title: TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: the TIRATROP Study, a Randomized Controlled Trial

acronym: TIRATROP

summary: Rotational atherectomy (RA) prior to angioplasty is the reference treatment for highly calcified atherosclerotic coronary lesions. It aims at fragmenting calcium deposits into microscopic particulates to allow less hazardous coronary revascularization and stenting. The main drawback associated with the procedure is the subsequent enhancement of platelet aggregation which promotes the distal embolization of micro-thrombi and atherosclerotic fragments. In order to limit these complications, a double antiplatelet therapy is required (generally Clopidogrel + Aspirin) when RA procedures are performed. Clopidogrel inhibits the protein P2Y12 which is a cornerstone in platelet aggregation. Ticagrelor is a new antiplatelet agent that provides faster and greater P2Y12 inhibition than Clopidogrel. It is currently indicated to reduce risk of cardiovascular events in patients hospitalized for coronary revascularization after an acute coronary syndrome. Ticagrelor has never been evaluated so far in stable coronary patients treated with rotational atherectomy prior to angioplasty.

location_facility:
University Hospital
Fédération de Cardiologie CHU TOULOUSE
Clinique Pasteur
Hospices civils de Lyon


intervention_type: Other

status: Terminated

study_start_date_type: Actual

study_type: Observational

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

enrollment_type: Actual

acronym: MONITUX

time_perspective: Prospective

location_facility:
Hôpital Edouard Herriot
Hôpital de la Croix Rousse
CHU Saint-Etienne
CH Lyon Sud

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis : a Predictive Factor of Clinical Outcome? (MONITUX)

summary:
The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels could be an interesting tool in the follow-up of ANCA-associated vasculitis patients.

All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or the relapse of a known ANCA-associated vasculitis, in which the decision to start an induction regimen with rituximab has been taken, will be included.

Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be analyzed.

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: One-year Follow-up of Iron in Basal Ganglia - R2*: a Biomarker of Parkinson's Disease Progression?

summary: The study of non-invasive and reliable biomarkers to track progression of Parkinson's disease (PD) is essential while disease-modifying treatments are being developed. Many clinical biological or imaging biomarkers have been tested but no "gold standard" has been found as of yet. Among these, Magnetic Resonance Imaging (MRI) relaxometry using R2* measurement (R2* = 1/T2*), which is a validated marker for estimating brain iron concentration, appears to be an attractive technique because its safety, rapidly measured in clinical conditions and its ease to ensure individual longitudinal follow-up. Current data of cross sectional studies of R2*, which have shown an iron increase in Substantia Nigra (SN), led to suppose that it could be a biomarker of disease vulnerability. Recently, the investigators have conducted the first longitudinal follow-up of R2* (1.5 T MRI), which showed a rapid R2* increase in both parts of the SN and in the caudal putamen. We propose, here, a multicenter prospective study of one-year cohort follow-up of R2* variations (ΔR2*) in three regions of interest (ROIs) (the SN, the Ventral Tegmental Area (VTA) and the Putamen) of 160 patients with PD, using a 3 Tesla MRI, to evaluate the potential interest of R2* as a biomarker of disease progression. The variation of R2* (ΔR2*) will be correlated with clinical markers of disease progress, non-motor symptoms. 80 healthy controls subjects will also be included to assess the effect of aging on cerebral physiological iron levels.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Chu Poitiers
Chu Grenoble
Chu Pellegrin
Chu Dupuytren
Chu Lille
Chu Nancy
Hôpital Henri Mondor
Chu Reims
CHU Clermont-Ferrand
CHU Pitié Salpétrière
Chu Toulouse
Chu Montpellier
Hôpital neurologique Pierre Wertheimer

intervention_type: Procedure


title: A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

summary: The purpose of this study is to compare two ways of using anti-HIV drugs to help health care providers and patients decide how to best use anti-HIV treatments over many years. Many health care providers now treat patients with daily drugs to keep the viral load as low as possible. This approach helps patients with CD4 counts less than 200-250 cells/mm3 live longer without serious diseases. But it is not known if this is the best way to treat patients with higher CD4 counts. There is information suggesting that these patients may be able to wait to use anti-HIV drugs while CD4 counts are above 250 cells/mm3. Because this study will be carried out over several years, it will provide information on the long-term advantages and disadvantages of these two treatment strategies.

status: Completed

ReferenceType: background

ReferenceCitation: Lederman MM, Valdez H. Immune restoration with antiretroviral therapies: implications for clinical management. JAMA. 2000 Jul 12;284(2):223-8.

ReferenceCitation: Carpenter CC, Cooper DA, Fischl MA, Gatell JM, Gazzard BG, Hammer SM, Hirsch MS, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Saag MS, Schechter M, Schooley RT, Thompson MA, Vella S, Yeni PG, Volberding PA. Antiretroviral therapy in adults: updated recommendations of the International AIDS Society-USA Panel. JAMA. 2000 Jan 19;283(3):381-90. Review.

ReferenceCitation: Mocroft A, Katlama C, Johnson AM, Pradier C, Antunes F, Mulcahy F, Chiesi A, Phillips AN, Kirk O, Lundgren JD. AIDS across Europe, 1994-98: the EuroSIDA study. Lancet. 2000 Jul 22;356(9226):291-6.

ReferenceCitation: Tebas P, Henry K, Mondy K, Deeks S, Valdez H, Cohen C, Powderly WG. Effect of prolonged discontinuation of successful antiretroviral therapy on CD4+ T cell decline in human immunodeficiency virus-infected patients: implications for intermittent therapeutic strategies. J Infect Dis. 2002 Sep 15;186(6):851-4. Epub 2002 Aug 28. Erratum in: J Infect Dis 2002 Oct 15;186(8):1198.

ReferenceCitation: Yerly S, Kaiser L, Perneger TV, Cone RW, Opravil M, Chave JP, Furrer H, Hirschel B, Perrin L. Time of initiation of antiretroviral therapy: impact on HIV-1 viraemia. The Swiss HIV Cohort Study. AIDS. 2000 Feb 18;14(3):243-9.

ReferenceType: derived

ReferenceCitation: Borges ÁH, Neuhaus J, Sharma S, Neaton JD, Henry K, Anagnostou O, Staub T, Emery S, Lundgren JD; INSIGHT SMART; START Study Groups. The Effect of Interrupted/Deferred Antiretroviral Therapy on Disease Risk: A SMART and START Combined Analysis. J Infect Dis. 2019 Jan 7;219(2):254-263. doi: 10.1093/infdis/jiy442.

name: Center of Excellence for Health, Infections and Immunity, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark

family: Borges

full_name: Álvaro H Borges

given: Álvaro H

sequence: first

name: Division of Biostatistics, School of Public Health, University of Minnesota

family: Neuhaus

full_name: Jacqueline Neuhaus

given: Jacqueline

sequence: additional

family: Sharma

full_name: Shweta Sharma

given: Shweta

family: Neaton

full_name: James D Neaton

given: James D

name: Hennepin County Medical Center, Minneapolis, Minnesota

family: Henry

full_name: Keith Henry

given: Keith

family: Anagnostou

full_name: Olga Anagnostou

given: Olga

name: Centre Hospitalier de Luxembourg, Service des Maladies Infectieuses, Luxembourg

family: Staub

full_name: Teresa Staub

given: Teresa

name: Faculty of Medicine, University of Queensland, Brisbane, Australia

family: Emery

full_name: Sean Emery

given: Sean

family: Lundgren

full_name: Jens D Lundgren

given: Jens D

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Journal of Infectious Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

repository_institution: The University of Queensland - Queensland's institutional digital repository

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
PubMed Central
Pure (Denmark)
espace.library.uq.edu.au

repositories_institution: The University of Queensland - Queensland's institutional digital repository

repositories_institution: University of Copenhagen - Research at the University of Copenhagen

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Castillo-Mancilla JR, Phillips AN, Neaton JD, Neuhaus J, Collins S, Mannheimer S, Pett S, Touzeau-Römer V, Polizzotto MN, Lundgren JD, Gardner EM; INSIGHT SMART Study Group. Association of Suboptimal Antiretroviral Therapy Adherence With Inflammation in Virologically Suppressed Individuals Enrolled in the SMART Study. Open Forum Infect Dis. 2017 Dec 22;5(1):ofx275. doi: 10.1093/ofid/ofx275. eCollection 2018 Jan.

name: University of Colorado-AMC, Medicine/Infectious Diseases, Aurora, Colorado

family: Castillo-Mancilla

full_name: Jose R Castillo-Mancilla

given: Jose R

name: Institute for Global Health, University College London, London, UK

family: Phillips

full_name: Andrew N Phillips

given: Andrew N

name: University of Minnesota, School of Public Health, Minneapolis, Minnesota

family: Collins

full_name: Simon Collins

name: Columbia University Medical Center, Harlem Hospital Center, New York, New York

name: Kirby Institute, University of New South Wales, Sydney, Australia

name: University of Vienna Medical School, AKH, Division of Immunology, Allergy and Infectious Diseases, Vienna, Austria

name: CHIP, Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark

name: Denver Health Medical Center, Denver, Colorado

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

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Larson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.

name: Coordinating Centers for Biometric Research, Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA

name: The Kirby Institute, University of New South Wales, Sydney, NSW, Australia

name: Copenhagen HIV Programme, University of Copenhagen, Copenhagen, Denmark

name: Sponsored Projects Administration, University of Minnesota, Minneapolis, MN, USA

name: Veterans Affairs Medical Center, Washington, DC, USA

ReferenceCitation: Nordell AD, McKenna M, Borges ÁH, Duprez D, Neuhaus J, Neaton JD; INSIGHT SMART, ESPRIT Study Groups; SILCAAT Scientific Committee. Severity of cardiovascular disease outcomes among patients with HIV is related to markers of inflammation and coagulation. J Am Heart Assoc. 2014 May 28;3(3):e000844. doi: 10.1161/JAHA.114.000844.

name: Department of Infectious Diseases, Rigshospitalet and Copenhagen HIV Programme, University of Copenhagen, Copenhagen, Denmark

name: Cardiovascular Division, University of Minnesota, Minneapolis, MN

name: the INSIGHT SMART, ESPRIT Study Groups, and SILCAAT Scientific Committee

journal_name: Journal of the American Heart Association

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

repositories_institution: Griffith University, Queensland, Australia - Griffith Research Online

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Severity of Cardiovascular Disease Outcomes Among Patients With HIV Is Related to Markers of Inflammation and Coagulation

ReferenceCitation: Lucas GM, Cozzi-Lepri A, Wyatt CM, Post FA, Bormann AM, Crum-Cianflone NF, Ross MJ; INSIGHT SMART Study Group. Glomerular filtration rate estimated using creatinine, cystatin C or both markers and the risk of clinical events in HIV-infected individuals. HIV Med. 2014 Feb;15(2):116-23. doi: 10.1111/hiv.12087. Epub 2013 Sep 11.

name: Johns Hopkins University; Baltimore MD USA

name: University of Minnesota; Minneapolis MN USA

name: Mount Sinai School of Medicine; New York NY USA

name: King's College London School of Medicine; London UK

name: Naval Medical Center San Diego; San Diego CA USA

name: Infectious Disease Clinical Research Program; Uniformed Services University of the Health Sciences; Bethesda MD USA

ReferenceCitation: Baker JV, Brummel-Ziedins K, Neuhaus J, Duprez D, Cummins N, Dalmau D, DeHovitz J, Lehmann C, Sullivan A, Woolley I, Kuller L, Neaton JD, Tracy RP; INSIGHT SMART Study Team. HIV replication alters the composition of extrinsic pathway coagulation factors and increases thrombin generation. J Am Heart Assoc. 2013 Jul 29;2(4):e000264. doi: 10.1161/JAHA.113.000264.

name: Hennepin County Medical Center, Minneapolis, MN

name: University of Minnesota, Minneapolis, MN

name: Hospital Mutua de Terrassa Departamento Medicina Interna, Hospital Mutua de Terrassa, Barcelona, Spain

name: SUNY Downstate Medical Center, Brooklyn, NY

name: First Department of Internal Medicine, University of Cologne, Cologne, Germany

name: Chelsea and Westminster Hospital, London, United Kingdom

name: Monash Infectious Diseases, Melbourne, Australia

name: University of Pittsburgh, Pittsburgh, PA

title: HIV Replication Alters the Composition of Extrinsic Pathway Coagulation Factors and Increases Thrombin Generation

ReferenceCitation: Hoy J, Grund B, Roediger M, Ensrud KE, Brar I, Colebunders R, Castro ND, Johnson M, Sharma A, Carr A; INSIGHT SMART Body Composition Substudy Group. Interruption or deferral of antiretroviral therapy reduces markers of bone turnover compared with continuous therapy: The SMART body composition substudy. J Bone Miner Res. 2013 Jun;28(6):1264-74. doi: 10.1002/jbmr.1861.

name: The Alfred Hospital and Monash University; Melbourne; Australia

name: University of Minnesota; Minneapolis; MN; USA

name: VA Medical Center and University of Minnesota; Minneapolis; MN; USA

name: Institute of Tropical Medicine; HIV AIDS Center; Antwerp; Belgium

name: AP-HP; Groupe Hospitalier Lariboisière Saint-Louis; Paris; France

name: Royal Free Hospital; London; United Kingdom; USA

name: SUNY Downstate Medical Center; Brooklyn; NY; USA

name: St. Vincent's Hospital and University of New South Wales; Sydney; Australia

name: for the INSIGHT SMART Body Composition Substudy Group

ReferenceCitation: Zetterberg E, Neuhaus J, Baker JV, Somboonwit C, Llibre JM, Palfreeman A, Chini M, Lundgren JD; INSIGHT SMART Study Group. Platelet count kinetics following interruption of antiretroviral treatment. AIDS. 2013 Jan 2;27(1):59-68. doi: 10.1097/QAD.0b013e32835a104d.

title: Platelet count kinetics following interruption of antiretroviral treatment

ReferenceCitation: Mocroft A, Neuhaus J, Peters L, Ryom L, Bickel M, Grint D, Koirala J, Szymczak A, Lundgren J, Ross MJ, Wyatt CM; INSIGHT SMART Study Group; ESPRIT Study Group. Hepatitis B and C co-infection are independent predictors of progressive kidney disease in HIV-positive, antiretroviral-treated adults. PLoS One. 2012;7(7):e40245. Epub 2012 Jul 20.

ReferenceCitation: Baker JV, Neuhaus J, Duprez D, Cooper DA, Hoy J, Kuller L, Lampe FC, Liappis A, Friis-Moller N, Otvos J, Paton NI, Tracy R, Neaton JD; INSIGHT SMART Study Group. Inflammation predicts changes in high-density lipoprotein particles and apolipoprotein A1 following initiation of antiretroviral therapy. AIDS. 2011 Nov 13;25(17):2133-42. doi: 10.1097/QAD.0b013e32834be088.

ReferenceCitation: Mocroft A, Lifson AR, Touloumi G, Neuhaus J, Fox Z, Palfreeman A, Vjecha MJ, Hodder S, De Wit S, Lundgren JD, Phillips AN; INSIGHT SMART Study Group. Haemoglobin and anaemia in the SMART study. Antivir Ther. 2011;16(3):329-37. doi: 10.3851/IMP1746.

title: Haemoglobin and anaemia in the SMART study

ReferenceCitation: Duprez DA, Neuhaus J, Tracy R, Kuller LH, Deeks SG, Orkin C, Stoehr A, Woolley IJ, Neaton JD; INSIGHT SMART Group. N-terminal-proB-type natriuretic peptide predicts cardiovascular disease events in HIV-infected patients. AIDS. 2011 Mar 13;25(5):651-7. doi: 10.1097/QAD.0b013e32834404a1.

ReferenceCitation: Lampe FC, Duprez DA, Kuller LH, Tracy R, Otvos J, Stroes E, Cooper DA, Hoy J, Paton NI, Friis-Møller N, Neuhaus J, Liappis AP, Phillips AN; INSIGHT SMART Study Group. Changes in lipids and lipoprotein particle concentrations after interruption of antiretroviral therapy. J Acquir Immune Defic Syndr. 2010 Jul;54(3):275-84.

ReferenceCitation: Dore GJ, Soriano V, Rockstroh J, Kupfer B, Tedaldi E, Peters L, Neuhaus J, Puoti M, Klein MB, Mocroft A, Clotet B, Lundgren JD; SMART INSIGHT study group. Frequent hepatitis B virus rebound among HIV-hepatitis B virus-coinfected patients following antiretroviral therapy interruption. AIDS. 2010 Mar 27;24(6):857-65. doi: 10.1097/QAD.0b013e328334bddb.

title: Frequent hepatitis B virus rebound among HIV–hepatitis B virus-coinfected patients following antiretroviral therapy interruption

ReferenceCitation: Rodger AJ, Fox Z, Lundgren JD, Kuller LH, Boesecke C, Gey D, Skoutelis A, Goetz MB, Phillips AN; INSIGHT Strategies for Management of Antiretroviral Therapy (SMART) Study Group. Activation and coagulation biomarkers are independent predictors of the development of opportunistic disease in patients with HIV infection. J Infect Dis. 2009 Sep 15;200(6):973-83. doi: 10.1086/605447.

name: the INSIGHT Strategies for Management of Antiretroviral Therapy (SMART) Study Group

repository_institution: University of Liège - Open Repository and Bibliography

repositories_institution: University of Liège - Open Repository and Bibliography

title: Activation and Coagulation Biomarkers Are Independent Predictors of the Development of Opportunistic Disease in Patients with HIV Infection

ReferenceCitation: Grund B, Peng G, Gibert CL, Hoy JF, Isaksson RL, Shlay JC, Martinez E, Reiss P, Visnegarwala F, Carr AD; INSIGHT SMART Body Composition Substudy Group. Continuous antiretroviral therapy decreases bone mineral density. AIDS. 2009 Jul 31;23(12):1519-29. doi: 10.1097/QAD.0b013e32832c1792.

title: Continuous antiretroviral therapy decreases bone mineral density

ReferenceCitation: Duprez DA, Kuller LH, Tracy R, Otvos J, Cooper DA, Hoy J, Neuhaus J, Paton NI, Friis-Moller N, Lampe F, Liappis AP, Neaton JD; INSIGHT SMART Study Group. Lipoprotein particle subclasses, cardiovascular disease and HIV infection. Atherosclerosis. 2009 Dec;207(2):524-9. doi: 10.1016/j.atherosclerosis.2009.05.001. Epub 2009 May 13.

title: Lipoprotein particle subclasses, cardiovascular disease and HIV infection

ReferenceCitation: Mocroft A, Wyatt C, Szczech L, Neuhaus J, El-Sadr W, Tracy R, Kuller L, Shlipak M, Angus B, Klinker H, Ross M; INSIGHT SMART Study Group. Interruption of antiretroviral therapy is associated with increased plasma cystatin C. AIDS. 2009 Jan 2;23(1):71-82. doi: 10.1097/QAD.0b013e32831cc129.

ReferenceCitation: Fox Z, Phillips A, Cohen C, Neuhaus J, Baxter J, Emery S, Hirschel B, Hullsiek KH, Stephan C, Lundgren J; SMART Study Group. Viral resuppression and detection of drug resistance following interruption of a suppressive non-nucleoside reverse transcriptase inhibitor-based regimen. AIDS. 2008 Nov 12;22(17):2279-89. doi: 10.1097/QAD.0b013e328311d16f.

ReferenceCitation: Tedaldi E, Peters L, Neuhaus J, Puoti M, Rockstroh J, Klein MB, Dore GJ, Mocroft A, Soriano V, Clotet B, Lundgren JD; SMART Study Group and International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). Opportunistic disease and mortality in patients coinfected with hepatitis B or C virus in the strategic management of antiretroviral therapy (SMART) study. Clin Infect Dis. 2008 Dec 1;47(11):1468-75. doi: 10.1086/593102.

name: the SMART Study Group and International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

title: Opportunistic Disease and Mortality in Patients Coinfected with Hepatitis B or C Virus in the Strategic Management of Antiretroviral Therapy (SMART) Study

ReferenceCitation: Kuller LH, Tracy R, Belloso W, De Wit S, Drummond F, Lane HC, Ledergerber B, Lundgren J, Neuhaus J, Nixon D, Paton NI, Neaton JD; INSIGHT SMART Study Group. Inflammatory and coagulation biomarkers and mortality in patients with HIV infection. PLoS Med. 2008 Oct 21;5(10):e203. doi: 10.1371/journal.pmed.0050203.

repository_institution: University of Pittsburgh - D-Scholarship@Pitt

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: University of Pittsburgh - D-Scholarship@Pitt

repositories_institution: University of Zurich - Zurich Open Repository and Archive

title: Inflammatory and Coagulation Biomarkers and Mortality in Patients with HIV Infection

ReferenceCitation: SMART Study Group, El-Sadr WM, Grund B, Neuhaus J, Babiker A, Cohen CJ, Darbyshire J, Emery S, Lundgren JD, Phillips A, Neaton JD. Risk for opportunistic disease and death after reinitiating continuous antiretroviral therapy in patients with HIV previously receiving episodic therapy: a randomized trial. Ann Intern Med. 2008 Sep 2;149(5):289-99.

