title: Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

acronym: PROMINENT

summary:
The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:

nonfatal Myocardial Infarction (MI)
nonfatal ischemic stroke
coronary revascularization; or
Cardio Vascular (CV) death.

primary_purpose: Prevention

ReferenceCitation: Pradhan AD, Paynter NP, Everett BM, Glynn RJ, Amarenco P, Elam M, Ginsberg H, Hiatt WR, Ishibashi S, Koenig W, Nordestgaard BG, Fruchart JC, Libby P, Ridker PM. Rationale and design of the Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT) study. Am Heart J. 2018 Dec;206:80-93. doi: 10.1016/j.ahj.2018.09.011. Epub 2018 Sep 29. Review.

family: Pradhan

full_name: Aruna D. Pradhan

given: Aruna D.

family: Paynter

full_name: Nina P. Paynter

given: Nina P.

family: Everett

full_name: Brendan M. Everett

given: Brendan M.

family: Glynn

full_name: Robert J. Glynn

given: Robert J.

family: Amarenco

full_name: Pierre Amarenco

given: Pierre

family: Elam

full_name: Marshall Elam

given: Marshall

family: Ginsberg

full_name: Henry Ginsberg

given: Henry

family: Hiatt

full_name: William R. Hiatt

given: William R.

family: Ishibashi

full_name: Shun Ishibashi

given: Shun

family: Koenig

full_name: Wolfgang Koenig

given: Wolfgang

family: Nordestgaard

full_name: Børge G. Nordestgaard

given: Børge G.

family: Fruchart

full_name: Jean-Charles Fruchart

given: Jean-Charles

family: Libby

full_name: Peter Libby

given: Peter

family: Ridker

full_name: Paul M Ridker

given: Paul M

journal_name: American Heart Journal

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

lead_sponsor: Kowa Research Institute, Inc.

location_country:
Romania
Russian Federation
Denmark
Ukraine
India
France
Japan
Poland
Slovakia
Argentina
Canada
Colombia
South Africa
Netherlands
Bulgaria
Hungary
Puerto Rico
United States
Germany
United Kingdom
Brazil
Mexico
Czechia
Israel
Spain

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location_facility: Saul Vizel Professional Medicine Corporation

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location_facility: Hospital Regional Universitario de Malaga

location_facility: Huntington Hospital - Research Department

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Tokushukai Kishiwada Tokushukai Hospital

location_facility: Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu"

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location_facility: Nemocnica arm. generala L. Svobodu Svidnik, a.s.,

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location_facility: National Center For Geriatrics And Gerontology

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Okinawa Tokushukai Chubu Tokushukai Hospital

location_facility: LMC Clinical Research dba Manna Research Inc. Toronto

location_facility: Ivano-Frankivsk CCH Dept of Therapy #1 SHEI Ivano-Frankivsk NMU

location_facility: Shiga University of Medical Science Hospital

location_facility: Royal Alexandra Hospital, CK Hui Heart Centre

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location_facility: Synexus Scotland Clinical Research Centre

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location_facility: AMH Feasterville Family Health Care Center

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location_facility: Synexus Lancashire Clinical Research Centre

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location_facility: Hadassah University Hospital - Ein Kerem

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location_facility: Southern New Hampshire Diabetes and Endocrinology

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location_facility: Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Nakakinen Clinic Medical Corporation Kensei-kai

location_facility: KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

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location_facility: Eurolatino Natal Pesquisas Médicas Ltda.

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location_facility: South Shore Internal Medicine Associates

location_facility: Houston Methodist Research Institute - CCAT Pearland

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location_facility: FSBI "Central Clinical Hospital with Polyclinic of the Department for Presidential Affairs of the RF

location_facility: Stratton Veterans Affairs Medical Center - Albany

location_facility: Fundación Oftalmológica de Santander - FOSCAL

location_facility: Morgan Medical Management & Consultants Inc.

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location_facility: NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

location_facility: Kyiv CH on Railway Transport #2 of Branch Center of Healthcare Public Company Ukr Railway

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 KCC

location_facility: SPb SBIH "City Multy-field Hospital # 2"

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location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: CI Ivano-Frankivsk Reg Cl Card Center Dept of Chronic Ischemic Heart Dis SHEI Ivano-Frank NMU

location_facility: LMC Clinical Research dba Manna Research Inc. Mirabel

location_facility: State Budgetary Healthcare Institution Clinical Medical Sani

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Lviv Communal 4th City Clinical Hospital

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location_facility: MUDr. Jan KVASNICKA CSc. Angiologie kardiologie a interna

location_facility: L2IP - Instituto de Pesquisas Clínicas Ltda.

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location_facility: Alta Pharmaceutical Research Center, Inc.

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location_facility: Vinnytsia RC Highly Special.Endocr.Center Dept of Therapy #2 M.I. Pyrogov NMU

location_facility: Institut fuer klinische Forschung und Entwicklung Berlin GmbH

location_facility: Shri B. D. Mehta Mahavir Heart Institute

location_facility: Joanne F. Liutkus Medicine Professional Corporation

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location_facility: Synexus Manchester Clinical Research Centre

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location_facility: Diabetes and Thyroid Center of Fort Worth

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location_facility: BC Diabetes As Operated by Dr. TG Elliott, Inc.

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location_facility: Novant Health - Heart and Vascular Institute

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location_facility: Diagnostic Consultation Center CONVEX EOOD


type: EudraCT Number

title: RE-SPECT CVT: a Randomised, Open-label, Exploratory Trial With Blinded Endpoint Adjudication (PROBE), Comparing Efficacy and Safety of Oral Dabigatran Etexilate Versus Oral Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis Over a 24-week Period

summary: This is a multi-center, prospective, international, randomized (1:1), open-label study with two parallel groups. This phase III study is planned to investigate the efficacy and safety of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with blinded endpoint adjudication.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Ferro JM, Bendszus M, Jansen O, Coutinho JM, Dentali F, Kobayashi A, Aguiar de Sousa D, Neto LL, Miede C, Caria J, Huisman H, Diener HC; RE-SPECT CVT Study Group. Recanalization after cerebral venous thrombosis. A randomized controlled trial of the safety and efficacy of dabigatran etexilate versus dose-adjusted warfarin in patients with cerebral venous and dural sinus thrombosis. Int J Stroke. 2021 Apr 4:17474930211006303. doi: 10.1177/17474930211006303. [Epub ahead of print]

name: Department of Neurosciences and Mental Health, Serviço de Neurologia, Hospital Santa Maria, Lisbon, Portugal

name: Instituto de Medicina Molecular, Universidade de Lisboa, Lisboa, Portugal

name: Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal

family: Ferro

full_name: José M Ferro

given: José M

sequence: first

family: Bendszus

full_name: Martin Bendszus

given: Martin

sequence: additional

name: Department of Radiology and Neuroradiology, University of Kiel, Kiel, Germany

family: Jansen

full_name: Olav Jansen

given: Olav

name: Department of Neurology, Amsterdam University Medical Centers, Amsterdam, the Netherlands

family: Coutinho

full_name: Jonathan M Coutinho

given: Jonathan M

family: Dentali

full_name: Francesco Dentali

given: Francesco

family: Kobayashi

full_name: Adam Kobayashi

given: Adam

family: Aguiar de Sousa

full_name: Diana Aguiar de Sousa

given: Diana

name: Serviço de Neuroradiologia, Hospital Santa Maria/Centro Hospitalar Lisboa Norte, Lisboa, Portugal

family: Neto

full_name: Lia L Neto

given: Lia L

family: Miede

full_name: Corinna Miede

given: Corinna

family: Caria

full_name: Jorge Caria

given: Jorge

family: Huisman

full_name: Holger Huisman

given: Holger

name: Faculty of Medicine, University Duisburg-Essen, Essen, Germany

family: Diener

full_name: Hans-Christoph Diener

given: Hans-Christoph

name: on behalf of the RE-SPECT CVT Study Group

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: International Journal of Stroke

