title: EMPACT-MI: A Streamlined, Multicentre, Randomised, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalisation for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction

summary:
This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease.

People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes.

Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
United States
India
Serbia
Netherlands
Spain
Germany
France
Bulgaria
Japan
Israel
Poland
Romania
Hungary
Argentina
Russian Federation
China
Canada
Korea, Republic of
Ukraine

location_facility: Texas Health Presbyterian Hospital Allen

location_facility: Cardiology and Cardiovascular Rehabilitation Clinic

location_facility: CI of Healthcare Kharkiv CCH #8, Kharkiv

location_facility: Military Central Clinical Emergency Hospital

location_facility: Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego

location_facility: Institute for Cardiovascular diseases Dedinje

location_facility: Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept.

location_facility: NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.

location_facility: Central Hospital of Medical Academy, Warsaw

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia

location_facility: Timisoara Municipal Emergency Clinical Hospital

location_facility: Cardiovascular Specialists of Central Maryland

location_facility: Emergency County Clinical Hospital, Sibiu

location_facility: Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH

location_facility: Eternal Heart Care Centre & Research Institute Pvt. Ltd.

location_facility: University Multiprofile Hospital 'Alexandrovska', Sofia

location_facility: Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: MHAT Sv.Anna, Clinic of Internal Diseases, Sofia

location_facility: Dr Alfred Sokołowski Specialist Hospital

location_facility: Regional Clinical Hospital No.1 n.a. Ochapovskiy, Krasnodar

location_facility: Missouri Cardiovascular Specialists, LLP

location_facility: L.T. Malaya Institute of Therapy AMS of Ukraine

location_facility: Cardiovascular Consultants of South Georgia, LLC

location_facility: Corporacion Medica de Gral. San Martin S.A.

location_facility: Prof.C.C.Iliescu Hospital, National Institute of Cardiology

location_facility: GUZ Ryazanskiy Regional Clin. Cardiology Dispensary, Ryazan

location_facility: Heart Institute "Niculae Stancioiu", Cluj Napoca

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Institute for Treatment and Rehabilitation, Niska Banja

location_facility: Lady Davis Carmel Medical Center, Haifa 34362

location_facility: The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow

location_facility: Advanced Heart Care, LLC, Medicoricum, LLC

location_facility: State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr

location_facility: General Hospital Subotica, Internal Medicine

location_facility: Multiprofile Hospital For Active Treatment - Pazardzhik AD

location_facility: George Washington University Medical Faculty Associates

location_facility: IKARDIA - Center for Invasive Cardiology

location_facility: Cardiovascular Innovation and Research Center

location_facility: University of Florida Health Jacksonville

location_facility: Podhalanski Special.Hosp,Intern.Med&Cardiology Dept,Nowy Tag

location_facility: SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv

location_facility: City Joint Emergency Hospital, Dnepropetrovsk

location_facility: Lausmed Kft. Outpatient Unit of Internal Medicine

location_facility: Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser

location_facility: Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine

location_facility: Fejer County Saint George University Teaching Hospital

location_facility: Clinical Hospital Center Dr. Dragisa Misovic

location_facility: Cardiology Partners Clinical Research Institute

location_facility: Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako

location_facility: The University of North Carolina at Chapel Hill

location_facility: Centro de Investigacion Clinica Coronel Suarez

location_facility: Multiprofile Hospital For Active Treatment Dr. Nikola Vasiliev AD

location_facility: Penza Regional Clinical Hospital named after N.N.Burdenko

location_facility: CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur

location_facility: Cardiovascular Associates of East Texas, PA

location_facility: Medical Academy named after I. Mechnikov, St. Petersburg

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: Emergency Clinical County Hospital, Baia Mare

location_facility: Cardiovascular Diseases Institute "Prof. Georgescu", Iasi

location_facility: Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: Clincal Reabilitation Hospital, Cluj Napoca

location_facility: Spitalul Clinic Judetean de Urgenta Brasov

location_facility: ProHealth Care Research Institute and Cardiology Associates

location_facility: Independent Public Healthcare, Dept. of Cardiology, Pulawy

location_facility: MHAT "Deva Maria", Dept. of Cardiology, Burgas

location_facility: Emergency Clinical Hospital "St. John" Bucharest

location_facility: Multiprofile Hospital For Active Treatment Pulse AD

location_facility: Jan Mikulicz-Radecki UnivClinic Hosp,Cardiology Dept,Wroclaw

location_facility: Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu"

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Clinical Medical Center Zvezdara, Belgrade

location_facility: CIUSSS de la Mauricie-et-du-Centre-du-Quebec

location_facility: State Healthcare Institution Clinical Hosp. No. 51, Moscow

location_facility: Centennial Heart Cardiovascular Consultants, LLC

location_facility: Emergency Clinical Hospital "Bagdasar-Arseni"

location_facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet

location_facility: Ivano-Frankivsk City Central Clinical Hospital

location_facility: Multiprofile Hospital for Active Treatment AD Haskovo

location_facility: Emergency University Hospital, Bucharest

location_facility: First City Clinical Hospital named after E. E. Volosevich

location_facility: Cardiovascular Research of Northwest Indiana, LLC

location_facility: Zhytomyr Regional Clinical Hospital, Dept. Endocrinology

location_facility: Fundación Favaloro para la Docencia e Investigación Medica

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: Comprehensive Cardiovascular Medical Group

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

location_facility: Specialized Hospital for Active Treatment Sv. Georgi - Pernik

location_facility: Tidewater Physicians Multispecialty Group

location_facility: Specialized Hospital for Active Treatment Cardiology Varna - EAD

location_facility: Komi Republican Cardiological Dispensary

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvar

location_facility: Oklahoma Heart Hospital Research Foundation, Incorporated

location_facility: Sri Jayadeva Institute of Cardiovascular Sciences & Research

location_facility: Amarillo Heart Clinical Research Institute, Incorporated

location_facility: Clinical Medical Diagnostic Center Simedgroup

location_facility: Tokyo Bay Urayasu Ichikawa Medical Center

location_facility: 4. Military Clinical Hospital with Polyclinic SP ZOZ

location_facility: City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia

location_facility: Multiprofile Hospital MHATEM 'Pirogov', Sofia

location_facility: Transcarpathian Regional Clinical Center

location_facility: Bacs-Kiskun Megyei Onkormanyzat Hospital


title: EF-32: Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

summary: To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: NovoCure GmbH

location_country:
Austria
United States
Switzerland
Germany
France
Czechia
Israel
Australia
Belgium
Canada

location_facility: University of Minnesota Health Clinics and Surgery Center

location_facility: Providence St. Joseph Medical Center and The Roy and Patricia Disney Family Cancer Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute, Inc

location_facility: John Peter Smith Health Network - JPS Cancer Center

location_facility: The University of Vermont Medical Center - University of Vermont Cancer Center

location_facility: University of California - Irvine/UCI Medical Center

location_facility: Maine Medical Partners Neurology - Neurosurgery & Spine Associates

location_facility: Parkview Cancer Institute - Fort Wayne Radiation Oncology Associates

location_facility: JFK Neuroscience Institute, HMH JFK University Medical Center

location_facility: Case Western - University Hospitals Case Medical Center

location_facility: Walter Reed National Military Medical Center

location_facility: Texas Oncology Midtown - Austin Brain Tumor Center

location_facility: John Wayne Cancer Institute at St. John's Health Center

location_facility: West Virginia University Cancer Institute

location_facility: Northwell Health System Brain Tumor Center

location_facility: Universite de Sherbrooke - Sherbrooke Centre Hospitalier Universita

location_facility: UW Medical Center - Alvord Brain Tumor Center

location_facility: University of California at San Diego - Moores Cancer Center

location_facility: MUSC Radiation Oncology Brain & Spine Tumor Program

location_facility: University of Colorado Cancer Center Anschutz

location_facility: University of Missouri - Ellis Fischel Cancer Center

location_facility: Baylor Charles A. Sammons Cancer Center - Baylor University Medical Center

location_facility: Massey Cancer Center - VCU Medical Center

location_facility: Hartford Healthcare Medical Group - Hartford Hospital The Gray Cancer Center

location_facility: GenesisCare Wesley - Wesley Medical Centre

location_facility: Abbott Northwestern Hospital - Givens Brain Tumor Center

location_facility: University of California San Francisco Medical Center

location_facility: University Institute Cancer Toulouse Oncopole

location_facility: UT Health Mischer Neuroscience - Memorial Herman - UT Neurosciences

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Health Midwest Ventures Group, Inc - Sarah Cannon HCA Midwest Brain and Spine

location_facility: NYU Langone - Laura & Issac Perimutter Cancer Center

location_facility: Washington University School of Medicine

location_facility: HCA Research Institute - Blue Sky Neurology - Denver

location_facility: Wake Forest Baptist Comprehensive Cancer Center

location_facility: Novant Health Medical Center Huntersville

location_facility: St. Joseph's Hospital and Medical Center - Barrow Neurological Institute

location_facility: TRIO - St. Jude Heritage Healthcare/St. Jude Medical Center

location_facility: University of Cincinnati Cancer Institute

location_facility: New York Presbyterian - Columbia University

location_facility: Lynn Cancer Institute, Marcus Neuroscience Institute

location_facility: The James Cancer Hospital and Solove Research Institute - Arthur G James Cancer Hospital

location_facility: The Emory Clinic - Emory Healthcare - Winship Cancer Institute

location_facility: University of North Carolina Brain Tumor Program - UNC Lineberger Comprehensive Cancer Center

location_facility: Hoag Memorial Hospital - Hoag Cancer Center

location_facility: GenesisCare Hurstville - Centre for radiation oncology Waratah Private Hospital

location_facility: University of Louisville - James Graham Brown Cancer Center

location_facility: Norris Comprehensive Cancer Center at USC

location_facility: NeuroMedical Center - Mary Bird Cancer Center

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

location_facility: Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase III, Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Atezolizumab Given in Combination With Cabozantinib Versus Docetaxel Monotherapy in Patients With Metastatic Non-Small Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy

summary: This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing EGFR mutation or ALK translocation, who have progressed following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially.

status: Active, not recruiting

enrollment_type: Actual

ipd_sharing: Yes

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/members/ourmembers/). 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).

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
Spain
Germany
France
Japan
Greece
Poland
Australia
Belgium
Russian Federation
Portugal
United States
United Kingdom
Korea, Republic of

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Consultants in Medical Oncology and Hematology

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Hospitalier de Mulhouse - Hopital Emile Muller

location_facility: SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej

location_facility: Hospital Pulido Valente; Servico de Pneumologia

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

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

location_facility: Huntsman Cancer Institute at The University of Utah

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: IPO do Porto; Servico de Oncologia Medica

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Huddersfield Royal Infirmary; The Learning Centre

location_facility: Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH

location_facility: GBUZ Leningradskaya state clinical hospital

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: Austin Hospital Olivia Newton John Cancer Centre

location_facility: AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

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

location_facility: Universitaetsklinikum Giessen und Marburg GmbH; Medizinische Klinik IV und V

location_facility: Szpital Wojewódzki im. Mikołaja Kopernika; Oddział Dzienny Chemioterapii

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Quincy Medical Group; Canc Ctr at Blessing Hosp

location_facility: Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie

location_facility: Virginia Cancer Specialists (Fairfax) - USOR

location_facility: Zentralklinik Bad Berka GmbH; Pneumologie

location_facility: Barts & London School of Med; Medical Oncology

intervention_type: Drug


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

lead_sponsor: Sanofi

location_country:
Peru
Greece
Romania
Belgium
Australia
Russian Federation
Ukraine
France
Poland
Lithuania
Slovakia
Argentina
Canada
Colombia
South Africa
Chile
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Brazil
Serbia
Mexico
Czechia
Spain
Latvia

acronym: NOTUS

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Investigational Site Number :8400009
Investigational Site Number :2500003
Investigational Site Number :2760013
Investigational Site Number :0320010
Investigational Site Number :8400061
Investigational Site Number :8400018
Investigational Site Number :8400017
Investigational Site Number :2500008
Investigational Site Number :4840007
Investigational Site Number :4840009
Investigational Site Number :7240007
Investigational Site Number :5280007
Investigational Site Number :2760003
Investigational Site Number :8400013
Investigational Site Number :2500002
Investigational Site Number :6160007
Investigational Site Number :8400015
Investigational Site Number :8400039
Investigational Site Number :4280003
Investigational Site Number :8400006
Investigational Site Number :0560002

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation

summary:
Primary Objective:

To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by

Annualized rate of acute moderate or severe COPD exacerbation (AECOPD)

Secondary Objectives:

To evaluate the effect of dupilumab administered every 2 weeks on

Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo
Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ)
Pre-bronchodilator FEV1 over 52 weeks compared to placebo
Lung function assessments
Moderate and severe COPD exacerbations
To evaluate safety and tolerability
To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)


title: A Phase III, Randomized, Controlled, Open-label, Multicenter, Global Study of Capmatinib Versus SoC Docetaxel Chemotherapy in Previously Treated Patients With EGFR wt, ALK Negative, Locally Advanced or Metastatic (Stage IIIB/IIIC or IV) NSCLC Harboring MET Exon 14 Skipping Mutation (METΔex14).

acronym: GeoMETry-III

summary: The purpose of the study is to learn whether the study drug (capmatinib) helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients suffering from a particular type of lung cancer. This type of cancer is called non-small cell lung cancer (NSCLC) with certain specific genetic alterations (called mutations) of a gene called MET, within a specific part of the gene called exon 14.

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Brazil
South Africa
India
Netherlands
Spain
Vietnam
France
Malaysia
Lithuania
Thailand
Hungary
Belgium
Australia
Russian Federation
Portugal
Germany
Korea, Republic of


intervention_type: Radiation

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Peru
Romania
Russian Federation
Ukraine
France
Japan
Poland
Thailand
Norway
Canada
Korea, Republic of
Turkey
Chile
Hungary
China
Germany
United States
United Kingdom
Italy
Mexico
Czechia
Spain
Estonia
Latvia

location_facility: Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1911)

location_facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 0060)

location_facility: Seoul National University Bundang Hospital ( Site 2801)

location_facility: Kansai Medical University Hospital ( Site 3103)

location_facility: Ege University Medical Faculty ( Site 2005)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 2208)

location_facility: Zhongshan Hospital Fudan University ( Site 3220)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0013)

location_facility: Severance Hospital Yonsei University Health System ( Site 2808)

location_facility: Peking University Shenzhen Hospital ( Site 3216)

location_facility: H.R.U Málaga - Hospital General ( Site 1206)

location_facility: Mid Florida Hematology and Oncology Center ( Site 0022)

location_facility: Gyeongsang National University Hospital ( Site 2804)

location_facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)

location_facility: Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0606)

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 0003)

location_facility: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095)

location_facility: Xiangya Hospital of Central South University ( Site 3637)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 1001)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910)

location_facility: Second Xiangya Hospital of Central-South University ( Site 3227)

location_facility: Keimyung University Dongsan Hospital ( Site 2807)

location_facility: Hospital Universitario Virgen Macarena ( Site 1205)

location_facility: Peking Union Medical College Hospital ( Site 3201)

location_facility: Orlando Health, UF Health Cancer Center Inc ( Site 0092)

location_facility: Long Beach Memorial Medical Center ( Site 0006)

location_facility: Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075)

location_facility: Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 3001)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2305)

location_facility: Masarykuv onkologicky ustav ( Site 2206)

location_facility: VA St. Louis Health Care System ( Site 0047)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 3110)

location_facility: Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3200)

location_facility: A.O.U. Santa Maria della Misericordia di Udine ( Site 1004)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 1909)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0500)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108)

location_facility: Krajska nemocnice Liberec, a.s. ( Site 2209)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0066)

location_facility: Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103)

location_facility: Pauls Stradins Clinical University Hospital ( Site 1501)

location_facility: Vestre Viken HF Drammen Sykehus ( Site 1101)

location_facility: Oslo Universitetssykehus HF. Ulleval ( Site 1100)

location_facility: Instituto Nacional de Cancerologia ( Site 0502)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2001)

location_facility: Akershus Universitetssykehus HF ( Site 1106)

location_facility: Daping Hospital,Third Military Medical University ( Site 3235)

location_facility: Clinique de l'Europe-Service de pneumologie ( Site 0816)

location_facility: Institutul Regional de Oncologie Iasi ( Site 2505)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 1000)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213)

location_facility: Juntendo University Hospital ( Site 3111)

location_facility: The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3232)

location_facility: Hospital Nacional Cayetano Heredia ( Site 0602)

location_facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401)

location_facility: SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology (

location_facility: Centro Investigación del Cáncer James Lind ( Site 0202)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0110)

location_facility: Duke University Medical Center ( Site 0050)

location_facility: Franciscan St. Francis Health ( Site 0031)

location_facility: University College Hospital NHS Foundation Trust ( Site 1403)

location_facility: C.H.R.U. de Brest - Hopital Morvan ( Site 0806)

location_facility: Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2309)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 3219)

location_facility: Queen Elizabeth II Health Sciences Centre ( Site 0100)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 2306)

location_facility: West China Hospital of Sichuan University ( Site 3202)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 3104)

location_facility: CLIMERS Clinical Medical Research ( Site 0506)

location_facility: Centro Oncologico Antofagasta ( Site 0204)

location_facility: Johannes Wesling Klinikum Minden ( Site 0908)

location_facility: Medical institute named after Berezin Sergey ( Site 1906)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 1914)

location_facility: Riga East Clinical University Hospital ( Site 1500)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604)

location_facility: Azienda Ospedaliera Vito Fazzi ( Site 1003)

location_facility: Shanghai Pulmonary Hospital ( Site 3203)

location_facility: Fakultni nemocnice v Motole ( Site 2210)

location_facility: Hospital Universitario La Fe ( Site 1203)

location_facility: Azienda Ospedaliera Umberto I- Torrette ( Site 1009)

location_facility: St Joseph Heritage Healthcare ( Site 0011)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 3108)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0054)

location_facility: LLC Ukrainian Center of Tomotherapy ( Site 2105)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0088)

location_facility: Zentralklinik Bad Berka GmbH ( Site 0905)

location_facility: Hospital Universitario Quiron Madrid ( Site 1200)

location_facility: Hospital Clinic de Barcelona ( Site 1204)

location_facility: The Cancer Institute Hospital of JFCR ( Site 3107)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2506)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400)

location_facility: Torrance Memorial Physician Network / Cancer Center ( Site 0093)

location_facility: Medipol Universite Hastanesi ( Site 2003)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 2101)

location_facility: Royal Marsden Hospital (Sutton) ( Site 1407)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2503)

location_facility: Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905)

location_facility: St. Bernards Medical Center ( Site 0089)

location_facility: Srinagarind Hospital. Khon Kaen University ( Site 3002)

location_facility: Kyiv City Clinical Oncology Center ( Site 2100)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913)

location_facility: Centre Hospitalier Annecy Genevois ( Site 0811)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 0902)

location_facility: Kobe Minimally Invasive Cancer Center ( Site 3100)

location_facility: Washington University Siteman Cancer Center ( Site 0046)

location_facility: North Estonia Medical Centre Foundation ( Site 1601)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 3204)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: The Second Affiliated Hospital of Nanchang University ( Site 3206)

location_facility: Niigata Cancer Center Hospital ( Site 3109)

location_facility: Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035)

location_facility: Chungbuk National University Hospital ( Site 2802)

location_facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)

location_facility: Piedmont Hematology-Oncology Associates ( Site 0080)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008)

location_facility: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900)

location_facility: Guys and St Thomas NHS Foundation Trust ( Site 1410)

location_facility: Fort Wayne Medical Oncology and Hematology ( Site 0094)

location_facility: Massachusetts General Hospital ( Site 0038)

location_facility: Policlinico Agostino Gemelli ( Site 1002)

location_facility: Osaka International Cancer Institute ( Site 3106)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 2805)

location_facility: Fujian Provincial Cancer Hospital ( Site 3226)

location_facility: Spitalul Universitar de Urgenta Bucuresti ( Site 2508)

location_facility: Fakultni Nemocnice Kralovske Vinohrady ( Site 2200)

location_facility: MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0901)

type: Registry Identifier

title: A Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)

summary:
The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:

Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis

summary: The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.

ReferenceType: derived

ReferenceCitation: Cheng PTW, Kaltenbach RF 3rd, Zhang H, Shi J, Tao S, Li J, Kennedy LJ, Walker SJ, Shi Y, Wang Y, Dhanusu S, Reddigunta R, Kumaravel S, Jusuf S, Smith D, Krishnananthan S, Li J, Wang T, Heiry R, Sum CS, Kalinowski SS, Hung CP, Chu CH, Azzara AV, Ziegler M, Burns L, Zinker BA, Boehm S, Taylor J, Sapuppo J, Mosure K, Everlof G, Guarino V, Zhang L, Yang Y, Ruan Q, Xu C, Apedo A, Traeger SC, Cvijic ME, Lentz KA, Tirucherai G, Sivaraman L, Robl J, Ellsworth BA, Rosen G, Gordon DA, Soars MG, Gill M, Murphy BJ. Discovery of an Oxycyclohexyl Acid Lysophosphatidic Acid Receptor 1 (LPA(1)) Antagonist BMS-986278 for the Treatment of Pulmonary Fibrotic Diseases. J Med Chem. 2021 Nov 11;64(21):15549-15581. doi: 10.1021/acs.jmedchem.1c01256. Epub 2021 Oct 28.

name: Fibrosis Chemistry, Small Molecule Drug Discovery, Research & Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

family: Cheng

full_name: Peter T. W. Cheng

given: Peter T. W.

sequence: first

family: Kaltenbach

full_name: Robert F. Kaltenbach

given: Robert F.

sequence: additional

suffix: III

family: Zhang

full_name: Hao Zhang

given: Hao

family: Shi

full_name: Jun Shi

given: Jun

family: Tao

full_name: Shiwei Tao

given: Shiwei

family: Li

full_name: Jun Li

family: Kennedy

full_name: Lawrence J. Kennedy

given: Lawrence J.

family: Walker

full_name: Steven J. Walker

given: Steven J.

full_name: Yan Shi

given: Yan

family: Wang

full_name: Ying Wang

given: Ying

name: Biocon-Bristol Myers Squibb Research & Development Center, Bangalore 560099, India

family: Dhanusu

full_name: Suresh Dhanusu

given: Suresh

family: Reddigunta

full_name: Ramesh Reddigunta

given: Ramesh

family: Kumaravel

full_name: Selvakumar Kumaravel

given: Selvakumar

name: Computer Aided Drug Design, Molecular Structure & Design, Research & Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

family: Jusuf

full_name: Sutjano Jusuf

given: Sutjano

name: Discovery Chemistry Synthesis, Small Molecule Drug Discovery, Research & Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

family: Smith

full_name: Daniel Smith

given: Daniel

family: Krishnananthan

full_name: Subramaniam Krishnananthan

given: Subramaniam

name: Discovery Chemistry Synthesis, Small Molecule Drug Discovery, Research & Early Development, Bristol Myers Squibb Company, Cambridge, Massachusetts 02140, United States

full_name: Jianqing Li

given: Jianqing

name: Lead Evaluation, Small Molecule Drug Discovery, Research & Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

full_name: Tao Wang

given: Tao

family: Heiry

full_name: Rebekah Heiry

given: Rebekah

family: Sum

full_name: Chi Shing Sum

given: Chi Shing

name: Cardiovascular & Fibrosis Discovery Biology, Research & Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

family: Kalinowski

full_name: Stephen S. Kalinowski

given: Stephen S.

family: Hung

full_name: Chen-Pin Hung

given: Chen-Pin

family: Chu

full_name: Ching-Hsuen Chu

name: Metabolism & Pharmacokinetics, Preclinical Candidate Optimization, Research & Early Development, Bristol Myers Squibb Company, Cambridge, Massachusetts 02140, United States

name: Pharmaceutics, Preclinical Candidate Optimization, Research & Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

name: Metabolism & Pharmacokinetics, Preclinical Candidate Optimization, Research & Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

name: Biotransformation, Preclinical Candidate Optimization, Research & Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

name: Bioanalytical Chemistry, Preclinical Candidate Optimization, Research & Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

name: Discovery Analytical Sciences, Preclinical Candidate Optimization, Research & Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

name: Discovery Analytical Sciences, Small Molecule Drug Discovery, Research and Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

name: Clinical Pharmacology, Immunology, Cardiovascular and Fibrosis, Research and Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-5326, United States;

name: Nonclinical Safety Evaluation, Research & Development, Bristol Myers Squibb Company, New Brunswick, New Jersey 08903-0191, United States

name: Discovery Toxicology, Preclinical Candidate Optimization, Research and Early Development, Bristol Myers Squibb Company, Princeton, New Jersey 08543-4000, United States

title: Discovery of an Oxycyclohexyl Acid Lysophosphatidic Acid Receptor 1 (LPA1) Antagonist BMS-986278 for the Treatment of Pulmonary Fibrotic Diseases

location_country:
Italy
Brazil
Chile
Mexico
Germany
France
Japan
Korea, Republic of
Israel
Belgium
Argentina
Australia
Spain
United States
United Kingdom
Canada
Taiwan

location_facility: Royal Prince Alfred Hospital-Department of Respiratory Medicine

location_facility: Fiona Stanley Hospital-Advanced Lung Disease Unit

location_facility: The Prince Charles Hospital-Queensland Lung Transplant Service Research

location_facility: Hospices Civils de Lyon-HEMOSTASE CLINIQUE

location_facility: Gallipoli Medical Research Foundation-GMRF CTU

location_facility: Royal Adelaide Hospital-Respiratory Clinical Trials Unit

location_facility: University of Kansas Medical Center-Division of Pulmonary and Critical Care Medicine

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen

location_facility: Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik V

location_facility: Austin Health-Respiratory and Sleep Medicine

location_facility: Westmead Hospital-Department of Respiratory and Sleep Medicine

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf

location_facility: Robert-Bosch-Krankenhaus-Klinik-Schillerhöhe- Abteilung für Pneumologie und Beatmungsmedizin


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.

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

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

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

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

location_facility: The Central Slovakia Institute of Cardiovascular Diseases

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

location_facility: San Antonio Methodist/TX Transplant Physicians Group

location_facility: The General Hospital of Northern Theater Command

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

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

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

location_facility: National University Heart Centre, Singapore

location_facility: Narodny ustav srdcovych a cievnych chorob

location_facility: Toho University Medical Center Omori Hospital

location_facility: Ivano-Frankivsk City Central Clinical Hospital

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

location_facility: The Second Xiangya Hospital of Central South Hospital

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

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

location_facility: Tianjin Medical University General Hospital

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

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

location_facility: University of Wisconsin Hospital and Clinics

location_facility: University Health Network - Toronto General Hospital

location_facility: Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

location_facility: St.Marianna University School of Medicine

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

location_facility: Scientific and Research Institution of Cardiovascular Diseases Complex Problems

location_facility: Instituto Medico de La Fundacion Estudios Clinicos

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

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B

location_facility: Policlinico Gemelli Universita Cattolica

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

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

location_facility: Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Instituto Modelo De Cardiología Privado Srl

location_facility: Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

location_facility: Volgograd Regional Clinical Cardiological Center

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: University Medical Center Ho Chi Minh city

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

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Samara Regional Clinical Cardiological Dispensary

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU

location_facility: Hospital General de Agudos Dr Cosme Argerich

location_facility: Washington University School of Medicine

location_facility: National Cerebral and Cardiovascular Center Hospital

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

location_facility: Lindner Clinical Trial Center/Christ Hospital

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

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

location_facility: ISMETT Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione

location_facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez

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

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

location_facility: Niigata University Medical & Dental Hospital

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

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

location_facility: Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud

location_facility: Centro de Investigacion Clinica Chapultepec

location_facility: Ruhr-Universität Bochum / Diabeteszentrum

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

location_facility: Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

location_facility: Siyami Ersek Training and Research Hospital

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

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

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

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente

location_facility: The Eastern Slovakia Institute of Cardiovascular Diseases

location_facility: Policlinico di Modena - Azienda Ospedaliero - Universitaria Modena

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

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

location_facility: Institute for Pulmonary Disease of Vojvodina

location_facility: Phramongkutklao Hospital and Medical College

location_facility: Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez

location_facility: Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

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

location_facility: CHU de Brest - Hôpital de la Cavale Blanche


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

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

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

location_facility: The General Hospital of Northern Theater Command

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

location_facility: Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

location_facility: Wojewodzki Szpital Specjalistyczny, Oddzial Kardiologiczny

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

location_facility: National University Heart Centre, Singapore

location_facility: Narodny ustav srdcovych a cievnych chorob

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

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

location_facility: Tianjin Medical University General Hospital

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

location_facility: Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

location_facility: University Health Network - Toronto General Hospital

location_facility: St.Marianna University School of Medicine

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

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

location_facility: Hospital Provincial Dr. Jose Maria Cullen

location_facility: The second Xiangya Hospital of Central South University

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

location_facility: University of California San Diego Medical Center

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

location_facility: Policlinico Gemelli Universita Cattolica

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

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: The Affiliated Hospital of Medical College Qingdao University

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

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: Toho University Medical Center, Ohashi Hospital

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Instituto Modelo De Cardiología Privado Srl

location_facility: University of New Mexico School of Medicine

location_facility: Volgograd Regional Clinical Cardiological Center

location_facility: University of Colorado - Anschutz Medical Campus

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Istanbul University - Cerrahpasa Cardiology Institution

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

location_facility: National Cerebral and Cardiovascular Center Hospital

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

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez

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

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

location_facility: The Houston Methodist Research Institute

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

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

location_facility: Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud

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

location_facility: Centro de Investigacion Clinica Chapultepec

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II

location_facility: Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

location_facility: Centro Cardiovascular Colombiano Clínica Santa María

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: Siyami Ersek Training and Research Hospital

location_facility: Medizinische Hochschule Hannover Zentrum Innere Medizin Klinik für Pneumologie

location_facility: St Vincents Lung, Sleep And Critical Care

location_facility: The First Affiliated Hospital of Chongqing Medical University

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


status: Terminated

lead_sponsor: Alexion Pharmaceuticals

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

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

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: University of Colorado Anschutz Medical Campus School of Medicine

location_facility: Aarhus University Hospital Department of Neurology

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

location_facility: University of California San Diego Medical Center

location_facility: Shiga University of Medical Science Hospital

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: University Hospital of Quebec-Universite Laval

location_facility: Neuromuscular Research Center and Clinic

location_facility: Perron Institute for Neurological and Translational Science

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

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Medical Hospital, Tokyo Medical and Dental University

location_facility: University of California San Francisco Medical Center

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Montreal Neurological Institute and Hospital

location_facility: Niigata University Medical & Dental Hospital

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

location_facility: Johns Hopkins University School Of Medicine

location_facility: University of Florida at Shands Jacksonville

location_facility: Houston Methodist Neurological Institute-Movement Disorders Clinic

study_completion_date_type: Actual

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)

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

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.

family: Kereiakes

full_name: Dean J. Kereiakes

given: Dean J.

family: Cutlip

full_name: Donald E. Cutlip

given: Donald E.

family: Applegate

full_name: Robert J. Applegate

given: Robert J.

full_name: John Wang

given: John

family: Yaqub

full_name: Manejeh Yaqub

given: Manejeh

family: Sood

full_name: Poornima Sood

given: Poornima

family: Su

full_name: Xiaolu Su

given: Xiaolu

full_name: Guoping Su

given: Guoping

family: Farhat

full_name: Naim Farhat

given: Naim

family: Rizvi

full_name: Ali Rizvi

given: Ali

family: Simonton

full_name: Charles A. Simonton

given: Charles A.

family: Sudhir

full_name: Krishnankutty Sudhir

given: Krishnankutty

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of the American College of Cardiology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Outcomes in Diabetic and Nondiabetic Patients Treated With Everolimus- or Paclitaxel-Eluting Stents

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.

name: From the New York–Presbyterian Hospital, Columbia University Medical Center and The Cardiovascular Research Foundation, New York, NY (G.W.S., H.P., M.F.); Maasstad Ziekenhuis, Rotterdam, the Netherlands (E.K., P.C.S.); The Christ Hospital Heart and Vascular Center/Lindner Research Center, Cincinnati, OH (D.J.K.); and Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands (P.W.S.).

full_name: Gregg. W. Stone

given: Gregg. W.

family: Kedhi

full_name: Elvin Kedhi

given: Elvin

family: Parise

full_name: Helen Parise

given: Helen

family: Fahy

full_name: Martin Fahy

given: Martin

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Differential Clinical Responses to Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents in Patients With and Without Diabetes Mellitus

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.

title: In-Stent Restenosis in the Drug-Eluting Stent Era

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.

title: Changes to Polymer Surface of Drug-Eluting Stents During Balloon Expansion

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.

title: Impact of Drug-Eluting Stents Among Insulin-Treated Diabetic Patients

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.

title: 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††A list of participating centers and investigators appears in the Appendix.

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.

title: Comparison of an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease

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.

title: TAXUS Liberté Attenuates the Risk of Restenosis in Patients With Medically Treated Diabetes Mellitus

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.

title: 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

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.

name: Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA

name: Interventional Cardiology, Cork University Hospital, Cork, Ireland

name: US Food and Drug Administration, Washington, DC, USA

name: Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, US

name: Clinical Trials Center, Cardiovascular Research Foundation and Division of Cardiology, Columbia University Medical Center, New York, US

name: Mid America Heart Institute, University of Missouri, Kansas City, USA

name: Stanford University Medical Center, Stanford, CA, USA

name: Nuffield Department of Surgery, University of Oxford, Oxford, UK

name: Department of Cardiothoracic Surgery, Thoraxcenter, Erasmus Medical Canter, Rotterdam, The Netherlands

name: Duke University Medical Center/Duke Clinical Research Institute, Durham, North Carolina, US

name: Hartcentrum Hasselt and Faculty of Medicine and Life Sciences University of Hasselt, Hasselt, Belgium

name: Bern University Hospital, Bern, Switzerland

name: Harvard Clinical Research Institute, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA

name: Centre for International Cardiovascular Health, Imperial College London UK

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

title: Standardized End Point Definitions for Coronary Intervention Trials

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.

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

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

title: Fourth Universal Definition of Myocardial Infarction (2018)

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.

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

title: Standardized Bleeding Definitions for Cardiovascular Clinical Trials

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

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

location_facility: Instituto nacional de cardiologia ignacio chavez

location_facility: Antwerp Cardiovascular Center Middelheim

location_facility: Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie

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

location_facility: National Heart Foundation Hospital & Research Institute

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

location_facility: Groupe Hospitalier Mutualiste de Grenoble

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

location_facility: National University of Ireland, Galway Galway University Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: King's College Hospital NHS Foundation Trust

location_facility: UKSH, Campus Kiel, Department of Cardiology

location_facility: University Hospital Královské Vinohrady, Department of Medecine Cardiology

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

location_facility: Szpital Kliniczny Przemienienia Pańskiego

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

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Örebro Univ. Hospital, Dpt. of cardiology

location_facility: University Hospital Brno, Department of Medecine Cardiology

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

location_facility: XII Oddział Kardiologiczny PAKS w Bełchatowie

location_facility: Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie

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

location_facility: Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH

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

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

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

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

location_facility: Worcestershire Acute NHS Trust, Worcestershire Royal Hospital

location_facility: Oddział Kardiologii Szpitale Polskie Sztum

location_facility: Brighton & Sussex University NHS Hospitals Trust


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.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_country:
United States
Belgium
Croatia
France

location_facility: Centre Hospitalier Universitaire de Nantes

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

location_facility: Department of Nephrology, Centre Hospitalier Universitaire de Montpellier

location_facility: Virginia Commonwealth University School of Medicine

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

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

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

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

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

location_facility: Bretonneau Hospital, Nephrology and Immunology Department

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

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

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

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: Belgium France

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


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 patients 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 patients 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

status: Completed

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

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

status_simplified: Completed