title: Double-blind, Randomized, 8-week Placebo-controlled, and 16-week Open-label Extension Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic Sclerosis

summary:
Primary Objective:

- To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis.

Secondary Objectives:

To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor signaling markers in blood and skin;
To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the modified Rodnan Skin Score (mRSS);
To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ);
To document long term safety of SAR100842 during the extension part.

ReferenceCitation: Allanore Y, Distler O, Jagerschmidt A, Illiano S, Ledein L, Boitier E, Agueusop I, Denton CP, Khanna D. Lysophosphatidic Acid Receptor 1 Antagonist SAR100842 for Patients With Diffuse Cutaneous Systemic Sclerosis: A Double-Blind, Randomized, Eight-Week Placebo-Controlled Study Followed by a Sixteen-Week Open-Label Extension Study. Arthritis Rheumatol. 2018 Oct;70(10):1634-1643. doi: 10.1002/art.40547. Epub 2017 Nov 6.

name: Rheumatology A department; Cochin Hospital; Paris Descartes University; Paris France

family: Allanore

full_name: Yannick Allanore

given: Yannick

name: University Hospital Zurich; Zurich Switzerland

family: Distler

full_name: Oliver Distler

given: Oliver

family: Jagerschmidt

full_name: Alexandre Jagerschmidt

given: Alexandre

family: Illiano

full_name: Stephane Illiano

given: Stephane

family: Ledein

full_name: Laetitia Ledein

given: Laetitia

family: Boitier

full_name: Eric Boitier

given: Eric

family: Agueusop

full_name: Inoncent Agueusop

given: Inoncent

family: Denton

full_name: Christopher P. Denton

given: Christopher P.

family: Khanna

full_name: Dinesh Khanna

given: Dinesh

journal_name: Arthritis & Rheumatology

repository_institution: University of Michigan - Deep Blue

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

location_country:
Italy
Switzerland
France
United States
United Kingdom

location_facility:
Investigational Site Number 840004
Investigational Site Number 250003
Investigational Site Number 826002
Investigational Site Number 840001
Investigational Site Number 840008
Investigational Site Number 840003
Investigational Site Number 840006
Investigational Site Number 380001
Investigational Site Number 756001
Investigational Site Number 840002
Investigational Site Number 840007
Investigational Site Number 826001
Investigational Site Number 250001


type: EudraCT Number

title: A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis

summary: The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8:CD008227. doi: 10.1002/14651858.CD008227.pub4.

family: Somaraju

full_name: Usha Rani R Somaraju

given: Usha Rani R

sequence: additional

name: Servicio de Neumología; Hospital Nacional de Niños; San José Costa Rica

family: Solis-Moya

full_name: Arturo Solis-Moya

given: Arturo

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Taylor CJ, Thieroff-Ekerdt R, Shiff S, Magnus L, Fleming R, Gommoll C. Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. J Cyst Fibros. 2016 Sep;15(5):675-80. doi: 10.1016/j.jcf.2016.02.010. Epub 2016 Mar 21.

family: Taylor

full_name: C.J. Taylor

sequence: first

family: Thieroff-Ekerdt

full_name: R. Thieroff-Ekerdt

given: R.

family: Shiff

full_name: S. Shiff

given: S.

family: Magnus

full_name: L. Magnus

given: L.

family: Fleming

full_name: R. Fleming

family: Gommoll

full_name: C. Gommoll

given: C.

journal_name: Journal of Cystic Fibrosis

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Forest Laboratories

location_country:
Italy
France
Bulgaria
Poland
Belgium
Germany
United Kingdom

location_facility: Universitaetsklinik für Kinder- und Jugendmedizin Tuebingen

location_facility: NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii

location_facility: Azienda Ospedaliero Universitaria, Ospedali Riuniti, Ospedale Pediatrico G. Salesi

location_facility: Universitair Ziekenhuis Gent, Centrum voor Mucoviscidose

location_facility: Universita degli Studi di Roma La Sapienza, Azienda Policlinico Umberto I, Dipartimento di Pediatria, Centro Fibrosi Cistica Regione Lazio

location_facility: Ruhr-Universitaet Bochum - St. Josef Hospital

location_facility: Clinica di Malattie dell'Apparato Respiratorio

location_facility: Clinic of Paediatric Diseases at UMHAT Dr Georgi Stranski

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: Multiprofile Clinic for Specialized Pediatric Clinic at MHAT Sveta Marina

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino, Gastroenterologia Pediatrica E Fibrosi Cistica

location_facility: Specjalistyczny Zespot Opieki Zdrowotnej nad Matka i Dzieckiem Poradnia Leczenia Mukowiscydozy

location_facility: Istituto Azienda Ospedaliera Universitaria

location_facility: University Federico II of Naples, Pediatrics Department

location_facility: Universitätsklinikum Essen Zentrum f.Kinderheilkunde Klinik f.Kinderheilkunde III

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitaetsklinikum Essen gGmbH

location_facility: Wojewodzki Szpital Specjalistyczny im Kopernika

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden

location_facility: ALERGOTEST s.c Specjalistyczne Centrum Medyczne

location_facility: Azienda Ospedaliera Universitaria Integrata, Centro Fibrosi Cistica-Ospedale Civile Maggiore

location_facility: Centrum Pulmonologii i Alergologii w Karpaczu

location_facility: University Hospital Antwerp - Universitair Ziekenhuis Antwerpen (UZA)

location_facility: Sheffield Children's Hospital, The Academic Unit of Child Health

location_facility: Clinic of Genetic and Paediatric Diseases at UMHAT Sveti Georgi

location_facility: Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin

location_facility: Specialized Hospital for Active Treatment of Pulmological and Phtisiatric Disease

location_facility: Bambino Gesu Hospital, Cystic Fibrosis Unit

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: An Observational Disease and Clinical Outcomes Registry of Patients With Lysosomal Acid Lipase (LAL) Deficiency

summary: This is an observational, multi-center, international disease registry designed to collect longitudinal data and create a knowledge base that will be utilized to improve the care and treatment of patients with LAL Deficiency. Participation in the Registry by both physicians and patients is voluntary.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Soll D, Spira D, Hollstein T, Haberbosch L, Demuth I, Steinhagen-Thiessen E, Bobbert T, Spranger J, Kassner U. Clinical outcome of a patient with lysosomal acid lipase deficiency and first results after initiation of treatment with Sebelipase alfa: A case report. Mol Genet Metab Rep. 2019 Jun 18;20:100479. doi: 10.1016/j.ymgmr.2019.100479. eCollection 2019 Sep.

apc_source: openAPC

family: Soll

full_name: Dominik Soll

given: Dominik

family: Spira

full_name: Dominik Spira

family: Hollstein

full_name: Tim Hollstein

given: Tim

family: Haberbosch

full_name: Linus Haberbosch

given: Linus

family: Demuth

full_name: Ilja Demuth

given: Ilja

family: Steinhagen-Thiessen

full_name: Elisabeth Steinhagen-Thiessen

given: Elisabeth

family: Bobbert

full_name: Thomas Bobbert

given: Thomas

family: Spranger

full_name: Joachim Spranger

given: Joachim

family: Kassner

full_name: Ursula Kassner

given: Ursula

currency_apc_doaj: USD

journal_name: Molecular Genetics and Metabolism Reports

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

ipd_sharing: No

lead_sponsor: Alexion Pharmaceuticals

location_country:
Italy
United States
Switzerland
Netherlands
France
Spain
Germany
United Kingdom

status_simplified: Ongoing


type: Other Identifier

title: A Phase 2/3, Multicenter, Open-label Clinical Study to Assess the Safety and Efficacy of BAY86-6150 in Subjects With Hemophilia A or B With Inhibitors, Composed of 2 Parts (A & B). Part A: Sequential Cohorts of Four Dose Levels of the Modified rFVIIa BAY86-6150 Assessed in a Non-controlled Dose Response Design in Acutely Bleeding Subjects and for PK/ PD in an Intra-individual Crossover Design Compared With One Fixed Dose of Eptacog Alfa in Non-bleeding Subjects. Part B: Confirmatory Study to Further Investigate the Efficacy and Safety of BAY86-6150

summary:
Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability.

The current haemophilia standard of care is to maintain FVIII activity level above 1%. Sometimes, patients can develop antibodies (so called "inhibitors") against FVIII and it is no longer effective at controlling bleeds. Bleeds in these patients are currently treated using other proteins involved in the clotting process.

The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds in "inhibitor" patients. This study consists of two parts, A and B. The purpose of part A is to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The purpose of part B is to confirm efficacy and safety of the dose found in part A in all participating patients (confirmatory part). Part B is expected to last 12-32 months.

Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study.

Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.

design_allocation: Non-Randomized

lead_sponsor: Bayer

location_country:
Romania
Australia
Russian Federation
Denmark
Taiwan
Ukraine
India
France
Japan
Poland
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Netherlands
Bulgaria
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Israel
New Zealand
Turkey


title: A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of Evolocumab (AMG145) on LDL-C in Subjects With Severe Familial Hypercholesterolemia

acronym: TAUSSIG

summary: A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Raal FJ, Hovingh GK, Blom D, Santos RD, Harada-Shiba M, Bruckert E, Couture P, Soran H, Watts GF, Kurtz C, Honarpour N, Tang L, Kasichayanula S, Wasserman SM, Stein EA. Long-term treatment with evolocumab added to conventional drug therapy, with or without apheresis, in patients with homozygous familial hypercholesterolaemia: an interim subset analysis of the open-label TAUSSIG study. Lancet Diabetes Endocrinol. 2017 Apr;5(4):280-290. doi: 10.1016/S2213-8587(17)30044-X. Epub 2017 Feb 16.

