title: A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

summary: To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced subjects with Parkinson's disease (PD) who have motor fluctuations.

lead_sponsor: Impax Laboratories, LLC

location_country:
Italy
United States
France
Czechia
Poland
Spain
Germany
United Kingdom

location_facility: Parkinsons's Disease Treatment Center of Southwest Florida (131)

location_facility: INSERM, Centre d'investigation Clinique 1402, CHU de Poitiers (402)

location_facility: Hospital Genral Universitario de Elche (509)

location_facility: Azienda Ospedaliero-Universitaria Pisana (602)

location_facility: Hospital Universitari Mutua Terrassa (506)

location_facility: St. Josef-Hospital, Universitatsklinik fur Neurologie, Klinisches Forschungszentrum fur Neurodegeneration (301)

location_facility: Rocky Mountain Movement Disorders Center (116)

location_facility: Wake Forest Baptist Health Sciences (127)

location_facility: Hospital Universitario Vall d' Hebron (505)

location_facility: Hospital Universitario de la Princesa (508)

location_facility: Medical Professional Clinical Research Center, INC (163)

location_facility: Northwestern Medical Group Neurology Clinic(145)

location_facility: CHU de Montpellier, Hopital Gui de Chauliac(405)

location_facility: Department "G.F. Ingrassia" Section of neuroscience-Policlinico "Vittorio Emanuele" (608)

location_facility: Krakowska Akademia Neurologii Sp. z o.o.(802)

location_facility: University of Florida Health Science Center(129)

location_facility: Hospital Universitari General de Catalunya (504)

location_facility: University of Miami-UHealth at Boca Raton (152)

location_facility: Roseman Medical Research Institute/Roseman Medical Group (154)

location_facility: Curiositas ad sanum, Studien und Beratungs GmbH(311)

location_facility: Klinik Haag i. OB, Geriatric Hospital (305)

location_facility: Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus fUr Bewegungsstorungen/Parkinson (300)

location_facility: Premiere Research Institute at Palm Beach Neurology (174)

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health (142)

location_facility: University of Texas Southwestern Medical Center (143)

location_facility: Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)

location_facility: Centre Hospitalier Universitaire de Nice (400)

location_facility: St. Joseph's Hospital & Medical Center/ Barrow Neurological Institute (156)

location_facility: Gemeinschaftspraxis Dr. med. Joachim Springub/ Wolfgang Schwarz, Studienzentrum Nord-West (306)

location_facility: Hospital De La Santa Creu i Sant Pau (502)

location_facility: Centre d'Investigation Clinique 1436-CHU Purpan-Hopital Pierre Paul Riquet (403)

location_facility: Movement Disorder Clinic of Oklahoma (115)

location_facility: Imperial College Healthcare NHS Trust (200)

location_facility: NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion (120)

location_facility: Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)

location_facility: Dr. med. REINHARDT Ehret Neurologie Berlin Schlobstr. 29 (309)

location_facility: Hospital Universitario Ramon y Cajal (500)

location_facility: Hospital Universitario y politecnico La Fe (515)

location_facility: CHU de Clermont-Ferrand - Hopital Gabriel Montpied (404)

location_facility: Hospital Universitario Quiron Dexeus (501)

location_facility: Fondazione lstituto Neurologico Nazionale "C. Mondino" (606)

location_facility: University of Rome Tor Vergata/Hospital Tor Vergata (605)

location_facility: Mount Sinai West-Department of Neurology(172)

location_facility: VCU Health - Neuroscience, Orthopaedic and Wellness Center (124)

location_facility: Loma Linda University Health Care, Department of Neurology (137)

location_facility: Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)

location_facility: Neurology Consultants of Dallas, PA (108)

location_facility: Medical University of South Carolina (150)

location_facility: Klinikum rechts der lsar der TUM, Klinik und Poliklinik fur Neurologie (303)

location_facility: Neurologicka ordinace FORBELI s.r.o.(706)

location_facility: Hospital Universitario Virgen del Rocio (503)

location_facility: NZOZ Neuromed M. i M Nastaj Spolka Partnerska(800)

location_facility: University of Toledo, Gardner-McMaster Parkinson Center (122)

location_facility: Houston Methodist Neurological Institute/Movement Disorders Clinic (135)

location_facility: Universitatsklinikum Carl Gustav Carus, Klinik und Poliklinik fur Neurologie (307)

location_facility: University of Arkansas for Medical Sciences (117)

location_facility: Centro Ricerca Parkinson San Raffaele Cassino (601)

location_facility: Hoag Memorial Hospital Presbyterian (134)

location_facility: Indiana University Health Neuroscience Center (164)

location_facility: University of Kansas Medical Center (118)

location_facility: Keck School of Medicine of USC/University of Southern California (106)

location_facility: Hospital Universitario Infanta Sofia (513)

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton (121)

location_facility: Christiana Care Neurology Specialists (153)

location_facility: Department of Neuroscience, Mental Health and Sensory System (NeSMOS), Sapienza University (603)

location_facility: University Hospitals Cleveland Medical Center (123)

location_facility: Henry Ford West Bloomfield Hospital (100)

location_facility: Booth Gardner Parkinson's Care Center (112)


type: EudraCT Number

title: An Open-label, International, Multicenter, Interventional Study Exploring the Efficacy of Once-daily Oral Rivaroxaban (BAY 59-7939) for the Treatment of Left Atrial/Left Atrial Appendage Thrombus in Subjects With Nonvalvular Atrial Fibrillation or Atrial Flutter

acronym: X-TRA

summary: A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to rivaroxaban for treatment of thrombi. The study will measure thrombus outcomes based on echo image and common clinical outcomes such as bleeding and stroke or thromboembolism.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, Morandi E, van Eickels M, Cohen A. Rationale and design of a study exploring the efficacy of once-daily oral rivaroxaban (X-TRA) on the outcome of left atrial/left atrial appendage thrombus in nonvalvular atrial fibrillation or atrial flutter and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2015 Apr;169(4):464-71.e2. doi: 10.1016/j.ahj.2014.12.020. Epub 2015 Jan 6.

family: Lip

full_name: Gregory Y.H. Lip

given: Gregory Y.H.

sequence: first

family: Hammerstingl

full_name: Christoph Hammerstingl

given: Christoph

sequence: additional

family: Marin

full_name: Francisco Marin

given: Francisco

family: Cappato

full_name: Riccardo Cappato

given: Riccardo

family: Meng

full_name: Isabelle Ling Meng

given: Isabelle Ling

family: Kirsch

full_name: Bodo Kirsch

given: Bodo

family: Morandi

full_name: Eolo Morandi

given: Eolo

family: van Eickels

full_name: Martin van Eickels

given: Martin

family: Cohen

full_name: Ariel Cohen

given: Ariel

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Heart Journal

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

license_normalized: no license

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Bayer

location_country:
France
Bulgaria
Poland
Russian Federation
Turkey
Germany
Ukraine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: An Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults 18 Years of Age or Older With Solid Tumours Receiving Chemotherapy

summary: The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults with solid tumours undergoing chemotherapy.

study_start_date_type: Actual

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Vink P, Delgado Mingorance I, Maximiano Alonso C, Rubio-Viqueira B, Jung KH, Rodriguez Moreno JF, Grande E, Marrupe Gonzalez D, Lowndes S, Puente J, Kristeleit H, Farrugia D, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Godeaux O, López-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Zoster-028 Study Group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial. Cancer. 2019 Apr 15;125(8):1301-1312. doi: 10.1002/cncr.31909. Epub 2019 Feb 1. Erratum in: Cancer. 2020 Jun 15;126(12):2941.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
France
Czechia
Spain
Canada
United Kingdom
Korea, Republic of


title: A Phase IB, Open-Label Study Evaluating the Safety and Pharmacokinetics of Venetoclax (GDC-0199, ABT-199) in Combination With Bendamustine+Rituximab (BR) or Bendamustine+Obinutuzumab (BG) in Patients With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia

summary: This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with first-line (1L)/previously untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). The study will explore two venetoclax combination regimens in participants with 1L CLL: BR+venetolax (V) and BG+V. Participants with R/R CLL will be administered BR+V.

design_allocation: Non-Randomized

lead_sponsor: Genentech, Inc.

location_country:
Germany
United States
France

location_facility: Apotheke des Universitätsklinikums Freiburg

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: University of California San Diego Medical Center

location_facility: Ingalls Hospital; Cancer Clinical Trials


title: 12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

summary: This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

ReferenceCitation: Trenkwalder C, Stocchi F, Poewe W, Dronamraju N, Kenney C, Shah A, von Raison F, Graf A. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies. Mov Disord. 2016 Jul;31(7):1054-8. doi: 10.1002/mds.26585. Epub 2016 May 23.

name: Paracelsus-Elena Klinik, Kassel 34128, Germany; Department of Neurosurgery; University Medical Center; Goettingen Germany

family: Trenkwalder

full_name: Claudia Trenkwalder

given: Claudia

family: Stocchi

full_name: Fabrizio Stocchi

given: Fabrizio

name: Department of Neurology; Medical University; Innsbruck Austria

family: Poewe

full_name: Werner Poewe

given: Werner

name: Novartis Pharmaceuticals Corporation; East Hanover New Jersey USA

family: Dronamraju

full_name: Nalina Dronamraju

given: Nalina

family: Kenney

full_name: Chris Kenney

given: Chris

family: Shah

full_name: Amy Shah

given: Amy

family: von Raison

full_name: Florian von Raison

given: Florian

family: Graf

full_name: Ana Graf

given: Ana

journal_name: Movement Disorders

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Mavoglurant in Parkinson's patients withl-Dopa-induced dyskinesias: Two randomized phase 2 studies

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
France
Hungary
Spain
Germany
Canada


title: Perceval S Valve Clinical Trial for Extended CE Mark

acronym: CAVALIER

summary: The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: LivaNova

location_country:
Austria
Switzerland
Netherlands
France
Poland
Belgium
Germany
United Kingdom

location_facility: RHÖN Klinikum AG, Herz- und Gefäß-Klinik GmbH

location_facility: Inselspital, Universitätsklinik für Herz- und Gefässchirurgie

location_facility: Academic Medical Center, Division of Cardio-thoracic Surgery

intervention_type: Device

status_simplified: Unknown


type: Other Identifier

title: A Post-Market, Open Observational Long-term Effectiveness Follow-up Study of Participants With Drug-resistant Epilepsy With Partial-onset Seizures Previously Enrolled in a Randomized Controlled Trial (E-100: PuLsE) Comparing Best Medical Practice With or w/o Adjunctive Vagus Nerve Stimulation Therapy

acronym: PuLsE 2

summary: This is a post-market, open observational long-term effectiveness follow-up study of participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in a randomized controlled trial (PuLsE) comparing Best Medical Practice with or without adjunctive Vagus Nerve Stimulation Therapy.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Cyberonics, Inc.

location_country:
Italy
Netherlands
France
Belgium
Germany
United Kingdom
Canada

location_facility: Azienda Ospedialiera "Bianchi Melacrino Morelli"

location_facility: Hopital Neurologique Unite d' epileptologie

location_facility: QE2 Health Sciences Centre Department of Neurology

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Universitatsklinl Erlangen Zentrum fur Epilepsie

location_facility: Hopital Roger Salengro Service de Neurologie


title: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..

summary: A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.

lead_sponsor: AstraZeneca

location_country:
Sweden
France
Bulgaria
Poland
Russian Federation
Denmark
United Kingdom


title: A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke

summary: This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by imaging of the affected artery and functional testing.

lead_sponsor: Grifols Therapeutics LLC

location_country: Austria Serbia France Slovakia Australia Spain

location_facility: Clinical Center Niš, Center of Radiology

location_facility: Clinical Center of Vojvodina, Center for Radiology

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Neurology Clinic Hospital with Policlinic of F.D. Roosevelt

location_facility: Heidelberg Repatriation Hospital, Melbourne

location_facility: Neurology Clinic, Faculty Hospital Nitra

location_facility: Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie

location_facility: Radiology Clinic, University Hospital Martin

location_facility: Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Special Hospital for Cerebrovascular Diseases "Sveti Sava"

location_facility: Clinical Center Kragujevac, Center for Radiology Diagnostic

location_facility: I. Neurology Clinic, University Hospital Bratislava

location_facility: Neurology Clinic, Central Military Faculty Hospital

location_facility: Hospital General Vall d'Hebron, Barcelona

intervention_type: Biological


title: A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multicentre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 for the Prevention of Migraine

summary: Evaluation of ADX10059 to prevent migraine attacks

status: Terminated

enrollment_type: Anticipated

lead_sponsor: Addex Pharma S.A.

location_country:
Austria
France
Belgium
Germany
United Kingdom

location_facility:
05
10
Liverpool
Dreseden
02
Göppingen
24
Sint-Truiden
Liège
Leipzig
Toulouse
Hamburg
Itzehoe
Wilrijk
Magdeburg
28
Paris
Freiburg
Görlitz
Lille
Manchester
06
Wiesbaden
Bochum
Berlin Hellersdorf 11
Nice
Frankfurt
Münster
Berkshire
Cardiff


title: A Double Blind, Within Patient, Placebo Controlled Trial to Assess the Efficacy of Juvista (Avotermin) in Conjunction With Scar Revision Surgery for the Improvement of Disfiguring Scars.

acronym: Revise

summary: This trial is to determine whether Juvista can prevent scar formation or improve the appearance of scars following scar revision surgery. The trial will involve comparing Juvista to placebo.

lead_sponsor: Renovo

location_country:
Italy
United Kingdom
Germany
France
Poland
Hungary
Spain
Denmark
United States
Latvia

location_facility: Hospital de la Santa Creu I Sant Pau, Departamento Cirugía Plástica

location_facility: Fővárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelőintézet

location_facility: Hôpital Emile Muller, Service de chirurgie plastique

location_facility: Fondazione S. Maugeri, U.O. DI CHIRURGIA PLASTICA E RICOSTRUTTIVA

location_facility: Chirurgia Plastica, Umberto I Policlinico di Roma

location_facility: Paula Stradina Clinical University Hospital

location_facility: Wojskowy Instytut Medyczny Kliniczny Oddział Chirurgii Plastycznej,

location_facility: Hospital de Conxo-Complejo Hospitalario Universitario de Santiago de Compostela, Servicio de Cirugía plástica

location_facility: Kenézy Kórház Rendelőintézet Egészségügyi Szolgáltató Kft.

location_facility: Friedrich-Schiller-Universität Jena, Klinik für Dermatologie, Erfurter Strasse 35

location_facility: Hospital Clinic, Departament o Cirugia plástica

location_facility: Wojewódzki Szpital Specjalistyczny im. Ludwika Rydygiera, os. Złotej Jesieni 1

location_facility: Hospital Universitario Nuestra Señora del Perpetuo Socorro

location_facility: Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej Zachodniopomorski

location_facility: Unfallkrankenhaus Berlin, Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Warener Strasse 7

location_facility: Universitätsklinikum Schleswig-Holstein- Campus Lübec Plastische Chirurgie, Handchirurgie, Ratzeburger Allee 160

location_facility: Renovo Clinical Trials Unit, 48 Grafton Street

location_facility: Sollorod Privethospital, Primary Clinic, Hjortholmsvej 2C

location_facility: Ospedale di Circolo di Varese "Fondazione Macchi", Chirurgia Plastica

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Magyarországi Református Egyház Bethesda Gyermekkórháza Égéssérült Gyermekeket Ellátó Országos Központ

location_facility: Klinikum Offenbach GmbH - Chirurgische Klinik III, Starkenburgring 66

