ipd_sharing_description: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.

lead_sponsor: Ipsen

location_country:
Italy
Austria
Brazil
Sweden
Spain
Germany
France
Czechia
Greece
Israel
Korea, Republic of
Hungary
Australia
Belgium
Russian Federation
Portugal
United States
United Kingdom
Canada

acronym: NAPOLI 3

location_facility: Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo)

location_facility: Hospital de la Santa Creu i Sant Pau Barcelona

location_facility: Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

location_facility: Compass Oncology - Rose Quarter Cancer Center

location_facility: Siouxland Hematology - Oncology Associates, LLP

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Florida Cancer Specialists - St. Petersburg

location_facility: McGill University Faculty of Medicine - Royal Victoria Hospital

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Umea University Hospital (Umeå University Hospital)

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: University of Oklahoma - Health Sciences Center

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Centro Regional Integrado de Oncologia (CRIO)

location_facility: Mercy Health - St. Elizabeth Youngstown Hospital

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

location_facility: University Hospital Olomouc, Department of Oncology

location_facility: Washington University School of Medicine in St. Louis

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

location_facility: Limited Liability Company- Clinica Druzhkovyh

location_facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

location_facility: Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria

location_facility: The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

location_facility: St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare

location_facility: Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

location_facility: UniKlinikum Heidelberg- NCT Nationales Centrum für Tumorerkrankungen

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet

location_facility: Chattanooga Oncology Hematology Care - Tennessee Oncology

location_facility: AUSL di Piacenza-Ospedale Guglielmo Da Saliceto

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: University of South Alabama - Division of Clinical Research

location_facility: University of California, Los Angeles (UCLA)

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Alberta Health Services Cross Cancer Institute

location_facility: SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh

location_facility: ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame

location_facility: Mount Sinai Medical Center of Florida, Inc.

location_facility: Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov

location_facility: Dél-pesti Centrumkórház - Szent László Kórház telephely

location_facility: Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano

location_facility: University of Kentucky Markey Cancer Center

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

location_facility: Instituto do Cancer do Estado de São Paulo (ICESP)

location_facility: Oregon Health & Science University (OHSU)

location_facility: Sunnybrook Health Sciences Centre (Odette Cancer Center)

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: Institut Catala d'Oncologia - L'Hospitalet

location_facility: University of California - Irvine Medical Center

location_facility: Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Banner Health- MD Anderson Cancer Center

location_facility: University of Calfornia- Irvine Health Cancer Cente

location_facility: Presbyterian Intercommunity Hospital (PIH)

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Martin Luther Universitat Halle-Wittenberg

location_facility: National and Kapodistrian University of Athens

location_facility: The Center for Cancer and Blood Disorders

location_facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika

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

location_facility: Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital

location_facility: Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists

location_facility: Centro de Pesquisas Clinicas de Natal - CPCLIN

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: Azienda Ospedaliero-Universitaria di Modena

location_facility: CIP Centro Integrado de Pesquisas do Hospital de Base

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho EPE

location_facility: Torrance Memorial Physician Network Cancer Care

title: An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas

summary: The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.


intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

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

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

lead_sponsor: Celgene

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Italy
United States
Sweden
Lebanon
Netherlands
Germany
France
Bulgaria
Greece
Israel
Malaysia
Thailand
Tunisia
Belgium
Australia
Spain
Turkey
Canada
United Kingdom
Taiwan

location_facility: Ente Ospedaliero Ospedali Galliera - Centro della Microcitemia e delle Anemie Congenite

location_facility: The Leeds Teaching Hospitals NHS Trust - St James's University Hospital

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi

location_facility: Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Laiko General Hospital of Athens - Center of Thalassemia

location_facility: Barts Health NHS Trust - The Royal London Hospital

location_facility: Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Hospital of the University of Pennsylvania

location_facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Chiang Mai University - Maharaj Nakorn Chiang Mai Hospital

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital Universitario Central de Asturias

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Medizinisches Versorgungszentrum (MVZ) Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Multiprofile Hospital for Active Treatment Sveta Marina EAD

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Aghia Sophia' Children's General Hospital of Athens

location_facility: Maggiore Polyclinic Hospital, IRCCS Ca' Granda

location_facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: Azienda Ospedaliero Universitaria S. Luigi Gonzaga

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: General Hospital of Thessaloniki Hippokration

location_facility: Azienda Sanitaria Locale (ASL) Cagliari - Ospedale Regionale per le Microcitemie

location_facility: Instituto Catalan de Oncologia-Hospital Duran i Reynals

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: Ann & Robert H Lurie Children's Hospital of Chicago

location_facility: Oxford University Hospitals NHS Foundation Trust-Churchill Hospital-Cancer and Haematology Centre

location_facility: Specialized Hospital for Active Treatment of Haematological Diseases - Sofia

location_facility: Karolinska Universitetssjukhuset - Huddinge

location_facility: Chulalongkorn University Faculty of Medicine - King Chulalongkorn Memorial Hospital

location_facility: Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo

location_facility: General Hospital Georgios Gennimatas of Athens

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: Registry Identifier

type: EudraCT Number

source: euctr

title: A Phase 3b, Open Label, Single-arm Rollover Study to Evaluate Long Term Safety in Subjects Who Have Participated in Other Luspatercept (Ace-536) Clinical Trials.

summary:
A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following subjects:

Subjects receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit in the opinion of the investigator from continuing treatment with luspatercept.
Placebo arm subjects from parent protocol (at the time of unblinding or in follow-up) crossing over to luspatercept treatment (provided subjects have met all requirements for entering the rollover study as per the parent protocol).
Subjects in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met (unless they meet requirements as per parent protocol to cross-over to luspatercept treatment).

The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Subjects will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase.

Transition Phase (Screening): up to 21 days prior to enrollment
Treatment Phase: For subjects in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. For placebo arm subjects from parent protocol (at the time of unblinding or in follow-up) crossing over to luspatercept treatment (provided subjects have met all requirements for entering the rollover study as per the parent protocol) will start at a luspatercept dose of 1.0 mg/kg every 3 weeks (Q3W). This does not apply to subjects that are in long-term follow-up from the parent protocol.

Follow-up Phase:

42 Day Safety Follow-up Phase: subjects will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting.
Long-term Post-treatment Follow-up (LTPTFU) Phase:

All subjects who are continuing in the LTPTFU Phase, will continue to be followed for 5 years from Dose 1 of the parent protocol, or 3 years of post-treatment from last dose of the parent protocol, whichever occurs later. Subjects will be followed every 6 months until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Subjects will also be monitored for progression to AML or any malignancies/pre- malignancies. New anticancer or disease related therapies should be collected at the same time schedule.

Subjects transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study.

The rollover study will be terminated, and relevant subjects will discontinue from the study when all subjects fulfill 5 years from Dose 1 of the parent protocol, or 3 years of post-treatment from last dose of the parent protocol, whichever occurs later. The shift to commercial drug is an alternative way to stop the study.

lead_sponsor_type: industriel

status_simplified: Ongoing


design_allocation: Randomized

intervention_type: Biological

lead_sponsor: Bristol-Myers Squibb

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Chile
Sweden
Switzerland
Netherlands
Singapore
Ireland
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Spain

location_facility: Hôpital Bichat - Claude-Bernard-Thoracic Oncology

location_facility: Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec

location_facility: Centre hospitalier universitaire Vaudois (CHUV)

location_facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

location_facility: Texas Oncology-Central Austin Cancer Center

location_facility: Texas Oncology-Methodist Dallas Cancer Center

location_facility: Charleston Hematology Oncology Associates, Pa

location_facility: University Hospitals Cleveland Medical Center

location_facility: Louis Stokes Cleveland VA Medical Center - Wade Park Campus Location

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: Centre de Cancerologie du Grand Montpellier

location_facility: Azienda Ospedaliero-Universitaria Mater Domini

location_facility: Universitaetsmedizin Der Johannes Gutenberg-Universitaet

title: A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

summary: The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab (Arm A) vs CCRT followed by durvalumab (Arm C) in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)


type: Other Identifier

title: A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With Established Cardiovascular Disease

acronym: Lp(a)HORIZON

summary: This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

ReferenceType: derived

ReferenceCitation: Tsimikas S, Reeves RR, Patel MP. Always Present, But Now Rediscovered: Lp(a) as a Predictor of Long-Term Outcomes in PCI. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2069-2072. doi: 10.1016/j.jcin.2021.08.032.

family: Tsimikas

full_name: Sotirios Tsimikas

given: Sotirios

sequence: first

family: Reeves

full_name: Ryan R. Reeves

given: Ryan R.

sequence: additional

family: Patel

full_name: Mitul P. Patel

given: Mitul P.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JACC: Cardiovascular Interventions

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Always Present, But Now Rediscovered

ReferenceCitation: Plakogiannis R, Sorbera M, Fischetti B, Chen M. The Role of Antisense Therapies Targeting Lipoprotein(a). J Cardiovasc Pharmacol. 2021 Jul 1;78(1):e5-e11. doi: 10.1097/FJC.0000000000001045. Review.

family: Plakogiannis

full_name: Roda Plakogiannis

given: Roda

family: Sorbera

full_name: Maria Sorbera

given: Maria

family: Fischetti

full_name: Briann Fischetti

given: Briann

family: Chen

full_name: Mandy Chen

given: Mandy

journal_name: Journal of Cardiovascular Pharmacology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

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 the 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:
Peru
Guatemala
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Iceland
India
France
Japan
Poland
Slovakia
Norway
Argentina
Canada
Slovenia
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Switzerland
Bulgaria
Hungary
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey


title: A 64-week, Two-arm, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen in Patients With Neovascular Agerelated Macular Degeneration (TALON)

acronym: TALON

summary: The study is a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with nAMD (neovascular age related macular degeneration) who have not previously received anti-VEGF (vascular endothelial growth factor) treatment. Patients who consent will undergo screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria.

status: Active, not recruiting

enrollment_type: Actual

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

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Spain
Germany
France
Czechia
Korea, Republic of
Israel
Malaysia
Argentina
Australia
Belgium
Portugal
United States
United Kingdom
Canada
Taiwan


title: Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes

acronym: SOUL

summary: The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Malaysia
Romania
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
Croatia
France
Japan
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Hong Kong
Netherlands
Algeria
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey


title: A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL

summary: The purpose of this study is to determine the recommended Phase 2 dose regimen or the maximum tolerated dose of JNJ-67856633 in participants with relapsed/ refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia.

design_allocation: Non-Randomized

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: Janssen Research & Development, LLC

location_country:
Italy
United States
Spain
France
Japan
Greece
Israel
Australia
China
Germany
United Kingdom
Korea, Republic of

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

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

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

location_facility: Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: The First Affiliated Hospital of NanChang University


lead_sponsor: BeiGene

location_country:
Italy
Spain
Germany
France
Czechia
Japan
Poland
Romania
Belgium
Australia
Russian Federation
China
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: CHU De BesanÃ§on-Jean Minjoz - Oncologie MÃ©dicale

location_facility: Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology

location_facility: Orenburg Regional Clinical Oncology Center

location_facility: Smilow Cancer Hospital at Yale-New Haven - Neurology

location_facility: Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology

location_facility: Rostov Research Institute of Oncology (RRIO)

location_facility: Shandong Cancer Hospital - oncology - Oncology

location_facility: Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica

location_facility: The Sixth Affiliated Hospital ,Sun Yat-Sen University - Oncology

location_facility: Kobe City Medical Center General Hospital - Medical Oncology

location_facility: The First Affiliated Hospital of Zhengzhou University - Oncology

location_facility: University Hospital, Kyoto Prefectural Univ of Medicine - Gastroenterology

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie

location_facility: Kansai Rosai Hospital - Gastroenterological Surgery

location_facility: Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre

location_facility: Osaka International Cancer Institute - Clinical Oncology

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospi

location_facility: Chonnam National University Hwasun Hospital - Hematology and Oncology Clinic

location_facility: The Affiliated Hospital of Xuzhou Medical University - Radiology

location_facility: Institut Jules Bordet - Oncologie Médicale

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Institut Hospitalier Franco-Britannique (IHFB) - Levallois-Perret - 4 Rue Kleber

location_facility: The First Affiliated Hospital of Xiamen University - Oncology

location_facility: SLK Kliniken Heilbronn GmbH - Klinik für Radiologie, Minimalinvasive Therapien und Nuklearmedizin

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology

location_facility: China Medical University Hospital - Oncology - Taichung

location_facility: The first Affiliated Hospital of guangzhou University of traditional chinese medicine - Oncology

location_facility: Hopital Europeen Georges Pompidou - Digestive Oncology

location_facility: Harbin Medical University Cancer Hospital - Oncology

location_facility: AOU Città della Salute e della Scienza di Torino - Molinette

location_facility: Samsung Medical Center - Hematology-Oncology

location_facility: The First People's Hospital of Changzhou - Oncology

location_facility: Chi Mei Medical Center - YongKang - Chi Mei Medical Center

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Kaohsiung Veterans General Hospital - Thoracic Surgery

location_facility: Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Tianjin Cancer Hospital - Gastroinstinal Oncology

location_facility: Hospital Universitario Central de Asturias

location_facility: Clinical Research Center Sp. z o.o., Medic-R Sp. K.

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Seoul National University Bundang Hospital - Hematology/Oncology

location_facility: Sir Run Run Shaw Hospital, Zhejiang University

location_facility: Nantong Tumor Hospital - Medical Oncology

location_facility: Gachon University Gil Medical Center - Oncology

location_facility: Quanzhou First Hospital - Radiotherapy/Nuclear Medicine

location_facility: Anhui Medical University - The Second Hospital

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

location_facility: The First Saint-Petersburg State Medical University named after Academician I.P. Pavlov

location_facility: Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca

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

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Groupe Hospitalier Paris Saint Joseph - Oncologie

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Hopital Saint-Antoine / Service d'Hepato-Gastro-Enterologie

location_facility: Ballarat Oncology & Haematology Services

location_facility: Kanagawa Cancer Center - Gastroenterological surgery

location_facility: Guangxi Medical University Affiliated tumor hospital

location_facility: National Hospital Organization Kyushu Cancer Center - GI and Medical Oncology

location_facility: Arkhangelsk Regional Clinical Oncological Dispensary

location_facility: Fujian Provincial Cancer Hospital - Oncology

location_facility: Saitama Cancer Center - Gastroenterology

location_facility: Guangdong Province Traditional Chinese Medical Hospital

location_facility: Peking Union Medical College Hospital - Oncology

location_facility: University of Texas Health Science Center of San Antonio

location_facility: CHA Bundang Medical Center, CHA University - Oncology

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: The Christie NHS Foundation Trust - Oak Road Treatment Centr

location_facility: Beatson West of Scotland Cancer Centre - Oncology

location_facility: Korea University Guro Hospital - Hematology-Oncology

location_facility: Hospital Regional Universitario de Málaga

location_facility: Medical University of South Carolina Hollings Cancer Center

location_facility: National Cancer Center Hospital East - Gastrointestinal Oncology

location_facility: Russian Academy of Medical Sciences (RAMS)

location_facility: Hiroshima University Hospital - Gastrointestinal Surgery

location_facility: Keimyung University Dongsan Medical Center

location_facility: SMG-SNU Boramae Medical Center - Oncology

location_facility: Chi Mei Hospital, Liouying - Department of Oncology

location_facility: Osaka University Hospital - Medical Oncology

location_facility: Wuxi Fourth People's Hospital - Oncology

location_facility: Kyushu Medical Center - Gastroenterological Surgery

location_facility: National Cancer Center Hospital - Gastrointestinal Oncology

title: A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

summary: The purpose of this study is to evaluate the efficacy and safety of Tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic ESCC.


title: A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

acronym: Clarity AD

summary: This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

lead_sponsor: Eisai Inc.

location_country:
Italy
United States
Sweden
Spain
Germany
France
Japan
Singapore
Australia
Russian Federation
China
Canada
United Kingdom
Korea, Republic of

location_facility: Renji Hospital Shanghai Jiaotong Universtiy School of Medicine

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

location_facility: Associated Neurologists of Southern Connecticut

location_facility: Neuropsychiatric Research Center of Southwest FL

location_facility: True North Clinical Research Halifax, Inc.

location_facility: Banner Alzheimer's Institute- Clinical Trials Department

location_facility: The Second Hospital of Hebei Medical University

location_facility: MoCA Clinic and Institute/NeuroSearch Developpements Inc.

location_facility: Nanjing Brain Hospital, Affiliated to Nanjing Medical University

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

location_facility: Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais

location_facility: Seoul National University Boramae Medical Center

location_facility: Neurological Associates of Tucson dba Center for Neurosciences

location_facility: North Bay Neuroscience Research Institute

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: Austin Health - Medical and Cognitive Research Unit

location_facility: St Vincent's Hospital - Translational Research Centre

location_facility: Alzheimer's Research and Treatment Center

location_facility: The First Bethune Hospital of Jilin University

location_facility: Institute for Neurodegenerative Disorders

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Australian Alzheimer's Research Foundation

location_facility: National Clinical Research Inc.-Richmond

location_facility: Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company

location_facility: Emory University Cognitive Neurology Clinic & ADRC

location_facility: Advanced Memory Research Institute of NJ, PC

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Memory Assessment & Research Centre (MARC),

location_facility: Central Adelaide Local Health Network, The Queen Elizabeth Hospital and the Royal Adelaide Hospital

location_facility: Ospedale S. Maria della Misericordia, S. Andrea delle Fratte

location_facility: Fondazione Policlinico Agostino Gemelli - UCSC

location_facility: Prima Clinica Neurologica, Primo Policlinico AOU "L. Vanvitelli"

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: New York University Medical Center PRIME

location_facility: The Prince Charles Hospital/Internal Medicine & Dementia Research Unit

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Butler Hospital - Memory and Aging Program

location_facility: Memory Clinic, Malmö University Hospital

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Seoul National University Bundang Hospital

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane

location_facility: University of Kansas Medical Center Research Institute

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Allied Biomedical Research (Clinical Trial)

location_facility: True North Clinical Research Kentville, Inc.

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - U.O.S.D. Malattie Neurodegenerative

location_facility: Baylor College of Medicine AD and Memory Disorders Center

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: ANI Neurology, PLLC d/b/a Alzheimer's Memory Center

location_facility: Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory Clinic

location_facility: Raleigh Neurology Associates, P.A. - Research Department

location_facility: Centre de Recherche Clinique du Gérontopôle

location_facility: HammondCare Malvern Clinical Trials Unit

location_facility: Sun Yat-Sent Memorial Hospital of Sun Yat-Sen University

location_facility: Xiangya Hospital Central South University


lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Malaysia
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
Sweden
Hong Kong
Switzerland
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Brazil
Israel
New Zealand
Spain
Turkey

location_facility: Toranomon Hospital Kajigaya ( Site 0109)

location_facility: Regional Clinical Onco Dispensary_ State Medical University ( Site 0782)

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174)

location_facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482)

location_facility: Yokohama City University Medical Center ( Site 0110)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0332)

location_facility: Fundación favaloro para la Docencia e Investigación Médica ( Site 0808)

location_facility: University Hospital Antwerp (UZA) ( Site 0374)

location_facility: Musashino Red Cross Hospital ( Site 0107)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0826)

location_facility: Bezmialem Vakif University School of Medicine ( Site 0732)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757)

location_facility: Namik Kemal Universitesi Tip Fakultesi ( Site 0738)

location_facility: Karolinska Universitetssjukhuset, Huddinge ( Site 0689)

location_facility: Indiana University Simon Cancer Center ( Site 0075)

location_facility: Medical Center Dobrobut Clinic ( Site 0785)

location_facility: City Clinical Hospital 1 na. NI. Pirogov ( Site 0662)

location_facility: Klinikum rechts der Isar der Technischen Universitaet ( Site 0470)

location_facility: Kagawa Prefectural Central Hospital ( Site 0122)

location_facility: Hopital Claude Huriez CHRU LILLE ( Site 0440)

location_facility: Hospital Universiti Sains Malaysia ( Site 0295)

location_facility: Samara Regional Clinical Oncology Center ( Site 0656)

location_facility: Southern Medical University Nanfang Hospital ( Site 0172)

location_facility: Hospital Universitari Parc Tauli ( Site 0681)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 0711)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0118)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0550)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 0294)

location_facility: The University of Arizona Cancer Center - North Campus ( Site 0039)

location_facility: Altay Regional Oncology Dispensary ( Site 0919)

location_facility: MTZ Clinical Research Sp. z o. o. ( Site 0608)

location_facility: Taipei Veterans General Hospital ( Site 0331)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0211)

location_facility: Hospital de Cancer de Pernambuco ( Site 0815)

location_facility: Hospital Universitari Vall d Hebron ( Site 0674)

location_facility: Princess Alexandra Hospital ( Site 0228)

location_facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606)

location_facility: Anhui Provincil Hospital South District ( Site 0181)

location_facility: Hospital Universitario Puerta de Hierro ( Site 0678)

location_facility: Hiroshima University Hospital ( Site 0117)

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0813)

location_facility: Staedtisches Klinikum Dresden ( Site 0471)

location_facility: Inonu University Faculty of Medicine ( Site 0729)

location_facility: Clinica de Oncologia Reichow ( Site 0818)

location_facility: University Malaya Medical Centre ( Site 0288)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604)

location_facility: Zhongshan Hospital Fudan University ( Site 0193)

location_facility: Vanderbilt Ingram Cancer Center ( Site 0006)

location_facility: Hospital Universitario Austral ( Site 0795)

location_facility: Blokhin National Medical Oncology ( Site 0645)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0657)

location_facility: Odense Universitets Hospital ( Site 0422)

location_facility: Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0484)

location_facility: St Vincent's University Hospital ( Site 0498)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661)

location_facility: University Medical Center New Orleans ( Site 0014)

location_facility: Medizinische Hochschule Hannover ( Site 0458)

location_facility: Fudan University Shanghai Cancer Center ( Site 0161)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0828)

location_facility: Universitaetsklinikum Frankfurt ( Site 0467)

location_facility: The Third Xiangya Hospital of Central South University ( Site 0167)

location_facility: Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481)

location_facility: Wakayama Medical University Hospital ( Site 0115)

location_facility: Road Hospital JSC Russian railways ( Site 0649)

location_facility: Pamela Youde Nethersole Eastern Hospital ( Site 0271)

location_facility: Fujian Provincial Cancer Hospital ( Site 0165)

location_facility: Hunan Provincial People Hospital ( Site 0192)

location_facility: University of Massachusetts Worcester ( Site 0017)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0483)

location_facility: McGill University Health Centre ( Site 0207)

location_facility: Adnan Menderes University Medical Faculty ( Site 0737)

location_facility: Kings College Hospital NHS Foundation Trust ( Site 0758)

location_facility: The University of Tokyo Hospital ( Site 0105)

location_facility: Peking University People's Hospital ( Site 0191)

location_facility: North Shore-Long Island Jewish Health System ( Site 0068)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0755)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0541)

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157)

location_facility: Instituto COI de Pesquisa Educacao e Gestao ( Site 0825)

location_facility: Hospital Provincial del Centenario ( Site 0794)

location_facility: Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802)

location_facility: A O U Policlinico di Modena ( Site 0548)

location_facility: Konya Necmettin Erbakan University Medical Faculty ( Site 0736)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648)

location_facility: James Graham Brown Cancer Center ( Site 0088)

location_facility: Virginia Mason Medical Center ( Site 0028)

location_facility: Saitama Medical University Hospital ( Site 0104)

location_facility: Privolzhsky District Medical Center ( Site 0655)

location_facility: National Cheng Kung University Hospital ( Site 0334)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0156)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0820)

location_facility: Shalimov s NI of Surgery and Transplantation ( Site 0781)

location_facility: St Vincents Hospital Melbourne ( Site 0227)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0208)

location_facility: National Taiwan University Hospital ( Site 0330)

location_facility: Kanazawa University Hospital ( Site 0111)

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164)

location_facility: National Medical Research Radiological Centre ( Site 0660)

location_facility: Hospital Central de Asturias ( Site 0667)

location_facility: MI Odessa Regional Oncological Centre ( Site 0776)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102)

location_facility: Leeds Teaching Hospitals NHS Trust ( Site 0751)

location_facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 0754)

location_facility: West China Hospital of Sichuan University ( Site 0162)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 0042)

location_facility: Royal Prince Alfred Hospital AW ( Site 0225)

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie ( Site 0620)

location_facility: Casa de Saude Santa Marcelina ( Site 0821)

location_facility: Norrlands Universitetssjukhus ( Site 0687)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0779)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 0750)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335)

location_facility: Universitaets Klinikum Wuerzburg ( Site 0468)

location_facility: CI City Clinical Hospital # 3 ( Site 0783)

location_facility: Istituto Tumori Giovanni Paolo II ( Site 0543)

location_facility: Seoul National University Hospital ( Site 0312)

location_facility: Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0676)

location_facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315)

location_facility: Regional Oncology Center of Kharkiv ( Site 0777)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 0665)

location_facility: Azienda Ospedaliero Universitaria Pisana ( Site 0546)

location_facility: Universitaetsklinikum Koeln ( Site 0463)

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0469)

location_facility: Massachusetts General Hospital ( Site 0062)

location_facility: Complejo Hospitalario Universitario de Santiago ( Site 0668)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0730)

location_facility: SLK-Kliniken Heilbronn GmbH ( Site 0460)

location_facility: Japanese Red Cross Osaka Hospital ( Site 0113)

location_facility: Oslo Universitetssykehus HF. Ulleval ( Site 0433)

location_facility: Beth Israel Deaconess Medical Ctr. ( Site 0033)

location_facility: CHUV (centre hospitalier universitaire vaudois) ( Site 0712)

location_facility: Hospital Britanico de Buenos Aires ( Site 0792)

location_facility: University Hospital, Kyoto Prefectural University of Medicine ( Site 0112)

location_facility: China Medical University Hospital ( Site 0333)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540)

location_facility: Zhongshan Hospital affiliated to Fudan University ( Site 0153)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0691)

location_facility: Seoul National University Bundang Hospital ( Site 0313)

location_facility: Universitaetsklinikum Tuebingen ( Site 0466)

location_facility: Haddassah Medical Organization - Ein Kerem ( Site 0519)

location_facility: Nottingham University Hospitals NHS Trust ( Site 0756)

location_facility: Osaka City University Hospital ( Site 0114)

location_facility: Banner MD Anderson Cancer Center ( Site 0026)

location_facility: Hospital Universitario La Paz ( Site 0677)

location_facility: Henry Ford Hospital-GI/Hepatology Research ( Site 0047)

location_facility: Universitatsklinikum Carl Gustav Carus ( Site 0459)

location_facility: Hospital Universitario Virgen del Rocio ( Site 0670)

location_facility: Maharaj Nakorn Chiangmai Hospital ( Site 0353)

location_facility: Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733)

location_facility: Siberian Clinical Center of FMBA ( Site 0918)

location_facility: City Clinical Oncology Center ( Site 0646)

location_facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 0741)

location_facility: Miami Valley Hospital South ( Site 0093)

location_facility: Aarhus Universitets hospital ( Site 0420)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 0549)

location_facility: Hospital Universitario de Donostia ( Site 0671)

location_facility: City of Hope Medical Center ( Site 0027)

location_facility: Baylor Scott & White Medical Center - Temple ( Site 0089)

location_facility: Charite - Campus Virchow Klinikum ( Site 0457)

location_facility: Saga-Ken Medical Centre Koseikan ( Site 0120)

location_facility: Severance Hospital Yonsei University Health System ( Site 0309)

location_facility: University of Cincinnati Medical Center ( Site 0084)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0461)

location_facility: Tallaght University Hospital ( Site 0499)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0824)

title: A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)

summary: This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).


title: A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia

summary:
This is a study in adults with schizophrenia. The study tests whether a medicine called BI 425809 together with brain training improves mental abilities.

Participants take study medication once a day for 12 weeks. At the start of the study, the participants are put into 2 groups. It is decided by chance who gets into which group. One group gets BI 425809 tablets every day. The other group gets placebo tablets every day. Placebo tablets look like the BI 425809 tablets, but contain no medicine. During the study, all participants do brain training using a computer.

The doctors regularly test mental abilities of the participants. The results of the mental ability tests are compared between the groups. The doctors also check the general health of the patients.

ReferenceCitation: Harvey PD, Bowie CR, McDonald S, Podhorna J. Evaluation of the Efficacy of BI 425809 Pharmacotherapy in Patients with Schizophrenia Receiving Computerized Cognitive Training: Methodology for a Double-blind, Randomized, Parallel-group Trial. Clin Drug Investig. 2020 Apr;40(4):377-385. doi: 10.1007/s40261-020-00893-8.

family: Harvey

full_name: Philip D. Harvey

given: Philip D.

family: Bowie

full_name: Christopher R. Bowie

given: Christopher R.

family: McDonald

full_name: Sean McDonald

given: Sean

family: Podhorna

full_name: Jana Podhorna

given: Jana

bso_classification: Social sciences

journal_name: Clinical Drug Investigation

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

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.

lead_sponsor: Boehringer Ingelheim

location_country:
United States
France
Australia
New Zealand
Canada
United Kingdom

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: Monash Alfred Psychiatry Research Centre

location_facility: Jerome Golden Center for Behavioral Health

location_facility: Centre for Addiction and Mental Health (CAMH)

location_facility: BC Mental Health and Addictions Research Institute (University of British Columbia)

location_facility: IUSMM Institut Universitaire en Sante Mentale de Montreal

location_facility: North Carolina Psychiatric Research Center


title: Phase IIa Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to an Anti- Tumor Necrosis Factor Alpha (Tnfα) Therapy, or Intolerance to Anti-Tnfα Therapy

summary: This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one or more anti- tumor necrosis factor alpha (TNFα) therapies.

ipd_sharing: Undecided

lead_sponsor: Abivax S.A.

location_country: France Czechia Poland Hungary Belgium

location_facility: CMed Rehabilitációs és Diagnosztikai Központ


intervention_type: Other

status: Completed

lead_sponsor: Enyo Pharma

location_country:
France
Puerto Rico
Belgium
United States
United Kingdom

location_facility:
ENYO PHARMA Investigative site
ENYO PHARMA Investigative site 0405
ENYO PHARMA Investigative site 0421
ENYO PHARMA Investigative site 0201
ENYO PHARMA Investigative site 0412
ENYO PHARMA Investigative site 0402
ENYO PHARMA Investigative site 0415
ENYO PHARMA Investigative site 0407
ENYO PHARMA Investigative site 0301
ENYO PHARMA Investigative site 0424
ENYO PHARMA Investigative site 0103
ENYO PHARMA Investigative site 0305
ENYO PHARMA Investigative site 0401
ENYO PHARMA Investigative site 0104
ENYO PHARMA Investigative site 0304
ENYO PHARMA Investigative site 0403
ENYO PHARMA Investigative site 0404
ENYO PHARMA Investigative site 0203
ENYO PHARMA Investigative site 0204
ENYO PHARMA Investigative site 0416
ENYO PHARMA Investigative site 0303
ENYO PHARMA Investigative site 0414
ENYO PHARMA Investigative site 0406
ENYO PHARMA Investigative site 0419
ENYO PHARMA Investigative site 0409
ENYO PHARMA Investigative site 0101
ENYO PHARMA Investigative site 0429
ENYO PHARMA Investigative site 0417
ENYO PHARMA Investigative site 0410
ENYO PHARMA Investigative site 0105
ENYO PHARMA Investigative site 0420
ENYO PHARMA Investigative site 0302
ENYO PHARMA Investigative site 0413
ENYO PHARMA Investigative site 0418
ENYO PHARMA Investigative site 0207
ENYO PHARMA Investigative site 0422
ENYO PHARMA Investigative site 0411
ENYO PHARMA Investigative site 0408
ENYO PHARMA Investigative site 0423
ENYO PHARMA Investigative site 0205
ENYO PHARMA Investigative site 0206
ENYO PHARMA Investigative site 0202

study_completion_date_type: Actual

title: A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis

summary: The purpose of this study is to assess the effects of EYP001a with respect to safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with NASH

status_simplified: Completed


title: An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

acronym: RAPTOR

summary: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO).

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

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

location_country:
Italy
Austria
Hong Kong
Spain
Switzerland
Germany
France
Czechia
Japan
Israel
Slovakia
Puerto Rico
Russian Federation
China
Denmark
United States
United Kingdom
Canada
Taiwan


ReferenceCitation: Coates LC, Gossec L, Theander E, Bergmans P, Neuhold M, Karyekar CS, Shawi M, Noël W, Schett G, McInnes IB. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). Ann Rheum Dis. 2021 Nov 24. pii: annrheumdis-2021-220991. doi: 10.1136/annrheumdis-2021-220991. [Epub ahead of print]

family: Coates

full_name: Laura C Coates

given: Laura C

family: Gossec

full_name: Laure Gossec

given: Laure

family: Theander

full_name: Elke Theander

given: Elke

family: Bergmans

full_name: Paul Bergmans

given: Paul

family: Neuhold

full_name: Marlies Neuhold

given: Marlies

family: Karyekar

full_name: Chetan S Karyekar

given: Chetan S

family: Shawi

full_name: May Shawi

given: May

family: Noël

full_name: Wim Noël

given: Wim

family: Schett

full_name: Georg Schett

given: Georg

family: McInnes

full_name: Iain B McInnes

given: Iain B

journal_name: Annals of the Rheumatic Diseases

oa_host_type: publisher

evidence: open (via page says license)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

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 Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Italy
Spain
France
Bulgaria
Greece
Israel
Poland
Hungary
Belgium
Russian Federation
Portugal
Germany
United Kingdom
Ukraine

acronym: COSMOS

location_facility: Barts Health NHS Trust Whipps Cross University Hospital NHS Trust

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

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

location_facility: Tula Regional Clinical Dermatovenerological Dispensary

location_facility: Republican Clinical Hospital - G.G. Kuvatov

location_facility: WroMedica I.Bielicka, A.Strzałkowska s.c.

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

location_facility: Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

location_facility: Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

location_facility: Krasnodar Clinical Dermatovenerologic Dispensary

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Multiprofile Hospital for Active Treatment - Plovdiv

location_facility: VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council

location_facility: Smolensk regional hospital on Smolensk railway station

location_facility: Poltava Regional Clinical Hospital Named After M.V.Sklifosovsk

location_facility: Kyiv Railway Station Clinical Hospital #2

location_facility: Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Kyiv City Clinical Hospital #3, National Medical University

location_facility: Vital Medical Center Orvosi es Fogaszati Kozpont

location_facility: Samara Regional Clinical Hospital Named After V.D.Seredavin

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

location_facility: Royal National Hospital for Rheumatic Diseases

location_facility: Rostov Regional Clinical Dermatovenerological Dispensary

location_facility: Mazowieckie Centrum Reumatologii i Osteoporozy

location_facility: Ryazan Regional Clinical Dermatovenerological Dispensary

location_facility: Diagnostic - Consulting Center II-Pleven

location_facility: Guy's and St Thomas' NHS Foundation Trust - Rheumatoid Arthritis (RA) Clinic

location_facility: Clinical Emergency Hospital n.a. N.V. Solovyev

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

location_facility: Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital

location_facility: Clinic of SI 'NSC 'The M.D.Strazhesko Institute of Cardiology' of NAMS of Ukraine'

location_facility: Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Municipal institution Central Clinical Hospital #1 Zhytomir

location_facility: City Multifield Hospital #18, Mechnikov Institute of Microbiology and Immunology of NAMS

location_facility: Hopital Pellegrin Tripode - CHU de Bordeaux

location_facility: Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz

title: Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy

summary: The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease.


ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Chile
Netherlands
Philippines
Vietnam
United States
Germany
United Kingdom
Italy
Brazil
Czechia
Israel
Spain
Turkey

acronym: NIAGARA

title: A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer.

summary: A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer


ReferenceCitation: Khushalani NI, Diab A, Ascierto PA, Larkin J, Sandhu S, Sznol M, Koon HB, Jarkowski A, Zhou M, Statkevich P, Geese WJ, Long GV. Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design. Future Oncol. 2020 Oct;16(28):2165-2175. doi: 10.2217/fon-2020-0351. Epub 2020 Jul 29.

name: Moffitt Cancer Center, Tampa, FL 33612, USA

family: Khushalani

full_name: Nikhil I Khushalani

given: Nikhil I

name: Department of Melanoma Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX 77030, USA

family: Diab

full_name: Adi Diab

given: Adi

name: Unit of Medical Oncology and Innovative Therapy, Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale IRCCS, Napoli, Italy

family: Ascierto

full_name: Paolo A Ascierto

given: Paolo A

name: Department of Medical Oncology, Royal Marsden Hospital NHS Foundation Trust, London, UK

family: Larkin

full_name: James Larkin

given: James

name: Peter MacCallum Cancer Centre, The University of Melbourne, Melbourne, Victoria, Australia

family: Sandhu

full_name: Shahneen Sandhu

given: Shahneen

name: Yale Cancer Center, Yale–New Haven Hospital, New Haven, CT 06511, USA

family: Sznol

full_name: Mario Sznol

given: Mario

name: Bristol Myers Squibb, Princeton, NJ 08543, USA

family: Koon

full_name: Henry B Koon

given: Henry B

family: Jarkowski

full_name: Anthony Jarkowski

given: Anthony

family: Zhou

full_name: Ming Zhou

given: Ming

family: Statkevich

full_name: Paul Statkevich

family: Geese

full_name: William J Geese

given: William J

name: Melanoma Institute Australia, The University of Sydney, Royal North Shore & Mater Hospital, St Leonards, NSW, Australia

family: Long

full_name: Georgina V Long

given: Georgina V

journal_name: Future Oncology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
France
Poland
Argentina
Canada
Chile
Sweden
Switzerland
Netherlands
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain

location_facility: Dermatovenerologicka klinika 3. LF UK a FNKV

location_facility: Instituto Nazionale Tumori Fondazione G. Pascale

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Universitatsklinikum AoR Klinik fur Dermatologie, Venerologie und Allergologie

location_facility: Winship Cancer Institute, Emory University

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: Dermatovenerologicka klinika VFN a 1. LF UK

location_facility: Medizinische Hochschule Hannover (Hannover Medical School)

location_facility: Hospital General Universitario De Valencia

location_facility: Smilow Cancer Center at Yale New Haven Hospital

location_facility: Instituto Medico Especialazado Alexander Fleming

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Washington University School Of Medicine

location_facility: Nationales Centrum Fuer Tumorerkrakungen (Nct) Heidelberg

title: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

summary: The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread


title: A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-2)

summary: The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.

status: Terminated

ipd_sharing: No

lead_sponsor: Chengdu Kanghong Biotech Co., Ltd.

location_country:
Italy
United Kingdom
France
Czechia
Bulgaria
Israel
Slovakia
Hungary
China
Denmark
United States
Latvia

status_simplified: Unknown


lead_sponsor: Idorsia Pharmaceuticals Ltd.

primary_purpose: Prevention

location_country:
Italy
Austria
United States
Sweden
Germany
Finland
France
Czechia
Poland
Israel
Hungary
Belgium
Spain
Denmark
Canada

acronym: REACT

location_facility: University Hospitals Case Medical Center - Department of Neurosurgery

location_facility: Masarykova nemocnice v Ústí nad Labem Neurochirurgie

location_facility: Helsingin yliopistollinen keskussairaala Neurokirurgian klinikka

location_facility: Azienda Ospedaliero Universitaria di Parma, struttura complessa Neurochirurgia

location_facility: Temple University Hospital - Lung Center

location_facility: The Chaim Sheba Medical Centre - Neurosurgery

location_facility: Universitätsklinikum Schleswig Hollstein Lübeck (UKSH) Klinik für Neurochirugie

location_facility: University of Erlangen-Nürnberg, Dpt. of Neurosurgery

location_facility: Lunds Universitetssjukhus, Neurokirurgiska avd. NIVA

location_facility: Penn State Milton S Hershey Medical Center, Neurosurgery

location_facility: Universitätsklinik Frankfurt, Klinik und Poliklinik für Neurochirurgie, Dept of neurosurgery

location_facility: Winnipeg Regional Health Authority Health Sciences Centre

location_facility: Neurology Department, University Hospital

location_facility: University of Calgary & Foothills Medical Centre

location_facility: Fakultní nemocnice Ostrava Neurochirurgická klinika

location_facility: Hôpital Pitié-Salpêtrière, Service de neuroréanimation chirurgicale Babinski

location_facility: Landeskrankenhaus und Medizinische Universität Graz; Neurochirurgie

location_facility: Szpital Uniwersytecki nr 1 im. dr. Antoniego Jurasza

location_facility: Hôpital de la Timone 2, Intensive Care Unit SAR 1

location_facility: Halifax Infirmary, Nova Scotia Health Authority

location_facility: Neurochirurgische Universitätklinik des Heidelberg, Dept of Neurosurgery

location_facility: The Ohio State University - Wexner Medical Center

location_facility: Hospital Vall d'Hebron Departamento Neuroradiología

location_facility: Odense Universitets Hospital Neurokirurgisk afdelning

location_facility: Beth Israel Deaconess Medical Center Dept of Neurosurgery

location_facility: Hôpital Gabriel Montpied, ICU DEPT, Neuro reanimation departement

location_facility: Vanderbilt University Medical Center - Department of Neurosurgery

location_facility: Hôpital neurologique Pierre Wertheimer Service de Reanimation

location_facility: Albert Einstein Medical Center Dept of Neurology

location_facility: Virginia Commonwealth University, Department of Neurosurgery

location_facility: Technical University-Klinikum rechts der Isar, Abt. Neurochirurgie

location_facility: University Hospital of Essen, Department of Neurosurgery

location_facility: University Hospital of Hamburg-Eppendorf, Dpt. of Neurosurgery

location_facility: Pécsi Tudományegyetem Klinikai Központ, Idegsebészeti Klinika

location_facility: Rambam Healthcare Campus, Neurology Department

location_facility: Tampereen yliopistollinen sairaala Neurokirurgian klinika

location_facility: ASST Monza, Hospital San Gerardo, TERAPIA INTENSIVA Neurochirurgica

location_facility: Samodzielny Publiczny Szpital Klinicznu Nr 4 w Lublinie

location_facility: Oddział Neurochirurgii i Neurotraumatologii z Pododdziałem Leczenia Chorób Naczyniowych Centralnego Układu Nerwowego

location_facility: Oddział Kliniczny Neurochirurgii i Neurotraumatologii

location_facility: Corporació Sanitària Parc Taulí, Hospital Parc Taulí

location_facility: Hospital Universitario Germans Trias i Pujol - Neurology Department

location_facility: Heinrich-Heine Universität Düsseldorf -Klinik für Neurochirugie

location_facility: Kepler Universitätsklinikum, Universitätsklinik für Neurochirurgie

location_facility: Istituto delle Scienze Neurologiche di Bologna, Dipartimento di Neurochirurgia e Neuroradiologia Interventistica

location_facility: Katedra i Klinika Neurochirurgii Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

location_facility: University of Illinois - Department of Neurosurgery

location_facility: Turku University Hospital Neurosurgery, T-hospital

location_facility: BAZ Megyei Kórház és Egyetemi Oktató Kórház Neuroradiológiai és angiográphiás osztály

location_facility: Asklepios Klinik St. Georg - Neurochirugie

location_facility: University of Alberta Hospital Department of Neurological Surgery

location_facility: Azienda Ospedaliera Padova-Università degli Studi di Padova - Istituto di Anestesia e Rianimazione

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore, UOS Terapia Intensiva Neurochirurgic

location_facility: Medizinische Universität Innsbruck; Universitätsklinik für Neurologie und Psychiatrie

location_facility: Hospital Universitario 12 de Octubre, Departamento Neurosurgery Division Neuroradiology

location_facility: Boston University School of Medicine / Boston University Medical Center

location_facility: Thomas Jefferson University School of Medicine Dept. of Neurosurgery

location_facility: "Fakultní nemocnice Hradec Králové Neurochirurgická klinika"

location_facility: Hospital UZ Leuven, Neurosurgery Department

location_facility: Oklahoma University Health Sciences Center - Department of Neurology

location_facility: Sahlgrenska Universitetssjukhuset, Verksamheten för neurokirurgi, Neurosjukvården

location_facility: University Hospital in Pilsen, Department of Neurosurgery

location_facility: Columbia University Medical Center Dept. of Neurology - Neurological Intensive Care Unit

location_facility: University Regensburg, Dpt. of Neurosurgery

location_facility: Bezirkskrankenhaus Günzburg - Klinik für Neurochirugie

location_facility: Linköping Universitetssjukhuset, Neurokirurgiska kliniken

location_facility: Stanford Hospital & Clinics - Stanford School of Medicine Dept. of Neurosurgery

location_facility: Beilinson Hospital, Rabin Medical Center, Department of Neurosurgery

location_facility: Klinik für Diagnostische Radiologie und Neuroradiologie, Augsburg

location_facility: Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, Idegsebészeti Klinika

location_facility: Nemocnice České Budějovice Neurochirurgické oddělení

location_facility: Univ Hosp Toulouse, University Hospital Purpan Pierre Paul Riquet Hospital

location_facility: University of Maryland Medical Systems - Neurosurgery

location_facility: Northwell Health, Department of Neurosurgery

location_facility: Ústřední vojenská nemocnice Praha Neurochirurgická klinika

location_facility: University Hospital of Gran Canaria Dr. Negrin

location_facility: Charite Universitätsmedizin Berlin - Klinik und Poliklinik für Neurochirurgie

location_facility: Royal University Hospital Department of Neurology

location_facility: Washington University - Dept. of Neurosurgery

location_facility: Hospital Erasme, Service de Soins Intensifs

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

location_facility: Hospital - Cliniques Universitaires Saint-Luc, Service de Neurochirurgie

location_facility: University of Texas Southwestern Medical Center

location_facility: Fakultní nemocnice Brno Neurochirurgická klinika

title: A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Assess the Efficacy and Safety of Clazosentan in Preventing Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI), in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage (aSAH)

summary: This study will evaluate if clazosentan (on top of normal routine medical care) can reduce the risk of developing complications related to cerebral vasospasm and permanent brain damage as compared to normal routine medical care alone.