title: Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

summary: The goal of this research study is to evaluate the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.

ReferenceCitation: Ballard C, Sauter M, Scheltens P, He Y, Barkhof F, van Straaten EC, van der Flier WM, Hsu C, Wu S, Lane R. Efficacy, safety and tolerability of rivastigmine capsules in patients with probable vascular dementia: the VantagE study. Curr Med Res Opin. 2008 Sep;24(9):2561-74. doi: 10.1185/03007990802328142 . Epub 2008 Jul 31.

name: Wolfson Centre for Age-Related Diseases, King's College, London, UK

family: Ballard

full_name: C. Ballard

given: C.

name: Westmoreland Neurology, Greensburg, Pennsylvania, USA

family: Sauter

full_name: M. Sauter

given: M.

name: Department of Neurology, Radiology and Alzheimer Center, VU University Medical Center, Amsterdam, The Netherlands

family: Scheltens

full_name: P. Scheltens

given: P.

name: Clinical Pharmacogenetics, Novartis Pharmaceuticals Corporation, Cambridge, MA, USA

family: He

full_name: Y. He

given: Y.

name: Department of Radiology and Image Analysis Center, VU University Medical Center, Amsterdam, The Netherlands

family: Barkhof

full_name: F. Barkhof

given: F.

family: van Straaten

full_name: E. C. W. van Straaten

given: E. C. W.

family: van der Flier

full_name: W. M. van der Flier

given: W. M.

name: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA

family: Hsu

full_name: C. Hsu

family: Wu

full_name: S. Wu

given: S.

family: Lane

full_name: R. Lane

given: R.

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

location_country:
Italy
Austria
Switzerland
Germany
France
Russian Federation
Spain
United States
United Kingdom
Canada


title: Open-label Follow-up Study of the VIPES Study to Evaluate Long-term Efficacy and Safety of the Viaskin Peanut

acronym: OLFUS-VIPES

summary:
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are:

To assess the efficacy of Viaskin Peanut after up to 36 months of treatment.
To evaluate the safety of long-term treatment with Viaskin Peanut.
To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lewis MO, Brown-Whitehorn TF, Cianferoni A, Rooney C, Spergel JM. Peanut-allergic patient experiences after epicutaneous immunotherapy: peanut consumption and impact on QoL. Ann Allergy Asthma Immunol. 2019 Jul;123(1):101-103. doi: 10.1016/j.anai.2019.04.006. Epub 2019 Apr 10.

family: Lewis

full_name: Megan O. Lewis

given: Megan O.

sequence: first

family: Brown-Whitehorn

full_name: Terri F. Brown-Whitehorn

given: Terri F.

sequence: additional

family: Cianferoni

full_name: Antonella Cianferoni

given: Antonella

family: Rooney

full_name: Courtney Rooney

given: Courtney

family: Spergel

full_name: Jonathan M. Spergel

given: Jonathan M.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Allergy, Asthma & Immunology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: DBV Technologies

location_country:
United States
Canada
France
Netherlands

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin

location_facility: Ottawa Allergy Asthma Research Institute

location_facility: University of California, Rady Childrens Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Centre de Recherche Appliquée en Asthme et Allergie de Québec

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.

summary: This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

design_allocation: Randomized

ReferenceCitation: Levin NW, Fishbane S, Cañedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D; MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007 Oct 20;370(9596):1415-21. Erratum in: Lancet. 2008 Feb 2;371(9610):386.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Switzerland
France
Norway
Spain
Germany
Canada

intervention_type: Drug


title: An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in Millennium Protocol M34101-039

summary: The purpose of this study is to allow patients to receive VELCADE™ (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.

ReferenceCitation: van Duin M, Broyl A, de Knegt Y, Goldschmidt H, Richardson PG, Hop WC, van der Holt B, Joseph-Pietras D, Mulligan G, Neuwirth R, Sahota SS, Sonneveld P. Cancer testis antigens in newly diagnosed and relapse multiple myeloma: prognostic markers and potential targets for immunotherapy. Haematologica. 2011 Nov;96(11):1662-9. doi: 10.3324/haematol.2010.037978. Epub 2011 Jul 26.

family: van Duin

full_name: M. van Duin

family: Broyl

full_name: A. Broyl

given: A.

family: de Knegt

full_name: Y. de Knegt

family: Goldschmidt

full_name: H. Goldschmidt

given: H.

family: Richardson

full_name: P. G. Richardson

given: P. G.

family: Hop

full_name: W. C. J. Hop

given: W. C. J.

family: van der Holt

full_name: B. van der Holt

given: B.

family: Joseph-Pietras

full_name: D. Joseph-Pietras

given: D.

family: Mulligan

full_name: G. Mulligan

given: G.

family: Neuwirth

full_name: R. Neuwirth

family: Sahota

full_name: S. S. Sahota

given: S. S.

family: Sonneveld

full_name: P. Sonneveld

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: publisher-specific license

license_normalized: publisher-specific

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
France
Israel
Ireland
Belgium
Spain
Canada
United Kingdom

location_facility: Belfast City Hospital, Haematology Department

location_facility: Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie

location_facility: St. Vincent's Comprehensive Cancer Center

location_facility: Texas Oncology at Medical City Dallas Hospital

location_facility: Universitatsklinikum Charite Medizinische Klinik und Poliklinik

location_facility: Azienda Ospedaliera, S. Giovanni Battista

location_facility: Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology

location_facility: University of Erlangen-Nurenberg, Division of Hematology/Oncology

location_facility: University Hospital of Salamanca, Hematology Dept

location_facility: Washington University School of Medicine

location_facility: Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique

location_facility: Uniklinikum Muenster, Medizinische Klinik und Poliklinik A

location_facility: Division of Hematology/Stem Cell Transplant

location_facility: Charlotte Hematology Oncology Associates

location_facility: Medical University Clinic (Oncology/Haematology)

location_facility: Johannes-Gutenberg-University Medical School, Department of Medicine III

location_facility: McGill University Clinical Research Program

location_facility: Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet

location_facility: Lombardi Cancer Center, Georgetown University Medical Center

location_facility: Leeds General Infirmary, Department of Haematology

location_facility: Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1

location_facility: Loyola University Medical Center: Cardinal Bernardin Cancer Center

location_facility: Hospital Clinico Universitario de Barcelona, Hematologia

location_facility: C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie

location_facility: University of Rochester Medical Center, James P. Wilmot Cancer Center

location_facility: Huddinge University Hospital M54, Department of Haematology

location_facility: Weill Medical College of Cornell University, NY Presbyterian Hospital

location_facility: Hackensack University Medical Center, David Jurist Research Building

location_facility: University of Pennsylvania Cancer Center


summary: The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and heparin are drugs that inhibit blood clotting.

status: Withdrawn

lead_sponsor: Schering-Plough

location_country:
United States
Canada
France

location_facility: Vancouver Hospital & Health Sciences Centre

location_facility: Sunnybrook & Women's College Health Sciences Center

location_facility: QE II Health Sciences Centre, New Halifax Infirmary

location_facility: Centre Hospitalier de Lagny-Marne La Vallee

location_facility: University of Chicago - Section of Cardiology

location_facility: University of Michigan, Dept. of Internal Medicine

intervention_type: Procedure

status_simplified: Unknown


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of 10 Mg Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer

summary: This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer.

lead_sponsor: Abbott

location_country:
Italy
Austria
United States
South Africa
Sweden
Switzerland
Netherlands
Germany
France
Poland
Greece
Ireland
Australia
Belgium
New Zealand
Spain
Canada
United Kingdom

location_facility: The University Of North Carolina At Chapel Hill

location_facility: St. Vincent's Medical Center - Staten Island

location_facility: University Of Washington School Of Medicine

location_facility: Klinik Und Poliklinik für Urologie und Kinder

location_facility: Chefarzt Urologische Klinik - Universitätsspital Zürich

location_facility: Clinica Urologica I - Università di Bari

location_facility: Landesklinik fur Urologie und Andrologie

location_facility: Winship Cancer Institute Emory University

location_facility: Istituto Nazionale per la Ricerca sul Cancro -IST

location_facility: Dept of Veteran's Affairs North Texas Healthcare System

location_facility: The Institute Of Cancer Research - Royal Marsden Hospital

location_facility: Clinical Research Centre - St Georges Hospital

location_facility: Katedra i Klinika Urologii - Akademia Medyczna w Gdansku

location_facility: Clinica Urologica - Università Di Milano

location_facility: Universitätsklinikum Carl Gustav Carus an der

location_facility: Albany Medical Center South Clinical Campus

location_facility: Urologische Klinik Und Poliklinik Grosshadern

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: University Of Natal - Nelson R Mandela School of Medicine

location_facility: Hillcrest Urological Medical Group, Inc.

location_facility: Institute Of Cancer Studies - University of Birmingham


type: Other Identifier

title: A Phase II/III Double Blind Randomized Trial of BMS-275291 vs. Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel and carboplatin are more effective with or without BMS-275291 for non-small cell lung cancer.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of paclitaxel and carboplatin with or without BMS-275291 in treating patients who have advanced or metastatic non-small cell lung cancer.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Bradbury PA, Twumasi-Ankrah P, Ding K, et al.: The impact of brain metastases on overall survival (OS) in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) clinical trials (CT) in advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-8075, 2009.