ReferenceCitation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review.

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

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

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

family: Schmidt

full_name: Amand F Schmidt

given: Amand F

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

family: Carter

full_name: John-Paul L Carter

given: John-Paul L

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

family: Pearce

full_name: Lucy S Pearce

given: Lucy S

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

family: Wilkins

full_name: John T Wilkins

given: John T

name: Medicines Discovery Catapult; Alderly Edge UK

family: Overington

full_name: John P Overington

given: John P

family: Hingorani

full_name: Aroon D Hingorani

given: Aroon D

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

family: Casas

full_name: JP Casas

given: JP

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

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

ReferenceCitation: Stein EA, Honarpour N, Wasserman SM, Xu F, Scott R, Raal FJ. Effect of the proprotein convertase subtilisin/kexin 9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia. Circulation. 2013 Nov 5;128(19):2113-20. doi: 10.1161/CIRCULATIONAHA.113.004678. Epub 2013 Sep 6.

name: From the Metabolic and Atherosclerosis Research Center, Cincinnati, OH (E.A.S.); Global Development (N.H., S.M.W., R.S.) and Biostatistics (F.X.), Amgen Inc, Thousand Oaks, CA; and Carbohydrate & Lipid Metabolism Research Unit, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa (F.J.R.).

family: Stein

full_name: Evan A. Stein

given: Evan A.

family: Honarpour

full_name: Narimon Honarpour

given: Narimon

family: Wasserman

full_name: Scott M. Wasserman

given: Scott M.

family: Xu

full_name: Feng Xu

given: Feng

family: Scott

full_name: Rob Scott

given: Rob

family: Raal

full_name: Frederick J. Raal

given: Frederick J.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Effect of the Proprotein Convertase Subtilisin/Kexin 9 Monoclonal Antibody, AMG 145, in Homozygous Familial Hypercholesterolemia

location_country:
Italy
United States
Brazil
South Africa
Hong Kong
Lebanon
Netherlands
France
Czechia
Greece
Israel
Japan
Belgium
Australia
New Zealand
Spain
Canada
United Kingdom


ReferenceCitation: Wu YL, Zhang L, Kim DW, Liu X, Lee DH, Yang JC, Ahn MJ, Vansteenkiste JF, Su WC, Felip E, Chia V, Glaser S, Pultar P, Zhao S, Peng B, Akimov M, Tan DSW. Phase Ib/II Study of Capmatinib (INC280) Plus Gefitinib After Failure of Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy in Patients With EGFR-Mutated, MET Factor-Dysregulated Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Nov 1;36(31):3101-3109. doi: 10.1200/JCO.2018.77.7326. Epub 2018 Aug 29. Erratum in: J Clin Oncol. 2019 Jan 20;37(3):261.

name: Yi-Long Wu, Guangdong General Hospital and Guangdong Academy of Medical Sciences; Li Zhang, Sun Yat-sen University Cancer Center, Guangdong; Xiaoqing Liu, Affiliated Hospital of the Chinese Academy of Military Medical Sciences, Beijing; Sylvia Zhao and Bin Peng, Novartis Institutes for Biomedical Research, Shanghai, People’s Republic of China; Dong-Wan Kim, Seoul National University Hospital; Dae Ho Lee, University of Ulsan College of Medicine; Myung-Ju Ahn, Samsung Medical Center, Seoul, Republic of...

family: Wu

full_name: Yi-Long Wu

given: Yi-Long

family: Zhang

full_name: Li Zhang

given: Li

family: Kim

full_name: Dong-Wan Kim

given: Dong-Wan

family: Liu

full_name: Xiaoqing Liu

given: Xiaoqing

family: Lee

full_name: Dae Ho Lee

given: Dae Ho

family: Yang

full_name: James Chih-Hsin Yang

given: James Chih-Hsin

family: Ahn

full_name: Myung-Ju Ahn

given: Myung-Ju

family: Vansteenkiste

full_name: Johan F. Vansteenkiste

given: Johan F.

family: Su

full_name: Wu-Chou Su

given: Wu-Chou

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Chia

full_name: Vincent Chia

given: Vincent

family: Glaser

full_name: Sabine Glaser

given: Sabine

family: Pultar

full_name: Philippe Pultar

given: Philippe

family: Zhao

full_name: Sylvia Zhao

given: Sylvia

family: Peng

full_name: Bin Peng

given: Bin

family: Akimov

full_name: Mikhail Akimov

given: Mikhail

family: Tan

full_name: Daniel S.W. Tan

given: Daniel S.W.

journal_name: Journal of Clinical Oncology

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

publisher: American Society of Clinical Oncology (ASCO)

title: Phase Ib/II Study of Capmatinib (INC280) Plus Gefitinib After Failure of Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy in Patients With EGFR-Mutated, MET Factor–Dysregulated Non–Small-Cell Lung Cancer

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Netherlands
Spain
France
Japan
Thailand
Israel
Singapore
Belgium
Australia
China
Germany
Korea, Republic of
Taiwan

ipd_sharing: Yes

source: euctr

title: A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment

summary: This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.


title: The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.

summary: The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

ReferenceCitation: Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen FEG, Jaff MR, Guo J, Dobranszki R, Zeller T; IN.PACT Global Investigators. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25.

name: Department of Vascular Surgery, St Franziskus-Hospital Münster, Germany

family: Torsello

full_name: Giovanni Torsello

given: Giovanni

name: Department of Vascular Surgery, Ludwig-Maximilians-University Hospital Munich, Germany

family: Stavroulakis

full_name: Konstantinos Stavroulakis

given: Konstantinos

family: Brodmann

full_name: Marianne Brodmann

given: Marianne

name: Department of Cardiology, Humanitas Gavazzeni Hospital, Bergamo, Italy

family: Micari

full_name: Antonio Micari

given: Antonio

name: Institute of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany

family: Tepe

full_name: Gunnar Tepe

given: Gunnar

name: Vascular Surgery and Transplant Unit, University of Catania, Italy

family: Veroux

full_name: Pierfrancesco Veroux

given: Pierfrancesco

name: Division of Interventional Radiology, Faculté de Medecine, Université de Sherbrooke, Quebec, Canada

family: Benko

full_name: Andrew Benko

given: Andrew

name: Department of Internal Medicine, Yonsei University Hospital, Seoul, South Korea

family: Choi

full_name: Donghoon Choi

given: Donghoon

name: Department of Vascular Surgery, Ghent University Hospital, Gent, Belgium

family: Vermassen

full_name: Frank E. G. Vermassen

given: Frank E. G.

family: Jaff

full_name: Michael R. Jaff

given: Michael R.

family: Guo

full_name: Jia Guo

given: Jia

name: Medtronic, Bakken Research Center BV, Maastricht, Netherlands

family: Dobranszki

full_name: Reka Dobranszki

given: Reka

name: Universitäts-Herzzentrum Freiburg–Bad Krozingen, Bad Krozingen, Germany

family: Zeller

full_name: Thomas Zeller

given: Thomas

family: Peeters

full_name: Patrick Peeters

given: Patrick

family: Scheinert

full_name: Dierk Scheinert

given: Dierk

family: Bosiers

full_name: Marc Bosiers

given: Marc

family: Maene

full_name: Lieven Maene

given: Lieven

family: Do

full_name: Dai-Do Do

given: Dai-Do

family: Hendriks

full_name: Jeroen Hendriks

given: Jeroen

family: Keirse

full_name: Koen Keirse

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_normalized: HELDA - Digital Repository of the University of Helsinki

ReferenceCitation: Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieché C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.

ReferenceCitation: Reijnen MMPJ, van Wijck I, Zeller T, Micari A, Veroux P, Keirse K, Lee SW, Li P, Voulgaraki D, Holewijn S. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. 2019 Jun;26(3):305-315. doi: 10.1177/1526602819839044. Epub 2019 Apr 1.

name: Department of Vascular Surgery, Rijnstate, Arnhem, the Netherlands

name: University Heart Center Freiburg–Bad Krozingen, Bad Krozingen, Germany

name: Department of Cardiology, Humanitas Gavazzeni, Bergamo, Italy

name: Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

name: Medtronic, Bakken Research Center BV, Maastricht, the Netherlands

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

ReferenceCitation: Tepe G, Micari A, Keirse K, Zeller T, Scheinert D, Li P, Schmahl R, Jaff MR; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):484-493. doi: 10.1016/j.jcin.2018.12.004.

