title: Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis

acronym: BIOLUVE

summary:
Toxoplasmosis affects one to two newborn each 10000 births. Among them, 1 to 2 % develop learning disabilities or die, and 4 to 27 % develop a chorioretinitis sometimes leading to an amblyopia responsible for visual impairment. Toxoplasmosis uveitis affects too adults immunocompetent and immunodepressed who have had an acquired toxoplasmosis. Clinical diagnosis of ocular toxoplasmosis is more complicated in presence of posterior neuro-retinitis, inflammation of the papilla, uveitis without chorioretinitis, fuchs heterochromic iridocyclitis, scleritis, diffuse necrotizing or multifocal retinitis. In this situation biological markers diagnostic and prognostic of toxoplasmosis uveitis are useful.

Highly kept molecules (during evolution) like stress proteins (Hsp) are are found in the host and the pathogen and there can trigger a crossed immune response. Stress proteins haven't been explored yet, in the context of toxoplasmosis uveitis on humans.

The hypothesis is that Hsp70 and antibodies anti-Hsp70 are diagnostic and prognostic markers of ocular toxoplasmosis.

The goal is to evaluate diagnosis value of biological markers (Hsp70 and antibodies IgG anti-Hsp70) in toxoplasmosis uveitis.

ReferenceCitation: Bonfioli AA, Orefice F. Toxoplasmosis. Semin Ophthalmol. 2005 Jul-Sep;20(3):129-41. doi: 10.1080/08820530500231961.

ReferenceCitation: Bouillet L, Sarrot-Reynauld F, Gonzalvez B, Massot C, Romanet J, Mouillon M. [Diagnostic strategy in uveitis: a prospective study in 125 cases]. J Fr Ophtalmol. 2000 Jun;23(6):569-75. French.

ReferenceCitation: Brenier-Pinchart MP, Morand-Bui V, Fricker-Hidalgo H, Equy V, Marlu R, Pelloux H. Adapting a conventional PCR assay for Toxoplasma gondii detection to real-time quantitative PCR including a competitive internal control. Parasite. 2007 Jun;14(2):149-54. doi: 10.1051/parasite/2007142149.

ReferenceCitation: Chen M, Aosai F, Norose K, Mun HS, Yano A. The role of anti-HSP70 autoantibody-forming V(H)1-J(H)1 B-1 cells in Toxoplasma gondii-infected mice. Int Immunol. 2003 Jan;15(1):39-47. doi: 10.1093/intimm/dxg004.

ReferenceCitation: Chumpitazi BF, Boussaid A, Pelloux H, Racinet C, Bost M, Goullier-Fleuret A. Diagnosis of congenital toxoplasmosis by immunoblotting and relationship with other methods. J Clin Microbiol. 1995 Jun;33(6):1479-85. doi: 10.1128/jcm.33.6.1479-1485.1995.

ReferenceCitation: Chumpitazi BF, Bouillet L, Drouet MT, Kuhn L, Garin J, Zarski JP, Drouet C. Biological autoimmunity screening in hepatitis C patients by anti-HepG2 lysate and anti-heat shock protein 70.1 autoantibodies. Eur J Clin Microbiol Infect Dis. 2009 Feb;28(2):137-46. doi: 10.1007/s10096-008-0599-y. Epub 2008 Aug 12.

ReferenceCitation: Delair E, Monnet D, Grabar S, Dupouy-Camet J, Yera H, Brezin AP. Respective roles of acquired and congenital infections in presumed ocular toxoplasmosis. Am J Ophthalmol. 2008 Dec;146(6):851-5. doi: 10.1016/j.ajo.2008.06.027. Epub 2008 Aug 23.

ReferenceCitation: Derouin F, Bultel C, Roze S. (Coordination rédactionnelle). Toxoplasmose: état des connaissances et évaluation du risque lié à l'alimentation. Rapport du groupe de travail " Toxoplasma gondii " de l'Afssa. Coordination éditoriale : Thomann C & Ribeiro F. AFSSA Déc. 2005, pp318.

ReferenceCitation: Desmonts G. Definitive serological diagnosis of ocular toxoplasmosis. Arch Ophthalmol. 1966 Dec;76(6):839-51. doi: 10.1001/archopht.1966.03850010841012. No abstract available.

ReferenceCitation: Direskeneli H, Saruhan-Direskeneli G. The role of heat shock proteins in Behcet's disease. Clin Exp Rheumatol. 2003 Jul-Aug;21(4 Suppl 30):S44-8.

ReferenceCitation: Echeverria PC, Matrajt M, Harb OS, Zappia MP, Costas MA, Roos DS, Dubremetz JF, Angel SO. Toxoplasma gondii Hsp90 is a potential drug target whose expression and subcellular localization are developmentally regulated. J Mol Biol. 2005 Jul 22;350(4):723-34. doi: 10.1016/j.jmb.2005.05.031.

ReferenceCitation: Fang H, Aosai F, Mun HS, Norose K, Ahmed AK, Furuya M, Yano A. Anaphylactic reaction induced by Toxoplasma gondii-derived heat shock protein 70. Int Immunol. 2006 Oct;18(10):1487-97. doi: 10.1093/intimm/dxl081. Epub 2006 Aug 30.

ReferenceCitation: Holland GN. Reconsidering the pathogenesis of ocular toxoplasmosis. Am J Ophthalmol. 1999 Oct;128(4):502-5. doi: 10.1016/s0002-9394(99)00263-9.

ReferenceCitation: Imamura Y, Kurokawa MS, Yoshikawa H, Nara K, Takada E, Masuda C, Tsukikawa S, Ozaki S, Matsuda T, Suzuki N. Involvement of Th1 cells and heat shock protein 60 in the pathogenesis of intestinal Behcet's disease. Clin Exp Immunol. 2005 Feb;139(2):371-8. doi: 10.1111/j.1365-2249.2005.02695.x.

ReferenceCitation: Kodjikian L, Wallon M, Fleury J, Denis P, Binquet C, Peyron F, Garweg JG. Ocular manifestations in congenital toxoplasmosis. Graefes Arch Clin Exp Ophthalmol. 2006 Jan;244(1):14-21. doi: 10.1007/s00417-005-1164-3. Epub 2005 May 20.

ReferenceCitation: Lyons RE, Johnson AM. Heat shock proteins of Toxoplasma gondii. Parasite Immunol. 1995 Jul;17(7):353-9. doi: 10.1111/j.1365-3024.1995.tb00902.x.

ReferenceCitation: Maubon D, Ajzenberg D, Brenier-Pinchart MP, Darde ML, Pelloux H. What are the respective host and parasite contributions to toxoplasmosis? Trends Parasitol. 2008 Jul;24(7):299-303. doi: 10.1016/j.pt.2008.03.012. Epub 2008 May 29.

ReferenceCitation: Pelloux H, Mouillon M, Romanet JP, Reynier P, Ligeon P, Goullier-Fleuret A, Ambroise-Thomas P. [Ocular toxoplasmosis. Comparison between two biological methods to study aqueous humor]. Presse Med. 1991 Oct 26;20(34):1655-8. French.

ReferenceCitation: Quintana FJ, Cohen IR. Heat shock proteins as endogenous adjuvants in sterile and septic inflammation. J Immunol. 2005 Sep 1;175(5):2777-82. doi: 10.4049/jimmunol.175.5.2777.

ReferenceCitation: SenGupta D, Norris PJ, Suscovich TJ, Hassan-Zahraee M, Moffett HF, Trocha A, Draenert R, Goulder PJ, Binder RJ, Levey DL, Walker BD, Srivastava PK, Brander C. Heat shock protein-mediated cross-presentation of exogenous HIV antigen on HLA class I and class II. J Immunol. 2004 Aug 1;173(3):1987-93. doi: 10.4049/jimmunol.173.3.1987.

ReferenceCitation: Silva NM, Gazzinelli RT, Silva DA, Ferro EA, Kasper LH, Mineo JR. Expression of Toxoplasma gondii-specific heat shock protein 70 during In vivo conversion of bradyzoites to tachyzoites. Infect Immun. 1998 Aug;66(8):3959-63. doi: 10.1128/IAI.66.8.3959-3963.1998.

ReferenceCitation: Wang XH, Qin Y, Hu MH, Xie Y. Dendritic cells pulsed with gp96-peptide complexes derived from human hepatocellular carcinoma (HCC) induce specific cytotoxic T lymphocytes. Cancer Immunol Immunother. 2005 Oct;54(10):971-80. doi: 10.1007/s00262-005-0662-9. Epub 2005 Jun 18.

intervention_type: Drug


title: Catalytic Antibodies to Predict Uninvasively Late Transplant Failure

acronym: CATAPULT

summary: Chronic Allograft Nephropathy (CAN), a major cause of late allograft failure, is characterized by a progressive decline in graft function correlating with tissue destruction. Recent data suggest that it may be possible to delay graft destruction if adequate management is initiated early (ie, at the stage of subclinical CAN). It is therefore essential to design new tests allowing physicians to predict transplant recipients prone to develop CAN

status: Completed

study_completion_date_type: Actual

study_type: Interventional

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care

acronym: BEACON

summary: The purpose of this study is to compare mechanical ventilation following advice from the Beacon Caresystem to that of routine care in patients from the state of requiring invasive mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to routine care to investigate whether use of the system results in similar care and reduced time for weaning from mechanical ventilation.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Device

status_simplified: Unknown


title: Orthopedic Digital Planning for Total Hip Arthroplasties

acronym: ORTHOPLAN

summary:
Preoperative planning has been carried out to allow for response preparedness . A layer technique is usually used with standard radiography .The investigators have a record of routine preoperative radiographs by standard recognized as having an advantage over the reproducibility of measurements compared with plain radiography . The Toulouse Hospitals have developed this technology and is part of the routine assessment of hip prothesis pre and postoperatively.