ReferenceCitation: Asmis TR, Ding K, Seymour L, Shepherd FA, Leighl NB, Winton TL, Whitehead M, Spaans JN, Graham BC, Goss GD; National Cancer Institute of Canada Clinical Trials Group. Age and comorbidity as independent prognostic factors in the treatment of non small-cell lung cancer: a review of National Cancer Institute of Canada Clinical Trials Group trials. J Clin Oncol. 2008 Jan 1;26(1):54-9. doi: 10.1200/JCO.2007.12.8322.

ReferenceCitation: Wheatley-Price P, Le Maître A, Ding K, et al.: The influence of sex on efficacy, toxicity and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) non-small cell lung cancer (NSCLC) chemotherapy trials. [Abstract] J Clin Oncol 26 (Suppl 15): A-8054, 2008.

ReferenceCitation: Hicks L, Cheung M, Hasan B, et al.: Venous thromboembolism and non-small cell lung cancer: a pooled analysis of National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) trials. [Abstract] Blood 110 (11): A-3995, 2007.

ReferenceCitation: Douillard JY, Peschel C, Shepherd F, Paz-Ares L, Arnold A, Davis M, Tonato M, Smylie M, Tu D, Voi M, Humphrey J, Ottaway J, Young K, Vreckem AV, Seymour L. Randomized phase II feasibility study of combining the matrix metalloproteinase inhibitor BMS-275291 with paclitaxel plus carboplatin in advanced non-small cell lung cancer. Lung Cancer. 2004 Dec;46(3):361-8.

ReferenceType: result

ReferenceCitation: Leighl NB, Paz-Ares L, Douillard JY, Peschel C, Arnold A, Depierre A, Santoro A, Betticher DC, Gatzemeier U, Jassem J, Crawford J, Tu D, Bezjak A, Humphrey JS, Voi M, Galbraith S, Hann K, Seymour L, Shepherd FA. Randomized phase III study of matrix metalloproteinase inhibitor BMS-275291 in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: National Cancer Institute of Canada-Clinical Trials Group Study BR.18. J Clin Oncol. 2005 Apr 20;23(12):2831-9.

ReferenceCitation: Leighl NB, Shepherd F, Paz-Ares L, et al.: Randomized phase II-III study of matrix metalloproteinase inhibitor (MMPI) BMS-275291 in combination with paclitaxel (P) and carboplatin (C) in advanced non-small cell lung cancer (NSCLC): NCIC-CTG BR.18. [Abstract] J Clin Oncol 22 (Suppl 14): A-7038, 626s, 2004.

ipd_sharing: No

lead_sponsor: NCIC Clinical Trials Group

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Spain
Germany
Finland
France
Poland
Belgium
Portugal
Canada
United Kingdom

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Hotel Dieu Health Sciences Hospital - Niagara

location_facility: Division of Medical Oncology - Vanderbilt

location_facility: University of Arkansas for Medical Sciences

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Baptist Regional Cancer Center - Knoxville

location_facility: Cancer Care Ontario-Hamilton Regional Cancer Centre

location_facility: University of Alabama at Birmingham Comprehensive Cancer Center

location_facility: Central Georgia Hematology Oncology, P.C.

location_facility: Klinikum Rechts Der Isar/Technische Universitaet Muenchen

location_facility: Cancer Care Ontario - Windsor Regional Cancer Centre

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Memorial Hospital Cancer Center - Chattanooga

location_facility: Stadisches Krankenhaus Martha Maria Halle-Dolau

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: University of Oklahoma Health Sciences Center


title: COBRA PZF™ Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term Dual Anti-Platelet Therapy

summary: This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year and annually for 5 years post index stenting procedure.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: CeloNova BioSciences, Inc.

location_country:
United States
Serbia
Switzerland
France
Spain
Germany
Latvia

location_facility: Oklahoma Foundation for Cardiovascular Research

location_facility: San Antonio Endovascular & Heart Institute

location_facility: Paul Stradins Clinical University Hospital

intervention_type: Device


title: A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Flexible Dosing of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

summary: To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type

ReferenceCitation: Grossberg GT, Kohegyi E, Mergel V, Josiassen MK, Meulien D, Hobart M, Slomkowski M, Baker RA, McQuade RD, Cummings JL. Efficacy and Safety of Brexpiprazole for the Treatment of Agitation in Alzheimer's Dementia: Two 12-Week, Randomized, Double-Blind, Placebo-Controlled Trials. Am J Geriatr Psychiatry. 2020 Apr;28(4):383-400. doi: 10.1016/j.jagp.2019.09.009. Epub 2019 Oct 1.

family: Grossberg

full_name: George T. Grossberg

given: George T.

family: Kohegyi

full_name: Eva Kohegyi

given: Eva

family: Mergel

full_name: Victor Mergel

given: Victor

family: Josiassen

full_name: Mette Krog Josiassen

given: Mette Krog

family: Meulien

full_name: Didier Meulien

given: Didier

family: Hobart

full_name: Mary Hobart

given: Mary

family: Slomkowski

full_name: Mary Slomkowski

family: Baker

full_name: Ross A. Baker

given: Ross A.

family: McQuade

full_name: Robert D. McQuade

given: Robert D.

family: Cummings

full_name: Jeffrey L. Cummings

given: Jeffrey L.

journal_name: The American Journal of Geriatric Psychiatry

ipd_sharing: Yes

ipd_sharing_description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
United Kingdom
Finland
France
Bulgaria
Russian Federation
United States
Slovenia
Canada
Ukraine


lead_sponsor: Bayer

location_country:
Italy
Austria
Hong Kong
Switzerland
Germany
France
Czechia
Japan
Thailand
Hungary
Belgium
New Zealand
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

acronym: Refametinib in RAS mutant HCC

type: EudraCT Number

source: euctr

title: A Prospective, Single-arm, Multicenter, Uncontrolled, Open-label Phase II Trial of Refametinib (BAY86-9766) in Patients With RAS Mutant Hepatocellular Carcinoma (HCC)

summary:
This is a study to investigate the potential clinical benefit of refametinib in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review.

Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib improves the response rate in this RAS mutation patient population.


title: RANDOMIZED PHASE III STUDY OF INDUCTION (ICE VS MICE VS DCE) AND INTENSIVE CONSOLIDATION (IDIA VS NOVIA VS DIA) FOLLOWED BY BONE MARROW TRANSPLANTATION IN ACUTE MYELOGENOUS LEUKEMIA: AML 10 PROTOCOL

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

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with acute myelogenous leukemia.

ReferenceCitation: Maurillo L, Buccisano F, Spagnoli A, et al.: In acute myeloid leukemia, the use in induction of standard dose arac is associated with a better quality of response as compared to an induction regimen containing high dose arac. [Abstract] Blood 114 (22): A-1584, 2009.

ReferenceCitation: Oosterveld, M, Suciu S, Muus P, et al.: A new prognostic disease specific model to predict survival after intensive antileukemic treatment for young patients with poor-risk MDS and AML: results of the CRIANT and AML-10 studies conducted by the EORTC/GIMEMA/SAKK/HOVON/EBMT groups. [Abstract] Blood 104 (11): A-2020, 2004.

ReferenceCitation: Mandelli F, Vignetti M, Suciu S, Stasi R, Petti MC, Meloni G, Muus P, Marmont F, Marie JP, Labar B, Thomas X, Di Raimondo F, Willemze R, Liso V, Ferrara F, Baila L, Fazi P, Zittoun R, Amadori S, de Witte T. Daunorubicin versus mitoxantrone versus idarubicin as induction and consolidation chemotherapy for adults with acute myeloid leukemia: the EORTC and GIMEMA Groups Study AML-10. J Clin Oncol. 2009 Nov 10;27(32):5397-403. doi: 10.1200/JCO.2008.20.6490. Epub 2009 Oct 13. Erratum in: J Clin Oncol. 2010 Mar 10;28(8):1438.

name: From the Department of Cellular Biotechnologies and Hematology, “Sapienza” University; Department of Hematology, National Cancer Institute “Regina Elena”; Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) Data Center, GIMEMA Foundation; Department of Hematology, “Tor Vergata” University Hospital, Rome; Department of Medical Sciences, “Regina Apostolorum” Hospital, Albano Laziale; Department of Hematology “Le Molinette”, “S.G. Battista” Hospital, Turin; Department of Hematology, “Ferrarotto”...

family: Mandelli

full_name: Franco Mandelli

given: Franco

family: Vignetti

full_name: Marco Vignetti

given: Marco

family: Suciu

full_name: Stefan Suciu

given: Stefan

family: Stasi

full_name: Roberto Stasi

given: Roberto

family: Petti

full_name: Maria-Concetta Petti

given: Maria-Concetta

family: Meloni

full_name: Giovanna Meloni

given: Giovanna

family: Muus

full_name: Petra Muus

given: Petra

family: Marmont

full_name: Filippo Marmont

given: Filippo

family: Marie

full_name: Jean-Pierre Marie

given: Jean-Pierre

family: Labar

full_name: Boris Labar

given: Boris

family: Thomas

full_name: Xavier Thomas

given: Xavier

family: Di Raimondo

full_name: Francesco Di Raimondo

given: Francesco

family: Willemze

full_name: Roel Willemze

given: Roel

family: Liso

full_name: Vincenzo Liso

given: Vincenzo

family: Ferrara

full_name: Felicetto Ferrara

given: Felicetto

family: Baila

full_name: Liliana Baila

given: Liliana

family: Fazi

full_name: Paola Fazi

given: Paola

family: Zittoun

full_name: Robert Zittoun

given: Robert

family: Amadori

full_name: Sergio Amadori

given: Sergio

family: de Witte

full_name: Theo de Witte

given: Theo

journal_name: Journal of Clinical Oncology

oa_host_type: repository

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

repository_institution: Tor Vergata University - Cineca Institutional Research Information System

publisher: American Society of Clinical Oncology (ASCO)

title: Daunorubicin Versus Mitoxantrone Versus Idarubicin As Induction and Consolidation Chemotherapy for Adults With Acute Myeloid Leukemia: The EORTC and GIMEMA Groups Study AML-10