ReferenceCitation: Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25. Review. Erratum in: J Am Coll Cardiol. 2019 Feb 28;:.

journal_name: Journal of the American College of Cardiology

title: Mortality Not Correlated With Paclitaxel Exposure

ReferenceCitation: Zeller T, Brodmann M, Micari A, Keirse K, Peeters P, Tepe G, Scheinert D, Jaff MR, Rocha-Singh KJ, Li P, Schmahl R, Ansel GM; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain. Circ Cardiovasc Interv. 2019 Jan;12(1):e007730. doi: 10.1161/CIRCINTERVENTIONS.118.007730.

name: Universitäts-Herzzentrum Freiburg—Bad Krozingen, Germany (T.Z.).

name: Division of Angiology, Department of Internal Medicine, Medical University, Graz, Austria (M.B.).

name: GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.).

name: Department of Vascular Surgery, Regional Hospital Heilig Hart Tienen, Belgium (K.K.).

name: Imelda Hospital, Bonheiden, Belgium (P.P.).

name: RoMed Klinikum, Department of Diagnostic and Interventional Radiology, Rosenheim, Germany (G.T.).

name: Division of Interventional Angiology, University Hospital Leipzig, Germany (D.S.).

name: Massachusetts General Hospital, Boston (M.R.J.).

name: Prairie Heart Institute, Springfield, IL (K.J.R.-S.).

name: Medtronic, Bakken Research Center BV, Maastrict, the Netherlands (R.S.).

name: Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.).

name: For the IN.PACT Global Study Investigators

ReferenceCitation: Banerjee S, Khalili H. Drug-Coated Balloon for Long Femoropopliteal Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007084. doi: 10.1161/CIRCINTERVENTIONS.118.007084.

name: Veterans Affairs North Texas Health Care System, Dallas. University of Texas Southwestern Medical Center, Dallas.

title: Drug-Coated Balloon for Long Femoropopliteal Lesions

ReferenceCitation: Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. 2018 Oct;11(10):e005654. doi: 10.1161/CIRCINTERVENTIONS.117.005654.

name: Department of Angiology, University Hospital Leipzig, Germany (D.S.).

name: Division of Angiology, Medical University, Graz, Austria (M.B.).

name: RoMed Klinikum, Rosenheim, Germany (G.T.).

name: Medtronic, Bakken Research Center, BV, Maastricht, the Netherlands (R.S.).

name: Universitäts-Herzzentrum Freiburg – Bad Krozingen, Bad Krozingen, Germany (T.Z.).

name: on behalf of the IN.PACT Global Study Investigators

ReferenceCitation: Ansel GM, Brodmann M, Keirse K, Micari A, Jaff MR, Rocha-Singh K, Fernandez EJ, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study. J Endovasc Ther. 2018 Dec;25(6):673-682. doi: 10.1177/1526602818803119. Epub 2018 Oct 3.

name: Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus, OH, USA

name: Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria

name: Department of Vascular Surgery, Regional Hospital Heilig Hart, Tienen, Belgium

name: Newton-Wellesley Hospital, Newton, MA, USA

name: Prairie Heart Institute, Springfield, IL, USA

name: for the IN.PACT Global Study Investigators

ReferenceCitation: Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repositories_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: Università Cattolica del Sacro Cuore - PubliCatt

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
France
Poland
Lithuania
Slovakia
Argentina
Canada
Slovenia
Korea, Republic of
Colombia
Sweden
Switzerland
Netherlands
Singapore
Hungary
Portugal
Germany
United Kingdom
Italy
Austria
Czechia
Israel
Egypt

location_facility: Centre hospitalier universitaire Sherbrooke (CHUS)

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)

location_facility: Les Hospitaux Universitaires de Strasbourg

location_facility: Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)

location_facility: City Clinical Hospital named after M.E. Zhadkevich

location_facility: Helsingin Seudun Yliopistollinen Keskussairaala

location_facility: Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)

location_facility: Ziekenhuis Oost Limburg - Campus St.-Jan

location_facility: Rabin Medical Center - Beilison Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2


title: Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

acronym: RENEW

summary: Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System

status: Terminated

ReferenceCitation: Hartman JE, Shah PL, Sciurba F, Herth FJF, Slebos DJ; RENEW Study Group. Endobronchial coils for emphysema: Dual mechanism of action on lobar residual volume reduction. Respirology. 2020 Nov;25(11):1160-1166. doi: 10.1111/resp.13816. Epub 2020 Apr 8.

name: Department of Pulmonary diseases, University Medical Center Groningen University of Groningen  Groningen The Netherlands

family: Hartman

full_name: Jorine E. Hartman

given: Jorine E.

name: Royal Brompton and Harefield NHS Trust Chelsea and Westminster Hospital and Imperial College  London UK

family: Shah

full_name: Pallav L. Shah

given: Pallav L.

name: Department of medicine, division of Pulmonary, Allergy and Critical Care Medicine University of Pittsburgh School of Medicine  Pittsburgh PA USA

family: Sciurba

full_name: Frank Sciurba

given: Frank

name: Thoraxklinik and Translational Lung Research Center (TLRC) University of Heidelberg  Heidelberg Germany

family: Herth

full_name: Felix J.F. Herth

given: Felix J.F.

family: Slebos

full_name: Dirk‐Jan Slebos

given: Dirk‐Jan

full_name: F.J.F. Herth

family: Gompelmann

full_name: D. Gompelmann

given: D.

family: Schuhmann

full_name: M. Schuhmann

given: M.

family: Eberhardt

full_name: R. Eberhardt

given: R.

family: Harzheim

full_name: D. Harzheim

family: Rump

full_name: B. Rump

given: B.

full_name: D.J. Slebos

family: Ten Hacken

full_name: N. Ten Hacken

given: N.

family: Klooster

full_name: K. Klooster

given: K.

full_name: J.E. Hartman

family: Augustijn

full_name: S. Augustijn

given: S.

full_name: P.L Shah

family: Caneja

full_name: C. Caneja

given: C.

family: McNulty

full_name: W. McNulty

given: W.

family: Garner

full_name: J. Garner

given: J.

family: Deslée

full_name: G. Deslée

given: G.

family: Vallerand

full_name: H. Vallerand

given: H.

family: Dury

full_name: S. Dury

family: Gras

full_name: D. Gras

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

ReferenceCitation: Slebos DJ, Cicenia J, Sciurba FC, Criner GJ, Hartman JE, Garner J, Deslée G, Delage A, Jantz M, Marquette CH, Strange C, Hatipoglu U, Mehta AC, LaPrad AS, Schmid-Bindert G, Herth FJF, Shah PL; RENEW Study Group. Predictors of Response to Endobronchial Coil Therapy in Patients With Advanced Emphysema. Chest. 2019 May;155(5):928-937. doi: 10.1016/j.chest.2019.02.012. Epub 2019 Feb 21.

ReferenceCitation: Sciurba FC, Criner GJ, Strange C, Shah PL, Michaud G, Connolly TA, Deslée G, Tillis WP, Delage A, Marquette CH, Krishna G, Kalhan R, Ferguson JS, Jantz M, Maldonado F, McKenna R, Majid A, Rai N, Gay S, Dransfield MT, Angel L, Maxfield R, Herth FJ, Wahidi MM, Mehta A, Slebos DJ; RENEW Study Research Group. Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial. JAMA. 2016 May 24-31;315(20):2178-89. doi: 10.1001/jama.2016.6261.

name: University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania

name: Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania

name: Medical University of South Carolina, Charleston

name: National Institute for Health Research Unit, Royal Brompton and Harefield NHS Foundation Trust, Imperial College, London, England5Chelsea and Westminster Hospital, London, England

name: New York University School of Medicine, New York, New York

name: Pulmonary, Critical Care, and Sleep Medicine, Houston, Texas

name: University Hospital of Reims, INSERM U903, Reims, France

name: OSF HealthCare–Illinois Lung and Critical Care Institute, Peoria

name: Quebec Heart and Lung Institute, Quebec City, Quebec, Canada

name: University Nice Sophia Antipolis, IRCAN, ONCOAGE, Nice, France

name: Palo Alto Medical Foundation/El Camino Hospital, Mountain View, California

name: Northwestern University, Chicago, Illinois

name: University of Wisconsin School of Medicine, Madison

name: Cedars-Sinai Medical Center, Los Angeles, California

name: Beth Israel Deaconess Medical Center, Boston, Massachusetts

name: Franciscan Research Center, Tacoma, Washington

name: University of Alabama at Birmingham, Birmingham

name: New York Presbyterian Hospital/Columbia University, New York, New York

name: Thoraxklinik at the University of Heidelberg, Heidelberg, Germany

name: Duke University Medical Center, Durham, North Carolina

name: Cleveland Clinic Foundation, Cleveland, Ohio

name: University of Groningen, University Medical Center Groningen, Groningen, the Netherlands

location_country:
United States
Netherlands
France
Germany
United Kingdom
Canada

location_facility: Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital

location_facility: University of Texas Health Sciences Center at San Antonio

location_facility: El Camino Hospital/Palo Alto Medical Foundation

location_facility: Pulmonary and Critical Care Associates of Baltimore

location_facility: Yale University School of Medicine - Yale New Haven Hospital

location_facility: Royal Brompton Hospital & Chelsea Westminster

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

location_facility: New York Presbyterian Columbia University Medical Center

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Emphysema COPD Research Center, University of Pittsburgh

location_facility: University of Wisconsin School of Medicine & Public Health

location_facility: University of Alabama Lung Health Center

location_facility: University of Illinois Hospital and Health Center


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

summary: The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.

