title: A Phase I, Dose-escalation Study of a Combination AS703569 and Gemcitabine Given to Subjects With Advanced Malignancies

summary: In clinical practice and research, combination of anticancer agents is often used to improve efficacy of treatment. In vitro and in vivo experiments have shown additive-synergistic anti-tumour effects of AS703569 treatment when combined with gemcitabine. Specifically, additive-synergistic anti-tumour effects were noticed when the two agents were given sequentially and not concomitantly i.e. AS703569 given the day before or the day after gemcitabine. This trial was designed to investigate in parallel two regimens testing sequential administration of AS703569 either the day after gemcitabine infusion, (Regimen 1) or the day before (Regimen 2).

ReferenceCitation: Raymond E, Alexandre J, Faivre S, Goldwasser F, Besse-Hammer T, Gianella-Borradori A, Jego V, Trandafir L, Rejeb N, Awada A. A phase I schedule dependency study of the aurora kinase inhibitor MSC1992371A in combination with gemcitabine in patients with solid tumors. Invest New Drugs. 2014 Feb;32(1):94-103. doi: 10.1007/s10637-013-9950-y. Epub 2013 Mar 29.

family: Raymond

full_name: E. Raymond

given: E.

family: Alexandre

full_name: J. Alexandre

given: J.

family: Faivre

full_name: S. Faivre

given: S.

family: Goldwasser

full_name: F. Goldwasser

given: F.

family: Besse-Hammer

full_name: T. Besse-Hammer

given: T.

family: Gianella-Borradori

full_name: A. Gianella-Borradori

given: A.

family: Jego

full_name: V. Jego

given: V.

family: Trandafir

full_name: L. Trandafir

given: L.

family: Rejeb

full_name: N. Rejeb

given: N.

family: Awada

full_name: A. Awada

journal_name: Investigational New Drugs

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_facility: Service Inter-Hospitalier de Canderologie Bichat-Beaujon (SIHC) Hopital Beaujon

location_facility: Unite d'Oncologie Medicale Hopital COCHIN


title: A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence

summary: A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication. This study is not designed to statistically demonstrate safety and efficacy of the device.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Publications on study data currently in draft by physicians.

lead_sponsor: Boston Scientific Corporation

location_country: Belgium France

location_facility:
Clinique Jules Verne
Universitaire Ziekenhuisen Leuven
Hopital Edouard Herriot

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of Single Oral Doses of NSA-789 on Auditory P50 Suppression in Nonsmoking Patients With Stabilized Schizophrenia

summary: The purpose of this study is to evaluate the effect of single doses of NSA-789 on the P50 component of the auditory evoked potentials and to assess the safety, tolerability and the concentration of NSA-789 in the blood, in nonsmoking patients with schizophrenia.

study_start_date_type: Anticipated

status: Withdrawn

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
United States
France

intervention_type: Drug

status_simplified: Unknown


title: Observational Study on the Systemic Inflammatory Response During Brain Death.

summary: We hypothesized that brain death is associated with an early systemic inflammatory response, possibly combined with activation of apoptotic cell death, two events that may contribute to induce rapid organ dysfunction. In this study of brain-dead donors and controls, we assayed plasma cytokines and soluble factors, investigated plasma endotoxin levels as a triggering factor for inflammation, measured ex vivo cytokine production by blood leukocytes to determine whether immunosuppression occurred after brain death, and examined skeletal muscle biopsies to look for evidence of inflammation and increased apoptosis in peripheral tissue.