The TraumaCad software can superimpose implants on Picture Archiving and Communication System and evaluate digital and reproducible size of the implants and their correct position .

This is to demonstrate the superiority of modern digital tools in the preoperative preparation in Orthopaedics set.

primary_purpose: Treatment

lead_sponsor: University Hospital, Toulouse


title: Study of Mental Flexibility and Inhibition Processes as Cognitive Vulnerability Markers of Alcohol Dependence

acronym: CoVAD

summary: The purpose of this study is to specify the cognitive and genetic pattern associated with alcohol dependence. Results will help identifying more precisely vulnerability factors associated with this disorder.

status: Terminated

design_allocation: Non-Randomized

ReferenceType: background

ReferenceCitation: Gierski F, Hubsch B, Stefaniak N, Benzerouk F, Cuervo-Lombard C, Bera-Potelle C, Cohen R, Kahn JP, Limosin F. Executive functions in adult offspring of alcohol-dependent probands: toward a cognitive endophenotype? Alcohol Clin Exp Res. 2013 Jan;37 Suppl 1:E356-63. doi: 10.1111/j.1530-0277.2012.01903.x. Epub 2012 Dec 14.

ReferenceCitation: Benzerouk F, Gierski F, Gorwood P, Ramoz N, Stefaniak N, Hubsch B, Kaladjian A, Limosin F. Brain-derived neurotrophic factor (BDNF) Val66Met polymorphism and its implication in executive functions in adult offspring of alcohol-dependent probands. Alcohol. 2013 Jun;47(4):271-4. doi: 10.1016/j.alcohol.2013.03.001. Epub 2013 Apr 10.

ReferenceCitation: Raucher-Chene D, Gierski F, Hubsch B, Cuervo-Lombard CV, Bera-Potelle C, Cohen R, Kahn JP, Kaladjian A, Limosin F. Depression, anxiety and personality dimensions in female first-degree relatives of alcohol-dependent probands. Arch Womens Ment Health. 2012 Jun;15(3):229-32. doi: 10.1007/s00737-012-0271-5. Epub 2012 Mar 13.

ReferenceCitation: Benzerouk F, Gierski F, Raucher-Chene D, Ramoz N, Gorwood P, Kaladjian A, Limosin F. Association study between reward dependence and a functional BDNF polymorphism in adult women offspring of alcohol-dependent probands. Psychiatr Genet. 2015 Oct;25(5):208-11. doi: 10.1097/YPG.0000000000000099.

lead_sponsor: CHU de Reims

intervention_type: Genetic


title: Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Patients Carriers of Leg Ulcers

acronym: MecaSkin

summary: This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product) production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7) with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary biopsies are planned to be done in order to be transferred to laboratory. Then, the possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use for skin substitute production in clinical condition is evaluated (primary outcome).

ipd_sharing: Yes

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Procedure


title: Etude de Cohorte évaluant l'Impact de l'Association chimiothérapie et Bevacizumab en 1ère Ligne du Cancer Colorectal métastatique Sur la qualité de Vie Relative Des Patients. Etude COBEQOL

acronym: COBEQOL

summary: The primary aim of this french multicenter national study is to assess and compare time to quality of life score deterioration (targeted dimensions : global health, fatigue and emotional functionning of EORTC QLQC30 according to the first line chemotherapy associated with bevacizumab in metastatic colorectal patients.

study_type: Observational

time_perspective: Prospective

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: Calibration of a New Reflectance Oximeter.

summary:
This study is about the development of a new medical device for the monitoring of of sleep disordered breathing. This device is developed by the CEA-LETI-LE2S and will be composed of an oximeter, an actimeter in order to measure the activity level of the subject, his state of sleeplessness/sleep, and a CO2 partial pressure transcutaneous sensor (PtcCO2).

Developing this device is realized in several steps : a study (ALMOST) is already in progress and its goal is to acquire a database of polysomnography to create automatic algorithms in order to detect respiratory disorders with this device under development.

The main goal of the study is to calibrate the oxymeter under development.

ReferenceCitation: Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.

ReferenceCitation: Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. Physiol Rev. 2010 Jan;90(1):47-112. doi: 10.1152/physrev.00043.2008. Erratum In: Physiol Rev.2010 Apr;90(2):797-8.

ReferenceCitation: Chouri-Pontarollo N, Borel JC, Tamisier R, Wuyam B, Levy P, Pepin JL. Impaired objective daytime vigilance in obesity-hypoventilation syndrome: impact of noninvasive ventilation. Chest. 2007 Jan;131(1):148-55. doi: 10.1378/chest.06-1159.

ReferenceCitation: Becker HF, Piper AJ, Flynn WE, McNamara SG, Grunstein RR, Peter JH, Sullivan CE. Breathing during sleep in patients with nocturnal desaturation. Am J Respir Crit Care Med. 1999 Jan;159(1):112-8. doi: 10.1164/ajrccm.159.1.9803037.

ReferenceCitation: Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.

ReferenceCitation: Perrin C, Unterborn JN, Ambrosio CD, Hill NS. Pulmonary complications of chronic neuromuscular diseases and their management. Muscle Nerve. 2004 Jan;29(1):5-27. doi: 10.1002/mus.10487.

ReferenceCitation: Flemons WW, Reimer MA. Development of a disease-specific health-related quality of life questionnaire for sleep apnea. Am J Respir Crit Care Med. 1998 Aug;158(2):494-503. doi: 10.1164/ajrccm.158.2.9712036.

ReferenceCitation: Nitzan M, Romem A, Koppel R. Pulse oximetry: fundamentals and technology update. Med Devices (Auckl). 2014 Jul 8;7:231-9. doi: 10.2147/MDER.S47319. eCollection 2014.

ReferenceCitation: Mollard P, Bourdillon N, Letournel M, Herman H, Gibert S, Pichon A, Woorons X, Richalet JP. Validity of arterialized earlobe blood gases at rest and exercise in normoxia and hypoxia. Respir Physiol Neurobiol. 2010 Jul 31;172(3):179-83. doi: 10.1016/j.resp.2010.05.017. Epub 2010 May 21.

ReferenceCitation: Richalet JP, Larmignat P, Poitrine E, Letournel M, Canoui-Poitrine F. Physiological risk factors for severe high-altitude illness: a prospective cohort study. Am J Respir Crit Care Med. 2012 Jan 15;185(2):192-8. doi: 10.1164/rccm.201108-1396OC. Epub 2011 Oct 27.

ReferenceCitation: Savourey G, Launay JC, Besnard Y, Guinet-Lebreton A, Alonso A, Sauvet F, Bourrilhon C. Normo or hypobaric hypoxic tests: propositions for the determination of the individual susceptibility to altitude illnesses. Eur J Appl Physiol. 2007 May;100(2):193-205. doi: 10.1007/s00421-007-0417-8. Epub 2007 Feb 24.

ReferenceCitation: Aguilaniu B, Maitre J, Diab S, Perrault H, Peronnet F. Detection of disturbances in pulmonary gas exchanges during exercise from arterialized earlobe PO2. Respir Physiol Neurobiol. 2011 Jun 30;177(1):30-5. doi: 10.1016/j.resp.2011.03.005. Epub 2011 Mar 17.

lead_sponsor: University Hospital, Grenoble


title: Higher Percentage of CD34+ CD38- Cells Detected by Multiparameter Flow Cytometry From Leukapheresis Products Predicts Unsustained Complete Remission in Acute Myeloid Leukemia

summary:
Over recent decades, improvements have been made in the treatment of adult acute myeloid leukemia (AML). This has been mainly attributed to improvements in supportive therapy and to intensification of treatment strategies. The introduction of a post-induction myeloablative regimen followed by allogeneic stem cell transplant (SCT) has reduced the relapse rate in younger adults. However, this procedure is limited by the availability of human leukocyte antigen (HLA)-identical donors and conventional SCT preparative regimens according to patient age. In the absence of a compatible donor, myeloablative chemotherapy followed by autologous peripheral blood (PB) SCT remains one treatment strategy in adult patients with AML, allowing 35 - 50% long-term survivors. Despite several advantages of the CD34+ cell mobilization procedure, recent data have shown that relapse was higher and leukemia-free survival (LFS) shorter compared with bone marrow (BM) autografts. Higher doses of CD34+ peripheral blood stem cells (PBSCs) are collected to ensure engraftment and possibly reduce the incidence of treatment-related mortality (TRM). Although there is a threshold CD34+ cell dose below which engraftment is delayed in AML, the positive linear correlation of the number of CD34+ cells and kinetics of engraftment reaches a limit above which an increase in the number of progenitor cells does not provide any additional benefit. Relapse has been shown to be higher and survival shorter for those who receive the highest CD34+ PB doses. Although highly active against the leukemia bulk, intensive chemotherapy often spares the hardiest leukemia stem cells (LSCs) responsible for relapse. Detection of minimal residual disease (MRD) in autologous PBSC products may reflect inadequate in vivo purging, at least in part responsible for relapse. Although representing a heterogeneous cell population including both normal and leukemia cells, and despite that recent data have challenged the CD34+ CD38- phenotype of LSCs in AML, the CD34+ CD38- cell population generally remains considered enriched for LSCs.

