title: Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early & Advanced Stage Superficial Venous Disease

summary: Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease

lead_sponsor: Medtronic Endovascular

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
United States
Korea, Republic of
Spain
Canada
France

location_facility: Azienda Ospedaliera di Padova Ospendale Sant' Antonio

location_facility: Bedfordshire Hospitals NHS Foundation Trust

location_facility: Praxis fur Innere Medizin und Gefäβkrankheiten

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: West London Vascular and Interventional Centre

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: Sanitas Hospital Universitario La Zarzuela

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)

intervention_type: Device


title: A Phase 2a/b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects With Prurigo Nodularis

summary: Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: Kiniksa Pharmaceuticals, Ltd.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Austria
Belgium
United States
Korea, Republic of
Taiwan
Czechia
Canada
France

location_facility:
Site 4304
Site 4207
Site 1135
Site 1107
Site 1158
Site 1115
Site 122
Site 1150
Site 101
Site 1121
Site 2301
Site 2504
Site 2008
Site 4104
Site 1155
Site 1306
Site 2102
Site 2001
Site 1118
Site 130
Site 2101
Site 2701
Site 1102
Site 1159
Site 4303
Site 1307
Site 117
Site 1166
Site 2503
Site 4302
Site 4201
Site 2702
Site 2003
Site 4204
Site 104
Site 4106
Site 303
Site 123
Site 2302
Site 1113
Site 2603
Site 1301
Site 1163
Site 1127
Site 1309
Site 2502
Site 2011
Site 1305
Site 1132
Site 128
Site 2604
Site 1151
Site 4105
Site 2207
Site 125
Site 1165
Site 2005
Site 1110
Site 1133
Site 1116
Site 1308
Site 2002
Site 114
Site 2204
Site 2201
Site 2903
Site 2901
Site 106
Site 111
Site 105
Site 4203
Site 1154
Site 137
Site 1167
Site 108
Site 1139

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: STAND

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.

status: Active, not recruiting

title: A Phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab Versus Placebo, With or Without Hydroxyurea/ Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Vaso-Occlusive Crises (STAND)

type: EudraCT Number

source: euctr

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

study_completion_date_type: Anticipated

location_country:
Finland
Germany
Brazil
Turkey
Canada
France
Colombia
United States
India
Lebanon
Belgium
Oman
Ghana
Italy
United Kingdom
Netherlands
Spain
Greece
Panama
South Africa
Jordan

ipd_sharing: Yes

status_simplified: Ongoing


acronym: HITSOVA

lead_sponsor: Aspen Global Incorporated

summary: An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)

location_facility: Zentrum für Klinische Transfusionsmedizin

location_facility: Clinical Hospital № 122 N. A. L.G. Sokolov

location_facility: Centre Hospitalier Universitaire Amiens Picardie

location_facility: University Hospital Greifswald Dpt. of Hematology

location_facility: University Clinical Centre of the Republic of Srpska, Clinic for cardiology

location_facility: Clinical centre of Serbia, Clinic for Pulmonology

location_facility: Vivantes Klinikum im Friedrichhain Hämophiliezentrum, Gerinnungssprechstunde Landsberger Allee 49

location_facility: First City Hospital N.A. E.E. Volosevich

location_facility: Clinical Centre of Serbia, Clinic for Emergency Internal Medicine

location_facility: The Institute for Pulmonary Disease of Vojvodina, Pulmonary thromboembolism department

location_facility: Wojewódzki Szpital Zespolony im. L. Rydygiera

location_facility: The Ohio State University Wexner Medical Center

location_facility: Clinical Center of the Republic of Srpska, Medical Intesnive Care Unit

location_facility: Clinical Center University of Sarajevo, Clinic for Lung Diseases

location_facility: Azienda Ospedaliero Universitaria S.Orsola-Malpighi - UO Angiologia e Malattie della Coagulazione

location_facility: AOU Careggi, SOD Malattie Aterotrombotiche

location_facility: Instituto Scientifico San Raffaele- Servizio Coagulazione e Centro Trombosi

location_facility: Instiute of Cardiovascular Diseases "Dedinje"

location_facility: University Clinical Centre of the Republic of Srpska, Lung Clinic

location_facility: Universitatstklinikum Halle (Saale), Medizinische Klinik III

location_facility: Universitätsklinikum Gießen und Marburg GmbH, Klinik für Herz-, Kinderherz- und Gefäßchirurgie Standort Gießen

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Clinical Center University of Sarajevo, Clinic for Heart, Blood Vessels and Rheumatic Diseases

location_facility: ASST Papa Giovanni XIII, Servizio di Immunoematologia e Medicina Trasfusionale

location_facility: Centrum Medyczne HCP Sp. z o.o. Szpital im. Św. Jana Pawła II

status: Terminated

title: Open-Label, Randomised, Active Controlled, Multi-Centre Ph 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Acute HIT

location_country:
Germany
Italy
Poland
United States
Bosnia and Herzegovina
Canada
Serbia
Russian Federation
France

ipd_sharing: No

status_simplified: Unknown


type: Other Identifier

title: An International, Prospective Registry Investigating the Natural History of Participants With Achondroplasia

summary:
This is a registry study in children with achondroplasia, age 0-10 years, to be conducted at multiple clinical centers in several countries. Information collected will include in anthropometric characteristics, related symptoms, tests, & treatments

Children's information will be collected in the registry for a maximum of 5 years.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Germany
Italy
Portugal
United Kingdom
Denmark
Australia
Japan
Switzerland
Belgium
United States
China
Spain
Canada
France

location_facility: Alfred I. duPont Hospital for Children - Wilmington

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center

location_facility: Center for Rare Skeletal Diseases in Childhood and Adolescence

location_facility: Beijing Children's Hospital, Capital Medical University

location_facility: Sheffield Childrens NHS Foundation Trust

location_facility: Center for Rare Diseases, Department of Pediatrics, Polo Salute Donna e Bambino

location_facility: Centre Hospitalier Univesitaire La Timone

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Guy's & St Thomas NHS Trust, St Thomas' Hospital

location_facility: Los Angeles Biomedical Research Institute At Harbour-UCLA Medical Centre

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS -CHUV Hôpital Neslé

location_facility: Centre Hospitalier Universitaire Vaudois -CHUV

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Newcastle Hospitals NHS Foundation Trust

location_facility: Fondazione Policlinico Universitario A.Gemelli

location_facility: Centre Hospitalier Universitaire La Timone


lead_sponsor: Daiichi Sankyo, Inc.

summary:
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.

Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it has come back after remission or is not responding to treatment.

sponsor_collaborators: Innovative Therapies For Children with Cancer Consortium

location_facility: Columbia University/Herbert Irving Cancer Center

location_facility: The University of Texas Southwestern Medical Center Children's Health

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Fondazione IRCCS San Gerardo dei Tintori

location_facility: Schneider Children's Medical Center of Israel

location_facility: Washington University School of Medicine

location_facility: Prinses Maxima Centrum voor Kinderoncologie

location_facility: University of Minnesota/Masonic Cancer Center

location_facility: University of Mississippi Medical Center

location_facility: NHS Greater Glasgow and Clyde - The Queen Elizabeth University Hospital

location_facility: Sahlgrenska Universitetssjukhuset - Drottning Silvias Barn- och Ungdomssjukhus

location_facility: Riley Hospital for Children - Indiana University

status: Recruiting

title: A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations

enrollment_type: Anticipated

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Italy
Israel
United Kingdom
Denmark
Sweden
Netherlands
Belgium
United States
Spain
Canada
France


title: A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-689 in Patients With Relapsed or Refractory Lymphoma

summary: An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability and PK of HMPL-689 in patients with relapsed or refractory lymphomas

lead_sponsor: Hutchmed

location_country:
Finland
Italy
Poland
United States
Spain
France

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Winship Cancer Institute of Emory University

location_facility: Baylor Scott and White Research Institute

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS


title: An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

acronym: FORTRESS

summary: This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.

lead_sponsor: Spexis AG

location_country:
Italy
United Kingdom
Argentina
Brazil
Belgium
United States
Korea, Republic of
Spain
Taiwan
Czechia
Ukraine
Russian Federation
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Research Oncology Institute of Tomsk Scientific Center

location_facility: Florida Cancer Specialists NORTH - SCRI - PPDS

location_facility: Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

location_facility: CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre

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

location_facility: Budgetary Healthcare Institution of the Omsk region "Clinical Oncology Dispensary"

location_facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

location_facility: Saint Luke's Cancer Institute 150 Entrance

location_facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

location_facility: Municipal Institution SubCarpathian Clinical Oncological Centre

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: California Cancer Associates for Research and Excellence

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Universidade de Caxias do Sul (IPCEM-UCS)

location_facility: LLC Medical Center Family Medicine Clinic

location_facility: Florida Cancer Specialists PAN - SCRI - PPDS

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: CAIPO Centro para la atención integral del paciente oncológico

location_facility: Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy

location_facility: CHIREC Centre Hospitalier Interregional Edith Cavell

location_facility: OHSU Knight Cancer Institute Hematology Oncology

location_facility: Florida Cancer Specialists EAST - SCRI - PPDS

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

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

location_facility: Florida Cancer Specialists SOUTH - SCRI - PPDS

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS

location_facility: Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli"

location_facility: Herbert-Herman Cancer Center, Sparrow Hospital

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda


acronym: Flare Treatment Phase II Trial in GPP

lead_sponsor: Boehringer Ingelheim

summary: To evaluate efficacy, safety, and tolerability of spesolimab (BI 655130) compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.

ReferenceType: derived

ReferenceCitation: Bachelez H, Choon SE, Marrakchi S, Burden AD, Tsai TF, Morita A, Navarini AA, Zheng M, Xu J, Turki H, Anadkat MJ, Rajeswari S, Hua H, Vulcu SD, Hall D, Tetzlaff K, Thoma C, Lebwohl MG; Effisayil 1 Trial Investigators. Trial of Spesolimab for Generalized Pustular Psoriasis. N Engl J Med. 2021 Dec 23;385(26):2431-2440. doi: 10.1056/NEJMoa2111563.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Washington University School of Medicine - Digital Commons@Becker

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

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Choon SE, Lebwohl MG, Marrakchi S, Burden AD, Tsai TF, Morita A, Navarini AA, Zheng M, Xu J, Turki H, Rajeswari S, Deng H, Tetzlaff K, Thoma C, Bachelez H. Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021 Mar 30;11(3):e043666. doi: 10.1136/bmjopen-2020-043666.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Monash University - Monash University Research Portal

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

location_facility: Tianjin Medical University General Hospital

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: The First Hospital of Dalian Medical University

location_facility: 2nd Affiliated Hosp Zhejiang University College of Medical

location_facility: Hedi Chaker Hospital, Department of Dermatology

title: Effisayil™ 1:Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of Spesolimab (BI 655130) in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity

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:
Germany
Singapore
Japan
Switzerland
Tunisia
United States
China
Korea, Republic of
Thailand
Malaysia
Taiwan
France


title: A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors

summary: The main purpose of this study is to investigate the safety of LY3405105 in participants with advanced cancer. The study has two parts phase 1a and phase 1b. Participants will only enroll in one part.

ReferenceCitation: Sava GP, Fan H, Coombes RC, Buluwela L, Ali S. CDK7 inhibitors as anticancer drugs. Cancer Metastasis Rev. 2020 Sep;39(3):805-823. doi: 10.1007/s10555-020-09885-8.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repository_institution: Imperial College London - Spiral

repositories_concat: PubMed Central;spiral.imperial.ac.uk

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

lead_sponsor: Eli Lilly and Company

location_country:
United States
Spain
Taiwan
Canada
France

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: University of Texas MD Anderson Cancer Center


title: A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure

acronym: SEQUOIA

summary: A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.

ipd_sharing_description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

lead_sponsor: Theravance Biopharma

location_country:
Germany
Poland
New Zealand
Australia
Canada
France
Portugal
Hungary
Denmark
United States
Ukraine
Estonia
Italy
United Kingdom
Austria
Spain
Bulgaria
Russian Federation
Israel

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Medizinische Universitat Innsbruck Abteilung Fur Neurologie

location_facility: Charite - Campus Virchow-Klinikum, Klinik fur Neurologie

location_facility: Alexianer St. Joseph-Krankenhaus Berlin-Weißensee, Klinik für Neurologie

location_facility: Ospedale San Raffaele I U.O. di Neurologia

location_facility: The Ohio State University Wexner Medical Center

location_facility: Ospedale San Giovanni Battista del Sovrano Militare Ordine di Malta

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej

location_facility: Universitaetsklinikum Freiburg - Klinik fur Neurologie und Neurophysiologie

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona Umberto I - G.M. Lancisi - G. Salesi, SOD Clinica di Neuroriabilitazione

location_facility: University of Texas Southwestern Medical Center

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology

location_facility: Montreal Neurological Institute and Hospital

location_facility: Fondazione PTV - Policlinico Tor Vergata I U.O.C. Neurologia

location_facility: Charite Universitatsmedizin Berlin - Campus Benjamin Franklin

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Communal Institution City Clinical Hospital #6

location_facility: University Health Network - Toronto Western Hospital Movement Disorders Clinic

location_facility: Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala

location_facility: Communal Noncommercial Enterprise City Policlinic #9 of Kharkiv City Council

location_facility: Regional State Budgetary Institution of Healthcare Smolensk Regional Clinical Hospital

location_facility: Colorado Springs Neurological Associates, PC

location_facility: State Autonomous Institution of Healthcare Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan

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

location_facility: Georgetown University Hospital, Dept. of Neurology

location_facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria

location_facility: Pecsi Tudomanyegyetem, Neurologiai Klinika

location_facility: Policlinico Umberto I - Universita degli Studi di Roma La Sapienza / Neurologia

location_facility: Gemeinschaftspraxis Dr. med. J. Springub/ W. Schwarz

location_facility: Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency

location_facility: Federal State Budgetary Institution National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev of the Ministry of Healthcare of the Russian Federation

location_facility: Communal Institution Dnipropetrovsk I.I.Mechnikov RCH

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: Hospital Senhora da Oliveira - Guimaraes, EPE

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

location_facility: Parkinson's Disease and Movement Disorders Center

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Saint Petersburg State Budgetary Institution of Healthcare City Hospital # 40 of Kurortnyi Region

location_facility: Fixel Institute for Neurological Diseases

location_facility: Federal State Budgetary Educational Institution of Additional Professional Education Russian Medical Academy of Continuous Postgraduate Education of the Ministry of Healthcare of the Russian Federation

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital Dept of Neurology

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento

location_facility: UMHAT Sveti Georgi EAD Clinic of Neurological Diseases

location_facility: Universita Gabriele D'Annunzio- Cesi-Met

location_facility: Wilhelminenspital Wien Abteilung fur Neurologie

location_facility: Azienda Ospedaliero - Universitaria Policlinico Vittorio Emanuele. - P.O G. Rodolico, Clinica Neurologica

location_facility: NHI Central Clinical Hospital #2 of JSC Russian Railways N.A. Semashko

location_facility: Perron Institute for Neurological and Translational Science, QEII Medical Centre

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: UMHAT Alexandrovska EAD Clinic of Neurological Diseases


title: A PHASE 3, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY OF TISLELIZUMAB (BGB-A317) PLUS CHEMORADIOTHERAPY FOLLOWED BY TISLELIZUMAB MONOTHERAPY IN NEWLY DIAGNOSED, STAGE III SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER

summary: This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .

lead_sponsor: Celgene

sponsor_collaborators: Celgene BeiGene

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Japan
Canada
France
Portugal
Hungary
United States
Romania
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation

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

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain

location_facility: EUROMEDICA General Clinic of Thessaloniki

location_facility: The Hillingdon Hospitals NHS Foundation Trust - Mount Vernon Hospital

location_facility: Sf. Apostol Andrei Constanta Emergency Clinical County Hospital

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Manchester University NHS Foundation Trust - Wythenshawe Hospital - North West Lung Centre

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

location_facility: University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Zhejiang Medical University - Zhejiang Cancer Hospital

location_facility: Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes

location_facility: Ryazan State Medical University n.a. I.P. Pavlov

location_facility: East Suffolk and North Essex NHS Foundation Trust - Colchester Hospital

location_facility: Beijing Cancer Hospital - Beijing Institute for Cancer Research

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Clinical Hospital of the Russian Academy of Sciences

location_facility: IRCCS AziendaOspedaliera Universitaria San Martino

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Oncology Institute Professor Doctor Alexandru Trestioreanu

location_facility: National Hospital Organization - Nagoya Medical Center

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

location_facility: Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Cancer Specialists of North Florida - Jacksonville

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Sichuan University - West China Hospital

location_facility: The First Hospital of Xinjiang Medical University

location_facility: Hospital General Universitario de Alicante

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Seoul National University Bundang Hospital

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

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

location_facility: Fujian Medical University - Fujian Provincial Cancer Hospital

location_facility: Chinese PLA General Hospital / 307 Hospital

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

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Hospital Universitario Central de Asturias

location_facility: Health Nordhessen Holding AG - Klinikum Kassel - Medical Clinic IV

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital

location_facility: The Affiliated Hospital of Xuzhou Medical University

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

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

location_facility: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

location_facility: Florence Nightingale KH der Kaiserwerther Diakonie

location_facility: Zhejiang University School of Medicine - The Second Affiliated Hospital

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: University General Hospital of Heraklion

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: Norton Healthcare - Norton Cancer Institute

location_facility: Zhengzhou University (ZZU) - Henan Cancer Hospital

location_facility: Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

location_facility: Medical Study Company NORD-WEST GmbH Oncology Aurich

location_facility: Insular-Maternal and Child University Hospital Complex

location_facility: Centro Hospitalar E Universitario de Coimbra EPE

location_facility: Bengbu Medical College - First Affiliated Hospital

location_facility: University of Mississippi Medical Center

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Central South University - Xiangya School of Medicine - Hunan Cancer Hospital

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Istituto Nazionale Tumori Regina Elena di Roma

location_facility: Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov


summary:
This is a Phase 1/2, open-label, single arm, multicohort study to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL.

Phase 1 will identify a recommended Phase 2 dose (RP2D). Phase 2 will evaluate the efficacy of JCAR017 RP2D in the following three disease cohorts: Cohort 1 (r/r B-ALL), Cohort 2 (MRD+ B-ALL) and Cohort 3 (r/r B-NHL, [DLBCL, BL, or PMBCL]). A Simon's Optimal two-stage study design will be applied to Cohort 1 and 2 in Phase 2.

location_facility:
Local Institution - 500
Local Institution - 163
Local Institution - 602
Local Institution - 250
Local Institution - 501
Local Institution - 301
Local Institution - 251
Local Institution - 400
Local Institution - 167
Local Institution - 300
Local Institution - 161
Local Institution - 160
Local Institution - 601
Local Institution - 164
Local Institution - 600
Local Institution - 166
Local Institution - 168
Local Institution - 162
Local Institution - 165

title: A Phase 1/2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL).

type: Registry Identifier

location_country:
Germany
Italy
Netherlands
United States
Spain
France


acronym: DUET

lead_sponsor: UCB Biopharma SRL

summary: The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.

ReferenceType: result

ReferenceCitation: Rademacher M, Toledo M, Van Paesschen W, Liow KK, Milanov IG, Esch ML, Wang N, MacPherson M, Byrnes WJ, Minh TDC, Webster E, Werhahn KJ. Efficacy and safety of adjunctive padsevonil in adults with drug-resistant focal epilepsy: Results from two double-blind, randomized, placebo-controlled trials. Epilepsia Open. 2022 Dec;7(4):758-770. doi: 10.1002/epi4.12656. Epub 2022 Oct 22.

oa_host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Finland
Germany
Ireland
Poland
Australia
Japan
Bosnia and Herzegovina
Turkey
Croatia
Czechia
Serbia
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Estonia
Italy
Norway
United Kingdom
Spain
Greece
Bulgaria
Sweden


title: A Phase 2 Randomized, Multicenter, Double-blind, Vehicle Controlled, 90-Day, Safety, Efficacy & Systemic Exposure Study of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents With Autosomal Recessive Ichthyosis With Lamellar Scale

summary: This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 90 day, safety, efficacy, and systemic exposure study followed by a 90 day open-label extension of trifarotene cream in adults and adolescents with autosomal recessive ichthyosis with lamellar scale.

lead_sponsor: Mayne Pharma International Pty Ltd

location_country:
Germany
Israel
United Kingdom
Australia
United States
Spain
Canada
Ukraine
France

location_facility: Community Institution "Zaporizhzhya Regional Dermatovenereology Clinical Hospital"

location_facility: Medical Center of Private Enterprise "Dzerkalo"

location_facility: Ternopil Regional Clinical Dermatovenereological Dispensary

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Dnipropetrovsk State Hospital of Dermatovenerology

location_facility: Royal London Hospital Barts Health Nhs Trust


acronym: Pioneer

lead_sponsor: Blueprint Medicines Corporation

summary: This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group.

ReferenceCitation: Padilla B, Shields AL, Taylor F, Li X, Mcdonald J, Green T, Boral AL, Lin HM, Akin C, Siebenhaar F, Mar B. Psychometric evaluation of the Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) in a phase 2 clinical study. Orphanet J Rare Dis. 2021 Oct 18;16(1):434. doi: 10.1186/s13023-021-02037-3.

repository_institution: University of Michigan - Deep Blue

repositories_concat: PubMed Central;deepblue.lib.umich.edu

location_facility: Universitätsmedizin Mannheim, III. Medizinische Klinik

location_facility: A.O.U di Bologna - IRCCS, Istituto di Ematologia Lorenzo e Ariosto Seragnoli, Ematologia

location_facility: NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Hôpital Pitié-Salpêtrière, Service de Dermatologie

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Poloclinico, UOC Ematologia

location_facility: Karolinska University Hospital, Hematologimottagningen R51

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

location_facility: Virginia Commonwealth University Medical Center

location_facility: University Clinic Hamburg Eppendorf, University Cancer Center Hamburg (UCCH)

location_facility: Universitätsklinik Mainz, Universitäts-Hautklinik, Clinical Research Center

location_facility: University Medical Center Groningen (UMCG)

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Klinikum rechts der Isar, Technische Universität München

location_facility: Washington University School of Medicine

location_facility: Herbert Irving Comprehensive Cancer Center

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: lnstituto de Estudios de Mastocitosis de Castilla la Mancha, Hospital Virgen del Valle - Complejo Hospitalario de Toledo

location_facility: Winship Cancer Institute, Emory University

location_facility: Michigan Medicine, University of Michigan

location_facility: A.O. OO.RR. S.Giovanni di Dio e Ruggi d'Aragona, University of Salerno

location_facility: Oslo Universitetssykehus, Rikshospitalet, Department of Hematology

location_facility: Hôpital de la Timone, Service de dermatologie

location_facility: CHU Toulouse Larrey, CEREMAST, Service de Dermatologie et Allergologie cutanée

location_facility: Odense Universitetshospital, ORCA/Allergicentret, Hudafdeling I og Allergicenter

title: A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis With Symptoms Inadequately Controlled With Standard Therapy

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Canada
France


title: A Long-term, Multicenter, Single-arm, Open-label Extension of the SERENADE Study, to Assess the Safety and Efficacy of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

acronym: SERENADE OL

summary: The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the treatment in the double-blind parent SERENADE study (AC-055G202, NCT03153111). Furthermore, this OL extension study will give eligible subjects of the main study (SERENADE/AC-055G202, NCT03153111) an opportunity to continue or start receiving macitentan.

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: Actelion

collaborators: Frontier Science & Technology Research Foundation, Inc.

location_country:
Germany
Poland
Hungary
Argentina
Denmark
Israel
Brazil
Romania
Austria
Sweden
United Kingdom
United States
Bulgaria
Russian Federation
France

location_facility: Northwestern University Feinberg School of Medicine

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: Federal State Budget Scientific Institution

location_facility: Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie

location_facility: Maestri E Kormann Consultoria Médico- Científica Ltda

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Semmelweis Egyetem Városmajor Szív- és Érgyógyászati Klinika

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

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

location_facility: Instituto de Investigaciones Clinicas Mar del Plata


title: A Phase III Clinical Trial to Demonstrate Efficacy / Safety of Liposomal Cyclosporine A + Standard of Care (SoC) vs SoC Alone in Treating Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans in Patients Post Double Lung Transplant

summary: The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in double lung transplant recipients.

lead_sponsor: Zambon SpA

location_country:
Germany
Israel
United Kingdom
Denmark
Austria
Belgium
United States
Spain
France

location_facility: University of Kentucky Albert B. Chandler Hospital

location_facility: University of Texas Southwestern Medical Center


intervention_type: Biological

lead_sponsor: Hookipa Biotech GmbH

summary: HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative patients receiving a kidney transplant from a CMV-Seropositive living donor and CMV-Seropositive patients.Patients enrolled should have a living donor kidney transplantation ideally planned between two to four months after the first injection of study drug (HB-101 or placebo).

location_facility: University Hospitals Cleveland Medical Center

location_facility: Thomas E. Starzl Transplantation Institute

location_facility: Centre Hospitalier Universitaire de Bordeaux Hôpital Pellegrin

location_facility: University of Cincinnati (UC) - College of Medicine

title: A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation From Living CMV-Seropositive Donors (D+).

primary_purpose: Prevention

location_country:
Germany
Norway
United Kingdom
Denmark
United States
France


title: The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

acronym: RADIANCE-II

summary: The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.

ReferenceCitation: Azizi M, Saxena M, Wang Y, Jenkins JS, Devireddy C, Rader F, Fisher NDL, Schmieder RE, Mahfoud F, Lindsey J, Sanghvi K, Todoran TM, Pacella J, Flack J, Daemen J, Sharp ASP, Lurz P, Bloch MJ, Weber MA, Lobo MD, Basile J, Claude L, Reeve-Stoffer H, McClure CK, Kirtane AJ; RADIANCE II Investigators and Collaborators. Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. JAMA. 2023 Feb 28;329(8):651-661. doi: 10.1001/jama.2023.0713. Erratum In: JAMA. 2023 Jun 13;329(22):1989.

repositories_concat: PubMed Central

publisher_dissemination: American Medical Association

lead_sponsor: ReCor Medical, Inc.

location_country:
Ireland
Germany
United Kingdom
Netherlands
Switzerland
Belgium
United States
France

location_facility: University Hospitals Dorset NHS Foundation Trust

location_facility: Hôpital Européen Georges-Pompidou (HEGP)

location_facility: Centre Hospitalier Universitaire Saint-Pierre

location_facility: University of Pennsylvania Health System

location_facility: The Cardiothoracic Centre Basildon University Hospital

location_facility: The University of Tennessee Health Science Center

location_facility: The University of North Carolina at Chapel Hill


lead_sponsor: CymaBay Therapeutics, Inc.

summary:
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

location_facility: Center for Liver Disease and Transplantation

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Univeristy of Colorado Denver and Hospital

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Asheville Gastroenterology Associates, a Division of Digestive Health Partners, P.A.

location_facility: Severance Hospital Yonsei University Health System

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: Toronto Digestive Disease Associates Inc

location_facility: Yale School of Medicine Digestive Diseases, Internal Medicine

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Schiff Center for Liver Diseases University of Miami

location_facility: University of Minnesota Medical Center, Fairview

location_facility: University of California Davis Medical Center

location_facility: Indianapolis Gastroenterology Research Foundation

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

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Gastroenterologisch Hepatologisches Zentrum Kiel

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Pius Brinzeu Emergency Clinical County Hospital

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: Southern Therapy and Advance Research (STAR) LLC

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: American Research Corporation at Texas Liver Institute

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

location_facility: Centro de Investigaciones Clínicas Vina del Mar

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Consultorio de la Doctora Maria Sarai Gonzalez Huezo

location_facility: University General Hospital of Heraklion

location_facility: ifi-Institute for Interdisciplinary Medicine

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy

location_facility: The Newcastle Upon Tyne Hospital NHS Foundation Trust

location_facility: ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

title: A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Chile
Canada
Serbia
France
Hungary
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Israel


title: Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries

summary: The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

ReferenceCitation: Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.

oa_host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Kereiakes DJ, Hill JM, Ben-Yehuda O, Maehara A, Alexander B, Stone GW. Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial. Am Heart J. 2020 Jul;225:10-18. doi: 10.1016/j.ahj.2020.04.005. Epub 2020 Apr 18.

oa_host_type: closed

ReferenceCitation: Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: Shockwave Medical, Inc.

location_country:
United States
United Kingdom
Germany
France

location_facility: Clinique des Domes - Pole Sante Republique

location_facility: Rheinland Klinikum Neuss GmbH - Lukaskrankenhaus Neuss

location_facility: Charleston Area Medical Center (CAMC) - Health Education & Research Institute

location_facility: University of California, San Diego (UCSD) - Medical Center

location_facility: Columbia University Medical Center/ New York Presbyterian

location_facility: St. Vincent Heart Center of Indiana, LLC

location_facility: Universitaetsklinikum Giessen and Marburg GmbH

location_facility: Hospital of the University of Pennsylvania

location_facility: Advocate Health and Hospitals Corporation - Edward Hospital

location_facility: New York University (NYU) Langone Medical Center

location_facility: Pinnacle Health Cardiovascular Institute Inc.


lead_sponsor: Idorsia Pharmaceuticals Ltd.

summary: The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

ReferenceType: background

ReferenceCitation: Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021 Mar;14(2):249-268. doi: 10.1007/s40271-020-00474-z. Epub 2020 Nov 1.

ReferenceCitation: Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1. Erratum In: Lancet Neurol. 2022 Jan 20;: Lancet Neurol. 2022 Jun;21(6):e6.

location_facility: Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck

location_facility: 3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu

location_facility: Jacksonville Center for Clinical Research

location_facility: Dm Clinical Research / Martin Diagnostic Clinic

location_facility: University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring

location_facility: Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg

location_facility: CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique

location_facility: Sleep Disorders Center of the Mid-Atlantic

location_facility: Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1

location_facility: 1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu

location_facility: B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu

location_facility: Clinical Research Group of St. Petersburgh

location_facility: Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset

location_facility: Fleming Island Center for Clinical Research

location_facility: Artemis Institute For Clinical Research - Riverside

location_facility: Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)

location_facility: Acibadem City Clinic Tokuda Hospital EAD

location_facility: Hospital UZ Leuven_ Pneumology Department

location_facility: Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory

location_facility: 3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu

location_facility: Fakultní nemocnice Ostrava, Spánková laboratoř

location_facility: SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

location_facility: Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály

location_facility: Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu

location_facility: Baptist Health Center for Clinical Research

location_facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin

location_facility: 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu

location_facility: Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University

location_facility: 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu

location_facility: B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu

location_facility: Wesley Neurology Clinic Pc (Multiple Sclerosis)

location_facility: Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar

location_facility: Universitetssjukhuset Örebro Neurokliniken, Sömnenheten

location_facility: 8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu

location_facility: Clinique beau soleil - Department Sleep and Neurology

location_facility: HOSPITAL AZ SINT-JAN_Neurology department

title: Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder

location_country:
Finland
Germany
Hungary
Sweden
Belgium
United States
Korea, Republic of
Czechia
Bulgaria
Canada
France


acronym:
JAVELIN BRCA/ATM

 JAVELIN BRCA/ATM

lead_sponsor: Pfizer

summary: Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.

ReferenceCitation: Schram AM, Colombo N, Arrowsmith E, Narayan V, Yonemori K, Scambia G, Zelnak A, Bauer TM, Jin N, Ulahannan SV, Colleoni M, Aftimos P, Donoghue MTA, Rosen E, Rudneva VA, Telli ML, Domchek SM, Galsky MD, Hoyle M, Chappey C, Stewart R, Blake-Haskins JA, Yap TA. Avelumab Plus Talazoparib in Patients With BRCA1/2- or ATM-Altered Advanced Solid Tumors: Results From JAVELIN BRCA/ATM, an Open-Label, Multicenter, Phase 2b, Tumor-Agnostic Trial. JAMA Oncol. 2023 Jan 1;9(1):29-39. doi: 10.1001/jamaoncol.2022.5218. Erratum In: JAMA Oncol. 2023 Jul 1;9(7):1009.

evidence: open (via free pdf)

location_facility: Amsterdam University Medical Centre, location VUmc

location_facility: Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: The Ohio State University Wexner Medical Center

location_facility: IRCCS-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: UPMC Hillman Cancer Center Investigational Drug Service

location_facility: Northside Hospital, Inc. - Central Research Department

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Unità di Farmacologia Clinica

location_facility: Azienda Policlinico Umberto I, Universita La Sapienza, Oncologia B

location_facility: Presidio AO-U, Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

location_facility: Evelyn H. Lauder Breast and Imaging Center

location_facility: Northside Hospital, Inc. - GCS/Northside

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: NYU Langone Radiology Ambulatory Care Center East 41st Street

location_facility: Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

location_facility: Magee-Women's Hospital Women's Cancer Center

location_facility: Stephanie Spielman Comprehensive Breast Cancer

location_facility: Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori

location_facility: Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: Washington University School of Medicine

location_facility: Hospital of the University of Pennsylvania/Penn Investigational Drug Services

location_facility: Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

location_facility: Azienda Socio-Sanitaria Territoriale Monza, Ospedale San Gerardo

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

location_facility: Rockefeller Outpatient Pavilion (53rd Street)

location_facility: Memorial Sloan Kettering Cancer Center- Westchester

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth

location_facility: Fondazione IRCCS, Istituto Nazionale dei Tumori

location_facility: Washington University Infusion Center Pharmacy

title: A PHASE 2 STUDY TO EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH TALAZOPARIB IN PATIENTS WITH BRCA OR ATM MUTANT TUMORS JAVELIN BRCA/ATM

location_country:
Italy
United Kingdom
Denmark
Japan
Netherlands
Belgium
United States
Spain
France


acronym: CONQUER

summary: The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.

ReferenceCitation: Ailani J, Andrews JS, Tockhorn-Heidenreich A, Wenzel R, Rettiganti M. Effect of Galcanezumab on Total Pain Burden in Patients Who Had Previously Not Benefited from Migraine Preventive Medication (CONQUER Trial): A Post Hoc Analysis. Adv Ther. 2022 Oct;39(10):4544-4555. doi: 10.1007/s12325-022-02233-y. Epub 2022 Aug 5.

ReferenceCitation: Ailani J, Kuruppu DK, Rettiganti M, Oakes T, Schroeder K, Wietecha L, Port M, Blumenfeld AM. Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022 Feb;62(2):198-207. doi: 10.1111/head.14257. Epub 2022 Jan 25.

ReferenceCitation: Tepper SJ, Ailani J, Ford JH, Nichols RM, Li LQ, Kemmer P, Hand AL, Tockhorn-Heidenreich A. Effects of Galcanezumab on Health-Related Quality of Life and Disability in Patients with Previous Failure of 2-4 Migraine Preventive Medication Categories: Results from a Phase IIIb Randomized, Placebo-Controlled, Multicenter Clinical Trial (CONQUER). Clin Drug Investig. 2022 Mar;42(3):263-275. doi: 10.1007/s40261-021-01115-5. Epub 2022 Jan 18. Erratum In: Clin Drug Investig. 2022 Mar 7;:

ReferenceCitation: Okonkwo R, Tockhorn-Heidenreich A, Stroud C, Paget MA, Matharu MS, Tassorelli C. Efficacy of galcanezumab in patients with migraine and history of failure to 3-4 preventive medication categories: subgroup analysis from CONQUER study. J Headache Pain. 2021 Sep 30;22(1):113. doi: 10.1186/s10194-021-01322-7.

repository_institution: PubMed Central - Europe PMC

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

ReferenceCitation: Reuter U, Lucas C, Dolezil D, Hand AL, Port MD, Nichols RM, Stroud C, Tockhorn-Heidenreich A, Detke HC. Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial. Adv Ther. 2021 Nov;38(11):5465-5483. doi: 10.1007/s12325-021-01911-7. Epub 2021 Sep 20.

ReferenceCitation: Citrome L, Sanchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15.

ReferenceCitation: Kuruppu DK, Tobin J, Dong Y, Aurora SK, Yunes-Medina L, Green AL. Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments. BMC Neurol. 2021 Apr 23;21(1):175. doi: 10.1186/s12883-021-02196-7.

ReferenceCitation: Schwedt TJ, Kuruppu DK, Dong Y, Standley K, Yunes-Medina L, Pearlman E. Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. J Headache Pain. 2021 Mar 25;22(1):15. doi: 10.1186/s10194-021-01230-w.

ReferenceCitation: Mulleners WM, Kim BK, Lainez MJA, Lanteri-Minet M, Pozo-Rosich P, Wang S, Tockhorn-Heidenreich A, Aurora SK, Nichols RM, Yunes-Medina L, Detke HC. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020 Oct;19(10):814-825. doi: 10.1016/S1474-4422(20)30279-9. Epub 2020 Sep 16.

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Nowon Eulji Medical Center, Eulji University

location_facility: Instituto de Neurologia Dra. Ivonne Fraga

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Michigan Head, Pain and Neurological Institute

location_facility: Higashi Sapporo Neurology and Neurosurgery Clinic

location_facility: Healthy Perspectives Innovative Mental Health Services, PL

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Severance Hospital Yonsei University Health System

location_facility: Neurologicka ambulance, Neurologie Brno s.r.o.

location_facility: Medical corporation Shinmatsudakai Atago Hospital

title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study

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

location_country:
Germany
Hungary
United Kingdom
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Czechia
Canada
Puerto Rico
France


lead_sponsor: Hoffmann-La Roche

summary: Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.

location_facility: Instytut "Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii

location_facility: Children'S Mercy Hospital; Pediatric Nephrology

location_facility: Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii

location_facility: Debreceni Egyetem Klinikai Központ; Gyermekklinika

location_facility: UT Southwestern Medical Center; Pediatrics Dept.

location_facility: Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center

location_facility: Emory University School of Med; Pediatrics

location_facility: University of Alabama at Birmingham; Pediatric Nephrology

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

location_facility: Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto

location_facility: Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

location_facility: East Carolina University; Brody School of Medicine

location_facility: Uniwersytecki Szpital Dziecięcy w Krakowie; Oddz.Nefrologii i Nadciśnienia Tętniczego/Stacja Dializ

title: An Open-Label, Single-Arm, Multicenter Study to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

location_country:
Lithuania
Italy
Poland
Hungary
United States
Spain
France


title: A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability Pharmacokinetics Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects With Advanced Solid Tumors.

summary: The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.

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: MedImmune LLC

location_country:
Italy
Portugal
Australia
Netherlands
United States
Korea, Republic of
Spain
Taiwan
France


title: Randomized, Double-blind, Placebo-controlled Trial Investigating the Efficacy and Safety of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)

summary:
The aim of this trial was to investigate the efficacy and safety of intravenous neridronic acid in subjects with Complex Regional Pain Syndrome (CRPS).

The trial consisted of an Enrollment Period lasting up to 60 days, Treatment Period A consisting of 4 infusions (neridronic acid or placebo) over 10 days, and a Follow-up Period 1 until Week 26.

At Week 26, participants not meeting the pre-specified criteria to continue into Treatment Period B continued in Follow-up Period 2 until Week 52. Participants meeting the pre-specified criteria entered the open-label Treatment Period B with 4 additional infusions (neridronic acid) over 10 days and follow-up visits until Week 52.

ReferenceCitation: Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006. Erratum In: Ann Intern Med. 2011 Sep 20;155(6):408.

ipd_sharing_description: Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.

lead_sponsor: Grünenthal GmbH

location_country:
Germany
New Zealand
Australia
United States
Korea, Republic of
Spain
France

location_facility: US015 - Tennessee Valley Pain Consultants

location_facility: US041 - Better Health Clinical Research, Inc.

location_facility: FR004 - Centre Hospitalier Universitaire Amiens Picardie

location_facility: AU002 - Royal North Shore Hospital Michael J Cousins Pain Management and Research Centre

location_facility: KR002 - Seoul National University Hospital

location_facility: KR007 - Konkuk University Medical Center

location_facility: KR008 - Chungnam National University Hospital

location_facility: US038 - DiGiovanna Institute For Medical Education

location_facility: DE011 - Klinische Forschung Berlin Mitte GmbH

location_facility: DE006 - Center for Clinical Research Dr. med. I. Schoel

location_facility: Nz001 - Bay of Plenty Clinical Trials Unit, Bay of Plenty District Health Board

location_facility: FR001 - Centre Hospitalier Universitaire Grenoble Alpes Centre de la douleur

location_facility: ES004 - Hospital Universitario Puerto Real Unidad de Anestesiologia

location_facility: US007 - Neurology Offices of South Florida

location_facility: US046 - Clinical Research of West Florida, Inc.

location_facility: US047 - The Center for Clinical Research

location_facility: AU001 - The Avenue Cardiovascular Centre Level 1 Masada Private Hospital

location_facility: FR002 - L'Hôpital Privé du Confluent Département d'évaluation et traitement de la douleur

location_facility: US030 - Gulfcoast Clinical Research Center

location_facility: DE002 - Klinische Forschung Hamburg GmbH

location_facility: ES002 - Hospital de la Santa Creu i Sant Pau

location_facility: US049 - Orange County Research Institute

location_facility: ES008 - Hospital Lluis Alcanyis Anesthesiology and Pain Unit

location_facility: ES007 - Hospital Clínico Universitario de Valencia

location_facility: DE005 - Klinische Forschung Schwerin GmbH

location_facility: KR003 - Seoul National University Bundang Hospital

location_facility: US018 - Carolinas Center for Advanced Management of Pain

location_facility: US045 - Holland Center for Family Health

location_facility: DE010 - Klinische Forschung Hannover Mitte

location_facility: DE013 - Klinik und Poliklinik für Neurologie Universitätsmedizin Mainz

location_facility: ES005 - Hospital Sanitas La Moraleja Pain Unit

location_facility: US005 - Hometown Urgent Care and Research

location_facility: US044 - The Helm Center for Pain Management

location_facility: DE009 - BAG Anästhesie, Schmerztherapie, Palliativmedizin

location_facility: ES006 - Hospital Infanta Luisa Rheumatology

location_facility: NZ002 - Southern Clinical Trials Group Ltd


lead_sponsor: Novo Nordisk A/S

summary: This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.

title: Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients With Severe Haemophilia A

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

design_allocation: Non-Randomized

location_country:
Germany
Australia
Brazil
Japan
Turkey
Croatia
Canada
France
Lithuania
Portugal
Hungary
Denmark
Switzerland
United States
Ukraine
Malaysia
Puerto Rico
Italy
Norway
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Israel


title: A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer

summary:
This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens.

Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab.

The study will be done in two parts:

Part 1 is to identify the recommended dose to use for treatment.
Part 2 is to find out how well the combination works, and how safe and tolerable it is.

status: Unknown status

lead_sponsor: Daiichi Sankyo, Inc.

collaborators:
Bristol-Myers Squibb
AstraZeneca

sponsor_collaborators:
Daiichi Sankyo, Inc.
Bristol-Myers Squibb
AstraZeneca

location_country:
Germany
Italy
United Kingdom
Belgium
United States
Spain
France

location_facility: Hospital Universitario Ramon y Cajal Madrid

location_facility: Levine Cancer Institute Carolinas Healthcare System

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center

location_facility: Tennessee Oncology - Sara Cannon Research Institute

location_facility: Azienda Ospedaliera Universitaria Senese U.O.C. Immunoterapia Oncologica


title: A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3

summary: This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Czechia
Canada
Serbia
France
Lithuania
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
Ukraine
India
Romania
Belgium
China
Malaysia
Moldova, Republic of
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Georgia
Russian Federation
Israel

location_facility: Centres Médico Chirurgicaux - Clinique Ambroise Paré

location_facility: Transcarpathian Regional Hospital im.Andriya Novak

location_facility: Henry Ford Medical Center - Columbus Center

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Diaservis - Medical and Diagnostic Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Szpital Miejski im. Jana Pawła II w Elblagu

location_facility: National Hospital Organization Takasaki General Medical Centar

location_facility: Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Xiangya Hospital Central South University

location_facility: The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: The Second Afilliated Hospital of Hebei Medical University

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Central Sooner Research - Oklahoma - Northwest 47th Street

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Tokushukai Sapporo Higashi Tokushukai Hospital

location_facility: NorthShore University HealthSystem - Evanston Hospital

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Centre Hospitalier de Wallonie Picarde - Site Notre Dame

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: Endomedix Diagnosztikai Központ - Miskolc

location_facility: Grant Medical Foundation - Ruby Hall Clinic

location_facility: Private Enterprise Private Manufacturing Company Acinus

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Research Institute of Physiology and Fundamental Medicine

location_facility: Care Access Research LLC - Salt Lake City

location_facility: Pusat Perubatan University Kebangsaan Malaysia

location_facility: Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: MNGI Digestive Health - Plymouth Endoscopy Center & Clinic

location_facility: NYU Langone Long Island Clinical Research Associates

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

location_facility: Indiana University Health University Hospital

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Medical Clinical Investigational Center of Medical Center Health Clinic

location_facility: The First People's Hospital of Yunnan Province

location_facility: The Second Affiliated Hospital of Zhengzhou University

location_facility: Tokyo Medical And Dental University Medical Hospital

location_facility: SHI of Yaroslavl Region Clinical Hospital #8

location_facility: Ishida Clinic of IBD and Gastroenterology

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Univerzitná nemocnica Bratislava - Nemocnica Ružinov

location_facility: Nizhny Novgorod Regional Hospital N.A. Semashko

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Lviv Regional Clinical Hospital - Lviv National Medical University named Danylo Galician

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"

location_facility: Renji Hospital Shanghai Jiao Tong University School of Medicine

location_facility: Nanjing Medical University - Nanjing Jiangning Hospital

location_facility: First Pavlov State Medical University of Saint Petersburg

location_facility: Tongji Hospital Tongji Medical,Science & Technology

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: Scientific Centre of Reconstructive and Restorative Surgery

location_facility: Southwest Hospital of Third Military Medical University

location_facility: HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen

location_facility: Carolina Digestive Diseases and Endoscopy Center

location_facility: Encore Borland-Groover Clinical Research

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University

location_facility: Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho

location_facility: West China Hospital of Sichuan University

location_facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: The First Affiliated Hospital Of Fujian Medical University

location_facility: Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council

location_facility: Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod

location_facility: Regional Hospital Dr Radivoj Simonovic Sombor

location_facility: Gastroenterology Research of San Antonio

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research

location_facility: North-Western State Medical University named after I.I.Mechnikov

location_facility: Showa University Northern Yokohama Hospital


acronym: TANDEM

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

ReferenceCitation: Pedrosa M, Seyedkazemi S, Francque S, Sanyal A, Rinella M, Charlton M, Loomba R, Ratziu V, Kochuparampil J, Fischer L, Vaidyanathan S, Anstee QM. A randomized, double-blind, multicenter, phase 2b study to evaluate the safety and efficacy of a combination of tropifexor and cenicriviroc in patients with nonalcoholic steatohepatitis and liver fibrosis: Study design of the TANDEM trial. Contemp Clin Trials. 2020 Jan;88:105889. doi: 10.1016/j.cct.2019.105889. Epub 2019 Nov 13.

ReferenceCitation: Parthasarathy G, Malhi H. Macrophage Heterogeneity in NASH: More Than Just Nomenclature. Hepatology. 2021 Jul;74(1):515-518. doi: 10.1002/hep.31790. Epub 2021 May 22. No abstract available.

publisher_dissemination: Wolters Kluwer Health

sponsor_collaborators:
Novartis Pharmaceuticals
Allergan

title: A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis

location_country:
Germany
Italy
Russian Federation
India
Israel
Argentina
Singapore
United Kingdom
Belgium
United States
Latvia
Spain
Turkey
Czechia
Canada
Egypt
France


title: OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI

summary: The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

ReferenceCitation: Ali Z, Landmesser U, Karimi Galougahi K, Maehara A, Matsumura M, Shlofmitz RA, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG, Wijns W, Mintz GS, Ben-Yehuda O, McGreevy RJ, Zhang Z, Rapoza RR, West NEJ, Stone GW. Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI - design and rationale of ILUMIEN IV: OPTIMAL PCI. EuroIntervention. 2021 Jan 20;16(13):1092-1099. doi: 10.4244/EIJ-D-20-00501.

publisher_dissemination: Europa Digital & Publishing

lead_sponsor: Abbott Medical Devices

sponsor_collaborators:
Abbott Medical Devices
Abbott

location_country:
Germany
New Zealand
Australia
Japan
Canada
France
Portugal
Hong Kong
Denmark
Switzerland
United States
India
Belgium
Italy
United Kingdom
Singapore
Netherlands
Spain
Taiwan
Sweden

location_facility: Via Christi Regional Medical Center - St. Francis Campus

location_facility: University of Massachusetts Medical Center

location_facility: Cardiovascular Research Institute of Kansas

location_facility: University Hospitals Cleveland Medical Center

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: Eastern Heart Clinic - Prince of Wales Hospital

location_facility: University of North Carolina at Chapel Hill

location_facility: Sahlgrenska University Hospital - Gothenburg

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

location_facility: The Cardiac & Vascular Institute Research Foundation, LLC

location_facility: New York Presbyterian Hospital/Columbia University

location_facility: University of California at San Diego (UCSD) Medical Center

location_facility: Montefiore Medical Center - Moses Division

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

location_facility: University of California - Davis Medical Center

location_facility: Centennial Heart Cardiovascular Consultants

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel


summary: This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).

ReferenceCitation: Jacob S, Veenstra-VanderWeele J, Murphy D, McCracken J, Smith J, Sanders K, Meyenberg C, Wiese T, Deol-Bhullar G, Wandel C, Ashford E, Anagnostou E. Efficacy and safety of balovaptan for socialisation and communication difficulties in autistic adults in North America and Europe: a phase 3, randomised, placebo-controlled trial. Lancet Psychiatry. 2022 Mar;9(3):199-210. doi: 10.1016/S2215-0366(21)00429-6. Epub 2022 Feb 10.

location_facility: University of Minnesota Medical Center-Fairview

location_facility: Uni of Chicago; Centre For Advanced Medicine

location_facility: McGill University Health Centre - Glen Site

location_facility: Queen Elizabeth University Hospital; Clinical Research Facility

location_facility: Yale University / Yale-New Haven Hospital

location_facility: ASL TO2; Centro Pilota Regione Piemonte - Dip. Salute Mentale

location_facility: University of California , Los Angeles (UCLA); Child, Adolescent Psychiatry

location_facility: Hospices Civils de Lyon; Centre d'Investigation Clinique Pédiatrique

location_facility: A.O.U. Policlinico - V. Emanuele - P.O. Gaspare Rodolico; Dip. Terapia integrata disturbi resistenti

location_facility: Hopital Charles Perrens; Centre de Ressources Autisme Aquitaine

location_facility: Vanderbilt University Medical Center; Department of Psychiatry

location_facility: Center for Autism and the Developing Brain

location_facility: UPMC Western Psychiatric Institute and Clinic

location_facility: Holland Bloorview Kids Rehabilitation Hospital; Autism Research Centre

location_facility: University of California at San Francisco

location_facility: ASST di Pavia; Dip. di Scienze del Sistema Nervoso e del Comportamento

location_facility: RE:Cognition Health; RE:Cognition Health

location_facility: Hospital Mutua de Terrassa; Departamento de Psiquiatria

location_facility: Kings College Hospital; Kings Clinical Research Facility

location_facility: AUSL di Piacenza; Psichiatria di Collegamento

location_facility: Hospital Universitari Vall d'Hebron; Sevicio de Psiquiatría

location_facility: Southwest Autism Research & Resource Center

location_facility: Western General Hospital; Wellcome Trust CRF

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Psiquiatria del niño y del adolescente

location_facility: Hospital Universitario Rio Hortega; Departamento de Psiquiatria

location_facility: Nathan S. Kline Institute for Psychiatric Research

location_facility: Centre hospitalier du Rouvray; CRAHN Centre de Ressources Autisme Haute-Normandie

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

location_country:
Italy
United Kingdom
United States
Spain
Canada
France


lead_sponsor: BeiGene

summary:
This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts:

Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type)
Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL)
Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS)

Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant).

ReferenceCitation: Huiqiang Huang, et al. Tislelizumab (BGB-A317) for relapsed/refractory extranodal NK/T-cell lymphoma: preliminary efficacy and safety results from a phase 2 study. Poster Abstract EP1268, European Hematology Association 2020.

ReferenceCitation: Pier Luigi Zinzani, et al. Tislelizumab (BGB-A317) for relapsed/refractory peripheral T-cell lymphomas: Safety and efficacy results from a phase 2 study. Poster Abstract EP1235, European Hematology Association 2020.

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Fujian Medical University Union Hospital

location_facility: The affiliated hospital of Xuzhou medical university

location_facility: Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi

location_facility: Ospedale Policlinico San Martino - IRCCS per l'Oncologia

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: West China Hospital of Sichuan University

location_facility: UBC - British Columbia Cancer Agency - The Vancouver Centre

location_facility: Institut d'hématologie de Basse Normandie

location_facility: A.O.U. Pisana, Stabilimento di Santa Chiara

location_facility: Centre hospitalier Universitaire de Limoges

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

title: A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK-cell Neoplasms

location_country: Germany Italy China Taiwan Canada France


lead_sponsor: Actelion

summary: The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.

location_facility: Wojewodzki Szpital Specjalistyczny We Wroclawiu

location_facility: Federal State Budget Scientific Institution

location_facility: Institut Za Zdravstvenu Zaštitu Majke I Deteta Srbije ''Dr Vukan Čupić''

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

location_facility: Municipal Institution Of The Zaporizhzhya Regional Council

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Samara Regional Clinical Cardiological Dispensary

location_facility: Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

location_facility: Municipal Enterprise Of The Dnipropetrovsk Regional Council

location_facility: Moscow Scientific Research Institute For Pediatrics And Childrens Surgery Of Rosmedtechnologies

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

location_facility: Children'S Hospital Cardiac Care Center University Of Colorado

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: State Institution Of The Ministry Of Health Of Ukraine

title: A Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension

location_country:
Germany
Belarus
Poland
Hungary
Israel
United Kingdom
Belgium
United States
China
Malaysia
Taiwan
Canada
Ukraine
Serbia
Russian Federation
France


acronym: PLATforM

summary: The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma

location_facility: The Angeles Clinic and Research Institute

location_facility: NYU Laura and Isaac Perlmutter Cancer Center Perlmutter Cancer Center

location_facility: Massachusetts General Hospital Massachusetts Gen. Hospital CC

title: A Randomized, Open-label, Phase II Open Platform Study Evaluating the Efficacy and Safety of Novel Spartalizumab (PDR001) Combinations in Previously Treated Unresectable or Metastatic Melanoma

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

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