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Queen Victoria Hospital (QVH) NHS Foundation Trust

location_facility: St Josef und St Elisabeth Hospital, Klinik fur Dermatologie und Allergologie, Gundrunstrasse 56

location_facility: Klinkia Chirurgii Plastycznej, Akademickie Centrum Kliniczne

location_facility: Krankenhaus Barmherzige Brüder Regensburg

location_facility: Chirurgia Plastica e Ricostruttiva, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone


lead_sponsor: Cephalon

location_country: Italy Austria France Belgium Spain Germany

location_facility:
Teva Investigational Site 9
Teva Investigational Site 20
Teva Investigational Site 2
Teva Investigational Site 32
Teva Investigational Site 8
Teva Investigational Site 33
Teva Investigational Site 14
Teva Investigational Site 30
Teva Investigational Site 25
Teva Investigational Site 5
Teva Investigational Site 27
Teva Investigational Site 34
Teva Investigational Site 26
Teva Investigational Site 23
Teva Investigational Site 1
Teva Investigational Site 21
Teva Investigational Site 29
Teva Investigational Site 3
Teva Investigational Site 4
Teva Investigational Site 16
Teva Investigational Site 15
Teva Investigational Site 11

source: euctr

title: Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Trastuzumab, in Neoadjuvant Setting in Treatment-Naive Patients With HER2-Positive Breast Cancer

summary: Evaluate the efficacy and safety of treatment with MYOCET® in combination with Cyclophosphamide and Trastuzumab, 4 cycles, followed by Docetaxel plus Trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the HER2 gene.


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

acronym: BRAVE II

summary: The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

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:
Italy
South Africa
Chile
India
Serbia
Philippines
France
Japan
Poland
Romania
Argentina
Spain
United States
Korea, Republic of
Colombia

location_facility: Suite 509 Umhlanga Netcare Medical Centre

location_facility: Institute for Treatment and Rehabilitation Niska Banja

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Arizona Arthritis & Rheumatology Research

location_facility: HPTU-El Hospital con alma Pablo Tobon Uribe

location_facility: Johns Hopkins University School of Medicine

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Angeles University Foundation and Medical Center

location_facility: Azienda Ospedaliera Santa Maria Della Misericordia

location_facility: Integral Rheumatology & Immunology Specialists

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

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Craiova Emergency Clinical County Hospital

location_facility: Comite de Etica en Investigacion - CEMIC

location_facility: Aprillus Asistencia e Investigacion - Servicio de neurologia

location_facility: Kasturba Medical College Hospital, Mangalore

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: Glacier View Research Institute - Endocrinology

location_facility: IR Medical Center S.A. Instituto de Reumatologia

location_facility: ChanRe Rheumatology And Immunology Center And Research

location_facility: University of Occupational and Enviromental Health

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Box Arthritis & Rheumatology of the Carolinas, PLLC

location_facility: Napoca Emergency Clinical County Hospital

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: Seoul National University Bundang Hospital

location_facility: Arizona Arthritis & Rheumatology Associates, P. C.

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

location_facility: NHL Municipal Medical College & VS General Hospital

location_facility: Centro Integral de Reumatologia e Inmunologia

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

location_facility: Centre hospitalier universitaire Pellegrin

location_facility: Sushruta Multispecialty Hospital & Research Center Pvt Ltd

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: Synexus Affiliate - Sujata Birla Hospital & Medical Research Center

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu

location_facility: Sociedad Medica Del Aparato Locomotor SA


title: Protocol H7T-MC-TABL(a) PRasugrel IN Comparison to Clopidogrel for Inhibition of PLatelet Activation and AggrEgation (PRINCIPLE) - TIMI 44

acronym: PRINCIPLE

summary: The purpose of this study is to provide information of the relative potency of prasugrel and clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects undergoing elective percutaneous coronary intervention (PCI).

location_country:
Israel
Germany
United States
France

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


title: A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, Formerly PT2977) Monotherapy in Participants With Advanced Pheochromocytoma/Paraganglioma (PPGL) or Pancreatic Neuroendocrine Tumor (pNET)

summary: This is a study to evaluate the efficacy and safety of Belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL) or pancreatic neuroendocrine tumor (pNET). The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

status: Recruiting

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
Sweden
France
Hungary
Russian Federation
Spain
Turkey
Denmark
United States
United Kingdom

location_facility: Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)

location_facility: Vanderbilt University Medical Center ( Site 0107)

location_facility: Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (

location_facility: Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)

location_facility: MD Anderson Cancer Center-Oncology ( Site 1102)

location_facility: CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)

location_facility: GBUZ Republican Clinical Oncological Dispensary ( Site 0804)

location_facility: Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)

location_facility: Hammersmith Hospital-Medical Oncology ( Site 1304)

location_facility: Hospital Universitari Vall d'Hebron ( Site 1100)

location_facility: Skanes University Hospital Lund ( Site 1200)

location_facility: Hôpital Edouard Herriot-oncologie ( Site 0405)

location_facility: Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 0901)

location_facility: Cedars-Sinai Medical Center ( Site 0110)

location_facility: Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)

location_facility: Ege University Medicine of Faculty ( Site 0900)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)

location_facility: Rigshospitalet-Department of Endocrinology ( Site 0303)

location_facility: Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site

location_facility: University of Texas MD Anderson Cancer Center ( Site 0112)

location_facility: Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)

location_facility: University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)

status_simplified: Ongoing


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

primary_purpose: Other

location_country:
Italy
United States
Brazil
Sweden
Saudi Arabia
Germany
France
Japan
Greece
Israel
Belgium
Australia
Spain
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Ege Universitesi Tip Fakultesi Hematoloji BD

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Center for Child Health and Development

location_facility: Akdeniz University Medical Faculty Hospital

location_facility: Nagoya University Hospital - Transfusion Medicine

location_facility: Indiana Hemophilia & Thrombosis Center, Inc.

location_facility: SODc. Malattie Emorragiche e della Coagulazione Centro di Riferimento Regionale per le

location_facility: lnstituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO

location_facility: General Hospital of Athens "Hippokration"

location_facility: The Chaim Sheba Medical Center, The National Hemophilia Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus

location_facility: Acibadem Adana Hospital, Department of Pediatric Hematology

location_facility: Gaziantep University Sahinbey Training and Research Hospital

location_facility: Centro de Hemoterapia e Hematologia do Para - Fundação HEMOPA

location_facility: University of California, San Francisco - Clinical Research Center

location_facility: University of California San Francisco - UCSF HTC

location_facility: Penn Comprehensive Hemophilia & Thrombosis Program, Hospital of the University of Pennsylvania

location_facility: Cliniques universitaires Saint-Luc/Unité d'Hématology et Hémostase

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: General Hospital of Athens "LAIKO", 2nd Regional Blood Transfusion Center

location_facility: Università degli studi di Roma "La Sapienza"- Policlinico Umberto I

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: Universitatsklinikum Bonn. Anstalt des oeffentlichen Rechts

location_facility: Clinical and Translational Research Unit (CTRU)

location_facility: Mississippi Center for Advanced Medicine

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: McMaster University Medical Centre - Hamilton Health Sciences

location_facility: University of California, San Francisco - Outpatient Hematology Clinic

location_facility: Ege Universitesi Tip Fakultesi Cocuk Sagligi Ve Hastaliklari Anabilim Dali Pediatric Hematoloji

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

location_facility: Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

title: AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, LEAD-IN STUDY TO EVALUATE AT LEAST 6 MONTHS OF PROSECTIVE EFFICACY AND SAFETY DATA OF FACTOR IX OR FACTOR VIII PROPHYLAXIS REPLACEMENT THERAPY IN THE USUAL CARE SETTING OF MODERATELY SEVERE TO SEVERE ADULT HEMOPHILIA B SUBJECTS (FIX:C≤2%) WHO ARE NEGATIVE FOR nAb TO AAV VECTOR-SPARK100 AND MODERATELY SEVERE TO SEVERE HEMOPHILIA A ADULT SUBJECTS (FVIII:C≤1%) WHO ARE NEGATIVE FOR nAb TO AAV VECTOR SB-525 CAPSID (AAV6), PRIOR TO THE RESPECTIVE THERAPEUTIC PH 3 GENE THERAPY STUDIES (See Detailed Description Section for Official Protocol Title)

summary:
To establish a minimum of 6 months of prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study.

To establish a minimum of 6 months of prospective efficacy data of current FVIII prophylaxis replacement therapy in the usual care setting of hemophilia A subjects, who are negative for nAb to SB-525 capsid (AAV6), prior to the Phase 3 gene therapy study.

The enrollment for hemophilia A participants is completed. At this time participants are only being enrolled for hemophilia B cohort.


intervention_type: Other

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

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

location_country:
Peru
Guatemala
Malaysia
Greece
Russian Federation
Oman
Denmark
India
Croatia
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Bulgaria
Singapore
Hungary
Puerto Rico
Germany
United States
Austria
Brazil
Czechia
Spain
Turkey

ipd_sharing: Undecided

title: A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

summary:
The purpose of this study is to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.

The study population will consist of approximately 1050 male and female subjects aged ≥ 12 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-antihistamines. Of these, approximately 1000 adults and 50 adolescents are planned for inclusion in the study.

This is a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.


status: Active, not recruiting

location_country:
Finland
Romania
Belgium
Australia
Russian Federation
Taiwan
India
France
Japan
Poland
Slovakia
Argentina
Chile
Netherlands
Philippines
Vietnam
Germany
United States
United Kingdom
Italy
Brazil
Lebanon
Mexico
Israel
Tunisia
Spain
Estonia


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis

acronym: SPIRIT

summary: The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.

ReferenceCitation: Shenderov K, Collins SL, Powell JD, Horton MR. Immune dysregulation as a driver of idiopathic pulmonary fibrosis. J Clin Invest. 2021 Jan 19;131(2). pii: 143226. doi: 10.1172/JCI143226. Review.

family: Shenderov

full_name: Kevin Shenderov

given: Kevin

family: Collins

full_name: Samuel L. Collins

given: Samuel L.

family: Powell

full_name: Jonathan D. Powell

given: Jonathan D.

family: Horton

full_name: Maureen R. Horton

given: Maureen R.

journal_name: Journal of Clinical Investigation

publisher: American Society for Clinical Investigation

lead_sponsor: Biogen

location_country:
Italy
Chile
Netherlands
Spain
France
Czechia
Greece
Israel
Poland
Belgium
Argentina
Australia
Russian Federation
Denmark
United States
United Kingdom
Korea, Republic of

location_facility:
Research Site
Reserach Site


ReferenceCitation: Reich K, Teixeira HD, de Bruin-Weller M, Bieber T, Soong W, Kabashima K, Werfel T, Zeng J, Huang X, Hu X, Hendrickson BA, Ladizinski B, Chu AD, Silverberg JI. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 5;397(10290):2169-2181. doi: 10.1016/S0140-6736(21)00589-4. Epub 2021 May 21. Erratum in: Lancet. 2021 Jun 19;397(10292):2336. Lancet. 2021 Aug 28;398(10302):746.

family: Reich

full_name: Kristian Reich

given: Kristian

family: Teixeira

full_name: Henrique D Teixeira

given: Henrique D

family: de Bruin-Weller

full_name: Marjolein de Bruin-Weller

given: Marjolein

family: Bieber

full_name: Thomas Bieber

given: Thomas

family: Soong

full_name: Weily Soong

given: Weily

family: Kabashima

full_name: Kenji Kabashima

given: Kenji

family: Werfel

full_name: Thomas Werfel

family: Zeng

full_name: Jiewei Zeng

given: Jiewei

family: Huang

full_name: Xiaohong Huang

given: Xiaohong

family: Hu

full_name: Xiaofei Hu

given: Xiaofei

family: Hendrickson

full_name: Barbara A Hendrickson

given: Barbara A

family: Ladizinski

full_name: Barry Ladizinski

given: Barry

family: Chu

full_name: Alvina D Chu

given: Alvina D

family: Silverberg

full_name: Jonathan I Silverberg

given: Jonathan I

journal_name: The Lancet

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Greece
Australia
Belgium
France
Japan
Slovakia
Norway
Canada
Sweden
Hong Kong
Netherlands
Hungary
Ireland
Puerto Rico
China
United States
Germany
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain

acronym: AD Up

location_facility: Kepler Universitaetsklinikum GmbH /ID# 201075

location_facility: Osaka Habikino Medical Center /ID# 204243

location_facility: Dermatology Physicians of Connecticut /ID# 201004

location_facility: Univerzitna nemocnica Martin /ID# 203851

location_facility: Vital Prospects Clinical Research Institute, PC /ID# 200901

location_facility: IMTR - Grand Hopital de Charleroi /ID# 202029

location_facility: Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373

location_facility: Universitaetsklinikum Frankfurt /ID# 202095

location_facility: Beth Israel Deaconess Medical Center /ID# 200545

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 201193

location_facility: Duplicate_Tokai University Hachioji Hospital /ID# 201711

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372

location_facility: GCM Medical Group PSC - Hato Rey /ID# 202003

location_facility: Hiroshima University Hospital /ID# 201914

location_facility: South Infirmary Victoria University Hospital /ID# 201079

location_facility: Advanced Clinical Research - Woseth Dermatology /ID# 213745

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742

location_facility: Dartmouth-Hitchcock Medical Center /ID# 200918

location_facility: Queens Square Medical Center dermatology allergology /ID# 203850

location_facility: Yamate Dermatological Clinic /ID# 202130

location_facility: Jichi Medical University Hospital /ID# 201913

location_facility: Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 210897

location_facility: Clinical Research Puerto Rico /ID# 203644

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 202045

location_facility: Sahlgrenska University Hospital /ID# 201274

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 202052

location_facility: Advanced Dermatology and Skin Care Centre /ID# 213550

location_facility: AP-HM - Hopital de la Timone /ID# 206128

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 204642

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 200751

location_facility: 401 GSNA - 401 Army General Hospital /ID# 211963

location_facility: University Hospital Waterford /ID# 201253

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240

location_facility: Oregon Dermatology and Research Center /ID# 200601

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132

location_facility: The First Hospital of China Medical University /ID# 209840

location_facility: Psoriasis Treatment Center of Central New Jersey /ID# 200714

location_facility: Juntendo University Hospital /ID# 202888

location_facility: Dermatology Associates of Seattle /ID# 200717

location_facility: Medizinische Hochschule Hannover /ID# 202098

location_facility: Universitetssykehuset N-Norge, Tromso /ID# 201270

location_facility: Universitair Medisch Centrum Utrecht /ID# 202194

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256

location_facility: Therapeutics Clinical Research /ID# 200593

location_facility: Medizinische Universitaet Wien /ID# 201080

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 200330

location_facility: Hospital Universitario 12 de Octubre /ID# 201135

location_facility: University of California Irvine /ID# 200902

location_facility: Clin Res Inst of Michigan, LLC /ID# 208020

location_facility: Arizona Research Center, Inc. /ID# 200546

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 205780

location_facility: Florida Academic Centers Research and Education /ID# 200544

location_facility: Epiphany Dermatology of Kansas LLC /ID# 203026

location_facility: Universitetssykehuset N-Norge, Harstad /ID# 201269

location_facility: Soroka University Medical Center /ID# 206652

location_facility: Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 201765

location_facility: University General Hospital Attikon /ID# 201126

location_facility: Center for Clinical Studies - Webster TX /ID# 203186

location_facility: Sanatorium profesora Arenbergera /ID# 202082

location_facility: Hospital Universitario de la Princesa /ID# 201517

location_facility: Skane University Hospital Lund /ID# 201244

location_facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728

location_facility: Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403

location_facility: Total Skin and Beauty Derm Ctr /ID# 200548

location_facility: National Hospital Organization Sagamihara National Hospital /ID# 201658

location_facility: Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822

location_facility: Michigan Center for Research Company /ID# 200560

location_facility: General Hospital Andreas Syggros /ID# 201123

location_facility: Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248

location_facility: Hospital Universitario La Paz /ID# 205438

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669

location_facility: Hospital Santa Creu i Sant Pau /ID# 201325

location_facility: CHRU Tours - Hopital Gatien de Clocheville /ID# 218209

location_facility: Universitair Medisch Centrum Groningen /ID# 202195

location_facility: Clinical Research of West Florida, Inc /ID# 203643

location_facility: Universitaetsklinik Heidelberg /ID# 202097

location_facility: CMS3 Company for Medical Study /ID# 205195

location_facility: Karolinska University Hospital /ID# 201243

location_facility: Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124

location_facility: Medical Corporation Matsuo Clinic /ID# 202312

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194

location_facility: Progressive Clinical Research /ID# 201582

location_facility: Eastern Canada Cutaneous Resea /ID# 200335

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 209567

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 201106

location_facility: Hospital General Universitario Alicante /ID# 200873

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 202392

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144

location_facility: Northwestern University Feinberg School of Medicine /ID# 201646

location_facility: Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628

location_facility: Colorado Center for Dermatology, PLLC /ID# 203626

location_facility: St George Dermatology & Skin Cancer Centre /ID# 204788

location_facility: Duplicate_Western States Clinical Research, Inc. /ID# 201702

location_facility: Chinese PLA General Hospital /ID# 206786

location_facility: Dermatology Research Institute Inc. /ID# 200341

location_facility: Rivergate Dermatology & Skin Care Center /ID# 201698

location_facility: NHS Greater Glasgow and Clyde /ID# 201374

location_facility: Hospital Universitario de Puerto Real /ID# 200875

location_facility: Arlington Research Center, Inc /ID# 200559

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093

location_facility: Tel Aviv Sourasky Medical Center /ID# 201608

location_facility: Huashan Hospital of Fudan University /ID# 207437

location_facility: Children's Hosp P. A. Kyriakou /ID# 217573

location_facility: Angela Montgomery Medicine Professional Corporation /ID# 212653

location_facility: Bakersfield Derma & Skin Cance /ID# 200892

location_facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556

location_facility: Universitaetsklinikum Muenster /ID# 202094

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744

location_facility: Clear Dermatology & Aesthetics Center /ID# 201257

location_facility: University of Wisconsin - Madison /ID# 204933

location_facility: Haukeland University Hospital /ID# 201152

location_facility: Xiangya Hospital Central South University /ID# 207510

location_facility: The Centre for Clinical Trials /ID# 205404

title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

summary: The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe Atopic dermatitis (AD) who are candidates for systemic therapy.


location_country:
Serbia
France
Spain
United States
Korea, Republic of
Taiwan

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: National Cheng Kung University Hospital; Internal Medicine

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Institut De Cancerologie De L'Ouest; Medical Oncology

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Centro Medico Quironsalud Sagrado Corazon

location_facility: SCRI Florida Cancer Specialists North; Research Office North Region.

location_facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Hospital General Universitario de Alicante

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil

location_facility: Taipei Medical University -Shuang Ho Hospital

location_facility: Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Hopital Nord AP-HM; Service Clinique des bronches allergies et sommeil

title: A Phase II, Randomized, Blinded, Placebo-Controlled Study of Tiragolumab, An Anti-TIGIT Antibody, In Combination With Atezolizumab In Chemotherapy-Naïve Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

summary: This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.


ReferenceCitation: Rab MAE, Van Oirschot BA, Kosinski PA, Hixon J, Johnson K, Chubukov V, Dang L, Pasterkamp G, Van Straaten S, Van Solinge WW, Van Beers EJ, Kung C, Van Wijk R. AG-348 (Mitapivat), an allosteric activator of red blood cell pyruvate kinase, increases enzymatic activity, protein stability, and ATP levels over a broad range of PKLR genotypes. Haematologica. 2021 Jan 1;106(1):238-249. doi: 10.3324/haematol.2019.238865.

family: Rab

full_name: Minke A.E. Rab

given: Minke A.E.

family: Van Oirschot

full_name: Brigitte A. Van Oirschot

given: Brigitte A.

family: Kosinski

full_name: Penelope A. Kosinski

given: Penelope A.

family: Hixon

full_name: Jeffrey Hixon

given: Jeffrey

family: Johnson

full_name: Kendall Johnson

given: Kendall

family: Chubukov

full_name: Victor Chubukov

given: Victor

family: Dang

full_name: Lenny Dang

given: Lenny

family: Pasterkamp

full_name: Gerard Pasterkamp

given: Gerard

family: Van Straaten

full_name: Stephanie Van Straaten

given: Stephanie

family: Van Solinge

full_name: Wouter W. Van Solinge

given: Wouter W.

family: Van Beers

full_name: Eduard J. Van Beers

given: Eduard J.

family: Kung

full_name: Charles Kung

given: Charles

family: Van Wijk

full_name: Richard Van Wijk

given: Richard

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

evidence: oa journal (via doaj)

license: publisher-specific license

license_normalized: publisher-specific

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Italy
Brazil
Switzerland
Netherlands
Spain
Germany
France
Czechia
Japan
Korea, Republic of
Thailand
Portugal
Turkey
Denmark
United States
United Kingdom
Canada

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: Wayne State University School of Medicine, Children's Hospital of Michigan

location_facility: AOU Policlinico, Università della Campania "Luigi Vanvitelli"

location_facility: Institute of Hematology and Blood Transfusion

location_facility: Primary Children's Hospital Univ. of Utah

location_facility: Toronto General Hospital, University Health Network

location_facility: Department of Paediatrics and Thalassaemia Center, Faculty of Medicine Siriraj

location_facility: University of Arkansas for Medical Sciences

location_facility: Kansai Medical University, Department of Pediatrics, Hirakata Hospital

location_facility: McMaster University - Health Sciences Centre

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Hospital U. Vall d'Hebron Servicio de Hematología Clínica

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: The Children's Hospital Corporation d/b/a Boston's Children Hospital

location_facility: The Royal Liverpool and Broadgreen University

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: University of Copenhagen, Herlev Hospital

location_facility: UNICAMP - Hemocentro (Centro de Hematologia e Hemoterapia) Predio Dos Ambulatorios

location_facility: Hospital Central da Faculdade de Medicina USP Cidade Universitaria

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: Hospital Clinico Universitario Virgen de la Arricaxa

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency

summary: Study AG348-C-006 will evaluate the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase deficiency (PKD), who are not regularly receiving blood transfusions. Participants will be randomized 1:1 to receive either AG-348 or matching placebo. The study is comprised of two parts. During the Part 1 Dose Optimization Period of the study, participants will start on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1, each participant's dose of AG-348 may be sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During the Part 2 Fixed-Dose Period, participants will receive AG-348 at their optimized dose from Part 1.


lead_sponsor: Jazz Pharmaceuticals

location_country:
Finland
France
Czechia
Poland
Belgium
Spain
United States
United Kingdom

location_facility: Ohio Sleep Medicine and Neuroscience Institute

location_facility: lnstytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej

location_facility: Hospital Vithas Nuestra Señora de America

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Southern California Institute for Respiratory Diseases, Inc.

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: SleepCare Research Institute d/b/a Clinical Research

location_facility: Montefiore Medical Center/Sleep-Wake Disorders Center

ipd_sharing: No

title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

summary: This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.


ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

lead_sponsor: LEO Pharma

location_country:
United States
Netherlands
Germany
France
Japan
Poland
Belgium
Australia
Canada
United Kingdom

location_facility:
LEO Pharma Investigational Site
Leo Pharma Investigationel Site
Leo Pharma Investigational Site

title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy

summary:
Primary objective:

To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo.

To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.


lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Brazil
United States
Chile
Hong Kong
Mexico
Netherlands
Spain
France
Argentina
Australia
Russian Federation
China
Turkey
Canada
United Kingdom

acronym: CheckMate 9UT

location_facility: Instituto Nazionale Tumori Fondazione G. Pascale

location_facility: Centro De Estudios Y Prevencion Del Cancer A. C.

location_facility: Rutgers, the State University of New Jersey

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Kaiser Permanente Medical Group - Southern California

title: A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

summary: A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer


title: An Open-Label Phase 1/2a Study of the Safety and Efficacy of Melflufen and Dexamethasone in Combination With Either Bortezomib or Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma

acronym: ANCHOR

summary: This is an open-label Phase 1/2a study which will enroll patients that have relapsed or relapsed-refractory multiple myeloma following 1-4 lines of prior therapy. Patients will receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab and are required to be IMiD refractory to be enrolled to the bortezomib regimen, and to not have any prior exposure to daratumumab or other antiCD-38 mAb to be enrolled to the daratumumab regimen.

lead_sponsor: Oncopeptides AB

location_country:
United States
France
Czechia
Spain

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Centre Hospitalier Universitaire Institut Gustave Roussy

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Universitai Germans Trias i Pujol


location_country:
United States
Peru
France
Czechia
Japan
Israel
Poland
Hungary
Argentina
Spain
Turkey
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Kamei Internal Medicine and Respiratory Clinic ( Site 1509)

location_facility: Osaka Habikino Medical Center ( Site 1546)

location_facility: MeDiNova Yorkshire Dedicated Research Centre ( Site 2708)

location_facility: CEMEDIC - Centro de Especialidades Medicas ( Site 0304)

location_facility: Midwest Allergy Sinus Asthma, SC ( Site 0081)

location_facility: National Hospital Organization Ibarakihigashi National Hospital ( Site 1526)

location_facility: Sher Allergy Specialists/Center For Cough ( Site 0078)

location_facility: Prywatny Gabinet Specjalistyczny ( Site 1927)

location_facility: Recep Tayyip Erdogan Universitesi Tip Fakultesi Egitim ve Aras. Has ( Site 2620)

location_facility: Hospital Chancay y Servicios Basicos de Salud ( Site 1810)

location_facility: Taichung Veterans General Hospital ( Site 2401)

location_facility: National Hospital Organization Fukuoka Hospital ( Site 1552)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 1503)

location_facility: Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)

location_facility: Hospital Clinico Universitario de Santiago ( Site 2303)

location_facility: Yedikule Gogus Hast. ve Gogus Cer. Egitim ve Arastirma Hastanesi ( Site 2601)

location_facility: Ishikawa Prefectural Central Hospital ( Site 1554)

location_facility: Medical Corporation Shintokai Yokohama Minoru Clinic ( Site 1568)

location_facility: Clinical Research Institute LLC ( Site 0004)

location_facility: Investigaciones en Patologias Respiratorias ( Site 0325)

location_facility: Prywatny Gabinet Internistyczno ( Site 1928)

location_facility: Pneumologie Varnsdorf S.R.O. ( Site 0706)

location_facility: Idaimae Minamiyojo Int Clinic ( Site 1521)

location_facility: Konkuk University Medical Center ( Site 2205)

location_facility: Pulmonary Associates of Richmond Inc. ( Site 0101)

location_facility: Kanazawa University Hospital ( Site 1536)

location_facility: Intermountain Clinical Research ( Site 0033)

location_facility: Biosolutions Clinical Research Center ( Site 0070)

location_facility: Research Solutions of Arizona PC ( Site 0036)

location_facility: Tokyo Metropolitan Geriatric Hospital ( Site 1577)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 2309)

location_facility: CCBR AS Vejle, Center for Clinical & Basic Research ( Site 0801)

location_facility: Changhua Christian Hospital ( Site 2403)

location_facility: Tokyo Medical University Hachioji Medical Center ( Site 1569)

location_facility: The Catholic University of Korea St. Mary s Hospital ( Site 2215)

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2606)

location_facility: Asociacion Civil por la Salud ( Site 1805)

location_facility: Pharmaceutical Research & Consulting, Inc. ( Site 0029)

location_facility: Saiseikai Yokohamashi Nanbu Hospital ( Site 1533)

location_facility: Florida Pulmonary Research Institute, LLC ( Site 0019)

location_facility: Juntendo University Hospital ( Site 1578)

location_facility: Wonju Severance Christian Hospital ( Site 2214)

location_facility: Chaim Sheba Medical Center. ( Site 1304)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 1519)

location_facility: Incheon St. Mary s Hospital ( Site 2200)

location_facility: JA Niigatakoseiren Niigata Medical Center ( Site 1522)

location_facility: Centro Medico Privado de Reumatologia ( Site 0309)

location_facility: National Hospital Organization Disaster Medical Center ( Site 1558)

location_facility: Nagoya City University Hospital ( Site 1528)

location_facility: Cotton-O'Neil Clinical Research Center ( Site 0052)

location_facility: Yokohama City Minato Red Cross Hospital ( Site 1506)

location_facility: I.U. Cerrahpasa Tip Fakultesi Gogus Hastaliklari Anabilim Dali ( Site 2600)

location_facility: 167877 Canada Inc. Dr. Jaime Del Carpio ( Site 0506)

location_facility: Center for Clinical Trials, LLC ( Site 0059)

location_facility: National Clinical Research-Richmond, Inc. ( Site 0073)

location_facility: National Hospital Organization Tokyo National Hospital ( Site 1557)

location_facility: Terada Clinic Respiratory Medicine & General Practice ( Site 1565)

location_facility: Sirius Clinical Research, LLC ( Site 0102)

location_facility: Kawaguchi Respiratory Clinic ( Site 1504)

location_facility: Q & T Research Sherbrooke Inc. ( Site 0512)

location_facility: Clinical Research of Gastonia ( Site 0043)

location_facility: Vital Prospects Clinical Research Institute, PC ( Site 0037)

location_facility: Seoul National University Hospital ( Site 2210)

location_facility: Korea University Guro Hospital ( Site 2213)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 2611)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 1539)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1206)

location_facility: Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)

location_facility: Mainland Medical Research Institute ( Site 0003)

location_facility: Hillel Yaffe Medical Center ( Site 1303)

location_facility: Plicni stredisko Teplice s. r. o ( Site 0700)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 1574)

location_facility: Far Eastern Memorial Hospital ( Site 2402)

location_facility: Centrum Medyczne Pratia Gdynia ( Site 1910)

location_facility: Centrum Medyczne Pratia Czestochowa ( Site 1926)

location_facility: CCBR AS Aalborg, Center for Clinical & Basic Research ( Site 0802)

location_facility: NZOZCentrum Medyczne Kermed ( Site 1905)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2613)

location_facility: Well Pharma Medical Research, Corp. ( Site 0093)

location_facility: National Hospital Organization Minami-Okayama Medical Center ( Site 1553)

location_facility: Hospital Nacional Adolfo Guevara Velasco ( Site 1808)

location_facility: Centrum Medyczne Pratia Bydgoszcz ( Site 1418)

location_facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2209)

location_facility: Hospital Privado Universitario de Cordoba ( Site 0313)

location_facility: Asthma Nasal Disease & Allergy Research Center of New England ( Site 0075)

location_facility: Shizuoka Prefectural Hospital Organization Shizuoka General Hospital ( Site 1524)

location_facility: Medinova Lakeside Dedicated Research Centre ( Site 2710)

location_facility: MUDr. I. Cierna Peterova s.r.o. ( Site 0707)

location_facility: National Hospital Organization Ehime Medical Center ( Site 1556)

location_facility: Charlottesville Medical Research Center, LLC ( Site 0006)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0900)

location_facility: Hiroshima Allergy & Respiratory Clinic ( Site 1529)

location_facility: Hallym University Sacred Heart Hospital ( Site 2208)

location_facility: Bernstein Clinical Research Center, LLC ( Site 0005)

location_facility: InAER Investigaciones en Alergia y Enfermedades Respiratorias ( Site 0324)

location_facility: Chang Gung Medical Foundation - Keelung Branch ( Site 2404)

location_facility: Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2815)

location_facility: National Taiwan University Hospital ( Site 2400)

location_facility: The Center for Pharmaceutical Research PC ( Site 0016)

location_facility: Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)

location_facility: F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)

location_facility: Hopital Arnaud de Villeneuve ( Site 0905)

type: Registry Identifier

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN027)

summary: The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.


lead_sponsor: GlaxoSmithKline

location_country:
Brazil
South Africa
Mexico
Finland
France
Russian Federation
Spain
Estonia
Turkey

acronym: MENACWY CONJ-069 (V59_78)

title: Immunogenicity, Reactogenicity and Safety Study of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) When Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age

summary:
MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries.

The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by storage at 2-8ºC.


title: A Prospective, Multi-center Study to Evaluate the Safety and Performance of the Hyperion™ ASD and PDA Closure Systems.

summary: The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD and PDA patients.

lead_sponsor: European Cardiovascular Research Center

location_country: Germany France Algeria China

location_facility: Hôpital cardiologique Haut-Leveque (CHU Bordeaux)

location_facility: Centre Médico-chirurgical infantile Bou Ismail


title: A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects With Chronic Genotype 1 or Genotype 4 HCV Infection

summary: The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection.

ReferenceCitation: Asselah T, Moreno C, Sarrazin C, Gschwantler M, Foster GR, Craxí A, Buggisch P, Ryan R, Lenz O, Scott J, Van Dooren G, Lonjon-Domanec I, Schlag M, Buti M. An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1). PLoS One. 2016 Jul 18;11(7):e0158526. doi: 10.1371/journal.pone.0158526. eCollection 2016.

family: Asselah

full_name: Tarik Asselah

given: Tarik

family: Moreno

full_name: Christophe Moreno

given: Christophe

family: Sarrazin

full_name: Christoph Sarrazin

given: Christoph

family: Gschwantler

full_name: Michael Gschwantler

given: Michael

family: Foster

full_name: Graham R. Foster

given: Graham R.

family: Craxí

full_name: Antonio Craxí

given: Antonio

family: Buggisch

full_name: Peter Buggisch

given: Peter

family: Ryan

full_name: Robert Ryan

given: Robert

family: Lenz

full_name: Oliver Lenz

given: Oliver

family: Scott

full_name: Jane Scott

given: Jane

family: Van Dooren

full_name: Gino Van Dooren

given: Gino

family: Lonjon-Domanec

full_name: Isabelle Lonjon-Domanec

given: Isabelle

family: Schlag

full_name: Michael Schlag

family: Buti

full_name: Maria Buti

given: Maria

currency_apc_doaj: USD

journal_name: PLOS ONE

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

repository_institution: Queen Mary University of London - Queen Mary Research Online

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

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

location_country:
Austria
Saudi Arabia
France
Belgium
Spain
Germany
United Kingdom


title: Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation.

summary: The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial fibrillation (AF).

ReferenceCitation: Pavlovic N, Chierchia GB, Velagic V, Hermida JS, Healey S, Arena G, Badenco N, Meyer C, Chen J, Iacopino S, Anselme F, Dekker L, Scazzuso F, Packer DL, de Asmundis C, Pitschner HF, Piazza FD, Kaplon RE, Kuniss M; Cryo-FIRST Investigators. Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms. Am Heart J. 2021 Dec;242:103-114. doi: 10.1016/j.ahj.2021.08.007. Epub 2021 Sep 8.

family: Pavlovic

full_name: Nikola Pavlovic

given: Nikola

family: Chierchia

full_name: Gian-Battista Chierchia

given: Gian-Battista

family: Velagic

full_name: Vedran Velagic

given: Vedran

family: Hermida

full_name: Jean Sylvain Hermida

given: Jean Sylvain

family: Healey

full_name: Stewart Healey

given: Stewart

family: Arena

full_name: Giuseppe Arena

given: Giuseppe

family: Badenco

full_name: Nicolas Badenco

given: Nicolas

family: Meyer

full_name: Christian Meyer

given: Christian

family: Chen

full_name: Jian Chen

given: Jian

family: Iacopino

full_name: Saverio Iacopino

given: Saverio

family: Anselme

full_name: Frédéric Anselme

given: Frédéric

family: Dekker

full_name: Lukas Dekker

given: Lukas

family: Scazzuso

full_name: Fernando Scazzuso

given: Fernando

family: Packer

full_name: Douglas L. Packer

given: Douglas L.

family: de Asmundis

full_name: Carlo de Asmundis

given: Carlo

family: Pitschner

full_name: Heinz-Friedrich Pitschner

given: Heinz-Friedrich

family: Piazza

full_name: Fabio Di Piazza

given: Fabio Di

family: Kaplon

full_name: Rachelle E. Kaplon

given: Rachelle E.

family: Kuniss

full_name: Malte Kuniss

given: Malte

family: Cryo-FIRST Investigators

full_name: Cryo-FIRST Investigators

oa_host_type: publisher

title: Initial Rhythm Control with Cryoballoon Ablation versus Drug Therapy: Impact on Quality of Life and Symptoms

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: Italy Netherlands France Croatia Norway Belgium Argentina Australia Germany

location_facility: Klinicki bolnicki centar Sestre Milosrdnice

location_facility: Heart Rhythm Management Centre, UZ Brussels - VUB Brussel


ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Baxalta now part of Shire

location_country:
Italy
Austria
Switzerland
Germany
France
Japan
Poland
Spain
United States
United Kingdom

acronym: A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX 930

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital General Universitario de Alicante

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Medical Hospital, Tokyo Medical and Dental University

title: A Phase 3, Prospective, Randomized, Controlled, Open-label, Multicenter, 2 Period Crossover Study With a Single Arm Continuation Evaluating the Safety And Efficacy of BAX 930 (rADAMTS13) in the Prophylactic And On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP])

summary:
Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body. The clots can limit or block the flow of oxygen-rich blood to the body's organs, such as the brain, kidneys, and heart. As a result, serious health problems can develop. The increased clotting that occurs in TTP uses up the cells that help the blood to clot, called platelets. With fewer platelets available in the blood, bleeding problems can occur. People who have TTP may bleed underneath the skin forming purple bruises or purpura, or from the surface of the skin. TTP also can cause anemia, a condition in which red blood cells break apart faster than the body can replace them leading to lower than normal number of red blood cells.

A lack of activity in the ADAMTS13 enzyme, a protein in the blood involved in blood clotting, causes TTP. The enzyme breaks up another blood protein called von Willebrand factor that clumps together with platelets to form blood clots. Some people are born with this condition, others get the condition during their life. Many people who born with TTP experience frequent flareups that need to be treated right away. If not treated It can be fatal or cause lasting damage, such as brain damage or a stroke. BAX 930 is a medicine that replaces ADAMTS13 and can prevent or control TTP flareups, called TTP episodes.

The main aim of this study is to compare the number of TTP episodes in people born with severe TTP when they treated with BAX 930 versus when they are treated with the standard treatment. Treatment will be given in 2 ways:

BAX 930 or standard treatment given to prevent TTP episodes from happening.
BAX 930 or standard treatment given to control an acute TTP episode when it happens, according to the clinic's standard practice.

Both BAX 930 and standard treatment are given slowly through a vein (infusion).

At the first visit, the study doctor will check if you can participate in the study. If you are eligible and enter the study, you will follow an assigned schedule and either start with BAX 930 (Period 1) and then switch to standard treatment (Period 2) or start with standard treatment (Period 1) and then switch to BAX 930 (Period 2). Everyone will be treated with BAX 930 again for Period 3. Each Period will last approximately 6 months.

If you enter the study to control an acute TTP episode, you will follow a schedule receiving either BAX 930 or standard care to treat your acute TTP episode. Once the acute TTP episode has gotten better, you can decide to continue in the study and be given treatment to prevent TTP episodes from happening, following the schedule above.

Another study's aim is to assess side effects from treatment with BAX 930 and standard treatment. To do that, the study doctor will ask you questions about your health at each study visit.

The study doctors will also check how long BAX 930 stays in the blood of the participants, over time. They will do this from blood samples taken after participants receive their specific infusions of BAX 930. This will happen at different times during the study.

1 month after all treatment has been completed, participants will visit the clinic for a final check-up.


title: A Randomized, Double Blind, Cross-over Study to Evaluate the Safety and Efficacy of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

summary: The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.

location_country: Denmark Sweden France Czechia


ReferenceCitation: Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Español de Médula Ósea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68.

ReferenceCitation: Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15. Review.

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9:CD013365. doi: 10.1002/14651858.CD013365.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Ernst

full_name: Moritz Ernst

given: Moritz

family: Oeser

full_name: Annika Oeser

given: Annika

family: Besiroglu

full_name: Burcu Besiroglu

given: Burcu

family: Caro-Valenzuela

full_name: Julia Caro-Valenzuela

given: Julia

name: Department of Surgery; Mayo Clinic; Rochester Minnesota USA

family: Abd El Aziz

full_name: Mohamed Abd El Aziz

given: Mohamed

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department I of Internal Medicine; University Hospital of Cologne; Cologne Germany

family: Borchmann

full_name: Peter Borchmann

given: Peter

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

family: Goldkuhle

full_name: Marius Goldkuhle

given: Marius

ReferenceCitation: Kambhampati S, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.

family: Kambhampati

full_name: Swetha Kambhampati

given: Swetha

family: Hunter

full_name: Bradley Hunter

given: Bradley

family: Varnavski

full_name: Andrei Varnavski

given: Andrei

family: Fakhri

full_name: Bita Fakhri

given: Bita

family: Kaplan

full_name: Lawrence Kaplan

given: Lawrence

family: Ai

full_name: Weiyun Z. Ai

given: Weiyun Z.

family: Pampaloni

full_name: Miguel Pampaloni

given: Miguel

family: Huang

full_name: Chiung-Yu Huang

given: Chiung-Yu

family: Martin

full_name: Thomas Martin

given: Thomas

suffix: III

family: Damon

full_name: Lloyd Damon

given: Lloyd

family: Andreadis

full_name: Charalambos B. Andreadis

given: Charalambos B.

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
France
Israel
Australia
Belgium
Spain
Canada
United Kingdom

location_facility: Instituto di Ematologia "L. e A. Seragnoli" - Dipartimento di Medicina Specialistica Diagnostica e Sperimentale

location_facility: Centre Hospitalier Universataire de Nantes

location_facility: University of Iowa Hospitals and Clinincs

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: CHU de Quebec-Universite Laval, Hopital de L'Enfante-Jesus

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Washington University School of Medicine

location_facility: IOSI, OSpedale Regionale Bellinzona e Valli

location_facility: Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

location_facility: Centre Hospitalier Lyon-Sud - Service d'Hematologie clinique

location_facility: University of Maryland, Greenbaum Comprehensive Cancer Center

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

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Universitatsklinikum Graz, Division of Hematology

location_facility: Uninversity Health Network - Princess Margaret Cancer Center

title: A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma

summary: The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).


ReferenceCitation: Ruhayel SD, Valvi S. Daratumumab in T-cell acute lymphoblastic leukaemia: A case report and review of the literature. Pediatr Blood Cancer. 2021 May;68(5):e28829. doi: 10.1002/pbc.28829. Epub 2020 Nov 27. Review.

name: Department of Clinical Haematology Oncology and Bone Marrow Transplantation Perth Children's Hospital  Perth Western Australia Australia

family: Ruhayel

full_name: Sandra D. Ruhayel

given: Sandra D.

family: Valvi

full_name: Santosh Valvi

given: Santosh

journal_name: Pediatric Blood & Cancer

oa_host_type: repository

repository_institution: Authorea - Authorea

repository_normalized: Authorea - Authorea

title: Daratumumab in T‐cell acute lymphoblastic leukaemia: A case report and review of the literature

lead_sponsor: Janssen Research & Development, LLC

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

location_facility: Children'S Healthcare Of Atlanta/Emory Univ. Dept. Of Pediatrics

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Charite-Universitätsmedizin Berlin - Berlin

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

location_facility: University of Utah Primary Children's Medical Center

location_facility: Dell Children's Medical Center of Central Texas/Children's Blood and Cancer Center

location_facility: Washington Univeristy School of Medicine/ Pediatrics

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: New York University Langone Medical Center

location_facility: AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita

title: An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

summary: The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.


title: A Global, Open-Label, Multicenter, Phase 1/2 Study of the Safety and Dose Escalation of BAX 888, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing B-Domain Deleted Factor VIII (BDD-FVIII) in Severe Hemophilia A Subjects Administered a Single Intravenous Infusion

summary:
The main aim of this study is to check if there are side effects from BAX 888 and to determine the dose of BAX 888 for treating severe hemophilia A in male adults.

Participants will receive one infusion with BAX 888 at the hemophilia treatment center. During the study, participants will visit their study clinic multiple times.

ipd_sharing_description: Takeda does not provide access to Individual Participant Data when a study is in a very limited (small) study population due to participant privacy concerns such as potential reidentification of study participants.

location_country:
Austria
France
Hungary
Spain
United States

location_facility: Gulf States Hemophilia and Thrombophilia Center City

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: Hospital Regional Universitario de Malaga

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: University of Colorado Hemophilia & Thrombosis Center

location_facility: Medical University of South Carolina (MUSC)


title: A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 28-week Treatment Period as Adjunctive Therapy to Antipsychotic Treatment for the Prevention of Relapse in Patients With Schizophrenia.

summary: The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms.

lead_sponsor: Boehringer Ingelheim

location_country:
France
Japan
Canada
Spain
United States
Korea, Republic of
Taiwan

location_facility: Orange County Neuropsychiatric Research Center LLC

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: National Hospital Organization Hizen Psychiatric Medical Center

location_facility: Chatham-Kent Clinical Trials Research Centre

location_facility: National Center for Global Health and Medicine Kohnodai Hospital

location_facility: Centre for Addiction and Mental Health (CAMH)

location_facility: Okehazama Hospital Fujita Kokoro Care Center

location_facility: Seoul National University Bundang Hospital

location_facility: IUSMM Institut Universitaire en Sante Mentale de Montreal

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: National Center Neurology and Psychiatry

location_facility: St. Charles Psychiatric Associates & Midwest Research Group


lead_sponsor: EMD Serono

location_country:
United States
France

acronym: AS703026 in Hematological Malignancies

location_facility: Hospital Saint Louis, Service des Maladies du Sang

location_facility: CHU du Haut-Leveque, Service des Maladies du Sang Unite de Recherche Clinique

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: Hospital Edouard Herriot, Service d'Hematologie Clinique

location_facility: Hospital Hotel Dieu, Service D'Hematologie

title: Phase II Trial With Safety-Run-In of MEK Inhibitor MSC1936369B in Subjects With Poor Prognosis Acute Myeloid Leukemia and Other Hematological Malignancies

summary:
This is an open-label, multi-center, dose-escalation trial of pimasertib (MSC1936369B) in blood and bone marrow cancers. The trial will be conducted in two parts:

Part 1 (safety run-in period): Will determine the maximum tolerated dose (MTD) of the study drug in subjects with advanced hematological malignancies.

Part 2: Will assess the anti-leukemic activity of the study drug in older subjects with newly diagnosed poor prognosis acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy.