title: A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

summary: A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

ReferenceCitation: Rogers KA, Thompson PA, Allan JN, Coleman M, Sharman JP, Cheson BD, Jones D, Izumi R, Frigault MM, Quah C, Raman RK, Patel P, Wang MH, Kipps TJ. Phase II study of acalabrutinib in ibrutinib-intolerant patients with relapsed/refractory chronic lymphocytic leukemia. Haematologica. 2021 Sep 1;106(9):2364-2373. doi: 10.3324/haematol.2020.272500.

family: Rogers

full_name: Kerry A. Rogers

given: Kerry A.

family: Thompson

full_name: Philip A. Thompson

given: Philip A.

family: Allan

full_name: John N. Allan

given: John N.

family: Coleman

full_name: Morton Coleman

given: Morton

family: Sharman

full_name: Jeff P. Sharman

given: Jeff P.

family: Cheson

full_name: Bruce D. Cheson

given: Bruce D.

family: Jones

full_name: Daniel Jones

given: Daniel

family: Izumi

full_name: Raquel Izumi

given: Raquel

family: Frigault

full_name: Melanie M. Frigault

given: Melanie M.

family: Quah

full_name: Cheng Quah

given: Cheng

family: Raman

full_name: Rakesh K. Raman

given: Rakesh K.

family: Patel

full_name: Priti Patel

given: Priti

family: Wang

full_name: Min Hui Wang

given: Min Hui

family: Kipps

full_name: Thomas J. Kipps

given: Thomas J.

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. Epub 2016 Sep 6.

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: Acerta Pharma BV

location_country:
France
Israel
Belgium
Spain
United States
United Kingdom


ReferenceType: derived

ReferenceCitation: Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clin Cancer Res. 2020 Mar 15;26(6):1247-1257. doi: 10.1158/1078-0432.CCR-18-4071. Epub 2019 Sep 16.

family: Falchook

full_name: Gerald Falchook

given: Gerald

sequence: first

family: Rosen

full_name: Seth Rosen

given: Seth

sequence: additional

family: LoRusso

full_name: Patricia LoRusso

given: Patricia

family: Watts

full_name: Justin Watts

given: Justin

family: Gupta

full_name: Shilpa Gupta

given: Shilpa

family: Coombs

full_name: Catherine C. Coombs

given: Catherine C.

family: Talpaz

full_name: Moshe Talpaz

given: Moshe

family: Kurzrock

full_name: Razelle Kurzrock

given: Razelle

family: Mita

full_name: Monica Mita

given: Monica

family: Cassaday

full_name: Ryan Cassaday

given: Ryan

family: Harb

full_name: Wael Harb

given: Wael

family: Peguero

full_name: Julio Peguero

given: Julio

family: Smith

full_name: David C. Smith

given: David C.

family: Piha-Paul

full_name: Sarina A. Piha-Paul

given: Sarina A.

family: Szmulewitz

full_name: Russ Szmulewitz

given: Russ

family: Noel

full_name: Marcus S. Noel

given: Marcus S.

family: Yeleswaram

full_name: Swamy Yeleswaram

given: Swamy

family: Liu

full_name: Phillip Liu

given: Phillip

family: Switzky

full_name: Julie Switzky

given: Julie

family: Zhou

full_name: Gongfu Zhou

given: Gongfu

family: Zheng

full_name: Fred Zheng

given: Fred

family: Mehta

full_name: Amitkumar Mehta

given: Amitkumar

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Cancer Research

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Association for Cancer Research (AACR)

location_facility: MultiCare Institute for Research and Innovation

location_facility: University of North Carolina at Chapel Hill

location_facility: Sarah Cannon Research Institute at Health One

location_facility: Hematology - Oncology Associates of Treasure Coast

location_facility: HÔPITAL SAINT-LOUIS, Service Hématologie Adultes

location_facility: Institut Jules Bordet, Clinical Trial Conduct Unit

location_facility: University of Rochester, Wilmot Cancer Center

title: A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

summary:
The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies.

Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.


title: A Phase 1 Multicenter, Open-label, Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors

summary: The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: MedImmune LLC

location_country:
United States
France
Netherlands

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients With Primary Sclerosing Cholangitis

summary: The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

design_allocation: Randomized

ReferenceCitation: Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun.

family: Sanyal

full_name: Arun J. Sanyal

given: Arun J.

family: Ling

full_name: Lei Ling

given: Lei

family: Beuers

full_name: Ulrich Beuers

given: Ulrich

family: DePaoli

full_name: Alex M. DePaoli

given: Alex M.

family: Lieu

full_name: Hsiao D. Lieu

given: Hsiao D.

family: Harrison

full_name: Stephen A. Harrison

given: Stephen A.

family: Hirschfield

full_name: Gideon M. Hirschfield

given: Gideon M.

journal_name: JHEP Reports

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: NGM Biopharmaceuticals, Inc

location_country:
United States
United Kingdom
France
Netherlands

location_facility:
NGM Clinical Study Site 101
NGM Clinical Study Site 120
NGM Clinical Study Site 117
NGM Clinical Study Site 504
NGM Clinical Study Site 109
NGM Clinical Study Site 125
NGM Clinical Study Site 406
NGM Clinical Study Site 107
NGM Clinical Study Site 401
NGM Clinical Study Site 110
NGM Clinical Study Site 118
NGM Clinical Study Site 122
NGM Clinical Study Site 407
NGM Clinical Study Site 502
NGM Clinical Study Site 402
NGM Clinical Study Site 116
NGM Clinical Study Site 113
NGM Clinical Study Site 119
NGM Clinical Study Site 404
NGM Clinical Study Site 124
NGM Clinical Study Site 505
NGM Clinical Study Site 405
NGM Clinical Study Site 301
NGM Clinical Study Site 111
NGM Clinical Study Site 114
NGM Clinical Study Site 115
NGM Clinical Study Site 105
NGM Clinical Study Site 503
NGM Clinical Study Site 103
NGM Clinical Study Site 121
NGM Clinical Study Site 501
NGM Clinical Study Site 126
NGM Clinical Study Site 127
NGM Clinical Study Site 112
NGM Clinical Study Site 102
NGM Clinical Study Site 108
NGM Clinical Study Site 104
NGM Clinical Study Site 106

intervention_type: Other


intervention_type: Genetic

status: Enrolling by invitation

study_type: Observational

lead_sponsor: bluebird bio

enrollment_type: Anticipated

location_country:
Brazil
Germany
France
Argentina
Australia
United States
United Kingdom

time_perspective: Prospective

location_facility: Boston Children's Hospital/Massachusetts General Hospital

location_facility: Hospital das Clínicas da Universidade de São Paulo

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: Long-term Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product

summary:
This is a multi-center, long-term safety and efficacy follow-up study for participants with cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product in a parent clinical study.

After completing a parent clinical study (approximately 2 years), eligible participants will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.

status_simplified: Unknown


intervention_type: Drug

status: Terminated

lead_sponsor: ThromboGenics

location_country:
Italy
United States
France
Czechia
Israel
Hungary
Spain
Germany
United Kingdom

acronym: CIRCLE

title: A Phase 2, Randomised, Double Masked, Sham Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total Posterior Vitreous Detachment (PVD) in Subjects With Non-proliferative Diabetic Retinopathy (NPDR)

summary: The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment (PVD) in order to reduce the risk of disease progression to proliferative diabetic retinopathy (PDR).


title: A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma

acronym: FOCUS

summary: This study will evaluate patients who have melanoma that has spread from the eye to the liver: Patients in the study will be treated with Melphalan/HDS up to 6 total treatment, and will be followed until death. This study will evaluate the safety and effects of the treatment on how long patients live and how long it takes for the cancer to advance or respond to the treatment.

status: Active, not recruiting

ipd_sharing: No

lead_sponsor: Delcath Systems Inc.

location_country:
Italy
Austria
Switzerland
Germany
France
Belgium
Spain
United States
United Kingdom

location_facility: Universitätsklinikum Giessen und Marburg

location_facility: Ohio State University James Cancer Center

location_facility: Charité Unversitätsmedizin Berlin Comprehensive Cancer Center

location_facility: University Hospital Southampton NHS Trust

location_facility: University of Tennessee Health Science Center

intervention_type: Combination Product

status_simplified: Ongoing


title: Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation, a Multicenter Study (INTERHEART)

summary: Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care for heart transplant patients.

status: Recruiting

ReferenceType: background

ReferenceCitation: Parkes MD, Aliabadi AZ, Cadeiras M, Crespo-Leiro MG, Deng M, Depasquale EC, Goekler J, Kim DH, Kobashigawa J, Loupy A, Macdonald P, Potena L, Zuckermann A, Halloran PF. An integrated molecular diagnostic report for heart transplant biopsies using an ensemble of diagnostic algorithms. J Heart Lung Transplant. 2019 Jun;38(6):636-646. doi: 10.1016/j.healun.2019.01.1318. Epub 2019 Feb 6.

ReferenceType: result

ReferenceCitation: Loupy A, Duong Van Huyen JP, Hidalgo L, Reeve J, Racapé M, Aubert O, Venner JM, Falmuski K, Bories MC, Beuscart T, Guillemain R, François A, Pattier S, Toquet C, Gay A, Rouvier P, Varnous S, Leprince P, Empana JP, Lefaucheur C, Bruneval P, Jouven X, Halloran PF. Gene Expression Profiling for the Identification and Classification of Antibody-Mediated Heart Rejection. Circulation. 2017 Mar 7;135(10):917-935. doi: 10.1161/CIRCULATIONAHA.116.022907. Epub 2017 Feb 1.

name: From Paris Descartes University and Hôpital Necker, Assistance Publique-Hôpitaux de Paris, France (A.L., J.P.D.V.H., M.R.); Paris Translational Research Centre for Organ Transplantation, INSERM, UMR-S970, France (A.L., J.P.D.V.H., O.A., T.B., J.P.E., C.L., P.B., X.J.); Pathology Department, Necker Hospital, Paris, France (J.P.D.V.H.); Alberta Transplant Applied Genomics Centre; University of Alberta, Edmonton, AB, Canada (L.H., J.R., J.M.V., K.F., P.F.H.); Cardiology Department and Intensive Care (M...

family: Loupy

full_name: Alexandre Loupy

given: Alexandre

family: Duong Van Huyen

full_name: Jean Paul Duong Van Huyen

given: Jean Paul

family: Hidalgo

full_name: Luis Hidalgo

given: Luis

family: Reeve

full_name: Jeff Reeve

given: Jeff

family: Racapé

full_name: Maud Racapé

given: Maud

family: Aubert

full_name: Olivier Aubert

given: Olivier

family: Venner

full_name: Jeffery M. Venner

given: Jeffery M.

family: Falmuski

full_name: Konrad Falmuski

given: Konrad

family: Bories

full_name: Marie Cécile Bories

given: Marie Cécile

family: Beuscart

full_name: Thibaut Beuscart

given: Thibaut

family: Guillemain

full_name: Romain Guillemain

given: Romain

family: François

full_name: Arnaud François

given: Arnaud

family: Pattier

full_name: Sabine Pattier

given: Sabine

family: Toquet

full_name: Claire Toquet

given: Claire

family: Gay

full_name: Arnaud Gay

family: Rouvier

full_name: Philippe Rouvier

given: Philippe

family: Varnous

full_name: Shaida Varnous

given: Shaida

family: Leprince

full_name: Pascal Leprince

given: Pascal

family: Empana

full_name: Jean Philippe Empana

given: Jean Philippe

family: Lefaucheur

full_name: Carmen Lefaucheur

given: Carmen

family: Bruneval

full_name: Patrick Bruneval

given: Patrick

family: Jouven

full_name: Xavier Jouven

given: Xavier

family: Halloran

full_name: Philip F. Halloran

given: Philip F.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Halloran PF, Potena L, Van Huyen JD, Bruneval P, Leone O, Kim DH, Jouven X, Reeve J, Loupy A. Building a tissue-based molecular diagnostic system in heart transplant rejection: The heart Molecular Microscope Diagnostic (MMDx) System. J Heart Lung Transplant. 2017 Nov;36(11):1192-1200. doi: 10.1016/j.healun.2017.05.029. Epub 2017 May 29.

journal_name: The Journal of Heart and Lung Transplantation

ReferenceCitation: Halloran PF, Reeve J, Aliabadi AZ, Cadeiras M, Crespo-Leiro MG, Deng M, Depasquale EC, Goekler J, Jouven X, Kim DH, Kobashigawa J, Loupy A, Macdonald P, Potena L, Zuckermann A, Parkes MD. Exploring the cardiac response to injury in heart transplant biopsies. JCI Insight. 2018 Oct 18;3(20). pii: 123674. doi: 10.1172/jci.insight.123674.

publisher: American Society for Clinical Investigation

ReferenceCitation: Halloran PF, Madill-Thomsen K, Aliabadi-Zuckermann AZ, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Gökler J, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A. Many heart transplant biopsies currently diagnosed as no rejection have mild molecular antibody-mediated rejection-related changes. J Heart Lung Transplant. 2021 Aug 26. pii: S1053-2498(21)02458-X. doi: 10.1016/j.healun.2021.08.004. [Epub ahead of print]

ReferenceCitation: Halloran PF. Integrating molecular and histologic interpretation of transplant biopsies. Clin Transplant. 2021 Apr;35(4):e14244. doi: 10.1111/ctr.14244. Epub 2021 Feb 17.

name: Alberta Transplant Applied Genomics Centre Edmonton AB Canada

name: Division of Nephrology and Transplant Immunology Department of Medicine University of Alberta Edmonton AB Canada

location_country:
Italy
Austria
United States
France
Australia
Spain
Canada

location_facility: Alberta Transplant Applied Genomics Center, University of Alberta

location_facility: Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute

location_facility: Cardiovascular Medicine, University of Utah Health

location_facility: Heart Failure and Heart Transplant Unit, University of Bologna

location_facility: Division of Cardiology, University of Alberta

location_facility: Virginia Commonwealth University, Division of Cardiology

location_facility: Service de Néphrologie-Dialyse Adultes , Hôpital Necker-Enfants Malades

location_facility: Department of Cardiac Surgery, Medical University of Vienna


title: A Multi-Center, Prospective, Observational Study to Assess Outcomes for Patients Treated for Lumbar Spinal Conditions Using an OLIF25™ and/or OLIF51™Approach

summary: The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.

lead_sponsor: Medtronic Spinal and Biologics

location_country:
Italy
France
Czechia
Belgium
Puerto Rico
Portugal
United States

location_facility: Foundation for Orthopaedic Research and Education (FORE)

location_facility: Alleghany Health Network Research Institute

location_facility: Azienda Ospedaliera - Ospedale Civile di Legnano

location_facility: University of California San Francisco (UCSF)

intervention_type: Procedure


title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)

summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in subjects with NDD-CKD

ReferenceCitation: Chertow GM, Pergola PE, Farag YMK, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K, McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU; PRO2TECT Study Group. Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med. 2021 Apr 29;384(17):1589-1600. doi: 10.1056/NEJMoa2035938.

name: From Stanford University School of Medicine, Palo Alto, CA (G.M.C., E.F.L.); Renal Associates, San Antonio (P.E.P.), U.S. Renal Care, Plano (G.A.B.), Baylor University Medical Center, Baylor Heart and Vascular Hospital, Baylor Heart and Vascular Institute, Dallas (P.A.M.), and the Section of Nephrology, Baylor College of Medicine, Houston (W.C.W.) — all in Texas; Akebia Therapeutics, Cambridge (Y.M.K.F., S.B., Z.K., W.L., B.J.M., A.S., D.L.V.), and the Division of Nephrology, Tufts Medical Center, Tufts...

family: Chertow

full_name: Glenn M. Chertow

given: Glenn M.

family: Pergola

full_name: Pablo E. Pergola

given: Pablo E.

family: Farag

full_name: Youssef M.K. Farag

given: Youssef M.K.

family: Agarwal

full_name: Rajiv Agarwal

given: Rajiv

family: Arnold

full_name: Susan Arnold

given: Susan

family: Bako

full_name: Gabriel Bako

given: Gabriel

family: Block

full_name: Geoffrey A. Block

given: Geoffrey A.

family: Burke

full_name: Steven Burke

given: Steven

family: Castillo

full_name: Fausto P. Castillo

given: Fausto P.

family: Jardine

full_name: Alan G. Jardine

given: Alan G.

family: Khawaja

full_name: Zeeshan Khawaja

given: Zeeshan

family: Koury

full_name: Mark J. Koury

given: Mark J.

family: Lewis

full_name: Eldrin F. Lewis

given: Eldrin F.

family: Lin

full_name: Tim Lin

given: Tim

family: Luo

full_name: Wenli Luo

given: Wenli

family: Maroni

full_name: Bradley J. Maroni

given: Bradley J.

family: Matsushita

full_name: Kunihiro Matsushita

given: Kunihiro

family: McCullough

full_name: Peter A. McCullough

given: Peter A.

family: Parfrey

full_name: Patrick S. Parfrey

given: Patrick S.

family: Roy-Chaudhury

full_name: Prabir Roy-Chaudhury

given: Prabir

family: Sarnak

full_name: Mark J. Sarnak

family: Sharma

full_name: Amit Sharma

given: Amit

family: Spinowitz

full_name: Bruce Spinowitz

given: Bruce

title: Vadadustat in Patients with Anemia and Non–Dialysis-Dependent CKD

location_country:
Italy
Brazil
South Africa
Mexico
Spain
France
Bulgaria
Malaysia
Israel
Poland
Hungary
Argentina
Australia
New Zealand
Puerto Rico
Russian Federation
United States
United Kingdom
Korea, Republic of
Ukraine

location_facility:
Research Site #3
Research Site
Research Site #1
Research Site #2


title: A Prospective, Multi-center, Post Market Randomized Controlled Trial Comparing VT Ablation Outcomes Using Remote MAGNETIC Navigation Guided Substrate Mapping and Ablation Versus Manual Approach in a Low LVEF Population

acronym: MAGNETIC-VT

summary: The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.

ReferenceCitation: Di Biase L, Tung R, Szili-Torok T, Burkhardt JD, Weiss P, Tavernier R, Berman AE, Wissner E, Spear W, Chen X, Neužil P, Skoda J, Lakkireddy D, Schwagten B, Lock K, Natale A; MAGNETIC VT investigators. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population. J Interv Card Electrophysiol. 2017 Apr;48(3):237-245. doi: 10.1007/s10840-016-0217-3. Epub 2017 Jan 7.

family: Di Biase

full_name: Luigi Di Biase

given: Luigi

family: Tung

full_name: Roderick Tung

given: Roderick

family: Szili-Torok

full_name: Tamás Szili-Torok

given: Tamás

family: Burkhardt

full_name: J. David Burkhardt

given: J. David

family: Weiss

full_name: Peter Weiss

given: Peter

family: Tavernier

full_name: Rene Tavernier

given: Rene

family: Berman

full_name: Adam E. Berman

given: Adam E.

family: Wissner

full_name: Erik Wissner

given: Erik

family: Spear

full_name: William Spear

given: William

family: Chen

full_name: Xu Chen

given: Xu

family: Neužil

full_name: Petr Neužil

given: Petr

family: Skoda

full_name: Jan Skoda

given: Jan

family: Lakkireddy

full_name: Dhanunjaya Lakkireddy

given: Dhanunjaya

family: Schwagten

full_name: Bruno Schwagten

given: Bruno

family: Lock

full_name: Ken Lock

given: Ken

family: Natale

full_name: Andrea Natale

given: Andrea

journal_name: Journal of Interventional Cardiac Electrophysiology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Stereotaxis

location_country:
Netherlands
France
Czechia
Belgium
Australia
Denmark
United States

location_facility: Texas Cardiac Arrhythmia Research Foundation

intervention_type: Device


title: Longterm Follow-up of Subjects With Hemoglobinopathies Treated With Ex Vivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector

summary: This is a multi-center, long-term safety and efficacy follow-up study for subjects with hemoglobinopathies (β-thalassemia or severe sickle cell disease) who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored clinical studies. After completing the parent clinical study (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in the study.

location_country:
Italy
United States
France
Thailand
Australia
Germany
United Kingdom


title: A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects With Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation

acronym: VALOR (Part C)

summary:
The primary objectives of Parts A and B of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of BIIB067 (tofersen) in adults with ALS and a documented superoxide dismutase 1 (SOD1) mutation. The primary objective of Part C of this study is to evaluate the clinical efficacy of BIIB067 administered to adults with ALS and a confirmed SOD1 mutation.

The secondary objective of Parts A and B of this study is to evaluate the effects of BIIB067 on levels of total SOD1 protein in the cerebrospinal fluid (CSF). The secondary objectives of Part C are to evaluate the safety, tolerability, pharmacodynamic (PD), and biomarker effects of BIIB067.

ReferenceCitation: Miller T, Cudkowicz M, Shaw PJ, Andersen PM, Atassi N, Bucelli RC, Genge A, Glass J, Ladha S, Ludolph AL, Maragakis NJ, McDermott CJ, Pestronk A, Ravits J, Salachas F, Trudell R, Van Damme P, Zinman L, Bennett CF, Lane R, Sandrock A, Runz H, Graham D, Houshyar H, McCampbell A, Nestorov I, Chang I, McNeill M, Fanning L, Fradette S, Ferguson TA. Phase 1-2 Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. 2020 Jul 9;383(2):109-119. doi: 10.1056/NEJMoa2003715.

name: From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) — both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching...

family: Miller

full_name: Timothy Miller

given: Timothy

family: Cudkowicz

full_name: Merit Cudkowicz

given: Merit

family: Shaw

full_name: Pamela J. Shaw

given: Pamela J.

family: Andersen

full_name: Peter M. Andersen

given: Peter M.

family: Atassi

full_name: Nazem Atassi

given: Nazem

family: Bucelli

full_name: Robert C. Bucelli

given: Robert C.

family: Genge

full_name: Angela Genge

given: Angela

family: Glass

full_name: Jonathan Glass

given: Jonathan

family: Ladha

full_name: Shafeeq Ladha

given: Shafeeq

family: Ludolph

full_name: Albert L. Ludolph

given: Albert L.

family: Maragakis

full_name: Nicholas J. Maragakis

given: Nicholas J.

family: McDermott

full_name: Christopher J. McDermott

given: Christopher J.

family: Pestronk

full_name: Alan Pestronk

given: Alan

family: Ravits

full_name: John Ravits

given: John

family: Salachas

full_name: François Salachas

given: François

family: Trudell

full_name: Randall Trudell

given: Randall

family: Van Damme

full_name: Philip Van Damme

given: Philip

family: Zinman

full_name: Lorne Zinman

given: Lorne

family: Bennett

full_name: C. Frank Bennett

given: C. Frank

family: Lane

full_name: Roger Lane

given: Roger

family: Sandrock

full_name: Alfred Sandrock

given: Alfred

family: Runz

full_name: Heiko Runz

given: Heiko

family: Graham

full_name: Danielle Graham

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

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

title: Phase 1–2 Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

location_country:
Italy
United States
Germany
France
Japan
Poland
Belgium
Australia
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility: University of Calgary - Health Sciences Centre

location_facility: University of California San Diego Medical Center

location_facility: Northwestern University Feinberg School of Medicine

location_facility: New Orleans Center for Clinical Research/Volunteer Research Group, an AMR Company

location_facility: ALS Center - Dept. of Neuroscience "Rita Levi Montalcini", University of Turin


title: Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension

summary:
The TOPP-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further insights in the disease course and long-term outcome of PH in childhood.

Patients will undergo clinical assessments and receive standard medical care, as determined by treating physicians in their daily clinical practice. The TOPP-2 registry is specifically designed to capture the variables that have been proposed as treatment goals in PePH and the reasons for changes in treatment strategy.

The TOPP-2 registry uses the new clinical classification of PH as outlined at the 5th World Symposium for Pulmonary Hypertension (WSPH) in Nice 2013 and includes new characterizations for children with PH.

The registry is planned and implemented under the scientific leadership of the Association for Pediatric Pulmonary Hypertension (PePH), independently from the financial sponsors.

All enrolled patients will have a follow-up period of 18 months.

location_country:
Italy
Brazil
United States
Sweden
Saudi Arabia
Switzerland
Mexico
Netherlands
Germany
France
Japan
Poland
Israel
Hungary
Australia
China
Canada
Colombia

location_facility: Beatrix Children's Hospital, University Medical Center Groningen

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Colorado Denver School of Medicine, Children's Hospital Colorado

location_facility: Vanderbilt University Children's Hospital

location_facility: Hadassah, Hebrew University Medical Center


type: Registry Identifier

title: A Randomised Two Arm Open Label Controlled Trial Comparing Standard Immediate Cord Clamping Versus Deferring Cord Clamping for 60 Seconds or More in Babies Born Less Than 30 Weeks of Gestation to Determine Which Cord Clamping Method Results in Improved Survival and Less Disability.

acronym: APTS

summary: To establish if placental transfusion, using deferred cord clamping for 60 seconds or more while holding the baby at or below the level of the placenta, will improve survival without disability compared with standard early cord clamping in preterm babies less than 30 weeks of gestation.

primary_purpose: Prevention

lead_sponsor: University of Sydney

location_country:
United States
Pakistan
France
Australia
New Zealand
Canada
United Kingdom

location_facility:
Royal North Shore Hospital
Nepean Hospital
Monash Medical Centre
Hôpital Antoine-Béclère
Auckland Hospital
Wellington Hospital
King Edward Memorial Hospital
University of Vermont Medical Centre
Craigavon Area Hospital
Royal Jubilee Maternity Hospital
Mater Mother's Hospital
Townsville Hospital
Baylor College of Medicine
Dunedin Hospital
Canberra Hospital
John Hunter Hospital
Royal Brisbane and Women's Hospital
Royal Prince Alfred Hospital
Waikato Hospital
Aga Khan University Hospital
Mercy Hospital for Women
Royal Hospital for Women
Liverpool Hospital
IWK Health Center
Christchurch Hospital
Flinders Medical Centre

lead_sponsor_type: academique


lead_sponsor: Biogen

location_country:
Italy
United States
Sweden
Hong Kong
Germany
France
Japan
Belgium
Australia
Spain
Turkey
Canada
United Kingdom
Korea, Republic of

acronym: SHINE

location_facility:
Research site
Research Site

title: An Open-Label Extension Study for Patients With Spinal Muscular Atrophy Who Previously Participated in Investigational Studies of ISIS 396443

summary: The primary objective is to evaluate the long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.


type: Other Identifier

title: An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

summary: The purpose of this clinical phase I/II study is to investigate the safety and tolerability of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumors (NETs). Secondary objectives of these study are the assessment of biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201.

lead_sponsor: Ipsen

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

location_facility: Peter MacCallum Cancer Centre, Molecular Imaging and Targeted Therapeutics Laboratory

location_facility: University Hospital Aarhus, Department of Hepatology and Gastroenterology

location_facility: MD Anderson Cancer Center, Department of Nuclear Medicine

location_facility: CHU de Nantes, Hotel Dieu, Service de Medecine Nucleaire

location_facility: Ramsay Hollywood Private Hospital, Department of Nuclear Medicine

location_facility: University Hospital Basel, Department of Nuclear Medicine

location_facility: Royal Free Hospital, Department of Nuclear Medicine

location_facility: University Hospital Vienna, Department of Nuclear Medicine

location_facility: CHU de Quebec - Universite Laval Research Center, Department of Radiology and Nuclear Medicine


ReferenceCitation: Amato AA, Hanna MG, Machado PM, Badrising UA, Chinoy H, Benveniste O, Karanam AK, Wu M, Tankó LB, Schubert-Tennigkeit AA, Papanicolaou DA, Lloyd TE, Needham M, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Aoki M, Katsuno M, Morihata H, Murata K, Nodera H, Nishino I, Romano CD, Williams VSL, Vissing J, Zhang Auberson L; RESILIENT Study Extension Group. Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT. Neurology. 2021 Mar 23;96(12):e1595-e1607. doi: 10.1212/WNL.0000000000011626. Epub 2021 Feb 17.

family: Amato

full_name: Anthony A. Amato

given: Anthony A.

family: Hanna

full_name: Michael G. Hanna

given: Michael G.

family: Machado

full_name: Pedro M. Machado

given: Pedro M.

family: Badrising

full_name: Umesh A. Badrising

given: Umesh A.

family: Chinoy

full_name: Hector Chinoy

given: Hector

family: Benveniste

full_name: Olivier Benveniste

given: Olivier

family: Karanam

full_name: Ananda Krishna Karanam

given: Ananda Krishna

family: Wu

full_name: Min Wu

given: Min

family: Tankó

full_name: László B. Tankó

given: László B.

family: Schubert-Tennigkeit

full_name: Agnes Annette Schubert-Tennigkeit

given: Agnes Annette

family: Papanicolaou

full_name: Dimitris A. Papanicolaou

given: Dimitris A.

family: Lloyd

full_name: Thomas E. Lloyd

given: Thomas E.

family: Needham

full_name: Merrilee Needham

given: Merrilee

family: Liang

full_name: Christina Liang

given: Christina

family: Reardon

full_name: Katrina A. Reardon

given: Katrina A.

family: de Visser

full_name: Marianne de Visser

given: Marianne

family: Ascherman

full_name: Dana P. Ascherman

given: Dana P.

family: Barohn

full_name: Richard J. Barohn

given: Richard J.

family: Dimachkie

full_name: Mazen M. Dimachkie

given: Mazen M.

family: Miller

full_name: James A.L. Miller

given: James A.L.

family: Kissel

full_name: John T. Kissel

given: John T.

family: Oskarsson

full_name: Björn Oskarsson

given: Björn

family: Joyce

full_name: Nanette C. Joyce

given: Nanette C.

family: Van den Bergh

full_name: Peter Van den Bergh

given: Peter

family: Baets

full_name: Jonathan Baets

name: on behalf of the RESILIENT Study Extension Group

location_country:
Italy
Switzerland
Netherlands
France
Japan
Belgium
Australia
Denmark
United States
United Kingdom

title: Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body Myositis

summary:
This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patient eligibility), followed by a Treatment Period 1 epoch (double-blind and placebo-controlled), and a Treatment Period 2 epoch (open-label). A Post-treatment Follow-up (FUP) epoch was also planned for patients who discontinued prematurely. Patients who complete the core study and qualify for this extension study entered Treatment Period 1 and continued on the study drug to which they were randomized in the core study (either to one of the three bimagrumab doses (1 mg/kg, 3 mg/kg, and 10mg/kg) or placebo) during Treatment Period 1. Thus, Treatment Period 1 was double-blind and placebo-controlled. Participants were to continue in Treatment Period 1 until the dose with the best benefit-risk profile was determined from the core study data and selected (duration of Treatment Period 1 was estimated to be between 6 and 8 months). Once the dose with the best benefit-risk profile was selected, all participants (including those who were receiving placebo) were planned to enter Treatment Period 2 and switch to open-label treatment with bimagrumab at the selected dose. The core study has been completed but since the core study did not meet the primary end point (no bimagrumab dose was identified based on the core study efficacy results) the extension study was terminated as per protocol/sponsor's decision; therefore, no patients had entered Treatment Period 2. Instead, all patients were to return for the End of Treatment Period 1 (EOT1) visit at their next scheduled visit. As per protocol, all patients who discontinued study medication during Treatment Period 1 for any reason, including due to the study having been stopped as per protocol/sponsor's decision, were to have entered and complete the 6-month FUP after their EOT1 visit.

Due to the nature of the design of the core and extension studies and termination of study medication in the extension study, the treatment duration for individual patients varied considerably. Consequently, the number of patients contributing data to the efficacy analyses at Week 104 and later timepoints was decreased.


ReferenceCitation: Chapman K, van Zyl-Smit R, Maspero J, Kerstjens HAM, Gon Y, Hosoe M, Tanase AM, Pethe A, Shu X, D'Andrea P. One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies. BMJ Open Respir Res. 2021 Aug;8(1). pii: e000819. doi: 10.1136/bmjresp-2020-000819.

family: Chapman

full_name: Kenneth Chapman

given: Kenneth

family: van Zyl-Smit

full_name: Richard van Zyl-Smit

given: Richard

family: Maspero

full_name: Jorge Maspero

given: Jorge

family: Kerstjens

full_name: Huib A M Kerstjens

given: Huib A M

family: Gon

full_name: Yasuhiro Gon

given: Yasuhiro

family: Hosoe

full_name: Motoi Hosoe

given: Motoi

family: Tanase

full_name: Ana-Maria Tanase

given: Ana-Maria

family: Pethe

full_name: Abhijit Pethe

given: Abhijit

family: Shu

full_name: Xu Shu

given: Xu

family: D’Andrea

full_name: Peter D’Andrea

currency_apc_doaj: GBP

journal_name: BMJ Open Respiratory Research

license: cc-by-nc

license_normalized: cc-by-nc

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

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

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Kerstjens HAM, Maspero J, Chapman KR, van Zyl-Smit RN, Hosoe M, Tanase AM, Lavecchia C, Pethe A, Shu X, D'Andrea P; IRIDIUM trial investigators. Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study. Lancet Respir Med. 2020 Oct;8(10):1000-1012. doi: 10.1016/S2213-2600(20)30190-9. Epub 2020 Jul 9.

full_name: Kenneth R Chapman

given: Kenneth R

full_name: Richard N van Zyl-Smit

given: Richard N

family: Lavecchia

full_name: Catherine Lavecchia

given: Catherine

title: Once-daily, single-inhaler mometasone–indacaterol–glycopyrronium versus mometasone–indacaterol or twice-daily fluticasone–salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study

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:
Peru
Jordan
Finland
Greece
Romania
Belgium
Russian Federation
Denmark
India
Croatia
France
Japan
Lithuania
Poland
Slovakia
Thailand
Argentina
Canada
Colombia
South Africa
Chile
Sweden
Switzerland
Netherlands
Philippines
Vietnam
Bulgaria
Hungary
Ireland
China
Portugal
Germany
United Kingdom
Italy
Austria
Lebanon
Mexico
Israel
Spain
Estonia
Latvia

acronym:
Safety and Efficacy study of QVM149 in asthmatic patients

 Sécurité d'emploi et efficacité du traitement QVM149 chez les patients asthmatiques

title: A Multicenter, Randomized, 52-week, Double-blind, Parallelgroup, Active Controlled Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

summary: The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.


title: STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)

summary:
The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to standard initiation, leads to:

Improved survival (primary outcome); and
Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days

ReferenceCitation: STARRT-AKI Investigators; Canadian Critical Care Trials Group; Australian and New Zealand Intensive Care Society Clinical Trials Group; United Kingdom Critical Care Research Group; Canadian Nephrology Trials Network; Irish Critical Care Trials Group, Bagshaw SM, Wald R, Adhikari NKJ, Bellomo R, da Costa BR, Dreyfuss D, Du B, Gallagher MP, Gaudry S, Hoste EA, Lamontagne F, Joannidis M, Landoni G, Liu KD, McAuley DF, McGuinness SP, Neyra JA, Nichol AD, Ostermann M, Palevsky PM, Pettilä V, Quenot JP, Qiu H, Rochwerg B, Schneider AG, Smith OM, Thomé F, Thorpe KE, Vaara S, Weir M, Wang AY, Young P, Zarbock A. Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury. N Engl J Med. 2020 Jul 16;383(3):240-251. doi: 10.1056/NEJMoa2000741. Erratum in: N Engl J Med. 2020 Jul 15;:.

journal_name: New England Journal of Medicine

oa_colors: green other

evidence: open (via free article)

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: Queen's University Belfast - Research Portal

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: STARRT-AKI Investigators. Statistical analysis plan for the Standard versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial. Crit Care Resusc. 2019 Sep;21(3):162-170.

ReferenceCitation: STARRT-AKI Investigators. STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury: Study Protocol for a Multi-National, Multi-Center, Randomized Controlled Trial. Can J Kidney Health Dis. 2019 Jun 10;6:2054358119852937. doi: 10.1177/2054358119852937. eCollection 2019.

currency_apc_doaj: USD

journal_name: Canadian Journal of Kidney Health and Disease

repository_institution: PubMed Central - Europe PMC

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Unity Health Toronto

location_country:
Italy
Austria
Brazil
Switzerland
Germany
Finland
France
Ireland
Australia
Belgium
New Zealand
China
United States
United Kingdom
Canada

location_facility: Centre de sante et de services sociaux de Trois-Rivieres (CIUSSS MCQ)

location_facility: Centre hospitalier de l'université de Montréal (Notre Dame)

location_facility: London Health Sciences Centre, University Hospital

location_facility: Trillium Health Partners - Mississauga Hospital

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: The First Affiliated Hospital of Xi'An Jiaotong University

location_facility: St. Paul's Hospital - Providence Health Care

location_facility: Centre hospitalier de l'université de Montréal (St. Luc)

location_facility: Centre Hôspitalier universitaire de Sherbrooke (CHUS)

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Western Health (Footscray Hospital & Sunshine Hospital)

location_facility: Eastern Hospital (Box Hill and Maroondah Hospital)

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: London Health Sciences Centre, Victoria Hospital

location_facility: Hospital de Clínicas de Porto Alegre - Rio Grande do Sul

location_facility: Xiangya Hospital Central South University

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval (IUCPQ)

location_facility: Centre Hospitalier Universitaire de Quebec (CHUQ)


lead_sponsor: Actelion

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
France
Ireland
Australia
Belgium
Spain
Denmark
Canada
United Kingdom

acronym: TRITON

location_facility: Washington University School of Medicine

location_facility: Piedmont Pulmonary and Critical Care Research

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

location_facility: University of Texas Southwestern Medical Center

location_facility: London Health Sciences Centre - Victoria Hospital

title: The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study

summary: The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.


title: A Phase I, First-Time-in-Human Study of MEDI9197, a TLR 7/8 Agonist, Administered Intratumorally as a Single Agent in Subjects With Solid Tumors or CTCL and in Combination With Durvalumab and/or Palliative Radiation in Subjects With Solid Tumors

summary: To evaluate MEDI9197 when administered by intratumoral injection to subjects with solid tumors and in combination with durvalumab in subjects with solid tumors.

ReferenceCitation: Siu L, Brody J, Gupta S, Marabelle A, Jimeno A, Munster P, Grilley-Olson J, Rook AH, Hollebecque A, Wong RKS, Welsh JW, Wu Y, Morehouse C, Hamid O, Walcott F, Cooper ZA, Kumar R, Ferté C, Hong DS. Safety and clinical activity of intratumoral MEDI9197 alone and in combination with durvalumab and/or palliative radiation therapy in patients with advanced solid tumors. J Immunother Cancer. 2020 Oct;8(2). pii: e001095. doi: 10.1136/jitc-2020-001095.

family: Siu

full_name: Lillian Siu

given: Lillian

family: Brody

full_name: Joshua Brody

given: Joshua

family: Gupta

full_name: Shilpa Gupta

given: Shilpa

family: Marabelle

full_name: Aurélien Marabelle

given: Aurélien

family: Jimeno

full_name: Antonio Jimeno

given: Antonio

family: Munster

full_name: Pamela Munster

given: Pamela

family: Grilley-Olson

full_name: Juneko Grilley-Olson

given: Juneko

family: Rook

full_name: Alain H Rook

given: Alain H

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

family: Wong

full_name: Rebecca K S Wong

given: Rebecca K S

family: Welsh

full_name: James W Welsh

given: James W

family: Wu

full_name: Yuling Wu

given: Yuling

family: Morehouse

full_name: Christopher Morehouse

given: Christopher

family: Hamid

full_name: Oday Hamid

given: Oday

family: Walcott

full_name: Farzana Walcott

given: Farzana

family: Cooper

full_name: Zachary A Cooper

given: Zachary A

family: Kumar

full_name: Rakesh Kumar

given: Rakesh

family: Ferté

full_name: Charles Ferté

given: Charles

family: Hong

full_name: David S Hong

given: David S

journal_name: Journal for ImmunoTherapy of Cancer

repository_institution: California Digital Library - eScholarship


title: A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon Percutaneous Transluminal Angioplasty (PTA) Catheter for Treatment of Below-the-Knee (BTK) Arteries

acronym: BTKRegistry

summary: The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

lead_sponsor: C. R. Bard

location_country:
Italy
Austria
Saudi Arabia
Switzerland
Spain
France
Greece
Belgium
Portugal
Germany
United Kingdom

location_facility: Medical University Vienna, Department of Angiology

location_facility: A.O.U. Citta della Salute e della Scienza di Torino

location_facility: King Faisal Hospital and Medical research Center

location_facility: Hospital Santa Marta (C.H.Lisboa Central)

location_facility: Medical University Vienna, Department of Radiodiagnostic

location_facility: Universitäts-Herzzentrum Freiburg Bad Krozingen


title: An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

summary: An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease

lead_sponsor: Sunovion

location_country:
Italy
Austria
Germany
France
Spain
United States
United Kingdom
Canada

location_facility: Muhammed Ali Parkinson and Movement Disorder Center/Barrow Neurological Institute

location_facility: Columbia University Medical Center - Neurological Institute, Movement Disorders

location_facility: Emory University Department of Neurology

location_facility: University of Colorado School of Medicine

location_facility: St. Josef-Hospital, Klinikum der Ruhr-Universitaet-Bochum, Neurologische Klinik

location_facility: Hospital Universitari General de Catalunya

location_facility: Aging Research Center, Ce.S.I. University Foundation, Chieti-Pescara Behavioural Neurology & Movement Disorders Unit

location_facility: Parkinsons Disease and Movement Disorders Center

location_facility: Jefferson University Hospital Philadelphia

location_facility: Centre d'Investigation Clinique, CIC 1436, CHU Purpan

location_facility: USF Parkinson's Disease and Movement Disorder Center

location_facility: Central DuPage Hospital - Neurodegenerative Clinic - Movement Disorders Center

location_facility: Kansas University Medical Center-Department of Neurology

location_facility: Wilhelminenspital Department of Neurology

location_facility: IRCCS San Raffaele Pisana - Clinical Trial Center

location_facility: Royal Devon & Exeter NHS Foundation Trust

location_facility: Houston Methodist Neurological Institute

location_facility: University of Miami, Miller School of Medicine

location_facility: Bendheim Parkinson's and Movement Disorder Center (Mount Sinai Medical Center)

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Michigan State University - Dept. of Neurology

location_facility: The Ohio State University Wexner Medical Center

location_facility: UC Irvine Health Gottschalk Medical Plaza

location_facility: Universitätsklinikum Ulm Neurologisches Studienzentrum im RKU

location_facility: Park Nicolet Institute - Stuthers Parkinson's Center

location_facility: Kings College, The Maurice Wohl Neuroscience Institute

location_facility: SUNY Downstate Medical Center, Department of Neurology

location_facility: The Parkinson's and Movement Disorder Institute

location_facility: Parkinson's Disease Treatment Center of Southwest Florida

location_facility: Duke University - Movement Disorders Clinic

location_facility: Medical University Innsbruck Neurology Department


title: A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma

summary: Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.

primary_purpose: Health Services Research

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
United Kingdom
Netherlands
Spain
Germany
France
Bulgaria
Hungary
Belgium
Russian Federation
Portugal
Denmark
Canada
Latvia

location_facility: Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

location_facility: Clinical Research Center of Alabama, LLC

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: North Manchester Hospital; Respiratory Department

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Universitätsklinikum Freiburg, Abteilung Pneumologie

location_facility: AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia

location_facility: Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

location_facility: Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde

location_facility: Matrai Állami Gyógyintézet ; Bronchológia

location_facility: Hospital Universitario Reina Sofia; Servicio de Neumología

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neumologia

location_facility: Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia

location_facility: City Hospital #40 of Resort Administrative District

location_facility: FSBI "National Research Center - Institute of Immunology" of FMBA of Russia

location_facility: Saratov State Medical University; Chair Of Clinical Allergology

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: Hvidovre Hospital, Lungemedicinsk Afdeling

location_facility: A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B

location_facility: Latvian University postgraduate institute

location_facility: Research Institute of Complex Cardiovascular Pathology

location_facility: Debrecen Uni Medical School; Dept of Pulmonary Medicine

location_facility: Hospital de Galdakano; Servicio de Neumologia

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

location_facility: Berks-Schuylkill Respiratory Specialists, Ltd

location_facility: Institut für Allergie- und Asthmaforschung Berlin, IAAB

location_facility: Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás

location_facility: St. Paul's Hospital University of British Colambia Division of Hematology

location_facility: Clinical Hospital Gailezers; Dept of Pulmonology

location_facility: SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )

location_facility: Jewish General Hospital; Endoscopy Department

location_facility: Georgia Pollens Clinical Research Centers

location_facility: Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia

location_facility: Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio

location_facility: SBIH "Clinical dermatovenerologic dispensary " of Ministry of Health of the Krasnodar region

location_facility: Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases

location_facility: Hospital Clinic I provincial; Servicio de Neumologia

location_facility: IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE

location_facility: SBHI of NN region "RCH of NN n.a. N.A.Semashko"

location_facility: SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology

location_facility: Lungemedicinsk afd. L, Bispebjerg Hospital

location_facility: Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre

location_facility: KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt

location_facility: Riga 1st hospital, outpatient clinic Bruninieks


title: A Phase 2b/3 Prospective, Randomized, Double-Blind, Sham-Controlled 3-Part Trial of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Subjects With Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) Disease

summary:
Due to different study designs, the sponsor separated Part C into a separate registration (NCT04958642), leaving Parts A/B here in NCT02534844.

This study is to find out how safe and effective VTS-270 is for patients with Niemann-Pick Type C1 (NPC1) disease who have neurologic symptoms (listed under Keywords).

In Parts A/B, two out of every three patients will receive the study drug. The third patient will receive 1 to 2 small needle pricks at the location where the LP and IT injection is normally made (sham control).

In Part C, all participants will receive study drug, as described in the Part C registration record.

Start date for this record is the first day a participant was enrolled in Parts A/B. The trial is actually continuing until the last primary outcome measure of safety data are collected from Part C participants. The last primary outcome measure of safety, along with final adverse events results will be posted in the separate Part C registration record.

ipd_sharing_description: Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT02534844) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

lead_sponsor: Mandos LLC

location_country:
United States
France
Singapore
Australia
New Zealand
Spain
Turkey
Germany
United Kingdom

location_facility: National University Hospital (Singapore) Pte, Ltd

location_facility: Birmingham Women's and Children's NHS Trust

location_facility: Eunice Kennedy Shriver National Institute of Child Health and Human Development

location_facility: CHU Paris Est - Hospital d'Enfants Armand-Trousseau

location_facility: Dell Children's Medical Center of Central Texas

location_facility: Multicare Institute for Research and Innovation


title: A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

summary: The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

lead_sponsor: Gilead Sciences

location_country:
United States
Netherlands
Germany
France
Belgium
Australia
Canada
United Kingdom


title: A Phase I, Open-Label Study of GSK3174998 Administered Alone and in Combination With Anticancer Agents Including Pembrolizumab in Subjects With Selected Advanced Solid Tumors

summary:
This is a first time in human (FTIH), open-label, non-randomized, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary clinical activity of GSK3174998 administered intravenously to participants with selected advanced or recurrent solid tumors. This dose-escalation study will assess the safety, activity of GSK3174998 as monotherapy (Part 1), in combination with pembrolizumab (Part 2), and potentially in combination with additional therapies.

The study will be conducted in 2 parts, each part consisting of starting with a dose-escalation phase followed by a cohort expansion phase. GSK3174998 will first be evaluated as monotherapy in escalating doses. Once a dose of GSK3174998 has been identified that is both tolerable and demonstrates pharmacodynamic activity, enrollment of Part 2 may begin. In Part 2, escalating doses of GSK3174998 will be evaluated with fixed doses of pembrolizumab.

The maximum duration of treatment with GSK3174998 and pembrolizumab will be approximately 2 years or 35 cycles, whichever comes first. The follow-up period for safety assessments will be a minimum of 3 months from the date of the last dose. The post-treatment follow-up period will include disease assessments every 12 weeks until documented progressive disease (PD). Approximately 141 participants with selected advanced or recurrent solid tumors will be enrolled.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
United States
Canada
France
Netherlands


title: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN

acronym: TANGO

summary: This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.

ReferenceCitation: Markman JD, Bolash RB, McAlindon TE, Kivitz AJ, Pombo-Suarez M, Ohtori S, Roemer FW, Li DJ, Viktrup L, Bramson C, West CR, Verburg KM. Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety. Pain. 2020 Sep 1;161(9):2068-2078. doi: 10.1097/j.pain.0000000000001928.

family: Markman

full_name: John D. Markman

given: John D.

family: Bolash

full_name: Robert B. Bolash

given: Robert B.

family: McAlindon

full_name: Timothy E. McAlindon

given: Timothy E.

family: Kivitz

full_name: Alan J. Kivitz

given: Alan J.

family: Pombo-Suarez

full_name: Manuel Pombo-Suarez

given: Manuel

family: Ohtori

full_name: Seiji Ohtori

given: Seiji

family: Roemer

full_name: Frank W. Roemer

given: Frank W.

family: Li

full_name: David J. Li

given: David J.

family: Viktrup

full_name: Lars Viktrup

given: Lars

family: Bramson

full_name: Candace Bramson

given: Candace

family: West

full_name: Christine R. West

given: Christine R.

family: Verburg

full_name: Kenneth M. Verburg

given: Kenneth M.

journal_name: Pain

evidence: open (via page says license)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Sweden
France
Japan
Korea, Republic of
Hungary
Spain
Denmark
United States
Canada

location_facility: National Clinical Research - Richmond, Inc.

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Hospital Universitario Quiron-Dexeus. Servicio de Farmacia

location_facility: Hospital Regional Universitario de Malaga

location_facility: London Road Diagnostic Clinic & Medical Centre

location_facility: KLR Business Group dba Arkansas Clinical Research

location_facility: CTC (Clinical Trial Center) Sahlgrenska University Hospital

location_facility: The Center for Rheumatology and Bone Research

location_facility: Midland Florida Clinical Research Center, LLC

location_facility: CTC Pharmacy, Seoul National University Hospital

location_facility: Valley Medical Research/Valley Medical Primary Care

location_facility: Willis-Knighton Physician Network/WKB Family Medicine Associates

location_facility: Lowcountry Orthopaedics & Sports Medicine

location_facility: CRU Hungary Ltd., MISEK-Radiology Department

location_facility: Professional Research Network of Kansas, LLC

location_facility: Bekes Megyei Koezponti Korhaz Dr Rethy Pal Tagkorhaz

location_facility: Lafayette Regional Vein and Laser Center

location_facility: Northwestern University, Feinberg School of Medicine, Lavin Pavilion

location_facility: Hospital Regional Universitario del Malaga

location_facility: Centex Studies, Inc./Clear Lake Family Physicians

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Fukushima Medical University Aizu Medical Center

location_facility: Collaborative Neuroscience Network, LLC.

location_facility: Chicago Clinical Research Institute, Inc.

location_facility: Medical corporate corporation hoshikai Onishi medical clinic

location_facility: Charlottesville Medical Research Center, LLC

location_facility: Complejo Hospitalario Universitario A Coruna. Servicio de Farmacia

location_facility: Georgia Institute for Clinical Research, LLC

location_facility: National Hospital Organization Beppu Medical Center

location_facility: Willis-Knighton Physician Network/ Spine and Pain Specialist

location_facility: Center for Advanced Research & Education

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: Clinical Trial Pharmacy, Samsung Medical Center

location_facility: Tokyo Medical and Dental University Medical Hospital

location_facility: Northwestern Memorial Hospital - Arkes Pavilion, Diagnostic Testing Center

location_facility: New Mexico Clinical Research & Osteoporosis Center, Inc.

location_facility: Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly

location_facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.


title: A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The primary objectives of this study are as follows: 1) To evaluate the efficacy of andecaliximab to induce endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission at Week 8 (Cohort 1); 2) To evaluate the efficacy of andecaliximab to maintain EBS clinical remission at Week 52 (Cohort 2); and 3) To evaluate the safety and tolerability of andecaliximab. The study will consist of 3 parts: Induction Phase (Cohort 1), Maintenance Phase (Cohort 2), and an optional Extended Treatment Phase.

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Poland
Slovakia
Canada
Korea, Republic of
South Africa
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
United States
United Kingdom
Italy
Czechia
New Zealand
Latvia


lead_sponsor: Novartis Pharmaceuticals

location_country:
Switzerland
Netherlands
Germany
France
Denmark
United States

title: A Randomized, Sponsor Open, Site and Subject Double Blind, Parallel Group, Placebo-controlled Study to Evaluate the Safety and Efficacy of LHW090 After 4 Weeks Treatment in Patients With Resistant Hypertension

summary: The purpose of the present study was to determine whether LHW090 displays the clinical safety and efficacy profile to support further development in patients with resistant hypertension.


ReferenceCitation: Laterre PF, Berry SM, Blemings A, Carlsen JE, François B, Graves T, Jacobsen K, Lewis RJ, Opal SM, Perner A, Pickkers P, Russell JA, Windeløv NA, Yealy DM, Asfar P, Bestle MH, Muller G, Bruel C, Brulé N, Decruyenaere J, Dive AM, Dugernier T, Krell K, Lefrant JY, Megarbane B, Mercier E, Mira JP, Quenot JP, Rasmussen BS, Thorsen-Meyer HC, Vander Laenen M, Vang ML, Vignon P, Vinatier I, Wichmann S, Wittebole X, Kjølbye AL, Angus DC; SEPSIS-ACT Investigators. Effect of Selepressin vs Placebo on Ventilator- and Vasopressor-Free Days in Patients With Septic Shock: The SEPSIS-ACT Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1476-1485. doi: 10.1001/jama.2019.14607. Erratum in: JAMA. 2019 Nov 12;322(18):1830.

name: Department of Critical Care Medicine, St. Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium

family: Laterre

full_name: Pierre-Francois Laterre

given: Pierre-Francois

family: Berry

full_name: Scott M. Berry

given: Scott M.

name: Ferring Pharmaceuticals A/S, Copenhagen, Denmark

family: Blemings

full_name: Allan Blemings

given: Allan

family: Carlsen

full_name: Jan E. Carlsen

given: Jan E.

name: Medical-Surgical Intensive Care Unit, Inserm CIC1435, Dupuytren Teaching Hospital, Limoges, France

family: François

full_name: Bruno François

given: Bruno

family: Graves

full_name: Todd Graves

given: Todd

family: Jacobsen

full_name: Karsten Jacobsen

given: Karsten

name: Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California

name: Los Angeles Biomedical Research Institute, Torrance, California

name: Department of Emergency Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California

family: Lewis

full_name: Roger J. Lewis

given: Roger J.

name: Division of Infectious Diseases, Alpert Medical School of Brown University, Providence, Rhode Island

family: Opal

full_name: Steven M. Opal

given: Steven M.

family: Perner

full_name: Anders Perner

given: Anders

name: Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, the Netherlands

family: Pickkers

full_name: Peter Pickkers

given: Peter

name: Center for Heart Lung Innovation and the Division of Critical Care Medicine, St. Paul’s Hospital, University of British Columbia, Vancouver, Canada

family: Russell

full_name: James A. Russell

given: James A.

family: Windeløv

full_name: Nis A. Windeløv

given: Nis A.

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

family: Yealy

full_name: Donald M. Yealy

given: Donald M.

name: Centre Hospitalier Universitaire d’Angers, Angers, France

family: Asfar

full_name: Pierre Asfar

given: Pierre

name: Nordsjaellands Hospital in Hilleroed, Copenhagen, Denmark

family: Bestle

full_name: Morten H. Bestle

given: Morten H.

name: Centre Hospitalier Régional, Hopital de La Source, Orléans, France

family: Muller

full_name: Grégoire Muller

given: Grégoire

name: Fondation Hôpital Saint Joseph. Paris, France

family: Bruel

full_name: Cédric Bruel

given: Cédric

name: Medical Intensive Care Unit, Nantes University Hospital, Nantes, France

family: Brulé

full_name: Noëlle Brulé

given: Noëlle

name: Ghent University Hospital, Ghent, Belgium

family: Decruyenaere

full_name: Johan Decruyenaere

given: Johan

name: CHU UCL Manur, Mont-Godinne, Yvoir, Belgium

family: Dive

full_name: Alain-Michel Dive

given: Alain-Michel

name: Clinique Saint-Pierre, Ottignies, Belgium

family: Dugernier

full_name: Thierry Dugernier

given: Thierry

name: Eastern Idaho Regional Medical Center, Idaho Falls

family: Krell

full_name: Kenneth Krell

given: Kenneth

name: Centre Hospitalier Universitaire de Nîmes, Nîmes, France

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

name: Lariboisière Hospital, Paris-Diderot University, INSERM UMRS-1144, Paris, France

family: Megarbane

full_name: Bruno Megarbane

name: Centre Hospitalier Régional et Universitaire de Tours, Tours, France

name: Centre Hospitalier Régional et Universitaire de Dijon, Dijon, France

name: Aalborg Universitetshospital, Aalborg, Denmark

name: Randers Regions Hospital, Randers, Denmark

name: Centre Hospitalier Departemental de Vendee, La Roche sur Yon, France

name: Bispebjerg Hospital, Copenhagen, Denmark

name: Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care, University of Pittsburgh, Pittsburgh, Pennsylvania

ReferenceCitation: Lewis RJ, Angus DC, Laterre PF, Kjølbye AL, van der Meulen E, Blemings A, Graves T, Russell JA, Carlsen JE, Jacobsen K, Yealy DM, Opal SM, Windeløv NA, François B, Perner A, Pickkers P, Berry SM. Rationale and Design of an Adaptive Phase 2b/3 Clinical Trial of Selepressin for Adults in Septic Shock. Selepressin Evaluation Programme for Sepsis-induced Shock-Adaptive Clinical Trial. Ann Am Thorac Soc. 2018 Feb;15(2):250-257. doi: 10.1513/AnnalsATS.201708-669SD.

name: Department of Emergency Medicine, Harbor–UCLA Medical Center, Torrance, California

name: Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania

name: Center for Heart Lung Innovation and the Division of Critical Care Medicine, St. Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada

name: Infectious Disease Division, Alpert Medical School of Brown University, Providence, Rhode Island

name: Centre d’Investigation Clinique 1435 and Intensive Care Unit, Centre Hospitalier Universitaire, Limoges, France

name: Department of Intensive Care, Rigshospitalet, Copenhagen, Denmark; and

title: Rationale and Design of an Adaptive Phase 2b/3 Clinical Trial of Selepressin for Adults in Septic Shock. Selepressin Evaluation Programme for Sepsis-induced Shock—Adaptive Clinical Trial

location_country:
Netherlands
France
Belgium
Denmark
United States

location_facility: Centre Hospitalier et Universitaire de Limoges (there may be other sites in this country)

location_facility: Wake Forest University School of Medicine

location_facility: Northshore University Healthsystem Research Institute

location_facility: Cliniques Universitaires Saint-Luc (there may be other sites in this country)

location_facility: Radboud University Nijmegen Medical Centre (there may be other sites in this country)

location_facility: Aalborg Universitetshospital (there may be other sites in this country)

location_facility: University of Oklahoma Health Sciences Center

title: A Double-blind, Randomised, Placebo-Controlled, Phase 2b/3 Adaptive Clinical Trial Investigating the Efficacy and Safety of Selepressin as Treatment for Patients With Vasopressor-dependent Septic Shock

summary: This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. The trial is designed to investigate the efficacy and safety of multiple dosing regimens of selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of adult patients with septic shock requiring vasopressor.


title: Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin

summary:
This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC.

The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.

ReferenceCitation: Hussein M, Maglakelidze M, Richards DA, Sabatini M, Gersten TA, Lerro K, Sinielnikov I, Spira A, Pritchett Y, Antal JM, Malik R, Beck JT. Myeloprotective Effects of Trilaciclib Among Patients with Small Cell Lung Cancer at Increased Risk of Chemotherapy-Induced Myelosuppression: Pooled Results from Three Phase 2, Randomized, Double-Blind, Placebo-Controlled Studies. Cancer Manag Res. 2021 Aug 9;13:6207-6218. doi: 10.2147/CMAR.S313045. eCollection 2021.

family: Hussein

full_name: Maen Hussein

given: Maen

family: Maglakelidze

full_name: Marina Maglakelidze

given: Marina

family: Richards

full_name: Donald A Richards

given: Donald A

family: Sabatini

full_name: Marielle Sabatini

given: Marielle

family: Gersten

full_name: Todd A Gersten

given: Todd A

family: Lerro

full_name: Keith Lerro

given: Keith

family: Sinielnikov

full_name: Ivan Sinielnikov

given: Ivan

family: Spira

full_name: Alexander Spira

given: Alexander

family: Pritchett

full_name: Yili Pritchett

given: Yili

family: Antal

full_name: Joyce M Antal

given: Joyce M

family: Malik

full_name: Rajesh Malik

given: Rajesh

family: Beck

full_name: J Thaddeus Beck

given: J Thaddeus

journal_name: Cancer Management and Research

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Ferrarotto R, Anderson I, Medgyasszay B, García-Campelo MR, Edenfield W, Feinstein TM, Johnson JM, Kalmadi S, Lammers PE, Sanchez-Hernandez A, Pritchett Y, Morris SR, Malik RK, Csőszi T. Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy-induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials. Cancer Med. 2021 Sep;10(17):5748-5756. doi: 10.1002/cam4.4089. Epub 2021 Aug 18.

name: University of Texas MD Anderson Cancer Center Houston TX USA

family: Ferrarotto

full_name: Renata Ferrarotto

given: Renata

name: St Joseph Heritage Healthcare Santa Rosa CA USA

family: Anderson

full_name: Ian Anderson

given: Ian

name: Veszprém County Lung Medicine Institute Veszprém Hungary

family: Medgyasszay

full_name: Balazs Medgyasszay

given: Balazs

name: University Hospital A Coruña A Coruña Spain

family: García‐Campelo

full_name: Maria Rosario García‐Campelo

given: Maria Rosario

name: Prisma Health Cancer Institute Greenville SC USA

family: Edenfield

full_name: William Edenfield

given: William

name: Piedmont Cancer Institute Atlanta GA USA

name: Thomas Jefferson University Hospital Philadelphia PA USA

name: Ironwood Cancer & Research Center Chandler AZ USA

name: Hospital Provincial de Castellon Castelló Spain

name: G1 Therapeutics, Inc. Research Triangle Park NC USA

title: Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy‐induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials

ReferenceCitation: Li C, Hart L, Owonikoko TK, Aljumaily R, Rocha Lima CM, Conkling PR, Webb RT, Jotte RM, Schuster S, Edenfield WJ, Smith DA, Sale M, Roberts PJ, Malik RK, Sorrentino JA. Trilaciclib dose selection: an integrated pharmacokinetic and pharmacodynamic analysis of preclinical data and Phase Ib/IIa studies in patients with extensive-stage small cell lung cancer. Cancer Chemother Pharmacol. 2021 May;87(5):689-700. doi: 10.1007/s00280-021-04239-9. Epub 2021 Feb 17.

ReferenceCitation: Lai AY, Sorrentino JA, Dragnev KH, Weiss JM, Owonikoko TK, Rytlewski JA, Hood J, Yang Z, Malik RK, Strum JC, Roberts PJ. CDK4/6 inhibition enhances antitumor efficacy of chemotherapy and immune checkpoint inhibitor combinations in preclinical models and enhances T-cell activation in patients with SCLC receiving chemotherapy. J Immunother Cancer. 2020 Oct;8(2). pii: e000847. doi: 10.1136/jitc-2020-000847.

ReferenceCitation: Weiss JM, Csoszi T, Maglakelidze M, Hoyer RJ, Beck JT, Domine Gomez M, Lowczak A, Aljumaily R, Rocha Lima CM, Boccia RV, Hanna W, Nikolinakos P, Chiu VK, Owonikoko TK, Schuster SR, Hussein MA, Richards DA, Sawrycki P, Bulat I, Hamm JT, Hart LL, Adler S, Antal JM, Lai AY, Sorrentino JA, Yang Z, Malik RK, Morris SR, Roberts PJ, Dragnev KH; G1T28-02 Study Group. Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial. Ann Oncol. 2019 Oct 1;30(10):1613-1621. doi: 10.1093/annonc/mdz278.

location_country:
France
Poland
Georgia
Hungary
Spain
Moldova, Republic of
United States

location_facility: ARENSIA Exploratory Medicine Phase I Unit, The Institute of Oncology

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

location_facility: Oklahoma University - Peggy and Charles Stephenson Cancer Center

location_facility: UNC - Lineberger Comprehensive Cancer Center

location_facility: University of Colorado Health, Oncology Clinical Research Northern Region

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet, XI. Tudobelosztaly

location_facility: Memorial Hospital - Univ. of Colorado Health

location_facility: Samodzielny Publiczny ZespAA GruAicy i ChorAb PA¿uc

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Hanna Cancer Associates - University of Tennessee

location_facility: Boca Raton Regional Hospital - Lynn Cancer Institute

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Hospital Regional Universitario HRU Carlos Haya Malaga


title: An Observational Study to Evaluate the Effectiveness and Safety of Ipilimumab, Administered During the European Expanded Access Programme in Pretreated Patients With Advanced (Unresectable or Metastatic) Melanoma

summary: Observational study to evaluate the effectiveness and safety of ipilimumab, administered during the European expanded access programme (EAP) in pretreated patients with advanced (unresectable or metastatic) melanoma.

time_perspective: Retrospective

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Switzerland
Netherlands
Germany
France
Czechia
Norway
Hungary
Belgium
Ireland
Russian Federation
Spain
Denmark
United States
United Kingdom

location_facility:
Outcome Sciences Inc Dba Outcome
Local Institution
Elbe Klinikum Buxtehude


title: Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow

summary: The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.

lead_sponsor: Zimmer Biomet

location_country:
Italy
United States
Netherlands
Finland
France
Australia
Germany
United Kingdom

location_facility: Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)


title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis

acronym: focuSSced

summary: This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.

ReferenceCitation: Roofeh D, Lin CJF, Goldin J, Kim GH, Furst DE, Denton CP, Huang S, Khanna D; focuSSced Investigators. Tocilizumab Prevents Progression of Early Systemic Sclerosis-Associated Interstitial Lung Disease. Arthritis Rheumatol. 2021 Jul;73(7):1301-1310. doi: 10.1002/art.41668. Epub 2021 May 25.

family: Roofeh

full_name: David Roofeh

given: David

name: Genentech  South San Francisco California

family: Lin

full_name: Celia J. F. Lin

given: Celia J. F.

family: Goldin

full_name: Jonathan Goldin

given: Jonathan

family: Kim

full_name: Grace Hyun Kim

given: Grace Hyun

name: University of California, Los Angeles, University of Washington, Seattle, and University of Florence  Florence Italy

family: Furst

full_name: Daniel E. Furst

given: Daniel E.

family: Denton

full_name: Christopher P. Denton

given: Christopher P.

family: Huang

full_name: Suiyuan Huang

given: Suiyuan

family: Khanna

full_name: Dinesh Khanna

given: Dinesh

journal_name: Arthritis & Rheumatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Tocilizumab Prevents Progression of Early Systemic Sclerosis–Associated Interstitial Lung Disease

ReferenceCitation: Khanna D, Lin CJF, Furst DE, Goldin J, Kim G, Kuwana M, Allanore Y, Matucci-Cerinic M, Distler O, Shima Y, van Laar JM, Spotswood H, Wagner B, Siegel J, Jahreis A, Denton CP; focuSSced investigators. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2020 Oct;8(10):963-974. doi: 10.1016/S2213-2600(20)30318-0. Epub 2020 Aug 28. Erratum in: Lancet Respir Med. 2020 Oct;8(10):e75. Lancet Respir Med. 2021 Mar;9(3):e29.

full_name: Celia J F Lin

given: Celia J F

full_name: Daniel E Furst

given: Daniel E

full_name: Grace Kim

given: Grace

family: Kuwana

full_name: Masataka Kuwana

given: Masataka

family: Allanore

full_name: Yannick Allanore

given: Yannick

family: Matucci-Cerinic

full_name: Marco Matucci-Cerinic

given: Marco

family: Distler

full_name: Oliver Distler

given: Oliver

family: Shima

full_name: Yoshihito Shima

given: Yoshihito

family: van Laar

full_name: Jacob M van Laar

given: Jacob M

family: Spotswood

full_name: Helen Spotswood

given: Helen

repository_institution: University College London - UCL Discovery

location_country:
Greece
Romania
Belgium
Denmark
France
Japan
Lithuania
Poland
Argentina
Canada
Switzerland
Netherlands
Bulgaria
Hungary
Puerto Rico
Portugal
United States
Germany
United Kingdom
Italy
Mexico
Spain

location_facility: Hospital of the University of Occupational and Environmental Health,Japan

location_facility: Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine

location_facility: Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika

location_facility: University Hospital of Patras; Rheumatology

location_facility: Aarhus Universitetshospital Skejby, Hud- og Kønssygdomme

location_facility: Mount Sinai Hospital; Rebecca Macdonald Centre For Arthritis & Autoimmune Disease

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob

location_facility: Cantacuzino Hospital; Department of Internal Medicine and Rheumatology

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Wewnetrznych, Chorob Tkanki Łacznej i Geriatrii

location_facility: Thomas Jefferson Uni ; Division of Rheumatology

location_facility: Unidad De Enfermedades; Cronico Degenerativas, SC.

location_facility: Szpital Specjalistyczny im Jozefa Dietla; Centrum Reumatologii, Immunologii i Rehabilitacji, I Oddzi

location_facility: Universitätsspital Zürich; Klinik für Rheumatologie

location_facility: Ospedale Maggiore Policlinico; Unità Operativa Complessa di Allergologia e Immunologia Clinica

location_facility: Bispebjerg Hospital, Dermatologisk afdeling

location_facility: Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept.

location_facility: National Institute of Rheumatology and Physiology

location_facility: Klaipeda University Hospital; Department of Rheumatology

location_facility: Vilnius University Hospital Santariskiu Clinic Public Insti

location_facility: Hospital Prof. Dr. Fernando Fonseca; Medicina IV

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

location_facility: Arthritis Associates of Southern California

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Puerto Rico Clinical & Translational Research Consortium

location_facility: Univ of Calif., Los Angeles; Rheumatology

location_facility: Hopital Claude Huriez; Internal Medicine

location_facility: Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia

location_facility: Hospital Garcia de Orta; Servico de Reumatologia

location_facility: Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

location_facility: Uni ' Cattolica Del Sacro Cuore; Facoltà Di Medicina E Chirurgia A.Gemelli-Clinica Reumatologica

location_facility: Academisch Ziekenhuis Leiden; Dept of Rheumatology

location_facility: SPSK NR 4; Reumatologii i Ukladowych Chorob Tkanki

location_facility: Queen Elizabeth Hospital; Rheumatology Dept.

location_facility: Rheumatology Assoc. of S. Florida - Clinical Research Center

location_facility: Uni Hospital Aintree; Academic Rheumatology Unit

location_facility: Universitätsspital Basel; Rheumatologische Poliklinik

location_facility: St. Paul's Hospital University of British Colambia Division of Hematology

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher

location_facility: Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

location_facility: Arthritis and Rheumatology; Center of Oklahoma PLLC

location_facility: Universitätsklinikum Dresden; Technische Universität Dresden; Rheumatologie, Innere Medizin III

location_facility: Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Medicina Interna/Reumatologia

location_facility: Royal Free Hospital; Department of Rheumatology

location_facility: Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens

location_facility: Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna

location_facility: MHAT St.Ivan Rilski; Rheumtology Department

location_facility: Policlinico Universitario-II Università di Napoli; Reumatologia

location_facility: Centro de Investigaciones Reumatologicas Tucuman

location_facility: Spitalul Judetean Cluj; Sectia de Reumatologie

location_facility: MHAT Sv.Ivan Rilski; Clinic of Rheumatology