title: A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients With AdvanCed Gastrointestinal Stromal TUmorS Who Have Received Treatment With Prior Anticancer Therapies

acronym: INVICTUS

summary: This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients were randomized in a 2:1 ratio to ripretinib 150 mg QD or placebo

ReferenceCitation: Symcox M, Somaiah N. Ripretinib for advanced gastrointestinal stromal tumor: Plain language summary of the INVICTUS study. Future Oncol. 2021 Oct 18. doi: 10.2217/fon-2021-0803. [Epub ahead of print]

name: Patient author; GIST Support International, Doylestown, PA, USA

family: Symcox

full_name: Marina Symcox

given: Marina

name: Sarcoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

family: Somaiah

full_name: Neeta Somaiah

given: Neeta

journal_name: Future Oncology

license: cc-by-nd

license_normalized: cc-by-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, Schöffski P, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Meade J, Shi K, Ruiz-Soto R, George S, von Mehren M. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jul;21(7):923-934. doi: 10.1016/S1470-2045(20)30168-6. Epub 2020 Jun 5. Erratum in: Lancet Oncol. 2020 Jul;21(7):e341.

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Serrano

full_name: César Serrano

given: César

family: Heinrich

full_name: Michael C Heinrich

given: Michael C

family: Zalcberg

full_name: John Zalcberg

given: John

family: Bauer

full_name: Sebastian Bauer

given: Sebastian

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Jones

full_name: Robin L Jones

given: Robin L

family: Attia

full_name: Steven Attia

given: Steven

family: D'Amato

full_name: Gina D'Amato

given: Gina

family: Chi

full_name: Ping Chi

given: Ping

family: Reichardt

full_name: Peter Reichardt

given: Peter

family: Meade

full_name: Julie Meade

given: Julie

family: Shi

full_name: Kelvin Shi

given: Kelvin

family: Ruiz-Soto

full_name: Rodrigo Ruiz-Soto

given: Rodrigo

family: George

full_name: Suzanne George

given: Suzanne

family: von Mehren

full_name: Margaret von Mehren

given: Margaret

location_country:
Italy
United States
Netherlands
Germany
Finland
France
Poland
Singapore
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: Maria Sklodowska-Curie Memorial Cancer Center

location_facility: University of Southern California - Norris

location_facility: Hospitalario Universitario Virgen del Rocío


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Participants With Cisplatin Ineligible and Cisplatin Eligible Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
France
Japan
Poland
Russian Federation
Spain
Turkey
United States
Korea, Republic of
Taiwan

location_facility: Monter Cancer Center - Center for Advanced Medicine Location

location_facility: Cancer Care - Torrance Memorial Physician Network

location_facility: Winship Cancer Insitute, Emory Crawford Long Hospital

location_facility: Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: The University of Texas MD Anderson Cancer Center-merge

intervention_type: Radiation

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion

summary: The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=) 2 gram per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increases Hgb to >= 12 g/dL and obviates the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who have a recent history of blood transfusion.The purpose of Part B is to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD.

ReferenceType: result

ReferenceCitation: Alexander Röth, Wilma Barcellini, Shirley D'Sa, Yoshitaka Miyakawa, Catherine M Broome, Marc Michel, David J. Kuter, Bernd Jilma, Tor Henrik Anderson Tvedt, Stella Lin, Xiaoyu Jiang, Caroline Reuter, William Hobbs, Sigbjørn Berentsen; Inhibition of Complement C1s with Sutimlimab in Patients with Cold Agglutinin Disease (CAD): Results from the Phase 3 Cardinal Study. Blood 2019; 134 (Supplement_2): LBA-2. doi: https://doi.org/10.1182/blood-2019-132490

ReferenceType: derived

ReferenceCitation: Röth A, Barcellini W, D'Sa S, Miyakawa Y, Broome CM, Michel M, Kuter DJ, Jilma B, Tvedt THA, Fruebis J, Jiang X, Lin S, Reuter C, Morales-Arias J, Hobbs W, Berentsen S. Sutimlimab in Cold Agglutinin Disease. N Engl J Med. 2021 Apr 8;384(14):1323-1334. doi: 10.1056/NEJMoa2027760.

name: From the Department of Hematology and Stem Cell Transplantation, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany (A.R.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, Milan, Italy (W.B.); the Centre for Waldenström’s Macroglobulinaemia and Related Conditions, University College London Hospitals National Health Service Foundation Trust, London (S.D.); the Thrombosis and Hemostasis Center, Saitama...

family: Röth

full_name: Alexander Röth

given: Alexander

sequence: first

family: Barcellini

full_name: Wilma Barcellini

given: Wilma

sequence: additional

family: D’Sa

full_name: Shirley D’Sa

given: Shirley

family: Miyakawa

full_name: Yoshitaka Miyakawa

given: Yoshitaka

family: Broome

full_name: Catherine M. Broome

given: Catherine M.

family: Michel

full_name: Marc Michel

given: Marc

family: Kuter

full_name: David J. Kuter

given: David J.

family: Jilma

full_name: Bernd Jilma

given: Bernd

family: Tvedt

full_name: Tor H.A. Tvedt

given: Tor H.A.

family: Fruebis

full_name: Joachim Fruebis

given: Joachim

family: Jiang

full_name: Xiaoyu Jiang

given: Xiaoyu

family: Lin

full_name: Stella Lin

given: Stella

family: Reuter

full_name: Caroline Reuter

given: Caroline

family: Morales-Arias

full_name: Jaime Morales-Arias

given: Jaime

family: Hobbs

full_name: William Hobbs

given: William

family: Berentsen

full_name: Sigbjørn Berentsen

given: Sigbjørn

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Sutimlimab in Cold Agglutinin Disease

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Bioverativ, a Sanofi company

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Japan
Israel
Norway
Australia
Belgium
Spain
Canada
United Kingdom

location_facility: Hospital of the University of Pennsylvania

location_facility: Hospital Clinci i Provincial de Barcelona

location_facility: U.O.C. Ematologia- Policlinico "A. Gemelli"

location_facility: Univ Ulm, Inst Klin. Transfusions. Immungen

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: The Oncology Institute of Hope and Innovation

location_facility: New York Medical College at Westchester Medical Center

location_facility: St Olavs Hospital, Avdeling for blodsykdommer

intervention_type: Drug


title: Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma

summary:
RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma.

PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.

ReferenceCitation: Judson I, Verweij J, Gelderblom H, Hartmann JT, Schöffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litière S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. doi: 10.1016/S1470-2045(14)70063-4. Epub 2014 Mar 5.

family: Judson

full_name: Ian Judson

given: Ian

family: Verweij

full_name: Jaap Verweij

given: Jaap

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

family: Hartmann

full_name: Jörg T Hartmann

given: Jörg T

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Kerst

full_name: J Martijn Kerst

given: J Martijn

family: Sufliarsky

full_name: Josef Sufliarsky

given: Josef

family: Whelan

full_name: Jeremy Whelan

given: Jeremy

family: Hohenberger

full_name: Peter Hohenberger

given: Peter

family: Krarup-Hansen

full_name: Anders Krarup-Hansen

given: Anders

family: Alcindor

full_name: Thierry Alcindor

given: Thierry

family: Marreaud

full_name: Sandrine Marreaud

given: Sandrine

family: Litière

full_name: Saskia Litière

given: Saskia

family: Hermans

full_name: Catherine Hermans

given: Catherine

family: Fisher

full_name: Cyril Fisher

given: Cyril

family: Hogendoorn

full_name: Pancras C W Hogendoorn

given: Pancras C W

family: dei Tos

full_name: A Paolo dei Tos

given: A Paolo

family: van der Graaf

full_name: Winette T A van der Graaf

given: Winette T A

journal_name: The Lancet Oncology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

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

location_country:
Austria
Switzerland
Netherlands
Germany
France
Slovakia
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

location_facility: Copenhagen County Herlev University Hospital

location_facility: McGill Cancer Centre at McGill University

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Cross Cancer Institute at University of Alberta

location_facility: Aarhus Universitetshospital - Aarhus Sygehus

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

intervention_type: Procedure


title: A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne) Photodynamic Therapy in Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration

summary: This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.

ReferenceCitation: Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44.

ReferenceCitation: Kaiser PK, Brown DM, Zhang K, Hudson HL, Holz FG, Shapiro H, Schneider S, Acharya NR. Ranibizumab for predominantly classic neovascular age-related macular degeneration: subgroup analysis of first-year ANCHOR results. Am J Ophthalmol. 2007 Dec;144(6):850-857. Epub 2007 Oct 22.

ReferenceCitation: Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T; ANCHOR Study Group. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Two-year results of the ANCHOR study. Ophthalmology. 2009 Jan;116(1):57-65.e5. doi: 10.1016/j.ophtha.2008.10.018.

family: Brown

full_name: David M. Brown

given: David M.

family: Michels

full_name: Mark Michels

given: Mark

family: Kaiser

full_name: Peter K. Kaiser

given: Peter K.

family: Heier

full_name: Jeffrey S. Heier

given: Jeffrey S.

family: Sy

full_name: Judy P. Sy

given: Judy P.

family: Ianchulev

full_name: Tsontcho Ianchulev

given: Tsontcho

journal_name: Ophthalmology

title: Ranibizumab versus Verteporfin Photodynamic Therapy for Neovascular Age-Related Macular Degeneration: Two-Year Results of the ANCHOR Study

ReferenceCitation: Suñer IJ, Kokame GT, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: validation studies from two phase 3 clinical trials. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3629-35. doi: 10.1167/iovs.08-3225. Epub 2009 Feb 28.

name: From the Retina Associates of Florida, Tampa, Florida;

family: Sun~er

full_name: Ivan J. Sun~er

given: Ivan J.

name: The Retina Center at Pali Momi, University of Hawaii School of Medicine, Aiea, Hawaii;

family: Kokame

full_name: Gregg T. Kokame

given: Gregg T.

name: Genentech, Inc., South San Francisco, California; and the

family: Yu

full_name: Elaine Yu

given: Elaine

family: Ward

full_name: James Ward

given: James

family: Dolan

full_name: Chantal Dolan

given: Chantal

name: Retina Division, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.

family: Bressler

full_name: Neil M. Bressler

given: Neil M.

journal_name: Investigative Opthalmology & Visual Science

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

title: Responsiveness of NEI VFQ-25 to Changes in Visual Acuity in Neovascular AMD: Validation Studies from Two Phase 3 Clinical Trials

ReferenceCitation: Bressler NM, Chang TS, Fine JT, Dolan CM, Ward J; Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration (ANCHOR) Research Group. Improved vision-related function after ranibizumab vs photodynamic therapy: a randomized clinical trial. Arch Ophthalmol. 2009 Jan;127(1):13-21. doi: 10.1001/archophthalmol.2008.562.

journal_name: Archives of Ophthalmology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Improved Vision-Related Function After Ranibizumab vs Photodynamic Therapy

ReferenceCitation: Thach AB, Yau L, Hoang C, Tuomi L. Time to clinically significant visual acuity gains after ranibizumab treatment for retinal vein occlusion: BRAVO and CRUISE trials. Ophthalmology. 2014 May;121(5):1059-66. doi: 10.1016/j.ophtha.2013.11.022. Epub 2014 Jan 11.

family: Thach

full_name: Allen B. Thach

given: Allen B.

family: Yau

full_name: Linda Yau

given: Linda

family: Hoang

full_name: Carol Hoang

given: Carol

family: Tuomi

full_name: Lisa Tuomi

given: Lisa

title: Time to Clinically Significant Visual Acuity Gains after Ranibizumab Treatment for Retinal Vein Occlusion

ReferenceCitation: Weinberg DV, Shapiro H, Ehrlich JS. Ranibizumab treatment outcomes in phakic versus pseudophakic eyes: an individual patient data analysis of 2 phase 3 trials. Ophthalmology. 2013 Jun;120(6):1278-82. doi: 10.1016/j.ophtha.2012.11.042. Epub 2013 Feb 28.

title: Ranibizumab Treatment Outcomes in Phakic versus Pseudophakic Eyes

ReferenceCitation: Bressler NM, Chang TS, Varma R, Suñer I, Lee P, Dolan CM, Ward J, Ianchulev T, Fine J. Driving ability reported by neovascular age-related macular degeneration patients after treatment with ranibizumab. Ophthalmology. 2013 Jan;120(1):160-8. doi: 10.1016/j.ophtha.2012.07.027. Epub 2012 Sep 23.

title: Driving Ability Reported by Neovascular Age-related Macular Degeneration Patients after Treatment with Ranibizumab

ReferenceCitation: Rosenfeld PJ, Shapiro H, Ehrlich JS, Wong P; MARINA and ANCHOR Study Groups. Cataract surgery in ranibizumab-treated patients with neovascular age-related macular degeneration from the phase 3 ANCHOR and MARINA trials. Am J Ophthalmol. 2011 Nov;152(5):793-8. doi: 10.1016/j.ajo.2011.04.025. Epub 2011 Jul 26.

title: Cataract Surgery in Ranibizumab-Treated Patients With Neovascular Age-Related Macular Degeneration From the Phase 3 ANCHOR and MARINA Trials

ReferenceCitation: Rosenfeld PJ, Shapiro H, Tuomi L, Webster M, Elledge J, Blodi B; MARINA and ANCHOR Study Groups. Characteristics of patients losing vision after 2 years of monthly dosing in the phase III ranibizumab clinical trials. Ophthalmology. 2011 Mar;118(3):523-30. doi: 10.1016/j.ophtha.2010.07.011.

title: Characteristics of Patients Losing Vision after 2 Years of Monthly Dosing in the Phase III Ranibizumab Clinical Trials

ReferenceCitation: Barbazetto IA, Saroj N, Shapiro H, Wong P, Ho AC, Freund KB. Incidence of new choroidal neovascularization in fellow eyes of patients treated in the MARINA and ANCHOR trials. Am J Ophthalmol. 2010 Jun;149(6):939-946.e1. doi: 10.1016/j.ajo.2010.01.007. Epub 2010 Apr 8.

title: Incidence of New Choroidal Neovascularization in Fellow Eyes of Patients Treated in the MARINA and ANCHOR Trials

ReferenceCitation: Bressler NM, Chang TS, Suñer IJ, Fine JT, Dolan CM, Ward J, Ianchulev T; MARINA and ANCHOR Research Groups. Vision-related function after ranibizumab treatment by better- or worse-seeing eye: clinical trial results from MARINA and ANCHOR. Ophthalmology. 2010 Apr;117(4):747-56.e4. doi: 10.1016/j.ophtha.2009.09.002. Epub 2010 Mar 2.

title: Vision-Related Function after Ranibizumab Treatment by Better- or Worse-Seeing Eye

location_country:
United States
France
Hungary
Australia
Germany
Czech Republic

location_facility: Retina-Vitreous Associates Medical Group

location_facility: No. California Retina-Vitreous Associates

location_facility: Cleveland Clinic Foundation/Cole Eye Institute

location_facility: Duke Univ Medical Center/Duke Eye Center

location_facility: University of Melbourne, Department of Ophthalmology

location_facility: Semmelweis University, 1st Ophthalmological Department

location_facility: California Vitreoretinal Research Center


title: Study to Assess the Safety, Overall Tolerability, and Antiviral Activity of Brincidofovir Versus Standard of Care for Treatment of Adenovirus in High-risk Pediatric Allogeneic Hematopoietic Transplant Recipients

acronym: AdAPT

summary: This study was designed to assess the safety, overall tolerability, and antiviral activity of "short course" brincidofovir (BCV) therapy, as compared with current standard of care (SoC), for the treatment of adenovirus (AdV) infections in high-risk (i.e., T cell depleted) pediatric allogeneic hematopoietic cell transplant (HCT) recipients. A virologic response-driven approach to the duration of treatment was to be evaluated, in which subjects randomized to BCV therapy were to be treated until AdV viremia was confirmed as undetectable or until a maximum of 16 weeks of therapy, whichever occurred first. The formulation of BCV used in this study was oral tablet/suspension.

