lead_sponsor: Genentech, Inc.

summary: This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

ReferenceCitation: Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31.

sponsor_collaborators:
Genentech, Inc.
Roche Pharma AG

location_facility: Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken

location_facility: CHU De Caen; Service De Neurologie Dejerine

location_facility: Michigan Institute for Neurological Disorders

location_facility: Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology

location_facility: University of Virginia - Fontain Research Park

location_facility: Fakultni nemocnice Motol; Neurologicka klinika

location_facility: Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: Uni of British Columbia Hospital; Ms Clinical Research Group

location_facility: Shepherd Center; Multiple Sclerosis Center

location_facility: Uni Hospital Queens Medical Centre; Neurology

location_facility: Spitalul Clinic Colentina; Clinica de Neurologie

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

location_facility: CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge

location_facility: Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: Central Clinical Hospital #2 N.A. Semashko OAO RJHD

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: Shat of Cardiovascular Diseases; Clinic of Neurology

location_facility: McGill University; Montreal Neurological Institute; Neurological and Psychiatric

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Columbia University Medical Center; The Neurological Institute of New York

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: Hospital Universitario La Fe; Unidad de Esclerosis Multiple

location_facility: Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases

location_facility: Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states

location_facility: Clinical Center Nis; Clinic for Mental Health

location_facility: UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY

location_facility: Ohio State University Med Ctr; MS Center

location_facility: Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT

location_facility: Krajska Nemocnice Pardubice Neurologicka Klinika

location_facility: SHI Sverdlovsk Regional Clinical Hospital #1;Neurology

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

location_facility: MRC for Oncology and Neurology; Neurology

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU

location_facility: Nemocnica s Poliklinikou Spisska Nova Ves, a.s.

location_facility: Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie

location_facility: Fletcher Allen Health Care/University of Vermont

location_facility: CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY

location_facility: Clinical Center of Serbia; Institute of Neurology

location_facility: Fakultna Nemocnica Nitra; Neurologicka Klinika

location_facility: Legacy Health System; Clinical Research & Tech Ctr

location_facility: East Bay Physicians Med Group;Sutter East Bay Med Foundation

location_facility: LLC Research Medical Complex Vashe Zdorovie

location_facility: Suny At Stony Brook; Department Of Neurology

location_facility: Asklepios Klinik Nord-Heidberg; Neurologie

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie

location_facility: Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum

location_facility: Dartmouth-Hitchcock Medical Center; Dept of Neurology

title: Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS

location_country:
Germany
Italy
Slovakia
United Kingdom
Denmark
Romania
Switzerland
Mexico
Belgium
United States
Spain
Czechia
Ukraine
Bulgaria
Canada
Serbia
Russian Federation
France

status_simplified: Ongoing


title: Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes

summary: This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum In: Diabetes Ther. 2020 Dec;11(12):3011-3013.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

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_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Informa

ReferenceCitation: Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.

ReferenceCitation: Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer

ReferenceCitation: Russell-Jones D, Cuddihy RM, Hanefeld M, Kumar A, Gonzalez JG, Chan M, Wolka AM, Boardman MK; DURATION-4 Study Group. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012 Feb;35(2):252-8. doi: 10.2337/dc11-1107. Epub 2011 Dec 30.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Eli Lilly and Company

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Canada
France
Slovakia
Hungary
United States
India
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Russian Federation
Israel

location_facility:
Research SIte
Research Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy

acronym: REFINE-ICD

summary: This study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack in the prior 5 years, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Perkiomaki J, Exner DV, Piira OP, Kavanagh K, Lepojarvi S, Talajic M, Karvonen J, Philippon F, Junttila J, Coutu B, Huikuri H. Heart Rate Turbulence and T-Wave Alternans in Patients with Coronary Artery Disease: The Influence of Diabetes. Ann Noninvasive Electrocardiol. 2015 Sep;20(5):481-7. doi: 10.1111/anec.12244. Epub 2015 Jan 15.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ipd_sharing: Undecided

ipd_sharing_description: uncertain

lead_sponsor: University of Calgary

collaborators: Canadian Institutes of Health Research (CIHR)

location_country:
Finland
Germany
Italy
Slovakia
Hungary
Norway
United Kingdom
Sweden
Belgium
United States
Saudi Arabia
Spain
South Africa
Canada
France

location_facility: CHRU Brest - Hôpital de la Cavale Blanche

location_facility: Aurora St. Luke's Medical Center/Aurora Cardiovascular Services

location_facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS)

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Northeast Ohio Cardiovascular Specialists

location_facility: HUCH Helsinki University Central Hospital

location_facility: Hospital Universitario Clinic de Barcelona

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: St. Paul's Hospital/Providence Health Care

location_facility: Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)

location_facility: Hospital General Universitario de Alicante (HGUA)

location_facility: Libin Cardiovascular Institute of Alberta

location_facility: Associated Cardiovascular Consultants/Lourdes Cardiology Services

location_facility: Hôpital Guillaume et René Laënnec - CHU de Nantes

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection Versus Amiodarone in Subjects With Recent Onset Atrial Fibrillation

acronym: AVRO

summary: The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The secondary objective is to compare the safety of vernakalant to amiodarone.

ReferenceCitation: Camm AJ, Capucci A, Hohnloser SH, Torp-Pedersen C, Van Gelder IC, Mangal B, Beatch G; AVRO Investigators. A randomized active-controlled study comparing the efficacy and safety of vernakalant to amiodarone in recent-onset atrial fibrillation. J Am Coll Cardiol. 2011 Jan 18;57(3):313-21. doi: 10.1016/j.jacc.2010.07.046.

lead_sponsor: Advanz Pharma

location_country:
Finland
France
Germany
Lithuania
Poland
Slovakia
Denmark
Australia
Sweden
Netherlands
Latvia
Ukraine
Canada
Estonia
Serbia
Czech Republic

location_facility: Latvian Center of Cardiology, P. Stradins Clinical University Hospital

location_facility: Middle Slovak Institute of Cardiovascular Diseases (SUSCCH)

location_facility: Royal Hobart Hospital Cardiology Research

location_facility: Oulu University Hospital - Dept of Internal Medicine

location_facility: Kiev City Clinical Hospital No 5, Coronary Care Unit

location_facility: East Tallinn Central Hospital-Clinic of Cardiology

location_facility: Slovensky ustav srdcovych a cevnych chorob

location_facility: Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre Dept of Myocardial Infarction

location_facility: Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

location_facility: Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Szpital Wojewódzki im. Jana Bożego w Lublinie

location_facility: Herzzentrum Brandenburg in Bernau Innere Medizin

location_facility: Universitätsklinikum Bonn, Med. Klinik und Poliklinik II

location_facility: Institute of Treatment and Reahabilitation 'Niska Banja'

location_facility: Johann Wolfgang Goethe Universitaet Med Klinik III - Kardiologie

location_facility: Interna klinika FN Trnava, Fakultna nemocnica Trnava

location_facility: Robert-Bosch-Krankenhaus, Abt. Kardiologie / Pulmologie

location_facility: Szpital Miejski im. J. Brudzinskiego Oddzial Kardiologii

location_facility: Medizinische Klinik, Klinikum Hannover Nordstadt

location_facility: Kaunas Medical University Hospital - Department of Cardiology

location_facility: Launceston General Hospital Cardiac Research Unit

location_facility: CHU de Nancy - Hopital Brabois - Service de Cardiologie

location_facility: Clinical Center of Serbia, Institute of CV Diseases

location_facility: Klinikum der Universität Köln, Medizinische Klinik III

location_facility: Klinika Chorob Wewnetrznych z Oddzialem Farmakologii Klinicznej i Terapii Monitorowanej

location_facility: N.D. Strazhesko Institute of Cardiology Intensive Care Unit

location_facility: Nemocnice Kutna Hora s.r.o. Interni Oddeleni

location_facility: City Clinical Hospital #1 Intensive Care Unit

location_facility: Vilnius University Hospital Santariskiu Clinic - Center of Cardiology and Angiology

location_facility: Centre de santé et de services sociaux du Sud de Lanaudière - Hôpital Pierre-Le Gardeur

location_facility: Klinikum Pirna GmbH, Innere Medizin II, Kardiologie

location_facility: McGill University Health Center The Montreal General Hospital

location_facility: Gentofte Amtssygehus Kardiologisk afdeling

location_facility: Lugansk First Clinical Multiprofile Hospital #1, Cardiology

location_facility: Hopital Trousseau - Service de Cardiologie

location_facility: WCN - Department of Cardiology Rijnstate Ziekenhuls

location_facility: Oddział Kardiologiczno-Internistyczny Specjalistyczny Szpital Miejski im. Mikołaja Kopernika

location_facility: Oblastni nemocnice Pribram Interni Oddeleni

location_facility: Charite Campus Mitte, Med. Klinik und Poliklinik mit Schwerpunkt Kardiologie und Angiologie

location_facility: III Klinika Chorob Wewnetrznych i Kardiologii

location_facility: Osrodek Chorob Serca, Klinika Kardiologii, 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny

location_facility: City Clinical Hospital #9 Dept of Arrhythmia

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Ustredni vojenska nemocnice Koronarni jednotka

location_facility: Ambulantes Herzzentrum Kassel Innere Medizin

location_facility: Campus Virchow-Klinikum, Charite - Universitaetsmedizin Berlin

location_facility: Clinical Center Zemun, Dept. of Cardiology

location_facility: Klinika Kardiologii Zachowawczej Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie

location_facility: Oddzial Kardiologii Inwazyjnej Szpital Specjalistyczny im. E.Szczeklika w Tarnowie

location_facility: CHU de Strasbourg - Hopital Hautepierre - Service de Cardiologie

location_facility: Okregowy Szpital Kolejowy w Lublinie Samodzielny

location_facility: Martin-Luther Universitat Halle, Med. Klinik und Poliklinik III- Fachrichtung Kardiologie

location_facility: Centre Hopitalier de L'Universite de Montreal - Hotel Dieu

location_facility: Oddzial Kardiologiczny Wielospecjalityczny Szpital Miejski im.


intervention_type: Biological

lead_sponsor: Eli Lilly and Company

summary:
This multicenter study will enroll approximately 185 participants with metastatic or advanced sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication. Participants will be stratified into five tiers according to diagnosis:

Ewing's sarcoma/peripheral neuroectodermal tumor (PNET)
rhabdomyosarcoma
leiomyosarcoma
adipocytic sarcoma
synovial sarcoma.

A total of 85 participants will be enrolled initially, 17 in each tier. Participants will receive single agent IMC-A12 every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.

Safety and response in the initial 17 participants in each tier will be used to determine whether to extend enrollment to the target total of 37 participants per tier.

ReferenceCitation: Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.

title: A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent Every 2 Weeks in Patients With Previously-Treated, Advanced or Metastatic Soft Tissue and Ewing's Sarcoma/PNET

type: EudraCT Number

type: Other Identifier

source: euctr

location_country:
Germany
Poland
Netherlands
Belgium
United States
Spain
France


acronym: Pediatric trial with Intelence as an Active NNRTI Option (PIANO)

lead_sponsor: Tibotec Pharmaceuticals, Ireland

summary: The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.

ReferenceCitation: Tambuyzer L, Thys K, Hoogstoel A, Nijs S, Tomaka F, Opsomer M, De Meyer S, Vingerhoets J. Assessment of etravirine resistance in HIV-1-infected paediatric patients using population and deep sequencing: final results of the PIANO study. Antivir Ther. 2016;21(4):317-27. doi: 10.3851/IMP3011. Epub 2015 Nov 13.

publisher_dissemination: SAGE Publications

title: A Phase II, Open-label Trial, to Evaluate the Safety, Tolerability and Antiviral Activity of TMC125 in Antiretroviral Experienced HIV-1 Infected Children and Adolescents

location_country:
Portugal
United Kingdom
Argentina
Romania
Brazil
Netherlands
United States
Spain
Thailand
South Africa
Canada
Puerto Rico
France


title: MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid for the Treatment of Subjects With Acute Exacerbations of Chronic Bronchitis.

summary: A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.

ReferenceType: result

ReferenceCitation: Wilson R, Anzueto A, Miravitlles M, Arvis P, Farago G, Haverstock D, Trajanovic M, Sethi S. A novel study design for antibiotic trials in acute exacerbations of COPD: MAESTRAL methodology. Int J Chron Obstruct Pulmon Dis. 2011;6:373-83. doi: 10.2147/COPD.S21071. Epub 2011 Jun 29.

ReferenceCitation: Wilson R, Anzueto A, Miravitlles M, Arvis P, Haverstock D, Trajanovic M, Sethi S. Prognostic factors for clinical failure of exacerbations in elderly outpatients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2015 Jun 2;10:985-93. doi: 10.2147/COPD.S80926. eCollection 2015.

repository_institution: Imperial College London - Spiral

repositories_concat: PubMed Central;spiral.imperial.ac.uk

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

lead_sponsor: Bayer

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Thailand
Croatia
Chile
Pakistan
Canada
France
Czech Republic
Andorra
Lithuania
Colombia
Portugal
Hong Kong
Switzerland
Latvia
Indonesia
Belgium
China
Peru
Philippines
Italy
United Kingdom
Netherlands
Mexico
Spain
Greece
South Africa


title: A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With Neurogenic Detrusor Overactivity

acronym: SONIC

summary: A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder symptoms due to spinal cord injury or multiple sclerosis

study_start_date_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

location_country:
Germany
Italy
Hungary
United Kingdom
Australia
Netherlands
Belgium
Spain
Czechia
Russian Federation
France


lead_sponsor: H. Lundbeck A/S

summary: This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.

status: Terminated

title: Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active Referenced Study of Lu AA34893 to Evaluate the Efficacy and Safety of Three Doses Lu AA34893 in the Treatment of Depression in Patients With Bipolar I or II Disorder

location_country:
Germany
Lithuania
Poland
Bulgaria
Slovakia
United Kingdom
Romania
Australia
Sweden
Austria
Belgium
Korea, Republic of
Malaysia
Taiwan
Canada
Ukraine
Philippines
France


title: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Investigate The Clinical Efficacy And Safety of DiaPep277® in Newly Diagnosed Type 1 Diabetes Patients

acronym: DIA-AID

summary: The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.

ReferenceCitation: Raz I, Ziegler AG, Linn T, Schernthaner G, Bonnici F, Distiller LA, Giordano C, Giorgino F, de Vries L, Mauricio D, Prochazka V, Wainstein J, Elias D, Avron A, Tamir M, Eren R, Peled D, Dagan S, Cohen IR, Pozzilli P; DIA-AID 1 Writing Group. Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial. Diabetes Care. 2014;37(5):1392-400. doi: 10.2337/dc13-1391.

