title: International Randomized Comparison Between DES Limus Carbostent and Taxus Drug Eluting Stents in the Treatment of De-novo Coronary Lesions. The NEXT Study.

acronym: NEXT

summary: The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.

ReferenceCitation: Carrié D, Berland J, Verheye S, Hauptmann KE, Vrolix M, Violini R, Dibie A, Berti S, Maupas E, Antoniucci D, Schofer J. A multicenter randomized trial comparing amphilimus- with paclitaxel-eluting stents in de novo native coronary artery lesions. J Am Coll Cardiol. 2012 Apr 10;59(15):1371-6. doi: 10.1016/j.jacc.2011.12.009. Epub 2012 Jan 25.

family: Carrié

full_name: Didier Carrié

given: Didier

family: Berland

full_name: Jacques Berland

given: Jacques

family: Verheye

full_name: Stefan Verheye

given: Stefan

family: Hauptmann

full_name: Karl Eugen Hauptmann

given: Karl Eugen

family: Vrolix

full_name: Mathias Vrolix

given: Mathias

family: Violini

full_name: Roberto Violini

given: Roberto

family: Dibie

full_name: Alain Dibie

given: Alain

family: Berti

full_name: Sergio Berti

given: Sergio

family: Maupas

full_name: Eric Maupas

given: Eric

family: Antoniucci

full_name: David Antoniucci

given: David

family: Schofer

full_name: Joachim Schofer

given: Joachim

journal_name: Journal of the American College of Cardiology

title: A Multicenter Randomized Trial Comparing Amphilimus- With Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions

lead_sponsor: CID - Carbostent & Implantable Devices

location_country: Italy Germany Belgium France

location_facility:
Hôpital de Rangueil
Krankenhaus der Barmherzigen Brüder
Clinique les Franciscaines
Azienda Ospedaliera Careggi
Ziekenhuis Oost Limburg
Istituto di Fisiologia Clinica del CNR
Academisch Ziekenhuis Middelheim
Ospedale S. Camillo
Clinique Saint-Hilaire
Institut Mutualiste Montsouris
Medizinisches Versorgungszentrum


title: Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis

summary: NutriPEPA2 is a randomized, single-blind, prospective, multicenter trial, in two parallel arms to confirm that the adsorbent PEPA membrane may decrease mortality related to inflammation and malnutrition encountered in HD or HDF-treated stage 5 renal failure compared to a non-adsorbent synthetic membrane.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Theradial

location_country: Monaco France

location_facility:
Ch La Rochelle
Ch Metz-Thionville
Ch Chartres
CH MEAUX
Ch Besancon
Ch Annonay
CH Saint Brieuc
CH Saint Quentin
Chru Tours
CHPM Monaco
Ch Toulouse Larrey
Aura Paris Plaisance

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


type: Other Identifier

title: Study of the Impact of the Stage of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors (ITK) in Patients Treated for Metastatic Kidney Cancer

acronym: IREKI

summary: The study of the blood concentration of ITK what are pazopanib and cabozantinib at 1 month and 3 months from the start of treatment will allow to evaluate the impact of renal failure on their efficacy and toxicity in patients with metastatic kidney cancer.

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceType: background

ReferenceCitation: van Erp NP, Gelderblom H, Guchelaar HJ. Clinical pharmacokinetics of tyrosine kinase inhibitors. Cancer Treat Rev. 2009 Dec;35(8):692-706. doi: 10.1016/j.ctrv.2009.08.004. Epub 2009 Sep 5. Review.

ReferenceCitation: Hendrayana T, Wilmer A, Kurth V, Schmidt-Wolf IG, Jaehde U. Anticancer Dose Adjustment for Patients with Renal and Hepatic Dysfunction: From Scientific Evidence to Clinical Application. Sci Pharm. 2017 Feb 27;85(1). pii: E8. doi: 10.3390/scipharm85010008.

ReferenceCitation: Verheijen RB, Bins S, Mathijssen RH, Lolkema MP, van Doorn L, Schellens JH, Beijnen JH, Langenberg MH, Huitema AD, Steeghs N; Dutch Pharmacology Oncology Group. Individualized Pazopanib Dosing: A Prospective Feasibility Study in Cancer Patients. Clin Cancer Res. 2016 Dec 1;22(23):5738-5746. Epub 2016 Jul 28.

ReferenceCitation: Lacy S, Yang B, Nielsen J, Miles D, Nguyen L, Hutmacher M. A population pharmacokinetic model of cabozantinib in healthy volunteers and patients with various cancer types. Cancer Chemother Pharmacol. 2018 Jun;81(6):1071-1082. doi: 10.1007/s00280-018-3581-0. Epub 2018 Apr 23.

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: CHU de Nîmes, Institut de Cancérologie du Gard

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole

intervention_type: Other

status_simplified: Ongoing


title: Oral Care and Cancer: Assessing the Contribution of Training Healthcare Teams to Support the Oral Status of Patients Hospitalized in Palliative Situation

summary: The purpose of this study is to measure the impact of training on the practical assessment and management of the oral status of patients hospitalized in palliative situation.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Henri Becquerel
Centre François Baclesse
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret

status_simplified: Completed


title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma.

ipd_sharing: Yes

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Italy
Switzerland
Netherlands
United Kingdom
France
Slovenia

location_facility: Inselspital, Universitätsklinik für Kinderheilkunde

location_facility: Division of Pediatric Oncology Universitäts-Kinderspital Zürich

location_facility: Ostschweizer Kinderspital Hämatologie/Onkologie Claudiusstrasse 6

location_facility: Luzerner Kantonsspital, Kinderspital pädiatrische Hämatologie/Onkologie

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust

location_facility: University medical center Ljubljana, University Children's Hospital Ljubljana, Slovenia

location_facility: Universitäts-Kinderspital beider Basel (UKBB)

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois

location_facility: HUG Hôpitaux Universitaires de Genève Unité d'Hémato-Oncologie Pédiatrique

location_facility: Ospedale San Giovanni Pediatria, Emato-oncologia pediatrica

location_facility: Kantonsspital Aarau AG Klinik für Kinder und Jugendliche

intervention_type: Radiation

lead_sponsor_type: academique


type: EudraCT Number

title: Randomized Phase II Trial Evaluating the Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab as Perioperative Treatment in Patients With Resectable Liver Metastases From Wild Type KRAS/NRAS Colorectal Cancer

summary:
Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases,resection should be considered after limited chemotherapy.

There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended.

The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome.

It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase II study.

Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery

status: Terminated

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

location_country: Austria Switzerland Netherlands France Belgium Spain

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

location_facility: CHU Saint-Etienne - CHU de Saint-Etienne - Hopital Nord

location_facility: CHU de Lyon - Centre Hospitalier Lyon Sud

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly

location_facility: Assistance Publique - Hôpitaux de Paris - Hopital De Bicetre AP-HP

intervention_type: Procedure


title: Prognostic Value of Quick Sequential Organ Failure Assessment Kinetics After Fluids Challenge in the Emergency Department

acronym: DELTASCREEN

summary: The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of Sepsis, i.e. an initial qSOFA of at least of 2.

ipd_sharing_description: data will be available upon request to the principal investigator

lead_sponsor: Societe Française de Medecine d'urgence

location_country: Belgium France Spain

location_facility:
CHU Strasbourg
Hopital Europeen Georges Pompidou
Hospital Clinic
Lariboisière
Cochin
Saint Antoine
Hopital Pitié-Salpêtrière
Cliniques St Luc
CHU Nimes
Hopital Tenon


lead_sponsor: Direction Centrale du Service de Santé des Armées

acronym: SALUTOX

location_facility: Institut Universitaire de Réadaptation Clémenceau

source: euctr

title: Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)

summary: The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.


title: A 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis

summary: The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.

lead_sponsor: AB Science

location_country: Poland France Bulgaria Greece Romania Spain Germany

location_facility: "St. Ivan Rilski" University Multiprofile Hospital for Active Treatment

intervention_type: Drug


title: A Prospective, Multicenter, Randomized, Open-label, Active Controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Dacarbazine in the Treatment of Patients With Non-resectable or Metastatic Stage 3 or Stage 4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of C-kit

summary: The objective is to assess the efficacy and safety of masitinib at 7.5 mg/kg/day in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit and who have not previously been treated for melanoma.

location_country:
Italy
United States
France
Czechia
Russian Federation
Spain
Germany

location_facility: N.N.Blokhin Russian Cancer Research Centre

location_facility: Klinik und Poliklinik für Hautkrankheiten


title: Bivalirudin Infusion for Ventricular Infarction Limitation

acronym: BIVAL

summary: The purpose of this study is to evaluate whether the use of bivalirudin will reduce extent of the damage done to the heart muscle in participants who suffered a heart attack, compared to the comparator treatment (heparin).

ReferenceCitation: Alderman EL, Stadius M. The angiographic definitions of the Bypass Angioplasty Revascularization Investigation. Coronary Artery Disease 1992;3: 1189-1207

ReferenceCitation: Graham MM, Faris PD, Ghali WA, Galbraith PD, Norris CM, Badry JT, Mitchell LB, Curtis MJ, Knudtson ML; APPROACH Investigators (Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease. Validation of three myocardial jeopardy scores in a population-based cardiac catheterization cohort. Am Heart J. 2001 Aug;142(2):254-61.

