title: Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) An Imaging Study in Patients With Unstable Atherosclerotic Lesions

summary: PROSPECT is a multi-center prospective registry of Acute Coronary Syndromes (ACS) patients with single or double vessel coronary artery disease. Approximately 700 patients with ACS will be enrolled into the study at sites in the United States and European Union.

ReferenceCitation: Stone Gregg W, Lansky A.; Carlier S. et. al. A prospective, natural history study of multimodality invasive imaging to characterize vulnerable plaque: First report of the baseline findings from the PROSPECT trial. Journal of the American College of Cardiology 49(9, Suppl. B): p 19B MAR 6 2007.

ReferenceCitation: Ostuka Masato; Bruining N.; Van Pelt, N.; et.al. Three-dimensional quantification of coronary plaque burden by 64-slice computed tomography: A PROS-PECT-MSCT substudy. Journal of the American College of Cardiology 49(9, Suppl. A): p 114A MAR 6 2007

ReferenceCitation: Tanaka K; Carlier SG; Mintz GS; et.al. High risk fibroatheroma lesions are remote from the minimal lumen area site: A virtual histology IVUS analysis from the PROSPECT study AMERICAN JOURNAL OF CARDIOLOGY, 2006, V 98, N8A, P 94M-94M.

ReferenceCitation: Farhan S, Redfors B, Maehara A, McAndrew T, Ben-Yehuda O, De Bruyne B, Mehran R, Vogel B, Giustino G, Serruys PW, Mintz GS, Stone GW. Relationship between insulin resistance, coronary plaque, and clinical outcomes in patients with acute coronary syndromes: an analysis from the PROSPECT study. Cardiovasc Diabetol. 2021 Jan 7;20(1):10. doi: 10.1186/s12933-020-01207-0.

family: Farhan

full_name: Serdar Farhan

given: Serdar

family: Redfors

full_name: Björn Redfors

given: Björn

family: Maehara

full_name: Akiko Maehara

given: Akiko

family: McAndrew

full_name: Thomas McAndrew

given: Thomas

family: Ben-Yehuda

full_name: Ori Ben-Yehuda

given: Ori

family: De Bruyne

full_name: Bernard De Bruyne

family: Mehran

full_name: Roxana Mehran

given: Roxana

family: Vogel

full_name: Birgit Vogel

given: Birgit

family: Giustino

full_name: Gennaro Giustino

given: Gennaro

family: Serruys

full_name: Patrick W. Serruys

given: Patrick W.

family: Mintz

full_name: Gary S. Mintz

given: Gary S.

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

currency_apc_doaj: GBP

journal_name: Cardiovascular Diabetology

oa_colors: green gold

evidence: oa journal (via doaj)

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Farhan S, Redfors B, Maehara A, McAndrew T, Ben-Yehuda O, De Bruyne B, Mehran R, Giustino G, Kirtane AJ, Serruys PW, Mintz GS, Stone GW. Impact of Pre-Diabetes on Coronary Plaque Composition and Clinical Outcome in Patients With Acute Coronary Syndromes: An Analysis From the PROSPECT Study. JACC Cardiovasc Imaging. 2019 Apr;12(4):733-741. doi: 10.1016/j.jcmg.2017.06.023. Epub 2017 Oct 18.

ReferenceCitation: Zheng B, Mintz GS, McPherson JA, De Bruyne B, Farhat NZ, Marso SP, Serruys PW, Stone GW, Maehara A. Predictors of Plaque Rupture Within Nonculprit Fibroatheromas in Patients With Acute Coronary Syndromes: The PROSPECT Study. JACC Cardiovasc Imaging. 2015 Oct;8(10):1180-1187. doi: 10.1016/j.jcmg.2015.06.014.

ReferenceCitation: Goto K, Mintz GS, Litherland C, Lansky AJ, Weisz G, McPherson JA, De Bruyne B, Serruys PW, Stone GW, Maehara A. Lumen Measurements From Quantitative Coronary Angiography and IVUS: A PROSPECT Substudy. JACC Cardiovasc Imaging. 2016 Aug;9(8):1011-3. doi: 10.1016/j.jcmg.2015.07.006. Epub 2015 Sep 9.

ReferenceCitation: Xie Y, Mintz GS, Yang J, Doi H, Iñiguez A, Dangas GD, Serruys PW, McPherson JA, Wennerblom B, Xu K, Weisz G, Stone GW, Maehara A. Clinical outcome of nonculprit plaque ruptures in patients with acute coronary syndrome in the PROSPECT study. JACC Cardiovasc Imaging. 2014 Apr;7(4):397-405. doi: 10.1016/j.jcmg.2013.10.010. Epub 2014 Mar 13.

title: Clinical Outcome of Nonculprit Plaque Ruptures in Patients With Acute Coronary Syndrome in the PROSPECT Study

ReferenceCitation: Inaba S, Mintz GS, Farhat NZ, Fajadet J, Dudek D, Marzocchi A, Templin B, Weisz G, Xu K, de Bruyne B, Serruys PW, Stone GW, Maehara A. Impact of positive and negative lesion site remodeling on clinical outcomes: insights from PROSPECT. JACC Cardiovasc Imaging. 2014 Jan;7(1):70-8. doi: 10.1016/j.jcmg.2013.10.007.

title: Impact of Positive and Negative Lesion Site Remodeling on Clinical Outcomes

ReferenceCitation: Dohi T, Mintz GS, McPherson JA, de Bruyne B, Farhat NZ, Lansky AJ, Mehran R, Weisz G, Xu K, Stone GW, Maehara A. Non-fibroatheroma lesion phenotype and long-term clinical outcomes: a substudy analysis from the PROSPECT study. JACC Cardiovasc Imaging. 2013 Aug;6(8):908-16. doi: 10.1016/j.jcmg.2013.04.008. Epub 2013 Jul 10.

title: Non-Fibroatheroma Lesion Phenotype and Long-Term Clinical Outcomes

ReferenceCitation: Golinvaux N, Maehara A, Mintz GS, Lansky AJ, McPherson J, Farhat N, Marso S, de Bruyne B, Serruys PW, Templin B, Cheong WF, Aaskar R, Fahy M, Mehran R, Leon M, Stone GW. An intravascular ultrasound appraisal of atherosclerotic plaque distribution in diseased coronary arteries. Am Heart J. 2012 Apr;163(4):624-31. doi: 10.1016/j.ahj.2011.07.031.

ReferenceCitation: Sanidas EA, Mintz GS, Maehara A, Cristea E, Wennerblom B, Iñiguez A, Fajadet J, Fahy M, Dressler O, Weisz G, Templin B, Zhang Z, Lansky AJ, de Bruyne B, Serruys P, Stone GW. Adverse cardiovascular events arising from atherosclerotic lesions with and without angiographic disease progression. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S95-S105. doi: 10.1016/j.jcmg.2011.08.024.

title: Adverse Cardiovascular Events Arising From Atherosclerotic Lesions With and Without Angiographic Disease Progression

ReferenceCitation: Brener SJ, Mintz GS, Cristea E, Weisz G, Maehara A, McPherson JA, Marso SP, Farhat N, Botker HE, Dressler O, Xu K, Templin B, Zhang Z, Lansky AJ, de Bruyne B, Serruys PW, Stone GW. Characteristics and clinical significance of angiographically mild lesions in acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S86-94. doi: 10.1016/j.jcmg.2011.12.007.

title: Characteristics and Clinical Significance of Angiographically Mild Lesions in Acute Coronary Syndromes

ReferenceCitation: McPherson JA, Maehara A, Weisz G, Mintz GS, Cristea E, Mehran R, Foster M, Verheye S, Rabbani L, Xu K, Fahy M, Templin B, Zhang Z, Lansky AJ, de Bruyne B, Serruys PW, Stone GW. Residual plaque burden in patients with acute coronary syndromes after successful percutaneous coronary intervention. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S76-85. doi: 10.1016/j.jcmg.2012.01.005.

title: Residual Plaque Burden in Patients With Acute Coronary Syndromes After Successful Percutaneous Coronary Intervention

ReferenceCitation: Lansky AJ, Ng VG, Maehara A, Weisz G, Lerman A, Mintz GS, De Bruyne B, Farhat N, Niess G, Jankovic I, Lazar D, Xu K, Fahy M, Serruys PW, Stone GW. Gender and the extent of coronary atherosclerosis, plaque composition, and clinical outcomes in acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S62-72. doi: 10.1016/j.jcmg.2012.02.003.

title: Gender and the Extent of Coronary Atherosclerosis, Plaque Composition, and Clinical Outcomes in Acute Coronary Syndromes

ReferenceCitation: Baber U, Stone GW, Weisz G, Moreno P, Dangas G, Maehara A, Mintz GS, Cristea E, Fahy M, Xu K, Lansky AJ, Wennerblom B, Mathey DG, Templin B, Zhang Z, Serruys PW, Mehran R. Coronary plaque composition, morphology, and outcomes in patients with and without chronic kidney disease presenting with acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S53-61. doi: 10.1016/j.jcmg.2011.12.008.

title: Coronary Plaque Composition, Morphology, and Outcomes in Patients With and Without Chronic Kidney Disease Presenting With Acute Coronary Syndromes

ReferenceCitation: Marso SP, Mercado N, Maehara A, Weisz G, Mintz GS, McPherson J, Schiele F, Dudek D, Fahy M, Xu K, Lansky A, Templin B, Zhang Z, de Bruyne B, Serruys PW, Stone GW. Plaque composition and clinical outcomes in acute coronary syndrome patients with metabolic syndrome or diabetes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S42-52. doi: 10.1016/j.jcmg.2012.01.008.

title: Plaque Composition and Clinical Outcomes in Acute Coronary Syndrome Patients With Metabolic Syndrome or Diabetes

ReferenceCitation: Papadopoulou SL, Neefjes LA, Garcia-Garcia HM, Flu WJ, Rossi A, Dharampal AS, Kitslaar PH, Mollet NR, Veldhof S, Nieman K, Stone GW, Serruys PW, Krestin GP, de Feyter PJ. Natural history of coronary atherosclerosis by multislice computed tomography. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S28-37. doi: 10.1016/j.jcmg.2012.01.009.

title: Natural History of Coronary Atherosclerosis by Multislice Computed Tomography

ReferenceCitation: Brugaletta S, Garcia-Garcia HM, Serruys PW, Maehara A, Farooq V, Mintz GS, de Bruyne B, Marso SP, Verheye S, Dudek D, Hamm CW, Farhat N, Schiele F, McPherson J, Lerman A, Moreno PR, Wennerblom B, Fahy M, Templin B, Morel MA, van Es GA, Stone GW. Relationship between palpography and virtual histology in patients with acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S19-27. doi: 10.1016/j.jcmg.2011.02.026.

title: Relationship Between Palpography and Virtual Histology in Patients With Acute Coronary Syndromes

ReferenceCitation: Wykrzykowska JJ, Mintz GS, Garcia-Garcia HM, Maehara A, Fahy M, Xu K, Inguez A, Fajadet J, Lansky A, Templin B, Zhang Z, de Bruyne B, Weisz G, Serruys PW, Stone GW. Longitudinal distribution of plaque burden and necrotic core-rich plaques in nonculprit lesions of patients presenting with acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S10-8. doi: 10.1016/j.jcmg.2012.01.006.

title: Longitudinal Distribution of Plaque Burden and Necrotic Core–Rich Plaques in Nonculprit Lesions of Patients Presenting With Acute Coronary Syndromes

ReferenceCitation: Maehara A, Cristea E, Mintz GS, Lansky AJ, Dressler O, Biro S, Templin B, Virmani R, de Bruyne B, Serruys PW, Stone GW. Definitions and methodology for the grayscale and radiofrequency intravascular ultrasound and coronary angiographic analyses. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S1-9. doi: 10.1016/j.jcmg.2011.11.019.

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

title: Definitions and Methodology for the Grayscale and Radiofrequency Intravascular Ultrasound and Coronary Angiographic Analyses

ReferenceCitation: Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358. Erratum in: N Engl J Med. 2011 Nov 24;365(21):2040.

title: A Prospective Natural-History Study of Coronary Atherosclerosis

ReferenceCitation: Oviedo C, Maehara A, Mintz GS, Araki H, Choi SY, Tsujita K, Kubo T, Doi H, Templin B, Lansky AJ, Dangas G, Leon MB, Mehran R, Tahk SJ, Stone GW, Ochiai M, Moses JW. Intravascular ultrasound classification of plaque distribution in left main coronary artery bifurcations: where is the plaque really located? Circ Cardiovasc Interv. 2010 Apr;3(2):105-12. doi: 10.1161/CIRCINTERVENTIONS.109.906016. Epub 2010 Mar 2.

name: From the Cardiovascular Research Foundation and Columbia University Medical Center (C.O., A.M., G.S.M., S.-Y.C., K.T., T.K., H.D., A.J.L., G.D., M.B.L., R.M., G.W.S., J.W.M.), New York, NY; Showa University Northern Yokohama Hospital (H.A., M.O.), Yokohama, Japan; Abbott Vascular (B.T.), Santa Clara, Calif; and Ajou University Hospital (S.J.T.), Suwon, Korea.

title: Intravascular Ultrasound Classification of Plaque Distribution in Left Main Coronary Artery Bifurcations

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

location_facility: St. Vincent's Hospital and Health Care Center

location_facility: Universitäres Herz- und Gefäßzentrum Hamburg

location_facility: St. Joseph's Hospital and Medical Center


title: CoreValve® ADVANCE Direct Aortic Study

summary: This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Medtronic Bakken Research Center

location_country:
Italy
Netherlands
France
Czechia
Germany
United Kingdom

location_facility: Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital

location_facility: Azienda spedaliera Niguarda Ca' Granda Milano

location_facility: Azienda spedaliera Spedali Civili Di Brescia

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: BREATHER (PENTA 16) Short-Cycle Therapy (SCT) (5 Days on/2 Days Off) in Young People With Chronic HIV-infection

acronym: BREATHER

summary:
The overall aim of the BREATHER trial is to evaluate the role of Short-Cycle Therapy (SCT) in the management of HIV-infected young people who have responded well to antiretroviral therapy (ART) and to determine whether young people with chronic HIV infection undergoing Short-Cycle Therapy of five days on ART and two days off maintain the same level of viral load suppression as those on continuous therapy, over 48 weeks.

To assess the advantages and disadvantages of the strategy, the incidence of toxicities, immunological control, resistance mutations, acceptability, quality of life and adherence to the randomised strategy will also be compared.

Importantly, because of insufficient data on short-term viral load rebound after stopping ART in this population, the trial will incorporate an initial pilot phase in selected centres, to assess the safety of the SCT strategy by evaluating detailed HIV-1 RNA profiles of participants on the SCT strategy.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Turkova A, Moore CL, Butler K, Compagnucci A, Saïdi Y, Musiime V, Nanduudu A, Kaudha E, Cressey TR, Chalermpantmetagul S, Scott K, Harper L, Montero S, Riault Y, Bunupuradah T, Volokha A, Flynn PM, Bologna R, Ramos Amador JT, Welch SB, Nastouli E, Klein N, Giaquinto C, Ford D, Babiker A, Gibb DM; BREATHER (PENTA 16) trial Group. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents and young adults (BREATHER): Extended follow-up results of a randomised, open-label, non-inferiority trial. PLoS One. 2018 Apr 23;13(4):e0196239. doi: 10.1371/journal.pone.0196239. eCollection 2018.

apc_source: openAPC

family: Turkova

full_name: Anna Turkova

given: Anna

sequence: first

family: Moore

full_name: Cecilia L. Moore

given: Cecilia L.

sequence: additional

family: Butler

full_name: Karina Butler

given: Karina

family: Compagnucci

full_name: Alexandra Compagnucci

given: Alexandra

family: Saïdi

full_name: Yacine Saïdi

given: Yacine

family: Musiime

full_name: Victor Musiime

given: Victor

family: Nanduudu

full_name: Annet Nanduudu

given: Annet

family: Kaudha

full_name: Elizabeth Kaudha

given: Elizabeth

family: Cressey

full_name: Tim R. Cressey

given: Tim R.

family: Chalermpantmetagul

full_name: Suwalai Chalermpantmetagul

given: Suwalai

family: Scott

full_name: Karen Scott

given: Karen

family: Harper

full_name: Lynda Harper

given: Lynda

family: Montero

full_name: Samuel Montero

given: Samuel

family: Riault

full_name: Yoann Riault

given: Yoann

family: Bunupuradah

full_name: Torsak Bunupuradah

given: Torsak

family: Volokha

full_name: Alla Volokha

given: Alla

family: Flynn

full_name: Patricia M. Flynn

given: Patricia M.

family: Bologna

full_name: Rosa Bologna

given: Rosa

family: Ramos Amador

full_name: Jose T. Ramos Amador

given: Jose T.

family: Welch

full_name: Steven B. Welch

given: Steven B.

family: Nastouli

full_name: Eleni Nastouli

given: Eleni

family: Klein

full_name: Nigel Klein

given: Nigel

family: Giaquinto

full_name: Carlo Giaquinto

name: on behalf of the BREATHER (PENTA 16) trial Group

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

repository_institution: University College London - UCL Discovery

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

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

ReferenceCitation: Bernays S, Paparini S, Seeley J, Namukwaya Kihika S, Gibb D, Rhodes T. Qualitative study of the BREATHER trial (Short Cycle antiretroviral therapy): is it acceptable to young people living with HIV? BMJ Open. 2017 Feb 17;7(2):e012934. doi: 10.1136/bmjopen-2016-012934.

repositories:
PubMed Central
UCL Discovery
researchonline.lshtm.ac.uk

location_country:
United States
Thailand
France
Uganda
Ireland
Germany
United Kingdom
Ukraine

location_facility: Program for HIV Prevention and Treatment (PHPT)/IRD 174

location_facility: HIV-NAT Thai Red Cross AIDS Research Centre


title: Screening for Advanced Heart Failure Treatment (SEE-HF)

acronym: SEE-HF

summary: Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.

lead_sponsor: Abbott Medical Devices

location_country:
Sweden
Netherlands
France
Denmark
Germany
United Kingdom

location_facility: University Hospital of South Manchester NHS Trust


title: Airflow Limitation in Cardiac Diseases in Europe

acronym: ALICE

summary: This is a cross-sectional, observational study, investigating the point prevalence of Airflow Limitation in current or former smokers with established ischemic heart disease. The study will recruit up to 3000 patients from cardiology clinics at hospitals across Europe.

time_perspective: Cross-Sectional

ReferenceCitation: Franssen FM, Soriano JB, Roche N, Bloomfield PH, Brusselle G, Fabbri LM, García-Rio F, Kearney MT, Kwon N, Lundbäck B, Rabe KF, Raillard A, Muellerova H, Cockcroft JR. Lung Function Abnormalities in Smokers with Ischemic Heart Disease. Am J Respir Crit Care Med. 2016 Sep 1;194(5):568-76. doi: 10.1164/rccm.201512-2480OC.

family: Franssen

full_name: Frits M. E. Franssen

given: Frits M. E.

family: Soriano

full_name: Joan B. Soriano

given: Joan B.

family: Roche

full_name: Nicolas Roche

given: Nicolas

family: Bloomfield

full_name: Paul H. Bloomfield

given: Paul H.

family: Brusselle

full_name: Guy Brusselle

given: Guy

family: Fabbri

full_name: Leonardo M. Fabbri

given: Leonardo M.

family: García-Rio

full_name: Francisco García-Rio

given: Francisco

family: Kearney

full_name: Mark T. Kearney

given: Mark T.

family: Kwon

full_name: Namhee Kwon

given: Namhee

family: Lundbäck

full_name: Bo Lundbäck

given: Bo

family: Rabe

full_name: Klaus F. Rabe

given: Klaus F.

family: Raillard

full_name: Alice Raillard

given: Alice

family: Muellerova

full_name: Hana Muellerova

given: Hana

family: Cockcroft

full_name: John R. Cockcroft

given: John R.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

lead_sponsor: GlaxoSmithKline

location_country: Italy Sweden Netherlands France Greece Ireland Belgium Spain Germany

intervention_type: Procedure


intervention_type: Drug

lead_sponsor: Chiesi Farmaceutici S.p.A.

location_country:
Italy
France
Bulgaria
Poland
Slovakia
Romania
Hungary
Russian Federation
Spain
Germany
Ukraine

location_facility: NZZ- Detská pneumologická a ftizeologická ambulanci

location_facility: Spitalul Clinic Universitar de Urgenta Elias

source: euctr

title: A Phase III, 12-week, Multicentre, Multinational, Randomised, Double-blind, Double-dummy, 3 Arm-parallel Group Study to Test the Efficacy of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate (BDP) Plus Formoterol Fumarate (FF)) Versus a Free Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate and Versus a Monotherapy of Beclomethasone Dipropionate in Partly Controlled Asthmatic Children

summary: The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP) and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung functions in asthmatic children patients.


title: A Single-arm Dose-finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE225 in Combination With Nilotinib in Chronic or Accelerated Phase of Chronic Myeloid Leukemia Patients Who Have Failed Prior Therapy With Other BCR-ABL Tyrosine-kinase Inhibitors

summary: The purpose of this study is to determine the feasibility of administering the combination of nilotinib and LDE225 to patients with chronic or accelerated phase of chronic myeloid leukemia and to establish the maximum tolerated dose (MTD) and/or recommended Phase II dose level (RP2D) of LDE225 in combination with nilotinib.

lead_sponsor: Novartis Pharmaceuticals

location_country: Italy France Spain Germany Canada


title: A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

summary: The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.

status: Terminated

lead_sponsor: Aeris Therapeutics

location_country: Israel Austria Germany France

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice

location_facility: LMU Medizinische Klinik und Poliklinik Klinikum Großhadern

status_simplified: Unknown


lead_sponsor: Allergan

location_country:
Italy
Philippines
France
United States
United Kingdom
Korea, Republic of
Taiwan

acronym: Bimatoprost 0.03% Preservative-free Ophthalmic Solution in Paediatric Glaucoma

title: A Multicenter, Double-masked, Randomized, Active-controlled, Parallel Study of the Safety and Efficacy of Once-daily Bimatoprost Preservative-free Ophthalmic Solution Compared to Twice-daily Timolol Ophthalmic Solution in Paediatric Patients With Glaucoma

summary: The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.


ReferenceCitation: Webb NJA, Baumann U, Camino M, Frauca E, Undre N; OPTION Study Group. Pharmacokinetics of tacrolimus granules in pediatric de novo liver, kidney, and heart transplantation: The OPTION study. Pediatr Transplant. 2019 Feb;23(1):e13328. doi: 10.1111/petr.13328. Epub 2019 Jan 21.

name: Department of Paediatric Nephrology and NIHR/Wellcome Trust Manchester Clinical Research Facility; University of Manchester, Manchester Academic Health Science Centre, Royal Manchester Children's Hospital; Manchester UK

family: Webb

full_name: Nicholas J. A. Webb

given: Nicholas J. A.

name: Division of Paediatric Gastroenterology and Hepatology, Children’s Hospital; Hannover Medical School; Hannover Germany

family: Baumann

full_name: Ulrich Baumann

given: Ulrich

name: Hospital Universitario Gregorio Marañon; Madrid Spain

family: Camino

full_name: Manuela Camino

given: Manuela

name: Hospital Universitario La Paz; Madrid Spain

family: Frauca

full_name: Esteban Frauca

given: Esteban

name: Astellas Pharma EMEA; Chertsey Surrey UK

family: Undre

full_name: Nasrullah Undre

given: Nasrullah

journal_name: Pediatric Transplantation

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

study_start_date_type: Actual

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe Ltd.

primary_purpose: Prevention

location_country:
France
Poland
Belgium
Spain
Germany
United Kingdom

acronym: OPTION

location_facility:
Site 21
Site 30
Site: 60
Site 20
Site 50
Site 31
Site 10
Site 40
Site 13
Site 22

ipd_sharing: Yes

title: A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients

summary: The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide how much Modigraf in future can be given safely to children and young people following transplantation.


title: Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)

summary: A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.

lead_sponsor: Edwards Lifesciences

location_country:
Austria
Germany
United Kingdom
France

location_facility: University Hospital Essen, West German Heart Center

location_facility: Medizinische Universitat Wien Univ.Klinik f.Chirurgie


type: Other Identifier

title: BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program

summary: This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.

ReferenceType: result

ReferenceCitation: Pozzilli C, Schweikert B, Ecari U, Oentrich W; BetaPlus Study group. Supportive strategies to improve adherence to IFN β-1b in multiple sclerosis--results of the βPlus observational cohort study. J Neurol Sci. 2011 Aug 15;307(1-2):120-6. doi: 10.1016/j.jns.2011.04.026. Epub 2011 Jun 1.

family: Pozzilli

full_name: Carlo Pozzilli

given: Carlo

family: Schweikert

full_name: Bernd Schweikert

given: Bernd

family: Ecari

full_name: Ugo Ecari

given: Ugo

family: Oentrich

full_name: Wolfgang Oentrich

given: Wolfgang

journal_name: Journal of the Neurological Sciences

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Supportive strategies to improve adherence to IFN beta-1b in Multiple Sclerosis — Results of the BetaPlus observational cohort study

lead_sponsor: Bayer

location_country:
Italy
Jordan
Saudi Arabia
Lebanon
Netherlands
Spain
France
Israel
Portugal
Turkey
Germany
Czech Republic
Korea, Republic of
Taiwan
Iran, Islamic Republic of


title: A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

summary: The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

ReferenceType: background

ReferenceCitation: Emery P, Durez P, Dougados M, Legerton CW, Becker JC, Vratsanos G, Genant HK, Peterfy C, Mitra P, Overfield S, Qi K, Westhovens R. Impact of T-cell costimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial). Ann Rheum Dis. 2010 Mar;69(3):510-6. doi: 10.1136/ard.2009.119016. Epub 2009 Nov 23. Erratum in: Ann Rheum Dis. 2011 Aug;70(8):1519.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Mexico
Germany
France
Belgium
Australia
Puerto Rico
Spain
United States
United Kingdom


title: Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

summary: Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.

location_country:
Italy
Sweden
United Kingdom
France
Greece
Israel
Slovakia
Hungary
Russian Federation
Germany
Czech Republic


title: A Randomised Double-blind Study to Compare the Analgesic Efficacy and Safety Profiles of M6G and Morphine, as a Loading Dose Followed by PCA, in Patients Suffering Moderate to Severe Post-operative Pain Requiring PCA for at Least 24 Hours

summary: To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.

lead_sponsor: Paion UK Ltd.

location_country:
United Kingdom
Netherlands
Poland
France
Germany
Czech Republic

location_facility: Department of Anaesthesiology, Leiden University Medical Centre

location_facility: Anaesthetisia - Resuscitation Department, Tenon Hospital

location_facility: Teaching Hospital Bulovka, Department of Urology

location_facility: Universitätsklinikum Bonn, Klinik und Poliklinik f. Anaesthesiologie

location_facility: Intensive Care Unit, Level 5, Western Infirmary,


title: An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

summary: The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.

lead_sponsor: Ferring Pharmaceuticals

location_country:
United States
Former Serbia and Montenegro
Netherlands
Germany
Finland
France
Romania
Belgium
Russian Federation
Canada
United Kingdom

location_facility: Level 7, Urology Research Unit, Derriford Hospital

location_facility: Helsinki University Hospital, Maria Hospital, Dept Urology

location_facility: Ward 10, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary

location_facility: Oulu University Hospital, Department of Surgery Division of Urology

location_facility: Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department

location_facility: Gemeinschaftspraxis Dres Effert und Benedic

location_facility: South Orange County Medical Research Center

location_facility: University CF Hospital No.2, Urology Clinic

location_facility: Clinical Center Novi Sad, Clinic of Urology Hajduk

location_facility: Klinik fuer Urologie, Vivantes Klinikum Am Urban

location_facility: University of Missouri, Urology, Deptof Surgery

location_facility: The Male/Female Health Centres and Research

location_facility: Central Hospital, North Karelian, Dept. of Urology

location_facility: Tampere University Hospital, Dept. of Urology

location_facility: Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department

location_facility: Mount Vernon Cancer Centre, Marie Curie Research Wing

location_facility: Clinical Center of Serbia Institute of Urology and Nephrology

location_facility: Centre Hospitalier Départemental des Oudairies, Chirurgie Urologie

location_facility: Pavlov State Medical University, Urology Department


ReferenceCitation: Geoerger B, Kieran MW, Grupp S, Perek D, Clancy J, Krygowski M, Ananthakrishnan R, Boni JP, Berkenblit A, Spunt SL. Phase II trial of temsirolimus in children with high-grade glioma, neuroblastoma and rhabdomyosarcoma. Eur J Cancer. 2012 Jan;48(2):253-62. doi: 10.1016/j.ejca.2011.09.021. Epub 2011 Oct 25.

family: Geoerger

full_name: Birgit Geoerger

given: Birgit

family: Kieran

full_name: Mark W. Kieran

given: Mark W.

family: Grupp

full_name: Stephan Grupp

given: Stephan

family: Perek

full_name: Danuta Perek

given: Danuta

family: Clancy

full_name: Jill Clancy

given: Jill

family: Krygowski

full_name: Mizue Krygowski

given: Mizue

family: Ananthakrishnan

full_name: Revathi Ananthakrishnan

given: Revathi

family: Boni

full_name: Joseph P. Boni

given: Joseph P.

family: Berkenblit

full_name: Anna Berkenblit

given: Anna

family: Spunt

full_name: Sheri L. Spunt

given: Sheri L.

journal_name: European Journal of Cancer

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

lead_sponsor: Pfizer

location_country:
United States
Mexico
France
Poland
Russian Federation
Germany
Canada

title: A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors

summary:
This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors.

Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Tolerability of Licarbazepine 1000-2000mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder Over 3 Weeks

summary: This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.

location_country:
United States
Russian Federation
France


title: An Open Label Extension Study to Evaluate Safety and Efficacy of Mepolizumab in Patients With Hypereosinophilic Syndromes

summary: This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.

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.

location_country:
Italy
United States
Germany
France
Belgium
Australia
Canada


ReferenceCitation: Rath BA, Brzostek J, Guillén S, Niranjan V, Chappey C, Rayner CR, Clinch B. Safety, virology and pharmacokinetics of oseltamivir in infants with laboratory-confirmed influenza: a Phase I/II, prospective, open-label, multicentre clinical trial. Antivir Ther. 2015;20(8):815-25. doi: 10.3851/IMP2967. Epub 2015 May 27.

family: Rath

full_name: Barbara A Rath

given: Barbara A

family: Brzostek

full_name: Jerzy Brzostek

given: Jerzy

family: Guillén

full_name: Sara Guillén

given: Sara

family: Niranjan

full_name: Vis Niranjan

given: Vis

family: Chappey

full_name: Colombe Chappey

given: Colombe

family: Rayner

full_name: Craig R Rayner

given: Craig R

family: Clinch

full_name: Barry Clinch

given: Barry

journal_name: Antiviral Therapy

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Safety, virology and pharmacokinetics of oseltamivir in infants with laboratory-confirmed influenza: a Phase I/II, prospective, open-label, multi-centre clinical trial

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

location_country: Italy France Poland Belgium Spain Germany

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas

location_facility: Fondazione Ospedale Maggiore Policlinico

location_facility: Samodzielny Publiczny Zakład Opieki; Wcześniaków I Intensywnej Terapii

location_facility: Onkologische Schwerpunktpraxis Dr. Med. O. Burkhard & B. Reimann

location_facility: Zespol Opieki Zdrowotnej Debica; Oddzial Dzieciecy

location_facility: CAMPUS VIRCHOW-KLINIKUM CharitéCentrum 17 Klinik f.Pädiatrie Abt.Pneumologie u.Immunologie

location_facility: Hospital Universitario de Getafe; Servicio de Pediatria

location_facility: Hôpital Femme Mère Enfant; Service de rhumatologie pédiatrique

title: An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu®) in the Treatment of Infants 0 to <12 Months of Age With Confirmed Influenza Infection

summary: This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir [Tamiflu] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). The anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants.


title: CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients

summary:
The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability.

As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.

ReferenceCitation: Kuzman I, Bezlepko A, Kondova Topuzovska I, Rókusz L, Iudina L, Marschall HP, Petri T. Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI). BMC Pulm Med. 2014 Jun 30;14:105. doi: 10.1186/1471-2466-14-105.

family: Kuzman

full_name: Ilija Kuzman

given: Ilija

family: Bezlepko

full_name: Alexandr Bezlepko

given: Alexandr

family: Kondova Topuzovska

full_name: Irena Kondova Topuzovska

given: Irena

family: Rókusz

full_name: László Rókusz

given: László

family: Iudina

full_name: Liudmyla Iudina

given: Liudmyla

family: Marschall

full_name: Hans-Peter Marschall

given: Hans-Peter

family: Petri

full_name: Thomas Petri

given: Thomas

journal_name: BMC Pulmonary Medicine

oa_host_type: publisher;repository

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

location_country: Macedonia, The Former Yugoslav Republic of


type: Other Grant/Funding Number

title: Evaluation of Integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease

acronym: EVINCI

summary:
Main purpose of the study:

To comparatively assess the diagnostic performance of non invasive anatomical and functional imaging modalities to detect significant obstructive coronary artery disease as demonstrated at invasive coronary angiography and functional evaluation of coronary lesions (fractional flow reserve).

primary_purpose: Diagnostic

ReferenceCitation: Caselli C, De Caterina R, Smit JM, Campolo J, El Mahdiui M, Ragusa R, Clemente A, Sampietro T, Clerico A, Liga R, Pelosi G, Rocchiccioli S, Parodi O, Scholte A, Knuuti J, Neglia D; EVINCI and SMARTool. Triglycerides and low HDL cholesterol predict coronary heart disease risk in patients with stable angina. Sci Rep. 2021 Oct 20;11(1):20714. doi: 10.1038/s41598-021-00020-3.

family: Caselli

full_name: Chiara Caselli

given: Chiara

family: De Caterina

full_name: Raffaele De Caterina

given: Raffaele

family: Smit

full_name: Jeff M Smit

given: Jeff M

family: Campolo

full_name: Jonica Campolo

given: Jonica

family: El Mahdiui

full_name: Mohammed El Mahdiui

given: Mohammed

family: Ragusa

full_name: Rosetta Ragusa

given: Rosetta

family: Clemente

full_name: Alberto Clemente

given: Alberto

family: Sampietro

full_name: Tiziana Sampietro

given: Tiziana

family: Clerico

full_name: Aldo Clerico

given: Aldo

family: Liga

full_name: Riccardo Liga

given: Riccardo

family: Pelosi

full_name: Gualtiero Pelosi

given: Gualtiero

family: Rocchiccioli

full_name: Silvia Rocchiccioli

given: Silvia

family: Parodi

full_name: Oberdan Parodi

given: Oberdan

family: Scholte

full_name: Arthur Scholte

given: Arthur

family: Knuuti

full_name: Jhuani Knuuti

given: Jhuani

family: Neglia

full_name: Danilo Neglia

given: Danilo

currency_apc_doaj: USD

journal_name: Scientific Reports

ReferenceCitation: Caselli C, Del Turco S, Ragusa R, Lorenzoni V, De Graaf M, Basta G, Scholte A, De Caterina R, Neglia D. Association of PCSK9 plasma levels with metabolic patterns and coronary atherosclerosis in patients with stable angina. Cardiovasc Diabetol. 2019 Oct 31;18(1):144. doi: 10.1186/s12933-019-0949-3.

repository_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Carpeggiani C, Picano E, Brambilla M, Michelassi C, Knuuti J, Kauffman P, Underwood SR, Neglia D; EVINCI Study Investigators. Variability of radiation doses of cardiac diagnostic imaging tests: the RADIO-EVINCI study (RADIationdOse subproject of the EVINCI study). BMC Cardiovasc Disord. 2017 Feb 16;17(1):63. doi: 10.1186/s12872-017-0474-9.

repositories:
PubMed Central
Zenodo
spiral.imperial.ac.uk

ReferenceCitation: Neglia D, Rovai D, Caselli C, Pietila M, Teresinska A, Aguadé-Bruix S, Pizzi MN, Todiere G, Gimelli A, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Perrone Filardi P, Fernández-Golfín C, Rincón LM, Graner FP, de Graaf MA, Fiechter M, Stehli J, Gaemperli O, Reyes E, Nkomo S, Mäki M, Lorenzoni V, Turchetti G, Carpeggiani C, Marinelli M, Puzzuoli S, Mangione M, Marcheschi P, Mariani F, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Kaufmann PA, Underwood SR, Knuuti J; EVINCI Study Investigators. Detection of significant coronary artery disease by noninvasive anatomical and functional imaging. Circ Cardiovasc Imaging. 2015 Mar;8(3). pii: e002179. doi: 10.1161/CIRCIMAGING.114.002179.

name: From the Institute of Clinical Physiology, CNR, Pisa, Italy (D.N., D.R., C. Caselli, C. Carpeggiani, M. Marinelli, F. Mariani, D.G., R.S.); Cardiothoracic Department (D.N., G. Todiere), Imaging Department (A.G., M.L.) and Technology Department (S.P., M. Mangione, P.M.), Fondazione Toscana G. Monasterio, Pisa, Italy; Heart Center (M.P.) and Turku PET Center (M.Mäki, J.K.), University of Turku and Turku University Hospital, Turku, Finland; Department of Nuclear Medicine, Institute of Cardiology,...

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Detection of Significant Coronary Artery Disease by Noninvasive Anatomical and Functional Imaging

lead_sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

location_country:
Italy
Switzerland
Netherlands
Finland
France
Poland
Spain
Germany
United Kingdom

location_facility:
CNR
RBHT
U.Turku
FGM
LUMC
NIC
Ospedale Versilia
TUM
UZH
APHP
UniGE
UniNA
QUEEN MARY Hospital London
SERMAS
KAE Goeppingen
Huvhebron


title: Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy

summary: This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.

ReferenceCitation: A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.

ReferenceCitation: Scrima L, Hartman PG, Johnson FH Jr, Thomas EE, Hiller FC. The effects of gamma-hydroxybutyrate on the sleep of narcolepsy patients: a double-blind study. Sleep. 1990 Dec;13(6):479-90.

ReferenceCitation: Lammers GJ, Arends J, Declerck AC, Ferrari MD, Schouwink G, Troost J. Gammahydroxybutyrate and narcolepsy: a double-blind placebo-controlled study. Sleep. 1993 Apr;16(3):216-20.

ReferenceCitation: A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.

ReferenceCitation: Black J, Houghton WC. Sodium oxybate improves excessive daytime sleepiness in narcolepsy. Sleep. 2006 Jul;29(7):939-46.

ReferenceCitation: Black J, Pardi D, Hornfeldt CS, Inhaber N. The nightly use of sodium oxybate is associated with a reduction in nocturnal sleep disruption: a double-blind, placebo-controlled study in patients with narcolepsy. J Clin Sleep Med. 2010 Dec 15;6(6):596-602.

ReferenceCitation: Husain AM, Bujanover S, Ryan R, Scheckner B, Black J, Profant J. Incidence and duration of common, early-onset adverse events occurring during 2 randomized, placebo-controlled, phase 3 studies of sodium oxybate in participants with narcolepsy. J Clin Sleep Med. 2020 Sep 15;16(9):1469-1474. doi: 10.5664/jcsm.8530.

name: Duke University Medical Center, Durham, North Carolina

family: Husain

full_name: Aatif M. Husain

given: Aatif M.

name: Jazz Pharmaceuticals, Palo Alto, California

family: Bujanover

full_name: Shay Bujanover

given: Shay

name: Jazz Pharmaceuticals, Philadelphia, Pennsylvania

family: Ryan

full_name: Robert Ryan

given: Robert

family: Scheckner

full_name: Brian Scheckner

given: Brian

name: Stanford University Sleep Medicine Center, Redwood City, California

family: Black

full_name: Jed Black

given: Jed

family: Profant

full_name: Judi Profant

given: Judi

journal_name: Journal of Clinical Sleep Medicine

oa_colors: green other

evidence: open (via free pdf)

publisher: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Dauvilliers Y, Roth T, Guinta D, Alvarez-Horine S, Dynin E, Black J. Effect of sodium oxybate, modafinil, and their combination on disrupted nighttime sleep in narcolepsy. Sleep Med. 2017 Dec;40:53-57. doi: 10.1016/j.sleep.2017.07.030. Epub 2017 Oct 7.

family: Dauvilliers

full_name: Yves Dauvilliers

given: Yves

family: Roth

full_name: Thomas Roth

given: Thomas

family: Guinta

full_name: Diane Guinta

given: Diane

family: Alvarez-Horine

full_name: Sarah Alvarez-Horine

given: Sarah

family: Dynin

full_name: Efim Dynin

given: Efim

journal_name: Sleep Medicine

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: Jazz Pharmaceuticals

location_country:
Germany
United States
France
Switzerland

location_facility: The Center for Sleep and Wake Disorders/Midwest Neurology

location_facility: Community Research Management Associates,Inc.

location_facility: Neurologische Poliklinik -- Universitats Spital Zurich

location_facility: CSC Research -- Grove City Sleep Diagnostic Center

location_facility: Hopital Pitie Salpetriere -- Federation des Pathologies du sommeil

location_facility: SLEEP WALKER -- Sleep Disorders Center & Neurodiagnostics--Lung Diagnostics, Ltd.

location_facility: Clinical Research Group of St. Petersburg, Inc.

location_facility: St. Jude Medical Center -- Sleep Disorders Institute

location_facility: New Jersey Neuroscience Institute at JFK Medical Center

location_facility: Centre du sommeil -- Hopital Gui de Chauliac

location_facility: ALL-TRIALS Clinical Research, LLC -- Summit Sleep Disorder

location_facility: Chest Medicine Associates DBA -- Sleep Medicine Specialists

location_facility: Cincinnati Clinic & Sleep Management Institute

location_facility: Lehigh Valley Hospital Sleep Disorders Center

location_facility: Sleep Disorders Center -- Union Hospital of Cecil County

location_facility: Community Research & Sleep Management Institute

location_facility: Vermont Medical Sleep Disorders Center, Inc.


title: A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

summary: This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.

ReferenceCitation: Lüscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Münzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16.

family: Lüscher

full_name: Thomas F. Lüscher

given: Thomas F.

family: Taddei

full_name: Stefano Taddei

given: Stefano

family: Kaski

full_name: Juan-Carlos Kaski

given: Juan-Carlos

family: Jukema

full_name: J. Wouter Jukema

given: J. Wouter

family: Kallend

full_name: David Kallend

given: David

family: Münzel

full_name: Thomas Münzel

family: Kastelein

full_name: John J.P. Kastelein

given: John J.P.

family: Deanfield

full_name: John E. Deanfield

given: John E.

journal_name: European Heart Journal

oa_colors: green hybrid

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

repository_institution: reroDoc Digital Library

repositories_institution: University of Zurich - Zurich Open Repository and Archive

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Kastelein JJ, Duivenvoorden R, Deanfield J, de Groot E, Jukema JW, Kaski JC, Münzel T, Taddei S, Lehnert V, Burgess T, Kallend D, Lüscher TF. Rationale and design of dal-VESSEL: a study to assess the safety and efficacy of dalcetrapib on endothelial function using brachial artery flow-mediated vasodilatation. Curr Med Res Opin. 2011 Jan;27(1):141-50. doi: 10.1185/03007995.2010.536207. Epub 2010 Dec 6.

name: Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands

family: Duivenvoorden

full_name: Raphaël Duivenvoorden

given: Raphaël

name: Cardiothoracic Unit, Great Ormond Street Hospital, London, UK

full_name: John Deanfield

given: John

family: de Groot

full_name: Eric de Groot

given: Eric

name: Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands

name: Department of Cardiovascular Sciences, St George's University of London, London, UK

name: Department of Medicine II, Johannes Gutenberg-University Mainz, Mainz, Germany

name: Hypertension Service, Università di Pisa, Pisa, Italy

name: F. Hoffmann-La Roche Ltd, Basel, Switzerland

name: F. Hoffmann-La Roche Inc., Nutley, NJ, USA

name: Cardiovascular Center, Department of Cardiology, University Hospital Zurich, Zurich, Switzerland

location_country:
Italy
Austria
Switzerland
Netherlands
France
Germany
United Kingdom


title: Idiopathic Pulmonary Fibrosis International Group Exploring NAC I Annual Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)

acronym: IFIGENIA

summary: The purpose of this study is to determine whether NAC added to prednisone, and azathioprine has a better effect on lung function, radiology and clinical condition than placebo + prednisone in combination with azathioprine after 6 and 12 months.

ReferenceCitation: Demedts M, Behr J, Buhl R, Costabel U, Dekhuijzen R, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Capron F, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Corvasce G, Lankhorst I, Sardina M, Montanari M; IFIGENIA Study Group. High-dose acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med. 2005 Nov 24;353(21):2229-42.

ReferenceCitation: Behr J, Demedts M, Buhl R, Costabel U, Dekhuijzen RP, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Lankhorst I, Sardina M, Boissard G; IFIGENIA study group. Lung function in idiopathic pulmonary fibrosis--extended analyses of the IFIGENIA trial. Respir Res. 2009 Oct 27;10:101. doi: 10.1186/1465-9921-10-101.

family: Behr

full_name: Jürgen Behr

given: Jürgen

family: Demedts

full_name: Maurits Demedts

given: Maurits

family: Buhl

full_name: Roland Buhl

given: Roland

family: Costabel

full_name: Ulrich Costabel

given: Ulrich

family: Dekhuijzen

full_name: Richard PN Dekhuijzen

given: Richard PN

family: Jansen

full_name: Henk M Jansen

given: Henk M

family: MacNee

full_name: William MacNee

given: William

family: Thomeer

full_name: Michiel Thomeer

given: Michiel

family: Wallaert

full_name: Benoit Wallaert

given: Benoit

family: Laurent

full_name: Francois Laurent

given: Francois

family: Nicholson

full_name: Andrew G Nicholson

given: Andrew G

family: Verbeken

full_name: Eric K Verbeken

given: Eric K

family: Verschakelen

full_name: Johny Verschakelen

given: Johny

family: Flower

full_name: CDR Flower

given: CDR

family: Petruzzelli

full_name: Stefano Petruzzelli

family: De Vuyst

full_name: Paul De Vuyst

given: Paul

family: Bosch

full_name: van den JMM Bosch

given: van den JMM

family: Rodriguez-Becerra

full_name: Eulogio Rodriguez-Becerra

given: Eulogio

family: Lankhorst

full_name: Ida Lankhorst

given: Ida

family: Sardina

full_name: Marco Sardina

given: Marco

family: Boissard

full_name: Gabrielle Boissard

given: Gabrielle

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

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

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

title: Lung function in idiopathic pulmonary fibrosis - extended analyses of the IFIGENIA trial

location_country:
Italy
Netherlands
France
Belgium
Spain
Germany
United Kingdom

location_facility: The University of Edinburgh-Medical School


title: Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants

acronym: NEOBRAIN

summary: NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage mainly observed in preterm newborns. (Copy from www.neobrain.eu)

ReferenceCitation: Dammann O, Cesario A, Hallen M. NEOBRAIN--an EU-funded project committed to protect the newborn brain. Neonatology. 2007;92(4):217-8. Epub 2007 May 21.

lead_sponsor: Hannover Medical School

location_country: Italy Austria Sweden Switzerland Netherlands France Germany

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Fondazione I.R.C.C.S Ospedale Maggiore Policlinico MA.RE.


title: A Randomized, Open-label, Active-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride (HCl) Formulation Versus 5% Amorolfine Nail Lacquer for 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis

summary: This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.

lead_sponsor: Novartis

location_country:
Finland
France
Poland
Norway
Hungary
Russian Federation
Spain
Turkey
Germany
Iceland


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Fixed-Dose, 8-Week Treatment, Multi-Center Trial Evaluating the Efficacy and the Safety of 3 Oral Doses of Surinabant as an Aid to Smoking Cessation in Cigarette Smokers

summary:
Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which might be clinically useful in the treatment of dependence to nicotine.

The primary study objective is the assessment of efficacy of 3 doses of surinabant on abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of surinabant on body weight and its clinical and biological safety.

ReferenceCitation: Tonstad S, Aubin HJ. Efficacy of a dose range of surinabant, a cannabinoid receptor blocker, for smoking cessation: a randomized controlled clinical trial. J Psychopharmacol. 2012 Jul;26(7):1003-9. doi: 10.1177/0269881111431623. Epub 2012 Jan 4.

name: Oslo University Hospital, Department of Preventive Cardiology Ullevål, Oslo, Norway

family: Tonstad

full_name: Serena Tonstad

given: Serena

name: Hôpital Paul Brousse, Univ Paris-Sud, Villejuif, France

family: Aubin

full_name: Henri-Jean Aubin

given: Henri-Jean

journal_name: Journal of Psychopharmacology

lead_sponsor: Sanofi

location_country: Italy Sweden Switzerland France Norway Belgium Spain Germany


title: A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis

summary: This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

ReferenceCitation: Bianchi G, Czerwinski E, Kenwright A, Burdeska A, Recker RR, Felsenberg D. Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension. Osteoporos Int. 2012 Jun;23(6):1769-78. doi: 10.1007/s00198-011-1793-9.

family: Bianchi

full_name: G. Bianchi

given: G.

family: Czerwinski

full_name: E. Czerwinski

given: E.

family: Kenwright

full_name: A. Kenwright

given: A.

family: Burdeska

full_name: A. Burdeska

family: Recker

full_name: R. R. Recker

given: R. R.

family: Felsenberg

full_name: D. Felsenberg

given: D.

journal_name: Osteoporosis International

location_country:
Italy
United States
South Africa
United Kingdom
Mexico
Germany
France
Poland
Norway
Hungary
Belgium
Australia
Spain
Denmark
Canada
Czech Republic


title: Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis

summary: This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

location_country:
Italy
United States
Brazil
South Africa
Switzerland
Mexico
Germany
France
Czechia
Poland
Norway
Hungary
Belgium
Australia
Romania
Spain
Denmark
Canada
United Kingdom

intervention_type: Dietary Supplement


title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic / Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke

summary: The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours.

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


title: An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

summary: In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.

location_country:
United States
Netherlands
France
Germany
United Kingdom
Canada


title: Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia in Recurrent or Refractory Non-Burkitt's, Non-Hodgkin's Lymphoma (NHL) or Hodgkin's Disease Receiving DHAP (Dexamethasone, High-Dose Cytarabine and Cisplatin) Chemotherapy

summary: Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has been demonstrated to increase platelet counts. This study will test the safety and efficacy of the investigational drug in the prevention of thrombocytopenia in patients with recurrent or refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL), or Hodgkin's disease receiving DHAP (Dexamethasone, high-dose Cytarabine, and Cisplatin) chemotherapy.

location_country:
Hong Kong
France
Poland
Greece
Singapore
Australia
Russian Federation
United States


title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer

summary: This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.

location_country:
United States
France

location_facility: Wayne State University Karmanos Cancer Center


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis

summary: The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).

ReferenceCitation: Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911-23.

lead_sponsor: Biogen

location_country:
Italy
Austria
Germany
France
Israel
Belgium
United States

location_facility: Wake Forest University School of Medicine, Department of Neurology

location_facility: Michigan Institute for Neurological Disorders

location_facility: University of Mississippi Medical Center

location_facility: University of Pittsburgh, Department of Neurology

location_facility: Maimonides Medical Center, Division of Neurology

location_facility: University of Alabama-Birmingham, Department of Neurology

location_facility: Alexian Brothers Center for Clinical Research

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Fachbereich Neurologie und Klinische Neurophysiologie

location_facility: Hospital of the University of Pennsylvania

location_facility: St. Francis Hospital, Center for Neurological Disorders

location_facility: Greenstein Neurology Associates & MS Institute

location_facility: Medizinische Hochschule Hannover, Neurologische Klinik

location_facility: The Multiple Sclerosis Center of Atlanta

location_facility: Hadassah Hebrew Uni Hospital, Department of Neurology

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

location_facility: University of Miami, Department of Neurology

location_facility: University of Maryland Hospital, Department of Neurology

location_facility: St. Luke's Roosevelt Hospital, MS Research & Treatment Center

location_facility: Georgetown Univesity Hospital, Research Pharmacy

location_facility: Northwestern University, Department of Neurology

location_facility: Baylor Methodist International MS Center

location_facility: Springfield Clinic Neuroscience Institute

location_facility: Buffalo General Hospital, Department of Neurology

location_facility: New York Hospital - Cornell Medical Center

location_facility: Universita di Genova, Clinica Neurologica

location_facility: University of Arkansas For Medical Sciences

location_facility: Universitaetsklinikum Giessen, Oberarzt Neurologie


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis

summary: The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.

ReferenceCitation: Voloshyna N, Havrdová E, Hutchinson M, Nehrych T, You X, Belachew S, Hotermans C, Paes D. Natalizumab improves ambulation in relapsing-remitting multiple sclerosis: results from the prospective TIMER study and a retrospective analysis of AFFIRM. Eur J Neurol. 2015 Mar;22(3):570-7. doi: 10.1111/ene.12618. Epub 2014 Dec 15.

ReferenceCitation: Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910.

ReferenceCitation: Balcer LJ, Galetta SL, Polman CH, Eggenberger E, Calabresi PA, Zhang A, Scanlon JV, Hyde R. Low-contrast acuity measures visual improvement in phase 3 trial of natalizumab in relapsing MS. J Neurol Sci. 2012 Jul 15;318(1-2):119-24. doi: 10.1016/j.jns.2012.03.009. Epub 2012 Apr 21.

family: Balcer

full_name: Laura J. Balcer

given: Laura J.

family: Galetta

full_name: Steven L. Galetta

given: Steven L.

family: Polman

full_name: Chris H. Polman

given: Chris H.

family: Eggenberger

full_name: Eric Eggenberger

given: Eric

family: Calabresi

full_name: Peter A. Calabresi

given: Peter A.

family: Zhang

full_name: Annie Zhang

given: Annie

family: Scanlon

full_name: James V. Scanlon

given: James V.

family: Hyde

full_name: Robert Hyde

given: Robert

location_country:
United States
United Kingdom
Netherlands
Germany
France
Belgium
Canada
Czech Republic

location_facility: North Staffordshire Royal Infirmary - Neurology Department

location_facility: Faculty Hospital Motol - Neurological Clinic

location_facility: Oregon Health Sciences University, Department of Neurology

location_facility: Michigan Institute for Neurological Disorders

location_facility: The Radcliffe Infirmary, University Department of Clinical Neurology

location_facility: UC Davis School of Medicine, Department of Neurology

location_facility: General Teaching Hospital - Neurological Department

location_facility: University of Miami School of Medicine, Department of Neurology

location_facility: Ipswich Hospital NHS Trust - Department of Clinical Neurology

location_facility: Faculty Hospital Plzen - Clinic of Neurology

location_facility: Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group

location_facility: University of Kansas Medical Center, Department of Neurology

location_facility: Hopital de la Timone, Service de Neurologie

location_facility: MS Research Unit, Center for Clinical Research

location_facility: Lehigh Valley Hospital, Neurosciences Research

location_facility: University of Washington MS Research Center

location_facility: Hospital Pardubice - Department of Neurology

location_facility: St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum

location_facility: Sunnybrook and Women's College and Health Science Centre

location_facility: St. James University Hospital, Department of Neurology

location_facility: CHRU - Hopital de Pontchaillou, Service de Neurologie

location_facility: University of Toronto, MS Clinic, St. Michael's Hospital

location_facility: Yale University School of Medicine, Department of Neurology

location_facility: Kings College Hospital, Kings Neuroscience Center


title: A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer

summary: This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

location_country:
Australia
Russian Federation
Taiwan
Ukraine
India
France
Poland
Lithuania
Norway
Canada
South Africa
Sweden
Hong Kong
Netherlands
Bulgaria
Hungary
China
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Israel
Spain
Turkey


title: Phase III, Randomized, Multicenter Study to Assess the Efficacy and Safety of HuM195 (Recombinant Humanized Anti-CD33 Monoclonal Antibody) in Combination With Standardized Chemotherapy Compared to Standardized Chemotherapy Alone in the Treatment of Patients With Refractory or First-Relapsed Acute Myelogenous Leukemia (AML)

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy for acute myelogenous leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have refractory or relapsed acute myelogenous leukemia.

lead_sponsor: Facet Biotech

location_country:
United States
Netherlands
Germany
France
Belgium
Canada
United Kingdom

location_facility: Louisiana State University School of Medicine

location_facility: New York Presbyterian Hospital - Cornell Campus

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Jonsson Comprehensive Cancer Center, UCLA

location_facility: Washington University Barnard Cancer Center

location_facility: Queen Elizabeth II Health Science Center

location_facility: University of California Davis Cancer Center

location_facility: Beckman Research Institute, City of Hope

location_facility: Massachusetts General Hospital Cancer Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Klinikum Rechts Der Isar/Technische Universitaet Muenchen

location_facility: North Mississippi Hematology and Oncology Associates, Ltd.

location_facility: Albert Einstein Comprehensive Cancer Center

location_facility: Lineberger Comprehensive Cancer Center, UNC

location_facility: University of Pennsylvania Cancer Center


title: Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin's lymphoma.

ReferenceCitation: Deconinck E, Miadi-Fargier H, Pen CL, Brice P. Cost effectiveness of rituximab maintenance therapy in follicular lymphoma: long-term economic evaluation. Pharmacoeconomics. 2010;28(1):35-46. doi: 10.2165/11314070-000000000-00000.

ReferenceCitation: Pompen M, Huijgens PC, et al.: Cost-effectiveness of rituximab for maintenance in patients with follicular non-Hodgkin's lymphoma in the Dutch setting. [Abstract] Blood 112 (11): A-2364, 2008.

ReferenceCitation: Van Oers MH, Hagenbeek A, Van Glabbeke M, Teodorovic I. Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma: a phase III randomized clinical trial--Intergroup Collaborative Study. Ann Hematol. 2002 Oct;81(10):553-7. Epub 2002 Oct 17.

ReferenceCitation: van Oers MH, Tönnissen E, Van Glabbeke M, Giurgea L, Jansen JH, Klasa R, Marcus RE, Wolf M, Kimby E, Vranovsky A, Holte H, Hagenbeek A, van der Reijden BA. BCL-2/IgH polymerase chain reaction status at the end of induction treatment is not predictive for progression-free survival in relapsed/resistant follicular lymphoma: results of a prospective randomized EORTC 20981 phase III intergroup study. J Clin Oncol. 2010 May 1;28(13):2246-52. doi: 10.1200/JCO.2009.25.0852. Epub 2010 Apr 5.

name: Academic Medical Center, Amsterdam; Radboud University Nijmegen Medical Centre, Nijmegen; University Medical Center, Utrecht; the Netherlands; European Organisation for Research and Treatment of Cancer, Brussels, Belgium; British Columbia Cancer Agency, Vancouver, Canada; Addenbrook Hospital, London, United Kingdom; Peter MacCallum Cancer Center, Melbourne, Australia; Karolinska Institutet, Stockholm, Sweden; National Institute of Cancer, Bratislava, Slovak Republic; and Radium Hospital, Oslo, Norway.

family: van Oers

full_name: Marinus H.J. van Oers

given: Marinus H.J.

family: Tönnissen

full_name: Evelyn Tönnissen

given: Evelyn

family: Van Glabbeke

full_name: Martine Van Glabbeke

given: Martine

family: Giurgea

full_name: Livia Giurgea

given: Livia

family: Jansen

full_name: Joop H. Jansen

given: Joop H.

family: Klasa

full_name: Richard Klasa

given: Richard

family: Marcus

full_name: Robert E. Marcus

given: Robert E.

family: Wolf

full_name: Max Wolf

given: Max

family: Kimby

full_name: Eva Kimby

given: Eva

family: Vranovsky

full_name: Andrej Vranovsky

given: Andrej

family: Holte

full_name: Harald Holte

given: Harald

family: Hagenbeek

full_name: Anton Hagenbeek

given: Anton

family: van der Reijden

full_name: Bert A. van der Reijden

given: Bert A.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: BCL-2/IgH Polymerase Chain Reaction Status at the End of Induction Treatment Is Not Predictive for Progression-Free Survival in Relapsed/Resistant Follicular Lymphoma: Results of a Prospective Randomized EORTC 20981 Phase III Intergroup Study

ReferenceCitation: van Oers MH, Van Glabbeke M, Giurgea L, Klasa R, Marcus RE, Wolf M, Kimby E, van t Veer M, Vranovsky A, Holte H, Hagenbeek A. Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J Clin Oncol. 2010 Jun 10;28(17):2853-8. doi: 10.1200/JCO.2009.26.5827. Epub 2010 May 3.

name: From the European Organisation for Research and Treatment of Cancer (EORTC) Lymphoma Group, Hovon, Belgium; EORTC Data Center, National Cancer Institute Canada, Clinical Trials Group, Hematology Group, Vancouver, British Columbia, Canada; British National Lymphoma Investigation, London, United Kingdom; Australasian Leukemia and Lymphoma Group, Melbourne, Victoria, Australia; and Nordic Lymphoma Group, Oslo, Norway.

title: Rituximab Maintenance Treatment of Relapsed/Resistant Follicular Non-Hodgkin's Lymphoma: Long-Term Outcome of the EORTC 20981 Phase III Randomized Intergroup Study

ReferenceCitation: van Oers MH, Klasa R, Marcus RE, Wolf M, Kimby E, Gascoyne RD, Jack A, Van't Veer M, Vranovsky A, Holte H, van Glabbeke M, Teodorovic I, Rozewicz C, Hagenbeek A. Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial. Blood. 2006 Nov 15;108(10):3295-301. Epub 2006 Jul 27.

ReferenceCitation: Mattiola I, Mantovani A, Locati M. The tetraspan MS4A family in homeostasis, immunity, and disease. Trends Immunol. 2021 Sep;42(9):764-781. doi: 10.1016/j.it.2021.07.002. Epub 2021 Aug 9. Review.

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

location_country:
Italy
South Africa
Sweden
United Kingdom
Netherlands
France
Poland
Slovakia
Norway
Hungary
Belgium
Australia
Egypt
New Zealand
Denmark
Canada
Slovenia
Portugal

location_facility: Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

location_facility: University of Auckland School of Medicine

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: Medisch Centrum Rynmond-Zuid - Lokatie Zuider

location_facility: St. George Hospital and Community Health Service

location_facility: Medisch Centrum Rynmond Zuid - Lokatie: Clara

location_facility: Berkshire Cancer Centre at Royal Berkshire Hospital

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: McGill Cancer Centre at McGill University

location_facility: Karolinska University Hospital - Huddinge

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Royal Free and University College Medical School

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Ijselmeer Ziekenhuis - Zuiderzeeziekenhuis

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Windsor Regional Cancer Centre at Windsor Regional Hospital

location_facility: Northeastern Ontario Regional Cancer Centre

location_facility: Leeds General Infirmary at Leeds Teaching Hospital NHS Trust

location_facility: Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

location_facility: Trillium Health Centre - Mississauga Site

location_facility: Allan Blair Cancer Centre at Pasqua Hospital

location_facility: British Columbia Cancer Agency - Vancouver Cancer Centre

location_facility: Twee Steden Ziekenhuis Vestiging Tilburg

location_facility: Cross Cancer Institute at University of Alberta

location_facility: Royal Marsden NHS Foundation Trust - London

location_facility: Maxima Medisch Centrum - locatie Eindhoven

location_facility: Nanaimo Cancer Clinic at Nanaimo Regional General Hospital

location_facility: Fraser Valley Cancer Centre at British Columbia Cancer Agency

location_facility: Royal Marsden NHS Foundation Trust - Surrey

location_facility: Institute of Oncology at Prince of Wales Hospital

location_facility: London Regional Cancer Program at London Health Sciences Centre

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Sahlgrenska University Hospital at Gothenburg University

location_facility: Velindre Cancer Center at Velinde Hospital

location_facility: Westmead Breast Centre at NSW Breast Cancer Institute

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Newfoundland Cancer Treatment and Research Foundation

location_facility: Academisch Medisch Centrum at University of Amsterdam

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

location_facility: Hotel Dieu Health Sciences Hospital - Niagara

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

location_facility: Cancer Therapy Centre at Liverpool Hospital

location_facility: Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

location_facility: Haukeland Hospital - University of Bergen

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.


title: An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens

summary: This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
United Kingdom
Argentina
France


title: A Prospective Randomised Controlled Trial Of Hyperfractionated Versus Conventionally Fractionated Radiotherapy In Standard Risk Medulloblastoma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways with combination chemotherapy may kill any remaining tumor cells following surgery. It is not yet known which radiation therapy regimen combined with combination chemotherapy is more effective in treating medulloblastoma.

PURPOSE: Randomized phase III trial to compare different radiation therapy regimens plus combination chemotherapy in treating children who have undergone surgery for medulloblastoma.

lead_sponsor: University of Leicester

location_country:
Italy
Sweden
Netherlands
France
Belgium
Spain
Germany
United Kingdom

location_facility: Royal Liverpool Children's Hospital, Alder Hey

intervention_type: Radiation

lead_sponsor_type: academique


title: Comparative Study of Intravesical BCG Standard Dose Long-Term Maintenance Versus BCG 1/3 Dose Long-Term Maintenance Versus BCG Standard Dose Short-Term Maintenance Versus BCG 1/3 Dose Short-Term Maintenance in Intermediate and High Risk Ta, T1 Papillary Carcinoma of the Urinary Bladder

summary:
RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: This randomized phase III trial is studying four different regimens of BCG and comparing how well they work in treating patients who have undergone surgery for bladder cancer.

ReferenceCitation: Cambier S, Sylvester RJ, Collette L, Gontero P, Brausi MA, van Andel G, Kirkels WJ, Silva FC, Oosterlinck W, Prescott S, Kirkali Z, Powell PH, de Reijke TM, Turkeri L, Collette S, Oddens J. EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non-Muscle-invasive Stage Ta-T1 Urothelial Bladder Cancer Patients Treated with 1-3 Years of Maintenance Bacillus Calmette-Guérin. Eur Urol. 2016 Jan;69(1):60-9. doi: 10.1016/j.eururo.2015.06.045. Epub 2015 Jul 23.

family: Cambier

full_name: Samantha Cambier

given: Samantha

family: Sylvester

full_name: Richard J. Sylvester

given: Richard J.

family: Collette

full_name: Laurence Collette

given: Laurence

family: Gontero

full_name: Paolo Gontero

given: Paolo

family: Brausi

full_name: Maurizio A. Brausi

given: Maurizio A.

family: van Andel

full_name: George van Andel

given: George

family: Kirkels

full_name: Wim J. Kirkels

given: Wim J.

family: Silva

full_name: Fernando Calais Da Silva

given: Fernando Calais Da

family: Oosterlinck

full_name: Willem Oosterlinck

given: Willem

family: Prescott

full_name: Stephen Prescott

given: Stephen

family: Kirkali

full_name: Ziya Kirkali

given: Ziya

family: Powell

full_name: Philip H. Powell

given: Philip H.

family: de Reijke

full_name: Theo M. de Reijke

given: Theo M.

family: Turkeri

full_name: Levent Turkeri

given: Levent

full_name: Sandra Collette

given: Sandra

family: Oddens

full_name: Jorg Oddens

given: Jorg

journal_name: European Urology

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

title: EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non–Muscle-invasive Stage Ta–T1 Urothelial Bladder Cancer Patients Treated with 1–3 Years of Maintenance Bacillus Calmette-Guérin

ReferenceCitation: Brausi M, Oddens J, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Turkeri L, Marreaud S, Collette S, Oosterlinck W. Side effects of Bacillus Calmette-Guérin (BCG) in the treatment of intermediate- and high-risk Ta, T1 papillary carcinoma of the bladder: results of the EORTC genito-urinary cancers group randomised phase 3 study comparing one-third dose with full dose and 1 year with 3 years of maintenance BCG. Eur Urol. 2014 Jan;65(1):69-76. doi: 10.1016/j.eururo.2013.07.021. Epub 2013 Jul 24.

full_name: Maurizio Brausi

given: Maurizio

full_name: Richard Sylvester

family: Bono

full_name: Aldo Bono

given: Aldo

title: Side Effects of Bacillus Calmette-Guérin (BCG) in the Treatment of Intermediate- and High-risk Ta, T1 Papillary Carcinoma of the Bladder: Results of the EORTC Genito-Urinary Cancers Group Randomised Phase 3 Study Comparing One-third Dose with Full Dose and 1 Year with 3 Years of Maintenance BCG

ReferenceCitation: Oddens J, Brausi M, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Hoeltl W, Turkeri L, Marreaud S, Collette S, Oosterlinck W. Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guérin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance. Eur Urol. 2013 Mar;63(3):462-72. doi: 10.1016/j.eururo.2012.10.039. Epub 2012 Nov 2.

title: Final Results of an EORTC-GU Cancers Group Randomized Study of Maintenance Bacillus Calmette-Guérin in Intermediate- and High-risk Ta, T1 Papillary Carcinoma of the Urinary Bladder: One-third Dose Versus Full Dose and 1 Year Versus 3 Years of Maintenance

location_country:
Italy
Austria
Netherlands
France
Greece
Israel
Romania
Belgium
Portugal
Turkey
United Kingdom

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: St. James's University Hospital at Leeds Teaching Hospital NHS Trust

location_facility: Dokuz Eylul University School of Medicine

location_facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

location_facility: Azienda Ospedale S. Luigi - Universita Di Turin

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Azienda Ospedaliera Maggiore Della Carita


title: Chlorambucil Versus 2x2 Gy Involved Field Radiotherapy in Stage III/IV Previously Untreated Follicular Lymphoma Patients. A Prospective, Randomized Phase III Clinical Trial

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chlorambucil is more effective than radiation therapy in treating follicular lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of radiation therapy in treating patients who have stage III or stage IV follicular lymphoma that has not been previously treated.

ReferenceCitation: Haas RL, Girinsky T. HOVON 47/EORTC 20013: chlorambucil vs 2x2 Gy involved field radiotherapy in stage III/IV previously untreated follicular lymphoma patients. Ann Hematol. 2003 Jul;82(7):458-62. Epub 2003 May 20.

lead_sponsor: Commissie Voor Klinisch Toegepast Onderzoek

location_country: Belgium France Netherlands

location_facility: Daniel Den Hoed Cancer Center at Erasmus University Medical Center


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Anti-viral Efficacy of Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

summary: The objective of the study is to evaluate the anti-viral efficacy of 3 different dosages of masitinib in patients with symptomatic mild to moderate COVID-19.

status: Recruiting

ipd_sharing_description: Masitinib is under clinical investigation and has not yet been approved in any sought-after indication by any health authority worldwide. As such, there is no plan for data-sharing at this point in time.

lead_sponsor: AB Science

location_country:
South Africa
Russian Federation
France

location_facility: Intensive Care Unit, CHU Gabriel-Montpied

location_facility: Gabrichevsky Institute of Epidemiology and Microbiology

status_simplified: Ongoing


title: A Phase 2 Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis

summary:
This is an open-label, multicenter, Phase 2 study in subjects with previously treated patients with light chain (AL) amyloidosis in need for therapy.

Approximately 35 subjects will receive therapy with belantamab mafodotin. Subject participation will include a Screening Phase, a Treatment Phase, a Post-Treatment Observation Phase, and a Long-term Follow-up Phase.

A safety run-in will be conducted in 6 subjects treated with belantamab mafodotin for at least 1 cycle.

According to the two-stage statistical design of the study, an interim analysis of efficacy will occur. If after 15 patients have been enrolled at least 3 complete or very good partial responses have been recorded, the accrual will continue until all planned patients have been enrolled

lead_sponsor: European Myeloma Network

location_country:
Italy
Netherlands
France
Greece
Germany
United Kingdom

location_facility: Centre hospitalier Universitaire de Limoges -

location_facility: Fondazione I.R.C.C.S Policlinico "San Matteo"


title: Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours

acronym: BoB

summary:
The Global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations.

The objective of module 1 will be to determine the overall response rate by RECIST 1.1 of atezolizumab in several arms. Subjects will be separated into arms depending on the mutations of their tumour. All patients in genomically selected populations will receive atezolizumab 1200 mg IV every 3 weeks

lead_sponsor: Vall d'Hebron Institute of Oncology

location_country:
Sweden
Netherlands
France
Spain
Germany
United Kingdom


title: A Phase II Trial in Patients With Early Cervical Cancer to Study The Safety and The Immunological Effects of Vaccination With TA-HPV, A Live Recombinant Vaccinia Virus Expressing The Human Papilloma Virus 16 and 18 E6 and E7 Proteins

summary:
RATIONALE: Vaccines made from human papillomavirus may make the body build an immune response to and kill cervical cancer cells. Combining vaccine therapy with surgery may be a more effective treatment for cervical cancer.

PURPOSE: This phase II trial is studying how well giving vaccine therapy together with surgery works in treating patients with early cervical cancer.

location_country:
Austria
Sweden
Netherlands
France
Norway
Germany
United Kingdom

location_facility: I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Velindre Cancer Center at Velinde Hospital