ReferenceCitation: Baron F, Stevens-Kroef M, Kicinski M, Meloni G, Muus P, Marie JP, Halkes CJM, Thomas X, Vrhovac R, Albano F, Lefrère F Sr, Sica S, Mancini M, Venditti A, Hagemeijer A, Jansen JH, Amadori S, de Witte T, Willemze R, Suciu S. Impact of induction regimen and allogeneic hematopoietic cell transplantation on outcome in younger adults with acute myeloid leukemia with a monosomal karyotype. Haematologica. 2019 Jun;104(6):1168-1175. doi: 10.3324/haematol.2018.204826. Epub 2018 Dec 6.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Baron F, Stevens-Kroef M, Kicinski M, Meloni G, Muus P, Marie JP, Halkes CJM, Thomas X, Vrhovac R, Specchia G, Lefrere F Sr, Sica S, Mancini M, Venditti A, Hagemeijer A, Becker H, Jansen JH, Amadori S, de Witte T, Willemze R, Suciu S. Cytogenetic clonal heterogeneity is not an independent prognosis factor in 15-60-year-old AML patients: results on 1291 patients included in the EORTC/GIMEMA AML-10 and AML-12 trials. Ann Hematol. 2018 Oct;97(10):1785-1795. doi: 10.1007/s00277-018-3396-4. Epub 2018 Jun 20.

repository_institution: University of Liège - Open Repository and Bibliography

title: Cytogenetic clonal heterogeneity is not an independent prognosis factor in 15–60-year-old AML patients: results on 1291 patients included in the EORTC/GIMEMA AML-10 and AML-12 trials

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

location_country:
Italy
Austria
Netherlands
Croatia
France
Hungary
Belgium
Portugal
Turkey
Germany
Czech Republic

location_facility: Universita Degli Studi di Firenze - Policlin. di Careggi

location_facility: Policlinico P. Giaccone - Universita Di Palermo

location_facility: Azienda Ospedaliera Ospedale E. Mortelli

location_facility: Institute of Hematology and Blood Transfusion

location_facility: Ospedale Gen. Provinciale Santa Maria Goretti

location_facility: Universita Degli Studi di Bari Policlinico

location_facility: Azienda Ospedale S. Luigi - Universita Di Torino

location_facility: Istituto di Ematologia Universita - University di Sassari

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: University and I.R.C.C.S. Policlinico San Matteo

location_facility: Ospedale San Martino/Cliniche Universitarie Convenzionale

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore


title: A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia

summary:
Background:

- Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase III multicenter trial designed to confirm these results.

ReferenceCitation: Bouroncle BA. Thirty-five years in the progress of hairy cell leukemia. Leuk Lymphoma. 1994;14 Suppl 1:1-12. Review.

ReferenceCitation: Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66.

ReferenceCitation: Sharpe RW, Bethel KJ. Hairy cell leukemia: diagnostic pathology. Hematol Oncol Clin North Am. 2006 Oct;20(5):1023-49. Review.

ReferenceCitation: Kreitman RJ, Tallman MS, Robak T, Coutre S, Wilson WH, Stetler-Stevenson M, Fitzgerald DJ, Lechleider R, Pastan I. Phase I trial of anti-CD22 recombinant immunotoxin moxetumomab pasudotox (CAT-8015 or HA22) in patients with hairy cell leukemia. J Clin Oncol. 2012 May 20;30(15):1822-8. doi: 10.1200/JCO.2011.38.1756. Epub 2012 Feb 21.

ReferenceCitation: Kreitman RJ, Dearden C, Zinzani PL, Delgado J, Karlin L, Robak T, Gladstone DE, le Coutre P, Dietrich S, Gotic M, Larratt L, Offner F, Schiller G, Swords R, Bacon L, Bocchia M, Bouabdallah K, Breems DA, Cortelezzi A, Dinner S, Doubek M, Gjertsen BT, Gobbi M, Hellmann A, Lepretre S, Maloisel F, Ravandi F, Rousselot P, Rummel M, Siddiqi T, Tadmor T, Troussard X, Yi CA, Saglio G, Roboz GJ, Balic K, Standifer N, He P, Marshall S, Wilson W, Pastan I, Yao NS, Giles F. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. 2018 Aug;32(8):1768-1777. doi: 10.1038/s41375-018-0210-1. Epub 2018 Jul 20.

ReferenceCitation: Kreitman RJ, Dearden C, Zinzani PL, Delgado J, Robak T, le Coutre PD, Gjertsen BT, Troussard X, Roboz GJ, Karlin L, Gladstone DE, Kuptsova-Clarkson N, Liu S, Patel P, Rotolo F, Mitry E, Pastan I, Giles F; Study 1053 investigators. Moxetumomab pasudotox in heavily pre-treated patients with relapsed/refractory hairy cell leukemia (HCL): long-term follow-up from the pivotal trial. J Hematol Oncol. 2021 Feb 24;14(1):35. doi: 10.1186/s13045-020-01004-y.

family: Kreitman

full_name: Robert J. Kreitman

given: Robert J.

family: Dearden

full_name: Claire Dearden

given: Claire

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Delgado

full_name: Julio Delgado

given: Julio

family: Robak

full_name: Tadeusz Robak

given: Tadeusz

family: le Coutre

full_name: Philipp D. le Coutre

given: Philipp D.

family: Gjertsen

full_name: Bjørn T. Gjertsen

given: Bjørn T.

family: Troussard

full_name: Xavier Troussard

family: Roboz

full_name: Gail J. Roboz

given: Gail J.

family: Karlin

full_name: Lionel Karlin

given: Lionel

family: Gladstone

full_name: Douglas E. Gladstone

given: Douglas E.

family: Kuptsova-Clarkson

full_name: Nataliya Kuptsova-Clarkson

given: Nataliya

family: Liu

full_name: Shiyao Liu

given: Shiyao

family: Patel

full_name: Priti Patel

given: Priti

family: Rotolo

full_name: Federico Rotolo

given: Federico

family: Mitry

full_name: Emmanuel Mitry

given: Emmanuel

family: Pastan

full_name: Ira Pastan

given: Ira

family: Giles

full_name: Francis Giles

given: Francis

currency_apc_doaj: GBP

journal_name: Journal of Hematology & Oncology

license: cc-by

license_normalized: cc-by

ReferenceCitation: Abou Dalle I, Ravandi F. Moxetumomab pasudotox for the treatment of relapsed and/or refractory hairy cell leukemia. Expert Rev Hematol. 2019 Sep;12(9):707-714. doi: 10.1080/17474086.2019.1643231. Epub 2019 Aug 1. Review.

name: Department of leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

location_country:
Italy
United States
Serbia
Germany
France
Czechia
Poland
Israel
Norway
Ireland
Belgium
Spain
Canada
United Kingdom


lead_sponsor: Puma Biotechnology, Inc.

location_country:
United States
France

location_facility: Washington University School of Medicine

location_facility: University of Pittsburgh Cancer Institute

location_facility: CHU de Grenoble Hopital Albert Michallon

location_facility: Hopitaux universitaires de Strasbourg Nouvel Hopital Civil

title: A Phase 2 Study of Neratinib and Neratinib Plus Temsirolimus in Patients With Non-Small Cell Lung Cancer Carrying Known HER2 Activating Mutations

summary: This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations.


title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization

acronym: GLAGOV

summary: This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.

ReferenceCitation: Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951.

ReferenceCitation: Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJP, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Honda S, Shishikura D, Scherer DJ, Borgman M, Brennan DM, Wolski K, Nissen SE. Effect of Evolocumab on Coronary Plaque Composition. J Am Coll Cardiol. 2018 Oct 23;72(17):2012-2021. doi: 10.1016/j.jacc.2018.06.078.

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

name: Institute of Cardiovascular Science; University College London; London UK

name: Department of Cardiology, Division Heart and Lungs; UMC Utrecht; Utrecht Netherlands

family: Schmidt

full_name: Amand F Schmidt

given: Amand F

name: Department of Clinical Pharmacology and Therapeutics; University College London Hospital; London UK

family: Carter

full_name: John-Paul L Carter

given: John-Paul L

name: Department of Non-communicable Disease Epidemiology; London School of Hygiene & Tropical Medicine; London UK

family: Pearce

full_name: Lucy S Pearce

given: Lucy S

name: The Department of Medicine (Cardiology) and the Department of Preventive Medicine; Northwestern University Feinberg School of Medicine; Chicago Illinois USA

family: Wilkins

full_name: John T Wilkins

given: John T

name: Medicines Discovery Catapult; Alderly Edge UK

family: Overington

full_name: John P Overington

given: John P

family: Hingorani

full_name: Aroon D Hingorani

given: Aroon D

name: Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC); VA Boston Healthcare System; Boston Massachusetts USA

family: Casas

full_name: JP Casas

given: JP

journal_name: Cochrane Database of Systematic Reviews

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

version: acceptedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Puri R, Nissen SE, Somaratne R, Cho L, Kastelein JJ, Ballantyne CM, Koenig W, Anderson TJ, Yang J, Kassahun H, Wasserman SM, Scott R, Borgman M, Nicholls SJ. Impact of PCSK9 inhibition on coronary atheroma progression: Rationale and design of Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound (GLAGOV). Am Heart J. 2016 Jun;176:83-92. doi: 10.1016/j.ahj.2016.01.019. Epub 2016 Feb 17.

family: Puri

full_name: Rishi Puri

given: Rishi

family: Nissen

full_name: Steven E. Nissen

given: Steven E.

family: Somaratne

full_name: Ransi Somaratne

given: Ransi

family: Cho

full_name: Leslie Cho

given: Leslie

family: Kastelein

full_name: John J.P. Kastelein

given: John J.P.

family: Ballantyne

full_name: Christie M. Ballantyne

location_country:
Malaysia
Greece
Belgium
Australia
Russian Federation
Denmark
Taiwan
Iceland
France
Poland
Norway
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Switzerland
Netherlands
Philippines
Singapore
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain


title: A Phase 2, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Standard of Care in Subjects With Previously Untreated and Advanced (Unresectable or Metastatic) Non-clear Cell Renal Cell Carcinoma (nccRCC)

acronym: SUNIFORECAST

summary: SUNNIFORECAST (Sunitinib vs. Nivolumab + Ipilimumab as First line treatment Of REnal cell CAncer of non-clear cell SubTypes) is a Phase II, randomized, open-label investigator initiated trial (IIT) of Nivolumab (BMS-936558) combined with Ipilimumab vs standard of care in subjects with previously untreated and advanced (unresectable or metastatic) non-clear cell renal cell carcinoma (nccRCC).

status: Recruiting

ReferenceCitation: Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.

family: Motzer

full_name: Robert J. Motzer

given: Robert J.

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: McDermott

full_name: David F. McDermott

given: David F.

family: George

full_name: Saby George

given: Saby

family: Hammers

full_name: Hans J. Hammers

given: Hans J.

family: Srinivas

full_name: Sandhya Srinivas

given: Sandhya

family: Tykodi

full_name: Scott S. Tykodi

given: Scott S.

family: Sosman

full_name: Jeffrey A. Sosman

given: Jeffrey A.

family: Procopio

full_name: Giuseppe Procopio

given: Giuseppe

family: Plimack

full_name: Elizabeth R. Plimack

given: Elizabeth R.

family: Castellano

full_name: Daniel Castellano

given: Daniel

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

family: Gurney

full_name: Howard Gurney

given: Howard

family: Donskov

full_name: Frede Donskov

given: Frede

family: Bono

full_name: Petri Bono

given: Petri

family: Wagstaff

full_name: John Wagstaff

given: John

family: Gauler

full_name: Thomas C. Gauler

given: Thomas C.

family: Ueda

full_name: Takeshi Ueda

given: Takeshi

family: Tomita

full_name: Yoshihiko Tomita

given: Yoshihiko

family: Schutz

full_name: Fabio A. Schutz

given: Fabio A.

family: Kollmannsberger

full_name: Christian Kollmannsberger

given: Christian

family: Larkin

full_name: James Larkin

given: James

family: Ravaud

full_name: Alain Ravaud

given: Alain

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

ReferenceCitation: Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016 Mar;17(3):378-388. doi: 10.1016/S1470-2045(15)00515-X. Epub 2016 Jan 13.

ReferenceCitation: Vera-Badillo FE, Templeton AJ, Duran I, Ocana A, de Gouveia P, Aneja P, Knox JJ, Tannock IF, Escudier B, Amir E. Systemic therapy for non-clear cell renal cell carcinomas: a systematic review and meta-analysis. Eur Urol. 2015 Apr;67(4):740-9. doi: 10.1016/j.eururo.2014.05.010. Epub 2014 Jun 2. Review.

ReferenceCitation: Ahrens M, Scheich S, Hartmann A, Bergmann L; IAG-N Interdisciplinary Working Group Kidney Cancer of the German Cancer Society. Non-Clear Cell Renal Cell Carcinoma - Pathology and Treatment Options. Oncol Res Treat. 2019;42(3):128-135. doi: 10.1159/000495366. Epub 2019 Feb 23. Review.

ReferenceCitation: Motzer RJ, Tannir NM, McDermott DF, Arén Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthélémy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.

name: From Memorial Sloan Kettering Cancer Center, New York (R.J.M.), and Roswell Park Cancer Institute, Buffalo (S.G.) — both in New York; University of Texas M.D. Anderson Cancer Center, Houston (N.M.T., P. Sharma); Beth Israel Deaconess Medical Center, Dana–Farber/Harvard Cancer Center (D.F.M.), and Dana–Farber Cancer Institute, Brigham and Women’s Hospital, and Harvard Medical School (T.K.C.), Boston; Centro Internacional de Estudios Clínicos (O.A.F.) and Fundación Arturo López Pérez (P. Salman), Santiago,...

repository_institution: Tampere University - Tampere University Institutional Repository

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

location_country:
Netherlands
France
Czechia
Belgium
Spain
Germany
United Kingdom

location_facility: Mount Vernon Cancer Center Medical Oncology

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Charité Universitätsmedizin Berlin (Campus BF)

location_facility: Gent University Hospital (Universitair Ziekenhuis Gent)

location_facility: Nationales Zentrum für Tumorerkrankungen (NCT)

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: Les Hoptaux Universitaires de Strasbourg

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Charite Berlin (Campus Virchow-Klinikum)


title: A Phase 1 Trial to Investigate the Safety, Pharmacokinetic Profiles and the Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies

summary: This study evaluates the efficacy, safety and pharmacokinetics of tinostamustine (EDO-S101) in patients with relapsed/refractory hematologic malignancies. All patients will receive tinostamustine.

ipd_sharing_description: relevant patient listing data of de-identified patients may be reviewed

lead_sponsor: Mundipharma-EDO GmbH

location_country:
Italy
United States
Switzerland
Netherlands
France
Spain
Germany

location_facility: CHU ESTAING Service de thérapie Cellulaire et hématologique Clinique

location_facility: National Cancer Institute, Fondazione 'G. Pascale'

location_facility: Institut Català d'Oncologia de Barcelona

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Institute of Hematology "L. A. Seràgnoli", University of Bologna

location_facility: University Hospital of Ulm, Department of Internal Medicine III

status_simplified: Ongoing


title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

acronym: TRAFFIC

summary: The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

name: Department of Women's and Children's Health; University of Liverpool; Liverpool UK

family: Southern

full_name: Kevin W Southern

given: Kevin W

family: Murphy

full_name: Jared Murphy

given: Jared

family: Sinha

full_name: Ian P Sinha

given: Ian P

name: Department of Biostatistics; University of Liverpool; Liverpool UK

family: Nevitt

full_name: Sarah J Nevitt

given: Sarah J

ReferenceCitation: Flume PA, Suthoff ED, Kosinski M, Marigowda G, Quittner AL. Measuring recovery in health-related quality of life during and after pulmonary exacerbations in patients with cystic fibrosis. J Cyst Fibros. 2019 Sep;18(5):737-742. doi: 10.1016/j.jcf.2018.12.004. Epub 2018 Dec 23.

family: Flume

full_name: Patrick A. Flume

given: Patrick A.

family: Suthoff

full_name: Ellison D. Suthoff

given: Ellison D.

family: Kosinski

full_name: Mark Kosinski

given: Mark

family: Marigowda

full_name: Gautham Marigowda

given: Gautham

family: Quittner

full_name: Alexandra L. Quittner

given: Alexandra L.

journal_name: Journal of Cystic Fibrosis

ReferenceCitation: McColley SA, Konstan MW, Ramsey BW, Stuart Elborn J, Boyle MP, Wainwright CE, Waltz D, Vera-Llonch M, Marigowda G, Jiang JG, Rubin JL. Lumacaftor/Ivacaftor reduces pulmonary exacerbations in patients irrespective of initial changes in FEV(1). J Cyst Fibros. 2019 Jan;18(1):94-101. doi: 10.1016/j.jcf.2018.07.011. Epub 2018 Aug 23.

family: McColley

full_name: Susanna A. McColley

given: Susanna A.

family: Konstan

full_name: Michael W. Konstan

given: Michael W.

family: Ramsey

full_name: Bonnie W. Ramsey

given: Bonnie W.

family: Stuart Elborn

full_name: J. Stuart Elborn

given: J.

family: Boyle

full_name: Michael P. Boyle

given: Michael P.

family: Wainwright

full_name: Claire E. Wainwright

given: Claire E.

family: Waltz

full_name: David Waltz

given: David

family: Vera-Llonch

full_name: Montserrat Vera-Llonch

title: Lumacaftor/Ivacaftor reduces pulmonary exacerbations in patients irrespective of initial changes in FEV1

ReferenceCitation: Elborn JS, Ramsey BW, Boyle MP, Konstan MW, Huang X, Marigowda G, Waltz D, Wainwright CE; VX-809 TRAFFIC and TRANSPORT study groups. Efficacy and safety of lumacaftor/ivacaftor combination therapy in patients with cystic fibrosis homozygous for Phe508del CFTR by pulmonary function subgroup: a pooled analysis. Lancet Respir Med. 2016 Aug;4(8):617-626. doi: 10.1016/S2213-2600(16)30121-7. Epub 2016 Jun 10.

repository_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Wainwright CE, Elborn JS, Ramsey BW, Marigowda G, Huang X, Cipolli M, Colombo C, Davies JC, De Boeck K, Flume PA, Konstan MW, McColley SA, McCoy K, McKone EF, Munck A, Ratjen F, Rowe SM, Waltz D, Boyle MP; TRAFFIC Study Group; TRANSPORT Study Group. Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR. N Engl J Med. 2015 Jul 16;373(3):220-31. doi: 10.1056/NEJMoa1409547. Epub 2015 May 17.

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

title: Lumacaftor–Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR

location_country:
Italy
United States
Sweden
United Kingdom
Netherlands
Germany
France
Ireland
Australia
Canada
Czech Republic


title: A 12-Week Efficacy and Safety Evaluation of Budesonidel/Formoterol SPIROMAX® 160/4.5 mcg Inhalation Powder Versus SYMBICORT® TURBOHALER® 200/6 mcg in Adult and Adolescent Patients With Persistent Asthma

summary: The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) SPIROMAX 160/4.5 mcg is as effective as SYMBICORT TURBOHALER 200/6 mcg administered twice daily in patients with persistent asthma.

ReferenceCitation: Virchow JC, Rodriguez-Roisin R, Papi A, Shah TP, Gopalan G. A randomized, double-blinded, double-dummy efficacy and safety study of budesonide-formoterol Spiromax® compared to budesonide-formoterol Turbuhaler® in adults and adolescents with persistent asthma. BMC Pulm Med. 2016 Mar 17;16:42. doi: 10.1186/s12890-016-0200-x.

family: Virchow

full_name: J. Christian Virchow

given: J. Christian

family: Rodriguez-Roisin

full_name: Roberto Rodriguez-Roisin

given: Roberto

family: Papi

full_name: Alberto Papi

given: Alberto

family: Shah

full_name: Tushar P. Shah

given: Tushar P.

family: Gopalan

full_name: Gokul Gopalan

given: Gokul

journal_name: BMC Pulmonary Medicine

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: A randomized, double-blinded, double-dummy efficacy and safety study of budesonide–formoterol Spiromax® compared to budesonide–formoterol Turbuhaler® in adults and adolescents with persistent asthma

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Italy
Austria
Sweden
United Kingdom
Netherlands
Finland
France
Poland
Israel
Hungary
Belgium
Russian Federation
Spain
Denmark
Germany
Czech Republic

location_facility:
Teva Investigational Site 39021
Teva Investigational Site 35089
Teva Investigational Site 38048
Teva Investigational Site 51073
Teva Investigational Site 32241
Teva Investigational Site 53114
Teva Investigational Site 34027
Teva Investigational Site 53103
Teva Investigational Site 51067
Teva Investigational Site 80038
Teva Investigational Site 32258
Teva Investigational Site 51076
Teva Investigational Site 34029
Teva Investigational Site 50175
Teva Investigational Site 33019
Teva Investigational Site 54059
Teva Investigational Site 31056
Teva Investigational Site 40001
Teva Investigational Site 51075
Teva Investigational Site 53110
Teva Investigational Site 39020
Teva Investigational Site 33020
Teva Investigational Site 32246
Teva Investigational Site 40004
Teva Investigational Site 35093
Teva Investigational Site 51065
Teva Investigational Site 37030
Teva Investigational Site 40003
Teva Investigational Site 53113
Teva Investigational Site 50178
Teva Investigational Site 34022
Teva Investigational Site 33018
Teva Investigational Site 35090
Teva Investigational Site 53101
Teva Investigational Site 32252
Teva Investigational Site 37029
Teva Investigational Site 53119
Teva Investigational Site 53116
Teva Investigational Site 53107
Teva Investigational Site 50177
Teva Investigational Site 35091
Teva Investigational Site 51068
Teva Investigational Site 54064
Teva Investigational Site 32247
Teva Investigational Site 42011
Teva Investigational Site 50179
Teva Investigational Site 53120
Teva Investigational Site 34028
Teva Investigational Site 32253
Teva Investigational Site 34026
Teva Investigational Site 54061
Teva Investigational Site 53102
Teva Investigational Site 32255
Teva Investigational Site 32243
Teva Investigational Site 50173
Teva Investigational Site 53111
Teva Investigational Site 80039
Teva Investigational Site 53104
Teva Investigational Site 32240
Teva Investigational Site 53106
Teva Investigational Site 53115
Teva Investigational Site 30055
Teva Investigational Site 37031
Teva Investigational Site 51077
Teva Investigational Site 34024
Teva Investigational Site 31054
Teva Investigational Site 31051
Teva Investigational Site 51072
Teva Investigational Site 50174
Teva Investigational Site 31053
Teva Investigational Site 53099
Teva Investigational Site 38049
Teva Investigational Site 32250
Teva Investigational Site 53100
Teva Investigational Site 51070
Teva Investigational Site 40002
Teva Investigational Site 80035
Teva Investigational Site 53105
Teva Investigational Site 35092
Teva Investigational Site 80040
Teva Investigational Site 54065
Teva Investigational Site 54063
Teva Investigational Site 32249
Teva Investigational Site 80041
Teva Investigational Site 53109
Teva Investigational Site 51074
Teva Investigational Site 54058
Teva Investigational Site 32256
Teva Investigational Site 35088
Teva Investigational Site 50172
Teva Investigational Site 32259
Teva Investigational Site 54067


title: A Phase I/II Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) Antibody-radionuclide-conjugate for Treatment of Relapsed Non-Hodgkin Lymphoma.

summary: This study is a phase I/II open-label study in patients with relapsed indolent NHL (Part A) or relapsed/refractory FL (Part B). Part A of the study assessed the safety and preliminary efficacy. This seamless design study now has four parts: 1) Part A, Ph I - dose escalation, 2) Part A, Ph II - dose expansion, 3) Part B, Ph II randomized - refinement of dose, and 4) Part B, Phase II, single-arm. As of August 7, 2020, patients are enrolling in the fourth part of the study.

ReferenceCitation: Dahle J, Repetto-Llamazares AH, Mollatt CS, Melhus KB, Bruland OS, Kolstad A, Larsen RH. Evaluating antigen targeting and anti-tumor activity of a new anti-CD37 radioimmunoconjugate against non-Hodgkin's lymphoma. Anticancer Res. 2013 Jan;33(1):85-95.

ReferenceCitation: Repetto-Llamazares AH, Larsen RH, Mollatt C, Lassmann M, Dahle J. Biodistribution and dosimetry of (177)Lu-tetulomab, a new radioimmunoconjugate for treatment of non-Hodgkin lymphoma. Curr Radiopharm. 2013 Mar;6(1):20-7.

ReferenceCitation: Løndalen A, Blakkisrud J, Revheim ME, Madsbu UE, Dahle J, Kolstad A, Stokke C. FDG PET/CT parameters and correlations with tumor-absorbed doses in a phase 1 trial of (177)Lu-lilotomab satetraxetan for treatment of relapsed non-Hodgkin lymphoma. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1902-1914. doi: 10.1007/s00259-020-05098-x. Epub 2020 Nov 16.

family: Løndalen

full_name: Ayca Løndalen

given: Ayca

family: Blakkisrud

full_name: Johan Blakkisrud

given: Johan

family: Revheim

full_name: Mona-Elisabeth Revheim

given: Mona-Elisabeth

family: Madsbu

full_name: Ulf Erik Madsbu

given: Ulf Erik

family: Dahle

full_name: Jostein Dahle

given: Jostein

family: Kolstad

full_name: Arne Kolstad

given: Arne

family: Stokke

full_name: Caroline Stokke

given: Caroline

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

oa_colors: green hybrid

repository_institution: University of Oslo - Duo Research Archive

title: FDG PET/CT parameters and correlations with tumor-absorbed doses in a phase 1 trial of 177Lu-lilotomab satetraxetan for treatment of relapsed non-Hodgkin lymphoma

ReferenceCitation: Kolstad A, Illidge T, Bolstad N, Spetalen S, Madsbu U, Stokke C, Blakkisrud J, Løndalen A, O'Rourke N, Beasley M, Jurczak W, Fagerli UM, Kaščák M, Bayne M, Obr A, Dahle J, Rojkjaer L, Pascal V, Holte H. Phase 1/2a study of 177Lu-lilotomab satetraxetan in relapsed/refractory indolent non-Hodgkin lymphoma. Blood Adv. 2020 Sep 8;4(17):4091-4101. doi: 10.1182/bloodadvances.2020002583.

name: Department of Oncology, Oslo University Hospital, Radiumhospitalet, Oslo, Norway;

name: University of Manchester, National Institutes of Health Research Manchester Biomedical Research Centre, Christie Hospital, Manchester, United Kingdom;

family: Illidge

full_name: Tim Illidge

given: Tim

name: Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway;

family: Bolstad

full_name: Nils Bolstad

given: Nils

name: Department of Pathology, Oslo University Hospital, Radiumhospitalet, Oslo, Norway;

family: Spetalen

full_name: Signe Spetalen

given: Signe

name: Department of Radiology and Nuclear Medicine,

full_name: Ulf Madsbu

given: Ulf

name: Department of Nuclear Medicine, Oslo University Hospital, Radiumhospitalet, Oslo, Norway;

name: Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom;

family: O'Rourke

full_name: Noelle O'Rourke

given: Noelle

name: Bristol Cancer Institute, Bristol, United Kingdom;

name: Maria Sklodowska-Curie National Institute of Oncology, Kraków, Poland;

name: St. Olav’s Hospital and Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway;

name: Department of Hematooncology, University Hospital Ostrava and Faculty of Medicine, Ostrava University, Ostrava, Czech Republic;

name: Dorset Cancer Centre, Poole, United Kingdom;

name: Department of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacky University and University Hospital, Olomouc, Czech Republic; and

location_country:
Finland
Australia
Belgium
Denmark
Croatia
France
Poland
Norway
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Singapore
Hungary
Ireland
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Turkey

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: University Of Arkansas For Medical Sciences

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Helsinki University Hospital Comprehensive Cancer Center

location_facility: Orszagos Onkologiai Intezet, A-Belgyogyaszati Onkologiai Osztaly

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Cukurova Universitesi Tip Fakültesi, Ic Hastaliklari Anabilim Dali

location_facility: University of California, San Francisco (UCSF)

location_facility: Eskisehir Osmangazi Universitesi Tip Fakultesi Ic Hastaliklar

location_facility: Health Research Institute La Fe - Hospital La Fe

location_facility: Medizinische Universität Wien - AKH Wien, Universitaetsklinik fuer Innere Medizin I

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

location_facility: "Istituto Nazionale Tumori Fondazione G. Pascale"

location_facility: University College London Hospitals Nhs Foundation Trust

location_facility: Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi Ic

location_facility: SS Antonio & Biagio and C. Arrigo Hospital

location_facility: "Istituto di Ematologia ed Oncologia Medica "" L. & A. Seragnoli""-Policlinico S. Orsola Malpighi"

location_facility: Semmelweis Egyetem, I Belgyogyaszati Klinika, Hematologiai Osztaly

location_facility: Universita Degli Studi Di Firenze-Azienda Ospedaliero-Universitaria Careggi (AOUC)

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama

location_facility: Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau


title: A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis

summary: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, participants in remission will stop study treatment and enter long-term follow-up, whereas participants with disease activity or flares will receive open-label tocilizumab or other treatment at the discretion of the investigator for a maximum period of 104 weeks.

ReferenceCitation: Khanna D, Lin CJF, Furst DE, Wagner B, Zucchetto M, Raghu G, Martinez FJ, Goldin J, Siegel J, Denton CP; focuSSced investigators. Long-Term Safety and Efficacy of Tocilizumab in Early Systemic Sclerosis-Interstitial Lung Disease: Open Label Extension of a Phase 3 Randomized Controlled Trial. Am J Respir Crit Care Med. 2021 Dec 1. doi: 10.1164/rccm.202103-0714OC. [Epub ahead of print]

ReferenceCitation: Stone JH, Spotswood H, Unizony SH, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Spiera R, Bao M. New-onset versus relapsing giant cell arteritis treated with tocilizumab: 3-year results from a randomized controlled trial and extension. Rheumatology (Oxford). 2021 Oct 29. pii: keab780. doi: 10.1093/rheumatology/keab780. [Epub ahead of print]

journal_name: Rheumatology

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: OUP accepted manuscript

ReferenceCitation: Unizony SH, Bao M, Han J, Luder Y, Pavlov A, Stone JH. Treatment failure in giant cell arteritis. Ann Rheum Dis. 2021 Nov;80(11):1467-1474. doi: 10.1136/annrheumdis-2021-220347. Epub 2021 May 28.

family: Unizony

full_name: Sebastian H Unizony

given: Sebastian H

family: Bao

full_name: Min Bao

given: Min

family: Han

full_name: Jian Han

given: Jian

family: Luder

full_name: Yves Luder

given: Yves

family: Pavlov

full_name: Andrey Pavlov

given: Andrey

family: Stone

full_name: John H Stone

given: John H

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Treatment failure in giant cell arteritis

ReferenceCitation: Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schulze-Koops H, Schett G, Spiera R, Unizony SH, Collinson N. Glucocorticoid Dosages and Acute-Phase Reactant Levels at Giant Cell Arteritis Flare in a Randomized Trial of Tocilizumab. Arthritis Rheumatol. 2019 Aug;71(8):1329-1338. doi: 10.1002/art.40876. Epub 2019 Jul 3.

name: Massachusetts General Hospital and Harvard Medical School Boston Massachusetts

full_name: John H. Stone

given: John H.

family: Tuckwell

full_name: Katie Tuckwell

given: Katie

name: Roche Products Ltd. Welwyn Garden City UK

family: Dimonaco

full_name: Sophie Dimonaco

given: Sophie

family: Klearman

full_name: Micki Klearman

given: Micki

name: University Medical Center and Technische Universität Dresden Dresden Germany

family: Aringer

full_name: Martin Aringer

given: Martin

name: University Hospitals Gasthuisberg Leuven Belgium

family: Blockmans

full_name: Daniel Blockmans

given: Daniel

name: University of Groningen and University Medical Center Groningen Groningen The Netherlands

family: Brouwer

full_name: Elisabeth Brouwer

given: Elisabeth

name: University Hospital Clínic de Barcelona and University of Barcelona Barcelona Spain

family: Cid

full_name: Maria C. Cid

given: Maria C.

name: Southend University HospitalNHS Foundation Trust Southend UK

family: Dasgupta

full_name: Bhaskar Dasgupta

given: Bhaskar

name: Universitätsklinikum Erlangen Erlangen Germany

family: Rech

full_name: Juergen Rech

given: Juergen

name: Azienda USL‐IRCCS di Reggio Emilia and Università di Modena and Reggio Emilia Reggio Emilia Italy

name: Hospital for Special Surgery New York New York

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

title: Glucocorticoid Dosages and Acute‐Phase Reactant Levels at Giant Cell Arteritis Flare in a Randomized Trial of Tocilizumab

ReferenceCitation: Strand V, Dimonaco S, Tuckwell K, Klearman M, Collinson N, Stone JH. Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial. Arthritis Res Ther. 2019 Feb 20;21(1):64. doi: 10.1186/s13075-019-1837-7.

ReferenceCitation: Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schett G, Schulze-Koops H, Spiera R, Unizony SH, Collinson N. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med. 2017 Jul 27;377(4):317-328. doi: 10.1056/NEJMoa1613849.

location_country:
Italy
United States
Sweden
Netherlands
Spain
Germany
France
Poland
Norway
Belgium
Portugal
Denmark
Canada
United Kingdom

location_facility: Università Degli Studi Di Genova - Dimi; Reumatologia

location_facility: University of Edinburgh; The Queens Medical Research Institute

location_facility: Hospital de Basurto; Servicio de Reumatologia

location_facility: Akademisch Ziekenhuis St. Radboud; Rheumatology

location_facility: University of Utah; Division of Rheumatology

location_facility: Rikshospitalet; Revmatologisk Avd Seksjon Barnerevmatologi

location_facility: Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

location_facility: Irccs San Raffele; Div Med Gen Immunologia Clinica

location_facility: Hospital Universitario de Canarias;servicio de Reumatologia

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Hospital Geral de Santo Antonio; Servico de Imunologia Clinica

location_facility: Haywood Hospital; Staffordshire Rheumatology Centre

location_facility: Karolinska Sjukhuset; Reumatologkliniken D2-1

location_facility: Nordsjællands Hospital - Hillerød;Department of Rheumatology 0731

location_facility: Universitätsklinikum Jena; Klinik für Innere Medizin III

location_facility: Royal Cornwall Hospital; Rhuematololgy Dept

location_facility: Hospital For Special Surgery; Dept of Medicine - Rheumatology

location_facility: Asheville Arthritis & Osteoporosis Center, PA

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

location_facility: Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Akademiska Sjukhuset; Lungmedicinska Kliniken

location_facility: Kreiskliniken Esslingen gGmbH Klinik Plochingen Medizinische Klinik

location_facility: Arcispedale Santa Maria Nuova; Reumatologia

location_facility: Univ of Calif., Los Angeles; Rheumatology

location_facility: Hopital Claude Huriez; Internal Medicine

location_facility: Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

location_facility: Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

location_facility: University of Barcelona; Dept. of Internal Medicine,

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Policlinico Univ. Uni Degli Sudi Di Udine; Clinica Di Reumatologia

location_facility: Rheumatology Assoc. of S. Florida - Clinical Research Center

location_facility: CHAPEL ALLERTON HOSPITAL; Unit of Musculoskeletal Disease

location_facility: Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II

location_facility: Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie

location_facility: Skånes Universitetssjukhus Malmö; Reumatologkliniken

location_facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie

location_facility: Southend Hospital; Rheumatology Department

location_facility: Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie

location_facility: Azienda Ospedaliera di Padova; Cattedra e Divisione di Reumatologia

location_facility: Old Queen Elizabeth Hospital; Pharmacy Building;Clinical Research offices

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie

location_facility: Colchester General Hospital; Aseptic Dept, Pharmacy Support Unit

location_facility: Hospital Universitari de Bellvitge; Servicio de Reumatologia


title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

summary: This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.

ReferenceCitation: Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.

ReferenceCitation: Kroenke MA, Weeraratne DK, Deng H, Sloey B, Subramanian R, Wu B, Serenko M, Hock MB. Clinical immunogenicity of the d-amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments. J Immunol Methods. 2017 Jun;445:37-44. doi: 10.1016/j.jim.2017.03.005. Epub 2017 Mar 6.

ReferenceCitation: Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.

ReferenceCitation: Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.

ReferenceCitation: Chen P, Narayanan A, Wu B, Gisleskog PO, Gibbs JP, Chow AT, Melhem M. Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis. Clin Pharmacokinet. 2018 Jan;57(1):71-85. doi: 10.1007/s40262-017-0550-4.

ReferenceCitation: Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.

ReferenceCitation: Cunningham J, Block GA, Chertow GM, Cooper K, Evenepoel P, Iles J, Sun Y, Ureña-Torres P, Bushinsky DA. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019 Apr 16;4(7):987-994. doi: 10.1016/j.ekir.2019.04.010. eCollection 2019 Jul.

ReferenceCitation: Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.

ReferenceCitation: Hain D, Tomlin H, Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrol Nurs J. 2019 May-Jun;46(3):315-290.

lead_sponsor: Amgen

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Czechia
Poland
Israel
Hungary
Belgium
Australia
Russian Federation
Spain
Canada


title: A Prospective Study of Sexual Function in Sexually Active Men Treated for BPH

summary:
This is an European double-blind, placebo controlled parallel group comparison of DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and placebo.

PRIMARY OBJECTIVE:

To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with DUODART, compared to men treated with placebo .

ReferenceCitation: Roehrborn CG, Manyak MJ, Palacios-Moreno JM, Wilson TH, Roos EPM, Santos JC, Karanastasis D, Plastino J, Giuliano F, Rosen RC. A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int. 2018 Apr;121(4):647-658. doi: 10.1111/bju.14057. Epub 2017 Nov 16.

name: Department of Urology; University of Texas (UT) Southwestern Medical Center; Dallas TX USA

family: Roehrborn

full_name: Claus G. Roehrborn

given: Claus G.

name: GlaxoSmithKline (GSK); Washington DC USA

family: Manyak

full_name: Michael J. Manyak

given: Michael J.

family: Palacios-Moreno

full_name: Juan Manuel Palacios-Moreno

given: Juan Manuel

family: Wilson

full_name: Timothy H. Wilson

given: Timothy H.

name: Antonius Ziekenhuis Sneek; Sneek The Netherlands

family: Roos

full_name: Erik P.M. Roos

given: Erik P.M.

name: Hospital Universitario Infanta Leonor; Madrid Spain

family: Santos

full_name: Javier Cambronero Santos

given: Javier Cambronero

name: Urologic Clinic; General Hospital of Athens ‘Elpis’; Athens Greece

family: Karanastasis

full_name: Dimitrios Karanastasis

given: Dimitrios

family: Plastino

full_name: Janet Plastino

given: Janet

name: Neuro-Urology R. Poincare Hospital AP-HP; Garches; UMR1179 Inserm-UVSQ-Paris Saclay University; Paris, France France

family: Giuliano

full_name: François Giuliano

given: François

name: New England Research Institutes; Watertown MA USA

family: Rosen

full_name: Raymond C. Rosen

given: Raymond C.

journal_name: BJU International

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country: Netherlands France Greece Hungary Australia Spain Germany


title: Interventional, Open-label Effectiveness Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder Comorbid With Generalized Anxiety Disorder

acronym: RECONNECT

summary: This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.

ipd_sharing: Undecided

lead_sponsor: H. Lundbeck A/S

location_country:
Italy
France
Poland
Spain
Estonia
Korea, Republic of

location_facility: Chonnam National University Hospital (KR0003)

location_facility: Niepubliczny Zaklad Opieki Psychiatrycznej Mentis (PL0004)

location_facility: Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k. (PL0007)

location_facility: Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0003)

location_facility: MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk (PL0009)

location_facility: NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. (PL0003)

location_facility: Cabinet du Docteur Karim Boutayeb (FR0001)

location_facility: Centrum Medyczne Luxmed Sp.Z O.O. (PL0006)

location_facility: Inje University Ilsan Paik Hospital (KR0002)

location_facility: Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0001)

location_facility: Cabinet du Docteur Patrick Bourgoin (FR0002)

location_facility: Instituto Internacional de Neurociencias Aplicadas (ES0001)


title: Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy

summary: stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

ReferenceCitation: Koole S, van Stein R, Sikorska K, Barton D, Perrin L, Brennan D, Zivanovic O, Mosgaard BJ, Fagotti A, Colombo PE, Sonke G, Driel WJV; OVHIPEC-2 Steering Committee and the Dutch OVHIPEC group. Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial. Int J Gynecol Cancer. 2020 Jun;30(6):888-892. doi: 10.1136/ijgc-2020-001231. Epub 2020 Mar 23.

family: Koole

full_name: Simone Koole

given: Simone

family: van Stein

full_name: Ruby van Stein

given: Ruby

family: Sikorska

full_name: Karolina Sikorska

given: Karolina

family: Barton

full_name: Desmond Barton

given: Desmond

family: Perrin

full_name: Lewis Perrin

given: Lewis

family: Brennan

full_name: Donal Brennan

given: Donal

family: Zivanovic

full_name: Oliver Zivanovic

given: Oliver

family: Mosgaard

full_name: Berit Jul Mosgaard

given: Berit Jul

family: Fagotti

full_name: Anna Fagotti

given: Anna

family: Colombo

full_name: Pierre-Emmanuel Colombo

given: Pierre-Emmanuel

family: Sonke

full_name: Gabe Sonke

given: Gabe

family: Driel

full_name: W J van Driel

given: W J van

journal_name: International Journal of Gynecologic Cancer

lead_sponsor: The Netherlands Cancer Institute

location_country:
Italy
Sweden
Netherlands
France
Ireland
Denmark
United States

location_facility: Institut de Cancerologie de l'Ouest, ICO Nantes)

location_facility: Mater Misericordiae University Hospital, Dublin

location_facility: Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse)


title: A Phase II, Open-Label, Multi-Centre, International Safety Study of Durvalumab Following Sequential Chemotherapy and Radiation Therapy in Patients With Stage III, Unresectable Non-Small Cell Lung Cancer (PACIFIC 6).

summary: This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) every 4 weeks [q4w] in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based sequential chemoradiation therapy (sCRT). This study will be conducted in Europe and North America.

status: Active, not recruiting

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: AstraZeneca

location_country:
Italy
United States
France
Spain
Germany
United Kingdom


title: An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations

summary: A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations ("OFF" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations ("OFF" Episodes)

ipd_sharing_description: IPD for this study may be made available upon request via the Clinical Study Data Request site.

lead_sponsor: Sunovion

location_country:
Italy
Austria
France
Spain
Germany
United Kingdom

location_facility: AOU San Giovanni di Dio e Ruggid'Aragona-CEMAND

location_facility: Universitatsklinikum Carol Gustav Carus an der TU dDresden, Klinik umd Poliklinik fur Neurologie

location_facility: IRCCS San Raffaele Pisana-Clinical Trial Center

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: Centre d'Investigation Clinique, CIC 43, CHU Purpan, Hopital Pierre-Paul Riquet, place du Dr. Baylac, Hall D, 2 eme etage -TSA

location_facility: 10W, Imperial Memory/PD Research Unit, Imperial College Healthcare NHS Trust

location_facility: Medical University Innsbruck, Neurolgy Dept

location_facility: St. Josef Hospital, Klnikum der Ruhr-Universitat-Bochum, Neurologische Klinik

location_facility: Hospital de la Santa Creu i Sant Pau c/Mas de Casanovas 90

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Wilhelminenspital, Department of Neurology

location_facility: Hopital la Timone, Neurologie et pathologie due mouvement

location_facility: Charite-University Medicine Berlin, Department of Neurology, Campus charite Mitte

location_facility: A.O.U. Universita degli Studi della Campania "Luigi Vanvitelli" Dipartamento di Scienze Mediche e Chirurgiche Avanzate

location_facility: CINAC, Hospital Universitario HB Pueta del Sur

location_facility: Istituto Clinico Humanitas, Dipartmento di Neurologia 1

location_facility: University Hospitals Plymouth NHS Trust-Derriford Hospital-The Lind Research Center, Level 5, Terence Lewis Building

location_facility: NHS Forth Valley, Pennine Actue NHS Trust, Fairfield General Hospital

location_facility: University Hospital Policlinico-Vittorio Emanuele, Department "G.F. Ingrassia", Section of Neurosciences

location_facility: Klinken Beelitz GmbH Neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson

location_facility: Hospital Universitario de Cruces, Neurology

location_facility: Academic Neuroscience Department, C Floor, South Block, Nottingham University Hospitals NHS Trust Queens Medical Centre

location_facility: St. Joseph Krankenhaus Berlin - Weissensee, Abteilung fur Neurologie


ReferenceCitation: Loebinger MR, Polverino E, Chalmers JD, Tiddens HAWM, Goossens H, Tunney M, Ringshausen FC, Hill AT, Pathan R, Angyalosi G, Blasi F, Elborn SJ, Haworth CS; iBEST-1 Trial Team. Efficacy and safety of TOBI Podhaler in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study. Eur Respir J. 2021 Jan 5;57(1). pii: 2001451. doi: 10.1183/13993003.01451-2020. Print 2021 Jan.

family: Loebinger

full_name: Michael R. Loebinger

given: Michael R.

family: Polverino

full_name: Eva Polverino

given: Eva

family: Chalmers

full_name: James D. Chalmers

given: James D.

family: Tiddens

full_name: Harm A.W.M. Tiddens

given: Harm A.W.M.

family: Goossens

full_name: Herman Goossens

given: Herman

family: Tunney

full_name: Michael Tunney

given: Michael

family: Ringshausen

full_name: Felix C. Ringshausen

given: Felix C.

family: Hill

full_name: Adam T. Hill

given: Adam T.

family: Pathan

full_name: Rashidkhan Pathan

given: Rashidkhan

family: Angyalosi

full_name: Gerhild Angyalosi

given: Gerhild

family: Blasi

full_name: Francesco Blasi

given: Francesco

family: Elborn

full_name: Stuart J. Elborn

given: Stuart J.

family: Haworth

full_name: Charles S. Haworth

given: Charles S.

journal_name: European Respiratory Journal

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

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ReferenceCitation: Loebinger MR, Polverino E, Blasi F, Elborn SJ, Chalmers JD, Tiddens HA, Goossens H, Tunney M, Zhou W, Angyalosi G, Hill AT, Haworth CS; iBEST-1 Trial Team. Efficacy and safety of tobramycin inhalation powder in bronchiectasis patients with P. aeruginosa infection: Design of a dose-finding study (iBEST-1). Pulm Pharmacol Ther. 2019 Oct;58:101834. doi: 10.1016/j.pupt.2019.101834. Epub 2019 Aug 18.

full_name: Harm AWM. Tiddens

given: Harm AWM.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Italy
France
Belgium
Spain
Germany
United Kingdom

title: A Randomized, Blinded, Parallel Group, Multi-center Dose-finding Study, to Assess the Efficacy, Safety and Tolerability of Different Doses of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection

summary: The purpose of this study was to support the selection of a safe and tolerable tobramycin inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P. aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa colonization.


title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-risk Kidney Allograft Recipients

summary: This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess the safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a preemptive approach for prevention of CMV disease. Participants will be randomized into two treatment groups: active or placebo control; both arms will be followed preemptively. The study has a planned enrollment of approximately 120 participants (60 active and 60 placebo).

ReferenceCitation: Deng R, Wang Y, Maia M, Burgess T, McBride JM, Liao XC, Tavel JA, Hanley WD. Pharmacokinetics and Exposure-Response Analysis of RG7667, a Combination of Two Anticytomegalovirus Monoclonal Antibodies, in a Phase 2a Randomized Trial To Prevent Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2018 Jan 25;62(2). pii: e01108-17. doi: 10.1128/AAC.01108-17. Print 2018 Feb.

name: Genentech, Inc., South San Francisco, California, USA

family: Deng

full_name: Rong Deng

given: Rong

family: Wang

full_name: Yehong Wang

given: Yehong

family: Maia

full_name: Mauricio Maia

given: Mauricio

family: Burgess

full_name: Tracy Burgess

given: Tracy

family: McBride

full_name: Jacqueline M. McBride

given: Jacqueline M.

family: Liao

full_name: X. Charlene Liao

given: X. Charlene

family: Tavel

full_name: Jorge A. Tavel

given: Jorge A.

family: Hanley

full_name: William D. Hanley

given: William D.

journal_name: Antimicrobial Agents and Chemotherapy

evidence: open (via free pdf)

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

ReferenceCitation: Ishida JH, Patel A, Mehta AK, Gatault P, McBride JM, Burgess T, Derby MA, Snydman DR, Emu B, Feierbach B, Fouts AE, Maia M, Deng R, Rosenberger CM, Gennaro LA, Striano NS, Liao XC, Tavel JA. Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2017 Jan 24;61(2). pii: e01794-16. doi: 10.1128/AAC.01794-16. Print 2017 Feb.

name: Department of Medicine, Division of Nephrology, University of California, San Francisco, California, USA

family: Ishida

full_name: Julie H. Ishida

given: Julie H.

name: Henry Ford Transplant Institute, Detroit, Michigan, USA

family: Patel

full_name: Anita Patel

given: Anita

name: Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA

family: Mehta

full_name: Aneesh K. Mehta

given: Aneesh K.

name: Department of Nephrology and Clinical Immunology, CHRU de Tours and EA 4245, University François Rabelais, Tours, France

family: Gatault

full_name: Philippe Gatault

given: Philippe

family: Derby

full_name: Michael A. Derby

given: Michael A.

name: Department of Medicine, Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts, USA

family: Snydman

full_name: David R. Snydman

given: David R.

family: Emu

location_country:
United States
Sweden
France
Norway
Belgium
Spain
Germany
United Kingdom

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

location_facility: University of Colorado Health Sciences Center; Dept of Medicine

location_facility: University of Cincinnati / University of Cincinnati College of Medicine

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Univ of CA San Francisco; Kidney Transplant Service

location_facility: CHU de Nantes; Institut de transplantation urologie-néphrologie

location_facility: Akademiska Sjukhuset; Transplantation Surgery

location_facility: Hopital Rangueil; Gastro Enterologie Et Nutrition

location_facility: Washington Uni School of Medicine/Barnes Jewish Hospital; Renal

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik III

location_facility: Universitätsklinikum Essen Zentrum f.Innere Medizin Abt.Nephrologie

location_facility: Erie County Medical Center; Dept. of Nephrology

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Georgetown Uni Hospital; Division of Transplant Surgery

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

location_facility: Henry Ford Health System; Gastroenterology


status: Terminated

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
United States
Canada
France

location_facility: John H. Stroger, Jr. Hospital Of Cook County

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Va Nebraska-Western Iowa Health Care System (Nwihcs)

location_facility: George Washington University Medical Faculty Associates

location_facility: The Ohio State University Wexner Medical Center

location_facility: Northeast Clinical Research Of San Antonio, Llc

location_facility: Health Sciences Centre Diabetes Research Centre

location_facility: Lmc Diabetes & Endocrinology (Thornhill)

title: A Double-Blind, Placebo-Controlled, Randomized, Two-stage, Parallel-Group, Adaptive Design Phase 2a Study to Evaluate the Effects of BMS-813160 in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (DKD) Who Have Residual Macroalbuminuria Despite Treatment With an Inhibitor of the Renin-Angiotensin System

summary: The purpose of this study is to determine whether BMS-813160 will reduce the amount of protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

summary: To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.

ReferenceCitation: Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6). pii: 18m12680. doi: 10.4088/JCP.18m12680.

family: Newcomer

full_name: John W. Newcomer

given: John W.

family: Eriksson

full_name: Hans Eriksson

given: Hans

family: Zhang

full_name: Peter Zhang

given: Peter

family: Meehan

full_name: Stine R. Meehan

given: Stine R.

family: Weiss

full_name: Catherine Weiss

given: Catherine

journal_name: The Journal of Clinical Psychiatry

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

ReferenceCitation: Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.

name: Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey (Drs Hobart, Zhang, and Weiss); H. Lundbeck A/S, Valby, Denmark (Drs Meehan and Eriksson)

family: Hobart

full_name: Mary Hobart

given: Mary

full_name: Stine Rasmussen Meehan

given: Stine Rasmussen

journal_name: International Journal of Neuropsychopharmacology

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

location_country:
United States
Serbia
France
Poland
Russian Federation
Germany
Canada


title: Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve

summary: The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

design_allocation: Non-Randomized

ReferenceCitation: Vahanian A, Urena M, Walther T, Treede H, Wendler O, Lefèvre T, Spence MS, Redwood S, Kahlert P, Rodes-Cabau J, Leipsic J, Webb J. Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial. EuroIntervention. 2016 Jun 12;12(2):e235-43. doi: 10.4244/EIJV12I2A37.

family: Vahanian

full_name: Alec Vahanian

given: Alec

family: Urena

full_name: Marina Urena

given: Marina

family: Walther

full_name: Thomas Walther

given: Thomas

family: Treede

full_name: Hendrik Treede

given: Hendrik

family: Wendler

full_name: Olaf Wendler

given: Olaf

family: Lefèvre

full_name: Thierry Lefèvre

given: Thierry

family: Spence

full_name: Mark S. Spence

given: Mark S.

family: Redwood

full_name: Simon Redwood

given: Simon

family: Kahlert

full_name: Philipp Kahlert

given: Philipp

family: Rodes-Cabau

full_name: Josep Rodes-Cabau

given: Josep

family: Leipsic

full_name: Jonathon Leipsic

given: Jonathon

family: Webb

full_name: John Webb

given: John

journal_name: EuroIntervention

publisher: Europa Digital & Publishing

publisher_dissemination: Europa Digital & Publishing

publisher_group: Europa Digital & Publishing

publisher_normalized: Europa Digital & Publishing

ReferenceCitation: Webb J, Gerosa G, Lefèvre T, Leipsic J, Spence M, Thomas M, Thielmann M, Treede H, Wendler O, Walther T. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014 Dec 2;64(21):2235-43. doi: 10.1016/j.jacc.2014.09.026. Epub 2014 Nov 24.

family: Gerosa

full_name: Gino Gerosa

given: Gino

full_name: Mark Spence

given: Mark

family: Thomas

full_name: Martyn Thomas

given: Martyn

family: Thielmann

full_name: Matthias Thielmann

given: Matthias

journal_name: Journal of the American College of Cardiology

title: Multicenter Evaluation of a Next-Generation Balloon-Expandable Transcatheter Aortic Valve

location_country:
Italy
France
Germany
United Kingdom
Canada

location_facility: Laval, Institut universitaire de cardiologie et de pneumologie de Quebec