ReferenceCitation: Kim RJ, Fieno DS, Parrish TB, Harris K, Chen EL, Simonetti O, Bundy J, Finn JP, Klocke FJ, Judd RM. Relationship of MRI delayed contrast enhancement to irreversible injury, infarct age, and contractile function. Circulation. 1999 Nov 9;100(19):1992-2002.

ReferenceCitation: Lowe JE, Reimer KA, Jennings RB. Experimental infarct size as a function of the amount of myocardium at risk. Am J Pathol. 1978 Feb;90(2):363-79.

ReferenceCitation: Ortiz-Pérez JT, Meyers SN, Lee DC, Kansal P, Klocke FJ, Holly TA, Davidson CJ, Bonow RO, Wu E. Angiographic estimates of myocardium at risk during acute myocardial infarction: validation study using cardiac magnetic resonance imaging. Eur Heart J. 2007 Jul;28(14):1750-8. Epub 2007 Jun 22.

ReferenceCitation: Reimer KA, Ideker RE, Jennings RB. Effect of coronary occlusion site on ischaemic bed size and collateral blood flow in dogs. Cardiovasc Res. 1981 Nov;15(11):668-74.

ReferenceCitation: Seiler C, Kirkeeide RL, Gould KL. Basic structure-function relations of the epicardial coronary vascular tree. Basis of quantitative coronary arteriography for diffuse coronary artery disease. Circulation. 1992 Jun;85(6):1987-2003.

ReferenceCitation: Seiler C, Kirkeeide RL, Gould KL. Measurement from arteriograms of regional myocardial bed size distal to any point in the coronary vascular tree for assessing anatomic area at risk. J Am Coll Cardiol. 1993 Mar 1;21(3):783-97.

ReferenceCitation: Wu E, Judd RM, Vargas JD, Klocke FJ, Bonow RO, Kim RJ. Visualisation of presence, location, and transmural extent of healed Q-wave and non-Q-wave myocardial infarction. Lancet. 2001 Jan 6;357(9249):21-8.

lead_sponsor: The Medicines Company

location_country: France Netherlands

location_facility:
VUMC Amsterdam
Hospital Lariboisière
Erasmus Medical Center
Hopital Ambroise Paré


title: A Prospective,Multicenter, Phase II Study to Evaluate the Contribution of the Imaging TEP to the Expression of intégrines αvβ3 for the Characterization of the Residual Masses of Non-seminoma Tumors at the End of Chemotherapy

acronym: TERMATEP

summary:
The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy.

The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.

primary_purpose: Diagnostic

location_facility:
Centre François Baclesse
CHU Rouen
Institut Claudius Regaud
Centre Henri Becquerel
CHU


title: Randomized Controlled Study Evaluating the Effect of a Biotherapy Treatment (Anti-RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease

acronym: HDENO

summary:
Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:

on bone mineral density (femoral T-score) at 24 months
on bone mineral density evolution (femoral T-score) after 24 months of follow-up
on bone mineral density evolution (lumbar T-score) after 24 months of follow-up
on coronary and abdominal aorta calcification scores evolution after 24 months of follow-up
on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of follow-up
on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
the tolerance after 24 months of follow-up

ReferenceType: derived

ReferenceCitation: Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7:CD013424. doi: 10.1002/14651858.CD013424.pub2.

name: Department of Healthcare Epidemiology; Kyoto University Graduate School of Medicine/School of Public Health; Kyoto Japan

family: Hara

full_name: Takashi Hara

given: Takashi

sequence: additional

family: Hijikata

full_name: Yasukazu Hijikata

given: Yasukazu

name: Department of Nephrology; Hiroshima University Hospital; Hiroshima Japan

family: Matsubara

full_name: Yukiko Matsubara

given: Yukiko

name: Department of Psychiatry; Soseikai General Hospital; Kyoto Japan

family: Watanabe

full_name: Norio Watanabe

given: Norio

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: University Hospital, Montpellier

location_facility:
AP-HM, Nephrology department
CHL Castelnau Le Lez
Clinique Médipole Cabestany
CH Perpignan, Nephrology department
CHU Montpellier, Nephrology department
CHU Nimes, Nephrology department
CHU Lyon Sud, Nephrology department
AIDER
CHU Nice, Nephrology department


title: New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis

summary: To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin, fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a 7 year follow-up.

primary_purpose: Supportive Care

location_facility: CHU Montpellier, Endocrinology department

location_facility: CHU Montpellier, Internal medicine department


title: Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device

summary: The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.

lead_sponsor: Phenox GmbH

location_country:
Italy
France
Bulgaria
Poland
Romania
Belgium
Argentina
Russian Federation
Germany
United Kingdom

location_facility: Hôpital Gui de Chauliac (CHU Montpellier)

location_facility: Federal Almazov North-West Medical Research Centre

location_facility: Uniwersytecki Szpital Kliniczny we Wroclawiu

location_facility: Ospedale Bellaria Carlo Alberto Pizzardi


title: Essai thérapeutique randomisé Multicentrique en Double Insu, Comparant l'énoxaparine 40mg Versus Placebo, en Une Injection Sous-cutanée Quotidienne, Dans Les Fausses Couches spontanées récurrentes inexpliquées

acronym: PREFIX

summary: Standard investigations fail to reveal any apparent cause in 50% of the cases of recurrent spontaneous abortion. Prothrombotic mechanisms were initially evoked. Factor V Leiden, Prothrombin G20210A mutation and protein S deficiency are implicated in the meta-analysis of Rey (Lancet).However, they do not account for a large number of miscarriages.Gris JC and coworkers (Blood 2004)carried out an open trial, low-molecular-weight heparin versus low-dose aspirin, in women with one fetal loss and with a constitutional thrombophilic disorder. They conclude for a benefit action of Low-molecular-weight heparin. There is actually no trials concerning women with unexplained recurrent abortions and without known thrombophilia. Nevertheless,aspirin or enoxaparin are often prescribed. It is time to assess these practices. We therefore initiate a multisite, double blind randomized study, enoxaparine versus placebo, in women without known thrombophilia, which experienced unexplained recurrent abortions.

ReferenceCitation: Pasquier E, de Saint Martin L, Bohec C, Chauleur C, Bretelle F, Marhic G, Le Gal G, Debarge V, Lecomte F, Denoual-Ziad C, Lejeune-Saada V, Douvier S, Heisert M, Mottier D. Enoxaparin for prevention of unexplained recurrent miscarriage: a multicenter randomized double-blind placebo-controlled trial. Blood. 2015 Apr 2;125(14):2200-5. doi: 10.1182/blood-2014-11-610857. Epub 2015 Jan 30.

name: EA 3878 Groupe d'Etude de la Thrombose de Bretagne Occidentale, Department of Internal Medicine and Chest Diseases, Brest University Hospital, La Cavale Blanche Hospital, Brest, France;

family: Pasquier

full_name: Elisabeth Pasquier

given: Elisabeth

sequence: first

family: de Saint Martin

full_name: Luc de Saint Martin

given: Luc

name: Division of Gynaecology, François Mitterand Hospital, Pau, France;

family: Bohec

full_name: Caroline Bohec

given: Caroline

name: Division of Gynaecology, Saint Etienne University Hospital, Saint Etienne, France;

family: Chauleur

full_name: Céline Chauleur

given: Céline

name: Division of Gynaecology, Université de la Méditerranée, Hôpital Nord, Marseille, France;

family: Bretelle

full_name: Florence Bretelle

given: Florence

family: Marhic

full_name: Gisèle Marhic

given: Gisèle

name: EA 3878 Groupe d'Etude de la Thrombose de Bretagne Occidentale, Centres d'Investigation Clinique-INSERM 1412, La Cavale Blanche Hospital, Brest, France;

family: Le Gal

full_name: Grégoire Le Gal

given: Grégoire

name: Division of Gynaecology, Lille University Hospital, Lille, France;

family: Debarge

full_name: Véronique Debarge

given: Véronique

name: Division of Internal Medicine, Bretagne Sud Hospital, Lorient, France;

family: Lecomte

full_name: Frédéric Lecomte

given: Frédéric

name: Division of Gynaecology, Caen University Hospital, Clemenceau Hospital, Caen, France;

family: Denoual-Ziad

full_name: Christine Denoual-Ziad

given: Christine

name: Division of Gynaecology, Paris University Hospital, Necker Hospital, Paris, France;

family: Lejeune-Saada

full_name: Véronique Lejeune-Saada

name: Division of Gynaecology, Dijon University Hospital, Complexe du Bocage, Dijon, France; and

family: Douvier

full_name: Serge Douvier

given: Serge

name: Division of Gynaecology, Groupe Hospitalier du Sud de la Réunion, Saint Pierre, France

family: Heisert

full_name: Michel Heisert

given: Michel

family: Mottier

full_name: Dominique Mottier

given: Dominique

journal_name: Blood

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: University Hospital, Brest

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de St Etienne

location_facility: Centre Hospitalier Régional Universitaire de Caen


title: Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters

summary: The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.