study_type: Observational

lead_sponsor: Delafontaine Hospital

location_facility:
Delafontaine Hospital
Tenon Hospital
Liege Hospital

intervention_type: Procedure

lead_sponsor_type: academique


title: A Descriptive Pharmaco-epidemiological Study of a Hypertensive Patient Population Treated With a Fixed-dose Combination of Telmisartan 80 mg and Hydrochlorothiazide 25 mg and of Conditions for the Management of Arterial Hypertension

summary: It is a national, retrospective , observational study in hypertensive patients treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg. The primary objective is to assess the control rate (systolic and diastolic blood pressure). Key secondary objectives are to assess the blood pressure reduction after at least 8 weeks of treatment, describe the population treated with this new fixed dose combination

time_perspective: Retrospective

lead_sponsor: Boehringer Ingelheim

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location_facility: Boehringer Ingelheim Investigator site 58


title: A Mirror Assessment of the Words Used By Patients and Physicians to Express Asthma Symptoms, According To the Patient's Level of Asthma Control In General Medicine

acronym: SYMPTOMES

summary: To evaluate the concordance of the most frequently used words by the patients and the physicians to express asthma symptoms, according to the patient's level of asthma control.

time_perspective: Cross-Sectional

lead_sponsor: AstraZeneca


title: A European Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Enzalutamide Treatment in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

acronym: PREMISE

summary: The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.

study_start_date_type: Actual

time_perspective: Prospective

ipd_sharing: No

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 Europe Ltd.

location_country:
Italy
Austria
United Kingdom
Netherlands
Spain
France
Czechia
Bulgaria
Greece
Hungary
Belgium
Ireland
Portugal
Denmark
Germany
Slovenia

location_facility:
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title: Intermittent Positive-Pressure Breathing Effects in Patients With High Spinal Cord Injury

summary:
Background: To determine whether intermittent positive-pressure breathing (IPPB) improved lung compliance, work of breathing, and respiratory function in patients with recent high spinal cord injury (SCI).

Methods: Two months of IPPB and two months of conventional treatment have to evaluated prospectively in random order in 14 patients with SCI. Noninvasive lung function tests and arterial blood gas measurements have to be obtained repeatedly. Repeated measurements of dynamic compliance and work of breathing have to be performed in 7 of the 14 patients.

status: Terminated

ReferenceType: background

ReferenceCitation: McCool FD, Mayewski RF, Shayne DS, Gibson CJ, Griggs RC, Hyde RW. Intermittent positive pressure breathing in patients with respiratory muscle weakness. Alterations in total respiratory system compliance. Chest. 1986 Oct;90(4):546-52.

ReferenceCitation: Trebbia G, Lacombe M, Fermanian C, Falaize L, Lejaille M, Louis A, Devaux C, Raphaël JC, Lofaso F. Cough determinants in patients with neuromuscular disease. Respir Physiol Neurobiol. 2005 Apr 15;146(2-3):291-300.

ReferenceType: derived

ReferenceCitation: Laffont I, Bensmail D, Lortat-Jacob S, Falaize L, Hutin C, Le Bomin E, Ruquet M, Denys P, Lofaso F. Intermittent positive-pressure breathing effects in patients with high spinal cord injury. Arch Phys Med Rehabil. 2008 Aug;89(8):1575-9. doi: 10.1016/j.apmr.2007.12.037. Epub 2008 Jul 7.

family: Laffont

full_name: Isabelle Laffont

given: Isabelle

sequence: first

family: Bensmail

full_name: Djamel Bensmail

given: Djamel

sequence: additional

family: Lortat-Jacob

full_name: Sylvie Lortat-Jacob

given: Sylvie

family: Falaize

full_name: Line Falaize

given: Line

family: Hutin

full_name: Claudette Hutin

given: Claudette

family: Le Bomin

full_name: Elisabeth Le Bomin

given: Elisabeth

family: Ruquet

full_name: Maria Ruquet

given: Maria

family: Denys

full_name: Pierre Denys

given: Pierre

family: Lofaso

full_name: Frédéric Lofaso

given: Frédéric

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Archives of Physical Medicine and Rehabilitation

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University of Versailles

location_facility: Innovation Technological Center-Hôpital R. Poincaré


title: Characterisation of Macrophage Infiltration in Obesity and Its Complications

summary: Quantification of macrophage infiltration and characterization of macrophage phenotype in adipose tissue of 60 obese subjects and 20 non obese subjects

ReferenceCitation: Sell H, Poitou C, Habich C, Bouillot JL, Eckel J, Clément K. Heat Shock Protein 60 in Obesity: Effect of Bariatric Surgery and its Relation to Inflammation and Cardiovascular Risk. Obesity (Silver Spring). 2017 Dec;25(12):2108-2114. doi: 10.1002/oby.22014. Epub 2017 Oct 11.

name: Paul-Langerhaus-Group Integrative Physiology, German Diabetes Center; Düsseldorf Germany

family: Sell

full_name: Henrike Sell

given: Henrike

name: INSERM, U1166, team 6 Nutriomique, Université Pierre et Marie Curie-Paris 6; Paris France

name: Institute of Cardiometabolism and Nutrition (ICAN), Assistance Publique-Hôpitaux de Paris, Pitié-Salpêtrière Hospital, Nutrition Department; Paris France

family: Poitou

full_name: Christine Poitou

given: Christine

name: Institute for Clinical Diabetology, German Diabetes Center; Düsseldorf Germany

family: Habich

full_name: Christiane Habich

given: Christiane

name: Assistance Publique-Hôpitaux de Paris, Hôtel-Dieu Hospital, Surgery Department; Paris France

family: Bouillot

full_name: Jean-Luc Bouillot

given: Jean-Luc

family: Eckel

full_name: Jürgen Eckel

given: Jürgen

family: Clément

full_name: Karine Clément

given: Karine

journal_name: Obesity

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Reggio S, Rouault C, Poitou C, Bichet JC, Prifti E, Bouillot JL, Rizkalla S, Lacasa D, Tordjman J, Clément K. Increased Basement Membrane Components in Adipose Tissue During Obesity: Links With TGFβ and Metabolic Phenotypes. J Clin Endocrinol Metab. 2016 Jun;101(6):2578-87. doi: 10.1210/jc.2015-4304. Epub 2016 Apr 6.

family: Reggio

full_name: Sophie Reggio

given: Sophie

family: Rouault

full_name: Christine Rouault

family: Bichet

full_name: Jean-Christophe Bichet

given: Jean-Christophe

family: Prifti

full_name: Edi Prifti

given: Edi

family: Rizkalla

full_name: Salwa Rizkalla

given: Salwa

family: Lacasa

full_name: Danièle Lacasa

given: Danièle

family: Tordjman

full_name: Joan Tordjman

given: Joan

journal_name: The Journal of Clinical Endocrinology & Metabolism

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

version: publishedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

ReferenceCitation: Poitou C, Dalmas E, Renovato M, Benhamo V, Hajduch F, Abdennour M, Kahn JF, Veyrie N, Rizkalla S, Fridman WH, Sautès-Fridman C, Clément K, Cremer I. CD14dimCD16+ and CD14+CD16+ monocytes in obesity and during weight loss: relationships with fat mass and subclinical atherosclerosis. Arterioscler Thromb Vasc Biol. 2011 Oct;31(10):2322-30. doi: 10.1161/ATVBAHA.111.230979. Epub 2011 Jul 28.

name: From the Institut National de la Santé et de la Recherche Médicale, U872, Team 7 Nutriomique and Team 13, Cordeliers Research Center, Paris, France (C.P., E.D., M.R., V.B., F.H., N.V., S.R., W.H.F., C.S.-F., K.C., I.C., M.A.); Université Pierre et Marie Curie-Paris 6, UMR S 872, Paris, France (C.P., E.D., M.R., V.B., F.H., N.V., S.R., W.H.F., C.S.-F., K.C., I.C., M.A.); Université Paris Descartes, UMR S 872, Paris, France (C.P., E.D., M.R., V.B., F.H., N.V., S.R., W.H.F., C.S.-F., K.C., I.C.);...

journal_name: Arteriosclerosis, Thrombosis, and Vascular Biology

publisher: Ovid Technologies (Wolters Kluwer Health)

title: CD14 dim CD16 + and CD14 + CD16 + Monocytes in Obesity and During Weight Loss

