title: Phase III Open-Label Randomized Study of Amonafide L-Malate in Combination With Cytarabine Compared to Daunorubicin in Combination With Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- The ACCEDE Study

summary:
Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML.

The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.

status: Unknown status

ReferenceCitation: Stone RM, Mazzola E, Neuberg D, Allen SL, Pigneux A, Stuart RK, Wetzler M, Rizzieri D, Erba HP, Damon L, Jang JH, Tallman MS, Warzocha K, Masszi T, Sekeres MA, Egyed M, Horst HA, Selleslag D, Solomon SR, Venugopal P, Lundberg AS, Powell B. Phase III open-label randomized study of cytarabine in combination with amonafide L-malate or daunorubicin as induction therapy for patients with secondary acute myeloid leukemia. J Clin Oncol. 2015 Apr 10;33(11):1252-7. doi: 10.1200/JCO.2014.57.0952. Epub 2015 Mar 2.

name: Richard M. Stone, Emanuele Mazzola, and Donna Neuberg, Dana-Farber Cancer Institute, Boston; Ante S. Lundberg, Antisoma, Cambridge, MA; Steven L. Allen, Hofstra North Shore–Long Island Jewish School of Medicine, Lake Success; Meir Wetzler, Roswell Park Cancer Institute, Buffalo; Martin S. Tallman, Memorial Sloan Kettering Cancer Center, New York, NY; Arnaud Pigneux, Hopital Haut-Leveque, Pessac, France; Robert K. Stuart, Medical University of South Carolina, Charleston, SC; David Rizzieri, Duke...

family: Stone

full_name: Richard M. Stone

given: Richard M.

family: Mazzola

full_name: Emanuele Mazzola

given: Emanuele

family: Neuberg

full_name: Donna Neuberg

given: Donna

family: Allen

full_name: Steven L. Allen

given: Steven L.

family: Pigneux

full_name: Arnaud Pigneux

given: Arnaud

family: Stuart

full_name: Robert K. Stuart

given: Robert K.

family: Wetzler

full_name: Meir Wetzler

given: Meir

family: Rizzieri

full_name: David Rizzieri

given: David

family: Erba

full_name: Harry P. Erba

given: Harry P.

family: Damon

full_name: Lloyd Damon

given: Lloyd

family: Jang

full_name: Jun-Ho Jang

given: Jun-Ho

family: Tallman

full_name: Martin S. Tallman

given: Martin S.

family: Warzocha

full_name: Krzysztof Warzocha

given: Krzysztof

family: Masszi

full_name: Tamás Masszi

given: Tamás

family: Sekeres

full_name: Mikkael A. Sekeres

given: Mikkael A.

family: Egyed

full_name: Miklos Egyed

given: Miklos

family: Horst

full_name: Heinz-August Horst

given: Heinz-August

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

family: Solomon

full_name: Scott R. Solomon

given: Scott R.

family: Venugopal

full_name: Parameswaran Venugopal

given: Parameswaran

family: Lundberg

full_name: Ante S. Lundberg

given: Ante S.

full_name: Bayard Powell

given: Bayard

publisher_group: American Society of Clinical Oncology (ASCO)

title: Phase III Open-Label Randomized Study of Cytarabine in Combination With Amonafide L-Malate or Daunorubicin As Induction Therapy for Patients With Secondary Acute Myeloid Leukemia

ReferenceCitation: Lindsley RC, Mar BG, Mazzola E, Grauman PV, Shareef S, Allen SL, Pigneux A, Wetzler M, Stuart RK, Erba HP, Damon LE, Powell BL, Lindeman N, Steensma DP, Wadleigh M, DeAngelo DJ, Neuberg D, Stone RM, Ebert BL. Acute myeloid leukemia ontogeny is defined by distinct somatic mutations. Blood. 2015 Feb 26;125(9):1367-76. doi: 10.1182/blood-2014-11-610543. Epub 2014 Dec 30.

name: Department of Medical Oncology, Division of Hematological Malignancies,

name: Department of Biostatistics and Computational Biology, Dana Farber Cancer Institute, Boston MA;

name: Division of Hematology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA;

name: Hofstra North Shore–LIJ School of Medicine, Hempstead, NY;

name: Hôpital Haut-Leveque, Centre Hospitalier Universitaire Bordeaux, Pessac, France;

name: Roswell Park Cancer Institute, Buffalo, NY;

name: Hollings Cancer Center, Medical University of South Carolina, Charleston, SC;

name: Division of Hematology and Oncology, University of Alabama, Birmingham, Birmingham, AL;

name: Helen Diller Family Comprehensive Cancer Center, The University of California, San Francisco, CA;

name: Comprehensive Cancer Center of Wake Forest University, Winston Salem, NC; and

name: Department of Pathology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA

location_country:
Romania
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
Ukraine
Ecuador
France
Poland
Argentina
Canada
Korea, Republic of
Chile
Hungary
Germany
United States
United Kingdom
Italy
Austria
Israel
Spain
Estonia

location_facility: M.I. Pyrohov Vinnytsya Regional Clinical Hospital

location_facility: State Medical Institution Irkutsk Regional Clinical Hospital

location_facility: State Higher Educational Instution Rostov State

location_facility: State Medical Institution Republican Hospital n.a. V.A. Baranov

location_facility: Northwestern University School of Medicine

location_facility: Instituto Ecuatoriano de Seguridad Social Hospital Regional Teodoro Maldonado Carbó

location_facility: Univ of Southern California Comprehensive Cancer Center

location_facility: State Medical Institution Territorial Clinical Oncological Center

location_facility: Federal Center of Heart, Blood and Endocrinology

location_facility: Teaching Hospital of the Medical University in Bialystok

location_facility: Fundeni Clinical Institute "Stefan Berceanu" Center for Hematology and Bone Marrow Transplant

location_facility: Università degli Studi di Roma "La Sapienza"

location_facility: Moscow State Medical Institution Municipal

location_facility: Markische Kliniken GmbH Klinikim Ludenscheid

location_facility: Szent Istvan and Szent Laszlo Corporate Hospital - Out-patient Clinic of the Municipality Government

location_facility: Poznan Stare Miasto Health Care Facility

location_facility: Ivano-Frankivsk State Medical University

location_facility: Academic Clinical Centre - Teaching Hospital of the Medical University of Gdansk

location_facility: State Medical Institution Sverdlovsk Regional Clinical Hospital #1

location_facility: LSU Health Sciences Center, Feist-Weiller Cancer Center

location_facility: Rocky Mountain Blood and Marrow Transplant Program

location_facility: Winship Cancer Institute, Emory University

location_facility: University of Colorado Health Sciences Center

location_facility: Brasov County Emergency Clinical Hospital

location_facility: Janusz Korczak Provincial Specialist Hospital

location_facility: Nicolaus Copernicus Provincial Specialist Hospital in Lodz

location_facility: University Hospital Kralovske Vinohrady Prague

location_facility: O.F. Herbachevsky Zhytomyr Regional Clinical Hospital

location_facility: Dnipropetrovsk City General Clinical Hospital #4

location_facility: Chinese Medical University Hospital (CMUH)

location_facility: National Taiwan University Hospital (NTUH)

location_facility: Sibiu County Clinical Hospital, Internal Clinic II

location_facility: Chang Gung Memorial Hospital Kao Hsiung Branch

location_facility: Independent Public University Hospital No. 1 in Wroclaw

location_facility: The Blood and Marrow Transplant Group of GA

location_facility: Veterans General Hospital Taipei (VGH-TP)

location_facility: Colentina Clinical Hospital, Internal Medicine Department

location_facility: State Institution 'Institute of Blood Pathology and Transfusion Medicine under the UAMS'

location_facility: National Cheng Kung University Hospital (NCKUH)

location_facility: Institute of Hematology and Transfusiology

location_facility: Public Institution 'Cherkasy Regional Oncology Center'

location_facility: Municipal Medical Institution Municipal Hospital #1

location_facility: State Medical Institution Territorial Clinical Hospital #1

location_facility: Hospital General de Agudos "Dr. Teodoro Alvarez"

location_facility: Institute of Haematology and Blood Transfusion Prague

location_facility: State Institution Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences

location_facility: Northshore Hospital - Monter Cancer Center

location_facility: Dr. Constantin Opris County Emergency Hospital, Internal Medicine Department

location_facility: State Medical Institution Leningrad Regional Clinical Hospital

location_facility: State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development


title: An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 Versus Placebo in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

acronym: EXAM

summary:
The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.

The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Schlumberger M, Elisei R, Müller S, Schöffski P, Brose M, Shah M, Licitra L, Krajewska J, Kreissl MC, Niederle B, Cohen EEW, Wirth L, Ali H, Clary DO, Yaron Y, Mangeshkar M, Ball D, Nelkin B, Sherman S. Overall survival analysis of EXAM, a phase III trial of cabozantinib in patients with radiographically progressive medullary thyroid carcinoma. Ann Oncol. 2017 Nov 1;28(11):2813-2819. doi: 10.1093/annonc/mdx479.

family: Schlumberger

full_name: M. Schlumberger

given: M.

sequence: first

family: Elisei

full_name: R. Elisei

given: R.

sequence: additional

family: Müller

full_name: S. Müller

given: S.

family: Schöffski

full_name: P. Schöffski

given: P.

family: Brose

full_name: M. Brose

family: Shah

full_name: M. Shah

family: Licitra

full_name: L. Licitra

given: L.

family: Krajewska

full_name: J. Krajewska

given: J.

family: Kreissl

full_name: M.C. Kreissl

family: Niederle

full_name: B. Niederle

given: B.

family: Cohen

full_name: E.E.W. Cohen

family: Wirth

full_name: L. Wirth

family: Ali

full_name: H. Ali

given: H.

family: Clary

full_name: D.O. Clary

family: Yaron

full_name: Y. Yaron

given: Y.

family: Mangeshkar

full_name: M. Mangeshkar

family: Ball

full_name: D. Ball

given: D.

family: Nelkin

full_name: B. Nelkin

family: Sherman

full_name: S. Sherman

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Elisei R, Schlumberger MJ, Müller SP, Schöffski P, Brose MS, Shah MH, Licitra L, Jarzab B, Medvedev V, Kreissl MC, Niederle B, Cohen EE, Wirth LJ, Ali H, Hessel C, Yaron Y, Ball D, Nelkin B, Sherman SI. Cabozantinib in progressive medullary thyroid cancer. J Clin Oncol. 2013 Oct 10;31(29):3639-46. doi: 10.1200/JCO.2012.48.4659. Epub 2013 Sep 3. Erratum in: J Clin Oncol. 2014 Jun 10;32(17):1864.

name: Rossella Elisei, University of Pisa, Pisa; Lisa Licitra, Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico-Istituto Nazionale dei Tumori, Milan, Italy; Martin J. Schlumberger, Institut Gustave Roussy, University Paris-Sud, Villejuif, France; Stefan P. Müller, Universitatsklinikum Essen, Essen; Michael C. Kreissl, Universitätsklinikum Würzburg, Würzburg, Germany; Patrick Schöffski, University Hospitals Leuven, Leuven, Belgium; Marcia S. Brose, University of Pennsylvania Abramson Cancer Center...

repositories:
LIRIAS (KU Leuven)
PubMed Central
arpi.unipi.it

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

publisher: American Society of Clinical Oncology (ASCO)

title: Cabozantinib in Progressive Medullary Thyroid Cancer

location_country:
Peru
Greece
Belgium
Russian Federation
Denmark
India
France
Poland
Canada
Korea, Republic of
Chile
Sweden
Saudi Arabia
Switzerland
Netherlands
Portugal
United States
Germany
United Kingdom
Italy
Austria
Brazil
Israel
Spain

location_facility: Hospital of the University of Pennsylvania

location_facility: University of Alabama at Birmingham, Comprehensive Cancer Center

location_facility: Indo-American Cancer Institute and Research Center

location_facility: Deenanath Mangeshkar Hospital & Research Center

location_facility: TGEN Clinical Research Service at Scottsdale Healthcare

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen

location_facility: University of Arkansas for Medical Sciences

location_facility: Washington University School of Medicine

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: H. Lee Moffet Cancer Center and Research Institute

location_facility: Vermont Cancer Center at Fletcher Allen Health Care

location_facility: Capitol Comprehensive Cancer Care Clinic and Research Institute

location_facility: Netaji Subhash Chandra Bose Cancer Hospital Research Institute

location_facility: Klinik fuer Nuklearmedizin des Universitaetsklinikums Essen

location_facility: Ohio State University, James Cancer Hospital

location_facility: SEAROC Cancer Institute, S.K. Soni Hospital


ReferenceCitation: Tanaka Y, Escobar R, Upadhyaya HP. Assessment of effects of atomoxetine in adult patients with ADHD: consistency among three geographic regions in a response maintenance study. Atten Defic Hyperact Disord. 2017 Jun;9(2):113-120. doi: 10.1007/s12402-016-0212-7. Epub 2017 Jan 6.

family: Tanaka

full_name: Yoko Tanaka

given: Yoko

family: Escobar

full_name: Rodrigo Escobar

given: Rodrigo

family: Upadhyaya

full_name: Himanshu P. Upadhyaya

given: Himanshu P.

journal_name: ADHD Attention Deficit and Hyperactivity Disorders

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Upadhyaya H, Tanaka Y, Lipsius S, Kryzhanovskaya LA, Lane JR, Escobar R, Trzepacz PT, Allen AJ. Time-to-onset and -resolution of adverse events before/after atomoxetine discontinuation in adult patients with ADHD. Postgrad Med. 2015;127(7):677-85. doi: 10.1080/00325481.2015.1083394. Epub 2015 Sep 2.

full_name: Himanshu Upadhyaya

given: Himanshu

family: Lipsius

full_name: Sarah Lipsius

given: Sarah

family: Kryzhanovskaya

full_name: Ludmila A Kryzhanovskaya

given: Ludmila A

family: Lane

full_name: Jeannine R Lane

given: Jeannine R

family: Trzepacz

full_name: Paula T Trzepacz

given: Paula T

family: Allen

full_name: Albert J Allen

given: Albert J

journal_name: Postgraduate Medicine

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Upadhyaya H, Adler LA, Casas M, Kutzelnigg A, Williams D, Tanaka Y, Arsenault J, Escobar R, Allen AJ. Baseline characteristics of European and non-European adult patients with attention deficit hyperactivity disorder participating in a placebo-controlled, randomized treatment study with atomoxetine. Child Adolesc Psychiatry Ment Health. 2013 May 6;7(1):14. doi: 10.1186/1753-2000-7-14.

family: Adler

full_name: Lenard A Adler

given: Lenard A

family: Casas

full_name: Miguel Casas

given: Miguel

family: Kutzelnigg

full_name: Alexandra Kutzelnigg

given: Alexandra

family: Williams

full_name: David Williams

given: David

family: Arsenault

full_name: Jody Arsenault

given: Jody

journal_name: Child and Adolescent Psychiatry and Mental Health

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Spain
Finland
France
Belgium
Portugal
Germany
United Kingdom

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

title: Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study

summary: LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).


intervention_type: Drug

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
France
Japan
Poland
Argentina
Korea, Republic of
Chile
Hong Kong
Bulgaria
Hungary
China
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Israel
Spain

acronym: EXPAND

location_facility:
Research site
Research Site

type: EudraCT Number

source: euctr

title: Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction

summary:
The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).

Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes

summary: This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

ReferenceCitation: Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31. Erratum in: Drugs Aging. 2021 Apr 23;:.

family: Liao

full_name: Solomon S. Liao

given: Solomon S.

family: Slatkin

full_name: Neal E. Slatkin

given: Neal E.

family: Stambler

full_name: Nancy Stambler

given: Nancy

journal_name: Drugs & Aging

license_normalized: no license

repository_normalized: California Digital Library - eScholarship

evidence: oa repository (via pmcid lookup)

ReferenceCitation: Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. Epub 2016 Aug 29. Erratum in: Ann Oncol. 2018 Apr 1;29(4):1076.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Italy
United States
Brazil
Sweden
Mexico
Germany
France
Belgium
Australia
Spain
Canada
United Kingdom

location_facility:
Salix Investigational Site
Pfizer Investigational Site


design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Hong Kong
Germany
France
Singapore
Belgium
Australia
Canada
United Kingdom
Korea, Republic of

location_facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)

location_facility: St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)

location_facility: Wake Forest University Baptist Medical Center Dept. of Industry Research (2)

title: A Phase IA/II, Multi-center, Open-label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies (CHIR-12.12-LYM-01)

summary: This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.


lead_sponsor: Astellas Pharma Inc

location_country:
Switzerland
United Kingdom
France
Romania
Belgium
Germany
Czech Republic

acronym: ASTER

title: Protocol for a Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week Treatment, Adaptive Proof-of-principle Study of Twice Daily Oral Dosing of a Novel PDE4 Inhibitor (ASP9831) in Subjects With Non-alcoholic Steatohepatitis (NASH)

summary: The aim of this study is to explore the effect of a new drug (ASP9831) in patients with non-alcoholic steatohepatitis (NASH) by assessing clinical signs, laboratory data and biomarkers during a 12 week treatment period


status: Terminated

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
Finland
France
Greece
Lithuania
Slovakia
Hungary
Belgium
Estonia
Denmark
Canada
Latvia
Korea, Republic of

acronym: 48-week comparison of Tiotropium/Salmeterol Inhalation Powder with the individual components

location_facility: 1184.14.01012 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3301A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36005 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.35802 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.82001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01018 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.82002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37102 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.43001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.35801 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49008 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01011 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.46003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01021 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02010 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01013 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37103 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01005 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.30006 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3303A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.45001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.30004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02007 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.46002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49006 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01009 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02005 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01007 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01015 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01017 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.32001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01014 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3302A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01008 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01022 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.39001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3303C Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37202 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.30001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02008 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3304A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37101 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.42103 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01020 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01019 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37201 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.46001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.32004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3303B Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49007 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01010 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.45002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.82003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01006 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36002 Boehringer Ingelheim Investigational Site

title: 1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

summary: The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined by the SGRQ and the effect on COPD exacerbations.

status_simplified: Unknown


title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults

summary: To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.

lead_sponsor: Pfizer

location_country:
Italy
United States
India
Netherlands
Finland
France
Norway
Belgium
Germany
United Kingdom


type: Other Identifier

title: Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

acronym: VITAL

summary: The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.

study_start_date_type: Actual

ReferenceCitation: Kovanda LL, Desai AV, Lu Q, Townsend RW, Akhtar S, Bonate P, Hope WW. Isavuconazole Population Pharmacokinetic Analysis Using Nonparametric Estimation in Patients with Invasive Fungal Disease (Results from the VITAL Study). Antimicrob Agents Chemother. 2016 Jul 22;60(8):4568-76. doi: 10.1128/AAC.00514-16. Print 2016 Aug.

name: Antimicrobial Pharmacodynamics and Therapeutics, Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom

name: Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA

family: Kovanda

full_name: Laura L. Kovanda

given: Laura L.

family: Desai

full_name: Amit V. Desai

given: Amit V.

family: Lu

full_name: Qiaoyang Lu

given: Qiaoyang

family: Townsend

full_name: Robert W. Townsend

given: Robert W.

family: Akhtar

full_name: Shahzad Akhtar

given: Shahzad

family: Bonate

full_name: Peter Bonate

given: Peter

family: Hope

full_name: William W. Hope

given: William W.

journal_name: Antimicrobial Agents and Chemotherapy

license: cc-by

license_normalized: cc-by

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

ReferenceCitation: Thompson GR 3rd, Rendon A, Ribeiro Dos Santos R, Queiroz-Telles F, Ostrosky-Zeichner L, Azie N, Maher R, Lee M, Kovanda L, Engelhardt M, Vazquez JA, Cornely OA, Perfect JR. Isavuconazole Treatment of Cryptococcosis and Dimorphic Mycoses. Clin Infect Dis. 2016 Aug 1;63(3):356-62. doi: 10.1093/cid/ciw305. Epub 2016 May 11.

family: Thompson

full_name: George R. Thompson

given: George R.

suffix: III

family: Rendon

full_name: Adrian Rendon

given: Adrian

family: Ribeiro dos Santos

full_name: Rodrigo Ribeiro dos Santos

family: Queiroz-Telles

full_name: Flavio Queiroz-Telles

given: Flavio

family: Ostrosky-Zeichner

full_name: Luis Ostrosky-Zeichner

given: Luis

family: Azie

full_name: Nkechi Azie

given: Nkechi

family: Maher

full_name: Rochelle Maher

given: Rochelle

family: Lee

full_name: Misun Lee

given: Misun

repositories: California Digital Library - eScholarship

ReferenceCitation: Marty FM, Ostrosky-Zeichner L, Cornely OA, Mullane KM, Perfect JR, Thompson GR 3rd, Alangaden GJ, Brown JM, Fredricks DN, Heinz WJ, Herbrecht R, Klimko N, Klyasova G, Maertens JA, Melinkeri SR, Oren I, Pappas PG, Ráčil Z, Rahav G, Santos R, Schwartz S, Vehreschild JJ, Young JH, Chetchotisakd P, Jaruratanasirikul S, Kanj SS, Engelhardt M, Kaufhold A, Ito M, Lee M, Sasse C, Maher RM, Zeiher B, Vehreschild MJGT; VITAL and FungiScope Mucormycosis Investigators. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect Dis. 2016 Jul;16(7):828-837. doi: 10.1016/S1473-3099(16)00071-2. Epub 2016 Mar 9.

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

location_country:
Brazil
Chile
South Africa
India
Lebanon
Mexico
Germany
France
Korea, Republic of
Poland
Israel
Thailand
Belgium
Argentina
Australia
Egypt
Russian Federation
United States
Canada

location_facility: Hospital de Clinicas da FMUSP - Ribeirao Preto

location_facility: Fred Hutchinson Cancer Research Center, Clinical Research

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Upstate Infectious Diseases Association LLP

location_facility: University of Chicago, Division of Infectious Diseases

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador

location_facility: Tata Memorial Hopital, Department of Anesthesia

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Regional Infection Diseases Infusion Center Inc.

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: University Of Colorado Health Sciences Center

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Republican Hospital named after V.A. Baranov

location_facility: Hospital Nuestra Senora de la Misericordia

location_facility: Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Shirdi Sai Baba Cancer Hospital K. M. C. Hospital

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Hospital Universitario Clementino Fraga Filho

location_facility: University of California Davis Health System

location_facility: Wayne State University School of Medicine

location_facility: Hamilton Health Sciences - Henderson Site

location_facility: State Institution "Hematology Research Center" RAMS

location_facility: American University of Beirut Medical Center

location_facility: Hadassah Universtiy Hospital - Ein Kerem

location_facility: University of California at San Francisco

location_facility: Hospital Central Dr Ignacio Morones Prieto


title: A Phase III Randomised Study Comparing Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer.

summary: The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.

lead_sponsor: European Lung Cancer Working Party

location_country: Spain Belgium France Greece

location_facility: Department of Pneumology Centre Hospitalier de Mouscron

location_facility: Department of Pneumology Clinique Saint-Luc

location_facility: Service de Pneumologie Centre Hospitalier de Douai

location_facility: Department of Pneumology CHR St Joseph-Warquignies

location_facility: Department of Pneumology RHMS Hôpital de la Madeleine

location_facility: Service de Pneumologie Hôpital de Hayange

location_facility: Department of Pneumology Hôpital Saint-Joseph

location_facility: Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil

location_facility: Department of Pneumology Hospital Ixelles-Molière

location_facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet


ReferenceType: background

ReferenceCitation: Daviskas E, Anderson SD. Hyperosmolar agents and clearance of mucus in the diseased airway. J Aerosol Med. 2006 Spring;19(1):100-9. Review.

ReferenceCitation: Daviskas E, Anderson SD, Gomes K, Briffa P, Cochrane B, Chan HK, Young IH, Rubin BK. Inhaled mannitol for the treatment of mucociliary dysfunction in patients with bronchiectasis: effect on lung function, health status and sputum. Respirology. 2005 Jan;10(1):46-56.

ReferenceCitation: Daviskas E, Robinson M, Anderson SD, Bye PT. Osmotic stimuli increase clearance of mucus in patients with mucociliary dysfunction. J Aerosol Med. 2002 Fall;15(3):331-41. Review.

ReferenceCitation: Robinson M, Bye PT. Mucociliary clearance in cystic fibrosis. Pediatr Pulmonol. 2002 Apr;33(4):293-306. Review.

ReferenceCitation: Daviskas E, Anderson SD, Eberl S, Chan HK, Young IH. The 24-h effect of mannitol on the clearance of mucus in patients with bronchiectasis. Chest. 2001 Feb;119(2):414-21.

ReferenceCitation: Robinson M, Daviskas E, Eberl S, Baker J, Chan HK, Anderson SD, Bye PT. The effect of inhaled mannitol on bronchial mucus clearance in cystic fibrosis patients: a pilot study. Eur Respir J. 1999 Sep;14(3):678-85.

ReferenceCitation: Daviskas E, Anderson SD, Eberl S, Chan HK, Bautovich G. Inhalation of dry powder mannitol improves clearance of mucus in patients with bronchiectasis. Am J Respir Crit Care Med. 1999 Jun;159(6):1843-8.

ReferenceCitation: Daviskas E, Anderson SD, Brannan JD, Chan HK, Eberl S, Bautovich G. Inhalation of dry-powder mannitol increases mucociliary clearance. Eur Respir J. 1997 Nov;10(11):2449-54.

ReferenceCitation: Jaques A, Daviskas E, Turton JA, McKay K, Cooper P, Stirling RG, Robertson CF, Bye PTP, LeSouëf PN, Shadbolt B, Anderson SD, Charlton B. Inhaled mannitol improves lung function in cystic fibrosis. Chest. 2008 Jun;133(6):1388-1396. doi: 10.1378/chest.07-2294. Epub 2008 Mar 13.

ReferenceCitation: Nevitt SJ, Thornton J, Murray CS, Dwyer T. Inhaled mannitol for cystic fibrosis. Cochrane Database Syst Rev. 2020 May 1;5:CD008649. doi: 10.1002/14651858.CD008649.pub4.

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

family: Nevitt

full_name: Sarah J Nevitt

given: Sarah J

name: Centre for Clinical Practice; National Institute for Health and Care Excellence; Manchester UK

family: Thornton

full_name: Judith Thornton

given: Judith

name: Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair; University of Manchester and University Hospital of South Manchester; Manchester UK

family: Murray

full_name: Clare S Murray

given: Clare S

name: Central Clinical School, Sydney Medical School; University of Sydney; Sydney Australia

name: Discipline of Physiotherapy, Faculty of Health Sciences; University of Sydney; Sydney Australia

family: Dwyer

full_name: Tiffany Dwyer

given: Tiffany

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Inhaled mannitol for cystic fibrosis

ReferenceCitation: Aitken ML, Bellon G, De Boeck K, Flume PA, Fox HG, Geller DE, Haarman EG, Hebestreit HU, Lapey A, Schou IM, Zuckerman JB, Charlton B; CF302 Investigators. Long-term inhaled dry powder mannitol in cystic fibrosis: an international randomized study. Am J Respir Crit Care Med. 2012 Mar 15;185(6):645-52. doi: 10.1164/rccm.201109-1666OC. Epub 2011 Dec 28.

family: Aitken

full_name: Moira L. Aitken

given: Moira L.

family: Bellon

full_name: Gabriel Bellon

given: Gabriel

family: De Boeck

full_name: Kris De Boeck

given: Kris

family: Flume

full_name: Patrick A. Flume

given: Patrick A.

family: Fox

full_name: Howard G. Fox

given: Howard G.

family: Geller

full_name: David E. Geller

given: David E.

family: Haarman

full_name: Eric G. Haarman

given: Eric G.

family: Hebestreit

full_name: Helge U. Hebestreit

given: Helge U.

family: Lapey

full_name: Allen Lapey

given: Allen

family: Schou

full_name: I. Manjula Schou

given: I. Manjula

family: Zuckerman

full_name: Jonathan B. Zuckerman

given: Jonathan B.

family: Charlton

full_name: Brett Charlton

given: Brett

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Long-Term Inhaled Dry Powder Mannitol in Cystic Fibrosis

location_country:
United States
Netherlands
Germany
France
Belgium
Argentina
Canada

location_facility: Hospital de Ninos del la Santisima Trinidad

location_facility: Hospital de Ninos Superiora Sor Maria Ludovica de La Plata

location_facility: Central Connecticut Cystic Fibrosis Center

location_facility: Nebraska Medical Center - Nebraska Regional CF Center

location_facility: Hospital Gral. de Ninos Pedro de Elizalde

location_facility: Christus Santa Rosa Children's Hospital Cystic Fibrosis Center

location_facility: University of Munich Medizinischen Klinik Innenstadt

location_facility: Clinica Universitaria Privada Reina Fabiola - Universidad Cotolica de Cordoba

location_facility: Universitats Kinderklinik Tubungen Wurzburg

location_facility: Louisiana State University Health Sciences Center

location_facility: Hospital de Ninos Dr Ricardo Gutierrez, Pediatria

location_facility: The Toledo Hospital and Toledo Childrens Hospital

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital Interzonal Dr Jose Penna Bahia Blanca

location_facility: Batchelor Children's Research Institute - University of Miami

title: Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study

summary: The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.


ReferenceCitation: van den Bent MJ, Tesileanu CMS, Wick W, Sanson M, Brandes AA, Clement PM, Erridge S, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Rogers L, Taal W, Rudà R, Weller M, McBain C, Reijneveld J, Enting RH, Caparrotti F, Lesimple T, Clenton S, Gijtenbeek A, Lim E, Herrlinger U, Hau P, Dhermain F, de Heer I, Aldape K, Jenkins RB, Dubbink HJ, Kros JM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, French P, Baumert BG. Adjuvant and concurrent temozolomide for 1p/19q non-co-deleted anaplastic glioma (CATNON; EORTC study 26053-22054): second interim analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2021 Jun;22(6):813-823. doi: 10.1016/S1470-2045(21)00090-5. Epub 2021 May 14.

family: van den Bent

full_name: Martin J van den Bent

given: Martin J

family: Tesileanu

full_name: C Mircea S Tesileanu

given: C Mircea S

family: Wick

full_name: Wolfgang Wick

given: Wolfgang

family: Sanson

full_name: Marc Sanson

given: Marc

family: Brandes

full_name: Alba Ariela Brandes

given: Alba Ariela

family: Clement

full_name: Paul M Clement

given: Paul M

family: Erridge

full_name: Sarah Erridge

given: Sarah

family: Vogelbaum

full_name: Michael A Vogelbaum

given: Michael A

family: Nowak

full_name: Anna K Nowak

given: Anna K

family: Baurain

full_name: Jean Français Baurain

given: Jean Français

family: Mason

full_name: Warren P Mason

given: Warren P

family: Wheeler

full_name: Helen Wheeler

given: Helen

family: Chinot

full_name: Olivier L Chinot

given: Olivier L

family: Gill

full_name: Sanjeev Gill

given: Sanjeev

family: Griffin

full_name: Matthew Griffin

given: Matthew

family: Rogers

full_name: Leland Rogers

given: Leland

family: Taal

full_name: Walter Taal

given: Walter

family: Rudà

full_name: Roberta Rudà

given: Roberta

family: Weller

full_name: Michael Weller

given: Michael

family: McBain

full_name: Catherine McBain

given: Catherine

family: Reijneveld

full_name: Jaap Reijneveld

given: Jaap

family: Enting

full_name: Roelien H Enting

given: Roelien H

family: Caparrotti

full_name: Francesca Caparrotti

given: Francesca

family: Lesimple

full_name: Thierry Lesimple

given: Thierry

family: Clenton

full_name: Susan Clenton

given: Susan

ReferenceCitation: van den Bent MJ, Baumert B, Erridge SC, Vogelbaum MA, Nowak AK, Sanson M, Brandes AA, Clement PM, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Brachman DG, Taal W, Rudà R, Weller M, McBain C, Reijneveld J, Enting RH, Weber DC, Lesimple T, Clenton S, Gijtenbeek A, Pascoe S, Herrlinger U, Hau P, Dhermain F, van Heuvel I, Stupp R, Aldape K, Jenkins RB, Dubbink HJ, Dinjens WNM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, Wick W, Kros JM. Interim results from the CATNON trial (EORTC study 26053-22054) of treatment with concurrent and adjuvant temozolomide for 1p/19q non-co-deleted anaplastic glioma: a phase 3, randomised, open-label intergroup study. Lancet. 2017 Oct 7;390(10103):1645-1653. doi: 10.1016/S0140-6736(17)31442-3. Epub 2017 Aug 8. Erratum in: Lancet. 2017 Oct 7;390(10103):1644.

repository_institution: University of Zurich - Zurich Open Repository and Archive

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

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Israel
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: Memorial Health University Medical Center

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Akron City Hospital - Summa Health System

location_facility: UPMC - Heritage Valley Health System - The Medical Center

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Hopital Cantonal Universitaire De Geneve

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Cancer Centers of the Carolinas - Eastside

location_facility: State University of New York Upstate Medical University

location_facility: Assistance Publique - Hôpitaux de Marseille - C.H.U. De La Timone

location_facility: Erasmus MC - Daniel den Hoed Cancer Center

location_facility: Massachussets General Hospital Cancer Center

location_facility: University Of Wisconsin Comprehensive Cancer Center

location_facility: Maastro Clinic - Maastricht Radiation Oncology

location_facility: ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Nottingham University Hospitals NHS Trust - City Hospital campus

location_facility: Cancer Centers of the Carolinas - Greer Radiation Oncology

location_facility: Azienda Ospedaliera San Giovanni Battista Di Torino-Universita Di Torino

location_facility: Froedtert and the Medical College of Wisconsin

location_facility: Dixie Medical Center Regional Cancer Center

location_facility: Cancer Centers of the Carolinas - Seneca

location_facility: University Of Utah - Huntsman Cancer Institute

location_facility: University of Rochester - James P. Wilmot Cancer Center

location_facility: Cancer Centers of the Carolinas - Faris Road

location_facility: University Health Network - Oci / Princess Margaret Hospital

location_facility: Southwest General Health Center Ireland Cancer Center

location_facility: UCSF University of California San Francisco Medical Center-Mount Zion

title: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.

PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.


title: PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-coated Coils

acronym: PRET

summary: The PRET study aims at comparing two types of coils used in the endovascular treatment of intracranial aneurysms. The first type made of platinum has been used for more than 15 years. The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET study is that the newer hydrocoil will be more effective and yet as safe as the older platinum coil.

ReferenceCitation: Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2.

family: Naggara

full_name: Olivier Naggara

given: Olivier

family: Darsaut

full_name: Tim Darsaut

given: Tim

family: Trystram

full_name: Denis Trystram

given: Denis

family: Tselikas

full_name: Lambros Tselikas

given: Lambros

family: Raymond

full_name: Jean Raymond

given: Jean

journal_name: The Lancet Neurology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country:
Chile
France
Japan
United States
United Kingdom
Canada

location_facility: CHU de Nantes - Hôpital Guillaume et René Laennec

location_facility: Stony Brook University Medical Center (SUNY)

location_facility: Kobe City Medical Center General Hospital

location_facility: Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital

location_facility: University of Wisconsin Hospital and Clinics

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: University of Oklahoma Health Sciences Center

intervention_type: Procedure

lead_sponsor_type: academique


title: A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)

acronym: APRIL-SLE

summary: This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.

ReferenceCitation: Isenberg D, Gordon C, Licu D, Copt S, Rossi CP, Wofsy D. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis. 2015 Nov;74(11):2006-15. doi: 10.1136/annrheumdis-2013-205067. Epub 2014 Jun 20. Erratum in: Ann Rheum Dis. 2016 May;75(5):946.

apc_source: openAPC

family: Isenberg

full_name: David Isenberg

given: David

family: Gordon

full_name: Caroline Gordon

given: Caroline

family: Licu

full_name: Daiana Licu

given: Daiana

family: Copt

full_name: Samuel Copt

given: Samuel

family: Rossi

full_name: Claudia Pena Rossi

given: Claudia Pena

family: Wofsy

full_name: David Wofsy

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

repository_institution: University of California - eScholarship University of California

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

location_country:
Malaysia
Greece
Australia
Russian Federation
Czech Republic
Taiwan
Ukraine
India
Croatia
France
Lithuania
Poland
Argentina
Korea, Republic of
South Africa
Switzerland
Netherlands
Philippines
Bulgaria
Germany
United States
United Kingdom
Austria
Serbia
Lebanon
Mexico
Israel
Spain
Latvia

location_facility: Feinstein Institute for Medical Research

location_facility: Division of Clinical Immunology and Rheumatology - UAB

location_facility: University of Cincinnati Medical Center, Division of Immunology


title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Enzastaurin With 5-FU/LV Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colorectal Cancer

summary: This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients with Metastatic Colorectal Cancer.

ReferenceCitation: Wolff RA, Fuchs M, Di Bartolomeo M, Hossain AM, Stoffregen C, Nicol S, Heinemann V. A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. Cancer. 2012 Sep 1;118(17):4132-8. doi: 10.1002/cncr.26692. Epub 2011 Dec 27.

family: Wolff

full_name: Robert A. Wolff

given: Robert A.

family: Fuchs

full_name: Martin Fuchs

given: Martin

family: Di Bartolomeo

full_name: Maria Di Bartolomeo

given: Maria

family: Hossain

full_name: Anwar M. Hossain

given: Anwar M.

family: Stoffregen

full_name: Clemens Stoffregen

given: Clemens

family: Nicol

full_name: Steven Nicol

given: Steven

family: Heinemann

full_name: Volker Heinemann

given: Volker

journal_name: Cancer

oa_host_type: publisher

evidence: open (via free pdf)

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Austria
Germany
France
Puerto Rico
United States

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group Polysomnography Study to Assess the Efficacy and Safety of a 16-day Oral Administration of ACT-078573 in Adult Subjects With Chronic Primary Insomnia

acronym: RESTORA 1

summary: A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

ReferenceCitation: Black J, Pillar G, Hedner J, Polo O, Berkani O, Mangialaio S, Hmissi A, Zammit G, Hajak G. Efficacy and safety of almorexant in adult chronic insomnia: a randomized placebo-controlled trial with an active reference. Sleep Med. 2017 Aug;36:86-94. doi: 10.1016/j.sleep.2017.05.009. Epub 2017 May 29.

family: Black

full_name: Jed Black

given: Jed

family: Pillar

full_name: Giora Pillar

given: Giora

family: Hedner

full_name: Jan Hedner

given: Jan

family: Polo

full_name: Olli Polo

given: Olli

family: Berkani

full_name: Ouali Berkani

given: Ouali

family: Mangialaio

full_name: Sara Mangialaio

given: Sara

family: Hmissi

full_name: Abdel Hmissi

given: Abdel

family: Zammit

full_name: Gary Zammit

given: Gary

family: Hajak

full_name: Goran Hajak

given: Goran

journal_name: Sleep Medicine

lead_sponsor: Midnight Pharma, LLC

location_country:
Italy
Austria
South Africa
Sweden
Switzerland
United Kingdom
Finland
France
Bulgaria
Poland
Israel
Slovakia
Hungary
Australia
Belgium
Spain
Denmark
Germany
Czech Republic
Ukraine

location_facility: Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie

location_facility: Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie und Psychotherapie

location_facility: CH Jolimont / Sleep Disorders Center, Hospital de Jolimont

location_facility: Burnside Hospital Clinical Trials Centre

location_facility: Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica

location_facility: Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology

location_facility: Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH

location_facility: Soroka University Medical Center, Unit for Sleep Research

location_facility: Centrum pro poruchy spanku a bdeni, Neurologicka klinika

location_facility: Laboratorium Diagnostyka Snu, Pro-Medica

location_facility: Institute for Breathing and Sleep (IBAS)

location_facility: IRCCS Neurologico Casimiro Mondino, Centro Multidisciplinare di Medicina del Sonno, Servizio di Neurofisiopatologia

location_facility: IRCCS Fondazione San Raffaele del Monte Tabor, Centro per i Disturbi del Sonno

location_facility: Technion Sleep Medicine Center, Rambam Medical Center

location_facility: Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG

location_facility: Centro del Sonno, Dipartimento di Neuroscienze, Clinica Neuroligica, Università di Pisa

location_facility: Department of Neurology , University of Debrecen

location_facility: Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris

location_facility: Örebro University Hospital, Neurology department Sleep Unit

location_facility: Sleep Disorders Laboratory, Royal Adelaide Hospital

location_facility: Sleep Disorder Centre, State Health Centre

location_facility: Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej

location_facility: University of Turku, Sleep Research Unit

location_facility: Neurologicka klinika, FN L. Pasteura Kosice

location_facility: KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna

location_facility: University of Vienna - Department of Neurology

location_facility: Monash Adult Sleep Center, Monash Medical Centre

location_facility: Medical University of Innsbruck, Department of Neurology

location_facility: National Medical University n.a. O.O. BohomoletsChair of Diseases of Nervous System, City Clinical Hospital No.4, Neurological Departments I and II

location_facility: Westmead Hospital, Department of Respiratory

location_facility: Hospital Son Dureta, Unidad de Psicologia

location_facility: Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee

location_facility: Poradna pro porchy spanku a spankova, Laborator Unimeds s.r.o.

location_facility: Oddeleni nasledne pece, Nemocnice Ceske Budejovice

location_facility: Hospital La Fe, Unidad de Neurofisiologi

location_facility: Australian Clinical Research Organisation

location_facility: Service de Neurologie B, Hopital Gui de Chauliac

location_facility: Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg

location_facility: The Woolcock Institute of Medical Research

location_facility: I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto

location_facility: Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY

location_facility: Hospital MAZ, Unidad de Neurofisiologia y Sueno

location_facility: University Hospital Zurich (USZ) Neurology Polyclinic, Center for Sleep Medicine

location_facility: WITS Sleep Laboratory School of Physiology

location_facility: Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu


title: A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Patients With Active Rheumatoid Arthritis Who Have Previously Had an Inadequate Response to One or More TNF Antagonist Therapies

summary: This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Peru
Sweden
Netherlands
France
Norway
Argentina
Spain
Denmark
Germany
United Kingdom
Korea, Republic of


ReferenceCitation: Bateman ED, Bleecker ER, Lötvall J, Woodcock A, Forth R, Medley H, Davis AM, Jacques L, Haumann B, Busse WW. Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial. Respir Med. 2012 May;106(5):642-50. doi: 10.1016/j.rmed.2012.01.004. Epub 2012 Feb 18.

ReferenceCitation: Psaila B, Bussel JB, Linden MD, Babula B, Li Y, Barnard MR, Tate C, Mathur K, Frelinger AL, Michelson AD. In vivo effects of eltrombopag on platelet function in immune thrombocytopenia: no evidence of platelet activation. Blood. 2012 Apr 26;119(17):4066-72. doi: 10.1182/blood-2011-11-393900. Epub 2012 Jan 31.

ReferenceCitation: O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157.

ReferenceCitation: Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.

family: Gross

full_name: Annette S. Gross

given: Annette S.

family: Goldfrad

full_name: Caroline Goldfrad

given: Caroline

family: Hozawa

full_name: Soichiro Hozawa

given: Soichiro

family: James

full_name: Mark H. James

given: Mark H.

family: Clifton

full_name: Christine S. Clifton

given: Christine S.

family: Sugiyama

full_name: Yutaro Sugiyama

given: Yutaro

family: Jacques

full_name: Loretta Jacques

given: Loretta

currency_apc_doaj: GBP

journal_name: BMC Pulmonary Medicine

oa_colors: green gold

evidence: oa journal (via doaj)

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

location_country:
Peru
Sweden
Mexico
Philippines
Germany
France
Bulgaria
Korea, Republic of
Poland
Slovakia
Russian Federation
Estonia
United States
Canada

ipd_sharing: Yes

title: A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Administered Once Daily and Fluticasone Propionate Inhalation Powder 100mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Non-Steroidal, Asthma Therapy

summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.


title: Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Early Stage Severe Sepsis

summary: Adult Patients with Severe Sepsis

ReferenceCitation: Laterre PF, Macias WL, Janes J, Williams MD, Nelson DR, Girbes AR, Dhainaut JF, Abraham E. Influence of enrollment sequence effect on observed outcomes in the ADDRESS and PROWESS studies of drotrecogin alfa (activated) in patients with severe sepsis. Crit Care. 2008;12(5):R117. doi: 10.1186/cc7011. Epub 2008 Sep 11.

family: Laterre

full_name: Pierre-François Laterre

given: Pierre-François

family: Macias

full_name: William L Macias

given: William L

family: Janes

full_name: Jonathan Janes

given: Jonathan

family: Williams

full_name: Mark D Williams

given: Mark D

family: Nelson

full_name: David R Nelson

given: David R

family: Girbes

full_name: Amand RJ Girbes

given: Amand RJ

family: Dhainaut

full_name: Jean-François Dhainaut

given: Jean-François

family: Abraham

full_name: Edward Abraham

given: Edward

journal_name: Critical Care

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

repositories:
PubMed Central
Pure (Denmark)

publisher_dissemination: Springer

publisher_group: Springer

location_country:
Austria
Brazil
Chile
Finland
France
Argentina
Australia
Belgium
Egypt
Denmark
Canada
Czech Republic

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


lead_sponsor: Eisai Inc.

location_country: Italy France Poland Hungary Belgium Spain Estonia Latvia Ukraine

acronym: CATZ

title: A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures

summary: The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.


title: An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are Not on Dialysis

summary: This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Hong Kong
Germany
France
Poland
Greece
Israel
Thailand
Hungary
Belgium
Australia
Russian Federation
Spain
Canada
Korea, Republic of
Taiwan


title: A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Patients With COPD

summary: This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

lead_sponsor: Novartis

location_country:
Italy
South Africa
Chile
Peru
United Kingdom
France
Poland
Lithuania
Norway
Hungary
Belgium
Argentina
Ireland
Romania
Turkey
Germany
Latvia

location_facility:
novartis Investigator site
Novartis investigator site
Novartis Investigator site
Novartis Investigator Site - 2 sites
Novartis Investigator Site


title: Randomized Phase II Study to Investigate the Efficacy, Safety and Tolerability of ZK 230211 (25 mg vs. 100 mg) as Second-line Endocrine Therapy for Postmenopausal Women With Hormone Receptor-positive Metastatic Breast Cancer

summary: Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (100 mg vs. 25 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer.Once the cancer has spread beyond the lymph nodes to areas such as e.g. the skin, soft tissues, lung, and liver it is called metastatic breast cancer. Patients who have been diagnosed with metastatic breast cancer that has progressed since their previous cancer treatment and that cannot be removed completely by surgery are eligible to be treated within this trial.Treatment with a new drug called Progesterone Receptor Antagonist ZK 230211 (ZK PRA) targets the progesterone receptor which may be expressed on breast cancer tumour cells. Therefore only patients with this progesterone receptor on their tumour cells can be included in this study.Progesterone receptor antagonists (including onapristone) have already shown efficacy in postmenopausal women with advanced breast cancer (Klijn et al. 2000). This phase II study investigates the efficacy (proof of concept), safety and tolerability of ZK PRA at two dose levels (25 mg and 100 mg) before initiating pivotal phase III trials.

ReferenceCitation: Jonat W, Bachelot T, Ruhstaller T, Kuss I, Reimann U, Robertson JFR. Randomized phase II study of lonaprisan as second-line therapy for progesterone receptor-positive breast cancer. Ann Oncol. 2013 Oct;24(10):2543-2548. doi: 10.1093/annonc/mdt216. Epub 2013 Jun 20.

lead_sponsor: Bayer

location_country:
Italy
Austria
Sweden
Switzerland
Finland
France
Poland
Spain
Germany
United Kingdom


title: Evaluation of Belatacept as First Line Immunosuppression in De Novo Liver Transplant Recipients

summary: The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant

primary_purpose: Prevention

ReferenceCitation: Klintmalm GB, Feng S, Lake JR, Vargas HE, Wekerle T, Agnes S, Brown KA, Nashan B, Rostaing L, Meadows-Shropshire S, Agarwal M, Harler MB, Garcia-Valdecasas JC. Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study. Am J Transplant. 2014 Aug;14(8):1817-27.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
United States
Brazil
Germany
France
Argentina
Spain
Canada

location_facility: Hospital Of The University Of Pennsylvania

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Washington University School Of Medicine

location_facility: University Of California San Francisco Medical Center


lead_sponsor: AstraZeneca

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
India
France
Japan
Poland
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico

acronym: ENTHUSE M1

title: A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.

summary:
Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.
ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases.
All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy.
Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
No patients will be deprived of standard prostate cancer therapy.


ReferenceCitation: Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DA; CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1829-39. doi: 10.1016/S0140-6736(12)61768-1. Epub 2012 Nov 1.

ReferenceCitation: Coles AJ, Arnold DL, Bass AD, Boster AL, Compston DAS, Fernández Ó, Havrdová EK, Nakamura K, Traboulsee A, Ziemssen T, Jacobs A, Margolin DH, Huang X, Daizadeh N, Chirieac MC, Selmaj KW. Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial. Ther Adv Neurol Disord. 2021 Apr 23;14:1756286420982134. doi: 10.1177/1756286420982134. eCollection 2021.

name: Department of Clinical Neurosciences, University of Cambridge, Box 165, Addenbrooke’s Hospital, Cambridge CB2 0QQ, UK

family: Coles

full_name: Alasdair J. Coles

given: Alasdair J.

name: NeuroRx Research, Montréal, Québec, Canada

name: Department of Neurology and Neurosurgery, Montréal Neurological Institute, McGill University, Montréal, Québec, Canada

family: Arnold

full_name: Douglas L. Arnold

given: Douglas L.

name: Neurology Center of San Antonio, San Antonio, TX, USA

family: Bass

full_name: Ann D. Bass

given: Ann D.

family: Boster

full_name: Aaron L. Boster

given: Aaron L.

name: Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK

family: Compston

full_name: D. Alastair S. Compston

given: D. Alastair S.

name: Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain

family: Fernández

full_name: Óscar Fernández

given: Óscar

name: Department of Neurology and Center for Clinical Neuroscience, First Medical Faculty, Charles University, Prague, Czech Republic

family: Havrdová

full_name: Eva Kubala Havrdová

given: Eva Kubala

name: Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH, USA

family: Nakamura

full_name: Kunio Nakamura

given: Kunio

name: The University of British Columbia, Vancouver, British Columbia, Canada

family: Traboulsee

full_name: Anthony Traboulsee

given: Anthony

family: Ziemssen

full_name: Tjalf Ziemssen

given: Tjalf

family: Jacobs

full_name: Alan Jacobs

given: Alan

family: Margolin

full_name: David H. Margolin

given: David H.

family: Huang

full_name: Xiaobi Huang

given: Xiaobi

family: Daizadeh

full_name: Nadia Daizadeh

given: Nadia

name: Vertex Pharmaceuticals, Inc., Boston, MA, USA

family: Chirieac

full_name: Madalina C. Chirieac

given: Madalina C.

name: Department of Neurology, University of Warmia and Mazury, Olsztyn, Poland

family: Selmaj

full_name: Krzysztof W. Selmaj

given: Krzysztof W.

currency_apc_doaj: USD

journal_name: Therapeutic Advances in Neurological Disorders

repository_institution: University of Cambridge - Apollo

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Horáková D, Boster A, Bertolotto A, Freedman MS, Firmino I, Cavalier SJ, Jacobs AK, Thangavelu K, Daizadeh N, Poole EM, Baker DP, Margolin DH, Ziemssen T; CARE-MS I, CARE-MS II, and CAMMS03409 Investigators. Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Mult Scler J Exp Transl Clin. 2020 Dec 18;6(4):2055217320972137. doi: 10.1177/2055217320972137. eCollection 2020 Oct-Dec.

name: Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic

family: Horáková

full_name: Dana Horáková

name: The Boster Center for Multiple Sclerosis, Columbus, USA

name: University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Canada

name: Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden,  Germany  *Employees of Sanofi  during study conduct  and analysis.

name: on behalf of the CARE-MS I, CARE-MS II, and CAMMS03409 Investigators

journal_name: Multiple Sclerosis Journal - Experimental, Translational and Clinical

ReferenceCitation: Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x.

name: CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators

ReferenceCitation: Gilmore W, Lund BT, Li P, Levy AM, Kelland EE, Akbari O, Groshen S, Cen SY, Pelletier D, Weiner LP, Javed A, Dunn JE, Traboulsee AL. Repopulation of T, B, and NK cells following alemtuzumab treatment in relapsing-remitting multiple sclerosis. J Neuroinflammation. 2020 Jun 15;17(1):189. doi: 10.1186/s12974-020-01847-9.

ReferenceCitation: Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernández Ó, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25.

name: Department of Neurology, University Vita-Salute San Raffaele, Milan, Italy

name: Department of Medicine, Amiri Hospital, Sharq, Kuwait

name: OhioHealth Neurological Physicians, Columbus, OH, USA

name: Keck School of Medicine, University of Southern California, Los Angeles, CA, USA/Regina Berkovich, MD, PhD, Inc., West Hollywood, CA, USA

name: Research Institute and Hospital, National Cancer Center, Goyang, South Korea

name: Klinik für Neurologie und Palliativmedizin, Cologne, Germany

name: Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden

name: Department of Neurology, Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia

name: NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals, University of Sheffield, Sheffield, UK

name: Univ. Lille, INSERM U995, CHU Lille, FHU Imminent, F-59000 Lille, France

name: Department of Neurology, University of Münster, Münster, Germany

name: Division of Neurology, Department of Medicine, The University of British Columbia, Vancouver, BC, Canada

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

ReferenceCitation: Van Wijmeersch B, Singer BA, Boster A, Broadley S, Fernández Ó, Freedman MS, Izquierdo G, Lycke J, Pozzilli C, Sharrack B, Steingo B, Wiendl H, Wray S, Ziemssen T, Chung L, Margolin DH, Thangavelu K, Vermersch P. Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Mult Scler. 2020 Nov;26(13):1719-1728. doi: 10.1177/1352458519881759. Epub 2019 Nov 1.

name: Rehabilitation and MS Center Overpelt; BIOMED, Hasselt University, Hasselt, Belgium

name: The MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA

name: School of Medicine, Griffith University, Southport, QLD, Australia

name: Fundación IMABIS, Hospital Universitario Carlos Haya, Málaga, Spain

name: University of Ottawa and The Ottawa Hospital Research Institute, Ottawa, ON, Canada

name: Virgen Macarena University Hospital, Seville, Spain

name: Institution of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

name: Sapienza University of Rome, Rome, Italy

name: Fort Lauderdale Multiple Sclerosis Center, Fort Lauderdale, FL, USA

name: Sanofi, Cambridge, MA, USA; Cerevance, Boston, MA, USA

name: Sanofi, Cambridge, MA, USA; EMD Serono, Billerica, MA, USA

name: University of Lille, INSERM U995, CHU Lille, FHU Imminent, Lille, France

title: Efficacy of alemtuzumab over 6 years in relapsing–remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies

ReferenceCitation: Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25.

name: the CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators

ReferenceCitation: Arroyo R, Bury DP, Guo JD, Margolin DH, Melanson M, Daizadeh N, Cella D. Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis. Mult Scler. 2020 Jul;26(8):955-963. doi: 10.1177/1352458519849796. Epub 2019 May 30.

name: Department of Neurology, Hospital Universitario Quirónsalud, Madrid, Spain

name: Contractor to Sanofi Genzyme, Cambridge, MA, USA

name: Sanofi, Cambridge, MA, USA; Bristol-Myers Squibb, Lawrence Township, NJ, USA

name: Sanofi, Cambridge, MA, USA; Cerevance, Inc., Boston, MA, USA

name: Department of Medical Social Sciences, Center for Patient-Centered Outcomes, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

ReferenceCitation: Li Z, Richards S, Surks HK, Jacobs A, Panzara MA. Clinical pharmacology of alemtuzumab, an anti-CD52 immunomodulator, in multiple sclerosis. Clin Exp Immunol. 2018 Dec;194(3):295-314. doi: 10.1111/cei.13208. Epub 2018 Oct 1.

ReferenceCitation: Grafals M, Smith B, Murakami N, Trabucco A, Hamill K, Marangos E, Gilligan H, Pomfret EA, Pomposelli JJ, Simpson MA, Azzi J, Najafian N, Riella LV. Immunophenotyping and efficacy of low dose ATG in non-sensitized kidney recipients undergoing early steroid withdrawal: a randomized pilot study. PLoS One. 2014 Aug 11;9(8):e104408. doi: 10.1371/journal.pone.0104408. eCollection 2014.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repositories_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

title: Immunophenotyping and Efficacy of Low Dose ATG in Non-Sensitized Kidney Recipients Undergoing Early Steroid Withdrawal: A Randomized Pilot Study

location_country:
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
Croatia
France
Poland
Argentina
Canada
Sweden
Netherlands
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Israel
Spain

location_facility: Department Of Neurosciences, Addenbrookes Hospital

location_facility: Department of Neurology 1st Faculty of Medicine and General Teaching Hospital, MS Center

location_facility: Servicio de Neurología Hospital Vall d'Hebron Paseo de Vall d'Hebron

location_facility: Spectrum Health Medical Group, Neurology (Previously known as Michigan Medical P.C., Neurology)

location_facility: Ruan Neurology Clinic and Research Center

location_facility: Tel Aviv Sourasky Medical Center, Department of Neurology

location_facility: Independent Public Teaching Hospital No. 4 in Lublin

location_facility: Liverpool Hospital, Neurology Department

location_facility: Heliodor Swiecicki Teaching Hospital of the Poznan, University of Medical Sciences

location_facility: University Hospital Leuven, Campus Gasthuisberg, Neurology

location_facility: Louisiana State University Health Sciences Center

location_facility: Krankenhaus Hohe Warte, Betriebsstätte der Bayreuth

location_facility: University of Louisville Research Foundation

location_facility: Cliniques Universitaires Saint-Luc, Neurology

location_facility: Orbis Medisch Centrum, Department of Neurology

location_facility: Danylo Halytsky Lviv National Medical University, Department of Neurology

location_facility: Wake Forest University Health Science, Department of Neurology

location_facility: Research Medical Complex "Your Health" Ltd

location_facility: CHU Clermont-Ferrand, Hôpital Gabriel Montpied

location_facility: University of Pittsburgh, Kaufmann Medical Building

location_facility: Royal Melbourne Hospital, Department of Neurology

location_facility: Servicio de Neurología Hospital Clínico San Carlos

location_facility: Josephson Wallack Munshower Neurology P.C.

location_facility: East Bay Physicians Medical Group/Sutter East Bay Medical Foundation

location_facility: Servicio de Neurología Hospital Virgen de la Macarena

location_facility: London Health Sciences Centre- University Hospital

location_facility: St.Petersburg State Medical Institution, "City Multispecialty Hospital #2"

location_facility: Moscow State Medical Institution City Clinical Hospital #11, Moscow City Center for Multiple Sclerosis

location_facility: Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

location_facility: Wayne State University, School of Medicine, Department of Neurology

location_facility: Klinikum Ingolstadt, Neurologische Klinik

location_facility: State Medical Institution, "Samara Regional Clinical Hospital n.a. M.I. Kalinin"

location_facility: George Washington University Medical Faculty Associates

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Rockstock

location_facility: Hôpital Civil, Departement de Neurologie

location_facility: Sahlgrenska University Hospital, Neurologkliniken

location_facility: University of Chicago Medical Center, Department of Neurology

location_facility: Mayo Clinic Arizona, Department of Neurology

location_facility: Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine

location_facility: University of Colorado Hospital, Anschutz Outpatient Pavilioin

location_facility: Emory University, Department of Neurology

location_facility: Hôpital Pitié Salpétrière, Service de Neurologie

location_facility: SUNY Upstate Medical University, Department of Neurology

location_facility: Multiple Sclerosis Clinic, Connell 7, Kingston General Hospital

location_facility: Centre de Sante et de Services Sociaux de Gatineau-Hull Hospital

location_facility: Irmandade da Santa Casa de Misericordia de Sao Paulo

location_facility: Concord Repatriation General Hospital, Neurosciences Department

location_facility: Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis

location_facility: Lehigh Valley Hospital, Neuroscience and Pain Research

location_facility: Århus Universitetshospital, Scleroseklinikken, Århus Sygehus

location_facility: AKH Wien, Universitätsklinikum für Neurologie

location_facility: Clinic of Neurology, Clinical Centre of Serbia

location_facility: Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.

location_facility: University of South Florida, Department of Neurology

location_facility: Multiple Sklerose Zentrum am, Zentrum für klinische Neurowissenschaften, Neurologische Uniklinik Dresden

location_facility: Montreal Neurological Institute and Hospital

location_facility: Clinique Neuro rive-sud, Recherche sepmus inc

location_facility: Griffith School of Medicine, Gold Coast Campus, Griffith University

location_facility: Università di Genova Dipartimento di Neuroscienze Oftalmologia e Genetica

location_facility: University of Kansas Medical Center, Department of Neurology

location_facility: University of North Carolina-Chapel Hill, Department of Neurology

location_facility: St. Petersburg Pavlov State Medical University, Department of Neurology and Neurosurgery with a Clinic

location_facility: Federal State Institution: Siberian District Medical Center

location_facility: Klinikum Rechts der Isar, Klinik für Neurologie

location_facility: Servicio de Neurología Hospital Carlos Haya

location_facility: Unidad de Investigación en Salud de Chihuahua, S.C.

location_facility: University of Michigan Department of Neurology

location_facility: Salford Royal NHS Foundation Trust, Clinical Trials Unit

location_facility: Renown Institute for Neurosciences / Renown regional Medical Center

location_facility: Municipal Treatment and Prevention Institution, "City Hospital #33"

location_facility: University of Florida Neuroscience Institute

location_facility: Clinical Centre Vojvodina Institute of Neurology

location_facility: University of New Mexico, Health Sciences Center, MS Specialty Clinic

location_facility: Department of Neurology, Keck School of Medicine, University of Southern California

location_facility: University of California, Davis Medical Center

location_facility: Cleveland Clinic Foundation, Mellen Center

location_facility: General Hospital Varazdin, Department of neurology

location_facility: Negroski, Stein, Sutherland and Hanes Neurology

location_facility: St.Petersburg State Medical Institution, "Nikolayevskaya Hospital"

location_facility: Azienda Ospedaliera Sant'Andrea Neurologia

location_facility: Department of Neurology Glossop Road, Royal Hallamshire Hospital

location_facility: Kyiv Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System

location_facility: Institution of the Russian Academy of Medical Sciences, "Neurology Scientific Center under RAMS"

location_facility: Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department

location_facility: Neurology Consultants of Kansas City, Inc.

location_facility: Ospedale Binaghi - Centro Sclerosi Multipla

location_facility: North Central Neurology Associates, P.C.

location_facility: Idaho Falls Multiple Sclerosis Center, PLLC

location_facility: Clinical Hospital Centre Rijeka, Clinic for Neurology

location_facility: Ospedale Civile di Brescia c/o Ospedale Richiedei, Centro di riferimento per la Sclerosi Multiple

location_facility: Hospital Angeles del Pedregal; Camino a Santa Teresa

location_facility: Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz

location_facility: Moscow State Public Medical Institution, City Clinical Hospital #11

location_facility: Partners Multiple Sclerosis Center/Brigham and Women's Hospital

location_facility: Indiana University School of Medicine, Department of Neurology

location_facility: Winthrop University Hospital, Clinical Trials Center

location_facility: General Hospital " Sveti Duh", Department of neurology

location_facility: Institution of the Russian Academy of Sciences, "Institute of the Human Brain n.a. N.P. Bekhtereva within the Russian Academy of Sciences"

location_facility: Krajska zdravotni a.s. - Hospital Teplice

location_facility: St. Vincent's Hospital, MS Education & Research, Department of Clinical Neurosciences

location_facility: Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science Barts and The London School of Medicine and Dentistry

location_facility: Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center

title: A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy

summary: The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.