title: European Registry of Type A Aortic Dissection

acronym: ERTAAD

summary: Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Biancari F, Mariscalco G, Yusuff H, Tsang G, Luthra S, Onorati F, Francica A, Rossetti C, Perrotti A, Chocron S, Fiore A, Folliguet T, Pettinari M, Dell'Aquila AM, Demal T, Conradi L, Detter C, Pol M, Ivak P, Schlosser F, Forlani S, Chetty G, Harky A, Kuduvalli M, Field M, Vendramin I, Livi U, Rinaldi M, Ferrante L, Etz C, Noack T, Mastrobuoni S, De Kerchove L, Jormalainen M, Laga S, Meuris B, Schepens M, El Dean Z, Vento A, Raivio P, Borger M, Juvonen T. European registry of type A aortic dissection (ERTAAD) - rationale, design and definition criteria. J Cardiothorac Surg. 2021 Jun 10;16(1):171. doi: 10.1186/s13019-021-01536-5. Erratum in: J Cardiothorac Surg. 2021 Aug 9;16(1):225.

family: Biancari

full_name: Fausto Biancari

given: Fausto

family: Mariscalco

full_name: Giovanni Mariscalco

given: Giovanni

family: Yusuff

full_name: Hakeem Yusuff

given: Hakeem

family: Tsang

full_name: Geoffrey Tsang

given: Geoffrey

family: Luthra

full_name: Suvitesh Luthra

given: Suvitesh

family: Onorati

full_name: Francesco Onorati

given: Francesco

family: Francica

full_name: Alessandra Francica

given: Alessandra

family: Rossetti

full_name: Cecilia Rossetti

given: Cecilia

family: Perrotti

full_name: Andrea Perrotti

given: Andrea

family: Chocron

full_name: Sidney Chocron

given: Sidney

family: Fiore

full_name: Antonio Fiore

given: Antonio

family: Folliguet

full_name: Thierry Folliguet

given: Thierry

family: Pettinari

full_name: Matteo Pettinari

given: Matteo

family: Dell’Aquila

full_name: Angelo M. Dell’Aquila

given: Angelo M.

family: Demal

full_name: Till Demal

given: Till

family: Conradi

full_name: Lenard Conradi

given: Lenard

family: Detter

full_name: Christian Detter

given: Christian

family: Pol

full_name: Marek Pol

given: Marek

family: Ivak

full_name: Peter Ivak

given: Peter

family: Schlosser

full_name: Filip Schlosser

given: Filip

family: Forlani

full_name: Stefano Forlani

given: Stefano

family: Chetty

full_name: Govind Chetty

given: Govind

family: Harky

full_name: Amer Harky

given: Amer

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

location_country:
Italy
Finland
France
Czechia
Belgium
Spain
Germany
United Kingdom

location_facility: Institute of Clinical and Experimental Medicine

location_facility: University Heart & Vascular Centre Hamburg


title: A Long Term Prospective Observational Post Market Clinical Follow-Up (PMCF) Registry of Ethicon Gynecare Pelvic Mesh Products for The Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

summary: The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

lead_sponsor: Ethicon, Inc.

location_country:
Sweden
Germany
France
Czechia
Poland
Denmark
United States

location_facility:
Universitatsklinikum Tubingen
UPMC
Żelazna Medical Center
Karolinska Institute
CHU de Clermont-Ferrand
General University Hospital
Hopital Jeanne de Flandres
University of Pennsylvania
Duke University
Herlev Hospital
Yale University

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Dose-Blind Extension Study With Double-blind, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Safety and Explore the Pharmacokinetics and Pharmacodynamics of TAK-994 in Adults With Narcolepsy With Cataplexy (Narcolepsy Type 1)

summary:
Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study.

The main aim of this study is to check if participants have side effects from TAK-994.

Participants will take one of 3 different TAK-994 dose for 8 weeks.

Then, half the participants will continue with their dose of TAK-994 and half will take a placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any medicine in it. Participants will take TAK-994 or placebo for 4 weeks.

Participants will visit the clinic for a final check-up 2 weeks after their last dose of TAK-994 or placebo.

The study doctors will check for side effects from TAK-994 and placebo throughout the study.

Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK 994-1501 study.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https:// clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Italy
Finland
France
Czechia
Japan
Korea, Republic of
Hungary
Spain
United States
Canada

location_facility: Keimyung University Dongsan Hospital 300144594

location_facility: Gokeikai Osaka Kaisei Hospital Dept of Sleep Medicine

location_facility: Hospital General de Castellon Servicio de Neurofisiologia

location_facility: Florida Pulmonary Research Institute, LLC 300127039

location_facility: Hospital Universitario Araba Sede Santiago Sleep Unit

location_facility: University of Kansas Medical Center Research Institute, Inc. University of Kansas Hospital

location_facility: Fakultni nemocnice Hradec Kralove Dept of Neurologicka klinika

location_facility: Beth Israel Deaconess Medical Center CardioVascular Institute

location_facility: Sleep Therapy & Research Center 300151246

location_facility: Hopital Roger Salengro - CHU Lille service de neurologie D

location_facility: Hospital Vithas Nuestra Senora de America Neurofisiologia Clinica

location_facility: Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" 150119420

location_facility: Respiratory Specialists Berks Schuylkill Respiratory Specialists Ltd

location_facility: Terveystalo Helsinki Uniklinikka 300186257

location_facility: Sleep & Stress Clinic Dept of Psychiatry

location_facility: Howakai Kuwamizu Hospital Dept of Internal Medicine

location_facility: Ospedale San Raffaele (San Raffaele Turro) Clinica Neurologica- Div Malattie del Sonno

location_facility: Kyowakai Hannan Hospital Dept of Psychiatry

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata U.O.C. Neurologia

location_facility: SOUSEIKAI PS Clinic Dept of Internal Medicine

location_facility: The Catholic University of Korea, St. Vincent's Hospital 300187879

location_facility: Jinyukai Kotorii Isahaya Hospital Dept of Psychiatry

location_facility: You Ariyoshi Sleep Clinic Dept of Psychiatry

location_facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic Dept of Internal Medicine

location_facility: Yoyogi Sleep Disorder Center Dept of Psychiatry

location_facility: Vseobecna fakultni nemocnice v Praze Dept of Neurologicka klinika 1.LF UK a VFN v Praze

location_facility: Hospital Clinic de Barcelona Servicio de Neurologia

location_facility: Sleep Support Clinic Dept of Psychosomatic Medicine/Psychiatry

location_facility: Delta Waves Sleep Disorders and Research Center 300148510

location_facility: Shunkaikai Inoue Hospital Dept of Respiratory Medicine

location_facility: Medical University of South Carolina (MUSC) PARENT

location_facility: Hopital Gui de Chauliac Service de Neurologie

location_facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche

location_facility: Kurume University Hospital Dept of Neuropsychiatry

location_facility: Ohio Sleep Medicine and Neuroscience Institute 186

location_facility: Sleep Medicine Specialists of South Florida

location_facility: Fort Wayne Neurological Center 150711262

location_facility: Nihon University Itabashi Hospital Dept of Neuropsychiatry

location_facility: Koishikawa Tokyo Hospital Dept of Psychiatry

intervention_type: Drug

status_simplified: Unknown


title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

summary: This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

status: Recruiting

lead_sponsor: Concert Pharmaceuticals

location_country:
United States
France
Poland
Hungary
Spain
Germany
Canada

location_facility: Twoja Przychodnia - Centrum Medyczne Nowa Sól

location_facility: The Rector and Visitors of the University of Virginia

location_facility: Semmelweis Egyetem, Általános Orvostudományi Kar, Bőr-, Nemikórtani És Bőronkológiai Klinika

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital Archet 2

location_facility: Universitätsklinikum Frankfurt Klinik Für Dermatologie, Venerologie Und Allergologie

location_facility: Szte Áok Szent-Györgyi Albert Klinikai Központ Bőrgyógyászati És Allergológiai Klinika

location_facility: Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin

location_facility: Wromedica I. Bielicka, A. Strzalkowska S.C.

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitan

location_facility: Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O.

location_facility: Columbia University Medical Center - Department of Dermatology

location_facility: Velocity Clinical Research/Swinyer-Woseth Dermatology

location_facility: Fachklinik Bad Bentheim - Dermatologische Studienambulanz

location_facility: Klinikum Rechts Der Isar, Technische Universität München

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Hospital Universitario Ramón Y Cajal - Edificio Consultas Externas

location_facility: North Texas Center for Clinical Research

location_facility: Pécsi Tudományegyetem Klinikai Központ, Bőr-, Nemikórtani És Onkodermatológiai Klinika

location_facility: Clinical Research Institute of Michigan, LLC


title: A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study

acronym: HI-PEITHO

summary:
There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE.

Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

ReferenceType: background

ReferenceCitation: Barco S, Vicaut E, Klok FA, Lankeit M, Meyer G, Konstantinides SV; PEITHO Investigators. Improved identification of thrombolysis candidates amongst intermediate-risk pulmonary embolism patients: implications for future trials. Eur Respir J. 2018 Jan 18;51(1). pii: 1701775. doi: 10.1183/13993003.01775-2017. Print 2018 Jan.

ReferenceCitation: Marti C, John G, Konstantinides S, Combescure C, Sanchez O, Lankeit M, Meyer G, Perrier A. Systemic thrombolytic therapy for acute pulmonary embolism: a systematic review and meta-analysis. Eur Heart J. 2015 Mar 7;36(10):605-14. doi: 10.1093/eurheartj/ehu218. Epub 2014 Jun 10. Review.

ReferenceCitation: Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7. Erratum in: Chest. 2016 Oct;150(4):988.

ReferenceCitation: Jaff MR, McMurtry MS, Archer SL, Cushman M, Goldenberg N, Goldhaber SZ, Jenkins JS, Kline JA, Michaels AD, Thistlethwaite P, Vedantham S, White RJ, Zierler BK; American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; American Heart Association Council on Peripheral Vascular Disease; American Heart Association Council on Arteriosclerosis, Thrombosis and Vascular Biology. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation. 2011 Apr 26;123(16):1788-830. doi: 10.1161/CIR.0b013e318214914f. Epub 2011 Mar 21. Erratum in: Circulation. 2012 Aug 14;126(7):e104. Circulation. 2012 Mar 20;125(11):e495.

ReferenceCitation: Becattini C, Agnelli G, Lankeit M, Masotti L, Pruszczyk P, Casazza F, Vanni S, Nitti C, Kamphuisen P, Vedovati MC, De Natale MG, Konstantinides S. Acute pulmonary embolism: mortality prediction by the 2014 European Society of Cardiology risk stratification model. Eur Respir J. 2016 Sep;48(3):780-6. doi: 10.1183/13993003.00024-2016. Epub 2016 May 12.

ReferenceCitation: Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galiè N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.

family: Meyer

full_name: Guy Meyer

given: Guy

sequence: first

family: Vicaut

full_name: Eric Vicaut

given: Eric

sequence: additional

family: Danays

full_name: Thierry Danays

family: Agnelli

full_name: Giancarlo Agnelli

given: Giancarlo

family: Becattini

full_name: Cecilia Becattini

family: Beyer-Westendorf

full_name: Jan Beyer-Westendorf

given: Jan

family: Bluhmki

full_name: Erich Bluhmki

given: Erich

family: Bouvaist

full_name: Helene Bouvaist

given: Helene

family: Brenner

full_name: Benjamin Brenner

given: Benjamin

family: Couturaud

full_name: Francis Couturaud

given: Francis

family: Dellas

full_name: Claudia Dellas

given: Claudia

family: Empen

full_name: Klaus Empen

given: Klaus

family: Franca

full_name: Ana Franca

given: Ana

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

family: Geibel

full_name: Annette Geibel

given: Annette

family: Goldhaber

full_name: Samuel Z. Goldhaber

given: Samuel Z.

family: Jimenez

full_name: David Jimenez

given: David

family: Kozak

full_name: Matija Kozak

given: Matija

family: Kupatt

full_name: Christian Kupatt

family: Kucher

full_name: Nils Kucher

given: Nils

family: Lang

full_name: Irene M. Lang

given: Irene M.

family: Lankeit

full_name: Mareike Lankeit

repository_institution: University of Bern - Bern Open Repository and Information System

title: Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism

ReferenceCitation: Bajaj NS, Kalra R, Arora P, Ather S, Guichard JL, Lancaster WJ, Patel N, Raman F, Arora G, Al Solaiman F, Clark DT 3rd, Dell'Italia LJ, Leesar MA, Davies JE, McGiffin DC, Ahmed MI. Catheter-directed treatment for acute pulmonary embolism: Systematic review and single-arm meta-analyses. Int J Cardiol. 2016 Dec 15;225:128-139. doi: 10.1016/j.ijcard.2016.09.036. Epub 2016 Sep 20. Review.

ReferenceCitation: Kucher N, Boekstegers P, Müller OJ, Kupatt C, Beyer-Westendorf J, Heitzer T, Tebbe U, Horstkotte J, Müller R, Blessing E, Greif M, Lange P, Hoffmann RT, Werth S, Barmeyer A, Härtel D, Grünwald H, Empen K, Baumgartner I. Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation. 2014 Jan 28;129(4):479-86. doi: 10.1161/CIRCULATIONAHA.113.005544. Epub 2013 Nov 13.

ReferenceCitation: Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-1392. doi: 10.1016/j.jcin.2015.04.020.

ReferenceCitation: Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.

ReferenceCitation: Tapson VF, Sterling K, Jones N, Elder M, Tripathy U, Brower J, Maholic RL, Ross CB, Natarajan K, Fong P, Greenspon L, Tamaddon H, Piracha AR, Engelhardt T, Katopodis J, Marques V, Sharp ASP, Piazza G, Goldhaber SZ. A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial. JACC Cardiovasc Interv. 2018 Jul 23;11(14):1401-1410. doi: 10.1016/j.jcin.2018.04.008.

ReferenceCitation: Steering Committee. Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: rationale and design of the Pulmonary Embolism Thrombolysis (PEITHO) trial. Am Heart J. 2012 Jan;163(1):33-38.e1. doi: 10.1016/j.ahj.2011.10.003.

title: Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: Rationale and design of the Pulmonary Embolism Thrombolysis (PEITHO) trial

ReferenceCitation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449.

name: The BARC represents a collaboration of independent academic research organizations (Cardialysis, Rotterdam, the Netherlands; Cardiovascular Research Foundation, New York City, NY; Duke Clinical Research Institute, Durham, NC; TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA; Harvard Clinical Research Institute, Boston, MA; Green Lane Coordinating Centre, Auckland, New Zealand; Cleveland Clinic Coordinating Center for Clinical Research,...

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Standardized Bleeding Definitions for Cardiovascular Clinical Trials

ReferenceCitation: GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993 Sep 2;329(10):673-82.

ReferenceCitation: Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4.

ReferenceCitation: Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010.

ReferenceCitation: Liu VX, Lu Y, Carey KA, Gilbert ER, Afshar M, Akel M, Shah NS, Dolan J, Winslow C, Kipnis P, Edelson DP, Escobar GJ, Churpek MM. Comparison of Early Warning Scoring Systems for Hospitalized Patients With and Without Infection at Risk for In-Hospital Mortality and Transfer to the Intensive Care Unit. JAMA Netw Open. 2020 May 1;3(5):e205191. doi: 10.1001/jamanetworkopen.2020.5191.

ReferenceCitation: Smith GB, Prytherch DR, Meredith P, Schmidt PE, Featherstone PI. The ability of the National Early Warning Score (NEWS) to discriminate patients at risk of early cardiac arrest, unanticipated intensive care unit admission, and death. Resuscitation. 2013 Apr;84(4):465-70. doi: 10.1016/j.resuscitation.2012.12.016. Epub 2013 Jan 4.

ReferenceCitation: Quiroz R, Kucher N, Schoepf UJ, Kipfmueller F, Solomon SD, Costello P, Goldhaber SZ. Right ventricular enlargement on chest computed tomography: prognostic role in acute pulmonary embolism. Circulation. 2004 May 25;109(20):2401-4. Epub 2004 May 17.

ReferenceCitation: Stein PD, Matta F, Yaekoub AY, Goodman LR, Sostman HD, Weg JG, Hales CA, Hull RD, Leeper KV Jr, Beemath A, Saeed IM, Woodard PK. Reconstructed 4-chamber views compared with axial imaging for assessment of right ventricular enlargement on CT pulmonary angiograms. J Thromb Thrombolysis. 2009 Oct;28(3):342-7. doi: 10.1007/s11239-009-0331-5. Epub 2009 Mar 27.

ReferenceCitation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

ReferenceCitation: Klok FA, Cohn DM, Middeldorp S, Scharloo M, Büller HR, van Kralingen KW, Kaptein AA, Huisman MV. Quality of life after pulmonary embolism: validation of the PEmb-QoL Questionnaire. J Thromb Haemost. 2010 Mar;8(3):523-32. doi: 10.1111/j.1538-7836.2009.03726.x. Epub 2009 Dec 15.

ReferenceCitation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

ReferenceCitation: Burnett AE, Mahan CE, Vazquez SR, Oertel LB, Garcia DA, Ansell J. Guidance for the practical management of the direct oral anticoagulants (DOACs) in VTE treatment. J Thromb Thrombolysis. 2016 Jan;41(1):206-32. doi: 10.1007/s11239-015-1310-7. Review.

ReferenceCitation: Cech DJ, Martin ST. Evaluation of function, activity, and participation. Functional Movement Development Across the Life Span (Third Edition), 2012.

ReferenceCitation: Saris-Baglama RN, Dewey CJ, Chisholm GB, et al. QualityMetric health outcomes™ scoring software 4.0. Lincoln, RI: QualityMetric Incorporated, 2010, p. 138.

ReferenceCitation: Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jiménez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ní Áinle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405.

location_country:
Austria
Switzerland
Netherlands
Germany
France
Poland
United States
United Kingdom

location_facility: Erasmus MC - University Medical Center Rotterdam

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Guys and St. Thomas NHS Foundation Trust

location_facility: University of Oklahoma Health Science Center

location_facility: University of Maryland School of Medicine


ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
France
Czechia
Poland
Thailand
Singapore
Belgium
Russian Federation
Spain
Turkey
Denmark
Germany
Korea, Republic of
Taiwan
Ukraine

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

location_facility: Taipei Veterans General Hospital; Department of Oncology

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Complejo Hospitalario de Navarra; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Dicle Uni Medical Faculty; Internal Medicine

location_facility: Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

location_facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.

location_facility: NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii

location_facility: Szpital Morski im. PCK; Poradnia Onkologiczna

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: National Cancer Centre; Medical Oncology

location_facility: Van Yuzuncu Yil University Hospital; Medical Oncology

location_facility: Chonnam National University Hwasun Hospital

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: National Taiwan University Hospital; Oncology

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

source: euctr

title: A 3-Arm, Randomized, Blinded, Active-Controlled, Phase II Study of RO7121661, a PD1-TIM3 Bispecific Antibody and RO7247669, a PD1-LAG3 Bispecific Antibody, Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus

summary: This is a Phase II, randomized, blinded, active-controlled, global, multicenter study designed to evaluate the safety and efficacy of RO7121661 and RO7247669, compared with nivolumab, in patients with advanced or metastatic esophageal squamous-cell carcinoma (ESCC) refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen.


intervention_type: Other

lead_sponsor: Bristol-Myers Squibb

location_country:
France
Poland
Australia
Spain
Canada
United Kingdom

location_facility:
Sinclair Dermatology
The Skin Hospital
Hopital Robert Debre
Local Institution
Veracity Clinical Research

title: A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of BMS-986165 in Adolescent Subjects With Moderate to Severe Plaque Psoriasis

summary: The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of BMS-986165 in adolescent participants aged 12 to <18 years with moderate to severe plaque psoriasis. This study has two parts. Part A will evaluate the drug levels of BMS-986165 in adolescent participants ages 12 to <18 years to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in adolescents participants with moderate to severe plaque psoriasis.


title: 58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)

summary: The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson's Disease.

ipd_sharing: No

lead_sponsor: Cerevel Therapeutics, LLC

location_country:
Italy
United States
France
Czechia
Poland
Australia
Spain
Germany

location_facility:
Fresno, California
Coral Springs, Florida
Durham, North Carolina
Kirkland, Washington
Rock Hill, South Carolina
Georgetown, Texas
Nîmes cedex 09
Móstoles, Madrid
Toledo, Ohio
Scarborough, Maine
Woolloongabba, Queensland
Valencia
Spokane, Washington
Warsaw
Scottsdale, Arizona
Chocen
Asheville, North Carolina
Haag in Oberbayern
Pamplona
Lawrence, Massachusetts
West Bloomfield, Michigan
Lady Lake, Florida
Ocala, Florida
Dayton, Ohio
Clayton, Victoria
Lubbock, Texas
San Sebastian
Albany, New York
Houston, Texas
Round Rock, Texas
Rychnov nad Kněžnou
Barcelona
Maitland, Florida
Naples, Florida
Chicago, Illinois
Tampa, Florida
Winfield, Illinois
Toms River, New Jersey
Virginia Beach, Virginia
Richmond, Virginia
Katowice
Parkville, Victoria
Creteil,
Milano
North Dartmouth, Massachusetts
Sant Cugat del Vallés Barcelona
Englewood, Colorado
Pasadena, California
Little Rock, Arkansas
Rome
Terrassa
Birmingham, Alabama
Boca Raton, Florida
Reseda, California
Erina, New South Wales
Madrid
Burlington, Vermont
Elche
Gera
München


title: A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD

acronym: ShORe

summary: A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

lead_sponsor: Opthea Limited

location_country:
Malaysia
Greece
Australia
Russian Federation
Denmark
Ukraine
India
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Israel
Spain
Latvia

location_facility:
ShORe Investiagtional Site
ShORe Investigational Site
ShORe Investigational site

intervention_type: Procedure


title: A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype

summary: This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
France
Czechia
Poland
Russian Federation
Spain
United States


title: AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy

summary: AGAVE-201 is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in patients with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy due to progression of disease, intolerability or toxicity.

lead_sponsor: Syndax Pharmaceuticals

location_country:
Italy
United States
France
Spain

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: Washington University School of Medicine

location_facility: Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

location_facility: University of Pittsburgh Medical Center - Hillman Cancer Center

location_facility: Fondazione Policlinica Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: University of Massachusetts Memorial Medical Center

location_facility: University of Oklahoma - Health Sciences Center


type: Other Identifier

title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Response of Guselkumab in Adult Participants With Celiac Disease

summary: The purpose of this study is to evaluate the safety and tolerability of guselkumab compared to placebo in participants with celiac disease.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Sweden
Finland
France
Australia
United States

location_facility: The Wesley - St Andrew's Research Institute

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Clinical Research Institute of Michigan, LLC


title: A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

summary: The objective of this retrospective trial is to assess safety and efficacy of eculizumab in aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.

status: Completed

time_perspective: Retrospective

lead_sponsor: Alexion Pharmaceuticals

location_country:
Austria
Switzerland
Netherlands
Germany
France
Spain
United States
Canada

status_simplified: Completed


title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects With Heterozygous Familial Hypercholesterolemia

summary: The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).

ReferenceCitation: Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.

ReferenceCitation: Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.

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

ReferenceCitation: Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16.

ReferenceCitation: Raal FJ, Stein EA, Dufour R, Turner T, Civeira F, Burgess L, Langslet G, Scott R, Olsson AG, Sullivan D, Hovingh GK, Cariou B, Gouni-Berthold I, Somaratne R, Bridges I, Scott R, Wasserman SM, Gaudet D; RUTHERFORD-2 Investigators. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jan 24;385(9965):331-40. doi: 10.1016/S0140-6736(14)61399-4. Epub 2014 Oct 1.

ReferenceCitation: Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.

ReferenceCitation: Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.

lead_sponsor: Amgen

location_country:
United States
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Germany
France
Norway
Australia
New Zealand
Spain
Canada
United Kingdom


title: A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor

summary: The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

ReferenceCitation: Cho L, Dent R, Stroes ESG, Stein EA, Sullivan D, Ruzza A, Flower A, Somaratne R, Rosenson RS. Persistent Safety and Efficacy of Evolocumab in Patients with Statin Intolerance: a Subset Analysis of the OSLER Open-Label Extension Studies. Cardiovasc Drugs Ther. 2018 Aug;32(4):365-372. doi: 10.1007/s10557-018-6817-7.

ReferenceCitation: Cho L, Rocco M, Colquhoun D, Sullivan D, Rosenson RS, Dent R, Xue A, Scott R, Wasserman SM, Stroes E. Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy. Clin Cardiol. 2014 Mar;37(3):131-9. doi: 10.1002/clc.22248. Epub 2014 Jan 29.

ReferenceCitation: Stroes E, Colquhoun D, Sullivan D, Civeira F, Rosenson RS, Watts GF, Bruckert E, Cho L, Dent R, Knusel B, Xue A, Scott R, Wasserman SM, Rocco M; GAUSS-2 Investigators. Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab. J Am Coll Cardiol. 2014 Jun 17;63(23):2541-2548. doi: 10.1016/j.jacc.2014.03.019. Epub 2014 Mar 30.

ReferenceCitation: Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, López JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.

ReferenceCitation: Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.

location_country:
United States
South Africa
Hong Kong
Netherlands
Switzerland
Germany
France
Poland
Belgium
Australia
Spain
Denmark
Canada
United Kingdom


ReferenceType: derived

ReferenceCitation: Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

family: Warden

full_name: Bruce A. Warden

given: Bruce A.

family: Duell

full_name: Paul Barton Duell

given: Paul Barton

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Cardiovascular Pharmacology

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Inclisiran: A Novel Agent for Lowering Apolipoprotein B–containing Lipoproteins

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Malaysia
Greece
Australia
Russian Federation
Taiwan
Croatia
France
Poland
Norway
Canada
Slovenia
South Africa
Switzerland
Netherlands
Singapore
Hungary
United States
Germany
United Kingdom
Italy
Brazil
Lebanon
Israel
Spain
Turkey

location_facility: Research Institute for Complex Issues of Cardiovascular Disease

location_facility: Lipids Center Sheba Medical Center, Israel

location_facility: Unidade de pesquisa clinica - Hospital Universitario Walter Cantidio

location_facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul

location_facility: Setor de Lípides, Aterosclerose e Biologia

location_facility: Hippokrateion General Hospital of Athens Greece

location_facility: Hippokratiou Hospital, Thessaloniki, Greece

location_facility: University of Tennessee Health Science Center

title: Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Heterozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-16)

summary: This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C).


title: An Exploratory, Open-label, Multicenter Phase 1b Trial to Evaluate Safety and Efficacy of Sym021 (Anti-PD 1) in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) or Sym023 and Irinotecan in Patients With Recurrent Advanced Biliary Tract Carcinomas

summary: The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinoma by assessing overall response rates (ORRs) per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 The study will also evaluate the safety and tolerability profile of the 3 combinations

status: Active, not recruiting

lead_sponsor: Symphogen A/S

location_country:
United States
Canada
France
Spain

location_facility: University of Kansas Medical Center (KUMC)

location_facility: Centre Georges-François Leclerc, Department of Medical Oncology


title: International Chemotherapy Induced Peripheral Neurotoxicity (CIPN) Assessment and Validation Study

acronym: ICAVS

summary: This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.

lead_sponsor: University of Milano Bicocca

location_country:
Italy
Austria
Brazil
Switzerland
Spain
Germany
France
Korea, Republic of
Greece
Bangladesh
Australia
Portugal
Denmark
United States
Canada
Kenya

location_facility: Cancer Center/Wexner Medical Center - Ohio State Medical Oncology Division

location_facility: Dong-A University - Internal Medicine Dept.

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho

location_facility: Dept. of Neurology, Medical University of Vienna

location_facility: University of Michigan School of Nursing

location_facility: Medical Oncoloy Unit - University of Nairobi

location_facility: International Centre for Diarrhoeal Disease Research

location_facility: Hospital Universitari de Bellvitge-ICO L'Hospitalet

location_facility: Columbia University Irving Medical Center

location_facility: University of Basel - Department of Sport, Exercise and Health

lead_sponsor_type: academique


title: A Modular Phase I/II, Open-label, Multicentre Study to Assess AZD4573 in Novel Combinations With Anti-cancer Agents in Patients With Advanced Haematological Malignancies

summary:
This is a modular, multicentre, open-label, non-randomised, Phase I/II, dose-setting and expansion study including an intra-participant ramp-up.

AZD4573 will be administered intravenously, in novel combinations with anti-cancer agents, to participants with relapsed/refractory haematological malignancies.

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:
Italy
United States
Germany
France
Poland
Ireland
Australia
Spain
Canada
United Kingdom
Korea, Republic of


title: A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients With Huntington's Disease

summary: WVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362331 (SNP2). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP2-001.

lead_sponsor: Wave Life Sciences Ltd.

location_country:
Germany
France
Poland
Australia
Denmark
Canada
United Kingdom

location_facility: Centre Hospitalier de l-Universite de Montreal

location_facility: Institut du Cerveau et de la Moelle Epinière

location_facility: Royal Devon and Exeter Hospital NHS Trust

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: Odense University Hospital and University of Southern Denmark


location_country:
United States
France
Australia
Germany
United Kingdom

location_facility: St Jude s Childrens Research Hospital Dept of Oncology

location_facility: Cincinnati Children's Hospital Medical Center Dept of Oncology

location_facility: UCSF Medical Center Dept of Pediatic Oncology

location_facility: Childrens Healthcare of Atlanta Dept of Oncology

title: A Phase I, Multi-center, Open-label Study of LEE011 in Patients With Malignant Rhabdoid Tumors and Neuroblastoma

summary: LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo activity in both tumor models. The primary purpose of this study was to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in pediatric patients and to delineate a clinical dose to be used in future studies. This study was also to have assessed the safety, tolerability, PK and preliminary evidence of antitumor activity of LEE011 in patients with MRT or neuroblastoma.


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

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

location_country:
Hong Kong
Switzerland
Finland
France
Thailand
Romania
Singapore
China
Turkey
United States
United Kingdom

location_facility: Lurie Children's Hospital of Chicago Clinical Research Office

location_facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Dept of Onc

location_facility: University of California at Los Angeles UCLA

location_facility: Karmanos Cancer Institute Oncology Department

location_facility: Oregon Health and Science University Dept of Oncology

location_facility: Fox Chase Cancer Center Dept.ofFoxChaseCancerCtr.

location_facility: University of Texas MD Anderson Cancer Center UT MD Anderson

location_facility: Weill Cornell Medical Center Dept. of Oncology

title: An Open Label, Multi-center Imatinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Imatinib Study and Are Judged by the Investigator to Benefit From Continued Imatinib Treatment

summary: The purpose of this study is to allow continued use of imatinib in patients who are on imatinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.


ReferenceCitation: Schwartz GJ, Muñoz A, Schneider MF, Mak RH, Kaskel F, Warady BA, Furth SL. New equations to estimate GFR in children with CKD. J Am Soc Nephrol. 2009 Mar;20(3):629-37. doi: 10.1681/ASN.2008030287. Epub 2009 Jan 21.

lead_sponsor: Horizon Pharma USA, Inc.

location_country:
Italy
Netherlands
France
Belgium
United States
United Kingdom

location_facility: California Pacific Medical Center (CPMC) Research Institute

location_facility: Baylor College of Medicine / Texas Childrens Hospital

location_facility: Radboud University Nijmegen Medical Center

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

ipd_sharing: Undecided

title: A Long-Term, Open-Label, Safety, Tolerability and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients With Cystinosis

summary:
The purpose of this study is to gather information about the effectiveness (how well it works to treat cystinosis) and safety of a new form of cysteamine bitartrate called RP103, compared to the already-approved drug cystinosis patients are taking called Cystagon®.

In cystinosis, the body builds up cystine. When taken regularly, the active ingredient of Cystagon® (cysteamine bitartrate) reduces cystine in the body. RP103 has the same active ingredient as Cystagon® and is designed to reduce cystine in a similar way that Cystagon® does. To decide if RP103 is better than Cystagon®, the study will look at two types of blood tests. One test is pharmacodynamics (PD), which measures the amount of white blood cell (WBC) cystine after taking study drug. WBC cystine is a laboratory test used to find out if cysteamine bitartrate is reducing cystine levels in the body. The second test is pharmacokinetics (PK), which measures the amount of cysteamine in the blood after taking the drug.

RP103 is different from Cystagon®: Instead of the cysteamine bitartrate being absorbed from the stomach, RP103 is designed to be absorbed from the small intestine. This may make the effects of the drug last longer, so that it can be taken twice a day instead of four times a day like Cystagon®.

Some cystinosis patients have bad breath (halitosis) when they take Cystagon®. Study participants who experience bad breath with Cystagon® will be asked if they would like to participate in an optional "halitosis substudy" to investigate this issue by collecting some extra PK blood samples.


title: A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 1358894 Once Daily Over 12 Week Treatment Period in Patients With Borderline Personality Disorder

summary:
This study is open to adults with borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study.

Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take different doses of BI 1358894. Participants in the fifth group take placebo. Participants take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894 tablets but do not contain any medicine.

Participants are in the study for about 5 months. During this time, they visit the study site about 12 times and get about 6 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups and the placebo group are then compared. The doctors also regularly check the general health of the participants.

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Sweden
Mexico
Germany
France
Bulgaria
Czechia
Israel
Japan
Poland
Belgium
Argentina
Australia
Spain
Denmark
United States

location_facility: Peninsula Therapeutic and Research Group

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Monash Alfred Psychiatry Research Centre

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Fundación FunDaMos para la asistencia e investigación en psiquiatría

location_facility: CEN (Centro Especializado Neurociencias)

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: University Multiprofile Hospital 'Alexandrovska', Sofia

location_facility: Specialist Psychiatric Healthcare Centre in Lodz

location_facility: Pacific Clinical Research Management Group LLC

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Centro de Estudios Clinicos de Queretaro S.C

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: University at Buffalo, The State University of New York

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Region Zealand, Psychiatric Research Unit

location_facility: Universitair Psychiatrisch Centrum Duffel (UPC Duffel)

location_facility: IRCCS San Giovanni Di Dio Fatebenefratelli

location_facility: Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)

location_facility: Centro de Investigacion y Asistencia en Psiquiatria (CIAP)


type: Registry Identifier

title: A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

summary: This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.

ReferenceType: result

ReferenceCitation: Tosetto A, Neff A, Lentz SR, Santagostino E, Nemes L, Sathar J, Meijer K, Chowdary P, Shen C, Landorph A, Hampton K. Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials. Haemophilia. 2020 May;26(3):450-458. doi: 10.1111/hae.13980. Epub 2020 Apr 15.

name: Hematology Department Haemophilia and Thrombosis Center San Bortolo Hospital Vicenza Italy

family: Tosetto

full_name: Alberto Tosetto

given: Alberto

name: Department of Hematology/Oncology Cleveland Clinic Cleveland OH USA

family: Neff

full_name: Anne Neff

given: Anne

name: Division of Hematology, Oncology, and Blood & Marrow Transplantation Department of Internal Medicine University of Iowa Carver College of Medicine Iowa City IA USA

family: Lentz

full_name: Steven R. Lentz

given: Steven R.

name: Fondazione IRCCS Cà Granda ‐ Ospedale Maggiore Policlinico Angelo Bianchi Bonomi Haemophilia and Thrombosis Center Milan Italy

family: Santagostino

full_name: Elena Santagostino

given: Elena

name: National Haemophilia Centre and Haemostasis Department Medical Centre of Hungarian Defence Forces Budapest Hungary

family: Nemes

full_name: Laszlo Nemes

given: Laszlo

name: Department of Haematology Ampang Hospital Selangor Malaysia

family: Sathar

full_name: Jameela Sathar

given: Jameela

name: Department of Haematology University Medical Centre Groningen University of Groningen Groningen The Netherlands

family: Meijer

full_name: Karina Meijer

given: Karina

name: Katharine Dormandy Haemophilia and Thrombosis Centre Royal Free Hospital London UK

family: Chowdary

full_name: Pratima Chowdary

given: Pratima

family: Shen

full_name: Chunduo Shen

given: Chunduo

family: Landorph

full_name: Andrea Landorph

given: Andrea

name: Department of Cardiovascular Science University of Sheffield Sheffield UK

family: Hampton

full_name: Kingsley Hampton

given: Kingsley

journal_name: Haemophilia

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

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

version: submittedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Šaulytė Trakymienė S, Economou M, Kenet G, Landorph A, Shen C, Kearney S. Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: Final results from pathfinder5. J Thromb Haemost. 2020 Sep;18 Suppl 1:15-25. doi: 10.1111/jth.15036.

name: Center for Pediatric Oncology and Hematology; Children's Hospital; Vilnius University Hospital Santaros Klinikos; Vilnius Lithuania

family: Šaulytė Trakymienė

full_name: Sonata Šaulytė Trakymienė

given: Sonata

name: 1st Department of Pediatrics; Hippokration General Hospital; Aristotle University of Thessaloniki; Thessaloniki Greece

family: Economou

full_name: Marina Economou

given: Marina

name: Sackler Faculty of Medicine; Tel Aviv University; Tel Aviv Israel

name: The Israeli National Hemophilia Center and Thrombosis Unit; Sheba Medical Center; Tel Hashomer Israel

name: The Amalia Biron Research Institute of Thrombosis and Hemostasis; Sheba Medical Center; Tel Hashomer Israel

family: Kenet

full_name: Gili Kenet

given: Gili

name: Center for Bleeding and Clotting Disorders; Children's Hospital Minnesota; Minneapolis MN USA

location_country:
Italy
Brazil
Switzerland
France
Japan
Greece
Israel
Lithuania
Malaysia
Puerto Rico
Portugal
Turkey
United States
United Kingdom
Canada
Ukraine


title: A Randomized, Double-Blind Study of the Efficacy and Safety of Alirocumab Added on to Atorvastatin Versus Ezetimibe Added on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin

summary: This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

name: Li Ka Shing Knowledge Institute; St Michael's Hospital; University of Toronto; Toronto ON Canada

family: Leiter

full_name: L. A. Leiter

given: L. A.

name: Department of Clinical Endocrinology and Nutrition (IBIMA); Hospital Virgen de la Victoria; University of Málaga; CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn); Instituto de Salud Carlos III; Málaga Spain

family: Tinahones

full_name: F. J. Tinahones

given: F. J.

name: Sidney Kimmel Medical College; Thomas Jefferson University; Philadelphia PA USA

family: Karalis

full_name: D. G. Karalis

given: D. G.

family: Bujas-Bobanovic

full_name: M. Bujas-Bobanovic

given: M.

name: Biostatistics and Programming Department; Sanofi, Chilly-Mazarin France

family: Letierce

full_name: A. Letierce

given: A.

family: Mandel

full_name: J. Mandel

given: J.

name: Regeneron Pharmaceuticals, Inc.; Tarrytown NY USA

family: Samuel

full_name: R. Samuel

given: R.

name: Baylor College of Medicine; Houston TX USA

family: Jones

full_name: P. H. Jones

given: P. H.

journal_name: Diabetic Medicine

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. Epub 2016 Oct 24.

ReferenceCitation: Bays H, Gaudet D, Weiss R, Ruiz JL, Watts GF, Gouni-Berthold I, Robinson J, Zhao J, Hanotin C, Donahue S. Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial. J Clin Endocrinol Metab. 2015 Aug;100(8):3140-8. doi: 10.1210/jc.2015-1520. Epub 2015 Jun 1.

family: Bays

full_name: Harold Bays

given: Harold

family: Gaudet

full_name: Daniel Gaudet

given: Daniel

family: Weiss

full_name: Robert Weiss

given: Robert

family: Ruiz

full_name: Juan Lima Ruiz

given: Juan Lima

family: Watts

full_name: Gerald F. Watts

given: Gerald F.

family: Gouni-Berthold

full_name: Ioanna Gouni-Berthold

given: Ioanna

family: Robinson

full_name: Jennifer Robinson

given: Jennifer

family: Zhao

full_name: Jian Zhao

given: Jian

journal_name: The Journal of Clinical Endocrinology & Metabolism

ReferenceCitation: Robinson JG, Colhoun HM, Bays HE, Jones PH, Du Y, Hanotin C, Donahue S. Efficacy and safety of alirocumab as add-on therapy in high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg): design and rationale of the ODYSSEY OPTIONS Studies. Clin Cardiol. 2014 Oct;37(10):597-604. doi: 10.1002/clc.22327. Epub 2014 Sep 30.

name: Departments of Epidemiology and Medicine, College of Public Health University of Iowa  Iowa City Iowa

name: Division of Population Health Sciences, School of Medicine University of Dundee  Dundee Scotland

name: Louisville Metabolic and Atherosclerosis Research Center  Louisville Kentucky

name: Clinical Studies Unit Baylor College of Medicine  Houston Texas

name: Department of Biostatistics Regeneron Pharmaceuticals, Inc.  Tarrytown New York

name: Department of Clinical Research Sanofi  Paris France

name: Department of Clinical Sciences Regeneron Pharmaceuticals, Inc.  Tarrytown New York

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

repository_institution: University of Dundee - Discovery Research Portal

title: Efficacy and Safety of Alirocumab as Add‐on Therapy in High–Cardiovascular‐Risk Patients With Hypercholesterolemia Not Adequately Controlled With Atorvastatin (20 or 40 mg) or Rosuvastatin (10 or 20 mg): Design and Rationale of the ODYSSEY OPTIONS Studies

location_country:
Italy
United States
Mexico
Germany
France
Australia
Spain
Canada
United Kingdom


title: A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis

acronym: BE MOVING

summary: The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).

status: Enrolling by invitation

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Netherlands
Germany
France
Czechia
Bulgaria
Japan
Poland
Hungary
Belgium
Spain
Turkey
United States
United Kingdom


ReferenceCitation: Hart DP. Commentary on "Development of a novel fully functional coagulation factor VIII with reduced immunogenicity utilizing an in silico prediction and deimmunization approach" - Will we ever be able to avoid inhibitor formation in hemophilia A? J Thromb Haemost. 2021 Sep;19(9):2125-2126. doi: 10.1111/jth.15404.

name: The Royal London Hospital Haemophilia Centre Barts Health NHS Trust London UK

name: Centre for Immunobiology Blizard InstituteBarts and The London School of Medicine & DentistryQMUL London UK

family: Hart

full_name: Daniel P. Hart

given: Daniel P.

journal_name: Journal of Thrombosis and Haemostasis

title: Commentary on “Development of a novel fully functional coagulation factor VIII with reduced immunogenicity utilizing an in silico prediction and deimmunization approach” ‐ Will we ever be able to avoid inhibitor formation in hemophilia A?

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
Brazil
South Africa
Switzerland
Netherlands
Germany
France
Israel
Australia
Belgium
Spain
Turkey
United States
United Kingdom
Canada

acronym: HAVEN 7

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Adana Acibadem Hospital; Pediatric Hematology

location_facility: Sheba Medical Center - National Hemophilia Center

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"

location_facility: AORN Santobono Pausilipon; UOC di Ematologia - Centro Emofilia e Trombosi

location_facility: CH de Bicetre; Centre de Traitement d' Hemophilie

location_facility: Medizinische Universität Wien; Univ. Klinik für Kinder und Jugendheilkunde

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: AOU di Parma; Dip Emergenza-Urgenza Centro Riferimento Regionale per l'emofilia

location_facility: Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation

location_facility: Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia

location_facility: Ege University, School of Medicine; Pediatrics Department

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: University of Colorado Denver, Children's Hospital

location_facility: Tulane University Health Sciences Center

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

location_facility: Hospital das Clínicas Faculdades Médicas de Ribeirão Preto

location_facility: The Gulf States Hemophilia and Thrombophilia Center

title: A Phase IIIb, Multicenter, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Patients From Birth to 12 Months of Age With Hemophilia A Without Inhibitors

summary: This is a Phase IIIb, multicenter, open-label, single-arm study of prophylactic emicizumab in previously untreated and minimally treated patients at study enrollment from birth to ≤12 months of age with severe hemophilia A (intrinsic factor VIII [FVIII] level <1%) without FVIII inhibitors. The study is designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at 3 milligrams per kilogram of body weight (mg/kg) once every 2 weeks (Q2W) for 52 weeks. After 1 year of treatment, participants will continue to receive emicizumab (1.5 mg/kg once every week [QW], 3 mg/kg Q2W or 6 mg/kg once every 4 weeks [Q4W]) over a 7-year long-term follow-up period under this study frame.


title: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment

acronym: ROSY-O

summary: The rationale of the ROSY-O study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

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.

location_country:
Finland
Belgium
Russian Federation
Denmark
France
Poland
Canada
Slovenia
Korea, Republic of
Sweden
Bulgaria
Hungary
Portugal
United States
United Kingdom
Germany
Italy
Czechia
Israel
Spain
Turkey


location_country:
Italy
Austria
Switzerland
Germany
Finland
France
Czechia
Singapore
Australia
Belgium
Spain
United States
United Kingdom
Taiwan

location_facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med

location_facility: University of Pittsburgh Cancer Institute HIllman Cancer Center

location_facility: Massachusetts General Hospital Massachusetts General Hospital

location_facility: Emory University School of Medicine/Winship Cancer Institute

title: A Phase II, Open Label, Randomized, Parallel Arm Study of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy Gemcitabine/Nab-paclitaxel, and Gemcitabine/Nab-paclitaxel Alone in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

summary: The purpose of this Phase II study is to assess the efficacy and safety of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in untreated mPDAC.


title: Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase 1/2a Dose Escalation Trial With Dose Expansion Cohorts

summary: The aim of this first-in-human trial is to characterize the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic characteristics of GEN3009 (DuoHexabody®-CD37) in subjects with relapsed/refractory B-cell Non-Hodgkin Lymphoma (NHL).

lead_sponsor: Genmab

location_country:
Netherlands
France
Belgium
Spain
Denmark
United States
United Kingdom

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: University Hospitals Cleveland Medical Center

location_facility: The University of Texas Southwestern Medical Center

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: Medical University of South Carolina (MUSC)

location_facility: Hospital Universitario Fundacion Jimenez Diaz


title: A Prospective, Concurrent Controlled, Open-Label, Multicenter Clinical Study to Assess the Long-Term Safety of the PRESERFLO® MicroShunt in Subjects With Primary Open-Angle Glaucoma Who Have Completed Participation in the INN-005 Randomized Controlled Study.

summary: This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.

lead_sponsor: InnFocus Inc.

location_country:
Italy
France
Spain
United States
United Kingdom

location_facility: Arizona Advance Eye Research Institute, LLC.

location_facility: Pole Ophtalmologique de la Clinique Mutualiste

location_facility: UCLA Medical Center Jules Stein Eye Institute

location_facility: Ophthalmic Surgeons and Consultants of Ohio

location_facility: New York Eye and Ear Infirmary of Mt. Sinai

location_facility: Stiles Eye Care Excellence & Glaucoma Institute

location_facility: Pôle Ophtalmologique de la Clinique Mutualiste

location_facility: University of California at Davis Eye Center

location_facility: Glaucoma Consultants of the Capital Region

location_facility: A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello


title: Efficacy, Safety and Pharmacokinetics of 3 Doses of REC 0/0559 Eye Drops for the Treatment of Stage 2 (Moderate) and 3 (Severe) Neurotrophic Keratitis in Adult Patients

summary: A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559 in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of America.

lead_sponsor: Recordati Rare Diseases

location_country:
Italy
United States
France
Hungary
Spain
Germany
United Kingdom

location_facility: Semmelweis University, Dept. of Ophthalmology

location_facility: University of Maryland School of Medicine UMSOM

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: University of Pecs - Dpt of Ophthalmology

location_facility: Royal Liverpool University Hospital - St Paul's Clinical Eye Research Centre

location_facility: Cartuja Vision - Centro de Servicios Oftlamologicos

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

location_facility: University of Szeged Department of Ophthalmology

location_facility: Houston Eye Associates HEA - Gramercy Location

location_facility: The University of Tennessee Health Science Center (UTHSC) - College of Medicine (COM) - Hamilton Eye Institute


title: Assessment of MEchaNical Dyssynchrony as Selection Criterion for Cardiac Resynchronization Therapy

acronym: AMEND-CRT

summary: Previous experience with cardiac resynchronization therapy (CRT) candidates suggests that selection of these patients can be improved. Current clinical guideline approaches are mainly too unspecific and lead to a high non-responder rate of 30-40%, which causes a burden on health care systems and puts patients at risk of an unnecessary treatment who might benefit more from a conservative approach. Previous work indicated that using the assessment of mechanical dyssynchrony on echocardiography can lower the non-responder rate at least by 50% without compromising sensitivity for detecting amendable patients. The current prospective, randomized, multi-center trial was therefore designed to prove that the characterization of the mechanical properties of the left ventricle can improve patient selection for CRT. Patients will be randomized into one of two study arms: a control study arm with treatment recommendation based on clinical guidelines criteria, or an experimental study arm with treatment recommendation based on the presence of mechanical dyssynchrony. All patients will receive a CRT implantation. In the control study arm, bi-ventricular pacing will be turned on. In the experimental study arm, bi-ventricular pacing will be turned on or off, depending on the presence or absence of mechanical dyssynchrony, respectively. The primary endpoint will be non-inferiority in outcome of a treatment recommendation based on mechanical dyssynchrony, achieved with a lower number of CRT devices implanted, effectively leading to a lower number needed to treat. Outcome measures are the average relative change in continuously measured LVESV per arm and the percentage 'worsened' according to the Packer Clinical Composite Score per arm after 1 year follow-up.

ipd_sharing_description: Available upon reasonable request after acceptance of publications.

lead_sponsor: Universitaire Ziekenhuizen Leuven

location_country: France Poland Romania Belgium Germany

location_facility: Groupements des hôpitaux de l'institut catholique de Lille


title: Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device

summary: Early feasibility study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

lead_sponsor: Edwards Lifesciences

location_country:
United States
Canada
France
Switzerland

location_facility: Hospital of the University of Pennsylvania

location_facility: Columbia University Irving Medical Center / NYPH

location_facility: CHU Bordeaux, Hôpital Cardiologique Haut Lévêque

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)


title: A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients With Relapsed/Refractory Multiple Myeloma

summary: An open-label, Phase 1/2 study of HPN217 as monotherapy to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma

design_allocation: Non-Randomized

lead_sponsor: Harpoon Therapeutics

location_country:
Germany
United States
France
Spain

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: Josep Carreras Leukaemia Research Institute

location_facility: University of Washington - Seattle Cancer Center Alliance

location_facility: University of Rochester James P Wilmot Cancer Institute


title: The Value of FEops HEARTguideTM Patient-Specific Computational Simulation in the Planning of Percutaneous Left Atrial Appendage Closure With the AmplatzerTM AmuletTM Device (PREDICT-LAA)

summary:
To ensure a successful percutaneous left atrial appendage (LAA) closure, it is important to select the correct size of the closure device used for each patient. To define and measure the size of the LAA, 2D transesophageal echocardiography (TEE) has been typically used. An increasing number of hospitals recently switched to measure the size of the LAA using a cardiac computed tomography (CT) scan. Although this CT scan helps to better define and measure the LAA, it is still difficult to determine the exact anticipated 'landing zone' or 'position' of the closure device. A novel strategy of preprocedural planning includes the use of preoperative computer simulations based on CT imaging (Feops HEARTguideTM), where the device is deployed with a computer simulation into the patient-specific LAA anatomy to provide the operator both optimal and suboptimal scenario's showing different sizes and positions of the closure device.

The aim of this study is to assess whether use of FEops HEARTguide computer simulations based on cardiac CT-imaging can contribute to a better preprocedural planning and improved procedural outcomes of percutaneous LAA closure procedures with an Amplatzer Amulet device.

The PREDICT-LAA trial will investigate the possible positive effect of a computer simulation using a CT scan of the LAA performed prior to the procedure. The hypothesis is that by using this new computer simulation, better planning of the intervention can be obtained.

primary_purpose: Supportive Care

ReferenceCitation: Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. Erratum in: JAMA. 2015 Mar 10;313(10):1061.

ReferenceCitation: Chow DH, Bieliauskas G, Sawaya FJ, Millan-Iturbe O, Kofoed KF, Søndergaard L, De Backer O. A comparative study of different imaging modalities for successful percutaneous left atrial appendage closure. Open Heart. 2017 Jun 30;4(2):e000627. doi: 10.1136/openhrt-2017-000627. eCollection 2017.

ReferenceCitation: Korsholm K, Jensen JM, Nielsen-Kudsk JE. Intracardiac Echocardiography From the Left Atrium for Procedural Guidance of Transcatheter Left Atrial Appendage Occlusion. JACC Cardiovasc Interv. 2017 Nov 13;10(21):2198-2206. doi: 10.1016/j.jcin.2017.06.057. Epub 2017 Aug 30.

ReferenceCitation: Otton JM, Spina R, Sulas R, Subbiah RN, Jacobs N, Muller DW, Gunalingam B. Left Atrial Appendage Closure Guided by Personalized 3D-Printed Cardiac Reconstruction. JACC Cardiovasc Interv. 2015 Jun;8(7):1004-6. doi: 10.1016/j.jcin.2015.03.015.

ReferenceCitation: de Jaegere P, Rocatello G, Prendergast BD, de Backer O, Van Mieghem NM, Rajani R. Patient-specific computer simulation for transcatheter cardiac interventions: what a clinician needs to know. Heart. 2019 Mar;105(Suppl 2):s21-s27. doi: 10.1136/heartjnl-2018-313514. Review.

ReferenceCitation: Rocatello G, El Faquir N, De Santis G, Iannaccone F, Bosmans J, De Backer O, Sondergaard L, Segers P, De Beule M, de Jaegere P, Mortier P. Patient-Specific Computer Simulation to Elucidate the Role of Contact Pressure in the Development of New Conduction Abnormalities After Catheter-Based Implantation of a Self-Expanding Aortic Valve. Circ Cardiovasc Interv. 2018 Feb;11(2):e005344. doi: 10.1161/CIRCINTERVENTIONS.117.005344.

ReferenceCitation: Bavo AM, Wilkins BT, Garot P, De Bock S, Saw J, Søndergaard L, De Backer O, Iannaccone F. Validation of a computational model aiming to optimize preprocedural planning in percutaneous left atrial appendage closure. J Cardiovasc Comput Tomogr. 2020 Mar - Apr;14(2):149-154. doi: 10.1016/j.jcct.2019.08.010. Epub 2019 Aug 20.

ReferenceCitation: Swaans MJ, Huijboom MFM, Boersma LVA. Fluoroscopic Guidance: An Echo From the Past? JACC Cardiovasc Interv. 2021 Aug 23;14(16):1827-1829. doi: 10.1016/j.jcin.2021.07.003.

family: Swaans

full_name: Martin J. Swaans

given: Martin J.

family: Huijboom

full_name: Marina F.M. Huijboom

given: Marina F.M.

family: Boersma

full_name: Lucas V.A. Boersma

given: Lucas V.A.

journal_name: JACC: Cardiovascular Interventions

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Fluoroscopic Guidance

ReferenceCitation: Garot P, Iriart X, Aminian A, Kefer J, Freixa X, Cruz-Gonzalez I, Berti S, Rosseel L, Ibrahim R, Korsholm K, Odenstedt J, Nielsen-Kudsk JE, Saw J, Sondergaard L, De Backer O. Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study. Open Heart. 2020 Aug;7(2). pii: e001326. doi: 10.1136/openhrt-2020-001326.

family: Garot

full_name: Philippe Garot

given: Philippe

family: Iriart

full_name: Xavier Iriart

given: Xavier

family: Aminian

full_name: Adel Aminian

given: Adel

family: Kefer

full_name: Joelle Kefer

given: Joelle

family: Freixa

full_name: Xavier Freixa

family: Cruz-Gonzalez

full_name: Ignacio Cruz-Gonzalez

given: Ignacio

family: Berti

full_name: Sergio Berti

given: Sergio

family: Rosseel

full_name: Liesbeth Rosseel

given: Liesbeth

family: Ibrahim

full_name: Reda Ibrahim

given: Reda

family: Korsholm

full_name: Kasper Korsholm

given: Kasper

family: Odenstedt

full_name: Jacob Odenstedt

given: Jacob

family: Nielsen-Kudsk

full_name: Jens-Erik Nielsen-Kudsk

given: Jens-Erik

family: Saw

full_name: Jaqueline Saw

given: Jaqueline

family: Sondergaard

full_name: Lars Sondergaard

given: Lars

family: De Backer

full_name: Ole De Backer

given: Ole

currency_apc_doaj: GBP

location_country: Italy Sweden France Belgium Spain Denmark Canada

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Hopital Civil Marie Curie CHU de Charleroi


title: A First In Human Study of the MCL-1 Inhibitor, ABBV-467

summary: This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).

lead_sponsor: AbbVie

location_country:
France
Japan
Israel
Australia
Spain
United States
Taiwan

location_facility: Prisma Health Cancer Institute-Faris Road /ID# 219076

location_facility: Nagoya City University Hospital /ID# 214696

location_facility: Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418

location_facility: National Taiwan University Hospital /ID# 209322

location_facility: University of Arizona Cancer Center - North Campus /ID# 219102

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739

location_facility: China Medical University Hosp /ID# 209323

location_facility: National Cancer Center Hospital East /ID# 214697

location_facility: Hospital Universitario Virgen de la Victoria /ID# 214756

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 215480

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 214672

location_facility: Hospital Universitario Vall d'Hebron /ID# 214690

location_facility: St Vincent's Hospital Melbourne /ID# 222066

location_facility: National Cancer Center Hospital /ID# 214801

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170


title: A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System

summary: This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.

lead_sponsor: Abbott Medical Devices

location_country:
Italy
United States
Netherlands
France
Japan
Israel
Spain
Germany

location_facility: University of California - Davis Medical Center

location_facility: Hudson Valley Cardiovascular Practice, P.C.

location_facility: Hospital Alvaro Cunqueiro Dept of Interventional Cardiology

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Immanuelklinikum Bernau und Herzzentrum Brandenburg

location_facility: The Sakakibara Heart Insitute of Okayama

location_facility: Klinikum der Ruprecht-Karls-Universität Heidelberg

location_facility: Medizinische Einrichtungen der Universität Düsseldorf

location_facility: Medizinische Einrichtungen der Universitat zu Koln

location_facility: Cardiology Associates of Fairfield County, PC


title: A Phase I/II Study of AZD5363 Combined With Paclitaxel in Patients With Advanced or Metastatic Breast Cancer. Comprising a Safety Run-In and a Placebo-controlled Randomised Expansion in ER+ve Patients Stratified by PIK3CA Mutation Status

acronym: BEECH

summary: The purpose of this study is to investigate the safety and efficacy of different doses and schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with advanced or metastatic breast cancer. Also to investigate a selected dose and schedule of AZD5363 in combination with paclitaxel vs. paclitaxel in combination with placebo in treatment of patients with estrogen receptor-positive advanced or metastatic breast cancer, including a subgroup who have the phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA) tumour mutation.

ReferenceCitation: Hrebien S, Citi V, Garcia-Murillas I, Cutts R, Fenwick K, Kozarewa I, McEwen R, Ratnayake J, Maudsley R, Carr TH, de Bruin EC, Schiavon G, Oliveira M, Turner N. Early ctDNA dynamics as a surrogate for progression-free survival in advanced breast cancer in the BEECH trial. Ann Oncol. 2019 Jun 1;30(6):945-952. doi: 10.1093/annonc/mdz085.

family: Hrebien

full_name: S. Hrebien

given: S.

family: Citi

full_name: V. Citi

given: V.

family: Garcia-Murillas

full_name: I. Garcia-Murillas

given: I.

family: Cutts

full_name: R. Cutts

given: R.

family: Fenwick

full_name: K. Fenwick

given: K.

family: Kozarewa

full_name: I. Kozarewa

family: McEwen

full_name: R. McEwen

family: Ratnayake

full_name: J. Ratnayake

given: J.

family: Maudsley

full_name: R. Maudsley

family: Carr

full_name: T.H. Carr

family: de Bruin

full_name: E.C. de Bruin

family: Schiavon

full_name: G. Schiavon

given: G.

family: Oliveira

full_name: M. Oliveira

given: M.

family: Turner

full_name: N. Turner

given: N.

journal_name: Annals of Oncology

evidence: oa repository (semantic scholar lookup)

ReferenceCitation: Turner NC, Alarcón E, Armstrong AC, Philco M, López Chuken YA, Sablin MP, Tamura K, Gómez Villanueva A, Pérez-Fidalgo JA, Cheung SYA, Corcoran C, Cullberg M, Davies BR, de Bruin EC, Foxley A, Lindemann JPO, Maudsley R, Moschetta M, Outhwaite E, Pass M, Rugman P, Schiavon G, Oliveira M. BEECH: a dose-finding run-in followed by a randomised phase II study assessing the efficacy of AKT inhibitor capivasertib (AZD5363) combined with paclitaxel in patients with estrogen receptor-positive advanced or metastatic breast cancer, and in a PIK3CA mutant sub-population. Ann Oncol. 2019 May 1;30(5):774-780. doi: 10.1093/annonc/mdz086.

full_name: N.C. Turner

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

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:
Peru
Mexico
France
Japan
Czechia
Bulgaria
Singapore
Spain
Canada
United Kingdom
Korea, Republic of