acronym: JAVELIN Bladder 100

title: A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY

lead_sponsor: Pfizer

ReferenceCitation: Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullén A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte RJ, Huang B, Costa N, Blake-Haskins JA, Grivas P. Plain language summary of results from the JAVELIN Bladder 100 study: avelumab maintenance treatment for advanced urothelial cancer. Future Oncol. 2022 Jun;18(19):2361-2371. doi: 10.2217/fon-2021-1631. Epub 2022 Apr 13. Review.

ReferenceCitation: Tomita Y, Yamamoto Y, Tsuchiya N, Kanayama H, Eto M, Miyake H, Powles T, Yoshida M, Koide Y, Umeyama Y, di Pietro A, Uemura H. Avelumab first-line maintenance plus best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Japanese subgroup analysis. Int J Clin Oncol. 2022 Feb;27(2):383-395. doi: 10.1007/s10147-021-02067-8. Epub 2022 Jan 1.

ReferenceCitation: Powles T, Sridhar SS, Loriot Y, Bellmunt J, Mu XJ, Ching KA, Pu J, Sternberg CN, Petrylak DP, Tambaro R, Dourthe LM, Alvarez-Fernandez C, Aarts M, di Pietro A, Grivas P, Davis CB. Avelumab maintenance in advanced urothelial carcinoma: biomarker analysis of the phase 3 JAVELIN Bladder 100 trial. Nat Med. 2021 Dec;27(12):2200-2211. doi: 10.1038/s41591-021-01579-0. Epub 2021 Dec 10.

ReferenceCitation: Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulović S, Demey W, Ullén A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte R, Wang J, Huang B, Davis C, Fowst C, Costa N, Blake-Haskins JA, di Pietro A, Grivas P. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020 Sep 24;383(13):1218-1230. doi: 10.1056/NEJMoa2002788. Epub 2020 Sep 18.

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_country:
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
India
Israel
Mexico
Norway
Sweden
Brazil
Canada
Hungary
Denmark
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny

location_facility: EUROMEDICA General Clinic of Thessaloniki

location_facility: Clinical Trial Pharmacy, China Medical University Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centro di Riferimento Oncologico - IRCCS

location_facility: Hôpital Privé Toulon-Hyères - Clinique Sainte Marguerite

location_facility: CHUM - Centre Hospitalier de l'Universite de Montreal

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Fundacion Maria Rafols para la investigacion del Diagnostico de la imagen

location_facility: National Cancer Center Urology center for Prostate Cancer

location_facility: Hospital Regional Dr. Enrique Vera Barros

location_facility: Principal Military Clinical Hospital n.a. N.N. Burdenko

location_facility: National Cancer Center - Clinical Trial Pharmacy

location_facility: Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Farmácia Oncológica

location_facility: Hirosaki University School of Medicine & Hospital

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Guy's & St. Thomas' NHS Foundation Trust

location_facility: Institut Catalá d'Oncología - Hospital Duran i Reynals

location_facility: Saitama Medical University International Medical Center

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Hospital Comarcal General de Elda de Virgen de la Salud

location_facility: Azienda Ospedaliero-Universitaria Policlinico S.Orsola Malpighi

location_facility: Ballarat Oncology & Haematology Services

location_facility: Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo

location_facility: University of Colorado Denver, CTO (CTRC)

location_facility: Centro Integrado de Pesquisa Clinica - CIP

location_facility: Azienda Ospedaliera San Camillo Forlanini_Oncologia Medica

location_facility: University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

location_facility: Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: Klinik for Klinisk Fysiologi,Nuklearmedicin og PET

location_facility: Alexandra General Hospital, Oncology Department

location_facility: Servizio Farmacia Ospedaliera - Farmacia Oncologica

location_facility: Centre de Radiothérapie - Clinique Sainte Anne

location_facility: AUSL della Romagna - RAVENNA, Presidio Ospedaliero di Faenza

location_facility: Kobe City Medical Center General Hospital

location_facility: Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital

location_facility: University General Hospital of Patras, Division of Oncology

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Giovanni Pascale

location_facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE

location_facility: CHU Nimes - Institut de Cancerologie du Gard

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: State Budgetary Healthcare Insti. Republican Clinical Oncology Dispensary of the MoH of Bashk. Rep.

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

location_facility: Rigshospitalet, Onkologisk Klinik, afsnit 5073

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

location_facility: Moscow Research Oncology Institute named after P. A. Gertsen

location_facility: CENOB Centro de Oncologia da Bahia S/S Ltda. / Oncovida

location_facility: Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.- Matosinhos

location_facility: Severance Hospital Yonsei University Health System

location_facility: Royal United Hospitals Bath NHS Foundation Trust

location_facility: Icon Cancer Care SA trading as Icon Pharmacy Adelaide

location_facility: C.H. Universitario de Vigo- Hospital Meixoeiro

location_facility: BHI of Omsk region "Clinical oncological dispensary"

location_facility: Chungnam National University Hospital, Clinical Pharmacy

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: St. Bartholomew's Hospital, Barts Health NHS Trust

location_facility: Seoul National University Bundang Hospital, Clinical Pharmacy

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Churchill Hospital, Oxford University Hospitals NHS Trust

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Sociedade Beneficente de Senhoras Hospital Sírio Libanês/ Instituo Sirio Libanes de Ensino e Pesqu

location_facility: C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos

location_facility: Asan Medical Center - Clinical Trial Pharmacy

location_facility: SHI YR "Regional Clinical Oncology Hospital"

location_facility: Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Ambulatório Quimioterapia

location_facility: FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov

location_facility: Centro Oncologico Riojano Integral (Cori)

location_facility: FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov" MoH RF

location_facility: Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli

location_facility: St Bartholomew 's Hospital, Barts Health NHS Trust

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centro de Investigación Clínica de Leon S.C.

location_facility: Althaia. Xarxa Assistencial Universitaria de Manresa

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: Hospital de La Santa Creu i Sant pau_Oncology department

location_facility: Institut de cancérologie de l'Ouest - Site Paul Papin

location_facility: Fundacao Faculdade de Medicina / Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Department of Pharmacy, National Cheng Kung University Hospital

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: Hospital Universitario Central de Asturias

location_facility: Dr Ram Manohar Lohia (RML) Hospital & PGI MER

location_facility: Chemotherapy pharmacy, Chang Gung Memorial Hospital, Linkou

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Anschutz Cancer Center Pavilion Pharmacy

location_facility: Samsung Medical Center Clinical Trial Pharmacy

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: FSBEI HE "First St. Petersburg State Medical University n. a. academician l.P Pavlov" MoH RF

location_facility: Rajiv Gandhi Cancer Institute And Research Centre

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: National Hospital Organization hokkaido Cancer Center

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: FGBIH "Clinical Hospital #122 n.a. L.G. Sokolov of Federal Medico-biological agency"

location_facility: Hospital Médica Campestre (Administradora Hospitalaria S.A de C.V.)

location_facility: Fondazione IRCCS Istituto Nazionale Dei Tumori

location_facility: Niigata University Medical & Dental Hospital

location_facility: Investigational Drug services, National Taiwan University Hospital

location_facility: Federal State Budgetary Institution "National medical research radiology center" MoH RF

location_facility: Inova Schar Cancer Institute Infusion Pharmacy

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera, Szpital Specjalistyczny dla Dzieci I Doroslych

location_facility: Non-State Healthcare Institution "Railway Clinical Hospital JSC RZhD"

location_facility: Centre d'Oncologie et de Radiothérapie du Pays-Basque

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Private Medical Institution "Evromedservice"

location_facility: Uniao Brasileira de Educacao e Assistencia / Hospital Sao Lucas da PUCRS

location_facility: Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Centro de Abastecimento Farmaceu

location_facility: CIMS Cancer, Care Institute of Medical Sciences, CIMS Hospital

location_facility: Dokkyo Medical University Saitama Medical Center

summary: The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.


type: EudraCT Number

title: Clinical Trial of Nivolumab (BMS-936558) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma CheckMate 401: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 401

acronym: CheckMate 401

summary: The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
United Kingdom
Ireland
Austria
Australia
Italy
Finland
Switzerland
Sweden
France
Belgium
Norway
Germany

location_facility:
Mount Vernon Hospital
Local Institution

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg

acronym: UNISUS

summary: The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

enrollment_type: Anticipated

ipd_sharing: Yes

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:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Belarus
Greece
Thailand
Vietnam
Korea, Republic of
France
Colombia
Netherlands

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Washington University School of Medicine

location_facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez

location_facility: Lindner Clinical Trial Center/Christ Hospital

location_facility: San Antonio Methodist/TX Transplant Physicians Group

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

location_facility: Govindaswamy Kuppuswamy Naidu Memorial Hospital

location_facility: State Autonomous Healthcare Institution of Tyumen Region 'Scientific and Practical Medical Center'

location_facility: The Central Slovakia Institute of Cardiovascular Diseases

location_facility: Tianjin Medical University General Hospital

location_facility: Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

location_facility: Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

location_facility: ISMETT Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Scientific and Research Institution of Cardiovascular Diseases Complex Problems

location_facility: Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B

location_facility: Hospital Universitario Polydoro Ernani de Sao Thiago - UFSC

location_facility: University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

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

location_facility: FGBU Research Institute of Rheumatology named V.A.Nasonova

location_facility: Fundacao do ABC - Centro Universitario FMABC

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Policlinico di Modena - Azienda Ospedaliero - Universitaria Modena

location_facility: Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU

location_facility: The Second Xiangya Hospital of Central South Hospital

location_facility: Centro Cardiovascular Colombiano Clínica Santa María

location_facility: CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'

location_facility: General University Hospital II.department of Internal Medicine-cardiology and angiology

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Samara Regional Clinical Cardiological Dispensary

location_facility: Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

location_facility: State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

location_facility: Ahepa University General Hospital of Thessaloniki

location_facility: The Eastern Slovakia Institute of Cardiovascular Diseases

location_facility: Jawaharlal Institute of Postgraduate Medical Education and Research

location_facility: National Cerebral and Cardiovascular Center Hospital

location_facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii

location_facility: Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy

location_facility: Policlinico Gemelli Universita Cattolica

location_facility: University of Texas Medical School at Houston Division of Infectious Diseases

location_facility: Institute for Pulmonary Disease of Vojvodina

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud

location_facility: Ivano-Frankivsk City Central Clinical Hospital

location_facility: Siyami Ersek Training and Research Hospital

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: National University Heart Centre, Singapore

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Ascension | St. Vincent's Lung, Sleep and Critical Care specialists

location_facility: Froedtert & Medical College of Wisconsin - Pulmonary Medicine Outpatient Clinic

location_facility: University Medical Center Ho Chi Minh city

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

location_facility: GB Pant Institute of Post Graduate Medical Education & Research

location_facility: Hospital das Clínicas - Universidade Federal de Minas Gerais

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

location_facility: The Republican Scientific-Practical Center ''Cardiology''

location_facility: The Robert Larner, M.D. College of Medicine at The University of Vermont

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Baylor College of Medicine (BCM) - Baylor Heart Clinic

location_facility: Hospital Das Clinicas Da Universidade Federal De Goias

location_facility: Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: National Medical Research Center of Cardiology of MoH of Russian Federation

location_facility: Toho University Medical Center Omori Hospital

location_facility: Shengjing Hospital of China Medical University

location_facility: Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

location_facility: Centro Hospitalar e Universitário de Coimbra - Hospitais da Universidade de Coimbra

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Regional State Budgetary Healthcare Organization 'Regional Clinical Hospital'

location_facility: SRM Medical College Hospital & Research Centre

location_facility: Fondazione Toscana Gabriele Monasterio CNR

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

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: Moscow City Clinical Hospital #1 n.a. N.I.Pirogov

location_facility: Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente

location_facility: Ruhr-Universität Bochum / Diabeteszentrum

location_facility: Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

location_facility: Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine

location_facility: Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: University Health Network - Toronto General Hospital

location_facility: CNE' City Clinical Hospital #8' of Kharkiv City Council

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: The General Hospital of Northern Theater Command

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

location_facility: Centro de Investigacion Clinica Chapultepec

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Narodny ustav srdcovych a cievnych chorob

location_facility: Volgograd Regional Clinical Cardiology Center

location_facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

location_facility: Hospital General de Agudos Dr Cosme Argerich

location_facility: Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő

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

location_facility: Phramongkutklao Hospital and Medical College

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

location_facility: Ryazan State Medical University named after I.P.Pavlov

location_facility: Instituto Modelo De Cardiología Privado Srl

location_facility: Instituto Medico de La Fundacion Estudios Clinicos

status_simplified: Ongoing


title: A Prospective, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Adaptive Phase 3 Study With Open-label Extension to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

acronym: MACiTEPH

summary: The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

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

location_country:
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
Lithuania
Ukraine
United States
Romania
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Singapore
Slovakia
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Korea, Republic of
France
Colombia

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez

location_facility: Medizinische Fakultät Carl Gustav Carus Technische Universität Dresden

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu Sectia cardiologie III

location_facility: Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

location_facility: Tianjin Medical University General Hospital

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: Wojewodzki Szpital Specjalistyczny, Oddzial Kardiologiczny

location_facility: University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

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

location_facility: Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

location_facility: University of Colorado - Anschutz Medical Campus

location_facility: Centro Cardiovascular Colombiano Clínica Santa María

location_facility: The second Xiangya Hospital of Central South University

location_facility: CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'

location_facility: General University Hospital II.department of Internal Medicine-cardiology and angiology

location_facility: University of New Mexico School of Medicine

location_facility: Europejskie Centrum Zdrowia Otwock Sp. z o.o

location_facility: State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

location_facility: St Vincents Lung, Sleep And Critical Care

location_facility: National Cerebral and Cardiovascular Center Hospital

location_facility: Policlinico Gemelli Universita Cattolica

location_facility: Institute for Pulmonary Disease of Vojvodina

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud

location_facility: Hospital Provincial Dr. Jose Maria Cullen

location_facility: University of California San Diego Medical Center

location_facility: Siyami Ersek Training and Research Hospital

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: National University Heart Centre, Singapore

location_facility: State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Northwestern University Feinberg School of Medicine

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

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

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

location_facility: National Medical Research Center of Cardiology of MoH of Russian Federation

location_facility: CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

location_facility: The Affiliated Hospital of Medical College Qingdao University

location_facility: Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II

location_facility: Fondazione Toscana Gabriele Monasterio CNR

location_facility: Istanbul University - Cerrahpasa Cardiology Institution

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

location_facility: Moscow City Clinical Hospital #1 n.a. N.I.Pirogov

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: University of Utah Cardiovascular Center

location_facility: University Health Network - Toronto General Hospital

location_facility: Toho University Medical Center, Ohashi Hospital

location_facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego, PZOZ

location_facility: Medizinische Hochschule Hannover Zentrum Innere Medizin Klinik für Pneumologie

location_facility: A.O.U. Città della Salute e della Scienza

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: The Houston Methodist Research Institute

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine


status: Terminated

intervention_type: Biological

acronym: An Efficacy and Safety Study of Ravulizumab in ALS Patients

title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)

lead_sponsor: Alexion Pharmaceuticals

source: euctr

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

location_facility: University Hospital of Quebec-Universite Laval

location_facility: Aarhus University Hospital Department of Neurology

location_facility: University of California San Francisco Medical Center

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Medical Hospital, Tokyo Medical and Dental University

location_facility: University of Colorado Anschutz Medical Campus School of Medicine

location_facility: Niigata University Medical & Dental Hospital

location_facility: University of California San Diego Medical Center

location_facility: Perron Institute for Neurological and Translational Science

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Houston Methodist Neurological Institute-Movement Disorders Clinic

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Johns Hopkins University School Of Medicine

location_facility: University of Florida at Shands Jacksonville

location_facility: Montreal Neurological Institute and Hospital

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Shiga University of Medical Science Hospital

location_facility: Virginia Commonwealth University, Neurology Clinical and Translational Research Office

location_facility: Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

location_facility: Hospital Universitari i Politecnic La Fe

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

location_facility: Neuromuscular Research Center and Clinic

summary: The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.

status_simplified: Unknown


title: Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global - ABILITY Diabetes Global

acronym: ABILITY

summary: To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

status: Active, not recruiting

primary_purpose: Other

ReferenceType: background

ReferenceCitation: International Diabetes Federation 2015. IDF DIABETES ATLAS Seventh Edition. 2015; ISBN: 978-2-930229-81-2

ReferenceCitation: Thiele H, Zeymer U. Chapter: Cardiogenic shock in patients with acute coronary syndromes (p. 441), The ESC Textbook of Intensive and Acute Cardiovascular Care (2 ed.) [IACC]. Edited by Marco Tubaro, Pascal Vranckx, Susanna Price, and Christiaan Vrints. Updated on 22 February 2018 DOI: 10.1093/med/9780199687039.003.0049_update_003

doi: thiele

ReferenceType: result

ReferenceCitation: Kereiakes DJ, Cutlip DE, Applegate RJ, Wang J, Yaqub M, Sood P, Su X, Su G, Farhat N, Rizvi A, Simonton CA, Sudhir K, Stone GW. Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System). J Am Coll Cardiol. 2010 Dec 14;56(25):2084-9. doi: 10.1016/j.jacc.2010.10.006.

ReferenceCitation: Kufner S, Byrne RA, Dommasch M, Massberg S, Schoemig A, Kastrati A. Comparison of "limus"-eluting stents with permanent-vs biodegradable polymer in patients with diabetes mellitus with coronary artery disease. Eur Heart J 2012; 33: 558-9

ReferenceCitation: Stone GW, Kedhi E, Kereiakes DJ, Parise H, Fahy M, Serruys PW, Smits PC. Differential clinical responses to everolimus-eluting and Paclitaxel-eluting coronary stents in patients with and without diabetes mellitus. Circulation. 2011 Aug 23;124(8):893-900. doi: 10.1161/CIRCULATIONAHA.111.031070. Epub 2011 Aug 8.

ReferenceCitation: Cutlip DE, Chhabra AG, Baim DS, Chauhan MS, Marulkar S, Massaro J, Bakhai A, Cohen DJ, Kuntz RE, Ho KK. Beyond restenosis: five-year clinical outcomes from second-generation coronary stent trials. Circulation. 2004 Sep 7;110(10):1226-30. Epub 2004 Aug 30.

ReferenceCitation: Lee TT, Feinberg L, Baim DS, Holmes DR, Aroesty JM, Carrozza JP Jr, Cohen DJ, Ho KK, Cutlip DE. Effect of diabetes mellitus on five-year clinical outcomes after single-vessel coronary stenting (a pooled analysis of coronary stent clinical trials). Am J Cardiol. 2006 Sep 15;98(6):718-21. Epub 2006 Jul 13.

ReferenceCitation: Morgan KP, Kapur A, Beatt KJ. Anatomy of coronary disease in diabetic patients: an explanation for poorer outcomes after percutaneous coronary intervention and potential target for intervention. Heart. 2004 Jul;90(7):732-8. Review.

ReferenceCitation: Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76. Review.

ReferenceCitation: Schalkwijk CG, Stehouwer CD. Vascular complications in diabetes mellitus: the role of endothelial dysfunction. Clin Sci (Lond). 2005 Aug;109(2):143-59. Review.

ReferenceCitation: Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010 Nov 30;56(23):1897-907. doi: 10.1016/j.jacc.2010.07.028. Review.

ReferenceCitation: Lightell DJ Jr, Woods TC. Relative resistance to Mammalian target of rapamycin inhibition in vascular smooth muscle cells of diabetic donors. Ochsner J. 2013 Spring;13(1):56-60.

ReferenceCitation: Denardo SJ, Carpinone PL, Vock DM, Batich CD, Pepine CJ. Changes to polymer surface of drug-eluting stents during balloon expansion. JAMA. 2012 May 23;307(20):2148-50. doi: 10.1001/jama.2012.4111.

ReferenceCitation: Popma JJ, Leon MB, Moses JW, Holmes DR Jr, Cox N, Fitzpatrick M, Douglas J, Lambert C, Mooney M, Yakubov S, Kuntz RE; SIRIUS Investigators. Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries. Circulation. 2004 Dec 21;110(25):3773-80. Epub 2004 Dec 13.

ReferenceCitation: Mulukutla SR, Vlachos HA, Marroquin OC, Selzer F, Holper EM, Abbott JD, Laskey WK, Williams DO, Smith C, Anderson WD, Lee JS, Srinivas V, Kelsey SF, Kip KE. Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National Heart, Lung, and Blood Institute Dynamic Registry. JACC Cardiovasc Interv. 2008 Apr;1(2):139-47. doi: 10.1016/j.jcin.2008.02.005.

ReferenceCitation: Stenestrand U, James SK, Lindbäck J, Fröbert O, Carlsson J, Scherstén F, Nilsson T, Lagerqvist B; SCAAR/SWEDEHEART study group. Safety and efficacy of drug-eluting vs. bare metal stents in patients with diabetes mellitus: long-term follow-up in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J. 2010 Jan;31(2):177-86. doi: 10.1093/eurheartj/ehp424. Epub 2009 Nov 10.

ReferenceCitation: Maeng M, Jensen LO, Galloe AM, Thayssen P, Christiansen EH, Hansen KN, Helqvist S, Botker HE, Lassen JF, Thuesen L. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial. Am J Cardiol. 2009 Feb 1;103(3):345-9. doi: 10.1016/j.amjcard.2008.09.084. Epub 2008 Nov 12.

ReferenceCitation: Dibra A, Kastrati A, Mehilli J, Pache J, Schühlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schömig A; ISAR-DIABETES Study Investigators. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005 Aug 18;353(7):663-70. Epub 2005 Aug 16.

ReferenceCitation: Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.

ReferenceCitation: Mahmud E, Ormiston JA, Turco MA, Popma JJ, Weissman NJ, O'Shaughnessy CD, Mann T, Hall JJ, McGarry TF, Cannon LA, Webster MW, Mandinov L, Baim DS. TAXUS Liberté attenuates the risk of restenosis in patients with medically treated diabetes mellitus: results from the TAXUS ATLAS program. JACC Cardiovasc Interv. 2009 Mar;2(3):240-52. doi: 10.1016/j.jcin.2008.12.009.

ReferenceCitation: Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrié D, Thuesen L, Boone E, Miquel-Herbert K, Daemen J. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial. EuroIntervention. 2006 Nov;2(3):286-94.

ReferenceCitation: Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Džavík V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberté paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions. Am Heart J. 2012 May;163(5):867-875.e1. doi: 10.1016/j.ahj.2012.02.006. Epub 2012 Apr 11.

ReferenceCitation: Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.

ReferenceCitation: Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. Review.

ReferenceCitation: Lansky AJ, Messé SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045. Review.

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

ipd_sharing: No

lead_sponsor: Concept Medical Inc.

location_country:
United Kingdom
Italy
Belgium
Czechia
Poland
Austria
Australia
India
Mexico
Sweden
Malaysia
Singapore
Brazil
Bangladesh
Switzerland
Germany
Taiwan
Ireland
Korea, Republic of
France
Netherlands

location_facility: Charite Berlin, Department of Cardiology, Campus Benjamin Franklin

location_facility: Oddział Kardiologii Szpitale Polskie Sztum

location_facility: XII Oddział Kardiologiczny PAKS w Bełchatowie

location_facility: Klinik für Kardiologie und Angiologie II, Herz-Zentrum Bad Krozingen

location_facility: University Hospital Královské Vinohrady, Department of Medecine Cardiology

location_facility: Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH

location_facility: University Hospital Brno, Department of Medecine Cardiology

location_facility: Worcestershire Acute NHS Trust, Worcestershire Royal Hospital

location_facility: Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie

location_facility: INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School

location_facility: Department of Interventional Cardiology Med-Pro American Heart of Poland

location_facility: Helios Amper-Klinikum Dachau, Dept. of Cardiology & Pneumology

location_facility: Division of Cardiology, University of Campania "Luigi Vanvitelli"

location_facility: National Heart Foundation Hospital & Research Institute

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie

location_facility: Grupo Intervención San Luis - Hospital de Especialidades de la Salud - San Luis Potosí City

location_facility: Brighton & Sussex University NHS Hospitals Trust

location_facility: National University of Ireland, Galway Galway University Hospital

location_facility: Örebro Univ. Hospital, Dpt. of cardiology

location_facility: Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences

location_facility: X Department of Invasive Cardiology, Tychy American Heart of Poland SA

location_facility: Instituto nacional de cardiologia ignacio chavez

location_facility: Antwerp Cardiovascular Center Middelheim

location_facility: UKSH, Campus Kiel, Department of Cardiology

location_facility: Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Szpital Kliniczny Przemienienia Pańskiego

location_facility: Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii

location_facility: Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca

intervention_type: Device


title: Multicenter International Observational Study to Identify eGFR Trajectories and Their Determinants, and to Build a Multidimensional Prediction System to Predict the Probabilities of Belonging to eGFR Trajectories

acronym: TRAJAKT

summary:
The gold standard for characterizing chronic kidney disease (CKD) is the glomerular filtration rate (GFR), which is commonly estimated in both native and transplanted kidneys for patient monitoring and therapeutic management and ultimately guides decision-making about whether a patient needs renal replacement therapy. In particular, the National Kidney Foundation has defined CKD stages according to estimated GFR (eGFR) values and in several studies, the eGFR slope or change has been found to be strongly associated with end stage renal disease (ESRD).

However, little is known about the heterogeneity of eGFR evolution in time - i.e. eGFR trajectories - and the related progression to ESRD and death. To date, no studies have investigated eGFR trajectories in diversified cohorts and populations worldwide, although this approach could provide a better understanding of CKD evolution and hence improve risk stratification. In addition, determinants of eGFR trajectories remain poorly described.

An unsupervised approach could allow examining eGFR trajectories over time and could lead to the identification of patient groups according to the probability of the progression of their kidney disease.

Therefore, this study aims:

To identify the long-term eGFR trajectories after kidney transplantation using latent class mixed models;
To identify the clinical, immunological, histological and functional determinants of the eGFR trajectories using multinomial regressions;
To investigate the associations of the eGFR trajectories with the progression to ESRD and death.

Based on the results, the investigators will provide an easily accessible tool to calculate personalized probabilities of belonging to eGFR trajectories after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.

status: Unknown status

study_type: Observational

time_perspective: Prospective

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_country:
Croatia
United States
France
Belgium

location_facility: Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program

location_facility: Department of Nephrology and Renal Transplantation, University Hospitals Leuven

location_facility: Department of Nephrology, Centre Hospitalier Universitaire de Montpellier

location_facility: Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil

location_facility: Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center

location_facility: Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Department of Surgery, Johns Hopkins University School of Medicine

location_facility: William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic

location_facility: Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch

location_facility: Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School od Medicine University of Zagreb

location_facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris

location_facility: Bretonneau Hospital, Nephrology and Immunology Department

location_facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris

location_facility: Virginia Commonwealth University School of Medicine

intervention_type: Other


title: Treatment of Symptoms Associated With Vulvovaginal Atrophy in Postmenopausal Women by Hyaluronic Acid Injection Into the Vaginal Mucosa

acronym: SYLIVA

summary: DESIRIAL® is a CE-marketed hyaluronic acid gel intented to rehydrate vaginal and vestibular mucous membranes by mucosal injections. In this study, 121 postmenopausal women of minimum age 45 with symptoms associated with vulvovaginal atrophy, refusing estrogen therapies for treatment of symptoms or with contraindications for such therapies, with at least one moderate to severe vulvovaginal symptom among dryness sensation, dyspareunia, itching / irritation and pain, who have given her informed consent and met all the eligibility criteria, will be enrolled. Patients will randomly receive 1 injection of DESIRIAL® or placebo (ratio 2:1) in the vaginal mucosa at Day 0. If still eligible 12 weeks after, patients receiving placebo at Day 0 will be treated with DESIRIAL®. Patients will come to a total of 6 to 8 visits depending on the product injected at Day 0 over a period of 11 up to 12 months. Phone interview will be performed between 3 and 5 days after injection. Variation of vulvovaginal symptomatology, sexual function, vaginal pH and safety will be assessed.

lead_sponsor: Laboratoires Vivacy

location_country: France Belgium

location_facility:
MIRHA
Gynecology private office
Polyclinique de l'Atlantique
Clinique Georges V
Gynaecologie Dr Deniz Gulcan
Cabinet Dr Ali Bennani
Cabinet de gynécologie
Cabinet Gynécologie Obstétrique
CHRU Jeanne de Flandres
Cabinet de Gynécologie
Gynaecologisch Centrum


title: A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

summary:
Primary Objective:

To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable.

Secondary Objectives:

To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapy or when those therapies are not advisable.

To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.

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://vivli.org

lead_sponsor: Sanofi

location_country:
Taiwan
Portugal
Spain
Italy
United Kingdom
Canada
Hungary
Korea, Republic of
United States
Chile
France

location_facility:
Investigational Site Number :6200001
Investigational Site Number :4100003
Investigational Site Number :7240008
Investigational Site Number :2500005
Investigational Site Number :3800001
Investigational Site Number :1520001
Investigational Site Number :1520003
Investigational Site Number :2500006
Investigational Site Number :7240009
Investigational Site Number :7240007
Investigational Site Number :7240003
Investigational Site Number :3480004
Investigational Site Number :3800003
Investigational Site Number :1520006
Investigational Site Number :2500003
Investigational Site Number :8400001
Investigational Site Number :7240002
Investigational Site Number :1580002
Investigational Site Number :2500008
Investigational Site Number :1520004
Investigational Site Number :1580005
Investigational Site Number :8400002
Investigational Site Number :8400006
Investigational Site Number :1520005
Investigational Site Number :1240006
Investigational Site Number :3480002
Investigational Site Number :8260001
Investigational Site Number :2500002
Investigational Site Number :3480003
Investigational Site Number :4100005
Investigational Site Number :1240001
Investigational Site Number :6200003
Investigational Site Number :4100006
Investigational Site Number :1580001
Investigational Site Number :3800004
Investigational Site Number :1580008
Investigational Site Number :4100007
Investigational Site Number :3800002
Investigational Site Number :4100002
Investigational Site Number :7240001
Investigational Site Number :6200002
Investigational Site Number :1240002
Investigational Site Number :2500004
Investigational Site Number :1580006
Investigational Site Number :8400005
Investigational Site Number :4100001
Investigational Site Number :1240009
Investigational Site Number :8400003
Investigational Site Number :7240004
Investigational Site Number :2500001
Investigational Site Number :8400054
Investigational Site Number :8400008
Investigational Site Number :1240008
Investigational Site Number :3480005
Investigational Site Number :1520002
Investigational Site Number :2500007
Investigational Site Number :1240007


title: An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies

lead_sponsor: Merck Sharp & Dohme LLC

type: Registry Identifier

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Japan
Czechia
Hong Kong
Russian Federation
Turkey
Norway
Sweden
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Finland
Korea, Republic of
France
Chile
Colombia

location_facility: The Christie NHS Foundation Trust ( Site 1401)

location_facility: Orszagos Onkologiai Intezet ( Site 0503)

location_facility: Okayama University Hospital ( Site 1020)

location_facility: Universitaetsklinik fuer Urologie ( Site 0405)

location_facility: University of North Carolina at Chapel Hill ( Site 1537)

location_facility: Tokushima University Hospital-Department of Urology ( Site 1017)

location_facility: Massachusetts General Hospital ( Site 1558)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 1163)

location_facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0352)

location_facility: Oncology Hematology Care, Inc. ( Site 1524)

location_facility: St. Vincent Frontier Cancer Center ( Site 1549)

location_facility: Fakultni Thomayerova nemocnice ( Site 0107)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 0603)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1303)

location_facility: National Cancer Center Hospital ( Site 1003)

location_facility: Hospital General Universitario 12 de Octubre ( Site 1252)

location_facility: Northwest Georgia Oncology Centers PC ( Site 1520)

location_facility: Nara Medical University Hospital ( Site 1009)

location_facility: National Cancer Center Hospital East ( Site 1001)

location_facility: Fakultni nemocnice Kralovske Vinohrady ( Site 0102)

location_facility: University of Alabama - Birmingham ( Site 1538)

location_facility: SBIH City clinical hospital named after D.D. Pletniov ( Site 1160)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 1452)

location_facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 1306)

location_facility: Universitatsklinikum Hamburg-Eppendorf ( Site 0408)

location_facility: Hadassah Medical-Oncology department ( Site 1164)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1151)

location_facility: Omsk Clinical Oncology Dispensary ( Site 1150)

location_facility: Norrlands Universitetssjukhus ( Site 1856)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 1655)

location_facility: CHU de Bordeaux Hop St ANDRE ( Site 0359)

location_facility: Istituto Nazionale dei Tumori ( Site 0601)

location_facility: Aarhus University Hospital Skejby ( Site 0250)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1304)

location_facility: St Joseph Heritage Healthcare ( Site 1531)

location_facility: Yokohama City University Hospital ( Site 1015)

location_facility: Medical University of South Carolina ( Site 1518)

location_facility: Fondazione Salvatore Maugeri clinica del lavoro ( Site 0600)

location_facility: Texas Oncology-Austin Central ( Site 1533)

location_facility: Administradora Country SA - Clinica del Country ( Site 1701)

location_facility: Centre Alexis Vautrin Institut de Cancerologie de Lorraine ( Site 0356)

location_facility: Hospital Universitari Vall d Hebron ( Site 1250)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0152)

location_facility: Ankara Universitesi Tip Fakultesi ( Site 1311)

location_facility: Kyiv City Clinical Oncology Center ( Site 1450)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1523)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 1300)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1702)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 0605

location_facility: Taichung Veterans General Hospital ( Site 1105)

location_facility: Akershus universitetssykehus ( Site 0851)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0410)

location_facility: National Taiwan University Hospital ( Site 1100)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1709)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0505)

location_facility: Sunnybrook Research Institute ( Site 0153)

location_facility: Centro Avancado de Tratamento Oncologico ( Site 1657)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0404)

location_facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1650)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 1402)

location_facility: UCHealth Highlands Ranch Hospital ( Site 1560)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0350)

location_facility: Princess Margaret Hospital. ( Site 1053)

location_facility: Hamamatsu University Hospital ( Site 1005)

location_facility: Saitama Medical University International Medical Center ( Site 1012)

location_facility: Hiroshima University Hospital-Hiroshima University Hospital ( Site 1019)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 1308)

location_facility: University of California San Diego Moores Cancer Center ( Site 1546)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 1513)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 1651)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1850)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1409)

location_facility: Yamaguchi University Hospital ( Site 1018)

location_facility: Azienda Ospedaliera Policlinico di Bari ( Site 0610)

location_facility: Helse Bergen HF - Haukeland Universitetssykehus ( Site 0854)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 1703)

location_facility: Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1106)

location_facility: Centre Hospitalier Lyon Sud ( Site 0354)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0606)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0604)

location_facility: Masarykuv onkologicky ustav ( Site 0105)

location_facility: Kuopion Yliopistollinen Sairaala ( Site 0304)

location_facility: Oncologos del Occidente S.A. ( Site 1708)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1514)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0004)

location_facility: Azienda Ospedaliera Santa Maria ( Site 0602)

location_facility: University of Rochester Medical Center ( Site 1543)

location_facility: The Cancer Institute Hospital of JFCR ( Site 1000)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 1155)

location_facility: Severance Hospital Yonsei University Health System ( Site 1202)

location_facility: Taipei Veterans General Hospital ( Site 1101)

location_facility: CHU Besancon - Hopital Jean Minjoz ( Site 0351)

location_facility: Instituto Valenciano de Oncologia - IVO ( Site 1254)

location_facility: Nippon Medical School Hospital ( Site 1010)

location_facility: SBHI SPb Clinical Research Centre of specialized types of medical care ( Site 1159)

location_facility: BC Cancer - Vancouver Center ( Site 0155)

location_facility: Beth Israel Deaconess Medical Center ( Site 1501)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 1153)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1305)

location_facility: Cambridge University Hospitals NHSFT ( Site 1405)

location_facility: Dana Farber Cancer Institute ( Site 1505)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0150)

location_facility: The University of Chicago Medical Center ( Site 1539)

location_facility: National Cheng Kung University Hospital ( Site 1103)

location_facility: Universitaetsmedizin Berlin ( Site 0400)

location_facility: TYKS T-sairaala Syopatautien pkl ( Site 0301)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 0607)

location_facility: Sapporo Medical University Hospital ( Site 1008)

location_facility: Korea University Anam Hospital ( Site 1203)

location_facility: Tampereen yliopistollinen sairaala ( Site 0300)

location_facility: Kindai University Hospital- Osakasayama Campus-Urology ( Site 1011)

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 1453)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 1653)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1403)

location_facility: Fakultni nemocnice Hradec Kralove ( Site 0106)

location_facility: Universitaetsklinikum Essen ( Site 0401)

location_facility: Texas Oncology, P.A.-Dallas ( Site 1534)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0504)

location_facility: Royal Marsden Hospital Sutton-Surrey ( Site 1411)

location_facility: Medical Oncology Ospedale San Donato ( Site 0609)

location_facility: Chungnam National University Hospital ( Site 1205)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

location_facility: Central Clinical Hospital with Polyclinic ( Site 1157)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 0509)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 1104)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0403)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0151)

location_facility: Oregon Health & Science University ( Site 1553)

location_facility: Niigata University Medical & Dental Hospital ( Site 1022)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1302)

location_facility: City clinical oncological dispensary ( Site 1154)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 1251)

summary: The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

lead_sponsor: Hoffmann-La Roche

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data 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 the Sharing of Clinical 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).

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Turkey
Singapore
Canada
Hungary
China
Germany
Denmark
Taiwan
Greece
New Zealand
Thailand
Korea, Republic of
France

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Barts Health NHS Trust; Cancer Research Delivery Group

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: Churchill Hospital; Department of Oncology

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

location_facility: Auckland City Hospital; Clinical Oncology

location_facility: Tri-Service General Hospital, Division of General Surgery

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

location_facility: Kaiser Permanente;Clinical Trials Department

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

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

location_facility: Metropolitan Hospital; Dept. of Oncology

location_facility: Harbin Medical University Cancer Hospital

location_facility: Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Regional Oncology Dispensary; Dept of Chemotherapy

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Ospedale Santa Maria Annunziata; Oncologia

location_facility: Texas Tech University Health Sciences Center; Department of Internal Medicine

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

location_facility: Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

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

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

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

location_facility: Uzsoki Utcai Korhaz; Onkoradiológiai Osztály

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Princess Alexandra Hospital; Oncology Department

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Fujian Medical University Union Hospital

location_facility: Maidstone Hospital; Kent Oncology Centre

location_facility: National Cancer Centre; Medical Oncology

location_facility: Waikato Hospital; Dept of Medical Oncology

location_facility: The First Affiliated Hospital, Chongqing Medical University

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Austin Health; Cancer Clinical Trial Centre

location_facility: Azienda Ospedaliera Univ di Udine; Oncologia Medica

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Universitätsfrauenklinik Ulm; Abteilung Gynäkologie

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Winship Cancer Institute of Emory University

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Azienda Ospedaliero Universitaria Pisana; Unita Operativa Oncologia Medica 2

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

location_facility: Universitätsklinikum St. Pölten; Klinische Abteilung für Innere Medizin 1

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Providence Portland Medical Center; Providence Oncology and Hematology Clinic Westside

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Memorial Healthcare System - Memorial Regional Hospital

location_facility: Maryland Oncology Hematology; Maryland Oncology Hematology, Silver Spring

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kyungpook National University Medical Center

location_facility: Cairns Base Hospital; Cancer Care Centre

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

location_facility: London Regional Cancer Program, London Health Sciences Centre, Baines Centre

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Mount Vernon Hospital; Mount Vernon Cancer Centre

location_facility: Seoul National University Bundang Hospital

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Wake Forest University Baptist Medical Center

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie

location_facility: Rutherford Cancer Centre - Thames Valley

location_facility: Fraser Valley Centre British Columbia Cancer Agency

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Opolskie Centrum Onkologii; Onkologia Kliniczna z Odcinkiem Dziennym

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

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Ambulatorium Chemioterapii

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Townsville Hospital; Haematology and Oncology

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Westmead Hospital; Medical Oncology and Pallative Care

location_facility: Princess Alexandra Hospital; Cancer Trials Unit

location_facility: Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen

location_facility: Narodowy Instytut Onkologii Odział w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi

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

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

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

location_facility: Palmerston North Hospital; Regional Cancer Treatment Service

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Wojskowy Instytut Medyczny; Klinika Onkologii

location_facility: Helios Klinikum Krefeld; Zentrum für ambulante gynäkologische Onkologie (ZAGO)

location_facility: St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik

location_facility: St Georges University Hospitals NHS Foundation Trust

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Blokhin Cancer Research Center; Out-Patients Dept

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Centro Clinico Champalimaud; Oncologia Medica

location_facility: Texas Oncology San Antonio Medical Center

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.


title: A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations

lead_sponsor: Taiho Oncology, Inc.

location_country:
Hong Kong
Portugal
Spain
Italy
United Kingdom
Netherlands
Sweden
Korea, Republic of
United States
France
Singapore
Turkey
Belgium
Japan
Germany

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

location_facility: Centro Hospitalar do Porto, E.P.E - Hospital de Santo Antonio

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Georgetown University - Lombardi Comprehensive Cancer Center

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Trento)

location_facility: Karolinska universitetssjukhuset - Solna

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Mercy Clinic Oncology and Hematology - Coletta

location_facility: Seoul National University Bundang Hospital

summary: The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma [iCCA]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.


acronym: SYNERGY-NASH

title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

lead_sponsor: Eli Lilly and Company

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.

location_country:
Poland
Spain
Italy
United Kingdom
Mexico
United States
France
Israel
Belgium
Japan

location_facility: Synexus North Teesside Clinical Research Centre

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Aintree University Hospital NHS Foundation Trust

location_facility: Synexus North East Clinical Research Centre

location_facility: Queen's Medical Centre, Nottingham University Hospitals

location_facility: Groupe hospitalier mutualiste Les Portes du sud

location_facility: Synexus Midlands Clinical Research Center

location_facility: University at Buffalo-Clinical and Translational Research Center

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: The National Diabetes & Obesity Research Institute (NDORI)

location_facility: Harborview Medical Center/University of Washington

location_facility: Niigata University Medical & Dental Hospital

location_facility: Cotton O'Neil Diabetes and Endocrinology Center

location_facility: Synexus Manchester Clinical Research Centre

location_facility: National Hospital Organization Yokohama Medical Center

location_facility: Imperial College London and Imperial College Healthcare NHS Trust

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Virginia Commonwealth University Medical Center Gastroenterology Hepatology

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

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Di Foggia

location_facility: University of Alabama-The Kirklin Clinic

location_facility: NAFLD Research Center, UCSD Altman Clinical and Translational Research Institute (ACTRI)

location_facility: Southern Therapy and Advanced Research (STAR) LLC

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: Research Centers of America ( Hollywood )

location_facility: American Research Corporation at Texas Liver Institute

location_facility: Velocity Clinical Research, Huntington Park

location_facility: Diabetes & Endocrinology Consultants, PC

location_facility: A.O. Universitaria Policlinico P. Giaccone

location_facility: Synexus Clinical Research US, Inc - Orlando

location_facility: Hospital Universitario Marqués de Valdecilla

summary: The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).


title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)

lead_sponsor: GlaxoSmithKline

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

location_country:
Poland
Brazil
Spain
Greece
Italy
Australia
Netherlands
Canada
Russian Federation
United Kingdom
Hungary
Korea, Republic of
United States
France
China
Belgium
Japan
Germany
Bulgaria

summary: This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.


title: Clinical and Device Functional Assessment of Real World ICD Patients

acronym: CARAT

summary:
The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in terms of techniques and medical devices, based on the patient's condition.

It is extremely important in the clinical practice to identify which patients' subgroup benefits the most from the ICD therapy, which comorbidity has a major impact on the patients' prognosis, or which pre-intra-post procedural behaviors provoke less complications, and affect the patient's outcome (including prolonged or unwanted hospitalizations).

lead_sponsor: MicroPort CRM

location_country:
Portugal
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Switzerland
France
Germany
Slovakia
Czechia

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Professor Doutor Fernando Fonseca

location_facility: Hospital Universitario Clínico San Carlos


title: Non-Interventional Study on the Tolerability and Efficacy of IVIG

summary: Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%

lead_sponsor: Octapharma

location_country:
United Kingdom
Spain
Austria
Canada
France

location_facility:
St. Paul's Hospital
Hospital for Sick Children
Octapharma Research Site
Octapharma Research Location
Hamilton Health Sciences
Octapharma Research Center
Health Sciences Centre
St. Michael's Hospital