title: A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint

acronym: PARSC

summary:
The aim of this study is to enroll 785 eligible stage II colon cancer patients in order to validate the performance of ColoPrint in estimating 3-year relapse rate.

Secondary objectives include comparing the objective risk assessment results from the prognostic profile (ColoPrint) to both the risk assessment based on the ASCO criteria, as well as the Investigator's independent assessment. As this is the first prospective study of ColoPrint, this study will also address the logistics and quality assurance of using ColoPrint in clinical practice.

Patient treatment is at the discretion of the physician, adhering to National Comprehensive Cancer Network (NCCN)-approved regimens or a recognized alternative.

The enrollment period will be 6 years. It is expected that 1800 to 2400 patients will be enrolled in order to obtain 785 analysable stage II samples from eligible patients. Approximately 25-35 clinical sites will be involved worldwide.

The statistical analysis will be performed by Agendia and an independent research institute or hospital.

Study Design Extension Study:

This will be a prospective study to measure the impact of ColoPrint on adjuvant treatment in stage 2 colorectal cancer patients. After surgery the tumor sample will be shipped in RNA Retain to Agendia. The online Clinical Report Form (CRF) 0 will be completed to document if the patient fulfils the inclusion criteria. Baseline clinical data and the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict without knowing the ColoPrint result will be entered in CRF 1. After completion of CRF1 the ColoPrint result is released. CRF2 will be completed after the final treatment decision has been made.

This CRF will capture the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict, impact of ColoPrint and the actual treatment the patient will receive. CRF3 will be completed 12 months after enrolment and will capture the patient status, patient's perceived recurrence risk and decisional conflict. CRF4 and 5 will be completed 3 and 5 years after surgery and will capture the patient status. A sample size of 210 stage 2 colon cancer patients is required to detect a 10% overall treatment change (5% significance and 90% power).

Reporting of the Results:

Blinded Study; The ColoPrint results will not be reported to the physician and/or patient at the time of enrolment. All samples will be stored in a freezer until 550-575 eligible stage II patients have been enrolled. Samples will then be analyzed in one batch in a blinded fashion from the clinical results.

Extension Study; The ColoPrint results will be reported to the physician and patient after CRF1 has been completed.

study_completion_date_type: Anticipated

lead_sponsor: Agendia

location_country:
Austria
Sweden
Switzerland
Netherlands
Spain
Germany
France
Japan
China
Denmark
United States
United Kingdom

location_facility: IDIBELL Institut Catala d'Oncologia (ICO)

location_facility: Immunology Akademiska sjukhuset/ University Hospital

location_facility: University of Hong Kong/ Queen Mary Hospital

location_facility: Albert Einstein College of Medicine, Montefiore Medical Center

location_facility: Sutter Roseville Medical Center /Research

location_facility: South Orange County Surgical Medical Group


title: A 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES)

acronym: IMPRES

summary: A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (PAH).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Querejeta Roca G, Campbell P, Claggett B, Solomon SD, Shah AM. Right Atrial Function in Pulmonary Arterial Hypertension. Circ Cardiovasc Imaging. 2015 Nov;8(11):e003521; discussion e003521. doi: 10.1161/CIRCIMAGING.115.003521.

name: From the Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA.

family: Querejeta Roca

full_name: Gabriela Querejeta Roca

given: Gabriela

sequence: first

family: Campbell

full_name: Patricia Campbell

given: Patricia

sequence: additional

family: Claggett

full_name: Brian Claggett

given: Brian

family: Solomon

full_name: Scott D. Solomon

given: Scott D.

family: Shah

full_name: Amil M. Shah

given: Amil M.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Circulation: Cardiovascular Imaging

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Querejeta Roca G, Campbell P, Claggett B, Vazir A, Quinn D, Solomon SD, Shah AM. Impact of lowering pulmonary vascular resistance on right and left ventricular deformation in pulmonary arterial hypertension. Eur J Heart Fail. 2015 Jan;17(1):63-73. doi: 10.1002/ejhf.177. Epub 2014 Nov 4.

name: Division of Cardiovascular Medicine; Brigham and Women's Hospital; Boston MA USA

family: Vazir

full_name: Ali Vazir

given: Ali

name: Novartis Pharmaceuticals; East Hanover NJ USA

family: Quinn

full_name: Debbie Quinn

given: Debbie

journal_name: European Journal of Heart Failure

oa_host_type: repository

publisher: Wiley

ReferenceCitation: Shah AM, Campbell P, Rocha GQ, Peacock A, Barst RJ, Quinn D, Solomon SD; IMPRES Investigators. Effect of imatinib as add-on therapy on echocardiographic measures of right ventricular function in patients with significant pulmonary arterial hypertension. Eur Heart J. 2015 Mar 7;36(10):623-32. doi: 10.1093/eurheartj/ehu035. Epub 2014 Feb 23.

ReferenceCitation: Hoeper MM, Barst RJ, Bourge RC, Feldman J, Frost AE, Galié N, Gómez-Sánchez MA, Grimminger F, Grünig E, Hassoun PM, Morrell NW, Peacock AJ, Satoh T, Simonneau G, Tapson VF, Torres F, Lawrence D, Quinn DA, Ghofrani HA. Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: results of the randomized IMPRES study. Circulation. 2013 Mar 12;127(10):1128-38. doi: 10.1161/CIRCULATIONAHA.112.000765. Epub 2013 Feb 12.

name: From Medizinische Hochschule, Hannover, Germany (M.M.H.); Columbia University, New York, NY (R.J.B.); University of Alabama at Birmingham (R.C.B.); Arizona Pulmonary Specialists, Phoenix (J.F.); Baylor College of Medicine, Houston, TX (A.E.F.); Università di Bologna, Bologna, Italy (N.G.); Hospital Universitario Doce de Octubre, Madrid, Spain (M.A.G.-S.); University Hospital Giessen and Marburg GmbH, Giessen, Germany (F.G., H.G.); University Hospital Heidelberg, Heidelberg, Germany (E.G.); Johns...

title: Imatinib Mesylate as Add-on Therapy for Pulmonary Arterial Hypertension

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
France
Japan
Belgium
Spain
Canada
United Kingdom
Korea, Republic of

location_facility:
University Hospital Basel
Novartis Investigative Site
Novartis investigative site


title: A Phase I/II Multi-centre Study of AZD8931 in Combination With Weekly Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and in a Selected Population With Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer

acronym: THYME

summary: The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.

lead_sponsor: AstraZeneca

location_country:
Italy
Brazil
Peru
Sweden
Switzerland
United Kingdom
France
Bulgaria
Panama
Hungary
Belgium
Spain
Canada
Czech Republic

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Asymptomatic Carotid Surgery Trial-2 (ACST-2): an International Randomised Trial to Compare Carotid Endarterectomy With Carotid Artery Stenting to Prevent Stroke

summary:
The trial randomise patients with asymptomatic carotid artery narrowing in whom prompt physical intervention is thought to be needed, but there there is still substantial uncertainty shared by patient and doctor about whether surgery or stenting is the more appropriate choice.

The study is looking at immediate risks (within one month)and at long term benefits

status: Unknown status

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D; MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial. Lancet. 2004 May 8;363(9420):1491-502. Erratum in: Lancet. 2004 Jul 31;364(9432):416.

lead_sponsor: University of Oxford

location_country:
Greece
Belgium
Russian Federation
Spain
Croatia
France
Japan
Poland
Slovakia
Norway
Canada
Slovenia
Sweden
Switzerland
Netherlands
Bulgaria
Singapore
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Czechia
Israel
Egypt
Kazakhstan
Estonia

location_facility: Policlinico Universitario Campus Bio-medico di Roma

location_facility: Klinikum rechts der Isar derTechnischen Universität Muenchen

location_facility: University of Dresden 'Carl-Gustav-Carus'

location_facility: Nuovo Ospedale Civile Sant' Agostino Estense

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Dept. of Vascular Surgery, Attikon University Hospital

location_facility: Saint Petersburg Scientific Research Institute for Emergency Care

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: HCFM Ribeirao Preto da Universidade de Sao Paulo

location_facility: Novosibirsk Research Institute of Circulation Pathology

location_facility: Fondazione Policlinico U. Agostino Gemeli IRCCS

location_facility: Hospital Clinic 1 Provinical de Barcelona

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: V.A. Almazov National Medical Research Centre

location_facility: University of Warsaw/ Institute of Psychiatry

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Betaferon Treatment and Exercise Data Gathering IN Early MS

acronym: BEGIN

summary: The purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain information on factors potentially influencing the patients' level of activity.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Bayer

location_country:
Jordan
Greece
Belgium
Australia
Denmark
Oman
Czech Republic
Taiwan
Bahrain
Spain
France
Thailand
Kuwait
Norway
Indonesia
Canada
Slovenia
Korea, Republic of
Colombia
Sweden
United Arab Emirates
Switzerland
Netherlands
Portugal
Germany
United Kingdom
Italy
Austria
Lebanon
Mexico
Israel
Egypt
Kazakhstan


ReferenceCitation: Kennelly M, Dmochowski R, Schulte-Baukloh H, Ethans K, Del Popolo G, Moore C, Jenkins B, Guard S, Zheng Y, Karsenty G; 191622-094 Investigators. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. Neurourol Urodyn. 2017 Feb;36(2):368-375. doi: 10.1002/nau.22934. Epub 2015 Nov 24.

intervention_type: Biological

study_start_date_type: Actual

lead_sponsor: Allergan

location_country:
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Poland
Slovakia
Canada
South Africa
Netherlands
Singapore
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
New Zealand
Spain

source: euctr

title: A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

summary: The purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).


title: A Single and Repeat Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of GSK1223249 in ALS Patients

summary:
The drug being tested in this study is GSK1223249. It is being developed by GlaxoSmithKline to treat symptoms in patients with Amyotrophic Lateral Sclerosis (ALS).

The drug works by inhibiting the protein that prevents nerve growth.

This will be the first time the drug will be given to man. The trial is expected to involve approximately 76 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses or repeat dose escalation in patients with ALS.

ReferenceCitation: Meininger V, Pradat PF, Corse A, Al-Sarraj S, Rix Brooks B, Caress JB, Cudkowicz M, Kolb SJ, Lange D, Leigh PN, Meyer T, Milleri S, Morrison KE, Orrell RW, Peters G, Rothstein JD, Shefner J, Lavrov A, Williams N, Overend P, Price J, Bates S, Bullman J, Krull D, Berges A, Abila B, Meno-Tetang G, Wurthner J. Safety, pharmacokinetic, and functional effects of the nogo-a monoclonal antibody in amyotrophic lateral sclerosis: a randomized, first-in-human clinical trial. PLoS One. 2014 May 19;9(5):e97803. doi: 10.1371/journal.pone.0097803. eCollection 2014.

family: Meininger

full_name: Vincent Meininger

given: Vincent

family: Pradat

full_name: Pierre-François Pradat

given: Pierre-François

family: Corse

full_name: Andrea Corse

given: Andrea

family: Al-Sarraj

full_name: Safa Al-Sarraj

given: Safa

family: Rix Brooks

full_name: Benjamin Rix Brooks

given: Benjamin

family: Caress

full_name: James B. Caress

given: James B.

family: Cudkowicz

full_name: Merit Cudkowicz

given: Merit

family: Kolb

full_name: Stephen J. Kolb

given: Stephen J.

family: Lange

full_name: Dale Lange

given: Dale

family: Leigh

full_name: P. Nigel Leigh

given: P. Nigel

family: Meyer

full_name: Thomas Meyer

given: Thomas

family: Milleri

full_name: Stefano Milleri

given: Stefano

family: Morrison

full_name: Karen E. Morrison

given: Karen E.

family: Orrell

full_name: Richard W. Orrell

given: Richard W.

family: Peters

full_name: Gary Peters

given: Gary

family: Rothstein

full_name: Jeffrey D. Rothstein

given: Jeffrey D.

family: Shefner

full_name: Jeremy Shefner

given: Jeremy

family: Lavrov

full_name: Arseniy Lavrov

given: Arseniy

family: Williams

full_name: Nicola Williams

given: Nicola

family: Overend

full_name: Phil Overend

given: Phil

family: Price

full_name: Jeffrey Price

given: Jeffrey

family: Bates

full_name: Stewart Bates

given: Stewart

family: Bullman

full_name: Jonathan Bullman

given: Jonathan

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

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_institution: University of Sussex - Sussex Research Online

title: Safety, Pharmacokinetic, and Functional Effects of the Nogo-A Monoclonal Antibody in Amyotrophic Lateral Sclerosis: A Randomized, First-In-Human Clinical Trial

location_country:
Italy
United States
United Kingdom
France


title: PENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.

acronym: PEACE

summary: The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD.

status: Terminated

lead_sponsor: Ferring Pharmaceuticals

location_country:
Sweden
Germany
France
Belgium
Denmark
United States
United Kingdom

location_facility: Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln

location_facility: Center for Digestive and Liver Disease, Inc


title: Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use

acronym: PROCEEDII

summary: The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.

ReferenceCitation: Ardehali A, Esmailian F, Deng M, Soltesz E, Hsich E, Naka Y, Mancini D, Camacho M, Zucker M, Leprince P, Padera R, Kobashigawa J; PROCEED II trial investigators. Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial. Lancet. 2015 Jun 27;385(9987):2577-84. doi: 10.1016/S0140-6736(15)60261-6. Epub 2015 Apr 14.

family: Ardehali

full_name: Abbas Ardehali

given: Abbas

family: Esmailian

full_name: Fardad Esmailian

given: Fardad

family: Deng

full_name: Mario Deng

given: Mario

family: Soltesz

full_name: Edward Soltesz

given: Edward

family: Hsich

full_name: Eileen Hsich

given: Eileen

family: Naka

full_name: Yoshifumi Naka

given: Yoshifumi

family: Mancini

full_name: Donna Mancini

given: Donna

family: Camacho

full_name: Margarita Camacho

given: Margarita

family: Zucker

full_name: Mark Zucker

given: Mark

family: Leprince

full_name: Pascal Leprince

given: Pascal

family: Padera

full_name: Robert Padera

given: Robert

family: Kobashigawa

full_name: Jon Kobashigawa

given: Jon

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: TransMedics

location_facility: Azienda Ospedaliera S. Maria della Misericordia

intervention_type: Device


title: A Prospective Study to Establish Normative Values, Demographic Variations, Referent Diagnostic Values and Disease Severity Correlations for Dry Eye Disease and TearLab Osmometry.

acronym: CVS

summary: This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease.

ReferenceType: result

ReferenceCitation: Lemp MA, Bron AJ, Baudouin C, Benítez Del Castillo JM, Geffen D, Tauber J, Foulks GN, Pepose JS, Sullivan BD. Tear osmolarity in the diagnosis and management of dry eye disease. Am J Ophthalmol. 2011 May;151(5):792-798.e1. doi: 10.1016/j.ajo.2010.10.032. Epub 2011 Feb 18.

family: Lemp

full_name: Michael A. Lemp

given: Michael A.

family: Bron

full_name: Anthony J. Bron

given: Anthony J.

family: Baudouin

full_name: Christophe Baudouin

given: Christophe

family: Benítez del Castillo

full_name: José M. Benítez del Castillo

given: José M.

family: Geffen

full_name: David Geffen

given: David

family: Tauber

full_name: Joe Tauber

given: Joe

family: Foulks

full_name: Gary N. Foulks

given: Gary N.

family: Pepose

full_name: Jay S. Pepose

given: Jay S.

family: Sullivan

full_name: Benjamin D. Sullivan

given: Benjamin D.

journal_name: American Journal of Ophthalmology

title: Tear Osmolarity in the Diagnosis and Management of Dry Eye Disease

ReferenceCitation: Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14.

name: From the TearLab Corp., San Diego, California;

name: Starlab, Barcelona S.L., Barcelona, Spain;

family: Whitmer

full_name: Diane Whitmer

given: Diane

name: the College of Optometry, The Ohio State University, Columbus, Ohio;

family: Nichols

full_name: Kelly K. Nichols

given: Kelly K.

name: the Department of Vision Sciences, Glasgow Caledonian University, Glasgow, Scotland, United Kingdom;

family: Tomlinson

full_name: Alan Tomlinson

given: Alan

name: the Kentucky Lions Eye Center, University of Louisville, Louisville, Kentucky;

name: the Department of Ophthalmology, University of Würzburg, Würzburg, Germany; and

family: Geerling

full_name: Gerd Geerling

given: Gerd

name: the PeposeVision Institute, Chesterfield, Missouri.

family: Kosheleff

full_name: Valerie Kosheleff

given: Valerie

family: Porreco

full_name: Allison Porreco

given: Allison

journal_name: Investigative Opthalmology & Visual Science

publisher: Association for Research in Vision and Ophthalmology (ARVO)

title: An Objective Approach to Dry Eye Disease Severity

ReferenceCitation: Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a.

title: Distribution of Aqueous-Deficient and Evaporative Dry Eye in a Clinic-Based Patient Cohort

ipd_sharing_description: Data was published in AJO May 2011 and IOVS Dec.2010.

location_country:
United States
France
Spain
Germany
United Kingdom

location_facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: A Multi-center, Randomized, Controlled Study of Mechanical Left Ventricular Unloading With Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction - CRISP AMI

acronym: CRISP-AMI

summary: Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.

ReferenceCitation: Patel MR, Smalling RW, Thiele H, Barnhart HX, Zhou Y, Chandra P, Chew D, Cohen M, French J, Perera D, Ohman EM. Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: the CRISP AMI randomized trial. JAMA. 2011 Sep 28;306(12):1329-37. doi: 10.1001/jama.2011.1280. Epub 2011 Aug 29.

family: Patel

full_name: Manesh R. Patel

given: Manesh R.

family: Smalling

full_name: Richard W. Smalling

given: Richard W.

family: Thiele

full_name: Holger Thiele

given: Holger

family: Barnhart

full_name: Huiman X. Barnhart

given: Huiman X.

family: Zhou

full_name: Yi Zhou

given: Yi

family: Chandra

full_name: Praveen Chandra

given: Praveen

family: Chew

full_name: Derek Chew

given: Derek

family: Cohen

full_name: Marc Cohen

given: Marc

family: French

full_name: John French

given: John

family: Perera

full_name: Divaka Perera

given: Divaka

family: Ohman

full_name: E. Magnus Ohman

given: E. Magnus

journal_name: JAMA

oa_host_type: publisher

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Intra-aortic Balloon Counterpulsation and Infarct Size in Patients With Acute Anterior Myocardial Infarction Without Shock

ReferenceCitation: Patel MR, Thiele H, Smalling RW, Chandra P, Zhou Y, Cohen M, Perera D, Ohman EM. A multicenter, randomized, controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size prepercutaneous coronary intervention for acute myocardial infarction: rationale and design of the Counterpulsation Reduces Infarct Size Acute Myocardial Infarction trial. Am Heart J. 2011 Jul;162(1):47-55.e1. doi: 10.1016/j.ahj.2011.03.037.

full_name: Erik Magnus Ohman

given: Erik Magnus

title: A multicenter, randomized, controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size prepercutaneous coronary intervention for acute myocardial infarction: Rationale and design of the Counterpulsation Reduces Infarct Size Acute Myocardial Infarction trial

location_country:
Italy
India
Netherlands
Germany
France
Ireland
Belgium
Australia
United States
United Kingdom

location_facility: University of Texas Health Science Center at Houston

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: University of Rochester Medical Center-Strong Memorial Hospital

location_facility: Baroda Heart Institute and Research Centre

location_facility: Saint John's Medical College and Hospital

location_facility: Essentia Institute of Rural Health (St Mary's)

location_facility: Klinik fur Innere Medizin und Kardiologie

location_facility: Azienda Ospedaliero Universitaria Cargeei


title: Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery of Hip or Knee

acronym: XAMOS

summary: The main goal is to provide additional information to the risk-benefit assessment of the drug.

ReferenceCitation: Turpie AG, Haas S, Kreutz R, Mantovani LG, Pattanayak CW, Holberg G, Jamal W, Schmidt A, van Eickels M, Lassen MR. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost. 2014 Jan;111(1):94-102. doi: 10.1160/TH13-08-0666. Epub 2013 Oct 24.

ReferenceCitation: Turpie AG, Schmidt AC, Kreutz R, Lassen MR, Jamal W, Mantovani L, Haas S. Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery. Vasc Health Risk Manag. 2012;8:363-70. doi: 10.2147/VHRM.S30064. Epub 2012 Jun 1.

apc_source: doaj

family: Bramlage

full_name: Peter Bramlage

given: Peter

family: Turpie

full_name: Turpie

family: Schmidt

full_name: Schmidt

family: Kreutz

full_name: Reinhold Kreutz

given: Reinhold

family: Lassen

full_name: Michael Lassen

given: Michael

family: Jamal

full_name: Jamal

family: Mantovani

full_name: Mantovani

currency_apc_doaj: USD

journal_name: Vascular Health and Risk Management

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

location_country: Macedonia, The Former Yugoslav Republic of


type: EudraCT Number

title: CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS

summary: To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial

status: Active, not recruiting

ipd_sharing: No

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Italy
United States
France
Czechia
Japan
Hungary
Russian Federation
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Charité - Universitaetsmedizin Berlin, Charité Campus Mitte

location_facility: Providence Regional Medical Center Everett - Providence Regional Cancer Partnership

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: FSBSI "N.N. Blokhin Russian Cancer Research Center"

location_facility: University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center

location_facility: Fondazione IRCCS, Istituto Nazionale Tumori, S.S.D Oncologia Medica dei Tumori testa-collo

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar

location_facility: Nottingham City Hospital / Oncology Department

location_facility: University of Wisconsin - Hospital and Clinics

location_facility: Fondazione IRCCS, Istituto Nazionale Tumori, Laboratorio

location_facility: The University of Texas M.D. Anderson Cancer Center

status_simplified: Ongoing


type: Registry Identifier

title: A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients With High-Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial

acronym: CHALLENGE

summary:
RATIONALE: Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment.

PURPOSE: This randomized phase III trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.

status: Recruiting

primary_purpose: Other

ReferenceCitation: Courneya KS, Booth CM, Gill S, O'Brien P, Vardy J, Friedenreich CM, Au HJ, Brundage MD, Tu D, Dhillon H, Meyer RM. The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group. Curr Oncol. 2008 Dec;15(6):279-85.

ReferenceCitation: Vallance J, Lesniak SL, Belanger LJ, Courneya KS. Development and assessment of a physical activity guidebook for the Colon Health and Life-Long Exercise Change (CHALLENGE) trial (NCIC CO.21). J Phys Act Health. 2010 Nov;7(6):794-801.

ReferenceCitation: Courneya KS, Vardy JL, O'Callaghan CJ, Friedenreich CM, Campbell KL, Prapavessis H, Crawford JJ, O'Brien P, Dhillon HM, Jonker DJ, Chua NS, Lupichuk S, Sanatani MS, Gill S, Meyer RM, Begbie S, Bonaventura T, Burge ME, Turner J, Tu D, Booth CM. Effects of a Structured Exercise Program on Physical Activity and Fitness in Colon Cancer Survivors: One Year Feasibility Results from the CHALLENGE Trial. Cancer Epidemiol Biomarkers Prev. 2016 Jun;25(6):969-77. doi: 10.1158/1055-9965.EPI-15-1267. Epub 2016 Apr 8.

family: Courneya

full_name: Kerry S. Courneya

given: Kerry S.

family: Vardy

full_name: Janette L. Vardy

given: Janette L.

family: O'Callaghan

full_name: Christopher J. O'Callaghan

given: Christopher J.

family: Friedenreich

full_name: Christine M. Friedenreich

given: Christine M.

family: Campbell

full_name: Kristin L. Campbell

given: Kristin L.

family: Prapavessis

full_name: Harry Prapavessis

given: Harry

family: Crawford

full_name: Jennifer J. Crawford

given: Jennifer J.

family: O'Brien

full_name: Patti O'Brien

given: Patti

family: Dhillon

full_name: Haryana M. Dhillon

given: Haryana M.

family: Jonker

full_name: Derek J. Jonker

given: Derek J.

family: Chua

full_name: Neil S. Chua

given: Neil S.

family: Lupichuk

full_name: Sasha Lupichuk

given: Sasha

family: Sanatani

full_name: Michael S. Sanatani

given: Michael S.

family: Gill

full_name: Sharlene Gill

given: Sharlene

family: Meyer

full_name: Ralph M. Meyer

given: Ralph M.

family: Begbie

full_name: Stephen Begbie

given: Stephen

family: Bonaventura

full_name: Tony Bonaventura

given: Tony

family: Burge

full_name: Matthew E. Burge

given: Matthew E.

family: Turner

full_name: Jane Turner

given: Jane

family: Tu

full_name: Dongsheng Tu

given: Dongsheng

family: Booth

full_name: Christopher M. Booth

given: Christopher M.

journal_name: Cancer Epidemiology Biomarkers & Prevention

publisher: American Association for Cancer Research (AACR)

location_country:
United States
France
Australia
Canada
United Kingdom
Korea, Republic of

location_facility: North Coast Cancer Institute - Port Macquarie

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: University of North Carolina at Chapel Hill

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: Stronach Regional Health Centre at Southlake

location_facility: North Coast Cancer Institute Coffs Harbour

location_facility: Macarthur Cancer Therapy Centre - Campbelltown Hospital

location_facility: Exercise Medicine Center for Diabetes and Cancer


title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis

summary: This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 48 subjects. Part A of the study will enroll subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3 cohorts. Part B of the study will enroll SLE subjects with GN into 3 cohorts. The purpose of the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and pharmacokinetics.

lead_sponsor: Amgen

location_country:
Hong Kong
Mexico
France
Malaysia
United States


title: Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib

acronym: GIDEON

summary: In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.

ReferenceCitation: Ye SL, Chen X, Yang J, Bie P, Zhang S, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Yip CS, Lu Z. Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outcome from the Chinese patient subset of the GIDEON study. Oncotarget. 2016 Feb 9;7(6):6639-48. doi: 10.18632/oncotarget.6781.

name: Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China

family: Ye

full_name: Sheng-Long Ye

given: Sheng-Long

name: Department of Surgery, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

family: Chen

full_name: Xiaoping Chen

given: Xiaoping

name: Department of Special Treatment, Eastern Hepatobiliary Surgery Hospital, Shanghai, China

family: Yang

full_name: Jiamei Yang

given: Jiamei

name: Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing, China

family: Bie

full_name: Ping Bie

given: Ping

name: Department of General Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China

family: Zhang

full_name: Shuijun Zhang

given: Shuijun

name: Department of Interventional Radiology, Chinese PLA General Hospital, Beijing, China

family: Liu

full_name: Fengyong Liu

given: Fengyong

name: Shanghai Cancer Center, Fudan University, Shanghai, China

full_name: Luming Liu

given: Luming

name: Department of Hepatobiliary Surgery, Nanfang Hospital of Southern Medical University, Guangzhou, China

family: Zhou

full_name: Jie Zhou

given: Jie

name: Department of Hepatobiliary Surgery, Xijing Hospital, Xi'an, China

family: Dou

full_name: Kefeng Dou

given: Kefeng

name: Department of Hepato-Pancreato-Biliary Surgery, Beijing Cancer Hospital, Peking University, Beijing, China

family: Hao

full_name: Chunyi Hao

given: Chunyi

name: Department of Radiology, Zhejiang Cancer Hospital, Hangzhou, China

family: Shao

full_name: Guoliang Shao

given: Guoliang

name: Department of Liver Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

family: Xia

full_name: Qiang Xia

given: Qiang

name: Department of Hepatobiliary Surgery, Second Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China

full_name: Yajin Chen

given: Yajin

name: Department of Nuclear Medicine, Changhai Hospital, Second Military Medical University, Shanghai, China

full_name: Jijin Yang

given: Jijin

name: Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

family: Deng

full_name: Xiaxing Deng

given: Xiaxing

name: Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China

full_name: Yunpeng Liu

given: Yunpeng

name: Department of Hepatobiliary, Cancer Center, Sun Yat-sen University, Guangzhou, China

family: Yuan

full_name: Yunfei Yuan

given: Yunfei

name: Department of Liver Transplantation, Shanghai Changzheng Hospital, Shanghai, China

family: Fu

full_name: Zhiren Fu

given: Zhiren

name: Global Medical Affairs, Bayer Healthcare Pharmaceuticals, Montville, NJ, USA

family: Nakajima

full_name: Keiko Nakajima

given: Keiko

name: Medical Affairs Oncology, Bayer Healthcare Company Ltd., Beijing, China

family: Yip

full_name: Christina S.M. Yip

given: Christina S.M.

family: Lu

full_name: Zhengguang Lu

given: Zhengguang

journal_name: Oncotarget

evidence: oa journal (via observed oa rate)

ReferenceCitation: Ye SL, Yang J, Bie P, Zhang S, Chen X, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Lv Z. Safety assessment of sorafenib in Chinese patients with unresectable hepatocellular carcinoma: subgroup analysis of the GIDEON study. BMC Cancer. 2018 Mar 2;18(1):247. doi: 10.1186/s12885-018-4144-9.

ReferenceCitation: Kudo M, Lencioni R, Marrero JA, Venook AP, Bronowicki JP, Chen XP, Dagher L, Furuse J, Geschwind JF, Ladrón de Guevara L, Papandreou C, Sanyal AJ, Takayama T, Yoon SK, Nakajima K, Lehr R, Heldner S, Ye SL. Regional differences in sorafenib-treated patients with hepatocellular carcinoma: GIDEON observational study. Liver Int. 2016 Aug;36(8):1196-205. doi: 10.1111/liv.13096. Epub 2016 Apr 1.

name: Department of Gastroenterology and Hepatology; Kinki University School of Medicine; Osaka Japan

name: Division of Diagnostic Imaging and Intervention; Pisa University Hospital and School of Medicine; Pisa Italy

name: Division of Digestive and Liver Diseases; Department of Internal Medicine; University of Texas Southwestern Medical Center; Dallas TX USA

name: University of California; San Francisco CA USA

name: Department of Gastroenterology and Hepatology; INSERM U954; University Hospital; University of Lorraine; Nancy France

name: Hepatic Surgery Center; Tongji Hospital; Tongji Medical College; Huazhong University of Science and Technology; Wuhan China

name: Policlínica Metropolitana; Caracas Venezuela

name: Kyorin University School of Medicine; Tokyo Japan

name: Vascular and Interventional Radiology; Johns Hopkins University School of Medicine; Baltimore MD USA

name: Hospital Angeles Clínica Londres; Mexico City Mexico

name: University Hospital of Larissa; Larissa Greece

name: Virginia Commonwealth University Medical Center; Richmond VA USA

name: Department of Digestive Surgery; Nihon University School of Medicine; Tokyo Japan

name: The Catholic University of Korea; Seoul Korea

name: Global Medical Affairs; Bayer HealthCare Pharmaceuticals; Whippany NJ USA

name: Clinical Statistics; Bayer HealthCare Pharmaceuticals; Whippany NJ USA

name: Global Medical Affairs and Pharmacovigilance; Bayer Pharma AG; Berlin Germany

name: Liver Cancer Institute and Zhongshan Hospital; Fudan University; Shanghai China

ReferenceCitation: Lencioni R, Marrero J, Venook A, Ye SL, Kudo M. Design and rationale for the non-interventional Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with Sorafenib (GIDEON) study. Int J Clin Pract. 2010 Jul;64(8):1034-41. doi: 10.1111/j.1742-1241.2010.02414.x.

journal_name: International Journal of Clinical Practice

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

repository_institution: California Digital Library - eScholarship

title: Design and rationale for the non-interventional Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib (GIDEON) study

location_country:
Finland
Malaysia
Greece
Romania
Russian Federation
Czech Republic
Qatar
Ukraine
India
Spain
Pakistan
Uruguay
Croatia
France
Japan
Slovakia
Thailand
Norway
Indonesia
Canada
Korea, Republic of
Colombia
Libyan Arab Jamahiriya
Sweden
United Arab Emirates
Hong Kong
Vietnam
Philippines
Singapore
Hungary
China
Portugal
United States
Italy
Syrian Arab Republic
Mexico
Venezuela
Israel
Kazakhstan


design_allocation: Non-Randomized

location_country:
Italy
Peru
Mexico
Germany
France
Bulgaria
Poland
Romania
Belgium
United States
Colombia

title: An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

summary: The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.


title: An Open-label, Multicenter Protocol Providing Pegylated-interferon Alfa-2a (PEGASYS®) as Monotherapy or in Combination With Ribavirin (COPEGUS®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

summary: This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus, 800-1200 mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48 weeks in genotype G1 with a treatment-free follow up period of 24 weeks.

lead_sponsor: Hoffmann-La Roche

location_country:
Austria
Germany
France
Spain
United States
Canada


title: A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol

summary: The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
France
Greece
Singapore
Australia
Canada
United Kingdom


title: An Adaptive Dose-ranging, Multi-center, Single-blind, Double-dummy, Active-controlled Trial to Determine the Target Dose of Canakinumab (ACZ885) in the Treatment of Acute Flares in Gout Patients Who Are Refractory or Contraindicated to NSAIDs and/or Colchicine

summary: This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the corticosteroid triamcinolone acetonide.

ReferenceCitation: Chakraborty A, Van LM, Skerjanec A, Floch D, Klein UR, Krammer G, Sunkara G, Howard D. Pharmacokinetic and pharmacodynamic properties of canakinumab in patients with gouty arthritis. J Clin Pharmacol. 2013 Dec;53(12):1240-51. doi: 10.1002/jcph.162. Epub 2013 Sep 30.

name: Clinical Pharmacology; Novartis Pharmaceuticals Corporation; East Hanover NJ USA

family: Chakraborty

full_name: Abhijit Chakraborty

given: Abhijit

name: Advanced Quantitative Sciences; Novartis Institute for Biomedical Research; Cambridge MA USA

family: Van

full_name: Linh M. Van

given: Linh M.

name: Biologics & Safety Disposition; Novartis Institute for Biomedical Research; Basel Switzerland

family: Skerjanec

full_name: Andrej Skerjanec

given: Andrej

family: Floch

full_name: David Floch

given: David

family: Klein

full_name: Ulf R. Klein

given: Ulf R.

name: Clinical Development Unit, Department of Integrated Hospital Care Franchise; Novartis Pharma AG; Basel Switzerland

family: Krammer

full_name: Gerhard Krammer

given: Gerhard

name: Clinical PK/PD, Drug Metabolism and Pharmacokinetics; Novartis Institutes for Biomedical Research; East Hanover NJ USA

family: Sunkara

full_name: Gangadhar Sunkara

given: Gangadhar

family: Howard

full_name: Dan Howard

given: Dan

journal_name: The Journal of Clinical Pharmacology

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Schlesinger N, De Meulemeester M, Pikhlak A, Yücel AE, Richard D, Murphy V, Arulmani U, Sallstig P, So A. Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study. Arthritis Res Ther. 2011 Mar 25;13(2):R53. doi: 10.1186/ar3297.

family: Schlesinger

full_name: Naomi Schlesinger

given: Naomi

family: De Meulemeester

full_name: Marc De Meulemeester

given: Marc

family: Pikhlak

full_name: Andrey Pikhlak

given: Andrey

family: Yücel

full_name: A Eftal Yücel

given: A Eftal

family: Richard

full_name: Dominik Richard

given: Dominik

family: Murphy

full_name: Valda Murphy

given: Valda

family: Arulmani

full_name: Udayasankar Arulmani

given: Udayasankar

family: Sallstig

full_name: Peter Sallstig

given: Peter

family: So

full_name: Alexander So

given: Alexander

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

license: cc-by

license_normalized: cc-by

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

ReferenceCitation: So A, De Meulemeester M, Pikhlak A, Yücel AE, Richard D, Murphy V, Arulmani U, Sallstig P, Schlesinger N. Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, dose-ranging study. Arthritis Rheum. 2010 Oct;62(10):3064-76. doi: 10.1002/art.27600.

location_country:
United States
Switzerland
Germany
France
Poland
Belgium
Argentina
Russian Federation
Turkey
Canada
United Kingdom

location_facility: San Diego Arthritis & Osteoporosis Medical Clinic

location_facility: Center for Clinical Trials of San Gabriel

location_facility: Northern California Institute for Bone Health

location_facility: New Mexico Clinical Research & Osteoporosis Center, Inc.

location_facility: Regional Clinical Research Rheumatology Assoc.


ReferenceCitation: Bissler JJ, Kingswood JC, Radzikowska E, Zonnenberg BA, Frost M, Belousova E, Sauter M, Nonomura N, Brakemeier S, de Vries PJ, Whittemore VH, Chen D, Sahmoud T, Shah G, Lincy J, Lebwohl D, Budde K. Everolimus for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis (EXIST-2): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2013 Mar 9;381(9869):817-24.

ReferenceCitation: Bissler JJ, Nonomura N, Budde K, Zonnenberg BA, Fischereder M, Voi M, Louveau AL, Herbst F, Bebin EM, Curatolo P, Zonta A, Belousova E. Angiomyolipoma rebound tumor growth after discontinuation of everolimus in patients with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis. PLoS One. 2018 Sep 7;13(9):e0201005. doi: 10.1371/journal.pone.0201005. eCollection 2018.

family: Bissler

full_name: John J. Bissler

given: John J.

family: Nonomura

full_name: Norio Nonomura

given: Norio

family: Budde

full_name: Klemens Budde

given: Klemens

family: Zonnenberg

full_name: Bernard A. Zonnenberg

given: Bernard A.

family: Fischereder

full_name: Michael Fischereder

given: Michael

family: Voi

full_name: Maurizio Voi

given: Maurizio

family: Louveau

full_name: Anne-Laure Louveau

given: Anne-Laure

family: Herbst

full_name: Fabian Herbst

given: Fabian

family: Bebin

full_name: E. Martina Bebin

given: E. Martina

family: Curatolo

full_name: Paolo Curatolo

given: Paolo

family: Zonta

full_name: Andrea Zonta

given: Andrea

family: Belousova

full_name: Elena Belousova

given: Elena

journal_name: PLOS ONE

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ReferenceCitation: Bissler JJ, Budde K, Sauter M, Franz DN, Zonnenberg BA, Frost MD, Belousova E, Berkowitz N, Ridolfi A, Christopher Kingswood J. Effect of everolimus on renal function in patients with tuberous sclerosis complex: evidence from EXIST-1 and EXIST-2. Nephrol Dial Transplant. 2019 Jun 1;34(6):1000-1008. doi: 10.1093/ndt/gfy132.

name: St. Jude Children’s Research Hospital and Le Bonheur Children’s Hospital, Memphis, TN, USA

full_name: John J Bissler

given: John J

name: Charité Universitätsmedizin, Berlin, Germany

name: Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Munich, Germany

family: Sauter

full_name: Matthias Sauter

given: Matthias

name: Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

name: Universitair Medisch Centrum Utrecht, The Netherlands

name: Minnesota Epilepsy Group, St. Paul, MN, USA

name: Moscow Research and Clinical Institute of Pediatrics, Moscow, Russian Federation

name: Novartis Pharmaceuticals, East Hanover, NJ, USA

name: Novartis Pharmaceuticals S.A.S., Rueil-Malmaison, France

name: Royal Sussex County Hospital, Brighton, UK

ReferenceCitation: Sparagana S, Franz DN, Krueger DA, Bissler JJ, Berkowitz N, Burock K, Kingswood JC. Pooled analysis of menstrual irregularities from three major clinical studies evaluating everolimus for the treatment of tuberous sclerosis complex. PLoS One. 2017 Oct 12;12(10):e0186235. doi: 10.1371/journal.pone.0186235. eCollection 2017.

ReferenceCitation: Bissler JJ, Kingswood JC, Radzikowska E, Zonnenberg BA, Frost M, Belousova E, Sauter M, Nonomura N, Brakemeier S, de Vries PJ, Berkowitz N, Miao S, Segal S, Peyrard S, Budde K. Everolimus for renal angiomyolipoma in patients with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis: extension of a randomized controlled trial. Nephrol Dial Transplant. 2016 Jan;31(1):111-9. doi: 10.1093/ndt/gfv249. Epub 2015 Jul 8.

location_country:
Italy
United States
Netherlands
France
Japan
Poland
Russian Federation
Spain
Germany
United Kingdom
Canada

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Massachusetts General Hospital Massachussetts General Hospita

title: A Randomized, Double-blind, Placebo-controlled Study of RAD0001 in the Treatment of Angiomyolipoma in Patients With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)

summary: This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.


title: Betaferon Prospective Study on Adherence, Coping and Nursing Support

acronym: BEACON

summary:
The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.

ReferenceCitation: Patti F, Penaherrera JN, Zieger L, Wicklein EM. Clinical characteristics of middle-aged and older patients with MS treated with interferon beta-1b: post-hoc analysis of a 2-year, prospective, international, observational study. BMC Neurol. 2021 Aug 23;21(1):324. doi: 10.1186/s12883-021-02347-w.

family: Patti

full_name: Francesco Patti

given: Francesco

family: Penaherrera

full_name: Javier Nicolas Penaherrera

given: Javier Nicolas

family: Zieger

full_name: Lorissa Zieger

given: Lorissa

family: Wicklein

full_name: Eva-Maria Wicklein

given: Eva-Maria

journal_name: BMC Neurology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_country:
Jordan
Belgium
Czech Republic
Taiwan
Bahrain
Pakistan
France
Slovakia
Kuwait
Norway
Argentina
Canada
Slovenia
Korea, Republic of
Colombia
Iran, Islamic Republic of
Libyan Arab Jamahiriya
Sweden
United Arab Emirates
Saudi Arabia
Netherlands
Singapore
China
Portugal
Germany
United Kingdom
Italy
Bosnia and Herzegovina
Syrian Arab Republic
Lebanon
Mexico
Venezuela
Israel
Egypt
New Zealand
Estonia


title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AVE5530 When Added to Ongoing Stable Statin Therapy at High Doses in Patients With Severe Primary Hypercholesterolemia

summary:
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.

The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

lead_sponsor: Sanofi

location_country:
United States
South Africa
Netherlands
France
Bulgaria
Israel
Slovakia
Belgium
Australia
Russian Federation
Canada
Czech Republic
Ukraine

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

acronym: CARGOII

summary: The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test. Sensitive detection of cardiac allograft rejection and dysfunction is the basis for successful recipient management. The CARGO II Study will assess the correlation between the presence or absence of acute cellular rejection as determined by examination of endomyocardial biopsy specimens with results from the AlloMap Test. Of 17 participating transplant centers, 4 are in North America and 13 are in Europe.

ReferenceCitation: Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczyński M, Fiocchi R, Hoefer D, Colvin M, Deng MC, Leprince P, Elashoff B, Yee JP, Vanhaecke J. Clinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II. Eur Heart J. 2016 Sep 1;37(33):2591-601. doi: 10.1093/eurheartj/ehv682. Epub 2016 Jan 7.

family: Crespo-Leiro

full_name: Maria G. Crespo-Leiro

given: Maria G.

family: Stypmann

full_name: Jörg Stypmann

given: Jörg

family: Schulz

full_name: Uwe Schulz

given: Uwe

family: Zuckermann

full_name: Andreas Zuckermann

given: Andreas

family: Mohacsi

full_name: Paul Mohacsi

given: Paul

family: Bara

full_name: Christoph Bara

given: Christoph

family: Ross

full_name: Heather Ross

given: Heather

family: Parameshwar

full_name: Jayan Parameshwar

given: Jayan

family: Zakliczyński

full_name: Michal Zakliczyński

given: Michal

family: Fiocchi

full_name: Roberto Fiocchi

given: Roberto

family: Hoefer

full_name: Daniel Hoefer

given: Daniel

family: Colvin

full_name: Monica Colvin

given: Monica

family: Deng

full_name: Mario C. Deng

given: Mario C.

family: Leprince

full_name: Pascal Leprince

given: Pascal

family: Elashoff

full_name: Barbara Elashoff

given: Barbara

family: Yee

full_name: James P. Yee

given: James P.

family: Vanhaecke

full_name: Johan Vanhaecke

given: Johan

journal_name: European Heart Journal

evidence: open (via page says Open Access)

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

repository_normalized: dnet

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

ReferenceCitation: Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczyński M, Fiocchi R, Hoefer D, Deng M, Leprince P, Hiller D, Eubank L, Deljkich E, Yee JP, Vanhaecke J. Performance of gene-expression profiling test score variability to predict future clinical events in heart transplant recipients. BMC Cardiovasc Disord. 2015 Oct 9;15:120. doi: 10.1186/s12872-015-0106-1.

ReferenceCitation: Crespo-Leiro MG, Zuckermann A, Bara C, Mohacsi P, Schulz U, Boyle A, Ross HJ, Parameshwar J, Zakliczyński M, Fiocchi R, Stypmann J, Hoefer D, Lehmkuhl H, Deng MC, Leprince P, Berry G, Marboe CC, Stewart S, Tazelaar HD, Baron HM, Coleman IC, Vanhaecke J. Concordance among pathologists in the second Cardiac Allograft Rejection Gene Expression Observational Study (CARGO II). Transplantation. 2012 Dec 15;94(11):1172-7. doi: 10.1097/TP.0b013e31826e19e2.

title: Concordance Among Pathologists in the Second Cardiac Allograft Rejection Gene Expression Observational Study (CARGO II)

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

location_facility: Medical University of Vienna (Medizinische Universität Wien)

location_facility: UKM - Medizinische Klinik und Poliklinik C (Kardiologie und Angiologie)

location_facility: Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie

location_facility: Inselspital - Universitätsspital Bern Postfach 33


title: Efficacy and Safety of AP 12009 in Adult Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma as Compared to Standard Chemotherapy Treatment: A Randomized, Actively Controlled, Open Label Clinical Phase III Study.

acronym: SAPPHIRE

summary: In this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed recurrent or refractory anaplastic astrocytoma (WHO grade III) or secondary glioblastoma (WHO grade IV).

lead_sponsor: Isarna Therapeutics GmbH

location_country:
Austria
United States
Brazil
India
Mexico
Germany
France
Poland
Hungary
Argentina
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Samara Region Clinical Hospital M.I. Kalinin

location_facility: Universitätsklinikum Leipzig, Neurochirurgische Klinik

location_facility: Neurochirurgische Klinik an der Universität Ulm am Bezirkskrankenhaus Günzburg

location_facility: Manipal Hospital & Manipal Institute for Neurological Disorders

location_facility: Centrum Onkologii - Instytut Im. Marii Sklodowskiej-Curie

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Amrita Institute of Medical Sciences Research Center

location_facility: Wojskowy Szpital Kliniczny, Klinika Neurochirurgii

location_facility: Universitätsklinik Innsbruck, Abteilung für Neurologie

location_facility: Edinburgh Centre for Neuro-Oncology, Western General Hospital

location_facility: Medizinische Hochschule Hannover Neurochirurgische Klinik

location_facility: State Institution Russian Oncology Research Center N.N. Blokhin

location_facility: NJ Neuroscience Institute; JFK Medical Center

location_facility: Universitätsklinik Heidelberg Neurologische Klinik

location_facility: SP ZOZ Uniwersytecki Szpital Kliniczny nr 1, Klinika Neurochirurgii

location_facility: Montreal Neurological Institute and Hospital

location_facility: Universitätklinikum Hamburg-Eppendorf, Klinik für Neurochirurgie

location_facility: All India Institute of Medical Sciences (AIIMS)

location_facility: Severance Hospital, Yonsei University College of Medicine

location_facility: Otto-von-Guericke-Universität, Klinik für Neurochirurgie

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Russian Scientific Research Neurosurgical Institute A.L. Polenov

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Neurochirurgii i Neurochirurgii Dziecięcej

location_facility: Military Medical Academy, Neurosurgery Dept

location_facility: Advanced Centre for Treatment Research and Education in Cancer (ACTREC)

location_facility: Kliniczny Oddzial Neurochirurgii SUM w Sosnowcu Wojewódzki Szpital Specjalistyczny nr 5

location_facility: Postgraduate Institute of Medical Education & Research (PGIMER)

location_facility: Chelyabinsk City Hospital #3; Department of Neurosurgery

location_facility: Klinik und Poliklinik für Neurochirurgie


title: A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System

summary: A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Germany
France
Belgium
Denmark
United States

location_facility:
Evangelisches Krankenhaus Dusseldorf
Fox Chase Cancer Center
Indiana University Medical Center
University of Colorado Hospital
Mayo Clinic
California Pacific Medical Center
Bispebjerg Hospital, Denmark
Beth Israel Deaconess Medical Center
Medical University of South Carolina
Hopital Edouard Herriot
Erasme Hospital - Belgium
Policlinico Agostino Gemelli
Columbia University Medical Center
University of Pittsburgh
Cleveland Clinic Foundation


ReferenceCitation: Chen KS, Gosmanova EO, Curhan GC, Ketteler M, Rubin M, Swallow E, Zhao J, Wang J, Sherry N, Krasner A, Bilezikian JP. Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1-84). J Clin Endocrinol Metab. 2020 Oct 1;105(10). pii: dgaa490. doi: 10.1210/clinem/dgaa490.

name: Shire Human Genetic Therapies, Inc., Cambridge, Massachusetts (a Takeda company)

family: Chen

full_name: Kristina S Chen

given: Kristina S

name: Division of Nephrology, Albany Medical College and Nephrology Section, Stratton VA Medical Center, Albany, New York

family: Gosmanova

full_name: Elvira O Gosmanova

given: Elvira O

name: Renal Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

family: Curhan

full_name: Gary C Curhan

given: Gary C

name: Department of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany

name: Department of Medicine Program, University of Split School of Medicine, Split, Croatia

family: Ketteler

full_name: Markus Ketteler

given: Markus

name: Columbia University College of Physicians and Surgeons, New York, New York

family: Rubin

full_name: Mishaela Rubin

given: Mishaela

name: Analysis Group Inc., Boston, Massachusetts

family: Swallow

full_name: Elyse Swallow

given: Elyse

family: Zhao

full_name: Jing Zhao

given: Jing

family: Wang

full_name: Jessie Wang

given: Jessie

family: Sherry

full_name: Nicole Sherry

given: Nicole

family: Krasner

full_name: Alan Krasner

given: Alan

family: Bilezikian

full_name: John P Bilezikian

given: John P

journal_name: The Journal of Clinical Endocrinology & Metabolism

evidence: open (via crossref license)

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1–84)

ReferenceCitation: Vokes TJ, Mannstadt M, Levine MA, Clarke BL, Lakatos P, Chen K, Piccolo R, Krasner A, Shoback DM, Bilezikian JP. Recombinant Human Parathyroid Hormone Effect on Health-Related Quality of Life in Adults With Chronic Hypoparathyroidism. J Clin Endocrinol Metab. 2018 Feb 1;103(2):722-731. doi: 10.1210/jc.2017-01471.

family: Vokes

full_name: Tamara J Vokes

given: Tamara J

family: Mannstadt

full_name: Michael Mannstadt

given: Michael

family: Levine

full_name: Michael A Levine

given: Michael A

family: Clarke

full_name: Bart L Clarke

given: Bart L

family: Lakatos

full_name: Peter Lakatos

given: Peter

full_name: Kristina Chen

given: Kristina

family: Piccolo

full_name: Rebecca Piccolo

given: Rebecca

family: Shoback

full_name: Dolores M Shoback

repository_institution: Semmelweis University - Semmelweis University Repository

ReferenceCitation: Mannstadt M, Clarke BL, Vokes T, Brandi ML, Ranganath L, Fraser WD, Lakatos P, Bajnok L, Garceau R, Mosekilde L, Lagast H, Shoback D, Bilezikian JP. Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study. Lancet Diabetes Endocrinol. 2013 Dec;1(4):275-83. doi: 10.1016/S2213-8587(13)70106-2. Epub 2013 Oct 7. Erratum in: Lancet Diabetes Endocrinol. 2014 Jan;2(1):e3. Dosage error in article text.

title: Efficacy and safety of recombinant human parathyroid hormone (1–84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study

location_country:
Italy
United States
France
Hungary
Belgium
Denmark
Canada
United Kingdom

location_facility: Chetre Hospitalier Universitaire de Liege

location_facility: Capital District Health Authority, QEII Health Sciences Centre

location_facility: University of Cincinnati Bone Health and Osteoporosis Center

location_facility: University of California-San Francisco VA Medical Center

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism

summary: Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.


title: A Multicenter, Double-blind, Randomized, 12-month, Placebo-controlled Study to Evaluate the Lipid-lowering Effect, Safety and Tolerability of AVE5530 25 mg/Day and 50mg/Day When Added to Ongoing Stable Statin Therapy (HMG-CoA Reductase Inhibitors) in Patients With Primary Hypercholesterolemia

summary:
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.

The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

location_country:
United States
Sweden
Netherlands
Germany
France
Poland
Israel
Norway
Hungary
Belgium
Australia
Russian Federation
Spain
Denmark
Canada
Czech Republic

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic as Post-consolidation Therapy in Adult Patients With Acute Myeloid Leukemia

summary: This study is being done to evaluate the safety of a WT1 Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-consolidation therapy in adult patients with WT1-positive Acute Myeloid Leukemia in first complete remission. It will also be analyzed to what extent this treatment induces an immune response, specific to the malignancy.

lead_sponsor: GlaxoSmithKline

location_country:
United States
France


lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Sweden
Hong Kong
Switzerland
Germany
Finland
France
Poland
Thailand
Norway
Hungary
Belgium
Argentina
Australia
New Zealand
Canada
Colombia

title: A 3-year, Multicenter, Double-blind, Randomized, Placebo-controlled Extension to CZOL446H2301E1 to Evaluate the Efficacy and Long Term Safety of 6 and 9 Years Zoledronic Acid Treatment of Postmenopausal Women With Osteoporosis

summary: This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis


ReferenceCitation: Bruce IN, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016 Jun;25(7):699-709. doi: 10.1177/0961203315625119. Epub 2016 Mar 1.

ReferenceCitation: van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.

name: Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, The Netherlands

family: van Vollenhoven

full_name: Ronald F van Vollenhoven

given: Ronald F

name: University of Santo Tomas Hospital, Manila, Philippines

family: Navarra

full_name: Sandra V Navarra

given: Sandra V

name: Rio de Janeiro State University, Pedro Ernesto University Hospital, Rio de Janeiro, Brazil

family: Levy

full_name: Roger A Levy

given: Roger A

name: Kerala Institute of Medical Sciences (KIMS), Kerala, India

family: Thomas

full_name: Mathew Thomas

given: Mathew

family: Heath

full_name: Amy Heath

given: Amy

family: Lustine

full_name: Todd Lustine

given: Todd

family: Adamkovic

full_name: Anthony Adamkovic

given: Anthony

family: Fettiplace

full_name: James Fettiplace

given: James

full_name: Mei-Lun Wang

given: Mei-Lun

family: Ji

full_name: Beulah Ji

given: Beulah

family: Roth

full_name: David Roth

given: David

journal_name: Rheumatology

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Urowitz MB, Ohsfeldt RL, Wielage RC, Dever JJ, Zakerifar M, Asukai Y, Ramachandran S, Joshi AV. Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study. Lupus Sci Med. 2020 Oct;7(1). pii: e000412. doi: 10.1136/lupus-2020-000412.

family: Urowitz

full_name: Murray B Urowitz

given: Murray B

family: Ohsfeldt

full_name: Robert L Ohsfeldt

given: Robert L

family: Wielage

full_name: Ronald C Wielage

given: Ronald C

family: Dever

full_name: John J Dever

given: John J

family: Zakerifar

full_name: Mehdi Zakerifar

given: Mehdi

family: Asukai

full_name: Yumi Asukai

given: Yumi

family: Ramachandran

full_name: Sulabha Ramachandran

given: Sulabha

family: Joshi

full_name: Ashish V Joshi

given: Ashish V

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

lead_sponsor: Human Genome Sciences Inc., a GSK Company

location_country:
Peru
Romania
Belgium
Russian Federation
Taiwan
India
France
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Hong Kong
Netherlands
Philippines
Puerto Rico
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain

title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057

summary: This is a long-term continuation study to provide continuing treatment to subjects with SLE.


title: A Phase 2, Multicenter, Randomized, Double-Blind, Comparative Study Of The Safety And Efficacy of 2 Doses Of Tigecycline Versus Imipenem/Cilastatin For The Treatment Of Subjects With Hospital-Acquired Pneumonia

summary:
This study will compare the safety and efficacy of a tigecycline regimen versus an imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from a minimum of 7 & up to 14 consecutive days, the exact duration will be at the decision of the investigator based on the subject's condition. Additional protocol specified antibiotics may be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit will be done 10 to 21 days after the last day of therapy. The total duration of subject participation will be between 17 and 44 days, including a follow up period of 30 days after the last day of therapy for SAEs.

Subjects will be followed for safety and efficacy. The safety assessment will include: physical examinations, vital signs, assessment of the clinical signs and symptoms of pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology, serum chemistries, and coagulation parameters, & a serum or urine pregnancy test before study entry for women of childbearing potential. The clinical and microbiological efficacy will both be evaluated.

ReferenceCitation: Ramirez J, Dartois N, Gandjini H, Yan JL, Korth-Bradley J, McGovern PC. Randomized phase 2 trial to evaluate the clinical efficacy of two high-dosage tigecycline regimens versus imipenem-cilastatin for treatment of hospital-acquired pneumonia. Antimicrob Agents Chemother. 2013 Apr;57(4):1756-62. doi: 10.1128/AAC.01232-12. Epub 2013 Jan 28.

family: Ramirez

full_name: Julio Ramirez

given: Julio

family: Dartois

full_name: Nathalie Dartois

given: Nathalie

family: Gandjini

full_name: Hassan Gandjini

given: Hassan

family: Yan

full_name: Jean Li Yan

given: Jean Li

family: Korth-Bradley

full_name: Joan Korth-Bradley

given: Joan

family: McGovern

full_name: Paul C. McGovern

given: Paul C.

journal_name: Antimicrobial Agents and Chemotherapy

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: Randomized Phase 2 Trial To Evaluate the Clinical Efficacy of Two High-Dosage Tigecycline Regimens versus Imipenem-Cilastatin for Treatment of Hospital-Acquired Pneumonia

location_country:
Brazil
United States
Chile
Croatia
France
Hungary
Argentina
Australia
Russian Federation
Canada
Latvia
Korea, Republic of
Taiwan
Colombia


title: Study to Evaluate the Safety of GSK Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL in HSV Seropositive or Seronegative Subjects Without Genital Herpes Disease

summary: This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.

location_country:
Austria
United States
South Africa
Switzerland
Germany
France
Australia
Belgium
Puerto Rico
Spain
Denmark
Canada


title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date

summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

ReferenceCitation: Hughes JR, Russ C, Messig MA. Association of deferring a quit attempt with smoking cessation success: a secondary analysis. J Subst Abuse Treat. 2014 Feb;46(2):264-7. doi: 10.1016/j.jsat.2013.08.015. Epub 2013 Sep 24.

family: Hughes

full_name: John R. Hughes

given: John R.

family: Russ

full_name: Cristina Russ

given: Cristina

family: Messig

full_name: Michael A. Messig

given: Michael A.

journal_name: Journal of Substance Abuse Treatment

title: Association of deferring a quit attempt with smoking cessation success: A secondary analysis

ReferenceCitation: Rennard S, Hughes J, Cinciripini PM, Kralikova E, Raupach T, Arteaga C, St Aubin LB, Russ C; Flexible Quit Date Study Group. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012 Mar;14(3):343-50. doi: 10.1093/ntr/ntr220. Epub 2011 Nov 11.

family: Rennard

full_name: S. Rennard

given: S.

full_name: J. Hughes

given: J.

family: Cinciripini

full_name: P. M. Cinciripini

given: P. M.

family: Kralikova

full_name: E. Kralikova

given: E.

family: Raupach

full_name: T. Raupach

given: T.

family: Arteaga

full_name: C. Arteaga

given: C.

family: St Aubin

full_name: L. B. St Aubin

given: L. B.

full_name: C. Russ

journal_name: Nicotine & Tobacco Research

title: A Randomized Placebo-Controlled Trial of Varenicline for Smoking Cessation Allowing Flexible Quit Dates

location_country:
Italy
Brazil
United States
United Kingdom
Mexico
Germany
France
Hungary
Argentina
China
Canada
Czech Republic
Korea, Republic of
Taiwan


title: A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.

summary: The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.

ReferenceCitation: Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13.

ReferenceCitation: Mackey JR, Martin M, Pienkowski T, Rolski J, Guastalla JP, Sami A, Glaspy J, Juhos E, Wardley A, Fornander T, Hainsworth J, Coleman R, Modiano MR, Vinholes J, Pinter T, Rodríguez-Lescure A, Colwell B, Whitlock P, Provencher L, Laing K, Walde D, Price C, Hugh JC, Childs BH, Bassi K, Lindsay MA, Wilson V, Rupin M, Houé V, Vogel C; TRIO/BCIRG 001 investigators. Adjuvant docetaxel, doxorubicin, and cyclophosphamide in node-positive breast cancer: 10-year follow-up of the phase 3 randomised BCIRG 001 trial. Lancet Oncol. 2013 Jan;14(1):72-80. doi: 10.1016/S1470-2045(12)70525-9. Epub 2012 Dec 12.

family: Mackey

full_name: John R Mackey

given: John R

family: Martin

full_name: Miguel Martin

given: Miguel

family: Pienkowski

full_name: Tadeusz Pienkowski

given: Tadeusz

family: Rolski

full_name: Janusz Rolski

given: Janusz

family: Guastalla

full_name: Jean-Paul Guastalla

given: Jean-Paul

family: Sami

full_name: Amer Sami

given: Amer

family: Glaspy

full_name: John Glaspy

given: John

family: Juhos

full_name: Eva Juhos

given: Eva

family: Wardley

full_name: Andrew Wardley

given: Andrew

family: Fornander

full_name: Tommy Fornander

given: Tommy

family: Hainsworth

full_name: John Hainsworth

family: Coleman

full_name: Robert Coleman

given: Robert

family: Modiano

full_name: Manuel R Modiano

given: Manuel R

family: Vinholes

full_name: Jeferson Vinholes

given: Jeferson

family: Pinter

full_name: Tamas Pinter

given: Tamas

family: Rodríguez-Lescure

full_name: Álvaro Rodríguez-Lescure

given: Álvaro

family: Colwell

full_name: Bruce Colwell

given: Bruce

family: Whitlock

full_name: Pierre Whitlock

given: Pierre

family: Provencher

full_name: Louise Provencher

given: Louise

family: Laing

full_name: Kara Laing

given: Kara

family: Walde

full_name: David Walde

given: David

family: Price

full_name: Chris Price

given: Chris

family: Hugh

full_name: Judith C Hugh

given: Judith C

location_country:
Austria
United States
Brazil
South Africa
Sweden
United Kingdom
Spain
Germany
Uruguay
France
Poland
Greece
Israel
Slovakia
Hungary
Argentina
Egypt
Portugal
Canada
Czech Republic

location_facility:
Sanofi-aventis administrative office
Sanofi-aventis adminsitrative office
sanofi-aventis Administrative office
Sanofi-Aventis Administrative Office


title: Clinical Phase I/IIA Study of Subcutaneously Administration of Ofatumumab in Rheumatoid Arthritis Patients on Stable Dose Methotrexate

summary: This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.

ReferenceCitation: Kurrasch R, Brown JC, Chu M, Craigen J, Overend P, Patel B, Wolfe S, Chang DJ. Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics. J Rheumatol. 2013 Jul;40(7):1089-96. doi: 10.3899/jrheum.121118. Epub 2013 Jun 1.

family: Kurrasch

full_name: Regina Kurrasch

given: Regina

family: Brown

full_name: Judith C. Brown

given: Judith C.

family: Chu

full_name: Myron Chu

given: Myron

family: Craigen

full_name: Jenny Craigen

given: Jenny

family: Overend

full_name: Philip Overend

given: Philip

family: Patel

full_name: Bela Patel

given: Bela

family: Wolfe

full_name: Steven Wolfe

given: Steven

family: Chang

full_name: David J. Chang

given: David J.

bso_classification: Chemistry

journal_name: The Journal of Rheumatology

publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

publisher_normalized: The Journal of Rheumatology

title: Subcutaneously Administered Ofatumumab in Rheumatoid Arthritis: A Phase I/II Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics

location_country:
Italy
Spain
France
Poland
Belgium
Australia
New Zealand
Russian Federation
United States

intervention_type: Other


title: An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis

summary: Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
France
Australia
Denmark
Germany
United Kingdom

location_facility: Renal Research Unit, Launceston General Hospital

location_facility: Renal Unit, The Queen Elizabeth Hospital

location_facility: Melbourne Renal Research Group, Epworth Medical Centre

location_facility: Renal Dialysis Unit, Manchester Royal Infirmary

location_facility: Renal Department, The Royal London Hospital

location_facility: Universitätsklinikum Aachen, Medizinsche Klinik II

location_facility: Department of Renal Medicine, Hope Hospital

location_facility: Nephrology Department, Princess Alexandra Hospital

location_facility: The Royal Melbourne Hospital, Department of Nephrology

location_facility: Birmingham Hospital, Queen Elizabeth Medical Centre

location_facility: Medicinsk Afdeling, nefrologisk, Roskilde Sygehus

location_facility: Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin


title: A Randomized, Double-Blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-Severe Alzheimer's Disease

summary: The purpose of this study is to compare the effectiveness and safety of 2 years of treatment with galantamine as compared with placebo of patients who have mild to moderately severe Alzheimer's disease (AD).

ReferenceCitation: Hager K, Baseman AS, Nye JS, Brashear HR, Han J, Sano M, Davis B, Richards HM. Effect of concomitant use of memantine on mortality and efficacy outcomes of galantamine-treated patients with Alzheimer's disease: post-hoc analysis of a randomized placebo-controlled study. Alzheimers Res Ther. 2016 Nov 15;8(1):47.

ReferenceCitation: Hager K, Baseman AS, Nye JS, Brashear HR, Han J, Sano M, Davis B, Richards HM. Effects of galantamine in a 2-year, randomized, placebo-controlled study in Alzheimer's disease. Neuropsychiatr Dis Treat. 2014 Feb 21;10:391-401. doi: 10.2147/NDT.S57909. eCollection 2014. Erratum in: Neuropsychiatr Dis Treat. 2014;10:1997.

family: Baseman

full_name: Alan Baseman

given: Alan

family: Hager

full_name: Klaus Hager

given: Klaus

family: Nye

full_name: Jeffrey S. Nye

given: Jeffrey S.

family: Brashear

full_name: Robert Brashear

given: Robert

family: Han

full_name: John Han

given: John

family: Sano

full_name: Mary Sano

given: Mary

family: Davis

full_name: Bonnie Davis

given: Bonnie

family: Richards

full_name: Henry Richards

given: Henry

journal_name: Neuropsychiatric Disease and Treatment

lead_sponsor: Janssen Research & Development, LLC

location_country:
France
Greece
Lithuania
Slovakia
Romania
Latvia
Russian Federation
Slovenia
Estonia
Germany
Czech Republic
Ukraine


title: Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation

summary: This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Italy
United States
Mexico
Germany
France
Belgium
Australia
Portugal
Canada
United Kingdom

location_facility:
Salix Investigational Site
Pfizer Investigational Site


location_country:
United States
Sweden
Netherlands
France
Germany
United Kingdom
Canada

acronym: eXplore

title: A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Trial to Explore the Effects of 78 Weeks Omalizumab Treatment Given as Add on Therapy on Markers of Airway Inflammation and Remodeling in Patients With Moderate to Severe Persistent Allergic Asthma Receiving Inhaled Corticosteroids and Long Acting Beta-agonists

summary: This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists. This study will also investigate the correlation between systemic and pulmonary inflammation, and the correlation between clinical outcomes and changes within the tissue, to assist in the future identification of patients with tissue eosinophilia and their response to treatment, without the need for invasive bronchoscopy.


title: Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis

acronym: MORE

summary: To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.

ReferenceCitation: Melamed ML, Blackwell T, Neugarten J, Arnsten JH, Ensrud KE, Ishani A, Cummings SR, Silbiger SR. Raloxifene, a selective estrogen receptor modulator, is renoprotective: a post-hoc analysis. Kidney Int. 2011 Jan;79(2):241-9. doi: 10.1038/ki.2010.378. Epub 2010 Oct 6.

family: Melamed

full_name: Michal L. Melamed

given: Michal L.

family: Blackwell

full_name: Terri Blackwell

given: Terri

family: Neugarten

full_name: Joel Neugarten

given: Joel

family: Arnsten

full_name: Julia H. Arnsten

given: Julia H.

family: Ensrud

full_name: Kristine E. Ensrud

given: Kristine E.

family: Ishani

full_name: Areef Ishani

given: Areef

family: Cummings

full_name: Steven R. Cummings

given: Steven R.

family: Silbiger

full_name: Sharon R. Silbiger

given: Sharon R.

journal_name: Kidney International

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Eli Lilly and Company

location_country:
Finland
Australia
Belgium
Denmark
Czech Republic
France
Poland
Slovakia
Norway
Argentina
Canada
Slovenia
Sweden
Netherlands
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Mexico
Israel
New Zealand
Spain

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: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic

summary: The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor, R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy.

lead_sponsor: Rigel Pharmaceuticals

location_country:
Italy
United States
Peru
France
Belgium
Germany
Colombia

location_facility: Azienda Ospedaliera Santa Maria della Miseri

location_facility: Reumatologia Azienda Ospedaliera Universitaria

location_facility: Rheumazentrum am Universitatsklinikum Leipzig

location_facility: Memorial Medical Group Clinical Research Inst

location_facility: North Shore Long Island Jewich Health System

location_facility: Clinical Research Center of Reading, LLP

location_facility: The Osteoporosis & Clinical Trials Center

location_facility: Arthritis & Rheumatic Disease Specialties


title: Randomized, Double-Blind, Multicenter, Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

summary: To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.

location_country:
Brazil
United States
Peru
Sweden
Mexico
Spain
Germany
France
Slovakia
Belgium
Russian Federation
Portugal
Denmark
Canada
Slovenia


title: A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over

summary: To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

ReferenceCitation: Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.

family: Wirostko

full_name: B. M. Wirostko

given: B. M.

family: Tressler

full_name: C. Tressler

given: C.

family: Hwang

full_name: L.-J. Hwang

family: Burgess

full_name: G. Burgess

given: G.

family: Laties

full_name: A. M. Laties

given: A. M.

journal_name: BMJ

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Malaysia
Belgium
Australia
Denmark
France
Poland
Norway
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain


title: A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma

summary: The purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .

ReferenceCitation: Scherpereel A, Berghmans T, Lafitte JJ, Colinet B, Richez M, Bonduelle Y, Meert AP, Dhalluin X, Leclercq N, Paesmans M, Willems L, Sculier JP; European Lung Cancer Working Party (ELCWP). Valproate-doxorubicin: promising therapy for progressing mesothelioma. A phase II study. Eur Respir J. 2011 Jan;37(1):129-35. doi: 10.1183/09031936.00037310. Epub 2010 Jun 7.

family: Scherpereel

full_name: A. Scherpereel

given: A.

family: Berghmans

full_name: T. Berghmans

given: T.

family: Lafitte

full_name: J. J. Lafitte

given: J. J.

family: Colinet

full_name: B. Colinet

given: B.

family: Richez

full_name: M. Richez

given: M.

family: Bonduelle

full_name: Y. Bonduelle

given: Y.

family: Meert

full_name: A. P. Meert

given: A. P.

family: Dhalluin

full_name: X. Dhalluin

given: X.

family: Leclercq

full_name: N. Leclercq

given: N.

family: Paesmans

full_name: M. Paesmans

family: Willems

full_name: L. Willems

given: L.

family: Sculier

full_name: J. P. Sculier

given: J. P.

name: for the European Lung Cancer Working Party (ELCWP)

journal_name: European Respiratory Journal

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

lead_sponsor: European Lung Cancer Working Party

location_country: Belgium France

location_facility: Department of Pneumology Hôpital Ixelles-Molière

location_facility: Department of Pneumology CHR St joseph - Warquignies

location_facility: Department of Pneumology Hôpital Saint-Joseph

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