RetractionSource: Diabetes Care. 2015 Jan;38(1):178

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

unpaywall_oa_status: hybrid

publisher_dissemination: American Diabetes Association

ReferenceCitation: Pozzilli P, Raz I, Peled D, Elias D, Avron A, Tamir M, Eren R, Dagan S, Cohen IR. Evaluation of long-term treatment effect in a type 1 diabetes intervention trial: differences after stimulation with glucagon or a mixed meal. Diabetes Care. 2014;37(5):1384-91. doi: 10.2337/dc13-1392. Epub 2014 Jan 9.

RetractionSource: Diabetes Care. 2015 Jan;38(1):179

oa_host_type: publisher

evidence: open (via crossref license)

lead_sponsor: Andromeda Biotech Ltd.

location_country:
Finland
Germany
Italy
Israel
United Kingdom
Austria
Spain
Greece
South Africa
Czech Republic
France

location_facility: Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin

location_facility: Diabetes Centre for Children and Adolescents

location_facility: Hospital Nuestra Señora de La Candelaria


title: A Randomized, Phase 2 Study Of FOLFOX Or FOLFIRI With AG-013736 Or Bevacizumab (Avastin) In Patients With Metastatic Colorectal Cancer After Failure Of An Irinotecan Or Oxaliplatin-Containing First-Line Regimen

summary: The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.

lead_sponsor: Pfizer

location_country:
Italy
Poland
Japan
United States
Korea, Republic of
Spain
Canada
France


title: A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a GHRH Analog, in HIV Subjects With Excess Abdominal Fat Accumulation

summary: Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation

ReferenceCitation: Fourman LT, Czerwonka N, Feldpausch MN, Weiss J, Mamputu JC, Falutz J, Morin J, Marsolais C, Stanley TL, Grinspoon SK. Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV. AIDS. 2017 Oct 23;31(16):2253-2259. doi: 10.1097/QAD.0000000000001614.

version: acceptedVersion

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Stanley TL, Falutz J, Marsolais C, Morin J, Soulban G, Mamputu JC, Assaad H, Turner R, Grinspoon SK. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012 Jun;54(11):1642-51. doi: 10.1093/cid/cis251. Epub 2012 Apr 10.

ReferenceCitation: Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010 Sep;95(9):4291-304. doi: 10.1210/jc.2010-0490. Epub 2010 Jun 16.

ReferenceCitation: Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010 Mar;53(3):311-22. doi: 10.1097/QAI.0b013e3181cbdaff.

ipd_sharing: No

lead_sponsor: Theratechnologies

location_country:
United Kingdom
Belgium
United States
Spain
Canada
France

location_facility: Groupe de Recherche en Rhumatologie et maladies osseuses

location_facility: AIDS Community Research Initiative of America

location_facility: Indiana University Department of Medicine

location_facility: Centre Hospitalier Universitaire de Santé de l'Estrie

location_facility: McMaster University Health Sciences Centre

location_facility: University of North Carolina at Chapel Hill

location_facility: Infectious Disease Research Institute Inc.

location_facility: University of Texas Southwestern Medical Center at Dallas


title: A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 500mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent an

summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

ReferenceType: background

ReferenceCitation: Busse WW, Bleecker ER, Bateman ED, Lotvall J, Forth R, Davis AM, Jacques L, Haumann B, Woodcock A. Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Thorax. 2012 Jan;67(1):35-41. doi: 10.1136/thoraxjnl-2011-200308. Epub 2011 Aug 9.

ReferenceCitation: O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.

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
Australia
Estonia
Netherlands
Mexico
United States
Thailand
South Africa
Chile
Czechia
Bulgaria
Canada
Peru
Russian Federation
France


acronym: EMERALD 2

lead_sponsor: Affymax

summary: The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.

ReferenceCitation: Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A; EMERALD Study Groups. Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Med. 2013 Jan 24;368(4):307-19. doi: 10.1056/NEJMoa1203165.

oa_colors: green other

evidence: open (via free article)

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Macdougall IC, Provenzano R, Sharma A, Spinowitz BS, Schmidt RJ, Pergola PE, Zabaneh RI, Tong-Starksen S, Mayo MR, Tang H, Polu KR, Duliege AM, Fishbane S; PEARL Study Groups. Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis. N Engl J Med. 2013 Jan 24;368(4):320-32. doi: 10.1056/NEJMoa1203166.

sponsor_collaborators: Affymax Takeda

location_facility:
Research Facility
Research Facilities (2)

title: AFX01-14: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin

location_country:
Germany
Italy
Poland
United Kingdom
Romania
United States
Spain
Bulgaria
France


title: A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

acronym: SCORE

summary: This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of progression of structural joint damage in participants with active rheumatoid arthritis who had an inadequate clinical response to methotrexate. Participants were randomized to receive rituximab 500 mg intravenously (iv), rituximab 1000 mg iv, or placebo iv on days 1 and 15 every 24 weeks in the main study; all participants received concomitant methotrexate at a stable dose of 12.5-25 mg/week throughout the study. Further courses of rituximab were provided to eligible participants. Structural joint damage was assessed by magnetic resonance imaging (MRI) at baseline and at intervals during the study.

ReferenceCitation: Peterfy C, Emery P, Tak PP, Ostergaard M, DiCarlo J, Otsa K, Navarro Sarabia F, Pavelka K, Bagnard MA, Gylvin LH, Bernasconi C, Gabriele A. MRI assessment of suppression of structural damage in patients with rheumatoid arthritis receiving rituximab: results from the randomised, placebo-controlled, double-blind RA-SCORE study. Ann Rheum Dis. 2016 Jan;75(1):170-7. doi: 10.1136/annrheumdis-2014-206015. Epub 2014 Oct 29.

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

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

publisher_dissemination: British Medical Journal

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Argentina
Brazil
Turkey
Canada
Serbia
France
Czech Republic
Lithuania
Denmark
Switzerland
Latvia
Romania
Estonia
Norway
Netherlands
Spain
Greece
Russian Federation


title: A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

summary: This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

ReferenceCitation: Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13.

ReferenceCitation: Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.

ReferenceCitation: Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.

lead_sponsor: Novartis

location_country:
Finland
France
Germany
Colombia
India
Italy
Slovakia
Hungary
Denmark
Iceland
Taiwan
Peru
Canada
Russian Federation
Czech Republic

location_facility:
Novartis Investigative Site
Novartis investigator site
Novartis Investgative Site
Novartis Investigator Site
Novartis Investigator site
novartis Investigator site


summary: Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors

ReferenceCitation: Juergens H, Daw NC, Geoerger B, Ferrari S, Villarroel M, Aerts I, Whelan J, Dirksen U, Hixon ML, Yin D, Wang T, Green S, Paccagnella L, Gualberto A. Preliminary efficacy of the anti-insulin-like growth factor type 1 receptor antibody figitumumab in patients with refractory Ewing sarcoma. J Clin Oncol. 2011 Dec 1;29(34):4534-40. doi: 10.1200/JCO.2010.33.0670. Epub 2011 Oct 24.

title: A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors

design_allocation: Non-Randomized

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Brazil
United States
Spain
Chile
Canada
France


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

summary: PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.

ReferenceCitation: MacNee W, Allan RJ, Jones I, De Salvo MC, Tan LF. Efficacy and safety of the oral p38 inhibitor PH-797804 in chronic obstructive pulmonary disease: a randomised clinical trial. Thorax. 2013 Aug;68(8):738-45. doi: 10.1136/thoraxjnl-2012-202744. Epub 2013 Mar 28.

evidence: open (via free pdf)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

location_country:
Hungary
Argentina
United Kingdom
Australia
Netherlands
Korea, Republic of
Greece
South Africa
Chile
Czechia
Canada
Russian Federation
France


title: AMR PH GL 2007 CL001 Phase 3 A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

summary: This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.

ReferenceCitation: von Pawel J, Jotte R, Spigel DR, O'Brien ME, Socinski MA, Mezger J, Steins M, Bosquee L, Bubis J, Nackaerts K, Trigo JM, Clingan P, Schutte W, Lorigan P, Reck M, Domine M, Shepherd FA, Li S, Renschler MF. Randomized phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer. J Clin Oncol. 2014 Dec 10;32(35):4012-9. doi: 10.1200/JCO.2013.54.5392. Epub 2014 Nov 10.

lead_sponsor: Celgene

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Australia
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Czechia
Bulgaria
Canada
France

location_facility: Little Rock Hematology Oncology Associates

location_facility: Universitair Ziekenhuis Antwerpen, Dept. Respiratory Diseases

location_facility: Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC

location_facility: Centre Hospitalier Notre-Dame et Reine Fabiola

location_facility: Katholisches Klinikum Mainz, St. Hildegardis Krankenhaus

location_facility: St. Vincentius-Kliniken Karlsruhe, Hamatologie, Med Onkologie und Immunologie

location_facility: CHU Montpellier - Unité de Cancérologie Thoracique

location_facility: Universitätsklinikum Essen Innere Klinik und Poliklinik

location_facility: Országos Korányi Tbc és Pulmonológiai Intézet

location_facility: Tulane University Health Sciences Center

location_facility: University of Minnesota Medical Center, Cancer Center

location_facility: The Princess Alexandra Hospital, Dept of Respiratory Medicine

location_facility: Cancer Care Associates of Fresno Medical Group, Inc.

location_facility: New South Wales Southern Medical Day Care Centre

location_facility: UZ Brussel, Medical Oncology and Hematology

location_facility: Fairfax Northern Virginia Hematology/Oncology

location_facility: Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: University of Colorado Health Science Centre

location_facility: Klinikum Mannheim GmbH, Chirugische Klinik, Thorakale Onkologie

location_facility: Odense Universitetshospital,Onkologisk afdeling R

location_facility: III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)

location_facility: Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie

location_facility: Policlinico di Modena - University of Modena & Reggio Emilia, Dept Oncology & Hematology

location_facility: The Sarah Cannon Research Institute/TN Oncology

location_facility: University Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: Comprehensive Care Centers of Nevada (Main)

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital General Universitario de Valencia

location_facility: Wojewódzki Szpital Chorób Pluc im Alojzego Pawelca w Wodzislawiu Slaskim

location_facility: Klinika Nowotworow Ukladowych i Uogolnionych Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie

location_facility: Hospital Universitario Virgin de la Victoria

location_facility: Rocky Mountain Cancer Center - Midtown (Main)

location_facility: Texas Cancer Center at Medical City (Main)

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg AG

location_facility: Cancer & Hematology Specialists of Chicago (Main)

location_facility: Joliet Oncology-Hematology Associates, Ltd.

location_facility: Zespol nr 1 Szpitala im. St. Leszczynskiego

location_facility: Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis

location_facility: Alliance Hematology Oncology, P.A. (Main)

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej

location_facility: Fakultní Thomayerova nemocnice s poliklinikou

location_facility: SUNY Upstate Medical University - Regional Oncology Center

location_facility: Staedtisches Krankenhaus Martha-Maria Halle-Doelau

location_facility: Northwest Cancer Specialists - Vancouver (Main)

location_facility: Fundación Jiménez Díaz. Universidad Autónoma de Madrid

location_facility: Michigan Hematology & Oncology Institute

location_facility: Duran i Reynals Institut Catala d'Oncologia

location_facility: Wielkopolskie Centrum Pulmonologii i Tarakochirurgii Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

location_facility: Krankenhaus Grosshansdorf, Zentrum fur Pneumologie und Thoraxchirurgie

location_facility: Fraser Valley Cancer Centre-Surrey Memorial Hospital


title: A Phase III, Randomized, Double-blind Trial of TMC278 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-naive HIV-1 Infected Subjects.

summary: The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource utilization and treatment adherence.

ReferenceCitation: Rimsky L, Van Eygen V, Hoogstoel A, Stevens M, Boven K, Picchio G, Vingerhoets J. 96-Week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials. Antivir Ther. 2013;18(8):967-77. doi: 10.3851/IMP2636. Epub 2013 May 28.

ReferenceCitation: Nelson M, Amaya G, Clumeck N, Arns da Cunha C, Jayaweera D, Junod P, Li T, Tebas P, Stevens M, Buelens A, Vanveggel S, Boven K; ECHO and THRIVE Study Groups. Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials. J Antimicrob Chemother. 2012 Aug;67(8):2020-8. doi: 10.1093/jac/dks130. Epub 2012 Apr 24.

ReferenceCitation: Cohen CJ, Andrade-Villanueva J, Clotet B, Fourie J, Johnson MA, Ruxrungtham K, Wu H, Zorrilla C, Crauwels H, Rimsky LT, Vanveggel S, Boven K; THRIVE study group. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011 Jul 16;378(9787):229-37. doi: 10.1016/S0140-6736(11)60983-5.

location_country:
Germany
Australia
Brazil
Costa Rica
Thailand
Chile
Canada
France
Portugal
United States
India
Belgium
China
Puerto Rico
United Kingdom
Mexico
Spain
Panama
South Africa
Russian Federation


title: A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.

summary: The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

ReferenceCitation: McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL, Balske A, Burgio DE, Sarley J, McCullough LK, Recker RR. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporos Int. 2012 Jan;23(1):267-76. doi: 10.1007/s00198-011-1791-y. Epub 2011 Sep 27.

lead_sponsor: Warner Chilcott

location_country:
Poland
Hungary
Argentina
Belgium
United States
Canada
Estonia
France

location_facility:
Research Facility
Research Site


title: A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer

summary: The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Poland
India
United States
Ukraine
Russian Federation
France

location_facility: Acrc/Arizona Clinical Research Center, Inc.

location_facility: Southwest Cancer Treatment And Research Center

location_facility: Birmingham Hematology & Oncology Assoc. Llc

location_facility: Cmc-Northeast/ Northeast Oncology Associates

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: The Angeles Clinic & Research Institute, Inc


title: Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure.

acronym: VERITAS 1

summary: The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.

ReferenceCitation: Cotter G, Davison BA, Milo O, Bourge RC, Cleland JG, Jondeau G, Krum H, O'Connor CM, Metra M, Parker JD, Torre-Amione G, van Veldhuisen DJ, Kobrin I, Rainisio M, Senger S, Edwards C, McMurray JJ, Teerlink JR; VERITAS Investigators. Predictors and Associations With Outcomes of Length of Hospital Stay in Patients With Acute Heart Failure: Results From VERITAS. J Card Fail. 2016 Oct;22(10):815-22. doi: 10.1016/j.cardfail.2015.12.017. Epub 2015 Dec 22.

repository_institution: The University of Glasgow - Enlighten: Publications

publisher_dissemination: Elsevier

ReferenceCitation: McMurray JJ, Teerlink JR, Cotter G, Bourge RC, Cleland JG, Jondeau G, Krum H, Metra M, O'Connor CM, Parker JD, Torre-Amione G, van Veldhuisen DJ, Lewsey J, Frey A, Rainisio M, Kobrin I; VERITAS Investigators. Effects of tezosentan on symptoms and clinical outcomes in patients with acute heart failure: the VERITAS randomized controlled trials. JAMA. 2007 Nov 7;298(17):2009-19. doi: 10.1001/jama.298.17.2009.

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Germany
Poland
Israel
United Kingdom
Denmark
Switzerland
Austria
United States
Greece
France

location_facility: Klinika Kardiologii i Chorob Wewnetrznych, Samodzielny Publiczny Szpital

location_facility: Cardio Centro Ticino, Servizio Cardiovasculare

location_facility: Advanced Heart Failure and Transplant Service, Palo Alto VA Health Care System, Cardiology Section

location_facility: Medizinische Klinik I, Universitatsklinikum Aachen

location_facility: AKH University of Vienna, Abt. Medizinische Kardiologie

location_facility: Hopital Ambroise Pare, Service de Cardiologie

location_facility: Campus Virchow-Klinikum, Medizinishe Klinik mit Schwerpunkt Kardiologie

location_facility: I Klinika Kardiolgii, Collegium Medicum UJ

location_facility: Georg-August-Universitat Gottingen, Zentrum fur Innere Med

location_facility: Klinika Chorob Serca, Akademia Medyczna w Gdansku

location_facility: The Heart Hospital at Alledgheny General, Division of Cardiology

location_facility: Institute of Cardiology College, College of Medicine of Jagellonian University

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Hopitaux Universitaires de Strasbourg, Hopital Hautepierre

location_facility: Dept. of Cardiology, University of Athens, Alexandra Hospital


acronym: Pediatric commitment 1month-4years

lead_sponsor: UCB Pharma SA

summary: Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.

ReferenceCitation: Weinstock A, Ruiz M, Gerard D, Toublanc N, Stockis A, Farooq O, Dilley D, Karmon Y, Elgie MJ, Schiemann-Delgado J. Prospective Open-Label, Single-Arm, Multicenter, Safety, Tolerability, and Pharmacokinetic Studies of Intravenous Levetiracetam in Children With Epilepsy. J Child Neurol. 2013 Nov;28(11):1423-1429. doi: 10.1177/0883073813480241. Epub 2013 Mar 26.

title: Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy

location_country:
Germany
Mexico
Belgium
United States
Turkey
France


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease

summary: 1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate the effects of AST-120 versus placebo, on other measures of renal function.

ReferenceCitation: Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Arita K, Kato A, Shimizu M. Randomized Placebo-Controlled EPPIC Trials of AST-120 in CKD. J Am Soc Nephrol. 2015 Jul;26(7):1732-46. doi: 10.1681/ASN.2014010042. Epub 2014 Oct 27.

ReferenceCitation: Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Shimizu M, Kikuchi M, Shobu Y. Risk factors for progression of chronic kidney disease in the EPPIC trials and the effect of AST-120. Clin Exp Nephrol. 2018 Apr;22(2):299-308. doi: 10.1007/s10157-017-1447-0. Epub 2017 Jul 24.

ReferenceCitation: Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Shimizu M, Shobu Y, Kikuchi M. The effects of AST-120 on chronic kidney disease progression in the United States of America: a post hoc subgroup analysis of randomized controlled trials. BMC Nephrol. 2016 Sep 30;17(1):141. doi: 10.1186/s12882-016-0357-9.

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

sponsor_collaborators:
Mitsubishi Tanabe Pharma Corporation
Kureha Corporation

location_country:
Italy
Poland
Argentina
Brazil
Mexico
United States
Czechia
Canada
Ukraine
Puerto Rico
Russian Federation
France


title: A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Co-administration of CP-690,550 and Mycophenolate Mofetil / Mycophenolate Sodium in De Novo Renal Allograft Recipients

summary: A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.

primary_purpose: Prevention

location_country:
France
Germany
Italy
Poland
Portugal
Norway
Australia
Brazil
Netherlands
Belgium
United States
Korea, Republic of
Spain
Canada
Czech Republic


acronym: MAZE

lead_sponsor: Eisai Inc.

summary: This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects. Assessment of eligibility will take place at the Screening Visit. The subjects will be randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1 must occur as soon as possible (and at least within 14 days) of the Screening Visit in order to optimize subject care.

ReferenceCitation: Baulac M, Brodie MJ, Patten A, Segieth J, Giorgi L. Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol. 2012 Jul;11(7):579-88. doi: 10.1016/S1474-4422(12)70105-9. Epub 2012 Jun 8.

title: A Randomized, Multi-centre, Double-blind Study, to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy

location_country:
Germany
Italy
Poland
India
Slovakia
Hungary
United Kingdom
Denmark
Australia
Sweden
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Serbia
Russian Federation
France


acronym: MAGE3-AS15-NSC-001 (ADJ-Chemo)

summary: The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. A course of eight injections will be administered over 21 weeks; including screening for suitability and all tests, the duration of the study for a patient will be 30-35 weeks. During this period various tests will be performed, including physical examinations and blood tests. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

ReferenceCitation: Pujol JL, Vansteenkiste JF, De Pas TM, Atanackovic D, Reck M, Thomeer M, Douillard JY, Fasola G, Potter V, Taylor P, Bosquee L, Scheubel R, Jarnjak S, Debois M, de Sousa Alves P, Louahed J, Brichard VG, Lehmann FF. Safety and Immunogenicity of MAGE-A3 Cancer Immunotherapeutic with or without Adjuvant Chemotherapy in Patients with Resected Stage IB to III MAGE-A3-Positive Non-Small-Cell Lung Cancer. J Thorac Oncol. 2015 Oct;10(10):1458-67. doi: 10.1097/JTO.0000000000000653.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

title: Cancer Immunotherapeutic GSK1572932A as Adjuvant Therapy for Patients With MAGE-A3-positive Non-Small Cell Lung Cancer

location_country:
Germany
Italy
United Kingdom
Belgium
Canada
France


lead_sponsor: Amgen

summary: This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.

ReferenceCitation: Wirth LJ. PARTNER: a study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer. Commun Oncol. 2008;5(Supp 14):1-4.

title: A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…

location_country:
Lithuania
Slovakia
Austria
Belgium
United States
Spain
Czechia
Puerto Rico
France


lead_sponsor: Novo Nordisk A/S

summary:
This trial is conducted in Europe.

The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin

ReferenceCitation: Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabetes. 2011 Nov;12(7):632-41. doi: 10.1111/j.1399-5448.2010.00750.x. Epub 2011 Mar 21.

ReferenceCitation: Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial. Diabet Med. 2013 Feb;30(2):216-25. doi: 10.1111/dme.12041.

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

ReferenceCitation: Thalange N, Bereket A, Jensen LB, Hiort LC, Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016 Dec;7(4):713-724. doi: 10.1007/s13300-016-0196-5. Epub 2016 Sep 6.

title: An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes

location_country: Macedonia, The Former Yugoslav Republic of


title: A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)

summary: The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.

ReferenceCitation: Wolf BJ, Spainhour JC, Arthur JM, Janech MG, Petri M, Oates JC. Development of Biomarker Models to Predict Outcomes in Lupus Nephritis. Arthritis Rheumatol. 2016 Aug;68(8):1955-63. doi: 10.1002/art.39623.

ReferenceCitation: Furie R, Nicholls K, Cheng TT, Houssiau F, Burgos-Vargas R, Chen SL, Hillson JL, Meadows-Shropshire S, Kinaszczuk M, Merrill JT. Efficacy and safety of abatacept in lupus nephritis: a twelve-month, randomized, double-blind study. Arthritis Rheumatol. 2014 Feb;66(2):379-89. doi: 10.1002/art.38260.

ReferenceCitation: Wofsy D, Hillson JL, Diamond B. Comparison of alternative primary outcome measures for use in lupus nephritis clinical trials. Arthritis Rheum. 2013 Jun;65(6):1586-91. doi: 10.1002/art.37940.

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

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012 Nov;64(11):3660-5. doi: 10.1002/art.34624.

location_country:
Poland
India
United Kingdom
Argentina
Hong Kong
Australia
Brazil
Mexico
Belgium
United States
China
Korea, Republic of
South Africa
Turkey
Taiwan
Canada
Russian Federation
France

location_facility: University Of North Carolina At Chapel Hill

location_facility: The Feinstein Institute For Medical Research


title: A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer

summary:
Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Netherlands
Belgium
United States
Spain
France

location_facility: Wilshire Oncology Medical Group La Verne

location_facility: Compassionate Cancer Care Medical Group Dept.ofCCCMG

location_facility: Loma Linda University Dept.ofLomaLindaCancerCent(3)

location_facility: Peninsula Regional Medical Center Deptof Oncology and Hematology

location_facility: Cancer Centers of the Carolinas CC of C -Eastside

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)

location_facility: University of California at Los Angeles Dept.of UCLA Dept.ofMed.

location_facility: Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CRAD001J2101


acronym: OPTIMA

lead_sponsor: Abbott

summary: This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).

ReferenceCitation: Smolen J, Fleischmann R, Aletaha D, Li Y, Zhou Y, Sainsbury I, Galindo IL. Disease activity improvements with optimal discriminatory ability between treatment arms: applicability in early and established rheumatoid arthritis clinical trials. Arthritis Res Ther. 2019 Nov 10;21(1):231. doi: 10.1186/s13075-019-2005-9.

ReferenceCitation: Smolen JS, van Vollenhoven RF, Florentinus S, Chen S, Suboticki JL, Kavanaugh A. Predictors of disease activity and structural progression after treatment with adalimumab plus methotrexate or continued methotrexate monotherapy in patients with early rheumatoid arthritis and suboptimal response to methotrexate. Ann Rheum Dis. 2018 Nov;77(11):1566-1572. doi: 10.1136/annrheumdis-2018-213502. Epub 2018 Aug 3.

ReferenceCitation: Kavanaugh A, van Vollenhoven RF, Fleischmann R, Emery P, Sainsbury I, Florentinus S, Chen S, Guerette B, Kupper H, Smolen JS. Testing treat-to-target outcomes with initial methotrexate monotherapy compared with initial tumour necrosis factor inhibitor (adalimumab) plus methotrexate in early rheumatoid arthritis. Ann Rheum Dis. 2018 Feb;77(2):289-292. doi: 10.1136/annrheumdis-2017-211871. Epub 2017 Nov 16.

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Keystone EC, Breedveld FC, van der Heijde D, van Vollenhoven RF, Emery P, Smolen JS, Sainsbury I, Florentinus S, Kupper H, Chen K, Kavanaugh A. Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone. RMD Open. 2017 Sep 26;3(2):e000445. doi: 10.1136/rmdopen-2017-000445. eCollection 2017.

ReferenceCitation: Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

ReferenceCitation: Smolen JS, Emery P, Fleischmann R, van Vollenhoven RF, Pavelka K, Durez P, Guerette B, Kupper H, Redden L, Arora V, Kavanaugh A. Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone: the randomised controlled OPTIMA trial. Lancet. 2014 Jan 25;383(9914):321-32. doi: 10.1016/S0140-6736(13)61751-1. Epub 2013 Oct 26. Erratum In: Lancet. 2014 Jan 25;383(9914):308.

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title: A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Canada
France
Czech Republic
Slovakia
Hungary
United States
Belgium
Puerto Rico
Norway
United Kingdom
Netherlands
Austria
Mexico
Spain
South Africa
Sweden


title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

acronym: DEFINE

summary:
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse.

The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.

ReferenceCitation: Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020. Erratum In: Ther Adv Neurol Disord. 2020 Oct 21;13:1756286420968357.

ReferenceCitation: Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.

ReferenceCitation: Fox RJ, Gold R, Phillips JT, Okwuokenye M, Zhang A, Marantz JL. Efficacy and Tolerability of Delayed-release Dimethyl Fumarate in Black, Hispanic, and Asian Patients with Relapsing-Remitting Multiple Sclerosis: Post Hoc Integrated Analysis of DEFINE and CONFIRM. Neurol Ther. 2017 Dec;6(2):175-187. doi: 10.1007/s40120-017-0077-5. Epub 2017 Aug 2.

ReferenceCitation: Fernandez O, Giovannoni G, Fox RJ, Gold R, Phillips JT, Potts J, Okwuokenye M, Marantz JL. Efficacy and Safety of Delayed-release Dimethyl Fumarate for Relapsing-remitting Multiple Sclerosis in Prior Interferon Users: An Integrated Analysis of DEFINE and CONFIRM. Clin Ther. 2017 Aug;39(8):1671-1679. doi: 10.1016/j.clinthera.2017.06.012. Epub 2017 Jul 25.

ReferenceCitation: Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.

ReferenceCitation: Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.

ReferenceCitation: Giovannoni G, Gold R, Fox RJ, Kappos L, Kita M, Yang M, Sarda SP, Zhang R, Viglietta V, Havrdova E. Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies. Clin Ther. 2015 Nov 1;37(11):2543-51. doi: 10.1016/j.clinthera.2015.09.011. Epub 2015 Oct 31.

ReferenceCitation: Nakamura K, Brown RA, Narayanan S, Collins DL, Arnold DL; Alzheimer's Disease Neuroimaging Initiative. Diurnal fluctuations in brain volume: Statistical analyses of MRI from large populations. Neuroimage. 2015 Sep;118:126-32. doi: 10.1016/j.neuroimage.2015.05.077. Epub 2015 Jun 3.

ReferenceCitation: Kita M, Fox RJ, Gold R, Giovannoni G, Phillips JT, Sarda SP, Kong J, Viglietta V, Sheikh SI, Okwuokenye M, Kappos L. Effects of delayed-release dimethyl fumarate (DMF) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the phase 3 DEFINE and CONFIRM studies. Clin Ther. 2014 Dec 1;36(12):1958-1971. doi: 10.1016/j.clinthera.2014.08.013. Epub 2014 Oct 12. Erratum In: Clin Ther. 2018 Mar 7;:

ReferenceCitation: Fox RJ, Kita M, Cohan SL, Henson LJ, Zambrano J, Scannevin RH, O'Gorman J, Novas M, Dawson KT, Phillips JT. BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety. Curr Med Res Opin. 2014 Feb;30(2):251-62. doi: 10.1185/03007995.2013.849236. Epub 2013 Oct 22.

ReferenceCitation: Gold R, Kappos L, Arnold DL, Bar-Or A, Giovannoni G, Selmaj K, Tornatore C, Sweetser MT, Yang M, Sheikh SI, Dawson KT; DEFINE Study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1098-107. doi: 10.1056/NEJMoa1114287. Erratum In: N Engl J Med. 2012 Dec 13;367(24):2362.


summary: This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).

ReferenceCitation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

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

repositories_concat: PubMed Central;www.lenus.ie

ReferenceCitation: Wolf D, D'Haens G, Sandborn WJ, Colombel JF, Van Assche G, Robinson AM, Lazar A, Zhou Q, Petersson J, Thakkar RB. Escalation to weekly dosing recaptures response in adalimumab-treated patients with moderately to severely active ulcerative colitis. Aliment Pharmacol Ther. 2014 Sep;40(5):486-97. doi: 10.1111/apt.12863. Epub 2014 Jul 15.

ReferenceCitation: Feagan BG, Sandborn WJ, Lazar A, Thakkar RB, Huang B, Reilly N, Chen N, Yang M, Skup M, Mulani P, Chao J. Adalimumab therapy is associated with reduced risk of hospitalization in patients with ulcerative colitis. Gastroenterology. 2014 Jan;146(1):110-118.e3. doi: 10.1053/j.gastro.2013.09.032. Epub 2013 Sep 22.

ReferenceCitation: Sandborn WJ, Colombel JF, D'Haens G, Van Assche G, Wolf D, Kron M, Lazar A, Robinson AM, Yang M, Chao JD, Thakkar R. One-year maintenance outcomes among patients with moderately-to-severely active ulcerative colitis who responded to induction therapy with adalimumab: subgroup analyses from ULTRA 2. Aliment Pharmacol Ther. 2013 Jan;37(2):204-13. doi: 10.1111/apt.12145. Epub 2012 Nov 23.

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Site Ref # / Investigator 7473
Site Ref # / Investigator 7475
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title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

location_country:
France
Germany
Poland
Portugal
New Zealand
Hungary
Argentina
Denmark
Australia
Israel
Norway
Austria
Belgium
Switzerland
United States
Spain
Canada
Czech Republic


title: Controlled, Double-Blind, Randomized, Dose-ranging Study of Once-daily Regimen of BAY59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXaHIP-OD

acronym: ODIXaHIP-OD

summary: The purpose of this study is to assess different doses of a new drug (BAY 59-7939), taken as a tablet, are safe and can help prevent blood clots forming after a hip replacement operation. Patients undergoing hip replacement surgery are at risk of developing blood clots. To reduce this risk treatment to prevent clots forming is routinely given. The current treatments can include injections under the skin or other treatments that need frequent blood tests to monitor levels of drug in the body. Therefore there is a need for new drugs, which are easier to give and need less monitoring.

lead_sponsor: Bayer

location_country:
Germany
Italy
Poland
Israel
Norway
Denmark
United Kingdom
Sweden
Netherlands
Austria
Belgium
Spain
France


title: A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus

summary:
This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups:

Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day.

Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.

ReferenceCitation: Naegeli AN, Hayes RP. Expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction in insulin-naive patients with type 2 diabetes. Int J Clin Pract. 2010 Jun;64(7):908-16. doi: 10.1111/j.1742-1241.2010.02363.x. Epub 2010 Mar 30.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Alkermes, Inc.

location_country:
India
Argentina
Austria
Belgium
Mexico
United States
Spain
Puerto Rico
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 Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study Of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) In Closed Diaphyseal Tibial Fracture

summary: The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fracture union and return to normal function in subjects who have a closed diaphyseal tibial fracture when compared to standard of care alone.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Finland
Germany
Poland
Slovenia
India
United Kingdom
Argentina
Romania
Australia
Brazil
Sweden
Mexico
United States
Latvia
Spain
Canada
Serbia
France


lead_sponsor: Centocor, Inc.

summary: The purpose of this study is to assess the safety and efficacy of siltuximab administered in combination with mitoxantrone and prednisone in participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that grows and spreads in the body) (HRPC).

title: A Phase 2, Multicenter, Open-Label Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) in Combination With Mitoxantrone Versus Mitoxantrone in Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

location_country:
Germany
United Kingdom
Austria
Belgium
United States
Spain
France


title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopa

summary: The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well-controlled on their L-dopa medication.

ReferenceCitation: B P Hersh, S A Factor, L Giorgi Ropinirole 24-hour prolonged release improves motor function and activities of daily living as an adjunct to L-dopa in Parkinson's Disease. Eur J Neurol. September 2006/Suppl 2: 13/S2-P2202

ReferenceCitation: F Stocchi, B Hersh, N Earl, B Scott Safety and tolerability of ropinirole 24-hour prolonged release in patients with early and advanced Parkinson's Disease. Movement Disorders, November 2006; 21 (Suppl.15) S572/P894.

ReferenceCitation: F Stocchi, M A Stacy, L Giorgi, N L Earl Safety and tolerability of ropinirole 24-hour prolonged release as adjuctive therapy to L-dopa in patients with Parkinson's Disease. Eur J Neurol. September 2006/Suppl 2-13/a2P2201

ReferenceCitation: Reichmann H, Cooper J, Rolfe K, Martinez-Martin P. Sleep Duration and "on" Time during Different Periods of the Day and Night in Patients with Advanced Parkinson's Disease Receiving Adjunctive Ropinirole Prolonged Release. Parkinsons Dis. 2011;2011:354760. doi: 10.4061/2011/354760. Epub 2011 May 11.

ReferenceCitation: Ray Chaudhuri K, Martinez-Martin P, Rolfe KA, Cooper J, Rockett CB, Giorgi L, Ondo WG. Improvements in nocturnal symptoms with ropinirole prolonged release in patients with advanced Parkinson's disease. Eur J Neurol. 2012 Jan;19(1):105-13. doi: 10.1111/j.1468-1331.2011.03442.x. Epub 2011 Jun 23.

ReferenceCitation: K Sethi, N Earl, R Hauser Ropinirole 24-hour prolonged release improves disease-specific and global symptoms when used as adjunctive therapy to L-dopa in patients with advanced Parkinson's Disease. Movement Disorders, November 2006; 21 (Suppl.15) S570/P887

ReferenceCitation: M A Stacy, K D Sethi, N L Earl Ropinirole 24-hour prolonged release improves sleep but does not increase daytime sleepiness when used as adjunctive therapy in patients with Parkinson's Disease not optimally controlled by L-dopa. Movement Disorders, November 2006 S15/9.21:1543-1559

ReferenceCitation: M Stacy, R Pahwa, N Earl Ropinirole 24-hour prolonged release reduces "off" time and reduces the need for L-dopa when used as adjunctive therapy in patients with advanced Parkinson's Disease Movement Disorders, November 2006: 21 (Suppl 15) S596/P972

ReferenceCitation: R A Hauser, M A Stacy, B P Hersh Ropinirole 24 hour prolonged release reduces off time and improves depression when used as adjunctive therapy in patients with Parkinson's disease not optimally controlled with L-dopa Movement Disorders S15-21-P8

ReferenceCitation: R Pahwa, F Stocchi, M A Stacy Ropinirole 24-hour prolonged release is effective in sparing L-dopa dose and improving symptoms as adjuctive therapy in Parkinson's Disease. Eur J Neurol, September 2005/Suppl 2:s2-P2203

ReferenceCitation: R Pahwa, M Stacy, E Elmer, S Isaacson Ropinirole 24-hour prolonged release provides efficacy as early as Week 2 when used as adjunctive therapy to L-dopa in patients with advanced Parkinson's Disease Movement Disorders, November 2006: 21 (Suppl 15) S595/P968.

ReferenceCitation: Pahwa R, Stacy MA, Factor SA, Lyons KE, Stocchi F, Hersh BP, Elmer LW, Truong DD, Earl NL; EASE-PD Adjunct Study Investigators. Ropinirole 24-hour prolonged release: randomized, controlled study in advanced Parkinson disease. Neurology. 2007 Apr 3;68(14):1108-15. doi: 10.1212/01.wnl.0000258660.74391.c1.

ReferenceCitation: R Pahwa, S Factor, L Elmer Ropinirole 24 hour prolonged release reduces awake time spent "off" in patients with Parkinson's disease not optimally controlled with L-dopa. Neurology, April 2006. 66 (Suppl 2): A292. P05.135

ReferenceCitation: R Pahwa, SA Factor, L Elmer Ropinirole 24 hour prolonged release reduces "off" time in patients with Parkinson's disease not optimally controlled with L-dopa. Eur J Neurol, September 2006/Suppl2, 13/s2:P2154.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Poland
Hungary
Belgium
United States
Spain
Czech Republic
France


title: A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases

summary: This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.

lead_sponsor: Pfizer

location_country:
United States
Italy
Spain
France


title: Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/Neu-Positive Breast Cancer

summary: This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer

location_country:
Italy
Argentina
Belgium
United States
Spain
Peru
France

location_facility: University Of Texas Md Anderson Cancer Ctr


title: A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy, Safety and Tolerability of Eltrombopag Olamine (SB-497115-GR), a Thrombopoietin Receptor Agonist, Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP.

acronym: RAISE

summary: The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety and pharmacokinetics in a dose-finding Study (TRA100773). This Phase III study is a randomized, double-blind, placebo-controlled, Phase III study, to evaluate efficacy, safety and tolerability of eltrombopag, initially administered as 50 mg oral tablets once daily for six months in adult subjects with previously treated chronic ITP. Subjects will be randomized 2:1, eltrombopag to placebo, and will be stratified based upon splenectomy status, use of ITP medication at baseline and baseline platelet count less than or equal to 15,000/µL. Subjects will receive study medication for 6 months, during which the dose of study medication may be adjusted based upon individual platelet counts. In addition, subjects may taper off concomitant ITP medications and may receive any rescue treatments as dictated by local standard of care. After discontinuation of study medication, subjects will complete follow-up visits at weeks 1, 2, 4 and months 3 and 6.

ReferenceCitation: Cheng G, Saleh MN, Marcher C, Vasey S, Mayer B, Aivado M, Arning M, Stone NL, Bussel JB. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Lancet. 2011 Jan 29;377(9763):393-402. doi: 10.1016/S0140-6736(10)60959-2. Epub 2010 Aug 23. Erratum In: Lancet. 2011 Jan 29;377(9763):382.

ReferenceCitation: Haselboeck J, Pabinger I, Ay C, Koder S, Panzer S. Platelet activation and function during eltrombopag treatment in immune thrombocytopenia. Ann Hematol. 2012 Jan;91(1):109-13. doi: 10.1007/s00277-011-1249-5. Epub 2011 May 7.

ReferenceCitation: Hayes S, Ouellet D, Zhang J, Wire MB, Gibiansky E. Population PK/PD modeling of eltrombopag in healthy volunteers and patients with immune thrombocytopenic purpura and optimization of response-guided dosing. J Clin Pharmacol. 2011 Oct;51(10):1403-17. doi: 10.1177/0091270010383019. Epub 2010 Dec 8.

ReferenceCitation: Tarantino MD, Fogarty P, Mayer B, Vasey SY, Brainsky A. Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia. Blood Coagul Fibrinolysis. 2013 Apr;24(3):284-96. doi: 10.1097/MBC.0b013e32835fac99.

ReferenceCitation: Fogarty PF, Tarantino MD, Brainsky A, Signorovitch J, Grotzinger KM. Selective validation of the WHO Bleeding Scale in patients with chronic immune thrombocytopenia. Curr Med Res Opin. 2012 Jan;28(1):79-87. doi: 10.1185/03007995.2011.644849. Epub 2011 Dec 20.

ReferenceCitation: Signorovitch J, Brainsky A, Grotzinger KM. Validation of the FACIT-fatigue subscale, selected items from FACT-thrombocytopenia, and the SF-36v2 in patients with chronic immune thrombocytopenia. Qual Life Res. 2011 Dec;20(10):1737-44. doi: 10.1007/s11136-011-9912-9. Epub 2011 May 1.

location_country:
Finland
Germany
Poland
New Zealand
Vietnam
Canada
France
Czech Republic
Slovakia
Hong Kong
Denmark
United States
Ukraine
India
Tunisia
China
Peru
Italy
United Kingdom
Netherlands
Austria
Spain
Greece
Taiwan
Russian Federation


title: A Phase II Open Label Study of Brivanib (BMS582664), Administered Orally At A Dose of 800 mg Daily In Subjects With Unresectable, Locally Advanced or Metastatic Hepatocellular Carcinoma Who Have Received Either No Prior Systemic Therapy or One Prior Regimen of Angiogenesis Inhibitor Therapy

summary: The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the growth of advanced liver cancer. The safety of this treatment will also be studied.

ReferenceCitation: Park JW, Finn RS, Kim JS, Karwal M, Li RK, Ismail F, Thomas M, Harris R, Baudelet C, Walters I, Raoul JL. Phase II, open-label study of brivanib as first-line therapy in patients with advanced hepatocellular carcinoma. Clin Cancer Res. 2011 Apr 1;17(7):1973-83. doi: 10.1158/1078-0432.CCR-10-2011. Epub 2011 Feb 24.

location_country:
Hong Kong
Singapore
United States
Korea, Republic of
Malaysia
Taiwan
Philippines
France

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: University Of Miami Miller School Of Medicine

location_facility: University Of Iowa Hospitals And Clinics


title: The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures

summary: The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.

location_country:
Germany
Italy
Argentina
Australia
Brazil
Sweden
Mexico
Belgium
United States
Spain
Canada
Puerto Rico
France


title: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension

summary:
This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.

Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).

ReferenceCitation: Tapson VF, Torres F, Kermeen F, Keogh AM, Allen RP, Frantz RP, Badesch DB, Frost AE, Shapiro SM, Laliberte K, Sigman J, Arneson C, Galie N. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients on background endothelin receptor antagonist and/or phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C study): a randomized controlled trial. Chest. 2012 Dec;142(6):1383-1390. doi: 10.1378/chest.11-2212.

lead_sponsor: United Therapeutics

location_country:
Germany
Ireland
Italy
Poland
Israel
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
Spain
Canada
France

location_facility: Mater Misericordiae University Hospital Ltd

location_facility: University of Arizona Health Science Center

location_facility: Baylor College of Medicine, Pulmonary & Critical Care

location_facility: Vancouver Coastal Health Respiratory Clinic

location_facility: Stanford University, Pulmonary and Critical Care

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: University of Maryland School of Medicine

location_facility: National Tuberculosis and Lung Disease Research Institute

location_facility: Mary M Parkes Center for Asthma, Allergy and Pulmonary Care