acronym: U-Accomplish

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

ReferenceCitation: Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hébuterne X, D'Haens G, Nakase H, Panés J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26. Erratum in: Lancet. 2022 Sep 24;400(10357):996.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Slovakia
Bosnia and Herzegovina
Brazil
Canada
Switzerland
Hungary
China
Germany
Taiwan
Greece
Ireland
Estonia
Latvia
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Digestive Health Partners, P.A /ID# 206842

location_facility: Western Connecticut Medical Group /ID# 208290

location_facility: Yeungnam University Medical Center /ID# 206959

location_facility: Options Health Research, LLC /ID# 206707

location_facility: Revival Research Institute, LLC /ID# 207282

location_facility: Tokai University Hachioji Hospital /ID# 208903

location_facility: Texas Digestive Disease Consultants /ID# 209948

location_facility: Sapporo Medical University Hospital /ID# 206314

location_facility: Digestive Disease Specialists /ID# 206076

location_facility: Clin Res Inst of Michigan, LLC /ID# 207078

location_facility: Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216406

location_facility: United Medical Doctors - Murrieta /ID# 205313

location_facility: Showa University Fujigaoka Hospital /ID# 208224

location_facility: Hospital Nossa Senhora das Graças /ID# 206981

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 212426

location_facility: Washington Gastroenterology Associates /ID# 206177

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 205563

location_facility: Klinicki bolnicki centar Split /ID# 217027

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 207848

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 206351

location_facility: Inland Empire Clinical Trials, LLC /ID# 216164

location_facility: University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 205755

location_facility: Yonsei University Health System, Severance hospital /ID# 206958

location_facility: General Hospital of Athens Laiko /ID# 208671

location_facility: Taipei Veterans General Hosp /ID# 207849

location_facility: University Clinical Centre of the Republic of Srpska /ID# 208053

location_facility: Osaka City University Hospital /ID# 206457

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 207662

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 205265

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 206717

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 209573

location_facility: Umraniye Training and Res Hosp /ID# 208206

location_facility: University Clinical Center Kragujevac /ID# 206410

location_facility: Citrus Valley Gastroenterology /ID# 205627

location_facility: Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 208886

location_facility: Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211887

location_facility: Richmond University Medical Center /ID# 213185

location_facility: Basingstoke & North Hampshire /ID# 207985

location_facility: Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical /ID# 206939

location_facility: Hospital Santo Antonio dos Cap /ID# 206145

location_facility: Duplicate_CHA Bundang Medical Center /ID# 207432

location_facility: University Clinical Center Tuzla /ID# 208057

location_facility: The Vancouver Clinic, INC. PS /ID# 204973

location_facility: Gastro Health & Nutrition - Victoria /ID# 205378

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 206079

location_facility: Gazi University Med. Faculty /ID# 208040

location_facility: Kaiser Clinica e Hospital Dia /ID# 206982

location_facility: Inselspital, Universitaetsklinik /ID# 211312

location_facility: Hospital Universitario Reina Sofia /ID# 204412

location_facility: Indianapolis Gastroenterology /ID# 206381

location_facility: Vanderbilt University Medical Center /ID# 210405

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 207061

location_facility: Duplicate_General Hospital of Thessaloniki Hippokrateio /ID# 208822

location_facility: North Estonia Medical Centre /ID# 207357

location_facility: Klinicki bolnicki centar Rijeka /ID# 208650

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 206413

location_facility: Barts and the London NHS Trust /ID# 205153

location_facility: Centrum Medyczne Reuma Park w Warszawie /ID# 212913

location_facility: Great Lakes Gastroenterology Research LLC /ID# 205631

location_facility: Premier Medical Group - GI Division /ID# 206097

location_facility: Fukuoka University Chikushi Hospital /ID# 214405

location_facility: Tokyo Women's Medical University Hospital /ID# 206460

location_facility: Duplicate_Plains Clinical Research Center, LLC /ID# 205111

location_facility: China Medical University Hosp /ID# 207845

location_facility: TX Clinical Research Institute /ID# 206718

location_facility: AGA Clinical Research Associates, LLC /ID# 206880

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215813

location_facility: Huddersfield Royal Infirmary /ID# 217660

location_facility: Mautalen Salud e Investigacion /ID# 206033

location_facility: University Clinical Hospital Mostar /ID# 208054

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206332

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216611

location_facility: Hospital Universitario San Vic /ID# 208888

location_facility: CB Flock Research Corporation /ID# 206094

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 206350

location_facility: Hospital Universitario Dr. Negrin /ID# 206905

location_facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216300

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 211167

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 209626

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 206885

location_facility: Hospital de Clinicas de Porto Alegre /ID# 206985

location_facility: Virginia Mason - Seattle Orthapedics /ID# 206070

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 206175

location_facility: Moore UC San Diego Cancer Center /ID# 204919

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 206098

location_facility: Clinical Hosp Center Zvezdara /ID# 205258

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 205147

location_facility: University Clinical Center of Nis /ID# 206411

location_facility: Private Practice Dr MN Rajabally /ID# 205273

location_facility: Yamagata University Hospital /ID# 206465

location_facility: Iwate Medical University Uchimaru Medical Center /ID# 207051

location_facility: Hyogo College of Medicine Hospital /ID# 206455

location_facility: Hometown Urgent Care and Resea /ID# 205630

location_facility: Atlantic Digestive Health Inst /ID# 208748

location_facility: Shoyukai Fujita Gastroenterological Hospital /ID# 216493

location_facility: P. Stradins Clinical Univ Hosp /ID# 206827

location_facility: Juntendo University Urayasu Hospital /ID# 208784

location_facility: Niigata University Medical & Dental Hospital /ID# 218049

location_facility: Froedtert Memorial Lutheran Hospital /ID# 206945

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 207484

location_facility: University Clinical Centre of the Republic of Srpska /ID# 208055

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 206117

location_facility: Yokkaichi Hazu Medical Center /ID# 214348

location_facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205267

location_facility: Hospital Britanico de Buenos Aires /ID# 209497

location_facility: Ishida Clinic of IBD and Gastroenterology /ID# 210119

location_facility: Hospital Universitario La Paz /ID# 214540

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 209052

location_facility: Duplicate_Universitaetsklinikum Tuebingen /ID# 206737

location_facility: InSite Digestive Health Care - Oxnard /ID# 205628

location_facility: Medical University of Vienna /ID# 205763

location_facility: Japanese Red Cross Osaka Hospital /ID# 209478

location_facility: Duplicate_Mater Misericordiae /ID# 212687

location_facility: Universitetssykehuset Nord-Norge /ID# 205691

location_facility: Duplicate_Univ Hosp Schleswig-Holstein /ID# 206791

location_facility: Dayton Gastroenterology, Inc. /ID# 205639

location_facility: West China Hospital, Sichuan University /ID# 205332

location_facility: Agaplesion Markus Krankenhaus /ID# 206731

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 207992

location_facility: Pusan National University Hospital /ID# 206956

location_facility: Louisana Research Center, LLC /ID# 206064

location_facility: Kazan State Medical University /ID# 208256

location_facility: Faculdade de Medicina do ABC /ID# 206984

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 206917

location_facility: Duplicate_Tianjin Med Univ General Hosp /ID# 205246

location_facility: Southern Star Research Institute, LLC /ID# 205379

location_facility: Saiseikai Fukuoka Genaral Hospital /ID# 209482

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 205333

location_facility: University of Mississippi Medical Center /ID# 213116

location_facility: Republican hospital named after V.A. Baranov /ID# 206507

location_facility: Houma Digestive Health Special /ID# 206176

location_facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 206069

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 206354

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 211030

location_facility: Nagoya City University Hospital /ID# 206058

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 207507

location_facility: Duplicate_Tyler Research Institue /ID# 206075

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 206096

location_facility: Toho University Medical Center Sakura Hospital /ID# 207705

location_facility: Universitair Ziekenhuis Leuven /ID# 205988

location_facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 217218

location_facility: Huron Gastroenterology Assoc /ID# 205109

location_facility: Kanazawa University Hospital /ID# 206316

location_facility: Next Innovative Clinical Research - Chicago /ID# 217324

location_facility: Medical centre of CONSILIUM MEDICAL LLC /ID# 217447

location_facility: Gastroenterology Center of CT /ID# 208291

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 205554

location_facility: St Vincent's Hospital Melbourne /ID# 205758

location_facility: Macquarie University Hospital /ID# 211955

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205556

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 205314

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 205266

location_facility: Center Hospital of the National Center for Global Health and Medicine /ID# 209532

location_facility: NW State Medical Univ na Mechn /ID# 208258

location_facility: Tokyo Medical And Dental University, Medical Hospital /ID# 206453

location_facility: Duplicate_Toronto Digestive Disease Asso /ID# 205498

location_facility: Hospital Universitario y Politecnico La Fe /ID# 206904

location_facility: Riga East Clinical Univ Hosp /ID# 206828

location_facility: The University of Chicago Medical Center /ID# 206172

location_facility: Universal Axon Clinical Research /ID# 213462

location_facility: Clinical Research Trials of Florida, Inc. /ID# 206068

location_facility: Fakultna nemocnica s poliklini /ID# 211372

location_facility: National Hospital Organization Sendai Medical Center /ID# 209528

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 206504

location_facility: Wake Forest Baptist Medical Center /ID# 206067

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 204411

location_facility: Atlanta Gastroenterology Spec /ID# 206173

location_facility: Texas Digestive Disease Consultants /ID# 209805

location_facility: Klinicka bolnica Dubrava Zagreb /ID# 208460

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 209118

location_facility: Nature Coast Clinical Research - Inverness /ID# 206087

location_facility: Encore Borland-Groover Clinical Research /Id# 208128

location_facility: Duplicate_Praxis am Bayrischen Platz /ID# 206733

location_facility: Mentahaz Maganorvosi Kozpont /ID# 205882

location_facility: M y F Estudios Clínicos Ltda. /ID# 208035

location_facility: Gastroenterologische Gemeinschaftspraxis Herne /ID# 214576

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 208887

location_facility: Percuro Clinical Research, Ltd /ID# 205501

location_facility: Toyohashi Municipal Hospital /ID# 207625

location_facility: Akershus Universitetssykehus_MAIN /ID# 205293

location_facility: Hamamatsu University Hospital /ID# 206459

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206059

location_facility: Advanced Research Institute, Inc /ID# 206077

location_facility: East Tennessee Research Institute /ID# 206169

location_facility: Clinical Center University of Sarajevo /ID# 208058

location_facility: Queen Elizabeth University Hos /ID# 205154

location_facility: Hospital Clinic de Barcelona /ID# 206906

location_facility: University of New Mexico Department of Internal Medicine /ID# 214397

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 205271

location_facility: Nemocnice Pardubickeho kraje, a.s. /ID# 213540

location_facility: Ctr for Gastrointestinal Healt /ID# 208475

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 206142

location_facility: Klaipeda University Hospital /ID# 208790

location_facility: CCA Braga - Hospital de Braga /ID# 206144

location_facility: Atrium Health Carolinas Medical Center /ID# 206085

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 205672

location_facility: Hiroshima University Hospital /ID# 206464

location_facility: Hospital Garcia de Orta, EPE /ID# 206143

location_facility: National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210710

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 207137

location_facility: Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 206646

location_facility: Shimane University School of Medicine /ID# 208905

location_facility: Lenasia Clinical Trial Centre /ID# 214359

location_facility: Hospital Clinico Universidad De Los Andes /ID# 207426

location_facility: National Taiwan University Hospital /ID# 207847

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 206349

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215070

location_facility: St. Marianna University School of Medicine Hospital /ID# 209451

location_facility: University of Iowa Hospitals and Clinics /ID# 206167

location_facility: St.Luke's International Hospital /ID# 208076

location_facility: The First Affiliated Hospital of Nanchang University /ID# 212186

location_facility: University of Michigan Health Systems /ID# 206918

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 206907

location_facility: Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 211652

location_facility: Hospital Universitario Ramon y Cajal /ID# 204410

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 211326

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 211653

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 206347

location_facility: Erciyes University Medical Fac /ID# 207506

location_facility: Sapporo Higashi Tokushukai Hospital /ID# 208494

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 216940

location_facility: Charlotte Gastroenterology and Hepatology, PLLC /ID# 206138

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 216622

location_facility: Bekes Megyei Kozponti Korhaz /ID# 205885

location_facility: West Tallinn Central Hospital /ID# 207356

location_facility: Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216223

location_facility: Universitatsklinikum Mannheim /ID# 206811

location_facility: Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 208067

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 208068

location_facility: Immanuel Kant Baltic Federal University /ID# 208264

location_facility: MediSphere Medical Research Center /ID# 206073

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 206710

location_facility: The Sixth Affiliated Hosp Sun /ID# 205268

location_facility: University Clinical Center Serbia /ID# 205256

location_facility: Healthcare Research Consultant /ID# 206706

location_facility: National University Hospital /ID# 209099

location_facility: Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 208082

location_facility: East View Medical Research, LLC /ID# 216933

location_facility: East Tallinn Central Hospital /ID# 207564

location_facility: Asahikawa Medical University Hospital /ID# 206404

location_facility: Hospital Privado Univesitario /ID# 206030

location_facility: The First Hospital of Jilin University /ID# 210088

location_facility: Hospital Clinico Universitario de Salamanca /ID# 205013

location_facility: Centex Studies, Inc. - Houston /ID# 206168

summary: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).


title: Long Term Extension Trial of Setmelanotide (RM-493) for Patients Who Have Completed a Trial of Setmelanotide for the Treatment of Obesity Associated With Genetic Defects Upstream of the MC4 Receptor in the Leptin-melanocortin Pathway

summary: This is a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in patients who have completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Meyer JR, Krentz AD, Berg RL, Richardson JG, Pomeroy J, Hebbring SJ, Haws RM. Kidney failure in Bardet-Biedl syndrome. Clin Genet. 2022 Apr;101(4):429-441. doi: 10.1111/cge.14119.

ipd_sharing: No

lead_sponsor: Rhythm Pharmaceuticals, Inc.

location_country:
Spain
Greece
United Kingdom
Netherlands
Canada
United States
France
Germany

location_facility: Synexus Clinical Research US, Inc. - Phoenix Southeast

location_facility: Synexus Clinical Research US, Inc.- Primary Care Associates, PC

location_facility: Wellcome Trust-MRC Institute of Metabolic Science

location_facility: University of Florida College of Medicine

location_facility: University Hospitals Birmingham NHS Foundation Trust

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

type: EudraCT Number

title: A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects With Familial Adenomatous Polyposis

summary: The purpose of this study is to determine the effect of treatment with guselkumab in participants with familial adenomatous polyposis (FAP) on rectal/pouch polyp burden.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

enrollment_type: Actual

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Spain
Sweden
Puerto Rico
United States
Israel
France
Netherlands
Germany

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Washington University School of Medicine

location_facility: Wexner Medical Center at the Ohio State University

location_facility: Pan American Center for Oncology Trials LLC

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center

location_facility: University of Texas MD Anderson Cancer Center

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

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po

location_facility: University of Pennsylvania - Perelman School of Medicine

status_simplified: Completed


ipd_sharing: Yes

intervention_type: Other

title: Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis Imperfecta

lead_sponsor: Amgen

source: euctr

design_allocation: Non-Randomized

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Canada
Hungary
United States
France
Belgium
Germany
Czechia

location_facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Indiana University - Riley Hospital for Children

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

summary: To evaluate long-term safety of denosumab in subjects with pediatric osteogenesis imperfecta (OI) who completed end of study (EOS) on Study 20130173.


title: A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

lead_sponsor: Regeneron Pharmaceuticals

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

location_facility:
Regeneron Study Site
Regeneron Study Site #2
Regeneron Study Site #1

summary:
The primary objectives of the study by study part are:

Part A:

To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size determination for Part B.

Part B:

To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures.

Part C:

To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures.

The secondary objectives of the study are:

To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE
To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses
To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation
To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids


status: Active, not recruiting

acronym: BIANCA

intervention_type: Biological

title: A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Safety and Efficacy of Tisagenlecleucel in Pediatric Subjects With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma (NHL)

lead_sponsor: Novartis Pharmaceuticals

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.

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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Denmark
Spain
Italy
Austria
Australia
Netherlands
Canada
Finland
United Kingdom
United States
France
Norway
Japan
Germany

location_facility: Prinses Maxima Centrum voor Kinderoncologie

location_facility: University of Texas Southwestern Medical Center

location_facility: Memorial Sloan Kettering Cancer Center MSKCC (8)

location_facility: The Childrens Hospital of Philadelphia Drug Shipment

location_facility: Dana Farber Cancer Institute Dept.of DFCI

location_facility: Cincinnati Children s Hospital Medical Center

summary: The purpose of the study is to assess the efficacy and safety of tisagenlecleucel in children and adolescents with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). For pediatric patients who have r/r B-NHL, survival rates are dismal, only ~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.


title: A Phase 2, Multi-cohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With Clinical High-Risk Multiple Myeloma (KarMMa-2)

lead_sponsor: Celgene

location_country:
Spain
Italy
United Kingdom
United States
France
Germany

location_facility: MD Anderson Cancer Center The University of Texas

location_facility: King's College HospitalGKT School of Medicine

location_facility: Columbia University Medical Center/New York-Presbyterian Hospital

location_facility: University Of California San Francisco Medical Center

location_facility: Columbia University Medical Center / New York Presbyterian Hospital

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

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: University Of Texas Southwestern Medical Center

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

summary: This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1), in subjects with MM having progressed within 18 months of initial treatment including autologous stem cell transplantation (ASCT) (Cohort 2a), or without ASCT (Cohort 2b) or, in subjects with inadequate response post ASCT during initial treatment (Cohort 2c). Approximately 235 subjects will be enrolled into one of three cohorts. Cohort 1 will enroll approximately 97 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts will start in parallel and independently. Cohort 3 will enroll approximately 30 newly diagnosed multiple myeloma (NDMM) participants with suboptimal response to ASCT.


title: An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis

summary: This is an open-label, single arm, Phase 2 study evaluating the efficacy and safety of avapritinib (BLU-285) in patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive SM (ASM), SM with associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL)

ReferenceCitation: Reiter A, Gotlib J, Álvarez-Twose I, Radia DH, Lübke J, Bobbili PJ, Wang A, Norregaard C, Dimitrijevic S, Sullivan E, Louie-Gao M, Schwaab J, Galinsky IA, Perkins C, Sperr WR, Sriskandarajah P, Chin A, Sendhil SR, Duh MS, Valent P, DeAngelo DJ. Efficacy of avapritinib versus best available therapy in the treatment of advanced systemic mastocytosis. Leukemia. 2022 Aug;36(8):2108-2120. doi: 10.1038/s41375-022-01615-z. Epub 2022 Jul 5.

ReferenceCitation: Reiter A, Schwaab J, DeAngelo DJ, Gotlib J, Deininger MW, Pettit KM, Alvarez-Twose I, Vannucchi AM, Panse J, Platzbecker U, Hermine O, Dybedal I, Lin HM, Rylova SN, Ehlert K, Dimitrijević S, Radia DH. Efficacy and safety of avapritinib in previously treated patients with advanced systemic mastocytosis. Blood Adv. 2022 Nov 8;6(21):5750-5762. doi: 10.1182/bloodadvances.2022007539.

ReferenceCitation: Gotlib J, Reiter A, Radia DH, Deininger MW, George TI, Panse J, Vannucchi AM, Platzbecker U, Alvarez-Twose I, Mital A, Hermine O, Dybedal I, Hexner EO, Hicks LK, Span L, Mesa R, Bose P, Pettit KM, Heaney ML, Oh ST, Sen J, Lin HM, Mar BG, DeAngelo DJ. Efficacy and safety of avapritinib in advanced systemic mastocytosis: interim analysis of the phase 2 PATHFINDER trial. Nat Med. 2021 Dec;27(12):2192-2199. doi: 10.1038/s41591-021-01539-8. Epub 2021 Dec 6.

lead_sponsor: Blueprint Medicines Corporation

location_country:
Denmark
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
United States
France
Norway
Germany

location_facility: Universitätsmedizin Mannheim III. Medizinische Klinik

location_facility: Azienda Ospedaliero-Universitaria Careggi, CRIMM - Centro di Ricerca ed Innovazione per le Malattie Mieloproliferative

location_facility: Washington University School of Medicine

location_facility: Odense University Hospital, Department of Haematology

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

location_facility: University of Pennsylvania, Abramson Cancer Center

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

location_facility: University of Texas, MD Anderson Cancer Center

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

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

location_facility: Universitätsklinikum Leipzig, Medizinische Klinik und Poliklinik I - Hämatologie und Zelltherapie, lnternistische Onkologie, Hämostaseologie

location_facility: Herbert Irving Comprehensive Cancer Center

location_facility: Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie

location_facility: Klinik und Poliklinik für Innere Medizin III, Klinikum rechts der Isar der TU München

location_facility: Centro Ricerche Cliniche di Verona - Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltranslplantation

location_facility: Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie

location_facility: Oslo University Hospital-Rikshospitalet, Hematology

location_facility: University Medical Center Groningen (UMCG)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu, Klinice Hematologii, Nowotworów Krwi i Transplantacji Szpiku

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


acronym: ELARA

title: A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma

ReferenceCitation: Salles GA, Schuster SJ, Dreyling M, Fischer L, Kuruvilla J, Patten PE, von Tresckow B, Smith SM, Jiménez-Ubieto A, Davis KL, Anjos C, Chu J, Zhang J, Lobetti-Bodoni CL, Thieblemont C, Fowler NH, Dickinson M, Martínez-López J, Wang Y, Link BK. Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma. Blood Adv. 2022 Aug 16. pii: bloodadvances.2022008150. doi: 10.1182/bloodadvances.2022008150. [Epub ahead of print]

ReferenceCitation: Fowler NH, Dickinson M, Dreyling M, Martinez-Lopez J, Kolstad A, Butler J, Ghosh M, Popplewell L, Chavez JC, Bachy E, Kato K, Harigae H, Kersten MJ, Andreadis C, Riedell PA, Ho PJ, Pérez-Simón JA, Chen AI, Nastoupil LJ, von Tresckow B, Ferreri AJM, Teshima T, Patten PEM, McGuirk JP, Petzer AL, Offner F, Viardot A, Zinzani PL, Malladi R, Zia A, Awasthi R, Masood A, Anak O, Schuster SJ, Thieblemont C. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. Nat Med. 2022 Feb;28(2):325-332. doi: 10.1038/s41591-021-01622-0. Epub 2021 Dec 17.

location_country:
Spain
Italy
Austria
Australia
Netherlands
United Kingdom
United States
France
Norway
Belgium
Japan
Germany

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Michigan Medicine University of Michigan

location_facility: University of Chicago Medical Center Hematology and Oncology

location_facility: University of Pennsylvania Clinical Studies Unit Perelman Center for Adv Med

location_facility: University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)

summary: This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.


title: International Randomized Trial on the Effect of Revascularization or Optimal Medical Therapy of Chronic Total Coronary Occlusions With Myocardial Ischemia - ISCHEMIA-CTO Trial

acronym: ISCHEMIA-CTO

summary:
Study design

Prospective randomized open labeled multicenter study

Hypotheses

In asymptomatic patients with ≥ 10% of myocardial ischemia: PCI (Percutaneous Coronary Intervention) with latest generation of drug eluting stents is superior to optimal medical therapy in terms of relative reduction in MACCE (Major Adverse Cardiovascular and Cerebrovascular events).
In symptomatic patients with ≥ 5% of myocardial ischemia: PCI with latest generation of drug eluting stents is superior to optimal medical therapy (OMT) in terms of improved life quality measured as an increase of SAQ (Self Assessment Questionnaire) score of 8 points after 6 months.

Inclusion Criteria

CTO in native coronary artery
Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.
Age ≥18 yrs.
Able to provide written Informed consent and willing to comply with the specified follow-up contacts
Target artery ≥ 2.5 mm

Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into:

Cohort A: Asymptomatic (CCS < 2 and SAQ QoL > 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO

Cohort B: Symptomatic patients (CCS class ≥ 2 and/or SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO

Cohort C: patients enrolled but not randomized in cohort A or B

Exclusion criteria (for both cohort A and B)

NSTEMI or STEMI within 1 month
Coronary anatomy not suitable for CTO-procedure
Coronary artery disease involving the left main/three-vessel disease with indication for CABG following heart team conference
Life expectancy < 2 years
Severe chronic pulmonary disease (FEV1 < 30 % of predicted value)
Contraindication to dual anti-platelet therapy
Pregnancy
eGFR < 30 mL/min/1.73 m2
In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first.
Severe valvular heart disease

Primary endpoint

Cohort A: Composite endpoint of MACCE (all-cause mortality, stroke, any myocardial infarction, clinically driven revascularization*), hospitalization for heart failure or incidence of malignant arrhythmias.

*CCS class ≥ 2 and/or QoL score < 60. Same criteria used as for allocation to Cohort B

Cohort B: SAQ Quality of Life Assessment after 6 months.

Number of patients

1,560 (1200 in cohort A/360 in cohort B

Follow up time

Cohort A: 5 years Cohort B: 6 months

ReferenceCitation: Rinfret S, Sandesara PB. Reducing Ischemia With CTO PCI: Good News, But Questions Remain. JACC Cardiovasc Interv. 2021 Jul 12;14(13):1419-1422. doi: 10.1016/j.jcin.2021.05.028.

ipd_sharing: Undecided

lead_sponsor: Aarhus University Hospital Skejby

location_country:
Denmark
Spain
United Kingdom
Estonia
Finland
France
Sweden

location_facility: Belfast Health and Social Care Trust, Department of Cardiology

location_facility: Cardiovascular Institute, Groupe Hospitalier Mutualiste

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Stockholm South Central Hospital (Södersjukhuset)

lead_sponsor_type: academique


title: An Open-Label Study To Evaluate the Efficacy and Safety of AG-348 in Regularly Transfused Adult Subjects With Pyruvate Kinase (PK) Deficiency

summary: Study AG348-C-007 was a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, participants with pyruvate kinase (PK) deficiency, who were regularly receiving blood transfusions. The study was composed of two parts. During Part 1, Dose Optimization Period, participants started on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose of AG-348 was sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During Part 2, Fixed-Dose Period, participants received AG-348 at their optimized dose from Part 1.

ReferenceCitation: Glenthøj A, van Beers EJ, Al-Samkari H, Viprakasit V, Kuo KHM, Galactéros F, Chonat S, Porter J, Zagadailov E, Xu R, Oluyadi A, Hawkins P, Gheuens S, Beynon V, Barcellini W; ACTIVATE-T investigators. Mitapivat in adult patients with pyruvate kinase deficiency receiving regular transfusions (ACTIVATE-T): a multicentre, open-label, single-arm, phase 3 trial. Lancet Haematol. 2022 Oct;9(10):e724-e732. doi: 10.1016/S2352-3026(22)00214-9. Epub 2022 Aug 18.

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.

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Denmark
United Kingdom
Ireland
Italy
Canada
Thailand
United States
France
Netherlands

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

location_facility: University of Copenhagen, Herlev Hospital

location_facility: St James's Hospital Department of Haematology

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

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

location_facility: Toronto General Hospital, University Health Network


title: A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

lead_sponsor: Vertex Pharmaceuticals Incorporated

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

location_country:
Denmark
Poland
United Kingdom
Ireland
Australia
Switzerland
France
Belgium
Germany

location_facility: Nottingham University Hospital City Campus

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

location_facility: Hunter Medical Research Institute (HMRI)

location_facility: Klinika Mukowiscydozy, Oddział Chorób Płuc SZP ZOZ

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

summary: This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).


title: An Open-label, Multi Centre Drug-drug Interaction Trial to Investigate the Effects of Tralokinumab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Subjects With Moderate-to-severe Atopic Dermatitis

summary:
The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after:

14 weeks of treatment with tralokinumab
a single dose of tralokinumab

lead_sponsor: LEO Pharma

location_country:
Netherlands
United States
France


type: Registry Identifier

title: ATLAS-PPX: an Open-label, Multinational, Switching Study to Describe the Efficacy and Safety of Fitusiran Prophylaxis in Patients With Hemophilia A and B Previously Receiving Factor or Bypassing Agent Prophylaxis.

acronym: ATLAS-PPX

summary:
Primary Objective:

To characterize the frequency of bleeding episodes while receiving fitusiran treatment, relative to the frequency of bleeding episodes while receiving factor or bypassing agent (BPA) prophylaxis

Secondary Objectives:

To characterize the following while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis:
the frequency of spontaneous bleeding episodes
the frequency of joint bleeding episodes
health related quality of life (HRQOL) in patients ≥17 years of age
To characterize the frequency of bleeding episodes during the onset and treatment periods in patients receiving fitusiran
To characterize the safety and tolerability of fitusiran
Annualized weight-adjusted consumption of factor/BPA

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

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Denmark
United Kingdom
Ireland
Italy
Australia
Canada
Ukraine
Korea, Republic of
United States
France
China
Israel
Turkey
Japan
Malaysia

location_facility:
Investigational Site Number 0140
Investigational Site Number 8201
Investigational Site Number 6104
Investigational Site Number 8102
Investigational Site Number 8110
Investigational Site Number 6002
Investigational Site Number 8101
Investigational Site Number 8604
Investigational Site Number 8109
Investigational Site Number 8204
Investigational Site Number 6003
Investigational Site Number 8202
Investigational Site Number 6101
Investigational Site Number 9701
Investigational Site Number 4407
Investigational Site Number 0139
Investigational Site Number 8103
Investigational Site Number 8003
Investigational Site Number 8002
Investigational Site Number 9004
Investigational Site Number 9009
Investigational Site Number 1102
Investigational Site Number 4401
Investigational Site Number 5301
Investigational site number 9013
Investigational Site Number 3303
Investigational Site Number 3902
Investigational Site Number 8104
Investigational Site Number 9003
Investigational Site Number 4402
Investigational Site Number 3305
Investigational Site Number 9001
Investigational Site Number 9010
Investigational Site Number 9002
Investigational Site Number 9005
Investigational Site Number 4501
Investigational Site Number 9008
Investigational Site Number 1103
Investigational Site Number 6004
Investigational Site Number 0141
Investigational Site Number 9006
Investigational Site Number 8108
Investigational Site Number 4403
Investigational Site Number 0111


title: Evaluation of Adjunctive Procedural Assessments to Diagnose Post Drug-coated Balloon Flow-limiting Dissection and Residual Stenosis When Angiography is Inconclusive

summary:
Both drug-coated balloon and stents have been used for a number of years to treat subjects with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods. However, due to a higher risk of blood clot formation, requiring a longer anticoagulant treatment, and the challenge of treating re growth of tissue extending through the metal mesh of the stent, the physicians try to reserve stent placement to situation where it's really needed, in case of flow-limiting vessel dissection or acute re-narrowing.

The purpose of this study is to evaluate the utility of several procedural diagnostic techniques in helping the physicians to better decide whether a stent is needed or not.

The study will also estimate the safety and efficacy of Passeo-18 Lux drug-coated balloon associated to Pulsar 18 bare metal stent when and where needed to treat PAD

primary_purpose: Diagnostic

lead_sponsor: Biotronik AG

location_country: Spain Austria Australia France Belgium Germany

location_facility: Universitäts-Herzzentrum Freiburg • Bad Krozingen

intervention_type: Diagnostic Test


title: CHELATE STUDY: Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease

summary: This is a multicenter, randomized, open-label study with an active standard-of-care comparator (penicillamine)

ReferenceCitation: Schilsky ML, Czlonkowska A, Zuin M, Cassiman D, Twardowschy C, Poujois A, Gondim FAA, Denk G, Cury RG, Ott P, Moore J, Ala A, D'Inca R, Couchonnal-Bedoya E, D'Hollander K, Dubois N, Kamlin COF, Weiss KH; CHELATE trial investigators. Trientine tetrahydrochloride versus penicillamine for maintenance therapy in Wilson disease (CHELATE): a randomised, open-label, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2022 Dec;7(12):1092-1102. doi: 10.1016/S2468-1253(22)00270-9. Epub 2022 Sep 30.

lead_sponsor: Orphalan

location_country:
Denmark
Poland
Brazil
United Kingdom
Italy
United States
France
Belgium
Germany

location_facility: University of Surrey, Department of Clinical and Experimental Medicine

location_facility: Hospital Nossa Senhora das Graças (HNSG)

location_facility: Centre National de Référence Wilson, Hôpital Lariboisière

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Nucleo de Pesquisa e Desenvolvimento de Medicamentos - Universidade Federal do Ceará - Rodolfo Teófilo

location_facility: KU Leuven, Department of Clinical and Experimental Medicine


title: A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

summary: The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.

lead_sponsor: Incyte Corporation

location_country:
Austria
United States
Italy
France

location_facility: University Health System Inc., Dba the University of Tn Medical Center

location_facility: Weill Medical College of Cornell University

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITï¿½ DI NOVARA

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Regional Universitaire (Chru) de Lille


title: A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation

ReferenceCitation: Sawicki GS, Chilvers M, McNamara J, Naehrlich L, Saunders C, Sermet-Gaudelus I, Wainwright CE, Ahluwalia N, Campbell D, Harris RS, Paz-Diaz H, Shih JL, Davies JC. A Phase 3, open-label, 96-week trial to study the safety, tolerability, and efficacy of tezacaftor/ivacaftor in children ≥ 6 years of age homozygous for F508del or heterozygous for F508del and a residual function CFTR variant. J Cyst Fibros. 2022 Jul;21(4):675-683. doi: 10.1016/j.jcf.2022.02.003. Epub 2022 Feb 18.

location_country:
Denmark
Poland
United Kingdom
Ireland
Australia
Canada
Switzerland
United States
France
Belgium
Germany

location_facility: Riley Hospital for Children Indiana University Health

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Medical University of South Carolina (MUSC)

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

location_facility: Nemours/ Alfred I. duPont Hospital for Children

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: UBMD Pediatrics/ CF Center of Western New York

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: John Hunter Hospital & Hunter Medical Research Institute and John Hunter Children's Hospital

location_facility: Children's Hospital of The King's Daughters

location_facility: Children's Hospital & Clinics of Minnesota

location_facility: Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY

location_facility: Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Johns Hopkins All Children's Hospital Outpatient Care Center

location_facility: Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin

summary: This study will evaluate the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in subjects with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.


status: Enrolling by invitation

title: Long-term, Open-label Extension Study for Patients With Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen

lead_sponsor: Sarepta Therapeutics, Inc.

location_country:
Poland
Spain
Italy
United Kingdom
Canada
Sweden
United States
France
Israel
Belgium
Germany
Bulgaria
Czechia

location_facility: UOSD Centro Traslazionale di Miologia e Patologie Neurogenerative

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: University of Rochester Medical Center - Department of Neurology

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Uniwersyteckie Centrum Kliniczne, Klinica Neurologii Rozwojowej

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

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Abigail Wexner Research Institute at Nationwide Children's Hospital

location_facility: Fakultni nemocnice Brno, Klinika detske neurologie LF MU a FN Brno

location_facility: University Multiprofile Hospital for active treatment Aleksandrovska EAD Clinic of Neurological Diseases

location_facility: Children's Hopsital of Wisconsin, Corporate Center Suite 540

location_facility: Provningsenhet Barn, Drottning Silvias Och Ungdomssjukhus

location_facility: Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust

location_facility: UF Health: University of Florida Clinical Research Center

location_facility: Schneider Children's Medical Center of Israel

summary: The main objective of this study is to evaluate the safety and tolerability of long-term treatment with casimersen or golodirsen in patients with Duchenne muscular dystrophy (DMD).

status_simplified: Unknown


title: A Phase II, Open-label, Prospective, Single-arm, Study to Assess Ability of Eltrombopag to Induce Sustained Remission in Subjects With ITP Who Are Refractory or Relapsed After First-line Steroids

acronym: TAPER

summary:
This study will assess the ability of eltrombopag to induce sustained response off treatment in ITP subjects who relapsed or failed to respond to an initial treatment with steroids.

There is limited, mainly retrospective evidence that earlier use of eltrombopag after ITP diagnosis, will allow a larger proportion of subjects to achieve sustained response off treatment after tapering off drug. Clinically there is a need for a less toxic regimen that will provide responses and sustained response off treatment with a shorter treatment interval. This trial is designed to assess this.

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:
Brazil
Spain
Greece
Austria
Italy
Oman
Russian Federation
United Kingdom
Switzerland
United States
Chile
France
Turkey
Mexico
Japan

location_facility: Hematology Oncology Association of Rockland Drug Shipment


title: A Phase 1-2 Study of the Safety, Pharmacokinetics, and Activity of ASTX029 in Subjects With Advanced Solid Tumors

summary: This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to subjects with advanced solid malignancies who are not candidates for approved or available therapies.

ReferenceCitation: Munck JM, Berdini V, Bevan L, Brothwood JL, Castro J, Courtin A, East C, Ferraldeschi R, Heightman TD, Hindley CJ, Kucia-Tran J, Lyons JF, Martins V, Muench S, Murray CW, Norton D, O'Reilly M, Reader M, Rees DC, Rich SJ, Richardson CJ, Shah AD, Stanczuk L, Thompson NT, Wilsher NE, Woolford AJ, Wallis NG. ASTX029, a Novel Dual-mechanism ERK Inhibitor, Modulates Both the Phosphorylation and Catalytic Activity of ERK. Mol Cancer Ther. 2021 Oct;20(10):1757-1768. doi: 10.1158/1535-7163.MCT-20-0909. Epub 2021 Jul 30.

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
United Kingdom
United States
Spain
France

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: The Sidney Kimmel Comprehensive Cancer Center

location_facility: START - South Texas Accelerated Research Therapeutics, LLC

location_facility: City of Hope Comprehensive Cancer Center

location_facility: California Pacific Medical Center - Sutter Pacific Medical Center

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust Site #221

location_facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Hospital Universitari Vall d'Hebrón Servicio de Oncología, Sala coordinación UITM

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of California Davis Medical Center

location_facility: Centre Léon Bérard Service d'Oncologie Médicale

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Columbia University Irving Medical Center

location_facility: University of Southern California Norris Comprehensive Cancer Center


title: BlueSync Field Evaluation

summary: The purpose of this field evaluation is to collect and evaluate information related to CareLink transmission compliance as well as patient perceived benefit of BlueSync™ and the health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: There are not plans to share IPD with other researchers

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
United States
Italy
United Kingdom
France

location_facility: University Hospital of North Midlands NHS Trust


title: A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

lead_sponsor: Sanofi

location_country:
Spain
Italy
United States
South Africa
Czechia
Poland
Slovenia
Austria
Russian Federation
Argentina
Turkey
Mexico
Norway
Sweden
Brazil
Lebanon
Canada
Hungary
Bulgaria
Denmark
Taiwan
Finland
France
Netherlands

location_facility: Washington University School of Medicine-Site Number:8400006

location_facility: Excel Medical Clinical Trials, LLC-Site Number:8400001

location_facility: Presbyterian Novant Heart & Wellness-Site Number:8400002

location_facility: Cincinnati Children's Hospital Medical Center-Site Number:8400005

summary:
Primary Objective:

To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in patients with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins.

Secondary Objective:

To evaluate the efficacy of alirocumab versus placebo on low-density lipoprotein cholesterol (LDL-C) levels.
To evaluate the effects of alirocumab versus placebo on other lipid parameters.
To evaluate the safety and tolerability of alirocumab in comparison with placebo.
To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment.
To evaluate the development of anti-alirocumab antibodies.


title: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm , Efficacy and Safety Study in Prurigo Nodularis (PN) With Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)

acronym: PRISM

summary: To investigate the anti-pruritic efficacy and safety of Nalbuphine ER (NAL ER) tablets in Prurigo Nodularis. Subjects will be randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER and subjects who received placebo will crossover to NAL ER.

lead_sponsor: Trevi Therapeutics

location_country:
Poland
Austria
United States
France
Germany

location_facility:
Study Site 205
Study Site 144
Study Site 314
Study Site 308
Study Site 309
Study Site 150
Study Site 106
Study Site 215
Study Site 158
Study Site 143
Study Site 501
Study Site 128
Study Site 132
Study Site 216
Study Site 312
Study Site 204
Study Site 222
Study Site 148
Study Site 315
Study Site 301
Study Site 157
Study Site 109
Study Site 306
Study Site 302
Study Site 146
Study Site 137
Study Site 103
Study Site 121
Study Site 101
Study Site 147
Study Site 135
Study Site 213
Study Site 208
Study Site 131
Study Site 206
Study Site 212
Study Site 214
Study Site 151
Study Site 102
Study Site 202
Study Site 304
Study Site 221
Study Site 139
Study Site 502
Study Site 138
Study Site 220
Study Site 402
Study Site 120
Study Site 219
Study Site 118
Study Site 303
Study Site 108
Study Site 142
Study Site 136
Study Site 201
Study Site 401
Study Site 140
Study Site 141
Study Site 130
Study Site 134
Study Site 153
Study Site 305
Study Site 145
Study Site 209
Study Site 122
Study Site 107
Study Site 159
Study Site 310
Study Site 316
Study Site 313


title: A Randomized, Subject and Investigator Blinded, Placebo Controlled, Multi-center Study in Parallel Groups to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne

summary: The main purpose of this study is to assess preliminary efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne and to determine if LYS006 has an adequate clinical profile for further clinical development.

location_country:
Netherlands
Hungary
United States
France
Germany
Czechia


title: A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral Sclerosis

summary: A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)

lead_sponsor: KemPharm Denmark A/S

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

location_facility: Medizinische Hochschule Hannover (MHH) - Klinik fuer Neurologie

location_facility: University of Kansas Medical Center (KUMC) - Landon Center on Aging

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Gui De Chauliac

location_facility: Hospital Carlos III - Hospital Universitario La Paz, ALS Unit

location_facility: Kantonsspital St.Gallen, Muskelzentrum/ALS Clinic

location_facility: Azienda Ospedaliero Universitaria (AUO) di Torino - Citta'della Salute e della Scienza di Torino

location_facility: Montreal Neurological Institute and Hospital

location_facility: Instituti Clinica Scientifici Maugeri - IRCCS

location_facility: Hospital Universitario Vall d'Hebron ALS Unit. Consultas Externas; Office: 9-10-11

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Ambulanz fuer ALS und andere Motoneuronenerkrankungen

location_facility: University of Pensylvania, Perelman Center for Advanced Medicine - Penn Neuroscience Center

location_facility: Universitaetsklinikum Ulm - Klinik fuer Neurologie

location_facility: Leonard Wolfson Experimental Neurology Centre

location_facility: Groupe Hospitalier Pitie-Salpetriere - Centre d'Investigation Clinique Neurosciences 1422

location_facility: University of Texas Southwestern Medical Center

location_facility: UC Irvine Health ALS and Neuromuscular Center

location_facility: St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center


primary_purpose: Prevention

title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects With Hereditary Angioedema

lead_sponsor: BioCryst Pharmaceuticals

ReferenceCitation: Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11:CD013403. doi: 10.1002/14651858.CD013403.pub2. Review.

ReferenceCitation: Wedner HJ, Aygören-Pürsün E, Bernstein J, Craig T, Gower R, Jacobs JS, Johnston DT, Lumry WR, Zuraw BL, Best JM, Iocca HA, Murray SC, Desai B, Nagy E, Sheridan WP, Kiani-Alikhan S. Randomized Trial of the Efficacy and Safety of Berotralstat (BCX7353) as an Oral Prophylactic Therapy for Hereditary Angioedema: Results of APeX-2 Through 48 Weeks (Part 2). J Allergy Clin Immunol Pract. 2021 Jun;9(6):2305-2314.e4. doi: 10.1016/j.jaip.2021.03.057. Epub 2021 Apr 15.

ReferenceCitation: Zuraw B, Lumry WR, Johnston DT, Aygören-Pürsün E, Banerji A, Bernstein JA, Christiansen SC, Jacobs JS, Sitz KV, Gower RG, Gagnon R, Wedner HJ, Kinaciyan T, Hakl R, Hanzlíková J, Anderson JT, McNeil DL, Fritz SB, Yang WH, Tachdjian R, Busse PJ, Craig TJ, Li HH, Farkas H, Best JM, Clemons D, Cornpropst M, Dobo SM, Iocca HA, Kargl D, Nagy E, Murray SC, Collis P, Sheridan WP, Maurer M, Riedl MA. Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: A randomized, double-blind, placebo-controlled phase 3 trial. J Allergy Clin Immunol. 2021 Jul;148(1):164-172.e9. doi: 10.1016/j.jaci.2020.10.015. Epub 2020 Oct 21.

location_country:
Spain
United Kingdom
Austria
Canada
Hungary
North Macedonia
United States
France
Romania
Germany
Czechia

location_facility:
Study Center
Study center
Study Site

summary: This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.


title: A Longitudinal, Exploratory, Natural History Study to Further Characterize and Describe the Signs and Symptoms of Patients With Organic Acidemias

summary: Longitudinal, exploratory, natural history study of patients with MMA due to mut deficiency and PA to characterize the changes in blood disease biomarkers over time and the frequency and severity of clinical events related to their disease.

lead_sponsor: ModernaTX, Inc.

location_facility: Johns Hopkins University School of Medicine

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


title: A Phase 1 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

summary: Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs) and/or biologically active doses.

status: Terminated

lead_sponsor: Amgen

location_country:
Italy
Greece
Australia
United States
France
Japan

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi


title: COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device

summary: The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

ReferenceCitation: Hassan AE, Zaidat OO, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Fifi JT. Impact of interhospital transfer vs. direct admission on acute ischemic stroke patients: A subset analysis of the COMPLETE registry. Front Neurol. 2022 Aug 9;13:896165. doi: 10.3389/fneur.2022.896165. eCollection 2022.

ReferenceCitation: Zaidat OO, Fifi JT, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Tekle W, Singh IP, Matouk C, Thalwitzer J, Jargiello T, Skrypnik D, Beuing O, Berge J, Katz JM, Biondi A, Bonovich D, Sheth SA, Yoo AJ, Hassan AE; COMPLETE Registry Investigators. Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results. Stroke. 2022 Mar;53(3):769-778. doi: 10.1161/STROKEAHA.121.034268. Epub 2021 Sep 22.

lead_sponsor: Penumbra Inc.

location_country:
Poland
Spain
Russian Federation
United States
France
Germany

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Foundation Ophthalmic Adolphe De Rothschild

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck

intervention_type: Device


acronym: MO-Ped

title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Palovarotene in Subjects With Multiple Osteochondromas

lead_sponsor: Clementia Pharmaceuticals Inc.

ReferenceType: background

ReferenceCitation: Inubushi T, Lemire I, Irie F, Yamaguchi Y. Palovarotene Inhibits Osteochondroma Formation in a Mouse Model of Multiple Hereditary Exostoses. J Bone Miner Res. 2018 Apr;33(4):658-666. doi: 10.1002/jbmr.3341. Epub 2017 Nov 30.

location_country:
Portugal
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Turkey
Belgium
Japan
Netherlands

location_facility: Shriners Hospital for Children - Chicago

location_facility: Bezmialem Vakif University Medical Faculty Hospital

location_facility: The Children's Hospital of Philadelphia (CHOP)

location_facility: Hôpital universitaire Necker - Enfants Malades

location_facility: Shriners Hospital for Children - Sacramento

location_facility: Shriners Hospitals for Children - Portland

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Shriners Hospital for Children - Philadelphia

summary: This is a randomized, double-blind, placebo-controlled study comparing the safety and efficacy of 2 dosage regimens of palovarotene versus placebo in preventing disease progression in pediatric subjects with multiple osteochondromas (MO).


title: An Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

summary: this study extension objective is to evaluate the safety and tolerability of a 200-mcg dose every 4 weeks for 24 weeks of IPP-201101 in patients with active systemic lupus erythematosus (SLE) who had participated in the main study IP-005.

lead_sponsor: ImmuPharma

location_country:
Hungary
Puerto Rico
United States
France
Mauritius
Germany
Czechia

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: University of Debrecen Medical Center Department of Clinical Immunology

location_facility: Clinic for Rheumatology and Internal Medicine


title: Retrospective and Prospective International EkoSonic® Registry of the Treatment and Clinical OUTcomes of Patients With Pulmonary Embolism

acronym: KNOCOUT PE

summary: This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens used as standard of care globally for pulmonary embolism. The registry will include individuals who have already received the APT treatment and those that will undergo APT treatment.

time_perspective: Other

lead_sponsor: EKOS Corporation

location_country:
United Kingdom
Austria
Netherlands
Switzerland
United States
France
Turkey
Germany

location_facility: Metro Health - University of Michigan Health

location_facility: West Virginia University Heart & Vascular Institute

location_facility: St. Vincent Hospital, Allegheny Health Network

location_facility: Temple University Hospital, Department of Thoracic Medicine & Surgery

location_facility: AdventHealth Tampa Pepin Heart Institute

location_facility: St. Vincent Hospital/Reliant Medical Group

location_facility: Cardiology Associates of Northern Mississippi

location_facility: Healthfinity, PLLC Advanced Cardiac & Vascular Clinic


title: A Phase 1b/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Efavaleukin Alfa in Adult Subjects With Steroid Refractory Chronic Graft Versus Host Disease

summary:
Phase 1b: To evaluate the safety and tolerability of multiple ascending doses of efavaleukin alfa in subjects with steroid refractory chronic graft versus host disease (cGVHD).

Phase 2: To evaluate the efficacy of efavaleukin alfa in subjects with steroid refractory cGVHD as measured by overall response rate (ORR) at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Japan
United States
France
Belgium

location_facility: The Ohio State University Wexner Medical Center Arthur G James Cancer Hospital and Solove Research

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg


acronym: ATLAS-INH

title: ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX

lead_sponsor: Genzyme, a Sanofi Company

ReferenceCitation: The Lancet Haematology. The role of conferences in tackling inequalities. Lancet Haematol. 2022 Feb;9(2):e81. doi: 10.1016/S2352-3026(22)00008-4.

ReferenceCitation: Del Pozo Martín Y. 2021 ASH annual meeting. Lancet Haematol. 2022 Feb;9(2):e92-e93. doi: 10.1016/S2352-3026(21)00384-7. Epub 2021 Dec 16.

location_country:
Taiwan
Spain
Italy
United Kingdom
Australia
Canada
Ukraine
Korea, Republic of
United States
France
China
India
Malaysia
Japan
Germany
South Africa
Turkey

location_facility:
Investigational Site Number 6104
Investigational Site Number 8110
Investigational Site Number 0119
Investigational Site Number 4905
Investigational Site Number 9102
Investigational Site Number 0136
Investigational Site Number 3402
Investigational Site Number 8803
Investigational Site Number 8604
Investigational Site Number 8204
Investigational Site Number 8603
Investigational Site Number 8202
Investigational Site Number 9104
Investigational Site Number 6003
Investigational Site Number 0105
Investigational Site Number 8001
Investigational Site Number 3901
Investigational Site Number 6101
Investigational Site Number 0104
Investigational Site Number 4407
Investigational Site Number 8805
Investigational Site Number 0139
Investigational Site Number 2702
Investigational Site Number 0137
Investigational Site Number 9108
Investigational Site Number 0115
Investigational Site Number 8103
Investigational Site Number 9004
Investigational Site Number 8003
Investigational Site Number 8002
Investigational Site Number 9103
Investigational Site Number 8203
Investigational Site Number 8601
Investigational Site Number 1102
Investigational Site Number 3301
Investigational Site Number 9106
Investigational Site Number 3303
Investigational Site Number 2701
Investigational Site Number 0128
Investigational Site Number 9105
Investigational Site Number 4906
Investigational Site Number 9003
Investigational Site Number 9001
Investigational Site Number 0135
Investigational Site Number 0103
Investigational Site Number 9002
Investigational Site Number 9005
Investigational Site Number 8602
Investigational Site Number 2703
Investigational Site Number 8801
Investigational Site Number 6004
Investigational Site Number 0117
Investigational Site Number 8605
Investigational Site Number 3904
Investigational Site Number 9006
Investigational Site Number 8804
Investigational Site Number 0111
Investigational Site Number 9111

summary: The purpose of this study was to determine the frequency of bleeding episodes in participants receiving fitusiran as prophylactic treatment of hemophilia compared to participants who were assigned to continue with their regular medication. In addition, the study assessed safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).


title: A Phase 3, Randomized, Rater-Blinded, Multi-Center Study To Evaluate the Efficacy and Safety of ALXN1840 Administered For 48 Weeks Versus Standard of Care in Patients With Wilson Disease Aged 12 Years and Older

summary: The study will evaluate the efficacy and safety of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in Wilson Disease (WD) participants aged 12 and older in the Primary Evaluation Period. In addition, efficacy and safety will be evaluated during an optional 60-month Extension Period.

ipd_sharing_description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Serbia
Spain
United Kingdom
United States
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Israel
Turkey
Singapore
Canada
Hungary
Germany
Denmark
Taiwan
New Zealand
Korea, Republic of
France

location_facility: Kyungpook National University Children's Hospital

location_facility: Istanbul Uni. Istanbul Medical Faculty Hospital

location_facility: St. Petersburg Clinical Hospital of the Russian Academy of Sciences

location_facility: Ege University School of Medicine, Department of Gastroenterology

location_facility: Chang Gung Memorial Hospital-Linkou Branch

location_facility: National Scientific Institute of Nutrition

location_facility: Sandwell and West Birmingham Hospitals NHS Trust

location_facility: Royal Surrey County Hospital NHS Foundation Trust

location_facility: St. Luke's Health Baylor College of Medicine Medical Center

location_facility: Clinic of Rheumatology, Internal and Occupational Diseases

location_facility: Hospital Clínic i Provincial de Barcelona

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

location_facility: Hacettepe Universitesi - Tip Fakultesi (Hacettepe University Faculty of Medicine)

location_facility: Hadassah Ein-Karem Medical Center - Liver Unit

location_facility: "Volga Research Medical University" of the Ministry of Health of Russia

location_facility: Texas Children's Hospital (TCH) - Viral Hepatitis Clinic


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

lead_sponsor: Regeneron Pharmaceuticals

ReferenceCitation: Raal FJ, Rosenson RS, Reeskamp LF, Hovingh GK, Kastelein JJP, Rubba P, Ali S, Banerjee P, Chan KC, Gipe DA, Khilla N, Pordy R, Weinreich DM, Yancopoulos GD, Zhang Y, Gaudet D; ELIPSE HoFH Investigators. Evinacumab for Homozygous Familial Hypercholesterolemia. N Engl J Med. 2020 Aug 20;383(8):711-720. doi: 10.1056/NEJMoa2004215.

location_country:
Greece
Austria
Australia
Italy
Canada
Ukraine
United States
France
South Africa
Japan
Netherlands

location_facility:
Regeneron Research Site
Regeneron Research Site #3
Regeneron Research Site #2
Regeneron Research Site # 2

summary: The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.


title: FAST Trial Registry: Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

acronym: FAST Registry

summary: The FAST Trial Registry is a prospective observational cohort study of fetuses with a new diagnosis of atrial flutter (AF) or supraventricular tachycardia (SVT) that is severe enough to consider prenatal treatment (see eligibility criteria below). Aims of the Registry include to establish a large clinical database to determine and compare the efficacy and safety of different prenatal treatment strategies including observation without immediate treatment, transplacental antiarrhythmic fetal treatment and direct fetal treatment from the time of tachycardia diagnosis to death, neonatal hospital discharge or to a maximum of 30 days after birth.

lead_sponsor: The Hospital for Sick Children

location_country:
Brazil
Hong Kong
Spain
United Kingdom
Russian Federation
Australia
Canada
Finland
Switzerland
Sweden
United States
France
Netherlands
Czechia

location_facility: St George's University Hospital Foundation Trust

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Queen Elizabeth University Hospital, Glasgow

location_facility: West Virginia University Research Corporation

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Karolinska University Hospital, Astrid Lindgen Childrens Hospital

location_facility: Cincinnati Children's Hospital Medical Centre

location_facility: Inc Pediatric Cardiology of Austin Practice

location_facility: National medical research center for obstetrics, gynecology and perinatology

location_facility: Cohen Children's Medical Centre/Northwell Health - Lake Success

location_facility: Associação Beneficente Síria - Hospital do Coração


title: Open Label, Long-term Safety, Tolerability, and Efficacy Study of GIVINOSTAT in All DMD Patients Who Have Been Previously Treated in One of the GIVINOSTAT Studies

summary: This is an open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD (Duchenne's muscular dystrophy) patients who have been previously treated in one of the GIVINOSTAT studies.

lead_sponsor: Italfarmaco

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

location_facility: UCL Great Ormond Street Institute of Child Health, Dubowitz Neuromuscular Centre and MRC Centre for NMD

location_facility: Ospedale Pediatrico Bambino Gesù, Malattie Neuromuscolari e Neurodegenerative

location_facility: CHU de Nantes - Hotel-Dieu - Hopital Nord Laennec, rez-de-chausse haut ail Ouest

location_facility: Connecticut Children's Medical Center, Neurology Division

location_facility: Universitätsklinikum Essen - Kinder-und Jugendmedizin Neuropadiatrie

location_facility: The University of British Columbia, Children's and Womens Health Centre of BC Branch

location_facility: Hôpital Armand Trousseau I-Motion - Plateforme d'essais cliniques pédiatriques Bâtiment Lemariey - Porte 20 * 2ème étage 26 Avenue du Dr Arnold Nette

location_facility: U.O.S.D. Centro Traslazionale di Miologia e Patologie Neurodegenerative, Building 16 - ground floor IRCCS Istituto Giannina Gaslini,

location_facility: Klinik- und Poliklinik fur Kinder- und Jugendmedizin, Universitatsklinikum HamburgEppendorf, Martinistr. 52

location_facility: Hospital Universitari i Politècnic La Fe - Servicio Neurologia

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, UOS di Neurologia Pediatrica

location_facility: A.O.U. Policlinico G. Martino, U.O.C. Neurologia e Malattie Neuromuscolari

location_facility: Washington University School of Medicine in St Louis Department of Neurology 660 S.Euclid Avenue, Campus Box 8111

location_facility: Klinikum der Universitat Munchen, Campus Innenstadt, Lindwurmstr. 4

location_facility: Fondazione Policlinico Universitario "A.Gemelli", UOC Neuropsichiatria Infantile

location_facility: Virginia Commonwealth University Childrens Hospital of Richmond at

location_facility: The John Walton Muscular Dystrophy Research Centre

location_facility: Centro Clinico NeMO Fondazione Serena ONLUS Area SUD

location_facility: Kinsmen Research Centre - Alberta Children's Hospital

location_facility: Holland Bloorview Kids Rehabilitation Hospital

location_facility: Leiden University Medical Center LUMC, Albinusdreef 2

location_facility: University of California - Davis Medical Center - Devis Physical Medicine & Rehabilitation

location_facility: Rady Children's Hospital center - UCSD Department of Neuroscience

location_facility: Hospital de La Citadelle, Centre de Référence des Maladies Neuromuscolaires (CRMN)

location_facility: Neuromuscular Pathology Unit - Hospital Sant Joan de Déu

location_facility: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

location_facility: Clinic of Neurology and Psychiatry for Children and Youth - Neurology Department Dr. Subotic 6a,

location_facility: Institute of Neurology - Schneider Children's Medical Center of Israel Kaplan, 14

location_facility: The Children's Hospital of Philadelphia Colket Translational Research Building

location_facility: University Hospitals Leuven, Neuromuscular Reference Centre, Child Neurology


title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center, Exploratory Dose-response Study to Assess the Efficacy and Safety of Different Oral Doses of BAY1128688 in Women With Symptomatic Endometriosis Over a 12-week Treatment Period

summary: Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.

lead_sponsor: Bayer

location_country:
Denmark
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
Hungary
France
Belgium
Germany
Czechia

location_facility: Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: Hospital General Universitario de Valencia

location_facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

location_facility: NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Casa di Cura Privata Malzoni - Villa dei Platani

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: York Teaching Hospital NHS Foundation Trust

location_facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi

location_facility: IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro


title: A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients With Residual FVIII Levels ≤ 1 IU/dL Receiving Prophylactic FVIII Infusions

lead_sponsor: BioMarin Pharmaceutical

ReferenceCitation: Quinn J, Delaney KA, Wong WY, Miesbach W, Bullinger M. Psychometric Validation of the Haemo-QOL-A in Participants with Hemophilia A Treated with Gene Therapy. Patient Relat Outcome Meas. 2022 Jul 18;13:169-180. doi: 10.2147/PROM.S357555. eCollection 2022.

ReferenceCitation: Ozelo MC, Mahlangu J, Pasi KJ, Giermasz A, Leavitt AD, Laffan M, Symington E, Quon DV, Wang JD, Peerlinck K, Pipe SW, Madan B, Key NS, Pierce GF, O'Mahony B, Kaczmarek R, Henshaw J, Lawal A, Jayaram K, Huang M, Yang X, Wong WY, Kim B; GENEr8-1 Trial Group. Valoctocogene Roxaparvovec Gene Therapy for Hemophilia A. N Engl J Med. 2022 Mar 17;386(11):1013-1025. doi: 10.1056/NEJMoa2113708.

ReferenceCitation: Rosen S, Tiefenbacher S, Robinson M, Huang M, Srimani J, Mackenzie D, Christianson T, Pasi KJ, Rangarajan S, Symington E, Giermasz A, Pierce GF, Kim B, Zoog SJ, Vettermann C. Activity of transgene-produced B-domain-deleted factor VIII in human plasma following AAV5 gene therapy. Blood. 2020 Nov 26;136(22):2524-2534. doi: 10.1182/blood.2020005683.

location_country:
Taiwan
Brazil
Spain
Italy
United Kingdom
Australia
Korea, Republic of
United States
France
Israel
South Africa
Belgium
Germany

location_facility: University of Michigan, Pediatric Hematology and Oncology

location_facility: University Hospital Virgen del Rocio (HUVR)

location_facility: Arthur De Siqueira Cavalcanti Hematology State Institute

location_facility: Washington University School of Medicine, Department of Pediatrics, Division of Hematology/Oncology

location_facility: Campinas Estadual University (UNICAMP) / Campinas Hemocentro / Hematologia E Hemoterapia Center

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: St. Joseph's Children's Hospital, Center for Bleeding and Clotting Disorders

location_facility: Vivantes Clinic im Friedrichshain- Landsberger Allee

location_facility: Maggiore Polyclinic Hospital, IRCCS Ca' Granda, Center for Hemophilia and Thrombosis Angelo Bianchi Bonomi

location_facility: Glasgow Royal Infirmary, Department of Hematology

location_facility: Churchill Hospital, Oxford Hemophilia and Thrombosis Center

location_facility: Barts and The London School of Medicine and Dentistry, Haemophilia Centre

location_facility: Hopital de la Timone Marseille - Assistance Publique des Hopitaux de Marseille

location_facility: Wayne State University, Detroit Medical Center

location_facility: Holy Spirit Hematology and Hemotherapy Center

location_facility: University of California San Diego, Hematology and Oncology, Hemophilia &Thrombosis Treatment Center

location_facility: Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center

location_facility: Los Angeles Orthopedic Hospital, Orthopedic Hemophilia Treatment Center

location_facility: Parana's Hematology And Hemotherapy Center (HEMEPAR)

location_facility: Department of Pediatrics, Kyung Hee University Hospital at Gangdong

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Regional University Hospital of Lille (CHRU de Lille)

summary: This Phase III clinical study will assess the efficacy of BMN 270 defined as FVIII activity, during weeks 49-52 following intravenous infusion of BMN 270 and assess the impact of BMN 270 on usage of exogenous FVIII replacement therapy and the number of bleeding episodes from week 5 to last visit by data cutoff.


title: Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

acronym: Onyx ONE

summary: The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

ReferenceCitation: Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Kahar Bin Abdul Ghapar A, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Ali ZA, Parke M, Lung TH, Stone GW; Onyx ONE Investigators. Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE. JACC Cardiovasc Interv. 2022 Jun 13;15(11):1153-1163. doi: 10.1016/j.jcin.2022.04.010.

ReferenceCitation: Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Abdul Ghapar AKB, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Jankovic I, Brar S, Bousquette L, Liu M, Stone GW; ONYX ONE Investigators. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. 2020 Mar 26;382(13):1208-1218. doi: 10.1056/NEJMoa1910021. Epub 2020 Feb 12.

ReferenceCitation: Kedhi E, Latib A, Abizaid A, Kandzari D, Kirtane AJ, Mehran R, Price MJ, Simon D, Worthley S, Zaman A, Brar S, Liu M, Stone GW, Windecker S. Rationale and design of the Onyx ONE global randomized trial: A randomized controlled trial of high-bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy. Am Heart J. 2019 Aug;214:134-141. doi: 10.1016/j.ahj.2019.04.017. Epub 2019 May 6.

lead_sponsor: Medtronic Vascular

location_country:
Spain
Italy
United Kingdom
Lithuania
Belgium
Poland
Hong Kong
Austria
Australia
Norway
Sweden
Singapore
Malaysia
Slovakia
Switzerland
Bulgaria
Ireland
Latvia
New Zealand
Thailand
Korea, Republic of
France
Netherlands

location_facility: Institut Jantung Negara - National Heart Institute

location_facility: Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Galway University Hospitals - University Hospital Galway (UHG)

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: Maastricht Universitair Medisch Centrum (MUMC)

location_facility: Cardiff and Vale University Health Board - University Hospital of Wales (UHW)

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s

location_facility: A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: Stavanger Universitetssjukehus - Helse Stavanger HF

location_facility: Bundaberg Cardiology - Friendly Society Private Hospital

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital General Universitario de Alicante

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: Golden Jubilee National Hospital - NHS Trust

location_facility: Seoul National University Bundang Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Allgemeines Krankenhaus - Universitätskliniken Wien

location_facility: Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini

location_facility: Paula Stradina Kliniska universitates slimnica