ReferenceCitation: Aletaha D, Bingham CO 3rd, Tanaka Y, Agarwal P, Kurrasch R, Tak PP, Popik S. Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled, parallel-group, multinational, phase 3 study. Lancet. 2017 Mar 25;389(10075):1206-1217. doi: 10.1016/S0140-6736(17)30401-4. Epub 2017 Feb 16. Erratum in: Lancet. 2017 May 20;389(10083):1980.

family: Aletaha

full_name: Daniel Aletaha

given: Daniel

family: Bingham

full_name: Clifton O Bingham

given: Clifton O

suffix: III

family: Tanaka

full_name: Yoshiya Tanaka

given: Yoshiya

family: Agarwal

full_name: Prasheen Agarwal

given: Prasheen

family: Kurrasch

full_name: Regina Kurrasch

given: Regina

family: Tak

full_name: Paul P Tak

given: Paul P

family: Popik

full_name: Sharon Popik

given: Sharon

journal_name: The Lancet

lead_sponsor: Janssen Research & Development, LLC

location_country:
Australia
Belgium
Russian Federation
Taiwan
Croatia
France
Japan
Lithuania
Poland
Argentina
Canada
Korea, Republic of
Netherlands
Puerto Rico
Portugal
Germany
United States
United Kingdom
Austria
Mexico
New Zealand
Spain


location_country:
United States
Hong Kong
Netherlands
France
Singapore
Australia
Canada
Korea, Republic of
Taiwan

title: A Phase Ib Dose Escalation/Randomized Phase II, Multicenter, Open-label Study of BYL719 in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

summary:
This was a multi-center, open-label, Phase Ib dose escalation /Phase II study in recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be resistant, ineligible or intolerant to platinum-based chemotherapy. The Phase Ib included three arms. Three different methods of administration and two different BYL719 formulations were studied to determine the MTD and/or RP2D of BYL719 in combination with cetuximab:

Arm A - film-coated whole tablets were orally administered to patients who were able to swallow the tablets; Arm B - a drinkable suspension prepared from crushed film-coated tablets was administered orally to patients with swallowing dysfunction Arm C - a suspension from a dispersible tablet administered via G-tube, in patients with swallowing dysfunction. Arm C was used to investigate the pharmacokinetics (PK), compared to Arm A (film coated tablet), and safety of the dispersible tablet of the dispersible tablet formulation of BYL719.

The Phase II investigated the clinical efficacy of BYL719 and consisted of an open label, randomized Phase II part investigating BYL719 in combination with cetuximab compared to cetuximab alone in patients resistant or intolerant to platinum and naïve to cetuximab (Scheme 1: Arm 1 and Arm 2), and a non-randomized Phase II part Scheme 2: Arm 3. In addition, patients who experienced disease progression in Arm 2 (cetuximab) were allowed to switch to the combination regimen (cross-over, Arm 2B). The safety of the BYL719 in combination with cetuximab was also further characterized in Arms 1, 2B and 3.

Patients were treated until progression of disease), unacceptable toxicity, or withdrawal of informed consent, whichever occurred first (except for phase II Arm 2 had the opportunity to crossover to the combination treatment (Arm 2B). In the follow-up period all patients had to complete the safety follow-up assessments within 30 days after the last dose of the study treatment. Patients who did not have disease progression at the time of discontinuation of study treatment were radiologically followed for disease status until disease progression, initiation of subsequent anticancer therapies, or death, whichever occurred first. In addition, all patients enrolled in Phase II were followed for survival.

status_simplified: Unknown


title: An Open-Label Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

summary: The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.

location_country:
Italy
United States
South Africa
Serbia
Ukraine
France
Poland
Singapore
Hungary
Belgium
Australia
New Zealand
Spain
Estonia
Canada
Korea, Republic of
Colombia
Iceland

location_facility:
Forest Investigative Site 098
Forest Investigative Site 109
Forest Investigative Site 085
Forest Investigative Site 802
Forest Investigative Site 105
Forest Investigative Site 382
Forest Investigative Site 114
Forest Investigative Site 380
Forest Investigative Site 703
Forest Investigative Site 072
Forest Investigative Site 378
Forest Investigative Site 728
Forest Investigative Site 702
Forest Investigative Site 203
Forest Investigative Site 141
Forest Investigative Site 092
Forest Investigative Site 228
Forest Investigative Site 401
Forest Investigative Site 202
Forest Investigative Site 177
Forest Investigative Site 626
Forest Investigative Site 077
Forest Investigative Site 676
Forest Investigative Site 108
Forest Investigative Site 096
Forest Investigative Site 073
Forest Investigative Site 130
Forest Investigative Site 090
Forest Investigative Site 704
Forest Investigative Site 051
Forest Investigative Site 576
Forest Investigative Site 028
Forest Investigative Site 381
Forest Investigative Site 067
Forest Investigative Site 021
Forest Investigative Site 801
Forest Investigative Site 091
Forest Investigative Site 526
Forest Investigative Site 124
Forest Investigative Site 082
Forest Investigative Site 066
Forest Investigative Site 119
Forest Investigative Site 075
Forest Investigative Site 065
Forest Investigative Site 577
Forest Investigative Site 376
Forest Investigative Site 086
Forest Investigative Site 329
Forest Investigative Site 651
Forest Investigative Site 002
Forest Investigative Site 453
Forest Investigative Site 023
Forest Investigative Site 627
Forest Investigative Site 113
Forest Investigative Site 080
Forest Investigative Site 074
Forest Investigative Site 054
Forest Investigative Site 078
Forest Investigative Site 131
Forest Investigative Site 084
Forest Investigative Site 804
Forest Investigative Site 580
Forest Investigative Site 807
Forest Investigative Site 730
Forest Investigative Site 136
Forest Investigative Site 001
Forest Investigative Site 069
Forest Investigative Site 095
Forest Investigative Site 379
Forest Investigative Site 132
Forest Investigative Site 026
Forest Investigative Site 117
Forest Investigative Site 579
Forest Investigative Site 062
Forest Investigative Site 097
Forest Investigative Site 102
Forest Investigative Site 057
Forest Investigative Site 628
Forest Investigative Site 155
Forest Investigative Site 226
Forest Investigative Site 071
Forest Investigative Site 055
Forest Investigative Site 701
Forest Investigative Site 125
Forest Investigative Site 064
Forest Investigative Site 052
Forest Investigative Site 100
Forest Investigative Site 116
Forest Investigative Site 452
Forest Investigative Site 629
Forest Investigative Site 115
Forest Investigative Site 118
Forest Investigative Site 056
Forest Investigative Site 104
Forest Investigative Site 727
Forest Investigative Site 059
Forest Investigative Site 063
Forest Investigative Site 070
Forest Investigative Site 326
Forest Investigative Site 081
Forest Investigative Site 127
Forest Investigative Site 123
Forest Investigative Site 061
Forest Investigative Site 068
Forest Investigative Site 005
Forest Investigative Site 053
Forest Investigative Site 106
Forest Investigative Site 729
Forest Investigative Site 029
Forest Investigative Site 578
Forest Investigative Site 019
Forest Investigative Site 101
Forest Investigative Site 201
Forest Investigative Site 227
Forest Investigative Site 107
Forest Investigative Site 204
Forest Investigative Site 276
Forest Investigative Site 803


title: Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies

summary: The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.

status: Active, not recruiting

ReferenceCitation: Lesokhin AM, Ansell SM, Armand P, Scott EC, Halwani A, Gutierrez M, Millenson MM, Cohen AD, Schuster SJ, Lebovic D, Dhodapkar M, Avigan D, Chapuy B, Ligon AH, Freeman GJ, Rodig SJ, Cattry D, Zhu L, Grosso JF, Bradley Garelik MB, Shipp MA, Borrello I, Timmerman J. Nivolumab in Patients With Relapsed or Refractory Hematologic Malignancy: Preliminary Results of a Phase Ib Study. J Clin Oncol. 2016 Aug 10;34(23):2698-704. doi: 10.1200/JCO.2015.65.9789. Epub 2016 Jun 6.

name: Alexander M. Lesokhin and Deepika Cattry, Memorial Sloan Kettering Cancer Center; Alexander M. Lesokhin, Weill Cornell Medical College, New York, NY; Stephen M. Ansell, Mayo Clinic, Rochester, MN; Philippe Armand, Bjoern Chapuy, Gordon J. Freeman, Scott J. Rodig, and Margaret A. Shipp, Dana-Farber Cancer Institute; David Avigan, Beth Israel Deaconess Medical Center; Azra H. Ligon and Scott J. Rodig, Brigham and Women’s Hospital, Boston, MA; Emma C. Scott, Oregon Health & Science University Knight Cancer...

family: Lesokhin

full_name: Alexander M. Lesokhin

given: Alexander M.

family: Ansell

full_name: Stephen M. Ansell

given: Stephen M.

family: Armand

full_name: Philippe Armand

given: Philippe

family: Scott

full_name: Emma C. Scott

given: Emma C.

family: Halwani

full_name: Ahmad Halwani

given: Ahmad

family: Gutierrez

full_name: Martin Gutierrez

given: Martin

family: Millenson

full_name: Michael M. Millenson

given: Michael M.

family: Cohen

full_name: Adam D. Cohen

given: Adam D.

family: Schuster

full_name: Stephen J. Schuster

given: Stephen J.

family: Lebovic

full_name: Daniel Lebovic

family: Dhodapkar

full_name: Madhav Dhodapkar

given: Madhav

family: Avigan

full_name: David Avigan

given: David

family: Chapuy

full_name: Bjoern Chapuy

given: Bjoern

family: Ligon

full_name: Azra H. Ligon

given: Azra H.

family: Freeman

full_name: Gordon J. Freeman

given: Gordon J.

family: Rodig

full_name: Scott J. Rodig

given: Scott J.

family: Cattry

full_name: Deepika Cattry

given: Deepika

family: Zhu

full_name: Lili Zhu

given: Lili

family: Grosso

full_name: Joseph F. Grosso

given: Joseph F.

family: Bradley Garelik

full_name: M. Brigid Bradley Garelik

given: M. Brigid

family: Shipp

full_name: Margaret A. Shipp

given: Margaret A.

family: Borrello

full_name: Ivan Borrello

given: Ivan

family: Timmerman

full_name: John Timmerman

given: John

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med. 2015 Jan 22;372(4):311-9. doi: 10.1056/NEJMoa1411087. Epub 2014 Dec 6.

title: PD-1 Blockade with Nivolumab in Relapsed or Refractory Hodgkin's Lymphoma

location_country:
Italy
France
Poland
Greece
Belgium
United States

location_facility: Huntsman Cancer Institute At The Univ. Of Utah

location_facility: OHSU Center for Hematologic Malignancies

location_facility: Oddzial Hematologii i Transplantacji Szpiku

location_facility: Indiana University Melvin & Bren Simon Cancer Center

location_facility: Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: The Sidney Kimmel Comprehensive Cancer Center

location_facility: Klinika Hematologii Instytutu Hematologii I Transfuzjologii

location_facility: Division Of Hematology & Oncology Ctr. For Health Sciences


title: 2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

acronym: TESLA

summary: A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

ReferenceCitation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review.

ReferenceCitation: Raal FJ, Honarpour N, Blom DJ, Hovingh GK, Xu F, Scott R, Wasserman SM, Stein EA; TESLA Investigators. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jan 24;385(9965):341-50. doi: 10.1016/S0140-6736(14)61374-X. Epub 2014 Oct 1.

family: Raal

full_name: Frederick J Raal

given: Frederick J

family: Honarpour

full_name: Narimon Honarpour

given: Narimon

family: Blom

full_name: Dirk J Blom

given: Dirk J

family: Hovingh

full_name: G Kees Hovingh

given: G Kees

family: Xu

full_name: Feng Xu

given: Feng

family: Scott

full_name: Rob Scott

given: Rob

family: Wasserman

full_name: Scott M Wasserman

given: Scott M

family: Stein

full_name: Evan A Stein

given: Evan A

ReferenceCitation: Stein EA, Honarpour N, Wasserman SM, Xu F, Scott R, Raal FJ. Effect of the proprotein convertase subtilisin/kexin 9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia. Circulation. 2013 Nov 5;128(19):2113-20. doi: 10.1161/CIRCULATIONAHA.113.004678. Epub 2013 Sep 6.

name: From the Metabolic and Atherosclerosis Research Center, Cincinnati, OH (E.A.S.); Global Development (N.H., S.M.W., R.S.) and Biostatistics (F.X.), Amgen Inc, Thousand Oaks, CA; and Carbohydrate & Lipid Metabolism Research Unit, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa (F.J.R.).

full_name: Evan A. Stein

given: Evan A.

full_name: Scott M. Wasserman

given: Scott M.

full_name: Frederick J. Raal

given: Frederick J.

journal_name: Circulation

oa_host_type: publisher

evidence: open (via free pdf)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Amgen

location_country:
Italy
United States
South Africa
Hong Kong
Lebanon
Netherlands
France
Czechia
Belgium
New Zealand
Spain
Canada


title: A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma

acronym: SOURCE

summary: This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.

ReferenceCitation: Jones RL, Chawla SP, Attia S, Schöffski P, Gelderblom H, Chmielowski B, Le Cesne A, Van Tine BA, Trent JC, Patel S, Wagner AJ, Chugh R, Heyburn JW, Weil SC, Wang W, Viele K, Maki RG. A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas. Cancer. 2019 Jul 15;125(14):2445-2454. doi: 10.1002/cncr.32084. Epub 2019 Apr 29.

name: Seattle Cancer Care Alliance Seattle Washington

family: Jones

full_name: Robin L. Jones

given: Robin L.

name: Sarcoma Oncology Research Center Santa Monica California

family: Chawla

full_name: Sant P. Chawla

given: Sant P.

name: Mayo Clinic in Florida Jacksonville Florida

family: Attia

full_name: Steven Attia

given: Steven

name: Leuven Cancer Institute, Department of General Medical Oncology University Hospital Leuven Leuven Belgium

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

name: Department of Medical Oncology Leiden University Medical Center Leiden the Netherlands

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

name: Hematology/Oncology, Department of Medicine University of California Los Angeles Los Angeles California

family: Chmielowski

full_name: Bartosz Chmielowski

given: Bartosz

name: Department of Medicine Gustave Roussy Institute Villejuif France

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

name: Washington University in Saint Louis School of Medicine St. Louis Missouri

family: Van Tine

full_name: Brian A. Van Tine

given: Brian A.

name: Sylvester Comprehensive Cancer Center University of Miami School of Medicine Miami Florida

family: Trent

full_name: Jonathan C. Trent

given: Jonathan C.

name: The University of Texas MD Anderson Cancer Center Houston Texas

family: Patel

full_name: Shreyaskumar Patel

given: Shreyaskumar

name: Dana‐Farber Cancer Institute Boston Massachusetts

family: Wagner

full_name: Andrew J. Wagner

given: Andrew J.

name: Division of Hematology/Oncology University of Michigan Ann Arbor Michigan

family: Chugh

full_name: Rashmi Chugh

given: Rashmi

family: Heyburn

full_name: John W. Heyburn

given: John W.

family: Weil

full_name: Susan C. Weil

given: Susan C.

family: Wang

full_name: Wenquan Wang

given: Wenquan

family: Viele

full_name: Kert Viele

given: Kert

name: Monter Cancer Center/Northwell Health and Cold Spring Harbor Laboratory Long Island New York

family: Maki

full_name: Robert G. Maki

given: Robert G.

journal_name: Cancer

repositories_institution:
PubMed Central - Europe PMC
University of Michigan - Deep Blue

title: A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb‐004) in metastatic soft‐tissue sarcomas

location_country:
Italy
Netherlands
France
Belgium
Australia
United States

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: The University of North Carolina at Chapel Hill


title: A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia

summary: This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

lead_sponsor: Sunovion

location_country:
Italy
South Africa
Serbia
France
Slovakia
Russian Federation
United States

location_facility: PsychoLine s.r.o. Psychiatricka ambulancia

location_facility: Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'

location_facility: Research Unit, Department of Psychiatry Free State Psychiatric Complex

location_facility: Medical Research Group of Central Florida

location_facility: California Neuropsychopharmacolgoy Clinical Research Insitute

location_facility: Clinical Centre Vojvodine, Clinic for Psychiatry

location_facility: Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)

location_facility: Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie

location_facility: St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)

location_facility: A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4

location_facility: St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"

location_facility: Department of Psychiatry, University of Utah Health Sciences Center

location_facility: Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)

location_facility: Specialized hospital for psychiatric diseases "Sveti Vracevi"

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'

location_facility: St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1

location_facility: Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie

location_facility: Military Medical Academy, Clnic for Psychiatry

location_facility: Clinical Centre Nis, Clinic for mental health protection

location_facility: Clinical Centre Kragujevac, Clinic for psychiatry


title: Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY

acronym: REDUCE-HTN

summary: The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation device.

ReferenceType: result

ReferenceCitation: Sievert H, Schofer J, Ormiston J, Hoppe UC, Meredith IT, Walters DL, Azizi M, Diaz-Cartelle J, Cohen-Mazor M. Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. EuroIntervention. 2015 Feb;10(10):1213-20. doi: 10.4244/EIJY14M12_01.

family: Sievert

full_name: Horst Sievert

given: Horst

family: Schofer

full_name: Joachim Schofer

given: Joachim

family: Ormiston

full_name: John Ormiston

given: John

family: Hoppe

full_name: Uta C. Hoppe

given: Uta C.

family: Meredith

full_name: Ian T. Meredith

given: Ian T.

family: Walters

full_name: Darren L. Walters

given: Darren L.

family: Azizi

full_name: Michel Azizi

given: Michel

family: Diaz-Cartelle

full_name: Juan Diaz-Cartelle

given: Juan

family: Cohen-Mazor

full_name: Meital Cohen-Mazor

given: Meital

journal_name: EuroIntervention

publisher: Europa Digital & Publishing

publisher_dissemination: Europa Digital & Publishing

publisher_group: Europa Digital & Publishing

publisher_normalized: Europa Digital & Publishing

ReferenceCitation: Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323.

family: Persu

full_name: Alexandre Persu

given: Alexandre

family: Sapoval

full_name: Marc Sapoval

given: Marc

family: Monge

full_name: Matthieu Monge

given: Matthieu

family: Danse

full_name: Etienne Danse

given: Etienne

family: Hammer

full_name: Frank Hammer

given: Frank

family: Renkin

full_name: Jean Renkin

given: Jean

journal_name: Journal of Hypertension

lead_sponsor: Boston Scientific Corporation

location_country:
Austria
Switzerland
Netherlands
France
Australia
Belgium
New Zealand
Germany

location_facility: Vascular Center Berlin, Ev. Königin Elisabeth Hospital

location_facility: University Hospital of Geneva, Cardiology Center

location_facility: The Prince Charles Hospital, Cardiology Clinical Research Centre

location_facility: Saarland University Hospital Department of Internal Medicine III Non-surgical Intensive Care, Cardiology and Angiology

location_facility: CardioVascular Center, Sankt Katharinen Krakenhaus

location_facility: Monash Cardiovascular Research Centre (Monash Heart)

location_facility: Salzburger Landeskliniken Universitats Krankenhaus

location_facility: St. Vincenz Krankenhaus Abt. Kardiologie

location_facility: Hamburg University Cardiovascular Center

location_facility: Switzerland University Hospital Clinic for Cardiology

intervention_type: Device


ReferenceCitation: Tamborlane WV, Barrientos-Pérez M, Fainberg U, Frimer-Larsen H, Hafez M, Hale PM, Jalaludin MY, Kovarenko M, Libman I, Lynch JL, Rao P, Shehadeh N, Turan S, Weghuber D, Barrett T; Ellipse Trial Investigators. Liraglutide in Children and Adolescents with Type 2 Diabetes. N Engl J Med. 2019 Aug 15;381(7):637-646. doi: 10.1056/NEJMoa1903822. Epub 2019 Apr 28.

ReferenceCitation: Bensignor MO, Bomberg EM, Bramante CT, Divyalasya TVS, Hale PM, Ramesh CK, Rudser KD, Kelly AS. Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial. Pediatr Obes. 2021 Aug;16(8):e12778. doi: 10.1111/ijpo.12778. Epub 2021 Feb 25.

name: Department of Pediatrics University of Minnesota Medical School  Minneapolis Minnesota USA

name: Center for Pediatric Obesity Medicine University of Minnesota Medical School  Minneapolis Minnesota USA

family: Bensignor

full_name: Megan O. Bensignor

given: Megan O.

family: Bomberg

full_name: Eric M. Bomberg

given: Eric M.

name: Division of General Internal Medicine University of Minnesota Medical School  Minneapolis Minnesota USA

family: Bramante

full_name: Carolyn T. Bramante

given: Carolyn T.

family: Divyalasya

full_name: T. V. S. Divyalasya

given: T. V. S.

name: Novo Nordisk Inc.  Plainsboro New Jersey USA

family: Hale

full_name: Paula M. Hale

given: Paula M.

family: Ramesh

full_name: Chethana K. Ramesh

given: Chethana K.

name: Division of Biostatistics University of Minnesota School of Public Health  Minneapolis Minnesota USA

family: Rudser

full_name: Kyle D. Rudser

given: Kyle D.

family: Kelly

full_name: Aaron S. Kelly

given: Aaron S.

journal_name: Pediatric Obesity

license: cc-by

license_normalized: cc-by

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
North Macedonia
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
Morocco
Spain
Croatia
France
Poland
Thailand
Norway
Canada
Sweden
Netherlands
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Lebanon
Mexico
Israel
Egypt
New Zealand
Turkey

acronym: Ellipse™

type: Registry Identifier

title: Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

summary: This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.


title: A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) for Previously Treated Chronic Lymphocytic Leukemia A Companion Trial to Study GS-US-312-0116: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia

summary: The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.

ReferenceCitation: Coutre SE, Furman RR, Sharman, JP, Cheson BD, Pagel JM, Hillmen P, et al. Second Interim Analysis of a Phase 3 Study of Idelalisib (Zydelig®) Plus Rituximab for Relapsed Chronic Lymphocytic Leukemia: Efficacy Analysis in Patient Subpopulations with Del(17p) and Other Adverse Prognostic Factors. Blood 2014; 124 (21):330

ReferenceCitation: Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, et al. Efficacy of Idelalisib in CLL Subpopulations Harboring Del(17p) and Other Adverse Prognostic Factors: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Trial [Poster 7011]. American Society of Clinical Oncology (ASCO) 50th Annual Meeting; 2014 May 30-June 3; Chicago, IL. J Clin Oncol 32:5s, 2014 (suppl; abstr 7011)

ReferenceCitation: Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn IW, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Tausch E, Cramer P, Huang J, Mitra S, Hallek M, O'Brien SM, Stilgenbauer S. Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia. J Clin Oncol. 2019 Jun 1;37(16):1391-1402. doi: 10.1200/JCO.18.01460. Epub 2019 Apr 17.

name: Willamette Valley Cancer Institute and Research Center, US Oncology Research, Springfield, OR

family: Sharman

full_name: Jeff P. Sharman

given: Jeff P.

name: Stanford School of Medicine, Stanford, CA

family: Coutre

full_name: Steven E. Coutre

given: Steven E.

name: Weill Cornell Medical College, New York, NY

family: Furman

full_name: Richard R. Furman

given: Richard R.

name: Georgetown University Hospital, Washington DC

family: Cheson

full_name: Bruce D. Cheson

given: Bruce D.

family: Pagel

full_name: John M. Pagel

given: John M.

name: St James’s University Hospital, Leeds, United Kingdom

family: Hillmen

full_name: Peter Hillmen

given: Peter

name: Zucher School of Medicine at Hofstra/Northwell, New Hyde Park, NY

family: Barrientos

full_name: Jacqueline C. Barrientos

given: Jacqueline C.

name: Memorial Sloan Kettering Cancer Center, New York, NY

family: Zelenetz

full_name: Andrew D. Zelenetz

given: Andrew D.

name: University of California, San Diego, Moores Cancer Center, La Jolla, CA

family: Kipps

full_name: Thomas J. Kipps

given: Thomas J.

name: Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN

family: Flinn

full_name: Ian W. Flinn

given: Ian W.

name: Università Vita-Salute San Raffaele and Istituto Di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy

family: Ghia

full_name: Paolo Ghia

given: Paolo

name: David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA

family: Eradat

full_name: Herbert Eradat

given: Herbert

name: Venice Regional Bayfront Health, Venice, FL

family: Ervin

full_name: Thomas Ervin

given: Thomas

name: Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY

family: Lamanna

full_name: Nicole Lamanna

given: Nicole

name: Centre Hospitalier Lyon-Sud, Pierre Benite, France

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

name: University of Liverpool, Liverpool, United Kingdom

family: Pettitt

full_name: Andrew R. Pettitt

given: Andrew R.

name: Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL

family: Ma

full_name: Shuo Ma

given: Shuo

family: Tausch

full_name: Eugen Tausch

given: Eugen

name: University Hospital of Cologne, Cologne, Germany

family: Cramer

full_name: Paula Cramer

given: Paula

family: Huang

full_name: Julie Huang

given: Julie

family: Mitra

full_name: Siddhartha Mitra

given: Siddhartha

family: Hallek

full_name: Michael Hallek

given: Michael

name: University of California, Irvine, Orange, CA

family: O’Brien

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

location_country:
Italy
United States
France
Germany
United Kingdom

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: University of California, San Diego - Moores Cancer Center

location_facility: Rocky Mountain Blood and Marrow Transplant Program

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Hämatologische und Internistische Gemeinschaftspraxis Dres. Eckart / Häcker


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Polysomnography Study to Investigate Safety and Efficacy of the Rotigotine Transdermal Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis

summary:
This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.

The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigotine on quality of life and sleep.

lead_sponsor: UCB BIOSCIENCES GmbH

location_country:
Italy
Austria
Germany
Finland
France
United States


title: Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry

acronym: ANCHOR

summary:
The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study.

Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure.

Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS guidance.

ReferenceCitation: Jordan WD Jr, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Ouriel K, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry (ANCHOR) Workgroup Members. Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy. J Vasc Surg. 2014 Oct;60(4):885-92.e2. doi: 10.1016/j.jvs.2014.04.063. Epub 2014 Jul 31.

family: Jordan

full_name: William D. Jordan

given: William D.

suffix: Jr.

family: Mehta

full_name: Manish Mehta

given: Manish

family: Varnagy

full_name: David Varnagy

given: David

family: Moore

full_name: William M. Moore

given: William M.

family: Arko

full_name: Frank R. Arko

given: Frank R.

family: Joye

full_name: James Joye

given: James

family: Ouriel

full_name: Kenneth Ouriel

given: Kenneth

family: de Vries

full_name: Jean-Paul de Vries

given: Jean-Paul

full_name: Jean Paul de Vries

given: Jean Paul

family: Eckstein

full_name: H.H. Eckstein

family: van Herwaarden

full_name: Joost van Herwaarden

given: Joost

family: Bove

full_name: Paul Bove

given: Paul

family: Bohannon

full_name: William Bohannon

given: William

family: Fioole

full_name: Bram Fioole

given: Bram

family: Setacci

full_name: Carlo Setacci

given: Carlo

family: Resch

full_name: Timothy Resch

given: Timothy

family: Riambau

full_name: Vicente Riambau

given: Vicente

family: Scheinert

full_name: Dierk Scheinert

given: Dierk

family: Schmidt

full_name: Andrej Schmidt

given: Andrej

family: Clair

full_name: Daniel Clair

ReferenceCitation: Jordan WD Jr, Mehta M, Ouriel K, Arko FR, Varnagy D, Joye J, Moore WM Jr, de Vries JP. One-year results of the ANCHOR trial of EndoAnchors for the prevention and treatment of aortic neck complications after endovascular aneurysm repair. Vascular. 2016 Apr;24(2):177-86. doi: 10.1177/1708538115590727. Epub 2015 Jun 10.

name: University of Alabama-Birmingham, Birmingham, AL, USA

name: Carolinas Medical Center, Charlotte, NC, USA

name: Vascular Institute of Central Florida, Orlando, FL, USA

name: El Camino Hospital, Mountain View, CA, USA

name: Lexington Medical Center, Lexington, SC, USA

name: St. Antonius Hospital, Nieuwegein, The Netherlands

ReferenceCitation: van Noort K, Vermeulen JJM, Goudeketting SR, Ouriel K, Jordan WD Jr, Panneton JM, Slump CH, de Vries JPM. Sustainability of Individual EndoAnchor Implants in Therapeutic Use to Treat Type Ia Endoleak After Endovascular Aneurysm Repair. J Endovasc Ther. 2019 Jun;26(3):369-377. doi: 10.1177/1526602819837753. Epub 2019 Mar 25.

name: Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands

name: MIRA Institute of Biomedical Technology and Technical Medicine, University of Twente, Enschede, the Netherlands

name: Department of Vascular Surgery, Emory University School of Medicine, Atlanta, GA, USA

name: Division of Vascular Surgery, Eastern Virginia Medical School, Norfolk, VA, USA

name: Department of Surgery, Division of Vascular Surgery, University Medical Centre Groningen, the Netherlands

ReferenceCitation: Arko FR 3rd, Stanley GA, Pearce BJ, Henretta JP, Fugate MW, Mehta M, Torsello G, Panneton JM, Garrett HE Jr. Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. J Vasc Surg. 2019 Sep;70(3):732-740. doi: 10.1016/j.jvs.2018.11.033. Epub 2019 Mar 6.