In this setting, MRD remaining during morphological complete remission (CR) should be relatively enriched in CD34+ CD38- leukemia cells, and their persistence after CR achievement should correlate with disease recurrence. This was investigated in a cohort of 123 patients with AML following apheresis procedures after CR achievement. The investigators also studied the impact of the infused dose of subpopulations of CD34+ PB cells on the outcome of a subset of 71 patients who further underwent autologous PBSCT.

time_perspective: Retrospective

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet


title: Genetic Determinism of Epithelial Barrier Defects Induced by Increase in Proteases Activity in Irritable Bowel Syndrome

acronym: PROTIBS

summary: Irritable bowel syndrome (IBS) profoundly affects the quality of life. Mucosal micro-inflammation, epithelial permeability disorder and proteases activity increase have been demonstrated in the patients' gastrointestinal tract. Protease activity increase could be subjected to a genetic determinism (decrease in proteases inhibitors genes expression). Objectives: 1/ To study relations between proteases activity (in stool and colonic biopsies supernatants), proteases inhibitors genes expression and mucosal cellular infiltrate (IBS patients and healthy subjects). 2/ Establishing a correlation between proteases activity, mucosal micro-inflammation and symptoms. 3/ To evaluate proteases inhibitors therapeutic potential. Expected results: 1/ Decreased expression of proteases inhibitors genes in subjects with IBS. 2/ Correlation of symptoms with proteases activity intensity. 3/ Demonstration of restorative potential of proteases inhibitors.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Department of gastroenterology, Hopital Archet 2


title: Inappropriate Prescribing of Proton-pump Inhibitor is it Associated With the Burden of Comorbidities in Older Patients Over 75 Years Old ?

acronym: IPP SA

summary: Proton pump inhibitors (PPIs) are one of the most frequently prescribed classes of drugs in the world and the most effective drugs available to reduce gastric acid secretion. However, studies have shown that PPIs are not always prescribed with a clear indication. Indeed, between 25% and 86% of older individuals taking a PPI have been overprescribed these medications. In older patients, overprescribing of a PPI is associated with increases in morbidity, adverse drug events, hospitalization, and mortality. The hypothesis is that overprescription of PPIs is associated with the individual multimorbidities in older patients evaluated using the multimorbidities group criteria included in the CIRS. The aim of the present study was to establish a relationship between overprescribing of PPIs and multimorbidities in older patients.

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital


title: Evaluation and Modeling of the G-CSF Effect on the Evolution of Neutrophils During Chemotherapy Based on Eribulin

summary:
The anti-cancer cytotoxic chemotherapy is often the cause of neutropenia of grade IV or febrile neutropenia. Those neutropenia, in addition to being a comorbidity factor, result in dose reductions and/or temporary or permanent stop of chemotherapy, thus impacting clinical response. To avoid those episodes, or to shorten the duration and reduce the associated risk, administration of Granulocyte Colony Stimulating Factor (G-CSF) is recommended. Recombinant G-CSF reproduces the physiological effects of endogenous G-CSF by increasing the proliferation of granulocytes progenitors. Different forms of G-CSF are available: daily administration (such as filgrastim, lenograstim) and a single administration (pegfilgrastim).

Various international learned societies offer recommendations for primary care, secondary or curative neutropenia induced by chemotherapy based on G-CSF. However, guidance on the ideal time for the administration of growth factors and duration of administration are not very clear. If it seems clear that the treatment should not be initiated within the first 24 hours following administration of chemotherapy, summaries of the characteristics of different products do not provide evidence to optimize the administration day depending on the kinetics evolution of neutrophils. In addition, no information is given as to the choice of a formulation with respect to the other.

The pilot study the investigator propose aims to model the effect of exogenous G-CSF on the evolution of neutrophil function of time and explain the pharmacodynamic variability during the administration of chemotherapy based on eribulin. The description of the evolution of neutrophils when growth factors are administered give the opportunity to streamline administration regimens of these factors and to provide guidance on the circumstances in which they should or should not be given while weekly chemotherapy.

Expected benefits and foreseeable risks With the exception of surplus withdrawals during the first 2 cycles of treatment, this study will have no impact on the care of patients.

primary_purpose: Prevention

lead_sponsor: Centre Georges Francois Leclerc

lead_sponsor_type: industriel


title: Predictive Factors of Systolic Dysfunction in Non-complicated Hypertensive Patients (GLS OBservationAL Study in HyperTensioN - GLOBAL-HTN)

acronym: GLOBAL-HTN

summary: Hypertension is a major cardiovascular risk factor. Heart failure is one of its main complications but the factors that influence its development are still insufficiently known. The primary objective is to determine associated factors to the occurrence of left ventricular (LV) systolic dysfunction assessed by an alteration of the Global Longitudinal Strain (GLS) after more than the years of hypertension. The secondary objective is to estimate the prevalence of LV systolic dysfunction in a cohort of hypertensive people followed for over 10 years and formulate pathophysiological hypotheses on the development of this heart disease.

time_perspective: Other

lead_sponsor: University Hospital, Bordeaux


title: Enteric Nervous System in Alzheimer Disease

acronym: ENTEROMA

summary:
The close homology between the central and enteric nervous systems suggests that a disease process affecting the central nervous system could also involve its enteric counterpart. The investigators have recently shown in that the enteric neurons can be readily analyzed using routine colonic biopsies. This led us to propose that the enteric nervous system could represent a unique window to assess the neuropathology in living patients with a neurodegenerative disorder. The investigators have already used this approach to show that Parkinson's disease pathology was recapitulated in a single colonic biopsy. By contrast to Parkinson's disease, the detection of Alzheimer's disease (AD) pathology in the enteric neurons has so far failed. This may be due to the low number of human tissue samples in addition to the low sensitivity of the immunohistochemical methods that were used. The aim of the current research project will be therefore to reevaluate AD pathology in a large number of human colonic samples using both a morphological and biochemical approach .

The enteric nervous system could represent a unique window to assess the neuropathology in living patients with AD. This might open the way to the development of novel AD biomarkers that will directly assess the neuropathological process.

Main Aim : To Analyze the presence of beta-amyloid pathology in the enteric nervous system (ENS) in AD patients

Secondary Aim(s):

To analyze and describe the presence of tau in the enteric nervous system (ENS) in AD patients
To assess neuronal loss in submucosal tissue in AD patients.
To examine Glia cells in the enteric nervous system in AD patients..


type: Other Identifier

title: Genetic Susceptibility Factors Involved in Candidemia: Case-control Study.

summary: This is a prospective case-control physiopathological study, which main objective is to determine the genetic host factors predisposing to candidemia. Secondary objectives are to develop new diagnosis tools using the biological collection, to describe and update epidemiology, to analyse the influence of genetic polymorphisms on prognosis.

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Seventh Framework Programme
University of Lausanne Hospitals

location_facility: Hôpital Salengro, Intensive care departement, CHRU


title: Postoperative Cognitive Dysfunction After Intravenous Anesthesia or Closed-loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index for Noncardiac Surgery : a Randomized Monocenter Study

acronym: POCD ELA

summary:
Background: Postoperative cognitive dysfunction (POCD) in elderly patients after noncardiac surgery is a common problem.

Therefore,this study was designed to assess POCD after closed-loop coadministration of propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia in elderly patients undergoing major noncardiac surgery. Methods: After approval of the local ethical committee was obtained, 204 patients (American Society of Anesthesiologists physical status I-III; age, > 55 yr) undergoing surgery (duration, > 1 h) were enrolled into this pospective randomized monocenter study. Patients received anesthesia 3 days after using a neuropsychological test battery.

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Besch G, Vettoretti L, Claveau M, Boichut N, Mahr N, Bouhake Y, Liu N, Chazot T, Samain E, Pili-Floury S. Early post-operative cognitive dysfunction after closed-loop versus manual target controlled-infusion of propofol and remifentanil in patients undergoing elective major non-cardiac surgery: Protocol of the randomized controlled single-blind POCD-ELA trial. Medicine (Baltimore). 2018 Oct;97(40):e12558. doi: 10.1097/MD.0000000000012558.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health


title: Study Qbout the Screening of Niemann-Pick Disease, Type C in a Psychiatric Population

acronym: NPCPsy

summary:
Niemann-Pick disease, Type C is a rare genetic disorder characterized by a failing in intracellular cholesterol transport, inducing an accumulation of sphingolipids in the brain.

Neurological signs are at the forefront of the disease. There are also psychiatric signs of psychotic kind among 28 to 45 % of patients according to studies, and a thirty cases were published. These signs can be concomitant with neurological signs or precede them.

Is is likely that psychotic disorders are the first signs of a Niemann-Pick disease not yet non encore diagnosed for some patients. Yet, no prevalence study for this disease in a psychiatric population of patients currently exists. In response to this problem this study proposes to search patients whose disease could be of organic origin or patients whose disease is suspected, based on clinical data. The diagnosis will be confirmed certified with a genetic and/or biochemical test.

ReferenceCitation: Vanier MT. Niemann-Pick disease type C. Orphanet J Rare Dis. 2010 Jun 3;5:16. doi: 10.1186/1750-1172-5-16.

ReferenceCitation: NP-C Guidelines Working Group; Wraith JE, Baumgartner MR, Bembi B, Covanis A, Levade T, Mengel E, Pineda M, Sedel F, Topcu M, Vanier MT, Widner H, Wijburg FA, Patterson MC. Recommendations on the diagnosis and management of Niemann-Pick disease type C. Mol Genet Metab. 2009 Sep-Oct;98(1-2):152-65. doi: 10.1016/j.ymgme.2009.06.008. Epub 2009 Jun 14.

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ReferenceCitation: American Psychiatric Association - DSM IV TR, Manuel diagnostique et statistique des troubles mentaux, 4° édition, Texte révisé (Washington DC, 2000), Traduction française par J-D Guelfi et al., Masson, Paris, 2003, 1120 p.

intervention_type: Biological


title: Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients

acronym: EMOBISCHI

summary: In the case of psychotic disorders such as bipolar disorder or schizophrenia, attention dysfunction contribute, according to the theories of neuroscience, the development of mood disorders following disturbances in the interaction-care emotion. In this context, the general objective of this research project is to refine our understanding of the similarities and distinctions between bipolar and schizophrenic patients in the basic emotional information processing. Specifically, these are: 1) to better understand what level of basic emotional information processing both conditions differ or are comparable and in what sense and 2) estimate, in both pathologies, the specific influence of the nature of the task of processing emotional information. To answer these questions, the investigators have developed a protocol to specifically target different information processing channels playing on the nature of the spatial frequency content of emotional natural scenes. To estimate in both pathologies, the specific influence of the nature of the task on emotional processing, 3 types of tasks are proposed: 1) a simple task perception and 2) -3) two tasks whose categorization one focused on the emotional feelings of the individual and the other on the tendency to action. Both tasks categorization should involve more specifically the ventromedial prefrontal cortex (CPFVM) and the dorsolateral prefrontal cortex (DLPFC) respectively. All patient data will be compared with data from healthy control participants.


title: Multimodal Imaging Analysis of Tissue Changes Occurring During Treatment With Antiangiogenic (Bevacizumab) in Patients With Recurrent Glioblastoma

acronym: IMAGLIO

summary: The purpose of this study is to estimate the capacity of the multimodal imaging parameters measured at 15 days and 2 months of initiation of treatment with bevacizumab, to measure changes in clinical status (sensitivity to measure changes) in patients treated for recurrent glioblastoma.


title: A Randomized Controlled Double-blind Trial Assessing the Efficacy of a 400µg/kg Ivermectin /5% Permethrin / Emollient Cream Regimen in Patients With Crusted Scabies as Compared to a 200µg/kg Ivermectin /5% Permethrin /Emollient Cream Regimen

acronym: GALECRUSTED

summary: Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. Ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. However, response to ivermectin remains variable among studies, and there is no consensus on the schemes to adopt (dosages and administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of scabies (crusted and profuse).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: GALE CRUSTED

titre: Essai contrôlé randomisé en double insu évaluant l'efficacité de l'ivermectine à 400 µg/kg versus ivermectine à 200 µg/kg dans la gale hyperkératosique

discipline_principale: dermatologie

nom_porteur: PHAM

prenom_porteur: Giao


title: Search for New Mutations Genetic Predisposing to an Increased Risk Venous Thromboembolic Disease Idiopathic. Study "FIT GENETIQUE".

acronym: Fit-Génétique

summary: Identify new genetic mutations predisposing to an increased risk of VTE by locating and / or identifying genes involved in subjects at high risk for thrombotic and in whom screening for detectable hereditary thrombophilia was negative.

lead_sponsor: University Hospital, Brest


title: Biochip for HCMV Detection in Breast Milk From Lactating Women of Preterm Infants Less Than 33 Weeks

acronym: VIRUMILK

summary: Human cytomegalovirus (HCMV) is the leading cause of neonatal viral infection and can have a significant impact on the neurosensory development of newborns and especially preterm infants. HCMV infection may result from maternal-fetal transmission during pregnancy or postnatal transmission. While congenital HCMV infection affects about 2-5% of very preterm infants, the risk of postnatal infection, particularly through breast milk, is much higher in this population (prevalence of about 20%). Many learned societies wonder about the interest to inactivate HCMV (by freezing or pasteurization) in breast milk in order to reduce or eliminate contamination of these children. However, freezing is relatively inefficient to reduce contamination and pasteurization drastically alters the nutritional quality of the milk. Therefore, a systematic preventive treatment of breast milk for very preterm infants is not currently recommended. An alternative approach could consist in detecting HCMV in breast milk to target at-risk situations. This detection can be performed by PCR but its cost and the time required to obtain the result prohibits its use for a mass detection. Currently, viral status of breast milk is not explored in practice and, depending on the health centers, breastfeeding is continued as such or milk is systematically inactivated.The main objective of VIRUMILK is to study the feasibility of the CMV detection in breast milk from lactating mothers with a biochip.The ultimate goal is to prevent postnatal HCMV infection of preterm newborns less than 33 weeks.

time_perspective: Cross-Sectional


title: A Study to Characterize the Cardiac Phenotype of Individuals With Friedreich's Ataxia (CARFA Study)

summary:
Friedreich's ataxia (FA) is an autosomal recessive disease with an incidence of 1/50,000 in the Caucasian population. The main manifestations of FA are progressive sensory and cerebellar ataxia and cardiomyopathy (CM). It is the most common form of inherited ataxia. A severe CM affects ~60% of FA patients, mostly young adults, and leads to cardiac failure then death. Currently, no therapy can change the course of this severe cardiomyopathy.

This study is designed to characterize the cardiac manifestations of FA using cardiac magnetic resonance (CMR), echocardiography, serum cardiac biomarkers and evaluation of fatigue severity, in the context of the neurological disease.

lead_sponsor: Adverum Biotechnologies, Inc.

collaborators: Adverum Biotechnologies SAS, a wholly owned subsidiary of Adverum Biotechnologies, Inc.


title: What Benefit of a Full Analysis of Exome? Routine Care Study in Patients With Solid Tumors

acronym: EXOMA

summary:
The management of cancers and their therapeutic guidance was until shortly mostly based on histopathological considerations of the tumor. the development of targeted therapies is a turning point and keeps increase. These molecules target a specific molecular defect in the tumor making it more effective and more specific treatment. But these treatments are only effective if the tumor has a specific molecular abnormality that is characterized and known.

These therapeutic progresses have been made possible through the decoding of the human genome and the molecular defects occurring during the carcinogenesis process. Now, dozens of therapies targeting a specific molecular abnormality are available in the therapeutic arsenal and dozens more are under development in clinical trials Phase 1 to 3.

In recent years, the democratization of next generation sequencing has opened a new era in cancer research but also for molecular diagnostics. Indeed, the enormous sequencing capabilities offered by high-throughput sequencing technologies allow analysis in a limited time the entire coding sequence of the genome (exome), or even the entire genome of a tumor (whole genome sequencing). Thus, the evolution and the development of broadband and associated bioinformatics tools for genomics techniques now make it possible to establish the genetic profile of a tumor. Targeted diagnosis of molecular abnormalities and allows to propose and specifically targeted direct therapeutic identified genetic alterations and supposedly responsible for tumor development. An analysis of tumor exome by next-generation sequencing (NGS) and provides information on genetic modifications of these tumors.

This study did not aim to evaluate a therapeutic strategy or treatment. The objective of this study is to evaluate the clinical benefit of an analysis of exome performed in current practice at the Centre Georges-François Leclerc from Dijon. The analysis will be performed by quantifying the number of patients undergoing therapeutic proposal based on the results of the analysis of the profile of the tumor.

ReferenceCitation: Ratovomanana T, Cohen R, Svrcek M, Renaud F, Cervera P, Siret A, Letourneur Q, Buhard O, Bourgoin P, Guillerm E, Dorard C, Nicolle R, Ayadi M, Touat M, Bielle F, Sanson M, Le Rouzic P, Buisine MP, Piessen G, Collura A, Flejou JF, de Reynies A, Coulet F, Ghiringhelli F, Andre T, Jonchere V, Duval A. Performance of Next-Generation Sequencing for the Detection of Microsatellite Instability in Colorectal Cancer With Deficient DNA Mismatch Repair. Gastroenterology. 2021 Sep;161(3):814-826.e7. doi: 10.1053/j.gastro.2021.05.007. Epub 2021 May 13.

oa_host_type: repository

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

repository_normalized: HAL

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Elsevier


title: Brain Bases of Visual Perceptionnatural Scenes of Natural Scenes.

acronym: SCENES

summary:
Using the available data from psychophysics, cellular electrophysiology and functionnal neuroanatomy of visual pathway, current models of visual recognition suppose that the perception of scenes start with a parallel extraction of differents elementary visual characteristics to different spatial frequencies according to a default processing principle named : 'coarse-to-fine'.

According to this principle, the visual scene's analysis would be decomposed in two steps. Fisrt, the fast analysis of the global information borne by low frequency of the scene will provide an overview of the scene's structure and would enable a first perceptive categorisation which would be then refined, approved or denied by the latest analysis of the most local, detailed and precise information, carried by the very high spatial frequency of the scene.

The research carried out since several years is preparing a biologically plausible model and to find brain bases by different imaging techniques among healthy subjects but also patients with a brain lesion and patients with a peripheral lesion.

The main goal of this Magnetic Resonance Imaging study is to find brain bases of natural scenes's visual perception of the natural scenes.

Three studies in Magnetic Resonance Imaging will be conducted, during which subjects will have to categorize pictures of natural scenes filtered in spatial frequencies. The outcome of this study will allow to refine models of visual recognition, most of them based on analysis of spatial frequencies.

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ReferenceCitation: Epstein RA, Ward EJ. How reliable are visual context effects in the parahippocampal place area? Cereb Cortex. 2010 Feb;20(2):294-303. doi: 10.1093/cercor/bhp099. Epub 2009 May 20.

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ReferenceCitation: Hegde J. Time course of visual perception: coarse-to-fine processing and beyond. Prog Neurobiol. 2008 Apr;84(4):405-39. doi: 10.1016/j.pneurobio.2007.09.001. Epub 2007 Sep 29.

ReferenceCitation: Houde O, Pineau A, Leroux G, Poirel N, Perchey G, Lanoe C, Lubin A, Turbelin MR, Rossi S, Simon G, Delcroix N, Lamberton F, Vigneau M, Wisniewski G, Vicet JR, Mazoyer B. Functional magnetic resonance imaging study of Piaget's conservation-of-number task in preschool and school-age children: a neo-Piagetian approach. J Exp Child Psychol. 2011 Nov;110(3):332-46. doi: 10.1016/j.jecp.2011.04.008. Epub 2011 Jun 1.

ReferenceCitation: Hérault, J., Oliva, A., & Guérin-Dugué, A. (1997). Scene categorisation by curvilinear component analysis of low frequency spectra. Paper presented at the IANN'97, Bruges

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ReferenceCitation: Peyrin C, Chauvin A, Chokron S, Marendaz C. Hemispheric specialization for spatial frequency processing in the analysis of natural scenes. Brain Cogn. 2003 Nov;53(2):278-82. doi: 10.1016/s0278-2626(03)00126-x.

ReferenceCitation: Peyrin C, Chokron S, Guyader N, Gout O, Moret J, Marendaz C. Neural correlates of spatial frequency processing: A neuropsychological approach. Brain Res. 2006 Feb 16;1073-1074:1-10. doi: 10.1016/j.brainres.2005.12.051. Epub 2006 Jan 27.

ReferenceCitation: Peyrin C, Mermillod M, Chokron S, Marendaz C. Effect of temporal constraints on hemispheric asymmetries during spatial frequency processing. Brain Cogn. 2006 Dec;62(3):214-20. doi: 10.1016/j.bandc.2006.05.005. Epub 2006 Jul 11.

ReferenceCitation: Peyrin C, Michel CM, Schwartz S, Thut G, Seghier M, Landis T, Marendaz C, Vuilleumier P. The neural substrates and timing of top-down processes during coarse-to-fine categorization of visual scenes: a combined fMRI and ERP study. J Cogn Neurosci. 2010 Dec;22(12):2768-80. doi: 10.1162/jocn.2010.21424.

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title: Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1

acronym: ITHER

summary:
Recent scientific advances have shown the important role of immune system against cancer. Today, many immunological biotherapy like anti-PD1/PDL-1 are available in cancer treatment and generate durable clinical responses in some patients. The development of tools for monitoring anti-tumor immune responses dynamically is a major challenge to predict the effectiveness of immunotherapies anti-PD-1 and anti-PDL-1.

Thus, the objective of our study is to analyse the interest of the monitoring of anti-telomerase T helper 1 (TH1) responses in predicting the efficacy of immunotherapy, using an immunoassay developed by our group.

primary_purpose: Other


title: Development of a New Neuroimaging Method Aimed to Differentiate Mnesic Abilities of Alzheimer and Depressed Patients

acronym: RIHANNA

summary:
The purpose of this study is to use a new method to differentiate mnesic abilities of early alzheimer patients and patients with a depressive disorder.

This method is based on the recording of cerebral activity while patients listen to familiar, unfamiliar and newly-learned music.

ReferenceCitation: Gabriel D, Wong TC, Nicolier M, Giustiniani J, Mignot C, Noiret N, Monnin J, Magnin E, Pazart L, Moulin T, Haffen E, Vandel P. Don't forget the lyrics! Spatiotemporal dynamics of neural mechanisms spontaneously evoked by gaps of silence in familiar and newly learned songs. Neurobiol Learn Mem. 2016 Jul;132:18-28. doi: 10.1016/j.nlm.2016.04.011. Epub 2016 Apr 27.


title: Compact Biophotonic Platform for Drug Allergy Diagnosis

acronym: COBIOPHAD

summary:
The COBIOPHAD project targets the development of a highly sensitive, selective, and multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address the most prevalent drug hypersensitivity to betalactams antibiotics, (BLCs). During a retrospective study, BLC structures involved in drug hypersensitivity will be identified from sera of allergic patients (versus controls) and coupled on the device.

A prospective study will be performed for the recruitment of samples corresponding to patients with known IgE hypersensitivity to BLCs based on results from allergy tests and clinical history. Controls will include: non-allergic individuals with known tolerance to betalactams. The samples will be used for the validation of the COBIOPHAD device in real settings.

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
European Commission


title: Prospective Study Assessing Thyroidectomy Using Robot

acronym: EVATAR

summary:
The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in Asia and begins to spread in Western countries. The main advantage of the technique is to avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear to improve esthetic consequences and body image. It is not surgery minimally invasive but rather a way of remote access surgery.

Data from the literature including cohort studies and meta-analyzes attest the security of the procedure in comparison with classic thyroid surgery (which remains the "gold standard"). However there is few data on the effectiveness of the technique in terms of the completeness of the surgery, according to the routine standard criteria used in endocrinology and endocrine cancer, and no French medico-economic study has been performed.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity

acronym: NewBL

summary:
Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in the absence of contraindications), but there are no standardized protocols and most groups use hypothesis (clinically-driven) protocols.

investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171 patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they identified optimal doses to include in a data-driven protocol. This data-driven protocol will be applied to new prospective patients, to test its safety and benefits (gain in time, hospital and patient benefits).


title: Screening of Obstructive Sleep Apnea Syndrome in Residents of a Unit of Long-term Care Under Mixed Food

summary:
Obstructive sleep apnea is a condition that affects 40% to 62% of the population aged over 60 years with major consequences especially on the cardiovascular system.

This syndrome consists of a staff of the pharyngeal muscles. These muscles are also involved in swallowing phenomena and chews, or many elderly patients are subjected to a mixed diet, logically leading to atrophy of the muscles aerodigestive crossroads.

Muscle wasting ENT induced a mixed food could promote collapsibility of VAS, exposing the individual to a higher risk of apnea and hypopnea during sleep.

The objective of this study is to determine if there is a significant increase in the prevalence of obstructive sleep apnea syndrome in the elderly patients residing in long term care units, receiving a mixed food compared to residents in supply to normal texture.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


acronym: ACTARD

summary:
Oral anticoagulants are increasingly prescribed and the are not discontinued for invasive cardiac procedures .

Additional parenteral anticoagulation is necessary for these procedures (FA ablation and invasive coronary explorations).

The unfractionated heparin doses are adapted on a monitoring test heparin, activated clotting time (ACT) with the aim of obtaining and maintaining an ACT > 300-400 sec. This goal is the same whether the patient is on oral anticoagulant treatment or not, and regardless of the initial level of anticoagulation.

The effects of oral anticoagulants on routine coagulation tests (PT, APTT, TT) are well documented, but few data have been published on the effects of heparin monitoring tests, particularly on the ACT.

The aim of this stuy is to redefine the target values of ACT and unfractionated heparin doses to administer to optimize the efficacy / safety of invasive procedures in cardiology.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild


title: Biological Evaluation of a Novel Anti-inflammatory Treatment in Immune-mediated Inflammatory Diseases

acronym: Super-Bio

summary: The aim of the study is to investigate in vitro the impact of a novel anti-inflammatory treatment on costimulatory molecules expressed on monocytes.

status: Recruiting

status_simplified: Ongoing


title: Neuro Imaging and Multimodal Alzheimer's Disease

acronym: NIMAD

summary: The present study aimed at measuring cerebral changes in Alzheimer Disease (AD) patients, who responded to strict physiological criteria typical of AD pathology. The objective of the present study was to identify the earliest alterations in cerebral connections that could contribute to the initial episodic memory impairment.

ReferenceType: result

ReferenceCitation: Nemmi F, Saint-Aubert L, Adel D, Salabert AS, Pariente J, Barbeau EJ, Payoux P, Peran P. Insight on AV-45 binding in white and grey matter from histogram analysis: a study on early Alzheimer's disease patients and healthy subjects. Eur J Nucl Med Mol Imaging. 2014 Jul;41(7):1408-18. doi: 10.1007/s00259-014-2728-4. Epub 2014 Feb 27.

version: acceptedVersion

version: submittedVersion

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

publisher_dissemination: Springer

ReferenceCitation: Saint-Aubert L, Nemmi F, Peran P, Barbeau EJ, Payoux P, Chollet F, Pariente J. Comparison between PET template-based method and MRI-based method for cortical quantification of florbetapir (AV-45) uptake in vivo. Eur J Nucl Med Mol Imaging. 2014 May;41(5):836-43. doi: 10.1007/s00259-013-2656-8. Epub 2013 Dec 19.

oa_colors: green hybrid

evidence: open (via page says license)

unpaywall_oa_status: hybrid

ReferenceCitation: Saint-Aubert L, Barbeau EJ, Peran P, Nemmi F, Vervueren C, Mirabel H, Payoux P, Hitzel A, Bonneville F, Gramada R, Tafani M, Vincent C, Puel M, Dechaumont S, Chollet F, Pariente J. Cortical florbetapir-PET amyloid load in prodromal Alzheimer's disease patients. EJNMMI Res. 2013 Jun 3;3(1):43. doi: 10.1186/2191-219X-3-43.

intervention_type: Radiation


title: Assessment of a Cognitive-behavioral Group Intervention in Children With Diabetes Mellitus and Their Parents

acronym: DI-CO

summary: Diabetes mellitus in children and adolescents is a source of stress and poor quality of life for themselves and their family. Development of adaptive coping strategies may be improved by focused parent and children training. This study assesses a cognitive behavioral treatment (CBT) for children/adolescents with diabetes and their parents in comparison with standard health educational interventions. The investigators main aim is to verify that the CBT program improves overall balance of glycaemia better than phone contact without CBT content (control group). Secondary objectives are expected improvements of health-related quality of life and coping styles in parents and children.

primary_purpose: Supportive Care

intervention_type: Behavioral


title: Validation of a Scale of Well-Being Assessment (SIWA) in Patients With Alzheimer's Disease or a Related Disease.

acronym: SIWA

summary: Current scales are not suited to a direct measure for the elderly with cognitive disorders and are difficult to handle for the care teams. In this context, a visual analog scale was created to answer a single question "How are you feeling now, immediately?" with the help of pictograms. This study aims to assess the validity and reliability of the Scale of Well-Being Assessment (SIWA) (in french : Echelle d'Evaluation Instantanée du Bien-Etre (EVIBE)) in people with Alzheimer's disease or a related disease.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche Clinique " Vieillissement-Cerveau-Fragilité ", Hôpital des Charpennes, Hospices Civils de Lyon


title: Study of Anti-telomerase T CD4 Immunity in Melanoma: Predictive Biomarker and Implications for Immunotherapy

acronym: LyTéloMel

summary:
The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response might be required for their efficacy and highlight the critical role of antitumor T cell immunity.

Recent progresses on the field of tumor immunology underline the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.

In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators team have previously described novel promiscuous peptides (referred as UCP: Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.

By using UCP-based immuno-assay, UCP specific Th1 immune responses will be evaluated in this study in melanoma before and after treatment.

location_facility: Centre Hospitalier Régional Universitaire de Besançon


title: Work Package 4: HPV Vaccination of Women in Screening Ages

summary: The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.


title: Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

summary:
Analysis of 4 CSF Alzheimer's disease biomarkers (total and phosphorylated tau protein, Aß40 and Aß1-42) and morphological brain MRI in older patients (>60 year's old) with bipolar disorder, after an evaluation of their cognitive functions.

Comparison between two groups of patients : patients with cognitive disorders and patients without cognitive disorders.

The objective is to describe and compare the profile of those biomarkers in those two populations.

primary_purpose: Screening

ReferenceCitation: Ali SO, Denicoff KD, Altshuler LL, Hauser P, Li X, Conrad AJ, Smith-Jackson EE, Leverich GS, Post RM. Relationship between prior course of illness and neuroanatomic structures in bipolar disorder: a preliminary study. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Oct-Dec;14(4):227-32.

ReferenceCitation: Amieva H, Le Goff M, Millet X, Orgogozo JM, Peres K, Barberger-Gateau P, Jacqmin-Gadda H, Dartigues JF. Prodromal Alzheimer's disease: successive emergence of the clinical symptoms. Ann Neurol. 2008 Nov;64(5):492-8. doi: 10.1002/ana.21509.

ReferenceCitation: Augy Jennifer, Enjeux cliniques et évolutifs des troubles bipolaires. A partir d'une étude sur l'évaluation cognitive de patients bipolaires vieillissants. Thèse d'exercice. 2010.

ReferenceCitation: Bora E, Vahip S, Gonul AS, Akdeniz F, Alkan M, Ogut M, Eryavuz A. Evidence for theory of mind deficits in euthymic patients with bipolar disorder. Acta Psychiatr Scand. 2005 Aug;112(2):110-6. doi: 10.1111/j.1600-0447.2005.00570.x.

ReferenceCitation: Delaloye C, Moy G, Baudois S, de Bilbao F, Remund CD, Hofer F, Ragno Paquier C, Campos L, Weber K, Gold G, Moussa A, Meiler CC, Giannakopoulos P. Cognitive features in euthymic bipolar patients in old age. Bipolar Disord. 2009 Nov;11(7):735-43. doi: 10.1111/j.1399-5618.2009.00741.x. Epub 2009 Aug 28.

ReferenceCitation: Delaloye C, Moy G, de Bilbao F, Weber K, Baudois S, Haller S, Xekardaki A, Canuto A, Giardini U, Lovblad KO, Gold G, Giannakopoulos P. Longitudinal analysis of cognitive performances and structural brain changes in late-life bipolar disorder. Int J Geriatr Psychiatry. 2011 Dec;26(12):1309-18. doi: 10.1002/gps.2683. Epub 2011 Mar 10.

ReferenceCitation: Doring TM, Kubo TT, Cruz LC Jr, Juruena MF, Fainberg J, Domingues RC, Gasparetto EL. Evaluation of hippocampal volume based on MR imaging in patients with bipolar affective disorder applying manual and automatic segmentation techniques. J Magn Reson Imaging. 2011 Mar;33(3):565-72. doi: 10.1002/jmri.22473.

ReferenceCitation: Ewers M, Buerger K, Teipel SJ, Scheltens P, Schroder J, Zinkowski RP, Bouwman FH, Schonknecht P, Schoonenboom NS, Andreasen N, Wallin A, DeBernardis JF, Kerkman DJ, Heindl B, Blennow K, Hampel H. Multicenter assessment of CSF-phosphorylated tau for the prediction of conversion of MCI. Neurology. 2007 Dec 11;69(24):2205-12. doi: 10.1212/01.wnl.0000286944.22262.ff.

ReferenceCitation: Fagan AM, Mintun MA, Shah AR, Aldea P, Roe CM, Mach RH, Marcus D, Morris JC, Holtzman DM. Cerebrospinal fluid tau and ptau(181) increase with cortical amyloid deposition in cognitively normal individuals: implications for future clinical trials of Alzheimer's disease. EMBO Mol Med. 2009 Nov;1(8-9):371-80. doi: 10.1002/emmm.200900048.

ReferenceCitation: Hindley NJ, Jobst KA, King E, Barnetson L, Smith A, Haigh AM. High acceptability and low morbidity of diagnostic lumbar puncture in elderly subjects of mixed cognitive status. Acta Neurol Scand. 1995 May;91(5):405-11. doi: 10.1111/j.1600-0404.1995.tb07029.x.

ReferenceCitation: Kessing LV, Nilsson FM. Increased risk of developing dementia in patients with major affective disorders compared to patients with other medical illnesses. J Affect Disord. 2003 Feb;73(3):261-9. doi: 10.1016/s0165-0327(02)00004-6.

ReferenceCitation: Kessing LV, Andersen PK. Does the risk of developing dementia increase with the number of episodes in patients with depressive disorder and in patients with bipolar disorder? J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1662-6. doi: 10.1136/jnnp.2003.031773.

ReferenceCitation: Li G, Sokal I, Quinn JF, Leverenz JB, Brodey M, Schellenberg GD, Kaye JA, Raskind MA, Zhang J, Peskind ER, Montine TJ. CSF tau/Abeta42 ratio for increased risk of mild cognitive impairment: a follow-up study. Neurology. 2007 Aug 14;69(7):631-9. doi: 10.1212/01.wnl.0000267428.62582.aa.

ReferenceCitation: Martino DJ, Igoa A, Marengo E, Scapola M, Ais ED, Strejilevich SA. Cognitive and motor features in elderly people with bipolar disorder. J Affect Disord. 2008 Jan;105(1-3):291-5. doi: 10.1016/j.jad.2007.05.014. Epub 2007 Jun 18.

ReferenceCitation: Meeks S. Bipolar disorder in the latter half of life: symptom presentation, global functioning and age of onset. J Affect Disord. 1999 Jan-Mar;52(1-3):161-7. doi: 10.1016/s0165-0327(98)00069-x.

ReferenceCitation: Menecier P, Rouaud O, Arezes C, Nasr D, Menecier-Ossia L, Charvet-Blanc A, Ploton L. [Bipolar disorders and dementia: fortuitous association or filiation? A case-report and review of the literature]. Psychol Neuropsychiatr Vieil. 2007 Mar;5(1):23-34. French.

ReferenceCitation: Peskind ER, Riekse R, Quinn JF, Kaye J, Clark CM, Farlow MR, Decarli C, Chabal C, Vavrek D, Raskind MA, Galasko D. Safety and acceptability of the research lumbar puncture. Alzheimer Dis Assoc Disord. 2005 Oct-Dec;19(4):220-5. doi: 10.1097/01.wad.0000194014.43575.fd.

ReferenceCitation: Peskind E, Nordberg A, Darreh-Shori T, Soininen H. Safety of lumbar puncture procedures in patients with Alzheimer's disease. Curr Alzheimer Res. 2009 Jun;6(3):290-2. doi: 10.2174/156720509788486509.

ReferenceCitation: Preuss UW, Watzke S, Choi JH. Diagnostic correlates of Alzheimer dementia in a U.S. Nationwide inpatient sample. Am J Geriatr Psychiatry. 2010 Sep;18(9):821-9. doi: 10.1097/JGP.0b013e3181ca3a13.

ReferenceCitation: Tapiola T, Alafuzoff I, Herukka SK, Parkkinen L, Hartikainen P, Soininen H, Pirttila T. Cerebrospinal fluid beta-amyloid 42 and tau proteins as biomarkers of Alzheimer-type pathologic changes in the brain. Arch Neurol. 2009 Mar;66(3):382-9. doi: 10.1001/archneurol.2008.596.

ReferenceCitation: Thomann PA, Kaiser E, Schonknecht P, Pantel J, Essig M, Schroder J. Association of total tau and phosphorylated tau 181 protein levels in cerebrospinal fluid with cerebral atrophy in mild cognitive impairment and Alzheimer disease. J Psychiatry Neurosci. 2009 Mar;34(2):136-42.

ReferenceCitation: Vemuri P, Wiste HJ, Weigand SD, Knopman DS, Trojanowski JQ, Shaw LM, Bernstein MA, Aisen PS, Weiner M, Petersen RC, Jack CR Jr; Alzheimer's Disease Neuroimaging Initiative. Serial MRI and CSF biomarkers in normal aging, MCI, and AD. Neurology. 2010 Jul 13;75(2):143-51. doi: 10.1212/WNL.0b013e3181e7ca82.

ReferenceCitation: Wingo AP, Harvey PD, Baldessarini RJ. Neurocognitive impairment in bipolar disorder patients: functional implications. Bipolar Disord. 2009 Mar;11(2):113-25. doi: 10.1111/j.1399-5618.2009.00665.x.

ReferenceCitation: Zetterberg H, Tullhog K, Hansson O, Minthon L, Londos E, Blennow K. Low incidence of post-lumbar puncture headache in 1,089 consecutive memory clinic patients. Eur Neurol. 2010;63(6):326-30. doi: 10.1159/000311703. Epub 2010 Jun 3.


title: STREAMER : Stent Restenosis and Medicaments Release : Does Local Delivery of Paclitaxel be Safe and Efficient in Stenting of TransAtlantic InterSociety Consensus (TASC) Class C and D Femoropopliteal Artery Lesions

acronym: STREAMER

summary: It is a pilot study to evaluate the feasibility and the efficiency of local delivery of paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the realization of a large randomized multicentric study. Patients concerned are in critical ischemia.

location_facility: department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval


acronym: FEMTOHTO

summary:
The use of the femtosecond laser causes an increase in the intraocular pressure (IOP) between 100 mm Hg and 200 mm Hg for a period of about 80 seconds (suction phase).

If it is known that elevated IOP accelerates the degradation of retinal ganglion cells, whose axons form the optic nerve.

No data has been published to date on potential adverse effects of femtolaser cataract surgery performed in patients with glaucomatous optic neuropathy.

Since some time, spectral-domain optical coherence tomography (SD -OCT) provides a detailed analysis of ganglion cell complex (GCC) for which the loss is a marker of glaucomatous optic neuropathy. The resolution of this device, about a few microns, can detect even a tiny loss of this layer.

The investigators propose to evaluate the effects of elevated intraocular pressure in glaucoma patients undergoing femtolaser cataract surgery, studying the GCC through SD-OCT.

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild


title: Impact of Essential Oils on Anxiety of Patients Suffering From Metastasis Cancer - Feasibility Study

acronym: RHECAP

summary: This study evaluates the impact of essential oils massage on anxiety of patients who are suffering from cancer at a metastasis stage. Half of patients will be massaged first by essential oils and then by oil only. The other half will be massaged first by oil and then by essential oils.

ipd_sharing_description: Not authorized by French law

lead_sponsor: Center Eugene Marquis


title: Impact of Reduction Lung Volume Reduction by Coil on Hyperinflation in Severe Emphysema

acronym: HEAT-LVRC

summary: Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema

lead_sponsor: University Hospital, Toulouse


acronym: PELVI-EOS

summary: The purpose of this study and demonstrate the reliability of EOS imaging system in the measurement of internal diameters of obstetrical pelvis versus "Goldstandard current "that is the pelviscanner.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


summary: The purpose of this study is to compare the cervical muscular force control , taking into account the proprioceptive signals, in patients with and without cervical dystonia.

ReferenceCitation: Carment L, Maier MA, Sangla S, Guiraud V, Mesure S, Vidailhet M, Lindberg PG, Bleton JP. Does dystonic muscle activity affect sense of effort in cervical dystonia? PLoS One. 2017 Feb 13;12(2):e0172019. doi: 10.1371/journal.pone.0172019. eCollection 2017.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - hprints.org

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

endpoint_id: HAL

repository_institution: HAL

evidence: oa repository (semantic scholar lookup)

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

location_facility: Fondation Ophtalmique Adolphe de Rothschild


title: 3D Elastography (Shear Wave) : Assessment of Response to Neo-adjuvant Chemotherapy (NACT) : in Vivo Quantification, for Patients With a Locally Advanced Breast Cancer.

acronym: NEO-ELASTO

summary: Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy in patients with locally advanced breast cancer.

lead_sponsor: Institut Curie


title: ANI/NIPE Assessment of Pain Monitoring With ANI (Analgesia Nociceptive Index)/NIPE (Newborn Infant Parasympathetic Evaluation) Monitor Program in Pediatric Cardiac Surgery Postoperative.

acronym: ANI/NIPE

summary: The main objective is to assess correlation between ANI/NIPE values and external evaluation COMFORT B scale during painful medical cares and during said comfort medical cares in intubated children admitted in pediatric intensive care unit postoperative of cardiac surgery with extracorporeal circulation.


title: Atteinte Tissulaire au Cours de l'ischémie Chronique d'Effort. Validation d'un modèle d'étude du Muscle Sartorius Humain

acronym: SARTORIUS

summary:
The purpose of this study is to evaluate the effect of muscle ischemia during claudication on mitochondrial function.

Comparison to patients with arterial disease but absence of lower limb claudication (Cardiac group) feasibility study.

lead_sponsor: University Hospital, Angers


title: Impact of Patient Education Following a Stroke on Knowledge of Risk Factors, Stroke Warning Signs and What to do in Cases of Stroke

acronym: EPIC

summary:
The rapid diagnosis and treatment of acute ischemic stroke are critical in the reduction of morbidity, disability and stroke associated mortality Under-education about stroke may prevent people from recognizing symptoms early enough to seek immediate care.

The studies reported on stroke patients managed in stroke center have shown that 39-42% of patients could not name any symptoms of stroke and 36% to 43% no risk factor of stroke.

The stroke patients are therefore a population at high risk for neurological events and cardiac vascular recurrence. However, no studies have evaluated the interest of the development of therapeutic workshops in stroke unit to educate patients about symptoms suggestive of stroke, risk factors and what to do in cases of stroke.

Investigators assume that the setting up of a therapeutic education workshop in the stroke unit may allow a better understanding of the symptoms, risk factors and what to do following stroke. So there is a direct benefit to the patient represented by a better knowledge of stroke (warning signs, risk factors, what to do), improved treatment compliance and reduced risk of recurrence.

More generally, there is a real benefit to promote these messages to the public through the patient and his relatives

ReferenceCitation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

publisher_dissemination: Wiley

lead_sponsor: Hopital Foch


type: EudraCT Number

title: Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone: Tolerance and Safety Pilot Study

acronym: IDEXACOR

summary:
Immune rejection episodes after penetrating keratoplasty occur in 30% of patients and constitute one of the main factors reducing graft survival. They mainly occur during the first 18 months. Prevention usually relies on a topical treatment with dexamethasone or prednisolone for standard risk patients. Eye drops are instilled three times a day during at least 3 months then tapered.

OZURDEX is an absorbable small implant that releases a total of 700 micrograms dexamethasone during several months. It is indicated for intravitreal injection to treat macular edema.

The investigators hypothesized that this implant could be used after subconjunctival injection during corneal graft, to prevent immune rejection and avoid repeated eyedrop instillations.

