title: A Phase III Randomized, Double Blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer

summary: The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated. After signing consent there can be up to 28 days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a complete physical exam and vital signs. Treatment will be given in 21 day cycles with sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every cycle after the first 2 cycles. During the weekly visits the subjects will be check for any side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will be followed for overall survival.

ReferenceCitation: Baselga J, Costa F, Gomez H, Hudis CA, Rapoport B, Roche H, Schwartzberg LS, Petrenciuc O, Shan M, Gradishar WJ. A phase 3 tRial comparing capecitabinE in combination with SorafenIb or pLacebo for treatment of locally advanced or metastatIc HER2-Negative breast CancEr (the RESILIENCE study): study protocol for a randomized controlled trial. Trials. 2013 Jul 22;14:228. doi: 10.1186/1745-6215-14-228.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Baselga J, Zamagni C, Gomez P, Bermejo B, Nagai SE, Melichar B, Chan A, Mangel L, Bergh J, Costa F, Gomez HL, Gradishar WJ, Hudis CA, Rapoport BL, Roche H, Maeda P, Huang L, Meinhardt G, Zhang J, Schwartzberg LS. RESILIENCE: Phase III Randomized, Double-Blind Trial Comparing Sorafenib With Capecitabine Versus Placebo With Capecitabine in Locally Advanced or Metastatic HER2-Negative Breast Cancer. Clin Breast Cancer. 2017 Dec;17(8):585-594.e4. doi: 10.1016/j.clbc.2017.05.006. Epub 2017 May 22.

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
Onyx Therapeutics, Inc.

location_country:
Germany
Ireland
Poland
Argentina
Australia
Japan
Czechia
Canada
France
Hungary
United States
Belgium
China
Puerto Rico
Italy
United Kingdom
Sweden
Austria
Spain
Greece
South Africa
Russian Federation
Israel


title: BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

summary: The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
France
Italy
Hungary
Norway
Denmark
Sweden
Netherlands
Austria
Belgium
South Africa
Czech Republic

location_facility: 1160.19.43001 A.ö. Krankenhaus d. Statutarstadt Wiener Neustadt

location_facility: 1160.19.36004 Bács-Kiskun County Hospital

location_facility: 1160.19.39004 Ospedale di Circolo di Varese

location_facility: 1160.19.46004 Ortopediska kliniken, Länssjukhuset, Halmstad

location_facility: 1160.19.45042 Orthopedic Surgical Clinic

location_facility: 1160.19.39003 U. O. Ortopedia e Traumatologia

location_facility: 1160.19.46006 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.46009 Sahlgrenska Universitetssjukhuset, Mölndal

location_facility: 1160.19.39001 IRCCS Policlinico San Matteo

location_facility: 1160.19.42003 University Hospital Ostrava

location_facility: 1160.19.31006 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.36001 Kálmán Pándy County Hospital

location_facility: 1160.19.39005 Modulo Coordinazione Dipartimentale di Ricerca e Anestesia

location_facility: 1160.19.46003 Ortopediska kliniken, Länssjukhuset i Kalmar

location_facility: 1160.19.31003 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.42009 University Hospital Na Bulovce

location_facility: 1160.19.36002 Albert Szent-Györgyi Medical and Pharmacological Center

location_facility: 1160.19.31004 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.43004 Krankenhaus der Barmherzigen Schwestern Linz

location_facility: 1160.19.32006 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.39002 Fondazione Centro S. Raffaele

location_facility: 1160.19.46005 Kirurg Ortopediska kliniken, Sjukhuset i Lidköping

location_facility: 1160.19.47003 Helse Sunnmøre HF, Ålesund sykehus

location_facility: 1160.19.35801 Oulun yliopistollinen sairaala, Leikkaus- ja tehohoidon yks.

location_facility: 1160.19.47002 Sykehuset Telemark HF, Avd. Skien

location_facility: 1160.19.47001 Nordlandssykehuset HF, Bodø

location_facility: 1160.19.31001 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.43002 Orthopädisches Spital Speising

location_facility: 1160.19.47007 Sykehuset Innlandet HF, Avd. Elverum

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis

summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

study_start_date_type: Actual

study_completion_date_type: Actual

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Cutolo M, Myerson GE, Fleischmann RM, Liote F, Diaz-Gonzalez F, Van den Bosch F, Marzo-Ortega H, Feist E, Shah K, Hu C, Stevens RM, Poder A. A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial. J Rheumatol. 2016 Sep;43(9):1724-34. doi: 10.3899/jrheum.151376. Epub 2016 Jul 15.

ReferenceType: derived

ReferenceCitation: Mease PJ, Gladman DD, Kavanaugh A, McGonagle D, Nash P, Guerette B, Nakasato P, Brunori M, Teng L, McInnes IB. Articular and Extra-Articular Benefits in ACR20 Non-responders at Week 104 Treated With Apremilast: Pooled Analysis of Three Randomized Controlled Trials. Rheumatol Ther. 2021 Dec;8(4):1677-1691. doi: 10.1007/s40744-021-00369-x. Epub 2021 Sep 18.

ReferenceCitation: Mease PJ, Gladman DD, Ogdie A, Coates LC, Behrens F, Kavanaugh A, McInnes I, Queiro R, Guerette B, Brunori M, Teng L, Smolen JS. Treatment-to-Target With Apremilast in Psoriatic Arthritis: The Probability of Achieving Targets and Comprehensive Control of Disease Manifestations. Arthritis Care Res (Hoboken). 2020 Jun;72(6):814-821. doi: 10.1002/acr.24134. Epub 2020 May 8.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repositories_concat: PubMed Central;eprints.gla.ac.uk

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

ReferenceCitation: Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central;aleph.bib-bvb.de

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Gladman DD, Kavanaugh A, Gomez-Reino JJ, Wollenhaupt J, Cutolo M, Schett G, Lespessailles E, Guerette B, Delev N, Teng L, Edwards CJ, Birbara CA, Mease PJ. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018.

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

repository_institution: University of Massachusetts Medical School - eScholarship@UMMS

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

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

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Estonia
Belgium
United States
Spain
South Africa
Taiwan
Czechia
Bulgaria
Canada
Russian Federation
France

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Clinical and Translational Research Center of Alabama, PC

location_facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski

location_facility: City Clinical Hospital #1 n.a. N.I.Pirogov

location_facility: Seconda Universita degli Studi di Napoli

location_facility: St.Petersburg State Medical Academy n. a. I.I.Mechnikov

location_facility: Tacoma Center for Arthritis Research, PS

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: NZOZ Osteo-Medic sc A. Racewicz J. Supronik

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej REUMED

location_facility: Associated Internal Medical Specialist, PC

location_facility: Centre For Rheumatology, Immun. And Arthritis

location_facility: Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher

location_facility: Diagnostic-Consultative Center Sveta Anna

location_facility: Unifour Medical Research Associatets LLC

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

location_facility: Basingstoke and North Hampshire Hospital

location_facility: 17 Diagnostic and Consulting Centre Sofia EOOD

location_facility: Klinikum der Johann-Wolfgang Goethe-Universität


type: Other Identifier

title: A 52 Week Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Center, Multinational Trial In Islet Cell Transplant Subjects With Type 1 Diabetes Mellitus To Determine If The Early Use Of Liraglutide As An Adjunct To Standard Care Increases The Proportion Of Subjects Achieving Insulin Independence After First Transplantation

summary: This trial is conducted in Europe and North America. The aim of this trial is to investigate if liraglutide treatment can increase the proportion of insulin-independent subjects one year after islet cell transplantation who required only one (single-donor) islet cell transplant.

status: Terminated

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
United Kingdom
Switzerland
United States
Canada
France

status_simplified: Unknown


title: A Single-arm Study to Demonstrate the Efficacy and Safety of Privigen in the Treatment of Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

summary: The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.

ReferenceType: result

ReferenceCitation: Leger JM, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Shebl A, Bauhofer A, Zenker O, Merkies IS; PRIMA study investigators. Efficacy and safety of Privigen((R)) in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single-arm, open-label Phase III study (the PRIMA study). J Peripher Nerv Syst. 2013 Jun;18(2):130-40. doi: 10.1111/jns5.12017.

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;archive.ugent.be

ReferenceCitation: Merkies ISJ, Lawo JP, Edelman JM, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Leger JM; PRIMA trial investigators. Minimum clinically important difference analysis confirms the efficacy of IgPro10 in CIDP: the PRIMA trial. J Peripher Nerv Syst. 2017 Jun;22(2):149-152. doi: 10.1111/jns.12204. No abstract available.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

lead_sponsor: CSL Behring

location_country: Finland Germany Poland Belgium France

intervention_type: Biological


acronym: Full STEP™

summary: This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.

ReferenceCitation: Rodbard HW, Visco VE, Andersen H, Hiort LC, Shu DH. Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial. Lancet Diabetes Endocrinol. 2014 Jan;2(1):30-7. doi: 10.1016/S2213-8587(13)70090-1. Epub 2013 Sep 25. Erratum In: Lancet Diabetes Endocrinol. 2014 Jan;2(1):e3.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

title: A Randomised, Controlled, Open Label, Multicentre, Multinational, Treat-to-target Trial Investigating the Efficacy and Safety of Intensification With Addition of Bolus Insulin Aspart in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin With or Without Oral Anti-diabetic Drugs: Step-wise Addition Versus Complete Basal-bolus Therapy

source: euctr

location_country: Macedonia, The Former Yugoslav Republic of


title: TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI

acronym: TOTAL

summary: This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.

ReferenceCitation: Jolly SS, Cairns J, Yusuf S, Meeks B, Shestakovska O, Thabane L, Niemela K, Steg PG, Bertrand OF, Rao SV, Avezum A, Cantor WJ, Pancholy SB, Moreno R, Gershlick A, Bhindi R, Welsh RC, Cheema AN, Lavi S, Rokoss M, Dzavik V. Design and rationale of the TOTAL trial: a randomized trial of routine aspiration ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI. Am Heart J. 2014 Mar;167(3):315-321.e1. doi: 10.1016/j.ahj.2013.12.002. Epub 2013 Dec 14.

ReferenceCitation: Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.

oa_colors: green other

evidence: open (via free article)

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

repository_normalized: dnet

version: submittedVersion

repositories:
PubMed Central
dnet

repositories_concat: PubMed Central;dnet

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Alkhalil M, Kuzemczak M, Zhao R, Kavvouras C, Cantor WJ, Overgaard CB, Lavi S, Sharma V, Chowdhary S, Stankovic G, Kedev S, Bernat I, Bhindi R, Sheth T, Niemela K, Jolly SS, Dzavik V. Prognostic Role of Residual Thrombus Burden Following Thrombectomy: Insights From the TOTAL Trial. Circ Cardiovasc Interv. 2022 May;15(5):e011336. doi: 10.1161/CIRCINTERVENTIONS.121.011336. Epub 2022 May 17.

oa_host_type: publisher

evidence: open (via free pdf)

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Moxham R, Dzavik V, Cairns J, Natarajan MK, Bainey KR, Akl E, Tsang MB, Lavi S, Cantor WJ, Madan M, Liu YY, Jolly SS. Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial. JAMA Netw Open. 2021 Mar 1;4(3):e213505. doi: 10.1001/jamanetworkopen.2021.3505.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: PubMed Central

publisher_dissemination: American Medical Association

ReferenceCitation: Jolly SS, Cairns JA, Lavi S, Cantor WJ, Bernat I, Cheema AN, Moreno R, Kedev S, Stankovic G, Rao SV, Meeks B, Chowdhary S, Gao P, Sibbald M, Velianou JL, Mehta SR, Tsang M, Sheth T, Dzavik V; TOTAL Investigators. Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1589-1596. doi: 10.1016/j.jacc.2018.07.047.

ReferenceCitation: Sheth TN, Kajander OA, Lavi S, Bhindi R, Cantor WJ, Cheema AN, Stankovic G, Niemela K, Natarajan MK, Shestakovska O, Tittarelli R, Meeks B, Jolly SS. Optical Coherence Tomography-Guided Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneous Coronary Intervention Alone Trial. Circ Cardiovasc Interv. 2016 Apr;9(4):e003414. doi: 10.1161/CIRCINTERVENTIONS.115.003414.

ReferenceCitation: Jolly SS, Cairns JA, Yusuf S, Rokoss MJ, Gao P, Meeks B, Kedev S, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Bernat I, Cantor WJ, Cheema AN, Steg PG, Welsh RC, Sheth T, Bertrand OF, Avezum A, Bhindi R, Natarajan MK, Horak D, Leung RC, Kassam S, Rao SV, El-Omar M, Mehta SR, Velianou JL, Pancholy S, Dzavik V; TOTAL Investigators. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016 Jan 9;387(10014):127-35. doi: 10.1016/S0140-6736(15)00448-1. Epub 2015 Oct 22.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Jolly SS, Cairns JA, Yusuf S, Meeks B, Gao P, Hart RG, Kedev S, Stankovic G, Moreno R, Horak D, Kassam S, Rokoss MJ, Leung RC, El-Omar M, Romppanen HO, Alazzoni A, Alak A, Fung A, Alexopoulos D, Schwalm JD, Valettas N, Dzavik V; TOTAL Investigators. Stroke in the TOTAL trial: a randomized trial of routine thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction. Eur Heart J. 2015 Sep 14;36(35):2364-72. doi: 10.1093/eurheartj/ehv296. Epub 2015 Jun 29.

ReferenceCitation: Williams PD, Mamas MA, Fraser DG. A coronary artery cast. Can J Cardiol. 2011 Nov-Dec;27(6):871.e5-6. doi: 10.1016/j.cjca.2011.08.108. Epub 2011 Oct 14. No abstract available.

location_facility: Heart Center, Tampere University Hospital

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: University of New Mexico Health Sciences Center

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

location_facility: The Tenth People's Hospital Tongji University

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Yueyang Hospital Shanghai University of TCM

location_facility: Semmelweis University Heart and Vascular Center

location_facility: Barts and The London Heart and Chest Centre

location_facility: Queen Elizabeth the Queen Mother Hospital

location_facility: The First People's Hospital, Jiatong University

location_facility: Lindner Research Center at Christ Hospital

location_facility: Soonchunhyang University Cheonan Hospital

location_facility: Frimley Park Hospital, NHS Foundation Trust

location_facility: Hampshire Hospitals NHS Fuondation Trust


lead_sponsor: Amgen

summary: The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.

ReferenceCitation: Newland A, Godeau B, Priego V, Viallard JF, Lopez Fernandez MF, Orejudos A, Eisen M. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016 Jan;172(2):262-73. doi: 10.1111/bjh.13827. Epub 2015 Nov 5.

ReferenceCitation: Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.

ReferenceCitation: Kuter DJ, Newland A, Chong BH, Rodeghiero F, Romero MT, Pabinger I, Chen Y, Wang K, Mehta B, Eisen M. Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies. Br J Haematol. 2019 May;185(3):503-513. doi: 10.1111/bjh.15803. Epub 2019 Feb 21.

ReferenceCitation: Kuter DJ, Arnold DM, Rodeghiero F, Janssens A, Selleslag D, Bird R, Newland A, Mayer J, Wang K, Olie R. Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials. Am J Hematol. 2020 Jun;95(6):643-651. doi: 10.1002/ajh.25776. Epub 2020 Mar 21.

title: A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim

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


title: A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia

summary: The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.

ReferenceCitation: Glina S, Roehrborn CG, Esen A, Plekhanov A, Sorsaburu S, Henneges C, Buttner H, Viktrup L. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. J Sex Med. 2015 Jan;12(1):129-38. doi: 10.1111/jsm.12714. Epub 2014 Oct 29.

publisher_dissemination: Oxford University Press

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Poland
Argentina
Brazil
Mexico
Belgium
United States
Greece
Turkey
Canada
Russian Federation
France

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


title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus

summary: The primary objective of this study is to evaluate the efficacy of a 200 micrograms (mcg) dose of CEP-33457 compared with placebo in participants with active systemic lupus erythematosus (SLE) as assessed by the proportion of participants achieving a combined clinical response using the SLE responder index (SRI) at Week 24.

lead_sponsor: Cephalon, Inc.

location_country:
Germany
Poland
Portugal
Hungary
United Kingdom
Belgium
United States
Spain
Czechia
Ukraine
France

location_facility:
Teva Investigational Site 752
Teva Investigational Site 9
Teva Investigational Site 39
Teva Investigational Site 802
Teva Investigational Site 12
Teva Investigational Site 8
Teva Investigational Site 21
Teva Investigational Site 203
Teva Investigational Site 30
Teva Investigational Site 29
Teva Investigational Site 602
Teva Investigational Site 33
Teva Investigational Site 10
Teva Investigational Site 16
Teva Investigational Site 36
Teva Investigational Site 301
Teva Investigational Site 24
Teva Investigational Site 15
Teva Investigational Site 700
Teva Investigational Site 800
Teva Investigational Site 302
Teva Investigational Site 400
Teva Investigational Site 2
Teva Investigational Site 500
Teva Investigational Site 900
Teva Investigational Site 606
Teva Investigational Site 502
Teva Investigational Site 1
Teva Investigational Site 22
Teva Investigational Site 406
Teva Investigational Site 23
Teva Investigational Site 25
Teva Investigational Site 26
Teva Investigational Site 605
Teva Investigational Site 904
Teva Investigational Site 703
Teva Investigational Site 201
Teva Investigational Site 803
Teva Investigational Site 32
Teva Investigational Site 601
Teva Investigational Site 7
Teva Investigational Site 102
Teva Investigational Site 100
Teva Investigational Site 303
Teva Investigational Site 403
Teva Investigational Site 28
Teva Investigational Site 5
Teva Investigational Site 901
Teva Investigational Site 13
Teva Investigational Site 18
Teva Investigational Site 404
Teva Investigational Site 903
Teva Investigational Site 402
Teva Investigational Site 200
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acronym: HEPCAT

lead_sponsor: Bristol-Myers Squibb

summary: To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

ReferenceCitation: Hezode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, Thuluvath PJ, Tatum HA, Waked I, Esmat G, Lawitz EJ, Rustgi VK, Pol S, Weis N, Pockros PJ, Bourliere M, Serfaty L, Vierling JM, Fried MW, Weiland O, Brunetto MR, Everson GT, Zeuzem S, Kwo PY, Sulkowski M, Brau N, Hernandez D, McPhee F, Wind-Rotolo M, Liu Z, Noviello S, Hughes EA, Yin PD, Schnittman S. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015 Jun;64(6):948-56. doi: 10.1136/gutjnl-2014-307498. Epub 2014 Jul 30.

publisher_dissemination: British Medical Journal

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

location_facility: Upper Delaware Valley Infectious Diseases, Pc

location_facility: University Of California, San Francisco/Sf General Hospital

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: Transplant Center And Hepatology Clinic, B-154

location_facility: University Of North Carolina At Chapel Hill School Of Med

title: A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

location_country:
Germany
Italy
Denmark
Australia
Sweden
Mexico
United States
Canada
Puerto Rico
Egypt
France


acronym: SPARK

lead_sponsor: Novartis Pharmaceuticals

summary: This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.

ReferenceCitation: Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandstrom T, Taylor AF, D'Andrea P, Arrasate C, Chen H, Banerji D. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013 May;1(3):199-209. doi: 10.1016/S2213-2600(13)70052-3. Epub 2013 Apr 23.

title: A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

location_country:
Finland
Germany
Ireland
Poland
Argentina
Canada
France
Czech Republic
Colombia
Slovakia
Hungary
Denmark
United States
India
Peru
Estonia
Puerto Rico
Philippines
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Russian Federation
Israel


title: A 24-month, Multi-center, Open-label, Randomized, Controlled Trial to Investigate Efficacy, Safety and Evolution of Cardiovascular Parameters in de Novo Renal Transplant Recipients After Early Calcineurin Inhibitor to Everolimus Conversion

acronym: ELEVATE

summary: The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients

location_country:
Germany
Argentina
Australia
Thailand
Turkey
France
Lithuania
Portugal
Latvia
India
Romania
Belgium
Estonia
Italy
Norway
Netherlands
Austria
Mexico
Spain
Greece
Russian Federation


title: A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY2382770 in Patients With Diabetic Kidney Disease Due to Type 1 or Type 2 Diabetes

summary: The purpose of this study is to determine if LY2382770 is safe and effective at protecting kidney function in participants with kidney disease due to diabetes.

ipd_sharing: Yes

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Hungary
Israel
Australia
United States
Czechia
Puerto Rico
France


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

ReferenceCitation: Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repositories_concat: PubMed Central;dash.harvard.edu

ReferenceCitation: Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.

ReferenceCitation: Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.

ReferenceCitation: Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

ReferenceCitation: Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

ReferenceCitation: John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.

ReferenceCitation: Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

ReferenceCitation: Lavalle-Gonzalez FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.

repository_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.

ReferenceCitation: Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.

ReferenceCitation: Cefalu WT, Stenlof K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.

ReferenceCitation: Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.

ReferenceCitation: Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.

ReferenceCitation: Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.

ReferenceCitation: Polidori D, Mari A, Ferrannini E. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes. Diabetologia. 2014 May;57(5):891-901. doi: 10.1007/s00125-014-3196-x. Epub 2014 Mar 1.

ReferenceCitation: Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

location_country:
Guatemala
Hungary
Israel
United Kingdom
Australia
Mexico
Belgium
United States
Spain
Puerto Rico
Russian Federation
France


lead_sponsor: Seagen Inc.

summary: This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).

ReferenceCitation: Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. doi: 10.1016/S0140-6736(15)60165-9. Epub 2015 Mar 19. Erratum In: Lancet. 2015 Aug 8;386(9993):532. Lancet. 2015 Aug 8;386(9993):532.

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

ReferenceCitation: Moskowitz CH, Walewski J, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Viviani S, Bachanova V, Sureda A, McClendon T, Lee C, Lisano J, Sweetenham J. Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018 Dec 20;132(25):2639-2642. doi: 10.1182/blood-2018-07-861641. Epub 2018 Sep 28.

publisher_dissemination: American Society of Hematology

sponsor_collaborators:
Seagen Inc.
Millennium Pharmaceuticals, Inc.

location_facility: Medical Center of the University of Pecs, 1st Clinic for Internal Medicine

location_facility: Vseobecni fakultni nemocnice v Prahe-I. interni klinika

location_facility: Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju

location_facility: Service des Maladies du Sang / Hospital Saint Louis

location_facility: University of Chicago Section of Hematology/Oncology Lymphoma Program

location_facility: Federal Medical Biophysical Center n.a. A.I. Burnazyan

location_facility: Leningradskaja oblastnaja klinicheskaja bol'nica

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

location_facility: Guy's Hospital Haematology Department, 4th Floor Southwark Wing

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN

location_facility: Virginia Commonwealth University Medical Center

location_facility: Complejo Hospitalano de Navarra Servicio Hematologia

location_facility: Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno

location_facility: Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne

location_facility: Oregon Health and Science University / Center for Hematologic Malignancies

location_facility: Sverdlovskaja oblastnaja klinicheskaja bol'nica #1

location_facility: Klinika Hematologii, Instytut Hematologii i Transfuzjologii

location_facility: Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly

location_facility: Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380

location_facility: Hospital Clinic i Provincial Servicio Hematologia

location_facility: Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Burdenko Central Military Clinical Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular

location_facility: Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

location_facility: Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

location_facility: Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Vojnomedicinska akademija, Klinika za hematologiju

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego

location_facility: Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: James Cancer Hospital / Ohio State University

location_facility: Washington University School of Medicine

location_facility: Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach

location_facility: Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

location_facility: Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Instituto di Ematologia ed Oncologia Medica

location_facility: CHU Nantes - Hopital Hotel Dieu Service Hematologie

location_facility: University of California at San Francisco

location_facility: Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie

location_facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center

location_facility: Klinicki centar Srbije, Klinika za hematologiju

location_facility: Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

location_facility: Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania

location_facility: Respublikanskaja bol'nica im. V.A. Baranova

location_facility: St. Petersburg Pavlov State Medical University

title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Romania
United States
Spain
Czechia
Bulgaria
Serbia
Russian Federation
France


acronym: CADMUS

lead_sponsor: Janssen Research & Development, LLC

summary: This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.

ReferenceCitation: Leu JH, Shiff NJ, Clark M, Bensley K, Lomax KG, Berezny K, Nelson RM, Zhou H, Xu Z. Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations. Paediatr Drugs. 2022 Nov;24(6):699-714. doi: 10.1007/s40272-022-00533-y. Epub 2022 Sep 28.

ReferenceCitation: Landells I, Marano C, Hsu MC, Li S, Zhu Y, Eichenfield LF, Hoeger PH, Menter A, Paller AS, Taieb A, Philipp S, Szapary P, Randazzo B. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015 Oct;73(4):594-603. doi: 10.1016/j.jaad.2015.07.002. Epub 2015 Aug 7.

title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)

location_country:
Germany
Portugal
Hungary
United Kingdom
Sweden
Belgium
Canada
Ukraine
Russian Federation
France


title: A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride

summary: The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.

ReferenceCitation: Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.

ReferenceCitation: Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.

ReferenceCitation: Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015 Dec;38(12):2241-9. doi: 10.2337/dc14-1625. Epub 2015 Jun 18.

publisher_dissemination: American Diabetes Association

location_country:
Poland
Argentina
Australia
Brazil
Croatia
Canada
France
Czech Republic
Slovakia
Hungary
India
Romania
Belgium
Italy
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Sweden

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


acronym: COMPOSE EARLY

summary: A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.

title: A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)

location_country:
Finland
Germany
Ireland
Italy
Poland
Hungary
Israel
United Kingdom
Japan
United States
Korea, Republic of
Spain
South Africa
Canada
Czech Republic
France


title: A European, Prospective, Non-Interventional Study to Assess Health Related Quality of Life and to Identify Key Transitional Life Events in Patients With Moderate or Severe Haemophilia A Using Helixate NexGen

summary: The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The study will also assess the kinds of determinants, including key transitional life events, that might impact HRQoL in this patient population.

study_type: Observational

time_perspective: Prospective

location_country: Germany Italy Switzerland Austria Belgium Spain France

location_facility:
CSLB Study Site 66
CSLB Study Site 68
CSLB Study Site 21
CSLB Study Site 36
CSLB Study Site 91
CSLB Study Site 95
CSLB Study Site 74
CSLB Study Site 20
CSLB Study Site 26
CSLB Study Site 25
CSLB Study Site 64
CSLB Study Site 29
CSLB Study Site 24
CSLB Study Site 51
CSLB Study Site 1
CSLB Study Site 72
CSLB Study Site 35
CSLB Study Site 23
CSLB Study Site 65
CSLB Study Site 6
CSLB Study Site 3
CSLB Study Site 27
CSLB Study Site 4
CSLB Study Site 22
CSLB Study Site 73
CSLB Study Site 98
CSLB Study Site 71
CSLB Study Site 60
CSLB Study Site 7
CSLB Study Site 2
CSLB Study Site 52


acronym: CAMPANULA

lead_sponsor: Ipsen

summary: The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.

location_facility: Centrum Onkologii Instytut im.M. Sklodowskiej-Curie oddzial w Gliwicach

location_facility: Fakultní nemocnice Na Bulovce, Ústav radiační onkologie

location_facility: Donetsk National Medical University named after M. Gorkiy, Donetsk Regional Antitumor Center

location_facility: Uzhgorod national university, Postgraduate faculty, Uzhgorod Central City Clinical Hospital

location_facility: University Hospital, Internal Medicine - Oncology

location_facility: Voronezh Regional Clinical Oncology Dispensary

location_facility: Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways"

location_facility: Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea

location_facility: Latvian Oncology centre of Riga Eastern Clinical University Hospital

location_facility: Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan

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

location_facility: Akademiska Hospital, Dept of Oncology & Endocrinology

location_facility: Royal Preston Hospital, Sharoe Green Lane, Lancashire

location_facility: St-Petersburg State Institution of Public Health City Clinical Oncology dispensary

location_facility: Christie Hospital and Holt Radium Institute

location_facility: Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum

location_facility: St-Petersburg State Medical University named after academician Pavlov I.P.

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

title: Phase II, Open, Adaptive, Dose Escalating, Multicentre Titration Study to Assess the Efficacy and Safety of Repeated Subcutaneous Administration of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome

location_country:
Finland
Germany
Ireland
Italy
Poland
Slovakia
Israel
United Kingdom
Sweden
Netherlands
Austria
Belgium
Latvia
Spain
Czechia
Ukraine
Russian Federation
France


lead_sponsor: Astellas Pharma Inc

summary: The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.

location_facility: Site US55 Loyola University Hospital - Maywood

location_facility: Site ES1339 Hospital Universitario Ramon y Cajal

location_facility: Site ES2967 Hosptial Universitario Madrid Sanchinarro

location_facility: Site GB2624 The Christie NHS Foundation Trust

location_facility: Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel

location_facility: Site US2149 Gabrail Cancer Center Research

location_facility: Site US402 University of Texas Health Science Center - San Antonio

location_facility: Site ES1346 Hospital Universitario de Salamanca

title: A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin's Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant

location_country:
United States
Spain
United Kingdom
France


title: Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study

summary: The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

design_allocation: Non-Randomized

primary_purpose: Other

location_country:
Argentina
Brazil
Costa Rica
Thailand
Chile
Canada
France
Colombia
Portugal
Hungary
United States
Dominican Republic
Indonesia
Malaysia
Peru
Puerto Rico
Italy
Guatemala
Singapore
Mexico
Spain
Panama
South Africa
Taiwan
Russian Federation

location_facility:
St Josephs Cmprhnsv Rsch Inst
Tarrant County Inf Dis Assoc
Cri Of New England
Rand Schrader Clinic
University Of Nebraska Medical Center
St Francis Memorial Hospital
Infectious Disease Of Indiana, Psc
The Schrader Clinic
Clinical Research Puerto Rico, Inc.
Jemsek Clinic
V.A. Medical Center
Local Institution
Phoenix Body Positive, Inc
Univ Of Kansas Sch Of Med
Sbma Research, Llc


title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

summary: The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

ReferenceCitation: McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.

repository_institution: University of Hull - Repository@Hull (Worktribe)

repository_institution: King's College London - Research Portal

repository_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Jones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.

ReferenceCitation: Jones PW, Lamarca R, Chuecos F, Singh D, Agusti A, Bateman ED, de Miquel G, Caracta C, Garcia Gil E. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18.

publisher_dissemination: European Respiratory Society

ReferenceCitation: Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6. doi: 10.1183/09031936.00225511. Epub 2012 Mar 22.

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
Poland
Hungary
Spain
South Africa
Peru
Ukraine
Czech Republic
Russian Federation
France

location_facility:
Almirall Investigational Sites#6
Almirall Investigational Sites#8
Almirall Investigational Sites#7
Almirall Investigational Sites#1
Almirall Investigational Sites#14
Almirall Investigational Sites#3
Almirall Investigational Sites#12
Almirall Investigational Sites#24
Almirall Investigational Sites#25
Almirall Investigational Sites#5
Almirall Investigational Sites#9
Almirall Investigational Sites#19
Almirall Investigational Sites#10
Almirall Investigational Site#2
Almirall Investigational Sites#15
Almirall Investigational Sites#23
Almirall Investigational Site#16
Almirall Investigational Site#10
Almirall Investigational Site#7
Almirall Investigational Sites#11
Almirall Investigational Sites#13
Almirall Investigational Sites#18
Almirall Investigational Sites#4
Almirall Investigational Sites#16
Almirall Investigational Site#11
Almirall Investigational Sites#21
Almirall Investigational Sites#20
Almirall Investigational Sites#2


summary: The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.

ReferenceCitation: Price T, Kim TW, Li J, Cascinu S, Ruff P, Suresh AS, Thomas A, Tjulandin S, Guan X, Peeters M. Final results and outcomes by prior bevacizumab exposure, skin toxicity, and hypomagnesaemia from ASPECCT: randomized phase 3 non-inferiority study of panitumumab versus cetuximab in chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer. Eur J Cancer. 2016 Nov;68:51-59. doi: 10.1016/j.ejca.2016.08.010. Epub 2016 Oct 5.

ReferenceCitation: Price TJ, Peeters M, Kim TW, Li J, Cascinu S, Ruff P, Suresh AS, Thomas A, Tjulandin S, Zhang K, Murugappan S, Sidhu R. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol. 2014 May;15(6):569-79. doi: 10.1016/S1470-2045(14)70118-4. Epub 2014 Apr 14.

ReferenceCitation: Kim TW, Peeters M, Thomas A, Gibbs P, Hool K, Zhang J, Ang AL, Bach BA, Price T. Impact of Emergent Circulating Tumor DNA RAS Mutation in Panitumumab-Treated Chemoresistant Metastatic Colorectal Cancer. Clin Cancer Res. 2018 Nov 15;24(22):5602-5609. doi: 10.1158/1078-0432.CCR-17-3377. Epub 2018 Jun 13.

ReferenceCitation: Peeters M, Price T, Boedigheimer M, Kim TW, Ruff P, Gibbs P, Thomas A, Demonty G, Hool K, Ang A. Evaluation of Emergent Mutations in Circulating Cell-Free DNA and Clinical Outcomes in Patients with Metastatic Colorectal Cancer Treated with Panitumumab in the ASPECCT Study. Clin Cancer Res. 2019 Feb 15;25(4):1216-1225. doi: 10.1158/1078-0432.CCR-18-2072. Epub 2018 Nov 28.

ReferenceCitation: Price T, Ang A, Boedigheimer M, Kim TW, Li J, Cascinu S, Ruff P, Satya Suresh A, Thomas A, Tjulandin S, Peeters M. Frequency of S492R mutations in the epidermal growth factor receptor: analysis of plasma DNA from patients with metastatic colorectal cancer treated with panitumumab or cetuximab monotherapy. Cancer Biol Ther. 2020 Oct 2;21(10):891-898. doi: 10.1080/15384047.2020.1798695. Epub 2020 Oct 7.

ReferenceCitation: Taniguchi H, Yamanaka T, Sakai D, Muro K, Yamazaki K, Nakata S, Kimura H, Ruff P, Kim TW, Peeters M, Price T. Efficacy of Panitumumab and Cetuximab in Patients with Colorectal Cancer Previously Treated with Bevacizumab; a Combined Analysis of Individual Patient Data from ASPECCT and WJOG6510G. Cancers (Basel). 2020 Jun 28;12(7):1715. doi: 10.3390/cancers12071715.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories:
PubMed Central
irua

repositories_concat: PubMed Central;irua

publisher_dissemination: MDPI

ReferenceCitation: Graham CN, Maglinte GA, Schwartzberg LS, Price TJ, Knox HN, Hechmati G, Hjelmgren J, Barber B, Fakih MG. Economic Analysis of Panitumumab Compared With Cetuximab in Patients With Wild-type KRAS Metastatic Colorectal Cancer That Progressed After Standard Chemotherapy. Clin Ther. 2016 Jun;38(6):1376-1391. doi: 10.1016/j.clinthera.2016.03.023. Epub 2016 Apr 13.

title: A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer

location_country:
Poland
Australia
Czechia
Canada
Serbia
France
Lithuania
Slovakia
Hong Kong
United States
Latvia
India
Romania
Belgium
China
Malaysia
Peru
Philippines
Italy
United Kingdom
Singapore
Sweden
Netherlands
Korea, Republic of
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma

acronym: DREAM

summary: The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.

ReferenceCitation: Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4.

ReferenceCitation: Kim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26.

publisher_dissemination: Korean Association of Internal Medicine

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available.

ReferenceCitation: Ortega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15.

repository_institution: University of Southampton - ePrints Soton

ReferenceCitation: Gunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16.

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

ReferenceCitation: Ortega H, Li H, Suruki R, Albers F, Gordon D, Yancey S. Cluster analysis and characterization of response to mepolizumab. A step closer to personalized medicine for patients with severe asthma. Ann Am Thorac Soc. 2014 Sep;11(7):1011-7. doi: 10.1513/AnnalsATS.201312-454OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Prazma CM, Wenzel S, Barnes N, Douglass JA, Hartley BF, Ortega H. Characterisation of an OCS-dependent severe asthma population treated with mepolizumab. Thorax. 2014 Dec;69(12):1141-2. doi: 10.1136/thoraxjnl-2014-205581. Epub 2014 May 16.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
United Kingdom
Argentina
Romania
Australia
United States
Korea, Republic of
Chile
Canada
Ukraine
Russian Federation
France


lead_sponsor: Bial - Portela C S.A.

summary: The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.

ReferenceCitation: Mintz M, Pina-Garza JE, Wolf SM, McGoldrick PE, Jozwiak S, Grinnell T, Cantu D, Costa R, Moreira J, Li Y, Blum D. Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures. J Child Neurol. 2020 Mar;35(4):265-273. doi: 10.1177/0883073819890997. Epub 2019 Dec 26.

evidence: open (via page says license)

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: SAGE Publications

location_facility: Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology

location_facility: Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology

location_facility: Hospital Raja Perempuan Zainab II - Jabatan Paediatrik

location_facility: Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic

location_facility: Children Neurology Dept., Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie

location_facility: Department of Paediatric, Clarendon Wing, Leeds General Infirmary

location_facility: Hospital Sant Joan de Déu, Dep. Neuropediatría

location_facility: Spitalul Clinic de Urgenta pentru copii Luis Turcanu, Clinica de Psihiatrie si Neurologie pentru copii si adolescenti

location_facility: AKADEMIA MEDYCZNA im. Karola Marcinkowskiego w Poznaniu Katedra I Klinika Neurologii Wieku Rozwojowego

location_facility: Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1

location_facility: Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Department of Neurolog, Regional Pediatric Clinical Hospital No. 1 Ekaterinburg

location_facility: Perpetual Succour Hospital - Neuroscience Center, 7/F SPC Medical Specialty Center

location_facility: Institute of Neurology, Psychiatry and Narcology, AMS of Ukraine Acad.

location_facility: Taipei Veterans General Hospital - Department of Paediatrics

location_facility: University Putra Malaysia/Hospital Serdang - Department of Paediatrics, Faculty of Medicine and Health Sciences

location_facility: Clinical hospital Osjek Pediatric clinic, neuropediatric department

location_facility: Servizio di Neuropsichiatria Infantile Policlinico "G.B. Rossi" Borgo Roma

location_facility: Children Neurology Clinic, University Hospital Motol

location_facility: Child Neurology Service, Institute of Mother and Child Healthcare of Serbia "Dr. Vukan Cupic"

location_facility: Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department

location_facility: WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIĘCY im. ŚW. LUDWIKA W KRAKOWIE

location_facility: Hospital Son Dureta, Dep. Neuropediatría

location_facility: Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien

location_facility: Hospital Materno Infantil Virgen de las Nieves

location_facility: Pediatric Scientific-practical Center of cranio-facial surgery and neurology

location_facility: Nizhny Novgorod State Medical Academy Pediatric City Clinical Hospital No. 1

location_facility: Clinical Centre Banja Luka Pediatric Clinic Department of Neurology

location_facility: Research Center of Children Health of RAMS

location_facility: Azienda Ospedaliera Universitaria Senese Ospedale Santa Maria alle Scotte Dipartimento materno infantile Struttura Complessa di Pediatria

location_facility: IMSP Centrul National Stiintifico-Practic Medicina de Urgenta

location_facility: A.O.U. di Cagliari Clinica di neurologia infantile

location_facility: Tempus, s.r.o.Child Epileptology Ambulance

location_facility: Ukrainian Medical Rehabilitation Centre for Children with Organic Disorders of Nervous System

location_facility: Jose R. Reyes Memorial Medical Center - 5th Floor, Training and Research Office, Jose Reyes Memorial Hospital

location_facility: Children Neurology Dept., Institute of Child- and Adolescent Health Care of Vojvodina

location_facility: Clinica de Neurologie Peciatrica, Spitalul "Alexandru Obregia"

location_facility: IMAS Hospital del Mar - Servicio de Pediatria

location_facility: Manila Doctors Hospital - Child Nueroscience Center

location_facility: Clinic of Neurology and Psychiatry for Children and Youth

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

location_facility: Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz

location_facility: SAMODZIELNY PUBLICZNY SZPITAL KLINICZNY NR 6 ŚLĄSKIEJ AKADEMII MEDYCZNEJ W KATOWICACH GÓRNOŚLĄSKIE CENTRUM ZDROWIA DZIECKA I MATKI IM. JANA PAWŁA II Klinika Pediatrii i Neurologii Wieku Rozwojowego

location_facility: Clinical Centre Nis, Clinic of Children Internal Diseases, Child Neurology Department

location_facility: Université Paris Descartes, Hopital Necker-Enfants Malades, Département de Neuropédiatrie

location_facility: Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù

location_facility: Clinical Hospital for children, Paediatric Neurology clinic

location_facility: Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii

location_facility: National Taiwan University Hospital - Department of Paediatrics

location_facility: Child Neurology Clinic of the DNsP Ostrava

location_facility: Pécsi Tudományegyetem AOK Gyermekklinika

location_facility: Hospital Clínico San Carlos, Servicio de Neurología Pediátrica

location_facility: Hospital pediatrics of Odessa State Medical University Odessa

title: Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children

location_country:
Germany
Poland
Bosnia and Herzegovina
Croatia
Czechia
Serbia
France
Portugal
Slovakia
Hungary
Ukraine
Romania
Malaysia
Moldova, Republic of
Philippines
Italy
United Kingdom
Austria
Spain
Taiwan
Russian Federation


title: A Randomised, Placebo-controlled Trial of Erythropoietin in ICU Patients With Traumatic Brain Injury

acronym: EPO-TBI

summary: This study seeks to determine if erythropoietin alpha (EPO) administered to adult critical care patients with moderate or severe traumatic brain injury improves neurological function assessed at six months after injury.

ReferenceCitation: Skrifvars MB, Bailey M, Moore E, Martensson J, French C, Presneill J, Nichol A, Little L, Duranteau J, Huet O, Haddad S, Arabi YM, McArthur C, Cooper DJ, Bendel S, Bellomo R; Erythropoietin in Traumatic Brain Injury (EPO-TBI) Investigators and the Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group. A Post Hoc Analysis of Osmotherapy Use in the Erythropoietin in Traumatic Brain Injury Study-Associations With Acute Kidney Injury and Mortality. Crit Care Med. 2021 Apr 1;49(4):e394-e403. doi: 10.1097/CCM.0000000000004853.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;ora.ox.ac.uk

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

ReferenceCitation: Skrifvars MB, Moore E, Martensson J, Bailey M, French C, Presneill J, Nichol A, Little L, Duranteau J, Huet O, Haddad S, Arabi Y, McArthur C, Cooper DJ, Bellomo R; EPO-TBI Investigators and the ANZICS Clinical Trials Group. Erythropoietin in traumatic brain injury associated acute kidney injury: A randomized controlled trial. Acta Anaesthesiol Scand. 2019 Feb;63(2):200-207. doi: 10.1111/aas.13244. Epub 2018 Aug 21.

ReferenceCitation: Nichol A, French C, Little L, Haddad S, Presneill J, Arabi Y, Bailey M, Cooper DJ, Duranteau J, Huet O, Mak A, McArthur C, Pettila V, Skrifvars M, Vallance S, Varma D, Wills J, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group. Erythropoietin in traumatic brain injury (EPO-TBI): a double-blind randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2499-506. doi: 10.1016/S0140-6736(15)00386-4. Epub 2015 Oct 6.

ReferenceCitation: Nichol A, French C, Little L, Presneill J, Cooper DJ, Haddad S, Duranteau J, Huet O, Skrifvars M, Arabi Y, Bellomo R; EPO-TBI Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial. Trials. 2015 Feb 8;16:39. doi: 10.1186/s13063-014-0528-6.

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;www.lenus.ie

ReferenceCitation: Presneill J, Little L, Nichol A, French C, Cooper DJ, Haddad S, Duranteau J, Huet O, Skrifvars M, Arabi Y, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group. Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury. Trials. 2014 Dec 20;15:501. doi: 10.1186/1745-6215-15-501.

ReferenceCitation: Moore EM, Bellomo R, Nichol AD. Erythropoietin as a novel brain and kidney protective agent. Anaesth Intensive Care. 2011 May;39(3):356-72. doi: 10.1177/0310057X1103900306.

lead_sponsor: Australian and New Zealand Intensive Care Research Centre

collaborators: National Health and Medical Research Council, Australia

location_country:
Finland
Ireland
Germany
New Zealand
Australia
Saudi Arabia
France

location_facility:
Royal Hobart Hospital
Beaumont Hospital
Liverpool Hospital
The Alfred Hospital
Christchurch Hospital
The Townsville Hospital
Gold Coast University Hospital
CHU de Rouen
Hôpital universitaire Caremeau
Royal North Shore Hospital
John Hunter Hospital
Westmead Hospital
Hôpital Michallon
Kuopio University Hospital
St Vincent's Hospital Sydney
Royal Adelaide Hosptial
King Fahad National Guard Hospital
Royal Perth Hospital
Dunedin Hospital
Wellington Regional Hospital
The Royal Melbourne Hospital
Helsinki University Central Hospital
Canberra Hospital
Royal Prince Alfred Hospital
Hôpital Lariboisière
Auckland City Hospital
Hôpital de Bicêtre
Johannes Gutenberg-Universtität


title: 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

summary: This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.

enrollment_type: Anticipated

ReferenceCitation: Stocchi F, Rascol O, Destee A, Hattori N, Hauser RA, Lang AE, Poewe W, Stacy M, Tolosa E, Gao H, Nagel J, Merschhemke M, Graf A, Kenney C, Trenkwalder C. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord. 2013 Nov;28(13):1838-46. doi: 10.1002/mds.25561. Epub 2013 Jul 12.

lead_sponsor: Novartis

location_country: Finland Germany Italy Australia Japan Spain Canada France

location_facility: Parkinson's and Neurodegenerative Disorders Clinic

location_facility: Quebec Memory & Motor Skills Disorders Clinic


title: A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin

summary:
The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment.

The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

ReferenceCitation: Riddle MC, Forst T, Aronson R, Sauque-Reyna L, Souhami E, Silvestre L, Ping L, Rosenstock J. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1). Diabetes Care. 2013 Sep;36(9):2497-503. doi: 10.2337/dc12-2462. Epub 2013 Apr 5.

ReferenceCitation: Davidson JA, Stager W, Paranjape S, Berria R, Leiter LA. Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data. Clin Diabetes Endocrinol. 2020 Jan 14;6:2. doi: 10.1186/s40842-019-0088-5. eCollection 2020.

ReferenceCitation: Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.

repositories_concat: PubMed Central;ricerca.uniba.it

ReferenceCitation: Charbonnel B, Bertolini M, Tinahones FJ, Domingo MP, Davies M. Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis. J Diabetes Complications. 2014 Nov-Dec;28(6):880-6. doi: 10.1016/j.jdiacomp.2014.07.007. Epub 2014 Jul 18.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University of Leicester - Leicester Research Archive

repositories_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Riddle MC, Aronson R, Home P, Marre M, Niemoeller E, Miossec P, Ping L, Ye J, Rosenstock J. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013 Sep;36(9):2489-96. doi: 10.2337/dc12-2454. Epub 2013 Apr 29.

location_country:
Germany
Poland
Argentina
Brazil
Chile
Canada
France
Czech Republic
Colombia
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location_facility: Sanofi-Aventis Investigational Site Number 076207

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title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Using Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism

summary: Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant.

location_country:
Germany
Italy
Poland
Australia
Switzerland
Austria
Belgium
United States
Spain
Canada
France


title: Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

summary: The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.

lead_sponsor: Sequenom, Inc.

sponsor_collaborators:
Sequenom, Inc.
PRA Health Sciences

location_country:
United States
France

location_facility: Spectrum Health - Maternal Fetal Medicine

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Fetal Diagnostic Institution of the Pacific

location_facility: Centre Hospitalier Regional et Universitaire - Hopital Bretonneau


lead_sponsor: Centocor, Inc.

summary: This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad) on patients with chronic sarcoidosis with pulmonary and/or skin involvement. Patients with pulmonary involvement constitute the primary population for analysis, and patients with skin involvement constitute the secondary population; a patient may be in both populations. The study will be conducted at approximately 40 sites globally.

ReferenceCitation: Judson MA, Mack M, Beaumont JL, Watt R, Barnathan ES, Victorson DE. Validation and important differences for the Sarcoidosis Assessment Tool. A new patient-reported outcome measure. Am J Respir Crit Care Med. 2015 Apr 1;191(7):786-95. doi: 10.1164/rccm.201410-1785OC.

ReferenceCitation: Crommelin HA, Vorselaars AD, van Moorsel CH, Korenromp IH, Deneer VH, Grutters JC. Anti-TNF therapeutics for the treatment of sarcoidosis. Immunotherapy. 2014;6(10):1127-43. doi: 10.2217/imt.14.65.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Judson MA, Baughman RP, Costabel U, Drent M, Gibson KF, Raghu G, Shigemitsu H, Barney JB, Culver DA, Hamzeh NY, Wijsenbeek MS, Albera C, Huizar I, Agarwal P, Brodmerkel C, Watt R, Barnathan ES. Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis. Eur Respir J. 2014 Nov;44(5):1296-307. doi: 10.1183/09031936.00000914. Epub 2014 Jul 17.

title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study Evaluating the Safety and Efficacy of Treatment With Ustekinumab or Golimumab in Subjects With Chronic Sarcoidosis

location_country:
Germany
Norway
United Kingdom
Denmark
Romania
Netherlands
Belgium
United States
France