ReferenceCitation: Strategies for Management of Anti-Retroviral Therapy/INSIGHT; DAD Study Groups. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients. AIDS. 2008 Sep 12;22(14):F17-24. doi: 10.1097/QAD.0b013e32830fe35e.

ReferenceCitation: Gordin FM, Roediger MP, Girard PM, Lundgren JD, Miro JM, Palfreeman A, Rodriguez-Barradas MC, Wolff MJ, Easterbrook PJ, Clezy K, Slater LN. Pneumonia in HIV-infected persons: increased risk with cigarette smoking and treatment interruption. Am J Respir Crit Care Med. 2008 Sep 15;178(6):630-6. doi: 10.1164/rccm.200804-617OC. Epub 2008 Jul 10.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Pneumonia in HIV-infected Persons

ReferenceCitation: Phillips AN, Carr A, Neuhaus J, Visnegarwala F, Prineas R, Burman WJ, Williams I, Drummond F, Duprez D, Belloso WH, Goebel FD, Grund B, Hatzakis A, Vera J, Lundgren JD. Interruption of antiretroviral therapy and risk of cardiovascular disease in persons with HIV-1 infection: exploratory analyses from the SMART trial. Antivir Ther. 2008;13(2):177-87.

ReferenceCitation: Strategies for Management of Antiretroviral Therapy (SMART) Study Group, Lundgren JD, Babiker A, El-Sadr W, Emery S, Grund B, Neaton JD, Neuhaus J, Phillips AN. Inferior clinical outcome of the CD4+ cell count-guided antiretroviral treatment interruption strategy in the SMART study: role of CD4+ Cell counts and HIV RNA levels during follow-up. J Infect Dis. 2008 Apr 15;197(8):1145-55. doi: 10.1086/529523.

name: The Strategies for Management of Antiretroviral Therapy (SMART) Study Group

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories_institution: University of Geneva - Archive ouverte UNIGE

title: Inferior Clinical Outcome of the CD4+ Cell Count–Guided Antiretroviral Treatment Interruption Strategy in the SMART Study: Role of CD4+ Cell Counts and HIV RNA Levels during Follow-up

ReferenceCitation: Strategies for Management of Antiretroviral Therapy (SMART) Study Group, Emery S, Neuhaus JA, Phillips AN, Babiker A, Cohen CJ, Gatell JM, Girard PM, Grund B, Law M, Losso MH, Palfreeman A, Wood R. Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study. J Infect Dis. 2008 Apr 15;197(8):1133-44. doi: 10.1086/586713.

title: Major Clinical Outcomes in Antiretroviral Therapy (ART)–Naive Participants and in Those Not Receiving ART at Baseline in the SMART Study

ReferenceCitation: Carr A, Grund B, Neuhaus J, El-Sadr WM, Grandits G, Gibert C, Prineas RJ; SMART Study Investigators. Asymptomatic myocardial ischaemia in HIV-infected adults. AIDS. 2008 Jan 11;22(2):257-67.

ReferenceCitation: Burman WJ, Grund B, Roediger MP, Friedland G, Darbyshire J, Wu AW; SMART Study Group. The impact of episodic CD4 cell count-guided antiretroviral therapy on quality of life. J Acquir Immune Defic Syndr. 2008 Feb 1;47(2):185-93.

ReferenceCitation: Strategies for Management of Antiretroviral Therapy (SMART) Study Group, El-Sadr WM, Lundgren J, Neaton JD, Gordin F, Abrams D, Arduino RC, Babiker A, Burman W, Clumeck N, Cohen CJ, Cohn D, Cooper D, Darbyshire J, Emery S, Fätkenheuer G, Gazzard B, Grund B, Hoy J, Klingman K, Losso M, Markowitz N, Neuhaus J, Phillips A, Rappoport C. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006 Nov 30;355(22):2283-96.

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

location_country:
Luxembourg
Peru
Australia
Belgium
France
Japan
Lithuania
Poland
Thailand
Norway
Argentina
Canada
Switzerland
Martinique
Ireland
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
New Zealand
Spain
Estonia

location_facility: AIDS Research Consortium of Atlanta (ARCA) Central

location_facility: St. Joseph's Health Care Centre of London

location_facility: T1 Coleridge Unit, North Middlesex Hospital

location_facility: Centre hospitalier de l'universite Laval (CHUL)

location_facility: AID Atlanta/Morehouse Med School Ryan White Cl

location_facility: University of Mississippi Medical Center

location_facility: Dekalb County Health Dept Infectious Disease

location_facility: National Centre in HIV Epidemiology and Clinical Research

location_facility: Klinikum der Ruprecht-Karis-Universitat (U. Hospital)

location_facility: Community Research Initiatives of New England

location_facility: Centre Hospitalier Universitaire Sart-Tilman

location_facility: Vernon J. Harris East End Community Health Care Ct

location_facility: Michigan State University Infectious Diseases Clinic

location_facility: Watford Sexual Health Center;Watford General Hosp

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Hospital Universitario Professor Edgard Santos

location_facility: Dr. Melanie Thompson and Dr. Annette Bernard (Private Practice)

location_facility: Hospital Interzonall de San Juan de Dios

location_facility: Kaiser Permanente-Fremont/Hayward Medical Centers

location_facility: McGuire VA / Division of Infectious Diseases

location_facility: U.O. Malattie Infettive, H.S.Maria Annunziata

location_facility: Centro de Pesquisa Clinical do Hospital Guilherme

location_facility: The Research & Education Group / Multomah Cnty Hlth Dept

location_facility: AIDS Medical Center, International Medical Center

location_facility: Los Angeles Gay and Lesbian Community Service Ctr

location_facility: Johann Wolfgang Goethe University Hospital

location_facility: Homerton University Hospital NHS Foundation Trust

location_facility: Cooper Hospital Early Intervention Program

location_facility: Treasure Coast Infectious Disease Consultants

location_facility: SOCDU Malattie Infettive Ospedale Civile Asti

location_facility: University Of Wisconsin Hospital and Clinics/CORNET, HIV Care Program

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Servizio Regionale di Immunologia Clinica e Tipizz

location_facility: The Research & Education Grp / Oregon Hlth Sci Univ

location_facility: Cassiano Antonio de Moraes University Hospital

location_facility: Washington Reg AIDS Prog / Dept of Infect Dis

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Instituto de Malattie Infettive e Tropicali

location_facility: HIV Services Clinic/Family Practice Medical Center

location_facility: Montreal Chest Institute/Royal Victoria Hospital

location_facility: Providence Hosp- Newland Med Assoc. Inc.

location_facility: Dept. of Infection and Tropical Medicine - Royal Hallamshire Hospital

location_facility: Victoria General Hospital, Q.E. II Health Sciences

location_facility: Center for Prevention and Treatment of Infections

location_facility: Hospital Universitario Principe de Asturias

location_facility: University of Vienna Medical School, AKH

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: The Rsch & Ed Grp / Providence Portland Med Ctr

location_facility: Universidade Federal De Sao Paulo-Hospital Sao Paulo

location_facility: The Research & Education Group / The R & E Grp Office

location_facility: The Caldecot Centre, Kings College Hospital NHS Tr

location_facility: KU Medical School-Wichita, Midtown Clinic

location_facility: Southern Illinois University (SIU) School of Medicine

location_facility: Ambulatorio de Imunodeficiencias Secundarias/Der30

location_facility: Recherche Clinique Centre Medical Halles de Saint-

location_facility: Klein and Slotten Associates / AIDS Research Alliance

location_facility: Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit

location_facility: Infectious Disease Associates of Virginia

location_facility: Centro de Referencia e Treinamento DST/AIDS

location_facility: Cross Over Clinic / Div of Infectious Diseases

location_facility: Wayne State Univ / Medical College of Ohio at Toledo

location_facility: Universita degli Studi di Modena e Reggio Emilia

location_facility: Cobb-Douglas County Infectious Disease Clinic

location_facility: Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

location_facility: HIV Care Program, Windsor Regional Hospital

location_facility: Christiana Care Health Services HIV Program George

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Hawthorn House, Birmingham Heartlands NHS Trust

location_facility: Klinik fur Dermatologie, Venerologie, Allergologie

location_facility: New Jersey Community Research Initiative

location_facility: The Rsch & Ed Grp / Legacy Cln at Good Samaritan


title: Identification of Genetic Factors Predisposing to Dysglobulinemia

acronym: PreFamDys

summary:
Multiple Myeloma (MM) is a malignant proliferation of monoclonal plasma cells. Myeloma accounts for almost 14% of all hematologic cancers and is essentially incurable. Myeloma commonly evolves from a precursor disease, Monoclonal gammopathy of undetermined significance (MGUS). Despite intensive study, the etiology of MGUS and myeloma are unknown and no lifestyle or environmental exposure factors have been identified that are consistently linked to increased risk of MM, MGUS or the transition between the two.

The overall goal is to identify risk genes for dysglobulinemia, and more specifically Multiple Myeloma. This will involve the conservation of cells in a bank and genetic sequencing on samples obtained from families with at least two cases of dysglobulinemia. Material used for sequencing is likely to include fresh peripheral blood cells or lymphoblastoid lines established from peripheral blood lymphocytes of patients.

status: Recruiting

primary_purpose: Screening

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: CHU Groupe Hospitalier Sud Hématologie Clinique

location_facility: Service de Médecine Interne-Hématologie, CHU de Fort de France Fort de France

location_facility: Hématolgie- Hôpital privé Cesson-Sévigné

location_facility: Hôpital St Antoine Service des maladies du Sang

location_facility: Service d'Hématologie Clinique, CHU de Dijon

location_facility: Département d'Oncogénitique - Centre Jean Perrin

location_facility: Hôpital Robert Debré Service du Professeur A. DELMER Hématologie Clinique

location_facility: Hôpital Saint-Eloi, Département d'Hématologie clinique

location_facility: CH William Morey, Service d'Hémato-Oncologie

location_facility: CHR-Metz-Thionville, Hôpital de Mercy, Service d'Hématologie

location_facility: Jean Paul FermandService Immuno-Hématologie Hôpital Saint Louis

location_facility: Service d'Hématologie clinique et Thérapie Cellulaire, CHU de BORDEAUX

location_facility: Service d'Onco-hématologie, Hôpital Saint-Vincent GH-ICL

location_facility: Service d'Oncologie Médical, Centre Azuréen de Canrérologie-1

location_facility: Service d'Oncologie-Radiothérapie - CHU Pointe-à-Pitre/Abymes Guadeloupe

location_facility: Département d'Oncogénétique, Centre Paoli Calmettes

location_facility: Service d'Hématologie, CHU de Versailles

location_facility: Département d'Hématologie à l'Institut de Cancérologie de la Loire

intervention_type: Genetic

status_simplified: Ongoing


title: IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY

acronym: SENTIMAG

summary: The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Eugène Marquis
Centre Alexis Vautrin
Institut Claudius Regaud
Centre Oscar Lambret

lead_sponsor_type: industriel


title: Melatonin Dose-effect Relation in Childhood Autism

acronym: MELADOSE

summary:
Melatonin is a neurohormone produced from serotonin which promotes sleep. The alterations in central and peripheral serotonin neurobiology and in circadian sleep-wake rhythms observed in autistic disorder suggest abnormalities in melatonin secretion.

Several studies have reported a decrease in melatonin secretion in individuals with autism. Furthermore, nocturnal excretion of 6-Sulphatoxymelatonin (the predominant melatonin metabolite) was significantly negatively correlated with severity of autistic impairments in verbal communication and play. Melatonin could therefore have a therapeutic effect on sleep problems and may play a role in the pathophysiology of autistic disorder.

These data highlight the possible therapeutic interest of an oral administration of melatonin in patients with autistic disorder. Thus, the objective of this clinical trial is to study the relation between the melatonin dose administered and its effect on severity of autistic impairments especially in verbal communication and play.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Rennes University Hospital

location_facility: Pôle de Psychiatrie de l'Enfant et de l'Adolescent - Centre Hospitalier Guillaume Régnier

location_facility: Service de Psychiatrie de l'Enfant et de l'Adolescent - Hôpital de la Pitié-Salpêtrière

location_facility: Service de Psychothérapie de l'Enfant et de l'Adolescent - Hôpital Robert Debré

location_facility: Centre Hospitalier Spécialisé Henri Laborit

intervention_type: Drug

status_simplified: Completed


title: A Prospective, Non Randomized, Open, Multicenter Trial to Evaluate Non Specific Symptoms and Quality of Life (SF 36) Before and After Surgery for Mild Primary Hyperparathyroidism

summary: The purpose of this study is to evaluate the evolution of the non specific symptoms for 116 patients with mild primary hyperparathyroidism before and 3, 6 and 12 months after surgery. A clinical score predicting clinical improvement at one year will be created.

lead_sponsor: Nantes University Hospital

location_facility:
Angers University Hospital
Limoges University Hospital
Marseille University Hospital
Nantes University Hospital


title: Autism and Glutamatergic Synapse : Research of Genetic Mutations and Identification of Clinical and Neurophysiological Markers.

acronym: NMDA-Autism

summary: Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism

ReferenceType: result

ReferenceCitation: Bonnet-Brilhault F, Alirol S, Blanc R, Bazaud S, Marouillat S, Thépault RA, Andres CR, Lemonnier É, Barthélémy C, Raynaud M, Toutain A, Gomot M, Laumonnier F. GABA/Glutamate synaptic pathways targeted by integrative genomic and electrophysiological explorations distinguish autism from intellectual disability. Mol Psychiatry. 2016 Mar;21(3):411-8. doi: 10.1038/mp.2015.75. Epub 2015 Jun 9.

family: Bonnet-Brilhault

full_name: F Bonnet-Brilhault

given: F

family: Alirol

full_name: S Alirol

given: S

family: Blanc

full_name: R Blanc

given: R

family: Bazaud

full_name: S Bazaud

family: Marouillat

full_name: S Marouillat

family: Thépault

full_name: R-A Thépault

given: R-A

family: Andres

full_name: C R Andres

given: C R

family: Lemonnier

full_name: É Lemonnier

given: É

family: Barthélémy

full_name: C Barthélémy

given: C

family: Raynaud

full_name: M Raynaud

given: M

family: Toutain

full_name: A Toutain

given: A

family: Gomot

full_name: M Gomot

family: Laumonnier

full_name: F Laumonnier

journal_name: Molecular Psychiatry

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Tours

location_facility: CHRU - Centre de Ressources Autisme (CRA)


title: Study of Serum Hepcidin Rate Variations During Menstrual Cycle

acronym: HEPMEN

summary:
Hepcidin is the major hormone regulating Iron Metabolism. In a normal organism decrease iron stock causes a decrease in hepcidin synthesis thus promoting intestinal absorption of iron.

The interpretation of hepcidin dosage results requires to know the physiological variations of this hormone.

This study investigate whether there are significant variations in the values of serum hepcidin rates during the menstrual cycle in order to make recommendations on the practical dosage determination of hepcidin in premenopausal women.

location_facility:
CHU Rennes
Chru Tours
Chu Brest
CHU Nantes


title: Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma

summary: There is no effective treatment for hemangioma regardless of immediate severity. That is in this respect a orphan disease. These hemangiomas, sometimes large, will have a phase of proliferation of several months (very scary for parents) and regression over several years. The natural history is peppered with local complications (ulcers) and aesthetic and psychological sequelae (sometimes major for the child and the family). The effects of acebutolol and propranolol on the proliferative hemangiomas were discovered accidentally by two French teams (Montpellier for acebutolol and Bordeaux for propranolol). Acebutolol and propranolol have been used for many years for the treatment of hypertension and congenital heart disease, including infants, with few side effects. The effects of acebutolol and propranolol were immediately visible with reduced volume and skin whitening of the hemangioma. In a preliminary study, acebutolol was administered to 20 patients in Montpellier with big regression of hemangiomas. The aim of the study was to compare the clinical efficacy of acebutolol (10mg/Kg/jour) and propranolol (3mg/Kg/j) on the proliferative phase of infantile hemangioma in infants.

lead_sponsor: University Hospital, Montpellier

location_facility:
UH Marseill
Chirurgy Plastic Department
UH NCaremeau
UH Lyon


title: Evaluation of Advantages Linked to the Use of Humidification by ThermoSmart During Continuous Positive Airway Pressure

summary: This study aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it is possible to predict which patients benefit the most (i.e. be more adherent with therapy) from high levels of humidification delivered by ThermoSmart.

lead_sponsor: Fisher and Paykel Healthcare

location_facility:
Hôpital La Pitie Salpetriere
Hôpital Henri Mondor
Hôpital Bichat-Claude Bernard
Hôpital Louis Mourier

intervention_type: Device


title: Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial

summary: The purpose of this study is to test whether propranolol, when given during a re-evocation of a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that memory.

ReferenceCitation: Roullet P, Vaiva G, Véry E, Bourcier A, Yrondi A, Dupuch L, Lamy P, Thalamas C, Jasse L, El Hage W, Birmes P. Traumatic memory reactivation with or without propranolol for PTSD and comorbid MD symptoms: a randomised clinical trial. Neuropsychopharmacology. 2021 Aug;46(9):1643-1649. doi: 10.1038/s41386-021-00984-w. Epub 2021 Feb 21.

family: Roullet

full_name: Pascal Roullet

given: Pascal

family: Vaiva

full_name: Guillaume Vaiva

given: Guillaume

family: Véry

full_name: Etienne Véry

given: Etienne

family: Bourcier

full_name: Axel Bourcier

given: Axel

family: Yrondi

full_name: Antoine Yrondi

given: Antoine

family: Dupuch

full_name: Laetitia Dupuch

given: Laetitia

family: Lamy

full_name: Pierre Lamy

given: Pierre

family: Thalamas

full_name: Claire Thalamas

given: Claire

family: Jasse

full_name: Laurence Jasse

given: Laurence

family: El Hage

full_name: Wissam El Hage

given: Wissam

family: Birmes

full_name: Philippe Birmes

given: Philippe

journal_name: Neuropsychopharmacology

evidence: open (via free pdf)

lead_sponsor: University Hospital, Toulouse

location_facility:
Chru Lille
CHU Toulouse
Chu Montpellier
Centre Hospitalier Charles Perrens


title: Phase I Study of Escalated Pharmacologic Dose, of Oral Folinic Acid in Combination With Temozolomide, According to Stupp R. Regimen, in Patients With Operated Grade-IV Astocytoma and a Non-methylated Gene Status of MGMT.

acronym: FOLAGLI

summary: O6-méthylguanine méthyltransférase (MGMT) is the main repair gene after DNA lesion induced by Temozolomide in combination with radiation therapy of Glioblastoma (GBM) in Stupp.R et al published regimen. In preclinical models, it has been demonstrated that MGMT methylation (which is silencing the DNA repair process) is achievable by folic acid. About half of the patients with operated GBM have an un-methylated MGMT gene status and therefore a poorer prognosis. A phase-1 dose escalation study is proposed with pharmacologic doses of folinic acid in combination with temozolomide and radiotherapy of operated GBM.

ReferenceCitation: Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cacerologie de l'ouest - site Paul Papin

intervention_type: Radiation


title: Home-Based Technologies Coupled to Teleassistance Service: Efficacy for Preventing Falls at Home in Frail Elderly Population Losing Autonomy

acronym: DOMOLIM

summary:
The growth of the elderly population is associated with the autonomy failure and the increase of dependence problems. Fall incidents are the third cause of chronic disablement in older persons and are one of the major risk factors for entering in dependence.

The recent progress in home technologies and medical care are opportunities to search how to apply these tools to reduce and prevent falling at home.

The purpose of this study is to evaluate the cost effectiveness of simple home automation pack coupled to teleassistance service for preventing home falls in frail elderly population.

1200 patients will be enrolled and randmosied within two arms:

home with automation pack coupled to teleassistance service
home without this technology

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Limoges

location_facility:
CH de Gueret
CHU Limoges
CH Bourganeuf
CH Aubusson


title: Impact of Breast Cancer on Quality of Life of the Young Women, Her Life Partner and Her Couple

acronym: KALICOU

summary: The study aims to analyse and decode interviews of patient with breast cancer, and then established according a multidimensional profile specific to the population and to create a questionnaire tha will allow a practical and qualitative evaluation of the quality of life.

location_facility:
Oscar Lambret Center
Hospital
François Baclesse Center
Gustave Roussy Institut

intervention_type: Behavioral


summary: The purpose of this study is to evaluate the safety profile of a repeated application of a new transdermal patch compared to a reference product during 3 weeks, in a large population.

lead_sponsor: Pierre Fabre Medicament


title: Phase I Clinical and Pharmacokinetic Study of Pazopanib in a Population of Frail Elderly Patients According SIOG Criteria

acronym: VOTRAGE

summary:
This is an open-label, multicenter, non-randomized, phase 1 dose escalation clinical trial to determine the MTD (Maximal Tolerated Dose) of Pazopanib in a population of frail elderly patients, selected according to the International Society of Geriatric Oncology (SIOG)classification (Group 2).