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Ferro JM, Coutinho JM, Jansen O, Bendszus M, Dentali F, Kobayashi A, van der Veen B, Miede C, Caria J, Huisman H, Diener HC; RE-SPECT CVT Study Group. Dural Arteriovenous Fistulae After Cerebral Venous Thrombosis. Stroke. 2020 Nov;51(11):3344-3347. doi: 10.1161/STROKEAHA.120.031235. Epub 2020 Sep 25.

name: Serviço de Neurologia, Department of Neurosciences and Mental Health, Hospital Santa Maria/Centro Hospitalar Lisboa Norte, Portugal (J.M.F.).

full_name: José M. Ferro

given: José M.

name: Department of Neurology, Amsterdam University Medical Centers, the Netherlands (J.M.C., B.v.d.V.).

full_name: Jonathan M. Coutinho

given: Jonathan M.

name: Department of Radiology and Neuroradiology, University of Kiel, Germany (O.J.).

name: Neurologische Klinik, Abteilung für Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany (M.B.).

name: Department of Medicine and Surgery, Insubria University, Varese, Italy (F.D.).

name: Faculty of Health Sciences and Physical Education, Kazimierz Pulaski University of Technology and Humanities, Radom, Poland (A.K.).

family: van der Veen

full_name: Bas van der Veen

given: Bas

name: HMS Analytical Software GmbH, Weimar (Lahn), Germany (C.M.).

name: Boehringer Ingelheim International, Ingelheim am Rhein, Germany (J.C.).

name: Boehringer Ingelheim B.V., Alkmaar, the Netherlands (H.H.).

name: Faculty of Medicine, University Duisburg-Essen, Germany (H.-C.D.).

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Ferro JM, Coutinho JM, Dentali F, Kobayashi A, Alasheev A, Canhão P, Karpov D, Nagel S, Posthuma L, Roriz JM, Caria J, Frässdorf M, Huisman H, Reilly P, Diener HC; RE-SPECT CVT Study Group. Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients With Cerebral Venous Thrombosis: A Randomized Clinical Trial. JAMA Neurol. 2019 Dec 1;76(12):1457-1465. doi: 10.1001/jamaneurol.2019.2764.

name: Department of Neurosciences and Mental Health, Serviço de Neurologia, Hospital Santa Maria/Centro Hospitalar Lisboa Norte, Lisbon, Portugal

name: Instituto de Medicina Molecular and Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal

name: Department of Neurology, Academic Medical Centre, Amsterdam, the Netherlands

name: Department of Clinical and Experimental Medicine, Insubria University, Varese, Italy

name: Faculty of Health Sciences and Physical Education, Kazimierz Pulaski University of Technology and Humanities Radom, Warsaw, Poland

name: Interventional Stroke and Cerebrovascular Disease Treatment Center, Institute of Psychiatry and Neurology, Warsaw, Poland

name: Sverdlovsk Regional Clinical Hospital No 1, Yekaterinburg, Russia

name: Neurology Department, Regional State Budget Healthcare, City Hospital No. 5, Barnaul, Russia

name: Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany

name: Neurology Department, Centro Hospitalar de Entre o Douro e Vouga, Santa Maria da Feira, Portugal

name: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

name: Boehringer Ingelheim BV, Alkmaar, the Netherlands

name: Department of Clinical Development, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

ReferenceCitation: Ferro JM, Dentali F, Coutinho JM, Kobayashi A, Caria J, Desch M, Fraessdorf M, Huisman H, Diener HC. Rationale, design, and protocol of a randomized controlled trial of the safety and efficacy of dabigatran etexilate versus dose-adjusted warfarin in patients with cerebral venous thrombosis. Int J Stroke. 2018 Oct;13(7):766-770. doi: 10.1177/1747493018778125. Epub 2018 May 18.

name: Department of Neurosciences and Mental Health, Hospital Santa Maria, University of Lisbon, Lisbon, Portugal

name: Interventional Stroke and Cerebrovascular Disease Treatment Center and Department of Neuroradiology, Institute of Psychiatry and Neurology, Warsaw, Poland

name: Boehringer Ingelheim GmbH & Co. KG, Ingelheim am Rhein, Germany

name: Department of Neurology and Stroke Center, University Hospital Essen, Essen, Germany

location_country:
Italy
India
Netherlands
Spain
France
Poland
Russian Federation
Portugal
Germany

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan

location_facility: Reg.State Budget Hlthcare,City Hosp#5,Neurology Dept,Barnaul

location_facility: St.Petersb,State Hlthcare Instit. Elisabeth Hosp,Neurol.dept

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

location_facility: Nuovo Ospedale Civile S. Agostino-Estense

location_facility: Independent Public Clin.Hospital No.4,Neurol.Dept,Lublin


intervention_type: Drug

status: Active, not recruiting

lead_sponsor: Targovax Oy

location_country: France Spain

acronym: MESOS

location_facility: Hospital Universitari de Girona Doctor Josep Trueta - Institut Català d'Oncologia

source: euctr

title: A Randomised Phase II Open-label Study With a Phase Ib Safety lead-in Cohort of ONCOS-102, an Immune-priming GM-CSF Coding Oncolytic Adenovirus, and Pemetrexed/Cisplatin in Patients With Unresectable Malignant Pleural Mesothelioma

summary: The trial is an open-label, parallel group, multicentre trial that will recruit a total of 30 patients with malignant pleural mesothelioma. The trial will be conducted in 2 phases: a non-randomised safety phase and a randomised phase. The safety phase will consist of a lead-in cohort of 6 patients treated with ONCOS 102 and pemetrexed/cisplatin. The randomised phase will not commence until the DSMB has deemed the safety lead-in data appropriate for continuation. A total of 24 patients will be included in the randomised phase; 14 patients will be randomised to receive ONCOS 102 and pemetrexed/cisplatin, and 10 patients will receive pemetrexed/cisplatin alone. If cisplatin is seen to be too toxic after one or more cycles, the patient may change to carboplatin during the study. Furthermore, if treatment with cisplatin is deemed to be too toxic by the investigator due to age, presence of neurological toxicities or other relevant medical conditions, carboplatin can be administered from start of study. The trial's main objectives are determination of safety, immune activation, clinical response and the correlation between clinical outcome and the immunological data.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer Patients With Personalized Therapy (SUBITO) - an International Randomized Phase III Trial

acronym: Subito

summary: Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer patients) comparing optimized standard-dose chemotherapy with intensified, alkylating chemotherapy with stem cell rescue.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: The Netherlands Cancer Institute

location_country: France Netherlands

location_facility:
University Medical Center Utrecht
Maastricht University Medical Center
LUMC
AZVU
Hopital Tenon, University Marie-Curie
Antoni van Leeuwenhoek
Radboud UMC
University Medical Center Groningen
Institut Paoli Calmettes
Medical spectrum Twente
Erasmus Medical Center Cancer Institute


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

location_country:
Switzerland
Netherlands
France
Spain
United Kingdom

location_facility: Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Europeen Georges Pompidou

location_facility: Radboudumc - Radboud University Medical Center Nijmegen

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Royal Marsden Hospital - Chelsea, London

title: A Phase II Study of the Anti-PDL1 Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid to Investigate Safety and Efficacy of This Combination in Recurrent Platinum-resistant Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma

summary: This is a randomized phase II study, aimed at evaluating the efficacy (through progression free survival at 6 months) and safety of 5 different treatments involving atezolizumab, bevacizumab and/or acetylsalicylic acid in advanced recurrent platinum-resistant ovarian cancer patients in order to select the optimal treatments for further development in Phase III.


type: Other Identifier

title: A PHASE IIA PROSPECTIVE, OPEN-LABEL, MULTICENTER STUDY TO DETERMINE THE PHARMACOKINETICS (PK) AND SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) FOR THE TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAIS) IN HOSPITALIZED ADULTS

summary: Determine the PK and safety and tolerability of aztreonam-avibactam (ATM-AVI) in the treatment of hospitalized adults with cIAI

design_allocation: Non-Randomized

ReferenceCitation: Cornely OA, Cisneros JM, Torre-Cisneros J, Rodríguez-Hernández MJ, Tallón-Aguilar L, Calbo E, Horcajada JP, Queckenberg C, Zettelmeyer U, Arenz D, Rosso-Fernández CM, Jiménez-Jorge S, Turner G, Raber S, O'Brien S, Luckey A; COMBACTE-CARE consortium/REJUVENATE Study Group. Pharmacokinetics and safety of aztreonam/avibactam for the treatment of complicated intra-abdominal infections in hospitalized adults: results from the REJUVENATE study. J Antimicrob Chemother. 2020 Mar 1;75(3):618-627. doi: 10.1093/jac/dkz497.

name: University of Cologne, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Clinical Trials Centre Cologne (CTC Cologne), Faculty of Medicine, University Hospital Cologne, Department I of Internal Medicine, German Centre for Infection Research (DZIF) partner site Cologne, Cologne, Germany

family: Cornely

full_name: Oliver A Cornely

given: Oliver A

name: Hospital Universitario Virgen del Rocío, Seville, Spain

family: Cisneros

full_name: José M Cisneros

name: Reina Sofia University Hospital-IMIBIC-UCO, Córdoba, Spain

family: Torre-Cisneros

full_name: Julian Torre-Cisneros

given: Julian

family: Rodríguez-Hernández

full_name: María Jesús Rodríguez-Hernández

given: María Jesús

name: Hospital Universitario Virgen Macarena, Seville, Spain

family: Tallón-Aguilar

full_name: Luis Tallón-Aguilar

given: Luis

name: Hospital Universitario Mútua de Tarrasa and Universitat Internacional de Catalunya, Barcelona, Spain

family: Calbo

full_name: Esther Calbo

given: Esther

name: Hospital del Mar, IMIM, UAB, Barcelona, Spain

family: Horcajada

full_name: Juan P Horcajada

given: Juan P

family: Queckenberg

full_name: Christian Queckenberg

given: Christian

family: Zettelmeyer

full_name: Ulrike Zettelmeyer

given: Ulrike

family: Arenz

full_name: Dorothee Arenz

given: Dorothee

family: Rosso-Fernández

full_name: Clara M Rosso-Fernández

given: Clara M

family: Jiménez-Jorge

full_name: Silvia Jiménez-Jorge

given: Silvia

family: Turner

full_name: Guy Turner

given: Guy

family: Raber

full_name: Susan Raber

given: Susan

family: O’Brien

full_name: Seamus O’Brien

given: Seamus

family: Luckey

full_name: Alison Luckey

given: Alison

family: Aguado

full_name: Ana Cristina Padial Aguado

given: Ana Cristina Padial

family: Baranda

full_name: Miguel Montejo Baranda

given: Miguel Montejo

family: Bernedo

full_name: Carlos García Bernedo

given: Carlos García

family: Bludau

full_name: Marc Bludau

given: Marc

family: Boix-Palop

full_name: Lucía Boix-Palop

given: Lucía

family: Cheng

full_name: Karen Cheng

given: Karen

family: de Jonge

full_name: Boudewijn de Jonge

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

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.

location_facility: Universitaetsklinikum Koeln Innere Medizin I

location_facility: Universitaetsklinikum Schleswig-Holstein, Klinik fuer Infektiologie und Mikrobiologie, DZIF-CTU


title: Evaluation of the Effectiveness of the Abatacept (Orencia®) IV and SC Patient Alert Cards in Patients With Rheumatoid Arthritis in European Economic Area Countries

summary: The purpose of the study is to determine a) if the implementation of abatacept (Orencia®) patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: Bristol-Myers Squibb

location_country:
Sweden
France
Spain
Germany
United Kingdom

location_facility: APHM - Hopital Sainte-Marguerite, Marseille

status_simplified: Completed


title: A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of VYC-25L Hyaluronic Acid Injectable Gel for Restoration and Creation of Facial Volume in the Chin and Jaw

summary: This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.

lead_sponsor: Allergan

location_country: Germany France Netherlands

location_facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

location_facility: Rotes Kreuz Krankenhaus Kassel Gemeinnützige GmbH Klinik für Plastische, Rekonstruktive und Ästhetische Chirurgie

location_facility: Praxisgemeinschaft Theatiner46 Dres. Ogilvie und Dr. Bernd Schuster

location_facility: Hautzentrum Altenbochum - RuhrDERM Gemeinschaftspraxis Dr. med. Ardabili - Dr. med. Niesmann

location_facility: Dermatogische Privatpraxis CentroDerm GmbH

intervention_type: Device


title: SECURE - A poSt-market Registry in Patients With infrarEnal aortiC Aneurysm Undergoing endovasculaR Stenting With the New E-tegra Stent Graft System

acronym: SECURE

summary: The purpose of this study is to evaluate clinical and technical success as well as safety and feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.

time_perspective: Prospective

lead_sponsor: JOTEC GmbH

location_country: Switzerland France Poland Spain Germany

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Hospital Clinico Universitario Valladolid

location_facility: Szpital Uniwersytecki im. dr. Antoniego Jurasza

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1


title: An Open Label, Phase II, Multicenter Study to Evaluate the Efficacy and Safety of a Recombinant Humanized Antibody to HER2 (Pertuzumab) Administered Every 3 Weeks to Patients With Hormone-Refractory Prostate Cancer Who Have Not Been Treated With Chemotherapy

summary: This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50 participants may enter either cohort, for a total enrollment between 46 and 73 participants across 9 study centers.

status: Terminated

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Netherlands
France
Spain
Germany
United Kingdom

status_simplified: Unknown


ReferenceCitation: Fløisand Y, Schroeder MA, Chevallier P, Selleslag D, Devine S, Renteria AS, Mohty M, Yakoub-Agha I, Chen C, Parfionovas A, Quadri S, Jansson J, Akbari M, Chen YB. A phase 2a randomized clinical trial of intravenous vedolizumab for the treatment of steroid-refractory intestinal acute graft-versus-host disease. Bone Marrow Transplant. 2021 Oct;56(10):2477-2488. doi: 10.1038/s41409-021-01356-0. Epub 2021 Jun 9.

family: Fløisand

full_name: Yngvar Fløisand

given: Yngvar

family: Schroeder

full_name: Mark A. Schroeder

given: Mark A.

family: Chevallier

full_name: Patrice Chevallier

given: Patrice

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

family: Devine

full_name: Steven Devine

given: Steven

family: Renteria

full_name: Anne S. Renteria

given: Anne S.

family: Mohty

full_name: Mohamad Mohty

given: Mohamad

family: Yakoub-Agha

full_name: Ibrahim Yakoub-Agha

given: Ibrahim

family: Chen

full_name: Chunlin Chen

given: Chunlin

family: Parfionovas

full_name: Andrejus Parfionovas

given: Andrejus

family: Quadri

full_name: Syed Quadri

given: Syed

family: Jansson

full_name: Johan Jansson

given: Johan

family: Akbari

full_name: Mona Akbari

given: Mona

full_name: Yi-Bin Chen

given: Yi-Bin

journal_name: Bone Marrow Transplantation

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Sweden
France
Norway
Belgium
United States

location_facility: Oslo Universitetssykehus - Rikshospitalet

ipd_sharing: Yes

title: An Open-Label, Dose-Finding Study of Vedolizumab IV for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

summary: The purpose of this study is to assess the initial activity, tolerability, safety and to identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for treatment of steroid-refractory acute intestinal GvHD in participants who have undergone allo-HSCT.


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

More information provided by Eli Lilly and Company

lead_sponsor: Eli Lilly and Company

location_country:
France
Israel
Belgium
Australia
Spain
United States
United Kingdom
Taiwan

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

title: An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination With Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma

summary: The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs versus standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).


title: Phase 2 Study of a CDK4/6 Inhibitor for Patients With Relapsed or Refractory Mantle Cell Lymphoma

summary: The purpose of this study is to estimate the disease control rate with abemaciclib for relapsed or refractory mantle cell lymphoma.

ReferenceCitation: Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13.

family: Gelbert

full_name: Lawrence M. Gelbert

given: Lawrence M.

family: Cai

full_name: Shufen Cai

given: Shufen

family: Lin

full_name: Xi Lin

given: Xi

family: Sanchez-Martinez

full_name: Concepcion Sanchez-Martinez

given: Concepcion

family: del Prado

full_name: Miriam del Prado

given: Miriam

family: Lallena

full_name: Maria Jose Lallena

given: Maria Jose

family: Torres

full_name: Raquel Torres

given: Raquel

family: Ajamie

full_name: Rose T. Ajamie

given: Rose T.

family: Wishart

full_name: Graham N. Wishart

given: Graham N.

family: Flack

full_name: Robert Steven Flack

given: Robert Steven

family: Neubauer

full_name: Blake Lee Neubauer

given: Blake Lee

family: Young

full_name: Jamie Young

given: Jamie

family: Chan

full_name: Edward M. Chan

given: Edward M.

family: Iversen

full_name: Philip Iversen

given: Philip

family: Cronier

full_name: Damien Cronier

given: Damien

family: Kreklau

full_name: Emiko Kreklau

given: Emiko

family: de Dios

full_name: Alfonso de Dios

given: Alfonso

journal_name: Investigational New Drugs

evidence: open (via page says license)

repository_institution: PubMed Central - Europe PMC

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


title: Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study

acronym: EASE

summary: The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients.

ReferenceType: background

ReferenceCitation: Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH, Schlensak C, Carrel T. Clinical experience with the ATS 3f Enable® Sutureless Bioprosthesis. Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. Epub 2011 Feb 20.

ReferenceCitation: Englberger L, Carrel TP, Doss M, Sadowski J, Bartus K, Eckstein FF, Asch FM, Martens S. Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1681-7. doi: 10.1016/j.jtcvs.2014.03.054. Epub 2014 Apr 4.

lead_sponsor: Medtronic Bakken Research Center

location_country:
Italy
Switzerland
Netherlands
France
Spain
Germany
United Kingdom

location_facility: Azienda Complesso Ospedaliero S.Filippo Neri

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU)

location_facility: Centre Hospitalier Universitaire de Saint-Etienne Hôpital Nord

location_facility: Casa Di Cura Privata 'Montevergine' S.p.A.

intervention_type: Procedure


title: An Open-label, Single Arm, Multi-centre, Phase II Study to Evaluate the Safety and Efficacy of PC-A11 With Superficial and Interstitial Laser Light Application in Patients With Recurrent Head and Neck Squamous Cell Carcinoma Unsuitable for Surgery and Radiotherapy

summary: The purpose of this study is to evaluate the efficacy and safety of PC-A11 with superficial and/or interstitial laser light application in patients with recurrent SCCHN.

lead_sponsor: PCI Biotech AS

location_country:
Netherlands
Poland
France
Lithuania
Germany
United Kingdom

location_facility: The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital

location_facility: Centre Alexis Vautrin (CAV)-Nancy Université

location_facility: Institute of Oncology, Vilnius University


ReferenceCitation: Paez JG, Jänne PA, Lee JC, Tracy S, Greulich H, Gabriel S, Herman P, Kaye FJ, Lindeman N, Boggon TJ, Naoki K, Sasaki H, Fujii Y, Eck MJ, Sellers WR, Johnson BE, Meyerson M. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science. 2004 Jun 4;304(5676):1497-500. Epub 2004 Apr 29.

ReferenceCitation: Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Muñoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.

family: Rosell

full_name: Rafael Rosell

given: Rafael

family: Carcereny

full_name: Enric Carcereny

given: Enric

family: Gervais

full_name: Radj Gervais

given: Radj

family: Vergnenegre

full_name: Alain Vergnenegre

given: Alain

family: Massuti

full_name: Bartomeu Massuti

given: Bartomeu

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Palmero

full_name: Ramon Palmero

given: Ramon

family: Garcia-Gomez

full_name: Ramon Garcia-Gomez

family: Pallares

full_name: Cinta Pallares

given: Cinta

family: Sanchez

full_name: Jose Miguel Sanchez

given: Jose Miguel

family: Porta

full_name: Rut Porta

given: Rut

family: Cobo

full_name: Manuel Cobo

given: Manuel

family: Garrido

full_name: Pilar Garrido

given: Pilar

family: Longo

full_name: Flavia Longo

given: Flavia

family: Moran

full_name: Teresa Moran

given: Teresa

family: Insa

full_name: Amelia Insa

given: Amelia

family: De Marinis

full_name: Filippo De Marinis

given: Filippo

family: Corre

full_name: Romain Corre

given: Romain

family: Bover

full_name: Isabel Bover

given: Isabel

family: Illiano

full_name: Alfonso Illiano

family: Dansin

full_name: Eric Dansin

given: Eric

family: de Castro

full_name: Javier de Castro

given: Javier

family: Milella

full_name: Michele Milella

given: Michele

family: Reguart

full_name: Noemi Reguart

given: Noemi

family: Altavilla

full_name: Giuseppe Altavilla

ReferenceCitation: Kobayashi S, Boggon TJ, Dayaram T, Jänne PA, Kocher O, Meyerson M, Johnson BE, Eck MJ, Tenen DG, Halmos B. EGFR mutation and resistance of non-small-cell lung cancer to gefitinib. N Engl J Med. 2005 Feb 24;352(8):786-92.

ReferenceCitation: Kabbinavar F, Miller VA, Johnson BE, O'Connor P, Soh C-H, ATLAS Investigators. Overall survival in ATLAS, a Phase IIIb trial comparing bevacizumab therapy +/- erlotinib after completion of chemotherapy with bevacizumab for first-line treatment of locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC). J Clin Oncol 2010; 28 (May suppl; abstr 7526).

ReferenceCitation: Rosell R, Dafni U, Felip E, Curioni-Fontecedro A, Gautschi O, Peters S, Massutí B, Palmero R, Aix SP, Carcereny E, Früh M, Pless M, Popat S, Kotsakis A, Cuffe S, Bidoli P, Favaretto A, Froesch P, Reguart N, Puente J, Coate L, Barlesi F, Rauch D, Thomas M, Camps C, Gómez-Codina J, Majem M, Porta R, Shah R, Hanrahan E, Kammler R, Ruepp B, Rabaglio M, Kassapian M, Karachaliou N, Tam R, Shames DS, Molina-Vila MA, Stahel RA; BELIEF collaborative group. Erlotinib and bevacizumab in patients with advanced non-small-cell lung cancer and activating EGFR mutations (BELIEF): an international, multicentre, single-arm, phase 2 trial. Lancet Respir Med. 2017 May;5(5):435-444. doi: 10.1016/S2213-2600(17)30129-7. Epub 2017 Apr 10. Erratum in: Lancet Respir Med. 2018 Dec;6(12):e57.

location_country:
Italy
Switzerland
France
Greece
Ireland
Spain
Germany
United Kingdom

location_facility: Istituto Oncologica della Svizzera Italiana

location_facility: Fondation du centre Pluridisciplinaire d'Oncologie (CePO)

location_facility: Hospital Clinico Universitario San Carlos

location_facility: University General Hospital of Heraklion

location_facility: ICO - Hospital Universitari Germans Trias i Pujol

title: An Open-label Phase II Trial of Erlotinib and Bevacizumab in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations

summary:
Rationale:

Advanced non-small-cell lung cancer (NSCLC) patients harbouring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 14 months when treated with erlotinib. However, the presence of EGFR mutations can only imperfectly predict outcome. The investigators hypothesize that progression-free survival could be influenced both by the pretreatment EGFR T790M mutation and by components of DNA repair pathways.

The investigators propose a model of treatment whereby patients with EGFR mutations (single or with T790M) can attain a benefit with longer overall PFS when treated with erlotinib plus bevacizumab. When the patients are grouped by BRCA1 mRNA levels and T790M the hypothesis is that the combination of erlotinib plus bevacizumab can improve the PFS in all subgroups.


title: An Observational, Non-interventional Study to Determine the Role of Clostridium Difficile in the Pathogenesis of Disease Observed in Neonates and to Investigate the Feasibility of a Potential Study to Evaluate Safety, Efficacy and Pharmacokinetics of Fidaxomicin Oral Suspension in Neonates With Clostridium Difficile Associated Disease (CDAD)

acronym: DAISY

summary: The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin. The incidence and clinical aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.

lead_sponsor: Astellas Pharma Europe B.V.

location_country: Spain Germany France Netherlands


title: EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty

summary: Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in order to position this product on the market, a post-market release study was completed. The purpose of this study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve (TV) repair in a post-market environment.

ReferenceCitation: Guenzinger R, Lange RS, Rieß FC, Hanke T, Bischoff N, Obadia JF, Sahar G, Bitran D, Roberts H Jr, Li S, Bolling SF. Six-Month Performance of a 3-Dimensional Annuloplasty Ring for Repair of Functional Tricuspid Regurgitation. Thorac Cardiovasc Surg. 2020 Sep;68(6):478-485. doi: 10.1055/s-0038-1673665. Epub 2018 Nov 16.

name: Insure (Institute for Translational Cardiac Surgery), Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany

family: Guenzinger

full_name: Ralf Guenzinger

given: Ralf

family: Lange

full_name: Ruediger S. Lange

given: Ruediger S.

name: Clinic of Cardiac Surgery, Albertinen Cardiovascular Center, Hamburg, Germany

family: Rieß

full_name: Friedrich-Christian Rieß

given: Friedrich-Christian

name: Department of Cardiac Surgery, Asklepios Hospital Hamburg-Harburg, Hamburg, Germany

family: Hanke

full_name: Thorsten Hanke

given: Thorsten

name: Department of Thoracic and Cardiovascular Surgery, Mulhouse Hospital Center-Emile Muller Hospital, Mulhouse, France

family: Bischoff

full_name: Nicolas Bischoff

given: Nicolas

name: Cardiovascular Surgery and Cardiac Transplantation, Hospitals of Lyon-Louis Pradel Hospital, Bron cedex, France

family: Obadia

full_name: Jean-Francois Obadia

given: Jean-Francois

name: Department of Cardiothoracic Surgery, Soroka Medical Center, Be’er Sheva, Israel

family: Sahar

full_name: Gideon Sahar

given: Gideon

name: Department of Cardiothoracic Surgery, Shaare-Zedek Medical Center, Jerusalem, Israel

family: Bitran

full_name: Dani Bitran

given: Dani

name: West Virginia University Health Sciences Center, WVU Heart and Vascular Institute, Morgantown, WV Virginia, United States

family: Roberts

full_name: Harold Roberts

given: Harold

suffix: Jr.

name: Biostatistics Department, Medtronic, Mounds View, MN, USA

family: Li

full_name: Shuzhen Li

given: Shuzhen

name: Department of Cardiac Surgery, University of Michigan, Ann Arbor, MI, United States

family: Bolling

full_name: Steven F. Bolling

given: Steven F.

journal_name: The Thoracic and Cardiovascular Surgeon

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

ipd_sharing: No

location_country: Israel Germany France

location_facility:
Soroka Medical Center
Shaare Zedek Medical Center
Universitätsklinikum Schleswig-Holstein
Albertinen Herz- und Gefäßzentrum
Centre Hospitalier de Mulhouse
Deutsches Herzzentrum München
Hôpital de Lyon - Hôpital Louis Pradel


title: Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis

summary: The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.

status: Unknown status

lead_sponsor: Direct Flow Medical, Inc.

location_country:
Italy
Luxembourg
France
Germany
United Kingdom

location_facility: Medical Care Center, Prof Mathey, Prof Schofer

location_facility: Krankenhaus der Barmherzigen Brüder Trier


title: A Phase 1b, Open-label, Multi-center, Single Arm, Dose Finding Study to Assess Safety and Pharmacokinetics of the Oral Combination of Panobinostat and Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-polycythemia Vera-myelofibrosis (PPV-MF) or Post-essential Thrombocythemia-myelofibrosis (PET-MF)

summary: This study will assess safety as well as establish a Recommended Phase II dose of the combination of panobinostat and ruxolitinib in patients with or without the JAK2V617F mutation who have been diagnosed with primary myelofibrosis (PMF), Post Essential Thrombocythemia Myelofibrosis (PET MF), or Post-Polycythemia Vera Myelofibrosis (PPV MF).

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
France
Ireland
Germany
United Kingdom


title: A Phase I, Open-Label, Dose-Escalation Trial With BI 836826 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma of B Cell Origin

summary: The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma with at least prior treatments.

ReferenceCitation: Kroschinsky F, Middeke JM, Janz M, Lenz G, Witzens-Harig M, Bouabdallah R, La Rosée P, Viardot A, Salles G, Kim SJ, Kim TM, Ottmann O, Chromik J, Quinson AM, von Wangenheim U, Burkard U, Berk A, Schmitz N. Phase I dose escalation study of BI 836826 (CD37 antibody) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Invest New Drugs. 2020 Oct;38(5):1472-1482. doi: 10.1007/s10637-020-00916-3. Epub 2020 Mar 14. Erratum in: Invest New Drugs. 2020 May 31;:. Invest New Drugs. 2020 Jun 23;:.

family: Kroschinsky

full_name: Frank Kroschinsky

given: Frank

family: Middeke

full_name: Jan Moritz Middeke

given: Jan Moritz

family: Janz

full_name: Martin Janz

given: Martin

family: Lenz

full_name: Georg Lenz

given: Georg

family: Witzens-Harig

full_name: Mathias Witzens-Harig

given: Mathias

family: Bouabdallah

full_name: Reda Bouabdallah

given: Reda

family: La Rosée

full_name: Paul La Rosée

given: Paul

family: Viardot

full_name: Andreas Viardot

given: Andreas

family: Salles

full_name: Gilles Salles

given: Gilles

family: Kim

full_name: Seok Jin Kim

given: Seok Jin

full_name: Tae Min Kim

given: Tae Min

family: Ottmann

full_name: Oliver Ottmann

given: Oliver

family: Chromik

full_name: Joerg Chromik

given: Joerg

family: Quinson

full_name: Anne-Marie Quinson

given: Anne-Marie

family: von Wangenheim

full_name: Ute von Wangenheim

given: Ute

family: Burkard

full_name: Ute Burkard

family: Berk

full_name: Andreas Berk

family: Schmitz

full_name: Norbert Schmitz

given: Norbert

repository_institution: Max-Delbrueck-Center for Molecular Medicine - MDC Repository

location_facility: Universitätsklinikum Carl Gustav Carus Dresden


location_country:
Italy
Brazil
Sweden
Mexico
Germany
France
Czechia
Japan
Australia
United States
Korea, Republic of

location_facility: George Washington Medical Faculty Associates

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Articluaris Healthcare Group d/b/a ACME Research

location_facility: University Of Miami Miller School Of Medicine

location_facility: Centre for Rheumatology, Immunology and Arthritis

location_facility: Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

location_facility: The University of Kansas Medical Center - Parkinson's Disease & Movement Disorder Center

location_facility: The Ohio State University Wexner Medical Center

title: A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM)

summary: Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy


title: Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy

acronym: WiSE-CRT

summary: The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT.

ReferenceCitation: Auricchio A, Delnoy PP, Butter C, Brachmann J, Van Erven L, Spitzer S, Moccetti T, Seifert M, Markou T, Laszo K, Regoli F; Collaborative Study Group. Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the wireless stimulation endocardially for CRT (WiSE-CRT) study. Europace. 2014 May;16(5):681-8. doi: 10.1093/europace/eut435. Epub 2014 Feb 4.

family: Auricchio

full_name: A. Auricchio

given: A.

family: Delnoy

full_name: P.-P. Delnoy

family: Butter

full_name: C. Butter

given: C.

family: Brachmann

full_name: J. Brachmann

given: J.

family: Van Erven

full_name: L. Van Erven

given: L.

family: Spitzer

full_name: S. Spitzer

given: S.

family: Moccetti

full_name: T. Moccetti

given: T.

family: Seifert

full_name: M. Seifert

given: M.

family: Markou

full_name: T. Markou

family: Laszo

full_name: K. Laszo

given: K.

family: Regoli

full_name: F. Regoli

given: F.

family: Ramos

full_name: M. A. Ramos

given: M. A.

family: Pasotti

full_name: E. Pasotti

given: E.

family: Scopigni

full_name: F. Scopigni

family: Hagne

full_name: C. Hagne

family: Siclari

full_name: F. Siclari

family: Demertzis

full_name: S. Demertzis

family: Sinha

full_name: A. Sinha

family: Schalji

full_name: M. Schalji

family: Wellens

full_name: H. J. J. Wellens

given: H. J. J.

family: Padeletti

full_name: L. Padeletti

family: Van Hemel

full_name: N. Van Hemel

given: N.

title: Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the Wireless Stimulation Endocardially for CRT (WiSE-CRT) study

ReferenceCitation: Auricchio A, Delnoy PP, Regoli F, Seifert M, Markou T, Butter C; collaborative study group. First-in-man implantation of leadless ultrasound-based cardiac stimulation pacing system: novel endocardial left ventricular resynchronization therapy in heart failure patients. Europace. 2013 Aug;15(8):1191-7. doi: 10.1093/europace/eut124. Epub 2013 May 23.

location_facility:
Leiden University Medical Centre
Klinium Coburg gGmbH
Facharztzentrum Dresden-Neustadt GbR
Kerckhoff-Klinik
Isala Klinieken Zwolle
Hospital Pontchaillou-CHU
Herzzentrum Brandenburg
Cardiocentro Ticini
Nouvelles Clinicques Nantaises
Herzzentrum Leipzig GmbH


title: A MULTINATIONAL TRIAL TO EVALUATE THE PARACHUTE IMPLANT SYSTEM: PARACHUTE PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE

acronym: PARACHUTE

summary: The primary objective is to assess the safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease.

ReferenceCitation: Costa MA, Mazzaferri EL Jr, Sievert H, Abraham WT. Percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure: three-year outcomes of the PARACHUTE first-in-human study. Circ Heart Fail. 2014 Sep;7(5):752-8. doi: 10.1161/CIRCHEARTFAILURE.114.001127. Epub 2014 Jul 18.

name: From the Center for Research and Innovation Harrington Heart and Vascular Institute University Hospitals, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (M.A.C.); Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH (E.L.M., W.T.A.); CardioVascular Center, Frankfurt, Germany (H.S.).

family: Costa

full_name: Marco A. Costa

given: Marco A.

family: Mazzaferri

full_name: Ernest L. Mazzaferri

given: Ernest L.

suffix: Jr

family: Sievert

full_name: Horst Sievert

given: Horst

family: Abraham

full_name: William T. Abraham

given: William T.

family: Gradinac

full_name: Sinisa Gradinac

given: Sinisa

family: Sagic

full_name: Dragan Sagic

given: Dragan

family: Otasevic

full_name: Petar Otasevic

given: Petar

family: Hasan

full_name: Ayesha K. Hasan

given: Ayesha K.

family: Goff

full_name: Thomas L. Goff

given: Thomas L.

family: Wunderlich

full_name: Nina Wunderlich

given: Nina

family: DePuy

full_name: Venita DePuy

given: Venita

name: the PercutAneous Ventricular RestorAtion in Chronic Heart failUre PaTiEnts (PARACHUTE) Study Group; Dedinje Cardiovascular Institute, University of Belgrade School of Medicine, Belgrade, Serbia (S.G., D.S., P.O.); The Ohio State University, Columbus, OH (T.L.G.); CardioVascular Center, Sankt Katharinen, Germany (N.W.); Bowden Analytics, Apex, NC (V.D.); Clinipace Worldwide, Morrisville, NC (V.D.); and Louisiana State University, New Orleans, LA (F.S.).

family: Smart

full_name: Frank Smart

given: Frank

journal_name: Circulation: Heart Failure

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Percutaneous Ventricular Restoration Using the Parachute Device in Patients With Ischemic Heart Failure

ReferenceCitation: Costa MA, Pencina M, Nikolic S, Engels T, Templin B, Abraham WT. The PARACHUTE IV trial design and rationale: percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure and dilated left ventricles. Am Heart J. 2013 Apr;165(4):531-6. doi: 10.1016/j.ahj.2012.12.022. Epub 2013 Feb 19.

family: Pencina

full_name: Michael Pencina

given: Michael

family: Nikolic

full_name: Serjan Nikolic

given: Serjan

family: Engels

full_name: Thomas Engels

given: Thomas

family: Templin

full_name: Barry Templin

given: Barry

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: The PARACHUTE IV trial design and rationale: Percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure and dilated left ventricles

lead_sponsor: CardioKinetix, Inc

location_country:
Serbia
United Kingdom
Netherlands
France
Slovenia
Portugal
Germany
Latvia

location_facility: Pauls Stradins Clinical University Hospital

location_facility: University College of London (The Heart Hospital)

location_facility: Hospital of Cardiology Louis Pradel (Lyon)

location_facility: Ljubljana University Medical Center (Univerzitetni Klinicni Center Ljubljana)


ReferenceCitation: Vander Velde N, Guerin A, Ionescu-Ittu R, Shi S, Wu EQ, Lin SW, Hsu LI, Saum KU, de Ducla S, Wang J, Li S, Thåström A, Liu S, Shi L, Leppert JT. Comparative Effectiveness of Non-cisplatin First-line Therapies for Metastatic Urothelial Carcinoma: Phase 2 IMvigor210 Study Versus US Patients Treated in the Veterans Health Administration. Eur Urol Oncol. 2019 Feb;2(1):12-20. doi: 10.1016/j.euo.2018.07.003. Epub 2018 Aug 4.

family: Vander Velde

full_name: Nancy Vander Velde

given: Nancy

family: Guerin

full_name: Annie Guerin

given: Annie

family: Ionescu-Ittu

full_name: Raluca Ionescu-Ittu

given: Raluca

family: Shi

full_name: Sherry Shi

given: Sherry

family: Wu

full_name: Eric Q. Wu

given: Eric Q.

family: Lin

full_name: Shih-Wen Lin

given: Shih-Wen

family: Hsu

full_name: Ling-I Hsu

given: Ling-I

family: Saum

full_name: Kai-Uwe Saum

given: Kai-Uwe

family: de Ducla

full_name: Sabine de Ducla

given: Sabine

family: Wang

full_name: Jingjing Wang

given: Jingjing

family: Li

full_name: Shi Li

given: Shi

family: Thåström

full_name: AnnChristine Thåström

given: AnnChristine

family: Liu

full_name: Shuqian Liu

given: Shuqian

full_name: Lizheng Shi

given: Lizheng

family: Leppert

full_name: John T. Leppert

given: John T.

journal_name: European Urology Oncology

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

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Virginia Oncology Associates - Lake Wright Cancer Center

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Beth Israel Deaconess Medical Center, Harvard Medical School; Department of Medicine

location_facility: Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

location_facility: Urology Cancer Center & GU Research Network

location_facility: Mount Sinai School of Medicine - Tisch Cancer Institute

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

location_facility: Indiana University Health; Goshen Center for Cancer Care

location_facility: The Angeles Clinic and Research Institute - W LA Office

location_facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

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

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Institut Gustave Roussy; Oncologie Medicale

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Kimmel Cancer Center Thomas Jefferson University

location_facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

location_facility: Dana Farber Cancer Inst. ; Dept. of Medical Oncology

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: University of Chicago; Hematology/Oncology

location_facility: The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

title: A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

summary: This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.


title: A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 µg o.d. Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 µg b.i.d. as Active Control

summary: This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second [FEV1]) over the full 24-h time period

ReferenceCitation: Magnussen H, Verkindre C, Jack D, Jadayel D, Henley M, Woessner R, Higgins M, Kramer B; INPUT study investigators. Indacaterol once-daily is equally effective dosed in the evening or morning in COPD. Respir Med. 2010 Dec;104(12):1869-76. doi: 10.1016/j.rmed.2010.08.010. Epub 2010 Sep 20.

family: Magnussen

full_name: H. Magnussen

given: H.

family: Verkindre

full_name: C. Verkindre

given: C.

family: Jack

full_name: D. Jack

given: D.

family: Jadayel

full_name: D. Jadayel

family: Henley

full_name: M. Henley

given: M.

family: Woessner

full_name: R. Woessner

given: R.

family: Higgins

full_name: M. Higgins

family: Kramer

full_name: B. Kramer

given: B.

journal_name: Respiratory Medicine

oa_host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Novartis

location_country: Germany France Spain


title: Efficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept Study

summary:
Primary Objective:

To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in patients with dcSSc.

Secondary Objectives:

To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in patients with dcSSc.
To evaluate the efficacy of SAR156597 compared to placebo on respiratory function in patients with dcSSc.
To evaluate the safety profile of SAR156597 compared to placebo in patients with dcSSc.
To evaluate the potential for immunogenicity (anti-drug antibodies [ADA] response) of SAR156597 in patients with dcSSc.
To evaluate the pharmacokinetics (PK) (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.

ReferenceCitation: Allanore Y, Wung P, Soubrane C, Esperet C, Marrache F, Bejuit R, Lahmar A, Khanna D, Denton CP; Investigators. A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis. Ann Rheum Dis. 2020 Dec;79(12):1600-1607. doi: 10.1136/annrheumdis-2020-218447. Epub 2020 Sep 22.

family: Allanore

full_name: Yannick Allanore

given: Yannick

family: Wung

full_name: Peter Wung

given: Peter

family: Soubrane

full_name: Christina Soubrane

given: Christina

family: Esperet

full_name: Corinne Esperet

given: Corinne

family: Marrache

full_name: Frederic Marrache

given: Frederic

family: Bejuit

full_name: Raphael Bejuit

given: Raphael

family: Lahmar

full_name: Amel Lahmar

given: Amel

family: Khanna

full_name: Dinesh Khanna

given: Dinesh

family: Denton

full_name: Christopher P Denton

given: Christopher P

journal_name: Annals of the Rheumatic Diseases

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Sanofi

location_country:
Italy
Mexico
Germany
France
Poland
Romania
Belgium
Argentina
Russian Federation
Estonia
United States
United Kingdom
Ukraine

location_facility:
Investigational Site Number 3800001
Investigational Site Number 3800005
Investigational Site Number 2760004
Investigational Site Number 8040003
Investigational Site Number 8040004
Investigational Site Number 6430004
Investigational Site Number 2500002
Investigational Site Number 2760003
Investigational Site Number 6420001
Investigational Site Number 2500003
Investigational Site Number 6420003
Investigational Site Number 6420005
Investigational Site Number 3800006
Investigational Site Number 3800004
Investigational Site Number 2760001
Investigational Site Number 4840005
Investigational Site Number 6430003
Investigational Site Number 6430001
Investigational Site Number 4840001
Investigational Site Number 4840002
Investigational Site Number 6420004
Investigational Site Number 2500004
Investigational Site Number 2760002
Investigational Site Number 8040002
Investigational Site Number 0560001
Investigational Site Number 8400006
Investigational Site Number 0320001
Investigational Site Number 0320005
Investigational Site Number 8400002
Investigational Site Number 0320003
Investigational Site Number 0560002
Investigational Site Number 8260001
Investigational Site Number 6160003
Investigational Site Number 4840003
Investigational Site Number 6430005
Investigational Site Number 6430002
Investigational Site Number 0320002
Investigational Site Number 2330001
Investigational Site Number 8400005
Investigational Site Number 8040001
Investigational Site Number 6160002
Investigational Site Number 6420002
Investigational Site Number 6160001
Investigational Site Number 8400007


title: NGR016: Randomized Phase II Study Evaluating Two Doses of NGR-hTNF Administered Either as Single Agent or in Combination With Doxorubicin in Patients With Advanced Soft Tissue Sarcoma (STS)

summary: The main objective of the trial is to document the preliminary antitumor activity of two doses of NGR-hTNF administered either alone or in combination with doxorubicin in locally advanced or metastatic soft-tissue sarcoma (STS) patients untreated or previously treated with one or more prior systemic regimen.

lead_sponsor: AGC Biologics S.p.A.

location_country:
Italy
United Kingdom
France

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano


title: Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age

summary: Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD

lead_sponsor: H. Lundbeck A/S

location_country:
Italy
South Africa
Serbia
United Kingdom
Mexico
Germany
France
Bulgaria
Korea, Republic of
Israel
Poland
Hungary
Russian Federation
Spain
Estonia
United States
Latvia
Canada
Colombia
Ukraine

location_facility: Yaroslavl Regional Clinical Psychiatry Hospital

location_facility: Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS

location_facility: Arkhangelsk Regional Clinical Mental Hospital

location_facility: Stavropol Region Psychiatric Hospital #2

location_facility: Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...

location_facility: Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo

location_facility: City Psychiatric Hospital # 3 named after I.I. Skvortsov-Stepanov

location_facility: State Budgetary Healthcare Institution of Sverdlovsk Region Â¿Sverdlovsk Regional Clinical Psychi...

location_facility: Child and Adolescent Neurology and Psychiatry Clinic

location_facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

location_facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska

location_facility: E.S.E. Hospital Mental de Antioquia HOMO

location_facility: Scientific Institute Fondazione Stella Maris

location_facility: Diagnostic Consultative Center Mladost-M Varna OOD

location_facility: Soon Chun Hyang University Hospital Cheonan

location_facility: Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)

location_facility: U.O.C. Neuropsichiatria Infantile - IRCCS Istituto Giannina Gaslini

location_facility: Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...

location_facility: Daily Hospital for Children and Adolescents

location_facility: State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...

location_facility: Clinical Center of Vojvodina - Clinic of Psychiatry

location_facility: NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...

location_facility: Guz Saratov Regional Psychiatric Hospital St. Sofii

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry

location_facility: Medicorehabilitation Research Center Phoenix

location_facility: Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...

location_facility: Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu

location_facility: Klinik fur Kinderneurologie und Sozialpadiatrie Kinderzentrum Maulbronn gGmbH

location_facility: The University of Arizona Sarver Heart Center (SHC)

location_facility: Dip.Sc.Biomediche, Odont. e Imm.Funz.li, AOU Policlinico G. Martino

location_facility: Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C

location_facility: Odessa Regional Medical Centre of Mental Health

location_facility: Przychodnia Syntonia Poradnia Zdrowia Psychicznego

location_facility: LLC City Neurological Center Sibneuromed

location_facility: Kansas University School of Medicine-Wichita

location_facility: Vadaskert Child Psychiatric Hospital and Outpatient

location_facility: Lipetsk Regional Psychoneurological Hospital

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny


title: ADVICE: A Dose Range Finding Study of Formoterol Administered Once Daily in the Evening in Combination With Ciclesonide Using the Ultrahaler™ Versus Monotherapy of Each Drug in Asthmatic Patients

summary: The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.

lead_sponsor: AstraZeneca

location_country:
South Africa
Germany
Hungary
France


title: Phase II Open Label Study of CT-2106 as a Single Agent in Patients With Advanced Metastatic Ovarian Cancer Who Have Failed One Prior Platinum and Taxane Based Regimen

summary: The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.

lead_sponsor: CTI BioPharma


title: Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.

summary: Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.

lead_sponsor: Pfizer

location_country: Germany France Switzerland

location_facility: Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: (DKFZ) an der Universitäts-Hautklinik Mannheim

location_facility: Hôpital Ste Marguerite,Service de Dermatologie

location_facility: Hôpital Hotel Dieu, 1, Pace de l' Hôpital,

location_facility: Universitätsklinik und Poliklinik für Hautkrankheiten

location_facility: Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf


title: Double-Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study to Evaluate Efficacy and Safety of 4 and 8 Million Units Betaferon®/Betaseron® (Interferon Beta-1b) Given Subcutaneously Every Other Day Over 24 Weeks in Patients With Chronic Viral Cardiomyopathy

summary:
Chronic viral cardiomyopathy is a disease where the cardiac muscle is attacked by a virus and this may result in a reduction in the output of the heart (pump function) thereby causing complaints such as chest pain, shortness of breath and palpitations.

Betaferon (interferon beta-1b) is marketed for the treatment of Multiple Sclerosis already, but until now, it has not been proven whether it is also effective in patients with chronic viral myocardial disease.

This study will be conducted to examine the efficacy and safety of Betaferon in patients with this disease. The aim of the treatment is to eliminate the virus from the heart so that the heart function and clinical status can gradually improve.

lead_sponsor: Bayer

location_country:
Italy
Sweden
France
Poland
Spain
Germany
United Kingdom


title: A Randomized, Double-blind, Placebo Controlled, 3- Part, Adaptive Design, Multicenter Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH): FLIGHT-FXR

acronym: FLIGHT-FXR

summary: The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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:
Italy
Austria
India
Netherlands
Germany
France
Japan
Korea, Republic of
Slovakia
Singapore
Argentina
Australia
Belgium
Spain
United States
Canada
Taiwan


title: An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome

summary: The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.

location_country:
Italy
Germany
United Kingdom
France


title: A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes

summary: CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory high-risk myelodysplastic syndrome.

status: Suspended

ReferenceCitation: Surka C, Jin L, Mbong N, Lu CC, Jang IS, Rychak E, Mendy D, Clayton T, Tindall E, Hsu C, Fontanillo C, Tran E, Contreras A, Ng SWK, Matyskiela M, Wang K, Chamberlain P, Cathers B, Carmichael J, Hansen J, Wang JCY, Minden MD, Fan J, Pierce DW, Pourdehnad M, Rolfe M, Lopez-Girona A, Dick JE, Lu G. CC-90009, a novel cereblon E3 ligase modulator, targets acute myeloid leukemia blasts and leukemia stem cells. Blood. 2021 Feb 4;137(5):661-677. doi: 10.1182/blood.2020008676.

family: Surka

full_name: Christine Surka

given: Christine

name: Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada;

family: Jin

full_name: Liqing Jin

given: Liqing

family: Mbong

full_name: Nathan Mbong

given: Nathan

family: Lu

full_name: Chin-Chun Lu

given: Chin-Chun

family: Jang

full_name: In Sock Jang

given: In Sock

family: Rychak

full_name: Emily Rychak

given: Emily

family: Mendy

full_name: Derek Mendy

given: Derek

family: Clayton

full_name: Thomas Clayton

given: Thomas

family: Tindall

full_name: Elizabeth Tindall

given: Elizabeth

family: Hsu

full_name: Christy Hsu

given: Christy

family: Fontanillo

full_name: Celia Fontanillo

given: Celia

family: Tran

full_name: Eileen Tran

given: Eileen

family: Contreras

full_name: Adrian Contreras

given: Adrian

family: Ng

full_name: Stanley W. K. Ng

given: Stanley W. K.

family: Matyskiela

full_name: Mary Matyskiela

given: Mary

family: Wang

full_name: Kai Wang

given: Kai

family: Chamberlain

full_name: Philip Chamberlain

given: Philip

family: Cathers

full_name: Brian Cathers

given: Brian

family: Carmichael

full_name: James Carmichael

given: James

family: Hansen

full_name: Joshua Hansen

given: Joshua

name: Department of Medicine, University of Toronto, Toronto, ON, Canada;

name: Division of Medical Oncology and Hematology, University Health Network, Toronto, ON, Canada;

full_name: Jean C. Y. Wang

given: Jean C. Y.

family: Minden

full_name: Mark D. Minden

given: Mark D.

name: Bristol-Myers Squibb, San Francisco, CA; and

family: Fan

full_name: Jinhong Fan

given: Jinhong

name: Department of Molecular Genetics, University of Toronto, Toronto, ON, Canada

location_country:
France
Norway
Spain
United States
United Kingdom
Canada

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Oslo University Hospital, Rikshospitalet HF

location_facility: Washington University Siteman Cancer Center

location_facility: Princess Margaret Hospital University Health Network