ReferenceCitation: Wechsler RT, Li G, French J, O'Brien TJ, D'Cruz O, Williams P, Goodson R, Brock M; ALEX-MT Study Group. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014 Jul;55(7):1088-98. doi: 10.1111/epi.12681. Epub 2014 Jun 10.

name: Consultants in Epilepsy and Neurology PLLC Boise Idaho U.S.A

family: Wechsler

full_name: Robert T. Wechsler

given: Robert T.

name: Medsol Clinical Research Center Port Charlotte Florida U.S.A

family: Li

full_name: George Li

given: George

name: NYU Comprehensive Epilepsy Center New York New York U.S.A

family: French

full_name: Jacqueline French

given: Jacqueline

name: The Departments of Medicine and Neurology The Royal Melbourne Hospital The University of Melbourne Melbourne Victoria Australia

family: O'Brien

full_name: Terence J. O'Brien

given: Terence J.

family: D'Cruz

full_name: O'Neill D'Cruz

given: O'Neill

family: Williams

full_name: Paulette Williams

given: Paulette

family: Goodson

full_name: Robin Goodson

given: Robin

family: Brock

full_name: Melissa Brock

given: Melissa

journal_name: Epilepsia

oa_colors: green hybrid

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: PubMed Central - Europe PMC

title: Conversion to lacosamide monotherapy in the treatment of focal epilepsy: Results from a historical‐controlled, multicenter, double‐blind study

lead_sponsor: UCB BIOSCIENCES, Inc.

location_country:
Italy
Austria
United States
Germany
France
Poland
Ireland
Australia
Puerto Rico
Spain
Denmark
Canada
United Kingdom

acronym: ALEX-MT

title: A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400 mg/Day Monotherapy in Subjects With Partial-onset Seizures

summary: The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.


title: A Randomised, Double-Blind (With Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or Sulphasalazine

summary: The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. Patients will receive background treatment with either Methotrexate or Sulphasalazine

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Keystone EC, Wang MM, Layton M, Hollis S, McInnes IB; D1520C00001 Study Team. Clinical evaluation of the efficacy of the P2X7 purinergic receptor antagonist AZD9056 on the signs and symptoms of rheumatoid arthritis in patients with active disease despite treatment with methotrexate or sulphasalazine. Ann Rheum Dis. 2012 Oct;71(10):1630-5. Erratum in: Ann Rheum Dis. 2012 Dec;71(12):2064.

lead_sponsor: AstraZeneca

location_country:
United States
Mexico
France
Poland
Slovakia
Romania
Belgium
Argentina
Australia
Russian Federation
Canada
Czech Republic

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceCitation: Tan EH, Goss GD, Salgia R, Besse B, Gandara DR, Hanna NH, Yang JC, Thertulien R, Wertheim M, Mazieres J, Hensing T, Lee C, Gupta N, Pradhan R, Qian J, Qin Q, Scappaticci FA, Ricker JL, Carlson DM, Soo RA. Phase 2 trial of Linifanib (ABT-869) in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2011 Aug;6(8):1418-25. doi: 10.1097/JTO.0b013e318220c93e.

family: Tan

full_name: Eng-Huat Tan

given: Eng-Huat

sequence: first

family: Goss

full_name: Glenwood D. Goss

given: Glenwood D.

sequence: additional

family: Salgia

full_name: Ravi Salgia

given: Ravi

family: Besse

full_name: Benjamin Besse

given: Benjamin

family: Gandara

full_name: David R. Gandara

given: David R.

family: Hanna

full_name: Nasser H. Hanna

given: Nasser H.

family: Yang

full_name: James Chih-Hsin Yang

given: James Chih-Hsin

family: Thertulien

full_name: Raymond Thertulien

given: Raymond

family: Wertheim

full_name: Michael Wertheim

given: Michael

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Hensing

full_name: Thomas Hensing

given: Thomas

family: Lee

full_name: Christa Lee

given: Christa

family: Gupta

full_name: Neeraj Gupta

given: Neeraj

family: Pradhan

full_name: Rajendra Pradhan

given: Rajendra

family: Qian

full_name: Jiang Qian

given: Jiang

family: Qin

full_name: Qin Qin

given: Qin

family: Scappaticci

full_name: Frank A. Scappaticci

given: Frank A.

family: Ricker

full_name: Justin L. Ricker

given: Justin L.

family: Carlson

full_name: Dawn M. Carlson

given: Dawn M.

family: Soo

full_name: Ross A. Soo

given: Ross A.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Thoracic Oncology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Phase 2 Trial of Linifanib (ABT-869) in Patients with Advanced Non-small Cell Lung Cancer

location_country:
France
Singapore
United States
Canada
Taiwan

location_facility:
Site Reference ID/Investigator# 7194
Site Reference ID/Investigator# 6184
Site Reference ID/Investigator# 5663
Site Reference ID/Investigator# 6627
Site Reference ID/Investigator# 5603
Site Reference ID/Investigator# 6777
Site Reference ID/Investigator# 5640
Site Reference ID/Investigator# 5660
Site Reference ID/Investigator# 5534
Site Reference ID/Investigator# 5617
Site Reference ID/Investigator# 5648
Site Reference ID/Investigator# 5650
Site Reference ID/Investigator# 6572
Site Reference ID/Investigator# 8069
Site Reference ID/Investigator# 6739
Site Reference ID/Investigator# 5275
Site Reference ID/Investigator# 7616
Site Reference ID/Investigator# 5269
Site Reference ID/Investigator# 6680
Site Reference ID/Investigator# 6040
Site Reference ID/Investigator# 6042
Site Reference ID/Investigator# 7756
Site Reference ID/Investigator# 7868
Site Reference ID/Investigator# 5646
Site Reference ID/Investigator# 8068
Site Reference ID/Investigator# 8100
Site Reference ID/Investigator# 7934
Site Reference ID/Investigator# 5652

title: An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.


title: A Randomized, Double-Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B

summary:
The main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the immune tolerant phase of HBV infection.

The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events and changes in laboratory parameters.

Participants were randomized in a 1:1 ratio to receive tenofovir DF monotherapy or FTC plus tenofovir DF. All subjects were to continue on blinded study medication until the last subject reached Week 192. Participants who permanently discontinued study drug (on or before Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject reached Week 192.

lead_sponsor: Gilead Sciences

location_country:
United States
Hong Kong
Germany
France
Poland
Singapore
Australia
New Zealand
Canada
United Kingdom
Taiwan


status: Terminated

lead_sponsor: Grünenthal GmbH

location_country:
Chile
France
Argentina
United States
Latvia
Ukraine

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) Prolonged Release (PR*) in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain. *Prolonged Release and is the Recommended Nomenclature for Use in the European Union (EU). ER Means Extended Release and is the Recommended Nomenclature for Use in the United States of America (USA). "PR" is Synonymous With "ER" and is Interchangeable.

summary: The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.

status_simplified: Unknown


title: An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa

summary: The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

lead_sponsor: UCB Pharma

location_country:
Italy
Austria
South Africa
Sweden
United Kingdom
Finland
Croatia
France
Poland
Israel
Norway
Hungary
Australia
New Zealand
Spain
Germany
Czech Republic


title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).

ReferenceCitation: Adedokun OJ, Xu Z, Liao S, Strauss R, Reinisch W, Feagan BG, Sandborn WJ. Population Pharmacokinetics and Exposure-Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis. Clin Ther. 2020 Jan;42(1):157-174.e4. doi: 10.1016/j.clinthera.2019.11.010. Epub 2020 Jan 22.

family: Adedokun

full_name: Omoniyi J. Adedokun

given: Omoniyi J.

family: Xu

full_name: Zhenhua Xu

given: Zhenhua

family: Liao

full_name: Sam Liao

given: Sam

family: Strauss

full_name: Richard Strauss

given: Richard

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Feagan

full_name: Brian G. Feagan

given: Brian G.

family: Sandborn

full_name: William J. Sandborn

given: William J.

journal_name: Clinical Therapeutics

title: Population Pharmacokinetics and Exposure–Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis

ReferenceCitation: Rutgeerts P, Feagan BG, Marano CW, Padgett L, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Zhang H, Colombel JF, Reinisch W, Gibson PR, Sandborn WJ; PURSUIT-IV study group. Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis. Aliment Pharmacol Ther. 2015 Sep;42(5):504-14. doi: 10.1111/apt.13291. Epub 2015 Jun 29.

name: University Hospital; Gasthuisberg Leuven Belgium

family: Rutgeerts

full_name: P. Rutgeerts

given: P.

name: Robarts Research Institute; University of Western Ontario; London ON Canada

full_name: B. G. Feagan

given: B. G.

name: Janssen Research & Development; LLC; Spring House PA USA

family: Marano

full_name: C. W. Marano

given: C. W.

family: Padgett

full_name: L. Padgett

given: L.

full_name: R. Strauss

given: R.

family: Johanns

full_name: J. Johanns

given: J.

full_name: O. J. Adedokun

given: O. J.

family: Guzzo

full_name: C. Guzzo

given: C.

family: Zhang

full_name: H. Zhang

given: H.

name: Hôpital Claude Huriez; Lille Cedex France

name: Icahn School of Medicine at Mount Sinai; New York NY USA

family: Colombel

full_name: J.-F. Colombel

name: Universitätsklinik für Innere Medizin IV; Vienna Austria

full_name: W. Reinisch

given: W.

name: Alfred Hospital; Melbourne VIC Australia

family: Gibson

full_name: P. R. Gibson

given: P. R.

name: University of California San Diego; La Jolla CA USA

location_country:
Romania
Australia
Belgium
Russian Federation
Ukraine
India
France
Poland
Lithuania
Slovakia
Canada
Sweden
Netherlands
Bulgaria
Hungary
Germany
United States
Austria
Serbia
Israel
New Zealand
Latvia


intervention_type: Other

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Germany
France
Poland
Australia
Spain
Canada
Czech Republic
Korea, Republic of

acronym: ENEST

location_facility: Wayne State University/Wertz Clinical Cancer Center

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: Washington Hospital Center - Washington Cancer Institute

location_facility: UCLA's Jonsson Comprehensive Cancer Center

location_facility: St. Vincent's Comprehensive Cancer Center

location_facility: University of Texas/MD Anderson Cancer Center

title: A Randomized, Open-label, Multi-center Study to Evaluate the Efficacy of Nilotinib Versus Best Supportive Care With or Without a Tyrosine Kinase Inhibitor (Investigator's Choice) in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Both Imatinib and Sunitinib

summary: The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first and second line treatments.


lead_sponsor: Sanofi

location_country:
Italy
Netherlands
Germany
France
Belgium
Australia
Puerto Rico
United States
United Kingdom

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 276002

location_facility: Sanofi-Aventis Investigational Site Number 840023

location_facility: Sanofi-Aventis Investigational Site Number 056003

location_facility: Sanofi-Aventis Investigational Site Number 840005

location_facility: Sanofi-Aventis Investigational Site Number 380002

location_facility: Sanofi-Aventis Investigational Site Number 826005

location_facility: Sanofi-Aventis Investigational Site Number 840001

location_facility: Sanofi-Aventis Investigational Site Number 840020

location_facility: Sanofi-Aventis Investigational Site Number 630001

location_facility: Sanofi-Aventis Investigational Site Number 840022

location_facility: Sanofi-Aventis Investigational Site Number 840006

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 528002

location_facility: Sanofi-Aventis Investigational Site Number 840012

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 840008

location_facility: Sanofi-Aventis Investigational Site Number 840010

location_facility: Sanofi-Aventis Investigational Site Number 056006

location_facility: Sanofi-Aventis Investigational Site Number 840018

location_facility: Sanofi-Aventis Investigational Site Number 840002

location_facility: Sanofi-Aventis Investigational Site Number 840017

location_facility: Sanofi-Aventis Investigational Site Number 276001

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 840003

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 528003

location_facility: Sanofi-Aventis Investigational Site Number 056004

location_facility: Sanofi-Aventis Investigational Site Number 826002

location_facility: Sanofi-Aventis Investigational Site Number 276004

location_facility: Sanofi-Aventis Investigational Site Number 036001

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 826004

title: A Multicenter, Open-label, Single Arm Study of Weekly Alvocidib in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) Arising From CLL

summary:
Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients.

Primary objective is to determine overall response rate.

The secondary objectives are:

to assess overall safety,
to assess duration of response, progression free survival, and overall survival.

Clinical benefit and pharmacokinetics parameters are also evaluated.


ReferenceType: result

ReferenceCitation: Schaefer F, Coppo R, Bagga A, Senguttuvan P, Schlosshauer R, Zhang Y, Kadwa M. Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age. J Hypertens. 2013 May;31(5):993-1000. doi: 10.1097/HJH.0b013e32835f5721.

family: Schaefer

full_name: Franz Schaefer

given: Franz

family: Coppo

full_name: Rosanna Coppo

given: Rosanna

family: Bagga

full_name: Arvind Bagga

given: Arvind

family: Senguttuvan

full_name: Prabha Senguttuvan

given: Prabha

family: Schlosshauer

full_name: Rolf Schlosshauer

given: Rolf

full_name: Ying Zhang

given: Ying

family: Kadwa

full_name: Mahomed Kadwa

given: Mahomed

journal_name: Journal of Hypertension

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

study_start_date_type: Actual

location_country:
Italy
Brazil
South Africa
India
France
Poland
Hungary
Belgium
Turkey
United States

title: An Open Label Extension Study to Evaluate Safety, Tolerability, and Efficacy of 18 Weeks of Valsartan Treatment in Children 6 Months-5 Years Old With Hypertension

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.


title: Randomised, Controlled, Open-labelled, Multi-centre Comparison of Thalidomide Versus High-dose Dexamethasone for the Treatment of Relapsed Refractory Multiple Myeloma

acronym: OPTIMUM

summary: The primary objective is to compare the time to progression (TTP) of three daily doses of thalidomide (100, 200 and 400 mg) with high-dose dexamethasone in relapsed refractory multiple myeloma (MM) patients and to subsequently select the optimum thalidomide dose in terms of median TPP and toxicity.

ReferenceType: background

ReferenceCitation: Kropff M, Baylon HG, Hillengass J, Robak T, Hajek R, Liebisch P, Goranov S, Hulin C, Bladé J, Caravita T, Avet-Loiseau H, Moehler TM, Pattou C, Lucy L, Kueenburg E, Glasmacher A, Zerbib R, Facon T. Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial. Haematologica. 2012 May;97(5):784-91. doi: 10.3324/haematol.2011.044271. Epub 2011 Dec 1.

ReferenceCitation: Kropff M, et al. OPTIMUM Dose of Thalidomide for Relapsed Multiple Myeloma. Presented at American Society of Hematology 2009, New Orleans, LA. Abstract No. 959

lead_sponsor: Celgene

location_country:
Italy
South Africa
India
Serbia
Philippines
Croatia
Czechia
Bulgaria
France
Poland
Slovakia
Hungary
Portugal
Germany
United Kingdom

location_facility: Doctors Clinic - National Kidney & Transplant Institute

location_facility: Clinic of Haematology, University Multiprofiled Hospital for Active Treatment "G. Stranski"

location_facility: Charite, Universitatsmedizin Berlin, Campus Robert-Rossle Klinik

location_facility: Universitat Schleswig Holstein II Med. Klinik

location_facility: Hematologicka Klinika, Fakultni Nemocnice Hradec Kralove

location_facility: Military Medical Academy/Dept Haematology and Oncology

location_facility: Szent-Gyorgyi Albert University II Clinic of Internal Medicine

location_facility: Clinic of Haematology, Multiprofiled Hospital for Active Treatment "Sveta Marina"

location_facility: Abt. Haematologie - Onkologie/ Allg. Krankenhaus

location_facility: Med. Klinik II/Klinikum of the Julius-Maximilians-University

location_facility: KBC Zagreb - Klinika za Unutarnje Bolesti

location_facility: Pandy Kalman Megyei Korhaz, Megyei Onkologiai Centrum

location_facility: Klinika Hematologii Uniwersytetu Medycznego

location_facility: Klinika Hematologii Nowotworow Krwi i Transplantacji - Szpiku Akademii Medycznej

location_facility: Department of Medical Oncology/Tata Memorial Hospital

location_facility: Institute of Hematology, Clinical Centre of Serbia

location_facility: Dipartimento Medicina ed Oncologia Sperimentale - Divisione Universitaria di Ematologia Azienda Ospedaliera S. Giovanni Battista

location_facility: Hematology Department, University Hospital PJS

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ Poradnia Hematologii

location_facility: University of Multiprofiled Hospital for Active Treatment "Alexandrovska" - Sofia

location_facility: Hospital da Universidade de Coimbra - Servico de Hematologia Clinica

location_facility: Katedra i Klinika Hematologii, Onkologii I Chorob Wewnetrznych

location_facility: Department of Haematology-Oncology, The Royal Marsden NHS Foundation Trust

location_facility: Hospital Geral de Santo Antonio - Servico de Hematologia Clinica

location_facility: Clinic for Hematology, Clinical Centre Nis

location_facility: Katedra i Klinika Hematologii i Transplantacji Szpiku - Slaska Akademia Medyczna

location_facility: Klinicka Bolnica "Dubrava" Klinika za Unutarnje Bolesti

location_facility: Klinicka Bolnica "Sestre milosrdnice" Klinika za Unutarnje Bolesti

location_facility: Department of Medical Oncology, S.L. Raheja Hospital

location_facility: Hematologicka Klinika, Fakultni Nemocnice Kralovske Vinohrady Srobarova

location_facility: Tygerberg Hospital, University of Stellenbosch, Department of Haematology

location_facility: Instytut Hematologii i Transfuzjologii - Klinika Hematologiczna

location_facility: Department of Medical Oncology, Amrita Institute of Medical Sciences

location_facility: Department of Internal Medicine - Baguio General Hospital & Medical Center

location_facility: Department of Medical Oncology, Jaslok Hospital and Research Centre

location_facility: Klinika Chorob Wewnetrznych i Hemagologii

location_facility: Department of Medical Oncology, Dayanand Medical College DMCH

location_facility: Medizinische Klinik und Poliklinik I/Carl-Gustav-Carus University

location_facility: Universitaetsklinik - Abteilung Innere Medizin III

location_facility: Allgemeinse Krankenhaus St. Georg Hamatologische Abteilung

location_facility: Interni Klinika, Oddeleni Hematoonkologie

location_facility: Medizinische Klinik und Poliklinik III/Klinikum der Universitaet Muenchen

location_facility: Department of Internal Medicine, National Cancer Institute

location_facility: University of Free State, Faculty of Health Science, Dept of Hematology & Cell Biology

location_facility: Klinicki Bolnicki Centar Rijeka Interna Klinika

location_facility: Hematology Department University Hospital

location_facility: Department of Medical Oncology/Regional Cancer Centre

location_facility: Klinika Bolnica SPLIT - Klinika za Unutarnje Bolesti

location_facility: Klinika Hematologii Akademii Medycznej w Gdanskuul

location_facility: Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat

location_facility: Chris Hani Baragwanath Hospital, Clinical Haematology Unit

location_facility: Haematology Department - King's College Hospital

location_facility: Department of Medical Oncology, Deenanath Mangeshkar Hospital

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

location_facility: National Center of Haematology & Transfusiology

location_facility: Hematology, Oncology & Clinical Immunology/Heinrich-Heine-University

location_facility: Klinicka Bolnica MERKUR - Klinika za Unutarnje Bolesti

location_facility: Instituto di Ematologia e Oncologia Medica

location_facility: Hematologie - CHU Purpan Place du Dr. Baylac

location_facility: Nizam's Institute of Medical Sciences, Department of Medical Oncology

location_facility: Universitaetsklinik - Klinik fur innere Medizin

location_facility: Department of Haematology, UCT Medical School

location_facility: Johannesburg Hospital, Department of Medical Oncology

location_facility: Abteilung Haematologie - Univeresitaetsklinikum

location_facility: Clinic for Hematology, Clinical Centre Novi Sad

location_facility: Oncology Research Unit Heartlands Hospital

location_facility: SPSK, Klinika Hematologii Akademii Medycznej

location_facility: Medizinische Klinik Abteilung Innere V/Universitatsklinikum


title: A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/Day to 2.0 mg/Day) or Extended Release Venlafaxine XR (150 mg/Day to 225 mg/Day) Compared to Placebo in Adult s

summary: To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)

ReferenceCitation: Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell J, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Results of Two Double-Blind, Placebo- and Active-Controlled Studies of GSK372475, a Triple Monoamine Reuptake Inhibitor, in the Treatment of Major Depressive Disorder. [J Psychopharmacol EPublication ahead of print. DOI 10.1177/0269881111424931]. 2011;

ReferenceCitation: Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012 May;26(5):653-62. doi: 10.1177/0269881111424931. Epub 2011 Nov 2.

name: Neurosciences Discovery Medicine, Research Triangle Park, NC, USA and Verona, Italy

family: Learned

full_name: Susan Learned

given: Susan

family: Graff

full_name: Ole Graff

given: Ole

name: Neurosciences Medicines Development Center, Research Triangle Park, NC, USA and Harlow, UK

family: Roychowdhury

full_name: Suraja Roychowdhury

given: Suraja

name: Discovery Biometrics, GlaxoSmithKline, Harlow, UK

family: Moate

full_name: Rachel Moate

given: Rachel

name: Department of Psychiatry, Duke University, Durham, NC, USA

family: Krishnan

full_name: K Ranga Krishnan

given: K Ranga

family: Archer

full_name: Graeme Archer

given: Graeme

family: Modell

full_name: Jack G Modell

given: Jack G

family: Alexander

full_name: Robert Alexander

given: Robert

family: Zamuner

full_name: Stefano Zamuner

given: Stefano

family: Lavergne

full_name: Agnes Lavergne

given: Agnes

family: Evoniuk

full_name: Gary Evoniuk

given: Gary

family: Ratti

full_name: Emiliangelo Ratti

given: Emiliangelo

journal_name: Journal of Psychopharmacology

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: GlaxoSmithKline

location_country:
South Africa
India
Germany
Finland
France
Bulgaria
Poland
Slovakia
Belgium
Australia
Estonia
Canada


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

summary: This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.

lead_sponsor: Pfizer

location_country:
Italy
United States
France
Spain
Germany
United Kingdom
Canada


title: Efficacy and Safety of Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 40 mg Monotherapy

summary: The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.

ReferenceCitation: Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9.

name:
Assistance Publique – Hôpitaux de Paris, Université Pierre et Marie Curie
Paris France

family: Rosenbaum

full_name: David Rosenbaum

given: David

family: Girerd

full_name: Xavier Girerd

given: Xavier

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ipd_sharing: Yes

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country: France Czechia Bulgaria Poland Spain Germany Ukraine


ReferenceCitation: Duvic M, Dummer R, Becker JC, Poulalhon N, Ortiz Romero P, Grazia Bernengo M, Lebbé C, Assaf C, Squier M, Williams D, Marshood M, Tai F, Prince HM. Panobinostat activity in both bexarotene-exposed and -naïve patients with refractory cutaneous T-cell lymphoma: results of a phase II trial. Eur J Cancer. 2013 Jan;49(2):386-94. doi: 10.1016/j.ejca.2012.08.017. Epub 2012 Sep 13.

family: Duvic

full_name: Madeleine Duvic

given: Madeleine

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Becker

full_name: Jürgen C. Becker

given: Jürgen C.

family: Poulalhon

full_name: Nicolas Poulalhon

given: Nicolas

family: Ortiz Romero

full_name: Pablo Ortiz Romero

given: Pablo

family: Grazia Bernengo

full_name: Maria Grazia Bernengo

given: Maria

family: Lebbé

full_name: Celeste Lebbé

given: Celeste

family: Assaf

full_name: Chalid Assaf

given: Chalid

family: Squier

full_name: Margaret Squier

given: Margaret

family: Williams

full_name: Denise Williams

given: Denise

family: Marshood

full_name: Miriam Marshood

given: Miriam

family: Tai

full_name: Feng Tai

given: Feng

family: Prince

full_name: H. Miles Prince

given: H. Miles

journal_name: European Journal of Cancer

title: Panobinostat activity in both bexarotene-exposed and -naïve patients with refractory cutaneous T-cell lymphoma: Results of a phase II trial

design_allocation: Non-Randomized

location_country:
Italy
United States
Switzerland
Germany
Finland
France
Hungary
Belgium
Argentina
Australia
Spain
Canada

location_facility: Oregon Health & Science University Dept. of OHSU Cancer Institute

location_facility: Dana Farber Cancer Institute Deptof DanaFarberCancerInst(3)

location_facility: University of California at Los Angeles Dept. of Hematology-Oncology

location_facility: University of Alabama at Birmingham/ Kirklin Clinic Kirklin Clinic

location_facility: NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept. of NorthwesterUMed

location_facility: University of Michigan Health System Michigan HouseClinTrialsOffice

location_facility: University of Pittsburgh Medical Center Department of Dermatology

location_facility: Wake Forest University Baptist Medical Center OutpatientCmprehensivCancerCtr

location_facility: Boston Medical Center StudyCoordinator:CLBH589B2201

location_facility: Indiana University Dept. of IU Cancer Center

location_facility: Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia

location_facility: MD Anderson Cancer Center/University of Texas StudyCoordinator:CLBH589B2201

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)

title: A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma

summary: This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.


title: Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life

summary: To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner

ReferenceCitation: Porst H, Gacci M, Büttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.

family: Porst

full_name: Hartmut Porst

given: Hartmut

family: Gacci

full_name: Mauro Gacci

given: Mauro

family: Büttner

full_name: Hartwig Büttner

given: Hartwig

family: Henneges

full_name: Carsten Henneges

given: Carsten

family: Boess

full_name: Frank Boess

given: Frank

journal_name: European Urology

title: Tadalafil Once Daily in Men with Erectile Dysfunction: An Integrated Analysis of Data Obtained from 1913 Patients from Six Randomized, Double-blind, Placebo-controlled, Clinical Studies

ReferenceCitation: Shabsigh R, Seftel AD, Kim ED, Ni X, Burns PR. Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline. J Sex Med. 2013 Mar;10(3):844-56. doi: 10.1111/j.1743-6109.2012.02898.x. Epub 2012 Oct 4.

family: Shabsigh

full_name: Ridwan Shabsigh

given: Ridwan

family: Seftel

full_name: Allen D. Seftel

given: Allen D.

family: Kim

full_name: Edward D. Kim

given: Edward D.

family: Ni

full_name: Xiao Ni

given: Xiao

family: Burns

full_name: Patrick R. Burns

given: Patrick R.

journal_name: The Journal of Sexual Medicine

title: Efficacy and Safety of Once-Daily Tadalafil in Men with Erectile Dysfunction Who Reported No Successful Intercourse Attempts at Baseline

lead_sponsor: Eli Lilly and Company

location_country:
Austria
Mexico
Germany
France
United States

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


title: A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

summary: This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

location_country:
Italy
Austria
South Africa
United Kingdom
France
Poland
Hungary
Australia
Spain
Germany
Czech Republic


title: A Randomized, Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Proxinium Plus Best Supportive Care Versus Best Supportive Care Alone in Patients With Advanced SCCHN Who Have Received at Least One Anti-cancer Treatment Regimen for Advanced Disease

summary: The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.

lead_sponsor: Viventia Bio

location_country:
Italy
Brazil
India
Serbia
Mexico
Croatia
France
Poland
Israel
Slovakia
Romania
Hungary
Argentina
Russian Federation
Spain
Germany
United Kingdom
Ukraine

location_facility: Clinical Hospital Centre Zagreb, Clinic for ENT, Department for Head and Neck Surgery

location_facility: SIH Leningrad Regional Oncology Dispansery

location_facility: Biocor - Hospital de Doenças Cardiovasculares Ltda

location_facility: Oncology Institute of St. Elisabeth Clinic of Stomatology and Maxillofacial Surgery

location_facility: Department of Medical Oncology, Bangalore Institute of Oncology

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: SI Russian Oncology Scientific Center after NN Blokhin RAMS

location_facility: Birla Cancer Institute SMS Medical College Hospital

location_facility: Netaji Subash Chandra Bose Cancer Research Institute

location_facility: Asian Institute of Oncology, S L Raheja Hospital

location_facility: Department of Medical Oncology Dayanand Medical College & Hospital

location_facility: Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: Pro-Onco Centro De Tratamento Oncológico S/C Ltda

location_facility: Centro Regional Integrado de Oncologia - CRIO

location_facility: Universtity Hospital for Tumors, Department for Head and Neck Surgery

location_facility: Moscow Scientific-Research Oncology Institute after P.A. Gertsen

location_facility: Centro de Estudio y Tratamiento de las Enfermedades Neoplasicas (CETEN)

location_facility: Wojewodzki Szpital Specjalistyczny im. L.Rydygiera

location_facility: CECAN - Centro do Câncer Francisco Cunha Filho

location_facility: Kharkov Regional Clinical Oncology Dispensary

location_facility: Republican Clinical Oncological Dispenser Radiological Therapy

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: "Prof. Dr. I. Chiricuta" Institute of Oncology Medical Oncology and Radiotherapy II Department

location_facility: Amrita Institute of Medical Sciences and Research Centre

location_facility: Oradea Clinical County Hospital Department of Medical Oncology

location_facility: Centre Régional de Lutte contre le Cancer Val d'Aurelle

location_facility: PHI Dorozhnaya Clinical Hospital at Saratov II Station of Pryvolzhskaya railway OAO Russian Railways

location_facility: Centro Anticanceroso de la Cruz Roja Mexicana de Mérida

location_facility: Department of Medical Oncology Rajiv Gandhi Cancer Institute and Research Centre

location_facility: State Medical Institution Regional Clinical Oncology Dispensary

location_facility: Klinikum der Philipps-Universität Marburg

location_facility: PHI OAO RRW Railway Clinical Hospital at station Gorkiy

location_facility: Hospital Central "Dr. Ignacio Morones Prieto"

location_facility: Hospital de Clinicas "Jose de San Martin"

location_facility: Central Clinical Hospital #2 after MA Semashko OAO "RRW"

location_facility: Teaching Hospital with Policlinic of F. D. Roosevelt Department of Otorhinolaryngology and Surgery

location_facility: Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Regionalny Osrodek Onkologiczny

location_facility: Santo André Diagnósticos e Tratamentos Ltda

location_facility: Debreceni Egyetem OEC, Onkologiai Tanszek

location_facility: Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo

location_facility: Tambov Regional Oncological Dispensary Surgery Department

location_facility: Teaching Hospital with Policlinic Nové Zámky Clinic of Otorhinolaryngology

location_facility: Petz Aladar Megyei Korhaz, Ful-orr-gege, Fej, Nyak Sebeszet

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

location_facility: Cettro - Centro de Tratamento Oncológico Ltda.

location_facility: Teaching Hospital with Policlinic Bratislava 1st Clinic of Otorhinolaryngology

location_facility: SPBSIH City Clinical Oncology Dispensary

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Opolskie Centrum Onkologii

location_facility: Irmandade Santa Casa de Misericórdia de Porto Alegre

location_facility: Military Medical Academy (MMA) Clinic for Maxillofacial Surgery

location_facility: Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Fej-nyaksebeszet

location_facility: Zaporozhye Regional Clinical Oncology Dispensary

location_facility: Department of Medical Oncology AIIMS, Institute Rotary Cancer Hospital

location_facility: Stavropol Regional Oncology Center, Pyatigorsk branch Out-patient department

location_facility: Hospital Municipal de Agudos Leonidas Lucero

location_facility: State Medical Institution Kursk Regional Oncology Dispensary Out-patient department

location_facility: Instituto Ribeirãopretano de Combate ao Câncer


ReferenceCitation: Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. doi: 10.1200/JCO.2011.35.5040. Epub 2011 Oct 24. Erratum in: J Clin Oncol. 2013 Aug 20;31(24):3049.

name: Samuel A. Wells Jr, National Cancer Institute, National Institutes of Health, Bethesda, MD; Bruce G. Robinson, Kolling Institute of Medical Research, University of Sydney, Sydney, Australia; Robert F. Gagel, University of Texas MD Anderson Cancer Center, Houston, TX; Henning Dralle, Martin Luther University Halle-Wittenberg, Halle, Germany; James A. Fagin, Memorial Sloan-Kettering Cancer Center, New York, NY; Massimo Santoro, Universita' di Napoli Federico II, Naples, Italy; Eric Baudin and Martin J....

family: Wells

full_name: Samuel A. Wells

given: Samuel A.

suffix: Jr

family: Robinson

full_name: Bruce G. Robinson

given: Bruce G.

family: Gagel

full_name: Robert F. Gagel

given: Robert F.

family: Dralle

full_name: Henning Dralle

given: Henning

family: Fagin

full_name: James A. Fagin

given: James A.

family: Santoro

full_name: Massimo Santoro

given: Massimo

family: Baudin

full_name: Eric Baudin

given: Eric

family: Elisei

full_name: Rossella Elisei

given: Rossella

family: Jarzab

full_name: Barbara Jarzab

given: Barbara

family: Vasselli

full_name: James R. Vasselli

given: James R.

family: Read

full_name: Jessica Read

given: Jessica

family: Langmuir

full_name: Peter Langmuir

given: Peter

family: Ryan

full_name: Anderson J. Ryan

given: Anderson J.

family: Schlumberger

full_name: Martin J. Schlumberger

given: Martin J.

journal_name: Journal of Clinical Oncology

oa_host_type: repository

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society of Clinical Oncology (ASCO)

title: Vandetanib in Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer: A Randomized, Double-Blind Phase III Trial

status: Active, not recruiting

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
India
France
Poland
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Hungary
Portugal
Germany
United States
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Spain

location_facility:
Investigational Site Number 1801
Investigational Site Number 11
Investigational Site Number 18
Investigational Site Number 2005
Investigational Site Number 2506
Investigational Site Number 1702
Investigational Site Number 22
Investigational Site Number 1501
Investigational Site Number 3401
Investigational Site Number 2301
Investigational Site Number 2001
Investigational Site Number 15
Investigational Site Number 17
Investigational Site Number 6
Investigational Site Number 1203
Investigational Site Number 1402
Investigational Site Number 2403
Investigational Site Number 2505
Investigational Site Number 9
Investigational Site Number 14
Investigational Site Number 1205
Investigational Site Number 2504
Investigational Site Number 2803
Investigational Site Number 1101
Investigational Site Number 2601
Investigational Site Number 1102
Investigational Site Number 3003
Investigational Site Number 1701
Investigational Site Number 8
Investigational Site Number 1201
Investigational Site Number 2502
Investigational Site Number 2402
Investigational Site Number 1901
Investigational Site Number 2901
Investigational Site Number 3402
Investigational Site Number 3601
Investigational Site Number 3001
Investigational Site Number 1001
Investigational Site Number 2501
Investigational Site Number 2302
Investigational Site Number 1202
Investigational Site Number 1601
Investigational Site Number 2002
Investigational Site Number 7
Investigational Site Number 2102
Investigational Site Number 2101
Investigational Site Number 2902
Investigational Site Number 2802
Investigational Site Number 1401
Investigational Site Number 3102
Investigational Site Number 2404
Investigational Site Number 10
Investigational Site Number 2801
Investigational Site Number 3
Investigational Site Number 2701
Investigational Site Number 19
Investigational Site Number 3101
Investigational Site Number 1204
Investigational Site Number 21
Investigational Site Number 13
Investigational Site Number 2503
Investigational Site Number 1703
Investigational Site Number 2602
Investigational Site Number 3002
Investigational Site Number 3301
Investigational Site Number 2

study_completion_date_type: Anticipated

title: An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) Versus Placebo in Subjects With Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer

summary: The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.

status_simplified: Ongoing


title: A 10-week Randomised, DB, PG, PC Phase 2 Study to Investigate the Extent of Symptom Relief and the Safety and Tolerability of SMP-986 (20, 40, 80 and 120 mg) Administered Once Daily for 8 Weeks to Patients With Overactive Bladder Syndrome

summary: SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with SMP-986 compared to placebo, as well comparing the change in: the severity of urgency episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr and the mean void volume/void between SMP-986 and placebo.

lead_sponsor: Sunovion

location_country:
United States
United Kingdom
France
Poland
Lithuania
Spain
Estonia
Germany
Latvia

location_facility: Southern Research Group, Centre Point Boulevard

location_facility: Clinical Dept of Urology, Medical Postgraduate Education

location_facility: Gem. Praxis fur Urologie und Mannerheilkunde

location_facility: San Bernadino Urological Association Medical Group


title: Controlled, Double-Blind, Randomised, Dose-Ranging Study on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXa-HIP2 Study BAY 59-7939

summary: Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied by injections below the skin. The purpose of this study was to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug enoxaparin and to find the optimal dose of BAY 59-7939 for the anticipated phase III trials. Enoxaparin, a so-called low molecular weight heparin, is approved and widely used in the area of thromboprophylaxis and was given once daily subcutaneously. In this study 5 different doses of the investigational drug BAY 59-7939 were tested in comparison to Enoxaparin. The following doses of BAY 59-7939 were tested: 2.5 mg twice daily (5 mg total daily dose); 5 mg twice daily (10 mg total daily dose), 10 mg twice daily (20 mg total daily dose), 20 mg twice daily (40 mg total daily dose) and 30 mg twice daily ( 60 mg total daily dose). This study ran for approximately 7 months in a number of countries. In total, 726 patients were enrolled in this study.

primary_purpose: Prevention

lead_sponsor: Bayer

location_country:
Italy
Austria
Sweden
Netherlands
France
Poland
Israel
Norway
Belgium
Spain
Denmark
Germany
United Kingdom


title: Randomised,Double-blind,Placebo-controlled,Parallel Group Study TroVax, Added to First-line Standard of Care, Prolongs Survival of Patients With Locally Advanced or Metastatic Clear Cell Renal Adenocarcinoma.

summary: The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma.

ReferenceCitation: Amato RJ, Hawkins RE, Kaufman HL, Thompson JA, Tomczak P, Szczylik C, McDonald M, Eastty S, Shingler WH, de Belin J, Goonewardena M, Naylor S, Harrop R. Vaccination of metastatic renal cancer patients with MVA-5T4: a randomized, double-blind, placebo-controlled phase III study. Clin Cancer Res. 2010 Nov 15;16(22):5539-47. doi: 10.1158/1078-0432.CCR-10-2082. Epub 2010 Sep 29.

family: Amato

full_name: Robert J. Amato

given: Robert J.

family: Hawkins

full_name: Robert E. Hawkins

given: Robert E.

family: Kaufman

full_name: Howard L. Kaufman

given: Howard L.

family: Thompson

full_name: John A. Thompson

given: John A.

family: Tomczak

full_name: Piotr Tomczak

given: Piotr

family: Szczylik

full_name: Cezary Szczylik

given: Cezary

family: McDonald

full_name: Mike McDonald

given: Mike

family: Eastty

full_name: Sarah Eastty

given: Sarah

family: Shingler

full_name: William H. Shingler

given: William H.

family: de Belin

full_name: Jackie de Belin

given: Jackie

family: Goonewardena

full_name: Madusha Goonewardena

given: Madusha

family: Naylor

full_name: Stuart Naylor

given: Stuart

family: Harrop

full_name: Richard Harrop

given: Richard

journal_name: Clinical Cancer Research

oa_host_type: publisher;repository

evidence: open (via free pdf)

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

repositories_institution: The University of Manchester - Research Explorer

publisher: American Association for Cancer Research (AACR)

publisher_dissemination: American Association for Cancer Research

publisher_group: American Association for Cancer Research

publisher_normalized: American Association for Cancer Research

title: Vaccination of Metastatic Renal Cancer Patients with MVA-5T4: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

lead_sponsor: Oxford BioMedica

location_country:
United States
France
Poland
Israel
Romania
Russian Federation
Spain
Germany
United Kingdom
Ukraine

location_facility: State Institution of Nizhny Novgorod Region: "Nizhny Novgorod Oncology Center", Department of Oncology #5 (for chemotherapy treatment)

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

location_facility: Chelyabinsk Regional Oncological Center, Chemotherapy Department

location_facility: Municipal Medical Institution: Oncological Center, Chemotherapy Department

location_facility: Military Institute of Medicine, Department of Oncology

location_facility: Heamatology and Oncology Associates Inc.

location_facility: Sibiu Clinical County Hospital - Urology Clinic

location_facility: Maria Sklodowska-Curie Memorial Institute, Oncology Center Kraków Clinic Systemic and Generalized Neoplasms

location_facility: Lord's Transfiguration Independent Hospital Medical Academy Poznań

location_facility: Municipal Multi-Speciality Hospital #2, Department of Urology

location_facility: Lugansk Regional Clinical Oncological Center, Urology Department

location_facility: University Minnesota Fairview Medical Center

location_facility: Oncology department Rabin Medical center

location_facility: Dnepropetrovsk State Medical Academy, Department of Urology

location_facility: Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department

location_facility: Pyatigorsk Branch of Stavropol Territorial Clinical Oncological Center (State Medical Institution), Outpatient Department

location_facility: Russian Research Center of Roentgenology & Radiology , Surgery Department

location_facility: Dnepropetrovsk State Medical Academy, Oncology, Radiodiagnostics and Radiotherapy Department

location_facility: Hospital Severo Ochoa, Servicio de Oncologia - Primera planta

location_facility: Zaporozhye Medical Academy of Postgraduate Education, Oncology Department

location_facility: State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center,

location_facility: St. Petersburg State Medical Institution: Municipal Multi-Speciality Hospital #2, Department of Functional Diagnostics

location_facility: IIndependent Public Hospital #1- , Oncology and Radiotherapy Dept

location_facility: Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology and Surgical Nephrology

location_facility: Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Radiology Daignostics and Radiology Therapy

location_facility: Regional Public Institution: Krivoy Rog Oncological Center, Chemotherapy Department

location_facility: State Medical Institution of Healthcare: Clinical Oncological Center under the Ministry of Healthcare of the Republic of Tatarstan, Chemotherapy Department

location_facility: State Medical Institution: Tambov Regional Oncological Center, Surgery Department

location_facility: Universitätsklinikum C.G. Carus TU Dresden

location_facility: State Medical Institution: Stavropol Territorial Clinical Oncological Center, Department of Urology

location_facility: Kharkov Regional Clinical Urology and Nephrology Center, Oncourology Department

location_facility: Henry Ford Health System / Josephine Ford Cancer Center

location_facility: Bukovyna State Medical University, Department of Oncology, Radiodiagnostics and Radiotherapy

location_facility: Medical Radiological Research Center under the Russian Academy of Medical Sciences, Department of Urology

location_facility: Ivano-Frankovsk State Medical University; Oncology Department

location_facility: Independent Public Health Care Institution University Hospital in Krakow, Department of Oncology

location_facility: State Medical Institution: Arkhangelsk Regional Clinical Oncological Center, Surgery Department 7.

location_facility: Holycross Oncology Center in Kielce, Department of Urology

location_facility: Zaporozhye Medical Academy of Postgraduate Education, Urology Department

location_facility: Municipal Hospital #26, Department Of Urology

location_facility: Haematology and Oncology Associates at Bridgeport

location_facility: "Oncological Center", Department of Haematology and Chemotherapy

location_facility: Leningrad Regional Oncological Center, Surgical Department #3

location_facility: Non-State Medical Institution:Central Clinical Hospital

location_facility: Bashkir State Medical University, Urology Department

location_facility: Crimean Republican Clinical Oncological Center, Chemotherapy Department

location_facility: Independent Public Clinical Hospital #2 - Pomeranian Medical Academy in Szczecin, Urology Clinic

location_facility: Donetsk Regional Antitumor Center, Urology Department

location_facility: Rostov State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology

location_facility: St Luke's Cancer Centre, Royal Surrey County Hospital

location_facility: Murmansk Regional Oncological Center, Oncology Department #5

location_facility: Charleston Hematology and Oncology Associates,

location_facility: State Higher Educational Institution: Siberian State Medical University, Department of Urology

location_facility: Samara Regional Oncology Center, Chemotherapy Department

location_facility: St. Petersburg State Medical Institution: Municipal Hospital #15, Urology Department

location_facility: Oncology institute , Rambam /health Care Campus

location_facility: Regional State Medical Institution:"Orel Oncological Center", Oncology Department #5

location_facility: The Angeles Clinic and Reseach Institute

location_facility: Crimea State Medical University n.a. S.I. Georgievsky, Course in Urology at the Faculty Surgery#1 Department

location_facility: Fundeni Clinical Institute - Urology Department

location_facility: Urology Institute under the Ukrainian Academy of Medical Sciences, Plastic and Reconstructive Urology Department

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: State Medical Institution of Yaroslavl Region

location_facility: "Central Research Institute of Roentgenology & Radiology Federal Agency Healthcare Social Development"

location_facility: Oncology institute , The Chaim Sheba Medical center

location_facility: Department of Biotherapy and Bone Marrow Transplantation

location_facility: Urology Institute under the Ukrainian Academy of Medical Sciences, Oncourology Department

location_facility: Flower Hospital/ Promedica Health System

location_facility: "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic

location_facility: Oncology department, Assaf Harofeh Medical Center

location_facility: Regional Research Clinical Institute n.a M.F. Vladimirskiy, Urology Department #1

location_facility: Hospital Marques de Valdecilla Consultas de Oncologia 1st planta

location_facility: State Institution of Mariy El Republic: "Republican Clinical Hospital", Department Of Urology

location_facility: Moscow Research Oncological Institute n.a. P.A. Hertzen, Urology Departmen

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

location_facility: Republican Oncology Center" under the Ministry of Healthcare,

location_facility: St. Petersburg State Pediatric Medical Academy

location_facility: Maria Sklodowska-Curie Memorial Institute, Oncology Center in Warsaw, Clinic of Neoplasms of Urinary System

location_facility: Hospital Santa Creu i Sant Pau Hospital Nuevo-Servicio de Oncologia Medica

location_facility: Orenburg Regional Clinical Oncological Center, Chemotherapy Department

location_facility: Little Rock Hematology / Oncology Associates, P.A.

location_facility: Regional Specialistic Hospital in Wrocław, Department of Urology

location_facility: State Medical Institution: Omsk Regional Oncological Center, Chemotherapy Department

intervention_type: Biological


title: Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

summary: The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Brazil
France
Argentina
Australia
Spain
United States
Korea, Republic of
Taiwan

location_facility:
University Of Cincinnati Medical Center
University Of Nebraska Medical Center
Mayo Clinic
University Of Rochester Medical Center
Baylor College Of Medicine
Cleveland Clinic
Tulane University Hospital & Clinic
Baylor University Medical Center
Local Institution
Northwestern University


title: A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy

summary: The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.

location_country:
Italy
United States
Philippines
Indonesia
France
Poland
Greece
Thailand
Belgium
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility: University Of Florida College Of Medicine At Jacksonville

location_facility: University Of Texas Medical Branch Of Galveston

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: University Of Missouri Healthcare/Ellis Fischel Cancer Ctr

location_facility: Capital Comprehensive Cancer Care Center

location_facility: Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: Glendale Memorial Hospital And Health Center

location_facility: Hematology Oncology Centers Of The Northern Rockies, Pc

location_facility: South Texas Oncology And Hematology, P.A.

location_facility: Carolinas Hematology Oncology Associates

location_facility: Acrc/Arizona Clinical Research Center, Inc.

location_facility: The Center For Cancer And Blood Disorders

location_facility: Washington University School Of Medicine

location_facility: Guthrie Foundation For Education And Research

location_facility: Kansas City Veterans Affairs Medical Center


title: A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects

acronym: EAGER

summary: This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

location_country:
Italy
United States
Chile
Mexico
Netherlands
Germany
France
Israel
Hungary
Australia
Spain
Canada
United Kingdom
Colombia

location_facility: West Virginia University Health Sciences Center


title: Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer

summary: The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.

ReferenceCitation: Yu EY, Wilding G, Posadas E, Gross M, Culine S, Massard C, Morris MJ, Hudes G, Calabrò F, Cheng S, Trudel GC, Paliwal P, Sternberg CN. Phase II study of dasatinib in patients with metastatic castration-resistant prostate cancer. Clin Cancer Res. 2009 Dec 1;15(23):7421-8. doi: 10.1158/1078-0432.CCR-09-1691. Epub 2009 Nov 17.

location_country:
Italy
United States
France

location_facility: University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr

location_facility: Memorial Sloan-Kettering Cancer Center-Sidney Kimmel Center

location_facility: The Bunting Blaustein Cancer Research Building


title: The Comparison of the Efficacy and Safety of Arzoxifene Versus Raloxifene in Postmenopausal Women With Osteoporosis

summary: The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength).

location_country:
Italy
United States
France
Argentina
Australia
Spain
Canada
Taiwan

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.


ReferenceCitation: Rektor I, Krauss GL, Bar M, Biton V, Klapper JA, Vaiciene-Magistris N, Kuba R, Squillacote D, Gee M, Kumar D. Perampanel Study 207: long-term open-label evaluation in patients with epilepsy. Acta Neurol Scand. 2012 Oct;126(4):263-9. doi: 10.1111/ane.12001. Epub 2012 Aug 23.

family: Rektor

full_name: I. Rektor

given: I.

name: Johns Hopkins University; Baltimore; MD; USA

family: Krauss

full_name: G. L. Krauss

given: G. L.

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

family: Bar

full_name: M. Bar

given: M.

name: Arkansas Epilepsy Program; Little Rock; AR; USA

family: Biton

full_name: V. Biton

given: V.

name: Mile High Research Center; Denver; CO; USA

family: Klapper

full_name: J. A. Klapper

given: J. A.

name: Lithuanian University of Health Sciences; Kaunas; Lithuania

family: Vaiciene-Magistris

full_name: N. Vaiciene-Magistris

given: N.

family: Kuba

full_name: R. Kuba

given: R.

name: Eisai Neuroscience Product Creation Unit; Woodcliff Lake; NJ; USA

family: Squillacote

full_name: D. Squillacote

given: D.

family: Gee

full_name: M. Gee

family: Kumar

full_name: D. Kumar

journal_name: Acta Neurologica Scandinavica

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Eisai Inc.

location_country:
Sweden
United Kingdom
Netherlands
Germany
Finland
France
Lithuania
Latvia
Belgium
Australia
Spain
Estonia
United States
Czech Republic

title: An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 (Perampanel) as an Adjunctive Therapy in Patients With Refractory Partial Seizures

summary: The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures.


ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

family: Ben-Menachem

full_name: Elinor Ben-Menachem

given: Elinor

family: Baulac

full_name: Michel Baulac

given: Michel

family: Hong

full_name: Seung Bong Hong

given: Seung Bong

family: Cleveland

full_name: Jody M. Cleveland

given: Jody M.

family: Reichel

full_name: Christoph Reichel

given: Christoph

family: Schulz

full_name: Anne-Liv Schulz

given: Anne-Liv

family: Wagener

full_name: Gilbert Wagener

given: Gilbert

family: Brandt

full_name: Christian Brandt

given: Christian

journal_name: Epilepsy Research

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

repository_normalized: HAL

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

title: Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht–Lundborg disease: An open-label, long-term follow-up trial

ReferenceCitation: Kälviäinen R, Genton P, Andermann E, Andermann F, Magaudda A, Frucht SJ, Schlit AF, Gerard D, de la Loge C, von Rosenstiel P. Brivaracetam in Unverricht-Lundborg disease (EPM1): Results from two randomized, double-blind, placebo-controlled studies. Epilepsia. 2016 Feb;57(2):210-21. doi: 10.1111/epi.13275. Epub 2015 Dec 15.

name: Kuopio Epilepsy Center; Kuopio University Hospital and Institute of Clinical Medicine; School of Medicine; Faculty of Health Sciences; University of Eastern Finland; Kuopio Finland

family: Kälviäinen

full_name: Reetta Kälviäinen

given: Reetta

name: Henri Gastaut-Centre Saint Paul Hospital; Marseille France

family: Genton

full_name: Pierre Genton

given: Pierre

name: Neurogenetics Unit and Epilepsy Research Group; Montreal Neurological Hospital and Institute; Montreal Quebec Canada

name: Department of Neurology & Neurosurgery and Human Genetics; McGill University; Montreal Quebec Canada

family: Andermann

full_name: Eva Andermann

given: Eva

name: Seizure Clinic and Epilepsy Research Group; Montreal Neurological Hospital and Institute; Montreal Quebec Canada

name: Departments of Neurology & Neurosurgery and Pediatrics; McGill University; Montreal Quebec Canada

full_name: Frederick Andermann

given: Frederick

name: Department of Neurosciences; Epilepsy Center; University of Messina; Messina Italy

family: Magaudda

full_name: Adriana Magaudda

given: Adriana

name: Department of Neurology; Columbia University Medical Center; New York New York USA

family: Frucht

full_name: Steven J. Frucht

given: Steven J.

family: Schlit

full_name: Anne-Françoise Schlit

given: Anne-Françoise

family: Gerard

full_name: Danielle Gerard

given: Danielle

family: de la Loge

full_name: Christine de la Loge

given: Christine

family: von Rosenstiel

full_name: Philipp von Rosenstiel

location_country:
Serbia
Finland
France
Israel
Tunisia
Russian Federation
United States
Canada

title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (≥ 16 Years) With Genetically Ascertained Unverricht-Lundborg Disease

summary: The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).


title: A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus

summary: To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus

location_country:
Austria
Sweden
Netherlands
Spain
Finland
France
Norway
Ireland
Belgium
Portugal
Denmark
United States
United Kingdom


title: An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

summary: To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: PDL BioPharma, Inc.

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Norway
Hungary
Australia
Belgium
Ireland
Canada
Czech Republic
Ukraine


title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Morning Administration of GW679769 (10mg and 30 mg) on Polysomnograph Sleep Recordings, Subjective Sleep Assessment, Daytime Cognition and Psychomotor Function in Subjects With Primary Insomnia

summary: This study is designed to determine whether morning doses of GW679769, taken daily for 1 to 9 days, will promote sleep during the following night without significant post-dose thinking impairment and drowsiness in subjects with primary insomnia.

location_country:
Germany
United States
France


title: DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311-E)

acronym: Darusentan

summary: This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.

lead_sponsor: Gilead Sciences

location_country:
Brazil
United States
Sweden
France
Argentina
Denmark
Canada
United Kingdom

location_facility: Castlerock Clinical Research Consultants

location_facility: Northeast Clinical Research Centers, Inc.

location_facility: Hôpital Civil, Service HTA maladies vasculaires

location_facility: Centro Integrado Hospital do Rim e Hipertensao

location_facility: Green and Seidner Family Practice Associates

location_facility: Cardiovascular Research, Karolinska Institue

location_facility: Clinical Investigation Specialists, Inc.

location_facility: MedStar Diabetes Institute at Washington Hospital Center


ReferenceCitation: Wong RSM, Saleh MN, Khelif A, Salama A, Portella MSO, Burgess P, Bussel JB. Safety and efficacy of long-term treatment of chronic/persistent ITP with eltrombopag: final results of the EXTEND study. Blood. 2017 Dec 7;130(23):2527-2536. doi: 10.1182/blood-2017-04-748707. Epub 2017 Oct 17. Erratum in: Blood. 2018 Feb 8;131(6):709.

name: Sir YK Pao Centre for Cancer & Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong;

family: Wong

full_name: Raymond S. M. Wong

given: Raymond S. M.

name: Hematology & Oncology, The University of Alabama at Birmingham, Birmingham, AL;

family: Saleh

full_name: Mansoor N. Saleh

given: Mansoor N.

name: Hematology Department, Hôpital Farhat Hached, Sousse, Tunisia;

family: Khelif

full_name: Abderrahim Khelif

given: Abderrahim

name: Institute for Transfusion Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany;

family: Salama

full_name: Abdulgabar Salama

given: Abdulgabar

name: Oncology Clinical Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ;

family: Portella

full_name: Maria Socorro O. Portella

given: Maria Socorro O.

name: Oncology Global Development, Novartis Pharma, AG, Basel, Switzerland; and

family: Burgess

full_name: Paul Burgess

given: Paul

name: Pediatric Hematology/Oncology, Weill Cornell Medicine, New York, NY

family: Bussel

full_name: James B. Bussel

given: James B.

journal_name: Blood

evidence: open (via free article)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Tarantino MD, Fogarty P, Mayer B, Vasey SY, Brainsky A. Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia. Blood Coagul Fibrinolysis. 2013 Apr;24(3):284-96. doi: 10.1097/MBC.0b013e32835fac99.

family: Tarantino

full_name: Michael D. Tarantino

given: Michael D.

family: Fogarty

full_name: Patrick Fogarty

given: Patrick

family: Mayer

full_name: Bhabita Mayer

given: Bhabita

family: Vasey

full_name: Sandra Y. Vasey

given: Sandra Y.

family: Brainsky

full_name: Andres Brainsky

given: Andres

journal_name: Blood Coagulation & Fibrinolysis

ReferenceCitation: Saleh MN, Bussel JB, Cheng G, Meyer O, Bailey CK, Arning M, Brainsky A; EXTEND Study Group. Safety and efficacy of eltrombopag for treatment of chronic immune thrombocytopenia: results of the long-term, open-label EXTEND study. Blood. 2013 Jan 17;121(3):537-45. doi: 10.1182/blood-2012-04-425512. Epub 2012 Nov 20.

name: Georgia Cancer Specialists, Marietta, GA;

name: Weill Medical College of Cornell University, New York, NY;

name: The Chinese University of Hong Kong, Shatin, Hong Kong;

family: Cheng

full_name: Gregory Cheng

given: Gregory

name: Institute of Transfusion Medicine, Charité, Berlin, Germany; and

family: Meyer

full_name: Oliver Meyer

given: Oliver

family: Bailey

full_name: Christine K. Bailey

given: Christine K.

family: Arning

full_name: Michael Arning

given: Michael

ReferenceCitation: Fogarty PF, Tarantino MD, Brainsky A, Signorovitch J, Grotzinger KM. Selective validation of the WHO Bleeding Scale in patients with chronic immune thrombocytopenia. Curr Med Res Opin. 2012 Jan;28(1):79-87. doi: 10.1185/03007995.2011.644849. Epub 2011 Dec 20.

name:
Hospital of the University of Pennsylvania
Philadelphia, PAUSA

name:
The Bleeding and Clotting Disorders Institute
Peoria, ILUSA

ReferenceCitation: Signorovitch J, Brainsky A, Grotzinger KM. Validation of the FACIT-fatigue subscale, selected items from FACT-thrombocytopenia, and the SF-36v2 in patients with chronic immune thrombocytopenia. Qual Life Res. 2011 Dec;20(10):1737-44. doi: 10.1007/s11136-011-9912-9. Epub 2011 May 1.

location_country:
Peru
Finland
Greece
Romania
Australia
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
Pakistan
France
Poland
Thailand
Slovakia
Canada
Slovenia
Korea, Republic of
Sweden
Hong Kong
Netherlands
Vietnam
China
United States
Germany
United Kingdom
Italy
Austria
Tunisia
New Zealand
Spain

location_facility:
Novartis Investigative Site
Novartis investigative Site

title: EXTEND (Eltrombopag Extended Dosing Study): An Extension Study of Eltrombopag Olamine (SB-497115-GR) in Adults, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study.

summary: An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/μL will be investigated.


title: A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder

summary: The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.

lead_sponsor: Solvay Pharmaceuticals

location_country:
United States
France
Lithuania
Hungary
Argentina
Latvia
Estonia
Canada
Czech Republic

location_facility:
Site 223
Site 170
Site 303
Site 229
Site 197
Site 180
Site 110
Site 156
Site 109
Site 173
Site 152
Site 205
Site 154
Site 235
Site 164
Site 302
Site 207
Site 232
Site 188
Site 126
Site 114
Site 151
Site 102
Site 130
Site 195
Site 128
Site 134
Site 106
Site 104
Site 168
Site 174
Site 198
Site 211
Site 107
Site 108
Site 210
Site 306
Site 187
Site 208
Site 218
Site 308
Site 146
Site 178
Site 111
Site 176
Site 124
Site 225
Site 100
Site 113
Site 212
Site 145
Site 121
Site 147
Site 215
Site 153
Site 194
Site 231
Site 127
Site 216
Site 133
Site 112
Site 220
Site 191
Site 224
Site 131
Site 136
Site 305
Site 189
Site 171
Site 165
Site 101
Site 183
Site 236
Site 129
Site 115
Site 230
Site 196
Site 117
Site 222
Site 166
Site 228
Site 185
Site 172
Site 206
Site 169
Site 177
Site 184
Site 233
Site 213
Site 307
Site 201
Site 193
Site 179
Site 186
Site 142
Site 217
Site 301
Site 122
Site 204
Site 141
Site 161
Site 181
Site 116
Site 163
Site 304
Site 138
Site 219
Site 226
Site 175
Site 209
Site 221
Site 159
Site 162
Site 214
Site 182
Site 202
Site 234
Site 167
Site 190
Site 140
Site 203
Site 148


lead_sponsor: AstraZeneca

location_country:
Austria
Brazil
Switzerland
France
Argentina
Australia
Denmark
United States
United Kingdom
Canada

title: A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients With Unresectable AJCC Stage 3 or 4 Malignant Melanoma

summary: The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma


ReferenceCitation: Twelves C, Awada A, Cortes J, Yelle L, Velikova G, Olivo MS, Song J, Dutcus CE, Kaufman PA. Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer. Breast Cancer (Auckl). 2016 Jun 28;10:77-84. doi: 10.4137/BCBCR.S39615. eCollection 2016.

name: Section of Clinical Cancer Research, Leeds Institute of Cancer and Pathology and St James's Institute of Oncology, Leeds, UK.

family: Twelves

full_name: Chris Twelves

given: Chris

name: Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium.

family: Awada

full_name: Ahmad Awada

given: Ahmad

name: Vall D'Hebron University Institute of Oncology, Barcelona, Spain.

name: Oncology Department, Ramon y Cajal University Hospital, Madrid, Spain.

family: Cortes

full_name: Javier Cortes

given: Javier

name: Department of Medicine, University of Montreal, Montreal, QC, Canada.

family: Yelle

full_name: Louise Yelle

given: Louise

name: Department of Oncology, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, University of Leeds, Leeds, UK.

family: Velikova

full_name: Galina Velikova

given: Galina

name: Oncology PCU, Department of Clinical Development, Eisai Inc., Woodcliff Lake, NJ, USA.

family: Olivo

full_name: Martin S. Olivo

given: Martin S.

name: Formerly of Department of Medical Affairs, Eisai Inc., Woodcliff Lake, NJ, USA.

family: Song

full_name: James Song

given: James

name: Department of Clinical Development, Oncology, Eisai Inc., Woodcliff Lake, NJ, USA.

family: Dutcus

full_name: Corina E. Dutcus

given: Corina E.

name: Section of Hematology/Oncology, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.

family: Kaufman

full_name: Peter A. Kaufman

given: Peter A.

currency_apc_doaj: USD

journal_name: Breast Cancer: Basic and Clinical Research

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

version: submittedVersion

title: Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer

ReferenceCitation: Cortes J, Hudgens S, Twelves C, Perez EA, Awada A, Yelle L, McCutcheon S, Kaufman PA, Forsythe A, Velikova G. Health-related quality of life in patients with locally advanced or metastatic breast cancer treated with eribulin mesylate or capecitabine in an open-label randomized phase 3 trial. Breast Cancer Res Treat. 2015 Dec;154(3):509-20. doi: 10.1007/s10549-015-3633-7. Epub 2015 Nov 14.

family: Hudgens

full_name: Stacie Hudgens

given: Stacie

family: Perez

full_name: Edith A. Perez

given: Edith A.

family: McCutcheon

full_name: Susan McCutcheon

given: Susan

ReferenceCitation: Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.

name: Peter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal,...

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

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Phase III Open-Label Randomized Study of Eribulin Mesylate Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane

ReferenceCitation: Twelves C, Cortes J, Kaufman PA, Yelle L, Awada A, Binder TA, Olivo M, Song J, O'Shaughnessy JA, Jove M, Perez EA. "New" metastases are associated with a poorer prognosis than growth of pre-existing metastases in patients with metastatic breast cancer treated with chemotherapy. Breast Cancer Res. 2015 Dec 9;17(1):150. doi: 10.1186/s13058-015-0657-1.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

title: “New” metastases are associated with a poorer prognosis than growth of pre-existing metastases in patients with metastatic breast cancer treated with chemotherapy

ReferenceCitation: Twelves C, Cortes J, Vahdat LT, Wanders J, Akerele C, Kaufman PA. Phase III trials of eribulin mesylate (E7389) in extensively pretreated patients with locally recurrent or metastatic breast cancer. Clin Breast Cancer. 2010 Apr;10(2):160-3. doi: 10.3816/CBC.2010.n.023.

title: Phase III Trials of Eribulin Mesylate (E7389) in Extensively Pretreated Patients With Locally Recurrent or Metastatic Breast Cancer

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Poland
Argentina
Canada
South Africa
Bulgaria
Singapore
Hungary
Germany
United States
Italy
Brazil
Mexico
Czechia
Israel
Spain

location_facility: Hospital de Clinicas de Porto Alegre, Servicio de Oncologia

location_facility: CHU de Poitiers, Service d'Oncologie Medicale

location_facility: Centre Hospitalier Universitaire de Montreal, Hopital Notre Dame

location_facility: Pecsi Tudomanyegyetem, Onkoterapias Intezet

location_facility: Centre Hosptialier Universitaire Sart Tilman Liege

location_facility: Thunder Bay Regional Health Science Centre Northwestern Ontario

location_facility: Liverpool Hospital, Cancer Therapy Centre

location_facility: Servico de Quimioterapia de Pernambuco-SEQUIPE

location_facility: Instituto Argentino de Diagnostico y Tratamiento

location_facility: Centre Hospitalier La Roche sur Yon, CHD les Oudairies

location_facility: Hospital General de Agudos Teodoro Alvarez

location_facility: Grupo Paulista de Oncologia Integrada Ltda

location_facility: Bankstown Hospital, Oncology Trials Unit

location_facility: Instituto Brasileiro de Controle do Cancer-IBCC

location_facility: Institut Jules Bordet, Medical Oncology Unit

location_facility: Hospital das Clinicas de Faculdade de Medicina da Universidade de Sao

location_facility: Hospital do Cancer de Sao Paulo-AC. Camargo

location_facility: Augusta-Kranken-Anstalt, Klinik fur Hamatologie und Onkologie

location_facility: Hospital do Cancer de Sao Paulo-AC Camargo

location_facility: Instituto Ribeiraopretano de Combate ao Cancer

location_facility: Sir Charles Gairdner Hospital, Dept. of Medical Oncology

title: A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

summary: The purpose of this study is to compare E7389 versus capecitabine in patients with locally advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive either E7389 or capecitabine on a one-to-one ratio.


title: A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.

summary: This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

ReferenceCitation: Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. doi: 10.1002/mds.23590. Epub 2011 May 3.

family: Sampaio

full_name: Cristina Sampaio

given: Cristina

family: Bronzova

full_name: Juliana Bronzova

given: Juliana

family: Hauser

full_name: Robert A. Hauser

given: Robert A.

family: Lang

full_name: Anthony E. Lang

given: Anthony E.

family: Rascol

full_name: Olivier Rascol

given: Olivier

family: van de Witte

full_name: Serge V. van de Witte

given: Serge V.

family: Theeuwes

full_name: and Ad Theeuwes

given: and Ad

journal_name: Movement Disorders

title: Pardoprunox in early Parkinson's disease: Results from 2 large, randomized double-blind trials

location_country:
Italy
South Africa
India
United Kingdom
Netherlands
Spain
Germany
France
Malaysia
Lithuania
Poland
Thailand
Australia
Portugal
Estonia
United States
Czech Republic
Taiwan


title: A Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH®, MabCampath®) in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia

summary: This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for patients with relapsed or refractory B-CLL who have been previously treated.

location_country:
Serbia
United Kingdom
France
Belgium
United States
Czech Republic

location_facility: Clinic of Hematology, Clinical Centre Vojvodina Novi Sad

location_facility: University Hospital Hradec Kralove (UH HK)

location_facility: University of Colorado Cancer Center at University of Colorado Health Sciences Center

location_facility: North Mississippi Hematology & Oncology Associates, Ltd.

location_facility: Institute of Hematology, Clinical Centre of Serbia

location_facility: Hopital Hotel-Dieu, CHU de Nantes-Service d'Hematologie Clinique

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Royal Liverpool and Broadgreen Hospitals


title: A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)

summary: To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.

ReferenceCitation: Vizza CD, Jansa P, Teal S, Dombi T, Zhou D. Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial. BMC Cardiovasc Disord. 2017 Sep 6;17(1):239. doi: 10.1186/s12872-017-0674-3.

family: Vizza

full_name: Carmine Dario Vizza

given: Carmine Dario

family: Jansa

full_name: Pavel Jansa

given: Pavel

family: Teal

full_name: Simon Teal

given: Simon

family: Dombi

full_name: Theresa Dombi

given: Theresa

family: Zhou

full_name: Duo Zhou

given: Duo

currency_apc_doaj: GBP

journal_name: BMC Cardiovascular Disorders

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

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

location_country:
Italy
United States
France
Czechia
Greece
Israel
Australia
Germany
United Kingdom
Taiwan

location_facility: Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie

location_facility: Universitaetsklinikum des Saarlandes, Innere Medizin V

location_facility: Unita' di Ipertensione Polmonare, Dipartimento di Scienze Respiratorie e Cardiovascolari

location_facility: II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie

location_facility: Institut klinicke a experimentalni mediciny, Klinika kardiologie

location_facility: Praxis fuer Innere Medizin, Kardiologie und Angiologie

location_facility: Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig

location_facility: Department of Surgery, National Taiwan University Hospital

location_facility: Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen

location_facility: Missionsaerztliche Klinik Wuerzburg, Gemeinnuetzige Gesellschaft mbH

location_facility: Med. Klinik u. Poliklinik I der LMU Muenchen, Klinikum Grosshadern

location_facility: West Los Angeles VA Healthcare, Pulmonary Hypertension Program

location_facility: Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin

location_facility: Cardiologia, Azienda Ospedaliera Monaldi, Seconda Università di Napoli


title: A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients

summary: The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.

ReferenceCitation: Touraine P, D'Souza GA, Kourides I, Abs R, Barclay P, Xie R, Pico A, Torres-Vela E, Ekman B; GH Lipoatrophy Study Group. Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH. Eur J Endocrinol. 2009 Oct;161(4):533-40. doi: 10.1530/EJE-09-0422. Epub 2009 Aug 4.

family: Touraine

full_name: Philippe Touraine

given: Philippe

family: D'Souza

full_name: Gwyn A D'Souza

given: Gwyn A

family: Kourides

full_name: Ione Kourides

given: Ione

family: Abs

full_name: Roger Abs

given: Roger

family: Barclay

full_name: Paul Barclay

given: Paul

family: Xie

full_name: Rujia Xie

given: Rujia

family: Pico

full_name: Antonio Pico

given: Antonio

family: Torres-Vela

full_name: Elena Torres-Vela

given: Elena

family: Ekman

full_name: Bertil Ekman

given: Bertil

journal_name: European Journal of Endocrinology

publisher: Bioscientifica

publisher_dissemination: Bioscientifica

publisher_group: Bioscientifica

publisher_normalized: Bioscientifica

location_country:
Italy
Sweden
United Kingdom
Netherlands
France
Poland
Slovakia
Belgium
Spain
Denmark
Germany
Czech Republic