ReferenceCitation: Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. J Vasc Surg. 2018 Jun;67(6):1699-1707. doi: 10.1016/j.jvs.2017.10.059. Epub 2017 Dec 18.

ReferenceCitation: Jordan WD Jr, de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Henretta J. Midterm outcome of EndoAnchors for the prevention of endoleak and stent-graft migration in patients with challenging proximal aortic neck anatomy. J Endovasc Ther. 2015 Apr;22(2):163-70. doi: 10.1177/1526602815574685.

name: University of Alabama–Birmingham, Birmingham, AL, USA

name: St. Antonius Hospital, Nieuwegein, the Netherlands

title: Midterm Outcome of EndoAnchors for the Prevention of Endoleak and Stent-Graft Migration in Patients With Challenging Proximal Aortic Neck Anatomy

ReferenceCitation: Jordan WD Jr, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR. Outcome-based anatomic criteria for defining the hostile aortic neck. J Vasc Surg. 2015 Jun;61(6):1383-90.e1. doi: 10.1016/j.jvs.2014.12.063. Epub 2015 Feb 28.

ReferenceCitation: de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Jordan WD Jr; Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry ANCHOR Trial. Analysis of EndoAnchors for endovascular aneurysm repair by indications for use. J Vasc Surg. 2014 Dec;60(6):1460-7.e1. doi: 10.1016/j.jvs.2014.08.089. Epub 2014 Oct 3.

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Germany
France
Slovakia
Australia
New Zealand
Spain
United States
United Kingdom

location_facility: John L McClellan Memorial Veterans Hospital

location_facility: A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: Narodny ustav srdcovych a cievnych chorob

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: New York University Langone Medical Center

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Washington University School of Medicine, Barnes Jewish West County Hospital

location_facility: University of North Carolina (UNC) Memorial Hospital

location_facility: The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital

location_facility: Kaiser Permanente Moanalua Medical Center and Clinic

location_facility: University of California Irvine Medical Center

location_facility: Harborview Medical Center, University of Washington

location_facility: Medical University of South Carolina (MUSC)

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: Allgemeines Krankenhaus - Universitätskliniken Wien

location_facility: Unihospital San Giovanni di Dio Ruggi d'Aragona

location_facility: MedStar Georgetown University Hospital Vascular Surgery Dept.


title: An Open-label, Multicenter, Single-arm, Phase I Dose-escalation With Efficacy Tail Extension Study of Vemurafenib (RO5185426) in Pediatric Patients With Surgically Incurable and Unresectable Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations

summary: This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Chisholm JC, Suvada J, Dunkel IJ, Casanova M, Zhang W, Ritchie N, Choi Y, Park J, Das Thakur M, Simko S, Wan Rachel Tam N, Ferrari A. BRIM-P: A phase I, open-label, multicenter, dose-escalation study of vemurafenib in pediatric patients with surgically incurable, BRAF mutation-positive melanoma. Pediatr Blood Cancer. 2018 May;65(5):e26947. doi: 10.1002/pbc.26947. Epub 2018 Jan 19.

name: Children and Young People's Unit; The Royal Marsden NHS Foundation Trust; Sutton UK

family: Chisholm

full_name: Julia C. Chisholm

given: Julia C.

name: Department of Pediatric Hematology and Oncology; Children's Teaching Hospital and St. Elizabeth University; Bratislava Slovakia

family: Suvada

full_name: Jozef Suvada

given: Jozef

name: Memorial Sloan Kettering Cancer Center; New York New York

family: Dunkel

full_name: Ira J. Dunkel

given: Ira J.

name: Fondazione IRCCS Istituto Nazionale dei Tumori; Milan Italy

family: Casanova

full_name: Michela Casanova

given: Michela

name: Roche Innovation Center; New York New York

family: Zhang

full_name: Weijiang Zhang

given: Weijiang

name: Roche Products Limited; Welwyn Garden City UK

family: Ritchie

full_name: Natasha Ritchie

given: Natasha

name: Genentech; South San Francisco California

family: Choi

full_name: YounJeong Choi

given: YounJeong

family: Park

full_name: Jane Park

given: Jane

family: Das Thakur

full_name: Meghna Das Thakur

given: Meghna

family: Simko

full_name: Stephen Simko

given: Stephen

family: Wan Rachel Tam

full_name: Nga Wan Rachel Tam

given: Nga

family: Ferrari

full_name: Andrea Ferrari

given: Andrea

journal_name: Pediatric Blood & Cancer

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
France
Poland
Israel
Slovakia
Australia
Spain
Germany
United Kingdom


title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period

acronym: EDITION I

summary:
Primary Objective:

To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus

Secondary Objectives:

To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

ReferenceCitation: Riddle MC, Bolli GB, Ziemen M, Muehlen-Bartmer I, Bizet F, Home PD; EDITION 1 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014 Oct;37(10):2755-62. doi: 10.2337/dc14-0991. Epub 2014 Jul 30.

family: Riddle

full_name: Matthew C. Riddle

given: Matthew C.

family: Bolli

full_name: Geremia B. Bolli

given: Geremia B.

family: Ziemen

full_name: Monika Ziemen

given: Monika

family: Muehlen-Bartmer

full_name: Isabel Muehlen-Bartmer

given: Isabel

family: Bizet

full_name: Florence Bizet

given: Florence

family: Home

full_name: Philip D. Home

given: Philip D.

journal_name: Diabetes Care

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 2 Diabetes Using Basal and Mealtime Insulin: Glucose Control and Hypoglycemia in a 6-Month Randomized Controlled Trial (EDITION 1)

ReferenceCitation: Yale JF, Aroda VR, Charbonnel B, Sinclair AJ, Trescoli C, Cahn A, Bigot G, Merino-Trigo A, Brulle-Wohlhueter C, Bolli GB, Ritzel R. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL versus glargine 100 U/mL: A patient-level meta-analysis examining older and younger adults with type 2 diabetes. Diabetes Metab. 2020 Apr;46(2):110-118. doi: 10.1016/j.diabet.2018.10.002. Epub 2018 Oct 23.

family: Yale

full_name: J.-F. Yale

family: Aroda

full_name: V.R. Aroda

family: Charbonnel

full_name: B. Charbonnel

given: B.

family: Sinclair

full_name: A.J Sinclair

family: Trescoli

full_name: C. Trescoli

given: C.

family: Cahn

full_name: A. Cahn

given: A.

family: Bigot

full_name: G. Bigot

given: G.

family: Merino-Trigo

full_name: A. Merino-Trigo

family: Brulle-Wohlhueter

full_name: C. Brulle-Wohlhueter

full_name: G.B. Bolli

family: Ritzel

full_name: R. Ritzel

given: R.

journal_name: Diabetes & Metabolism

ReferenceCitation: Bonadonna RC, Renard E, Cheng A, Fritsche A, Cali A, Melas-Melt L, Umpierrez GE. Switching to insulin glargine 300 U/mL: Is duration of prior basal insulin therapy important? Diabetes Res Clin Pract. 2018 Aug;142:19-25. doi: 10.1016/j.diabres.2018.03.041. Epub 2018 Apr 9.

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

location_country:
South Africa
Mexico
Netherlands
Germany
Finland
France
Romania
Hungary
Latvia
Estonia
United States
Czech Republic
Canada

