acronym: CREAD

summary: This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.

ReferenceCitation: Ostrowitzki S, Bittner T, Sink KM, Mackey H, Rabe C, Honig LS, Cassetta E, Woodward M, Boada M, van Dyck CH, Grimmer T, Selkoe DJ, Schneider A, Blondeau K, Hu N, Quartino A, Clayton D, Dolton M, Dang Y, Ostaszewski B, Sanabria-Bohorquez SM, Rabbia M, Toth B, Eichenlaub U, Smith J, Honigberg LA, Doody RS. Evaluating the Safety and Efficacy of Crenezumab vs Placebo in Adults With Early Alzheimer Disease: Two Phase 3 Randomized Placebo-Controlled Trials. JAMA Neurol. 2022 Nov 1;79(11):1113-1121. doi: 10.1001/jamaneurol.2022.2909.

publisher_dissemination: American Medical Association

location_facility: Hospital Beatriz Angelo; Servico de Neurologia

location_facility: National Clinical Research Inc.-Richmond

location_facility: Queen Mary Hospital, Division of Geriatric Medicine

location_facility: Hospital Virgen del Puerto. Servicio de Neurología

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

location_facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde

location_facility: Coventry and Warwickshire Partnership NHS Trust

location_facility: Neurodegenerative Disorders Research; Neurology

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: University of California, Davis; Alzheimers Disease Center, Department of Neurology

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Clinica Ruber, 4 planta; Servicio de Neurologia

location_facility: The Cognitive and Research Center of New Jersey

location_facility: University of North Texas Health Science Center; Fort Worth Patient Care Center

location_facility: Semmelweis University; Department of Neurology

location_facility: SHI City Psychoneurological Dispensary #7

location_facility: Hospital General Universitario de Albacete; Servicio de Neurología

location_facility: Alexandrovska hospital; Neurology Department

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; S.C. Geriatria

location_facility: General Teaching Hospital, Departmetn of Neurology

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky

location_facility: Servicio de Neurología Hospital Viamed Montecanal.

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Szent Borbala Korhaz; Neurologiai es Stroke Osztaly

location_facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Steinwachs Klaus; Arztpraxis fur Neurologie u. Psychiatrie

location_facility: Osmangazi University School of Medicine,Neurology Department

location_facility: Alzheimer's Research and Treatment Center

location_facility: Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Ewha Womans University Mokdong Hospital; Dept of Neurology

location_facility: Vilnius University Hospital Santariskiu Clinic

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Institution of RAMS (Mental Health Research Center of RAMS)

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología

location_facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: Hopital Hautepierre; Centre dInvestigation Clinique

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer

location_facility: University of Szeged; Department of Psychiatry

location_facility: Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Caulfield Hospital; Aged Psychiatry Research Unit

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: Southern Illinois University, School of Medicine

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: D.F.Chebotarev Institute of Gerontology NAMS;Depart of Age Physiology&Pathology of Nervous System

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Universitäres Zentrum für Altersmedizin und Rehabilitation

location_facility: Institute for Neurodegenerative Disorders

location_facility: Regional mental hospital; Department of psychiatry, psychology and sexology

location_facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Karolinska Uni Hospital, Huddinge; Dept. of Geriatric Med

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: Charles University, Medical faculty, Hradec Kralove ;Department of Neurology

location_facility: Hospital Sant Joan de Deu; Servicio de Neurología

location_facility: Drexel Univ College of Med; Clinical Research Group

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

location_facility: National Center of Neurology and Psychiatry

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak - Jósa András Oktatókórház; Pszichiátria

location_facility: Konventhospital Barmherzige Brüder; Neurologie I

location_facility: Jávorszky Ödön Kórház, Neurológia és stroke osztály

location_facility: Hospital Mutua De Terrasa; Servicio de Neurologia

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: UCLA Medical Center, Department of Neurology

location_facility: Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry

location_facility: Jacksonville Center For Clinical Research

location_facility: Hospital Universitario de Burgos. Servicio de Neurología

location_facility: Advanced Memory Research Institute of NJ

location_facility: Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa

location_facility: SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF

location_facility: Alliance for Wellness, dba Alliance for Research

location_facility: Albany Medical Faculty Physicians COmmunity Division. The Neurology Group

location_facility: Clinical Hospital Centre Zagreb;Clinic for Neurology

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Hacettepe University School of Medicine; Neurology

location_facility: Surrey and Borders NHS Foundation Trust; Brain Science Research Unit

location_facility: Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia

location_facility: National Medical Academy of Postgraduate Education named after P.L.Shupik; Neurology Department #1

title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease.

location_country:
Finland
Germany
Poland
Australia
Costa Rica
Japan
Turkey
Croatia
Czechia
Canada
France
Slovenia
Lithuania
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Belgium
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Bulgaria
Russian Federation
Sweden


study_start_date_type: Actual

acronym: TRANSITION

intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

summary: To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.

ReferenceType: derived

ReferenceCitation: Pascual-Figal D, Wachter R, Senni M, Bao W, Noe A, Schwende H, Butylin D, Prescott MF; TRANSITION Investigators. NT-proBNP Response to Sacubitril/Valsartan in Hospitalized Heart Failure Patients With Reduced Ejection Fraction: TRANSITION Study. JACC Heart Fail. 2020 Oct;8(10):822-833. doi: 10.1016/j.jchf.2020.05.012. Epub 2020 Aug 12.

licence_repositories: cc-by-nc-nd cc-by-nc-sa

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Senni M, Wachter R, Witte KK, Straburzynska-Migaj E, Belohlavek J, Fonseca C, Mueller C, Lonn E, Chakrabarti A, Bao W, Noe A, Schwende H, Butylin D, Pascual-Figal D; TRANSITION Investigators. Initiation of sacubitril/valsartan shortly after hospitalisation for acutely decompensated heart failure in patients with newly diagnosed (de novo) heart failure: a subgroup analysis of the TRANSITION study. Eur J Heart Fail. 2020 Feb;22(2):303-312. doi: 10.1002/ejhf.1670. Epub 2019 Dec 9.

oa_host_type: publisher

evidence: open (via free article)

license_normalized: no license

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Wachter R, Senni M, Belohlavek J, Straburzynska-Migaj E, Witte KK, Kobalava Z, Fonseca C, Goncalvesova E, Cavusoglu Y, Fernandez A, Chaaban S, Bohmer E, Pouleur AC, Mueller C, Tribouilloy C, Lonn E, A L Buraiki J, Gniot J, Mozheiko M, Lelonek M, Noe A, Schwende H, Bao W, Butylin D, Pascual-Figal D; TRANSITION Investigators. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study. Eur J Heart Fail. 2019 Aug;21(8):998-1007. doi: 10.1002/ejhf.1498. Epub 2019 May 27.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

license: cc-by

license_normalized: cc-by

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

ReferenceCitation: Pascual-Figal D, Wachter R, Senni M, Belohlavek J, Noe A, Carr D, Butylin D. Rationale and design of TRANSITION: a randomized trial of pre-discharge vs. post-discharge initiation of sacubitril/valsartan. ESC Heart Fail. 2018 Apr;5(2):327-336. doi: 10.1002/ehf2.12246. Epub 2017 Dec 14.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

status: Completed

title: A Multicenter, Randomized, Open Label, Parallel Group Study Comparing Pre-discharge and posT-discharge tReatment Initiation With LCZ696 in heArt Failure patieNtS With Reduced ejectIon-fracTion hospItalized for an Acute decOmpensation eveNt (ADHF)

primary_purpose: Supportive Care

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
Argentina
Turkey
Czechia
Canada
France
Portugal
Slovakia
Switzerland
Lebanon
Belgium
Italy
Norway
United Kingdom
Saudi Arabia
Spain
Russian Federation
Sweden

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

summary: The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

primary_purpose: Treatment

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Germany
Italy
Poland
Norway
Australia
Sweden
United States
Spain
Canada
France

location_facility:
Local Institution - 0017
Local Institution - 0030
Local Institution - 0057
Local Institution - 0029
Local Institution - 0003
Local Institution - 0018
Local Institution - 0011
Local Institution - 0009
Local Institution - 0041
Local Institution - 0035
Local Institution - 0059
Local Institution - 0054
Local Institution - 0044
Local Institution - 0027
Local Institution - 0055
Local Institution - 0002
Local Institution - 0040
Local Institution - 0024
Local Institution - 0028
Local Institution - 0005
Local Institution - 0034
Local Institution - 0012
Local Institution - 0052
Local Institution - 0043
Local Institution - 0016
Local Institution - 0033
Local Institution - 0001
Local Institution - 0023
Local Institution - 0008
Local Institution
Local Institution - 0022
Local Institution - 0047
Local Institution - 0013
Local Institution - 0049
Local Institution - 0045
Local Institution - 0026
Local Institution - 0004
Local Institution - 0053
Local Institution - 0025
Local Institution - 0048
Local Institution - 0010
Local Institution - 0051
Local Institution - 0019
Local Institution - 0006
Local Institution - 0046
Local Institution - 0036
Local Institution - 0042


title: A Phase 1/2 Open-Label Study of the Safety, Tolerability and Efficacy of the Selective Inhibitor of Nuclear Export (SINE) Compound Eltanexor (KPT-8602) in Patients With Newly Diagnosed and Relapsed/Refractory Cancer Indications

summary:
This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in participants with relapsed/refractory multiple myeloma (MM), metastatic colorectal cancer (mCRC), metastatic castration resistant prostate cancer (mCRPC), higher risk myelodysplastic syndrome (HRMDS), acute myeloid leukemia (AML) and newly diagnosed intermediate/high-risk MDS.

Dose escalation and dose expansion may be included for all parts of the study as determined by ongoing study results.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceCitation: Lee S, Mohan S, Knupp J, Chamoun K, de Jonge A, Yang F, Baloglu E, Shah J, Kauffman MG, Shacham S, Bhatnagar B. Oral eltanexor treatment of patients with higher-risk myelodysplastic syndrome refractory to hypomethylating agents. J Hematol Oncol. 2022 Aug 3;15(1):103. doi: 10.1186/s13045-022-01319-y.

publisher_dissemination: Springer-Nature

ipd_sharing: Undecided

lead_sponsor: Karyopharm Therapeutics Inc

location_country:
United States
China
Spain
Canada
France

location_facility: John Theurer Cancer Center at Hackensack UMC

location_facility: University of Pennsylvania Abramson Cancer Center Clinical Research Unit

location_facility: Rocky Mountain Regional VA Medical Center

location_facility: Oncology Institute of Hope and Innovation

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: Sarah Cannon Cancer Center - (Colorado Blood Cancer Institute)

location_facility: Clinical Universidad de Navarra (Madrid site)

location_facility: Ohio State University, The James Cancer Hospital and Solove Research Institute

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

location_facility: Sarah Cannon Cancer Center (HCA Midwest KC)

status_simplified: Ongoing


title: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)

acronym: CheckMate 274

summary: The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

ReferenceCitation: Bajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Neif Antonio J Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2021 Jun 3;384(22):2102-2114. doi: 10.1056/NEJMoa2034442. Erratum In: N Engl J Med. 2021 Aug 26;385(9):864.

oa_colors: green other

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repository_institution: Radboud University - Radboud Repository

version: acceptedVersion

repositories:
PubMed Central
Pure (Denmark)
repository.ubn.ru.nl

repositories_institution:
Elsevier - Scopus
Radboud University - Radboud Repository

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

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

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

intervention_type: Other


title: A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant

acronym: ReGIFT

summary: The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from donors >45 years after brain death (DBD).

primary_purpose: Prevention

lead_sponsor: Quark Pharmaceuticals

location_country:
Germany
Argentina
Australia
Brazil
Netherlands
Belgium
United States
Spain
Czechia
Canada
France

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Medizinische Hochschule Hannover, Klinik für Nieren und Hochdruckerkrankungen

location_facility: Centre Hospitalier - Universitaire de Liège

location_facility: University of Florida Health, Shands Hospital

location_facility: Integris Nazih Zuhdi Transplant Institute

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: University Hospital Schleswig Holstein, Campus Kiel

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

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Fundação Oswaldo Ramos - Hospital do Rim

location_facility: Centre Hospitalier Universitaire de Rangueil

location_facility: Instituto de Nefrología Trasplante Renal y Renopancreatico

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

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum (CVK)

location_facility: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)


acronym: Phase II anetumab ravtansine as 2nd line treatment for malignant pleural mesothelioma (MPM)

lead_sponsor: Bayer

summary:
The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM).

210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine.

Treatment will continue until centrally confirmed disease progression or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required.

Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.

ReferenceCitation: Kindler HL, Novello S, Bearz A, Ceresoli GL, Aerts JGJV, Spicer J, Taylor P, Nackaerts K, Greystoke A, Jennens R, Calabro L, Burgers JA, Santoro A, Cedres S, Serwatowski P, Ponce S, Van Meerbeeck JP, Nowak AK, Blumenschein G Jr, Siegel JM, Kasten L, Kochert K, Walter AO, Childs BH, Elbi C, Hassan R, Fennell DA. Anetumab ravtansine versus vinorelbine in patients with relapsed, mesothelin-positive malignant pleural mesothelioma (ARCS-M): a randomised, open-label phase 2 trial. Lancet Oncol. 2022 Apr;23(4):540-552. doi: 10.1016/S1470-2045(22)00061-4.

oa_host_type: repository

unpaywall_oa_status: green

sponsor_collaborators:
Bayer
ImmunoGen and MorphoSys

title: A Randomized, Open-label, Active-controlled, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343) or Vinorelbine in Patients With Advanced or Metastatic Malignant Pleural Mesothelioma Overexpressing Mesothelin and Progressed on First Line Platinum/Pemetrexed-based Chemotherapy

location_country:
Finland
Italy
Poland
United Kingdom
Australia
Netherlands
Belgium
United States
Korea, Republic of
Spain
Turkey
Canada
Russian Federation
France


type: Other Identifier

title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer

acronym: CHRYSALIS

summary: The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of Amivantamab as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD) (combination therapy), and to determine recommended Phase 2 Dose (RP2q3W) with combination chemotherapy (Amivantamab in combination with standard of care carboplatin and pemetrexed) in 21 day treatment cycle for participants with advanced non-small cell lung cancer (NSCLC).

ReferenceCitation: Jatkoe T, Wang S, Odegaard JI, Velasco Roth AM, Osgood D, Martinez G, Lucas P, Curtin JC, Karkera J. Clinical Validation of Companion Diagnostics for the Selection of Patients with Non-Small Cell Lung Cancer Tumors Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutations for Treatment with Amivantamab. J Mol Diagn. 2022 Nov;24(11):1181-1188. doi: 10.1016/j.jmoldx.2022.07.003. Epub 2022 Aug 10.

oa_host_type: closed

ReferenceCitation: Park K, Haura EB, Leighl NB, Mitchell P, Shu CA, Girard N, Viteri S, Han JY, Kim SW, Lee CK, Sabari JK, Spira AI, Yang TY, Kim DW, Lee KH, Sanborn RE, Trigo J, Goto K, Lee JS, Yang JC, Govindan R, Bauml JM, Garrido P, Krebs MG, Reckamp KL, Xie J, Curtin JC, Haddish-Berhane N, Roshak A, Millington D, Lorenzini P, Thayu M, Knoblauch RE, Cho BC. Amivantamab in EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study. J Clin Oncol. 2021 Oct 20;39(30):3391-3402. doi: 10.1200/JCO.21.00662. Epub 2021 Aug 2.

evidence: open (via page says license)

repository_institution: The University of Manchester - Research Explorer

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Kohler J, Janne PA. Amivantamab: Treating EGFR Exon 20-Mutant Cancers With Bispecific Antibody-Mediated Receptor Degradation. J Clin Oncol. 2021 Oct 20;39(30):3403-3406. doi: 10.1200/JCO.21.01494. Epub 2021 Aug 2. No abstract available.

lead_sponsor: Janssen Research & Development, LLC

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


title: A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

summary: The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.

ReferenceType: result

ReferenceCitation: Daar ES, DeJesus E, Ruane P, Crofoot G, Oguchi G, Creticos C, Rockstroh JK, Molina JM, Koenig E, Liu YP, Custodio J, Andreatta K, Graham H, Cheng A, Martin H, Quirk E. Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2018 Jul;5(7):e347-e356. doi: 10.1016/S2352-3018(18)30091-2. Epub 2018 Jun 18.

ReferenceCitation: Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, Liu YP, Graham H, Quirk E, Martin H, White KL. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. J Antimicrob Chemother. 2019 Dec 1;74(12):3555-3564. doi: 10.1093/jac/dkz347. Erratum In: J Antimicrob Chemother. 2019 Dec 1;74(12):3646-3647.

publisher_dissemination: Oxford University Press

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
United Kingdom
Australia
Belgium
United States
Spain
Dominican Republic
Canada
Puerto Rico
France


title: COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention

acronym: COBRA-REDUCE

summary: The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.

status: Unknown status

ReferenceCitation: Colleran R, Joner M, Cutlip D, Urban P, Maeng M, Jauhar R, Barakat M, Michel JM, Mehran R, Kirtane AJ, Maillard L, Kastrati A, Byrne RA; COBRA-REDUCE investigators. Design and Rationale of a Randomized Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE). Cardiovasc Revasc Med. 2022 Jan;34:17-24. doi: 10.1016/j.carrev.2021.01.022. Epub 2021 Jan 22.

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

repository_institution: University of Illinois at Chicago - INDIGO

lead_sponsor: CeloNova BioSciences, Inc.

location_country:
Germany
Italy
Denmark
Switzerland
Belgium
United States
Latvia
France

location_facility: Paula Stradins Clinical University Hospital

location_facility: Sentara Heart Hospital (Sentara Cardiovascular Research Institute)

location_facility: University of Maryland St. Joseph Medical Center

location_facility: Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois

location_facility: Rutgers Robert Wood Johnson Medical Schoo

intervention_type: Device

status_simplified: Unknown


lead_sponsor: Boehringer Ingelheim

summary: The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin

ReferenceCitation: Rosenstock J, Marquard J, Laffel LM, Neubacher D, Kaspers S, Cherney DZ, Zinman B, Skyler JS, George J, Soleymanlou N, Perkins BA. Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials. Diabetes Care. 2018 Dec;41(12):2560-2569. doi: 10.2337/dc18-1749. Epub 2018 Oct 4.

evidence: open (via free pdf)

publisher_dissemination: American Diabetes Association

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_facility: VSV Centrs, Stalte Private Practice, Talsi

location_facility: SC Pelican Impex SRL, Cabinet Nr. 201, Diabetes Dept.

location_facility: Desert Endocrinology Clinical Research Center

location_facility: Instituto Jaliscience de Inv. en Diabetes y Obesidad, S.C.

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Dace Teterovska Doctor's Practice in Endocrinology,Ogre

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki

location_facility: NorCal Endocrinology and Internal Medicine

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

location_facility: Applied Medical Informatics Research INC.

location_facility: AIDIN VK s.r.o.,Department Diabetology, Hranice

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: Zala Country Hospital, Diabetic Outpatient Clinic

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: CRU Hungary Ltd, Private Practice, Miskolc

location_facility: City Hospital Saint Elizaveta, Dept. Endocrinology

location_facility: Endocrine-Diabetes Care and Resource Center

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occident

location_facility: General Hopsital of Thessaloniki "Ippokrateio"

location_facility: Milan Kvapil s.r.o.,Diabetology ambulance,Prague

location_facility: P. Stradins Clinical University Hospital, Riga

location_facility: Diabetes Endocrinology Research Center of Western New York

location_facility: DiaGolfova s.r.o., Department Diabetology, Prague

location_facility: Witold Chodzko Institute Rural Medic,Dep.Diabetology,Lublin

location_facility: A. Lucenko's Internist & Endocrinologist Doctor's Practice

location_facility: John Muir Physician Network Clinical Research Center

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: Endo-Diabesidad-Clínica Durán & Asociados

location_facility: Solutions Through Advanced Research, Inc.

location_facility: Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

location_facility: Clinique des maladies Lipidiques de Quebec

location_facility: Strand Physician Specialists dba Carolina Health Specialists

location_facility: Oslo Universitetssykehus HF, Lipidklinikken

location_facility: Clinical Research Center Medicome, Oswiecim

location_facility: Eagle's Landing Diabetes and Endocrinology

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: University of Maryland School of Medicine

location_facility: Institut für Diabetesforschung Münster GmbH

location_facility: SC Medical Centre "Sanatatea Ta" SRL, Bucharest

location_facility: Independent Public Clin.Hosp.no1Lublin,Dep.Internal Diseases

location_facility: Diabetes-Klinik Bad Mergentheim GmbH & Co. KG

location_facility: Policlinic No. 1 of Russian Academy of Sciences, St. Petersburg

location_facility: APDP - Associação Protectora dos Diabéticos de Portugal

location_facility: Clínica EndocrInol en Diabetes Obesidad y Tiroides (DOT)

location_facility: "Korgialeneio-Benakeio" Hellenic Red Cross Hospital

location_facility: Milit. Cent. Emerg. Univ. Hosp. Dr. Davila, Met. Dis. Dept.

location_facility: Richmond Road and Diagnostic Treatment Centre

location_facility: University Diabetes and Endocrine Consultants

location_facility: Osp. S. Giovanni Calibita Fatebenefratelli

title: A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-3)

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Czechia
Canada
France
Portugal
Hungary
United States
Latvia
Romania
Italy
Norway
United Kingdom
Netherlands
Mexico
Spain
Greece
South Africa
Russian Federation
Sweden


acronym:
Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF

 Innocuité, tolérance et PK du nintedanib combiné avec la pirfénidone dans la PFI

summary:
This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone.

A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combination with pirfenidone and to assess the exposure of pirfenidone when combined with nintedanib.

ReferenceCitation: Vancheri C, Kreuter M, Richeldi L, Ryerson CJ, Valeyre D, Grutters JC, Wiebe S, Stansen W, Quaresma M, Stowasser S, Wuyts WA; INJOURNEY Trial Investigators. Nintedanib with Add-on Pirfenidone in Idiopathic Pulmonary Fibrosis. Results of the INJOURNEY Trial. Am J Respir Crit Care Med. 2018 Feb 1;197(3):356-363. doi: 10.1164/rccm.201706-1301OC.

publisher_dissemination: American Thoracic Society

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

title: A Twelve Week, Open-label, Randomised, Parallel-group Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Oral Nintedanib in Combination With Oral Pirfenidone, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

location_country:
Germany
Italy
Netherlands
United States
Canada
France


acronym: GALILEO

summary:
To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).

To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an antiplatelet-based strategy, following TAVR.

ReferenceCitation: Okuno T, Dangas GD, Hengstenberg C, Sartori S, Herrmann HC, de Winter R, Gilard M, Tchetche D, Mollmann H, Makkar RR, Baldus S, De Backer O, Bendz B, Kini A, von Lewinski D, Mack M, Moreno R, Schafer U, Wohrle J, Seeger J, Snyder C, Nicolas J, Tijssen JGP, Welsh RC, Vranckx P, Valgimigli M, Mehran R, Kapadia S, Sondergaard L, Windecker S. Two-year clinical outcomes after successful transcatheter aortic valve implantation with balloon-expandable versus self-expanding valves: A subanalysis of the GALILEO trial. Catheter Cardiovasc Interv. 2022 Oct;100(4):636-645. doi: 10.1002/ccd.30370. Epub 2022 Aug 30.

ReferenceCitation: Dangas GD, Tijssen JGP, Wohrle J, Sondergaard L, Gilard M, Mollmann H, Makkar RR, Herrmann HC, Giustino G, Baldus S, De Backer O, Guimaraes AHC, Gullestad L, Kini A, von Lewinski D, Mack M, Moreno R, Schafer U, Seeger J, Tchetche D, Thomitzek K, Valgimigli M, Vranckx P, Welsh RC, Wildgoose P, Volkl AA, Zazula A, van Amsterdam RGM, Mehran R, Windecker S; GALILEO Investigators. A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. N Engl J Med. 2020 Jan 9;382(2):120-129. doi: 10.1056/NEJMoa1911425. Epub 2019 Nov 16.

license: public-domain

license_normalized: public-domain

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

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

repository_institution: UHasselt - Document Server@UHasselt

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

repository_institution: University of Zurich - Zurich Open Repository and Archive

repository_institution: University of Southampton - ePrints Soton

ReferenceCitation: Piayda K, Zeus T, Sievert H, Kelm M, Polzin A. Subclinical leaflet thrombosis. Lancet. 2018 Mar 10;391(10124):937-938. doi: 10.1016/S0140-6736(18)30534-8. No abstract available.

ReferenceCitation: Windecker S, Tijssen J, Giustino G, Guimaraes AH, Mehran R, Valgimigli M, Vranckx P, Welsh RC, Baber U, van Es GA, Wildgoose P, Volkl AA, Zazula A, Thomitzek K, Hemmrich M, Dangas GD. Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study. Am Heart J. 2017 Feb;184:81-87. doi: 10.1016/j.ahj.2016.10.017. Epub 2016 Oct 31.

repository_institution: University of Bern - Bern Open Repository and Information System

sponsor_collaborators:
Bayer
Janssen Research & Development, LLC

status: Terminated

title: Global Multicenter, Open-label, Randomized, Event-driven, Active-controlled Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement (TAVR) to Optimize Clinical Outcomes

location_country:
Germany
Italy
Poland
Norway
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Korea, Republic of
Spain
Czechia
Canada
France


title: A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinryze® (C1 Esterase Inhibitor [Human]) for the Treatment of Acute Antibody-mediated Rejection in Kidney Transplant Patients

summary: The main purpose of the study is to evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft in kidney transplant recipients as measured by the proportion of participants with new or worsening transplant glomerulopathy (TG) at 6 months after treatment initiation.

ReferenceCitation: Karpman D, Bekassy Z, Grunenwald A, Roumenina LT. A role for complement blockade in kidney transplantation. Cell Mol Immunol. 2022 Jul;19(7):755-757. doi: 10.1038/s41423-022-00854-5. Epub 2022 Mar 24. No abstract available.

ipd_sharing_description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Shire

location_country:
Germany
Netherlands
United States
Spain
Canada
France

location_facility: INTEGRIS Nazih Zuhdi Transplant Institute

location_facility: Kidney Transplant Research Office at UCLA

location_facility: Providence Health Care Research Institute

location_facility: New York Presbyterian Hospital - Weill-Cornell

location_facility: University of Utah Health Sciences Center

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Washington University School of Medicine

location_facility: University of Pennsylvania Health System

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: University Of Colorado School Of Medicine

location_facility: Groupe Hospitalier Necker Enfants Malades


title: Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Patients Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents

summary: To compare glycemic control and treatment satisfaction using a novel bolus insulin patch (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.

lead_sponsor: Calibra Medical, Inc.

sponsor_collaborators:
Calibra Medical, Inc.
Medpace, Inc.

location_country:
United States
United Kingdom
Germany
France

location_facility: BAG Unterm Heilig Kreuz Unterm Heilig Kreuz

location_facility: Texas Diabetes & Endocrinology, P.A.- Austin

location_facility: Rocky Mountain Diabetes and Osteoporosis Center PA

location_facility: Ninewells Hospital & Medical School Diabetes Support Unit

location_facility: Advanced Metabolic Care & Research Institute, Inc. (AMCR)

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Forth Valley Royal Hospital Dept. of Diabetes

location_facility: Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr.

location_facility: Diabetes Research Institute Mills-Peninsula Health Service

location_facility: Diabetes & Glandular Disease Clinic, P.A.

location_facility: Leicester General Hospital Leicester Diabetes Centre

location_facility: Northwestern University The Feinberg School of Medicine

location_facility: Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications

location_facility: John H. Stroger, Jr. Hospital of Cook County Diabetes Center

location_facility: Park Nicollet Institute International Diabetes Center

location_facility: Royal United Hospital, Diabetes & Lipid Research Wolfson Centre

location_facility: Lapeyronie Hospital, University Hospital Montpellier

location_facility: Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust


title: Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.

lead_sponsor: Arena Pharmaceuticals

location_country:
Germany
Poland
New Zealand
Australia
Czechia
Canada
France
Lithuania
Hungary
United States
Latvia
Ukraine
Romania
Belgium
United Kingdom
Austria
Korea, Republic of
Spain
Bulgaria
Russian Federation
Israel

location_facility:
Arena 1456
Arena 1116
Arena 1407
Arena 1304
Arena 1504
Arena 1102
Arena 1705
Arena 1138
Arena 1506
Arena 1480
Arena 1500
Arena 1477
Arena 1202
Arena 1103
Arena 1403
Arena 1210
Arena 1438
Arena 1101
Arena 1465
Arena 1441
Arena 1610
Arena 1495
Arena 1410
Arena 1448
Arena 1501
Arena 1111
Arena 1505
Arena 1119
Arena 1443
Arena 1486
Arena 1436
Arena 1419
Arena 1424
Arena 1409
Arena 1206
Arena 1607
Arena 1204
Arena 1406
Arena 1114
Arena 1498
Arena 1118
Arena 1428
Arena 1433
Arena 1141
Arena 1113
Arena 1444
Arena 1121
Arena 1417
Arena 1107
Arena 1615
Arena 1706
Arena 1108
Arena 1493
Arena 1454
Arena 1117
Arena 1475
Arena 1106
Arena 1432
Arena 1431
Arena 1481
Arena 1492
Arena 1459
Arena 1414
Arena 1464
Arena 1123
Arena 1137
Arena 1473
Arena 1703
Arena 1446
Arena 1490
Arena 1143
Arena 1458
Arena 1476
Arena 1470
Arena 1614
Arena 1439
Arena 1489
Arena 1437
Arena 1131
Arena 1451
Arena 1112
Arena 1422
Arena 1127
Arena 1208
Arena 1472
Arena 1702
Arena 1128
Arena 1421
Arena 1418
Arena 1478
Arena 1601
Arena 1491
Arena 1469
Arena 1484
Arena 1430
Arena 1605
Arena 1425
Arena 1604
Arena 1704
Arena 1466
Arena 1302
Arena 1133
Arena 1139
Arena 1209
Arena 1411
Arena 1462
Arena 1136
Arena 1105
Arena 1303
Arena 1471
Arena 1405
Arena 1109
Arena 1416
Arena 1115
Arena 1445
Arena 1420
Arena 1130
Arena 1142
Arena 1457
Arena 1460
Arena 1479
Arena 1408
Arena 1455
Arena 1497
Arena 1494
Arena 1474
Arena 1423


lead_sponsor: AbbVie

summary: This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication.

ReferenceCitation: Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

repository_institution: Queen's University Belfast - Research Portal

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

location_facility: Wolstan & Goldberg Eye Associates /ID# 235166

location_facility: Dr. Andrew Gardner Logan, FL /ID# 236946

location_facility: Medical Center Ophthalmology Associates /ID# 235016

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 235929

location_facility: Duplicate_Cornerstone Eye Care /ID# 235047

location_facility: University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129

location_facility: Scott and Christie and Associates /ID# 234594

location_facility: Internationale Innovative Ophthalmochirurgie /ID# 235263

location_facility: Advanced Glaucoma Specialists /ID# 234799

location_facility: California Eye Specialists Medical Group Inc. /ID# 235999

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 237148

location_facility: Clayton Eye Clinical Research, LLC /ID# 236678

location_facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966

location_facility: Albemarle Clinical Trials LLC /ID# 235144

location_facility: West Virginia University Eye Institute /ID# 235174

location_facility: University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875

location_facility: Moorfields Eye Hospital NHS Foundation Trust /ID# 237708

location_facility: Clinique Honore Cave - Pharmacie /ID# 235925

location_facility: California Center for Clin Res /ID# 237412

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 238315

location_facility: Carolinas Centers for Sight,PC /ID# 237017

location_facility: Emerson Clinical Research Institute /ID# 235977

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 236806

location_facility: Arizona Glaucoma Specialists /ID# 235066

location_facility: Peregrine Eye and Laser Institute /ID# 236220

location_facility: Epsom & St Helier University Hospital NHS Trust /ID# 236902

location_facility: ATX Clinical Trials Inc. dba Keystone Research /ID# 235869

location_facility: Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841

location_facility: Universitaetsklinikum Magdeburg /ID# 237284

location_facility: Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041

location_facility: Cincinnati Eye Institute- Edgewood /ID# 236714

location_facility: CHU de Nice - Hospital Pasteur 2 /ID# 235844

location_facility: Tel Aviv Sourasky Medical Center /ID# 237211

location_facility: The Lady Davis Carmel Medical Center /ID# 236757

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 237705

location_facility: CHU Strasbourg - Hopital Civil /ID# 237837

location_facility: Arizona Advanced Eye Research Institute /ID# 234947

location_facility: Manchester University NHS Foundation Trust /ID# 237318

location_facility: Speciality Eye Care Medical Group /ID# 236001

location_facility: Samara State Medical University /ID# 236997

location_facility: Ophthalmology Clinic Bellevue /ID# 234631

location_facility: Eye Associates of New Mexico /ID# 235115

location_facility: Northern New Jersey Eye Institute PA /ID# 234944

location_facility: Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879

location_facility: North Bay Eye Associates Inc. /ID# 235429

location_facility: Levenson Eye Associates Inc. /ID# 235021

location_facility: Cardinal Santos Medical Center /ID# 235325

location_facility: Imperial College Healthcare NHS Trust /ID# 234777

location_facility: Eye Associates of South West Florida /ID# 235424

title: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

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

location_country:
Germany
Poland
Russian Federation
New Zealand
Israel
United Kingdom
Denmark
Australia
United States
Canada
Philippines
France


acronym: LUPUZOR

lead_sponsor: ImmuPharma

summary: This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE.

location_facility: Clinic for Rheumatology and Internal Medicine

location_facility: University of Debrecen Medical Center Department of Clinical Immunology

location_facility: Egyesitett Szt.István és Szt. László Kórház

location_facility: Arthritis and Rheumatic Disease Specialties

title: A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

location_country:
Germany
Poland
Hungary
United States
Mauritius
Czechia
Puerto Rico
France


title: Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

summary: This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.

ReferenceCitation: Johnson CN, Ahn JS, Buck IM, Chiarparin E, Day JEH, Hopkins A, Howard S, Lewis EJ, Martins V, Millemaggi A, Munck JM, Page LW, Peakman T, Reader M, Rich SJ, Saxty G, Smyth T, Thompson NT, Ward GA, Williams PA, Wilsher NE, Chessari G. A Fragment-Derived Clinical Candidate for Antagonism of X-Linked and Cellular Inhibitor of Apoptosis Proteins: 1-(6-[(4-Fluorophenyl)methyl]-5-(hydroxymethyl)-3,3-dimethyl-1 H,2 H,3 H-pyrrolo[3,2- b]pyridin-1-yl)-2-[(2 R,5 R)-5-methyl-2-([(3R)-3-methylmorpholin-4-yl]methyl)piperazin-1-yl]ethan-1-one (ASTX660). J Med Chem. 2018 Aug 23;61(16):7314-7329. doi: 10.1021/acs.jmedchem.8b00900. Epub 2018 Aug 9.

publisher_dissemination: American Chemical Society

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
Italy
Hungary
United Kingdom
Belgium
United States
Spain
Canada
France

location_facility: START- South Texas Accelerated Research Therapeutics

location_facility: CRU de Tours - Hôpital Bretonneau, Hématologie -Thérapy Cellulaire

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

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

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

location_facility: Beatson Cancer Center and University of Glasgow

location_facility: Churchill Hospital, Oxford University Hospital NHS Trust

location_facility: Hospital Universitario Fundacion Jimenez Diaz Preview

location_facility: Dartmouth-Hitchcock Medical Center (DHMC)

location_facility: New York University Langone Medical Center

location_facility: Semmelweis Egyetem - I. sz. Belgyógyászati Klinika

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

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Socio Santaria Territoriale Monza- Osperdale San Gerado

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: The Ohio State University and Wexner Medical Center, James Cancer Hospital

location_facility: The Christie NHS Foundation Trust, Christie Hospital

location_facility: University of Oklahoma Stephenson Cancer Center

location_facility: Centre Antoine Lacassagne, Oncologie Médicale

location_facility: Emory University winship Cancer Institute

location_facility: New York Presbyterian Hospital Columbia University Medical Center

location_facility: University Hospitals of Leicester NHS Trust

location_facility: University of Washington, Seattle Cancer Care Alliance

location_facility: The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház

location_facility: Institut Universitaire du Cancer - Oncopôle, Department d'Hématologie

location_facility: University Hospital Southhampton NHS Foundation Trust - Somers Cancer Research

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: Summit Medical Group - Florham Park Campus/Atlantic Health


title: A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

acronym: VITALITY-ALS

summary: This study assessed the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.

ReferenceCitation: Andrews JA, Cudkowicz ME, Hardiman O, Meng L, Bian A, Lee J, Wolff AA, Malik FI, Shefner JM. VITALITY-ALS, a phase III trial of tirasemtiv, a selective fast skeletal muscle troponin activator, as a potential treatment for patients with amyotrophic lateral sclerosis: study design and baseline characteristics. Amyotroph Lateral Scler Frontotemporal Degener. 2018 May;19(3-4):259-266. doi: 10.1080/21678421.2018.1426770. Epub 2018 Feb 6. Erratum In: Amyotroph Lateral Scler Frontotemporal Degener. 2018 May;19(3-4):321.

repository_institution: Trinity College Dublin - Trinity's Access to Research Output (TARA)

version: submittedVersion

repositories_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: Informa

lead_sponsor: Cytokinetics

location_country:
Germany
Ireland
Italy
Portugal
United Kingdom
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: The Ohio State University Wexner Medical Center

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Clinical Research Centre, Beaumont Hospital

location_facility: Carol and Frank Morsini Center for Advanced Health Care - University of South Florida

location_facility: Montreal Neurological Institute and Hospital

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of California Davis Medical Center

location_facility: St. Joseph's Hospital & Medical Center - Barrow Neurology Clinics

location_facility: Froedtert Memorial Lutheran Hospital, Department of Neurology

location_facility: Dartmouth Hitchcock Medical Center Dept of Neurology

location_facility: University of Ulm, Department of Neurology

location_facility: University of Michigan Hospital and Health System

location_facility: Centro Clinico NEMO - Fondazione Serena Onlus, ASST Grande Ospedale Metropolitano Niguarda

location_facility: Neurological Institute Columbia University Medical Center

location_facility: Dipartimento di Neuroscienze "Rita Levi Moltalcini" A.O.U. Citta della Salute e della Scienza di Torino P.O. "Molinette"

location_facility: Neurosciences Institute: Neurology - Charlotte

location_facility: Clinical Research Centre, Royal London Hospital

location_facility: Providence Brain and Spine Institute ALS Center

location_facility: The Penn Comprehensive Neuroscience Center

location_facility: University of Massachusetts Memorial Medical Center

location_facility: West Virginia University Department of Neurology

location_facility: IRCCS Istituto Auxologico Italiano - U.O. Neurologia

location_facility: CHU de Quebec - Universite Laval Hopital de l'Enfant-Jesus

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion

location_facility: Walton Centre for Neurology and Neurosurgery

location_facility: Hannover Medical School, Department of Neurology

location_facility: Hospital Santa Maria-Centro Hospitalar Lisboa Norte

location_facility: University of Iowa Hospitals and Clinics

location_facility: George Washington University Medical Center

location_facility: University of Texas Health Science Center

location_facility: Charite Campus Virchow-Klinikum, Neurology Department


title: A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression

summary: The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.

ReferenceCitation: Williamson DJ, Gogate JP, Kern Sliwa JK, Manera LS, Preskorn SH, Winokur A, Starr HL, Daly EJ. Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression. J Clin Psychiatry. 2022 Sep 19;83(6):21m14318. doi: 10.4088/JCP.21m14318.

publisher_dissemination: Physicians Postgraduate Press, Inc

ReferenceCitation: Chen G, Chen L, Zhang Y, Li X, Lane R, Lim P, Daly EJ, Furey ML, Fedgchin M, Popova V, Singh JB, Drevets WC. Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression. Int J Neuropsychopharmacol. 2022 Apr 19;25(4):269-279. doi: 10.1093/ijnp/pyab084.

ReferenceCitation: Doty RL, Popova V, Wylie C, Fedgchin M, Daly E, Janik A, Ochs-Ross R, Lane R, Lim P, Cooper K, Melkote R, Jamieson C, Singh J, Drevets WC. Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. CNS Drugs. 2021 Jul;35(7):781-794. doi: 10.1007/s40263-021-00826-9. Epub 2021 Jul 7.

ReferenceCitation: Katz EG, Hough D, Doherty T, Lane R, Singh J, Levitan B. Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression. Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 Oct 13.

ReferenceCitation: Daly EJ, Trivedi MH, Janik A, Li H, Zhang Y, Li X, Lane R, Lim P, Duca AR, Hough D, Thase ME, Zajecka J, Winokur A, Divacka I, Fagiolini A, Cubala WJ, Bitter I, Blier P, Shelton RC, Molero P, Manji H, Drevets WC, Singh JB. Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Sep 1;76(9):893-903. doi: 10.1001/jamapsychiatry.2019.1189.

location_country:
Germany
Poland
Slovakia
Hungary
Brazil
Sweden
Mexico
Belgium
United States
Spain
Turkey
Czechia
Canada
Estonia
France


title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

acronym: TITAN

summary: The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

ReferenceCitation: Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Ozguroglu M, Juarez Soto A, Merseburger AS, Uemura H, Ye D, Given R, Basch E, Miladinovic B, Lopez-Gitlitz A, Chi KN. Apalutamide plus Androgen Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study. J Urol. 2021 Oct;206(4):914-923. doi: 10.1097/JU.0000000000001841. Epub 2021 May 27.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Chi KN, Chowdhury S, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Brookman-May S, Mundle SD, McCarthy SA, Larsen JS, Sun W, Bevans KB, Zhang K, Bandyopadhyay N, Agarwal N. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. J Clin Oncol. 2021 Jul 10;39(20):2294-2303. doi: 10.1200/JCO.20.03488. Epub 2021 Apr 29.

ReferenceCitation: Uemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0. Erratum In: BMC Urol. 2020 Oct 22;20(1):166.

evidence: oa repository (via page says license)

repository_normalized: Research Square

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

ReferenceCitation: Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Ozguroglu M, Juarez Soto A, Merseburger AS, Uemura H, Ye D, Given R, Cella D, Basch E, Miladinovic B, Dearden L, Deprince K, Naini V, Lopez-Gitlitz A, Chi KN; TITAN investigators. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019 Nov;20(11):1518-1530. doi: 10.1016/S1470-2045(19)30620-5. Epub 2019 Sep 29.

ReferenceCitation: Chi KN, Agarwal N, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez Soto A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Deprince K, Naini V, Li J, Cheng S, Yu MK, Zhang K, Larsen JS, McCarthy S, Chowdhury S; TITAN Investigators. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019 Jul 4;381(1):13-24. doi: 10.1056/NEJMoa1903307. Epub 2019 May 31.

lead_sponsor: Aragon Pharmaceuticals, Inc.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
United States
Ukraine
Romania
China
United Kingdom
Sweden
Mexico
Korea, Republic of
Spain
Russian Federation
Israel


acronym: ENGAGE

lead_sponsor: Biogen

summary: The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].

ReferenceCitation: Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J, Purcell D, Suhy J, Forrestal F, Tian Y, Umans K, Wang G, Singhal P, Budd Haeberlein S, Smirnakis K. Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease. JAMA Neurol. 2022 Jan 1;79(1):13-21. doi: 10.1001/jamaneurol.2021.4161.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

location_facility: Seconda Università degli Studi di Napoli

location_facility: National Clinical Research Inc.-Richmond

location_facility: Hospital Professor Doutor Fernando Fonseca, E.P.E.

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Groupe hospitalier Broca - La Rochefoucauld - La Collégiale

location_facility: The National Hospital for Neurology and Neurosurgery Centre

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

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

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Jacksonville Center for Clinical Research

location_facility: Christian-Doppler-Klinik - Universitätsklinikum Salzburg

location_facility: University of Tennessee Medical Center. Knoxville

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Azienda Ospedaliera Ospedali Riuniti di Bergamo

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Centro Hospitalar e Universitário de Coimbra E.P.E

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

location_facility: Medical University of South Carolina (MUSC)

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Torrance Clinical Research Institute, Inc.

location_facility: Advanced Memory Research Institute of NJ, PC

location_facility: Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: UT Southwestern Medical Center at Dallas

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

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Seoul National University Bundang Hospital

location_facility: Institute for Neurodegenerative Disorders

location_facility: Alexian Brothers Neurosciences Institute

location_facility: KARA Institute for Neurological Diseases

location_facility: New York University Medical Center PRIME

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: California Neuroscience Research Medical Group Inc.

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: Northeastern Pennsylvania Memory and Alzheimer's Center

location_facility: Central Coast Neurosciences Research, Gosford

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Azienda Ospedaliero Universitaria Pisana

title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

location_country:
Germany
Italy
Portugal
United Kingdom
Denmark
Australia
Japan
Austria
United States
Korea, Republic of
Spain
Taiwan
Canada
France


summary: The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.

ReferenceCitation: Peipert JD, Efficace F, Pierson R, Loefgren C, Cella D, He J. Patient-reported outcomes predict overall survival in older patients with acute myeloid leukemia. J Geriatr Oncol. 2022 Sep;13(7):935-939. doi: 10.1016/j.jgo.2021.09.007. Epub 2021 Sep 11.

title: A Randomized Phase 2/3 Study of DACOGEN® (Decitabine) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus DACOGEN (Decitabine) Alone in Patients With AML Who Are Not Candidates for Intensive Chemotherapy

location_country:
Germany
Poland
Israel
United Kingdom
Australia
Sweden
Belgium
United States
Korea, Republic of
Spain
Turkey
Taiwan
Russian Federation
France


summary: The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Zhang J, Chiorean M, Vermeire S, Lee SD, Kuhbacher T, Yacyshyn B, Cabell CH, Naik SU, Klassen P, Panes J. Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):550-561. doi: 10.1053/j.gastro.2019.10.035. Epub 2019 Nov 9.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

location_facility:
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Arena 1504
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title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis


title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

summary: The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in adult participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

ReferenceCitation: Bruce IN, van Vollenhoven RF, Morand EF, Furie RA, Manzi S, White WB, Abreu G, Tummala R. Sustained glucocorticoid tapering in the phase 3 trials of anifrolumab: a post hoc analysis of the TULIP-1 and TULIP-2 trials. Rheumatology (Oxford). 2023 Apr 3;62(4):1526-1534. doi: 10.1093/rheumatology/keac491.

ReferenceCitation: Bruce IN, Furie RA, Morand EF, Manzi S, Tanaka Y, Kalunian KC, Merrill JT, Puzio P, Maho E, Kleoudis C, Albulescu M, Hultquist M, Tummala R. Concordance and discordance in SLE clinical trial outcome measures: analysis of three anifrolumab phase 2/3 trials. Ann Rheum Dis. 2022 Jul;81(7):962-969. doi: 10.1136/annrheumdis-2021-221847. Epub 2022 May 17.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: British Medical Journal

ReferenceCitation: Vital EM, Merrill JT, Morand EF, Furie RA, Bruce IN, Tanaka Y, Manzi S, Kalunian KC, Kalyani RN, Streicher K, Abreu G, Tummala R. Anifrolumab efficacy and safety by type I interferon gene signature and clinical subgroups in patients with SLE: post hoc analysis of pooled data from two phase III trials. Ann Rheum Dis. 2022 Jul;81(7):951-961. doi: 10.1136/annrheumdis-2021-221425. Epub 2022 Mar 25.

ReferenceCitation: Loncharich MF, Anderson CW. Interferon Inhibition for Lupus with Anifrolumab: Critical Appraisal of the Evidence Leading to FDA Approval. ACR Open Rheumatol. 2022 Jun;4(6):486-491. doi: 10.1002/acr2.11414. Epub 2022 Feb 14.

ReferenceCitation: Chia YL, Zhang J, Tummala R, Rouse T, Furie RA, Morand EF. Relationship of anifrolumab pharmacokinetics with efficacy and safety in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2022 May 5;61(5):1900-1910. doi: 10.1093/rheumatology/keab704.

ReferenceCitation: Furie R, Morand EF, Askanase AD, Vital EM, Merrill JT, Kalyani RN, Abreu G, Pineda L, Tummala R. Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus. Lupus. 2021 Jul;30(8):1254-1263. doi: 10.1177/09612033211014267. Epub 2021 May 12.

publisher_dissemination: SAGE Publications

ReferenceCitation: Furie R, Morand EF, Bruce IN, Isenberg D, van Vollenhoven R, Abreu G, Pineda L, Tummala R. What Does It Mean to Be a British Isles Lupus Assessment Group-Based Composite Lupus Assessment Responder? Post Hoc Analysis of Two Phase III Trials. Arthritis Rheumatol. 2021 Nov;73(11):2059-2068. doi: 10.1002/art.41778. Epub 2021 Sep 22.

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

ReferenceCitation: Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, Bae SC, Brohawn PZ, Pineda L, Berglind A, Tummala R; TULIP-2 Trial Investigators. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020 Jan 16;382(3):211-221. doi: 10.1056/NEJMoa1912196. Epub 2019 Dec 18.

repositories_institution: The University of Manchester - Research Explorer

location_country:
Germany
Lithuania
Argentina
Japan
Brazil
Mexico
Belgium
United States
Korea, Republic of
Spain
South Africa
Bulgaria
Canada
Russian Federation
France


title: A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy, and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults

summary: The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.

ReferenceCitation: Morales-Ramirez J, Bogner JR, Molina JM, Lombaard J, Dicker IB, Stock DA, DeGrosky M, Gartland M, Pene Dumitrescu T, Min S, Llamoso C, Joshi SR, Lataillade M. Safety, efficacy, and dose response of the maturation inhibitor GSK3532795 (formerly known as BMS-955176) plus tenofovir/emtricitabine once daily in treatment-naive HIV-1-infected adults: Week 24 primary analysis from a randomized Phase IIb trial. PLoS One. 2018 Oct 23;13(10):e0205368. doi: 10.1371/journal.pone.0205368. eCollection 2018.

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central;epub.ub.uni-muenchen.de

publisher_dissemination: Public Library of Science

lead_sponsor: ViiV Healthcare

sponsor_collaborators:
ViiV Healthcare
GlaxoSmithKline

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Mexico
United States
Spain
South Africa
Chile
Canada
France


title: An Open Label, Phase 2 Study to Evaluate Efficacy and Safety of Daratumumab in Relapsed or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma

summary: The purpose of this study is to assess overall response rate [ORR, including complete response (CR) and partial response (PR)], of daratumumab in participants with non-Hodgkin's lymphoma [a cancer of the lymph nodes (or tissues)-NHL] and to evaluate association between ORR and CD38 expression level in order to determine a threshold for CD38 expression level in each NHL subtype, above which daratumumab activity is enhanced in participants with relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.

ReferenceCitation: Salles G, Gopal AK, Minnema MC, Wakamiya K, Feng H, Schecter JM, Wang M. Phase 2 Study of Daratumumab in Relapsed/Refractory Mantle-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2019 May;19(5):275-284. doi: 10.1016/j.clml.2018.12.013. Epub 2019 Jan 2.

location_country:
Australia
Netherlands
Belgium
United States
Korea, Republic of
Turkey
France


type: U.S. NIH Grant/Contract

type: Registry Identifier

title: A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

summary: This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

ReferenceCitation: Tan YY, Al-Bubseeree B, Irvine D, MacDonald G, McQuaker G, Parker A, Waterston A, White J. High-Dose Chemotherapy in Relapsed or Refractory Metastatic Germ-Cell Cancer: The Scotland Experience. Clin Genitourin Cancer. 2019 Apr;17(2):125-131. doi: 10.1016/j.clgc.2018.11.013. Epub 2018 Nov 17.

lead_sponsor: Alliance for Clinical Trials in Oncology

collaborators: European Organisation for Research and Treatment of Cancer - EORTC

collaborators: Institute of Cancer Research (ICR), United Kingdom

location_country:
Germany
Ireland
Italy
United Kingdom
Denmark
Australia
Netherlands
Switzerland
Belgium
United States
Spain
France

location_facility: Prisma Health Greenville Memorial Hospital

location_facility: University of Pittsburgh Cancer Institute (UPCI)

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Duran i Reynals Hospital-Catalan Institute of Oncology

location_facility: University of Berlin Charite Campus Benjamin Franklin

location_facility: Marshfield Medical Center-EC Cancer Center

location_facility: UNC Lineberger Comprehensive Cancer Center

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: BI-LO Charities Children's Cancer Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Vanderbilt University/Ingram Cancer Center

location_facility: USC / Norris Comprehensive Cancer Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: The Royal Marsden NHS Foundation Trust - Sutton

location_facility: University of Florida Health Science Center - Gainesville

location_facility: Prisma Health Cancer Institute - Butternut

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Children's Hospitals and Clinics of Minnesota - Minneapolis

location_facility: Prisma Health Cancer Institute - Eastside

location_facility: Hopital Tenon/Assistance Publique - Hopitaux de Paris

location_facility: University of Pennsylvania/Abramson Cancer Center

location_facility: Prisma Health Cancer Institute - Spartanburg

location_facility: Washington University School of Medicine

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Emory University Hospital/Winship Cancer Institute

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Carolinas Medical Center/Levine Cancer Institute

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Saint Joseph's Hospital/Children's Hospital-Tampa

location_facility: The Children's Hospital at TriStar Centennial

location_facility: Marshfield Medical Center-River Region at Stevens Point


title: T-STAR - T790M Mutation Positive 2nd Line STandard of cAre Registry

acronym: T-STAR

summary: The aim of the study is to collect real world information on patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin /Carboplatin).

status: Withdrawn

study_type: Observational

time_perspective: Prospective

lead_sponsor: AstraZeneca

sponsor_collaborators: AstraZeneca Parexel

location_country:
Germany
Italy
Netherlands
United States
China
Spain
Taiwan
Russian Federation
France


lead_sponsor: Bayer

summary: The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.

ReferenceCitation: Matasar MJ, Capra M, Ozcan M, Lv F, Li W, Yanez E, Sapunarova K, Lin T, Jin J, Jurczak W, Hamed A, Wang MC, Baker R, Bondarenko I, Zhang Q, Feng J, Geissler K, Lazaroiu M, Saydam G, Szomor A, Bouabdallah K, Galiulin R, Uchida T, Soler LM, Cao A, Hiemeyer F, Mehra A, Childs BH, Shi Y, Zinzani PL. Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):678-689. doi: 10.1016/S1470-2045(21)00145-5. Epub 2021 Apr 10. Erratum In: Lancet Oncol. 2021 Jun;22(6):e239.

location_facility:
MSK Westchester
MSK Basking Ridge
MSK Commack
MSK Bergen
MSK Monmoth
MSK Rockville Centre

title: A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Copanlisib in Combination With Rituximab in Patients With Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-3

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
United States
Ukraine
Romania
Belgium
China
Malaysia
Philippines
Italy
Singapore
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation


title: A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

summary: This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

ReferenceCitation: Kaminsky DA, Grosset DG, Kegler-Ebo DM, Cangiamilla S, Klingler M, Zhao P, Oh C. Natural history of lung function over one year in patients with Parkinson's disease. Respir Med. 2021 Jun;182:106396. doi: 10.1016/j.rmed.2021.106396. Epub 2021 Apr 16.

lead_sponsor: Acorda Therapeutics

location_country:
Germany
Poland
Hungary
Israel
Romania
United Kingdom
Netherlands
Austria
Belgium
United States
Spain
Czechia
Serbia
France

location_facility:
Acorda Site #7033
Acorda Site #7083
Acorda Site #7084
Acorda Site #7037
Acorda Site #7082
Acorda Site #7116
Acorda Site #7135
Acorda Site #7120
Acorda Site #7081
Acorda Site #7130
Acorda Site #7091
Acorda Site #7113
Acorda Site #7115
Acorda Site #7024
Acorda Site #7021
Acorda Site #7004
Acorda Site #7112
Acorda Site #7094
Acorda Site #7131
Acorda Site #7102
Acorda Site #7022
Acorda Site #7049
Acorda Site #7048
Acorda Site #7031
Acorda Site #7051
Acorda Site #7092
Acorda Site #7093
Acorda Site #7119
Acorda Site #7043
Acorda Site #7032
Acorda Site #7101
Acorda Site #7134
Acorda Site #7123
Acorda Site #7036
Acorda Site #7064
Acorda Site #7140
Acorda Site #7137
Acorda Site #7062
Acorda Site #7025
Acorda Site #7095
Acorda Site #7145
Acorda Site #7122
Acorda Site #7086
Acorda Site #7035
Acorda Site #7133
Acorda Site #7085
Acorda Site #7012
Acorda Site #7013
Acorda Site #7042
Acorda Site #7044
Acorda Site #7088
Acorda Site #7087
Acorda Site #7114
Acorda Site #7111
Acorda Site #7011
Acorda Site #7034
Acorda Site #7150
Acorda Site #7061
Acorda Site #7023
Acorda Site #7041
Acorda Site #7053
Acorda Site #7050
Acorda Site #7002
Acorda Site #7047
Acorda Site # 7142
Acorda Site #7141
Acorda Site #7148
Acorda Site #7063
Acorda Site #7121
Acorda Site #7139
Acorda Site #7138
Acorda Site #7118
Acorda Site #7103
Acorda Site #7003
Acorda Site #7045
Acorda Site #7046


acronym: RE-CIRCUIT

summary:
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study.

Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting.

It is not intended to assess confirmatory hypothesis, this is an exploratory study.

ReferenceCitation: Kimata A, Nogami A, Yamasaki H, Ohigashi T, Gosho M, Igarashi M, Sekiguchi Y, Ieda M, Calkins H, Aonuma K. Optimal interruption time of dabigatran oral administration to ablation (O-A time) in patients with atrial fibrillation: Integrated analysis of 2 randomized controlled clinical trials. J Cardiol. 2021 Jun;77(6):652-659. doi: 10.1016/j.jjcc.2020.12.010. Epub 2021 Jan 25.

repository_institution: University of Tsukuba - Terrestrial Environment Research Center

ReferenceCitation: Hohnloser SH, Calkins H, Willems S, Verma A, Schilling R, Okumura K, Nordaby M, Kleine E, Biss B, Gerstenfeld EP; RE-CIRCUIT(R) investigators. Regional differences in patient characteristics and outcomes during uninterrupted anticoagulation with dabigatran versus warfarin in catheter ablation of atrial fibrillation: the RE-CIRCUIT study. J Interv Card Electrophysiol. 2019 Aug;55(2):145-152. doi: 10.1007/s10840-019-00518-x. Epub 2019 Feb 13.

ReferenceCitation: Calkins H, Willems S, Gerstenfeld EP, Verma A, Schilling R, Hohnloser SH, Okumura K, Serota H, Nordaby M, Guiver K, Biss B, Brouwer MA, Grimaldi M; RE-CIRCUIT Investigators. Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation. N Engl J Med. 2017 Apr 27;376(17):1627-1636. doi: 10.1056/NEJMoa1701005. Epub 2017 Mar 19.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Radboud University - Radboud Repository

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

location_facility: University of Utah Health Sciences Center

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Mercy Medical Group, a service of Dignity Health Medical Foundation

location_facility: Japanese Red Cross Nagoya Daini Hospital

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

location_facility: Instit.of Surgery na Vishnevskiy,Treatm.of comp.arrhythm.dep

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Mission Cardiovascular Research Institute

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: CLI Nouvelles Cliniques Nantaises,Cardio,Nantes Cedex 2

location_facility: Yaroslavl Regional Clin. Hospital, Dept. Endocrinology

location_facility: University at Buffalo, The State University of New York

location_facility: Golden Jubilee National Hospital, Clydebank

location_facility: Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia

location_facility: University of Tennessee Methodist Physicians

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Antwerpen - HOSP ZNA Middelheim - Pneumo

location_facility: City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

title: Randomized Evaluation of Dabigatran Etexilate Compared to warfarIn in pulmonaRy Vein Ablation: Assessment of an Uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial)

location_country:
Germany
Italy
United Kingdom
Japan
Netherlands
Belgium
United States
Spain
Canada
Russian Federation
France


title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

summary: This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.

ReferenceCitation: Taylor-Cousar JL, Munck A, McKone EF, van der Ent CK, Moeller A, Simard C, Wang LT, Ingenito EP, McKee C, Lu Y, Lekstrom-Himes J, Elborn JS. Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del. N Engl J Med. 2017 Nov 23;377(21):2013-2023. doi: 10.1056/NEJMoa1709846. Epub 2017 Nov 3.

repositories_institution: Queen's University Belfast - Research Portal

repositories_institution: University of Zurich - Zurich Open Repository and Archive

lead_sponsor: Vertex Pharmaceuticals Incorporated

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


title: A Multi-centre, Double-blind, Parallel-group, Randomised Controlled Study to Investigate Efficacy, Safety and Tolerability of Orally Administered BI 409306 During a 12-week Treatment Period Compared to Placebo in Patients With Cognitive Impairment Due to Alzheimer's Disease

summary: The study is designed to compare the effects of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease

ReferenceCitation: Frolich L, Wunderlich G, Thamer C, Roehrle M, Garcia M Jr, Dubois B. Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer's disease. Alzheimers Res Ther. 2019 Feb 12;11(1):18. doi: 10.1186/s13195-019-0467-2.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Netherlands
Austria
Belgium
United States
Canada
France

location_facility: Institut universitaire de geriatrie Sherbrooke

location_facility: Private Practice for Psychiatry and Neurology

location_facility: Memory Enhancement Center of America, Inc.

location_facility: West Devon (Tavistock) CMHT & Memory Clinic (EDI)

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna

location_facility: Reg. Specialist Hospital Wroclaw, Research & Develop. Center

location_facility: St. Josef- und St. Elisabeth-Hospital gGmbH

location_facility: Non-Public Outpatient Clinic Neuromed M. i M. Nastaj

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

location_facility: Inst. of Rural Health, Spec. Outp. Clin. & Rural Occup. Dis.

location_facility: Psychiatry And Alzheimer's Care of Rochester, PLLC

location_facility: Neurologie und Psychiatrie / Psychotherapie

location_facility: Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: ANI Neurology, PLLC, dba Alzheimer's Memory Center