ILIADE

summary:
This study will examine whether interleukin-2 (IL-2) given before the interruption of antiretroviral (ARV) treatment could significantly extend the period of time that a patient is temporarily not taking ARV treatment and also preserve CD4 counts above 350 cells per microliter. There will be an evaluation of the toxicity, or extremely harmful effects, of ARV, and the effect on quality of life.

The use of ARV medications has greatly improved the condition and mortality of HIV-infected patients. But when used long term, those medications have been associated with great toxicities and medication fatigue. As a result, patients may not adhere to ARV use, and resistance to viruses may grow. The CD4 molecule is on the surface of helper T-lymphocytes, or T-helper cells. It serves as the primary receptor for HIV-1 and HIV-2, allowing the virus to gain entry into its host. The CD4 count increases immediately in response to ARV, giving an estimate of the state of a patient's immune system. Thus, it is a strong marker of the immediate risk of an opportunistic infection, one that takes advantage of a person's weakened immune system. IL-2 is a molecule naturally produced by activated T cells. In patients with HIV, IL-2 treatment can increase CD4 counts but the clinical importance of this increase is not clear. This study will compare the decline in CD4 count, when ARV is interrupted, in two random groups of participants: (1) those who will receive three cycles of IL-2 (one every 8 weeks) in combination with ARV therapy for the first 24 weeks of the study before stopping ARV and (2) those who will receive ARV therapy without IL-2 for 24 weeks before stopping ARV.

Patients 18 years of age or older who have HIV-1 infection and who have been on ARV therapy for at least 1 year, and who currently have a CD4 count 500 cells per microliter or higher and never had a CD4 count of less than 200 cells per microliter and a viral load less than the limit of detection, may be eligible for this study.

Participants will undergo the following procedures and tests:

Physical examination.
Blood tests to measure blood lipids (fats), sugar, complete blood count including platelets, and chemistries.
Assessment of fat distribution.
Questionnaire about quality of life.

In addition, those participants who are randomly placed in the group receiving IL-2 and ARV will get an echocardiogram at the beginning of the study and at week 24. They will receive a starting dose of 6 million units of IL-2 as an injection under the skin twice a day. Each of the three IL-2 cycles will last 5 days. After the 24-week period, participants in both groups will stop taking ARV medications if their CD4 count is still equal to or greater than 500 cells per microliter. The study will continue into 120 weeks. Participants will be asked to continue to visit the clinic every 8 weeks for evaluation of their viral load and CD4 counts. Every 24 weeks, they will be asked to answer a questionnaire about their quality of life. Blood tests and other measurements will also be done as follow-up.

ReferenceCitation: Arnó A, Ruiz L, Juan M, Jou A, Balagué M, Zayat MK, Marfil S, Martínez-Picado J, Martínez MA, Romeu J, Pujol-Borrell R, Lane C, Clotet B. Efficacy of low-dose subcutaneous interleukin-2 to treat advanced human immunodeficiency virus type 1 in persons with </=250/microL CD4 T cells and undetectable plasma virus load. J Infect Dis. 1999 Jul;180(1):56-60.

ReferenceCitation: Carr A, Emery S, Lloyd A, Hoy J, Garsia R, French M, Stewart G, Fyfe G, Cooper DA. Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol-modified interleukin-2 in human immunodeficiency virus-infected patients: a randomized, controlled, multicenter study. Australian IL-2 Study Group. J Infect Dis. 1998 Oct;178(4):992-9.

ReferenceCitation: Carr A, Cooper DA. Adverse effects of antiretroviral therapy. Lancet. 2000 Oct 21;356(9239):1423-30. Review.

lead_sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

location_country:
United States
France

location_facility: National Institutes of Health Clinical Center, 9000 Rockville Pike


title: A Dose Ranging Study Investigating the Efficacy and Safety of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma

summary: The purpose of this study is to investigate the efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with house dust mite-associated allergic asthma.

lead_sponsor: Stallergenes Greer

location_facility: NHC, Hôpitaux Universitaires de Strasbourg

location_facility: Universitätsmedizin Berlin - Allergie-Centrum-Charité

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi


title: A Two-period, Multicenter, Randomized, Open-label, Phase II Study Evaluating the Clinical Benefit of a Maintenance Treatment Targeting Tumor Molecular Alterations in Patients With Progressive Locally-advanced or Metastatic Solid Tumors

acronym: MOST plus

summary:
The MOST Plus study is a two-period phase II clinical trial, conducted in patients with all types of progressive solid tumors after at least 1 prior systemic treatment regimen for advanced disease (in the absence of a validated second line therapy).

The main goal of this study is to evaluate for these patients the clinical benefit of a maintenance treatment in patients with stable disease (SD) after induction treatment with a selected therapy (Molecular Targeted Therapy (MTT) or with SD, partial response (PR) or complete reponse (CR) with Immunotherapy (IT)).

For MTT, the first period of this trial (induction period) will enable to establish whether the identification of genomic alterations in genes encoding for "actionable" targets in the tumor cells, regardless of the histological subtype, can be used to select efficient treatment targeting the pathway activated by the mutation.

For Immunotherapy, induction period with durvalumab + tremelimumab is expected to be an innovative therapy for an efficient tumor control and may allow to identify types of cancer or molecular types of cancer that are more receptive to immunotherapy.

For all treatments, the second period (maintenance period) will use a randomized design to evaluate the clinical benefit of a maintenance treatment with the targeted therapy or immunotherapy selected based on tumor molecular profile in patients treated by MTT with SD and in patients treated by IT with SD, PR or CR.

Each patient enrolled will receive the matching targeted therapy during 12 weeks (MTT) or 52 weeks (IT). At the end of this induction period:

MTT cohorts :

patients with a tumor response (CR: complete response or PR: partial response) will continue the targeted therapy,
patients in progression will discontinue the targeted therapy and will be withdrawn from study and oriented towards standard treatments
patients with a stable disease at 12 weeks will be randomized in order to determine if they continue or stop the therapy.

IT cohort :

- patients with SD, PR or CR at 52 weeks will be randomized in order to determine if they continue or stop the therapy.

For each MTT treatment group: ~80 patients treated in the first step (induction period), 50 patients randomized in the second step (maintenance period, 25 patients per arm).

For IT treatment group: ~125 patients treated in the first step (induction period), 50 patients randomized in the second step (maintenance period, 25 patients per arm).

In total (for 7 treatment groups): ~ 600 patients treated in the induction period and 350 patients randomized in maintenance period.

location_facility:
Centre Hospitalier Lyon Sud
Institut Claudius Regaud
Institut Curie
Institut Paoli Calmettes
Centre Leon Berard
Institut Bergonié

intervention_type: Combination Product


title: Etude en Imagerie Par résonance magnétique Fonctionnelle et Structurelle Des mécanismes de Suppression mnésique Dans Les Troubles Obsessionnels Compulsifs

acronym: SUPTOC

summary: Mental-health conditions affect million people worldwide. The economic burden of mental illness is enormous and the economic health of both developing and developed nations will depend on controlling the staggering growth in costs from mental disorders. Obsessive-compulsive disorder (OCD) is a relatively common and frequent form of anxiety that affects approximately 2-3% of the population. OCD is characterized by anxiety, obsessions (persistent intrusive thoughts and images with highly distressing contents) and compulsions (repetitive activity), and severely impairs the lives of those affected. Despite their interest as effective and affordable care and rehabilitation, cognitive therapeutic profits too little from the increasing accumulation of knowledge in neuroscience, and neuroscientists pay too little attention to the challenges faced by clinical psychologists and psychiatrists. To reduce this cultural gap, two teams specialized in the study and multimodal imaging of healthy participants and clinical patients with mental health disorders, the UMR-S INSERM-EPHE-UNICAEN U1077 unit led by Francis Eustache, and ISTS team (UMR-S 6301 CNRS-CEA-UCBN) led by Sonia Dollfus, will joint their efforts to develop an integrated approach of the neural mechanisms at stake from basic neuroscience using state-of-art neuroimaging techniques, to novel and ground breaking psychological intervention. Both teams evolve at the brain imaging Cyceron center in Caen in connection with the Mental Health and Addictology Center, offering unique opportunities for such translational research. This project will capitalize on recent evidence showing that healthy participants can prevent unwanted images from entering consciousness using inhibitory control and memory suppression techniques, disrupting traces of the memories in sensory areas of the brain, and weakening their vividness and later reentrance. OCD is characterized by aberrant and excessive visual intrusions, usually extremely vivid, detailed, and unpleasant. These distressing images are particularly uncontrollable and may frequently initiate compulsive rituals. In a first phase of this proposal will use functional magnetic resonance imaging (fMRI) to develop a neurobiological model of the cognitive computations achieved by inhibition network to suppress memory. To achieve this goal we will develop an attentional model of healthy memory inhibition functioning, simulating the deployment of attentional resources and the different mental processes at stake during suppression. Using sophisticated analyzing tools of fMRI data, we will use this model to decode and infer the representational content of the brain inhibition network, and further refine the connectivity pathways which underlie such control. The lack of a strong neurobiological model prevents the development of therapies which would increase functionality of this network and optimize intervention aiming to disrupt mental intrusions and obsessions. In a second phase, we will assess whether memory suppression may be transferred and trained in OCD patients using images depicting their own obsessions, as a promising avenue to reduce their symptoms on the long run. In addition, fMRI and other brain structural acquisitions will be collected before and after cognitive training to memory suppression, offering a unique opportunity to observe the online dysfunction of intrusion control in OCD patients and to identify neurobiological markers predictive of training outcome and network reconfiguration with training. A fundamental goal of motivated forgetting involves not only to exclude unwelcome content from consciousness but also to reduce their later emotional impact by doing so. In parallel of these two main phases, we will thus also measure physiological markers of autonomic nervous system activity changes in response to suppressed images to better identify the consequences of memory suppression on emotional states, anxiety, and mental health in general.

lead_sponsor: University Hospital, Caen


title: Bone Marrow Transplantation HLA Haploidentical After a Reduced Intensity Conditioning and Prevention of GvHD Based on Post-transplant Cyclophosphamide Administration in Patients With Severe Sickle Cell Disease

acronym: DREPHAPLO

summary: multicentric interventional biomedical research phase II, prospective, non-randomized evaluating a haploidentical marrow transplants after reduced-intensity conditioning and prevention of GvHD based on cyclophosphamide administration post transplantation in patients with severe sickle cell disease.

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ReferenceCitation: Bolaños-Meade J, Fuchs EJ, Luznik L, Lanzkron SM, Gamper CJ, Jones RJ, Brodsky RA. HLA-haploidentical bone marrow transplantation with posttransplant cyclophosphamide expands the donor pool for patients with sickle cell disease. Blood. 2012 Nov 22;120(22):4285-91. doi: 10.1182/blood-2012-07-438408. Epub 2012 Sep 6.

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ReferenceCitation: Luznik L, O'Donnell PV, Symons HJ, Chen AR, Leffell MS, Zahurak M, Gooley TA, Piantadosi S, Kaup M, Ambinder RF, Huff CA, Matsui W, Bolaños-Meade J, Borrello I, Powell JD, Harrington E, Warnock S, Flowers M, Brodsky RA, Sandmaier BM, Storb RF, Jones RJ, Fuchs EJ. HLA-haploidentical bone marrow transplantation for hematologic malignancies using nonmyeloablative conditioning and high-dose, posttransplantation cyclophosphamide. Biol Blood Marrow Transplant. 2008 Jun;14(6):641-50. doi: 10.1016/j.bbmt.2008.03.005.

ReferenceCitation: McCurdy SR, Kanakry JA, Showel MM, Tsai HL, Bolaños-Meade J, Rosner GL, Kanakry CG, Perica K, Symons HJ, Brodsky RA, Gladstone DE, Huff CA, Pratz KW, Prince GT, Dezern AE, Gojo I, Matsui WH, Borrello I, McDevitt MA, Swinnen LJ, Smith BD, Levis MJ, Ambinder RF, Luznik L, Jones RJ, Fuchs EJ, Kasamon YL. Risk-stratified outcomes of nonmyeloablative HLA-haploidentical BMT with high-dose posttransplantation cyclophosphamide. Blood. 2015 May 7;125(19):3024-31. doi: 10.1182/blood-2015-01-623991. Epub 2015 Mar 26.

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ReferenceCitation: Bashey A, Zhang X, Jackson K, Brown S, Ridgeway M, Solh M, Morris LE, Holland HK, Solomon SR. Comparison of Outcomes of Hematopoietic Cell Transplants from T-Replete Haploidentical Donors Using Post-Transplantation Cyclophosphamide with 10 of 10 HLA-A, -B, -C, -DRB1, and -DQB1 Allele-Matched Unrelated Donors and HLA-Identical Sibling Donors: A Multivariable Analysis Including Disease Risk Index. Biol Blood Marrow Transplant. 2016 Jan;22(1):125-33. doi: 10.1016/j.bbmt.2015.09.002. Epub 2015 Sep 7.

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ReferenceCitation: Deotare U, Al-Dawsari G, Couban S, Lipton JH. G-CSF-primed bone marrow as a source of stem cells for allografting: revisiting the concept. Bone Marrow Transplant. 2015 Sep;50(9):1150-6. doi: 10.1038/bmt.2015.80. Epub 2015 Apr 27. Review.

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ReferenceCitation: Isola L, Scigliano E, Fruchtman S. Long-term follow-up after allogeneic granulocyte colony-stimulating factor--primed bone marrow transplantation. Biol Blood Marrow Transplant. 2000;6(4A):428-33.

ReferenceCitation: Ji SQ, Chen HR, Wang HX, Yan HM, Pan SP, Xun CQ. Comparison of outcome of allogeneic bone marrow transplantation with and without granulocyte colony-stimulating factor (lenograstim) donor-marrow priming in patients with chronic myelogenous leukemia. Biol Blood Marrow Transplant. 2002;8(5):261-7.

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ReferenceCitation: Serody JS, Sparks SD, Lin Y, Capel EJ, Bigelow SH, Kirby SL, Gabriel DA, Wiley JM, Brecher ME, Schell MJ, Folds J, Shea TC. Comparison of granulocyte colony-stimulating factor (G-CSF)--mobilized peripheral blood progenitor cells and G-CSF--stimulated bone marrow as a source of stem cells in HLA-matched sibling transplantation. Biol Blood Marrow Transplant. 2000;6(4A):434-40.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
Hospital Robert-Debré
intercommunal hospital of Créteil
CHU Henri-Mondor
CHU Strasbourg
CHU La Timone
Saint-Louis hospital
Hospital Necker


title: Genetic Characteristics and Determinants of Central Sensitization of Nociception in Fibromylagic Syndrome

acronym: FIDGIS

summary:
Fibromyalgia syndrome (FS) is characterized by widespread pain and affect 0.5 to 5 % of the general population, with a higher prevalence in women. Recognized as disease by World Health Organization since 1992, FS concern 1.2 to 2 million of French people and his etiology need to be clarified. This affection is characterized by a higher sensitivity to nociceptive stimulus, articular and muscular pain and associated to: fatigue, headache, sleep disorders, depression and irritated bowel syndrome. The presentation of this symptoms varied according to the patient with a heterogeneity of the clinical, physical, social and psychologic conditions and of the therapeutic responses.

Faced to the heterogeneity of FS, various hypotheses about the development mechanisms exist. Central sensitization could be one of the key mechanisms of FS, it is described as a loss of the natural balance between the transmission of a painful stimulus to the central nervous system and pain-inhibiting mechanisms, which results in permanent or chronic pain.

Moreover, work on the familial character of FS suggests that a genetic component may be involved in its development, but the identification of a genetic determinant is difficult given the multifactorial nature and complexity of FS.

The objective of this study is to characterize the predispositions of central sensitization and genetics in patients with FS compared to a control group, matched in age, sex and menopausal status.

lead_sponsor: University Hospital, Clermont-Ferrand