acronym: RADIANT

lead_sponsor: OSI Pharmaceuticals

summary: This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.

ReferenceCitation: Kelly K, Altorki NK, Eberhardt WE, O'Brien ME, Spigel DR, Crino L, Tsai CM, Kim JH, Cho EK, Hoffman PC, Orlov SV, Serwatowski P, Wang J, Foley MA, Horan JD, Shepherd FA. Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2015 Dec 1;33(34):4007-14. doi: 10.1200/JCO.2015.61.8918. Epub 2015 Aug 31.

repositories_institution: California Digital Library - eScholarship

location_facility: University of New Mexico Health Science Center

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4

location_facility: Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"

location_facility: Cancer Center of Southeastern Ontario at Kingston General Hospital

location_facility: Heartland Regional Medical Center d/b/a Heartland Clinic

location_facility: Cancer Care Centers of South Texas-HOAST

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza

location_facility: CHU - Hopital Pontchaillou - Service de pneumologie

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Hospital de Rehabilitación Respiratoria María Ferrer

location_facility: Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci

location_facility: State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: SMZ Baumgartner Hoehe - Otto Wagner Spital

location_facility: RS MacLaughlin Durham Regional Cancer Centre

location_facility: Comprehensive Cancer Center at Desert Regional Medical Center

location_facility: Gachon Medical School Ghil Medical Center

location_facility: Cancer Care Associates - Medical Oncology

location_facility: St James' Institute of Oncology, Bexley Wing, St James' University Hospital

location_facility: Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"

location_facility: Severance Hospital, Yonsei Univ. College of Medicine

location_facility: Stronach Regional cancer Centre at Southlake

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

location_facility: CHU Larrey Service de Pneumologie, Clinique des voies respiratoires

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta

location_facility: The Royal Surrey County Hospital NHS Trust

location_facility: Christus St. Vincent Regional Cancer Center

location_facility: C.H.U. Morvan, Institut de Cancerologie et d'Hématologie

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Peachtree Hematology-Oncology Consultants, P.C.

location_facility: Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie

location_facility: Országos Korányi TBC és Pulmonológiai Intézet

location_facility: Cancer Care Centers of South Texas - HOAST

location_facility: State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"

location_facility: The Hospital of the University of Pennsylvania

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar Pulmonologiai Klinika

location_facility: SMZ Baumgartner Höhe - Otto- Wagner-Spital

location_facility: Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"

location_facility: CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie

location_facility: Azienda Ospedaliero- Universitaria di Parma

location_facility: The New York Presbyterian-Weill Medical College of Cornell University

location_facility: Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego

location_facility: Thunder Bay Regional Health Science Centre

location_facility: State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University n.a. ac. I.P. Pavlov of the Ministry of Healthcare and Social Development of the Russian Federation"

location_facility: Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care

location_facility: Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care

location_facility: Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie

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

location_facility: Hopital De La Croix-Rousse Service de Pneumologie

location_facility: Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

location_facility: FN Bulovka Klinika plincni a hrrudni chirurgie

location_facility: Univ. of Washington/ Seattle Cancer Care Alliance

location_facility: "G. Papanikolaou" General Hospital of Thessaloniki

location_facility: State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"

location_facility: University of Chicago, Section of Hematology/Oncology

location_facility: St. Joseph Medical Center's Cancer Institute

location_facility: Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH

location_facility: Städtisches Krankenhaus Martha-Maria, Halle-Dölau

location_facility: Texas Oncology Texas Cancer Center at Medical City

location_facility: University of California, San Francisco Comprehensive Cancer Center

location_facility: Aultman Hospital/ North Canton Medical Foundation

location_facility: Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"

location_facility: Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II

location_facility: "Papageorgiou" General Hospital of Thessaloniki

location_facility: Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag

location_facility: Istituto Nazionale per la Ricerca e la Cura del Cancro

location_facility: Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina

location_facility: University of Arkansas for Medical Science

location_facility: State Healthcare Institution "Regional Clinical Oncology Dispensary"

title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors

location_country:
Germany
Poland
Argentina
Australia
Canada
France
Czech Republic
Hungary
United States
Romania
Belgium
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation


title: A Multicentre, Randomised, Double-blind, Double Dummy, Parallel Group Study to Compare the Salmeterol/Fluticasone Propionate Combination (SeretideTM) at a Dose of 50/100µg Twice Daily and Fluticasone Propionate (FlixotideTM) at a Dose of 200µg Twice Daily, Both Delivered Via a Dry Powder Inhaler (DiskusTM) for 12 Weeks in Asthma in Children Aged 4-11 Years Not Controlled by Inhaled Corticosteroids Alone at Medium Dose

summary: This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Lithuania
Poland
Norway
Denmark
Sweden
Netherlands
Belgium
Latvia
Spain
Russian Federation
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomised, Double-Blind Study Comparing the Efficacy and Safety of 145 mg Fenofibrate, 10 mg Ezetimibe and Their Combination in Patients With Type IIb Dyslipidemia and Features of the Metabolic Syndrome

summary: Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile of this patient population.

ReferenceType: derived

ReferenceCitation: Ansquer JC, Bekaert I, Guy M, Hanefeld M, Simon A; Study Investigators. Efficacy and safety of coadministration of fenofibrate and ezetimibe compared with each as monotherapy in patients with type IIb dyslipidemia and features of the metabolic syndrome: a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study. Am J Cardiovasc Drugs. 2009;9(2):91-101. doi: 10.1007/BF03256580.

lead_sponsor: Solvay Pharmaceuticals

location_country: Germany Belgium France

location_facility:
Site 107
Site 101
Site 305
Site 212
Site 204
Site 209
Site 110
Site 203
Site 207
Site 306
Site 310
Site 205
Site 302
Site 116
Site 104
Site 303
Site 206
Site 208
Site 210
Site 309
Site 311
Site 307
Site 201
Site 202
Site 314
Site 213
Site 301
Site 304
Site 103
Site 312
Site 114
Site 313
Site 106
Site 111
Site 105
Site 112
Site 102
Site 113
Site 109
Site 211
Site 115
Site 108
Site 308


title: A 54 Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Acetylcholinesterase Inhibitors on Cognition and Overall Clinical Response in APOE4-stratified Subjects With Mild to Moderate Alzheimer's Disease

summary:
Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG.

This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects the response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.

ReferenceType: background

ReferenceCitation: Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606. doi: 10.2174/156720511796391935.

location_country:
Finland
Germany
Poland
Australia
Czechia
Canada
France
Slovenia
Slovakia
Hong Kong
United States
Belgium
Malaysia
Philippines
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
South Africa
Bulgaria
Sweden


title: RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

summary: The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.

ReferenceCitation: Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts W; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2765-75. doi: 10.1056/NEJMoa0800374.

lead_sponsor: Bayer

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
Czech Republic
Lithuania
Colombia
Slovakia
Hungary
Denmark
United States
Belgium
Italy
Norway
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Israel


title: The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD

acronym: TNT

summary: The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Waters DD, LaRosa JC, Barter P, Fruchart JC, Gotto AM Jr, Carter R, Breazna A, Kastelein JJ, Grundy SM. Effects of high-dose atorvastatin on cerebrovascular events in patients with stable coronary disease in the TNT (treating to new targets) study. J Am Coll Cardiol. 2006 Nov 7;48(9):1793-9. doi: 10.1016/j.jacc.2006.07.041. Epub 2006 Oct 17.

ReferenceCitation: Vogt L, Bangalore S, Fayyad R, Melamed S, Hovingh GK, DeMicco DA, Waters DD. Atorvastatin Has a Dose-Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double-Blind Randomized Controlled Trials. J Am Heart Assoc. 2019 May 7;8(9):e010827. doi: 10.1161/JAHA.118.010827.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

license_normalized: no license

repository_institution: University of California - eScholarship University of California

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Bangalore S, Fayyad R, DeMicco DA, Colhoun HM, Waters DD. Body Weight Variability and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004724. doi: 10.1161/CIRCOUTCOMES.118.004724.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: California Digital Library - eScholarship

repository_institution: University of Edinburgh - Edinburgh Research Explorer

version: submittedVersion

unpaywall_oa_status: bronze

ReferenceCitation: Kaasenbrood L, Ray KK, Boekholdt SM, Smulders YM, LaRosa JC, Kastelein JJP, van der Graaf Y, Dorresteijn JAN, Visseren FLJ. Estimated individual lifetime benefit from PCSK9 inhibition in statin-treated patients with coronary artery disease. Heart. 2018 Oct;104(20):1699-1705. doi: 10.1136/heartjnl-2017-312510. Epub 2018 Apr 5.

oa_host_type: repository

repository_institution: Imperial College London - Spiral

unpaywall_oa_status: green

publisher_dissemination: British Medical Journal

ReferenceCitation: Vallejo-Vaz AJ, Fayyad R, Boekholdt SM, Hovingh GK, Kastelein JJ, Melamed S, Barter P, Waters DD, Ray KK. Triglyceride-Rich Lipoprotein Cholesterol and Risk of Cardiovascular Events Among Patients Receiving Statin Therapy in the TNT Trial. Circulation. 2018 Aug 21;138(8):770-781. doi: 10.1161/CIRCULATIONAHA.117.032318.

ReferenceCitation: Ong KL, Waters DD, Fayyad R, Vogt L, Melamed S, DeMicco DA, Rye KA, Barter PJ. Relationship of High-Density Lipoprotein Cholesterol With Renal Function in Patients Treated With Atorvastatin. J Am Heart Assoc. 2018 Jan 22;7(2):e007387. doi: 10.1161/JAHA.117.007387.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;escholarship.org

ReferenceCitation: Ports WC, Fayyad R, DeMicco DA, Laskey R, Wolk R. Effectiveness of Lipid-Lowering Statin Therapy in Patients With and Without Psoriasis. Clin Drug Investig. 2017 Aug;37(8):775-785. doi: 10.1007/s40261-017-0533-0.

ReferenceCitation: Bangalore S, Fayyad R, Laskey R, DeMicco DA, Messerli FH, Waters DD. Body-Weight Fluctuations and Outcomes in Coronary Disease. N Engl J Med. 2017 Apr 6;376(14):1332-1340. doi: 10.1056/NEJMoa1606148.

ReferenceCitation: Stam-Slob MC, van der Graaf Y, Greving JP, Dorresteijn JA, Visseren FL. Cost-Effectiveness of Intensifying Lipid-Lowering Therapy With Statins Based on Individual Absolute Benefit in Coronary Artery Disease Patients. J Am Heart Assoc. 2017 Feb 18;6(2):e004648. doi: 10.1161/JAHA.116.004648.

ReferenceCitation: Deedwania PC, Pedersen TR, DeMicco DA, Breazna A, Betteridge DJ, Hitman GA, Durrington P, Neil A; TNT, CARDS and IDEAL Steering Committees and Investigators. Differing predictive relationships between baseline LDL-C, systolic blood pressure, and cardiovascular outcomes. Int J Cardiol. 2016 Nov 1;222:548-556. doi: 10.1016/j.ijcard.2016.07.201. Epub 2016 Jul 30.

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

ReferenceCitation: Byun YS, Lee JH, Arsenault BJ, Yang X, Bao W, DeMicco D, Laskey R, Witztum JL, Tsimikas S; TNT Trial Investigators. Relationship of oxidized phospholipids on apolipoprotein B-100 to cardiovascular outcomes in patients treated with intensive versus moderate atorvastatin therapy: the TNT trial. J Am Coll Cardiol. 2015 Apr 7;65(13):1286-1295. doi: 10.1016/j.jacc.2015.01.050.

ReferenceCitation: Arsenault BJ, Barter P, DeMicco DA, Bao W, Preston GM, LaRosa JC, Grundy SM, Deedwania P, Greten H, Wenger NK, Shepherd J, Waters DD, Kastelein JJ; Treating to New Targets (TNT) Investigators. Prediction of cardiovascular events in statin-treated stable coronary patients of the treating to new targets randomized controlled trial by lipid and non-lipid biomarkers. PLoS One. 2014 Dec 22;9(12):e114519. doi: 10.1371/journal.pone.0114519. eCollection 2014.

ReferenceCitation: Dorresteijn JA, Boekholdt SM, van der Graaf Y, Kastelein JJ, LaRosa JC, Pedersen TR, DeMicco DA, Ridker PM, Cook NR, Visseren FL. High-dose statin therapy in patients with stable coronary artery disease: treating the right patients based on individualized prediction of treatment effect. Circulation. 2013 Jun 25;127(25):2485-93. doi: 10.1161/CIRCULATIONAHA.112.000712. Epub 2013 May 14.

ReferenceCitation: Semb AG, Kvien TK, DeMicco DA, Fayyad R, Wun CC, LaRosa JC, Betteridge J, Pedersen TR, Holme I. Effect of intensive lipid-lowering therapy on cardiovascular outcome in patients with and those without inflammatory joint disease. Arthritis Rheum. 2012 Sep;64(9):2836-46. doi: 10.1002/art.34524.

ReferenceCitation: Huijgen R, Boekholdt SM, Arsenault BJ, Bao W, Davaine JM, Tabet F, Petrides F, Rye KA, DeMicco DA, Barter PJ, Kastelein JJ, Lambert G. Plasma PCSK9 levels and clinical outcomes in the TNT (Treating to New Targets) trial: a nested case-control study. J Am Coll Cardiol. 2012 May 15;59(20):1778-84. doi: 10.1016/j.jacc.2011.12.043.

ReferenceCitation: Mora S, Wenger NK, Demicco DA, Breazna A, Boekholdt SM, Arsenault BJ, Deedwania P, Kastelein JJ, Waters DD. Determinants of residual risk in secondary prevention patients treated with high- versus low-dose statin therapy: the Treating to New Targets (TNT) study. Circulation. 2012 Apr 24;125(16):1979-87. doi: 10.1161/CIRCULATIONAHA.111.088591. Epub 2012 Mar 29.

ReferenceCitation: Arsenault BJ, Boekholdt SM, Hovingh GK, Hyde CL, DeMicco DA, Chatterjee A, Barter P, Deedwania P, Waters DD, LaRosa JC, Pedersen TR, Kastelein JJ; TNT and IDEAL Investigators. The 719Arg variant of KIF6 and cardiovascular outcomes in statin-treated, stable coronary patients of the treating to new targets and incremental decrease in end points through aggressive lipid-lowering prospective studies. Circ Cardiovasc Genet. 2012 Feb 1;5(1):51-7. doi: 10.1161/CIRCGENETICS.111.960252. Epub 2011 Dec 1.

ReferenceCitation: Arsenault BJ, Barter P, DeMicco DA, Bao W, Preston GM, LaRosa JC, Grundy SM, Deedwania P, Greten H, Wenger NK, Shepherd J, Waters DD, Kastelein JJ; TNT Study Investigators. Prediction of cardiovascular events in statin-treated stable coronary patients by lipid and nonlipid biomarkers. J Am Coll Cardiol. 2011 Jan 4;57(1):63-9. doi: 10.1016/j.jacc.2010.06.052.

ReferenceCitation: Hyde CL, Macinnes A, Sanders FA, Thompson JF, Mazzarella RA, Faergeman O, van Wijk DF, Wood L, Lira M, Paciga SA. Genetic association of the CCR5 region with lipid levels in at-risk cardiovascular patients. Circ Cardiovasc Genet. 2010 Apr;3(2):162-8. doi: 10.1161/CIRCGENETICS.109.897793. Epub 2010 Feb 3.

ReferenceCitation: Waters DD. Clinical insights from the Treating to New Targets trial. Prog Cardiovasc Dis. 2009 May-Jun;51(6):487-502. doi: 10.1016/j.pcad.2009.01.001.