ReferenceCitation: Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10:CD006008. doi: 10.1002/14651858.CD006008.pub5. Review.

name: Faculty of Health Sciences; University of Southampton; Southampton UK

family: Prieto

full_name: Jacqui A Prieto

given: Jacqui A

family: Murphy

full_name: Catherine L Murphy

given: Catherine L

name: c/o Cochrane Incontinence, Population Health Sciences Institute; Newcastle University; Newcastle upon Tyne UK

family: Stewart

full_name: Fiona Stewart

given: Fiona

family: Fader

full_name: Mandy Fader

given: Mandy

lead_sponsor: Coloplast A/S

location_country: Sweden France Norway Denmark Germany

location_facility: University Heidelberg, Neuro-Urology clinic,

location_facility: St. Olavs Hospital HF, Neurologi clinic,

location_facility: PrivatHospitalet Danmark, privat hospital,

location_facility: Hôpital Léon Berard, Rehabilitation clinic,

location_facility: Hôpital Tenon, Neuro-Urology and perineal explorations department,

location_facility: Hôpital Raymond Poincaré, Urology clinic

location_facility: Hôpital Henry Gabrielle, Urology clinic,


title: A Randomized Controlled Study of Velcade (Bortezomib) Plus Thalidomide Plus Dexamethasone Compared to Thalidomide Plus Dexamethasone for the Treatment of Myeloma Patients Progressing or Relapsing After Autologous Transplantation

summary:
This is an international study in adult patients diagnosed with multiple myeloma who have already received at least one autologous stem cell transplantation and who have responded but later progressed, or relapsed, at least one year after transplantation.

Eligible patients will be randomly assigned to one of two treatments: either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone.

Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression (measure of time after the disease is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country:
Italy
Austria
Switzerland
France
Czechia
Israel
Hungary
Belgium
Germany
United Kingdom

location_facility: Ospedale SS. Antonio e Biagio e Cesare Arrigo


title: Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults

acronym: NUTRIMEMO

summary: Nutrimemo aims to study the effect of a daily consumption of a mix of vitamin A and long chain n-3 Polyunsaturated Fatty Acids (PUFA) on the evolution of cognitive functions in healthy elderly subjects. The study is a randomized, double bind, parallel-groups (2 arms) placebo-controlled design.

primary_purpose: Prevention

lead_sponsor: Nutrimemo Consortium

location_facility: Universitary Hospital Center - USR 3413 SANPSY


title: A Prospective, Multicenter, Double-randomized, Double-blind, 2-parallel Groups, Phase 3 Study to Compare as First Line Therapy Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Gemcitabine in Combination With Placebo, in the Treatment of Patients With Non Resectable Locally Advanced or Metastatic Pancreatic Cancer

summary: The objective is to compare efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine, in treatment of patients with locally advanced or metastatic pancreatic cancer and who have pain related to the disease.

ipd_sharing: Undecided

location_country:
India
France
Greece
Slovakia
Tunisia
Russian Federation
Belgium
Ukraine

location_facility:
General University Hospital of Patras
Polyclinique de Limoges site CHENIEUX
Hospital AZ Sint-Jan
Centre Hospitalier de Longjumeau
Omsk Clinical oncology dispensary Omsk
Center of Surgical Innovations
National Oncology Institute
Institut Salah Azaiez de Cancerologie
Sanjeevani CBCC USA Cancer Hospital


title: Evaluation of Tele-expertise for Inmates With a Dermatological Lesion

acronym: TLM-Inmates

summary: The purpose of this study is to determine whether Tele-expertise would be effective and cost-effective by reducing the number of secure transportations for inmates in need of a dermatological consultation

time_perspective: Retrospective

ReferenceCitation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

ReferenceCitation: Zarca K, Charrier N, Mahé E, Guibal F, Carton B, Moreau F, Durand-Zaleski I. Tele-expertise for diagnosis of skin lesions is cost-effective in a prison setting: A retrospective cohort study of 450 patients. PLoS One. 2018 Sep 24;13(9):e0204545. doi: 10.1371/journal.pone.0204545. eCollection 2018.

family: Zarca

full_name: Kevin Zarca

given: Kevin

family: Charrier

full_name: Nathanael Charrier

given: Nathanael

family: Mahé

full_name: Emmanuel Mahé

given: Emmanuel

family: Guibal

full_name: Fabien Guibal

given: Fabien

family: Carton

full_name: Béatrice Carton

given: Béatrice

family: Moreau

full_name: François Moreau

given: François

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

name: the ARS Ile de France telemedicine group

family: Calinaud

full_name: Christine Calinaud

currency_apc_doaj: GBP

journal_name: BMC Health Services Research

location_facility:
UCSA Villepinte
UCSA Meaux
UCSA Réau
UCSA Osny
UCSA Nanterre


title: Assessment of Teleconsulting in Nursing Homes to Avoid Transportations to the Emergency Units

summary: The purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents.

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Résidence La Gentilhommière
Résidence de l'Orge
Résidence Notre Dame d'Espérance
Résidence Les Tisserins
Le Centenaire


title: Prospective Multicentric Randomized Trial of Efficiency and Safety of Laparoscopic Omega Loop Bypass Versus Roux-en-Y Gastric Bypass

acronym: YOMEGA

summary:
Several prospective trials and metaanalysis have demonstrated the superiority of bariatric surgery on the medical treatment of obesity. The Roux-en-Y Gastric ByPass (RYGBP) procedure has been practiced for more than 30 years, and is the procedure of choice for morbidly obese with metabolic disorders in most of the reference centers. Nevertheless, the RYGBP is a technically demanding procedure with a learning curve of more than 75 cases. The complication rate is around 10% in expert centers.

More recently another procedure has been described which seems as efficient on weight loss and co-morbidities as the RYGBP, with the advantage of being less technically difficult and less morbid, especially for multi-complicated obese and/or the super obese. It consists of a unique gastro-jejunal anastomosis between a long gastric pouch and a jejunal Omega loop. However, this procedure could be at risk of biliary reflux and anastomotic ulcers with dysplastic changes of the gastric and esophageal mucosa. As a result, the Omega loop bypass (OLB) has only been developed by a few teams and remains a controversial subject, particularly as only one monocentric randomized trial has compared it to the RYGBP, which is remains the gold standard. The first litterature results show similar or even better weight loss efficiency than RYGBP with a better feasibility. The early complication rate seems lower, but there are still insufficient data on long term morbidity and biliary reflux consequences.

By performing a randomized and prospective comparison of OLB to RYGBP, the aim of the investigators study is to analyze the weight loss efficiency, the morbidity and mortality, the feasibility, and the quality of life of both techniques, in order to validate the Omega loop bypass as a procedure of choice in bariatric surgery

Hypothesis :

The OLB, while being as efficient as RYGBP on weight loss and metabolic complications, could be less morbid.

ReferenceCitation: Robert M, Espalieu P, Pelascini E, Caiazzo R, Sterkers A, Khamphommala L, Poghosyan T, Chevallier JM, Malherbe V, Chouillard E, Reche F, Torcivia A, Maucort-Boulch D, Bin-Dorel S, Langlois-Jacques C, Delaunay D, Pattou F, Disse E. Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial. Lancet. 2019 Mar 30;393(10178):1299-1309. doi: 10.1016/S0140-6736(19)30475-1. Epub 2019 Mar 6. Erratum in: Lancet. 2019 Mar 30;393(10178):1298.

family: Robert

full_name: Maud Robert

given: Maud

family: Espalieu

full_name: Philippe Espalieu

given: Philippe

family: Pelascini

full_name: Elise Pelascini

given: Elise

family: Caiazzo

full_name: Robert Caiazzo

given: Robert

family: Sterkers

full_name: Adrien Sterkers

given: Adrien

family: Khamphommala

full_name: Lita Khamphommala

given: Lita

family: Poghosyan

full_name: Tigran Poghosyan

given: Tigran

family: Chevallier

full_name: Jean-Marc Chevallier

given: Jean-Marc

family: Malherbe

full_name: Vincent Malherbe

given: Vincent

family: Chouillard

full_name: Elie Chouillard

given: Elie

family: Reche

full_name: Fabian Reche

given: Fabian

family: Torcivia

full_name: Adriana Torcivia

given: Adriana

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

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family: Bin-Dorel

full_name: Sylvie Bin-Dorel

given: Sylvie

family: Langlois-Jacques

full_name: Carole Langlois-Jacques

given: Carole

family: Delaunay

full_name: Dominique Delaunay

family: Pattou

full_name: François Pattou

family: Disse

full_name: Emmanuel Disse

journal_name: The Lancet

oa_host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

publisher: Elsevier BV

location_facility: Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique et Transplantation Hépatique - Hôpital de la Pitié Salpêtrière

location_facility: Service de Chirurgie Digestive et Hépato-Biliaire-Centre Hospitalier Privé Saint Grégoire

location_facility: Service de Chirurgie Digestive, Générale et Cancérologique - Hôpital Européen Georges Pompidou - APHP

location_facility: Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche

location_facility: Clinique Universitaire de Chirurgie Digestive et de l'Urgence - CHU de Grenoble

location_facility: Service de Chirurgie Générale - Hôpital Privé de la Loire

location_facility: Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille

location_facility: Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye

location_facility: Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon


title: An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candidatE for Intensive Therapy (SOLSTICE Study)

acronym: SOLSTICE

summary: The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.

status: Active, not recruiting

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Romania
Australia
Russian Federation
Denmark
Ukraine
France
Poland
Lithuania
Slovakia
Argentina
Sweden
Netherlands
Bulgaria
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Czechia
Spain
Estonia
Latvia

location_facility: Hospital Germans Trias i Pujol Unidad de Investigación clínica (UIC) ICO-Oncología medica

location_facility: Aalborg Universitetshospital, Syd Onkologisk Afdelin

location_facility: Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III

location_facility: Clinical Oncology Dispensary No.1 Chemotherapy Department

location_facility: Leicester Royal Infirmary The HOPE Clinical Trials Unit

location_facility: Hospital Universitario Miguel Servet Servicio de Oncología

location_facility: Masarykuv onkologicky ustav Klinika komplexni onkologicke pece

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa

location_facility: S.C Oncolab S.R.L Sectia Oncologie Medicala

location_facility: Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej

location_facility: M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow

location_facility: Semmelweis University Radiology and Oncotherapy Clinic

location_facility: Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica

location_facility: Med. Universität Graz Klinische Abteilung für Onkologie

location_facility: Tartu University Hospital, Hematology - Oncology clinic, Radiotherapy and oncological therapy

location_facility: Sarah Cannon Research Institute UK Clinical Trials

location_facility: Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1

location_facility: Lviv Regional Oncology Center Chemotherapy department

location_facility: Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I

location_facility: Uzsoki Utcai Korhaz Onkoradiologiai Osztaly

location_facility: Arcispedale Santa Maria Nuova Unità di Oncologia

location_facility: HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica

location_facility: "UMHAT Sv. Ivan Rilski" EAD Clinic of clinical hematology, Dpt. of medical oncology

location_facility: Hospital Universitario Marqués de Valdecilla Oncología médica

location_facility: Riga East Univerity Hospital Oncology Centre of Latvia

location_facility: H. Universitario La Paz Oncología Médica

location_facility: Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)

location_facility: National Institute of Cancer Abdominal Oncology Department

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika

location_facility: University Hospitals Bristol Bristol Haematology & Oncology Centre

location_facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

location_facility: S.C ONCOMED S.R.L Departament Oncologie Medicala

location_facility: Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia

location_facility: Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Oddzial Kliniczny Onkologii i Immunoonkologii

location_facility: HOSPITAL DE BRAGA Medical Oncology Department

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly

location_facility: Kyiv City Clinical Oncology Centre Chemotherapy Department #2

location_facility: University Headache Clinic Outpatient oncology clinic

location_facility: Christie Hospital NHS Foundation Trust GI & Endocrine

location_facility: Nemocnica s poliklinikou Stefana Kukuru, Michalovce, a.s Oddelenie okologie a radioterapie

location_facility: Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit

location_facility: Glan Clwyd Hospital North Wales Cancer Treatment Centre

location_facility: North Estonia Medical Centre Foundation Oncology and Haematology clinic

location_facility: National Medical Research Center of Oncology N.N. Petrova

location_facility: Centro Hospitalar do Porto - Hospital de Santo Antonio Institute of Biomedical Sciences Abel Salazar

location_facility: Hospital CUF Infante Santo Oncology Department

location_facility: Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive

location_facility: Adventist HealthCare Integrated Cancer Centre

location_facility: CHU Jean Minjoz Service d'oncologie médicale

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa

location_facility: Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala

location_facility: Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie

location_facility: Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet

location_facility: SBIH of YR "Clinical oncology hospital" chemotherapy department

location_facility: Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale

location_facility: Moscow City Oncology Hospital # 62 chemotherapy department

location_facility: Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica

location_facility: Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei

location_facility: Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department

location_facility: Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", proctology department

location_facility: Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V

location_facility: Spec. hospital for active treatment of oncology dis. EOOD Department of medical oncology and palliative car

location_facility: Hôpital Saint-Antoine Service d'Oncologie Médicale

location_facility: Centrul de Oncologie Sf Nectarie Oncology Department

location_facility: Omsk Clinical Oncologic Dispensary Chemotherapy

location_facility: Podillia Regional Oncology Centre Chemotherapy Department

location_facility: Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica

location_facility: Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii

location_facility: Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie

location_facility: Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale

location_facility: Regional Clinical Oncological Dispensary Department of Oncology

location_facility: Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie

location_facility: Spitalul Clinic "Coltea" Sectia Oncologie Medicala

location_facility: Kursk Regional Clinical Oncology Dispensary Oncology Department

location_facility: Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN

location_facility: Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA

location_facility: CHU Toulouse Rangueil Oncologie médicale digestive

location_facility: Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales

location_facility: MHAT Serdika EOOD Department of Medical Oncology

location_facility: Hospital Quirónsalud Valencia Servicio de Oncología Médica

location_facility: Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK

location_facility: Policlinico Universitario Campus Biomedico UOC di Oncologia Medica

location_facility: Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy

location_facility: "Complex oncology center - Burgas" EOOD Department of medical oncology

location_facility: H. Clínico San Carlos Servicio de Oncología Médica

location_facility: Institute of Medical Radiology of S.P. Grygoryev of AMS UKR

location_facility: H. Valle de Hebrón Servicio de Oncología - (VHIR)

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.

location_facility: Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa

location_facility: Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre

location_facility: IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia

location_facility: Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer

location_facility: "Multiprofile hosp. for active treatmen Dr. Tota Venkova" AD Department of medical oncology

location_facility: A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2

location_facility: Hospital Garcia de Orta Serviço de Oncologia Médica

location_facility: "Complex oncology center - Plovdiv" EOOD, IInd base Dpt. of Med. oncology and onc. diseases in gastroenterology

location_facility: Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica

location_facility: Odesa Regional Oncology Dispensary Day patient Department

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

location_facility: CHU Morvan Institut de Cancérologie et d'Hématologie

location_facility: Del-Pesti Centrumkh-Orsz. Hematologiai es Infektologiai Int. Szent Laszlo Telephely

location_facility: Europejskie Centrum Zdrowia Otwock Oddzial Onkologii Klinicznej

location_facility: Hospital de la Santa Creu I Sant Pau Oncología Medica

location_facility: Centro Hospitalar e Universitário de Coimbra - CHUC Unidade de Inovação e Desenvolvimento (UID)

location_facility: Centre Antoine Lacassagne Dpt d'Oncologie Médicale

location_facility: Ustredna vojenska nemocnica Ruzomberok Klinika radiacnej a klinickej onkologie

location_facility: Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia

location_facility: Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala

location_facility: Ospedale S. Bortolo -ULSS8 Berica Distretto Est U.O. ONCOLOGIA

location_facility: Lanssjukhuset Ryhov Onkologiska kliniken

location_facility: Hospital A C Camargo Unidade de Pesquisa Clinica

location_facility: P. Stradins Clinical University Hospital

location_facility: Hospital Beatriz Ângelo Serviço de oncologia medic

location_facility: NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki II Sp. z o.o., Pododdzial Chemioterapi

location_facility: Norrlands Universitetssjukhus Cancercentrum Umea

location_facility: Blacktown Hospital Cancer and Haematology Centre

location_facility: Institutul Oncologic "Prof Alexandru Trestioreanu" Busuresti Sectia Oncologie Medicala I

location_facility: Scientific Centre for Specialized Medical Care (oncological) Chemotherapy

location_facility: Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09

location_facility: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala

location_facility: State Research Institution of Oncology of Tomsk Chemotherapy

location_facility: MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" Department of Oncology

location_facility: Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive

location_facility: Istituto Nazionale Tumori I.R.C.C.S "Fondazione G. Pascale" Struttura Complessa di Oncologia Medica Addominale

location_facility: Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly

location_facility: Cork University Hospital Department of Medical Oncology

location_facility: INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica

location_facility: Fakultni nemocnice Olomouc Onkologicka klinika

location_facility: Ospedale San Carlo U.O. Oncologia Medica

location_facility: Arkhangelsk Clinical Oncology Dispensary chemotherapy department

location_facility: Instituto Português de Oncologia do Porto FG, EPE -IPO Porto Medical Oncology Dept.

location_facility: Albert Schweitzer Ziekenhuis Interne Geneeskunde

location_facility: Catharina Ziekenhuis Interne Gesneeskunde/Oncologie

location_facility: Rostov Research Institute of Oncology Chemotherapy department

location_facility: Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

location_facility: 1st Floor East Wing Medical OncologyFulham Palace RoadHammersmith

location_facility: East Tallinn Central Hospital Center of Oncology

location_facility: Hospital São Rafael Centro Intergrado de Pesquisa

location_facility: Centro de Oncología e Investigación de Buenos Aires COIBA

location_facility: "Medical Center Nadezhda Clinical" EOOD Medical Oncology Department

location_facility: "Spec. hospital for active treatment of oncology dis." EOOD Department of medical oncology and palliative care

location_facility: Narodny onkologicky ustav Oddelenie klinickej onkologie

location_facility: Royal Marsden Hospital Department of Medicine

location_facility: Oncology Hospital, Branch of Hospital of Lithuanian Uni. of Health Sciences Kauno klinikos

location_facility: Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica

location_facility: SHAT of oncology diseases Dr. Marko Antonov Markov" EOOD Department of medical oncology and palliative therapy

location_facility: Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly

location_facility: Hospital Virgen de las Nieves Unidad de Oncología Médica

location_facility: Fundación COIR Centro Oncológico de Interación Regional

location_facility: St George Hospital St George Hospital Cancer Care Centre

location_facility: "Complex Ongology Center - Vratsa" EOOD Department of Medical oncology

location_facility: Fakultni nemocnice Ostrava Klinika onkologicka

location_facility: Hospital General Universitario Alicante Servicio de Oncología

location_facility: JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum

location_facility: Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica

location_facility: Hospital de Base Centro Integrado de Pesquisa

location_facility: Ordensklinikum Linz Barmherzige Schwestern Interne I

location_facility: Odense Universitetshospital Onkologisk Afdeling R

location_facility: Aberdeen Royal Infirmary Oncology Department

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly

location_facility: Frankston Private Peninsula and Southeast Oncology Group

location_facility: Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling


ReferenceCitation: Paul C, Sans B, Suarez F, Casassus P, Barete S, Lanternier F, Grandpeix-Guyodo C, Dubreuil P, Palmérini F, Mansfield CD, Gineste P, Moussy A, Hermine O, Lortholary O. Masitinib for the treatment of systemic and cutaneous mastocytosis with handicap: a phase 2a study. Am J Hematol. 2010 Dec;85(12):921-5. doi: 10.1002/ajh.21894.

ReferenceCitation: Lortholary O, Chandesris MO, Bulai Livideanu C, Paul C, Guillet G, Jassem E, Niedoszytko M, Barete S, Verstovsek S, Grattan C, Damaj G, Canioni D, Fraitag S, Lhermitte L, Georgin Lavialle S, Frenzel L, Afrin LB, Hanssens K, Agopian J, Gaillard R, Kinet JP, Auclair C, Mansfield C, Moussy A, Dubreuil P, Hermine O. Masitinib for treatment of severely symptomatic indolent systemic mastocytosis: a randomised, placebo-controlled, phase 3 study. Lancet. 2017 Feb 11;389(10069):612-620. doi: 10.1016/S0140-6736(16)31403-9. Epub 2017 Jan 7.

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family: Paul

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family: Guillet

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family: Niedoszytko

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family: Damaj

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family: Canioni

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family: Fraitag

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full_name: Christian Auclair

given: Christian

family: Mansfield

full_name: Colin Mansfield

given: Colin

family: Moussy

full_name: Alain Moussy

given: Alain

family: Dubreuil

full_name: Patrice Dubreuil

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

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

location_facility: Centre de référence de Mastocytose (CEREMAST)

location_facility: Centre Hospitalier Universitaire d'Amiens

title: Phase 3 Study to Compare Oral Masitinib to Placebo in Treatment of Patients With Smouldering or Indolent Severe Systemic Mastocytosis, Unresponsive to Optimal Symptomatic Treatment

summary: The purpose of this study is to evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients suffering from smouldering or indolent systemic mastocytosis with severe symptoms of mast cell mediator release, unresponsive to optimal symptomatic treatment.


title: Flow Cytometric Analysis of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes: A Pilot Diagnostic Accuracy Study

acronym: MPO-MDS-PILOT

summary:
Myelodysplastic syndromes (MDS) constitute a heterogeneous group of clonal bone marrow neoplasms that predominate in the elderly, with a median age at diagnosis of 70 years. MDS are characterized by peripheral blood cytopenia and morphologic dysplasia for one or more hematopoietic cell lineage, reflecting ineffective hematopoiesis.

The diagnostic work-up of MDS includes a bone marrow aspirate and biopsy, which is an invasive procedure, for cytomorphologic and cytogenetic evaluations. Because the prevalence of disease is lower than 20% in subjects referred for suspected MDS, many patients are exposed to unnecessary bone marrow aspiration-related discomfort and harms.

An objective assay is highly desirable for accurately ruling out MDS based on peripheral blood samples, which may obviate the need for invasive bone marrow aspiration and biopsy in patients with negative results.

Few studies have investigated the value of peripheral blood flow cytometric analysis for the diagnosis of MDS and/or chronic myelomonocytic leukemia (CMML). Although promising, these studies lacked replication of their results, used a case-control design, which was prone to spectrum bias, or yielded imprecise diagnostic accuracy estimates due to relatively limited sample sizes.

Anecdotal evidence supports the potential of flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for the diagnosis of MDS and CMML. Myeloperoxidase is an enzyme synthetized during myeloid differentiation that constitutes the major component of neutrophil azurophilic granules. Myeloperoxidase expression may reflect neutrophil hypogranulation, which is a classical although subjective dysplastic feature of MDS. Flow cytometric analysis of myeloperoxidase expression in bone marrow neutrophil granulocytes has been used for discriminating low versus high grade MDS. Yet a study reporting on the accuracy of flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for the diagnosis of MDS is still lacking, to our knowledge.

In this study, the investigators hypothesize that flow cytometric analysis of neutrophil myeloperoxidase expression in peripheral blood may accurately rule out MDS and obviate the need for bone marrow aspiration and biopsy, with sensitivity approaching 100%, in routine practice.

In this observational diagnostic accuracy study, burden will be null for recruited patients. No specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. Flow cytometry analysis of peripheral blood neutrophil myeloperoxidase expression will not require additional blood sample. A test result will have no impact on patient management. No follow-up visits are planned in this cross-sectional study.

time_perspective: Cross-Sectional

ReferenceCitation: Raskovalova T, Jacob MC, Bulabois CE, Mariette C, Scheffen L, Park S, Labarère J. Flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for ruling out myelodysplastic syndromes: a prospective validation study. Ann Hematol. 2021 May;100(5):1149-1158. doi: 10.1007/s00277-021-04446-7. Epub 2021 Feb 10.

family: Raskovalova

full_name: Tatiana Raskovalova

given: Tatiana

family: Jacob

full_name: Marie-Christine Jacob

given: Marie-Christine

family: Bulabois

full_name: Claude-Eric Bulabois

given: Claude-Eric

family: Mariette

full_name: Clara Mariette

given: Clara

family: Scheffen

full_name: Laura Scheffen

given: Laura

family: Park

full_name: Sophie Park

given: Sophie

family: Labarère

full_name: José Labarère

given: José

journal_name: Annals of Hematology

ipd_sharing_description: The principal investigators will respond directly to data requests by providing a de-identified data set. Individual participant data that underlie the results reported in the published articles (i.e., main text, tables, figures, and appendices) will be supplied.

lead_sponsor: University Hospital, Grenoble

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

intervention_type: Diagnostic Test


title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ReCap/Magnum in Total Hip Replacement and Resurfacing

summary: Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.

lead_sponsor: Zimmer Biomet

location_facility:
Polyclinique de Riaumont
Clinique Saint Andre
CHU Hôpital Sud
Polyclinique de Hénin Beaumont
CHU Pellegrin Tripode
CHU Amiens


title: Evaluation of the Efficacy of 6% Hydroxyethyl Starch (HES, 130/0.4) in Normal Saline Compared to Ringer's Lactate Solution for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section

acronym: CAESAR

summary: The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal hypotension in women undergoing spinal anesthesia for cesarean section

ReferenceCitation: Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7:CD002251. doi: 10.1002/14651858.CD002251.pub4.

name: Department of Women's Anaesthesia; Women's and Children's Hospital; Adelaide Australia

family: Chooi

full_name: Cheryl Chooi

given: Cheryl

family: Cox

full_name: Julia J Cox

given: Julia J

family: Lumb

full_name: Richard S Lumb

given: Richard S

name: Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute; Adelaide Australia

family: Middleton

full_name: Philippa Middleton

given: Philippa

name: Royal North Shore Hospital; Sydney Australia

family: Chemali

full_name: Mark Chemali

given: Mark

family: Emmett

full_name: Richard S Emmett

name: Department of Anaesthesia; Mercy Hospital for Women; Heidelberg Australia

family: Simmons

full_name: Scott W Simmons

given: Scott W

family: Cyna

full_name: Allan M Cyna

given: Allan M

ReferenceCitation: Mercier FJ, Diemunsch P, Ducloy-Bouthors AS, Mignon A, Fischler M, Malinovsky JM, Bolandard F, Aya AG, Raucoules-Aimé M, Chassard D, Keita H, Rigouzzo A, Le Gouez A; CAESAR Working Group. 6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial. Br J Anaesth. 2014 Sep;113(3):459-67. doi: 10.1093/bja/aeu103. Epub 2014 Jun 26.

family: Mercier

full_name: F.J. Mercier

family: Diemunsch

full_name: P. Diemunsch

given: P.

family: Ducloy-Bouthors

full_name: A.-S. Ducloy-Bouthors

family: Mignon

full_name: A. Mignon

given: A.

family: Fischler

full_name: M. Fischler

given: M.

family: Malinovsky

full_name: J.-M. Malinovsky

family: Bolandard

full_name: F. Bolandard

given: F.

family: Aya

full_name: A.G. Aya

family: Raucoules-Aimé

full_name: M. Raucoules-Aimé

family: Chassard

full_name: D. Chassard

given: D.

family: Keita

full_name: H. Keita

given: H.

family: Rigouzzo

full_name: A. Rigouzzo

title: 6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial ‡

location_facility: Höpital Louis-Mourier - Service d'Anesthesie

location_facility: CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation

location_facility: Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale

location_facility: Hopital de l'Archet, Service Anesthesie-Reanimation

location_facility: Hopital Robert Debre, CHU, Service Anesthesie

location_facility: Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation

location_facility: Hopital Hautepierre, CHU, Service Reanimation Chirurgicale

location_facility: Unité d'anesthésie - Maternité Paule de Viguier

location_facility: Hôpital Armand-Trousseau, Service d'anesthésie-réanimation

location_facility: Hopital Caremeau, CHU, Service Anesthesie

location_facility: Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre


title: Identification and Treatments of Basal Like Bladder Cancer (Study on Human Tumor Samples and Animal Models)

acronym: DIATRIBBE

summary: Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and no target therapies for this pathology are currently validated. By 40 gene expression signature realized on frozen samples, we have previously identified an aggressive sub-class of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim is to establish a standard diagnostic tool to differentiate the basal subtype of bladder cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR associated chemotherapy.


title: Study of Efficacy of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy

acronym: Béfinohl

summary: Study of the efficiency of Béfizal® 200 mg in 14 adult patients with a LHON that occurred for less than 5 years. Patient must have certain specific mutations

ipd_sharing_description: Undecided

lead_sponsor: Hôpital Necker-Enfants Malades


title: Evaluation of the Efficacy of Sildenafil on Time to Healing in Patients With Scleroderma and Ischaemic Digital Ulcers: a Prospective, Longitudinal, Randomized, Comparative, Double-blind, 2-parallel-arm, Placebo-controlled Study

acronym: SEDUCE

summary: Digital ulcers (DUs) are an expression of the microangiopathy in patients with scleroderma (SSc). DUs lead to pain and impaired hand use. DUs remain a severe complication for many patients and effective therapy remains elusive. In the present study, the investigators propose to evaluate the efficacy of Sildenafil in DUs healing in a randomized double blind control study in SSc patients.

ReferenceCitation: Hachulla E, Hatron PY, Carpentier P, Agard C, Chatelus E, Jego P, Mouthon L, Queyrel V, Fauchais AL, Michon-Pasturel U, Jaussaud R, Mathian A, Granel B, Diot E, Farge-Bancel D, Mekinian A, Avouac J, Desmurs-Clavel H, Clerson P; SEDUCE study group. Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study. Ann Rheum Dis. 2016 Jun;75(6):1009-15. doi: 10.1136/annrheumdis-2014-207001. Epub 2015 May 20.

family: Hachulla

full_name: Eric Hachulla

given: Eric

family: Hatron

full_name: Pierre-Yves Hatron

given: Pierre-Yves

family: Carpentier

full_name: Patrick Carpentier

given: Patrick

family: Agard

full_name: Christian Agard

given: Christian

family: Chatelus

full_name: Emmanuel Chatelus

given: Emmanuel

family: Jego

full_name: Patrick Jego

family: Mouthon

full_name: Luc Mouthon

given: Luc

family: Queyrel

full_name: Viviane Queyrel

given: Viviane

family: Fauchais

full_name: Anne-Laure Fauchais

given: Anne-Laure

family: Michon-Pasturel

full_name: Ulrique Michon-Pasturel

given: Ulrique

family: Jaussaud

full_name: Roland Jaussaud

given: Roland

family: Mathian

full_name: Alexis Mathian

given: Alexis

family: Granel

full_name: Brigitte Granel

given: Brigitte

family: Diot

full_name: Elisabeth Diot

given: Elisabeth

family: Farge-Bancel

full_name: Dominique Farge-Bancel

given: Dominique

family: Mekinian

full_name: Arsène Mekinian

given: Arsène

family: Avouac

full_name: Jérôme Avouac

given: Jérôme

family: Desmurs-Clavel

full_name: Hélène Desmurs-Clavel

given: Hélène

family: Clerson

full_name: Pierre Clerson

given: Pierre

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_facility:
University Hospital, Fort de France
Hôpital Edouard Herriot
Groupe Hospitalier Paris Saint Joseph
University Hospital, Rouen
Cochin Hospital / Médecine Interne
University Hospital, Tours
University Hospital, Grenoble
Jean Verdier Hospital
CHU de Rennes
CHU Dupuytren / dermatology
Hautepierre Hospital
University Hospital, Nantes
CHU Dijon
CHU de Caen
University Hospital, Lille
University Hospital, Amiens
Nord Hospital
University Hospital, Nice
St Louis Hospital
Saint Antoine Hospital
CHU Dupuytren / Médecine Interne
CHU de Reims
Cochin Hospital
La Pitié - Salpétriêre Hospital


title: A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.

summary:
Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a polyclonal antibody response.

This study will evaluate the safety of IFN-K in patients with mild to moderate SLE. It will also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE disease.

ReferenceCitation: Ducreux J, Houssiau FA, Vandepapelière P, Jorgensen C, Lazaro E, Spertini F, Colaone F, Roucairol C, Laborie M, Croughs T, Grouard-Vogel G, Lauwerys BR. Interferon α kinoid induces neutralizing anti-interferon α antibodies that decrease the expression of interferon-induced and B cell activation associated transcripts: analysis of extended follow-up data from the interferon α kinoid phase I/II study. Rheumatology (Oxford). 2016 Oct;55(10):1901-5. doi: 10.1093/rheumatology/kew262. Epub 2016 Jun 28.

family: Ducreux

full_name: Julie Ducreux

given: Julie

family: Houssiau

full_name: Frédéric A. Houssiau

given: Frédéric A.

family: Vandepapelière

full_name: Pierre Vandepapelière

family: Jorgensen

full_name: Christian Jorgensen

family: Lazaro

full_name: Estibaliz Lazaro

given: Estibaliz

family: Spertini

full_name: François Spertini

given: François

family: Colaone

full_name: Fabien Colaone

given: Fabien

family: Roucairol

full_name: Camille Roucairol

given: Camille

family: Laborie

full_name: Marion Laborie

given: Marion

family: Croughs

full_name: Thérèse Croughs

given: Thérèse

family: Grouard-Vogel

full_name: Géraldine Grouard-Vogel

given: Géraldine

family: Lauwerys

full_name: Bernard R. Lauwerys

given: Bernard R.

journal_name: Rheumatology

repository_institution: Université de Lausanne - SERVAL

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Lauwerys BR, Hachulla E, Spertini F, Lazaro E, Jorgensen C, Mariette X, Haelterman E, Grouard-Vogel G, Fanget B, Dhellin O, Vandepapelière P, Houssiau FA. Down-regulation of interferon signature in systemic lupus erythematosus patients by active immunization with interferon α-kinoid. Arthritis Rheum. 2013 Feb;65(2):447-56. doi: 10.1002/art.37785.

family: Hachulla

full_name: Eric Hachulla

location_country: Switzerland Croatia Bulgaria France Belgium Germany

location_facility: Centre Hospitalier Universitaire Vaudois


title: A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY)

acronym: AFFINITY

summary: This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.

ReferenceCitation: Saad F, Hotte S, North S, Eigl B, Chi K, Czaykowski P, Wood L, Pollak M, Berry S, Lattouf JB, Mukherjee SD, Gleave M, Winquist E; Canadian Uro-Oncology Group. Randomized phase II trial of Custirsen (OGX-011) in combination with docetaxel or mitoxantrone as second-line therapy in patients with metastatic castrate-resistant prostate cancer progressing after first-line docetaxel: CUOG trial P-06c. Clin Cancer Res. 2011 Sep 1;17(17):5765-73. doi: 10.1158/1078-0432.CCR-11-0859. Epub 2011 Jul 25.

ReferenceCitation: Chi KN, Hotte SJ, Yu EY, Tu D, Eigl BJ, Tannock I, Saad F, North S, Powers J, Gleave ME, Eisenhauer EA. Randomized phase II study of docetaxel and prednisone with or without OGX-011 in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Sep 20;28(27):4247-54. doi: 10.1200/JCO.2009.26.8771. Epub 2010 Aug 23.

ReferenceCitation: Beer TM, Hotte SJ, Saad F, Alekseev B, Matveev V, Fléchon A, Gravis G, Joly F, Chi KN, Malik Z, Blumenstein B, Stewart PS, Jacobs CA, Fizazi K. Custirsen (OGX-011) combined with cabazitaxel and prednisone versus cabazitaxel and prednisone alone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel (AFFINITY): a randomised, open-label, international, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1532-1542. doi: 10.1016/S1470-2045(17)30605-8. Epub 2017 Oct 9.

family: Beer

full_name: Tomasz M Beer

given: Tomasz M

family: Hotte

full_name: Sebastien J Hotte

given: Sebastien J

family: Saad

full_name: Fred Saad

given: Fred

family: Alekseev

full_name: Boris Alekseev

given: Boris

family: Matveev

full_name: Vsevolod Matveev

given: Vsevolod

family: Fléchon

full_name: Aude Fléchon

given: Aude

family: Gravis

full_name: Gwenaelle Gravis

given: Gwenaelle

family: Joly

full_name: Florence Joly

given: Florence

family: Chi

full_name: Kim N Chi

given: Kim N

family: Malik

full_name: Zafar Malik

given: Zafar

family: Blumenstein

full_name: Brent Blumenstein

given: Brent

family: Stewart

full_name: Patricia S Stewart

given: Patricia S

family: Jacobs

full_name: Cindy A Jacobs

given: Cindy A

family: Fizazi

full_name: Karim Fizazi

given: Karim

journal_name: The Lancet Oncology

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Achieve Life Sciences

location_country:
United States
United Kingdom
France
Hungary
Australia
Russian Federation
Canada
Czech Republic

location_facility: Szegedi Tudományegyetem, Onkoterápiás Klinika

location_facility: California Pacific Medical Center Research Institute

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie

location_facility: Haematology and Oncology Clinics of Australia

location_facility: Smilow Cancer Hospital at Yale New Haven Hospital

location_facility: Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: The Ottawa Hospital Regional Cancer Centre

location_facility: Chattanooga Oncology and Hematology Associates

location_facility: University of California Davis Medical Center

location_facility: Washington University School of Medicine

location_facility: R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa

location_facility: Institut de Cancérologie de l'Ouest - René Gauducheau

location_facility: Saint Petersburg City Oncological Dispensary

location_facility: Semmelweis Egyetem Általános Orvostudományi Kar

location_facility: Volgograd Regional Oncological Dispensary

location_facility: Clatterbridge Centre for Oncology NHS Foundation Trust

location_facility: Urology Cancer Center and GU Research Network


title: Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak

acronym: CLIECO

summary: In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. In children, reduced physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person contact with peers, poor or inadequate understanding of health risks may be risk factors of anxiety, stress, fatigue, sleep disorders (Brooks et al, 2020; Wang et al, 2020; Sprang et al, 2013). These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.) (Cluver et al, 2020; Liu et al, 2020).

lead_sponsor: University Hospital, Toulouse

location_facility:
Maison de Solenn (Hôpital Cochin AP-HP)
Centre Hospitalier de Versailles
Centre Hospitalier Esquirol
University hospital of Toulouse
Hôpital Robert-Debré (AP-HP)


title: Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock

acronym: APROCCHS

summary: This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock

ReferenceCitation: Annane D, Buisson CB, Cariou A, Martin C, Misset B, Renault A, Lehmann B, Millul V, Maxime V, Bellissant E; APROCCHSS Investigators for the TRIGGERSEP Network. Design and conduct of the activated protein C and corticosteroids for human septic shock (APROCCHSS) trial. Ann Intensive Care. 2016 Dec;6(1):43. doi: 10.1186/s13613-016-0147-3. Epub 2016 May 6. Erratum in: Ann Intensive Care. 2016 Dec;6(1):79.

ReferenceType: result

ReferenceCitation: Annane D, Timsit JF, Megarbane B, Martin C, Misset B, Mourvillier B, Siami S, Chagnon JL, Constantin JM, Petitpas F, Souweine B, Amathieu R, Forceville X, Charpentier C, Tesnière A, Chastre J, Bohe J, Colin G, Cariou A, Renault A, Brun-Buisson C, Bellissant E; APROCCHSS Trial Investigators. Recombinant human activated protein C for adults with septic shock: a randomized controlled trial. Am J Respir Crit Care Med. 2013 May 15;187(10):1091-7. doi: 10.1164/rccm.201211-2020OC.

family: Annane

full_name: Djillali Annane

given: Djillali

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

family: Megarbane

full_name: Bruno Megarbane

given: Bruno

family: Martin

full_name: Claude Martin

given: Claude

family: Misset

full_name: Benoit Misset

given: Benoit

family: Mourvillier

full_name: Bruno Mourvillier

family: Siami

full_name: Shidasp Siami

given: Shidasp

family: Chagnon

full_name: Jean-Luc Chagnon

given: Jean-Luc

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Petitpas

full_name: Franck Petitpas

given: Franck

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

family: Amathieu

full_name: Roland Amathieu

given: Roland

family: Forceville

full_name: Xavier Forceville

given: Xavier

family: Charpentier

full_name: Claire Charpentier

given: Claire

family: Tesnière

full_name: Antoine Tesnière

given: Antoine

family: Chastre

full_name: Jean Chastre

given: Jean

family: Bohe

full_name: Julien Bohe

given: Julien

family: Colin

full_name: Gwenhael Colin

given: Gwenhael

family: Cariou

full_name: Alain Cariou

given: Alain

family: Renault

full_name: Alain Renault

family: Brun-Buisson

full_name: Christian Brun-Buisson

given: Christian

family: Bellissant

full_name: Eric Bellissant

given: Eric

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Recombinant Human Activated Protein C for Adults with Septic Shock. A Randomized Controlled Trial

ReferenceCitation: Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, François B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohé J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.

name: From Service de Médecine Intensive et Réanimation, Hôpital Raymond Poincaré, Garches (D.A., V.M.), Laboratory of Infection and Inflammation Unité 1173, University of Versailles Saint-Quentin-en-Yvelines, INSERM, Montigny-le-Bretonneux (D.A.), Service de Pharmacologie Clinique–Centre d’Investigation Clinique (CIC) INSERM 1414, Centre Hospitalier Universitaire (CHU) de Rennes–Université de Rennes 1, Hôpital Pontchaillou, Rennes (A.R., E.B.), Service de Réanimation Médicale (C.B.-B.) and Service...

location_facility:
Pitié Salpêtrière Hospital
Henri Mondor Hospital
Saint Josef Hospital
Raymond Poincaré Hospital


title: French Multicentre Observational Study of a Prospective Cohort of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)

acronym: OPALE

summary:
Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up at one year.

Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-transplantation).

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma S.A.S.


title: A Cohort Study in Liver Transplant Patients Converted From a Tacrolimus Twice a Day (Prograf®) to Tacrolimus Once a Day (Advagraf®). French, Multisite, Observational Study

acronym: COBALT

summary: A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year after transplantation.


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multi-Center Study Evaluating the Efficacy and Safety of Four Doses of SR147778 in Obese Patients

summary: The purpose of this study is to assess the effect of SR147778 on weight loss over a period of 24 weeks when prescribed with a hypocaloric diet in obese patients. The secondary objective is to assess the safety and tolerability of SR147778 and to assess the effect of SR147778 on several secondary parameters (such as waist, metabolic parameters) over a period of 24 weeks when prescribed with a hypocaloric diet in obese patients.

lead_sponsor: Sanofi

location_country: Finland France Argentina Australia Spain

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: Randomised, Multicentre, Double-blind, Placebo-controlled Study to Assess the Safety, Efficacy and Pharmacodynamics After the Intravenous Administration of CAL02 in Severe Community-acquired Pneumonia Due to Streptococcus Pneumoniae

summary: The objectives of this study are to assess the safety, tolerability, clinical and microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused by Streptococcus pneumoniae after the intravenous administration of CAL02 in addition of standard of care antibiotic treatment.

ReferenceCitation: Laterre PF, Colin G, Dequin PF, Dugernier T, Boulain T, Azeredo da Silveira S, Lajaunias F, Perez A, François B. CAL02, a novel antitoxin liposomal agent, in severe pneumococcal pneumonia: a first-in-human, double-blind, placebo-controlled, randomised trial. Lancet Infect Dis. 2019 Jun;19(6):620-630. doi: 10.1016/S1473-3099(18)30805-3. Epub 2019 May 2.

family: Laterre

full_name: Pierre-François Laterre

given: Pierre-François

family: Dequin

full_name: Pierre-François Dequin

family: Dugernier

full_name: Thierry Dugernier

given: Thierry

family: Boulain

full_name: Thierry Boulain

family: Azeredo da Silveira

full_name: Samareh Azeredo da Silveira

given: Samareh

family: Lajaunias

full_name: Frédéric Lajaunias

given: Frédéric

family: Perez

full_name: Antonio Perez

given: Antonio

family: François

full_name: Bruno François

given: Bruno

journal_name: The Lancet Infectious Diseases

lead_sponsor: Combioxin SA

location_country: Belgium France

location_facility:
Clinique St Pierre
CHD Les Oudairies
CH Yves Le Foll
CHU Dupuytren
CHU Jean Minjoz
Hôpital Mignot
University Hospital Brussels
St Luc University Hospital
CHRU de Tours
Centre Hospitalier Régional d'ORLEANS


title: Molecular Targets for the Treatment of Histiocytosis

acronym: TARGET-HISTIO

summary:
The primary objective: to develop technical and operating procedures for detection mutations of histiocytosis during clinical practice of no-specialized molecular platforms, for diagnosis and follow-up of the disease.

The secondary objectives: to describe therapeutic target mutations in histiocytosis patients, and to develop the cellular tests to evaluate in vitro the sensibility of these mutations drive to inhibitors.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility: Biological research center, Ambroise Paré hospital, APHP

location_facility: Department of Pediatrics, Trousseau hospital, APHP

location_facility: Department of internal Medicine, Pitié-Salpétrière hospital, APHP


title: Definition for the Assessment of Time-to-event Endpoints in CANcer Trials (DATECAN-1) : Formal Consensus Method for the Development of Guidelines for Standardized Time-to-event Endpoints' Definitions in Cancer Clinical Trials

summary:
In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients. However, while these endpoints are frequently used, they are often poorly defined and definitions can differ between trials which may limit their use as primary endpoints. Moreover, this variability of definitions can impact on the trial's results by affecting estimation of treatments' effects. The aim of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project is to provide recommendations for standardised definitions of time-to-event endpoints in randomised cancer clinical trials.

We will use a formal consensus methodology based on experts' opinions which will be obtained in a systematic manner.

Definitions will be independently developed for several cancer sites, including pancreatic, breast, head and neck and colon cancer, as well as sarcomas and gastrointestinal stromal tumours (GISTs).

The DATECAN project should lead to the elaboration of recommendations that can then be used as guidelines by researchers participating in clinical trials. This process should lead to a standardisation of the definitions of commonly used time-to-event endpoints, enabling appropriate comparisons of future trials' results.

time_perspective: Other

ReferenceCitation: Bellera CA, Penel N, Ouali M, Bonvalot S, Casali PG, Nielsen OS, Delannes M, Litière S, Bonnetain F, Dabakuyo TS, Benjamin RS, Blay JY, Bui BN, Collin F, Delaney TF, Duffaud F, Filleron T, Fiore M, Gelderblom H, George S, Grimer R, Grosclaude P, Gronchi A, Haas R, Hohenberger P, Issels R, Italiano A, Jooste V, Krarup-Hansen A, Le Péchoux C, Mussi C, Oberlin O, Patel S, Piperno-Neumann S, Raut C, Ray-Coquard I, Rutkowski P, Schuetze S, Sleijfer S, Stoeckle E, Van Glabbeke M, Woll P, Gourgou-Bourgade S, Mathoulin-Pélissier S. Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†. Ann Oncol. 2015 May;26(5):865-872. doi: 10.1093/annonc/mdu360. Epub 2014 Jul 28. Review.

family: Bellera

full_name: C.A. Bellera

family: Penel

full_name: N. Penel

given: N.

family: Ouali

full_name: M. Ouali

given: M.

family: Bonvalot

full_name: S. Bonvalot

given: S.

family: Casali

full_name: P.G. Casali

family: Nielsen

full_name: O.S. Nielsen

family: Delannes

full_name: M. Delannes

family: Litière

full_name: S. Litière

family: Bonnetain

full_name: F. Bonnetain

given: F.

family: Dabakuyo

full_name: T.S. Dabakuyo

family: Benjamin

full_name: R.S. Benjamin

family: Blay

full_name: J.-Y. Blay

family: Bui

full_name: B.N. Bui

family: Collin

full_name: F. Collin

family: Delaney

full_name: T.F. Delaney

family: Duffaud

full_name: F. Duffaud

family: Filleron

full_name: T. Filleron

given: T.

family: Fiore

full_name: M. Fiore

family: Gelderblom

full_name: H. Gelderblom

given: H.

family: George

full_name: S. George

family: Grimer

full_name: R. Grimer

given: R.

family: Grosclaude

full_name: P. Grosclaude

given: P.

family: Gronchi

full_name: A. Gronchi

given: A.

family: Haas

full_name: R. Haas

family: Hohenberger

full_name: P. Hohenberger

family: Issels

full_name: R. Issels

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

ReferenceCitation: Bonnetain F, Bonsing B, Conroy T, Dousseau A, Glimelius B, Haustermans K, Lacaine F, Van Laethem JL, Aparicio T, Aust D, Bassi C, Berger V, Chamorey E, Chibaudel B, Dahan L, De Gramont A, Delpero JR, Dervenis C, Ducreux M, Gal J, Gerber E, Ghaneh P, Hammel P, Hendlisz A, Jooste V, Labianca R, Latouche A, Lutz M, Macarulla T, Malka D, Mauer M, Mitry E, Neoptolemos J, Pessaux P, Sauvanet A, Tabernero J, Taieb J, van Tienhoven G, Gourgou-Bourgade S, Bellera C, Mathoulin-Pélissier S, Collette L. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials). Eur J Cancer. 2014 Nov;50(17):2983-93. doi: 10.1016/j.ejca.2014.07.011. Epub 2014 Sep 22. Review.

ReferenceCitation: Bellera CA, Pulido M, Gourgou S, Collette L, Doussau A, Kramar A, Dabakuyo TS, Ouali M, Auperin A, Filleron T, Fortpied C, Le Tourneau C, Paoletti X, Mauer M, Mathoulin-Pélissier S, Bonnetain F. Protocol of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project: formal consensus method for the development of guidelines for standardised time-to-event endpoints' definitions in cancer clinical trials. Eur J Cancer. 2013 Mar;49(4):769-81. doi: 10.1016/j.ejca.2012.09.035. Epub 2012 Nov 2.

title: Protocol of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project: Formal consensus method for the development of guidelines for standardised time-to-event endpoints’ definitions in cancer clinical trials

ReferenceCitation: Gourgou-Bourgade S, Cameron D, Poortmans P, Asselain B, Azria D, Cardoso F, A'Hern R, Bliss J, Bogaerts J, Bonnefoi H, Brain E, Cardoso MJ, Chibaudel B, Coleman R, Cufer T, Dal Lago L, Dalenc F, De Azambuja E, Debled M, Delaloge S, Filleron T, Gligorov J, Gutowski M, Jacot W, Kirkove C, MacGrogan G, Michiels S, Negreiros I, Offersen BV, Penault Llorca F, Pruneri G, Roche H, Russell NS, Schmitt F, Servent V, Thürlimann B, Untch M, van der Hage JA, van Tienhoven G, Wildiers H, Yarnold J, Bonnetain F, Mathoulin-Pélissier S, Bellera C, Dabakuyo-Yonli TS. Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials). Ann Oncol. 2015 Dec;26(12):2505-6. doi: 10.1093/annonc/mdv478. Epub 2015 Oct 13.

ReferenceCitation: Kramar A, Negrier S, Sylvester R, Joniau S, Mulders P, Powles T, Bex A, Bonnetain F, Bossi A, Bracarda S, Bukowski R, Catto J, Choueiri TK, Crabb S, Eisen T, El Demery M, Fitzpatrick J, Flamand V, Goebell PJ, Gravis G, Houédé N, Jacqmin D, Kaplan R, Malavaud B, Massard C, Melichar B, Mourey L, Nathan P, Pasquier D, Porta C, Pouessel D, Quinn D, Ravaud A, Rolland F, Schmidinger M, Tombal B, Tosi D, Vauleon E, Volpe A, Wolter P, Escudier B, Filleron T; DATECAN Renal Cancer group. Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project†. Ann Oncol. 2015 Dec;26(12):2392-8. doi: 10.1093/annonc/mdv380. Epub 2015 Sep 14. Review.

repository_institution: University College London - UCL Discovery

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

ReferenceCitation: Cohen R, Vernerey D, Bellera C, Meurisse A, Henriques J, Paoletti X, Rousseau B, Alberts S, Aparicio T, Boukovinas I, Gill S, Goldberg RM, Grothey A, Hamaguchi T, Iveson T, Kerr R, Labianca R, Lonardi S, Meyerhardt J, Paul J, Punt CJA, Saltz L, Saunders MP, Schmoll HJ, Shah M, Sobrero A, Souglakos I, Taieb J, Takashima A, Wagner AD, Ychou M, Bonnetain F, Gourgou S, Yoshino T, Yothers G, de Gramont A, Shi Q, André T; ACCENT Group. Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative. Eur J Cancer. 2020 May;130:63-71. doi: 10.1016/j.ejca.2020.02.009. Epub 2020 Mar 12.

location_facility:
Institut Bergonié
Institut du Cancer de Montpellier
Centre Georges François Leclerc


title: Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise

acronym: CARDIBOX

summary: The high prevalence of childhood obesity is a major public health issue, worldwide. Childhood obesity is associated with a high risk of cardiovascular events in adulthood, but recent studies also point out the development of cardiovascular complications in childhood or adolescence justifying the need for early detection and appropriate therapeutic management to prevent the development of more severe abnormalities. This project proposes to evaluate the myocardial function in a fine and comprehensive way (longitudinal, circumferential and radial linear deformations, and rotation / torsion mechanics) from the deformation imaging (MRI and high-resolution echocardiography), in obese adolescents following a lifestyle intervention combining diet and physical activity.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Efficacy and Safety of Clobetasol Propionate Shampoo 0.05% Used in Association With an Antifungal Shampoo in the Treatment of Moderate to Severe Scalp Seborrheic Dermatitis

acronym: Escape

summary: The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.

ReferenceCitation: Ortonne JP, Nikkels AF, Reich K, Ponce Olivera RM, Lee JH, Kerrouche N, Sidou F, Faergemann J. Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study. Br J Dermatol. 2011 Jul;165(1):171-6. doi: 10.1111/j.1365-2133.2011.10269.x.

family: Ortonne

full_name: J.-P. Ortonne

family: Nikkels

full_name: A.F. Nikkels

family: Reich

full_name: K. Reich

given: K.

family: Ponce Olivera

full_name: R.M. Ponce Olivera

family: Lee

full_name: J.H. Lee

family: Kerrouche

full_name: N. Kerrouche

family: Sidou

full_name: F. Sidou

family: Faergemann

full_name: J. Faergemann

given: J.

journal_name: British Journal of Dermatology

lead_sponsor: Galderma R&D

location_country:
Mexico
France
Belgium
Germany
Korea, Republic of


title: Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness

summary: This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.

lead_sponsor: Theranexus

location_country:
United States
France
Czechia
Hungary
Germany

location_facility: MGH Neurological Clinical Research Institute

location_facility: Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály

location_facility: Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West, *ausgelagerte Praxisräume:

location_facility: Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály

location_facility: Neurologická klinika 1.LF UK a VFN v Praze

location_facility: Neurologische Praxis Dipl. med. Christian Oehlwein

location_facility: Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika

location_facility: Praxis Dr. Safavi, Neuroakademie Alzenau

location_facility: CHU de la Timone Service de Neuro et pathologie du mouvement

location_facility: Neurologické oddělení Nemocnice Na Homolce

location_facility: Neurologická klinika Fakultní nemocnice Hradec Králové

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház, Stroke, Vascularis és Általános Neurológiai és Toxikológiai Osztály

location_facility: Technische Universität München, Klinikum rechts der Isar, Neurologische Klinik und Poliklinik, Neuro-Kopf-Zentrum

location_facility: Neurologická klinika Fakultní nemocnice Ostrava

location_facility: ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière

location_facility: I. neurologická klinika Fakultní nemocnice u sv. Anny

location_facility: Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin