ReferenceCitation: Dimopoulos MA, Delforge M, Hájek R, Kropff M, Petrucci MT, Lewis P, Nixon A, Zhang J, Mei J, Palumbo A. Lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial. Haematologica. 2013 May;98(5):784-8. doi: 10.3324/haematol.2012.074534. Epub 2012 Dec 14.

family: Dimopoulos

full_name: M. A. Dimopoulos

given: M. A.

family: Delforge

full_name: M. Delforge

given: M.

family: Hajek

full_name: R. Hajek

given: R.

family: Kropff

full_name: M. Kropff

family: Petrucci

full_name: M. T. Petrucci

given: M. T.

family: Lewis

full_name: P. Lewis

given: P.

family: Nixon

full_name: A. Nixon

given: A.

family: Zhang

full_name: J. Zhang

given: J.

family: Mei

full_name: J. Mei

family: Palumbo

full_name: A. Palumbo

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Palumbo A, Hajek R, Delforge M, Kropff M, Petrucci MT, Catalano J, Gisslinger H, Wiktor-Jędrzejczak W, Zodelava M, Weisel K, Cascavilla N, Iosava G, Cavo M, Kloczko J, Bladé J, Beksac M, Spicka I, Plesner T, Radke J, Langer C, Ben Yehuda D, Corso A, Herbein L, Yu Z, Mei J, Jacques C, Dimopoulos MA; MM-015 Investigators. Continuous lenalidomide treatment for newly diagnosed multiple myeloma. N Engl J Med. 2012 May 10;366(19):1759-69. doi: 10.1056/NEJMoa1112704. Erratum in: N Engl J Med. 2012 Jul 19;367(3):285.

full_name: Antonio Palumbo

given: Antonio

full_name: Roman Hajek

given: Roman

full_name: Michel Delforge

given: Michel

full_name: Martin Kropff

given: Martin

full_name: Maria Teresa Petrucci

given: Maria Teresa

family: Catalano

full_name: John Catalano

given: John

family: Gisslinger

full_name: Heinz Gisslinger

given: Heinz

family: Wiktor-Jędrzejczak

full_name: Wiesław Wiktor-Jędrzejczak

given: Wiesław

family: Zodelava

full_name: Mamia Zodelava

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

title: Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma

ReferenceCitation: Dimopoulos MA, Petrucci MT, Foà R, Catalano J, Kropff M, Terpos E, Zhang J, Grote L, Jacques C, Palumbo A; MM-015 Investigators. Impact of maintenance therapy on subsequent treatment in patients with newly diagnosed multiple myeloma: use of "progression-free survival 2" as a clinical trial end-point. Haematologica. 2015 Aug;100(8):e328-30. doi: 10.3324/haematol.2014.120790. Epub 2015 Apr 3.

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
France
Poland
Sweden
Switzerland
Netherlands
Ireland
Germany
United Kingdom
Italy
Austria
Israel
Georgia
Belarus
Spain
Turkey

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Medizinische Klinik und Poliklinik II des Universitatsklinikums Wurzburg

location_facility: Hematology Oncology Clinics of Australia, Level 5, Mater Medical Centre

location_facility: Medical Radiological Research Center RAMS

location_facility: Institute of Hematology and Transfusiology of the UAMS Department of blood diseases

location_facility: Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik

location_facility: Institute of Urgent and Recovery Surgery

location_facility: Hope Directorate Haematology Oncology Service St. James Hospital

location_facility: University Hospital of Salzburg St Johanns Spital

location_facility: University College London Hospitals Cancer Clinical Trials Unitist FloorCentral wing

location_facility: UniversitatsSpital ZurichKlinik fur Onkologie

location_facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

location_facility: Hospital Universitaro Puerta del MarServicio de Hematologia

location_facility: Dipartmento Oncologico Struttura Complessa di ematlologiaA.O. Ospedale Niguarda Ca Granda

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

location_facility: Moscow Regional Research Institute n.a. Vladimirsky

location_facility: Divisione Di Ematologia Ospedale Cattedra di Ematologia

location_facility: Assistance Publique - Hôpitaux de Paris AP-HP

location_facility: Republican Scientific and Practical Centre of Radiation Medicine and Human Ecology

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Institute of Blood Pathology and Transfusion Medicine of the AMS of Ukraine

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Medizinische Klinik und Poliklinik II der Charite Campus Mitte

location_facility: G. GENNIMATAS General Hospital of Athens Department of Hematolgosy

location_facility: Burdenko Central Military Clinical Hospital

location_facility: Akademia Medyczna w Warszawie Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Hematology Institute, Hemato-Oncology Division,Davidoff Cancer Center, Rabin MC Beilinson Hospital

location_facility: Hospital Virgen del Rocio Servicio de Hematologia

location_facility: Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology

location_facility: Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V

location_facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science

location_facility: Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Klinika Hematologii Samodzielny Publiczny Szpital Kliniczny Akademii

location_facility: Institute of Internal Diseases University of Medicine

title: A Phase III, Multicentre, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study To Determine The Efficacy And Safety Of Lenalidomde (Revlimid®) In Combination With Melphalan And Prednisone Versus Placebo Plus Melphalan And Prednisone In Subjects With Newly Diagnosed Multiple Myeloma Who Are 65 Years Of Age Or Older

summary: The purpose of this study is to determine whether lenalidomide is safe and effective in the treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older.


type: Other Identifier

type: EudraCT Number

title: A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia

summary: The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gopal S, Gogate J, Pungor K, Kim E, Singh A, Mathews M. Improvement of Negative Symptoms in Schizophrenia with Paliperidone Palmitate 1-Month and 3-Month Long-Acting Injectables: Results from a Phase 3 Non-Inferiority Study. Neuropsychiatr Dis Treat. 2020 Mar 6;16:681-690. doi: 10.2147/NDT.S226296. eCollection 2020.

family: Gopal

full_name: Srihari Gopal

given: Srihari

sequence: first

family: Gogate

full_name: Jagadish Gogate

given: Jagadish

sequence: additional

family: Pungor

full_name: Katalin Pungor

given: Katalin

family: Kim

full_name: Edward Kim

given: Edward

family: Singh

full_name: Arun Singh

given: Arun

family: Mathews

full_name: Maju Mathews

given: Maju

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Neuropsychiatric Disease and Treatment

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153.

apc_source: doaj

name: Janssen Research & Development, LLC,  USA

family: Savitz

full_name: Adam J. Savitz

given: Adam J.

family: Xu

full_name: Haiyan Xu

given: Haiyan

family: Nuamah

full_name: Isaac Nuamah

given: Isaac

family: Soares

full_name: Bernardo Soares

given: Bernardo

bso_classification: Social sciences

journal_name: Brazilian Journal of Psychiatry

oa_colors: green diamond

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

repositories:
PubMed Central
pdfs.semanticscholar.org
scielo

ReferenceCitation: Nash AI, Turkoz I, Savitz AJ, Mathews M, Kim E. Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation. Neuropsychiatr Dis Treat. 2019 Mar 22;15:731-737. doi: 10.2147/NDT.S194264. eCollection 2019.

ReferenceCitation: Mathews M, Pei H, Savitz A, Nuamah I, Hough D, Alphs L, Gopal S. Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis. Clin Drug Investig. 2018 Aug;38(8):695-702. doi: 10.1007/s40261-018-0647-z.

ReferenceCitation: Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3.

ReferenceCitation: Samtani MN, Nandy P, Ravenstijn P, Remmerie B, Vermeulen A, Russu A, D'hoore P, Baum EZ, Savitz A, Gopal S, Hough D. Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy. Br J Clin Pharmacol. 2016 Nov;82(5):1364-1370. doi: 10.1111/bcp.13050. Epub 2016 Jul 24.

name: Janssen Research & Development LLC; New Jersey USA

name: Janssen Research & Development, a Division of Janssen Pharmaceutica NV; Beerse Belgium

journal_name: British Journal of Clinical Pharmacology

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Sweden
Bulgaria
Hungary
China
Portugal
Germany
United States
Austria
Brazil
Mexico
Spain


title: An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy

summary: The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer

ReferenceCitation: Machiels JP, Subramanian S, Ruzsa A, Repassy G, Lifirenko I, Flygare A, Sørensen P, Nielsen T, Lisby S, Clement PM. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol. 2011 Apr;12(4):333-43. doi: 10.1016/S1470-2045(11)70034-1. Epub 2011 Mar 4.

family: Machiels

full_name: Jean-Pascal Machiels

given: Jean-Pascal

family: Subramanian

full_name: Somasundaram Subramanian

given: Somasundaram

family: Ruzsa

full_name: Agnes Ruzsa

given: Agnes

family: Repassy

full_name: Gabor Repassy

given: Gabor

family: Lifirenko

full_name: Igor Lifirenko

given: Igor

family: Flygare

full_name: Annika Flygare

given: Annika

family: Sørensen

full_name: Per Sørensen

given: Per

family: Nielsen

full_name: Tina Nielsen

given: Tina

family: Lisby

full_name: Steen Lisby

given: Steen

family: Clement

full_name: Paul MJ Clement

given: Paul MJ

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Genmab

location_country:
Brazil
Sweden
Serbia
France
Poland
Lithuania
Hungary
Belgium
Russian Federation
Estonia
Canada
United Kingdom

location_facility: Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: NUZ Semashko Central Clinical Hospital No2 OAO

location_facility: Voronezh Region Clinical Oncology Dispensary

location_facility: Hôpital Beaujon- department of medical oncology

location_facility: Szent Borbála County Hospital Oncology Department

location_facility: IBCC - Instituto Brasileiro de Combate ao Câncer

location_facility: Samodzielny Publiczny Szpital Kiniczny Nr1

location_facility: GUZ Volgograd Region Clinical Oncology Dispensary No1

location_facility: Hôpital Tenon - department of medical oncology

location_facility: Russian Oncology Research Center n.a. Blokhin

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

location_facility: Stavropol Regional Clinical Oncology Dispensary

location_facility: Cepho - Centro de Estudos e pesquisa em Hematologia e Oncologia

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections

acronym: IOOX

summary: A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.

ReferenceCitation: Hayes RP, Curtis B, Ilag L, Nelson DR, Wong M, Funnell M. Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy. J Diabetes. 2013 Sep;5(3):358-67. doi: 10.1111/1753-0407.12037. Epub 2013 May 28.

name: Eli Lilly and Company; Indianapolis; Indiana; USA

family: Hayes

full_name: Risa P. Hayes

given: Risa P.

family: Curtis

full_name: Bradley Curtis

given: Bradley

family: Ilag

full_name: Liza Ilag

given: Liza

family: Nelson

full_name: David R. Nelson

given: David R.

family: Wong

full_name: Mayme Wong

given: Mayme

name: Michigan Center for Diabetes Translational Research; Ann Arbor; Michigan; USA

family: Funnell

full_name: Martha Funnell

given: Martha

journal_name: Journal of Diabetes

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy (2型糖尿病患

lead_sponsor: Eli Lilly and Company

location_country:
Mexico
France
Australia
Russian Federation
Spain
Canada
Korea, Republic of

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.

intervention_type: Drug


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Pregabalin in Subjects With Generalized Anxiety Disorder (GAD) Switching From Benzodiazepine Therapy.

acronym: GAD

summary: GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering off of alprazolam over 6 weeks. Subjects return weekly for assessment of safety/tolerability of pregabalin vs placebo as well as for assessment of anxiety and benzodiazepine withdrawal symptoms. Subjects successfully able to discontinue alprazolam, will continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use). The efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to discontinue/remain free of alprazolam will be compared among pregabalin and placebo treated groups. Hypothesis is that a greater proportion of subjects will be successful in discontinuing and remaining free from benzodiazepines who were treated with pregabalin as compared to subjects treated with placebo.

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

location_country:
Italy
Guatemala
Costa Rica
Mexico
France
Czechia
Spain


title: A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus

summary:
A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus.

This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes.

The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.

ReferenceCitation: Comulada AL, Renard E, Nakano M, Rais N, Mao X, Webb DM, Milicevic Z. Efficacy and safety of AIR inhaled insulin compared to insulin lispro in patients with type 1 diabetes mellitus in a 6-month, randomized, noninferiority trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S17-25. doi: 10.1089/dia.2009.0041.

name: Instituto de Endocrinología, Diabetes & Metabolismo, Toa Baja, Puerto Rico.

family: Comulada

full_name: Angel L. Comulada

given: Angel L.

name: Endocrinology Department, Centre Hospitalier Universitaire and University of Montpellier, Montpellier, France.

family: Renard

full_name: Eric Renard

given: Eric

family: Nakano

full_name: Masako Nakano

given: Masako

name: Chowpatty Medical Center, Mumbai, India.

family: Rais

full_name: Nadeem Rais

given: Nadeem

name: Eli Lilly and Co., Indianapolis, Indiana.

family: Mao

full_name: Xuejing Mao

given: Xuejing

family: Webb

full_name: David M. Webb

given: David M.

family: Milicevic

full_name: Zvonko Milicevic

given: Zvonko

journal_name: Diabetes Technology & Therapeutics

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

title: Efficacy and Safety of AIR Inhaled Insulin Compared to Insulin Lispro in Patients with Type 1 Diabetes Mellitus in a 6-Month, Randomized, Noninferiority Trial

location_country:
Italy
India
Mexico
Germany
France
Belgium
Argentina
Puerto Rico
United States


title: A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen With Insulin Aspart as Bolus Insulin, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN™: Young 1)

acronym: BEGIN™

summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10.

ReferenceType: result

ReferenceCitation: Thalange N, Deeb L, Iotova V, Kawamura T, Klingensmith G, Philotheou A, Silverstein J, Tumini S, Ocampo Francisco AM, Kinduryte O, Danne T. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2015 May;16(3):164-76. doi: 10.1111/pedi.12263. Epub 2015 Feb 12.

name: Jenny Lind Children's Department Norfolk & Norwich University Hospital  Norwich UK

family: Thalange

full_name: Nandu Thalange

given: Nandu

family: Deeb

full_name: Larry Deeb

given: Larry

name: First Paediatric Clinic University Hospital Sveta Marina  Varna Bulgaria

family: Iotova

full_name: Violeta Iotova

given: Violeta

name: Department of Pediatrics Osaka City University  Osaka Japan

family: Kawamura

full_name: Tomoyuki Kawamura

given: Tomoyuki

name: Barbara Davis Center for Childhood Diabetes University of California  Aurora CO USA

family: Klingensmith

full_name: Georgeanna Klingensmith

given: Georgeanna

name: Diabetes Clinical Trials Unit UCT Private Academic Hospital  Cape Town South Africa

family: Philotheou

full_name: Areti Philotheou

given: Areti

name: Department of Pediatrics University of Florida  Gainesville FL USA

family: Silverstein

full_name: Janet Silverstein

given: Janet

name: Pediatric Clinic Ospedale “SS.Annunziata”  Chieti Italy

family: Tumini

full_name: Stefano Tumini

given: Stefano

family: Ocampo Francisco

full_name: Ann‐Marie Ocampo Francisco

given: Ann‐Marie

family: Kinduryte

full_name: Ona Kinduryte

given: Ona

name: Department of General Pediatrics and Endocrinology/Diabetology Children's Hospital auf der Bult  Hannover Germany

family: Danne

full_name: Thomas Danne

given: Thomas

journal_name: Pediatric Diabetes

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
United States
South Africa
Netherlands
North Macedonia
Finland
France
Bulgaria
Japan
Russian Federation
Germany
United Kingdom


title: Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm

summary: This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).

ReferenceCitation: Nauck MA, Hompesch M, Filipczak R, Le TD, Zdravkovic M, Gumprecht J; NN2211-1499 Study Group. Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Sep;114(8):417-23.

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

family: Jensen

full_name: Troels M. Jensen

given: Troels M.

family: Saha

full_name: Kishore Saha

given: Kishore

family: Steinberg

full_name: William M. Steinberg

given: William M.

journal_name: Diabetes Care

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical Trials

location_country:
Austria
United Kingdom
France
Poland
Australia
Denmark
Germany
Czech Republic


title: Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve

summary: To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Prevention

ReferenceCitation: Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt JU, Simoons ML, Van de Werf F; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sep 26;369(13):1206-14. doi: 10.1056/NEJMoa1300615. Epub 2013 Aug 31.

family: Eikelboom

full_name: John W. Eikelboom

given: John W.

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

family: Brueckmann

full_name: Martina Brueckmann

given: Martina

family: Granger

full_name: Christopher B. Granger

given: Christopher B.

family: Kappetein

full_name: Arie P. Kappetein

given: Arie P.

family: Mack

full_name: Michael J. Mack

given: Michael J.

family: Blatchford

full_name: Jon Blatchford

given: Jon

family: Devenny

full_name: Kevin Devenny

given: Kevin

family: Friedman

full_name: Jeffrey Friedman

given: Jeffrey

family: Guiver

full_name: Kelly Guiver

given: Kelly

family: Harper

full_name: Ruth Harper

given: Ruth

family: Khder

full_name: Yasser Khder

given: Yasser

family: Lobmeyer

full_name: Maximilian T. Lobmeyer

given: Maximilian T.

family: Maas

full_name: Hugo Maas

given: Hugo

family: Voigt

full_name: Jens-Uwe Voigt

given: Jens-Uwe

family: Simoons

full_name: Maarten L. Simoons

given: Maarten L.

family: Van de Werf

full_name: Frans Van de Werf

given: Frans

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Dabigatran versus Warfarin in Patients with Mechanical Heart Valves

lead_sponsor: Boehringer Ingelheim

location_country:
Netherlands
Germany
France
Poland
Norway
Belgium
Denmark
Canada
Czech Republic

location_facility: 1160.138.48004 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.33003 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.31004 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.49002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.48003 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.47002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.47001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.48001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.31002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.45001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.49010 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.42004 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.45002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.11012 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.11001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.33002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.49001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.33004 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.33001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.32002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.11011 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.49004 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.32003 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.32001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.11007 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.11009 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.49003 Boehringer Ingelheim Investigational Site

status_simplified: Unknown


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis

acronym: ATLAS

summary: The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.

lead_sponsor: Biogen

location_country:
Peru
Malaysia
Belgium
Australia
Russian Federation
France
Poland
Thailand
Argentina
Korea, Republic of
Colombia
Hong Kong
Philippines
Hungary
Portugal
Germany
United States
Italy
Brazil
Mexico
Spain


title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Metmab Vs. Placebo in Combination With Either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum in Patients With Untreated Stage IIIb or IV Non-Squamous NSCLC

summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive 4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

lead_sponsor: Genentech, Inc.

location_country:
Italy
United States
United Kingdom
Mexico
Philippines
France
Malaysia
Israel
Argentina
Spain
Germany
Latvia
Taiwan


title: A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

summary: This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.

ReferenceCitation: Santagostino E, Martinowitz U, Lissitchkov T, Pan-Petesch B, Hanabusa H, Oldenburg J, Boggio L, Negrier C, Pabinger I, von Depka Prondzinski M, Altisent C, Castaman G, Yamamoto K, Álvarez-Roman MT, Voigt C, Blackman N, Jacobs I; PROLONG-9FP Investigators Study Group. Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial. Blood. 2016 Apr 7;127(14):1761-9. doi: 10.1182/blood-2015-09-669234. Epub 2016 Jan 11.

name: Istituto di Ricovero e Cura a Carattere Scientifico Ca’ Granda Foundation, Maggiore Hospital Policlinico, Milan, Italy;

family: Santagostino

full_name: Elena Santagostino

given: Elena

name: The Israeli National Haemophilia Center, Chaim Sheba Medical Center, Tel Hashomer, Israel;

family: Martinowitz

full_name: Uri Martinowitz

given: Uri

name: Department of Coagulation Disorders and Anemia, Specialized Hospital for Active Treatment Joan Pavel, Sofia, Bulgaria;

family: Lissitchkov

full_name: Toshko Lissitchkov

given: Toshko

name: Centre Hospitalier Régional Universitaire de Brest, Hôpital A. Morvan, Brest, France;

family: Pan-Petesch

full_name: Brigitte Pan-Petesch

given: Brigitte

name: Department of Hematology, Ogikubo Hospital, Tokyo, Japan;

family: Hanabusa

full_name: Hideji Hanabusa

given: Hideji

name: Institute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Bonn, Germany;

family: Oldenburg

full_name: Johannes Oldenburg

given: Johannes

name: Rush Hemophilia and Thrombophilia Center, Rush University, Chicago, IL;

family: Boggio

full_name: Lisa Boggio

given: Lisa

name: Centre Régional de Traitement de l’Hémophilie, Hôpital Edouard Herriot, University Claude Bernard, Lyon, France;

family: Negrier

full_name: Claude Negrier

given: Claude

name: Division of Haematology and Haemostaseology, Medical University of Vienna, Vienna, Austria;

family: Pabinger

full_name: Ingrid Pabinger

given: Ingrid

family: von Depka Prondzinski

full_name: Mario von Depka Prondzinski

given: Mario

name: Unitat Hemofilia, Hospital Vall d’Hebron, Barcelona, Spain;

family: Altisent

full_name: Carmen Altisent

given: Carmen

name: Haemophilia and Thrombosis Centre, Department of Haematology, San Bortolo Hospital, Vicenza, Italy;

name: Center for Bleeding Disorders, Careggi University Hospital, Florence, Italy;

family: Castaman

full_name: Giancarlo Castaman

given: Giancarlo

name: Nagoya University Hospital, Nagoya, Japan;

family: Yamamoto

full_name: Koji Yamamoto

given: Koji

family: Álvarez-Roman

full_name: Maria-Teresa Álvarez-Roman

given: Maria-Teresa

name: Clinical Research and Development, CSL Behring, King of Prussia, PA

full_name: Christine Voigt

given: Christine

family: Blackman

full_name: Nicole Blackman

given: Nicole

family: Jacobs

full_name: Iris Jacobs

given: Iris

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

location_country:
Italy
Austria
Germany
France
Bulgaria
Japan
Israel
Russian Federation
Spain
United States

location_facility: Osp. S.Bortolo ULSS N.6 [Terapie Cell. ed Ematologia]

location_facility: Hospital of the University of Pennsylvania

location_facility: FGU "Kirov Research Institute of Haemotology and Blood Trans

location_facility: SHAT "Joan Pavel" OOD [Hemorrhagic Diathesis and Anemia]

location_facility: Nara Medical University Hospital [PEDIATRICS]

location_facility: St. Marianna University, School of Medicine, Yokohama Seibu

location_facility: University of Occupational and Environmental Health

location_facility: CHU de Lyon - Hôpital Edouard Herriot [Hemophilie]

location_facility: IRCCS Ospedale Maggiore[Centro emofilia e Trombosi]

location_facility: Indiana Hemophilia and Thrombosis Center, Inc.

location_facility: Instit. für Experimentelle - Hämato & Transfusionsmedizin

location_facility: Universitätsklinikum Hamburg-Eppendorf, Abt für Pädiatr. Hämatologie

location_facility: A.O.U. di Parma [Centro di Rif. Reg. per la cura dell'Emofil

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Centre Hospitalier Universitaire de Brest/CHU Morvan


title: A Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

summary: The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.

ReferenceCitation: Keshav S, Vaňásek T, Niv Y, Petryka R, Howaldt S, Bafutto M, Rácz I, Hetzel D, Nielsen OH, Vermeire S, Reinisch W, Karlén P, Schreiber S, Schall TJ, Bekker P; Prospective Randomized Oral-Therapy Evaluation in Crohn's Disease Trial-1 PROTECT-1 Study Group. A randomized controlled trial of the efficacy and safety of CCX282-B, an orally-administered blocker of chemokine receptor CCR9, for patients with Crohn's disease. PLoS One. 2013;8(3):e60094. doi: 10.1371/journal.pone.0060094. Epub 2013 Mar 20.

family: Keshav

full_name: Satish Keshav

given: Satish

family: Vaňásek

full_name: Tomáš Vaňásek

given: Tomáš

family: Niv

full_name: Yaron Niv

given: Yaron

family: Petryka

full_name: Robert Petryka

given: Robert

family: Howaldt

full_name: Stephanie Howaldt

given: Stephanie

family: Bafutto

full_name: Mauro Bafutto

given: Mauro

family: Rácz

full_name: István Rácz

given: István

family: Hetzel

full_name: David Hetzel

given: David

family: Nielsen

full_name: Ole Haagen Nielsen

given: Ole Haagen

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Karlén

full_name: Per Karlén

given: Per

family: Schreiber

full_name: Stefan Schreiber

given: Stefan

family: Schall

full_name: Thomas J. Schall

given: Thomas J.

family: Bekker

full_name: Pirow Bekker

given: Pirow

name: the Prospective Randomized Oral-Therapy Evaluation in Crohn’s Disease Trial-1 (PROTECT-1) Study Group

journal_name: PLoS ONE

license: cc-by

license_normalized: cc-by

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

repository_institution: RePEc: Research Papers in Economics - RePEc

repository_normalized: RePEc

evidence: oa repository (semantic scholar lookup)

repositories:
PubMed Central
RePEc
pdfs.semanticscholar.org

title: A Randomized Controlled Trial of the Efficacy and Safety of CCX282-B, an Orally-Administered Blocker of Chemokine Receptor CCR9, for Patients with Crohn’s Disease

location_country:
Austria
Brazil
South Africa
Sweden
United Kingdom
Netherlands
Germany
France
Bulgaria
Poland
Israel
Hungary
Australia
Belgium
Denmark
Canada
Czech Republic

location_facility: Louis Leipoldt Gastroenterology Centre, Louis Leipoldt Medical Centre

location_facility: Klinika Gastroenterologii i Hepatologii, Akademii Medycznej

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4

location_facility: 10 Wojskowy Szpital Klinicznym, Oddzial Kliniczny Gasteroenterologii

location_facility: Dept of Gastroenterology, John Radcliffe Hospital

location_facility: Service d'Hépato-Gastroentérologie et de Nutrition Clinique

location_facility: Gastroenterologische Praxis am Germania-Campus

location_facility: Irmandade da Santa Casa de Misericórdia de Santos

location_facility: Isala Klinieken Locatie Sophia Afd. Interne Geneeskunde

location_facility: SOPMED Niepubliczny Zakład Opieki Zdrowotnej

location_facility: Charité Campus Mitte, Universitätsmedizin Berlin

location_facility: Hospital Universitário Clementino Fraga Filho

location_facility: GastroEnterology Unit, Groote Schuur Hospital

location_facility: Klinika Gastroenterologii i Chorób Wewnętrznych Samodzielny Publiczny Szpital Kliniczny nr 1 im. T. Sokołowskiego Pomorskiej Akademii Medycznej ul.Unii Lubelskiej 1

location_facility: Hepato-Gastroenterologie, Edvarda Benese 1549

location_facility: Santo André Diagnósticos e tratamentoLtda.

location_facility: Herlev Hospital Gastroenterologisk department

location_facility: Centre for Gastroenterology Royal Free Hospital

location_facility: Klinika Chorob Wewnetrznych I Gastroenterologii

location_facility: NZOZ Vivamed Zespół Lekarzy Specjalistów ul. Trocka 10A

location_facility: Fővárosi Önkormányzat Bajcsy-Zsilinszky Kórház

location_facility: Universitätsklinik für Innere Medizin III

location_facility: Medizinische Klinik m.S. Hepatologie, Gastroenterologie, Endokrinologie und Stoffwechsel

location_facility: Irmandade da Santa Casa de Misericórdia de São Paulo

location_facility: Centro Petropolitano de Reumatologia e Fisioterapia

location_facility: Medical department S Odense University hospital

location_facility: Service de Gastro-Enterologie et Nutrition

location_facility: Klinikum der Christian-Albrechts-Universität zu Kiel

location_facility: Medical Department V Århus University Hospital


title: A Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.

summary: This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
South Africa
Serbia
Mexico
Croatia
France
Romania
Spain
United States
Czech Republic
Canada
Taiwan


title: A 24-month, Multi-center, Randomized, Open-label, Non-inferiority Study of Efficacy and Safety Comparing Two Exposures of Concentration-controlled Everolimus With Reduced Cyclosporine Versus 3.0 g Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Heart Transplant Recipients

summary: This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
Spain
Germany
France
Norway
Argentina
Australia
Belgium
New Zealand
Puerto Rico
United States
United Kingdom
Canada
Taiwan

location_facility: Institut Univ. de cardiologie et pneumologie de Quebec

location_facility: Herz- u. Diabeteszentrum NRW/Ruhr-Univ. Bochum

location_facility: CHU de Strasbourg Hopital Civil Medicale B

location_facility: Stanford U Sch, Falk Cardiovasular Research Ctr.

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliera S. Camillo-Forlanini

location_facility: Az. Ospedaliero-Universitaria S. Giovanni Battista di Torino

location_facility: Methodist Hospital/DeBakey Heart Failure Research Center

location_facility: Az. Osp. di Bologna Policl. S. Orsola-Malpighi Univ. degli Studi

location_facility: Cardiovascular Center of Puerto Rico and the Caribbean

location_facility: St. Luke's Medical Center Cardiac Services

location_facility: University of Texas Medical Branch, Div of Cardio Thoracic

location_facility: University of Wisconsin - Madison Medical School

location_facility: A.O.-Universita di Padova-Universita degli Studi


ReferenceCitation: Brighton TA, Khot A, Harrison SJ, Ghez D, Weiss BM, Kirsch A, Magen H, Gironella M, Oriol A, Streetly M, Kranenburg B, Qin X, Bandekar R, Hu P, Guilfoyle M, Qi M, Nemat S, Goldschmidt H. Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Siltuximab in High-Risk Smoldering Multiple Myeloma. Clin Cancer Res. 2019 Jul 1;25(13):3772-3775. doi: 10.1158/1078-0432.CCR-18-3470. Epub 2019 Mar 19.

family: Brighton

full_name: Timothy A. Brighton

given: Timothy A.

family: Khot

full_name: Amit Khot

given: Amit

family: Harrison

full_name: Simon J. Harrison

given: Simon J.

family: Ghez

full_name: David Ghez

family: Weiss

full_name: Brendan M. Weiss

given: Brendan M.

family: Kirsch

full_name: Andres Kirsch

given: Andres

family: Magen

full_name: Hila Magen

given: Hila

family: Gironella

full_name: Mercedes Gironella

given: Mercedes

family: Oriol

full_name: Albert Oriol

given: Albert

family: Streetly

full_name: Matthew Streetly

given: Matthew

family: Kranenburg

full_name: Britte Kranenburg

given: Britte

family: Qin

full_name: Xiang Qin

given: Xiang

family: Bandekar

full_name: Rajesh Bandekar

given: Rajesh

family: Hu

full_name: Peter Hu

given: Peter

family: Guilfoyle

full_name: Mary Guilfoyle

given: Mary

family: Qi

full_name: Ming Qi

given: Ming

family: Nemat

full_name: Sepideh Nemat

given: Sepideh

family: Goldschmidt

full_name: Hartmut Goldschmidt

given: Hartmut

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

lead_sponsor: Janssen Research & Development, LLC

location_country:
Sweden
Germany
France
Greece
Israel
Belgium
Australia
Spain
United States
United Kingdom
Korea, Republic of

source: euctr

title: A Phase 2, Randomized, Blinded, Placebo-controlled, Multicenter Study of Siltuximab (Anti IL 6 Monoclonal Antibody) in Subjects With High-risk Smoldering Multiple Myeloma

summary: The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in patients with high-risk smoldering multiple myeloma (SMM).


title: A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects

summary: The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.

ReferenceCitation: Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Wirtz V, Lataillade M, Absalon J, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):323-32. doi: 10.1097/QAI.0b013e3181c990bf.

ReferenceCitation: Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Thiry A, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet. 2008 Aug 23;372(9639):646-55. doi: 10.1016/S0140-6736(08)61081-8.

ReferenceCitation: Zhu L, Liao S, Child M, Zhang J, Persson A, Sevinsky H, Eley T, Xu X, Krystal M, Farajallah A, McGrath D, Molina JM, Bertz R. Pharmacokinetics and inhibitory quotient of atazanavir/ritonavir versus lopinavir/ritonavir in HIV-infected, treatment-naive patients who participated in the CASTLE Study. J Antimicrob Chemother. 2012 Feb;67(2):465-8. doi: 10.1093/jac/dkr490. Epub 2011 Nov 25.

family: Zhu

full_name: L. Zhu

given: L.

family: Liao

full_name: S. Liao

given: S.

family: Child

full_name: M. Child

given: M.

family: Zhang

full_name: J. Zhang

given: J.

family: Persson

full_name: A. Persson

given: A.

family: Sevinsky

full_name: H. Sevinsky

given: H.

family: Eley

full_name: T. Eley

given: T.

family: Xu

full_name: X. Xu

given: X.

family: Krystal

full_name: M. Krystal

family: Farajallah

full_name: A. Farajallah

family: McGrath

full_name: D. McGrath

given: D.

family: Molina

full_name: J.-M. Molina

family: Bertz

full_name: R. Bertz

given: R.

journal_name: Journal of Antimicrobial Chemotherapy

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Uy J, Yang R, Wirtz V, Sheppard L, Farajallah A, McGrath D. Treatment of advanced HIV disease in antiretroviral-naïve HIV-1-infected patients receiving once-daily atazanavir/ritonavir or twice-daily lopinavir/ritonavir, each in combination with tenofovir disoproxil fumarate and emtricitabine. AIDS Care. 2011 Nov;23(11):1500-4. doi: 10.1080/09540121.2011.565033. Epub 2011 Jul 7.

name: a  Bristol-Myers Squibb, Research and Development ,  Plainsboro ,  USA

family: Uy

full_name: Jonathan Uy

given: Jonathan

name: b  Bristol-Myers Squibb, Research and Development ,  Wallingford ,  USA

family: Yang

full_name: Rong Yang

given: Rong

family: Wirtz

full_name: Victoria Wirtz

given: Victoria

name: c  Bristol-Myers Squibb, Research and Development ,  Braine-l'Alleud ,  Belgium

family: Sheppard

full_name: Louise Sheppard

given: Louise

full_name: Awny Farajallah

given: Awny

full_name: Donnie McGrath

given: Donnie

ReferenceCitation: Squires KE, Johnson M, Yang R, Uy J, Sheppard L, Absalon J, McGrath D. Comparative gender analysis of the efficacy and safety of atazanavir/ritonavir and lopinavir/ritonavir at 96 weeks in the CASTLE study. J Antimicrob Chemother. 2011 Feb;66(2):363-70. doi: 10.1093/jac/dkq457. Epub 2010 Dec 9.

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

location_country:
Peru
Guatemala
Australia
Belgium
Taiwan
Costa Rica
France
Panama
Thailand
Argentina
Indonesia
Canada
Colombia
South Africa
Chile
Hong Kong
Netherlands
Singapore
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Dominican Republic
Spain


title: A Phase III Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of TMC435 Plus PegIFNα-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Subjects Who Are Co-infected With Human Immunodeficiency Virus Type 1 (HIV-1)

summary: The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after the planned end of treatment.

ReferenceCitation: Andersohn F, Claes AK, Kulp W, Mahlich J, Rockstroh JK. Simeprevir with pegylated interferon alfa 2a plus ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a meta-analysis and historical comparison. BMC Infect Dis. 2016 Jan 11;16:10. doi: 10.1186/s12879-015-1311-3. Review.

family: Andersohn

full_name: Frank Andersohn

given: Frank

family: Claes

full_name: Anne-Kathrin Claes

given: Anne-Kathrin

family: Kulp

full_name: Werner Kulp

given: Werner

family: Mahlich

full_name: Jörg Mahlich

given: Jörg

family: Rockstroh

full_name: Jürgen Kurt Rockstroh

given: Jürgen Kurt

currency_apc_doaj: GBP

journal_name: BMC Infectious Diseases

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Saeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferrière V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study, Cohen J, Conway B, Cooper C, Côté P, Cox J, Gill J, Haider S, Harris M, Haase D, Hull M, Montaner J, Moodie E, Pick N, Rachlis A, Rouleau D, Sandre R, Tyndall JM, Vachon ML, Walmsley S, Wong D. How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World? Clin Infect Dis. 2016 Apr 1;62(7):919-926. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6.

family: Saeed

full_name: Sahar Saeed

given: Sahar

family: Strumpf

full_name: Erin C. Strumpf

given: Erin C.

family: Walmsley

full_name: Sharon L. Walmsley

given: Sharon L.

family: Rollet-Kurhajec

full_name: Kathleen Rollet-Kurhajec

given: Kathleen

family: Pick

full_name: Neora Pick

given: Neora

family: Martel-Laferrière

full_name: Valerie Martel-Laferrière

given: Valerie

family: Hull

full_name: Mark Hull

given: Mark

family: Gill

full_name: M. John Gill

given: M. John

family: Cox

full_name: Joseph Cox

given: Joseph

family: Cooper

full_name: Curtis Cooper

ReferenceCitation: Dieterich D, Rockstroh JK, Orkin C, Gutiérrez F, Klein MB, Reynes J, Shukla U, Jenkins A, Lenz O, Ouwerkerk-Mahadevan S, Peeters M, De La Rosa G, Tambuyzer L, Jessner W. Simeprevir (TMC435) with pegylated interferon/ribavirin in patients coinfected with HCV genotype 1 and HIV-1: a phase 3 study. Clin Infect Dis. 2014 Dec 1;59(11):1579-87. doi: 10.1093/cid/ciu675. Epub 2014 Sep 5.

title: Simeprevir (TMC435) With Pegylated Interferon/Ribavirin in Patients Coinfected With HCV Genotype 1 and HIV-1: A Phase 3 Study

location_country:
United States
Spain
France
Puerto Rico
Portugal
Germany
United Kingdom
Canada


title: PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment

acronym: PRESENT

summary:
Purpose of this trial:

To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine® (sargramostim, GM-CSF).
To evaluate and compare the disease free survival (DFS) in the vaccinated and control subjects.

ReferenceCitation: Amin A, Benavides LC, Holmes JP, Gates JD, Carmichael MG, Hueman MT, Mittendorf EA, Storrer CE, Jama YH, Craig D, Stojadinovic A, Ponniah S, Peoples GE. Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer Immunol Immunother. 2008 Dec;57(12):1817-25. doi: 10.1007/s00262-008-0509-2. Epub 2008 Apr 8.

ReferenceCitation: Mittendorf EA, Clifton GT, Holmes JP, Clive KS, Patil R, Benavides LC, Gates JD, Sears AK, Stojadinovic A, Ponniah S, Peoples GE. Clinical trial results of the HER-2/neu (E75) vaccine to prevent breast cancer recurrence in high-risk patients: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer. 2012 May 15;118(10):2594-602. doi: 10.1002/cncr.26574. Epub 2011 Oct 11.

ReferenceCitation: Mittendorf EA, Lu B, Melisko M, Price Hiller J, Bondarenko I, Brunt AM, Sergii G, Petrakova K, Peoples GE. Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial. Clin Cancer Res. 2019 Jul 15;25(14):4248-4254. doi: 10.1158/1078-0432.CCR-18-2867. Epub 2019 Apr 29.

family: Mittendorf

full_name: Elizabeth A. Mittendorf

given: Elizabeth A.

family: Lu

full_name: Biao Lu

given: Biao

family: Melisko

full_name: Michelle Melisko

given: Michelle

family: Price Hiller

full_name: Julie Price Hiller

given: Julie

family: Bondarenko

full_name: Igor Bondarenko

given: Igor

family: Brunt

full_name: Adrian Murray Brunt

given: Adrian Murray

family: Sergii

full_name: Grybach Sergii

given: Grybach

family: Petrakova

full_name: Katarina Petrakova

given: Katarina

family: Peoples

full_name: George E. Peoples

given: George E.

publisher_dissemination: American Association for Cancer Research

publisher_group: American Association for Cancer Research

publisher_normalized: American Association for Cancer Research

lead_sponsor: Galena Biopharma, Inc.

location_country:
United Kingdom
Germany
France
Bulgaria
Poland
Israel
Romania
Hungary
Russian Federation
United States
Czech Republic
Canada
Ukraine

location_facility: California Cancer Associates for Research and Excellence, Inc.

location_facility: Leeds Teaching Hospitals Trust, St. James University Hospital

location_facility: University of California, San Francisco (UCSF), Hellen Diller Family Comprehensive Cancer Center

location_facility: H.Lee Moffitt Cancer Center and Research Institute

location_facility: Oncology Center "Sf. Nectarie", Department of Medical Oncology

location_facility: Orenburg Regional Clinical Oncology Center

location_facility: Kirovohrad Regional Oncology Center, Department of Mammology

location_facility: Hetenyi Geza Hospital, Department of Oncology

location_facility: General University Hospital in Prague, Clinic of Oncology

location_facility: Interventional Spine and Pain Management

location_facility: Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Institut de Cancérologie de l'Ouest/René Gauducheau

location_facility: Public Institution: Kiev Regional Oncology Hospital within Kyiv Regional Council

location_facility: Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Klinik für Senologie/Brustzentrum

location_facility: Cancer Specialists of North Florida (ICON)

location_facility: Donetsk Regional Antitumor Center, Oncosurgery Department #2

location_facility: Krasnoyarsk Kryzhanovsky Regional Oncology Center

location_facility: Multicare Health System-Research Institute

location_facility: Nizhny Novgorod Regional Oncology Center

location_facility: Odesa Regional Clinical Hospital, Center for Mastology

location_facility: University Hospital Olomouc, Clinic of Oncology

location_facility: Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy

location_facility: State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine

location_facility: Rotkreuzklinikum München gGmbH, Frauenklinik

location_facility: Samara Regional Clinical Oncology Center

location_facility: South Orange County Surgical Medical Group

location_facility: Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Bucharest Universtiy Emergency Hosptial, Oncology Department

location_facility: University Hospital of North Staffordshire

location_facility: Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council

location_facility: Iasi Regional Oncology Institute, Department of Medical Oncology

location_facility: Brustzentrum Klinikum Bremen-Mitte gGmbH

location_facility: Moores UC San Diego Cancer Center (UCSD)

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy

location_facility: Non-Public Health Care Facility MAGODENT

location_facility: Kyiv City Clinical Oncology Center, Department of Chemotherapy

location_facility: Universitätsklinikum Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Florida Cancer Research Institute (Florida Cancer Care)

location_facility: Polish Red Cross Marine Hospital, Department of Chemotherapy

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Borsod-Abauj-Zemplen County Hospital and University Educational Hospital, Center for Clinical Oncology and Radiology

location_facility: Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Chemotheraphy

location_facility: Universitätsklinikum Münster, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

location_facility: UT Southwestern Medical Center / Simmons Comprehensive Cancer Center

location_facility: Mariupol City Interdistrict Oncology Center, Surgery Department #2

location_facility: St. Jude Medical Center, Virginia K. Crosson Cancer Center

location_facility: University of Pittsburgh Medical Center (UPMC) Cancer Center

location_facility: Oncology Center #2, Department of Healthcare of Krasnodar Territory Administration

location_facility: Center of Cancer and Blood Disorders (VEEDA network)

location_facility: Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

location_facility: Medisprof SRL, Department of Medical Oncology

location_facility: Chernivtsi Regional Clinical Oncology Center, Day Care Unit

location_facility: Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center

location_facility: Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center

location_facility: Institut de Cancérologie de l'Ouest Siet Paul Papin

location_facility: University of Colorado Cancer Center, Anschutz Medical Campus

location_facility: Greater Poland Cancer Center, Department of Chemotherapy

location_facility: N.N. Blokhin Russian Cancer Reserach Center

location_facility: University of Southern California/Norris Cancer Hospital

location_facility: Petz Aladar County Teaching Hospital, Center for Oncoradiology

location_facility: Coltea Clinical Hospital, Oncology Department

location_facility: Stamford Hospital, Bennett Cancer Center

location_facility: University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy

location_facility: Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik

location_facility: Kharkiv Regional Clinical Oncology Center, Day Care Unit

location_facility: Western Connecticut Health Network, Danbury Hospital

location_facility: Academic Unit of Oncology, Nottingham University Hospital-City Campus

location_facility: Mechnikov North-Western State Medical University

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center

location_facility: Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration

location_facility: Vinnytsia Regional Clinical Oncology Center

location_facility: Filantropia Clinical Hospital, Obstetrics and Gynaecology Department

location_facility: Tambov Regional Clinical Oncology Center

location_facility: Gemeinschaftspraxis für Innere Medizin, Haematologie und internistische Onkologie Dr. R Schlag/Dr. Schoettker

location_facility: Masaryk Memorial Cancer Institute, Comprehensive Cancer Care Clinic

location_facility: Dr. Constantin Opris County Emergency Hospital, Department of Oncology

location_facility: Physicians Pain Specialists of Alabama, P.C.

location_facility: Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie

location_facility: Szent Margit Hospital, V. Department of Internal Medicine, Oncology

location_facility: St. Alexius Medical Center, Mid Dakota Clinic, PC

location_facility: "Gavril Curteanu" Municipal Clinical Hospital

location_facility: Conemaugh Memorial Hospital-Memorial Medical Center

location_facility: "Prof. Dr. Ion Chiricuta" Institute of Oncology

location_facility: Lahey Clinic Department of Hematology and Oncology

location_facility: East Valley Hematology and Oncology Medical Group

location_facility: The West Clinic Comprehensive Breast Center

location_facility: Plymouth Oncology Centre, Derriford Hospital

location_facility: N.N. Blokhin Russian Cancer Research Center

location_facility: Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy

location_facility: Oncomed SRL, Department of Medical Oncology

location_facility: California Cancer Associates For Research and Excellence

location_facility: Semmelweis University, Department of Diagnostic Radiology and Oncotherapy

location_facility: James Graham Brown Cancer Center, University of Louisville

location_facility: Kaposi Mor County Teaching Hospital, Center for Clinical Oncology

intervention_type: Biological


title: A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZATM Plus Standard of Care Versus Standard of Care Alone in Subjects With Painful Diabetic Peripheral Neuropathy

acronym: PACE

summary: The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.

ReferenceCitation: Vinik AI, Perrot S, Vinik EJ, Pazdera L, Jacobs H, Stoker M, Long SK, Snijder RJ, van der Stoep M, Ortega E, Katz N. Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study. BMC Neurol. 2016 Dec 6;16(1):251.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
United Kingdom
Netherlands
France
Poland
Belgium
Russian Federation
Spain
Germany
Czech Republic
Ukraine

location_facility:
Site: 805
Site: 502
Site: 303
Site: 506
Site: 813
Site: 202
Site: 957
Site: 951
Site: 959
Site: 808
Site: 508
Site: 201
Site: 501
Site: 911
Site: 904
Site: 509
Site: 908
Site: 651
Site: 810
Site: 802
Site: 964
Site: 806
Site: 961
Site: 954
Site: 812
Site: 401
Site: 815
Site: 601
Site: 507
Site: 909
Site: 713
Site: 104
Site: 101
Site: 966
Site: 514
Site: 512
Site: 706
Site: 708
Site: 807
Site: 714
Site: 505
Site: 902
Site: 103
Site: 903
Site: 716
Site: 704
Site: 965
Site: 953
Site: 404
Site: 960
Site: 910
Site: 206
Site: 304
Site: 711
Site: 801
Site: 207
Site: 901
Site: 305
Site: 803
Site: 958
Site: 709
Site: 102
Site: 703
Site: 906


title: Second Study of the Effect of Teriparatide on Femoral Neck Fracture Healing

summary: The purpose of this study is to see whether teriparatide, given for 6 months versus placebo, will improve the healing of hip (femoral neck) fractures that are repaired during surgery using certain types of orthopedic screws. The study will enroll men and postmenopausal women at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for example, fall from standing height or less).

location_country:
United States
India
Switzerland
Netherlands
Croatia
France
Greece
Poland
Romania
Hungary
Belgium
Turkey
Germany
Korea, Republic of

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.

intervention_type: Dietary Supplement


title: An Open Label, Multicenter, Phase II Study to Evaluate Efficacy and Safety of the BiTE® Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

summary: The purpose of this study is to confirm whether the bispecific T cell engager antibody blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL).

ReferenceCitation: Gökbuget N, Kantarjian HM, Brüggemann M, Stein AS, Bargou RC, Dombret H, Fielding AK, Heffner L, Rigal-Huguet F, Litzow M, O'Brien S, Zugmaier G, Gao S, Nagorsen D, Forman SJ, Topp MS. Molecular response with blinatumomab in relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Blood Adv. 2019 Oct 22;3(20):3033-3037. doi: 10.1182/bloodadvances.2019000457.

name: Department of Medicine II, Goethe University, Frankfurt, Germany;

family: Gökbuget

full_name: Nicola Gökbuget

given: Nicola

name: Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;

family: Kantarjian

full_name: Hagop M. Kantarjian

given: Hagop M.

name: University Schleswig Holstein in the City Hospital, Kiel, Germany;

family: Brüggemann

full_name: Monika Brüggemann

given: Monika

family: Stein

full_name: Anthony S. Stein

given: Anthony S.

name: Comprehensive Cancer Center Mainfranken, Universitätsklinikum Würzburg, Würzburg, Germany;

family: Bargou

full_name: Ralf C. Bargou

given: Ralf C.

name: Hôpital Saint Louis, University of Paris, Paris, France;

family: Dombret

full_name: Hervé Dombret

given: Hervé

name: UCL Cancer Institute, University College London, London, United Kingdom;

family: Fielding

full_name: Adele K. Fielding

given: Adele K.

name: Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA;

family: Heffner

full_name: Leonard Heffner

given: Leonard

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

family: Rigal-Huguet

full_name: Françoise Rigal-Huguet

given: Françoise

name: Division of Hematology, Mayo Clinic, Rochester, MN;

family: Litzow

full_name: Mark Litzow

family: O’Brien

full_name: Susan O’Brien

given: Susan

name: Amgen Research (Munich) GmbH, Munich, Germany;

family: Zugmaier

full_name: Gerhard Zugmaier

given: Gerhard

family: Gao

full_name: Shan Gao

given: Shan

family: Nagorsen

full_name: Dirk Nagorsen

given: Dirk

family: Forman

full_name: Stephen J. Forman

given: Stephen J.

name: Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany

family: Topp

full_name: Max S. Topp

given: Max S.

journal_name: Blood Advances

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

ReferenceCitation: Zhu M, Kratzer A, Johnson J, Holland C, Brandl C, Singh I, Wolf A, Doshi S. Blinatumomab Pharmacodynamics and Exposure-Response Relationships in Relapsed/Refractory Acute Lymphoblastic Leukemia. J Clin Pharmacol. 2018 Feb;58(2):168-179. doi: 10.1002/jcph.1006. Epub 2017 Sep 18.

name: Clinical Pharmacology; Modeling and Simulation, Amgen Inc.; Thousand Oaks CA USA

name: Pharmacokinetics and Drug Metabolism; Amgen Research (Munich) GmbH; Munich Germany

name: Department of Global Biostatistical Science; Amgen Inc.; Washington DC USA

ReferenceCitation: Barlev A, Lin VW, Katz A, Hu K, Cong Z, Barber B. Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data. Adv Ther. 2017 Jan;34(1):148-155. doi: 10.1007/s12325-016-0447-x. Epub 2016 Nov 21.

ReferenceCitation: Zhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE(®)) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4.

title: Blinatumomab, a Bispecific T-cell Engager (BiTE®) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications

ReferenceCitation: Topp MS, Gökbuget N, Stein AS, Zugmaier G, O'Brien S, Bargou RC, Dombret H, Fielding AK, Heffner L, Larson RA, Neumann S, Foà R, Litzow M, Ribera JM, Rambaldi A, Schiller G, Brüggemann M, Horst HA, Holland C, Jia C, Maniar T, Huber B, Nagorsen D, Forman SJ, Kantarjian HM. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015 Jan;16(1):57-66. doi: 10.1016/S1470-2045(14)71170-2. Epub 2014 Dec 16. Erratum in: Lancet Oncol. 2015 Apr;16(4):e158.

location_country:
Italy
United States
France
Spain
Germany
United Kingdom

location_facility: Klinikum der Goethe Universität, Medizinische Klinik II

location_facility: Washington University School of Medicine

location_facility: Winship Cancer Institute of Emory University

location_facility: Julius-Maximilians-Universität, Medizinische Klinik und Poliklinik II


title: The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study

acronym: IMAGINE 3

summary:
The purpose of this study is:

To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment.
To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment.
To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment.
To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment

ReferenceCitation: Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.

family: Sanyal

full_name: Arun Sanyal

given: Arun

family: Cusi

full_name: Kenneth Cusi

given: Kenneth

family: Hartman

full_name: Mark L Hartman

given: Mark L

family: Zhang

full_name: Shuyu Zhang

given: Shuyu

family: Bastyr

full_name: Edward J Bastyr

given: Edward J

suffix: III

family: Bue-Valleskey

full_name: Juliana M Bue-Valleskey

given: Juliana M

family: Chang

full_name: Annette M Chang

given: Annette M

family: Haupt

full_name: Axel Haupt

given: Axel

family: Jacober

full_name: Scott J Jacober

given: Scott J

family: Konrad

full_name: Robert J Konrad

given: Robert J

full_name: Qianyi Zhang

given: Qianyi

family: Hoogwerf

full_name: Byron J Hoogwerf

given: Byron J

journal_name: Journal of Investigative Medicine

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.

family: Orchard

full_name: Trevor J. Orchard

given: Trevor J.

family: Cariou

full_name: Bertrand Cariou

given: Bertrand

family: Connelly

full_name: Margery A. Connelly

given: Margery A.

family: Otvos

full_name: James D. Otvos

given: James D.

family: Antalis

full_name: Caryl J. Antalis

given: Caryl J.

family: Ivanyi

full_name: Tibor Ivanyi

given: Tibor

full_name: Byron J. Hoogwerf

given: Byron J.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

ReferenceCitation: Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.

name: Division of Endocrinology, Diabetes and Metabolism; University of Florida; Gainesville Florida

name: Virginia Commonwealth University Medical Center; Richmond Virginia

name: Eli Lilly and Company, Lilly Corporate Center; Indianapolis Indiana

location_country:
United States
Brazil
South Africa
Sweden
Netherlands
Spain
Croatia
France
Greece
Israel
Lithuania
Poland
Ireland
Belgium
Australia
New Zealand
Slovakia
Denmark
Canada
United Kingdom


title: A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC

summary: This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.

ReferenceCitation: Crinò L, Cappuzzo F, Zatloukal P, Reck M, Pesek M, Thompson JC, Ford HE, Hirsch FR, Varella-Garcia M, Ghiorghiu S, Duffield EL, Armour AA, Speake G, Cullen M. Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized, phase II study. J Clin Oncol. 2008 Sep 10;26(26):4253-60. doi: 10.1200/JCO.2007.15.0672.

name: From the Department of Medical Oncology, Perugia Hospital, Perugia; and Instituto Clinico Humanitas Istituto di Recovero e Cura a Carattere Scientifico, Rozzano, Italy; Third Faculty of Medicine, Charles University, Faculty Hospital Bulovka and Postgraduate Medical Institute, Prague; and Charles University Medical Faculty, Plzen, Czech Republic; Hospital Grobhansdorf, Groβhansdorf, Germany; Birmingham Heartlands Hospital; Queen Elizabeth Hospital, Birmingham; Cambridge University Hospitals National...

family: Crinò

full_name: Lucio Crinò

given: Lucio

family: Cappuzzo

full_name: Federico Cappuzzo

given: Federico

family: Zatloukal

full_name: Petr Zatloukal

given: Petr

family: Reck

full_name: Martin Reck

given: Martin

family: Pesek

full_name: Milos Pesek

given: Milos

family: Thompson

full_name: Joyce C. Thompson

given: Joyce C.

family: Ford

full_name: Hugo E.R. Ford

given: Hugo E.R.

family: Hirsch

full_name: Fred R. Hirsch

given: Fred R.

family: Varella-Garcia

full_name: Marileila Varella-Garcia

given: Marileila

family: Ghiorghiu

full_name: Serban Ghiorghiu

given: Serban

family: Duffield

full_name: Emma L. Duffield

given: Emma L.

family: Armour

full_name: Alison A. Armour

given: Alison A.

family: Speake

full_name: Georgina Speake

given: Georgina

family: Cullen

full_name: Michael Cullen

given: Michael

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Gefitinib Versus Vinorelbine in Chemotherapy-Naïve Elderly Patients With Advanced Non–Small-Cell Lung Cancer (INVITE): A Randomized, Phase II Study

lead_sponsor: AstraZeneca

location_country:
Italy
Brazil
South Africa
United Kingdom
France
Australia
Germany
Czech Republic
Korea, Republic of
Taiwan


ReferenceCitation: Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601. Erratum in: J Clin Oncol. 2019 Dec 1;37(34):3327.

name: Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, Grosshansdorf; Michael Thomas, Translational Lung Research Center Heidelberg, Thoraxklinik im Universitätsklinikum Heidelberg, Heidelberg, Germany; Alexander Luft, Leningrad Regional Clinical Hospital, Leningrad, Russia; Aleksandra Szczesna, Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku, Otwocku, Poland; Libor Havel, Hospital Na Bulovce, Prague, Czech Republic; Sang-We Kim, Asan Medical Center and University of Ulsan...

family: Luft

full_name: Alexander Luft

given: Alexander

family: Szczesna

full_name: Aleksandra Szczesna

given: Aleksandra

family: Havel

full_name: Libor Havel

given: Libor

family: Kim

full_name: Sang-We Kim

given: Sang-We

family: Akerley

full_name: Wallace Akerley

given: Wallace

family: Pietanza

full_name: Maria Catherine Pietanza

given: Maria Catherine

family: Wu

full_name: Yi-long Wu

given: Yi-long

family: Zielinski

full_name: Christoph Zielinski

given: Christoph

family: Thomas

full_name: Michael Thomas

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Gold

full_name: Kathryn Gold

given: Kathryn

family: Horn

full_name: Leora Horn

given: Leora

family: Aerts

full_name: Joachim Aerts

given: Joachim

family: Nakagawa

full_name: Kazuhiko Nakagawa

given: Kazuhiko

family: Lorigan

full_name: Paul Lorigan

given: Paul

family: Pieters

full_name: Anne Pieters

given: Anne

family: Kong Sanchez

full_name: Teresa Kong Sanchez

given: Teresa

family: Fairchild

full_name: Justin Fairchild

given: Justin

family: Spigel

full_name: David Spigel

given: David

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Bristol-Myers Squibb

location_country:
Peru
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain

location_facility: Southeast Nebraska Hematology & Oncology Consultants, P.C.

location_facility: Presence Medical Group Hematology Oncology

location_facility: St. Francis Medical Group Oncology And Hematology Specialist

location_facility: Regional Cancer Care Associates, LLC/Cherry Hill Division

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Signal Point Clinical Research Center, Llc

location_facility: Joe Arrington Cancer Research And Treatment Center

location_facility: University Of Texas, M. D. Anderson Cancer Center

location_facility: Chattanooga Oncology Hematology Associates

title: Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

summary: The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.


type: Registry Identifier

title: A Randomised, Double-blind, Placebo-controlled Study to Determine the Long-term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

summary: The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).

ReferenceCitation: Mayer G, Wang-Weigand S, Roth-Schechter B, Lehmann R, Staner C, Partinen M. Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia. Sleep. 2009 Mar;32(3):351-60.

ReferenceCitation: Wang-Weigand S, McCue M, Ogrinc F, Mini L. Effects of ramelteon 8 mg on objective sleep latency in adults with chronic insomnia on nights 1 and 2: pooled analysis. Curr Med Res Opin. 2009 May;25(5):1209-13. doi: 10.1185/03007990902858527 .

name: Takeda Global Research and Development Center, Lake Forest, IL, USA

family: Wang-Weigand

full_name: Sherry Wang-Weigand

given: Sherry

family: McCue

full_name: Maggie McCue

given: Maggie

family: Ogrinc

full_name: Francis Ogrinc

given: Francis

name: Takeda Pharmaceuticals North America, Deerfield, IL, USA

family: Mini

full_name: Louis Mini

given: Louis

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

lead_sponsor: Takeda

location_country:
Italy
Germany
Finland
France
Belgium
Australia
Russian Federation
United States
Czech Republic


title: A Six-Week, Randomized, Double-Blind, Quadruple-Dummy Parallel Group Multiple Dose Study Comparing the Efficacy and Safety of Tiotropium Inhalation Capsules Plus Formoterol Inhalation Capsules to Salmeterol Inhalation Aerosol Plus Fluticasone Inhalation Aerosol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: To compare the efficacy and safety of tiotropium plus formoterol in comparison to salmeterol plus fluticasone in COPD patients.

ReferenceCitation: Rabe KF, Timmer W, Sagkriotis A, Viel K. Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD. Chest. 2008 Aug;134(2):255-262. doi: 10.1378/chest.07-2138. Epub 2008 Apr 10.

family: Rabe

full_name: Klaus F. Rabe

given: Klaus F.

family: Timmer

full_name: Wolfgang Timmer

given: Wolfgang

family: Sagkriotis

full_name: Alexandros Sagkriotis

given: Alexandros

family: Viel

full_name: Klaus Viel

given: Klaus

journal_name: Chest

title: Comparison of a Combination of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Moderate COPD

location_country:
Austria
South Africa
Sweden
Netherlands
France
Belgium
Denmark
Germany

location_facility: Lung- och allergikliniken, Universitetssjukhuset

location_facility: Lung- och allergikliniken, Länssjukhuset Ryhov

location_facility: Boehringer Ingelheim Investigational Site


title: A Multicenter, Multinational, Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)

summary: This Phase 3 extension study will evaluate the long-term efficacy and safety of BMN 110 2.0 mg/kg/week and/or BMN 110 2.0 mg/kg/every other week in patients with mucopolysaccharidosis IVA (Morquio A Syndrome).

ReferenceCitation: Hendriksz CJ, Parini R, AlSayed MD, Raiman J, Giugliani R, Mitchell JJ, Burton BK, Guelbert N, Stewart FJ, Hughes DA, Matousek R, Hawley SM, Decker C, Harmatz PR. Impact of long-term elosulfase alfa on activities of daily living in patients with Morquio A syndrome in an open-label, multi-center, phase 3 extension study. Mol Genet Metab. 2018 Feb;123(2):127-134. doi: 10.1016/j.ymgme.2017.11.015. Epub 2017 Dec 5.

family: Hendriksz

full_name: Christian J. Hendriksz

given: Christian J.

family: Parini

full_name: Rossella Parini

given: Rossella

family: AlSayed

full_name: Moeenaldeen D. AlSayed

given: Moeenaldeen D.

family: Raiman

full_name: Julian Raiman

given: Julian

family: Giugliani

full_name: Roberto Giugliani

given: Roberto

family: Mitchell

full_name: John J. Mitchell

given: John J.

family: Burton

full_name: Barbara K. Burton

given: Barbara K.

family: Guelbert

full_name: Norberto Guelbert

given: Norberto

family: Stewart

full_name: Fiona J. Stewart

given: Fiona J.

family: Hughes

full_name: Derralynn A. Hughes

given: Derralynn A.

family: Matousek

full_name: Robert Matousek

given: Robert

family: Hawley

full_name: Sara M. Hawley

given: Sara M.

family: Decker

full_name: Celeste Decker

given: Celeste

family: Harmatz

full_name: Paul R. Harmatz

given: Paul R.

journal_name: Molecular Genetics and Metabolism

repository_institution: University of Pretoria - UpSpace Institutional Repository

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Hughes D, Giugliani R, Guffon N, Jones SA, Mengel KE, Parini R, Matousek R, Hawley SM, Quartel A. Clinical outcomes in a subpopulation of adults with Morquio A syndrome: results from a long-term extension study of elosulfase alfa. Orphanet J Rare Dis. 2017 May 23;12(1):98. doi: 10.1186/s13023-017-0634-0.

full_name: D. Hughes

given: D.

full_name: R. Giugliani

repositories:
PubMed Central
UCL Discovery
www.lume.ufrgs.br

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

ReferenceCitation: Long B, Tompkins T, Decker C, Jesaitis L, Khan S, Slasor P, Harmatz P, O'Neill CA, Schweighardt B. Long-term Immunogenicity of Elosulfase Alfa in the Treatment of Morquio A Syndrome: Results From MOR-005, a Phase III Extension Study. Clin Ther. 2017 Jan;39(1):118-129.e3. doi: 10.1016/j.clinthera.2016.11.017. Epub 2016 Dec 10.

location_country:
Italy
Brazil
United States
Qatar
Saudi Arabia
Netherlands
Spain
Germany
France
Japan
Norway
Argentina
Portugal
Turkey
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan
Colombia