ReferenceCitation: Shepherd J, Kastelein JP, Bittner VA, Carmena R, Deedwania PC, Breazna A, Dobson S, Wilson DJ, Zuckerman AL, Wenger NK; Treating to New Targets Steering Committee and Investigators. Intensive lipid lowering with atorvastatin in patients with coronary artery disease, diabetes, and chronic kidney disease. Mayo Clin Proc. 2008 Aug;83(8):870-9.

ReferenceCitation: Shah SJ, Waters DD, Barter P, Kastelein JJ, Shepherd J, Wenger NK, DeMicco DA, Breazna A, LaRosa JC. Intensive lipid-lowering with atorvastatin for secondary prevention in patients after coronary artery bypass surgery. J Am Coll Cardiol. 2008 May 20;51(20):1938-43. doi: 10.1016/j.jacc.2007.12.054.

ReferenceCitation: Shepherd J, Kastelein JJ, Bittner V, Deedwania P, Breazna A, Dobson S, Wilson DJ, Zuckerman A, Wenger NK; TNT (Treating to New Targets) Investigators. Intensive lipid lowering with atorvastatin in patients with coronary heart disease and chronic kidney disease: the TNT (Treating to New Targets) study. J Am Coll Cardiol. 2008 Apr 15;51(15):1448-54. doi: 10.1016/j.jacc.2007.11.072.

ReferenceCitation: Barter P, Gotto AM, LaRosa JC, Maroni J, Szarek M, Grundy SM, Kastelein JJ, Bittner V, Fruchart JC; Treating to New Targets Investigators. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med. 2007 Sep 27;357(13):1301-10. doi: 10.1056/NEJMoa064278.

location_country:
Germany
Ireland
Italy
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
United States
Spain
South Africa
Canada
France


title: Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria

acronym: PLANET 1

summary: The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.

ReferenceCitation: de Zeeuw D, Anzalone DA, Cain VA, Cressman MD, Heerspink HJ, Molitoris BA, Monyak JT, Parving HH, Remuzzi G, Sowers JR, Vidt DG. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial. Lancet Diabetes Endocrinol. 2015 Mar;3(3):181-90. doi: 10.1016/S2213-8587(14)70246-3. Epub 2015 Feb 4.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: AstraZeneca

location_country:
Italy
Hungary
Argentina
Denmark
Romania
Brazil
Mexico
United States
Bulgaria
Canada
France

location_facility:
Research site
Research Site
Reasearch Site


title: A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).

summary:
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.

To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.

design_allocation: Non-Randomized

lead_sponsor: UCB Pharma

location_country: Finland Poland Switzerland Belgium Bulgaria France


title: Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

ReferenceCitation: Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. doi: 10.1007/s00125-007-0911-x. Epub 2008 Jan 16.

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Ireland
United Kingdom
Austria
Belgium
United States
France


title: A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Sulphonylurea Alone

summary: This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period

status: Terminated

location_country:
France
Norway
United Kingdom
Australia
Korea, Republic of
Spain
Vietnam
South Africa
Philippines
Israel

status_simplified: Unknown


type: EudraCT Number

type: Other Identifier

title: A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS

summary: The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.

ReferenceCitation: Coates LC, Gottlieb AB, Merola JF, Boone C, Szumski A, Chhabra A. Comparison of Different Remission and Low Disease Definitions in Psoriatic Arthritis and Evaluation of Their Prognostic Value. J Rheumatol. 2019 Feb;46(2):160-165. doi: 10.3899/jrheum.180249. Epub 2018 Oct 15.

oa_host_type: publisher

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available.

publisher_dissemination: Oxford University Press

ReferenceCitation: Kirkham B, de Vlam K, Li W, Boggs R, Mallbris L, Nab HW, Tarallo M. Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: findings from the etanercept PRESTA trial. Clin Exp Rheumatol. 2015 Jan-Feb;33(1):11-9. Epub 2014 Dec 22.

ReferenceCitation: Griffiths CE, Sterry W, Brock F, Dilleen M, Stefanidis D, Germain JM, Mallbris L. Pattern of response in patients with moderate-to-severe psoriasis treated with etanercept. Br J Dermatol. 2015 Jan;172(1):230-8. doi: 10.1111/bjd.13139. Epub 2014 Nov 13.

ReferenceCitation: Gniadecki R, Robertson D, Molta CT, Freundlich B, Pedersen R, Li W, Boggs R, Zbrozek AS. Self-reported health outcomes in patients with psoriasis and psoriatic arthritis randomized to two etanercept regimens. J Eur Acad Dermatol Venereol. 2012 Nov;26(11):1436-43. doi: 10.1111/j.1468-3083.2011.04308.x. Epub 2011 Oct 31.

ReferenceCitation: Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147.

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

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Finland
Germany
Poland
Argentina
Australia
Turkey
Czechia
France
Colombia
Portugal
Hungary
Denmark
Switzerland
Former Serbia and Montenegro
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
Taiwan
Sweden

location_facility: Zesp. Naukowo-Kliniczny IWOLANG, Uzdrowiskowa Klinika Dermat

location_facility: Semmelweis University - Faculty of Health Sciences

location_facility: University of Athens Andreas Syngros Hospital Athens, Greece

location_facility: Klinik fuer Dermatologie, Venerologie und Allergologie

location_facility: The Royal Free Hospital, Pond Street, Hampstead

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Klinik und Poliklinik für Dermatologie der Friedrich-Wilhelm

location_facility: Centro Integral de Reumatologia del Caribe S.A.S

location_facility: King Faisal Specialist Hospital & Research Centre

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum

location_facility: Clinic for Dermatology and Clinic for Medical Rehabilitation

location_facility: Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052

location_facility: Klinikum Innenstadt der Universitaet Muenchen

location_facility: University of Copenhagen - Roskilde Hospital

location_facility: Policlinico Umberto I - Universita La Sapienza

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Miskolc Megyei Jogu Varos Onkormanyzata, Miskolci Egeszsegui

location_facility: Guy's and St. Thomas' Trust St.Thomas' Hospital


title: A One Year, Open-label, Single-arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/Day) in Patients Diagnosed With Transfusion-dependent Iron Overload

summary: This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.

ReferenceCitation: Porter JB, El-Alfy M, Viprakasit V, Giraudier S, Chan LL, Lai Y, El-Ali A, Han J, Cappellini MD. Utility of labile plasma iron and transferrin saturation in addition to serum ferritin as iron overload markers in different underlying anemias before and after deferasirox treatment. Eur J Haematol. 2016 Jan;96(1):19-26. doi: 10.1111/ejh.12540. Epub 2015 Jun 23.

publisher_dissemination: Wiley

ReferenceCitation: Lee JW, Yoon SS, Shen ZX, Ganser A, Hsu HC, El-Ali A, Habr D, Martin N, Porter JB. Hematologic responses in patients with aplastic anemia treated with deferasirox: a post hoc analysis from the EPIC study. Haematologica. 2013 Jul;98(7):1045-8. doi: 10.3324/haematol.2012.077669. Epub 2013 Apr 12.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Pennell DJ, Porter JB, Cappellini MD, Chan LL, El-Beshlawy A, Aydinok Y, Ibrahim H, Li CK, Viprakasit V, Elalfy MS, Kattamis A, Smith G, Habr D, Domokos G, Roubert B, Taher A. Continued improvement in myocardial T2* over two years of deferasirox therapy in beta-thalassemia major patients with cardiac iron overload. Haematologica. 2011 Jan;96(1):48-54. doi: 10.3324/haematol.2010.031468. Epub 2010 Nov 11.

ReferenceCitation: Lee JW, Yoon SS, Shen ZX, Ganser A, Hsu HC, Habr D, Domokos G, Roubert B, Porter JB; EPIC study investigators. Iron chelation therapy with deferasirox in patients with aplastic anemia: a subgroup analysis of 116 patients from the EPIC trial. Blood. 2010 Oct 7;116(14):2448-54. doi: 10.1182/blood-2010-01-261289. Epub 2010 Jun 21.