status: Terminated

ipd_sharing: No

lead_sponsor: Chimerix

location_country:
Italy
United States
Netherlands
France
Poland
Ireland
Spain
Germany
United Kingdom

location_facility: University of Washington-Seattle Childrens Hospital

location_facility: Universitatsklinik fur Kinder-und Jugendmedizin

location_facility: Uniwerstytecki Azpital Kliniczny we Wroclawiu

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Dr. von Haunersches Kinderspital, Abteilung fur Padiatrische

location_facility: Joseph M. Sanzari Childrens Hospital-Regional Cancer Care

location_facility: Newcastle-upon-Tyne Hospitals-Great Childrens Hospital

location_facility: Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Great Ormond Street Hospital for Children

location_facility: IHOPe-Institut d'Homatologie et d'Oncologie Pediatrique

intervention_type: Other

status_simplified: Unknown


title: A Randomized Controlled Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

acronym: DIAMOND-AF

summary: The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.

ReferenceType: background

ReferenceCitation: Iwasawa J, Koruth JS, Petru J, Dujka L, Kralovec S, Mzourkova K, Dukkipati SR, Neuzil P, Reddy VY. Temperature-Controlled Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Aug 1;70(5):542-553. doi: 10.1016/j.jacc.2017.06.008.

family: Iwasawa

full_name: Jin Iwasawa

given: Jin

family: Koruth

full_name: Jacob S. Koruth

given: Jacob S.

family: Petru

full_name: Jan Petru

given: Jan

family: Dujka

full_name: Libor Dujka

given: Libor

family: Kralovec

full_name: Stepan Kralovec

given: Stepan

family: Mzourkova

full_name: Katerina Mzourkova

given: Katerina

family: Dukkipati

full_name: Srinivas R. Dukkipati

given: Srinivas R.

family: Neuzil

full_name: Petr Neuzil

given: Petr

family: Reddy

full_name: Vivek Y. Reddy

given: Vivek Y.

journal_name: Journal of the American College of Cardiology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

ReferenceCitation: Kautzner J, Albenque JP, Natale A, Maddox W, Cuoco F, Neuzil P, Poty H, Getman MK, Liu S, Starek Z, Dukkipati SR, Colley BJ 3rd, Al-Ahmad A, Sidney DS, McElderry HT. A Novel Temperature-Controlled Radiofrequency Catheter Ablation System Used to Treat Patients With Paroxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2021 Mar;7(3):352-363. doi: 10.1016/j.jacep.2020.11.009. Epub 2021 Jan 27.

family: Kautzner

full_name: Josef Kautzner

given: Josef

family: Albenque

full_name: Jean-Paul Albenque

given: Jean-Paul

family: Natale

full_name: Andrea Natale

given: Andrea

family: Maddox

full_name: William Maddox

given: William

family: Cuoco

full_name: Frank Cuoco

given: Frank

family: Poty

full_name: Herve Poty

given: Herve

family: Getman

full_name: Michael K. Getman

given: Michael K.

family: Liu

full_name: Shufeng Liu

given: Shufeng

family: Starek

full_name: Zdenek Starek

given: Zdenek

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
France
Czechia
United States
Canada

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Institut Klinicke a Experimentalni Mediciny (IKEM)


title: Gemtuzumab Ozogamicin (GO) Combined With Standard Intensive Chemotherapy Versus Standard Intensive Chemotherapy Alone For Induction/Consolidation In Patients 61-75 Years Old With Previously Untreated AML: A Randomized Phase III Trial (AML-17) Of The EORTC-LG and the GIMEMA-ALWP

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combining combination chemotherapy with monoclonal antibody therapy will kill more cancer cells.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia.

ReferenceCitation: Amadori S, Suciu S, Stasi R, Salih HR, Selleslag D, Muus P, De Fabritiis P, Venditti A, Ho AD, Lübbert M, Thomas X, Latagliata R, Halkes CJ, Falzetti F, Magro D, Guimaraes JE, Berneman Z, Specchia G, Karrasch M, Fazi P, Vignetti M, Willemze R, de Witte T, Marie JP. Sequential combination of gemtuzumab ozogamicin and standard chemotherapy in older patients with newly diagnosed acute myeloid leukemia: results of a randomized phase III trial by the EORTC and GIMEMA consortium (AML-17). J Clin Oncol. 2013 Dec 10;31(35):4424-30. doi: 10.1200/JCO.2013.49.0771. Epub 2013 Oct 14.

name: Sergio Amadori and Adriano Venditti, Tor Vergata University Hospital; Paolo De Fabritiis, St Eugenio Hospital; Roberto Latagliata, University Sapienza; Paola Fazi and Marco Vignetti, Gruppo Italiano Malattie Ematologiche dell'Adulto, Roma; Franca Falzetti, University Hospital, Perugia; Domenico Magro, Pugliese Hospital, Catanzaro; Giorgina Specchia, University Hospital, Bari, Italy; Stefan Suciu and Matthias Karrasch, European Organisation for Research and Treatment of Cancer, Brussels; Dominik Selleslag...

family: Amadori

full_name: Sergio Amadori

given: Sergio

family: Suciu

full_name: Stefan Suciu

given: Stefan

family: Stasi

full_name: Roberto Stasi

given: Roberto

family: Salih

full_name: Helmut R. Salih

given: Helmut R.

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

family: Muus

full_name: Petra Muus

given: Petra

family: De Fabritiis

full_name: Paolo De Fabritiis

given: Paolo

family: Venditti

full_name: Adriano Venditti

given: Adriano

family: Ho

full_name: Anthony D. Ho

given: Anthony D.

family: Lübbert

full_name: Michael Lübbert

given: Michael

family: Thomas

full_name: Xavier Thomas

given: Xavier

family: Latagliata

full_name: Roberto Latagliata

family: Halkes

full_name: Constantijn J.M. Halkes

given: Constantijn J.M.

family: Falzetti

full_name: Franca Falzetti

given: Franca

family: Magro

full_name: Domenico Magro

given: Domenico

family: Guimaraes

full_name: José E. Guimaraes

given: José E.

family: Berneman

full_name: Zwi Berneman

given: Zwi

family: Specchia

full_name: Giorgina Specchia

given: Giorgina

family: Karrasch

full_name: Matthias Karrasch

given: Matthias

family: Fazi

full_name: Paola Fazi

given: Paola

family: Vignetti

full_name: Marco Vignetti

given: Marco

family: Willemze

full_name: Roel Willemze

given: Roel

family: de Witte

full_name: Theo de Witte

given: Theo

family: Marie

publisher: American Society of Clinical Oncology (ASCO)

title: Sequential Combination of Gemtuzumab Ozogamicin and Standard Chemotherapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia: Results of a Randomized Phase III Trial by the EORTC and GIMEMA Consortium (AML-17)

location_country: Italy Austria Netherlands France Belgium Portugal Germany

location_facility: Azienda Ospedaliera - Universitaria di Modena

location_facility: Ruprecht - Karls - Universitaet Heidelberg

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung

location_facility: Klinikum der Albert - Ludwigs - Universitaet Freiburg

location_facility: Libero Istituto Universitario Campus Bio-Medico

location_facility: Azienda Ospedale S. Luigi at University of Torino

location_facility: Azienda Ospedaliera Policlinico Paolo Giaccone

location_facility: Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi

location_facility: Istituto di Ematologia Universita - University di Sassari

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Azienda Ospedaliera Maggiore Della Carita


title: A Phase II, Randomized, Open-Label Study of Single Agent CI-1033 in Patients With Metastatic Breast Cancer

summary: CI-1033 is an experimental drug that acts as an inhibitor of erbB (EGFR) receptors, which may be involved in tumor growth. The primary objective of this study is to assess the antitumor activity of CI-1033 in patients with metastatic breast cancer. Patients with histologically confirmed metastatic (Stage IV) breast cancer and who have received no more than 2 prior cytotoxic chemotherapy regimens are eligible for this study. CI-1033 is administered orally. Patients are required to have blood tests periodically while receiving treatment and will be closely monitored throughout the study for possible side effects and response to treatment. Patients may not have received any prior treatment with other agents that target erbB receptors, including Herceptin (trastuzumab) or Iressa (gefitinib).

lead_sponsor: Pfizer

location_country:
Italy
United States
Sweden
France
Ireland
Belgium
Spain
Canada
United Kingdom


ReferenceCitation: Damask C, Chen M, Holweg CTJ, Yoo B, Millette LA, Franzese C. Defining the Efficacy of Omalizumab in Nasal Polyposis: A POLYP 1 and POLYP 2 Subgroup Analysis. Am J Rhinol Allergy. 2021 Aug 12:19458924211030486. doi: 10.1177/19458924211030486. [Epub ahead of print]

name: Lake Mary ENT and Allergy, Lake Mary, Florida

family: Damask

full_name: Cecelia Damask

given: Cecelia

name: Genentech, Inc., South San Francisco, California

name: University of California, San Francisco, California

family: Chen

full_name: Meng Chen

given: Meng

family: Holweg

full_name: Cecile T. J. Holweg

given: Cecile T. J.

family: Yoo

full_name: Bongin Yoo

given: Bongin

family: Millette

full_name: Lauren A. Millette

given: Lauren A.

name: Department of Otolaryngology, University of Missouri, MU Health Care, Columbia, Missouri

family: Franzese

full_name: Christine Franzese

given: Christine

journal_name: American Journal of Rhinology & Allergy

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3:CD013513. doi: 10.1002/14651858.CD013513.pub3.

name: Nuffield Department of Surgical Sciences; University of Oxford; Oxford UK

family: Chong

full_name: Lee-Yee Chong

given: Lee-Yee

name: Department of Otorhinolaryngology; Faculty of Medicine, Khon Kaen University; Khon Kaen Thailand

family: Piromchai

full_name: Patorn Piromchai

given: Patorn

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

family: Sharp

full_name: Steve Sharp

given: Steve

name: Department of Otolaryngology, Faculty of Medicine; Chulalongkorn University; Bangkok Thailand

family: Snidvongs

full_name: Kornkiat Snidvongs

given: Kornkiat

name: Cochrane ENT; Nuffield Department of Surgical Sciences, University of Oxford; Oxford UK

family: Webster

full_name: Katie E Webster

given: Katie E

name: Department of Medicine; Norwich Medical School, University of East Anglia; Norwich UK

family: Philpott

full_name: Carl Philpott

given: Carl

name: ENT Department; Guy's Hospital; London UK

family: Hopkins

full_name: Claire Hopkins

given: Claire

family: Burton

full_name: Martin J Burton

given: Martin J

journal_name: Cochrane Database of Systematic Reviews

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

repository_institution: University of East Anglia - UEA Digital Repository

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Biologics for chronic rhinosinusitis

ReferenceCitation: Peters AT, Han JK, Hellings P, Heffler E, Gevaert P, Bachert C, Xu Y, Chuang CC, Neupane B, Msihid J, Mannent LP, Guyot P, Kamat S. Indirect Treatment Comparison of Biologics in Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2021 Jun;9(6):2461-2471.e5. doi: 10.1016/j.jaip.2021.01.031. Epub 2021 Feb 4.

family: Peters

full_name: Anju T. Peters

given: Anju T.

family: Han

full_name: Joseph K. Han

given: Joseph K.

family: Hellings

full_name: Peter Hellings

given: Peter

family: Heffler

full_name: Enrico Heffler

given: Enrico

family: Gevaert

full_name: Philippe Gevaert

given: Philippe

journal_name: The Journal of Allergy and Clinical Immunology: In Practice

location_country:
Mexico
Finland
France
Poland
Hungary
Belgium
Russian Federation
Spain
United States
Ukraine

location_facility: Kaiser Permanente - Rancho Cordova Medical Offices

location_facility: Nouvel Hopital Civil; Pole de Pathologie Thoracique

location_facility: Clinical Research Center of Alabama, LLC

location_facility: Central Clinical Hospital With Polyclinic of President Administration of RF

location_facility: Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

location_facility: Banner University of Arizona Medical Center

location_facility: Municipal Institution "City Clinical Hospital #3"

location_facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: SI Institute of Otolaryngology n.a. Prof. O.S. Kolomiychenko

location_facility: Allergy Associates Research Center LLC - CRN

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: CHUS - H. Clinico U. de Santiago; Servicio de Otorrinonaringologia

location_facility: Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

location_facility: University of Missouri, ENT and Allergy Center of Missouri

location_facility: Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Clinical Trial of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps

summary:
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments.

Study GA39688 (POLYP 1; NCT03280550) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.


title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.

summary: Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.

status: Enrolling by invitation

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Pharmacyclics Switzerland GmbH

location_country:
Italy
United States
Sweden
Spain
France
Czechia
Poland
Hungary
Belgium
Australia
New Zealand
Russian Federation
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Northwest Cancer Specialists, Compass Oncology

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

location_facility: University of Texas MD Anderson Cancer Center

location_facility: SBI of Ryazan region "Regional Clinical Hospital"

location_facility: University College Hospitals NHS Foundation Trust

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko

location_facility: Almazov National Medical Research Centre

location_facility: Concord Repatriation General Hospital - Haematology Clinical Trials

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell

location_facility: Norton Medical Plaza II, 3991 Dutchmans Lane

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: John Theurer Cancer Center, Hackensack UMC

location_facility: Kyungpook National University Hospital (KNUH)

location_facility: Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center

location_facility: Hematology and Oncology Masaryk University Hospital Brno

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika

location_facility: University of California Los Angeles (UCLA)

location_facility: Azienda Sanitaria Universitaria Integrata Udine

location_facility: TRIO - Comprehensive Cancer Centers of Nevada


title: A Phase 2 Study of Pembrolizumab in Combination With Daratumumab (Anti CD38) in Participants With Relapsed Refractory Multiple Myeloma (rrMM)

summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with daratumumab in participants with relapsed refractory multiple myeloma (rrMM). The primary outcome measure for this study is the assessment of Objective Response Rate (ORR) in participants with rrMM.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Sweden
France
Israel
Spain
United States
Canada

location_facility: Hospital Clinico Universitario de Salamanca ( Site 0300)

location_facility: Skaenes Universitetssjukhus Lund ( Site 0500)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 0302)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0303)

location_facility: Capital Health Queen Elizabeth II Health Sciences Centre ( Site 0101)

location_facility: Hospital Clinico Universitario de Valencia ( Site 0304)

location_facility: Clinica Universitaria de Navarra ( Site 0301)

location_facility: McGill University Health Centre ( Site 0100)

location_facility: Hopital Maisonneuve-Rosemont [Montreal, Canada] ( Site 0102)

location_facility: Calgary Lab Services - Foothills Medical Centre ( Site 0105)

location_facility: CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0106)

location_facility: Emory University School of Medicine ( Site 0002)

location_facility: Karolinska Universitetssjukhuset ( Site 0501)

location_facility: CHRU Lille Hospital Claude Huriez ( Site 0200)

intervention_type: Biological


title: Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization

summary: The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in participants with new onset Pseudomonas aeruginosa respiratory tract infection.

lead_sponsor: Gilead Sciences

location_country:
Italy
Austria
Netherlands
Germany
France
Greece
Israel
Belgium
Spain
Denmark
United States
United Kingdom

location_facility: University of Mississippi Medical center

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Royal Devon and Exeter Foundation NHS Trust

location_facility: University Hospitals of Leicester NHS trust

location_facility: General Hospital of Thessaloniki,3rd Dept of Pediatrics

location_facility: Ann & Robert H Lurie Childrens Hospital of Chicago

location_facility: Barts and the London Children's Hospital

location_facility: Johns Hopkins All Children's Hospital Outpatient Care Center

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Kings College Hospital NHS foundation Trust

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Hospital Regional Universitario de Malaga

location_facility: University Hospitals of North Midlands NHS trust Royal Stoke University Hospital

location_facility: Southampton University Hospitals NHS trust, Southampton General Hospital

location_facility: USC Department of Pediatrics/Division of Pediatric Pulmonology

location_facility: Hadassah University Hospital Mount Scopus

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: University of California San Francisco (UCSF) - Benioff Children's Hospital

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Schneider Children's Medical Center of Israel

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Azienda Policlinico Umberto - Universita La Sapienza di Roma


title: A Prospective International Multicenter Phase II Study to Evaluate the Efficacy, Safety and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Previous Therapy With Checkpoint Inhibitor Treatment

acronym: IO-PAZ

summary: An international, multicenter, single arm Phase II trial to determine the efficacy, safety and quality of life of pazopanib treatment after previous therapy with immune checkpoint treatment. Approximately 100 patients will be enrolled, with approximately 40 of those patients receiving pazopanib as 2nd-line therapy. Patients will receive treatment with standard dose pazopanib until disease progression, unacceptable toxicity, pregnancy, death, discontinuation from the study treatment for any other reason or until study end. All patients will be followed for survival. Patients who discontinue treatment without documented disease progression will be followed for efficacy.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Austria
United States
Chile
Germany
France
Czechia
Hungary
Argentina
Spain
Canada
United Kingdom

location_facility:
Roswell Park Cancer Institute
Novartis Investigative Site


ReferenceCitation: van der Heijde D, Song IH, Pangan AL, Deodhar A, van den Bosch F, Maksymowych WP, Kim TH, Kishimoto M, Everding A, Sui Y, Wang X, Chu AD, Sieper J. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019 Dec 7;394(10214):2108-2117. doi: 10.1016/S0140-6736(19)32534-6. Epub 2019 Nov 12.

status: Active, not recruiting

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Finland
Belgium
Australia
Denmark
Croatia
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Czechia
New Zealand
Spain

acronym: SELECT-AXIS 1

location_facility: Okayama Saiseikai Outpatient Center Hospital /ID# 165595

location_facility: Clinical Research Ctr Reading /ID# 164876

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 164549

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 165705

location_facility: Charite - Campus Benjamin Franklin Medizinische Klinik - Rheumatologie /ID# 165153

location_facility: National Hospital Organization Osaka Minami Medical Center /ID# 164365

location_facility: National Hospital Organization Asahikawa Medical Center /ID# 164566

location_facility: Arizona Arthritis & Rheumatolo /ID# 164446

location_facility: Hanyang University Seoul Hospi /ID# 165811

location_facility: Warrington and Halton Hospitals NHS Foundation Trust /ID# 166202

location_facility: Hospital Parc de Salut del Mar /ID# 165027

location_facility: Kyunghee University Hospital at Gangdong /ID# 164569

location_facility: Norfolk and Norwich Univ Hosp /ID# 165149

location_facility: Juntendo University Koshigaya Hospital /ID# 165809

location_facility: Japanese Red Cross Okayama Hospital /ID# 164376

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 166309

location_facility: Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 164741

location_facility: Gachon University Gil Medical Center /ID# 165114

location_facility: CHRU de Montpellier - Hôpital Lapeyronie /ID# 166308

location_facility: Clinical Investigation Specialists - Skokie /ID# 164385

location_facility: University of Alberta - Division of Rheumatology /ID# 165239

location_facility: Helsinki Univ Central Hospital /ID# 165794

location_facility: Kochi Medical School Hospital /ID# 164460

location_facility: Royal National Hosp for Rheuma /ID# 165147

location_facility: Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 168313

location_facility: Rheumatology Center of San Diego /ID# 166167

location_facility: Chonnam National University Hospital /ID# 164541

location_facility: Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 168107

location_facility: Corporac Sanitaria Parc Tauli /ID# 165029

location_facility: Universitair Medisch Centrum Groningen /ID# 165681

location_facility: Centro Hospitalar Lisboa Ocidental, EPE /ID# 168312

location_facility: Chungnam National University Hospital /ID# 164561

location_facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 165238

location_facility: Revita Reumatologiai Rendelo /ID# 164724

location_facility: Colorado Arthritis Associates /ID# 164444

location_facility: Arth and Osteo Clin Brazo Valley /ID# 165194

location_facility: ETYKA-Osrodek Badan Klinicznyc /ID# 165634

location_facility: Bay Area Arthritis and Osteo /ID# 165023

location_facility: CHRU Tours - Hopital Trousseau /ID# 165109

location_facility: Diagnostic Group Integrated He /ID# 165195

location_facility: Ospedale Sant Orsola Malpighi /ID# 165692

location_facility: Tokushima University Hospital /ID# 165108

location_facility: St.Luke's International Hospital /ID# 165219

location_facility: Osaka City University Hospital /ID# 165253

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 165028

location_facility: Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 165146

location_facility: Hospital of the University of Occupational and Environmental Health /ID# 164380

location_facility: Juntendo University Hospital /ID# 164738

location_facility: Saitama Medical University Hospital /ID# 164577

location_facility: Unidade Local De Saude Do Alto Minho /ID# 168310

location_facility: Instituto Portugues De Reumatologia /ID# 168314

source: euctr

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis

summary: The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).

status_simplified: Ongoing


lead_sponsor: Castle Creek Pharmaceuticals, LLC

location_country:
Austria
Netherlands
Germany
France
Israel
Australia
United States
United Kingdom

location_facility: University of North Carolina - Chapel Hill

location_facility: Ann and Robert H. Lurie Children's Hospital of Chicago

location_facility: Children's Hospital of San Antonio ; Texas Dermatology and Laser Specialists

location_facility: CHU de NICE - Hopital de l'Archet II - Service de Dermatologie

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Medical University of South Carolina (MUSC)

location_facility: St. Thomas' Hospital - St Johns Institute of Dermatology

title: An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex

summary: Epidermolysis bullosa simplex (EBS) is a rare genetic skin disease characterized by fragility of the skin and mucous membranes resulting in painful blisters and erosions after minor trauma. The purpose of this study is to compare the efficacy of diacerein 1% ointment to vehicle ointment when applied once-daily for 8 weeks in subjects with EBS.


lead_sponsor: Actelion

location_country:
United States
Germany
France
Czechia
Poland
Australia
New Zealand
China
Denmark
Canada
United Kingdom
Taiwan

acronym: RUBATO

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Massachusetts General Hospital Heart Center

location_facility: Deutsches Herzzentrum Berlinklinik Für Angeborene Herzfehler

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn

location_facility: Providence Medical Research Providence Health Care

location_facility: The Prince Charles Hospital, Adult Congenital Heart Disease Unit

location_facility: Wojewódzki Szpital Specjalistyczny We Wrocławiu

title: Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects

summary: The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.


title: A Phase 1 Study of SY-1365, a Selective CDK7 Inhibitor, in Adult Patients With Advanced Solid Tumors

summary:
This study consists of two parts. Part 1 is a dose-escalation/safety evaluation to provisionally identify a dose and regimen of SY-1365 for further evaluation in Part 2.

Following the identification of a recommended dose and regimen from Part 1, the study entered Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients with select solid tumors, and to confirm target engagement and downstream pathway impact in patients with any solid tumor histology.

design_allocation: Non-Randomized

ReferenceCitation: Sava GP, Fan H, Coombes RC, Buluwela L, Ali S. CDK7 inhibitors as anticancer drugs. Cancer Metastasis Rev. 2020 Sep;39(3):805-823. doi: 10.1007/s10555-020-09885-8. Review.

family: Sava

full_name: Georgina P. Sava

given: Georgina P.

family: Fan

full_name: Hailing Fan

given: Hailing

family: Coombes

full_name: R. Charles Coombes

given: R. Charles

family: Buluwela

full_name: Lakjaya Buluwela

given: Lakjaya

family: Ali

full_name: Simak Ali

given: Simak

journal_name: Cancer and Metastasis Reviews

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by

license_normalized: cc-by

repository_institution: Imperial College London - Spiral

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: CDK7 inhibitors as anticancer drugs

ipd_sharing: Undecided

lead_sponsor: Syros Pharmaceuticals

location_country:
United States
Canada
France

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: South Texas Accelerated Research Therapeutics

location_facility: Women and Infants Hospital of Rhode Island

location_facility: University of Texas Southwestern Medical Center


title: A Phase I Open Label Clinical Trial Evaluating the Safety and Anti-Tumor Activity of Autologous T Cells Expressing Enhanced TCRs Specific for Alpha Fetoprotein (AFPᶜ³³²T) in HLA-A2 Positive Subjects With Advanced Hepatocellular Carcinoma (HCC) or Other AFP Expressing Tumor Types

summary:
This first time in human study is intended for men and women between 18 and 75 years of age who have advanced liver cancer which has grown or returned after being treated or another AFP expressing tumor. Those who did not tolerate or refused other therapies may also participate. The purpose of this study is to test the safety of genetically changed T cells that target alpha-fetoprotein (AFP) and find out what effects, if any, they have in subjects with liver cancer or other AFP expressing tumor types. This study is for subjects who have a blood test positive for appropriate HLA-A*02 P Group and have adequate AFP protein in blood or tumor, and whose noncancerous liver tissue has very little AFP protein (Liver only).

The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.

The manufacturing of T cells takes about 1 month to complete. The T cells will be given back to the subject through an intravenous infusion after 3 days of chemotherapy. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose.

Subjects will be hospitalized for at least 1 week after receiving their T cells back and then seen frequently by the Study Physician for the next 6 months. After that, subjects will be seen every three months. If subjects have disease progression or withdraw from the study, they will then be entered into a long-term follow up for safety monitoring. In long-term follow up, subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion and annually for the next 10 years.

status: Recruiting

lead_sponsor: Adaptimmune

location_country:
United States
United Kingdom
France
Spain

location_facility: Mayo Clinic Clinical Trial Referral Office

location_facility: Winship Cancer Institute - Emory University

location_facility: University of Maryland, Greenebaum Cancer Center

location_facility: Washington University - School of Medicine

intervention_type: Genetic


title: A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis

summary: The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Finland
Romania
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Netherlands
Hungary
Puerto Rico
United States
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain

location_facility: Szpital Uniwersytecki nr 2 im. dr J. Biziela

location_facility: Arizona Arthritis & Rheumatology Research

location_facility: Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Investigación y Biomedicina de Chihuahua, SC

location_facility: Clinica en Investigación en Reumatologia y Obesidad S.C.

location_facility: Articularis Healthcare Group, INC dba Columbia Arthritis Ctr

location_facility: Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC

location_facility: Univ of Texas Health Science Center - Houston

location_facility: Sp Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: Shanahan Rheumatology & Immunotherapy, PLLC

location_facility: KH der Barmherzigen Schwestern Wien BetriebsGesmbH

location_facility: Kyunghee University Hospital at Gangdong

location_facility: Centre hospitalier universitaire Lapeyronie

location_facility: Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Unidad de Investigacion en Enfermedades Cronico Degenerative

location_facility: Interni a revmatologicka ambulance, Inrea s.r.o.

location_facility: Centro de Alta Especialidad Reumatologia Inv del Potosi SC

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA

location_facility: Centro de Enfermedades del Higado y Aparato Digestivo

location_facility: CIR Centro de Investigacions Reumatologicas


lead_sponsor: Ultragenyx Pharmaceutical Inc

location_country:
France
Denmark
United States
United Kingdom
Canada

acronym: ASTEROID

title: Protocol Title: A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804).

summary: The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.


title: An Open Phase II, Multi Center Trial of BAY 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma

summary: Almost two-thirds of lymphoma cases are Non-Hodgkin's Lymphomas (NHL). NHL is a malignant process that affects lymphoid cells found both in the lymph nodes and extranodally. Incidence and mortality rates from NHL are highest in developed countries. While many patients with aggressive NHL are curable with initial anthracycline-containing regimens, the majority of patients will relapse or prove refractory to initial therapy. The prognosis of patients with disease recurrence following a multidrug regimen is also limited. The current protocol is designed to test the safety and efficacy of BAY 59-8862 in patients with Aggressive Refractory Non-Hodgkin's Lymphoma.

lead_sponsor: Bayer

location_country:
United States
Netherlands
France
Germany
United Kingdom
Canada


title: A Phase IIIb/IV, Randomized, Open Label, Multicenter, Pilot Trial to Explore the Safety and Tolerability of GW433908 +/- Ritonavir (1400mg Twice Daily or 700mg/100mg Twice Daily) When Used in Combination With a Zidovudine-containing Regimen (TRIZIVIR or COMBIVIR Twice Daily) Over a 24 Week Period in Antiretroviral Therapy Naive HIV-1 Infected Subjects.

summary: Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of fosamprenavir with or without ritonavir in combination TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy.

lead_sponsor: GlaxoSmithKline

location_country:
United States
United Kingdom
France


ReferenceCitation: Dore GJ, Feld JJ, Thompson A, Martinello M, Muir AJ, Agarwal K, Müllhaupt B, Wedemeyer H, Lacombe K, Matthews GV, Schultz M, Klein M, Hezode C, Mercade GE, Kho D, Petoumenos K, Marks P, Tatsch F, Dos Santos AGP, Gane E; SMART-C Study Group. Simplified monitoring for hepatitis C virus treatment with glecaprevir plus pibrentasvir, a randomised non-inferiority trial. J Hepatol. 2020 Mar;72(3):431-440. doi: 10.1016/j.jhep.2019.10.010. Epub 2019 Oct 23.

family: Dore

full_name: Gregory J. Dore

given: Gregory J.

family: Feld

full_name: Jordan J. Feld

given: Jordan J.

family: Thompson

full_name: Alex Thompson

given: Alex

family: Martinello

full_name: Marianne Martinello

given: Marianne

family: Muir

full_name: Andrew J. Muir

given: Andrew J.

family: Agarwal

full_name: Kosh Agarwal

given: Kosh

family: Müllhaupt

full_name: Beat Müllhaupt

given: Beat

family: Wedemeyer

full_name: Heiner Wedemeyer

given: Heiner

family: Lacombe

full_name: Karine Lacombe

given: Karine

family: Matthews

full_name: Gail V. Matthews

given: Gail V.

family: Schultz

full_name: Michael Schultz

given: Michael

family: Klein

full_name: Marina Klein

given: Marina

family: Hezode

full_name: Christophe Hezode

given: Christophe

family: Mercade

full_name: Gerard Estivill Mercade

given: Gerard Estivill

family: Kho

full_name: Danny Kho

given: Danny

family: Petoumenos

full_name: Kathy Petoumenos

given: Kathy

family: Marks

full_name: Philippa Marks

given: Philippa

family: Tatsch

full_name: Fernando Tatsch

given: Fernando

family: Dos Santos

full_name: Ana Gabriela Pires Dos Santos

given: Ana Gabriela Pires

family: Gane

full_name: Ed Gane

given: Ed

journal_name: Journal of Hepatology

evidence: open (via free pdf)

repository_normalized: University of Melbourne - Minerva Access

ipd_sharing_description: No individual participant data will be shared. The results of the project will be presented at scientific meetings, and published in peer reviewed scientific literature. Sharing of data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We plan to make our results available to the community of scientists interested in recently acquired hepatitis C, community organisations representing the affected communities and participants. We also welcome collaboration with others who could make use of data and samples.

location_country:
United States
Switzerland
Germany
France
Australia
New Zealand
Canada
United Kingdom

location_facility: CIM-Centrum fuer Interdisziplinaere Medizin GmbH

location_facility: Center for HIV and Hepatogastroenterology

location_facility: zibp - Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: New York University Langone Medical Center

location_facility: Imperial College Healthcare NHS Trust (St Mary's Hospital)

title: A Phase IIIb, Open-label, Multicentre, International Randomised Controlled Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir (300mg)/Pibrentasvir (120mg) in Chronic HCV Treatment naïve Patients Without Cirrhosis

summary:
The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified.

Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV treatment simplification.

Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks.

One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).


title: Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer.

PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.

status: Unknown status

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

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

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

location_facility: Gloucestershire Oncology Centre at Cheltenham General Hospital

location_facility: Berkshire Cancer Centre at Royal Berkshire Hospital

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Marburg

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

location_facility: Aarhus Universitetshospital - Aarhus Sygehus

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Velindre Cancer Center at Velindre Hospital

location_facility: Rosemere Cancer Centre at Royal Preston Hospital

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: St. Johannes Hospital - Medical Klinik II

location_facility: Southend University Hospital NHS Foundation Trust

location_facility: Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster


title: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors

summary: The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Chile
Switzerland
Netherlands
Germany
Finland
France
Poland
Israel
Norway
Romania
Belgium
Argentina
Australia
Spain
Denmark
Canada

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Columbia University Medical Center (Cumc)

location_facility: Istituto Nazionale Tumori Fondazione Pascale


lead_sponsor: Iovance Biotherapeutics, Inc.

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

acronym: Study of LN-145 in the treatment of Patients with cervical cancer

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie

location_facility: University of Florida Health Cancer Center

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University of South Florida H. Lee Moffitt Cancer Center and Research Institute

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: St. Joseph's Hospital and Medical Center Center For Women's Health

location_facility: University of Oklahoma Health Sciences Center

title: A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Recurrent, Metastatic or Persistent Cervical Carcinoma

summary: Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma


title: A Phase IV Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222

summary: This is a Phase IV real-world, observational, non-interventional, prospective cohort study of adults vaccinated with AZD1222. The purpose of this study is to assess the safety and tolerability of AZD1222 in adults vaccinated in real-world settings.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country: Germany Sweden France Spain


location_country:
Italy
United States
Switzerland
Germany
France
Australia
Puerto Rico
Spain
Canada

title: Phase 1/2 Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab Combined With Daratumumab in Participants With Advanced or Metastatic Solid Tumors

summary: The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, that have advanced or have spread.


title: Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study

acronym: ARB-PMCF

summary: ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.

lead_sponsor: Abbott Medical Devices

location_country: Italy Netherlands France Spain Germany

location_facility: Herzzentrum-Bremen Klinikum Links der Weser

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel

location_facility: Herzchirurgische Abteilung Klinikum Passau

location_facility: Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden

intervention_type: Device


title: An Open-Label Phase 2 Study of Surufatinib in Patients With Neuroendocrine Tumours in Europe

summary: This is a Phase 2, open-label, multi-centre study of surufatinib in patients with low to intermediate grade (Grade 1 or Grade 2), well-differentiated neuroendocrine tumours (NETs).

lead_sponsor: Hutchison Medipharma Limited

location_country:
Italy
France
Norway
Spain
Germany
United Kingdom

location_facility: Universita degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi (AOUC)

location_facility: Universitatsklinikum Essen, Klinik fur Endokrinologie

location_facility: Institut Catala d'Oncologis (ICO) - Hospital Duran i Reynals

location_facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari


title: Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema; A Multicenter, Prospective Trial

acronym: CONVERT

summary:
This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 15 investigational sites. The Study plans to enroll 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System to occlude collateral air channels in a target lung lobe with collateral ventilation (CV) and convert the target lung lobe to having little to no collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study will have two Stages:

• Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted, provided that the total application volume from both the initial and the repeat treatments does not exceed 40 mL in up to three (3) segments.

Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment and repeated after the second treatment, if applicable. For the purpose of protocol follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2.

• Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1. Converted CV- target lobes will follow standard of care and receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction (BLVR).

Clinical assessments will be conducted at 45 Days, 3 and 6-months post-Zephyr Valve procedure.

lead_sponsor: Pulmonx Corporation

location_country:
Italy
Switzerland
Netherlands
France
Germany
United Kingdom

location_facility: ASST Spedali Civili, University Hospital


lead_sponsor: Alnylam Pharmaceuticals

location_country:
Italy
Sweden
France
Spain
Germany
United Kingdom
Portugal

title: An Open-label Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of Patisiran-LNP in Patients With Hereditary Transthyretin-mediated Amyloidosis (hATTR Amyloidosis) With Disease Progression Post-Orthotopic Liver Transplant

summary: The purpose of this study is to evaluate the efficacy and safety of patisiran in participants with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with disease progression after liver transplant.


title: A Randomized, Open-label, Multi-center, Controlled Clinical Study to Compare MAR-CUTIS With Dermabond Advanced in Closure of Surgical Incisions and Lacerations up to 15 Centimeters

summary: This was a randomized, open-label, multicenter, comparator-controlled clinical study to compare MAR-CUTIS with Dermabond Advanced in closure of surgical incisions and lacerations less than or equal to (<=)15 centimeter (cm). Eligible participants were randomized 2:1 to MAR-CUTIS or Dermabond Advanced.

lead_sponsor: Grünenthal GmbH

location_country:
Germany
United Kingdom
France
Spain

location_facility: 018 - Bristol Royal Hospital for Children

location_facility: 001 - Hospital Universitari Vall d'Hebron

location_facility: 014 - Queen Elizabeth the Queen Mother Hospital

location_facility: 022 - Hospital General Universitario Gregorio Maranon

location_facility: 003 - University Hospital Virgen del Rocío


title: A Prospective, Open, Multicentre Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in European Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

acronym: STAR-II

summary: The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

ReferenceCitation: García Feijoó J, Denis P, Hirneiß C, Aptel F, Perucho González L, Hussain Z, Lorenz K, Pfeiffer N; STAR-II Investigators. A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II). J Glaucoma. 2020 Oct;29(10):864-871. doi: 10.1097/IJG.0000000000001632.

family: García Feijoó

full_name: Julián García Feijoó

given: Julián

family: Denis

full_name: Philippe Denis

given: Philippe

family: Hirneiß

full_name: Christoph Hirneiß

given: Christoph

family: Aptel

full_name: Florent Aptel

given: Florent

family: Perucho González

full_name: Lucía Perucho González

given: Lucía

family: Hussain

full_name: Zubair Hussain

given: Zubair

family: Lorenz

full_name: Katrin Lorenz

given: Katrin

family: Pfeiffer

full_name: Norbert Pfeiffer

given: Norbert

journal_name: Journal of Glaucoma

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: iSTAR Medical

location_country: Germany France Spain

location_facility: Center Hospotalier Universitaire Genoble Alpes


title: A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safety of Savolitinib Versus Sunitinib in Patients With MET-Driven, Unresectable and Locally Advanced, Or Metastatic Papillary Renal Cell Carcinoma (PRCC)

summary: This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause.

ReferenceCitation: Choueiri TK, Heng DYC, Lee JL, Cancel M, Verheijen RB, Mellemgaard A, Ottesen LH, Frigault MM, L'Hernault A, Szijgyarto Z, Signoretti S, Albiges L. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. doi: 10.1001/jamaoncol.2020.2218. Erratum in: JAMA Oncol. 2020 Sep 1;6(9):1473.

name: Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

name: Department of Medical Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, Canada

family: Heng

full_name: Daniel Y. C. Heng

given: Daniel Y. C.

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

family: Lee

full_name: Jae Lyun Lee

given: Jae Lyun

name: CHU Bretonneau Centre, Tours University, France

family: Cancel

full_name: Mathilde Cancel

given: Mathilde

name: Oncology R&D, AstraZeneca, Cambridge, United Kingdom

family: Verheijen

full_name: Remy B. Verheijen

given: Remy B.

family: Mellemgaard

full_name: Anders Mellemgaard

given: Anders

family: Ottesen

full_name: Lone H. Ottesen

given: Lone H.

name: Oncology R&D, AstraZeneca, Boston, Massachusetts

family: Frigault

full_name: Melanie M. Frigault

given: Melanie M.

family: L’Hernault

full_name: Anne L’Hernault

given: Anne

family: Szijgyarto

full_name: Zsolt Szijgyarto

given: Zsolt

name: Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts

family: Signoretti

full_name: Sabina Signoretti

given: Sabina

name: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts

name: Department of Cancer Medicine, Institut Gustave Roussy, Villejuif, France

family: Albiges

full_name: Laurence Albiges

given: Laurence

journal_name: JAMA Oncology

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Italy
Brazil
France
Russian Federation
United States
Korea, Republic of
Ukraine


lead_sponsor: Actelion

primary_purpose: Other

location_country:
Austria
Sweden
Switzerland
Germany
France
Norway
Ireland
Portugal
United States
United Kingdom

acronym: TRACE

location_facility: Tufts Medical Center, Pulmonary/Critical Care & Sleep

location_facility: University of Pennsylvania, Pulmonary Vascular Disease Program

location_facility: Oslo University Hospital, dept of cardiology

location_facility: Universitaetsspital Zurich, Klinik für Pneumologie C HOER 11

location_facility: Freeman Hospital, Cardiothoracic Department

location_facility: Centro Hospitalar e Universitário de Coimbra, Serviço de Cardiologia

location_facility: Vanderbilt University Medical Center, Care Medicine

location_facility: Krankenhaus der Elisabethinen, Servicestelle Klinische Studien

location_facility: University of Nebraska Medical Center, Pulmonary, Critical Care & Sleep Medicine Division

location_facility: Katholisches Klinikum Lünen/Werne GmbH, Haus E

location_facility: CHRU de Lille - Hôpital Albert Calmette, Service de cardiologie

location_facility: Skåne University Hospital, VO Hjärt och Lungmedicin

location_facility: Kantonsspital St. Gallen, Klinik für Pneumologie und Schlafmedizin

location_facility: Hôpital Bicêtre, ervice de Pneumologie et Réanimation respiratoire

location_facility: Sahlgrenska University Hospital, Gothenburg

location_facility: The Royal Free Hospital, Cardiology Department

location_facility: University of Cincinnati, Heart, Lung and Vascular Institute

location_facility: Duke University School of Medicine, Duke Pulmonary Vascular Disease center

location_facility: Royal Hallamshire Hospital, Pulmonary Vascular Medicine

location_facility: Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin

location_facility: Papworth Hospital, Pulmonary Vascular Disease Unit

location_facility: University of Texas Health Science Center (San Antonio)

location_facility: Golden Jubilee National Hospital, Scottish Pulmonary Vascular Unit

location_facility: Medizinische Universität Innsbruck (MUI), Abt. für Pneumologie, Haus 2

location_facility: Universitätsklinikum Leipzig AöR, Abteilung Pneumologie

title: A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their Impacts

summary: The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.


title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

summary: The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

lead_sponsor: Gilead Sciences

location_country:
Italy
Austria
United States
Germany
France
Hungary
Belgium
Canada
United Kingdom

location_facility: John Hopkins Gastroenterology and Hepatology Services at the Green Spring Station Clinic

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: CHU de Rennes - Hôpital Pontchaillou (main office)

location_facility: Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology

location_facility: Bugát Pál Kórház, Gasztroenterológiai osztály

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: University of Louisville Clinical Trials Unit

location_facility: CHU Grenoble Alpes - Hopital Michallon (main office)

location_facility: Center for Interventional Endoscopy - Florida Hospital

location_facility: Royal Devon and Exeter Hospital, Department of Gastroenterology

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: University of South Florida South Tampa Campus


location_country:
United States
Mexico
Netherlands
Germany
France
Czechia
Poland
Hungary
Argentina
Puerto Rico
Russian Federation
Spain
Canada

acronym: Ixora-peds

location_facility: Instituto de Neumonología y Dermatología

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: SZTE AOK Borgyogyaszati es Allergologiai Klinika

location_facility: Fundación Estudios Clínicos- Servicio de Dermatología

location_facility: SSM Health Cardinal Glennon Children's Hospital

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: Tien Q. Nguyen, MD inc. DBA First OC Dermatology

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Hospital Univ. Dr. Jose Eleuterio Gonzalez

location_facility: Solutions Through Advanced Research, Inc.

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Centre hospitalier universitaire Pellegrin

location_facility: Universitair Medisch Centrum St Radboud Nijmegen

location_facility: University of North Carolina Dermatology and skin Cancer Cen

title: Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis

summary: The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.


title: Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG® Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System

acronym: SURPASS

summary: Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice.

ReferenceCitation: Torsello GF, Argyriou A, Stavroulakis K, Bosiers MJ, Austermann M, Torsello GB; SURPASS Registry Collaborators. One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System. J Endovasc Ther. 2020 Jun;27(3):421-427. doi: 10.1177/1526602820913007. Epub 2020 Mar 20.

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

name: Department of Diagnostic and Interventional Radiology and Nuclear Medicine, Charité Campus Virchow-Klinikum, Charité University Medicine Berlin, Germany

family: Torsello

full_name: Giovanni Federico Torsello

given: Giovanni Federico

family: Argyriou

full_name: Angeliki Argyriou

given: Angeliki

family: Stavroulakis

full_name: Konstantinos Stavroulakis

given: Konstantinos

family: Bosiers

full_name: Michel J. Bosiers

given: Michel J.

family: Austermann

full_name: Martin Austermann

given: Martin

full_name: Giovanni B. Torsello

given: Giovanni B.

family: Pérez

full_name: Manuel Alonso Pérez

given: Manuel Alonso

family: Böckler

full_name: Dittmar Böckler

given: Dittmar

family: Bonardelli

full_name: Stefano Bonardelli

given: Stefano

family: Brunkwall

full_name: Jan Brunkwall

given: Jan

family: Chakfé

full_name: Nabil Chakfé

given: Nabil

family: Dialetto

full_name: Giovanni Dialetto

given: Giovanni

family: Noya

full_name: Jorge Fernandez Noya

given: Jorge Fernandez

family: Heijmen

full_name: Robin Heijmen

given: Robin

family: Lechón Saz

full_name: José Antonio Lechón Saz

given: José Antonio

family: Loftus

full_name: Ian Loftus

given: Ian

family: Mangialardi

full_name: Nicola Mangialardi

given: Nicola

family: McPherson

full_name: Simon McPherson

given: Simon

family: Modarai

full_name: Bijan Modarai

given: Bijan

family: Pfister

full_name: Karin Pfister

given: Karin

family: Picquet

full_name: Jean Picquet

given: Jean

family: Pirouzram

full_name: Artai Pirouzram

given: Artai

full_name: Giovanni Torsello

repository_institution: Umeå University - DiVA at Umeå University

location_country:
Italy
Sweden
Netherlands
France
Spain
Germany
United Kingdom

location_facility: Azienda Ospedaliers San Camilla Forlanni

location_facility: Hospital Universitario Central de Asturias