title: PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

acronym: PLAISIR

summary: Nowadays, stenting is became a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR. FREERIDE, a French prospective cohort has been set up to evaluate the safety and the efficacy of drug eluting balloon (DEB) for the treatment of SFA atherosclerotic lesions.

ReferenceCitation: Bague N, Julia P, Sauguet A, Pernès JM, Chatelard P, Garbé JF, Penillon S, Cardon JM, Commeau P, Planché O, Guyomarch B, Gouëffic Y. Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial). Eur J Vasc Endovasc Surg. 2017 Jan;53(1):106-113. doi: 10.1016/j.ejvs.2016.10.002. Epub 2016 Nov 24.

family: Bague

full_name: N. Bague

given: N.

family: Julia

full_name: P. Julia

given: P.

family: Sauguet

full_name: A. Sauguet

given: A.

family: Pernès

full_name: J.M. Pernès

family: Chatelard

full_name: P. Chatelard

family: Garbé

full_name: J.F. Garbé

family: Penillon

full_name: S. Penillon

given: S.

family: Cardon

full_name: J.M. Cardon

family: Commeau

full_name: P. Commeau

family: Planché

full_name: O. Planché

given: O.

family: Guyomarch

full_name: B. Guyomarch

given: B.

family: Gouëffic

full_name: Y. Gouëffic

given: Y.

journal_name: European Journal of Vascular and Endovascular Surgery

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Nantes University Hospital


title: Anti Vitamin K Therapeutic Education With INR Self Measure Device Within Children From 0 to 18 Years

summary: The purpose of this study is to measure the INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) of children benefiting from the AVK therapeutic education program.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Abassi H, Bajolle F, Werner O, Auer A, Marquina A, Mura T, Lavastre K, Guillaumont S, Manna F, Auquier P, Bonnet D, Amedro P. Health-related quality of life correlates with time in therapeutic range in children on anticoagulants with International Normalised Ratio self-monitoring. Arch Cardiovasc Dis. 2020 Dec;113(12):811-820. doi: 10.1016/j.acvd.2020.05.022. Epub 2020 Oct 14.

family: Abassi

full_name: Hamouda Abassi

given: Hamouda

sequence: first

family: Bajolle

full_name: Fanny Bajolle

given: Fanny

sequence: additional

family: Werner

full_name: Oscar Werner

given: Oscar

family: Auer

full_name: Annie Auer

given: Annie

family: Marquina

full_name: Amandine Marquina

given: Amandine

family: Mura

full_name: Thibault Mura

given: Thibault

family: Lavastre

full_name: Kathleen Lavastre

given: Kathleen

family: Guillaumont

full_name: Sophie Guillaumont

given: Sophie

family: Manna

full_name: Federico Manna

given: Federico

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Bonnet

full_name: Damien Bonnet

given: Damien

family: Amedro

full_name: Pascal Amedro

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Archives of Cardiovascular Diseases

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Montpellier

location_facility: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Indication and Benefits of Nocturnal Oxygen Therapy in Cystic Fibrosis

acronym: MUCOXY

summary: This is an open, multicenter, prospective, randomised and cross over study, comparing in patients with cystic fibrosis aged > 6 years, 2 periods of 6 weeks of oxygen therapy or room air, separated by a wash out period of 2 to 6 weeks.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de pneumologie pédiatrique, Hôpital Armand Trousseau


title: Effectiveness and Safety of an Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers of the Fore Foot: a Prospective Randomised Pilot Study

acronym: SANIBA

summary: It's a pilot prospective opened multicentric randomised study. We measure the efficiency and the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK) to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with BAROUK shoe

status: Completed

intervention_type: Device

status_simplified: Completed


title: Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Injection 1g in Slow Infusion IV in Patients With Acute Pain

acronym: PARAJUG

summary: This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.

ReferenceType: derived

ReferenceCitation: Pickering G, Moustafa F, Macian N, Schmidt J, Pereira B, Dubray C. A New Transmucous-Buccal Formulation of Acetaminophen for Acute Traumatic Pain: A Non-inferiority, Randomized, Double-Blind, Clinical Trial. Pain Physician. 2015 May-Jun;18(3):249-57.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Drug


title: Proof of Concept of the Effect of Water Intake on the DNA Adducts Formation

summary: The main purpose of the study is to assess the effect of water intake on the formation of 4-ABP DNA adducts.

primary_purpose: Basic Science

lead_sponsor: Danone Research

lead_sponsor_type: industriel


title: Can Diaphragm Pacing Delay Non Invasive Ventilation in Amyotrophic Lateral Sclerosis ? a Randomized Controlled Study

acronym: RespiStimALS

summary: ALS is is characterized by a progressive degeneration of motor neurons, leading to progressive weakness of muscles, including respiratory muscles, the diaphragm. Although specific therapy is lacking, correct respiratory therapy improves quality of life and increases survival. Substituting the failing respiratory muscles by non invasive mechanical ventilatory assistance (NIV) is the current standard of care. Intradiaphragmatic phrenic nerve stimulation is a new treatment and has been the object of a preliminary international proof-of-concept multicenter trial. This trial suggests that the intradiaphragmatic phrenic nerve stimulation slows down the rate of decline of the diaphragm. Our new hypothesis is that phrenic stimulation induces diaphragm conditioning and can delay the need for mechanical ventilation in ALS patients. We will study, during 24 months, 2 groups of 37 patients at the beginning of the respiratory dysfunction, using a intradiaphragmatic phrenic nerve stimulation in one group and a sham stimulation in the other group. Although, all the patients will be implanted, thus, at the end of the study, all the patients will receive effective stimulation.

ReferenceCitation: Guimarães-Costa R, Similowski T, Rivals I, Morélot-Panzini C, Nierat MC, Bui MT, Akbar D, Straus C, Romero NB, Michel PP, Menegaux F, Salachas F, Gonzalez-Bermejo J, Bruneteau G; RespiStimALS team; contributors to the RespiStimALS study were:. Human diaphragm atrophy in amyotrophic lateral sclerosis is not predicted by routine respiratory measures. Eur Respir J. 2019 Feb 14;53(2). pii: 1801749. doi: 10.1183/13993003.01749-2018. Print 2019 Feb.

family: Guimarães-Costa

full_name: Raquel Guimarães-Costa

given: Raquel

family: Similowski

full_name: Thomas Similowski

given: Thomas

family: Rivals

full_name: Isabelle Rivals

given: Isabelle

family: Morélot-Panzini

full_name: Capucine Morélot-Panzini

given: Capucine

family: Nierat

full_name: Marie-Cécile Nierat

given: Marie-Cécile

family: Bui

full_name: Mai Thao Bui

given: Mai Thao

family: Akbar

full_name: David Akbar

given: David

family: Straus

full_name: Christian Straus

given: Christian

family: Romero

full_name: Norma Beatriz Romero

given: Norma Beatriz

family: Michel

full_name: Patrick Pierre Michel

given: Patrick Pierre

family: Menegaux

full_name: Fabrice Menegaux

given: Fabrice

family: Salachas

full_name: François Salachas

given: François

family: Gonzalez-Bermejo

full_name: Jésus Gonzalez-Bermejo

given: Jésus

family: Bruneteau

full_name: Gaëlle Bruneteau

given: Gaëlle

journal_name: European Respiratory Journal

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

version: publishedVersion

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ReferenceCitation: Gonzalez-Bermejo J, Morélot-Panzini C, Tanguy ML, Meininger V, Pradat PF, Lenglet T, Bruneteau G, Forestier NL, Couratier P, Guy N, Desnuelle C, Prigent H, Perrin C, Attali V, Fargeot C, Nierat MC, Royer C, Ménégaux F, Salachas F, Similowski T. Early diaphragm pacing in patients with amyotrophic lateral sclerosis (RespiStimALS): a randomised controlled triple-blind trial. Lancet Neurol. 2016 Nov;15(12):1217-1227. doi: 10.1016/S1474-4422(16)30233-2. Epub 2016 Oct 11. Erratum in: Lancet Neurol. 2016 Dec;15(13):1301.

family: Tanguy

full_name: Marie-Laure Tanguy

given: Marie-Laure

family: Meininger

full_name: Vincent Meininger

given: Vincent

family: Pradat

full_name: Pierre-François Pradat

given: Pierre-François

family: Lenglet


title: STUDY OF IMAGING MARKERS IN THE VERY EARLY STAGES OF DEMENTIA AMONG RETIRED RURAL FARM IN THE GIRONDE AND PARTICIPATING IN THE AMI COHORT EPIDEMIOLOGY: A LONGITUDINAL STUDY.

acronym: AMIMAGE 2

summary: It is now acknowledged that Alzheimer's disease is characterized by a long period of pathophysiological change. Developing new strategies to achieve diagnoses as early as possible has become a major goal for therapies aimed at slowing the progression of this disease. While diagnoses currently rely principally on clinical neuropsychology, the typical diagnostic criteria of NINCDS-ADRDA are inapplicable in the early stage of the disease. The goal of our project is to identify very early imaging markers for Alzheimer's disease among patients with no report of cognitive difficulties. In order to achieve this goal, we propose a longitudinal study in an elderly population cohort.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

location_facility: Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux


title: Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study

summary: Variable PSV is a new ventilatory mode which delivered a pressure support "variable" from 0 to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior, sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and "standard" (or fixed)-PSV during the weaning phase of critically ill patients who required mechanical ventilation.

location_facility: Department of Anesthesiology & Critical Care, St Eloi University Hospital


type: EudraCT Number

type: Other Identifier

title: First in Man Study Investigating the Biodistribution, the Safety and Optimal Recommended Dose of a New Radiolabelled Monoclonal Antibody Targeting Frizzled Homolog 10 (FZD10) in Patients With Relapsed or Refractory Non Resectable Synovial Sarcomas

acronym: SYNFRIZZ

summary:
Advanced synovial sarcoma represents an unmet medical need. The gene encoding frizzled homologue 10 (FZD10), a 7-transmenbrane receptor, member of the Wnt signalling receptor family, is overexpressed in SS and is undetectable in normal human tissues except placenta.

OncoTherapy Science Inc. has developed a chimeric humanized monoclonal antibody (mAb) against FZD10, named OTSA101. Non-radiolabeled OTSA101 antibody has only weak antagonistic activity on SS cell growth. However, Yttrium 90-radiolabeled OTSA101 (OTSA101-DTPA-90Y) showed significant antitumor activity following a single intravenous injection in mouse xenograft model.

This first in man clinical trial (Phase I) in relapsing SS patients resistant to Doxorubicin and ifosfamide will be divided in 2 parts.

In Part 1 (imaging part using OTSA101 radiolabelled with Indium 111 [111In]), the biodistribution and tumor uptake of OTSA101-DTPA-111In will be followed using 111In as radiotracer.

In Part 2 (therapeutic part with OTSA101 radiolabelled with Yttrium 90 [90Y]), the safety and PK profiles of OTSA101-DTPA-90Y will be determined and preliminary efficacy data will be collected.

This first in Man study should allow defining the optimal recommended dose of OTSA101-DTPA-90Y.

Patients will be followed during 1 year.

ReferenceType: background

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family: Jemal

full_name: A. Jemal

given: A.

family: Siegel

full_name: R. Siegel

given: R.

family: Xu

full_name: J. Xu

given: J.

family: Ward

full_name: E. Ward

given: E.

journal_name: CA: A Cancer Journal for Clinicians

evidence: oa journal (via observed oa rate)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Cancer Statistics, 2010

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ReferenceCitation: Ladanyi M. Fusions of the SYT and SSX genes in synovial sarcoma. Oncogene. 2001 Sep 10;20(40):5755-62. Review.

ReferenceCitation: Okcu MF, Munsell M, Treuner J, Mattke A, Pappo A, Cain A, Ferrari A, Casanova M, Ozkan A, Raney B. Synovial sarcoma of childhood and adolescence: a multicenter, multivariate analysis of outcome. J Clin Oncol. 2003 Apr 15;21(8):1602-11.

ReferenceCitation: Trassard M, Le Doussal V, Hacène K, Terrier P, Ranchère D, Guillou L, Fiche M, Collin F, Vilain MO, Bertrand G, Jacquemier J, Sastre-Garau X, Bui NB, Bonichon F, Coindre JM. Prognostic factors in localized primary synovial sarcoma: a multicenter study of 128 adult patients. J Clin Oncol. 2001 Jan 15;19(2):525-34.

ReferenceCitation: Laor T. MR imaging of soft tissue tumors and tumor-like lesions. Pediatr Radiol. 2004 Jan;34(1):24-37. Epub 2003 Dec 12. Review.

ReferenceCitation: Lewis JJ, Antonescu CR, Leung DH, Blumberg D, Healey JH, Woodruff JM, Brennan MF. Synovial sarcoma: a multivariate analysis of prognostic factors in 112 patients with primary localized tumors of the extremity. J Clin Oncol. 2000 May;18(10):2087-94.

ReferenceCitation: Singer S, Baldini EH, Demetri GD, Fletcher JA, Corson JM. Synovial sarcoma: prognostic significance of tumor size, margin of resection, and mitotic activity for survival. J Clin Oncol. 1996 Apr;14(4):1201-8.

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ReferenceCitation: Sleijfer S, Ouali M, van Glabbeke M, Krarup-Hansen A, Rodenhuis S, Le Cesne A, Hogendoorn PC, Verweij J, Blay JY. Prognostic and predictive factors for outcome to first-line ifosfamide-containing chemotherapy for adult patients with advanced soft tissue sarcomas: an exploratory, retrospective analysis on large series from the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group (EORTC-STBSG). Eur J Cancer. 2010 Jan;46(1):72-83. doi: 10.1016/j.ejca.2009.09.022.

ReferenceCitation: Le Cesne A, Blay JY, Judson I, Van Oosterom A, Verweij J, Radford J, Lorigan P, Rodenhuis S, Ray-Coquard I, Bonvalot S, Collin F, Jimeno J, Di Paola E, Van Glabbeke M, Nielsen OS. Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group trial. J Clin Oncol. 2005 Jan 20;23(3):576-84. Erratum in: J Clin Oncol. 2005 Aug 1;23(22):5276.

ReferenceCitation: Sleijfer S, Ray-Coquard I, Papai Z, Le Cesne A, Scurr M, Schöffski P, Collin F, Pandite L, Marreaud S, De Brauwer A, van Glabbeke M, Verweij J, Blay JY. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol. 2009 Jul 1;27(19):3126-32. doi: 10.1200/JCO.2008.21.3223. Epub 2009 May 18.

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ReferenceCitation: Lee YF, John M, Edwards S, Clark J, Flohr P, Maillard K, Edema M, Baker L, Mangham DC, Grimer R, Wooster R, Thomas JM, Fisher C, Judson I, Cooper CS. Molecular classification of synovial sarcomas, leiomyosarcomas and malignant fibrous histiocytomas by gene expression profiling. Br J Cancer. 2003 Feb 24;88(4):510-5.

ReferenceCitation: Nielsen TO, West RB, Linn SC, Alter O, Knowling MA, O'Connell JX, Zhu S, Fero M, Sherlock G, Pollack JR, Brown PO, Botstein D, van de Rijn M. Molecular characterisation of soft tissue tumours: a gene expression study. Lancet. 2002 Apr 13;359(9314):1301-7.

ReferenceCitation: Allander SV, Illei PB, Chen Y, Antonescu CR, Bittner M, Ladanyi M, Meltzer PS. Expression profiling of synovial sarcoma by cDNA microarrays: association of ERBB2, IGFBP2, and ELF3 with epithelial differentiation. Am J Pathol. 2002 Nov;161(5):1587-95.

ReferenceCitation: Nagayama S, Katagiri T, Tsunoda T, Hosaka T, Nakashima Y, Araki N, Kusuzaki K, Nakayama T, Tsuboyama T, Nakamura T, Imamura M, Nakamura Y, Toguchida J. Genome-wide analysis of gene expression in synovial sarcomas using a cDNA microarray. Cancer Res. 2002 Oct 15;62(20):5859-66.

ReferenceCitation: Ray-Coquard I, Le Cesne A, Whelan JS, Schoffski P, Bui BN, Verweij J, Marreaud S, van Glabbeke M, Hogendoorn P, Blay JY. A phase II study of gefitinib for patients with advanced HER-1 expressing synovial sarcoma refractory to doxorubicin-containing regimens. Oncologist. 2008 Apr;13(4):467-73. doi: 10.1634/theoncologist.2008-0065.

name: Centre Léon Bérard and UJOMM H. E. Herriot, Lyon, France;

family: Ray‐Coquard

full_name: Isabelle Ray‐Coquard

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

name: University College Hospital, London, United Kingdom;

family: Whelan

full_name: Jeremy S. Whelan

given: Jeremy S.

family: Schoffski

full_name: Patrick Schoffski

given: Patrick

full_name: Binh N. Bui

given: Binh N.

name: U.Z. and Erasmus, Rotterdam, The Netherlands;

family: Verweij

full_name: Jaap Verweij

given: Jaap

name: European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium;

family: Marreaud

full_name: Sandrine Marreaud

given: Sandrine

family: van Glabbeke

full_name: Martine van Glabbeke

given: Martine

family: Hogendoorn

full_name: Pancras Hogendoorn

given: Pancras

family: Blay

full_name: Jean‐Yves Blay

given: Jean‐Yves

title: A Phase II Study of Gefitinib for Patients with Advanced HER‐1 Expressing Synovial Sarcoma Refractory to Doxorubicin‐Containing Regimens

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ReferenceCitation: Hanaoka H, Katagiri T, Fukukawa C, Yoshioka H, Yamamoto S, Iida Y, Higuchi T, Oriuchi N, Paudyal B, Paudyal P, Nakamura Y, Endo K. Radioimmunotherapy of solid tumors targeting a cell-surface protein, FZD10: therapeutic efficacy largely depends on radiosensitivity. Ann Nucl Med. 2009 Jul;23(5):479-85. doi: 10.1007/s12149-009-0265-1. Epub 2009 May 2.

ReferenceCitation: Nagayama S, Fukukawa C, Katagiri T, Okamoto T, Aoyama T, Oyaizu N, Imamura M, Toguchida J, Nakamura Y. Therapeutic potential of antibodies against FZD 10, a cell-surface protein, for synovial sarcomas. Oncogene. 2005 Sep 15;24(41):6201-12.

ReferenceCitation: Fukukawa C, Hanaoka H, Nagayama S, Tsunoda T, Toguchida J, Endo K, Nakamura Y, Katagiri T. Radioimmunotherapy of human synovial sarcoma using a monoclonal antibody against FZD10. Cancer Sci. 2008 Feb;99(2):432-40. doi: 10.1111/j.1349-7006.2007.00701.x.

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ReferenceCitation: Pinkas L, Robins PD, Forstrom LA, Mahoney DW, Mullan BP. Clinical experience with radiolabelled monoclonal antibodies in the detection of colorectal and ovarian carcinoma recurrence and review of the literature. Nucl Med Commun. 1999 Aug;20(8):689-96. Review.

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ReferenceCitation: Tsai SW, Sun Y, Williams LE, Raubitschek AA, Wu AM, Shively JE. Biodistribution and radioimmunotherapy of human breast cancer xenografts with radiometal-labeled DOTA conjugated anti-HER2/neu antibody 4D5. Bioconjug Chem. 2000 May-Jun;11(3):327-34.

ReferenceCitation: Milowsky MI, Nanus DM, Kostakoglu L, Vallabhajosula S, Goldsmith SJ, Bander NH. Phase I trial of yttrium-90-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 for androgen-independent prostate cancer. J Clin Oncol. 2004 Jul 1;22(13):2522-31. Epub 2004 Jun 1.

ReferenceCitation: Tempero M, Leichner P, Baranowska-Kortylewicz J, Harrison K, Augustine S, Schlom J, Anderson J, Wisecarver J, Colcher D. High-dose therapy with 90Yttrium-labeled monoclonal antibody CC49: a phase I trial. Clin Cancer Res. 2000 Aug;6(8):3095-102.

ReferenceCitation: Richman CM, DeNardo SJ, O'Donnell RT, Goldstein DS, Shen S, Kukis DL, Kroger LA, Yuan A, Boniface GR, Griffith IJ, DeNardo GL. Dosimetry-based therapy in metastatic breast cancer patients using 90Y monoclonal antibody 170H.82 with autologous stem cell support and cyclosporin A. Clin Cancer Res. 1999 Oct;5(10 Suppl):3243s-3248s.

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ReferenceCitation: Pless M, Waldherr C, Maecke H, Buitrago C, Herrmann R, Mueller-Brand J. Targeted radiotherapy for small cell lung cancer using 90Yttrium-DOTATOC, an Yttrium-labelled somatostatin analogue: a pilot trial. Lung Cancer. 2004 Sep;45(3):365-71.

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ReferenceCitation: Kelly MP, Lee FT, Smyth FE, Brechbiel MW, Scott AM. Enhanced efficacy of 90Y-radiolabeled anti-Lewis Y humanized monoclonal antibody hu3S193 and paclitaxel combined-modality radioimmunotherapy in a breast cancer model. J Nucl Med. 2006 Apr;47(4):716-25.

ReferenceCitation: Knox SJ, Goris ML, Trisler K, Negrin R, Davis T, Liles TM, Grillo-López A, Chinn P, Varns C, Ning SC, Fowler S, Deb N, Becker M, Marquez C, Levy R. Yttrium-90-labeled anti-CD20 monoclonal antibody therapy of recurrent B-cell lymphoma. Clin Cancer Res. 1996 Mar;2(3):457-70.

ReferenceCitation: Nademanee A, Forman S, Molina A, Fung H, Smith D, Dagis A, Kwok C, Yamauchi D, Anderson AL, Falk P, Krishnan A, Kirschbaum M, Kogut N, Nakamura R, O'donnell M, Parker P, Popplewell L, Pullarkat V, Rodriguez R, Sahebi F, Smith E, Snyder D, Stein A, Spielberger R, Zain J, White C, Raubitschek A. A phase 1/2 trial of high-dose yttrium-90-ibritumomab tiuxetan in combination with high-dose etoposide and cyclophosphamide followed by autologous stem cell transplantation in patients with poor-risk or relapsed non-Hodgkin lymphoma. Blood. 2005 Oct 15;106(8):2896-902. Epub 2005 Jul 7.

ReferenceCitation: Lhommel R, van Elmbt L, Goffette P, Van den Eynde M, Jamar F, Pauwels S, Walrand S. Feasibility of 90Y TOF PET-based dosimetry in liver metastasis therapy using SIR-Spheres. Eur J Nucl Med Mol Imaging. 2010 Aug;37(9):1654-62. doi: 10.1007/s00259-010-1470-9. Epub 2010 Apr 27.

ReferenceCitation: Baechler S, Hobbs RF, Jacene HA, Bochud FO, Wahl RL, Sgouros G. Predicting hematologic toxicity in patients undergoing radioimmunotherapy with 90Y-ibritumomab tiuxetan or 131I-tositumomab. J Nucl Med. 2010 Dec;51(12):1878-84. doi: 10.2967/jnumed.110.079947.

ReferenceCitation: Minarik D, Sjögreen-Gleisner K, Linden O, Wingårdh K, Tennvall J, Strand SE, Ljungberg M. 90Y Bremsstrahlung imaging for absorbed-dose assessment in high-dose radioimmunotherapy. J Nucl Med. 2010 Dec;51(12):1974-8. doi: 10.2967/jnumed.110.079897. Epub 2010 Nov 15.

ReferenceCitation: Rault E, Staelens S, Van Holen R, De Beenhouwer J, Vandenberghe S. Fast simulation of yttrium-90 bremsstrahlung photons with GATE. Med Phys. 2010 Jun;37(6):2943-50.

ReferenceCitation: Walrand S, Flux GD, Konijnenberg MW, Valkema R, Krenning EP, Lhommel R, Pauwels S, Jamar F. Dosimetry of yttrium-labelled radiopharmaceuticals for internal therapy: 86Y or 90Y imaging? Eur J Nucl Med Mol Imaging. 2011 May;38 Suppl 1:S57-68. doi: 10.1007/s00259-011-1771-7. Epub 2011 Mar 11. Review.

ReferenceCitation: Shen D, Fritz T, Wu GL, Kulik B, Palestrant D, Unger E. Block co-polymeric magnetic resonance contrast agents. Invest Radiol. 1994 Jun;29 Suppl 2:S217-9.

ReferenceCitation: Giraudet AL, Cassier PA, Iwao-Fukukawa C, Garin G, Badel JN, Kryza D, Chabaud S, Gilles-Afchain L, Clapisson G, Desuzinges C, Sarrut D, Halty A, Italiano A, Mori M, Tsunoda T, Katagiri T, Nakamura Y, Alberti L, Cropet C, Baconnier S, Berge-Montamat S, Pérol D, Blay JY. A first-in-human study investigating biodistribution, safety and recommended dose of a new radiolabeled MAb targeting FZD10 in metastatic synovial sarcoma patients. BMC Cancer. 2018 Jun 8;18(1):646. doi: 10.1186/s12885-018-4544-x.

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


title: A Phase I Exploratory Study Evaluating 3 Formulations of LEO 29102 Plus Calcipotriol, Ointment, LEO 29102 Ointment, Calcipotriol Ointment, Daivonex® Ointment and Diprosone® Ointment in the Treatment of Psoriasis

summary: The purpose of the study is to compare the 3 ointment formulations containing LEO 29102 plus calcipotriol and Daivonex® ointment and Diprosone® ointment and to compare LEO 29102 plus calcipotriol to LEO 29102 alone and to calcipotriol alone in the same ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

lead_sponsor: LEO Pharma

location_facility: CPCAD - Centre de Pharmacologie Clinique Appliquée à la Dermatologie


title: Phase II Study of the Efficacy and Safety of a Radiotherapy Dose Complement in the Treatment of Hypoxic Lesions Identified by F-miso PET/CT in Patients With Stage III Non-small-cell Lung Cancer (NSCLC) Not Amenable to Curative Surgical Resection Who Are Candidate for Curative Radio-chemotherapy

summary:
This study will assess the efficacy and safety of a radiotherapy dose complement (boost) in the treatment of hypoxic lesions, measured by F-miso PET/CT, in patients with stage III NSCLC not amenable to surgery and candidate for chemoradiotherapy.

Preliminary studies in head and neck cancers have demonstrated the feasibility and support the medical benefit of this novel approach.

The aim of the study is to assess the efficacy and safety of a radiotherapy dose complement (boost) in this difficult medical condition for which only limited treatment options are available.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Ganem J, Thureau S, Gardin I, Modzelewski R, Hapdey S, Vera P. Delineation of lung cancer with FDG PET/CT during radiation therapy. Radiat Oncol. 2018 Nov 12;13(1):219. doi: 10.1186/s13014-018-1163-2.

family: Ganem

full_name: J. Ganem

family: Thureau

full_name: S. Thureau

given: S.

family: Gardin

full_name: I. Gardin

given: I.

family: Modzelewski

full_name: R. Modzelewski

family: Hapdey

full_name: S. Hapdey

family: Vera

full_name: P. Vera

given: P.

currency_apc_doaj: GBP

journal_name: Radiation Oncology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Thureau S, Dubray B, Modzelewski R, Bohn P, Hapdey S, Vincent S, Anger E, Gensanne D, Pirault N, Pierrick G, Vera P. FDG and FMISO PET-guided dose escalation with intensity-modulated radiotherapy in lung cancer. Radiat Oncol. 2018 Oct 23;13(1):208. doi: 10.1186/s13014-018-1147-2.

full_name: Sébastien Thureau

given: Sébastien

family: Dubray

full_name: Bernard Dubray

given: Bernard

full_name: Romain Modzelewski

given: Romain

family: Bohn

full_name: Pierre Bohn

given: Pierre

full_name: Sébastien Hapdey

family: Vincent

full_name: Sabine Vincent

given: Sabine

family: Anger

full_name: Elodie Anger

given: Elodie

family: Gensanne

full_name: David Gensanne

given: David

family: Pirault

full_name: Nicolas Pirault

given: Nicolas

family: Pierrick

full_name: Gouel Pierrick

given: Gouel

ReferenceCitation: Vera P, Thureau S, Chaumet-Riffaud P, Modzelewski R, Bohn P, Vermandel M, Hapdey S, Pallardy A, Mahé MA, Lacombe M, Boisselier P, Guillemard S, Olivier P, Beckendorf V, Salem N, Charrier N, Chajon E, Devillers A, Aide N, Danhier S, Denis F, Muratet JP, Martin E, Riedinger AB, Kolesnikov-Gauthier H, Dansin E, Massabeau C, Courbon F, Farcy Jacquet MP, Kotzki PO, Houzard C, Mornex F, Vervueren L, Paumier A, Fernandez P, Salaun M, Dubray B. Phase II Study of a Radiotherapy Total Dose Increase in Hypoxic Lesions Identified by (18)F-Misonidazole PET/CT in Patients with Non-Small Cell Lung Carcinoma (RTEP5 Study). J Nucl Med. 2017 Jul;58(7):1045-1053. doi: 10.2967/jnumed.116.188367. Epub 2017 Mar 2.

title: Phase II Study of a Radiotherapy Total Dose Increase in Hypoxic Lesions Identified by 18F-Misonidazole PET/CT in Patients with Non–Small Cell Lung Carcinoma (RTEP5 Study)


title: Past Pain Experience and Perception of Experimental Pain

summary:
Differences in pain perception between subjects with and without psychiatric illness may be influenced by the individual experience, and not primarily by the pathology, although the pathological frame may amplify it.The aim of this study is to establish if the characteristics of experimental pain feeling are influenced by the past pain experience, anxiety and emotion, independently from the diagnosis. The pain experience will be evaluated by an inventory of the potentially painful situations that one can come across through the life, to determine the following points : Number of painful events in the past, number of painful points during the last 6 months, number of painful events lasting more than 6 months, sum of pain intensities (graduated with Visual Analogic Scale VAS from 0 to 10), sum of gravity (evaluated from 0 to 5), the category of pain experience qualification (mostly affective, mostly sensorial, or both).

Schizophrenic, depressed and control participants will be recruited, and their pain experience throughout life will be put it in relation to experimental pain tests results (pressure application, ischemia induction), anxiety and emotion (Hospital Anxiety and Depression scale HAD), catastrophizing (Pain Catastrophizing Scale PCS), Heart Rate (HR) variation, Blood Pressure (BP) variation.

ReferenceCitation: Girard M, Plansont B, Bonnabau H, Malauzat D. Experimental pain hypersensitivity in schizophrenic patients. Clin J Pain. 2011 Nov-Dec;27(9):790-5. doi: 10.1097/AJP.0b013e31821d904c.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Esquirol


title: Evaluation of the Effectiveness of Individualized Exercise Program, Combined With a Balanced Diet Rich in Fruits and Vegetables, on the Evolution of Body Fat in Overweight or Obese Women, as Part of Type 2 Diabetes Prevention in Reunion Island.

acronym: LIPOXmax-RUN

summary: The purpose of this study is to evaluate the efficacy of 3 of physical exercise training programs, with a supplementation in fruits and vegetables, on body composition. 126 women will be randomized into 3 groups (42 subjects per group). The first program will be conducted at a relatively low intensity of effort, corresponding to the maximum rate of lipid oxidation (LIPOXmax)measured by indirect calorimetry. The second program will be at 60% of VO2peak and the third program will be prescribed according to the Good Practices physical Guidelines (30 minutes per day at a moderate intensity). All subjects will receive a free supplement of 5 fruits and vegetables per day during all the intervention. The intervention will last 5 months in total.

primary_purpose: Prevention

ReferenceCitation: Besnier F, Lenclume V, Gérardin P, Fianu A, Martinez J, Naty N, Porcherat S, Boussaid K, Schneebeli S, Jarlet E, Hatia S, Dalleau G, Verkindt C, Brun JF, Gonthier MP, Favier F. Individualized Exercise Training at Maximal Fat Oxidation Combined with Fruit and Vegetable-Rich Diet in Overweight or Obese Women: The LIPOXmax-Réunion Randomized Controlled Trial. PLoS One. 2015 Nov 10;10(11):e0139246. doi: 10.1371/journal.pone.0139246. eCollection 2015.

family: Besnier

full_name: Florent Besnier

given: Florent

family: Lenclume

full_name: Victorine Lenclume

given: Victorine

family: Gérardin

full_name: Patrick Gérardin

given: Patrick

family: Fianu

full_name: Adrian Fianu

given: Adrian

family: Martinez

full_name: Jérémy Martinez

given: Jérémy

family: Naty

full_name: Nadège Naty

given: Nadège

family: Porcherat

full_name: Sylvaine Porcherat

given: Sylvaine

family: Boussaid

full_name: Karim Boussaid

given: Karim

family: Schneebeli

full_name: Stéphane Schneebeli

given: Stéphane

family: Jarlet

full_name: Eric Jarlet

given: Eric

family: Hatia

full_name: Sarah Hatia

given: Sarah

family: Dalleau

full_name: Georges Dalleau

given: Georges

family: Verkindt

full_name: Chantal Verkindt

given: Chantal

family: Brun

full_name: Jean-Frédéric Brun

given: Jean-Frédéric

family: Gonthier

full_name: Marie-Paule Gonthier

given: Marie-Paule

family: Favier

full_name: François Favier

given: François

currency_apc_doaj: USD

journal_name: PLOS ONE

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

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

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

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology

acronym: BIOVAL

summary: In this study, the investigators will measure range of motion of the elbow in a geriatric assessment in 85 subjects aged 65 years or over. These measures will be made by an actigraph and the software analysis BioVal. This technique will be compared with the standard technique (inclinometer). It will also be evaluated during this study, the ease of use and feedback.

ReferenceCitation: Sacco G, Turpin JM, Marteu A, Sakarovitch C, Teboul B, Boscher L, Brocker P, Robert P, Guerin O. Inertial sensors as measurement tools of elbow range of motion in gerontology. Clin Interv Aging. 2015 Feb 23;10:491-7. doi: 10.2147/CIA.S70452. eCollection 2015.

family: Sacco

full_name: Guillaume Sacco

given: Guillaume

family: Turpin

full_name: Jean-Michel Turpin

given: Jean-Michel

family: Marteu

full_name: Audrey Marteu

given: Audrey

family: Sakarovitch

full_name: Charlotte Sakarovitch

given: Charlotte

family: Teboul

full_name: Bernard Teboul

given: Bernard

family: Boscher

full_name: Laure Boscher

given: Laure

family: Brocker

full_name: Patrice Brocker

given: Patrice

family: Robert

full_name: Philippe Robert

given: Philippe

family: Guerin

full_name: Olivier Guerin

given: Olivier

journal_name: Clinical Interventions in Aging

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Centre Memoire Ressources et Recherche, CHU de Nice


title: Pilot Pharmacokinetic Study of Three New Nicotine Lozenge Formulations (V0474) Versus Two Reference Formulations (V0018 B mg and Niquitin® Fresh Mint, 4mg) After Single Oral Administration in Healthy Male Smokers.

summary: The purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations (V0474) in comparison with two reference products. The clinical and biological safety of V0474 and the lozenge acceptability will also be assessed.

lead_sponsor: Pierre Fabre Medicament


title: Exploratory Study Evaluating the Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris, Using a Split-Face Model

summary: The aim of this proof of principle study is to evaluate efficacy and safety of the sequential application of two marketed products for the treatment of acne vulgaris, using the Split-Face model


title: Influence of Sleep Apnea Syndrome and Its Treatment by Positive Airway Pressure Therapy on Transcutaneous Oxygen Tension (PtcO2) in Patients With Foot Wound or at Risk for Foot Wound

acronym: SAS-FOOT

summary: Sleep apnea syndrome (SAS) is a common comorbidity of type 1 and type 2 diabetes. A low transcutaneous oxygen tension (PtcO2) measured on the foot is pejorative prognostic factor for the healing of a diabetic foot wound. SAS causes intermittent nocturnal hypoxia and sympathetic overactivity. The investigators hypothesized that SAS could be a factor reducing the PtcO2.Therefore, the main objective of this study is to assess the variation in PtcO2 between the end of the night and midday in patients with -or at risk of- diabetic foot wound according to the presence or not of sleep apnea syndrome.The secondary objective is to address the microvascularisation of diabetic patients having foot wounds according to their status regarding sleep apnea syndrome.

time_perspective: Cross-Sectional

ipd_sharing: Undecided

lead_sponsor: AGIR à Dom

location_facility: Diabetes and Endocrinology Unit, Grenoble University Hospital


title: Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer

acronym: BEAUTY

summary: Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer

ReferenceCitation: Saghatchian M, Lacas B, Charles C, Ghouadni A, Clain GT, Boinon D, Delaloge S, Vaz-Luis I, Dauchy S, Amiel P. BEAUTY and the breast: is adjuvant chemotherapy the right time for a beauty boost? Lessons learned from a large randomized controlled trial. Qual Life Res. 2021 Jul 29. doi: 10.1007/s11136-021-02947-6. [Epub ahead of print]

family: Saghatchian

full_name: Mahasti Saghatchian

given: Mahasti

family: Lacas

full_name: Benjamin Lacas

given: Benjamin

family: Charles

full_name: Cécile Charles

given: Cécile

family: Ghouadni

full_name: Amal Ghouadni

given: Amal

family: Clain

full_name: Gabrielle Tergemina Clain

given: Gabrielle Tergemina

family: Boinon

full_name: Diane Boinon

given: Diane

family: Delaloge

full_name: Suzette Delaloge

given: Suzette

family: Vaz-Luis

full_name: Ines Vaz-Luis

given: Ines

family: Dauchy

full_name: Sarah Dauchy

family: Amiel

full_name: Philippe Amiel

journal_name: Quality of Life Research

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Pressure Controlled Ventilation Versus Pressure Support Ventilation During the Night: New Strategy of Mechanical Ventilation Weaning?

acronym: REVENTIL

summary: The purpose of the study is to compare pressure controlled continuous mandatory ventilation versus pressure support ventilation during the night for weaning to mechanical ventilation in chronic obstructive pulmonary disease patients and their impact onto sleep quality.

ReferenceCitation: Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56.

ReferenceCitation: Epstein SK, Ciubotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest. 1997 Jul;112(1):186-92.

ReferenceCitation: Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903.

ReferenceCitation: Esteban A, Frutos F, Tobin MJ, Alía I, Solsona JF, Valverdú I, Fernández R, de la Cal MA, Benito S, Tomás R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50.

ReferenceCitation: Esteban A, Alía I. Clinical management of weaning from mechanical ventilation. Intensive Care Med. 1998 Oct;24(10):999-1008. Review.

ReferenceCitation: Aurell J, Elmqvist D. Sleep in the surgical intensive care unit: continuous polygraphic recording of sleep in nine patients receiving postoperative care. Br Med J (Clin Res Ed). 1985 Apr 6;290(6474):1029-32.

ReferenceCitation: Hilton BA. Quantity and quality of patients' sleep and sleep-disturbing factors in a respiratory intensive care unit. J Adv Nurs. 1976 Nov;1(6):453-68.

ReferenceCitation: Freedman NS, Gazendam J, Levan L, Pack AI, Schwab RJ. Abnormal sleep/wake cycles and the effect of environmental noise on sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 2001 Feb;163(2):451-7.

ReferenceCitation: Schwab RJ. Disturbances of sleep in the intensive care unit. Crit Care Clin. 1994 Oct;10(4):681-94. Review.

ReferenceCitation: Parthasarathy S, Tobin MJ. Effect of ventilator mode on sleep quality in critically ill patients. Am J Respir Crit Care Med. 2002 Dec 1;166(11):1423-9. Epub 2002 Sep 5.

ReferenceCitation: Parreira VF, Delguste P, Jounieaux V, Aubert G, Dury M, Rodenstein DO. Effectiveness of controlled and spontaneous modes in nasal two-level positive pressure ventilation in awake and asleep normal subjects. Chest. 1997 Nov 5;112(5):1267-77.

ReferenceCitation: Parreira VF, Delguste P, Jounieaux V, Aubert G, Dury M, Rodenstein DO. Glottic aperture and effective minute ventilation during nasal two-level positive pressure ventilation in spontaneous mode. Am J Respir Crit Care Med. 1996 Dec;154(6 Pt 1):1857-63.

ReferenceCitation: Bosma K, Ferreyra G, Ambrogio C, Pasero D, Mirabella L, Braghiroli A, Appendini L, Mascia L, Ranieri VM. Patient-ventilator interaction and sleep in mechanically ventilated patients: pressure support versus proportional assist ventilation. Crit Care Med. 2007 Apr;35(4):1048-54.

ReferenceCitation: Toublanc B, Rose D, Glérant JC, Francois G, Mayeux I, Rodenstein D, Jounieaux V. Assist-control ventilation vs. low levels of pressure support ventilation on sleep quality in intubated ICU patients. Intensive Care Med. 2007 Jul;33(7):1148-1154. doi: 10.1007/s00134-007-0659-2. Epub 2007 May 11.

ReferenceCitation: Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.

ReferenceCitation: Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. Erratum in: JAMA 1994 May 4;271(17):1321.

ReferenceCitation: Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10.

ReferenceCitation: Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4.

ReferenceCitation: Teasdale G, Murray G, Parker L, Jennett B. Adding up the Glasgow Coma Score. Acta Neurochir Suppl (Wien). 1979;28(1):13-6.

ReferenceCitation: Riker RR, Picard JT, Fraser GL. Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients. Crit Care Med. 1999 Jul;27(7):1325-9.

ReferenceCitation: Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9.

ReferenceCitation: Hansen-Flaschen J, Cowen J, Polomano RC. Beyond the Ramsay scale: need for a validated measure of sedating drug efficacy in the intensive care unit. Crit Care Med. 1994 May;22(5):732-3.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention

acronym: VEDROP

summary: To evaluate the kinetics of intestinal absorption of vitamin E water-soluble form from the classical lipid-soluble form in a population of patients with intestinal malabsorption (hypocholesterolemias family by retention of chylomicrons).

lead_sponsor: Hospices Civils de Lyon

location_facility: Hopital Femme Mere Enfant-Hospices Civils de Lyon


title: Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism

summary: Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality in insulin resistant states. The typical dyslipidemia that is associated with insulin resistance, which includes a postprandial increase of triglyceride-rich lipoproteins (TRL) with excess of intestinal triglyceride-rich-lipoprotein-apoB-48 (TRL-apoB-48), is felt to play an important role in the accelerated ASCD. Recently, intestinal TRL-apoB-48 overproduction appeared as a newly recognized component of insulin resistance. There is only a limited amount of information in the literature regarding the factors and the mechanisms modulating the metabolism of intestinal TRL-apoB-48 in the setting of insulin resistance

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation.

acronym: MUCO-IRC

summary:
Chronic renal failure is a serious complication of lung transplantation especially in patients with cystic fibrosis. Their medical history prior to the Lung Transplantation has already exposed to kidney damage. Post-lung transplantation, these patients are subjected to renal toxicity anticalcineurins they receive large doses.

The measurement of renal function of patients by formula to estimate GFR in routine use is unreliable and other markers seem indispensable.

The purpose of this study is to evaluate two markers, PIIINP (Procollagen III aminoterminal peptide N), whose urinary levels was correlated to the intensity of fibrosis in different types of kidney disease.

intervention_type: Biological


title: First Line Mantle Cell Lymphoma (MCL) Treatment by RiBVD Schema in Patients Older Than 65 Years or 18 to 65 Years Old Who Cannot or Refuse Receive Conditioning Regimen Followed by Autograft

acronym: RIBVD

summary: Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or refuse receive conditioning regimen followed by autograft.

lead_sponsor: French Innovative Leukemia Organisation


summary:
Study the factors that explain Health-Related Quality of Life (HRQL) in patients with Alzheimer disease including:

The influence of the environment (physical and human) on Health-Related Quality of Life (HRQL),
The influence of non-drug and drug treatments on Health-Related Quality of Life (HRQL),
The influence of formal and informal help mobilized,
The influence of interactions "patient - caregiver" on Health-Related Quality of Life (HRQL),
The influence of the ratio necessary cost on available resources on Health-Related Quality of Life (HRQL)

lead_sponsor: CHU de Reims


title: Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study

acronym: TgBEX

summary: Bexarotene is a RXR-selective retinoid, licensed for the treatment of cutaneous T cell lymphoma. The most frequent adverse effect is hypertriglyceridemia but its mechanism is not well known. The purpose of this study is to research a carbohydrate metabolism disorder associated in bexarotene-induced hypertriglyceridemia.

lead_sponsor: Rennes University Hospital

location_facility: Service de dermatologie - Hôpital de Pontchaillou


title: A Phase 1, Dose Escalation Study of Plerixafor in Combination With Induction and Consolidation Chemotherapy in Patients With Relapsed Acute Myeloid Leukemia

acronym: PRIMAL

summary: This is a phase 1, dose escalation study of Plerixafor in combination with granulocyte-colony stimulating factor , Daunorubicin and Cytarabine in adults patients with relapsed acute myeloid leukemia .


summary:
The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits.

Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet.

Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.

ReferenceCitation: Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.

family: Bernstein

full_name: David I. Bernstein

given: David I.

family: Kleine-Tebbe

full_name: Joerg Kleine-Tebbe

given: Joerg

family: Nelson

full_name: Harold S. Nelson

given: Harold S.

family: Bardelas

full_name: Jose A. Bardelas

given: Jose A.

suffix: Jr

family: Sussman

full_name: Gordon L. Sussman

given: Gordon L.

family: Lu

full_name: Susan Lu

given: Susan

family: Rehm

full_name: Dorte Rehm

given: Dorte

family: Svanholm Fogh

full_name: Bodil Svanholm Fogh

given: Bodil

family: Nolte

full_name: Hendrik Nolte

given: Hendrik

journal_name: Annals of Allergy, Asthma & Immunology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: ALK-Abelló A/S

location_facility: Department of Respiratory Diseases, Lapeyronie Hospital


title: Modification of Human Gut Microbiota in Massive Obesity After Bariatric Surgery: the Role of Energetic Restriction

acronym: microbaria

summary:
Gut microbiota ecology is altered in obesity and could link obesity and its complications. Bariatric surgery enables a major and sustained weight loss therefore improving obesity related disease.

the investigators primary aim is to evaluate gut microbiota adaptation to weight loss and the specific role of energetic restriction. Furthermore we aim to compare gut flora of obese patients post bariatric surgery to that of lean healthy volunteers.

Thus, the investigators plan to compare gut microbiota from 140 obese individuals before and after either restrictive (gastric banding) procedures or gastric bypass procedures to that of 40 lean healthy volunteers at baseline.

primary_purpose: Other

ReferenceCitation: Aron-Wisnewsky J, Prifti E, Belda E, Ichou F, Kayser BD, Dao MC, Verger EO, Hedjazi L, Bouillot JL, Chevallier JM, Pons N, Le Chatelier E, Levenez F, Ehrlich SD, Dore J, Zucker JD, Clément K. Major microbiota dysbiosis in severe obesity: fate after bariatric surgery. Gut. 2019 Jan;68(1):70-82. doi: 10.1136/gutjnl-2018-316103. Epub 2018 Jun 13.

family: Aron-Wisnewsky

full_name: Judith Aron-Wisnewsky

given: Judith

family: Prifti

full_name: Edi Prifti

given: Edi

family: Belda

full_name: Eugeni Belda

given: Eugeni

family: Ichou

full_name: Farid Ichou

given: Farid

family: Kayser

full_name: Brandon D Kayser

given: Brandon D

family: Dao

full_name: Maria Carlota Dao

given: Maria Carlota

family: Verger

full_name: Eric O Verger

given: Eric O

family: Hedjazi

full_name: Lyamine Hedjazi

given: Lyamine

family: Bouillot

full_name: Jean-Luc Bouillot

given: Jean-Luc

family: Chevallier

full_name: Jean-Marc Chevallier

given: Jean-Marc

family: Pons

full_name: Nicolas Pons

given: Nicolas

family: Le Chatelier

full_name: Emmanuelle Le Chatelier

given: Emmanuelle

family: Levenez

full_name: Florence Levenez

given: Florence

family: Ehrlich

full_name: Stanislav Dusko Ehrlich

given: Stanislav Dusko

family: Dore

full_name: Joel Dore

given: Joel

family: Zucker

full_name: Jean-Daniel Zucker

given: Jean-Daniel

family: Clément

full_name: Karine Clément

given: Karine

journal_name: Gut

oa_colors: green hybrid

version: acceptedVersion

publisher: BMJ


title: Identification of Non Invasive Biomarkers of Immune Endothelial Injury and Repair Associated With Cardiac Allograft Vasculopathy

summary: Heart transplantation is the best option for patients with end-stage heart failure. Cardiac allograft vasculopathy (CAV) is the leading cause of death following cardiac transplantation and is not managed by current therapies. Its pathogenesis traduces in an accelerated form of coronary artery disease (CAD) with similarities to atherosclerosis but also particular features of endothelial dysfunction associated to the alloimmune conflict and humoral responses toward the graft. Intravascular ultrasound (IVUS) is the validated invasive method for late CAV diagnosis, but occurs lesions are established. Identification of reliable non-invasive early endothelial injury biomarkers that reflect mechanisms of cardiac damage thus remain a major challenge to optimize therapeutic management of post transplant morbidity. Endothelial dysfunction is a central feature of both CAV and CAD and results from a desquilibrium in the balance of endothelial lesion and repair that is partly controlled by recipient immune system. Through their expression of receptors sensing antibodies (FcR CD16) and endothelial stress-induced signals (CX3CR1 fractalkine receptor and NKG2D MICA receptors), Natural Killer (NK) cells represent effector cells with unique potential to generate both humoral and innate immune injury of graft endothelium.

ReferenceCitation: Paul P, Picard C, Sampol E, Lyonnet L, Di Cristofaro J, Paul-Delvaux L, Lano G, Nicolino-Brunet C, Ravis E, Collart F, Dignat-George F, Dussol B, Sabatier F, Mouly-Bandini A. Genetic and Functional Profiling of CD16-Dependent Natural Killer Activation Identifies Patients at Higher Risk of Cardiac Allograft Vasculopathy. Circulation. 2018 Mar 6;137(10):1049-1059. doi: 10.1161/CIRCULATIONAHA.117.030435. Epub 2017 Nov 2.

name: Assistance Publique-Hôpitaux Marseille (AP-HM), Vascular Biology and Cell Therapy Department, France (P.P., L.L., C.N.B., F.D.G., F.S.).

name: INSERM, Aix-Marseille Université (AMU), VRCM, UMR-1076, France (P.P., F.D.G., F.S.).

family: Paul

full_name: Pascale Paul

given: Pascale

name: Immunogenetic Laboratory, Établissement Français du Sang, Marseille, France (C.P.).

name: Aix Marseille Université, Etablissement Français du Sang, CNRS, UMR 7268 ADÉS, France (C.P., J.D.C.).

family: Picard

full_name: Christophe Picard

given: Christophe

name: Assistance Publique-Hôpitaux Marseille (AP-HM), Pharmacokinetics Department, France (E.S.).

family: Sampol

full_name: Emmanuelle Sampol

family: Lyonnet

full_name: Luc Lyonnet

given: Luc

family: Di Cristofaro

full_name: Julie Di Cristofaro

given: Julie

name: ENSAE-Paristech, Data Science & Statistics Department, Paris, France (L.P.-D.).

family: Paul-Delvaux

full_name: Louise Paul-Delvaux

given: Louise

name: Assistance Publique-Hôpitaux Marseille (AP-HM), Aix Marseille Univ, Center for Clinical Investigation, France (G.L., B.D.).

family: Lano

full_name: Guillaume Lano

given: Guillaume

family: Nicolino-Brunet

full_name: Corinne Nicolino-Brunet

given: Corinne

name: Assistance Publique Hopitaux de Marseille (AP-HM), Adult Cardiac Surgery Department, France (E.R., F.C., A.M.B.).

family: Ravis

full_name: Eleonore Ravis

given: Eleonore

family: Collart

full_name: Frederic Collart

given: Frederic

family: Dignat-George

full_name: Francoise Dignat-George

given: Francoise

family: Dussol

full_name: Bertrand Dussol

given: Bertrand

family: Sabatier

full_name: Florence Sabatier

family: Mouly-Bandini

full_name: Annick Mouly-Bandini

given: Annick

journal_name: Circulation

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health


title: Diagosis of Breast Carcinoma: Characterization of Breast Lesions With CLEARPEMSONIC : Feasibility Study

summary:
Breast cancer is the first cancer in women, the second etiology of death by cancer and the first cause for women between 35 and 55 years.

Diagnostic tools and large screening have been realized with positive impact in a recent review with 31% less likely to die of breast cancer over nearly 30 years compared to women who didn't get regular screening mammograms. Diagnostic tools and treatment also are improving continuously.

However, for some women, breast cancer diagnosis is difficult, in case of high density breast, breast modifications after surgery… In these cases, breast MRI is currently the best imaging tool, with high sensitivity about 90% but with a lower specificity about 60%, that lead to futile biopsies.

Recently, molecular imaging with PET-CT scan with 18FDG has permitted to widely modify cancer treatment.

However, PET-CT scan is not a good imaging tool for initial diagnostic of breast tumor because of a lack in spatial resolution about 8mm. So, researchers developed dedicated PET scan for breast, called Positron Emission Mammography. Our project is in this field of view and is named CLEARPEMSONIC.

First clinical studies with PEM showed very good performance of this imaging modality for initial evaluation of breast tumors. PEM performance is not affected by breast density, hormonal status. Spatial resolution is less than 3mm. PEM seems complementary with MRI, adding a better specificity value.

In the field of CERIMED, ClearPemSonic Project aims to evaluate an new imaging tool which combined PEM scan and ultrasonography.

Technologic evaluation was made. Now a feasibility study is the first step for clinical applications.

The main objective of this project is to confirm the feasibility of PEM scan with the ClearPEmSonic.

Secondary objectives are to compare results with other conventional imaging modalities and MRI.

The gold standard will be histology of the breast tumor.


title: Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

summary: Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

lead_sponsor: Laboratoires Thea


title: Phenotypic Expressions in a French Pseudoxanthoma-Elasticum Cohort

summary: The cohort is intended to study the phenotypic expressions of the pseudoxanthoma elasticum (PXE) disease in various tissues (eye, skin, arteries, etc).

ReferenceCitation: Naouri M, Boisseau C, Bonicel P, Daudon P, Bonneau D, Chassaing N, Martin L. Manifestations of pseudoxanthoma elasticum in childhood. Br J Dermatol. 2009 Sep;161(3):635-9. doi: 10.1111/j.1365-2133.2009.09298.x. Epub 2009 Jun 9.

ReferenceCitation: Martin L, Maître F, Bonicel P, Daudon P, Verny C, Bonneau D, Le Saux O, Chassaing N. Heterozygosity for a single mutation in the ABCC6 gene may closely mimic PXE: consequences of this phenotype overlap for the definition of PXE. Arch Dermatol. 2008 Mar;144(3):301-6. doi: 10.1001/archderm.144.3.301.

ReferenceCitation: Bière L, Donal E, Terrien G, Furber A, Martin L, Prunier F. Left ventricular function in a large cohort of pseudoxanthoma elasticum patients. PLoS One. 2014 Mar 20;9(3):e90364. doi: 10.1371/journal.pone.0090364. eCollection 2014.

family: Bière

full_name: Loïc Bière

given: Loïc

family: Donal

full_name: Erwan Donal

given: Erwan

family: Terrien

full_name: Gwenola Terrien

given: Gwenola

family: Furber

full_name: Alain Furber

given: Alain

family: Martin

full_name: Ludovic Martin

given: Ludovic

family: Prunier

full_name: Fabrice Prunier

given: Fabrice

journal_name: PLoS ONE

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Left Ventricular Function in a Large Cohort of Pseudoxanthoma Elasticum Patients

lead_sponsor: University Hospital, Angers


title: Evaluation of Oxidative Stress Induced by Iron Injection in Healthy Volunteers Versus Critical Care Patients

acronym: SOFI

summary:
The purpose of this study is to evaluate the pro-oxidant toxicity of iron injections in critically ill patients and in healthy volunteers. The investigators hypothesize that the inflammatory state of critically ill patients will reduce the oxydative stress induced by iron injections, compared to the one induced in healthy volunteers. It will be an open "proof-of-concept" study aimed at evaluating iron toxicity in critically ill patients (n=40) as compared to healthy volunteers (n=40).

The investigators will compare the oxidative stress (principal judgment criteria= 8-iso-PGF2α) following a 100 mg injection of iron (at T0, T2, T6 and T24 hours post injection) in both groups and the investigators will compare the effect of repeated injections in the critically ill patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Pilot Study Evaluating the Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and the Establishment of a Mother-child Relationship in the Context of a Premature Birth

acronym: BBBox

summary: The main objective of this study is to compare the degree of maternal anxiety at Day 3 postpartum in mothers who did or did not have access to a video communication system (BB-Box system) from the time of initial separation with their baby.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


ReferenceCitation: Bidard FC, Kiavue N, Ychou M, Cabel L, Stern MH, Madic J, Saliou A, Rampanou A, Decraene C, Bouché O, Rivoire M, Ghiringhelli F, Francois E, Guimbaud R, Mineur L, Khemissa-Akouz F, Mazard T, Moussata D, Proudhon C, Pierga JY, Stanbury T, Thézenas S, Mariani P. Circulating Tumor Cells and Circulating Tumor DNA Detection in Potentially Resectable Metastatic Colorectal Cancer: A Prospective Ancillary Study to the Unicancer Prodige-14 Trial. Cells. 2019 May 28;8(6). pii: E516. doi: 10.3390/cells8060516.

family: Bidard

full_name: François-Clément Bidard

given: François-Clément

family: Kiavue

full_name: Nicolas Kiavue

given: Nicolas

family: Ychou

full_name: Marc Ychou

given: Marc

family: Cabel

full_name: Luc Cabel

family: Stern

full_name: Marc-Henri Stern

given: Marc-Henri

family: Madic

full_name: Jordan Madic

given: Jordan

family: Saliou

full_name: Adrien Saliou

given: Adrien

family: Rampanou

full_name: Aurore Rampanou

given: Aurore

family: Decraene

full_name: Charles Decraene

given: Charles

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Rivoire

full_name: Michel Rivoire

given: Michel

family: Ghiringhelli

full_name: François Ghiringhelli

given: François

family: Francois

full_name: Eric Francois

given: Eric

family: Guimbaud

full_name: Rosine Guimbaud

given: Rosine

family: Mineur

full_name: Laurent Mineur

given: Laurent

family: Khemissa-Akouz

full_name: Faiza Khemissa-Akouz

given: Faiza

family: Mazard

full_name: Thibault Mazard

given: Thibault

family: Moussata

full_name: Driffa Moussata

given: Driffa

family: Proudhon

full_name: Charlotte Proudhon

given: Charlotte

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

family: Stanbury

full_name: Trevor Stanbury

given: Trevor

family: Thézenas

full_name: Simon Thézenas

given: Simon

family: Mariani

full_name: Pascale Mariani

given: Pascale

currency_apc_doaj: CHF

journal_name: Cells

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

title: Phase II Multicentric Randomized Trial, Evaluating the Best Protocol of Chemotherapy, Associated With Targeted Therapy According to the Tumor KRAS Status, in Metastatic Colorectal Cancer (CCRM) Patients With Initially Non-resectable Hepatic Metastases

summary:
The main objective is to compare resection rates (R0 or R1) for hepatic metastases in the experimental arm (tri chemotherapy plus targeted therapy) versus the control arm (bi chemotherapy plus targeted therapy); in both arms the targeted therapy is selected according to K-Ras status of the patient's tumor.

The secondary objectives are to evaluate the objective response rate (CR and PR) after 4 cycles of treatment, according the RECIST V1.1 evaluation scale.

the rate of complete remission (CR) at 6 months after the last study treatment (hepatic surgery or last chemotherapy cycle).
the specific rates of resection R0, R1, R2.
the complete pathological response Rate,
the relapse-free survival rate in (R0 or R1) resected patients,
the response duration in non-resected patients,
the toxicity according to CTC AE V4 scale except for the neurotoxicity that will be evaluated with the Levi scale,
the post operative complications using the DINDO classification,
the progression-free survival (PFS) and overall survival (OS).

The objectives of the biological study are:

to evaluate tumor-related predictive factors such as somatic mutations (KRAS, BRAF, TP53) and genetic amplification related factors (EGFR),
to evaluate patient-related predictive factors in connection with genetic polymorphisms (Fc gamma and VEGF receptors),
to evaluate ADCC activity via immunohistochemistry in order to analyze the lympho free and progression-free survival,
to study circulating of tumor cells as prognostic factor for metastatic colorectal cancer, non- resectable at presentation.


summary: Main objective: investigate whether a functional polymorphism of CR1 (length, number of binding sites in C4b C3b, erythrocyte density, rate of soluble CR1 ...) so determined genetic or acquired, is a susceptibility factor for the disease Alzheimer's.

primary_purpose: Screening


title: Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke

acronym: AUTOTAB

summary:
Many patients retain upper-limb motor impairment following stroke. Most conventional rehabilitation techniques are aimed to improve motor intentional movement by repeated exercises. These techniques require attentional load and are responsible for significant fatigue that probably represents a limiting factor. Alternatively, the automatic control of action is now well documented. A rehabilitation method based on this principle could allow recovery of more natural movements.

Hypothesis: Stimulating automatic motricity improves upper-limb motor skills compared with a rehabilitation technique based on intentional movements.

location_facility: Service de Médecine Physique et de Réadaptation et Plateforme 'Mouvement et Handicap'


title: Microcephaly Genetic Deficiency in Neural Progenitors: Genotyping, Phenotyping and Functional Neuro-anatomy and Neurobiology Comparative Primitive Microcephaly (MCPH) and the Fanconi Anemia (FA)

acronym: MICROFANC

summary:
The purpose of this study is to:

I. Compare neuroradiological phenotype and cognitive functioning of MCPH patients caused by ASPM mutations already characterized and published (Passemard et al. 2009a) with other MCPH-related patients (patients with MCPH1, WDR62, CDK5RAP2, CEP 152, CENPJ, STIL, or PCNT mutations)

II. Describe the neuro-radiological and cognitive phenotype of microcephalic patients suffering from Fanconi anemia, and compared them to subjects with:

Fanconi anemia but normal OFC (head circumference)
MCPH patients
Healthy control subjects Our hypothesis is that mutations in genes responsible of microcephaly impact differentially cortical brain development and functioning

ReferenceCitation: Nasser H, Vera L, Elmaleh-Bergès M, Steindl K, Letard P, Teissier N, Ernault A, Guimiot F, Afenjar A, Moutard ML, Héron D, Alembik Y, Momtchilova M, Milani P, Kubis N, Pouvreau N, Zollino M, Guilmin Crepon S, Kaguelidou F, Gressens P, Verloes A, Rauch A, El Ghouzzi V, Drunat S, Passemard S. CDK5RAP2 primary microcephaly is associated with hypothalamic, retinal and cochlear developmental defects. J Med Genet. 2020 Jun;57(6):389-399. doi: 10.1136/jmedgenet-2019-106474. Epub 2020 Feb 3.

family: Nasser

full_name: Hala Nasser

given: Hala

family: Vera

full_name: Liza Vera

given: Liza

family: Elmaleh-Bergès

full_name: Monique Elmaleh-Bergès

given: Monique

family: Steindl

full_name: Katharina Steindl

given: Katharina

family: Letard

full_name: Pascaline Letard

given: Pascaline

family: Teissier

full_name: Natacha Teissier

given: Natacha

family: Ernault

full_name: Anais Ernault

given: Anais

family: Guimiot

full_name: Fabien Guimiot

given: Fabien

family: Afenjar

full_name: Alexandra Afenjar

given: Alexandra

family: Moutard

full_name: Marie Laure Moutard

given: Marie Laure

family: Héron

full_name: Delphine Héron

given: Delphine

family: Alembik

full_name: Yves Alembik

given: Yves

family: Momtchilova

full_name: Martha Momtchilova

given: Martha

family: Milani

full_name: Paolo Milani

given: Paolo

family: Kubis

full_name: Nathalie Kubis

given: Nathalie

family: Pouvreau

full_name: Nathalie Pouvreau

family: Zollino

full_name: Marcella Zollino

given: Marcella

family: Guilmin Crepon

full_name: Sophie Guilmin Crepon

given: Sophie

family: Kaguelidou

full_name: Florentia Kaguelidou

given: Florentia

family: Gressens

full_name: Pierre Gressens

given: Pierre

family: Verloes

full_name: Alain Verloes

given: Alain

family: Rauch

full_name: Anita Rauch

given: Anita

family: El Ghouzzi

full_name: Vincent El Ghouzzi

given: Vincent

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


title: Drug Interaction With Genes in Parkinson's Disease

acronym: DIGPD

summary: This observational study aims at identifying gene modifiers of Parkinson Disease (PD) and of treatment response and adverse events of antiparkinsonian drugs. Six hundred PD patients will be followed annually for up to 5 years. A biological collection will be associated with a full clinical assessment of motor and non motor symptoms, medical and treatment history, environmental factors. The association between candidate gene polymorphisms and disease or treatment complications will be analyzed.

ReferenceCitation: Marques A, Vidal T, Pereira B, Benchetrit E, Socha J, Pineau F, Elbaz A, Artaud F, Mangone G, You H, Cormier F, Galitstky M, Pomies E, Rascol O, Derkinderen P, Weintraub D, Corvol JC, Durif F; DIGPD study group. French validation of the questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS). Parkinsonism Relat Disord. 2019 Jun;63:117-123. doi: 10.1016/j.parkreldis.2019.02.026. Epub 2019 Mar 4.

family: Marques

full_name: Ana Marques

given: Ana

family: Vidal

full_name: Tiphaine Vidal

given: Tiphaine

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Benchetrit

full_name: Eve Benchetrit

given: Eve

family: Socha

full_name: Julie Socha

given: Julie

family: Pineau

full_name: Fanny Pineau

given: Fanny

family: Elbaz

full_name: Alexis Elbaz

given: Alexis

family: Artaud

full_name: Fanny Artaud

family: Mangone

full_name: Graziella Mangone

given: Graziella

family: You

full_name: Hana You

given: Hana

family: Cormier

full_name: Florence Cormier

given: Florence

family: Galitstky

full_name: Monique Galitstky

given: Monique

family: Pomies

full_name: Elsa Pomies

given: Elsa

family: Rascol

full_name: Olivier Rascol

given: Olivier

family: Derkinderen

full_name: Pascal Derkinderen

given: Pascal

family: Weintraub

full_name: Daniel Weintraub

given: Daniel

family: Corvol

full_name: Jean Christophe Corvol

given: Jean Christophe

family: Durif

full_name: Franck Durif

given: Franck

journal_name: Parkinsonism & Related Disorders

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

title: French validation of the questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease–Rating Scale (QUIP-RS)

ReferenceCitation: Corvol JC, Artaud F, Cormier-Dequaire F, Rascol O, Durif F, Derkinderen P, Marques AR, Bourdain F, Brandel JP, Pico F, Lacomblez L, Bonnet C, Brefel-Courbon C, Ory-Magne F, Grabli D, Klebe S, Mangone G, You H, Mesnage V, Lee PC, Brice A, Vidailhet M, Elbaz A; DIGPD Study Group. Longitudinal analysis of impulse control disorders in Parkinson disease. Neurology. 2018 Jul 17;91(3):e189-e201. doi: 10.1212/WNL.0000000000005816. Epub 2018 Jun 20.

location_facility: Centre d'Investigation Clinique Neuro - Bâtiment ICM - Hôpital Pitié-Salpêtrière


title: Characterization of LV Hemodynamics During Epicardial and Endocardial Pacing

summary: The purpose of this study is to evaluate the effects of epicardial and endocardial pacing at each side of the left ventricular (LV) segments on cardiac hemodynamics in patients with impaired LV function undergoing epicardial ablation and mapping procedure. Hemodynamic function will be assessed during a pacing protocol with a pressure catheter inserted in the LV.

lead_sponsor: Abbott Medical Devices


title: More Added Value of Therapeutic Education in the Management of Patients With Rheumatoid Arthritis

acronym: ETP-PR

summary: Taking into account the recommendations of the Health Authority [1] and the application of patients' associations, we have structured a course of therapeutic education includes three stages for patients with rheumatoid arthritis and followed at Nantes University Hospital. Step 1: initial interview with a nurse patient education for diagnosis and education with the patient to choose three subjects from among 10 offered him problematic; Step 2: Orientation in an educational path that provides access to 6 months group workshops (3 maximum) and / or interviews tailored to the three selected topics; Step 3: final interview with a nurse said therapeutic education formative assessment to take stock. The main objective of our work is to ensure that the patient finds it easier solutions to the three problematic topics him after 6 months of education after six months without treatment.

lead_sponsor: Nantes University Hospital


title: Phase 2 Study of the Effect of Zoledronate on Local Recurrence After Surgical Treatment of Giant Cell Tumors of Bone

acronym: Zometa

summary:
The giant cell tumor (GTC) is an aggressive benign bone tumor, growing at the metaphyseal-epiphyseal regions of long bones, especially around the knee and the distal radius.It is responsible for bony destruction in para-articular zone fracture and leading to the breakdown and destruction of the underlying joint.

Histologically, the tumor cell contains a contingent of monocytic cells round, a contingent of giant type cell of type osteoclastic responsible for bone resorption that accompanies these tumors and a contingent of lengthened cells fibroblast-like considered to be contingent tumor.

The treatment is exclusively surgical; or by resection of the lesion which takes away tumour and its environment, solution which, if it prevents local recurrence, imposes an important bony and articular reconstruction, always limited and deteriorating rapidly over time in these young patients; or by curettage of lesion, by "hollowing-out" of the bone, creating a hole which it will be necessary to fill up by a bony grafting or a substitute of the bone (cement). This last solution, if it preserves a better function, exposes at risk of local recurrence,putting into play the prognosis of articulation near, most often the knee.Despite different local adjuvants treatments used during surgical operation, after having curetted the cavity and before filling it up, the recidivism rates vary from 12 % to 41 % (average 25 %) in literature.

The beneficial effect of the adjuvants therapeutics suggests the concept broadly accepted by a tumoral microscopic residual at the origin of the local recidivism .Biphosphonates (BP) is molecules which settle in vivo on the hydroxyapatite of the bone; they inhibit the recruitment of the osteoclast forerunners and the activity of mature osteoclast. Besides, biphosphonates containing some nitrogen (N-BP), leads to the apoptose of mature osteoclast. These molecules also have a direct effect on tumor cells , causing apoptosis of neoplastic cells of myeloma, of breast cancer. Clinical controlled studies confirm the experimental data of N-BP. Two work also showed their effect on osteoclasts and stroma cells of tumours with giant cells but no clinical study assessed potential on the prevention of the local recurrence.

The investigators offer a study phase 2 of the effectiveness of N-BP (acid zoledronique) on the prevention of the local recurrence of tumours with primary huge cells after surgical treatment by curettage - filing by a surgeon referent in oncologic orthopedic surgery.

Number of patients: 24


title: Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance

summary:
Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where feasible, surgical removal of the home is the best therapeutic outcome.

Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical and experimental studies have shown that dysfunction of the blood-brain barrier (BBB) contributes to epileptogenesis and drug resistance. It is now recognized that cytokines exacerbate the excitability and permeability of the BBB, which was recently confirmed by studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have described an association between pathological angiogenesis and BBB permeability in the tissue of patients with excision of drug-resistant TLE. With experimental models, it was revealed an activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB.

The investigators hypothesis is that the identification of factors involved in BBB permeability may designate potential targets for drug-resistant partial epilepsy.

lead_sponsor: University Hospital, Montpellier


title: Single-centre, Randomised, Placebo-controlled, Double-blind, Dose Escalation Trial Investigating Pharmacokinetics, Pharmacodynamics and Tolerability of Three Different Single Intravenous Doses of Activated Recombinant Factor VIIa (rFVIIa/NovoSeven®) in Healthy Caucasian and Japanese Subjects

summary: This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.

ReferenceCitation: Fridberg MJ, Hedner U, Roberts HR, Erhardtsen E. A study of the pharmacokinetics and safety of recombinant activated factor VII in healthy Caucasian and Japanese subjects. Blood Coagul Fibrinolysis. 2005 Jun;16(4):259-66.

ReferenceCitation: Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33.

lead_sponsor: Novo Nordisk A/S


title: Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes

acronym: ISOL/STAND

summary:
Application of isolation (=contact precautions) in hospitalized patients is recommended when patient is colonized (or infected) by micro-organism known for its outbreak capacity or high pathogenicity. It allows the reinforcement of universal precautions (=standard precautions) in order to control patient-to-patient micro-organisms transmission. Recently, the efficacy of this measure is questioned and its impact on patient care seems deleterious.

In a particular context of Infectious Disease Unit, where standard precautions are handled (favorable architecture and appropriate practice for hand hygiene), assessment of contact precautions to reduce the incidence of acquired bacteria during hospitalization would be of interest.

The investigators design a non-inferiority comparative study to measure the colonization pressure in patients hospitalized in two different parts of the department: one unit only with standard precautions applied (intervention) and one unit with contact precautions (control) as current routine care.


title: Comparison of Diagnostic Performance of an Algorithm and a High Definition Classical Iterative Algorithm Positron Emission Tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) in the Evaluation of Axillary Lymph Node Invasion of Breast Tumors

acronym: TEP-Sein

summary: The primary endpoint of this study is to show that this algorithm in high definition is superior to the classical algorithm in the diagnosis of lymph node metastases.

lead_sponsor: Centre Francois Baclesse


title: Psychopathological Risk Factors Associated With Conversion From Mild Cognitive Impairment to Dementia

acronym: FPRMCI

summary:
Background: Dementias (Alzheimer's disease and related syndromes), in their sporadic form, have multifactorial origin. Several risk factors (RF) are currently recognized like the cardiovascular RF, some genes of susceptibility, but the impact [1] of traumatic life events (TLE), considered as psychosocial RF (Persson & Skoog, 1996; Charles et al, 2006), [2] of anxiety and/or depression, [3] of the premorbid personality (Clément et al, 2003) with his coping strategies, and [4] of the lifestyle (which results from the personality), for the moment are still underestimated. Dementia disease can be clinically preceded by a mild cognitive impairment (MCI) (Petersen et al, 1996) which is however potentially reversible.

Purpose: Actually, there is no study concerning the rate of conversion from MCI to dementia according to the presence or not of TLE. The aim of this study is to assess association between TLE and conversion rate from MCI to dementia.

Methods: Patients with MCI will be recruited in different memory clinics (Limoges and others) Primary outcome: Occurrence of dementia according to DSM-IV-TR criteria in MCI patients according to their cumulated score of TLE measured by EVVIE.

Secondary outcomes: Occurrence of dementia in MCI patients according to various other psychopathological factors: anxiety, depression, apathy, personality features, alexithymia and resilience levels and life style.

Study design: Epidemiologic cohort longitudinal and prospective multicenter study.

lead_sponsor: Centre Hospitalier Esquirol


title: Comparison of the Rates of Fetal Extractions Between a Systematic Practice of an Echography of Presentation and the Only Vaginal Touch Usually Realized During the Labor

acronym: PINKFINGER

summary: The main objective of this study is to compare the rate of fetal extractions between a systematic practice of an echography of presentation and the vaginal touch only one usually realized during the labor.


title: "Enfoncement de la Tige SL-PLUS et de la Tige SL-PLUS MIA:Etude Comparative"

acronym: SL-PLUS

summary:
Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL PLUS (study group).

We compare primary and secondary stability of both hip stems for radiographic outcome using EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.

Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings.

primary_purpose: Health Services Research

lead_sponsor: Smith & Nephew Orthopaedics AG

location_facility: Hopital Salengro, Service d'Orthopédie C

intervention_type: Procedure


title: Early Oculomotor Markers in Alzheimer's Disease: Test of Predictive Value in the Differential Diagnosis Depression/Alzheimer

acronym: MOMAD

summary:
The global aim of our study is to validate eye movement recording as an early differential diagnostic tool, in order to discriminate as early as possible between neurodegenerative dementias of Alzheimer type and depressive pseudodementias (DPD). The investigators want to put forward idiosyncratic oculomotor characteristics of Alzheimer's disease (AD) and DPD respectively. Eye movements are sensitive markers of neurological diseases and can be used in a variety of clinical neurological syndromes.

This study compares 3 groups of 98 patients: patients suffering of AD and DPD and healthy persons. The patients AD will be recruited in the Memory Centre of Resources and Research of Besançon and patients DPD will be selected in the psychiatric department of the University Hospital of Besançon. The control participants will be recruited from the entourage of researchers and patients. The selection of participants in the 3 different groups is based on clinical examinations in psychiatry and neurology and neuropsychological assessments. After giving informed consent, patients will be evaluated by a psychiatrist and a neuropsychologist. The complete assessment takes 150 minutes.

After having set up patients, eye movements will be recorded using video-oculography techniques. The following tasks are performed: the basic dynamic eye movements (latency, hypometric and hypermetric saccades, reaction time, saccade speed, accuracy, pupil diameter) will be evaluated by the pro-saccade, anti-saccade and predictive saccade tasks. The emotional connotation tasks will be assessed by scan of images pair with emotional connotation and portrait analysis. The assessment takes 30 minutes.

This study will include 3 groups:

an Alzheimer group;
a depressed group;
a control group with healthy persons. The population of this study will be comprised of patients over age 60 with a visual acuity over 9/10, not diagnosed with eye disease and not neuropsychological sequelae that could disrupt the functioning oculomotor.

These people will be recruited on a voluntary basis, after notification and consent in the research center, the Psychiatry Clinical Department of the University Hospital of Besançon. This study was conducted over a period of 36 months.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Univserity Hospital of Besançon - Psychiatry Department


ReferenceCitation: Wessel F, Chartier A, Meunier JP, Magnan A. Safety and tolerability of an SQ-standardized GRAss ALlergy immunotherapy tablet (GRAZAX®) in a real-life setting for three consecutive seasons - the GRAAL trial. Clin Drug Investig. 2012 Jul 1;32(7):451-63. doi: 10.2165/11634270-000000000-00000.

family: Wessel

full_name: François Wessel

given: François

family: Chartier

full_name: Antoine Chartier

given: Antoine

family: Meunier

full_name: Jean-Pierre Meunier

given: Jean-Pierre

family: Magnan

full_name: Antoine Magnan

journal_name: Clinical Drug Investigation

publisher_dissemination: Springer

publisher_group: Springer

title: Safety and Tolerability of an SQ-Standardized GRAss ALlergy Immunotherapy Tablet (GRAZAX®) in a Real-Life Setting for Three Consecutive Seasons – The GRAAL Trial

acronym: GRAAL

source: euctr

title: Observational National Clinical Trial of Safety and Tolerance in Patients Suffering of an Allergic Grass Pollen Rhinitis and Treated by Grazax in Real Life Settings

summary: The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons.


title: Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies

acronym: DARWIM

summary: Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses. An appropriate and rapid diagnosis is necessary, because morbidity and mortality are high and a specific treatment is needed. Currently the use of muscle MRI (magnetic resonance imaging) in departments managing IIM is common. In absence of recommendations fixing their place in the diagnostic phase, the practices observed are extremely heterogeneous. This practices diversity well reflects the lack of data in the literature, making it impossible to appreciate the real contribution of this test. The main aim of this interventional study is to evaluate the diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for patients who are suspected to suffer from IIM.


title: Prospective Double Blind Multicentre Randomized Trial of Vitamine D Estimating the Profit of a Treatment by Vitamin D3 at the Dose of 100000 UI by Comparison With a Treatment in the Dose of 12 000 UI at Renal Transplanted Patients

acronym: VITALE

summary: It has been proposed that the intake of high dose of cholecalciferol may have beneficial non classical effects (beside bone health). This could include the reduction of type 2 diabetes mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These pleiotropic effects are mostly documented by observational and experimental studies or small intervention trials. In renal transplant recipients, vitamin D insufficiency, defined as circulating 25(OH)vitamin D (25OHD) less than 30 ng/mL, is a frequent finding and this population is at risk of the previously cited complications.The primary purpose of this study is to compare the effects of high dose vs. low dose of cholecalciferol on a composite endpoint consisting in de novo diabetes mellitus, cardiovascular diseases, de novo cancer and patient death.Renal transplant recipients between 12 and 48 months after transplantation will be randomized to blindly receive either high or low dose of cholecalciferol with a follow-up of 2 years.

ReferenceCitation: Courbebaisse M, Alberti C, Colas S, Prié D, Souberbielle JC, Treluyer JM, Thervet E. VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI in renal transplant recipients: study protocol for a double-blind, randomized, controlled trial. Trials. 2014 Nov 6;15:430. doi: 10.1186/1745-6215-15-430.

family: Courbebaisse

full_name: Marie Courbebaisse

given: Marie

family: Alberti

full_name: Corinne Alberti

given: Corinne

family: Colas

full_name: Sandra Colas

given: Sandra

family: Prié

full_name: Dominique Prié

given: Dominique

family: Souberbielle

full_name: Jean-Claude Souberbielle

given: Jean-Claude

family: Treluyer

full_name: Jean-Marc Treluyer

given: Jean-Marc

family: Thervet

full_name: Eric Thervet

given: Eric

journal_name: Trials