location_facility:
Investigational Site Number 840075
Investigational Site Number 233004
Investigational Site Number 124015
Investigational Site Number 124007
Investigational Site Number 840053
Investigational Site Number 840016
Investigational Site Number 642004
Investigational Site Number 840106
Investigational Site Number 840100
Investigational Site Number 710006
Investigational Site Number 840103
Investigational Site Number 840089
Investigational Site Number 710002
Investigational Site Number 348006
Investigational Site Number 840136
Investigational Site Number 840085
Investigational Site Number 276006
Investigational Site Number 840058
Investigational Site Number 840011
Investigational Site Number 710003
Investigational Site Number 840008
Investigational Site Number 348013
Investigational Site Number 840076
Investigational Site Number 840090
Investigational Site Number 840117
Investigational Site Number 840084
Investigational Site Number 348007
Investigational Site Number 840074
Investigational Site Number 710004
Investigational Site Number 840047
Investigational Site Number 840068
Investigational Site Number 840057
Investigational Site Number 124020
Investigational Site Number 428002
Investigational Site Number 840060
Investigational Site Number 840155
Investigational Site Number 428006
Investigational Site Number 840082
Investigational Site Number 642002
Investigational Site Number 840043
Investigational Site Number 124018
Investigational Site Number 840007
Investigational Site Number 276003
Investigational Site Number 840121
Investigational Site Number 840116
Investigational Site Number 840143
Investigational Site Number 124023
Investigational Site Number 233005
Investigational Site Number 840126
Investigational Site Number 528006
Investigational Site Number 840049
Investigational Site Number 348009
Investigational Site Number 840080
Investigational Site Number 840045
Investigational Site Number 840042
Investigational Site Number 124014
Investigational Site Number 124008
Investigational Site Number 840112
Investigational Site Number 840005
Investigational Site Number 250002
Investigational Site Number 428003
Investigational Site Number 528005
Investigational Site Number 203010
Investigational Site Number 642006
Investigational Site Number 840009
Investigational Site Number 124009
Investigational Site Number 124004
Investigational Site Number 203009
Investigational Site Number 484003
Investigational Site Number 840123
Investigational Site Number 840083
Investigational Site Number 348017
Investigational Site Number 840020
Investigational Site Number 840023
Investigational Site Number 840156
Investigational Site Number 233006
Investigational Site Number 348012
Investigational Site Number 348011
Investigational Site Number 528009
Investigational Site Number 203007
Investigational Site Number 710005
Investigational Site Number 840120
Investigational Site Number 840059
Investigational Site Number 246005
Investigational Site Number 428005
Investigational Site Number 233003
Investigational Site Number 840097
Investigational Site Number 840001
Investigational Site Number 124021
Investigational Site Number 124001
Investigational Site Number 124002
Investigational Site Number 203001
Investigational Site Number 840036
Investigational Site Number 840152
Investigational Site Number 840018
Investigational Site Number 840052
Investigational Site Number 840010
Investigational Site Number 840071
Investigational Site Number 710001
Investigational Site Number 348010
Investigational Site Number 840114
Investigational Site Number 840034
Investigational Site Number 124026
Investigational Site Number 840127
Investigational Site Number 348003
Investigational Site Number 840013
Investigational Site Number 348005
Investigational Site Number 840019
Investigational Site Number 840048
Investigational Site Number 528008
Investigational Site Number 276002
Investigational Site Number 484001
Investigational Site Number 840122
Investigational Site Number 840035
Investigational Site Number 840041
Investigational Site Number 233001
Investigational Site Number 124025
Investigational Site Number 428004
Investigational Site Number 642003
Investigational Site Number 840091
Investigational Site Number 840021
Investigational Site Number 203005
Investigational Site Number 840050
Investigational Site Number 428001
Investigational Site Number 840099
Investigational Site Number 840015
Investigational Site Number 642009
Investigational Site Number 840159
Investigational Site Number 528004
Investigational Site Number 233002
Investigational Site Number 840092
Investigational Site Number 840070
Investigational Site Number 124024
Investigational Site Number 124005
Investigational Site Number 348018
Investigational Site Number 203006
Investigational Site Number 840148
Investigational Site Number 840032
Investigational Site Number 840039
Investigational Site Number 840146
Investigational Site Number 840002
Investigational Site Number 348014
Investigational Site Number 710008
Investigational Site Number 124022
Investigational Site Number 484006
Investigational Site Number 203004
Investigational Site Number 246002
Investigational Site Number 203003
Investigational Site Number 124006
Investigational Site Number 348004
Investigational Site Number 840022
Investigational Site Number 203002
Investigational Site Number 840055
Investigational Site Number 528007
Investigational Site Number 840145
Investigational Site Number 250004
Investigational Site Number 124011
Investigational Site Number 484007
Investigational Site Number 642008
Investigational Site Number 840004
Investigational Site Number 124017
Investigational Site Number 840078
Investigational Site Number 124019
Investigational Site Number 840124
Investigational Site Number 840107
Investigational Site Number 840003
Investigational Site Number 840081
Investigational Site Number 246001
Investigational Site Number 642005
Investigational Site Number 840086
Investigational Site Number 840119
Investigational Site Number 840129
Investigational Site Number 642007
Investigational Site Number 840067
Investigational Site Number 484004
Investigational Site Number 840098
Investigational Site Number 348008
Investigational Site Number 348001
Investigational Site Number 840104
Investigational Site Number 840066
Investigational Site Number 528002
Investigational Site Number 203008
Investigational Site Number 348015
Investigational Site Number 840079
Investigational Site Number 840062
Investigational Site Number 840065
Investigational Site Number 642001
Investigational Site Number 840133
Investigational Site Number 348002
Investigational Site Number 840012
Investigational Site Number 124010
Investigational Site Number 840102
Investigational Site Number 528001


title: PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Small Vessel Sub-trial

acronym: PLATINUM SV

summary: The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions can be located in vessels that are smaller than average-sized.

ReferenceCitation: Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrié D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070.

family: Kelly

full_name: Christopher R. Kelly

given: Christopher R.

family: Teirstein

full_name: Paul S. Teirstein

given: Paul S.

family: Meredith

full_name: Ian T. Meredith

given: Ian T.

family: Farah

full_name: Bruno Farah

given: Bruno

family: Dubois

full_name: Christophe L. Dubois

given: Christophe L.

family: Feldman

full_name: Robert L. Feldman

given: Robert L.

family: Dens

full_name: Joseph Dens

given: Joseph

family: Hagiwara

full_name: Nobuhisa Hagiwara

given: Nobuhisa

family: Rabinowitz

full_name: Abram Rabinowitz

given: Abram

family: Carrié

full_name: Didier Carrié

given: Didier

family: Pompili

full_name: Vincent Pompili

given: Vincent

family: Bouchard

full_name: Alain Bouchard

given: Alain

family: Saito

full_name: Shigeru Saito

given: Shigeru

family: Allocco

full_name: Dominic J. Allocco

given: Dominic J.

family: Dawkins

full_name: Keith D. Dawkins

given: Keith D.

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

journal_name: JACC: Cardiovascular Interventions

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Teirstein PS, Meredith IT, Feldman RL, Rabinowitz AC, Cannon LA, Lee TC, Dens J, Dubois CL, Mooney MR, Pompili VJ, Saito S, Allocco DJ, Dawkins KD, Stone GW. Two-year safety and effectiveness of the platinum chromium everolimus-eluting stent for the treatment of small vessels and longer lesions. Catheter Cardiovasc Interv. 2015 Feb 1;85(2):207-15. doi: 10.1002/ccd.25565. Epub 2014 Jul 4.

name: Scripps Clinic; Division of Cardiovascular Diseases; La Jolla California

name: MonashHEART; Southern Health, Monash Medical Centre; Clayton Victoria Australia

name: Munroe Regional Medical Center; Ocala Florida

name: TexSan Heart Hospital; San Antonio Texas

name: The Cardiac & Vascular Research Center; McLaren Northern Michigan; Petoskey Michigan

name: Bakersfield Memorial Hospital; Bakersfield California

name: Department of Cardiovascular Diseases; University Hospitals Leuven; Belgium

name: Department of Cardiovascular Sciences; University of Leuven; Belgium

name: Minneapolis Heart Institute Foundation; Minneapolis Minnesota

name: Ohio State University Medical Center; Columbus Ohio

name: Shonan Kamakura General Hospital; Kanagawa Japan

name: Boston Scientific Corporation; Marlborough Massachusetts

name: Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation; New York New York

journal_name: Catheterization and Cardiovascular Interventions

ipd_sharing_description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

location_country:
France
Japan
Belgium
Australia
New Zealand
United States

location_facility: Oklahoma Foundation for Cardiovascular Research

location_facility: Lindner Center for Research and Education at The Christ Hospital

location_facility: Ohio Health Research and Innovation Institute

location_facility: Mediquest Research at Munroe Regional Medical Center

location_facility: Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation


title: A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study

summary: This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.

location_country:
South Africa
India
Serbia
France
Lithuania
Slovakia
Romania
Russian Federation
Canada
Czech Republic
Colombia
Ukraine

location_facility: PsychoLine s.r.o. Psychiatricka ambulancia

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'

location_facility: Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Dnipropetrovsk Regional Clinical Hospital named Mechnikov

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations

location_facility: Brij Psychiatry Hospital & Muskaan Research Centre

location_facility: Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)

location_facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry

location_facility: St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)

location_facility: Seskines Outpatient Clinic, Public Institution

location_facility: Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia

location_facility: Brain Mind Behavior Neuroscience Research Institute

location_facility: St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"

location_facility: Seth K M School of P G Medicine & Research

location_facility: Regional Clinical Psychiatric Hospital, Dept #11

location_facility: Vijayawada Institute of Mental Health and Neurosciences

location_facility: Pro mente sana s.r.o. Psychiaricka ambulancia

location_facility: St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1

location_facility: Crimean republican Clinical Psychiatric Hospital

location_facility: Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry

location_facility: Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine

location_facility: Clinical Centre Nis, Clinic for mental health protection


title: A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors

summary: The purpose of the study is to evaluate the safety and to define the Maximal Tolerated Dose (MTD) or the Maximal Administered Dose (MAD) of oral azacitidine as a single agent and in combination with carboplatin (CBDCA) or paclitaxel protein bound particles (ABI-007,ABX) in subjects with relapsed or refractory solid tumors.

ReferenceCitation: LoRusso P, et al. A Phase Ib study of CC-486 (Oral Azacitidine) as a priming agent for carboplatin or NAB-paclitaxel in subjects with relapsed and refractory solid tumors . Presented at 25th AACR-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics, October 19-23, 2013, Boston, MA. Abstract No. A120.

lead_sponsor: Celgene

location_country:
Spain
United States
France
Netherlands

location_facility: South Texas Accelerated Research Therapeutics

location_facility: The Netherlands Cancer Instiute Antoni Van Leeuwenhoekziekenhuis

location_facility: Scottsdale Healthcare Research Institute

location_facility: Hospital General Universitario Gregorio Maranon


title: Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration

acronym: NSsaFe

summary: The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®

lead_sponsor: Guerbet

location_country:
Italy
Germany
France
Belgium
Argentina
Spain
Turkey
United States
United Kingdom
Korea, Republic of
Colombia

location_facility: University Hospital of North Staffodshire

location_facility: University of Texas Health Science Center

location_facility: Institute of Radiology and Neuroradiology

location_facility: CRC Hospital Universitari Sant Joan de Reus

location_facility: IATM (Instituto de alta tecnologia Medica de Antoquia)

location_facility: Medeniyet University Goztepe Research and Training Hospital