ReferenceCitation: Dalmas E, Rouault C, Abdennour M, Rovere C, Rizkalla S, Bar-Hen A, Nahon JL, Bouillot JL, Guerre-Millo M, Clément K, Poitou C. Variations in circulating inflammatory factors are related to changes in calorie and carbohydrate intakes early in the course of surgery-induced weight reduction. Am J Clin Nutr. 2011 Aug;94(2):450-8. doi: 10.3945/ajcn.111.013771. Epub 2011 Jun 15.

journal_name: The American Journal of Clinical Nutrition


title: Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children.

summary:
Primary objective:

to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for MAXOMAT®, in children, for 1 year.

design_allocation: Non-Randomized

lead_sponsor: Sanofi


type: EudraCT Number

title: A 48-week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-arm Parallel Group Clinical Study of "Fixed Combination" Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus "Fixed Combination" Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease (COPD)

summary: To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.

ReferenceCitation: Singh D, Corradi M, Spinola M, Petruzzelli S, Papi A. Extrafine beclometasone diproprionate/formoterol fumarate: a review of its effects in chronic obstructive pulmonary disease. NPJ Prim Care Respir Med. 2016 Jun 16;26:16030. doi: 10.1038/npjpcrm.2016.30. Review.

ReferenceType: result

ReferenceCitation: Calverley PM, Kuna P, Monsó E, Costantini M, Petruzzelli S, Sergio F, Varoli G, Papi A, Brusasco V. Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. Respir Med. 2010 Dec;104(12):1858-68. doi: 10.1016/j.rmed.2010.09.008. Epub 2010 Oct 20.

family: Calverley

full_name: P.M.A. Calverley

family: Kuna

full_name: P. Kuna

given: P.

family: Monsó

full_name: E. Monsó

given: E.

family: Costantini

full_name: M. Costantini

given: M.

family: Petruzzelli

full_name: S. Petruzzelli

given: S.

family: Sergio

full_name: F. Sergio

given: F.

family: Varoli

full_name: G. Varoli

given: G.

family: Papi

full_name: A. Papi

given: A.

family: Brusasco

full_name: V. Brusasco

given: V.

journal_name: Respiratory Medicine

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Beclomethasone/formoterol in the management of COPD: A randomised controlled trial

ipd_sharing_description:
Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

lead_sponsor: Chiesi Farmaceutici S.p.A.


ReferenceCitation: Seymour JF, Döhner H, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Récher C, Sandhu I, Del Castillo TB, Al-Ali HK, Falantes J, Stone RM, Minden MD, Weaver J, Songer S, Beach CL, Dombret H. Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens. BMC Cancer. 2017 Dec 14;17(1):852. doi: 10.1186/s12885-017-3803-6.

family: Seymour

full_name: John F. Seymour

given: John F.

family: Döhner

full_name: Hartmut Döhner

given: Hartmut

family: Butrym

full_name: Aleksandra Butrym

given: Aleksandra

family: Wierzbowska

full_name: Agnieszka Wierzbowska

given: Agnieszka

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

family: Jang

full_name: Jun Ho Jang

given: Jun Ho

family: Kumar

full_name: Rajat Kumar

given: Rajat

family: Cavenagh

full_name: James Cavenagh

given: James

family: Schuh

full_name: Andre C. Schuh

given: Andre C.

family: Candoni

full_name: Anna Candoni

given: Anna

family: Récher

full_name: Christian Récher

given: Christian

family: Sandhu

full_name: Irwindeep Sandhu

given: Irwindeep

family: del Castillo

full_name: Teresa Bernal del Castillo

given: Teresa Bernal

family: Al-Ali

full_name: Haifa Kathrin Al-Ali

given: Haifa Kathrin

family: Falantes

full_name: Jose Falantes

given: Jose

family: Stone

full_name: Richard M. Stone

given: Richard M.

family: Minden

full_name: Mark D. Minden

given: Mark D.

family: Weaver

full_name: Jerry Weaver

given: Jerry

family: Songer

full_name: Steve Songer

given: Steve

family: Beach

full_name: C. L. Beach

given: C. L.

family: Dombret

full_name: Hervé Dombret

given: Hervé

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_normalized: University of Melbourne - Minerva Access

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

repository_institution: Spanish National Research Council (CSIC) - DIGITAL.CSIC

ReferenceCitation: Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Récher C, Sandhu I, Bernal del Castillo T, Al-Ali HK, Martinelli G, Falantes J, Noppeney R, Stone RM, Minden MD, McIntyre H, Songer S, Lucy LM, Beach CL, Döhner H. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18.

name: Hôpital Saint Louis, Institut Universitaire d’Hématologie, University Paris Diderot, Paris, France;

name: Peter MacCallum Cancer Centre, East Melbourne, Australia, and University of Melbourne, Parkville, Australia;

name: Wroclaw Medical University, Wroclaw, Poland;

name: Medical University of Lodz, Lodz, Poland;

name: Algemeen Ziekenhuis Sint-Jan, Brugge, Belgium;

name: Samsung Medical Center, Seoul, Republic of Korea;

name: Barts Health National Health Service Trust, London, United Kingdom;

name: Princess Margaret Cancer Centre, Toronto, Canada;

name: Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Udine, Italy;

name: Centre Hospitalier Universitaire de Toulouse, Toulouse, France;

name: University of Alberta Hospital, Edmonton, Canada;

name: Hospital Central de Asturias, Oviedo, Spain;

name: Universitätsklinikum Leipzig, Leipzig, Germany;

name: Institute of Hematology and Medical Oncology “L. e A. Seràgnoli,” Bologna, Italy;

name: Hospital Universitario Virgen del Rocio/Instituto de BioMedicinia de Sevilla, Sevilla, Spain;

name: Universitätsklinikum Essen Klinik für Hämatologie, Essen, Germany;

name: Dana-Farber Cancer Institute, Boston, MA;

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

location_country:
Italy
Austria
United States
Netherlands
Spain
Germany
France
Czechia
Poland
Israel
Australia
Belgium
Russian Federation
China
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie

location_facility: Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud

location_facility: Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre

location_facility: Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Centre Hospitalier Universitaire Nantes, Hotel Dieu

location_facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Azienda Ospedaliera Sant'Orsola Malpighi

location_facility: Azienda Sanitaria Ospedaliera "San Luigi Gonzaga"

location_facility: Centre Hopitalier Universitaire Dupuytren

location_facility: Hospital Avicenne, Service d'hematologie Clinique

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: University of Rostock, Div. of Haematology and Oncology

location_facility: Taipei Veterans General Hospital Pei-Tou District

location_facility: Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot

location_facility: Fakultni nemocnice Olomouc, hemato-onkologicka klinika

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Centre Hospitalier de l'Université de Montréal pavilion Notre Dame

location_facility: City Clinical Hospital n.a. S. P. Botkin

location_facility: State Healthcare Institution "Nizhny Novgorod N.A. Semashko Regional Clinical Hospital"

location_facility: Chaim Sheba Medical Center - Tel Hashomer, Heart Institute

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Saint Petersburg State Academician I.P. Pavlov Medical University

location_facility: Shanghai Changhai Hospital,the Second Military Medical University

location_facility: Dolnoslaskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

title: A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

summary: The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.


title: A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma

acronym: ENDEAVOR

summary: The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.

ReferenceCitation: Moreau P, Joshua D, Chng WJ, Palumbo A, Goldschmidt H, Hájek R, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosiñol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Dimopoulos MA. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia. 2017 Jan;31(1):115-122. doi: 10.1038/leu.2016.186. Epub 2016 Jul 4.

ReferenceCitation: Chng WJ, Goldschmidt H, Dimopoulos MA, Moreau P, Joshua D, Palumbo A, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosiñol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Feng S, Aggarwal S, Hájek R. Carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR. Leukemia. 2017 Jun;31(6):1368-1374. doi: 10.1038/leu.2016.390. Epub 2016 Dec 27.

ReferenceCitation: Dimopoulos MA, Goldschmidt H, Niesvizky R, Joshua D, Chng WJ, Oriol A, Orlowski RZ, Ludwig H, Facon T, Hajek R, Weisel K, Hungria V, Minuk L, Feng S, Zahlten-Kumeli A, Kimball AS, Moreau P. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1327-1337. doi: 10.1016/S1470-2045(17)30578-8. Epub 2017 Aug 23. Erratum in: Lancet Oncol. 2017 Oct;18(10):e562.

ReferenceCitation: Ludwig H, Dimopoulos MA, Moreau P, Chng WJ, Goldschmidt H, Hájek R, Facon T, Pour L, Niesvizky R, Oriol A, Rosiñol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Palumbo A, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Joshua D. Carfilzomib and dexamethasone vs bortezomib and dexamethasone in patients with relapsed multiple myeloma: results of the phase 3 study ENDEAVOR (NCT01568866) according to age subgroup. Leuk Lymphoma. 2017 Oct;58(10):2501-2504. doi: 10.1080/10428194.2017.1298755. Epub 2017 Mar 17.

ReferenceCitation: Hari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25.

ReferenceCitation: Mateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15.

ReferenceCitation: Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545. Review.

ReferenceCitation: Ludwig H, Moreau P, Dimopoulos MA, Mateos MV, Kaiser M, Hajek R, Feng S, Cocks K, Buchanan J, Weisel K. Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma. Blood Cancer J. 2019 Feb 22;9(3):23. doi: 10.1038/s41408-019-0181-0.

ReferenceCitation: Dimopoulos M, Siegel D, White DJ, Boccia R, Iskander KS, Yang Z, Kimball AS, Mezzi K, Ludwig H, Niesvizky R. Carfilzomib vs bortezomib in patients with multiple myeloma and renal failure: a subgroup analysis of ENDEAVOR. Blood. 2019 Jan 10;133(2):147-155. doi: 10.1182/blood-2018-06-860015. Epub 2018 Nov 26.

ReferenceCitation: Dimopoulos MA, Moreau P, Iida S, Huang SY, Takezako N, Chng WJ, Zahlten-Kumeli A, Sersch MA, Li J, Huang M, Lee JH. Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials. Int J Hematol. 2019 Oct;110(4):466-473. doi: 10.1007/s12185-019-02704-z. Epub 2019 Aug 6.

family: Dimopoulos

full_name: Meletios A. Dimopoulos

given: Meletios A.

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Iida

full_name: Shinsuke Iida

given: Shinsuke

family: Huang

full_name: Shang-Yi Huang

given: Shang-Yi

family: Takezako

full_name: Naoki Takezako

given: Naoki

family: Chng

full_name: Wee Joo Chng

given: Wee Joo

family: Zahlten-Kumeli

full_name: Anita Zahlten-Kumeli

given: Anita

family: Sersch

full_name: Martina A. Sersch

given: Martina A.

family: Li

full_name: Julia Li

given: Julia

full_name: Mei Huang

given: Mei

family: Lee

full_name: Jae Hoon Lee

given: Jae Hoon

journal_name: International Journal of Hematology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Majer IM, Castaigne JG, Palmer S, DeCosta L, Campioni M. Modeling Covariate-Adjusted Survival for Economic Evaluations in Oncology. Pharmacoeconomics. 2019 May;37(5):727-737. doi: 10.1007/s40273-018-0759-6.

family: Majer

full_name: Istvan M. Majer

given: Istvan M.

family: Castaigne

full_name: Jean-Gabriel Castaigne

given: Jean-Gabriel

family: Palmer

full_name: Stephen Palmer

given: Stephen

family: DeCosta

full_name: Lucy DeCosta

given: Lucy

family: Campioni

full_name: Marco Campioni

given: Marco

journal_name: PharmacoEconomics

ReferenceCitation: Rosenthal A, Luthi J, Belohlavek M, Kortüm KM, Mookadam F, Mayo A, Fonseca R, Bergsagel PL, Reeder CB, Mikhael JR, Stewart AK. Carfilzomib and the cardiorenal system in myeloma: an endothelial effect? Blood Cancer J. 2016 Jan 15;6:e384. doi: 10.1038/bcj.2015.112.

ReferenceCitation: Dimopoulos MA, Moreau P, Palumbo A, Joshua D, Pour L, Hájek R, Facon T, Ludwig H, Oriol A, Goldschmidt H, Rosiñol L, Straub J, Suvorov A, Araujo C, Rimashevskaya E, Pika T, Gaidano G, Weisel K, Goranova-Marinova V, Schwarer A, Minuk L, Masszi T, Karamanesht I, Offidani M, Hungria V, Spencer A, Orlowski RZ, Gillenwater HH, Mohamed N, Feng S, Chng WJ; ENDEAVOR Investigators. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016 Jan;17(1):27-38. doi: 10.1016/S1470-2045(15)00464-7. Epub 2015 Dec 5.

repository_institution: University of Turin - Institutional Research Information System University of Turin

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Thailand
Canada
Korea, Republic of
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
New Zealand
Spain

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Municipal Institution of Health Protection "Clinical Hospital #8"

location_facility: MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center

location_facility: Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: National Hospital Organization Nishigunma National Hospital

location_facility: Università Tor Vergata Ospedale Sant Eugenio

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: Military Medical Academy Hospital for Active Treatment

location_facility: Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway

location_facility: GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin

location_facility: Instituto Centros Oncológicos Integrados de Educação e Pesquisa

location_facility: Azienda Ospedaliera Universitaria Maggiore della Carità

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu

location_facility: Specjalistyczny Szpital Miejski im. Mikolaja Kopernika

location_facility: Queen Elizabeth II Health Science Centre

location_facility: Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte

location_facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: Universitätsmedizin der Johannes Gutenberg Universität

location_facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I

location_facility: Azienda Ospedaliera Pisana Ospedale Santa Chiara

location_facility: Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

location_facility: Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy

location_facility: Hopital Hotel-Dieu - Service d'Hematologie

location_facility: The Ottawa Hospital Regional Cancer Centre

location_facility: Wake Forest University Health Sciences, Section on Hematology and Oncology

location_facility: Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia)

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: The Chaim Sheba Medical Center at Tel Hashomer

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

location_facility: Khmelnytsky Regional Hospital, Department of Hematology

location_facility: Medizinische Klinik der Universität Würzburg

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

location_facility: National Institute of Cancer, Oncohematology Department

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Multiprofile Hospital for Active Treatment, "Sveta Marina''

location_facility: Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

location_facility: Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations

location_facility: Egyesített Szent István és Szent László Kórház-Rendelointézet

location_facility: Zamojski Szpital Niepubliczny Sp. z o.o.

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Kobe City Medical Center General Hospital

location_facility: Haematology & Oncology Clinics of Australia

location_facility: First Saint Petersburg I.P. Pavlov State Medical University

location_facility: Irmandade da Santa Casa de Misericórdia de São Paulo

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: The Cancer Institute Hospital Of Japanese Foundation For Cancer Research

location_facility: Haematology and Oncology Clinics of Australia at Wesley

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Haematology and Oncology Clinics of Australia at Chermside

location_facility: Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

location_facility: Hospital Universitari i Politecnic La Fé de Valencia


status: Recruiting

lead_sponsor: Insmed Incorporated

enrollment_type: Anticipated

location_country:
Italy
United States
Chile
Germany
France
Israel
Hungary
Argentina
Australia
New Zealand
Spain
Denmark
Canada
Korea, Republic of
Taiwan

acronym: ENCORE

source: euctr

title: ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

summary: The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + Azithromycin + Ethambutol compared to the ELC (empty liposome control) + Azithromycin + Ethambutol on participant reported respiratory symptoms at Month 13.

status_simplified: Ongoing