ReferenceCitation: Trone MC, Poinard S, Crouzet E, Garcin T, Mentek M, Forest F, Matray M, Thuret G, Gain P. Dropless penetrating keratoplasty using a subconjunctival dexamethasone implant: safety pilot study. Br J Ophthalmol. 2023 Feb;107(2):181-186. doi: 10.1136/bjophthalmol-2021-319376. Epub 2021 Aug 23.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: British Medical Journal

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Neurofunctional Basis of Emotion Processing: Clinical, Genetic, Biological and Imaging Study in Patients With Schizophrenia and Healthy Relatives of Patients in Comparison With a Control Group

acronym: SCHIZOIMAGEN

summary:
Schizophrenia is an invalidating psychiatric illness with a strong genetic component characterized by abnormal processing of emotional information. This alteration in emotion processing has been described in acute as well as in remission phases of the illness. It has also been found in healthy relatives of patients with schizophrenia and in subjects at high risk of psychosis. Thus, alterations in emotional information processing are not only linked to the prognosis but can also be considered as a marker of vulnerability of schizophrenia. In addition, schizophrenia patients differ from healthy controls in neural activity in brain regions implicated in emotions processing. However, interpretation of findings in patients is limited by confounding factors, such as antipsychotic treatments or alterations due to the course of illness. Also, there is no data concerning genetic factors (polymorphisms or gene expression) underlying these patterns of cerebral activation in emotion information processing.

So, the main objective of this study is to compare the cerebral activity of schizophrenia patients to that of healthy siblings and healthy controls in an emotional processing task.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Pôle Psychiatrie Centre CHU Conception, Marseille, APHM

appel_a_projets: PHRCI

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

acronyme: SCHIZOIMAGEN

titre: Bases neuro-fonctionnelles du traitement des émotions: étude clinique, génétique, biologique et en imagerie focntionnelle chez les patients schizophrènes et leurs apparentés sains en comparaison d'un groupe contrôle.

discipline_principale: psychiatrie

nom_porteur: ZENDJIDJIAN

prenom_porteur: Xavier


title: Validation of a Classification of Types of Upper Limb and Hand in Patients With Cerebral Palsy

acronym: CLASS-MS

summary:
Cerebral palsy (CP) has been defined as "a group of permanent disorders of the development of movement and posture causing activity limitation(s) that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain".

Investigators previously developed two classification systems, one for the upper limb and one for the hand, based on 100 films of patients with cerebral palsy. Separate classifications were developed following an initial study in which investigators found no correlations between upper limb and hand patterns, meaning that specific upper limb patterns are not always associated with specific hand patterns. Thumb patterns were not included in these classifications since robust classifications already exist, moreover thumb patterns are independent from hand patterns.

The aim is to evaluate the inter- and intra-rater reliability of two previously developed classifications of upper limb and hand patterns.

location_facility: Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche - 162 avenue Lacassagne - Bâtiment A


title: Functional Magnetic Resonance Imaging Study: Theory of Mind Deficits in Schizophrenia and Bipolar Disorder

acronym: TOM-i

summary: Theory of mind (TOM), a main component of social cognition processes, refers to the capacity to infer one's own and other person's mental states. Deficits in social cognition are found in patients with schizophrenia and bipolar disorder. The purpose of this study is to compare the neurofunctional profiles of schizophrenic patients, bipolar patients and healthy participants during the performance of a TOM task. Results may help to understand the neural bases of the impairments in social cognition in schizophrenia and bipolar disorder, which may in turn help to propose potential new psychosocial therapeutic approaches in these disorders.

ReferenceCitation: Henry A, Raucher-Chene D, Obert A, Gobin P, Vucurovic K, Barriere S, Sacre S, Portefaix C, Gierski F, Caillies S, Kaladjian A. Investigation of the neural correlates of mentalizing through the Dynamic Inference Task, a new naturalistic task of social cognition. Neuroimage. 2021 Nov;243:118499. doi: 10.1016/j.neuroimage.2021.118499. Epub 2021 Aug 24.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

lead_sponsor: CHU de Reims


title: Impact Assessment of Positioning on Pain Sensitivity During a Lumbar Puncture in Children

acronym: PHIPA-PEPL

summary:
This protocol is a pilot study on standard care. The main goal is to assess the impact of positioning on lumbar puncture process especially on pain sensitivity in children.

It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is one year, and number of inclusions forecasted is about 30. Each patient will have one LP in a seated position and one in a lying position.

lead_sponsor: Centre Hospitalier Universitaire de Nice


type: Registry Identifier

title: Input of a Multidisciplinary Device Including a Psychological Approach, to Accompany the Announce of Diagnosis for Young Children With Serious Constitutional Hemorrhagic Disease and Their Families

acronym: ACADHEM

summary:
Severe forms of hemophilia and other constitutional bleeding disorders represent a group of rare diseases. In last decades, news therapies have dramatically increased life expectancy and joint's protection.

The investigators propose to set up a single-centre, descriptive, transversal pilot study, designed for the inclusion of around thirty children from 2 to 10 years, with haemophilia or allied hereditary bleeding disorders (HBD), who were referred to the Hemophilia Treatment Center (HTC) of Marseille at diagnosis. For those children who were able to benefit from the totality or part of the device accompanying the diagnostic announcement in the past 10 years.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Hopital Enfants de la Timone Assistance Publique Hôpitaux de Marseille


title: Comparison of the Number of Visits and the Quality of Life Versus Natural Cycle in Stimulated Cycle Before Frozen Embryo Transfer

acronym: SONTEC

summary: Embryo freezing is a technique used regularly to optimize the pregnancy rate in case of infertility. This method is performed in presence of supernumerary embryo(s) after fresh transfer, or after freeze all embryos in case of medical reasons. It is necessary to control that the transfer is performed when the endometrium is receptive, which is essential for embryo implantation and pregnancy. This period is defined as the "implantation window". Endometrial preparation can be achieved by hormone replacement therapy (HRT) or moderate ovarian stimulation (SO). The implantation window can also be assessed by monitoring of a natural cycle (NC). The objectives of this open randomized study is to compare the number of visits (ultrasound and blood tests) induced by the SO or NC as well as the women quality of life in both groups.

primary_purpose: Health Services Research

ReferenceCitation: Bjuresten K, Landgren BM, Hovatta O, Stavreus-Evers A. Luteal phase progesterone increases live birth rate after frozen embryo transfer. Fertil Steril. 2011 Feb;95(2):534-7. doi: 10.1016/j.fertnstert.2010.05.019. Epub 2010 Jun 26.

ReferenceCitation: Boivin J, Takefman J, Braverman A. The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum Reprod. 2011 Aug;26(8):2084-91. doi: 10.1093/humrep/der171. Epub 2011 Jun 10.

ReferenceCitation: de La Rochebrochard E, Quelen C, Peikrishvili R, Guibert J, Bouyer J. Long-term outcome of parenthood project during in vitro fertilization and after discontinuation of unsuccessful in vitro fertilization. Fertil Steril. 2009 Jul;92(1):149-56. doi: 10.1016/j.fertnstert.2008.05.067. Epub 2008 Aug 15.

ReferenceCitation: Eftekhar M, Rahmani E, Pourmasumi S. Evaluation of clinical factors influencing pregnancy rate in frozen embryo transfer. Iran J Reprod Med. 2014 Jul;12(7):513-8.

ReferenceCitation: El Bahja D, Hertz P, Schweitzer T, Lestrade F, Ragage JP. [Frozen embryo transfer protocol: does spontaneous cycle give good results?]. Gynecol Obstet Fertil. 2013 Nov;41(11):648-52. doi: 10.1016/j.gyobfe.2011.08.007. Epub 2012 Feb 16. French.

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lead_sponsor: Dr Massin Nathalie


title: Validation of Fibrosis Quantification Using T1 Mapping Against Histology as Reference and Comparison With Fibrosis Biomarkers

summary: Myocardial fibrosis is recognized as the pathologic entity of extracellular matrix remodeling. Diffuse, reactive fibrosis is increasingly recognized in a variety of conditions despite the absence of ischemia. Regardless of the etiology, fibrosis leads to increased myocardial stiffness thereby promoting cardiac dysfunction. This dysfunction may present clinically with symptoms of cardiac failure although this is often a subclinical disease. Various imaging modalities and collagen biomarkers have been used as surrogate markers to assess the presence, extent, and turnover of myocardial fibrosis. Techniques using echocardiography, cardiac magnetic resonance, and nuclear imaging have been developed to detect early features of systolic and diastolic left ventricular dysfunction and impaired contractile reserve. Further identification of diffuse reactive fibrosis may be possible with evolving cardiac magnetic resonance and molecular techniques. The goal of this protocol is to validate cardiac magnetic resonance imaging as a new tool for fibrosis quantification against histology as standard of reference.

location_facility: Assistance Publique Hopitaux de Marseille


title: Non-drug Taken Charge of Alzheimer's Disease: Profit Musical Activities

acronym: MusicAlzheimer

summary: Cares of Alzheimer's disease (AD) and related disorders are presenting a real public health challenge. Because of the limited effectiveness of pharmacological treatments, there is a growing interest in care approach based on nonpharmacological treatments, such as musical interventions. Several lines of evidence suggest that musical interventions could improve behaviour, emotion and even cognition in patients with AD. However, very few studies respond to the methodological constraints required for clinical controlled trials carried out in well selected groups of patients. The efficiency of such care approaches is not scientifically proved yet and the impact of musical interventions has rarely been compared to another pleasant intervention, leaving open the question about the specific benefits of music in patients with dementia. The main goal of this research project is to demonstrate short and longer-term efficiencies and the specificity of musical interventions in dementia by investigating their effects not only in patients but also in familial and professional caregivers.