It is expected that a total number of 30 patients maximum will be enrolled in the study on 30 months : 18 months accrual - 12 months follow up.

Eligible patients will be enrolled into a standard 3+3 design with a starting dose of Pazopanib administered orally at 400 mg per day, in 28-day cycles. Then, further dose levels will be explored.

Toxicity of the schedule will be assessed during the first cycle. Patients will receive study medication until disease progression. After treatment discontinuation, patients will be followed during one year.

lead_sponsor: Institut Claudius Regaud

location_facility:
Centre Léon BERARD
Hôpital Saint André
Centre François BACLESSE
Institut Claudius REGAUD


title: Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

acronym: TOMOSEIN

summary: This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)

location_facility:
Oscar Lambret Center
Centre Hospitalier
Clinique des Dentellières
Centre Hospitalier - Pavillon Paul Gelé


title: Allogeneic Hematopoietic Stem Cell Transplantation Using a Non-myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-thymocyte Globulin for Older Patients With Relapsed Lymphoid Malignancies

acronym: TLI-ATG

summary: Recent advances in allogeneic hematopoietic cell transplantation (allo-SCT) have led to reduce intensity preparative regimens that are non-myeloablative and reduce the toxicities associated with the transplant. Consequently non-relapse mortality has been reduced, including in elderly patients with comorbidities. However, despite this benefit in terms of toxicity, excessive reduction of the intensity preparative regimens may favor relapse of the initial illness. Thus, acute and chronic graft-versus-host disease and opportunistic fungal and viral infections are always serious complications. The aim of our study is to check if a new modality of reduced intensity preparative regimen combining total lymphoid irradiation (TLI) and thymoglobulin (ATG), would limit the toxicity of treatment and reduce the incidence of acute GVHD after allogeneic transplantation while preserving the antitumor benefit.

location_facility:
Besançon University Hospital
Lille University Hospital
Lyon University Hospital
Nantes University Hospital


title: Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome

acronym: CARDIOMEGA

summary: The overall aims of the present project are to investigate the impact of a nutritional approach based on omega-3 from vegetal origin on vascular function in hypertension associated with metabolic syndrome.

lead_sponsor: University Hospital, Rouen

location_facility:
Rangueil University Hospital
Mahes Hospital
George Pompidou European Hospital
Rouen University Hospital

intervention_type: Dietary Supplement


title: Impact of Essure Tubal Sterilization Devices on the Endometrium

summary: The mobilization of natural killer cells (uNK) triggers and coordinates all stages of embryo implantation. They are at the origin of the local secretion of cytokines, growth factors, chemokines affecting vascular development and the local immunotrophisme for the conceptus. The main objective of this study is to evaluate the expression of endometrial uNK cells before and after tubal obstruction by Essure devices. Endoluminal and endometrial levels of various cytokines and growth factors will also be studied.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: APHP - Centre Hospitalier Universitaire de Bicêtre

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve


title: Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families

summary: Relapse of post-traumatic stress disorder (PTSD) remains challenging. In addition, factors predicting PTSD relapse are still unknown. The aim of this study is to examine whether clinical and neuropsychological changes (e.g., attentional bias toward aversive cues) that characterized PTSD can be observed in people with past PTSD (children and their families) and whether these persistent changes are predictive of PTSD relapse.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Fondation Lenval
CHU de TOURS
CHU de TOULOUSE
CHU de NICE


title: Prevalence of Dissociative Disorders in Children in a Population Supported in the Medico-social and Health Structures in Provence Alpes Cote d'Azur

summary:
Schizophrenia beginning before 18 years is a clinical entity not well known because of its low incidence and difficulties in the clinical diagnosis.

However, in the investigators clinical practice, due to the specialization of the investigators service, the investigators are led to hospital to receive important feel active of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text revision (DSM IV-TR) precose schizophrenia.

The work of us team on the theme of the relationship between Pervasive Developmental Disorders and precose Schizophrenia led us to hypothesize that a number of children in care in the medical and educational institutes, hospitals and day shelters therapeutic part-time symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not diagnosed.

The main goal is to estimate the prevalence of dissociative disorders in a population of children in care institutions and medical education in child psychiatry in hospitals and others structures.

ReferenceCitation: Dor-Nedonsel E, Menard ML, Fernandez A, Sakarovitch C, Fontas E, Salle-Collemiche X, Poinso F, Tosello AL, Maria F, Manera V, Askenazy F, Thümmler S. Early-Onset Schizophrenia in a paediatric population of French psychiatric and medico-social care centres: A cross sectional study. PLoS One. 2020 Jul 27;15(7):e0236241. doi: 10.1371/journal.pone.0236241. eCollection 2020.

family: Dor-Nedonsel

full_name: Emmanuelle Dor-Nedonsel

given: Emmanuelle

family: Menard

full_name: Marie-Line Menard

given: Marie-Line

family: Fernandez

full_name: Arnaud Fernandez

given: Arnaud

family: Sakarovitch

full_name: Charlotte Sakarovitch

given: Charlotte

family: Fontas

full_name: Eric Fontas

given: Eric

family: Salle-Collemiche

full_name: Xavier Salle-Collemiche

given: Xavier

family: Poinso

full_name: François Poinso

given: François

family: Tosello

full_name: Anne-Lise Tosello

given: Anne-Lise

family: Maria

full_name: Fanny Maria

given: Fanny

family: Manera

full_name: Valeria Manera

given: Valeria

family: Askenazy

full_name: Florence Askenazy

given: Florence

family: Thümmler

full_name: Susanne Thümmler

given: Susanne

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

location_facility: Service de psychiatrie de l'enfant et de l'adolescent

location_facility: Psychiatrie infanto-juvénile-Pôle femme-mère -enfant

location_facility: Psychiatrie infanto-juvénile - Centre Hospitalier d'Antibes


title: NP137 - An Open-label, First in Human, Phase I Trial Aiming to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of a Humanized Monoclonal Antibody Targeting Netrin 1 (NP137) in Patients With Advanced/Metastatic Solid Tumors.

summary:
For most advanced solid tumors, current therapy is inadequate at improving quality of life, slowing progression of disease, prolonging survival, and providing a cure. Hence, there is a continuous need for innovative, safer and more effective anti-cancer therapies. Our study is based on the dependence receptor paradigm and the associated therapeutic strategy. In preclinical models, preventing Netrin-1 interaction with its receptors is sufficient to trigger Netrin-1-expressing tumor cell death in vitro as well as tumor growth and metastasis inhibition in vivo. This indicates that a therapeutic approach based on Netrin-1/Netrin-1 receptors interaction inhibition is both feasible and promising. NP137 is a "first-in-class" humanized monoclonal antibody targeting the Netrin-1 ligand, a secreted protein recently described as a driver of tumor initiation and progression. NP137 demonstrated anti-tumor activity as a single agent in several pre-clinical models of cancer, including breast and lung cancer. Taken together, several studies strongly support the rational for preclinical development and clinical evaluation of a highly potent and selective anti-Netrin-1 antibody in cancer patients. The proposed study is an open label, multicenter, Phase I dose escalation study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and preliminary anti-tumor activity of NP137 administered every 2 weeks (Q2W) as single agent in patients with locally advanced or metastatic solid tumors. This trial will be the First in Human (FIH) study for NP137; there is no clinical experience with this antibody in the clinic. The study consists of 3 parts:

Part 1) a dose escalation part to define the Maximum tolerated dose and the Recommended Phase II dose (MTD /RP2D) of NP137 as well as to research some PD biomarkers (Biological collection cohorts) - This part is now completed with Last Patient In on December 20th 2018 - Part 2) an expansion part#1 to investigate NP137 clinical activity as a single agent by collecting the 3-month objective response rate (ORR3m).

Part 3) an expansion part#2 to investigate NP137 clinical activity as a single agent by collecting the 3-month objective response rate (ORR3m) in RH+ patients with endometrial carcinoma.

ReferenceCitation: Sun Y, Manceau A, Frydman L, Cappuccio L, Neves D, Basso V, Wang H, Fombonne J, Maisse C, Mehlen P, Paradisi A. Δ40p53 isoform up-regulates netrin-1/UNC5B expression and potentiates netrin-1 pro-oncogenic activity. Proc Natl Acad Sci U S A. 2021 Sep 7;118(36). pii: e2103319118. doi: 10.1073/pnas.2103319118.

family: Sun

full_name: Yan Sun

given: Yan

family: Manceau

full_name: Ambroise Manceau

given: Ambroise

family: Frydman

full_name: Lisa Frydman

given: Lisa

family: Cappuccio

full_name: Lucie Cappuccio

given: Lucie

family: Neves

full_name: David Neves

given: David

family: Basso

full_name: Valeria Basso

family: Wang

full_name: Hong Wang

given: Hong

family: Fombonne

full_name: Joanna Fombonne

given: Joanna

family: Maisse

full_name: Carine Maisse

given: Carine

family: Mehlen

full_name: Patrick Mehlen

given: Patrick

family: Paradisi

full_name: Andrea Paradisi

given: Andrea

bso_classification: Biology (fond.)

journal_name: Proceedings of the National Academy of Sciences

oa_host_type: repository

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

repository_normalized: HAL

version: submittedVersion

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

lead_sponsor: Centre Leon Berard

location_facility:
Ico - Rene Gauducheau
IUCT-Oncopôle de Toulouse
Centre Léon Bérard


title: Randomized Controlled Trial of the Effectiveness of the Cognitive-behavioral Approach, Standard Plan Security on Relapse Suicidal Adolescents

acronym: SECURIPLAN

summary: The recommendation for the treatment of suicidal adolescents, Cognitive Behavioral Therapy (CBT) targeted new generation offer effective approaches to suicidal crisis and relapse prevention

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Chu Charles Nicolle
CHU CAEN
Chu Amiens Picardie


title: Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.

acronym: NeuroScS

summary: Systemic sclerosis is a rare disease with vascular involvement and systemic fibrosis. This disease is usually thought to spare central nervous system. However, neuropsychiatric manifestations like depression and cognitive functions impairment seem to be frequent. Pathophysiology of this neuropsychiatric manifestations is currently unknown. White matter hyperintensities have been reported suggested CNS vascular manifestations in systemic sclerosis. Whether this CNS vascular involvement plays a role in neuropsychiatric manifestations in systemic sclerosis is unknown. The primary objective of this prospective and multicentre study is to assess a link between neuropsychiatric manifestations and CNS involvement in systemic sclerosis. Secondary objectives are to assess the frequency of neuropsychiatric manifestations, to compare central nervous system abnormality between scleroderma patient and healthy subjects. Central nervous system involvement and neuropsychiatric manifestations will be systematically assessed through central nervous system imaging and questionnaires.

ReferenceCitation: Launay D, Remy-Jardin M, Michon-Pasturel U, Mastora I, Hachulla E, Lambert M, Delannoy V, Queyrel V, Duhamel A, Matran R, De Groote P, Hatron PY. High resolution computed tomography in fibrosing alveolitis associated with systemic sclerosis. J Rheumatol. 2006 Sep;33(9):1789-801.

lead_sponsor: University Hospital, Lille

location_facility:
Amiens Launay
Rouen University hospital
Lille University hosiptal
Caen University Hospital


title: Assessment of Tissue and Biomolecular Complements of Lower Limb Chronic Oedema

acronym: CHROEDEM

summary: The chroedem study is aiming to assess tissue and biomolecular components of chronic lower limb oedema (CO). The investigators working hypothesis is that according to the aetiology of CO, the proportion of oedema & composition of peri-oedema tissues (fat, muscle, fibrosis/inflammation) might differ and could at least in part explain differences in failure/success of compressive therapies from one patient to another. For that purpose, 24 patients with a post-thrombotic syndrome (PTS)-related oedema and 24 patients with a primary lymphedema will undergo a magnetic resonance imaging (MRI)) of the legs and biological (genetic) testing.

location_facility:
University Hospital Nimes
University Hospital of Montpellier
Pr Sophie BLAISE


title: Study of Gut Microbiota in Primary Immune Deficiencies, Possibly Associated With Inflammatory Bowel Disease (Chronic Granulomatous Disease, XIAP Gene Deficiency, or TTC7A Gene Deficiency)

acronym: DIPobiota

summary:
Some Primary Immune Deficiencies can be associated with an inflammatory bowel disease, mimicking Crohn disease : the Chronic Granulomatous Disease (CGD), the XIAP deficiency, and the TTC7A deficiency.

This inflammatory bowel disease is frequent but inconstant, raising questions about other factors contributing to the disease. The aim of our study is to analyze, describe and compare the gut microbiota of patients with those primary immune deficiency, with or without intestinal disease.

The investigators can expect, in the long term, to compare on a same patient, the gut microbiota evolution, and to assess the role of gut microbiota modifications on the onset of an inflammatory bowel disease.

lead_sponsor: Imagine Institute

location_facility:
Necker - Enfants Malades Hospital
Saint-Louis Hospital
CHRU

intervention_type: Biological


title: Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging

acronym: MRTOX

summary: The main objective of this study is to compare the proportions of late enhancement in patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.

lead_sponsor: Centre Francois Baclesse

location_facility:
Clinique du Bois
Centre Georges-François Leclerc
Centre François Baclesse
CHU de NANCY


title: Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation

acronym: AADAPT

summary:
A pharmacokinetics and pharmacogenetics study to complement the current knowledge of tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after renal transplantation.

Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus immediate release (Prograf®)

location_facility:
CHRU Tours Hôpital Bretonneau
CHU de Nice
Hôpital Bicêtre
CHU de Rangueil


title: Triple Negative Breast Cancer: Study of Molecular and Genetic Factors

summary:
Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. It is however a heterogenous group for histological and molecular level, but also for evolution. Most of the TN is part of the basal breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.

Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors. They would be much more frequent in the TN group. However, at this day, no prospective study was led to estimate this incidence, or to study the intervention of other genes of predisposition, as well to analyse the links between this phenotype and their consequences at the germinal or somatic level, in terms of associated molecular changes and prognosis.

The purpose of this study is, on a prospective study, to lead a joined analysis at the germinal level, in search of mutations of the main genes of breast cancer predisposition (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and transcriptome), by correlating these results to the main clinical parameters.

The 5 years relapse-free survival will also be estimated.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Centre jean Perrin
Institut Paoli-Calmettes
Centre Antoine Lacassagne
Hopital La Timone


title: Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation and Influence Over Mechanical Ventilation Weaning Period

acronym: ECHODIAPH II

summary: Extubation is a crucial step when patients are being weaned from mechanical ventilator support. Indeed, the patient has to face an increasing burden imposed to the ventilation system. The ability to overcome this event will determine the patient survival. A warning signal could be very useful is this situation. 2 recent studies have shown that measuring diaphragmatic cupolas and muscular fibers thickening fraction could help to spot a population with a high risk of "diaphragmatic weakness", characterized by a high failure extubation rate. This study aims to verify that this kind of group of patients does exist.

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

location_facility: Centre Hospitalier Universitaire de Poitiers


title: Effectiveness of Animated Cartoons for Improving Cooperation During the Delivery of Inhaled Treatments to Young Children With Asthma

acronym: DISTRACT

summary:
Up to 50% of infants and young children cry during the administration of their inhaled treatment for their asthma. This results in decreased lung deposition, and thus decreased effectiveness of their inhaled treatment.

The objective of this study is to evaluate whether animated cartoons can increase the cooperation of young children with asthma who are not cooperative during the delivery of their ICS therapy through a pMDI/spacer.

primary_purpose: Supportive Care

ReferenceCitation: Guilbert TW, Morgan WJ, Zeiger RS, Mauger DT, Boehmer SJ, Szefler SJ, Bacharier LB, Lemanske RF Jr, Strunk RC, Allen DB, Bloomberg GR, Heldt G, Krawiec M, Larsen G, Liu AH, Chinchilli VM, Sorkness CA, Taussig LM, Martinez FD. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N Engl J Med. 2006 May 11;354(19):1985-97.

ReferenceCitation: Iles R, Lister P, Edmunds AT. Crying significantly reduces absorption of aerosolised drug in infants. Arch Dis Child. 1999 Aug;81(2):163-5.

ReferenceCitation: Lee J, Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1168-73. doi: 10.1213/ANE.0b013e31824fb469. Epub 2012 Sep 25.

lead_sponsor: Hôpital Necker-Enfants Malades

location_facility: Department of pediatric pulmonology, Hopital Robert Debré

location_facility: Department of pediatrics, Mignot Hospital

location_facility: Department of pediatric pulmonology, Necker Hospital


acronym: IVT-RNFL

summary: The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is currently the standard treatment for retinal neovascularization. The VEGF stimulates endothelial cells' proliferation and migration. It also increases microvascular permeability. If the VEGFs have proven their efficiency in the decrease of choroidal neovascular proliferation, their impact of the head of the optic nerve's microvasculature is yet unknown. Knowing that this microvasculature provides the retinal nerve fibers with oxygen, located in the area of the head of the optic nerve, a vasoconstriction induced by the anti-VEGF may have an incidence on the loss of retinal nerve fibers.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Centre médical et chirurgical de la rétine

location_facility: Fondation Ophtalmologique A. de Rotchschild


title: Evaluation de l'Effet de la tDCS Sur Les Fonctions Cognitives de Patients Souffrant de Maladie d'Alzheimer et Maladies apparentées au Stade léger

acronym: ALSTICO

summary:
The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left Cortex DorsoLateral PreFrontal (CDLPF) of Alzheimer's or Primary Progressive Aphasia (PPA) patients compared to the application of a placebo tDCS (sham procedure) on cognitive functions, which are evaluated at short term (1 week post-treatment) and mild term (3 weeks post-treatment).

After unblinding, patients who received placebo treatment could be received active tDCS.

ReferenceCitation: Bereau M, Sylvestre G, Mauny F, Puyraveau M, Baudier F, Magnin E, Berger E, Vandel P, Galmiche J, Chopard G. [Assessment of 10 years of memory consultations in the Franche-Comté: Description and analysis of the RAPID regional database]. Rev Neurol (Paris). 2015 Sep;171(8-9):655-61. doi: 10.1016/j.neurol.2015.04.008. Epub 2015 Jul 23. French.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: CHU Besancon - Clinical Psychiatric Department


title: Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP

acronym: DIDOCAP

summary:
Nursing study, prospective, randomized, two-center open-label.

Patients will be randomized into two groups during their first laying Qutenza®:

Patients receiving the laying of Qutenza® without refrigerated cushion
Patients receiving the laying of Qutenza® associated with a refrigerated cushion

The objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (Qutenza®) in patients localized neuropathic pain.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHD Vendée de la Roche sur Yon
Clinique Brétéché
CHLVO de Challans


title: Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of Chronic Philadelphia Negative Myeloproliferative Neoplasms

acronym: MICROP-SMP

summary:
Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have a higher risk of arterial or deep-vein thrombosis. This is responsible for a significant increase in mortality (up to 31% of increase in thrombosis risk in ET). Cellular inflation and blood hyperviscosity, resulting from these diseases, fail to account for these thromboses, as more than 50% of thrombotic complications happen under adapted antineoplastic drug treatment.

These last years, cellular microparticles (MPs) have been shown to play a major role in thrombogenesis. MPs are generated by apoptosis or the activation of malignant cells, platelets, endothelial cells or monocytes. They are fragments of plasma membrane, smaller than 1 µm, rich in phosphatidylserine, which can express the tissue factor and serve as support for the coagulation factors. Increase in the plasma concentration of procoagulant platelet microparticles has been demonstrated in other thrombotic diseases (acute coronary syndrome, disseminated intravascular coagulation DIC, etc.). The working hypothesis is that platelet microparticles are involved in the hypercoagulability of MPNs patients.

lead_sponsor: Lille Catholic University

location_facility:
EFS
GHICL
CHRU Lille


title: Prospective Observational Study to Investigate the Added Value of the Health Related Quality of Life and Patient Reported Symptoms in the Identification of the Recommended Phase II Dose in Phase I Trials of Molecularly Targeted Therapies.

acronym: QoL Phase I

summary:
A prospective cohort of 250 patients with solid tumours included in phase I clinical trials of targeted agents will be enrolled. Patients will be treated with MTA in mono therapy or in association with chemotherapy or other targeted agents in 4 large phase I centers.

Patients from trials investigating chemotherapy alone will not be included. Quality of life will be assessed during the treatment period.

lead_sponsor: Institut Curie

location_facility:
Centre Claudius Regaud
Institut Curie
Centre Georges Francois Leclerc


title: Evaluation of an Organized Consultation "Return Home" of Patients With a Cancer (CREDO)

acronym: CREDO

summary:
Prospective, open label, randomized and multicentric study evaluating the efficacy of an organized consultation "return home" compared to a current standard of care in patient hospitalized due to metastatic solid tumor cancer.

Subject will be randomized (1:1) as described below :

• Arm A (standard) : current standard of care ; connection documentation faxed to GP ( General practitioner) on the day of patient's discharge Arm B (experimental) : CREDO standard of care, organized consultation "return home" between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP

status: Active, not recruiting

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Claudius Regaud
Hopital Rangueil
Centre Hospitalier Auch


title: Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI)

acronym: SDI

summary: The investigators want to validate the Sleep Diversity Index as a diagnosis tool of sleep fragmentation on 405 patients who will perform a polysomnography under spontaneous breathing.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (CHITS)


title: Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy

summary: Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma.

location_facility: Groupe Hospitalier Necker Enfants Malades


title: Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies. Prospective and Multicentric Study

acronym: MEDWATCH

summary:
Meningitis are serious infections. Evidenced by high rates of mortality and sequelae. However, these diseases have a relatively small impact. Also physician services Home Emergencies they must be vigilant, alert, for clinical signs to be suspected meningitis. Indeed, it is only after this essential clinical milestone that will be carried out a lumbar puncture which will confirm the diagnosis and to quickly begin treatment.

Unfortunately, if recent studies can improve the therapeutic management of patients with meningitis, no study was interested in yet fundamental step of diagnosis.

It seems therefore necessary to achieve a prospective clinical study to reassess the adequacy of the clinical signs in the diagnosis of meningitis. The ideal would be to achieve a predictive clinical score of the presence or absence of meningitis.

lead_sponsor: Nantes University Hospital

location_facility:
Nantes University Hospital
Châteaubriant Hospital
Saint-nazaire Hospital


title: Analgesia and Physiotherapy in Children With Cerebral Palsy (ANTALKINECP): Double Blind Cross-over Placebo Controlled Study of Ibuprofen in Children With Cerebral Palsy Undergoing Physiotherapy

acronym: ANTALKINECP

summary:
SPARCLE 1 and 2 studies followed a cohort of 818 children with cerebral palsy (CP) between 8 and 12 (SPARCLE 1) and 13 and 18 years old (SPARCLE 2) interviewed at home. The prevalence of pain in these populations was respectively 60 and 69% while it is about 35% in typically developed children of the same age.

The main location of the pain for 60% of children with CP was the lower limbs, caused by musculoskeletal pain and movement (for those who can) and therapeutic procedures. In SPARCLE 2, 50% of the children complained about pain during physical therapy.

If the pain is part of the management of physiotherapy, a recent review showed that for a condition such as chronic back pain, the level of evidence of the effectiveness of physiotherapy techniques in reducing pain is low. The effectiveness of these techniques would include higher efficacy on anxiety than pain itself.

Despite significant involvement of physiotherapists in the management of pain, the focus on pain should increase, in particular taking into account the procedural/induced pain (caused by treatment).

In addition to drugs, physical methods (analgesic therapy) or psychotherapy are used to reduce the pain of children during medical procedures. For the latter most of them require the presence of two individuals to provide the therapy. This is unsuited for out-patient care provided to the majority of children with CP.

Non steroid anti-inflammatory drug (NSAIDs), are first recommended, alone or in combination with the treatment of several indications in child pain (migraine, postoperative pain, etc.). Ibuprofen is commonly used in children during painful procedures and represented the 4th molecule among prescribed per os analgesic drugs in 2008 in the United States.

lead_sponsor: University Hospital, Brest

location_facility:
Ch Lannion-Trestel
Hopitaux de Saint-Maurice
Hôpital Morvan - CHRU Brest


title: Everolimus Modulation of Anti-tumor T CD4 Immune Responses

acronym: EMIR

summary:
Everolimus is an inhibitor of mammalian target of rapamycin, approved in patients with metastatic renal cell carcinoma.

The objective of this study is to investigated the influence of everolimus immune modulation on antitumor efficacy .

location_facility: Centre Hospitalier Universitaire de Besançon


title: Assessment of an Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People

summary:
The purpose of this study is to assess an innovative Visual Analogue Scale of pain (pictorial VAS) versus the usual VAS (VAS) among Deaf People.

The assumption of this study is that pictorial VAS is more suited to Deaf people than usual VAS.

ReferenceCitation: Dagron J. [Deafness and recourse to help, starting the dialog]. Soins. 2001 Dec;(661):37-9. French.

ReferenceCitation: Dagron J .Les silencieux. Chroniques de vingt ans de médecine avec les Sourds. Editions : Presse Pluriel, Paris. 2008 ; 287 p.

ReferenceCitation: Delaporte Y. Chapitre 1 : Qui sont les Sourds, histoire d'un mot. In : Les Sourds, c'est comme ça. Editions de la Maison des sciences de l'homme, Paris 2002 ; 398 p.

ReferenceCitation: Gillot Dominique. Le Droit des Sourds. Juin 1998. (mis en ligne le date : http://www.sante.gouv.fr/).

ReferenceCitation: Loi n°2005-102 du 11 février 2005. Pour l'égalité des droits et des chances, la participation et la citoyenneté des personnes handicapées.

ReferenceCitation: Circulaire ministérielle n°DHOS/E1/DGS/SD1B/SD1C/SD4A/2006/90 du 2 mars 2006. La Charte de la personne hospitalisée.

ReferenceCitation: Circulaire N°99-84 du 11.02.1999. (Relative à la mise en place de protocole de prise en charge de la douleur).

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital
La Pitié-Salpêtrière


title: A Prospective Multicentric Evaluation of the Rate of Incidence of Hypothyroidism After Supraclavicular Irradiation for Breast Cancer

acronym: EPITHERM

summary:
Prospective, multicentric, comparative, non randomised, in current care.

Primary objective:

To evaluate the incidence of hypothyroidism in breast cancer patients treated by radiotherapy including the supra-clavicular area over a period of 5 years (60 months).

Secondary objectives :

To calculate the dose of irradiation received by thyroid gland during the treatment.
To compare the rate of incidence of hypothyroidism in women who received a supra-clavicular irradiation (group 1)and in those who did not (group 2).
To estimate and compare the rate of incidence of chronic thyroid lesions in the 2 groups.
To look for predictive factors of hypothyroidism de novo in group 1 women particularly regarding the dose-volume parameters.
To propose recommendations for the thyroid follow-up after supra-clavicular irradiation.

ipd_sharing: Undecided

lead_sponsor: Institut Jean-Godinot

location_facility:
Institut de Cancerologie de Lorraine
Institut Jean Godinot
Centre Paul Strauss


title: Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma

acronym: MCSF-MYELOME

summary: The Primary objective of this study is to compare serum levels of Macrophage-Colony Stimulating Factor (M-CSF) in a population of patients with multiple myeloma (MM), in a population of patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and in a control population.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Ch Saint Quentin
CHU Amiens
CH Beauvais


title: A Multicenter, Randomized, Double-blinded, Placebo-controlled Study of IL-7 to Restore Absolute Lymphocyte Counts in Sepsis Patients

summary:
A multicenter, randomized, double-blinded, placebo-controlled study of two dosing frequencies of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte counts in sepsis patients; IRIS-7A (Immune Reconstitution of Immunosuppressed Sepsis patients).

A parallel study will be performed in United State of America to allow a common statistical analysis of the primary end points and analysis for the enrolled patient population.

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

family: Francois

full_name: Bruno Francois

given: Bruno

family: Jeannet

full_name: Robin Jeannet

given: Robin

family: Daix

full_name: Thomas Daix

given: Thomas

family: Walton

full_name: Andrew H. Walton

given: Andrew H.

family: Shotwell

full_name: Matthew S. Shotwell

given: Matthew S.

family: Unsinger

full_name: Jacqueline Unsinger

given: Jacqueline

family: Monneret

full_name: Guillaume Monneret

given: Guillaume

family: Rimmelé

full_name: Thomas Rimmelé

family: Blood

full_name: Teresa Blood

given: Teresa

family: Morre

full_name: Michel Morre

given: Michel

family: Gregoire

full_name: Anne Gregoire

given: Anne

family: Mayo

full_name: Gail A. Mayo

given: Gail A.

full_name: Jane Blood

given: Jane

family: Durum

full_name: Scott K. Durum

given: Scott K.

family: Sherwood

full_name: Edward R. Sherwood

given: Edward R.

family: Hotchkiss

full_name: Richard S. Hotchkiss

given: Richard S.

journal_name: JCI Insight

repository_institution: PubMed Central - Europe PMC

repository_institution: Washington University School of Medicine - Digital Commons@Becker

publisher: American Society for Clinical Investigation

lead_sponsor: University Hospital, Limoges

location_facility: Hospice Civil de Lyon - Hôpital Edouard Herriot - Service de Réanimation Médicale

location_facility: Hopital Lariboisière - Service d'anesthésie-réanimation


title: Muscle Oxygenation Modification During Effort in 4 Groups of Neuromuscular Diseases Compared to Healthy Controls, and Mitochondrial Function and Phenotype Assessment

acronym: OXYNEMU

summary:
Previous studies showed modifications of muscle oxygenation parameters in muscular dystrophies du to an impairment or an absence of dystrophin.

Our study aim at assessing muscle oxygenation during effort in different neuromuscular diseases (muscular dystrophies related and not related to dystrophin, non dystrophic myopathies and motor neuron diseases) compared to a group of healthy controls. Patients and controls are invited to perform an inframaximal , standardized effort of the knee extensors by the mean of an isokinetic dynamometer. Muscle oxygenation parameters are assessed through a Near Infrared Spectroscopy (NIRS) Device.

In patients affected by dystrophin related myopathies, a muscle biopsy will be performed in order to analyse mitochondrial oxygenation parameters and mitochondrial phenotype.

Our Hypothesis is that muscle oxygenation is impaired in dystrophin related muscular dystrophies compared to other neuromuscular diseases and healthy controls because of lack of muscle capillary vessels dilatation during effort and impairment of mitochondrial function.

ReferenceCitation: Allart E, Olivier N, Hovart H, Thevenon A, Tiffreau V. Evaluation of muscle oxygenation by near-infrared spectroscopy in patients with Becker muscular dystrophy. Neuromuscul Disord. 2012 Aug;22(8):720-7. doi: 10.1016/j.nmd.2012.04.011. Epub 2012 Jun 8.

lead_sponsor: University Hospital, Lille

location_facility: Hôpital Amiens Nord, Service de Neurologie


title: Medico-economic Evaluation of Robotic-assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy

acronym: ROBOTCAP

summary: In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA < 0.2).

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de Lyon

location_facility: Service d'Urologie - Institut Mutualiste Montsouris

location_facility: Service d'Urologie - Clinique St Augustin


ReferenceCitation: Gorduza D, Plotton I, Remontet L, Gay CL, El Jani M, Cheikhelard A, Blanc T, El Ghoneimi A, Leclair MD, Roy P, Pirot F, Mimouni Y, Gaillard S, Chatelain P, Morel Y, Kassai B, Mouriquand P. Preoperative Topical Estrogen Treatment vs Placebo in 244 Children With Midshaft and Posterior Hypospadias. J Clin Endocrinol Metab. 2020 Jul 1;105(7). pii: dgaa231. doi: 10.1210/clinem/dgaa231.

name: Centre de Référence Maladies Rares Développement Génital: du Fœtus à l’Adulte, Hospices Civils de Lyon, Bron, France

name: Service de Chirurgie Uro-Viscérale de l’Enfant-Hôpital Mère Enfant, Hospices Civils de Lyon, Bron, France

family: Gorduza

full_name: Daniela Gorduza

given: Daniela

name: Service d’Endocrinologie Pédiatrique, Hôpital Mère-Enfant, Centre Hospitalo-Universitaire de Lyon, Bron Cedex, France

family: Plotton

full_name: Ingrid Plotton

given: Ingrid

name: Université Lyon 1; CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Villeurbanne, France

name: Hospices Civils de Lyon, Service de Biostatistiques, Lyon, France

family: Remontet

full_name: Laurent Remontet

given: Laurent

family: Gay

full_name: Claire-Lise Gay

given: Claire-Lise

name: Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France

family: El Jani

full_name: Meriem El Jani

given: Meriem

name: Service de chirurgie viscérale et urologie pédiatrique, APHP, Hôpital Necker, Paris, France; Université Sorbonne Paris cité, Paris, France

family: Cheikhelard

full_name: Alaa Cheikhelard

given: Alaa

family: Blanc

full_name: Thomas Blanc

name: Service de chirurgie viscérale et urologie pédiatrique, Centre de Référence des Maladies Endocriniennes Rares de la Croissance, Hôpital Robert Debré, APHP, Université Paris Diderot, Paris, France

family: El Ghoneimi

full_name: Alaa El Ghoneimi

name: Service de chirurgie pédiatrique, CHU de Nantes, Nantes, Loire Atlantique, France

family: Leclair

full_name: Marc-David Leclair

given: Marc-David

family: Roy

full_name: Pascal Roy

given: Pascal

name: Service pharmaceutique, Plateforme FRIPHARM, Groupement Hospitalier Edouard Herriot, Lyon Cedex, France

name: Laboratoire de Recherche et Développement de Pharmacie Galénique Industrielle, Plateforme FRIPHARM, Faculté de Pharmacie, Laboratoire de Biologie Tissulaire et Ingénierie Thérapeutique – UMR 5305, Université Claude Bernard Lyon 1, Lyon Cedex, France

family: Pirot

full_name: Fabrice Pirot

given: Fabrice

family: Mimouni

full_name: Yanis Mimouni

given: Yanis

family: Gaillard,

full_name: Segolene Gaillard,

given: Segolene

family: Chatelain

full_name: Pierre Chatelain

given: Pierre

name: Laboratoire d’Hormonologie d’Endocrinologie Moléculaire et des Maladies Rares, INSERM 1208, Groupement Hospitalier Est, Hospices Civils de Lyon, Bron, France

family: Morel

full_name: Yves Morel

given: Yves

family: Kassai

full_name: Behrouz Kassai

given: Behrouz

name: Université Claude-Bernard-Lyon 1, Lyon, France

family: Mouriquand

full_name: Pierre Mouriquand

journal_name: The Journal of Clinical Endocrinology & Metabolism

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

primary_purpose: Prevention

acronym: HYPOSPADES

location_facility: Service de Chirurgie Pédiatrique Uro-génitale, Hopital femme Mere Enfant

title: Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications.

summary:
Hypospadias is a congenital abnormality of the penis that is caused by incomplete development of the anterior urethra. This pathology is one of the most common genital anomalies in paediatric urology .The incidence is reported to be 1 out of 250 live male births and is increasing regularly. The hypospadias surgeries present a high risk of post operative complications requiring re-interventions.

A great part of the post operative complications is related to imperfect healing issues. If androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact positively on the skin healing process. This point leads to the hypothesis that local transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the number of skin healing post-operative defects.

The objective of the study is to assess the effect of oestrogen (applied once daily for 2 months prior to surgery) on the post-operative complications.


title: Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin

summary:
Dowling Meara type of epidermolysis bullosa simplex (EBS-DM) is a rare genodermatosis due to keratin 5 and 14 mutation, characterized by skin fragility and spontaneous or post traumatic blisters. Neonatal period and infancy are critical since this autonomic dominant affection usually improves with age. Cyclins seem to be efficient in some cases of EBS but are prohibited in children younger than 8 years old. Erythromycin can be a good alternative in this population due to its antibacterial and anti-inflammatory potential.

The aim of this study is the evaluation of the efficiency of oral erythromycin to decrease the number of cutaneous blisters in severe EBS-DM patients from 6 months to 8 years old after 3 months of treatment.

Primary end point is the number of patients with decrease of blisters' number of at least 20% after 3 months of treatment by oral erythromycin.

It is a preliminary study on 8 patients. Treatment is oral erythromycin twice a day during 3 months. Follow up for each patient is 5 months. The duration of the study is 1 year.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Hôpital Purpan
CHU de Nice - Hôpital de Cimiez
CHU de Dijon
Hôpital Saint Eloi


title: Molecular Imaging of Cerebral Amyloid Plaques Using PET With Fluoro Tracker for Early Diagnosis of Alzheimer's Disease

acronym: FAIR-AD

summary:
Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a major matter of concern. There is now an important body of literature stating that early isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing AD. Several biomarkers are now available : specific and sensitive neuropsychological assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI, cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain glucose hypometabolism in temporo-parietal regions with PET [F18]FDG. However, PET imaging using labelled compounds specifically binding to APs has been suggested to improve the diagnostic reliability and to potentially help in shortening the delay until formal clinical diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to 15 minutes acquisition 50 to 60 minutes post injection.

Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD, MCI patients and Healthy Controls.

Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will have convert toward dementia versus those who will not, at two year follow-up period, to compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG hypometabolism, ApoE genotype.

Method: Prospective multicentric study. 65 patients expected to enter the study.

Primary outcome measure: Standard Uptake Volume ratios.

lead_sponsor: University Hospital, Tours

location_facility:
University Hospital of Tours
University Hospital of Toulouse
university hospital of CAEN
University Hospital of Lille


title: Influence of Intestinal Microbiota Implantation Parameters in the Neonatal Period in Premature Infants on Microbiota Profiles and Immune Orientation at 3 Years of Age

acronym: PrimiBiota

summary: The main objective of this research is to study the links between changes in the intestinal microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and the presence / absence of a TH1 immune status at 36 months of age.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve


title: Comparison of 2 Mattresses for the Prevention of Bedsores, AIRSOFT DUO and SENTRY 1200 A PRESSION CONSTANTE, by Measuring Skin Pressure in the Sacral Area - a Multicenter Crossover Study

summary: The main objective of this study is to compare the AIRSOFT DUO and the SENTRY 1200 constant pressure mattresses in terms of peak skin pressures measured at the sacral area.

study_start_date_type: Anticipated

status: Withdrawn

location_facility: Clinique de Soins de suite et réadaptation Saint Basile


title: Longitudinal Monitoring of Bone Microarchitecture by High Resolution Peripheral Quantitative Computed Tomography of (HR-pQCT) in the Transplant Patient

acronym: TRANSOS

summary:
The optimal management of calcium and phosphate metabolism regulation in chronic kidney disease (CKD) is important in preventing fracture risk and vascular calcification and thus morbidity and mortality, global and vascular.

Kidney transplant in a CKD context, usually with a pre-existing underlying renal osteodystrophy, malnutrition, chronic inflammation, hypogonadism and immunosuppression protocols still often made up of high-dose corticosteroid therapy, are all theoretical factors of post-transplantation bone disease. For other solid organ transplants, even though there is generally no underlying renal osteodystrophy before the transplant, the proportion of osteoporotic patients at the time of transplant is substantial. The bone risk in the immediate post-transplant period is notable.

Patients' follow-up is based on biological, radiological and histological tools. Bone densitometry (DXA) is used to measure bone mass. However, recent international recommendations do not consider DXA as a valid tool to assess bone health in CKD patients. Moreover, it is less informative than peripheral quantitative tomography resolution (HR-pQCT). This latest technique, available in Lyon and Saint-Etienne, is more precise, allowing a three-dimensional study of the trabecular microarchitecture and compartmental volumetric bone density (total, cortical, trabecular), while similar to DXA in terms of radiation (less than 5 μSv). The prevention of cardiovascular risk factors is also part of the daily care of patients with a regular cardiac monitoring (heart ultrasound) and vascular (blood pressure, Doppler of the supra-aortic trunks).

TRANSOS study aims to evaluate in a prospective cohort (longitudinal follow-up of 6 months), the bone status in patients receiving solid organ transplantation in the University Hospitals of Lyon and Saint-Etienne, using DXA and HR-pQCT (at baseline and month 6), in combination with classical biological and cardiovascular monitoring. Transplantation is an important activity in these two hospitals and this protocol provides the same bone follow-up for all solid organ transplants, with a reliable, efficient, non-invasive and low-dose radiation tool.

The primary objective of TRANSOS study is to evaluate changes in tibial cortical density between the baseline and the 6th month post-transplant measured by HR-pQCT.

location_facility:
CHU Saint Etienne
Hôpital Femme Mère Enfant
Hopital Edouard Herriot


title: Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation : a Randomized Double Blind Multicenter Prospective Phase III Trial

acronym: STOP MUCITES

summary:
The LLLT has an anti-inflammatory, analgesic effect and accelerates the healing of ulcerated lesions. There are little data in the literature showing its efficacy in prevention of mucositis in cohorts of patients with hematopoietic stem cells transplantation.

The main objective of this study is to assess the efficacy of a prophylactic low level laser therapy performed by nurses on the severity of oral mucositis during HSCT.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Prostate Embolization for Acute Urinary Retention Study (PARIS 1): An Open-label Prospective Study

summary: The purpose of this study is to assess the feasibility and safety of Prostate Artery Embolization (PAE) in patients suffering of Acute Urinary Retention (AUR) in the context Benign Prostatic Hypertrophy (BPH).

ipd_sharing: Yes

ipd_sharing_description: Global results will be available for patients.

lead_sponsor: ClinSearch

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Cochin
Hôpital Saint-Louis