ReferenceCitation: Pennell DJ, Porter JB, Cappellini MD, El-Beshlawy A, Chan LL, Aydinok Y, Elalfy MS, Sutcharitchan P, Li CK, Ibrahim H, Viprakasit V, Kattamis A, Smith G, Habr D, Domokos G, Roubert B, Taher A. Efficacy of deferasirox in reducing and preventing cardiac iron overload in beta-thalassemia. Blood. 2010 Mar 25;115(12):2364-71. doi: 10.1182/blood-2009-04-217455. Epub 2009 Dec 8.

ReferenceCitation: Cappellini MD, Porter J, El-Beshlawy A, Li CK, Seymour JF, Elalfy M, Gattermann N, Giraudier S, Lee JW, Chan LL, Lin KH, Rose C, Taher A, Thein SL, Viprakasit V, Habr D, Domokos G, Roubert B, Kattamis A; EPIC Study Investigators. Tailoring iron chelation by iron intake and serum ferritin: the prospective EPIC study of deferasirox in 1744 patients with transfusion-dependent anemias. Haematologica. 2010 Apr;95(4):557-66. doi: 10.3324/haematol.2009.014696. Epub 2009 Nov 30.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Australia
Thailand
Turkey
France
Hong Kong
Denmark
Switzerland
Lebanon
Belgium
China
Malaysia
Egypt
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Israel


title: Effectiveness and Safety of Use of NovoSeven® in the Treatment of Active Variceal Bleeding in Patients With Advanced Cirrhosis

summary: This trial is conducted in Asia and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding.

ReferenceCitation: Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.

location_country:
Finland
Germany
Italy
Poland
United Kingdom
Hong Kong
Denmark
Austria
Spain
Taiwan
Czech Republic
France


title: A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

summary: This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. After completion of the 2 year study participants could participate in the optional 3 year open label extension phase (year 3 to 5).

ReferenceCitation: Khawaja MN, Bergman MJ, Yourish J, Pei J, Reiss W, Keystone E. Routine Assessment of Patient Index Data 3 and the American College of Rheumatology/European League Against Rheumatism Provisional Remission Definitions as Predictors of Radiographic Outcome in a Rheumatoid Arthritis Clinical Trial With Tocilizumab. Arthritis Care Res (Hoboken). 2017 May;69(5):609-615. doi: 10.1002/acr.23008. Epub 2017 Apr 7.

ReferenceCitation: Kremer JM, Blanco R, Halland AM, Brzosko M, Burgos-Vargas R, Mela CM, Rowell L, Fleischmann RM. Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial. Clin Exp Rheumatol. 2016 Jul-Aug;34(4):625-33. Epub 2016 Apr 15.

ReferenceCitation: Bay-Jensen AC, Platt A, Siebuhr AS, Christiansen C, Byrjalsen I, Karsdal MA. Early changes in blood-based joint tissue destruction biomarkers are predictive of response to tocilizumab in the LITHE study. Arthritis Res Ther. 2016 Jan 20;18:13. doi: 10.1186/s13075-015-0913-x.

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer-Nature

ReferenceCitation: Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.

ReferenceCitation: Siebuhr AS, Bay-Jensen AC, Leeming DJ, Plat A, Byrjalsen I, Christiansen C, van de Heijde D, Karsdal MA. Serological identification of fast progressors of structural damage with rheumatoid arthritis. Arthritis Res Ther. 2013 Aug 14;15(4):R86. doi: 10.1186/ar4266.

publisher_dissemination: Springer

ReferenceCitation: Fleischmann RM, Halland AM, Brzosko M, Burgos-Vargas R, Mela C, Vernon E, Kremer JM. Tocilizumab inhibits structural joint damage and improves physical function in patients with rheumatoid arthritis and inadequate responses to methotrexate: LITHE study 2-year results. J Rheumatol. 2013 Feb;40(2):113-26. doi: 10.3899/jrheum.120447. Epub 2013 Jan 15.

ReferenceCitation: Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.

ReferenceCitation: Kremer JM, Blanco R, Brzosko M, Burgos-Vargas R, Halland AM, Vernon E, Ambs P, Fleischmann R. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011 Mar;63(3):609-21. doi: 10.1002/art.30158.

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Italy
Poland
Norway
Denmark
Australia
Brazil
Switzerland
Mexico
United States
China
Spain
Greece
South Africa
Puerto Rico
France


title: An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

summary:
This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot.

Key objectives of the study are to:

Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,
Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,
Determine the blood levels of IM olanzapine depot in patients during long-term treatment

ReferenceCitation: McDonnell DP, Landry J, Detke HC. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study. Int Clin Psychopharmacol. 2014 Nov;29(6):322-31. doi: 10.1097/YIC.0000000000000038.

oa_colors: green hybrid

evidence: open (via page says license)

unpaywall_oa_status: hybrid

ReferenceCitation: Atkins S, Detke HC, McDonnell DP, Case MG, Wang S. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.

ReferenceCitation: Peuskens J, Porsdal V, Pecenak J, Handest P, D'yachkova Y, Brousil R, Deberdt W. Schizophrenia symptoms and functioning in patients receiving long-term treatment with olanzapine long-acting injection formulation: a pooled analysis. BMC Psychiatry. 2012 Aug 31;12:130. doi: 10.1186/1471-244X-12-130.

ReferenceCitation: McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45. doi: 10.1186/1471-244X-10-45.

ReferenceCitation: Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43. doi: 10.1186/1471-244X-10-43.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Poland
Argentina
Australia
Brazil
Croatia
France
Czech Republic
Portugal
Slovakia
Hungary
United States
Romania
Belgium
Puerto Rico
Italy
Sweden
Netherlands
Austria
Mexico
Spain
South Africa
Taiwan
Russian Federation
Israel

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


type: Registry Identifier

title: A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer

acronym: ExCel

summary:
RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen.

PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.

ReferenceCitation: Richardson H, Johnston D, Pater J, Goss P. The National Cancer Institute of Canada Clinical Trials Group MAP.3 trial: an international breast cancer prevention trial. Curr Oncol. 2007 Jun;14(3):89-96. doi: 10.3747/co.2007.117.

ReferenceCitation: Goss PE, Richardson H, Chlebowski R, Johnston D, Sarto GE, Maunsell E, Ingle JN, Ales-Martinez JE. National Cancer Institute of Canada Clinical Trials Group MAP.3 Trial: evaluation of exemestane to prevent breast cancer in postmenopausal women. Clin Breast Cancer. 2007 Dec;7(11):895-900. doi: 10.3816/CBC.2007.n.057. No abstract available.

ReferenceCitation: Moy B, Richardson H, Johnston D, et al.: NCIC CTG MAP.3: enrollment and study drug adherence of ethnic minority women in a breast cancer prevention trial. [Abstract] Breast Cancer Res Treat 106 (1): A-3048, S141-2, 2007.

ReferenceCitation: Richardson H, Johnston D, Goss PE, et al.: Participant characteristics on an international NCIC CTG breast cancer prevention trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-1531, 2007.

ReferenceCitation: Goss PE, Ingle JN, Alés-Martinez J, Cheung A, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson K, Martin L, Winquist E, Sarto G, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H. Exemestane for primary prevention of breast cancer in postmenopausal women: NCIC CTG MAP.3 - A randomized placebo-controlled clinical trial. J Clin Oncol 29[suppl; abstr LBA504], 2011.

ReferenceCitation: Goss PE, Ingle JN, Ales-Martinez JE, Cheung AM, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson KC, Martin LW, Winquist E, Sarto GE, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H; NCIC CTG MAP.3 Study Investigators. Exemestane for breast-cancer prevention in postmenopausal women. N Engl J Med. 2011 Jun 23;364(25):2381-91. doi: 10.1056/NEJMoa1103507. Epub 2011 Jun 4. Erratum In: N Engl J Med. 2011 Oct 6;365(14):1361.

ReferenceCitation: Maunsell E, Goss PE, Chlebowski RT, Ingle JN, Ales-Martinez JE, Sarto GE, Fabian CJ, Pujol P, Ruiz A, Cooke AL, Hendrix S, Thayer DW, Rowland KM, Dube P, Spadafora S, Pruthi S, Lickley L, Ellard SL, Cheung AM, Wactawski-Wende J, Gelmon KA, Johnston D, Hiltz A, Brundage M, Pater JL, Tu D, Richardson H. Quality of life in MAP.3 (Mammary Prevention 3): a randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer. J Clin Oncol. 2014 May 10;32(14):1427-36. doi: 10.1200/JCO.2013.51.2483. Epub 2014 Apr 7.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ipd_sharing: No

lead_sponsor: NCIC Clinical Trials Group

collaborators: Grupo Espanol de Investigacion del Cancer de Mama

location_country:
United States
Canada
Puerto Rico
France

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: Cancer Centre of Southeastern Ontario at Kingston

location_facility: Mid-Illinois Hematology and Oncology Associates, Ltd.

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

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: BCCA - Cancer Centre for the Southern Interior

location_facility: Whittingham Cancer Center at Norwalk Hospital

location_facility: University of Cincinnati, Barrett Cancer Centre

location_facility: Washington University School of Medicine

location_facility: Los Angeles Biomedical Research Institute

location_facility: Ottawa Health Research Institute - General Division

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: Univ. Health Network-Princess Margaret Hospital

location_facility: Univ. of Wisconsin Center for Women's Health and

location_facility: The University of Chicago Medical Center


title: A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease

summary: This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

location_country:
Germany
Italy
United Kingdom
Australia
Sweden
Netherlands
Belgium
United States
Spain
Greece
Canada
Puerto Rico
France


title: A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

summary: This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of first day of study drug treatment. Subjects will receive study drug (CC-5013) in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement (Appendix I) is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.

ReferenceCitation: Raza A, Reeves JA, Feldman EJ, Dewald GW, Bennett JM, Deeg HJ, Dreisbach L, Schiffer CA, Stone RM, Greenberg PL, Curtin PT, Klimek VM, Shammo JM, Thomas D, Knight RD, Schmidt M, Wride K, Zeldis JB, List AF. Phase 2 study of lenalidomide in transfusion-dependent, low-risk, and intermediate-1 risk myelodysplastic syndromes with karyotypes other than deletion 5q. Blood. 2008 Jan 1;111(1):86-93. doi: 10.1182/blood-2007-01-068833. Epub 2007 Sep 24.

lead_sponsor: Celgene Corporation

location_country:
France
Germany
Italy
United Kingdom
Denmark
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Greece
Russian Federation
Czech Republic

location_facility: Royal Marsden NHS Foundation Trust - Haematology

location_facility: AO Universitaria San Martino - hematooncology

location_facility: Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II

location_facility: Rush Presbyterian-St. Luke's Medical Center

location_facility: Universitätsklinikum Ulm - Klinik fur Innere Medizin III

location_facility: Peter McCallum Cancer Institute - Directorate of Cancer Medecine

location_facility: Hospital Clinic i Provincial de Barcelona - Hematology

location_facility: Charles university Hospital - Internal Medicine

location_facility: Royal Wolverhampton hospitals trust - Research and development

location_facility: Wayne State University School of Medicine

location_facility: Centre Hospitalier Départemental Vendée - Onco-hematologie

location_facility: Frankston Hospital-peninsula Health - Oncology Day Unit

location_facility: Hospital Germans Trias i Pujol - Hematology

location_facility: University of Rochester-James P. Wilmot Cancer Center

location_facility: University of Athens - Alexandra Hospital; Clinical Therapeutics

location_facility: Inselspital, Institut für Medizinische Onkologie

location_facility: St. Luke's Oncology and Hematology Associates

location_facility: Royal Prince Alfred Hospital - Institute of Haematology

location_facility: Princess Alexandra Hospital - Haematology

location_facility: Nottingham City Hospital - Centre for Clinical Haematology

location_facility: Karolinska University Hospital Huddinge - Center of hematology

location_facility: Russian Research Institute of Hematology and Blood Transfusion - Hematology

location_facility: Università degli Studi di Bologna - Policlinico S. Orsola - Hematology

location_facility: Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie

location_facility: Fakultní nemocnice Hradec Králové - Hematology

location_facility: Royal Bournemouth Hospital - Haematology

location_facility: Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II

location_facility: Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A

location_facility: Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology

location_facility: A.O.U. San Giovanni Battista - Hematology

location_facility: Ospedale San Luigi AO Luigi Gonzaga - Hematology

location_facility: Centre Hospitalier Lyon sud - Hematologie

location_facility: Hôpital Saint Louis - Immuno-hematologie

location_facility: St James's University Hospital - Haematology

location_facility: CHU Saint Antoine - Service des maladies du sang

location_facility: Karolinska University Hospital Solna- medicine

location_facility: St. Vincents Comprehensive Cancer Center

location_facility: Centre Hospitalier de la côte basque - Hematologie

location_facility: Universita degli Studi di Padova - Clinical & Experimental Medicine

location_facility: Freeman Hospital - Northern Centre for Cancer Care

location_facility: Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II

location_facility: Universitätsklinikum Essen, Klinik für Hämatologie

location_facility: Unità di Ematologia Arcispedale S. Maria Nuova - Haematology

location_facility: Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology

location_facility: Northwest Georgia Oncology - Wellstar Cancer Research

location_facility: Ospedale Guglielmo da Saliceto - hematooncology

location_facility: State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology

location_facility: Hôpital Bretonneau - Hématologie & Thérapie cellulaire

location_facility: King's College Hospital - Haematology Clinical Trials

location_facility: CHRU de Lille - Service des maladies du sang

location_facility: Cliniques Universitaires ULC de Mont-Godinne - Hematology

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: St Bartholomew's Hospital - Medical Oncology

location_facility: Hospital Universitario Marqués de Valdecilla - Hematology

location_facility: CHU Angers - Service des maladies du sang

location_facility: Royal Adelaide Hospital - SA Pathology Haematology

location_facility: Royal hallamshire Hospital - Haematology

location_facility: Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich

location_facility: The Alfred Hospital - malignant haematology & stem cell transplantation

location_facility: Hôpitaux Universitaire de Genève - Oncologie

location_facility: Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie

location_facility: Sahlgrenska Hospital, University of Goteborg - Hematology

location_facility: Wake Forest University School of Medicine

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: University of Miami- Sylvester Comp Cancer Center


title: The Value of Dexamethasone Versus Prednisolone During Induction and Maintenance Therapy of Prolonged Versus Conventional Duration of L-Asparaginase Therapy During Consolidation and Late Intensification, and of Corticosteroid + VCR Pulses During Maintenance in Acute Lymphoblastic Leukemia and Lymphoblastic Non-Hodgkin Lymphoma of Childhood

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy plus steroid therapy is more effective for acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus steroid therapy in treating children who have acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Ducassou S, Ferlay C, Bergeron C, Girard S, Laureys G, Pacquement H, Plantaz D, Lutz P, Vannier JP, Uyttebroeck A, Bertrand Y. Clinical presentation, evolution, and prognosis of precursor B-cell lymphoblastic lymphoma in trials LMT96, EORTC 58881, and EORTC 58951. Br J Haematol. 2011 Feb;152(4):441-51. doi: 10.1111/j.1365-2141.2010.08541.x. Epub 2011 Jan 7.

ReferenceCitation: Clappier E, Collette S, Grardel N, Girard S, Suarez L, Brunie G, Kaltenbach S, Yakouben K, Mazingue F, Robert A, Boutard P, Plantaz D, Rohrlich P, van Vlierberghe P, Preudhomme C, Otten J, Speleman F, Dastugue N, Suciu S, Benoit Y, Bertrand Y, Cave H; EORTC-CLG. NOTCH1 and FBXW7 mutations have a favorable impact on early response to treatment, but not on outcome, in children with T-cell acute lymphoblastic leukemia (T-ALL) treated on EORTC trials 58881 and 58951. Leukemia. 2010 Dec;24(12):2023-31. doi: 10.1038/leu.2010.205. Epub 2010 Sep 23.

ReferenceCitation: Clappier E, Collette S, Grardel N, et al.: Prognostic significance of NOTCH1 and FBXW7 mutations in childhood T-cell acute lymphoblastic leukemia (T-ALL): results from the EORTC Children Leukemia Group. [Abstract] Blood 114 (22): A-909, 2009.

ReferenceCitation: Renneville A, Kaltenbach S, Clappier E, Collette S, Micol JB, Nelken B, Lepelley P, Dastugue N, Benoit Y, Bertrand Y, Preudhomme C, Cave H. Wilms tumor 1 (WT1) gene mutations in pediatric T-cell malignancies. Leukemia. 2010 Feb;24(2):476-80. doi: 10.1038/leu.2009.221. Epub 2009 Oct 22. No abstract available.

ReferenceCitation: Cave H, Suciu S, Preudhomme C, Poppe B, Robert A, Uyttebroeck A, Malet M, Boutard P, Benoit Y, Mauvieux L, Lutz P, Mechinaud F, Grardel N, Mazingue F, Dupont M, Margueritte G, Pages MP, Bertrand Y, Plouvier E, Brunie G, Bastard C, Plantaz D, Vande Velde I, Hagemeijer A, Speleman F, Lessard M, Otten J, Vilmer E, Dastugue N; EORTC-CLG. Clinical significance of HOX11L2 expression linked to t(5;14)(q35;q32), of HOX11 expression, and of SIL-TAL fusion in childhood T-cell malignancies: results of EORTC studies 58881 and 58951. Blood. 2004 Jan 15;103(2):442-50. doi: 10.1182/blood-2003-05-1495. Epub 2003 Sep 22.

ReferenceCitation: Mirebeau D, Acquaviva C, Suciu S, Bertin R, Dastugue N, Robert A, Boutard P, Mechinaud F, Plouvier E, Otten J, Vilmer E, Cave H; EORTC-CLG. The prognostic significance of CDKN2A, CDKN2B and MTAP inactivation in B-lineage acute lymphoblastic leukemia of childhood. Results of the EORTC studies 58881 and 58951. Haematologica. 2006 Jul;91(7):881-5.

ReferenceCitation: Cavé H, Suciu S, Preudhomme C, et al.: HOX11L2 expression linked to t(5;14)(q35;q32) is not associated with poor prognosis in childhood T-ALL treated in EORTC trials 58 881 and 58 951. [Abstract] Blood 100(11 pt 1): A-576, 153a, 2002.

ReferenceCitation: De Moerloose B, Suciu S, Bertrand Y, Mazingue F, Robert A, Uyttebroeck A, Yakouben K, Ferster A, Margueritte G, Lutz P, Munzer M, Sirvent N, Norton L, Boutard P, Plantaz D, Millot F, Philippet P, Baila L, Benoit Y, Otten J; Children's Leukemia Group of the European Organisation for Research and Treatment of Cancer (EORTC). Improved outcome with pulses of vincristine and corticosteroids in continuation therapy of children with average risk acute lymphoblastic leukemia (ALL) and lymphoblastic non-Hodgkin lymphoma (NHL): report of the EORTC randomized phase 3 trial 58951. Blood. 2010 Jul 8;116(1):36-44. doi: 10.1182/blood-2009-10-247965. Epub 2010 Apr 20.

ReferenceCitation: Bertrand Y, Suciu S, Benoit Y, et al.: Dexamethasone(DEX)(6mg/sm/d) and prednisolone(PRED)(60mg/sm/d) in induction therapy of childhood ALL are equally effective: results of the 2nd interim analysis of EORTC trial 58951. [Abstract] Blood 112 (11): A-8, 2008.

ReferenceCitation: Sirvent N, Suciu S, Benoit Y, et al.: Prognostic significance of central nervous system (CNS) status of children with acute lymphoblastic leukemia (ALL) treated without cranial irradiation: results of European Organization for Research and Treatment of Cancer (EORTC) Children Leukemia Group study 58951. [Abstract] Blood 112 (11): A-303, 2008.

ReferenceCitation: Bertrand Y, Goutagny MP, Poulat AL, et al.: Asparagine depletion, safety and antibody production after E coli asparaginase treatment in children with newly diagnosed acute lymphoblastic leukaemia treated with EORTC 58951 protocol: a single center report. [Abstract] Blood 110 (11): A-4337, 2007.

ReferenceCitation: Sirvent N, Suciu S, De Moerloose B, Ferster A, Mazingue F, Plat G, Yakouben K, Uyttebroeck A, Paillard C, Costa V, Simon P, Pluchart C, Poiree M, Minckes O, Millot F, Freycon C, Maes P, Hoyoux C, Cave H, Rohrlich P, Bertrand Y, Benoit Y; Children's Leukemia Group of the European Organisation for Research Treatment of Cancer. CNS-3 status remains an independent adverse prognosis factor in children with acute lymphoblastic leukemia (ALL) treated without cranial irradiation: Results of EORTC Children Leukemia Group study 58951. Arch Pediatr. 2021 Jul;28(5):411-416. doi: 10.1016/j.arcped.2021.04.009. Epub 2021 May 24.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_normalized: HAL

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

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

ReferenceCitation: Mondelaers V, Suciu S, De Moerloose B, Ferster A, Mazingue F, Plat G, Yakouben K, Uyttebroeck A, Lutz P, Costa V, Sirvent N, Plouvier E, Munzer M, Poiree M, Minckes O, Millot F, Plantaz D, Maes P, Hoyoux C, Cave H, Rohrlich P, Bertrand Y, Benoit Y; Children-s Leukemia Group (CLG) of the European Organization for Research and Treatment of Cancer (EORTC). Prolonged versus standard native E. coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma: final results of the EORTC-CLG randomized phase III trial 58951. Haematologica. 2017 Oct;102(10):1727-1738. doi: 10.3324/haematol.2017.165845. Epub 2017 Jul 27.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
archive.ugent.be
irua

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central;archive.ugent.be;irua

ReferenceCitation: Ghazavi F, Clappier E, Lammens T, Suciu S, Caye A, Zegrari S, Bakkus M, Grardel N, Benoit Y, Bertrand Y, Minckes O, Costa V, Ferster A, Mazingue F, Plat G, Plouvier E, Poiree M, Uyttebroeck A, van der Werff-Ten Bosch J, Yakouben K, Helsmoortel H, Meul M, Van Roy N, Philippe J, Speleman F, Cave H, Van Vlierberghe P, De Moerloose B. CD200/BTLA deletions in pediatric precursor B-cell acute lymphoblastic leukemia treated according to the EORTC-CLG 58951 protocol. Haematologica. 2015 Oct;100(10):1311-9. doi: 10.3324/haematol.2015.126953. Epub 2015 Jul 2.

ReferenceCitation: Clappier E, Grardel N, Bakkus M, Rapion J, De Moerloose B, Kastner P, Caye A, Vivent J, Costa V, Ferster A, Lutz P, Mazingue F, Millot F, Plantaz D, Plat G, Plouvier E, Poiree M, Sirvent N, Uyttebroeck A, Yakouben K, Girard S, Dastugue N, Suciu S, Benoit Y, Bertrand Y, Cave H; European Organisation for Research and Treatment of Cancer, Children's Leukemia Group (EORTC-CLG). IKZF1 deletion is an independent prognostic marker in childhood B-cell precursor acute lymphoblastic leukemia, and distinguishes patients benefiting from pulses during maintenance therapy: results of the EORTC Children's Leukemia Group study 58951. Leukemia. 2015 Nov;29(11):2154-61. doi: 10.1038/leu.2015.134. Epub 2015 Jun 8.

ReferenceCitation: Domenech C, Suciu S, De Moerloose B, Mazingue F, Plat G, Ferster A, Uyttebroeck A, Sirvent N, Lutz P, Yakouben K, Munzer M, Rohrlich P, Plantaz D, Millot F, Philippet P, Dastugue N, Girard S, Cave H, Benoit Y, Bertrandfor Y; Children's Leukemia Group (CLG) of European Organisation for Research and Treatment of Cancer (EORTC). Dexamethasone (6 mg/m2/day) and prednisolone (60 mg/m2/day) were equally effective as induction therapy for childhood acute lymphoblastic leukemia in the EORTC CLG 58951 randomized trial. Haematologica. 2014 Jul;99(7):1220-7. doi: 10.3324/haematol.2014.103507. Epub 2014 Apr 11.

ReferenceCitation: Dastugue N, Suciu S, Plat G, Speleman F, Cave H, Girard S, Bakkus M, Pages MP, Yakouben K, Nelken B, Uyttebroeck A, Gervais C, Lutz P, Teixeira MR, Heimann P, Ferster A, Rohrlich P, Collonge MA, Munzer M, Luquet I, Boutard P, Sirvent N, Karrasch M, Bertrand Y, Benoit Y. Hyperdiploidy with 58-66 chromosomes in childhood B-acute lymphoblastic leukemia is highly curable: 58951 CLG-EORTC results. Blood. 2013 Mar 28;121(13):2415-23. doi: 10.1182/blood-2012-06-437681. Epub 2013 Jan 15.

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

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Hopital Universitaire Des Enfants Reine Fabiola


title: An Open Randomised Comparative Multicentre Study of the Efficacy, Safety and Toleration of Voriconazole Versus Amphotericin-B in the Treatment of Acute Invasive Aspergillosis in Immunocompromised Patients

summary:
RATIONALE: Antifungal therapy with voriconazole or amphotericin B may be an effective treatment for aspergillosis. It is not yet known whether voriconazole is more effective than amphotericin B in treating patients with aspergillosis.

PURPOSE: Randomized phase III trial to compare the effectiveness of voriconazole with amphotericin B in treating patients with aspergillosis.

primary_purpose: Supportive Care

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

location_country:
Germany
Ireland
Italy
Hungary
Israel
United Kingdom
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Luxembourg
France

location_facility: Virchow Klinikum Humboldt Universitaet Berlin

location_facility: Hospital Clinic y Provincial de Barcelona

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: National Institute of Haematology and Immunology

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: University and I.R.C.C.S. Policlinico San Matteo

location_facility: Klinikum Rechts Der Isar/Technische Universitaet Muenchen

location_facility: Birmingham Heartlands and Solihull NHS Trust (Teaching)


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Amyloid Depleter ALXN2220 in Adult Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

acronym: DepleTTR-CM

summary: The primary objective of this study is to assess the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the composite endpoint of all-cause mortality (ACM) and total cardiovascular (CV) clinical events.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

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

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Switzerland
United States
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel

status_simplified: Ongoing


title: A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma (eVOLVE-Meso)

acronym: eVOLVE-Meso

summary: This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.

status: Recruiting

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

location_country:
Germany
Poland
Australia
Brazil
Japan
Turkey
Canada
France
Denmark
Switzerland
United States
Belgium
China
Italy
Norway
United Kingdom
Netherlands
Korea, Republic of
Spain
South Africa
Taiwan


title: A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

summary: The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

location_country:
Finland
Germany
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Portugal
United States
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Panama
Taiwan
Sweden


title: Outcome of Patients With Severe Functional Tricuspid Regurgitation

acronym: TRIGISTRY

summary:
Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common, especially in ageing populations, and affect 4% of the population >75 years old, totaling approximately 1.6 million in the US and 3 million in Europe. TR is associated with an increased risk of mortality and morbidity. Contrasting with TR prevalence and the magnitude of the problem, the vast majority of patients are medically treated with diuretics to relieve their symptoms and a curative surgical treatment for isolated severe TR is seldom performed. Reluctance to perform an ITVS can be explained in the one hand by the limited evidence that TR correction improves outcomes and on the other hand, ITVS is associated to high observed in-hospital mortality rates (≈ 10% remarkably consistent in most series across the literature). Severity of the clinical presentation is the main predictor of outcome after surgery. The TRI-SCORE, is a dedicated, simple and accurate risk score model to predict in-hospital mortality after ITVS that could guide the clinical decision-making process at the individual level. Excellent outcomes can be achieved when patients present with low TRI-SCORE. These results suggest adopting a more pro-active approach for TV interventions, and to intervene earlier in the course of the disease in patients with severe isolated TR, irrespective of TR mechanism / etiology, before the occurrence of advanced / irreversible consequences such as severe RV dilatation / dysfunction, renal and liver failure, and intractable heart failure. Recently transcatheter tricuspid valve interventions (TTVI) have emerged recently as a less invasive option to surgery to cure patients with TR.

What is the best treatment between medical, surgical or transcatheter therapy to consider and the best timing for each patient are not clearly defined. The aim of the study is to compare outcome of patients with significant functional TR according to medical, transcatheter or surgical treatment after matching per TRISCORE.

status: Enrolling by invitation

study_type: Observational

time_perspective: Retrospective

ipd_sharing_description: we have a steering committee which will organize the publication plan

lead_sponsor: Ottawa Heart Institute Research Corporation

location_country:
Germany
Italy
Israel
Netherlands
Austria
Switzerland
United States
Spain
Canada
France

location_facility: Cardiology Department, Centre Cardiologique du Nord

location_facility: Department of Cardiology, Bichat Claude Bernard Hospital

location_facility: APHM, La Timone Hospital, Cardiology Department

location_facility: Department of Cardiovascular Surgery and Transplantation, Louis Pradel Cardiovascular Hospital

location_facility: Department of Cardiology, University Hospital of Nancy-Brabois

intervention_type: Procedure


title: A Prospective, Non-interventional, Multi-country Cohort Study of the Effectiveness and Safety of Filgotinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis

acronym: GALOCEAN

summary: To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.

time_perspective: Prospective

lead_sponsor: Galapagos NV

location_country:
Germany
Norway
United Kingdom
Netherlands
Austria
Belgium
France

location_facility: Royal Devon University Healthcare NHS Foundation trust

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen

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


title: A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR)

acronym: AVANZAR

summary: This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

location_country:
Germany
Poland
Japan
Brazil
Vietnam
Turkey
Canada
France
Hungary
Denmark
United States
India
China
Peru
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Sweden


title: A Phase I/III Randomized, Double Blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre Exposure Prophylaxis of COVID 19 in Participants With Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19

acronym: SUPERNOVA

summary:
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.

The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061.

Sub-study:

This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19.

status: Active, not recruiting

ReferenceCitation: Al Jurdi A, Morena L, Cote M, Bethea E, Azzi J, Riella LV. Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave. Am J Transplant. 2022 Dec;22(12):3130-3136. doi: 10.1111/ajt.17128. Epub 2022 Jul 1.

ReferenceCitation: Alhumaid S, Al Mutair A, Al Alawi Z, Rabaan AA, Tirupathi R, Alomari MA, Alshakhes AS, Alshawi AM, Ahmed GY, Almusabeh HM, Alghareeb TT, Alghuwainem AA, Alsulaiman ZA, Alabdulmuhsin MA, AlBuwaidi EA, Dukhi AKB, Mufti HN, Al-Qahtani M, Dhama K, Al-Tawfiq JA, Al-Omari A. Anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines: a systematic review and meta-analysis. Allergy Asthma Clin Immunol. 2021 Oct 16;17(1):109. doi: 10.1186/s13223-021-00613-7.

ReferenceCitation: Bosch BJ, van der Zee R, de Haan CA, Rottier PJ. The coronavirus spike protein is a class I virus fusion protein: structural and functional characterization of the fusion core complex. J Virol. 2003 Aug;77(16):8801-11. doi: 10.1128/jvi.77.16.8801-8811.2003.

ReferenceCitation: CDC 2021 CDC (Centers for Disease Control and Prevention). General Best Practice Guidelines for Immunization: Altered Immunocompetence. Available from: https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html. Accessed 23 May 2022.

ReferenceCitation: Case JB, Mackin S, Errico JM, Chong Z, Madden EA, Whitener B, Guarino B, Schmid MA, Rosenthal K, Ren K, Dang HV, Snell G, Jung A, Droit L, Handley SA, Halfmann PJ, Kawaoka Y, Crowe JE Jr, Fremont DH, Virgin HW, Loo YM, Esser MT, Purcell LA, Corti D, Diamond MS. Resilience of S309 and AZD7442 monoclonal antibody treatments against infection by SARS-CoV-2 Omicron lineage strains. Nat Commun. 2022 Jul 2;13(1):3824. doi: 10.1038/s41467-022-31615-7.

ReferenceCitation: Dall'Acqua WF, Kiener PA, Wu H. Properties of human IgG1s engineered for enhanced binding to the neonatal Fc receptor (FcRn). J Biol Chem. 2006 Aug 18;281(33):23514-24. doi: 10.1074/jbc.M604292200. Epub 2006 Jun 21.

ReferenceCitation: Fact Sheet EUA Bebtelovimab 2022 US Food and Drug Administration. Fact Sheet For Healthcare Providers: Emergency Use Authorization for Bebtelovimab, March 2022. Available at: https://www.fda.gov/media/156152/download. Accessed 23 May 2022.

ReferenceCitation: Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Hebner CM, Sager J, Mogalian E, Tipple C, Peppercorn A, Alexander E, Pang PS, Free A, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. N Engl J Med. 2021 Nov 18;385(21):1941-1950. doi: 10.1056/NEJMoa2107934. Epub 2021 Oct 27.

ReferenceCitation: Harpaz R, Dahl RM, Dooling KL. Prevalence of Immunosuppression Among US Adults, 2013. JAMA. 2016 Dec 20;316(23):2547-2548. doi: 10.1001/jama.2016.16477. No abstract available.

ReferenceCitation: Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.

ReferenceCitation: Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, Yuan Y, Seegobin S, Ellery A, Levinson DJ, Ambery P, Arends RH, Beavon R, Dey K, Garbes P, Kelly EJ, Koh GCKW, Near KA, Padilla KW, Psachoulia K, Sharbaugh A, Streicher K, Pangalos MN, Esser MT; PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022 Jun 9;386(23):2188-2200. doi: 10.1056/NEJMoa2116620. Epub 2022 Apr 20.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Li F. Structure, Function, and Evolution of Coronavirus Spike Proteins. Annu Rev Virol. 2016 Sep 29;3(1):237-261. doi: 10.1146/annurev-virology-110615-042301. Epub 2016 Aug 25.

ReferenceCitation: Loo YM, McTamney PM, Arends RH, Abram ME, Aksyuk AA, Diallo S, Flores DJ, Kelly EJ, Ren K, Roque R, Rosenthal K, Streicher K, Tuffy KM, Bond NJ, Cornwell O, Bouquet J, Cheng LI, Dunyak J, Huang Y, Rosenbaum AI, Pilla Reddy V, Andersen H, Carnahan RH, Crowe JE Jr, Kuehne AI, Herbert AS, Dye JM, Bright H, Kallewaard NL, Pangalos MN, Esser MT. The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans. Sci Transl Med. 2022 Mar 9;14(635):eabl8124. doi: 10.1126/scitranslmed.abl8124. Epub 2022 Mar 9.

ReferenceCitation: Lusvarghi S, Pollett SD, Neerukonda SN, Wang W, Wang R, Vassell R, Epsi NJ, Fries AC, Agan BK, Lindholm DA, Colombo CJ, Mody R, Ewers EC, Lalani T, Ganesan A, Goguet E, Hollis-Perry M, Coggins SA, Simons MP, Katzelnick LC, Wang G, Tribble DR, Bentley L, Eakin AE, Broder CC, Erlandson KJ, Laing ED, Burgess TH, Mitre E, Weiss CD. SARS-CoV-2 BA.1 variant is neutralized by vaccine booster-elicited serum but evades most convalescent serum and therapeutic antibodies. Sci Transl Med. 2022 May 18;14(645):eabn8543. doi: 10.1126/scitranslmed.abn8543. Epub 2022 May 18.

ReferenceCitation: Maltezou HC, Anastassopoulou C, Hatziantoniou S, Poland GA, Tsakris A. Anaphylaxis rates associated with COVID-19 vaccines are comparable to those of other vaccines. Vaccine. 2022 Jan 21;40(2):183-186. doi: 10.1016/j.vaccine.2021.11.066. Epub 2021 Nov 27.

ReferenceCitation: NIH 2017 NIH. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Available at: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_50. Published 2017. Accessed 23 May 2022.

ReferenceCitation: Oganesyan V, Gao C, Shirinian L, Wu H, Dall'Acqua WF. Structural characterization of a human Fc fragment engineered for lack of effector functions. Acta Crystallogr D Biol Crystallogr. 2008 Jun;64(Pt 6):700-4. doi: 10.1107/S0907444908007877. Epub 2008 May 14.

ReferenceCitation: Parker EPK, Desai S, Marti M, Nohynek H, Kaslow DC, Kochhar S, O'Brien KL, Hombach J, Wilder-Smith A. Response to additional COVID-19 vaccine doses in people who are immunocompromised: a rapid review. Lancet Glob Health. 2022 Mar;10(3):e326-e328. doi: 10.1016/S2214-109X(21)00593-3. No abstract available.

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ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Germany
Poland
Australia
Thailand
Vietnam
Canada
France
Denmark
United States
Belgium
China
Malaysia
United Kingdom
Singapore
United Arab Emirates
Korea, Republic of
Spain
Taiwan
Israel

intervention_type: Biological


title: A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

summary: The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Portugal
Denmark
United States
India
Belgium
China
Malaysia
Italy
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Israel

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Saint Luke's Hospital - Saint Luke's Cancer Specialists

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Ospedale Santa Chiara AO Universitaria Pisana

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: First affiliated Hospital of Zhejiang University

location_facility: Institut Catala d'Oncologia L'Hospitalet

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: The Third Xiangya Hospital, Central South University

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: Fujian Meidical University Union Hospital

location_facility: Ankara Gulhane Training and Research Hospital

location_facility: Shengjing Hospital of China Medical University

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

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

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

location_facility: Niigata University Medical & Dental Hospital

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Hospitais Integradaos da Gavea S/A - DF Star

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: First Affiliated Hospital of Guangxi Medical University

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: A.O. Universitaria Senese- Ospedale Santa Maria alle Scotte

location_facility: The First Bethune Hospital of Jilin University

location_facility: National Hospital Organization Okayama Medical Center

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Hospital Universitario Central de Asturias

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: 'G. Papanikolaou' Hospital of Thessaloniki

location_facility: ASUI Santa Maria della Misericordia di Udine

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia

location_facility: Institute of Hematology & Blood Diseases Hospital

location_facility: Champalimaud Foundation Champalimaud Centre

location_facility: Harbin medical university cancer hospital

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)


title: A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal and Open-label Extension Study Followed by Long-term Open-label Treatment Cycles to Assess the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Chronic Spontaneous Urticaria Patients Who Completed the Preceding Remibrutinib Phase 3 Studies

summary:
The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 studies.

This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.

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

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Czechia
Canada
France
Colombia
Slovakia
Hungary
Denmark
Switzerland
United States
China
Malaysia
Puerto Rico
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation