type: Other Identifier

type: EudraCT Number

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis.

summary: The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum in: Drug Saf. 2019 Apr 22;:.

family: Ghosh

full_name: Subrata Ghosh

given: Subrata

family: Gensler

full_name: Lianne S. Gensler

given: Lianne S.

family: Yang

full_name: Zijiang Yang

given: Zijiang

family: Gasink

full_name: Chris Gasink

given: Chris

family: Chakravarty

full_name: Soumya D. Chakravarty

given: Soumya D.

family: Farahi

full_name: Kamyar Farahi

given: Kamyar

family: Ramachandran

full_name: Paraneedharan Ramachandran

given: Paraneedharan

family: Ott

full_name: Elyssa Ott

given: Elyssa

family: Strober

full_name: Bruce E. Strober

given: Bruce E.

journal_name: Drug Safety

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

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

repository_institution: California Digital Library - eScholarship

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

title: Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs

ReferenceCitation: Papp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, Yeilding N, Guzzo C, Hsu MC, Wang Y, Li S, Dooley LT, Reich K; PHOENIX 2 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008 May 17;371(9625):1675-84. doi: 10.1016/S0140-6736(08)60726-6.

family: Papp

full_name: Kim A Papp

given: Kim A

family: Langley

full_name: Richard G Langley

given: Richard G

family: Lebwohl

full_name: Mark Lebwohl

location_country:
Austria
Switzerland
Germany
France
United States
United Kingdom
Canada


title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung Cancer or Esophageal Cancer

summary: Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bayer

location_country:
Austria
United States
Germany
France
Australia
Belgium
Spain
Denmark
Canada
United Kingdom

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

summary: This trial is designed to determine whether an 8-week course of escalated dose conformal radiation can be compressed safely, and with similar efficacy into a 4-week course.

status: Completed

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Martin J, Frantzis J, Chung P, Langah I, Crain M, Cornes D, Plank A, Finch T, Jones M, Khoo E, Catton C. Prostate radiotherapy clinical trial quality assurance: how real should real time review be? (A TROG-OCOG Intergroup Project). Radiother Oncol. 2013 Jun;107(3):333-8. doi: 10.1016/j.radonc.2013.05.015. Epub 2013 Jun 8.

lead_sponsor: Ontario Clinical Oncology Group (OCOG)

location_country: Canada Australia France

location_facility: Ballarat Austin Radiation Oncology Centre (BAROC)

location_facility: Liverpool Hospital & Campbelltown Hospital

location_facility: Wollongong Hospital / Illawarra Cancer Care Centre

location_facility: Stronach Regional Cancer Centre, Southlake Regional Health Centre

location_facility: The Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Centre

location_facility: Northern Sydney Cancer Centre, Royal North Shore Hospital

location_facility: R.S. McLaughlin Durham Regional Cancer Centre

intervention_type: Procedure

status_simplified: Completed


study_start_date_type: Actual

lead_sponsor: Puma Biotechnology, Inc.

location_country:
India
Mexico
France
Belgium
Russian Federation
China
United States

location_facility: No. 81 Hospital of Chinese People's Liberation Army

location_facility: The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army

location_facility: Cancer Hospital Peking Union Medical College

location_facility: City Hospital N 31 Oncology Haematology Dept. For Adults

location_facility: St-Augustinus Ziekenhuis Oncology Department

location_facility: Hospital Regional Lic. Adolfo Lopez Mateos Oncología Médica

location_facility: Breast Tumor Department, N.N. Petrov Research Institute of Oncology

location_facility: N.N. Blokhin Russian Cancer Research Center of RAMS

location_facility: Institut Gustave ROUSSY Service de Pathologie Mammaire

location_facility: Medical Radiological Research Center of RAMS, Department of Radiation and Surgical Methods

location_facility: The Cleveland Clinic Taussig Cancer Center

location_facility: Institut Jules Bordet Unite du Chimiotherapie

location_facility: Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center

location_facility: Chinese People's Liberation Army General Hospital

source: euctr

title: Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer

summary: The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.


title: An Open-label, Fixed-dose, Multicenter, Phase II Study of MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma

summary: This study is an open-label, fixed-dose, multicenter study of MDX-060 in patients with ALCL who have relapsed or refractory disease. There will be 3 phases of this study: Induction, Maintenance, and Follow-up. Patients will be required to attend all protocol-required visits in the 4-week Induction Phase, in which administration of MDX-060 will occur, as well as other testing. Patients who complete the Induction Phase may be eligible for additional MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase. Patients who complete the Maintenance Phase with a response of stable disease or better will be followed every 2 months for 1 year or until disease progression. The purpose of this study is to determine objective response rate at Day 50 in patients with relapsed or refractory classic systemic ALCL or primary cutaneous ALCL treated with MDX-060. Other objectives will be evaluated.

status: Withdrawn

design_allocation: Non-Randomized

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
France

location_facility: The Cancer Institute of New Jersey - Robert Wood Johnson Unv. Hosp.

location_facility: California Oncology of the Central Valley

location_facility: Centre Hospitalier Regional Unv. de Lille, Hopital Claude Huriez


title: NICOREA : Evaluation multicentrique d'une stratégie de substitution nicotinique par timbre transdermique lors du sevrage de la ventilation mécanique de patients fumeurs hospitalisés en réanimation

acronym: NICOREA

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

status: Ongoing

lead_sponsor_type: academique

status_simplified: Ongoing


title: Rôle de l'axe CXCR4/CXCL12 dans le contrôle de l'immunité humorale et de l'auto-immunité chez les patients lupiques après vaccination anti-grippale- GRIPLUP

acronym: GRIPLUP


title: Traitement par le monoxyde d’azote inhalé (NO) du syndrome thoracique aigu (STA) chez l'enfant drépanocytaire : Essai randomisé, double aveugle, contre placebo, preuve de concept

acronym: INNOSTA PED

status: Prematurely Ended


title: A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects with Advanced and/or Metastatic Solid Tumors

lead_sponsor: Bristol-Myers Squibb International Corporation


title: Etude prospective multicentrique ouverte évaluant l'efficacité immunologique et la tolérance de la vaccination grippale chez des patients suivis pour une maladie inflammatoire chronique intestinale( MICI) traités ou non par immunosuppresseurs

acronym: MICIVAX


title: EVALUATION OF THE SAFETY AND EFFICACY OF WST11 MEDIATED VASCULAR TARGETED PHOTODYNAMIC THERAPY ON OBSTRUCTING ENDOBRONCHIAL NON-SMALL CELL LUNG CANCER

lead_sponsor: STEBA BIOTECH


title: Open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two different dose regimens of IPH 2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy

lead_sponsor: Innate Pharma


title: Utilisation d’un surfactant exogène chez des nouveau-nés grands prématurés présentant une détresse respiratoire sévère en prévention de la dysplasie bronchopulmonaire

acronym: Etude CURDYS

lead_sponsor: Maternite Regionale Universitaire de Nancy


title: Rôle neuroprotecteur de la Ciclosporine A dans l’infarctus cérébral traité par thrombolyse intraveineuse. Etude pilote monocentrique randomisée contrôlée versus placebo.

acronym: CsA Stroke

lead_sponsor: Hospices Civils de Lyon


title: Etude d’un traitement préopératoire par Cisplatine-Docétaxel et radiothérapie dans le cancer bronchique non à petites cellules de stade IIIA/IIIB (T1-4, N2): Etude de phase II

acronym: TAXCIS 2

lead_sponsor: CENTRE ANTOINE LACASSAGNE


title: Etude ouverte prospective randomisée sur l’utilisation du Flammacérium® dans les nécroses cutanées ischémiques du pied

lead_sponsor: CHRU Montpellier


title: IMPACT D’UNE INTENSIFICATION THERAPEUTIQUE PAR INHIBITEUR D’INTEGRASE +/- INHIBITEUR DE CCR5 SUR LE RESERVOIR LYMPHOÏDE DU VIH-1 CHEZ DES PATIENTS AU STADE CHRONIQUE DE L’INFECTION

acronym: IntensVIH

lead_sponsor: Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer


title: Etude bi-centrique, randomisée, en groupes parallèles et double aveugle contre placebo pour évaluer l’efficacité et la sécurité à long terme de la toxine botulique en deux administrations répétées sur les douleurs liées a une mononeuropathie ou polyneuropathie : Etude Botnep.

lead_sponsor: Association REDAR, Hôpital Ambroise Paré, Service d'Anesthésie et de Réanimation


title: A randomised, double-blind study of the safety and efficacy of Neoven compared to Vaminolact in infants and children requiring long-term parenteral nutrition

lead_sponsor: Fresenius Kabi Deutschland GmbH


title: Devenir de la spermatogénèse chez les hommes drépanocytaires traités médicalement  (HYDREP).

acronym: HYDREP


title: EVALUATION DU RETENTISSEMENT PSYCHIATRIQUE,  CARDIOVASCULAIRE ET SUR LA QUALITE DE VIE DE L’ HORMONOTHERAPIE FREINATRICE DANS UNE COHORTE DE PATIENTS THYROIDECTOMISES POUR CARCINOME THYROIDIEN PAPILLAIRE DIFFERENCIE

lead_sponsor: CHU de Nîmes


title:
Essai randomisé, en double aveugle, chez les femmes ménopausées ayant un cancer du sein RE+ comparant deux traitements néo-adjuvants : un anti-aromatase (Letrozole) VS un SERM (Tamoxifène).
 Effet sur des variables biologiques intermédiaires prédictives de la réponse au traitement

lead_sponsor: Centre Val d'Aurelle - Paul Lamarque


title: Traitement de l'insuffisance surrénale secondaire à un traumatisme crânien grave. Etude multicentrique, contrôlée, randomisée portant sur un médicament. - Etude Corti-TC"

acronym: Corti-TC

lead_sponsor: CHU de Nantes


title: Etude de phase II randomisée d’évaluation de la faisabilité d’une chimiothérapie par docetaxel prednisone sur un mode hebdomadaire ou toutes les 3 semaines dans une population de patients âgés (+75ans) «vulnérables » ou « fragiles », définis selon les critères de la SIOG, porteurs d’un adénocarcinome de prostate métastatique réfractaire à la castration et progressif.

lead_sponsor: FNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer)


title: Analysis of the sensory profile of two new transdermal patches (V0116TD07AF019  and V0116TD07AF020) 21 mg/24h  versus a reference transdermal patch (NICOTINELL TTS) 21 mg/24h.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A 12-MONTH OPEN-LABEL EXTENSION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF FLEXIBLE DOSES OF PREGABALIN IN PEDIATRIC PATIENTS WITH PARTIAL ONSET SEIZURES

lead_sponsor: Pfizer Inc.235 East 42nd Street, New York, NY 10017


title: A Phase II, Randomised, Placebo-Controlled Trial of the Safety, Efficacy, Pharmacodynamics of PTX3003 in Patients with Charcot-Marie-Tooth Disease Type 1A

acronym: non applicable

lead_sponsor: Pharnext


title: PHARMACOGENETIQUE DE LA GEMCITABINE : ETUDE DE L’IMPACT DU POLYMORPHISME GENETIQUE DE LA CYTIDINE DEAMINASE (CDA) SUR LA TOXICITE ET L’EFFICACITE THERAPEUTIQUE DANS LES ADENOCARCINOMES PANCREATIQUES RESEQUES

acronym: FFCD 1004

lead_sponsor: Fédération Francophone de Cancérologie Digestive (FFCD)


title: A prospective, multicentre, open-label, randomised, uncontrolled, phase 1/2 study to evaluate the efficacy and safety of masitinib in combination with 5-fluorouracil (5-FU) or capecitabine, or masitinib in combination with irinotecan, or masitinib in combination with irinotecan, 5-fluorouracil (5-FU) and folinic acid (FOLFIRI protocol), as second line chemotherapy in patients with gastric or gastro-oesophageal junction metastatic adenocarcinoma.

lead_sponsor: AB Science


title: Effets potentiels d’une supplémentation en oméga 3 sur la membrane des cardiomyocytes de patients atteints d’athérosclérose coronaire ?

lead_sponsor: CHU Clermont-Ferrand


title: Etude de phase II évaluant la tolérance et l’efficacité d’un traitement de consolidation par Rituximab sous-cutané à faibles doses chez des patients présentant une leucémie lymphoïde chronique en réponse après traitement d’induction.

acronym: LLCR - Lowdoz

lead_sponsor: Institut Paoli-Calmettes


title: Comparaison Glibenclamide/Insuline dans le traitement du diabète gestationnel. Essai randomisé multicentrique de non infériorité

acronym: INDAO

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title:
Rubinstein-Taybi syndrome: approach to functional imaging and therapeutic trial

 SYNDROME DE RUBINSTEIN-TAYBI : APPROCHE EN IMAGERIE FONCTIONNELLE ET ESSAI THERAPEUTIQUE

acronym: RUBIVAL

lead_sponsor: CHU de bordeaux


title:
Randomized double blind placebo-controlled phase II trial of Vargatef® in addition to first line chemotherapy with interval debulking surgery in patients with adenocarcinoma of the ovary, the fallopian tube or serous adenocarcinoma of the peritoneum

 Essai randomisé en double aveugle de phase II évaluant le Vargatef® (Nintedanib) en concomitance d’une première ligne de chimiothérapie avec chirurgie d’intervalle chez les patientes présentant un cancer de l’ovaire, de la trompe ou du péritoine.

acronym: CHIVA

lead_sponsor: ARCAGY


title: Etude de phase II évaluant l'association doxorubicine liposomale non-pégylée-dexaméthasone chez des patients immunocompétents présentant un lymphome cérébral réfractaire ou en rechute à une première ligne de chimiothérapie par méthotrexate à haute dose (MTXHD) et/ou cytarabine à forte dose.

acronym: MYLY

lead_sponsor: CHRU de Brest


title: Intérêt de la cryothérapie ou de l'aérosolisation par corticoïdes sur les troubles de la déglutition en post-opératoire précose après thyroïdectomie totale.

acronym: DEGLUTHYR

lead_sponsor: CHU Dijon


title: Phase II clinical trial evaluating the efficacy of the dual inhibition of PIK/Akt/mTor signaling pathway by PF-05212384 (PKI-587) for patients with myeloid neoplasm secondary to chemo-radiotherapy (t-AML/MDS) or de novo relapsed or refractory AML

acronym: LAM-PIK

lead_sponsor: INSTITUT CURIE


title:
Designing a Bayesian model of the plasma clearance of Calcium edetate de sodium, with a limited sampling strategy for the calculation of Glomerular Filtration Rate (GFR) and validity assessment compared to the renal clearance of Inulin.

 Conception d’un modèle bayésien de la clairance plasmatique du Calcium édétate de sodium, avec une stratégie de prélèvements limités, pour le calcul du Débit de Filtration Glomérulaire et évaluation de la validité par rapport à la clairance rénale à l’équilibre de l’Inuline.

acronym: DFGBay

lead_sponsor: University Hospital, Limoges


title: Étude randomisée en double-aveugle versus placebo des effets de l’iméglimine sur la sécrétion d’insuline au cours d’un clamp hyperglycémique chez le sujet diabétique de type

acronym: Étude des effets de l’iméglimine sur la sécrétion d’insuline au cours d’un clamp hyperglycémique

lead_sponsor: POXEL


title: INTERET DE L’ONDANSETRON INTRAVEINEUX EN PREVENTION DES HYPOTENSIONS INDUITES PAR LA RACHIANESTHESIE POUR CESARIENNE : ETUDE MONOCENTRIQUE RANDOMISEE CONTROLEE EN DOUBLE AVEUGLE

acronym: Etude ZORA (ZOphren - RAchis)

lead_sponsor: CHU de DIJON


title:
.

 Comparaison des concentrations plasmatiques pour une anesthésie optimale chez les obèses et les non obèses

acronym:
.

 COCOPOPONO

lead_sponsor: CHU de Clermont-Ferrand


title: A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer

summary: The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.

lead_sponsor: Puma Biotechnology, Inc.

location_country:
France
Poland
Hungary
Spain
United States

location_facility: Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy

location_facility: Wielkopolskie Centrum Chorób Płuc i Gruźlicy

location_facility: Dolnośląskie Centrum Chorób Płuc we Wrocławiu

location_facility: Massachusetts General Hospital, Yawkey Center for Outpatient Care

location_facility: Országos Korányi TBC és Pulmonológiai Intézet


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing Spondylitis

summary: The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis [AS(arthritis of the spine)]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effects on back pain and stiffness, physical function, range of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.

ReferenceType: derived

ReferenceCitation: Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):441-446. doi: 10.1093/rheumatology/key309.

name: Global Clinical Pharmacology, Janssen Research & Development, LLC, Spring House, PA, USA

family: Leu

full_name: Jocelyn H Leu

given: Jocelyn H

sequence: first

family: Adedokun

full_name: Omoniyi J Adedokun

given: Omoniyi J

sequence: additional

name: Clinical Biostatistics, Janssen Research & Development, LLC, Spring House, PA, USA

family: Gargano

full_name: Cynthia Gargano

given: Cynthia

name: Immunology, Janssen Research & Development, LLC, Spring House, PA, USA

family: Hsia

full_name: Elizabeth C Hsia

given: Elizabeth C

family: Xu

full_name: Zhenhua Xu

given: Zhenhua

name: Biologics Development Sciences, Janssen Research & Development, LLC, Spring House, PA, USA

family: Shankar

full_name: Gopi Shankar

given: Gopi

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Rheumatology

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Inman RD, Baraliakos X, Hermann KA, Braun J, Deodhar A, van der Heijde D, Xu S, Hsu B. Serum biomarkers and changes in clinical/MRI evidence of golimumab-treated patients with ankylosing spondylitis: results of the randomized, placebo-controlled GO-RAISE study. Arthritis Res Ther. 2016 Dec 28;18(1):304. doi: 10.1186/s13075-016-1200-1.

family: Inman

full_name: Robert D. Inman

given: Robert D.

family: Baraliakos

full_name: Xenofon Baraliakos

given: Xenofon

family: Hermann

full_name: Kay-Geert A. Hermann

given: Kay-Geert A.

family: Braun

full_name: Jürgen Braun

given: Jürgen

family: Deodhar

full_name: Atul Deodhar

given: Atul

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

full_name: Stephen Xu

given: Stephen

family: Hsu

full_name: Benjamin Hsu

given: Benjamin

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repositories:
PubMed Central
localhost
refubium.fu-berlin.de

ReferenceCitation: Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Zhou Y, Goldstein N, Braun J. Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. J Rheumatol. 2016 Dec;43(12):2120-2130. Epub 2016 Nov 1.

ReferenceCitation: Braun J, Baraliakos X, Hermann KG, Xu S, Hsu B. Serum C-reactive Protein Levels Demonstrate Predictive Value for Radiographic and Magnetic Resonance Imaging Outcomes in Patients with Active Ankylosing Spondylitis Treated with Golimumab. J Rheumatol. 2016 Sep;43(9):1704-12. doi: 10.3899/jrheum.160003. Epub 2016 Jul 15.

ReferenceCitation: Braun J, Baraliakos X, Hermann KG, Xu S, Hsu B. Serum Vascular Endothelial Growth Factor Levels Lack Predictive Value in Patients with Active Ankylosing Spondylitis Treated with Golimumab. J Rheumatol. 2016 May;43(5):901-6. doi: 10.3899/jrheum.150897. Epub 2016 Mar 1.

ReferenceCitation: Deodhar A, Braun J, Inman RD, van der Heijde D, Zhou Y, Xu S, Han C, Hsu B. Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 5-year results of the GO-RAISE study. Ann Rheum Dis. 2015 Apr;74(4):757-61. doi: 10.1136/annrheumdis-2014-205862. Epub 2014 Nov 11.

ReferenceCitation: van der Heijde D, Braun J, Deodhar A, Inman RD, Xu S, Mack ME, Hsu B. Comparison of three enthesitis indices in a multicentre, randomized, placebo-controlled trial of golimumab in ankylosing spondylitis (GO-RAISE). Rheumatology (Oxford). 2013 Feb;52(2):321-5. doi: 10.1093/rheumatology/kes251. Epub 2012 Sep 28.

ReferenceCitation: van der Heijde D, Deodhar A, Inman RD, Braun J, Hsu B, Mack M. Comparison of three methods for calculating the Bath Ankylosing Spondylitis Metrology Index in a randomized placebo-controlled study. Arthritis Care Res (Hoboken). 2012 Dec;64(12):1919-22. doi: 10.1002/acr.21771.

ReferenceCitation: Deodhar A, Braun J, Inman RD, Mack M, Parasuraman S, Buchanan J, Hsu B, Gathany T, van der Heijde D. Golimumab reduces sleep disturbance in patients with active ankylosing spondylitis: results from a randomized, placebo-controlled trial. Arthritis Care Res (Hoboken). 2010 Sep;62(9):1266-71. doi: 10.1002/acr.20233.

title: Golimumab reduces sleep disturbance in patients with active ankylosing spondylitis: Results from a randomized, placebo-controlled trial

location_country:
United States
Netherlands
Germany
Finland
France
Belgium
Canada
Korea, Republic of
Taiwan


title: Randomized, Multinational, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering Risk Factors

acronym: CRESCENDO

summary:
The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.

The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.

ReferenceType: result

ReferenceCitation: Topol EJ, Bousser MG, Fox KA, Creager MA, Despres JP, Easton JD, Hamm CW, Montalescot G, Steg PG, Pearson TA, Cohen E, Gaudin C, Job B, Murphy JH, Bhatt DL; CRESCENDO Investigators. Rimonabant for prevention of cardiovascular events (CRESCENDO): a randomised, multicentre, placebo-controlled trial. Lancet. 2010 Aug 14;376(9740):517-23. doi: 10.1016/S0140-6736(10)60935-X.

family: Topol

full_name: Eric J Topol

given: Eric J

family: Bousser

full_name: Marie-Germaine Bousser

given: Marie-Germaine

family: Fox

full_name: Keith AA Fox

given: Keith AA

family: Creager

full_name: Mark A Creager

given: Mark A

family: Despres

full_name: Jean-Pierre Despres

given: Jean-Pierre

family: Easton

full_name: J Donald Easton

given: J Donald

family: Hamm

full_name: Christian W Hamm

given: Christian W

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

family: Steg

full_name: P Gabriel Steg

given: P Gabriel

family: Pearson

full_name: Thomas A Pearson

given: Thomas A

family: Cohen

full_name: Eric Cohen

given: Eric

family: Gaudin

full_name: Christophe Gaudin

given: Christophe

family: Job

full_name: Bernard Job

given: Bernard

family: Murphy

full_name: Judith H Murphy

given: Judith H

family: Bhatt

full_name: Deepak L Bhatt

given: Deepak L

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Bhatia G, Bansal V, Harismendy O, Schork NJ, Topol EJ, Frazer K, Bafna V. A covering method for detecting genetic associations between rare variants and common phenotypes. PLoS Comput Biol. 2010 Oct 14;6(10):e1000954. doi: 10.1371/journal.pcbi.1000954.

family: Bhatia

full_name: Gaurav Bhatia

given: Gaurav

family: Bansal

full_name: Vikas Bansal

given: Vikas

family: Harismendy

full_name: Olivier Harismendy

given: Olivier

family: Schork

full_name: Nicholas J. Schork

given: Nicholas J.

full_name: Eric J. Topol

given: Eric J.

family: Frazer

repository_institution: Massachusetts Institute of Technology - DSpace@MIT

title: A Covering Method for Detecting Genetic Associations between Rare Variants and Common Phenotypes

location_country:
Peru
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
India
France
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Switzerland
Singapore
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Tunisia
Spain
Turkey

location_facility: sanofi-aventis Australia & New Zealand administrative office


title:
Réversion préventive systématique versus réversion en cas d'hémorragie intracranienne chez les patients prenant un traitement antivitamine K et venant de subir un traumatisme cranien léger

 Réversion préventive systématique versus réversion en cas d'hémorragie intracranienne chez les patients prenant un traitement antivitamine K et venant de subir un traumatisme cranien léger

lead_sponsor: CHU d'Angers


title: SERENDEM study: MD1003 in patients suffering from demyelinating neuropathies, an open label pilot study

lead_sponsor: MEDDAY PHARMACEUTICALS


title:
Dose-Finding of Propranolol in combination with metronomic fixed oral cyclophosphamide based on Bivariate efficacy-tolerability outcome in patients with locally advanced or metastatic angiosarcoma : A collaborative and  innovative phase I-II sequential trial by the French Sarcoma Group (GSF/GETO)

 Etude de determination de dose sur un critère modélisant efficacité-toxicité du Propranolol en association avec le cyclophosphamide métronomique à dose fixe, par voie orale, chez les patients atteints d’angiosarcome localement avancé ou métastatique : essai séquentiel collaboratif et innovant du Groupe Sarcome Français (GSF/GETO)

acronym:
PROPAN01

 PROPAN01

lead_sponsor: Assistance Publique Hôpitaux de MARSEILLE


title: Effects of MagneB6® (470.0 mg Magnesium Lactate Dihydrate + 5.0 mg Pyridoxine Hydrochloride, Coated Tablet) Supplementation (8 Weeks) on Stress Levels of Chronically Stressed Subjects, with Suboptimal Serum Magnesium Levels- A Randomized, Single-blind Active Comparator, Multicentric Clinical Trial - Comparison with Magnespasmyl®  (465.4 mg Magnesium Lactate Dihydrate, Coated Tablet)

acronym: MB6 SUPERIORITY

lead_sponsor: Sanofi-Aventis Group


title: Etude de phase II ouverte évaluant en fonction du polymorphisme du CYP2D6, le taux de réponse biologique au traitement par tamoxifène (TAM) administré en situation pré-opératoire chez des patientes présentant un  cancer du sein non métastatique RH+

acronym: TAM

lead_sponsor: Centre René Gauducheau


title:
Randomised phase III study testing nivolumab and ipilimumab versus a
 carboplatin based doublet in first line treatment of PS 2 or elderly (more
 than 70 years old) patients with advanced non-small cell lung cancer

 Etude randomisée de phase III testant l'association nivolumab et
 ipilimumab versus un doublet à base de carboplatine dans le traitement de première ligne du CBNPC chez des patients PS 2 ou de plus de 70 ans

acronym:
Lena eNERGY

 Lena eNERGY

lead_sponsor: CHU Rennes


title:
A Phase 2, Open-Label, Multicenter, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of ANF–Rho™ in Patients with Chronic Neutropenia

 Étude de phase 2, en ouvert, multicentrique, portant sur l’efficacité, la sécurité d’emploi, la tolérabilité et la pharmacocinétique d’ANF–Rho™ chez les patients souffrant de neutropénie chronique

lead_sponsor: Prolong Pharmaceuticals, LLC


title: Palatability testing in children of a new paediatric formulation of Racecadotril as oral suspension strawberry-flavored administered via an oral graduated syringe compared to the current formulation (apricot-flavored oral powder in sachet to be diluted).

lead_sponsor: BIOPROJET PHARMA


title:
Etude randomisée multicentrique évaluant l’efficacité et la tolérance de l’infliximab comparativement au Cyclophosphamide dans les formes sévères de maladie de Behçet " Multicenter, randomized, prospective trial comparing the Efficacy and Safety of Infliximab to that of Cyclophosphamide in severe Behçet's disease"

 Etude randomisée multicentrique évaluant l’efficacité et la tolérance de l’infliximab comparativement au Cyclophosphamide dans les formes sévères de maladie de Behçet " Multicenter, randomized, prospective trial comparing the Efficacy and Safety of Infliximab to that of Cyclophosphamide in severe Behçet's disease"

acronym: ITAC

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title:
Assessment of Dual antiplatelet therapy versus Rivaroxaban In atrial Fibrillation patients Treated with left atrial appendage closure: The randomized ADRIFT Study

 Evaluation de la double antiagrégation plaquettaire versus Rivaroxaban dans les suites de la fermeture d'auricule pour les patients souffrant de fibrillation atriale : Etude randomisée ADRIFT

acronym: ADRIFT


title:
TROPHIMMUN, a phase II trial of avelumab  in chemo-resistant gestational trophoblastic neoplasias (GTN)

 TROPHIMMUN, Essai de phase II pour évaluer l’efficacité de l’avelumab chez des patientes atteintes de tumeurs trophoblastiques chimio-résistantes

acronym:
TROPHIMMUN

 TROPHIMMUN

lead_sponsor: Hospices Civils de Lyon


title: CLArithromycin versus AZIthromycin in the treatment of Mycobacterium avium complex pulmonary infections:  A randomized prospective controlled study

acronym:
CLAZI

 CLAZI

lead_sponsor: CHU Amiens-Picardie


title:
Dynamic Contrast enhanced ultrasound for predict and assess rectal cancer response after neo-adjuvant chemoradiation – RECT

 Radio-chimiothérapie du cancer rectal : Apport de l’échographie de contraste quantitative pour prédire et évaluer la réponse tumorale - RECT

acronym:
RECT

 RECT

lead_sponsor: CHU DE BORDEAUX


title:
A pilot study of Ceftobiprole diffusion in bone and joint, in patients with BIJ( bone and joint infection) undergoing hip or knee replacement.

 Etude pilote de dosage du Ceftobiprole dans les infections ostéo-articulaires chez des patients infectés programmés pour une chirurgie de remplacement de prothèse de hanche ou de genou.


title:
SecOnd-line Chemotherapy with RAmucirumab +/- pacliTaxel in Elderly advanced gastric or gastroesophageal junction cancer patients

 SecOnde ligne de Chimiothérapie avec RAmucirumab +/- pacliTaxel chez le sujet âgE avec un cancer avancé de l’estomac ou de la jonction oeso-gastrique

acronym:
SOCRATE

 SOCRATE

lead_sponsor: Fédération Francophone de Cancérologie Digestive


title:
Essai, randomisé, contrôlé, ouvert, de deux schémas standardisés de décroissance, respectivement rapide (nord-américain) et lent (européen), de cortisone dans l’artérite à cellules géantes.

 Essai, randomisé, contrôlé, ouvert, de deux schémas standardisés de décroissance, respectivement rapide (nord-américain) et lent (européen), de cortisone dans l’artérite à cellules géantes.

acronym:
CORTODOSE

 CORTODOSE

lead_sponsor: CHU CAEN


title:
Therapeutic plasma exchange, rituximab and intravenous immunoglobulins (IVIg) for severe acute exacerbation of idiopathic pulmonary fibrosis admitted in ICU: an open, randomized, controlled trial

 Les échanges plasmatiques thérapeutiques, le rituximab et les immunoglobulines intraveineuses (IgIV) pour l'exacerbation aiguë sévère de fibrose pulmonaire idiopathique (EA-FPI) chez les patients admis en réanimation: essai ouvert, randomisé et contrôlé.

acronym:
EXCHANGE-IFP

 EXCHANGE-IFP


title:
Prevention of DElirium with MELatonine in intensive care unit : prospective, multicenter, randomized, double-blind, placebo, multi-arm, multi-stage trial.

 Prévention du DElirium en réanimation par la MELatonine: étude prospective, multicentrique, randomisée, en double aveugle, contre placebo, multi-bras, multi-stades.

acronym: DEMEL


title: Phase 2 Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Chikungunya Virus-Like Particle Vaccine,VRC-CHKVLP059-00-VP, in Healthy Adults

lead_sponsor: IMEA Fondation Leon Mba


title:
Cobimetinib for BRAF-wild-type histiocytoses : a randomized, placebo-controlled, double blind study

 Cobimetinib pour le traitement des histiocytoses sans mutation BRAFV600E : Une étude randomisée, contrôlée en double aveugle versus placebo

acronym:
COBRAH

 COBRAH

lead_sponsor: APHP


title:
A phase II trial of radiotherapy-durvalumab without prophylactic neck irradiation in squamous cell carcinoma of the head and neck

 Essai de phase II évaluant l’association radiothérapie-durvalumab sans irradiation prophylactique cervicale dans les carcincomes épidermoïdes de la tête et du cou

acronym: REWRITe

lead_sponsor: GORTEC


title:
ANRS 173 ALTAR A randomized, open-label, phase III trial comparing a dual nucleoside analogues strategy preceded by an induction period with an integrase inhibitor based triple therapy to an immediate two-drug strategy with dolutegravir plus lamivudine in ART naïve people living with HIV with viral load < 50 000 cp/mL and CD4 cells >300/mm3

 ANRS 173 ALTAR Essai randomisé de phase III, ouvert, comparant une stratégie de bithérapie d’analogues nucléosidiques précédée d’une phase d’induction avec une trithérapie à base d'inhibiteur d’intégrase à une stratégie de bithérapie immédiate comportant dolutegravir plus lamivudine chez des personnes vivant avec le VIH, naïves de traitement antirétroviral, ayant une charge virale < à 50 000 copies/mL et des lymphocytes CD4 > 300/mm3

acronym: ALTAR

lead_sponsor: INSERM ANRS


title:
IMMUNOTHERAPY WITH INTRAVENOUS IMMUNOGLOBULINS, CYCLOPHOSPHAMIDE AND METHYLPREDNISOLONE IN PATIENTS WITH PARANOPLASTIC SENSITIVE NEURONOPATHIES WITH ANTI-HU ANTIBODIES

 IMMUNOTHERAPIE PRECOCE PAR IMMUNOGLOBULINES INTRAVEINEUSES, CYCLOPHOSPHAMIDE ET METHYLPREDNISOLONE CHEZ DES PATIENTS AVEC NEURONOPATHIES SENSITIVES PARANEOPLASIQUES A ANTICORPS ANTI-HU

acronym:
NESPA

 NESPA


title: Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With BCG Plus a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Versus BCG Plus a Placebo as a Post-Surgical Treatment for Stage III Melanoma

summary: This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

status: Unknown status

lead_sponsor: CancerVax Corporation

location_country:
Italy
Brazil
United States
Switzerland
Netherlands
Germany
France
Israel
Ireland
Australia
New Zealand
Canada
United Kingdom

location_facility: The Cancer Cener at Hackensack University Medical Center

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: Winship Cancer Institute at Emory University

location_facility: St. Louis University Health Sciences Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: University of Arkansas for Medical Sciences

location_facility: Central Arkansas Veterans Healthcare System

location_facility: University of Pennsylvania Cancer Center

location_facility: Cedars Sinai Comprehensive Cancer Center

location_facility: Intermountain Health Care- Mckay-Dee Hospital

location_facility: Arthur G. James Cancer Hospital - Ohio State University

location_facility: Sidney Kimmel Comprehensive Cancer Center

location_facility: UCSF Cancer Center and Cancer Research Institute

location_facility: Lineberger Comprehensive Cancer Center, UNC

location_facility: The Cancer Institute at Good Samaritan Medical Center

intervention_type: Biological


title: A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-blind Trial of Clopidogrel Versus Placebo in High-risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low-dose ASA.

summary:
RATIONALE:

Atherothrombosis is a progressive and generalized vascular disease resulting in events leading to myocardial infarction (heart attack), stroke, and vascular death.
In patients at risk for this disease, it is characterized by an unpredictable, sudden disruption of atherosclerotic plaques, which may lead to total occlusion of artery due to formation of a clot. The use of aspirin (blood thinner agent) for reducing those major ischemic events is either indicated, or recommended by international guidelines. However, aspirin fails to prevent a high percentage of such life-threatening events. Therefore, more effective blood thinning therapy may provide additional clinical benefit to such patients.
The results of the CURE trial in patients with unstable angina demonstrate the additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood thinner agent), when administered in combination with standard therapy including aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of clopidogrel may apply to a broad population of high-risk patients receiving low-dose aspirin therapy. Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis.

OBJECTIVES:

To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in preventing cardiovascular morbidity/mortality. The study will compare the efficacy of the two regimens in preventing the occurrence of major cardiovascular complications (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise receiving low-dose aspirin therapy (75-162 mg daily).
To evaluate the safety of clopidogrel in this population, and more specifically the incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate the global benefit of clopidogrel in this patient population.

ReferenceCitation: Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. Epub 2006 Mar 12.

ReferenceCitation: Bhatt DL, Paré G, Eikelboom JW, Simonsen KL, Emison ES, Fox KA, Steg PG, Montalescot G, Bhakta N, Hacke W, Flather MD, Mak KH, Cacoub P, Creager MA, Berger PB, Steinhubl SR, Murugesan G, Mehta SR, Kottke-Marchant K, Lincoff AM, Topol EJ; CHARISMA Investigators. The relationship between CYP2C19 polymorphisms and ischaemic and bleeding outcomes in stable outpatients: the CHARISMA genetics study. Eur Heart J. 2012 Sep;33(17):2143-50. Epub 2012 Mar 26.

ReferenceCitation: Bangalore S, Bhatt DL, Steg PG, Weber MA, Boden WE, Hamm CW, Montalescot G, Hsu A, Fox KA, Lincoff AM. β-blockers and cardiovascular events in patients with and without myocardial infarction: post hoc analysis from the CHARISMA trial. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):872-81. doi: 10.1161/CIRCOUTCOMES.114.001073. Epub 2014 Sep 30.

family: Bangalore

full_name: S. Bangalore

given: S.

full_name: D. L. Bhatt

given: D. L.

full_name: P. G. Steg

given: P. G.

family: Weber

full_name: M. A. Weber

given: M. A.

family: Boden

full_name: W. E. Boden

given: W. E.

full_name: C. W. Hamm

given: C. W.

full_name: G. Montalescot

given: G.

family: Hsu

full_name: A. Hsu

given: A.

family: Fox

full_name: K. A. A. Fox

given: K. A. A.

family: Lincoff

full_name: A. M. Lincoff

given: A. M.

journal_name: Circulation: Cardiovascular Quality and Outcomes

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: -Blockers and Cardiovascular Events in Patients With and Without Myocardial Infarction: Post Hoc Analysis From the CHARISMA Trial

ReferenceCitation: Berger PB, Bhatt DL, Fuster V, Steg PG, Fox KA, Shao M, Brennan DM, Hacke W, Montalescot G, Steinhubl SR, Topol EJ; CHARISMA Investigators. Bleeding complications with dual antiplatelet therapy among patients with stable vascular disease or risk factors for vascular disease: results from the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial. Circulation. 2010 Jun 15;121(23):2575-83. doi: 10.1161/CIRCULATIONAHA.109.895342. Epub 2010 Jun 1.

name: From the Center for Clinical Studies, Geisinger Clinic, Danville, Pa (P.B.B.); Veterans Affairs Boston Healthcare System, Brigham and Women’s Hospital and Harvard Medical School, Boston, Mass (D.L.B.); Mount Sinai Medical Center, New York, NY (V.F.); INSERM U698, Universite Paris 7 and AP-HP, Paris, France (P.G.S.); University and Royal Infirmary of Edinburgh, Edinburgh, UK (K.A.A.F.); Cleveland Clinic, Cleveland, Ohio (M.S., D.M.B.); Department of Neurology, University of Heidelberg, Heidelberg,...

family: Berger

full_name: Peter B. Berger

given: Peter B.

full_name: Deepak L. Bhatt

given: Deepak L.

family: Fuster

full_name: Valentin Fuster

given: Valentin

full_name: P. Gabriel Steg

given: P. Gabriel

full_name: Keith A.A. Fox

given: Keith A.A.

family: Shao

full_name: Mingyuan Shao

given: Mingyuan

family: Brennan

full_name: Danielle M. Brennan

given: Danielle M.

family: Hacke

full_name: Werner Hacke

given: Werner

family: Steinhubl

full_name: Steven R. Steinhubl

given: Steven R.

family: Topol

title: Bleeding Complications With Dual Antiplatelet Therapy Among Patients With Stable Vascular Disease or Risk Factors for Vascular Disease

ReferenceCitation: Steinhubl SR, Bhatt DL, Brennan DM, Montalescot G, Hankey GJ, Eikelboom JW, Berger PB, Topol EJ; CHARISMA Investigators. Aspirin to prevent cardiovascular disease: the association of aspirin dose and clopidogrel with thrombosis and bleeding. Ann Intern Med. 2009 Mar 17;150(6):379-86.

ReferenceCitation: Mak KH, Bhatt DL, Shao M, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Montalescot G, Steg PG, Steinhubl SR, Fox KA, Topol EJ. The influence of body mass index on mortality and bleeding among patients with or at high-risk of atherothrombotic disease. Eur Heart J. 2009 Apr;30(7):857-65. doi: 10.1093/eurheartj/ehp037. Epub 2009 Feb 20.

ReferenceCitation: Eikelboom JW, Hankey GJ, Thom J, Bhatt DL, Steg PG, Montalescot G, Johnston SC, Steinhubl SR, Mak KH, Easton JD, Hamm C, Hu T, Fox KA, Topol EJ; Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) Investigators. Incomplete inhibition of thromboxane biosynthesis by acetylsalicylic acid: determinants and effect on cardiovascular risk. Circulation. 2008 Oct 21;118(17):1705-12. doi: 10.1161/CIRCULATIONAHA.108.768283. Epub 2008 Oct 6.

name: From McMaster University (J.W.E.), Hamilton, Ontario, Canada; Neurology Department (G.J.H.), Royal Perth Hospital, Perth, Australia; Haematology Department (J.T.), Royal Perth Hospital, Perth, Australia; VA Boston Healthcare System and Brigham and Women’s Hospital (D.L.B.), Boston, Mass; Cleveland Clinic (T.H.), Cleveland, Ohio; INSERM U-698 (P.G.S.), Université Paris VII, AP-HP, Paris, France; Institut de Cardiologie (APHP) and Unit 856 (INSERM), Pitié-Salpêtrière Hospital (G.M.), Paris,...

title: Incomplete Inhibition of Thromboxane Biosynthesis by Acetylsalicylic Acid

ReferenceCitation: Bhatt DL, Flather MD, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Fabry-Ribaudo L, Hu T, Topol EJ, Fox KA; CHARISMA Investigators. Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial. J Am Coll Cardiol. 2007 May 15;49(19):1982-8. Epub 2007 Apr 11.

location_country:
Finland
Malaysia
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
France
Poland
Norway
Argentina
Canada
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Spain
Turkey

location_facility:
Sanofi-aventis Administrative Office
The Cleveland Clinic Foundation


title:
Intérêt du TAP (Transverse Abdominis Plane) bloc bilatéral échoguidé pour l’analgésie post opératoire des chirurgies rachidiennes par voie antérieure.

 Intérêt du TAP (Transverse Abdominis Plane) bloc bilatéral échoguidé pour l’analgésie post opératoire des chirurgies rachidiennes par voie antérieure.

acronym: TAP ALIF

lead_sponsor: CHU de Rennes


title:
A double-blind, randomized study versus placebo of avdoralimab (IPH5401), an anti-C5aR antibody, in patients with COVID-19 induced pneumonia

 Etude clinique en double aveugle, randomisée versus placebo évaluant avdoralimab (IPH5401) anticorps anti-C5aR dans les pneumonies sévères induites par COVID-19

acronym: FORCE (FOR COVID-19 Elimination)

lead_sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE


title: A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab

summary: This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Sweden
Mexico
Germany
France
Poland
Norway
Belgium
Australia
Spain
Canada
United Kingdom


title:
Randomized open label trial assessing efficacy and safety of hydroxychloroquine plus azithromycin versus hydroxychloroquine for hospitalized patients with COVID-19

 Etude multicentrique, randomisée, de l’efficacité et la sécurité  de la Bithérapie Hydroxychloroquine + Azithromycine comparée à une Monothérapie par Hydroxychloroquine chez des adultes hospitalisés pour une infection COVID-19  avec une pneumonie non réanimatoire

lead_sponsor: University Hospital of Montpellier


title: An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)

summary: This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Lebanon
Netherlands
France
Lithuania
Slovakia
Hungary
Argentina
Australia
Puerto Rico
Portugal
Estonia
United States
Latvia
Turkey


title:
A PROOF OF CONCEPT STUDY TESTING THE VALUE OF IMATINIB IN PREVENTION OF COVID-19 IN AGED PATIENTS.

 ETUDE DE PREUVE DE CONCEPT TESTANT L’INTERET DE L’IMATINIB MESYLATE DANS LA PREVENTION DE COVID-19 CHEZ LES PATIENTS AGES.

lead_sponsor: CH de Versailles


title: An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (QLQ-PR25) For Assessing Quality Of Life Of Patients With Prostate Cancer

summary:
RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate and long-term effects of the treatment on these patients.

PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Arraras JI, Villafranca E, Arias de la Vega F, Romero P, Rico M, Vila M, Asín G, Chicata V, Domínguez MA, Lainez N, Manterola A, Martínez E, Martínez M. The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation study for Spanish patients. Clin Transl Oncol. 2009 Mar;11(3):160-4.

ReferenceCitation: Arraras Urdaniz JI, Villafranca Iturre E, Arias de la Vega F, Domínguez Domínguez MA, Lainez Milagro N, Manterola Burgaleta A, Martínez Lopez E, Romero Rojano P, Martínez Aguillo M. The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients. Arch Esp Urol. 2008 Oct;61(8):949-54.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
Netherlands
France
Norway
Romania
Belgium
Australia
Turkey
Denmark
Germany
United Kingdom

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Dokuz Eylul University School of Medicine

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Velindre Cancer Center at Velinde Hospital

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Azienda Ospedaliera Maggiore Della Carita

intervention_type: Other


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease

summary: The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.

ReferenceCitation: Cardiel MH, Tumlin JA, Furie RA, Wallace DJ, Joh T, Linnik MD; LJP 394-90-09 Investigator Consortium. Abetimus sodium for renal flare in systemic lupus erythematosus: results of a randomized, controlled phase III trial. Arthritis Rheum. 2008 Aug;58(8):2470-80. doi: 10.1002/art.23673.

family: Cardiel

full_name: Mario H. Cardiel

given: Mario H.

family: Tumlin

full_name: James A. Tumlin

given: James A.

family: Furie

full_name: Richard A. Furie

given: Richard A.

family: Wallace

full_name: Daniel J. Wallace

given: Daniel J.

family: Joh

full_name: Tenshang Joh

given: Tenshang

family: Linnik

full_name: Matthew D. Linnik

given: Matthew D.

journal_name: Arthritis & Rheumatism

oa_host_type: publisher

evidence: open (via free pdf)

license_normalized: no license

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Abetimus sodium for renal flare in systemic lupus erythematosus: Results of a randomized, controlled phase III trial

lead_sponsor: La Jolla Pharmaceutical Company

location_country:
Italy
Austria
Sweden
Mexico
Germany
France
Spain
United States
United Kingdom
Canada

location_facility: San Antonio Kidney Disease Center, Research Center

location_facility: Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU

location_facility: University of Michigan Health System, Internal Medicine-Rheumatology

location_facility: Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes

location_facility: Department of Rheumatology, Karolinska Hospital

location_facility: Wake Forest University School of Medicine

location_facility: Universitatklinikum Charite, Medizinische Universitatsklinik

location_facility: University of Connecticut Health Center, Division of Rheumatology

location_facility: Emory University School of Medicine, Renal Division

location_facility: Department of Rheumatology, University Hospital of Lund

location_facility: Service De Rhumatologie Hopital de Hautepierre

location_facility: Hospital Universitario La Paz Servico de Medicina

location_facility: LSU Health Sciences Center, Department of Rheumatology

location_facility: Thomas Jefferson University, Division of Rheumatology

location_facility: Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division

location_facility: Hospital for Joint Diseases, NYU Medical Center

location_facility: Saint Louis University Health Sciences Center

location_facility: Hospital for Joint Diseases, Department of Rheumatology

location_facility: Arthritis Center of Excellence, Toronto Western Hospital, University Health Network

location_facility: Hospital General Valle de Hebron Servicio Medicina Interna. Edificio

location_facility: Metrohealth Medical Center, Division of Rheumatology

location_facility: University of Pittsburgh, Div. of Rheumatology and Clinical Immun.

location_facility: University of Louisville, Dept of Medicine/Division of Rheumatology

location_facility: Texas Tech University Health Sciences Center, Department of Internal Medicine

location_facility: Lupus Research Unit St. Thomas Hospital, The Rayne Institute

location_facility: Division of Rheumatology, Department of Internal Medicine

location_facility: Department for Internal Medicine and Institute of Immunology and Rheumatology

location_facility: Rheumatology Associates of North Alabama

location_facility: Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology

location_facility: U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa

location_facility: Wayne State University, Rheumatology Division

location_facility: Presbyterian Hospital of Dallas, Arthritis Consultation Center


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety in Obese Patients With Type 2 Diabetes

acronym: RIO-Diabetes

summary: To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes

ReferenceCitation: Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF; RIO-Diabetes Study Group. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006 Nov 11;368(9548):1660-72. Erratum in: Lancet. 2006 Nov 11;368(9548):1650.

lead_sponsor: Sanofi

location_country:
United States
United Kingdom
Netherlands
Germany
Finland
France
Poland
Belgium
Argentina
Canada
Czech Republic

location_facility: Southern California Prevention and Research Center Inc. (SPARC)

location_facility: Jacksonville Center for Clinical Research

location_facility: Medical University of South Carolina, Division of Clinical Pharmacology

location_facility: Center for Nutrition and Preventive Medicine

location_facility: Endocrinology and Diabetes Consultants, PC

location_facility: Salem Veterans Affairs Medical Center (151)

location_facility: University of Oklahoma Health Sciences Center


title: Evaluation de l'efficacité de l'isotrétinoïne versus placebo à travers le taux de patients répondeurs chez des patients présentant une rosacée papulo-pustuleuse résistant au traitement classique. Essai national, multicentrique, prospectif, randomisé, en double aveugle sur 2 groupes parallèles

acronym: étude isotrétinoïne dans la rosacée

lead_sponsor: Laboratoires BIORGA


title: Exploration clinique, biologique et pharmacologique d'un polymorphisme de NEDD 4-2, protéine régulatrice du canal sodium épithélial

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: CLINICAL EFFICACY EVALUATION OF A FIXED COMBINATION OF CALCITRIOL 3 µg/g WITH THREE CONCENTRATIONS (100, 250, 500µg/g) OF CLOBETASOL PROPIONATE AS SPRAY FORMULATION USING THE MODIFIED DUMAS-SCHOLTZ PSORIASIS MINI PLAQUE TEST UNDER NON-OCCLUSIVE CONDITIONS

lead_sponsor: GALDERMA R&D SNC


title: A European Open-Label, Multicentre, Phase II Study of Inolimomab in the Treatment of Primary Steroid Resistant Acute Graft versus Host Disease (aGvHD) following allogeneic Stem Cell Transplantation for Hematological Malignancies in Adult patients

lead_sponsor: OPi


title: Evaluation de l'association Fofiri 3 et bévacizumab (Avastin) dans le traitement des cadénocarcinomes colorectaux métastasiques

lead_sponsor: CHU de Besançon


title: A dose-escalating, multicenter, single arm, open-label study of XRP9881 in combination with capecitabine (Xeloda®), in metastatic breast cancer patients with disease progressing after anthracycline and taxane therapy

lead_sponsor: sanofi-aventis recherche et développement


title: A multicentre randomised, double-blind, parallel-group study to compare the salmeterol xinafoate/fluticasone propionate combination (Seretide® Diskus® 50/100) 50/100 micrograms one inhalation twice daily with fluticasone propionate (Flixotide® Diskus® 100) 100 micrograms one inhalation twice daily as initial maintenance therapy for 12 weeks in adults with persistent moderate asthma.

lead_sponsor: Laboratoire GlaxoSmithKline


title: Evaluation pharmacologique des antagonistes du récepteur P2Y12 à l'ADP chez le volontaire sain

lead_sponsor: CHU Toulouse


title: Efficacité et sécurité du traitement de l'hypertension artérielle au cours de la pré-éclampsie sévère. Etude préliminaire d'équivalence entre l'Urapidil(Eupressyl*) et la nicardipine(Loxen*)

lead_sponsor: Hôpitaux Universitaires de Strasbourg


title: Effect of two distinct dosing regimen of  acetaminophen on the anticoagulant effect of warfarin

acronym: INPAWA 2

lead_sponsor: Unité de Recherches Thérapeutiques


title: EVALUATION CLINIQUE DE LA 18 F-F DOPA EN TOMOGRAPHIE PAR EMISSION DE POSITONS  DANS LES CANCERS MEDULLAIRES DE LA THYROÏDE.

acronym: DOPMET


title: Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study.

lead_sponsor: BIOCODEX


title: Effet d'une supplémentation en acides biliaires par de l'acide ursodesoxycholique sur la synthèse endogène du cholestérol et des triglycérides chez les patients ayant un grêle court

lead_sponsor: Hospices Civils de Lyon


title: TRAITEMENT NEOADJUVANT DU CANCER DE L’ŒSOPHAGE OPERABLE A VISEE CURATIVE PAR 5-FLUOROURACILE, CISPLATINE ET CETUXIMAB + RADIOTHERAPIE CONCOMITANTE. ÉTUDE DE PHASE I-II

acronym: FFCD 0505

lead_sponsor: Fédération Francophone de Cancérologie Digestive - FFCD


title: Essai randomisé contre placebo en double aveugle de l'efficacité d'un anti-TNF alpha chez des patients souffrant d'une arthrose digitale invalidante et réfractaire aux traitements usuels

acronym: DORA


title: Impact d'une campagne de vaccination des nourissons sur les hospitalisations pour le GEA à rotavirus : Etude prospective sur la communauté urbaine de Brest- protocole IVANHOE

acronym: IVANHOE

lead_sponsor: CHU de Brest


title: Evaluation of preference for a buprenorphine-based maintenance therapy, after a switch from buprenorphine alone (Subutex®) to the buprenorphine/naloxone combination (Suboxone®), in opioid-dependent patients with buprenorphine maintenance therapy

lead_sponsor: Schering-Plough


title: EFFICACY AND SAFETY OF 8% CLOBETASOL NAIL LACQUER FORMULATION VERSUS VEHICLE IN NAIL PSORIASIS

lead_sponsor: PIERRE FABRE DERMATOLOGIE represented by INSTITUT DE RECHERCHE PIERRE FABRE


title: Etude prospective, randomisée, en double aveugle, comparant l’efficacité du lévétiracétam à un placebo sur la prévention des crises d’épilepsie précoces et tardives chez les patients présentant un traumatisme crânien sévère

acronym: TRACK

lead_sponsor: Centre Hospitalier Universitaire Rennes


title: MESURE ET COMPARAISON DES CONCENTRATIONS PLASMATIQUES ARTERIELLES ET VEINEUSES DE PROPOFOL CHEZ DES PATIENTS DE REANIMATION SOUS SEDATION PAR LE SYSTEME AIVOC.

lead_sponsor: CHU Clermont-Ferrand


title: Multiple dose Phase II study of IPH1101 in monotherapy or associated with a low dose of IL2 (2MIU) in non previously treated hepatitis C patients

lead_sponsor: Innate Pharma


title: EFFET DU METHOTREXATE SUR LA RELATION DOSE - EFFET DE L'INFLIXIMAB DANS LA SPONDYLARTHRITE ANKYLOSANTE

acronym: SPAXIM

lead_sponsor: CHRU-TOURS


title: “Transdermal testosterone supplementation in elderly hypogonadal men with sarcopenia: effects on muscle function, physical performance, body composition and quality of life.” A randomized, double-blind, placebo-control, parallel-group study on 150 patients.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: LONG-TERM SAFETY AND EFFICACY STUDY OF IGNG, A NEW LIQUID PREPARATION OF HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE, ADMINISTERED IN CURRENT PRACTICE TO PRIMARY IMMUNODEFICIENT PATIENTS

lead_sponsor: LFB SA


title: Etude pharmacologique du Pemetrexed (Alimta) administré avec Cisplatine  et supplémentation vitaminique chez des patients porteurs d'un mésothéliome pleural non résécable

acronym: ALIMESO

lead_sponsor: Centre Oscar Lambret


title: Evaluation de l'efficacité de la thérapie photodynamique par Photofrin sur les cholangiocarcinomes non résécables de type III ou IV

acronym: CK/PDT

lead_sponsor: CHU Angers


title: Evaluation de l'efficacité et de la tolérance de rosuvastatine 5 mg versus pravastatine 40 mg et atorvastatine 10 mg chez des patients hypercholestérolémiques de type IIa et IIb

lead_sponsor: AstraZeneca SAS


title: FORCE : rituximab (anticorps monoclonal anti-CD20 dépléteur des lymphocytes B) pour le traitement des myopathies inflammatoires réfractaires avec auto-anticorps spécifiques et des myasthénies généralisées réfractaires.

acronym: FORCE

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: Essai de phase II, multicentrique, évaluant le G-CSF en prophylaxie primaire associé au schéma de chimiothérapie FOLFIRI + bévacizumab en 1ère ligne dans le cancer colorectal métastatique chez des patients, homozygotes pour le polymorphisme UGT1A1*28 du promoteur du gène codant pour l’enzyme UGT1A1


title: Essai clinique de Phase II évaluant une chimitohérapie systémique associée au Cetuximab en traitement adjuvant chez des patients complètement résèques par chirurgie de leur carcinose péritonéale isolée d'origine colorectale.

acronym: COCHISE 1

lead_sponsor: Institut Bergonié


title: Analyse du profil sensoriel du sirop antihistaminique Primalan®, versus un sirop antihistaminique de reference : Aerius®

lead_sponsor: Pierre Fabre Médicament


title: etude comparative randomisee intra-individuelle de l'efficacite du traitement d'hidradenite suppuree ou maladie de verneuil par injections sous cutanee de toxine botulinique versus placebo

lead_sponsor: acep


title: Anesthésie topique versus anesthésie épisclérale pour chirurgie de la cataracte

lead_sponsor: CHU de Nîmes


title: Dose finding Phase 2a Study of Inecalcitol in Combination with Standard Docetaxel Prednisone Regimen in Hormone-Refractory Prostate Cancer

lead_sponsor: Hybrigenics SA


title: Etude clinique ouverte randomisée évaluant le traitement préventif par doxycycline sur la survenue d’éruption type folliculite lors du traitement par erlotinib chez les patients atteints d’un cancer bronchique non à petites cellules localement avancé ou métastatique en rechute après une première ligne de chimiothérapie

acronym: CYTAR

lead_sponsor: ROCHE SAS


title: Neutropénie modérée persistante : intérêt d'une administration du G-CSF (granocytes colony stimulating factor) 1 jour sur 2 pour maintenir la dose intensité. Essai de phase III multicentrique chez des patients atteints de tumeur solide sous chimiothérapie

lead_sponsor: Centre François Baclesse


title: A Phase I/II Study of Vorinostat in Combination with Low Dose Ara-C for Patients with Intermediate-2 or High Risk Myelodysplastic Syndromes

lead_sponsor: Groupe Francophone des Myélodysplasies


title: Dota-Toc-(68Ga) dans les tumeurs endocrines digestives. Intérêt de l'imagerie TEP-TDM.


title: Etude de phase 2 randomisée comparant une irradiation encéphalique associée au témozolomide à une irradiation seule chez des patientes présentant des métastases cérébrales d'un cancer du sein.

acronym: RT/Témodal

lead_sponsor: Institut Curie


title: Effets de la supplémentation parentérale en carnitine chez le nouveau-né prématuré

acronym: CarniPréma

lead_sponsor: CHRU de Tours


title: Etude de l'échographie de contraste avec SonoVue chez les malades opérés d'une maladie de Crohn iléale: CROHN - SONOVUE

acronym: CROHN SONOVUE

lead_sponsor: Centre Hospitalier Universitaire de Besançon


title: A Pilot study to evaluate the Efficacy and Safety of GFT505 (30 mg) orally administered for 28 days in patients with Frederickson Type IIb Dyslipidemia (Mixed Hyperlipidemia). A double blind, placebo-controlled and randomized study.

lead_sponsor: GENFIT


title: A Pilot Phase II combination study of Taxotere (Docetaxel) and Erbitux (Cetuximab) as a NEOadjuvant therapy in patients with “triple-negative” (HR and Her2 negative) operable breast cancer. TENEO Study

acronym: TENEO study

lead_sponsor: Centre Jean Perrin


title: Faisabilité de la sédation par inhalation de Kalinox® 170 bar au cours des actes thérapeutiques en odontologie de ville

acronym: Faisabilité de la sédation avec Kalinox® en odontologie de ville

lead_sponsor: AIR LIQUIDE SANTE INTERNATIONAL


title: Evaluation d'une solution hydro-alcoolique de sumatriptan administrée par voie sublinguale dans le traitement d'une crise d'algie vasculaire de la face, à la dose de 2mg, 4mg ou 6mg déterminée par une première partie d'étude en "dose-ranging".

lead_sponsor: UNITHER PHARMACEUTICALS


title: Etude de phase II multicentrique stratifiée évaluant l’efficacité et la toxicité du Sorafenib dans le traitement des angiosarcomes  localement avancés ou métastatiques  non accessibles à une chirurgie curative

lead_sponsor: Centre Oscar Lambret


title: Effet de l’association fixe amlodipine/valsartan sur la Pression artérielle centrale chez des hypertendus essentiels non contrôlés par amlodipine 5mg

acronym: Etude EXPLOR

lead_sponsor: Novartis Pharma S.A.S.


title: A Randomized, double-blind, placebo-controlled pilot study of KB001 in mechanically-ventilated patients colonized with pseudomonas aeruginosa

lead_sponsor: KaloBios Pharmaceuticals, Inc.


lead_sponsor: Laboratoire BAILLY-CREAT


title: Study title: Double-blind vs Placebo, Randomized, Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 500 mg QD for One Month in Patients with Non-Alcoholic Steatohepatitis (NASH).

lead_sponsor: TROPHOS


title: Etude prospective, multicentrique contrôlée vs placebo, randomisée, en double insu comparant la protéine C activée, les faibles doses de corticoïdes et leur association dans le traitement du choc septique. Etude APPROCHS

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: pharmacokinetic study by microdialysis of the distribution of ertapeneme and levofloxacine in infected foot ulcers of diabetics patients.

lead_sponsor: CHU DE POITIERS


title: Intérêt de la tocolyse dans la prise en charge des ruptures prématurées des membranes entre 24 et 34 semaines d’aménorrhée.

acronym: TOCOPREMA

lead_sponsor: CHU de CAEN


title: ANALGESIE POSTOPERATOIRE APRES THORACOTOMIE SANS PERIDURALE THORACIQUE : INTERET DU CATHETER PARAVERTEBRAL ASSOCIE A UNE ANALGESIE MORPHINIQUE AUTOCONTROLEE

lead_sponsor: Hôpitaux Universitaires de strasbourg


title: Safety and Efficacy assessment of Geltim LP ® 1 mg/g (unpreserved Timolol gel – TG1030) in ocular hypertensive or glaucomatous patients stabilized by Xalatan® with ocular intolerance signs

acronym: GELTIM

lead_sponsor: Laboratoires THEA


title: Etude prospective, ouverte randomisée, comparant l'efficacité et la tolérance du Sirolimus (Rapamune R) au Tacrolimus (Prograf R) associé à un traitement de fond par Mycophénolate mofétil (Cellcept R) entre 14 et 24 mois après transplantation rénale

acronym: EPARGNE

lead_sponsor: CHU-Hôpitaux de Rouen


title: « OCTO : Quantification de l’impact des variations d’Observance d’une ChimioThérapie Orale par l’utilisation de piluliers électroniques et modélisation des marqueurs de toxicités»

acronym: OCTO

lead_sponsor: Hospices Civils de Lyon


title: EVALUATION DU MEOPA DANS L'INTERRUPTION VOLONTAIRE DE GROSSESSE SOUS ANESTHESIE LOCALE

lead_sponsor: Assistance Publique Hopitaux de marseille


title: Use of MEOPA by elderly with dementia

lead_sponsor: CHU de NICE


title: Impact des Inhibiteurs de Tyrosine Kinase sur la fertilité masculine. GLIFERTI

acronym: GLIFERTI


title: An Open Label, Multicenter Phase 2 Study of Single-Agent Enzastaurin HCl in Previously Treated Waldenstrom’s Macroglobulinemia or Multiple Myeloma

lead_sponsor: Eli Lilly and Company limited


title: Facteurs de variabilité des doses de méthadone nécessaires pour atteindre l'équilibre du traitement de substitution de la dépendance aux opiacés : Approches phénotypique et génotypique des biomarqueurs pharmacocinétiques et pharmacodynamiques

acronym: METHADOSE


title: A phase I dose escalation study of clofarabine given in combination with multi-agent therapy for remission induction in pediatric patients with acute lymphoblastic leukemia in first relapse or refractory to first line therapy –  VANDEVOL Study

acronym: vandevol

lead_sponsor: Centre Hospitalier Régional et Universitaire de Lille


title: "Evaluation of erectyle disfonction in patients suffering from testosterone deficiency, before and after tretament by Testopatch"

lead_sponsor: Pierre Fabre Médicament


title: A double blind, placebo controlled study of the effect of 330mg QD of TRO19622 in the treatment of Chemotherapy Induced Peripheral Neuropathy.

lead_sponsor: TROPHOS SA


title: Etude de Phase I-II multicentrique de l'association Cloretazine-Daunorubicine-Aracytine dans le traitement des leucémies aigües myéloïdes du groupe cytogénétique défavorable.

acronym: LAM-HR

lead_sponsor: Institut Paoli Calmette


title: An open label study to determine the effect of R1507 (RO4858696) plus Tarceva (erlotinib) on progression-free survival in patients with stage IIIB/IV non-small cell lung cancer with progressive disease after clinical benefit to second or third line erlotinib monotherapy.

lead_sponsor: F. Hoffmann-La Roche Ltd


title:
Azithromycin concentration into aqueous humor of patients undergoing cataract surgery, after 3 days of treatment by AZYTER ®
 Open randomised monocentre study with 2 groups of 15 patients

lead_sponsor: Laboratoires Thea


title: Evaluation de l’effet de la prise orale de perindopril orodispersible à la dose de 0,150 mg/kg/jour sur la fonction musculaire et myocardique dans la dystrophie musculaire de Duchenne à un stade précoce. Etude en double aveugle sur deux ans, randomisée contre placebo.

lead_sponsor: Institut de Recherches Internationales Servier


title: A phase II Study of Azacitidine (Vidaza®) combined to Epoetin beta (NeoRecormon®) in IPSS low-risk  and intermediate-1  MDS Patients, resistant to ESA

lead_sponsor: Groupe Francophone des Myélodysplasies


title: Comparaison de l'effet de deux doses d'Acide Tranexamique sur les besoins transfusionnels en chirurgie cardiaque

acronym: Exacyl-Cardio

lead_sponsor: Hopital Foch


title: Duloxetine Versus Placebo in the Long-Term Treatment of Patients with Late-Life Major Depression

acronym: HMFA

lead_sponsor: Eli Lilly and Company


title: Intérêt du rémifentanil dans l’anesthésie pour triple endoscopie en ventilation spontanée : étude randomisée contrôlée contre placebo Etude ENDOTANIL

acronym: ENDOTANIL

lead_sponsor: Centre Hospitalier Universitaire de Besançon


title: Etude ouverte, non comparative, évaluant chez des patients infectés par le VIH-1, ayant une charge virale indétectable avec un traitement comportant un inhibiteur de la protéase potentialisé par du ritonavir en deux prises par jour, la capacité du remplacement de l’inhibiteur de la protéase en cours par du darunavir/ritonavir 800/100 mg en une prise par jour, à maintenir la charge virale inférieure à 50 copies/ml à 24 semaines de traitement

acronym: RADAR

lead_sponsor: CREPATS


title: Etude randomisée de phase III comparant l’Exemestane à un  placebo chez des femmes ménopausées à risque élevé de cancer du sein.

acronym: MAP 3

lead_sponsor: FNCLCC


title: EFFETS DU SUNITINIB DANS L'EXPRESSION DU VEGF ET DE L'INTERLEUKINE 8 : EXPLICATION DES EFFETS ANTI ANGIOGENIQUES

acronym: SUVEGIL 8

lead_sponsor: CENTRE ANTOINE LACASSAGNE


title: Mycophénolate sodic in graded increased doses in the first 3 months of renal transplantation _  Pharmacokinetic descriptive Pilot study

lead_sponsor: CHU Saint-Etienne


title: COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE  DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS

acronym: Rituximab III

lead_sponsor: CHU-Hôpitaux de Rouen


title: Etude des effets de l’adjonction de clonidine au mélange anesthésique local + opiacé destiné à l’infusion péridurale autocontrôlée pour l’analgésie du travail obstétrical (lévobupivacaïne 0,568 mg/ml + sufentanil 0,45 μg/ml).

acronym: ADPO-clonidine

lead_sponsor: CHU Clermont-Ferrand


title: NOCETER essai multicentrique randomisé en double aveugle contre placebo. Réduction du taux de CEsariennes chez les patientes dépassant le TERme: Impact d'une maturation cervicale ambulatoire par donneurs de NO

acronym: NOCETER

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: Blocage des effets létaux de l'aldostérone dans l'infarctus du myocarde traité ou non par la reperfusion pour améliorer le pronostic et la survie à six mois : Etude randomisée comparant un blocage spécifique de l'aldostérone en plus du traitement usuel au traitement usuel seul débuté dans les 72 premières heures après la survenue d'un infarctus aigu du myocarde"ALBATROSS"

acronym: ALBATROSS


title: Bendamustine in patients with refractory or relapsed T-cell lymphoma. A phase II multicenter study “BENTLY”

acronym: BENTLY

lead_sponsor: GOELAMS


title: Etude de la relation dose-effet de la mélatonine dans l'autisme infantile.

acronym: MELADOSE

lead_sponsor: CHU de Rennes


title: Etude d'impact à 3 ans sur l'état de santé, la qualité de vie et les coûts, de deux stratégies thérapeutiques (Natalizumab en perfusions mensuelles pendant 3 ans versus Mitoxantrone en induction pendant 6 mois puis immunomodulateur au long cours) dans les formes rémittentes "agressives" de sclérose en plaques

acronym: QALY-SEP

lead_sponsor: CHU de RENNES


title: Réponse au VALDOXAN® et restauration des rythmes de vie dans la dépression unipolaire : Etude VALDOXAN® D-Rhythm. Etude clinique interventionnelle de phase IV, multicentrique

lead_sponsor: EUTHERAPIE / Les Laboratoires Servier


title: Relation dose-effet du propofol : comparaison en double aveugle des différentes

acronym: Les Propofols


title: A multicentre, randomised, open-label, active-controlled trial of the effectiveness of buprenorphine/naloxone in reducing intravenous buprenorphine misuse in France

acronym: RIME Study

lead_sponsor: Reckitt Benckiser Healthcare (UK) Limited


title: sevofluorane versus propofol pour l'intubation des nouveau-nés en réanimation

lead_sponsor: Assistance publique hôpitaux de marseille


title: Traitment of recessive nonbullous congenital ichthyosis with topic Epigallocatechin.

lead_sponsor: Nice University Hospital


title: Essai clinique comparant l’efficacité et la tolérance de deux stratégies thérapeutiques de maintenance: monothérapie par lopinavir/ritonavir ou trithérapie en comprimé unique quotidien par efavirenz/emtricitabine/tenofovir chez des patients infectés par le VIH-1 ayant une mesure de l’ARN VIH-1 plasmatique inférieure à 50 copies/ml.

acronym: DREAM

lead_sponsor: Agence nationale de recherches sur le sida et les hépatites virales. ANRS.


title: A single arm, open-label trial assessing the effect of Capecitabine (Xeloda®) on progression-free survival rate at four months in breast cancer patients with CNS progression after whole brain radiotherapy

acronym: RADEX

lead_sponsor: ROCHE


title: Etude d’imagerie multimodale dans la maladie d’Alzheimer

acronym: NIMAD

lead_sponsor: CHU TOULOUSE


title: Méthode d’évaluation de l’aptitude à la conduite chez des patients souffrant de pathologies de l’éveil: cirrhose avec ou sans encéphalopathie (AutoSoP "foie").

acronym: AUTOSOP

lead_sponsor: CHU Caen


title: Effet de l’association d’une statine au traitement antibiotique sur le pronostic des suspicions de pneumonies acquises sous ventilation mécanique

acronym: STATIN-VAP

lead_sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE


title: Etude multicentrique randomisée en double insu des effets de l'administration de norfloxacine ou d'un placebo sur la survie des malades atteints de cirrhose avec une insuffisance hépatocellulaire

acronym: NORFLOCIR


title: ImpImpact du remplissage vasculaire par des solutés équilibrés sur la morbidité des patients de réanimation (IRVASE) : étude randomisée contrôlée monocentrique

lead_sponsor: Institut d'Anesthésiologie des Alpes Maritimes


title: Phase IIB, multicenter, randomized, open-label trial of CPX-351 (Cytarabine:Daunorubicin) liposome injection versus intensive salvage therapy in adult patients ≤ 60 years old with AML in first relapse following an initial CR > 1 month duration

lead_sponsor: Celator Pharmaceuticals, Inc


title: Exploratory study of besipirdine efficacy and safety in male patients with persistent stress urinary incontinence after radical prostatectomy

lead_sponsor: Institut de Recherche Pierre Fabre


title: Etude de phase II randomisée évaluant l'immunogénicité et la tolérance du vaccin antigrippal A(H1N1)v adjuvanté comparativement au vaccin antigrippal A(H1N1)v non adjuvanté chez des patients infectés par le VIH (ANRS 151 HIFLUVAC)

acronym: HIFLUVAC

lead_sponsor: Agence nationale de recherches sur le sida et les hépatites virales


title: Chimiothérapie par temozolomide-bevacizumab dans les glioblastomes supratentoriels des sujets de 70 ans et plus présentant un état fonctionnel altéré (IK < 70)

acronym: ATAG

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: Essai de phase II non contrôlé multicentrique (national) évaluant l’intérêt du Nilotinib en première ou seconde ligne dans le traitement des mélanomes primitifs ou stade III inopérables et stade IV  avec mutations ou amplifications de cKIT


title: ISENTRESS® + TRUVADA® : Etude multicentrique relative à la tolérance d’une nouvelle trithérapie antirétrovirale prescrite dans le cadre de la prophylaxie post-exposition de personnes récemment soumises au risque de transmission d’une infection par le VIH

lead_sponsor: Groupe d’étude sur le risque d’exposition des soignants aux agents infectieux (GERES)


title: Evaluation of the effect of pasireotide LAR administration in the lymphocele prevention after axillary node dissection for breast cancer

acronym: SOM 230

lead_sponsor: Alliance pour la recherche en cancérologie


title: Evaluation de l’efficacité de l’Alfentanil chez l’enfant en réanimation infantile par rapport au Sufentanil - traitement de référence - sur le confort du patient lors de l’aspiration trachéale

acronym: DOLOREA PEDIA

lead_sponsor: Centre Hospitalier Universitaire de GRENOBLE


title: ESSAI DE PHASE II RANDOMISE EVALUANT L’EFFICACITE DE SEQUENCES THERAPEUTIQUES ASSOCIANT FOLFIRI + BEVACIZUMAB ASSOCIEES OU NON AU MAINTIEN DU BEVACIZUMAB PENDANT LES INTERVALLES LIBRES DE CHIMIOTHERAPIE DANS LE CANCER COLO-RECTAL METASTATIQUE

lead_sponsor: Fédération Francophone de Cancérologie Digestive


title: Multicenter randomized controlled study comparing the efficacy and safety of natural Multi-subtype interferon alpha (Multiferon) in association with ribavirin versus retreatment with pegylated interferon-alpha 2a and ribavirin in non-responding genotype 1 hepatitis C patients.

acronym: Must Have

lead_sponsor: Swedish Orphan International AB


title: Etude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS

acronym: DOSERALS


title: Etude prospective, randomisée, comparant les profils glycémiques sur 72 hr obtenus par enregistrement continu du glucose (CSGM) chez des patients diabétiques de type 2 insuffisamment contrôlés par la metformine en monothérapie, après 8 semaines de traitement adjuvant par Galvus® (vildagliptine) ou Januvia® (sitagliptine)

lead_sponsor: Novartis Pharma S.A.S


title: Quantification de la régression de l'albuminurie et de l'atteinte endothéliale dans une population de patients drépanocytaires  homozygotes hyperfiltrants traités par inhibiteurs du système rénine-angiotensine - Etude " RAND "

acronym: RAND


title: A prospective randomized phase II study evaluating the monitoring of imatinib mesylate (Gliveec®) plasmatic through level in patients newly diagnosed with chronic phase chronic myelogenous leukaemia (CP-CML).

acronym: OPTIM IMATINIB

lead_sponsor: CH VERSAILLES


title: Etude de l’efficacité de l’analgésie par infiltration continue cicatricielle dans la chirurgie du rachis lombaire ou thoracique

lead_sponsor: Centre Hospitalier Universitaire


title: A Phase II Trial of ProLindac™ and Paclitaxel Combination as Second Line-Treatment in Platinum Pretreated Patients with Advanced Ovarian Cancer

lead_sponsor: ACCESS Pharmaceuticals, Inc


type: Registry Identifier

title: Autologous Peripheral Blood Stem Cell Mobilization and Transplantation for Myelofibrosis

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelofibrosis.

ReferenceCitation: Anderson JE, Tefferi A, Craig F, Holmberg L, Chauncey T, Appelbaum FR, Guardiola P, Callander N, Freytes C, Gazitt Y, Razvillas B, Deeg HJ. Myeloablation and autologous peripheral blood stem cell rescue results in hematologic and clinical responses in patients with myeloid metaplasia with myelofibrosis. Blood. 2001 Aug 1;98(3):586-93.

lead_sponsor: Fred Hutchinson Cancer Research Center

location_country:
United States
United Kingdom
France

location_facility: University of Illinois College of Medicine

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: New York Presbyterian Hospital - Cornell Campus

location_facility: Washington University Siteman Cancer Center


title: Vancomycin Versus Placebo in Persistently Febrile Granulocytopenic Patients Given Piperacillin/Tazobactam

summary:
RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients.

PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.

primary_purpose: Supportive Care

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
United States
Switzerland
United Kingdom
Germany
Finland
France
Greece
Israel
Slovakia
Belgium
Turkey
Canada
Czech Republic

location_facility: Marlene & Stewart Greenebaum Cancer Center, University of Maryland

location_facility: Hellenic Institute for Cancer-Saint Savas Hospital

location_facility: Athens University-Laikon General Hospital

location_facility: Ottawa Regional Cancer Center - General Division

location_facility: Centre Hospitalier Universitaire Vaudois


title: Implication des radicaux libres produits par la xanthine oxydase dans les altérations mitochondriales du muscle squelettique de patients diabétiques

acronym: DIAXO

lead_sponsor: Hospices Civils de Lyon


title: Comparaison de la radiothérapie multichamps et du rituximab IV dans le traitement  des lymphomes B cutanés indolents à lésions multiples ou récidivantes.

acronym: Rituximab versus radiothérapie dans les lymphomes B cutanés indolents

lead_sponsor: Centre Hospitalier Universitaire de Reims


title: Efficacité et tolérance d’un traitement par inhibiteur de l’aromatase (Anastrozole) pour limiter l’avance de maturation osseuse liée à une adrénarche pathologique chez des enfants ayant un syndrome de Silver Russell ou de Prader Willi

acronym: ANASILPRA


title:
Phase 2 study of a reduced-toxicity myeloablative conditionning regimen using  fludarabine and full doses of IV busulfan in pediatric patients not eligible for standard myeloablative conditioning regimens.

 Etude de phase 2 d’un conditionnement myéloablatif à toxicité réduite de type Fludarabine et Busulfan intra-veineux à pleine dose dans certaines catégories d’enfants et d’adolescents non éligibles à une approche d’allogreffe standard

lead_sponsor: CHU Nantes


title: Prévention du développement de douleur neuropathique post-mastectomie / tumorectomie par l’administration de mémantine en pré et post-chirurgie

acronym: Prophylaxie de la douleur neuropathique par la mémantine

lead_sponsor: CHU de Clermont-Ferrand


title:
A phase Ib/II open-label study evaluating safety and efficacy of oral BKM120 in combination with lapatinib in HER2+/PI3K-activated, trastuzumab-resistant locally advanced, recurrent and metastatic breast cancer.

 Etude de phase Ib/II évaluant la sécurité et l’efficacité du BKM120 en combinaison avec le lapatinib dans les cancers du sein récidivants, localement avancés ou métastatiques, HER2+ résistants au trastuzumab avec activation de la voie PI3K

lead_sponsor: Institut Paoli-Calmettes


title: Ballon aortic valvuloplasty performed without heparin to decrease vascular and bleeding complications of the procedure

acronym: HEPAVALV

lead_sponsor: University Hospital of Montpellier


title: Etude  de phase  I/II  d'immunothérapie  par  protéine  recwt1-A10+AS01B après  greffe  allogénique  de  cellules  souches  hématopoïétiques  chez des patients porteurs d’une hémopathie myéloïde exprimant WT1.


title:
Front-line therapy with Carfilzomib, Lenalidomide, and Dexamethasone (CRd) induction followed by autologous stem cell transplantation, CRd consolidation and Lenalidomide maintenance  in Newly Diagnosed Multiple Myeloma Patients ≤65 years old :  a phase II study of the Intergroupe Francophone du Myélome (IFM)

 Traitement de première ligne par Carfilzomib, Lenalidomide et Dexamethasone (CRd) en induction suivi par une autogreffe de cellules souches, un traitement de consolidation par CRd et un entretien par Lenalidomide chez les patients de ≤ 65 ans atteints de Myélome Multiple de novo : une étude de phase II de l’Intergroupe Francophone du Myélome (IFM)

acronym:
IFM CRd

 Etude pilote IFM CRd

lead_sponsor: CHU de Toulouse


title: A phaseI-II trial of acadesine in ipss high and int 2 myelodysplastic syndromes, acute myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not responding to azacitidine or  decitabine for at least 6 courses or relapsing after a response

lead_sponsor: Groupe Francophone des Myélodysplasies (GFM)


title: A Randomized, Double-Blind Trial of Valacyclovir Hydrochloride (BW 256U87) Prophylaxis for Opportunistic Cytomegalovirus End-Organ Disease in Patients With Advanced HIV Infection (< 100 CD4+ Lymphocytes)

summary:
PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on survival.

SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug administered concurrently with standard antiretroviral agents and other essential therapies for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in suppressing activation of other herpesviruses. To evaluate serologic and virologic risk factors for the development of CMV disease, including assessment of HIV activation, and the risk of developing drug-resistant CMV, HSV, and VZV.

Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.

ReferenceCitation: Feinberg JE, Hurwitz S, Cooper D, Sattler FR, MacGregor RR, Powderly W, Holland GN, Griffiths PD, Pollard RB, Youle M, Gill MJ, Holland FJ, Power ME, Owens S, Coakley D, Fry J, Jacobson MA. A randomized, double-blind trial of valaciclovir prophylaxis for cytomegalovirus disease in patients with advanced human immunodeficiency virus infection. AIDS Clinical Trials Group Protocol 204/Glaxo Wellcome 123-014 International CMV Prophylaxis Study Group. J Infect Dis. 1998 Jan;177(1):48-56.

ReferenceCitation: Fry J, Coakley D, Power M, Feinberg J. International collaborative clinical trials: the ACTG 204 experience. Int Conf AIDS. 1996 Jul 7-12;11(2):276 (abstract no ThB4146)

ReferenceCitation: Griffiths PD, Feinberg J. Detection of cytomegalovirus in samples from patients enrolled in ACTG 204 / Glaxo Wellcome 123-014. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:54

ReferenceCitation: Brosgart C, Fisher E, Pulling C, Chaloner K, Cohn D, Elsadr W, Verheggen R, Schmetter B, Alston B. Prevalence of asymptomatic CMV retinitis (CMVR) in AIDS patients. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:152 (abstract no 453)

ReferenceCitation: Fisher E, Brosgart C, Cohn D, Chaloner K, Pulling C, Alston B, Schmetter B, El-Sadr W. Placebo (PLC)-controlled, multicenter trial of adefovir dipivoxil (ADV) in patients (pt) with HIV disease. . Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:160 (abstract no 491)

ReferenceCitation: Feinberg JE, Bell WR, Chulay JD. A thrombotic microangiopathy (TMA)-like syndrome in patients with advanced HIV disease in a cytomegalovirus (CMV) prophylaxis trial (ACTG 204). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:196 (abstract no 715)

ReferenceCitation: Sprenger HG, Law G, Pastoor G, Postma S, Schirm J, Weits J, The TH. Cytomegalovirus antigenemia (CMVAg) compared with other CMV tests during phase III study of valaciclovir (VACV) for CMV prophylaxis in advanced HIV disease (ACTG 204 study). Int Conf AIDS. 1996 Jul 7-12;11(2):285 (abstract no ThB4200)

ReferenceCitation: Bell WR, Chulay JD, Feinberg JE. Manifestations resembling thrombotic microangiopathy in patients with advanced human immunodeficiency virus (HIV) disease in a cytomegalovirus prophylaxis trial (ACTG 204). Medicine (Baltimore). 1997 Sep;76(5):369-80.

ReferenceCitation: Emery V, Sabin C, Feinberg J, Grywacz M, Knight S, Griffiths P. Quantitative effects of valaciclovir on the replication of cytomegalovirus in patients with advanced HIV disease. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:153 (abstract no 459)

ReferenceCitation: Weinberg A, Schneider SA, Clark JC. Acyclovir (ACV) and valacyclovir (VAL) prophylaxis of AIDS patients does not alter cytomegalovirus (CMV) susceptibility to ganciclovir (GCV) or foscarnet (FOS). Program Abstr Intersci Conf Antimicrob Agents Chemother. 1996 Sep 15-18:202 (abstract no I87)

ReferenceCitation: Nokta MA, Holland F, De Gruttola V, Emery VC, Jacobson MA, Griffiths P, Pollard RB, Feinberg JE; AIDS Clinical Trials Group, Protocol 204/GlaxoWellcome 123-014, International CMV Prophylaxis Study Group. Cytomegalovirus (CMV) polymerase chain reaction profiles in individuals with advanced human immunodeficiency virus infection: relationship to CMV disease. J Infect Dis. 2002 Jun 15;185(12):1717-22. Epub 2002 May 31.

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

location_country:
Italy
United States
Sweden
Switzerland
Germany
France
Australia
Denmark
Canada
United Kingdom

location_facility: Univ of California / San Diego Treatment Ctr

location_facility: Highland Gen Hosp / San Francisco Gen Hosp

location_facility: Birmingham Veterans Administration Med Ctr

location_facility: Southern Alberta HIV Clinic / Foothills Hosp

location_facility: Univ of North Carolina School of Medicine

location_facility: North Central Bronx Hosp / Bronx Municipal Hosp


title: A Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

summary:
To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP.

Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.

ReferenceCitation: Hughes W, et al. Comparison of 566C80 & trimethoprim-sulfamethoxazole (TMP-SMZ) for the treatment of P. carinii pneumonitis (PCP). An International Multicenter, CCTG & ACTG Collaboration. Int Conf AIDS. 1992 Jul 19-24;8(1):We48 (abstract no WeB 1019)

ReferenceCitation: Hughes W, Leoung G, Kramer F, Bozzette SA, Safrin S, Frame P, Clumeck N, Masur H, Lancaster D, Chan C, et al. Comparison of atovaquone (566C80) with trimethoprim-sulfamethoxazole to treat Pneumocystis carinii pneumonia in patients with AIDS. N Engl J Med. 1993 May 27;328(21):1521-7.

location_country:
United States
Netherlands
Germany
France
Belgium
Puerto Rico
Canada
United Kingdom

location_facility: Harlem AIDS Treatment Group / Harlem Hosp Ctr

location_facility: Natl Inst of Allergy & Infect Dis / Cln Ctr

location_facility: August-Viktoria-Krankenhaus Chefarst derII Inneren Abteilung

location_facility: Universitat Munchen / Medizinische Poliklinik

location_facility: Beth Israel Med Ctr / Peter Krueger Clinic

location_facility: San Juan Veterans Administration Med Ctr


title:
Comparing a diuretic vascular filling in the initial management of acute pulmonary embolism with right ventricular dysfunction normotensive

 Comparaison d’un traitement diurétique au remplissage vasculaire dans la prise en charge initiale de l’embolie pulmonaire grave normotensive avec dysfonction ventriculaire droite

lead_sponsor: CHU de Nice


title:
Impact of a treatment with zoledronic acid on bone mineral density in patients with metastatic castration-resistant prostate cancer, chemo-naïve and receiving abiraterone acetate

 Impact d’un traitement par acide zolédronique sur la densité osseuse chez des patients atteints de cancer de la prostate métastatique résistant à la castration, chimio-naïfs et recevant un traitement par acétate d’abiratérone

acronym:
AZALEE

 AZALEE

lead_sponsor: Centre Oscar Lambret


title: Efficacy of Testosterone gel to restore normal serum values of testosterone during the acute phase of critical illness in adult ICU patients. An open-label parallel randomized controlled pilot study

lead_sponsor: CHU  de Clermont-ferrand


title:
Endothelin and Ischemic optic Neuropathy study group

 Evaluation des effets du bosentan dans la prise en charge des patients à la phase aiguë de la neuropathie optique ischémique antérieure aiguë

acronym:
Endothelin and Ischemic Optic Neuropathy study group

 ENDOTHELION

lead_sponsor: Centre Hospitalier Universitaire de Grenoble