title: Adaptive Design Phase 2 to 3, Randomized, Double-blind, to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BIO101 in the Prevention of the Respiratory Deterioration in Hospitalized COVID-19 Patients

acronym: COVA

summary: The COVA clinical study is a global multicentric, double-blind, placebo-controlled, group sequential and adaptive 2 parts phase 2-3 study targeting in patients with SARS-CoV-2 pneumonia. Part 1 is a Phase 2 exploratory Proof of Concept (PoC) study to provide preliminary data on the activity, safety and tolerability of BIO101 in the target population. Part 2 is a phase 3 pivotal randomized study to provide further evidence of safety and efficacy of BIO101 after 28 days of double-blind dosing. BIO101 is the investigational new drug that activates the Mas receptor (MasR) through the protective arm of the Renin Angiotensin System (RAS).

ReferenceCitation: Dioh W, Chabane M, Tourette C, Azbekyan A, Morelot-Panzini C, Hajjar LA, Lins M, Nair GB, Whitehouse T, Mariani J, Latil M, Camelo S, Lafont R, Dilda PJ, Veillet S, Agus S. Testing the efficacy and safety of BIO101, for the prevention of respiratory deterioration, in patients with COVID-19 pneumonia (COVA study): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 11;22(1):42. doi: 10.1186/s13063-020-04998-5.

family: Dioh

full_name: W. Dioh

given: W.

family: Chabane

full_name: M. Chabane

given: M.

family: Tourette

full_name: C. Tourette

given: C.

family: Azbekyan

full_name: A. Azbekyan

given: A.

family: Morelot-Panzini

full_name: C. Morelot-Panzini

family: Hajjar

full_name: L. A. Hajjar

given: L. A.

family: Lins

full_name: M. Lins

family: Nair

full_name: G. B. Nair

given: G. B.

family: Whitehouse

full_name: T. Whitehouse

given: T.

family: Mariani

full_name: J. Mariani

given: J.

family: Latil

full_name: M. Latil

family: Camelo

full_name: S. Camelo

given: S.

family: Lafont

full_name: R. Lafont

given: R.

family: Dilda

full_name: P. J. Dilda

given: P. J.

family: Veillet

full_name: S. Veillet

family: Agus

full_name: S. Agus

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

location_country:
Brazil
France
Puerto Rico
Belgium
United States

location_facility: Hospital Municipal de Barueri Dr. Francisco Moran

location_facility: Barnum Medical Research, Inc. 1029 Keyser Ave Suite H

location_facility: Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto

location_facility: Centre Hospitalier Universitaire Bordeaux

location_facility: CHU CLU Namur (Saint-Elisabeth) Place Louise Godin

location_facility: Hospital e Maternidade Celso Pierro - PUCCAMP

location_facility: Hôpital Pitié-Salpêtrière, 47 bd de l'Hôpital, 75013 Paris

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: FDI Clinical Research - San Juan City Hospital

location_facility: Avenida Dr. Enéas de Carvalho Aguiar, 44 - Centro de Pesquisa Clínica Prof. Dr. Fúlvio Pileggi - Bloco 1 - 1º Andar

location_facility: Unité ambulatoire Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR) 47-83 Boulevard de l'Hôpital


type: Registry Identifier

type: EudraCT Number

title: A Phase 1/2, Multicenter, Open-label Study to Assess Safety, Pharmacokinetics, and Preliminary Efficacy of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas.

summary:
This Phase 1/2, multicenter, open-label study to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification.

Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
Italy
Germany
United States
France

location_facility: AOU Integrata Verona - Ospedale Policlinico Giambattista Rossi di Borgo Roma

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment With GSK3228836 in Participants With Chronic Hepatitis B Virus (B-Clear)

acronym: B-Clear

summary: Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if treatment with GSK3228836 can achieve sustained virologic response (SVR), that is hepatitis B virus surface antigen (HBsAg) less than (<) lower limit of quantitation (LLOQ) and HBV deoxyribonucleic acid (DNA) <LLOQ sustained for 24 weeks post-GSK3228836 treatment end. In addition, the study will also evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of GSK3228836 in the 4 dosing regimens. This study will assess the efficacy and safety of treatment with GSK3228836 in two populations of participants with CHB; participants on stable nucleos(t)ide treatment (Cohort 1) and participants who are not currently on nucleos(t)ide therapy (Cohort 2). For each population, participants will be randomized into one of the 4 different parallel arms to receive treatment. The study will consist of a screening, treatment, and post-treatment follow-up phase. Approximately, 440 participants will be enrolled in the study.

status: Active, not recruiting

design_allocation: Randomized

lead_sponsor: GlaxoSmithKline

location_country:
Malaysia
Romania
Russian Federation
Taiwan
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Hong Kong
Philippines
Bulgaria
Singapore
China
United States
Germany
United Kingdom
Italy
Spain


title: A Phase 3, Randomized, Open-label, Multicenter Study of the Efficacy and Safety of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a HER2 Exon 20 Mutation Who Progressed on or After Treatment With Platinum Based Chemotherapy

summary: This is a randomized, positive-controlled, open-label, international multicenter, Phase 3 clinical study to compare the efficacy and safety of pyrotinib versus docetaxel in patients with advanced non-squamous NSCLC harboring a HER2 exon 20 mutation who failed platinum based chemotherapy.

ipd_sharing: No

lead_sponsor: Jiangsu HengRui Medicine Co., Ltd.

location_country:
Italy
Spain
Germany
France
Poland
Belgium
Australia
Russian Federation
China
Turkey
United States
Korea, Republic of
Taiwan

location_facility: Shanghai Pulmonary Hospital, Tongji University

location_facility: beijing chest hospital,Capital medical university

location_facility: Hospital Regional Universitario de Malaga

location_facility: The First Affiliated Hospital of Guangdong Pharmaceutical University

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: The Second Affiliated of Nanchang University

location_facility: Sir Run Run Shaw Hospital ZheJiang University School Of Medicine

location_facility: Cangzhou Hospital of Integrated Tcm-Wm.Hebei

location_facility: Shandong Cancer Hospital Affiliated to Shandong University

location_facility: First Affiliated Hospital of ZhengzhouUniversity

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: The affiliated hospital of inner mongolia medical univerity

location_facility: ASST dei Sette Laghi-Ospedale di Circolo e Fondazione Macchi di Varese

location_facility: General Hospital of Tianjin Medical University

location_facility: Seoul St. Mary's Hospital, The Catholic University of Korea

location_facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

location_facility: Florida Cancer Specialists North Divisio

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

location_facility: the Second Affiliated Hospital of Anhui Medical University

location_facility: The second affiliated hospital of ChongQing medical university

location_facility: Necmettin Erbakan University Selcuklu Faculty of Medicine

location_facility: Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

location_facility: University of Kansas Medical Center (KUMC)

location_facility: Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)

location_facility: Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Petrov National Medical Research Center of Oncology

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Subei People's Hospital of Jiangsu Province

location_facility: Seoul National University Bundang Hospital

location_facility: The First Affiliated Hospital，ZheJiang University

location_facility: University of California - Irvine Medical Center

location_facility: Pius-Hospital Oldenburg, Centre of Radiotherapy and Medical Oncology, Dept. Medical Oncology

location_facility: Harbin Medical University Cancer Hospital

location_facility: Baskent University Adana Application and Research Center

location_facility: Clinical hospital RZD-Medicine of St. Petersburg

location_facility: University of California (UC) Davis Comprehensive Cancer Center

location_facility: Linkou Chang Gung Memorial Hospital (CGMHLK)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Florida Cancer Specialists South Divisio


type: Other Identifier

title: TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)

summary:
The TRANSLATE study aims to better understand why tumors become resistant to standard anti-cancer therapies.

New tumor biopsy and blood samples are collected after disease progression on standard-of-care anti-cancer treatment and compared to the initial (archival) tumor biopsy sample taken from the same patient.

Annotated reports of results from clinical Next Generation Sequencing (NGS) gene panel tests of both tumor and blood are sent directly from the testing lab to the study physician for discussion with the patient during the study.

Patients may participate in interventional treatment clinical trials at the same time as participating in the TRANSLATE study.

Primary data will be publicly available after the study to support further research.

status: Terminated

study_completion_date_type: Actual

primary_purpose: Other

enrollment_type: Actual

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:
France
Belgium
Argentina
United States
United Kingdom

location_facility: Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur

location_facility: The Oncology Institute of Hope Innovation

location_facility: Centro de Educacion Medica e Investigaciones Clinicas"Norberto Quirno" CEMIC

location_facility: Grand Hôpital de Charleroi - Site Notre Dame

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: UCI Medical Center-Chao Family Comprehensive Cancer Center

location_facility: The Oncology Institute of Hope and Innovation

intervention_type: Procedure

status_simplified: Unknown


title: A Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's Disease

summary: This is a Phase 2b study investigating the efficacy and safety of mesdopetam as adjunct therapy on daily ON-time without troublesome dyskinesia in patients with Parkinson disease. Mesdopetam is taken for 84 days.

ReferenceType: background

ReferenceCitation: Becanovic K, Vittoria de Donno M, Sousa VC, Tedroff J, Svenningsson P. Effects of a Novel Psychomotor Stabilizer, IRL790, on Biochemical Measures of Synaptic Markers and Neurotransmission. J Pharmacol Exp Ther. 2020 Jul;374(1):126-133. doi: 10.1124/jpet.119.264754. Epub 2020 May 1.

ReferenceCitation: Waters S, Sonesson C, Svensson P, Tedroff J, Carta M, Ljung E, Gunnergren J, Edling M, Svanberg B, Fagerberg A, Kullingsjö J, Hjorth S, Waters N. Preclinical Pharmacology of [2-(3-Fluoro-5-Methanesulfonyl-phenoxy)Ethyl](Propyl)amine (IRL790), a Novel Dopamine Transmission Modulator for the Treatment of Motor and Psychiatric Complications in Parkinson Disease. J Pharmacol Exp Ther. 2020 Jul;374(1):113-125. doi: 10.1124/jpet.119.264226. Epub 2020 May 1.

ReferenceCitation: Svenningsson P, Johansson A, Nyholm D, Tsitsi P, Hansson F, Sonesson C, Tedroff J. Safety and tolerability of IRL790 in Parkinson's disease with levodopa-induced dyskinesia-a phase 1b trial. NPJ Parkinsons Dis. 2018 Dec 6;4:35. doi: 10.1038/s41531-018-0071-3. eCollection 2018.

lead_sponsor: Integrative Research Laboratories AB

location_country:
Italy
Serbia
France
Poland
Israel
United States

location_facility: Hadassah University Hospital-Ein Kerem, Department of Neurology

location_facility: CHU Charles Nicolle; Service de Neurologie

location_facility: Elias Research Associates (Allied Biomedical Research Institute)

location_facility: Clinical Hospital Center Zvezdara, Clinical department of Neurology

location_facility: University Clinical Center of Serbia, Clinic for Neurology

location_facility: Rabin Medical Centre - Beilinson Hospital, Department of Neurology

location_facility: Rambam Health Care Campus, Department of Neurology

location_facility: The Chaim Sheba Medical Centre, Department of Neurology

location_facility: University of Kentucky, Department of Neurology

location_facility: Collaborative Neuroscience Research (CNS Research)

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona, Clinica Neurologica

location_facility: USF Parkinson's Disease and Movement Disorders Center

location_facility: University of Texas Southwestern Medical Center

location_facility: Tel Aviv Sourasky Medical Centre; Movement Disorders Unit

location_facility: Centre Hospitalier Regional Universitaire de Lille


title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema

acronym: Rhone-X

summary: This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

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

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

lead_sponsor: Hoffmann-La Roche

location_country:
Peru
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Hong Kong
Switzerland
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

location_facility: Hospital General de Catalunya; Servicio de oftalmologia

location_facility: Hospital de Braga; Servico de Oftalmologia

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: University of Colorado; dept of ophthalmology

location_facility: Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology

location_facility: Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

location_facility: Fisabio-Ofalmologia Medica; Servicio de Oftalmología

location_facility: University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit

location_facility: Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: "Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

location_facility: Hospital Universitario de Bellvitge; Servicio de oftalmologia

location_facility: Northern California Retina Vitreous Associates

location_facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

location_facility: Retina Consultants of Southern California

location_facility: National Defense Medical College Hospital

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: Universitätsklinikum Würzburg, Augenklinik und Poliklinik

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica

location_facility: Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

location_facility: Beetham Eye Institute, Joslin Diabetes Center

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

location_facility: Cleveland Clinic Foundation; Cole Eye Institute

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

location_facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia

location_facility: California Eye Specialists Medical group Inc.

location_facility: Rajavithi Hospital; Ophthalmology Department

location_facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

location_facility: Complejo Hospitalario de Navarra; Servicio de oftalmologia

location_facility: VISSUM Instituto Oftalmológico de Alicante

location_facility: Medical Center for Eye Health - Focus Ltd

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

location_facility: Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow

location_facility: King Chulalongkorn Memorial Hospital; Ophthalmology Department

location_facility: Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Specjalistyczny Ośrodek Okulistyczny Oculomedica

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Hospital Universitario Puerta de Hierro; Servicio de oftalmologia

location_facility: FN Hradec Králové, Oční klinika; Ophthalmology clinic

location_facility: California Retina Consultants - Santa Maria

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET; Intezeti Gyogyszertar

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology

location_facility: National University Hospital; Ophthalmology Department

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály

location_facility: Seoul National University Bundang Hospital

location_facility: Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: University Health Network Toronto Western Hospital

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia

location_facility: Southern California Permanente Medical Group

location_facility: Faculty Hospital Ostrava; Ophthalmology clinic

location_facility: Pentagram Eye Hospital (Medical Center "Pentagram")

location_facility: Specialized Hospital for Active Treatment of Eye Diseases Zora

location_facility: Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica

location_facility: Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch

location_facility: Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

location_facility: "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Kocaeli Üniversitesi Tıp Fakültesi; Department of Ophthalmology

location_facility: University of Utah; Division of Gastroenterology/Hepatology

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: The Ohio State University Havener Eye Institute

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Hospital Universitario de Gran Canaria; Servicio de oftalmologia

location_facility: Selcuk University Faculty of Medicine; Department Of Ophthalmology

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Hospital dos de maig; servicio de oftalmologia

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: National Taiwan University Hospital; Ophthalmology

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: Spec. Ophth. Hospital for Active Treatment- Academic Pashev

location_facility: Prairie Eye & LASIK Center / Prairie Retina Center

location_facility: Shiga University Of Medical Science Hospital

location_facility: St. Michael's Hospital; Department of Ophthalmology

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde

location_facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

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

location_facility: University Retina and Macula Associates, PC

location_facility: James Paget University Hospitals NHS Foundation Trust

location_facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

location_facility: Southeastern Retina Associates Chattanooga

location_facility: Semmelweis Egyetem Szemészeti Vizsgálóhely

intervention_type: Other


ReferenceType: derived

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

name: Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, OR 97213, USA

family: Taylor

full_name: Matthew H Taylor

given: Matthew H

sequence: first

name: Department of Clinical Oncology, Merck & Co. Inc., Kenilworth, NJ 07033, USA

family: Schmidt

full_name: Emmett V Schmidt

given: Emmett V

sequence: additional

name: Department of Clinical Research, Eisai Inc., Woodcliff Lake, NJ 07677, USA

family: Dutcus

full_name: Corina Dutcus

given: Corina

family: Pinheiro

full_name: Elaine M Pinheiro

given: Elaine M

name: Biomarker Research Translational Science Department, Eisai Co., Ltd., Tokyo, 112-0002, Japan

family: Funahashi

full_name: Yasuhiro Funahashi

given: Yasuhiro

family: Lubiniecki

full_name: Gregory Lubiniecki

given: Gregory

name: The START Center for Cancer Care, San Antonio, TX 78229, USA

family: Rasco

full_name: Drew Rasco

given: Drew

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
United States
France
Israel
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1508)

location_facility: Inova Schar Cancer Institute ( Site 1550)

location_facility: Mid North Coast Cancer Institute ( Site 0109)

location_facility: Penn State Hershey Medical Center ( Site 1561)

location_facility: University of Maryland Greenebaum Cancer Center ( Site 1522)

location_facility: University Of Nebraska Medical Center ( Site 1570)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 1566)

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 1523)

location_facility: Georgia Cancer Center at Augusta University ( Site 1575)

location_facility: Rigshospitalet University Hospital Copenhagen ( Site 1000)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 0508)

location_facility: Hematology Oncology Associates of Fredericksburg ( Site 1537)

location_facility: University Hospital Cleveland ( Site 1578)

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 1203)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0700)

location_facility: Hospital Universitari Vall d Hebron ( Site 0701)

location_facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 0510)

location_facility: Hospital General de Valencia ( Site 0703)

location_facility: National Taiwan University Hospital ( Site 1200)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 1204)

location_facility: Rush University Medical Center ( Site 1560)

location_facility: The Center For Cancer And Blood Disorders ( Site 1569)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 1555)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0601)

location_facility: VA Ann Arbor Healthcare System ( Site 1584)

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0509)

location_facility: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 0903)

location_facility: Perlmutter Cancer Center at Winthrop Oncology Hematology Associates NYU Langone Health ( Site 1597)

location_facility: Seoul National University Bundang Hospital ( Site 1801)

location_facility: National Cheng Kung University Hospital ( Site 1202)

location_facility: Medical University of South Carolina ( Site 1579)

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 1582)

location_facility: Hospital Virgen de la Victoria ( Site 0702)

location_facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 1505)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 0909)

location_facility: The Christie NHS Foundation Trust ( Site 0907)

location_facility: Gallipoli Medical Research Foundation-GMRF CTU ( Site 0105)

location_facility: Severance Hospital Yonsei University Health System ( Site 1800)

location_facility: Ohio State University Medical Center Arthur G. James Cancer Hospital ( Site 1558)

location_facility: Medical College of Wisconsin Clinical Cancer Center ( Site 1574)

location_facility: UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)

location_facility: Washington University School of Medicine ( Site 1500)

location_facility: University of Kansas Cancer Center ( Site 1538)

location_facility: Taipei Veterans General Hospital ( Site 1201)

source: euctr

title: A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors) (LEAP-009)

summary: This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.


title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

acronym: DELIVER

summary: Evaluation of eptinezumab in the prevention of migraine in patients with unsuccessful prior preventive treatments

status: Completed

lead_sponsor: H. Lundbeck A/S

location_country:
Italy
Sweden
Germany
Finland
France
Czechia
Bulgaria
Poland
Georgia
Slovakia
Hungary
Belgium
Russian Federation
Spain
Denmark
United States
United Kingdom

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD

location_facility: MUDr. Helena Hojdíkova s.r.o. Neurologicka Ambulance

location_facility: Assistance Publique Hôpitaux de Marseille

location_facility: Concept Medica Trials Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

location_facility: Clinical Research Institute Inc. - Minneapolis

location_facility: Synexus Midlands Clinical Research Centre

location_facility: Northern Care Alliance NHS Foundation Trust

location_facility: Michigan Headache and Neurological Institute

location_facility: Helsicore - Israeli-Georgian Medical Research Clinic

location_facility: Synexus - Scotland Clinical Research Centre

location_facility: Hometown Urgent Care & Occupational Health/Hometown Research - Huber Heights

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Simon Khechinashvili University Hospital

location_facility: Hospital Alvaro Cunqueiro - Clinico Universitario Vigo

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Clinical Neuroscience Solutions - Memphis

location_facility: Research Institute of Clinical Medicine - Todua Clinic

location_facility: Neurologie, MP-neuro s.r.o., poliklinika Modry pavilon

location_facility: First Multiprofile Hospital for Active Treatment - Sofia

location_facility: Synexus - Manchester Clinical Research Centre

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

location_facility: IRCCS Istituto Delle Scienze Neurologiche di Bologna

location_facility: Synexus - Thames Valley Clinical Research Centre

location_facility: Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

location_facility: Medicínske Centrum Konzílium - Dubnica nad Vahom

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Center

location_facility: Archangel Saint Michael Multiprofile Clinical Hospital

location_facility: Clinica Universidad de Navarra - Pamplona

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Indywidualna Praktyka Lekarska dr hab. n. med. Anna Szczepanska-Szerej

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Pisana

location_facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

location_facility: Hospital Clinico Universitario Lozano Blesa

status_simplified: Completed


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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
Switzerland
Netherlands
Germany
France
Israel
Norway
Argentina
Australia
Belgium
United States
United Kingdom

location_facility: The Angeles Clinic and Research Institute

location_facility: Florida Cancer Specialists Sarasota Office

location_facility: University of TX MD Anderson Cancer Center

location_facility: NYU Laura and Isaac Perlmutter Cancer Center

location_facility: H Lee Moffitt Cancer Center and Research Institute Moffitt McKinley Outpatient Ct

location_facility: Massachusetts General Hospital Massachusetts General Hospital

location_facility: Dana Farber Cancer Institute Dept.of DFCI

title: A Randomized, Open-label, Multi-arm, Two-part, Phase II Study to Assess Efficacy and Safety of Multiple LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma

summary: The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma


title: Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310

summary: This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.

lead_sponsor: United Therapeutics

location_country:
Greece
Australia
Denmark
Taiwan
India
France
Poland
Argentina
Canada
Korea, Republic of
Chile
Sweden
Netherlands
Singapore
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Perelman Center for Advanced Medicine, University of Pennsylvania

location_facility: University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine

location_facility: Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Complexo Hospitalar Santa Casa de Porto Alegre

location_facility: University of Iowa Hospitals and Clinics

location_facility: The First Affiliated Hospital of Nanjing Medical University

location_facility: University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Escola Paulista de Medicina, Universidade Federal de São Paulo

location_facility: Shanghai Pulmonary Hospital of Tongji University

location_facility: Universitätsmedizin der Johannes Gutenberg Universität

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina

location_facility: The University of Texas Health Science Center at Houston

location_facility: Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Renji Hospital of Shanghai Jiaotong University

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: The Second Affiliated Hospital of Nanchang Medical University

location_facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP

location_facility: The Chaim Sheba Medical Center at Tel Hashomer

location_facility: Hospital das Clínicas da Universidade Federal de Minas Gerais

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Hospital das Clinicas da Universidade Federal de Goias

location_facility: Sentara Cardiovascular Research Institute

location_facility: Unidad de Investigacion Clinica en Medicina S.C.

location_facility: Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

location_facility: Shenyang General Hospital of Shenyang Military Command

location_facility: University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program

location_facility: General Hospital of Thessaloniki, "G.Papanikolaou"

location_facility: Universitair Medisch Centrum Sint Radboud

location_facility: Centre Hospitalier Universitaire Hopital Nord

location_facility: University of California, San Francisco-Fresno


title: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy

acronym: FREEDOM-EV

summary: This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension.

ReferenceCitation: White RJ, Jerjes-Sanchez C, Bohns Meyer GM, Pulido T, Sepulveda P, Wang KY, Grünig E, Hiremath S, Yu Z, Gangcheng Z, Yip WLJ, Zhang S, Khan A, Deng CQ, Grover R, Tapson VF; FREEDOM-EV Investigators. Combination Therapy with Oral Treprostinil for Pulmonary Arterial Hypertension. A Double-Blind Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2020 Mar 15;201(6):707-717. doi: 10.1164/rccm.201908-1640OC.

name: Division of Pulmonary and Critical Care Medicine and the Mary M. Parkes Center, University of Rochester Medical Center, Rochester, New York

family: White

full_name: R. James White

given: R. James

name: Unidad de Investigación Clínica en Medicina, Monterrey, Mexico

family: Jerjes-Sanchez

full_name: Carlos Jerjes-Sanchez

given: Carlos

name: Complexo Hospitalar Santa Casa de Porto Alegre, Porto Alegre, Brazil

family: Bohns Meyer

full_name: Gisela Martina Bohns Meyer

given: Gisela Martina

name: Departamento de Cardioneumología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico

family: Pulido

full_name: Tomas Pulido

given: Tomas

name: Pontifica Universidad Católica de Chile, Santiago, Chile

family: Sepulveda

full_name: Pablo Sepulveda

given: Pablo

name: Taichung Veterans General Hospital, Taichung, Taiwan

family: Wang

full_name: Kuo Yang Wang

given: Kuo Yang

name: Thoraxclinic at University Hospital Heidelberg, Heidelberg, Germany

family: Grünig

full_name: Ekkehard Grünig

given: Ekkehard

name: Ruby Hall Clinic, Grant Medical Foundation, Pune, India

family: Hiremath

full_name: Shirish Hiremath

given: Shirish

name: Department of Cardiology, Xiangya Hospital of Central South University, Changsha, China

family: Yu

full_name: Zaixin Yu

given: Zaixin

name: Wuhan Asia Heart Hospital, Wuhan Shi, China

family: Gangcheng

full_name: Zhang Gangcheng

given: Zhang

name: Department of Cardiology, National University Heart Centre, Singapore, Singapore

family: Yip

full_name: Wei Luen James Yip

given: Wei Luen James

name: Peking Union Medical College Hospital, Beijing, China

family: Zhang

full_name: Shuyang Zhang

given: Shuyang

name: Oregon Health and Science University, Portland, Oregon

family: Khan

full_name: Akram Khan

given: Akram

name: United Therapeutics, Research Triangle Park, North Carolina; and

family: Deng

full_name: C. Q. Deng

given: C. Q.

family: Grover

full_name: Rob Grover

given: Rob

name: Division of Pulmonary and Critical Care Medicine, Cedars Sinai Medical Center, Los Angeles, California

family: Tapson

full_name: Victor F. Tapson

given: Victor F.

family: Svetliza

full_name: Graciela Noemi Svetliza

given: Graciela Noemi

family: Lescano

full_name: Adrian Jose Lescano

given: Adrian Jose

family: Bortman

full_name: Guillermo Roberto Bortman

given: Guillermo Roberto

family: Diez

full_name: Fabian Antonio Diez

given: Fabian Antonio

family: Botta

full_name: Christian Edgardo Botta

given: Christian Edgardo

family: Fitzgerald

full_name: John Fitzgerald

given: John

family: Feenstra

full_name: Eelke Feenstra

given: Eelke

full_name: Frederico Thadeu Assis Figueiredo Campos

journal_name: American Journal of Respiratory and Critical Care Medicine

repository_normalized: University of Melbourne - Minerva Access

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

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine

location_facility: Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: University of Iowa Hospitals and Clinics

location_facility: The First Affiliated Hospital of Nanjing Medical University

location_facility: University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute

location_facility: Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Escola Paulista de Medicina, Universidade Federal de São Paulo

location_facility: Shanghai Pulmonary Hospital of Tongji University

location_facility: Universitätsmedizin der Johannes Gutenberg Universität

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina

location_facility: University of Florida College of Medicine, Jacksonville

location_facility: The University of Texas Health Science Center at Houston

location_facility: Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Renji Hospital of Shanghai Jiaotong University

location_facility: Perelman Center for Advanced Medicine; University of Pennsylvania


title: A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis

summary: This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.

ReferenceCitation: Stifano G, Sornasse T, Rice LM, Na L, Chen-Harris H, Khanna D, Jahreis A, Zhang Y, Siegel J, Lafyatis R. Skin Gene Expression Is Prognostic for the Trajectory of Skin Disease in Patients With Diffuse Cutaneous Systemic Sclerosis. Arthritis Rheumatol. 2018 Jun;70(6):912-919. doi: 10.1002/art.40455.

name: Boston University School of Medicine; Boston Massachusetts

family: Stifano

full_name: Giuseppina Stifano

given: Giuseppina

family: Sornasse

full_name: Thierry Sornasse

given: Thierry

family: Rice

full_name: Lisa M. Rice

given: Lisa M.

full_name: Leo Na

given: Leo

family: Chen-Harris

full_name: Haiyin Chen-Harris

given: Haiyin

name: University of Michigan Scleroderma Program; Ann Arbor

family: Khanna

full_name: Dinesh Khanna

given: Dinesh

family: Jahreis

full_name: Angelika Jahreis

given: Angelika

full_name: Yuqing Zhang

given: Yuqing

family: Siegel

full_name: Jeff Siegel

given: Jeff

name: University of Pittsburgh Medical Center; Pittsburgh Pennsylvania

family: Lafyatis

full_name: Robert Lafyatis

given: Robert

journal_name: Arthritis & Rheumatology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Michigan - Deep Blue

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

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

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Denton CP, Ong VH, Xu S, Chen-Harris H, Modrusan Z, Lafyatis R, Khanna D, Jahreis A, Siegel J, Sornasse T. Therapeutic interleukin-6 blockade reverses transforming growth factor-beta pathway activation in dermal fibroblasts: insights from the faSScinate clinical trial in systemic sclerosis. Ann Rheum Dis. 2018 Sep;77(9):1362-1371. doi: 10.1136/annrheumdis-2018-213031. Epub 2018 May 31.

family: Denton

full_name: Christopher P Denton

given: Christopher P

family: Ong

full_name: Voon H Ong

given: Voon H

family: Xu

full_name: Shiwen Xu

given: Shiwen

family: Modrusan

full_name: Zora Modrusan

given: Zora

repository_institution: University College London - UCL Discovery

ReferenceCitation: Khanna D, Denton CP, Lin CJF, van Laar JM, Frech TM, Anderson ME, Baron M, Chung L, Fierlbeck G, Lakshminarayanan S, Allanore Y, Pope JE, Riemekasten G, Steen V, Müller-Ladner U, Spotswood H, Burke L, Siegel J, Jahreis A, Furst DE. Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate). Ann Rheum Dis. 2018 Feb;77(2):212-220. doi: 10.1136/annrheumdis-2017-211682. Epub 2017 Oct 24.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories:
PubMed Central
UCL Discovery
open-archive.highwire.org

ReferenceCitation: Khanna D, Denton CP, Jahreis A, van Laar JM, Frech TM, Anderson ME, Baron M, Chung L, Fierlbeck G, Lakshminarayanan S, Allanore Y, Pope JE, Riemekasten G, Steen V, Müller-Ladner U, Lafyatis R, Stifano G, Spotswood H, Chen-Harris H, Dziadek S, Morimoto A, Sornasse T, Siegel J, Furst DE. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial. Lancet. 2016 Jun 25;387(10038):2630-2640. doi: 10.1016/S0140-6736(16)00232-4. Epub 2016 May 5. Erratum in: Lancet. 2018 Apr 7;391(10128):1356.

location_country:
United States
France
Germany
United Kingdom
Canada


title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy

summary:
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy.

Patients must undergo molecular pre-screening prior to entry.

ReferenceCitation: Musolino A, Campone M, Neven P, Denduluri N, Barrios CH, Cortes J, Blackwell K, Soliman H, Kahan Z, Bonnefoi H, Squires M, Zhang Y, Deudon S, Shi MM, André F. Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR(+), HER2(-) breast cancer that had progressed during or after prior endocrine therapy. Breast Cancer Res. 2017 Feb 10;19(1):18. doi: 10.1186/s13058-017-0807-8.

family: Musolino

full_name: Antonino Musolino

given: Antonino

family: Campone

full_name: Mario Campone

given: Mario

family: Neven

full_name: Patrick Neven

given: Patrick

family: Denduluri

full_name: Neelima Denduluri

given: Neelima

family: Barrios

full_name: Carlos H. Barrios

given: Carlos H.

family: Cortes

full_name: Javier Cortes

given: Javier

family: Blackwell

full_name: Kimberly Blackwell

given: Kimberly

family: Soliman

full_name: Hatem Soliman

given: Hatem

family: Kahan

full_name: Zsuzsanna Kahan

given: Zsuzsanna

family: Bonnefoi

full_name: Hervé Bonnefoi

given: Hervé

family: Squires

full_name: Matthew Squires

given: Matthew

family: Zhang

full_name: Yong Zhang

given: Yong

family: Deudon

full_name: Stephanie Deudon

given: Stephanie

family: Shi

full_name: Michael M. Shi

given: Michael M.

family: André

full_name: Fabrice André

given: Fabrice

journal_name: Breast Cancer Research

oa_host_type: publisher;repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_normalized: dnet

title: Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR+, HER2− breast cancer that had progressed during or after prior endocrine therapy

location_country:
Italy
Austria
Brazil
Peru
South Africa
Netherlands
France
Poland
Hungary
Argentina
Belgium
Russian Federation
Spain
United States
Taiwan

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC

location_facility: Saint Barnabas Medical Center CancerCenter of Saint Barnabas

location_facility: Nebraska Methodist Hospital Estabrook Cancer Center

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)

location_facility: Cancer Centers of the Carolinas Dept. of CC of the Carolinas

location_facility: University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1

location_facility: Indiana University Health Goshen Center for Cancer SC

location_facility: Wenatchee Valley Medical Center Wenatchee Valley

location_facility: Virginia Cancer Specialists, PC Dept.ofFairfax SC

location_facility: New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

location_facility: Duke University Medical Center Duke (SC)

location_facility: City of Hope National Medical Center COH 3

location_facility: Oncology Specialists, SC Lutheran General Advanced Care

location_facility: Cedars Sinai Medical Center Samuel Oschin Cancer Center


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

lead_sponsor: Sanofi

location_country:
United States
Spain
Germany
France
Japan
Hungary
Argentina
Russian Federation
China
Canada
United Kingdom

acronym: CUPID

location_facility:
Investigational Site Number :1240002
Investigational Site Number :1560006
Investigational Site Number :0320005
Investigational Site Number :7240001
Investigational Site Number :0320001
Investigational Site Number :3920008
Investigational Site Number :0320003
Investigational Site Number :8260001
Investigational Site Number :7240009
Investigational Site Number :3480003
Investigational Site Number :8400019
Investigational Site Number :7240005
Investigational Site Number :1240007
Investigational Site Number :3920007
Investigational Site Number :0320008
Investigational Site Number :6430006
Investigational Site Number :3920005
Investigational Site Number :6430001
Investigational Site Number :1240006
Investigational Site Number :1560002
Investigational Site Number :8400011
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title: Master Protocol of Two Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab

summary:
Primary Objective:

To demonstrate the efficacy of dupilumab in study participants with CSU who remain symptomatic despite the use of H1 antihistamine (Study A: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders)

Secondary Objectives:

To demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints To demonstrate the efficacy of dupilumab on angioedema To demonstrate the efficacy of dupilumab on urticaria control To demonstrate improvement in health-related quality of life and overall disease status and severity To evaluate the ability of dupilumab in reducing the proportion of patients who require treatment with oral corticosteroids (OCS) To evaluate safety outcome measures To evaluate immunogenicity of dupilumab


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

lead_sponsor: Actelion

location_country:
Finland
Malaysia
Belgium
Australia
Russian Federation
Taiwan
Ukraine
Spain
France
Poland
Lithuania
Thailand
Canada
Korea, Republic of
Colombia
Sweden
Switzerland
Vietnam
Bulgaria
Hungary
Ireland
China
Portugal
Germany
United States
Italy
Brazil
Serbia
Mexico
Israel
Belarus
Turkey

acronym: SALTO

location_facility: Hospital de Messejana dr. Carlos Alberto Studart Gomes

location_facility: The General Hospital of Northern Theater Command

location_facility: Izmir Tepecik Training and Research Hospital

location_facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo

location_facility: Cukurova Balcali Hospital Application and Research Center

location_facility: Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital

location_facility: Guangzhou Women And Children's Medical Center

location_facility: Pusan National University Yangsan Hospital

location_facility: Veltischev Research and Clinical Institute for Pediatrics of the Pirogov RNRMU

location_facility: University of Virginia Division of Pediatric Cardiology

location_facility: AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita

location_facility: Vilnius University Hospital Santariskiu Clinics

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: CAPA Istanbul University Medical Faculty

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation

location_facility: Sumy Regional Childrens Clinical Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Complexo de Prevencao,Diagnostico,Terapia e Reabilitacao Respiratoria LTDA Hospital Dia do Pulmao

location_facility: Azienda Ospedaliera Policlinico S. Orsola-Malpighi

location_facility: Cardiovascular Pathology Research Institute of Siberian Branch of RAMS

location_facility: MI Zaporizhzhia Regional Clinical Childrens Hospital of Zaporizhzhia Regional Council

location_facility: Dr. Siyami Ersek Gogus Kalp ve Damar Cerrahisi Training and Research Hospital

location_facility: University Medical Center Ho Chi Minh city

location_facility: New Children's Hospital of the Helsinki University Hospital (HUS)

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu

location_facility: Samara Regional Clinical Cardiological Dispensary

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Scientific Practical Medical Center for Pediatric Cardiology and Cardio Surgery of the MOH

location_facility: MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

location_facility: Cnce of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: State Institution Republican Scientific And Practical Center For Pediatric Surgery

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka

location_facility: Mehmet Akif Ersoy Training and Research Hospital

location_facility: Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas

location_facility: Dnipropetrovsk clinical medical center of Mother and Child after prof. Rudnev

location_facility: Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Congenital Heart Center of the University of Florida

location_facility: Childrens City Clinical Hospital n.a. Bashlyaeva

location_facility: Drottning Silvias barn- och ungdomssjukhus

location_facility: Health Institution 4Th City Children'S Clinical Hospital

title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged >=2 to <18 Years With Pulmonary Arterial Hypertension

summary: The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.


title: A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

summary: DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). Two combination therapy cohorts will be opened for enrollment, DF1001 + nivolumab and DF1001 + Nab paclitaxel. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either selected solid tumors, or solid tumors expressing high levels of HER2.

lead_sponsor: Dragonfly Therapeutics

location_country:
Netherlands
France
Belgium
Denmark
United States

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

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Domaine Universitaire du Sart Tilman; CHU de Liege

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: Stichting Beoordeling Ethiek Biomedisch Onderzoek

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of California Irvine Medical Center

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center


title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects With Sjögren's Syndrome (SS)

acronym: SS

summary: The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).

lead_sponsor: Viela Bio

location_country:
Italy
Peru
India
Mexico
France
Poland
Hungary
United States
United Kingdom
Korea, Republic of

location_facility:
Research site
Research Site


ReferenceCitation: Liu AP, Cheuk DK. Disease-modifying treatments for primary autoimmune haemolytic anaemia. Cochrane Database Syst Rev. 2021 Mar 26;3:CD012493. doi: 10.1002/14651858.CD012493.pub2.

name: Department of Pediatrics and Adolescent Medicine; The University of Hong Kong, Queen Mary Hospital; Hong Kong China

family: Liu

full_name: Anthony Pak-yin Liu

given: Anthony Pak-yin

family: Cheuk

full_name: Daniel KL Cheuk

given: Daniel KL

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
United States
Netherlands
France
Czechia
Greece
Israel
Poland
Hungary
Spain
Germany
United Kingdom
Ukraine

location_facility: Klinika Hematologii i Transplantologii, UCK

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University General Hospital of Thessaloniki

location_facility: East Carolina University-School of Medicine

location_facility: Kyiv City Clinical Hospital #9, Department of infectious diseases

location_facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

location_facility: Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

location_facility: Hospital of the University of Pennsylvania

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

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: University of Colorado - Anschutz Medical Campus

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: Cherkassy Regional Oncology Dispensary, Department of Hematology

location_facility: Ternopil University Hospital of Ternopil Regional Council

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

location_facility: University of North Carolina Hemophilia and Thrombosis Center

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: General Hospital of Athens 'G. Gennimatas'

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu

location_facility: University General Hospital of Rio Patras

location_facility: Taussig Cancer Insititute - Cleveland Clinic

location_facility: Roswell Park Comprehensive Cancer Center

title: Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension

summary: The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).


title: A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program

acronym: BrainStorm

summary:
Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.

Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome.

In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

lead_sponsor: Jules Bordet Institute

location_country: Luxembourg Belgium France

location_facility: Institut Universitaire du Cancer - Oncopole

location_facility: CHU UCL Namur - Site de Sainte-Elisabeth


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

acronym: EDITION II

summary:
Primary Objective:

To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus

Secondary Objective:

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

ReferenceType: result

ReferenceCitation: Yki-Järvinen H, Bergenstal R, Ziemen M, Wardecki M, Muehlen-Bartmer I, Boelle E, Riddle MC; EDITION 2 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014 Dec;37(12):3235-43. doi: 10.2337/dc14-0990. Epub 2014 Sep 5.

family: Yki-Järvinen

full_name: Hannele Yki-Järvinen

given: Hannele

family: Bergenstal

full_name: Richard Bergenstal

given: Richard

family: Ziemen

full_name: Monika Ziemen

given: Monika

family: Wardecki

full_name: Marek Wardecki

given: Marek

family: Muehlen-Bartmer

full_name: Isabel Muehlen-Bartmer

given: Isabel

family: Boelle

full_name: Emmanuelle Boelle

given: Emmanuelle

family: Riddle

full_name: Matthew C. Riddle

given: Matthew C.

journal_name: Diabetes Care

evidence: open (via free pdf)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

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

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

family: Yale

full_name: J.-F. Yale

family: Aroda

full_name: V.R. Aroda

family: Charbonnel

full_name: B. Charbonnel

given: B.

family: Sinclair

full_name: A.J Sinclair

family: Trescoli

full_name: C. Trescoli

given: C.

family: Cahn

full_name: A. Cahn

given: A.

family: Bigot

full_name: G. Bigot

given: G.

family: Merino-Trigo

full_name: A. Merino-Trigo

family: Brulle-Wohlhueter

full_name: C. Brulle-Wohlhueter

family: Bolli

full_name: G.B. Bolli

family: Ritzel

full_name: R. Ritzel

given: R.

journal_name: Diabetes & Metabolism

oa_colors: green hybrid

ReferenceCitation: Bolli GB, Wysham C, Fisher M, Chevalier S, Cali AMG, Leroy B, Riddle MC. A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen. Diabetes Obes Metab. 2019 Feb;21(2):402-407. doi: 10.1111/dom.13515. Epub 2018 Oct 2.

name: Department of Medicine; University of Perugia; Perugia Italy

name: Diabetes and Endocrinology Center; Rockwood Clinic; Spokane Washington

name: Glasgow Royal Infirmary; University of Glasgow; Glasgow UK

name: Oregon Health and Science University; Portland Oregon

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

ReferenceCitation: Yale JF, Pettus JH, Brito-Sanfiel M, Lavalle-Gonzalez F, Merino-Trigo A, Stella P, Chevalier S, Buzzetti R. The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3. PLoS One. 2018 Jan 25;13(1):e0190579. doi: 10.1371/journal.pone.0190579. eCollection 2018.

repository_institution: California Digital Library - eScholarship

repository_institution: Universidad Autónoma de Nuevo León - El Repositorio Academico Digital de la UANL

ReferenceCitation: Yki-Järvinen H, Bergenstal RM, Bolli GB, Ziemen M, Wardecki M, Muehlen-Bartmer I, Maroccia M, Riddle MC. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 2015 Dec;17(12):1142-9. doi: 10.1111/dom.12532. Epub 2015 Sep 14.

name: Division of Diabetes, Faculty of Medicine University of Helsinki, Helsinki University Central Hospital  Helsinki Finland

name: Minerva Foundation Institute for Medical Research  Helsinki Finland

name: International Diabetes Center at Park Nicollet  Minneapolis MN USA

name: Department of Medicine University of Perugia  Perugia Italy

name: Sanofi‐Aventis Deutschland GmbH  Frankfurt am Main Germany

name: Division of Endocrinology, Diabetes & Clinical Nutrition Oregon Health & Science University  Portland OR USA

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repositories_institution:
PubMed Central - Europe PMC
University of Helsinki - Helda

title: Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12‐month trial including 6‐month extension

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

location_country:
South Africa
Chile
Mexico
Spain
Germany
Finland
France
Romania
Hungary
Russian Federation
Portugal
United States
Canada

location_facility:
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Investigational Site Number 840108
Investigational Site Number 124010


title: A Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without GDC-0941 in Patients With Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer

summary: This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib.

lead_sponsor: Genentech, Inc.

location_country:
Italy
Brazil
United States
Chile
Netherlands
Germany
France
Israel
Hungary
Argentina
Australia
Russian Federation
Spain
Canada
United Kingdom
Ukraine

location_facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

location_facility: Clinique Catherine de Sienne; Service de cancérologie

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Vas Megyei Markusovszky Korhaz ; Pulmonology

location_facility: Catharina-ziekenhuis; Longgeneeskunde en Tuberculose

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie

location_facility: Hematology Oncology PC; Bennett Cancer Center

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: Peachtree Hematology & Oncology Consultants, Pc

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Isis Centro Especializado de Luces; Oncology

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: Royal Prince Alfred Hospital; Sydney Cancer Centre

location_facility: Sumy Reg. Clin. Oncological Dispensary; Thoracall Department

location_facility: Hospital Nuestra Señora de Sonsoles; servicio de Oncologia

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Rsrch Onc Inst of Rosmed Tech; n.a. prof. N.N. Petrov; Dept of Surgery

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

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

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Florida Cancer Specialists - Fort Myers (Colonial Center Dr)

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezet

location_facility: Flinders Medical Centre; Medical Oncology

location_facility: Krankenhaus Grosshansdorf;Pneumologie & Thoraxchirurgie

location_facility: Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie

location_facility: Clinica de Tratamento e Pesquisa Oncologica - Oncotek

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.

location_facility: City Oncology Hospital; Chemotherapy Dept

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Royal Melbourne Hospital; Hematology and Medical Oncology

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Zala Megyei Korhaz; Dept of Pulmonary Medicine

location_facility: Crimean Republican Institute; Oncology Clin Dispensary; Chemotherapy Dept

location_facility: Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica

location_facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Wayne State University; Hemat/Onc, 4HW CRC

location_facility: Royal Surrey County Hospital; St. Lukes Cancer Centre

location_facility: Centre Hospitalier de Villefranche sur Saone


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)

acronym: BLISS-SC

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

ReferenceCitation: Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3). pii: e001747. doi: 10.1136/rmdopen-2021-001747.

family: Brunner

full_name: Hermine I Brunner

given: Hermine I

family: Abud-Mendoza

full_name: Carlos Abud-Mendoza

given: Carlos

family: Mori

full_name: Masaaki Mori

given: Masaaki

family: Pilkington

full_name: Clarissa A Pilkington

given: Clarissa A

family: Syed

full_name: Reema Syed

given: Reema

family: Takei

full_name: Syuji Takei

given: Syuji

family: Viola

full_name: Diego O Viola

given: Diego O

family: Furie

full_name: Richard A Furie

given: Richard A

family: Navarra

full_name: Sandra Navarra

given: Sandra

family: Zhang

full_name: Fengchun Zhang

given: Fengchun

family: Bass

full_name: Damon L Bass

given: Damon L

family: Eriksson

full_name: Gina Eriksson

given: Gina

family: Hammer

full_name: Anne E Hammer

given: Anne E

family: Ji

full_name: Beulah N Ji

given: Beulah N

family: Okily

full_name: Mohamed Okily

given: Mohamed

family: Roth

full_name: David A Roth

given: David A

family: Quasny

full_name: Holly Quasny

given: Holly

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

journal_name: RMD Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

ReferenceCitation: Maslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1). pii: e000459. doi: 10.1136/lupus-2020-000459.

ReferenceCitation: Lokhandwala T, Yue B, Coutinho AD, Bell CF. Within-trial economic analysis of flare data from the BLISS-SC trial of subcutaneous belimumab in systemic lupus erythematosus. Lupus Sci Med. 2021 Feb;8(1). pii: e000438. doi: 10.1136/lupus-2020-000438.

ReferenceCitation: Doria A, Bass D, Schwarting A, Hammer A, Gordon D, Scheinberg M, Fox NL, Groark J, Stohl W, Kleoudis C, Roth D. A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus. Lupus. 2018 Aug;27(9):1489-1498. doi: 10.1177/0961203318777634. Epub 2018 May 28.

name: Rheumatology Unit, Department of Medicine, University of Padova, Padua, Italy

name: GlaxoSmithKline R&D, Philadelphia, PA, USA

name: Division of Rheumatology, University Hospital Mainz, Mainz, Germany

name: ACURA Rheumazentrum Kliniken, Bad Kreuznach, Germany

name: Centro de Pesquisas Clinicas do Hospital Abreu Sodré, São Paulo, Brazil

name: Division of Rheumatology, University of Southern California Keck School of Medicine, Los Angeles, CA, USA

name: Parexel Clinical Research, Raleigh-Durham, NC, USA

ReferenceCitation: Doria A, Stohl W, Schwarting A, Okada M, Scheinberg M, van Vollenhoven R, Hammer AE, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Anti-Double-Stranded DNA-Positive, Hypocomplementemic Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2018 Aug;70(8):1256-1264. doi: 10.1002/art.40511. Epub 2018 Jun 15.

name: University of Southern California; Los Angeles

name: University Medical Center of Johannes Gutenberg University; Mainz Germany

name: St. Luke's International University; Tokyo Japan

name: Rheumatology Hospital Abreu Sodre; São Paulo Brazil

name: Amsterdam Rheumatology and Immunology Center; Amsterdam The Netherlands

name: GlaxoSmithKline; Research Triangle Park North Carolina

ReferenceCitation: Stohl W, Schwarting A, Okada M, Scheinberg M, Doria A, Hammer AE, Kleoudis C, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study. Arthritis Rheumatol. 2017 May;69(5):1016-1027. doi: 10.1002/art.40049. Epub 2017 Apr 7.

name: University of Southern CaliforniaLos Angeles

name: Acura Kliniken Rheinland‐Pfalz AGBad Kreuznach Germany

name: St. Luke's International HospitalTokyo Japan

name: Rheumatology Hospital Abreu SodreSão Paulo Brazil

name: GlaxoSmithKline, Research Triangle Park North Carolina

repository_institution: University of Padua - Padua Research Archive

title: Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty‐Two–Week Randomized, Double‐Blind, Placebo‐Controlled Study

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: Human Genome Sciences Inc., a GSK Company

location_country:
Malaysia
Romania
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
Croatia
France
Japan
Poland
Thailand
Argentina
Colombia
Chile
Sweden
Philippines
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Spain