acronym: JAVELIN Renal 101

lead_sponsor: Pfizer

summary: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma

ReferenceCitation: Rini BI, Moslehi JJ, Bonaca M, Schmidinger M, Albiges L, Choueiri TK, Motzer RJ, Atkins MB, Haanen J, Mariani M, Wang J, Hariharan S, Larkin J. Prospective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced Renal Cell Cancer: Data From the Phase III JAVELIN Renal 101 Trial. J Clin Oncol. 2022 Jun 10;40(17):1929-1938. doi: 10.1200/JCO.21.01806. Epub 2022 Mar 3.

ReferenceCitation: Masters JC, Khandelwal A, di Pietro A, Dai H, Brar S. Model-informed drug development supporting the approval of the avelumab flat-dose regimen in patients with advanced renal cell carcinoma. CPT Pharmacometrics Syst Pharmacol. 2022 Apr;11(4):458-468. doi: 10.1002/psp4.12771. Epub 2022 Feb 27.

ReferenceCitation: Rini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5.

ReferenceCitation: Choueiri TK, Larkin J, Pal S, Motzer RJ, Rini BI, Venugopal B, Alekseev B, Miyake H, Gravis G, Bilen MA, Hariharan S, Chudnovsky A, Ching KA, Mu XJ, Mariani M, Robbins PB, Huang B, di Pietro A, Albiges L. Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial. ESMO Open. 2021 Jun;6(3):100101. doi: 10.1016/j.esmoop.2021.100101. Epub 2021 Apr 23. Erratum In: ESMO Open. 2021 Aug;6(4):100177.

ReferenceCitation: Motzer RJ, Robbins PB, Powles T, Albiges L, Haanen JB, Larkin J, Mu XJ, Ching KA, Uemura M, Pal SK, Alekseev B, Gravis G, Campbell MT, Penkov K, Lee JL, Hariharan S, Wang X, Zhang W, Wang J, Chudnovsky A, di Pietro A, Donahue AC, Choueiri TK. Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial. Nat Med. 2020 Nov;26(11):1733-1741. doi: 10.1038/s41591-020-1044-8. Epub 2020 Sep 7.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Choueiri TK, Motzer RJ, Rini BI, Haanen J, Campbell MT, Venugopal B, Kollmannsberger C, Gravis-Mescam G, Uemura M, Lee JL, Grimm MO, Gurney H, Schmidinger M, Larkin J, Atkins MB, Pal SK, Wang J, Mariani M, Krishnaswami S, Cislo P, Chudnovsky A, Fowst C, Huang B, di Pietro A, Albiges L. Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Ann Oncol. 2020 Aug;31(8):1030-1039. doi: 10.1016/j.annonc.2020.04.010. Epub 2020 Apr 25.

ReferenceCitation: Motzer RJ, Penkov K, Haanen J, Rini B, Albiges L, Campbell MT, Venugopal B, Kollmannsberger C, Negrier S, Uemura M, Lee JL, Vasiliev A, Miller WH Jr, Gurney H, Schmidinger M, Larkin J, Atkins MB, Bedke J, Alekseev B, Wang J, Mariani M, Robbins PB, Chudnovsky A, Fowst C, Hariharan S, Huang B, di Pietro A, Choueiri TK. Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019 Mar 21;380(12):1103-1115. doi: 10.1056/NEJMoa1816047. Epub 2019 Feb 16.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke

location_facility: Beth Israel Deaconess Medical Center Pharmacy - BIDMC

location_facility: Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center

location_facility: Sahlgrenska University Hospital, Dept of Oncology

location_facility: Anschutz Cancer Center Pavilion Pharmacy

location_facility: Centre Eugene Marquis Service Pharmacie - Essais Cliniques

location_facility: Centre de Cancérologie de la Sarthe (CCS) - Clinique Victor Hugo

location_facility: British Columbia Cancer Agency - Kelowna

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

location_facility: Addenbrooke's Hospital, Central Pharmacy, Level 1

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Department of Medical Oncology, The Christie NHS Foundation Trust

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center - South County

location_facility: Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital

location_facility: Cleveland Clinic Investigational Pharmacy

location_facility: Sidney Kimmel Center for Prostate and Urologic Cancers

location_facility: Seoul National University Hospital, Clinical Pharmacy

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer

location_facility: Hirosaki University School of Medicine & Hospital

location_facility: University of Colorado Cancer Center Anschutz Cancer Pavilion

location_facility: Massachusetts General Hospital Clinical Trials Pharmacy

location_facility: Mount Vernon Cancer Centre, East & North Herts NHS Trust

location_facility: Tauranga Hospital, Bay of Plenty Clinical Trials Unit

location_facility: Evelyn H. Lauder Breast and Imaging Center

location_facility: Tokyo Women's Medical University Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Cedars-Sinai Advanced Health Sciences Pavilion

location_facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau

location_facility: Samsung Medical Center Clinical Trial Pharmacy

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely

location_facility: FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF

location_facility: Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital

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

location_facility: SHI YR Regional Clinical Oncology Hospital

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

location_facility: Clinique Victor Hugo Centre de Cancerologie de la Sarthe

location_facility: Russian Research Center for Radiology and Surgical Technologies

location_facility: Niigata University Medical & Dental Hospital

location_facility: Kyungpook National University Medical Center

location_facility: East Jefferson Hematology-Oncology Metairie Physician Service Inc.

location_facility: SBIH of Nizhegorodskaya region "Clinical-Diagnostics center"

location_facility: Institut de Cancerologie de Lorraine (ICL)

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

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Chungnam National University Hospital, Clinical Pharmacy

location_facility: Netherlands Cancer Institute / Apotheek MC Slotervaart

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: "Prof. Dr. Ion Chiricuta" Oncology Institute

location_facility: Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center - West County

location_facility: RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address)

location_facility: Oaxaca Site Management Organization S.C.

location_facility: The Sidney Kimmel Comprehensive Cancer Center

location_facility: University of Colorado Hospital - Clinical Trials Office (CTO)

location_facility: Ballarat Oncology & Haematology Services

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: Krankenhaus der Barmherzigen Schwestern Wien

location_facility: Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center

location_facility: SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary"

location_facility: Clinical Trial Pharmacy, National Cancer Center

location_facility: Moffitt Cancer Center and Research Institute

location_facility: MedStar Health Cardiology Associates, LLC.

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: FBIH "Privolzhskiy Regional Medical Center" of FMBA

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health

location_facility: Centro di Riferimento Oncologico - IRCCS

location_facility: Novant Health Clinical Research Onocolgy

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: BC Cancer GU Clinic - Fairmont Medical Building

location_facility: Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital

location_facility: Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal

location_facility: Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie

location_facility: Kyungpook National University Medical Center, Clinical Pharmacy

location_facility: Private medical institution "Euromedservice"

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy

location_facility: Investigational Drug Service, University of Pennsylvania

location_facility: Seoul National University Bundang Hospital, Clinical Pharmacy

location_facility: Clinical Hospital #122 n.a. L. G. Sokolov

location_facility: James Cancer Hospital and Solove Research Institute

location_facility: Monash Health Translational Precinct, Monash Medical Centre

location_facility: Hospital of the University of Pennsylvania

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior

location_facility: Winship Cancer Institute, Emory University

location_facility: LLC "Clinical Diagnostic Center "Medex-pert"

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone

location_facility: Alberta Health Services - Cancer Care, Tom Baker Cancer Centre

location_facility: Investigational Drug Service- Emory University

location_facility: Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen

location_facility: Washington University Infusion Center Pharmacy

location_facility: NS HI "Road Clinical Hospital of JSC "Russian Railways""

title: A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

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

location_country:
Germany
New Zealand
Australia
Japan
Canada
France
Hungary
Denmark
United States
Romania
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Russian Federation
Israel


title: Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease

acronym: Entyvio PASS

summary: The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Yes

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

lead_sponsor: Takeda

location_country:
Germany
Ireland
Croatia
Canada
France
Slovenia
Portugal
Denmark
Switzerland
United States
Belgium
Estonia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Israel

location_facility: Azienda Ospedaliera Per Lemergenza Cannizzaro

location_facility: Az Groeninge - Campus Kennedylaan - Gastro-Enterologie

location_facility: Ziekenhuis Oost Limburg - Gastro-Enterologie

location_facility: Ospedale Morgagni Pierantoni Forli U.O. Gastroenterologia Ed Endoscopia

location_facility: Tel Aviv University - Rabin Medical Center - Beilinson Hospital

location_facility: A.O. Guido Salvini Di Garbagnate Milanese

location_facility: Chu Hopital Nord, Marseille - Service D'Hepato-Gastro-Enterologie

location_facility: St. Marien Krankenhauses - Medizinischen Klinik I

location_facility: Medizinische Versorgungszentrum Portal 10

location_facility: Gemeinschaftspraxis - Endoskopiezentrum M. Hasenstein

location_facility: Technische Universitaet Dresden - Universitaetklinikum Carl Gustav Carus - Medizinische Klinik Und Poliklinik I

location_facility: Chu Saint Pierre - Service de Gastroenterologie

location_facility: Agaplesion Markus Krankenhaus, Medizinische Klinik 1

location_facility: Gastroenterologische Gemeinschaftspraxis Dr. Felten

location_facility: Nhs Trust - Weston Area Health - Weston General Hospital

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: King'S College Hospital (Kch) Nhs Foundation Trust

location_facility: Hopital Rangueil - Service de Gastroenterologie

location_facility: Service Gastro-Enterologie Hopital Nord - Chu de Saint Etienne

location_facility: University of Sheffield - Sheffield Teaching Hospitals Nhs Foundation Trust - Royal Hallamshire Hospital (Rhh)

location_facility: Nevill Hall Hospital - Aneurin Bevan Health Board

location_facility: General Hospital of Athens 'Evangelismos'

location_facility: Derby Hospitals Nhs Foundation Trust - Royal Derby Hospital (Derby City General Hospital)

location_facility: Spedali Civili Gastroenterology Unit University of Brescia

location_facility: Boston University Moakley Building Center For Digestive Disorders

location_facility: Universitaetsspital Bern - Inselspital - Universitaetsklinik Fuer Viszerale Chirurgie Und Medizin (Uvcm) - Klinik Und Poliklinik Fuer Gastroenterologie

location_facility: Centre Hospitalier Universitaire (Chu) de Nice - Hopital L'Archet 2 - Pole Digestif

location_facility: Medizinisches Versorgungszentrum (Mvz) Dachau

location_facility: Illinois Gastroenterology Groupllc Northwest Gastroenterologists

location_facility: Az Maria Middelares - Gastro-Enterologie

location_facility: Ordination Dr. Thomas Haas Darmpraxis Salzburg

location_facility: Ch Valenciennes - Hopital Jean Bernard - Service Maladies de L'Appareil Digestif Et de La Nutrition

location_facility: Gastroenterologische Fachpraxis Am Germania Campus

location_facility: Universitatsklinikum Magdeburg A. O. R. - Klinik Fur Gastroenterologie

location_facility: Medizinischen Universitat Wien - Allgemeines Krankenhaus (Akh) - Universitaetsklinik Fuer Innere Medizin Iii

location_facility: Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik

location_facility: University and General Hospital of Alexandroupoli

location_facility: Nhs Foundation Trust - Homerton University Hospital (Huh)

location_facility: Universitaetsmedizin Mainz, I.Med.Klinik, Geb.605, Eg, Zi.0240

location_facility: Complexo H. Pontevedra-Hospital de Montecelo

location_facility: Centre Hospitalier Universitaire (Chu) de Caen - Service D'Hepatogastroenterologie

location_facility: The Royal Wolverhampton Hospitals Nhs Trust - New Cross Hospital

location_facility: Chu de Clermont Ferrand - Hopital Estaing

location_facility: Charite Campus Virchow Klinikum - Medizinische Klinik Mit Schwerpunkt Hepatologie Und Gastroenterologie

location_facility: South Bay Gastroenterology Medical Group

location_facility: Universitat Leipzig, Medizinische Fakultat

location_facility: University Hospitals Coventry and Warwickshire Nhs Trust - University Hospital (Walsgrave Hospital)

location_facility: Chu Amiens Picardie - Service Hepato-Gastro-Enterologie

location_facility: The North West London Hospitals Nhs Trust (Nwlh) - St Mark'S Hospital

location_facility: Hopital Du Haut Leveque - Service D'Hepato-Gastro-Enterologie Et Nutritution, Unite de Soin Normalise

location_facility: Assaf Harofeh Medical Center (Ahmc) - Institute of Gastroenterology

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, Epe

location_facility: University Hospital Southampton Nhs Foundation Trust

location_facility: Rambam Health Care Campus (Rhcc) - Institute of Gastroenterology

location_facility: Nyu Langone Long Island Clinical Research Associates

location_facility: Centre Hospitalier Chretien (Chc) - Clinique Saint-Joseph (Hopital St-Joseph) - Gastro-Enterologie

location_facility: Middlesex Gastroenterology Associates, Llc

location_facility: Centre Hospitalo Universitaire (Chu) - Hopital Saint-Antoine

location_facility: Fondazione Irccs Ca' Granda Osp Magg Policlinico

location_facility: University and General Hospital of Heraklion

location_facility: Kantonsspital St. Gallen - Gastroenterologie

location_facility: Gastroenterology Center of Connecticut P.C.

location_facility: Emory University Hospital, the Emory Clinic

location_facility: Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot

location_facility: Universitatsklinikum Erlangen Medizinische Klinik I - Studien Ambulanz Ced

location_facility: Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona

location_facility: Blackpool Victoria Hospital (Bvh) - Gastroenterology Department

location_facility: Pinderfields Hospital - Mid Yorkshire Hospital Trust

location_facility: Centre Hospitalier Universitaire (Chu) de Rouen

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)

location_facility: Oslo Univeristy Hospital Ulleval Hospital

location_facility: Consultants in Gastroenterology - Columbia

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner Crohn-Colitis-Zentrum Hochhaus Lindenhofspital

location_facility: Centre Hospitalier Regional Universitaire (Chru) de Lille - Hopital Claude Huriez

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Toronto - St. Michaels Hospital

location_facility: University Hospital of Ioannina - Division of Gastroenterology

location_facility: Hospices Civils de Lyon (Hcl) - Centre Hospitalier Lyon-Sud - Hepatogastroenterologie

location_facility: Universitatsklinik Und Poliklinik Fur Innere Medizin I

location_facility: The Shrewsbury and Telford Hospital Nhs Trust - Royal Shrewsbury Hospital

location_facility: Western Sussex Hospitals Nhs Trust - Worthing Hospital

location_facility: St. Josef Krankenhaus Essen-Werden / Abteilung Fur Gastroenterologie

location_facility: Krankenhaus Martha-Maria Halle Dolau Ggmbii, Klinik Fur Innere Medizin I

location_facility: General and University Hospital of Western Athens 'Attiko'

location_facility: Praxis Fur Gastroenterologie Am Bayerischen Platz

location_facility: Centre Hospitalier de Wallonie Picardie, Site Notre Dame

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Cbf) - Medizinische Klinik I

location_facility: Gastroenterologische Gemeinschaftspraxis - Stade

location_facility: Universitaire Ziekenhuizen (Uz) Leuven - Gasthuisberg

location_facility: The University of Nottingham - Nottingham Digestive Diseases Centre (Nddc) (Wolfson Digestive Diseases Centre)

location_facility: Wake Forest University School of Medicine

location_facility: St. Panteleimon General Hospital of Nikaia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: On Demand vs Continuous Treatment of Endoscopy Negative Subjects With Gastroesophageal Reflux Disease (GERD) With Esomeprazole 20-mg Once Daily Over a 6 Months Long Term Treatment Phase. An Open, Randomised, Multicenter Study. NEED.

acronym: NEED

summary: The purpose of this study is to compare on demand with continuous treatment of endoscopy negative subjects with gastroesophageal reflux disease (GERD), with esomeprazole 20-mg once daily, with regards to willingness to continue in the study as a result of satisfactory treatment over a six-month long term management period, after initial symptom relief.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Bayerdorffer E, Bigard MA, Weiss W, Mearin F, Rodrigo L, Dominguez Munoz JE, Grundling H, Persson T, Svedberg LE, Keeling N, Eklund S. Randomized, multicenter study: on-demand versus continuous maintenance treatment with esomeprazole in patients with non-erosive gastroesophageal reflux disease. BMC Gastroenterol. 2016 Apr 14;16:48. doi: 10.1186/s12876-016-0448-x.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: AstraZeneca

location_country:
Germany
Austria
Spain
South Africa
France

location_facility: Gastroenterology Clinic, Milpark Hospital

location_facility: Gastroenterology Clinic, G73, Department of Internal Medicine, Universitas Hospital

location_facility: Gastroenterology Clinic, Parorama Medi-Clinic

location_facility: Gastroenterology Clinic, Parklands Medical Centre

location_facility: Carl Gustav Carus der Tecnischen Universität

location_facility: Gastroenterology Unit, Room C78, Tygerberg Hospital

location_facility: Gastroenterology Clinic, E23, Groote Schuur Hospital Observatory

location_facility: Gastroenterology Unit, Chris Hani Baragwanath Hospital


title: Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry

acronym: XARENO

summary:
The multicenter registry will collect clinical data from 1600 patients with non valvular atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2).

The overall objective of this registry is to assess chronic kidney disease (CKD) progression and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR 15-49 mL/min per 1.73 m2 in routine clinical practice.

ipd_sharing: No

lead_sponsor: GWT-TUD GmbH

sponsor_collaborators:
GWT-TUD GmbH
ClinStat GmbH

location_country: Germany Switzerland Austria Belgium France

location_facility: CHI Toulon La Seyne sur mer - Hopital Sainte Musse

location_facility: CHG de Chartres-Hôpital Général Louis Pasteur

location_facility: Gemeinschaftspraxis Scheuermann & Persicke

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel

location_facility: Praxis Dr. med. Christoph Axthelm & Kollegen

location_facility: Gemeinschaftspraxis Wittwer, Bargemann, Baar

location_facility: Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen

location_facility: CH Argenteuil Centre Hospitalier Victor Dupouy

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Gemeinschaftspraxis Dr. med. Sybille Jänsch

location_facility: Studienzentrum Dr. med. Karl-Friedrich Appel

location_facility: Marienkrankenhaus Klinikum St. Elisabeth

location_facility: Centre Hospitalier Universiatire du SART-TILMAN

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Kardiologische Praxis Dr. med. Ayham Al Zoebi

location_facility: Gemeinschaftspraxis Kellner und Ehrhardt

location_facility: Gemeinschaftspraxis im Altstadtcarree, Kardiologie

location_facility: St. Joseph Krankenhaus Berlin-Tempelhof GmbH

location_facility: Centre Hospitalier de Wallonie Picarde (Chwapi)

location_facility: Zentrum für Prävention und Rehabilitation

location_facility: Centre Hospitalier Chrétien (CHC) St Joseph

location_facility: Schilddrüsenzentrum Bergstrasse/Praxis Innere Medizin


type: EudraCT Number

title: A Randomized Parallel Group Phase III Trial of OSE2101 as 2nd or 3rd Line Compared With Standard Treatment (Docetaxel or Pemetrexed) in HLA-A2 Positive Patients With Advanced Non-Small-Cell Lung Cancer With Progressive Disease After Last Treatment With Immune Checkpoint Inhibitors (ICI). (OSE2101C301)

acronym: ATALANTE 1

summary: The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment after failure of immune checkpoint-inhibitor regimens.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Barve M, Bender J, Senzer N, Cunningham C, Greco FA, McCune D, Steis R, Khong H, Richards D, Stephenson J, Ganesa P, Nemunaitis J, Ishioka G, Pappen B, Nemunaitis M, Morse M, Mills B, Maples PB, Sherman J, Nemunaitis JJ. Induction of immune responses and clinical efficacy in a phase II trial of IDM-2101, a 10-epitope cytotoxic T-lymphocyte vaccine, in metastatic non-small-cell lung cancer. J Clin Oncol. 2008 Sep 20;26(27):4418-25. doi: 10.1200/JCO.2008.16.6462.

ReferenceCitation: Beebe M, Qin M, Moi M, Wu S, Heiati H, Walker L, Newman M, Fikes J, Ishioka GY. Formulation and characterization of a ten-peptide single-vial vaccine, EP-2101, designed to induce cytotoxic T-lymphocyte responses for cancer immunotherapy. Hum Vaccin. 2008 May-Jun;4(3):210-8. doi: 10.4161/hv.4.3.5291. Epub 2010 May 11.

ReferenceCitation: Nemunaitis J, Cunningham, C ,Bender, J, Ishioka, G, Maples, P, Pappen, B, Stephenson, J, Morse, M, Mills, B, Greco, A, McCune, D, Steis, R, Nugent, F, Khong, HT, Richards, D. Phase II trial of a 10-epitope CTL vaccine, IDM-2101, in metastatic NSCLC patients: Induction of immune responses and clinical efficacy. International Society for Biological Therapy of Cancer 2007, p 891-2.

lead_sponsor: OSE Immunotherapeutics

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

location_facility: UOC di Oncologia Medica, Policlinico Universitario Campus Biomedico

location_facility: U.O.C. Pneumologia a indirizzo oncologico, Presidio Ospedaliero Monaldi - Azienda Ospedaliera dei Colli - Via Leonardo Bianchi

location_facility: Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika

location_facility: Wojewódzki Szpital Zespolony , Oddział Chemioterapii Nowotworów

location_facility: Klinik für Innere Medizin II Hospital Martha-Maria Halle-Dölau gGmbH

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont II szamu telephely

location_facility: UOC di Oncologia Medica Policlinico Universitario Campus Biomedico

location_facility: East Valley Hematology and Oncology medical Group

location_facility: Hospital Universitario La Paz Servicio de Oncología Médica

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Országos Korányi TBC és Pulmonológiai Intézet XI Tüdőbelosztály

location_facility: Mazowieckie Centrum Leczenia chorób Płuc i Gruźlicy

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T)

location_facility: "Complejo Hospitalario Universitario A Coruna (CHUAC)"

location_facility: Klinika Onkologii i Radioterapii , Uniwersyteckie Centrum Kliniczne

location_facility: Azienda USL 2 Lucca - Dipartimento Oncologico

location_facility: Klinik für Innere Medizin II Universitätsklinikum Ulm

location_facility: Csongrad Megyei Mellkasi Betegsegek Szakkorháza I Tüdőosztály

location_facility: Krankenhaus Mehrheit - Kliniken der Stadt Köln - Lungenklinik

location_facility: Hospital Universitario Puerta de Hierro Majadahonda Servicio de Oncología Médica Consultas externas, 2ª planta

location_facility: Országos Korányi TBC és Pulmonológiai Intézet XIV Tüdőbelosztály

location_facility: Unità Operativa di Oncologia dell'Ospedale Vito Fazzi di Lecce, Piazza Muratore

location_facility: Universitätsklinikum Tübingen Medizinische Klinik II

location_facility: U.O Oncologia ed Ematologia, Ospedale Santa Maria delle Croci

status_simplified: Unknown


type: Other Identifier

title: Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

acronym: PIONEER 3

summary: This trial is conducted globally. The aim of the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.

ReferenceType: result

ReferenceCitation: Rosenstock J, Allison D, Birkenfeld AL, Blicher TM, Deenadayalan S, Jacobsen JB, Serusclat P, Violante R, Watada H, Davies M; PIONEER 3 Investigators. Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type 2 Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea: The PIONEER 3 Randomized Clinical Trial. JAMA. 2019 Apr 16;321(15):1466-1480. doi: 10.1001/jama.2019.2942.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: University of Leicester - Leicester Research Archive

repositories_concat: PubMed Central;lra.le.ac.uk

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Araki E, Terauchi Y, Watada H, Deenadayalan S, Christiansen E, Horio H, Kadowaki T. Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A post hoc subgroup analysis of the PIONEER 1, 3, 4 and 8 trials. Diabetes Obes Metab. 2021 Dec;23(12):2785-2794. doi: 10.1111/dom.14536. Epub 2021 Sep 27.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

ReferenceCitation: Eliasson B, Ericsson A, Fridhammar A, Nilsson A, Persson S, Chubb B. Long-Term Cost Effectiveness of Oral Semaglutide Versus Empagliflozin and Sitagliptin for the Treatment of Type 2 Diabetes in the Swedish Setting. Pharmacoecon Open. 2022 May;6(3):343-354. doi: 10.1007/s41669-021-00317-z. Epub 2022 Jan 21.

ReferenceCitation: Aroda VR, Bauer R, Christiansen E, Haluzik M, Kallenbach K, Montanya E, Rosenstock J, Meier JJ. Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Diabetes Obes Metab. 2022 Jul;24(7):1338-1350. doi: 10.1111/dom.14710. Epub 2022 May 9.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4.

ReferenceCitation: Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

repositories:
PubMed Central
cronfa.swan.ac.uk
localhost

repositories_institution:
Swansea University - Cronfa
University of Toronto - TSpace

ReferenceCitation: Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.

ReferenceCitation: Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

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

location_country:
Germany
India
Israel
Argentina
Romania
Japan
Brazil
United Kingdom
Mexico
United States
South Africa
Turkey
Ukraine
Russian Federation
France


lead_sponsor: Gilead Sciences

summary: The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.

ReferenceCitation: Jacobson IM, Asselah T, Nahass R, Bhandari BR, Tran A, Hyland RH, et al. A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6 HCV-Infected Patients: The POLARIS-2 Study [Abstract LB-12]. Hepatology AASLD Abstracts 2016;64 (6 (suppl)):1126A.

ReferenceCitation: Jacobson IM, Lawitz E, Gane EJ, Willems BE, Ruane PJ, Nahass RG, Borgia SM, Shafran SD, Workowski KA, Pearlman B, Hyland RH, Stamm LM, Svarovskaia E, Dvory-Sobol H, Zhu Y, Subramanian GM, Brainard DM, McHutchison JG, Brau N, Berg T, Agarwal K, Bhandari BR, Davis M, Feld JJ, Dore GJ, Stedman CAM, Thompson AJ, Asselah T, Roberts SK, Foster GR. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017 Jul;153(1):113-122. doi: 10.1053/j.gastro.2017.03.047. Epub 2017 Apr 5.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

version: submittedVersion

publisher_dissemination: Elsevier

title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection

source: euctr

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/about/ethics-and-code-of-conduct/policies.

location_country:
Germany
New Zealand
United Kingdom
Australia
United States
Canada
Puerto Rico
France


summary:
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.

Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.

ReferenceCitation: Bourlière M, Gordon SC, Ramji A, Ravendhran N, Tran TT, Hyland RH, et al. Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients with Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study [Abstract 194]. J Hepatology 2016;63 (1S):102A.

ReferenceCitation: Younossi ZM, Stepanova M, Gordon S, Zeuzem S, Mann MP, Jacobson I, Bourliere M, Cooper C, Flamm S, Reddy KR, Kowdley K, Younossi I, Hunt S. Patient-Reported Outcomes Following Treatment of Chronic Hepatitis C Virus Infection With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir. Clin Gastroenterol Hepatol. 2018 Apr;16(4):567-574.e6. doi: 10.1016/j.cgh.2017.11.023. Epub 2017 Nov 16.

ReferenceCitation: Bourliere M, Gordon SC, Schiff ER, Tran TT, Ravendhran N, Landis CS, Hyland RH, Stamm LM, Zhang J, Dvory-Sobol H, Subramanian GM, Brainard DM, McHutchison JG, Serfaty L, Thompson AJ, Sepe TE, Curry MP, Reddy KR, Manns MP. Deferred treatment with sofosbuvir-velpatasvir-voxilaprevir for patients with chronic hepatitis C virus who were previously treated with an NS5A inhibitor: an open-label substudy of POLARIS-1. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):559-565. doi: 10.1016/S2468-1253(18)30118-3. Epub 2018 May 31.

ReferenceCitation: Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

publisher_dissemination: Massachusetts Medical Society

title: A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection


intervention_type: Other

acronym: JAVELIN Bladder 100

summary: The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

ReferenceCitation: Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullen A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte RJ, Huang B, Costa N, Blake-Haskins JA, Grivas P. Plain language summary of results from the JAVELIN Bladder 100 study: avelumab maintenance treatment for advanced urothelial cancer. Future Oncol. 2022 Jun;18(19):2361-2371. doi: 10.2217/fon-2021-1631. Epub 2022 Apr 13.

evidence: open (via page says license)

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

repositories_concat: Zenodo

publisher_dissemination: Future Science Ltd

ReferenceCitation: Tomita Y, Yamamoto Y, Tsuchiya N, Kanayama H, Eto M, Miyake H, Powles T, Yoshida M, Koide Y, Umeyama Y, di Pietro A, Uemura H. Avelumab first-line maintenance plus best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Japanese subgroup analysis. Int J Clin Oncol. 2022 Feb;27(2):383-395. doi: 10.1007/s10147-021-02067-8. Epub 2022 Jan 1.

ReferenceCitation: Powles T, Sridhar SS, Loriot Y, Bellmunt J, Mu XJ, Ching KA, Pu J, Sternberg CN, Petrylak DP, Tambaro R, Dourthe LM, Alvarez-Fernandez C, Aarts M, di Pietro A, Grivas P, Davis CB. Avelumab maintenance in advanced urothelial carcinoma: biomarker analysis of the phase 3 JAVELIN Bladder 100 trial. Nat Med. 2021 Dec;27(12):2200-2211. doi: 10.1038/s41591-021-01579-0. Epub 2021 Dec 10.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

version: acceptedVersion

ReferenceCitation: Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullen A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte R, Wang J, Huang B, Davis C, Fowst C, Costa N, Blake-Haskins JA, di Pietro A, Grivas P. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020 Sep 24;383(13):1218-1230. doi: 10.1056/NEJMoa2002788. Epub 2020 Sep 18.

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: AUSL della Romagna - RAVENNA, Presidio Ospedaliero di Faenza

location_facility: Hirosaki University School of Medicine & Hospital

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

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

location_facility: C.H. Universitario de Vigo- Hospital Meixoeiro

location_facility: Niigata University Medical & Dental Hospital

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli

location_facility: Inova Schar Cancer Institute Infusion Pharmacy

location_facility: Fondazione IRCCS Istituto Nazionale Dei Tumori

location_facility: Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE

location_facility: Rigshospitalet, Onkologisk Klinik, afsnit 5073

location_facility: Hospital Universitario Central de Asturias

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: CHUM - Centre Hospitalier de l'Universite de Montreal

location_facility: Royal United Hospitals Bath NHS Foundation Trust

location_facility: C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro

location_facility: Seoul National University Bundang Hospital, Clinical Pharmacy

location_facility: Centro Oncologico Riojano Integral (Cori)

location_facility: Centre d'Oncologie et de Radiothérapie du Pays-Basque

location_facility: Klinik for Klinisk Fysiologi,Nuklearmedicin og PET

location_facility: FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov" MoH RF

location_facility: University of Colorado Denver, CTO (CTRC)

location_facility: Asan Medical Center - Clinical Trial Pharmacy

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

location_facility: FSBEI HE "First St. Petersburg State Medical University n. a. academician l.P Pavlov" MoH RF

location_facility: State Budgetary Healthcare Insti. Republican Clinical Oncology Dispensary of the MoH of Bashk. Rep.

location_facility: Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Farmácia Oncológica

location_facility: CIMS Cancer, Care Institute of Medical Sciences, CIMS Hospital

location_facility: Clinical Trial Pharmacy, China Medical University Hospital

location_facility: Department of Pharmacy, National Cheng Kung University Hospital

location_facility: National Hospital Organization hokkaido Cancer Center

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera, Szpital Specjalistyczny dla Dzieci I Doroslych

location_facility: CENOB Centro de Oncologia da Bahia S/S Ltda. / Oncovida

location_facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau

location_facility: Samsung Medical Center Clinical Trial Pharmacy

location_facility: BHI of Omsk region "Clinical oncological dispensary"

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Investigational Drug services, National Taiwan University Hospital

location_facility: Institut Catalá d'Oncología - Hospital Duran i Reynals

location_facility: Non-State Healthcare Institution "Railway Clinical Hospital JSC RZhD"

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

location_facility: Fundacao Faculdade de Medicina / Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Hospital Regional Dr. Enrique Vera Barros

location_facility: Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Ambulatório Quimioterapia

location_facility: Sociedade Beneficente de Senhoras Hospital Sírio Libanês/ Instituo Sirio Libanes de Ensino e Pesqu

location_facility: Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Centro de Abastecimento Farmaceu

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

location_facility: Smilow Cancer Hospital at Yale New Haven

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

location_facility: Centro di Riferimento Oncologico - IRCCS

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Uniao Brasileira de Educacao e Assistencia / Hospital Sao Lucas da PUCRS

location_facility: National Cancer Center - Clinical Trial Pharmacy

location_facility: SHI YR "Regional Clinical Oncology Hospital"

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Centre de Radiothérapie - Clinique Sainte Anne

location_facility: Hospital Médica Campestre (Administradora Hospitalaria S.A de C.V.)

location_facility: Azienda Ospedaliera San Camillo Forlanini_Oncologia Medica

location_facility: Institut de cancérologie de l'Ouest - Site Paul Papin

location_facility: Anschutz Cancer Center Pavilion Pharmacy

location_facility: Servizio Farmacia Ospedaliera - Farmacia Oncologica

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny

location_facility: Churchill Hospital, Oxford University Hospitals NHS Trust

location_facility: Severance Hospital Yonsei University Health System

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

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

location_facility: Alexandra General Hospital, Oncology Department

location_facility: University General Hospital of Patras, Division of Oncology

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Hôpital Privé Toulon-Hyères - Clinique Sainte Marguerite

location_facility: Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo

location_facility: Saitama Medical University International Medical Center

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE

location_facility: Centro Integrado de Pesquisa Clinica - CIP

location_facility: Althaia. Xarxa Assistencial Universitaria de Manresa

location_facility: Icon Cancer Care SA trading as Icon Pharmacy Adelaide

location_facility: Rajiv Gandhi Cancer Institute And Research Centre

location_facility: CHU Nimes - Institut de Cancerologie du Gard

location_facility: Chemotherapy pharmacy, Chang Gung Memorial Hospital, Linkou

location_facility: Moscow Research Oncology Institute named after P. A. Gertsen

location_facility: Hospital Comarcal General de Elda de Virgen de la Salud

location_facility: Private Medical Institution "Evromedservice"

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

location_facility: EUROMEDICA General Clinic of Thessaloniki

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Giovanni Pascale

location_facility: Hospital de La Santa Creu i Sant pau_Oncology department

location_facility: University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

location_facility: Centro de Investigación Clínica de Leon S.C.

location_facility: Kobe City Medical Center General Hospital

location_facility: Dr Ram Manohar Lohia (RML) Hospital & PGI MER

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: Federal State Budgetary Institution "National medical research radiology center" MoH RF

location_facility: Fundacion Maria Rafols para la investigacion del Diagnostico de la imagen

location_facility: Chungnam National University Hospital, Clinical Pharmacy

location_facility: Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP

location_facility: Ballarat Oncology & Haematology Services

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliero-Universitaria Policlinico S.Orsola Malpighi

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

location_facility: Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.- Matosinhos

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos

location_facility: FGBIH "Clinical Hospital #122 n.a. L.G. Sokolov of Federal Medico-biological agency"

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Hospital Clínico Universitario de Valencia

location_facility: National Cancer Center Urology center for Prostate Cancer

title: A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY

location_country:
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Czechia
Canada
Serbia
France
Portugal
Hungary
Hong Kong
Denmark
United States
India
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: Clinical Trial of Nivolumab (BMS-936558) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma CheckMate 401: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 401

acronym: CheckMate 401

summary: The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.

design_allocation: Non-Randomized

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Germany
Ireland
Italy
Norway
United Kingdom
Australia
Sweden
Switzerland
Austria
Belgium
France

location_facility:
Local Institution
Mount Vernon Hospital


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

summary:
The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease.

After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.

status: Terminated

ReferenceCitation: Gold SL, Cohen-Mekelburg S, Schneider Y, Steinlauf A. Perianal Fistulas in Patients With Crohn's Disease, Part 2: Surgical, Endoscopic, and Future Therapies. Gastroenterol Hepatol (N Y). 2018 Sep;14(9):521-528.

ReferenceCitation: Sands BE, Feagan BG, Sandborn WJ, Schreiber S, Peyrin-Biroulet L, Frederic Colombel J, Rossiter G, Usiskin K, Ather S, Zhan X, D'Haens G. Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study. Am J Gastroenterol. 2020 May;115(5):738-745. doi: 10.14309/ajg.0000000000000493.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Celgene

location_country:
Finland
Germany
Poland
New Zealand
Australia
Turkey
Croatia
Czechia
Canada
Serbia
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
Malaysia
Estonia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Bulgaria
Russian Federation
Israel

location_facility: SBIH of Perm territory City Clinical Hospital 2 na Fedor Khristoforovich Gral

location_facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

location_facility: Klinikum Mannheim GmbH Universitaetsklinikum

location_facility: KH der Barmherzigen Brüder St.Veit an der Glan

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Centre de sante et de services sociaux Champlain Charles Le Moyne

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow

location_facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC

location_facility: Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC

location_facility: Hospital da Senhora da Oliveira Guimaraes

location_facility: RSHI State Novosibirsk Regional Clinical Hospital

location_facility: University of North Carolina at Chapel Hill

location_facility: Gastroenterology Associates of Tidewater

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov

location_facility: Groupe Hospitalier Sud Hopital Haut Leveque USN

location_facility: General Hospital of Heraklion Benizeleio Pananeio

location_facility: Riga East Clinical University Hospital clinic Gailezers

location_facility: Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU

location_facility: Zentrum fuer HIV und Hepatogastroenterologie GmbH

location_facility: Wake Forest University Baptist Medical Center

location_facility: Gastroenterology Associates of Western Michigan PLC

location_facility: Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE

location_facility: Medical Research Center of Connecticut LLC

location_facility: Northwestern University-Feinberg School of Medicine

location_facility: University Hospitals Case Medical Center

location_facility: Szent Pantaleon Korhaz Rendelointezet Dunaujvaros

location_facility: General Hospital of Nikaea Piraeus Ag. Panteleimon

location_facility: SBI of Healthcare of Leningrad region Clinical Interregional Hospital of Tosno

location_facility: Gaziantep University Medical Faculty Sahinbey Educational Research Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal

location_facility: SBHI of Yaroslavl Region Clinical Hospital 8

location_facility: RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU

location_facility: Toronto Digestive Disease Associates Inc

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy

location_facility: North Shore Long Island Jewish Health System

location_facility: Anticancer Hospital of Thessaloniki THEAGENIO

location_facility: Texas Digestive Disease Consultants - Dallas

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

location_facility: Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: Private Educational Institution of Higher Education Medical university REAVIZ

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Azienda Ospedaliera Universitaria Policlinico G Martino

location_facility: Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner

location_facility: The Feinstein Institute for Medical Research PRIME

location_facility: Spitalul Clinic Judetean de Urgente Sf. Spiridon

location_facility: SEIHPE Rostov State Medical University of MoH of RF

location_facility: London Health Science Center U. Hospital

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona

location_facility: Clinexpert Egeszsegugyi Szolg es Ker Kft

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: New York - Presbyterian/Weill Cornell Medical Center

location_facility: General Hospital of Thessaloniki Hippokration

location_facility: Clinsante S.C. Osrodek Badan Klinicznych

location_facility: Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus

location_facility: NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways

location_facility: University General Hospital of Alexandroupolis

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: Nemocnica s poliklinikou sv Barbory Roznava a s

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La

location_facility: Universitaetsklinikum Schleswig Holstein Campus Kiel

location_facility: Ordination Dr. Thomas Haas Darmpraxis Salzburg

location_facility: McMaster University Health Sciences Center

location_facility: Medizinisches Zentrum Klinikum Lueneburg

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Soukroma Gastroenterologicka ambulance a endoskopie

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Internistische Gemeinschaftspraxis f. Verdauungs- und Stoffwechselerkrankungen

location_facility: Stavanger Unviversitetssjukehus Helse Stavanger HF

location_facility: University of Pennsylvania School of Medicine

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Ternopil City Communal Emergency Medical Care Hospital

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: Florida Medical Research - Southeastern Integrated Medical

location_facility: The Methodist Hospital Research Institute

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: SBHI of NN region RCH of NN n.a. N.A.Semashko

location_facility: University of California at San Francisco

location_facility: Centro Hospitalar E Universitario de Coimbra EPE

location_facility: University of Southern California Medical Center

location_facility: Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: McGill University Health Centre Glen Site Royal Victoria Hospital

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Henry Ford Medical Center - New Center One

location_facility: Oklahoma University Health Sciences Center

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: University of Washington School of Medicine

location_facility: Groupement Hospitalier Sud Hopital Bicetre

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Communal Institution City Policlinic #20 Cabinet of Gastroenterology

location_facility: Nottingham University Hospitals Queens Medical Centre

location_facility: Southwest Gastroenterology Associates PC

location_facility: Yeditepe University Medical School Hospital

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

location_facility: Lviv Regional Clinical Hospital D Halytskyi Lviv NMU

location_facility: Asheville Gastroenterology Associates, PA

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Texas Digestive Disease Consultants Dallas

location_facility: Seconda Universita Degli Studi Di Napoli

location_facility: Mercy Clinic East Communities d/b/a Mercy Health Research

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

location_facility: SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Indywidualna Praktyka Lekarska Maciej Zymla

location_facility: Johns Hopkins University School of Medicine

location_facility: University General Hospital of Heraklion

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.

location_facility: Universitaetsklinikum FreiburgInnere Med.1, Haematologie

location_facility: CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI

location_facility: SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: CHA Bundang Medical Center CHA University

location_facility: University of Texas Health Science Center at Houston

location_facility: SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Charite Universitaetsmedizin Berlin Campus Benjamin Franklin


title: A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis

acronym: REGENERATE

summary: The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

ReferenceCitation: Rinella ME, Dufour JF, Anstee QM, Goodman Z, Younossi Z, Harrison SA, Loomba R, Sanyal AJ, Bonacci M, Trylesinski A, Natha M, Shringarpure R, Granston T, Venugopal A, Ratziu V. Non-invasive evaluation of response to obeticholic acid in patients with NASH: Results from the REGENERATE study. J Hepatol. 2022 Mar;76(3):536-548. doi: 10.1016/j.jhep.2021.10.029. Epub 2021 Nov 15.

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

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Younossi ZM, Stepanova M, Nader F, Loomba R, Anstee QM, Ratziu V, Harrison S, Sanyal AJ, Schattenberg JM, Barritt AS, Noureddin M, Bonacci M, Cawkwell G, Wong B, Rinella M; RandomizEd Global Phase 3 Study to Evaluate the Impact on NASH with FibRosis of Obeticholic Acid TreatmEnt (REGENERATE) Study Investigators. Obeticholic Acid Impact on Quality of Life in Patients With Nonalcoholic Steatohepatitis: REGENERATE 18-Month Interim Analysis. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2050-2058.e12. doi: 10.1016/j.cgh.2021.07.020. Epub 2021 Jul 15.

ReferenceCitation: Younossi ZM, Ratziu V, Loomba R, Rinella M, Anstee QM, Goodman Z, Bedossa P, Geier A, Beckebaum S, Newsome PN, Sheridan D, Sheikh MY, Trotter J, Knapple W, Lawitz E, Abdelmalek MF, Kowdley KV, Montano-Loza AJ, Boursier J, Mathurin P, Bugianesi E, Mazzella G, Olveira A, Cortez-Pinto H, Graupera I, Orr D, Gluud LL, Dufour JF, Shapiro D, Campagna J, Zaru L, MacConell L, Shringarpure R, Harrison S, Sanyal AJ; REGENERATE Study Investigators. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Dec 14;394(10215):2184-2196. doi: 10.1016/S0140-6736(19)33041-7. Epub 2019 Dec 5. Erratum In: Lancet. 2020 Aug 1;396(10247):312. Lancet. 2021 Jun 19;397(10292):2336.

repository_institution: University of Turin - Institutional Research Information System University of Turin

repository_institution: University of Plymouth - PEARL

ReferenceCitation: Ratziu V, Sanyal AJ, Loomba R, Rinella M, Harrison S, Anstee QM, Goodman Z, Bedossa P, MacConell L, Shringarpure R, Shah A, Younossi Z. REGENERATE: Design of a pivotal, randomised, phase 3 study evaluating the safety and efficacy of obeticholic acid in patients with fibrosis due to nonalcoholic steatohepatitis. Contemp Clin Trials. 2019 Sep;84:105803. doi: 10.1016/j.cct.2019.06.017. Epub 2019 Jun 29.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - @rchiveSIC

repository_normalized: HAL

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

repositories_concat: HAL

lead_sponsor: Intercept Pharmaceuticals

location_country:
Finland
Germany
Poland
New Zealand
Australia
Canada
Serbia
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Puerto Rico
Italy
United Kingdom
Sweden
Austria
Spain
Israel

location_facility: Hospital (Universitario) Virgen de la Victoria

location_facility: The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Institute for Liver and Digestive Health

location_facility: University of Massachusetts Medical School

location_facility: Hospital General y Universitario de Alicante

location_facility: The University of Vermont Medical Center - Smith 2

location_facility: Virginia Commonwealth University Clinical Research Services Unit (CRSU)

location_facility: University di Bologna - Dipartimento di Scienze Mediche e Chirurgiche - DIMEC

location_facility: South Florida Center of Gastroenterology, P.A.

location_facility: Hospital Universitario Fundación Alcorcon

location_facility: Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik

location_facility: Florida Digestive Health Specialist Research Institute

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Universitätsklinik für Innere Medizin I Innsbruck

location_facility: St. Josef-Hospital, Ruhr University Bochum

location_facility: University of North Carolina at Chapel Hill, School of Medicine

location_facility: The University of Chicago Medical Center

location_facility: Saint Louis University Gastroenterology & Hepatology

location_facility: Friedrich-Alexander-Universität Erlangen Medizinische Klinik 1

location_facility: University Hospitals Case Medical Center

location_facility: University of Kentucky Chandler Medical Center

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: The Ohio State University Wexner Medical Center

location_facility: University at Buffalo, Clinical and Translational Research Center

location_facility: Universitätsklinikum Leipzig Klinik für Gastroenterologie und Rheumatologie-Sektion Hepatologie

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Baylor College of Medicine Ben Taub General Hospital

location_facility: University Hospitals Coventry & Warwickshire

location_facility: Rutgers University New Jersey Medical School

location_facility: Prisma Health- Upstate Gastroenterology and Liver Center

location_facility: Rambam Medical Center Center for Liver diseases

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Washington University School of Medicine - Gastroenterology

location_facility: Carolinas Center for Liver Disease/Carolinas HeatlhCare System

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University Hospital Bristol NHS Foundation Trust

location_facility: Universitatsklinikum Aachen, RWTH Aachen, Medizinische Klinik III

location_facility: Norfolk and Norwich University Hospitals

location_facility: Hospital Saint Antoine Department of Hepatology

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: UZ Leuven Campus Gathuisberg Hepatology Department

location_facility: Baylor Scott & White All Saints Medical Center

location_facility: Gastroenterology Department Hull Royal Infirmary

location_facility: Service d'Hepato-Gastroenterologie CHR Orleans - La Source

location_facility: CHU de Nancy - Hôpital de Brabois adultes

location_facility: Hôpital Henri Mondor - Service d'hépatologie

location_facility: Institute for Liver Health DBA Arizona Liver Health

location_facility: University of Colorado Denver and Hospital

location_facility: Digestive Health Specialists of the Southeast

location_facility: Hospital (Universitario) Marqués de Valdecilla

location_facility: Charite Universitätsmedizin Campus Virchow

location_facility: University of California Davis Medical Center

location_facility: Centro Hospitalar do Baixo Vouga, E.P.E.

location_facility: Wojewodzki Specjalistyczny Szpital im. Dr WI. Bieganskiego

location_facility: Nottingham Digestive Diseases and Biomedical Research Unit

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Krankenhaus Barmherzige Bruder Innere Medizin I - Gastroenterologie

location_facility: University Hosptial Cologne Clinics for Gastroenterology and Hepatology

location_facility: Northwestern University, Feinberg School of Medicine

location_facility: The Alfred Hospital, Department of Gastroenterology

location_facility: Hospital del Mar Gastroenterology Department

location_facility: Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo

location_facility: Hospital of the University of Pennsylvania

location_facility: California Pacific Medical Center (CPMC)

location_facility: Southern Therapy and Advanced Research, LLC

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Consorcio Hospital General Universitario

location_facility: Complejo Asistencial Universitario de Leon

location_facility: University of Louisville Medical, Clinical Trials Unit

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hosp. de Santa Maria

location_facility: Soroka Medical Center Division of Internal Medicine

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

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Indianapolis Gastroenterology & Hepatology

location_facility: Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: The Pennsylvania State University and The Milton S. Hershey Medical Center

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: London Health Sciences Centre University Hospital

location_facility: AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital

location_facility: Royal Adelaide Hospital Gastroenterology and Hepatology Dept.

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz

location_facility: Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research

location_facility: CHI Health Alegent Creighton Clinic Gastroenterology

location_facility: The Queen's Medical Center - Liver Center

location_facility: Universitätsklinikum Heidelberg Medizinischen Klinik IV Gastroenterologie und Hepatologie

location_facility: UF Health Jacksonville-Gastroenterology Emerson

location_facility: Walter Reed National Military Medical Center

location_facility: Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling

location_facility: University Clinic of Gastroenterology & Hepatology

location_facility: Indiana University Health University Hospital

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Asheville Gastroenterology Associates, PA

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Veteran Affairs Great Los Angeles Healthcare System

location_facility: The Research Institute of the McGill University Health Centre

location_facility: Centre de Recherche du Centre Hospitalier de l'Universite de Montreal

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Huron Gastroenterology Associates/Center for Digestive Care

location_facility: Methodist Healthcare, University Hospital

location_facility: Swedish Organ Transplant and Liver Center

location_facility: Gastroenterology Consultants of San Antonio

location_facility: New York University (NYU) Langone Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico

location_facility: Central Manchester University Hospital NHS Foundation Trust Manchester Royal Infirmary


title: A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

summary: This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

lead_sponsor: Amgen

location_country:
Germany
Poland
New Zealand
Australia
Turkey
Czechia
Canada
France
Lithuania
Portugal
Hungary
Denmark
Switzerland
United States
Latvia
Belgium
Italy
Sweden
Netherlands
Austria
Spain
Greece
Russian Federation
Israel


acronym: FIGARO-DKD

lead_sponsor: Bayer

summary: The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

ReferenceCitation: Ruilope LM, Agarwal R, Anker SD, Bakris GL, Filippatos G, Nowack C, Kolkhof P, Joseph A, Mentenich N, Pitt B; FIGARO-DKD study investigators. Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial. Am J Nephrol. 2019;50(5):345-356. doi: 10.1159/000503712. Epub 2019 Oct 30.

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;archive.ugent.be

publisher_dissemination: S. Karger AG

ReferenceCitation: Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.

ReferenceCitation: Filippatos G, Anker SD, Pitt B, Rossing P, Joseph A, Kolkhof P, Lambelet M, Lawatscheck R, Bakris GL, Ruilope LM, Agarwal R. Finerenone and Heart Failure Outcomes by Kidney Function/Albuminuria in Chronic Kidney Disease and Diabetes. JACC Heart Fail. 2022 Nov;10(11):860-870. doi: 10.1016/j.jchf.2022.07.013. Epub 2022 Oct 12. Erratum In: JACC Heart Fail. 2023 Aug;11(8 Pt 1):1034-1035.

ReferenceCitation: Pitt B, Agarwal R, Anker SD, Ruilope LM, Rossing P, Ahlers C, Brinker M, Joseph A, Lambelet M, Lawatscheck R, Filippatos GS; FIDELIO-DKD and FIGARO-DKD Investigators. Association of Finerenone Use With Reduction in Treatment-Emergent Pneumonia and COVID-19 Adverse Events Among Patients With Type 2 Diabetes and Chronic Kidney Disease: A FIDELITY Pooled Secondary Analysis. JAMA Netw Open. 2022 Oct 3;5(10):e2236123. doi: 10.1001/jamanetworkopen.2022.36123.

ReferenceCitation: Filippatos G, Anker SD, Agarwal R, Ruilope LM, Rossing P, Bakris GL, Tasto C, Joseph A, Kolkhof P, Lage A, Pitt B; FIGARO-DKD Investigators. Finerenone Reduces Risk of Incident Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabetes: Analyses From the FIGARO-DKD Trial. Circulation. 2022 Feb 8;145(6):437-447. doi: 10.1161/CIRCULATIONAHA.121.057983. Epub 2021 Nov 13.

repository_institution: Universidad Europea - ABACUS. Repositorio de Producción Científica

ReferenceCitation: Erraez S, Lopez-Mesa M, Gomez-Fernandez P. Mineralcorticoid receptor blockers in chronic kidney disease. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. English, Spanish.

ReferenceCitation: Agarwal R, Anker SD, Bakris G, Filippatos G, Pitt B, Rossing P, Ruilope L, Gebel M, Kolkhof P, Nowack C, Joseph A; FIDELIO-DKD and FIGARO-DKD Investigators. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone. Nephrol Dial Transplant. 2022 May 25;37(6):1014-1023. doi: 10.1093/ndt/gfaa294.

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.

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, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
China
Malaysia
Puerto Rico
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Previously Treated Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer

acronym: SUNRISE

summary: The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.

ReferenceCitation: Gerber DE, Horn L, Boyer M, Sanborn R, Natale R, Palmero R, Bidoli P, Bondarenko I, Germonpre P, Ghizdavescu D, Kotsakis A, Lena H, Losonczy G, Park K, Su WC, Tang M, Lai J, Kallinteris NL, Shan JS, Reck M, Spigel DR. Randomized phase III study of docetaxel plus bavituximab in previously treated advanced non-squamous non-small-cell lung cancer. Ann Oncol. 2018 Jul 1;29(7):1548-1553. doi: 10.1093/annonc/mdy177.

license: publisher-specific-oa

license_normalized: publisher-specific

lead_sponsor: Peregrine Pharmaceuticals

location_country:
Germany
Italy
Hungary
Romania
Australia
Belgium
United States
Korea, Republic of
Spain
Greece
Taiwan
Ukraine
Russian Federation
France

location_facility: Peregrine Pharmaceuticals Investigational Site


title: A Phase II, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Oral Corticosteroid-Sparing Effect of Lebrikizumab in Patients With Severe Corticosteroid Dependent Asthma

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.

lead_sponsor: Hoffmann-La Roche

location_country:
Slovenia
Poland
New Zealand
Slovakia
United Kingdom
Denmark
Australia
Netherlands
Mexico
Belgium
United States
Spain
Czechia
Canada
Puerto Rico
France

location_facility: Wythenshawe Hospital; North West Lung Research Centre

location_facility: Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde

location_facility: Derriford Hospital; The Lind Research Department

location_facility: Academisch Medisch Centrum; Afdeling Longziekten, F5-258

location_facility: Gartnavel General Hospital; Respiratory Department

location_facility: EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej

location_facility: Monash Medical Centre; Respiratory and Sleep Medicine

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: Complejo Hospitalario Universitario de Santiago; Servicio de Neumología

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Neumologia

location_facility: Centro Investigacion Medico Biologica y Terapia Avanzada

location_facility: Sheffield Clinical Research Facility; National Institute for Health Research

location_facility: Nouvel Hôpital Civil; Pôle de Pathologie Thoracique

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: Freeman Hospital; Respiratory Department

location_facility: CHU de Grenoble - Hôpital André Michallon

location_facility: Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Antonius Ziekenhuis; Dept of Lung Diseases

location_facility: University Clinic of Pulmonary and Allergic Diseases Golnik

location_facility: Belfast City Hospital; Respiratory Department

location_facility: Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine

location_facility: Allergy & Asthma Care Center of Southern California

location_facility: Glenfield Hospital; Respiratory -Allergy Unit

location_facility: San Juan Bautista School of Medicine-Clinical Research Unit

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala

location_facility: St Bartholomew's Hospital (Barts); Respiratory Department

location_facility: Southampton General Hospital; Respiratory Department

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Klinika Chorób Wewnetrznych i Alergologii MSW

location_facility: CHU Nantes - Hôpital Laennec; Service de Pneumologie

location_facility: Heartlands Hospital; Respiratory Department

location_facility: New Lister Buliding, Level 1; Clinical Research Facility

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

location_facility: Medical Research Inst. of New Zealand; Respiratory


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

summary:
Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs.

The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients.

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole - Institut Claudius Regaud

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Azienda Provinciale per i Servizi Sanitari - Ospedale Santa Chiara

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University Medical Center Groningen (UMCG)

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Universitaetsklinikum Jena-Radiation Therapy and Radiooncology Clinic

location_facility: Spaarne Gasthuis - Vrije Universiteit Medisch Centrum

location_facility: Radboud University Medical Center Nijmegen

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Tenon

location_facility: Athens University - Attikon University General Hospital

status: Active, not recruiting

title: A Randomized Phase II Study to Evaluate the Efficacy and Safety of Chemotherapy (CT) vs Androgen Deprivation Therapy (ADT) in Patients With Recurrent and/or Metastatic, Androgen Receptor (AR) Expressing, Salivary Gland Cancer (SGCs)

location_country: Germany Italy Hungary Netherlands Austria Belgium Greece France

status_simplified: Ongoing


acronym: COAST

summary: To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.

location_facility: Fujian Medical University Union Hospital

title: A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients With Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases

location_country:
Germany
Italy
Portugal
Israel
United Kingdom
Australia
Brazil
Japan
Belgium
United States
China
Spain
Canada
France


lead_sponsor: Boehringer Ingelheim

summary: This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.

ReferenceCitation: Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sorensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. doi: 10.1016/S2213-2600(19)30139-0. Epub 2019 May 15.

location_facility: University Hospital of Occupational and Environmental Health

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Onco.Cent. - Instit. of Maria Sklodowskiej-Curie

location_facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente

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

location_facility: University Clinic for Pulmonary Diseases

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

location_facility: Japan Labour Health and Safety Organization Okayama Rosai Hospital

location_facility: National Cancer Institute, Cairo University

location_facility: Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has.

location_facility: St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Rigshospitalet, København, Onkologisk afdeling

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland

location_facility: QEII Health Sciences Centre (Dalhousie University)

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: St. Olavs Hospital, Universitetssykehuset i Trondheim

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Oslo Universitetssykehus HF, Radiumhospitalet

location_facility: Centro Internacional de Estudios Clínicos - CIEC

location_facility: FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

location_facility: FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF

location_facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga

title: LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Croatia
Chile
Czechia
Canada
France
Portugal
Denmark
United States
Belgium
Egypt
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
South Africa
Russian Federation
Israel


title: A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

summary: The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

ReferenceCitation: Block GA, Bushinsky DA, Cheng S, Cunningham J, Dehmel B, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Moe SM, Patel UD, Silver J, Sun Y, Wang H, Chertow GM. Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial. JAMA. 2017 Jan 10;317(2):156-164. doi: 10.1001/jama.2016.19468.

ReferenceCitation: Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.

ReferenceCitation: Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.

ReferenceCitation: Wu B, Melhem M, Subramanian R, Chen P, Jaramilla Sloey B, Fouqueray B, Hock MB, Skiles GL, Chow AT, Lee E. Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis. J Clin Pharmacol. 2018 Jun;58(6):717-726. doi: 10.1002/jcph.1090. Epub 2018 Mar 13.

ReferenceCitation: Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.

ReferenceCitation: Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.

location_country:
Germany
Poland
New Zealand
Turkey
Czechia
Canada
France
Lithuania
Portugal
Hungary
Denmark
Switzerland
United States
Latvia
Belgium
Estonia
Italy
Austria
Spain
Greece
Russian Federation
Sweden


title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145

summary: This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

ReferenceCitation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.

ReferenceCitation: Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.

repository_institution: The University of Glasgow - Enlighten: Publications

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22.

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

ReferenceCitation: Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.

repository_institution: University of Cape Town - Open University of Cape Town

repository_normalized: localhost

repositories_concat: localhost

location_country:
Germany
Poland
New Zealand
Australia
Japan
Czechia
Canada
France
Hungary
Hong Kong
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Sweden