title: A Phase III, Multicentre, Prospective, Open Label Extension Study to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

ReferenceCitation: Delafont B, Carroll K, Vilain C, Pham E. Investigation of mixed model repeated measures analyses and non-linear random coefficient models in the context of long-term efficacy data. Pharm Stat. 2018 Sep;17(5):515-526. doi: 10.1002/pst.1868. Epub 2018 May 20.

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country:
Italy
Poland
Slovakia
Hungary
Belgium
United States
Czechia
Russian Federation
France

location_facility: University of North Texas HSC at Ben Hogan Center

location_facility: Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: National Institute for Medical Rehabilitation

location_facility: Southwestern Medical Center at Dallas University of Texas

location_facility: Associated Neurologist of Southern CT, PT

location_facility: Parkinson's Disease & Movement Disorders Center of Boca Raton

location_facility: Université catholique de Louvain av Hippocrate 10

location_facility: Rancho Los Amigos National Rehabilitation Center


type: EudraCT Number

title: A Multicenter, Randomized, Double-blind, Active-Controlled Study of the Efficacy and Safety of Flexibly-Dosed BMS-820836 in Patients With Treatment Resistant Major Depression

summary: The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued duloxetine in the treatment of patients with treatment resistant depression (TRD).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Sweden
United States
South Africa
Canada
France

location_facility: Belmont Center For Comprehensive Treatment

location_facility: California Neuroscience Research Medical Group, Inc.

location_facility: California Neuropsychopharmacology Clinical Research Inst.

location_facility: Oregon Center For Clinical Investigations, Inc. (Occi, Inc)

location_facility: Comprehensive Clinical Development, Inc.

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: K & S Professional Research Services, Llc

location_facility: Dean Foundation For Health Research & Education

location_facility: Atlanta Institute Of Medicine & Research

location_facility: University Of South Carolina School Of Medicine

location_facility: Oregon Center For Clinical Investigations, Inc (Occi, Inc)

location_facility: Independent Psychiatric Consultants, Sc, Dba, Ipc Research

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure

summary: The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to omecamtiv mecarbil or placebo.

ReferenceType: derived

ReferenceCitation: Teerlink JR, Felker GM, McMurray JJV, Ponikowski P, Metra M, Filippatos GS, Ezekowitz JA, Dickstein K, Cleland JGF, Kim JB, Lei L, Knusel B, Wolff AA, Malik FI, Wasserman SM; ATOMIC-AHF Investigators. Acute Treatment With Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure: The ATOMIC-AHF Study. J Am Coll Cardiol. 2016 Mar 29;67(12):1444-1455. doi: 10.1016/j.jacc.2016.01.031.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repository_institution: Imperial College London - Spiral

version: submittedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Cytokinetics

location_country:
Finland
Germany
Poland
Australia
Czechia
Canada
France
Lithuania
Slovakia
Hungary
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Greece
Bulgaria
Russian Federation


title: Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)

acronym: IPOD-PD

summary: The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD) patients and its evolution over a period of four years, independent of the PD treatment modality (APD or CAPD) and the PD solution type.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Verger C, Ronco C, Van Biesen W, Heaf J, Vrtovsnik F, Vera Rivera M, Puide I, Azar R, Gauly A, Atiye S, De Los Rios T. Association of Prescription With Body Composition and Patient Outcomes in Incident Peritoneal Dialysis Patients. Front Med (Lausanne). 2021 Dec 24;8:737165. doi: 10.3389/fmed.2021.737165. eCollection 2021.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Ghent University - Ghent University Academic Bibliography

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central;archive.ugent.be

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ReferenceCitation: Ronco C, Verger C, Crepaldi C, Pham J, De Los Rios T, Gauly A, Wabel P, Van Biesen W; IPOD-PD Study Group. Baseline hydration status in incident peritoneal dialysis patients: the initiative of patient outcomes in dialysis (IPOD-PD study)dagger. Nephrol Dial Transplant. 2015 May;30(5):849-58. doi: 10.1093/ndt/gfv013. Epub 2015 Mar 11.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Oxford University Press

lead_sponsor: Fresenius Medical Care Deutschland GmbH

location_country:
Finland
Germany
Brazil
Bosnia and Herzegovina
Turkey
Croatia
France
Czech Republic
Lithuania
Portugal
Denmark
Switzerland
Latvia
India
Belgium
Cuba
Estonia
Italy
Norway
United Kingdom
Venezuela
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Israel

location_facility: General University Hospital of Thessaloniki "AHEPA"

location_facility: General University Hospital of Alexandroupolis

location_facility: General Hospital of Athens G. Gennimatas

location_facility: Nephrologisches Zentrum Velbert Innere Medizin und Nephrologie

location_facility: AUB Quimper / Centre Hospitalier Laennec

intervention_type: Other


title: Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)

summary: The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

study_start_date_type: Actual

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Thailand
Chile
Czechia
Canada
France
Colombia
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
Romania
Belgium
China
Peru
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: University Of Illinois At Chicago Medical Center

location_facility: Wisconsin Institutes for Medical Research

location_facility: Oklahoma Oncology And Hematology, Pc Dba

location_facility: Presence Medical Group Hematology Oncology

location_facility: Southern Illinois University School Of Medicine

location_facility: Texas Oncology, PA - South Austin Cancer Center

location_facility: Lynn Cancer Institute Center For Hematology-Oncology

location_facility: Washington University School Of Medicine


title: Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)

acronym: SIMPLICITY

summary: The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.

time_perspective: Other

ReferenceCitation: Hehlmann R, Cortes JE, Zyczynski T, Gambacorti-Passerini C, Goldberg SL, Mauro MJ, Michallet M, Simonsson B, Williams LA, Gajavelli S, DeGutis I, Sen GP, Paquette RL. Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice: SIMPLICITY. Am J Hematol. 2019 Jan;94(1):46-54. doi: 10.1002/ajh.25306. Epub 2018 Oct 31.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repositories_concat: DiVA.org;PubMed Central

publisher_dissemination: Wiley

sponsor_collaborators:
Bristol-Myers Squibb
ICON Clinical Research

location_country:
Germany
Italy
Netherlands
United States
Spain
Puerto Rico
Russian Federation
France

location_facility: Little Rock Hematology Oncology Associates

location_facility: Providence Cancer Center at Sacred Heart Medical Center

location_facility: Hematology Oncology Associates of Fredricksburg

location_facility: Swedish Cancer Institute-Eastside Hematology/Oncology

location_facility: Tahoe Forest Health System Cancer Center

location_facility: Investigative Clinical Research of Indiana

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Texas Oncology-Odessa West Texas Cancer Center

location_facility: Texas Oncology-Methodist Charlton Cancer Center

location_facility: Medical Oncology and Blood Disorders, LLP

location_facility: Medical Oncology Associates of Wyoming Valley, PC

location_facility: Hematology-Oncology Associates of Northern NJ, PA

location_facility: Hematology And Medical Oncology Of Southern Palm Beach County

location_facility: Veterans Research Foundation of Pittsburgh

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: University of Louisville Hospital - Brown Cancer Center

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: Texas Oncology-Midland Allison Cancer Center

location_facility: Hematology and Oncology Associates of RI

location_facility: City Hospital - West Virginia University Hospital East

location_facility: Washington Hospital Center, Washington Cancer Institute

location_facility: St John's Clinic for Cancer and Hematology

location_facility: Indiana Blood and Marrow Transplantation


title: Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care (The RESPONSE Trial)

summary: This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

ReferenceCitation: Kiladjian JJ, Zachee P, Hino M, Pane F, Masszi T, Harrison CN, Mesa R, Miller CB, Passamonti F, Durrant S, Griesshammer M, Kirito K, Besses C, Moiraghi B, Rumi E, Rosti V, Blau IW, Francillard N, Dong T, Wroclawska M, Vannucchi AM, Verstovsek S. Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study. Lancet Haematol. 2020 Mar;7(3):e226-e237. doi: 10.1016/S2352-3026(19)30207-8. Epub 2020 Jan 23.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_concat: PubMed Central;air.unimi.it

ReferenceCitation: Kiladjian JJ, Guglielmelli P, Griesshammer M, Saydam G, Masszi T, Durrant S, Passamonti F, Jones M, Zhen H, Li J, Gadbaw B, Perez Ronco J, Khan M, Verstovsek S. Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies. Ann Hematol. 2018 Apr;97(4):617-627. doi: 10.1007/s00277-017-3225-1. Epub 2018 Feb 2.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

ReferenceCitation: Verstovsek S, Harrison CN, Kiladjian JJ, Miller C, Naim AB, Paranagama DC, Habr D, Vannucchi AM. Markers of iron deficiency in patients with polycythemia vera receiving ruxolitinib or best available therapy. Leuk Res. 2017 May;56:52-59. doi: 10.1016/j.leukres.2017.01.032. Epub 2017 Jan 31.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ReferenceCitation: Verstovsek S, Vannucchi AM, Griesshammer M, Masszi T, Durrant S, Passamonti F, Harrison CN, Pane F, Zachee P, Kirito K, Besses C, Hino M, Moiraghi B, Miller CB, Cazzola M, Rosti V, Blau I, Mesa R, Jones MM, Zhen H, Li J, Francillard N, Habr D, Kiladjian JJ. Ruxolitinib versus best available therapy in patients with polycythemia vera: 80-week follow-up from the RESPONSE trial. Haematologica. 2016 Jul;101(7):821-9. doi: 10.3324/haematol.2016.143644. Epub 2016 Apr 21.

repository_institution: University of Florence - Florence Research

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Vannucchi AM, Kiladjian JJ, Griesshammer M, Masszi T, Durrant S, Passamonti F, Harrison CN, Pane F, Zachee P, Mesa R, He S, Jones MM, Garrett W, Li J, Pirron U, Habr D, Verstovsek S. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015 Jan 29;372(5):426-35. doi: 10.1056/NEJMoa1409002.

evidence: open (via free article)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

sponsor_collaborators:
Incyte Corporation
Novartis Pharmaceuticals

location_country:
Germany
Italy
Hungary
Argentina
United Kingdom
Australia
Japan
Netherlands
Belgium
United States
China
Korea, Republic of
Spain
Thailand
Turkey
Canada
Russian Federation
France


summary: This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
United Kingdom
Brazil
Austria
Mexico
United States
Spain
Canada
Puerto Rico
France


type: Other Identifier

title: A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)

summary:
The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis.

This study is comprised of 2 periods:

Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).

Period 2: 48-week post-treatment follow-up

status: Terminated

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Croatia
France
Lithuania
Colombia
Slovakia
Hungary
United States
Sri Lanka
Ukraine
India
Romania
Malaysia
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation

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.

status_simplified: Unknown


acronym: TEMPO 4/4

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

summary: To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.

ReferenceCitation: Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5.

ReferenceCitation: Thimmappa ND, Blumenfeld JD, Cerilles MA, Dunning A, Donahue SL, Bobb WO, Zhang HL, Prince MR. Cisterna chyli in autosomal dominant polycystic kidney disease. J Magn Reson Imaging. 2015 Jan;41(1):142-8. doi: 10.1002/jmri.24527. Epub 2014 Jan 27.

oa_host_type: publisher

ReferenceCitation: Blumenfeld JD, Tepler J, Mauer A, Coller B, Bichet DG, Smith B. Tolvaptan inhibition of desmopressin effects on coagulation factors in a patient with decreased von Willebrand factor and polycystic kidney disease. Blood. 2011 Jul 14;118(2):474-6. doi: 10.1182/blood-2011-04-347328. No abstract available.

title: Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

source: euctr

ipd_sharing_description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Romania
Australia
Netherlands
Belgium
United States
Canada
Russian Federation
France

ipd_sharing: Yes


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-α Inhibitors (FLEX V)

acronym: FLEX V

summary:
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors.

This study is comprised of 2 periods:

Period 1: 24-week blinded treatment

Period 2: 48-week post-treatment follow-up

ReferenceCitation: Schiff M, Combe B, Dorner T, Kremer JM, Huizinga TW, Veenhuizen M, Gill A, Komocsar W, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-BAFF monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis and inadequate response to TNF inhibitors: results of a randomised, double-blind, placebo-controlled, phase 3 study. RMD Open. 2015 Aug 12;1(1):e000037. doi: 10.1136/rmdopen-2014-000037. eCollection 2015.

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: British Medical Journal

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
France
Colombia
United States
Malaysia
Italy
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation


lead_sponsor: Millennium Pharmaceuticals, Inc.

summary: This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Suri A, Chapel S, Lu C, Venkatakrishnan K. Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis. Clin Pharmacol Ther. 2015 Sep;98(3):336-44. doi: 10.1002/cpt.155. Epub 2015 Jul 14.

ReferenceCitation: Fizazi K, Jones R, Oudard S, Efstathiou E, Saad F, de Wit R, De Bono J, Cruz FM, Fountzilas G, Ulys A, Carcano F, Agarwal N, Agus D, Bellmunt J, Petrylak DP, Lee SY, Webb IJ, Tejura B, Borgstein N, Dreicer R. Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5. J Clin Oncol. 2015 Mar 1;33(7):723-31. doi: 10.1200/JCO.2014.56.5119. Epub 2015 Jan 26.

evidence: open (via free pdf)

title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy.

type: Registry Identifier

location_country:
Finland
Italy
Poland
Hungary
Australia
Netherlands
Belgium
United States
Spain
Greece
Czechia
Canada
Estonia
France


title: A Phase III, Multi-Center, Randomized, 24 Week, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-Blind Treatment Period

summary: This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. After 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to Week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. Participants initially randomized to placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm.

ReferenceCitation: Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.

ReferenceCitation: Bugarski-Kirola D, Blaettler T, Arango C, Fleischhacker WW, Garibaldi G, Wang A, Dixon M, Bressan RA, Nasrallah H, Lawrie S, Napieralski J, Ochi-Lohmann T, Reid C, Marder SR. Bitopertin in Negative Symptoms of Schizophrenia-Results From the Phase III FlashLyte and DayLyte Studies. Biol Psychiatry. 2017 Jul 1;82(1):8-16. doi: 10.1016/j.biopsych.2016.11.014. Epub 2016 Dec 15.

location_country:
Finland
Colombia
India
Hungary
Argentina
Romania
Australia
Sweden
United Kingdom
Mexico
United States
Korea, Republic of
Russian Federation
France

location_facility: CHU Strasbourg Nouvel Hôpital Civil;Service de Psychiatrie I

location_facility: Hôpital de la Conception; Pôle Psychiatrique Centre

location_facility: Petz Aladar Megyei Oktato Korhaz; Pszichiatria I.

location_facility: Centro de Investigaciones del Sistema Nervioso Limitada - Gr

location_facility: Resolution Psicopharmacology Research Institute

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

location_facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

location_facility: Belmont Center for Comprehensive Treatment; Research

location_facility: Centro de Investigacion Medica S.C; Hospital Santa Cecilia de Monterrey S.A. de C.V.

location_facility: Spitalul Clinic Judetean Arad; Departamentul de Psihiatrie

location_facility: St. Petersburg State Healthcare Institution "City Mental Hospital #3; I.I. Skvortsov-Stepanov

location_facility: Arkhangelsk Regional Clinical Psychiatric Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Cluj; Sectia Clinica de Psihiatrie III

location_facility: Facene Fund.Argentina Contra Enferm.Neur.Del Envejecimiento

location_facility: Hospital Lomas de San Luis Internacional

location_facility: Central Moscow Regional Clinical Psychiatric Hospital

location_facility: University of Iowa College of Medicine; Psychiatry Research

location_facility: Dr. Kenessey Albert Hospital; Psychiatry I.

location_facility: CIAP - Centro de Investigacion y Asistencia en Psiquiatria

location_facility: Centro de Investigacion Clinica Farmacologica en Psiquiatria

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Comunitara si Reintegrare Psihosociala

location_facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

location_facility: Fundacion para el Estudio y Tratamiento des las Enfi Mentales

location_facility: Federal State Institution Moscow SRI of Psychiatry of Minzdravsocrazvitia

location_facility: Kemerovo Regional Clinical Psychiatric Hospital

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

location_facility: Monash Medical Centre-Clayton Campus; School of Psychology and Psychiatry

location_facility: Danderyds Sjukhus AB; PRIMA Vuxenpsykiatri

location_facility: Institution of RAMS (Mental Health Research Center of RAMS)

location_facility: Fov.Onk.Szt Janos Korh. E-Budai Egyesitett Korhazai; Pszichiatriaci rehabilitacio

location_facility: Akademiska Sjukhuset; Psykosvård och rättspsykiatrisk vård

location_facility: Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichiatria I.

location_facility: Spitalul Universitar de Psihiatrie Socola

location_facility: Brij Psychiatry Hospital & Muskaan Research Centre; Maanav Health Foundation

location_facility: The Alfred Hospital; Monash Alfred Psychiatry Research Centre (MAP-RC)

location_facility: Spit Univ Urgenta Militar Dr. Carol Davila; Sectia Psihiatrie

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Clinical III Psihiatrie

location_facility: Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichatria II

location_facility: St. Petersburg GUZ City Psychiatric Hospital #6

location_facility: Karolinska Universitetssjukhuset Huddinge, Psykiatri Sydväst

location_facility: Gujarat Institute of Psychological Research (GIPS)

location_facility: Westmead Hospital; Department of Psychiatry

location_facility: Manav Neuropsychiatric Hospital Pvt. Ltd.

location_facility: Saint Petersburg Psychoneurological Research Institute of Roszdrav n.a. Bekhterev

location_facility: Instituto de Neurociencias San Agustín S.A.

location_facility: Samvedna Hospitals; Samvedana Psychiatry and Sex Therapy Hospital

location_facility: Spitalul de Psihiatrie Dr. Gh. Preda Sibiu;CSM Adulti Sibiu

location_facility: Centro de Asistencia e Investigación en Neurociencias

location_facility: Spitalul Clinic Municipal Dr. Gavril Curteanu; Sectia Clinica Psihiatrie I

location_facility: Frankston Hospital; Mental Health Service

location_facility: R. K.Yadav Memorial Mental Health & De-Addiction Hospital

location_facility: Scientifically Research Institute of Psychiatry of Ministry of Health of the Russian Federation

location_facility: GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department

location_facility: Centre Hospitalier Universitaire Caen; Pôle Psychiatrie - Addictologie

location_facility: CHU Gabriel Montpied; Service de Psychiatrie

location_facility: Semmelweis Egyetem AOK; Pszichiatriai es Pszichoterapias Klinika

location_facility: Comprehensive Clinical Development- Cerritos CA

location_facility: Cabinet Medical S.C. Lorentina 2102 S.R.L.; Psihiatrie

location_facility: Mhi City Clinical Hospital #2 Named After v.i. Razumousky

location_facility: North Carolina Psychiatric Research Center

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Sectia Clinica XIII Psihiatrie

location_facility: Instituto de informacion e investigacion en salud mental AC

location_facility: Centro de Psiquiatria Biologica Professor Julio J. Herrera; Psiquiatria


title: A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)

summary: This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

location_country: Germany Denmark Netherlands Switzerland China Spain Turkey Egypt France


summary: The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.

ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Taniguchi H, Yoshino T, Yamaguchi K, Yamazaki K, Nixon AB, Tabernero J, Van Cutsem E, Robling KR, Abada PB, Hozak RR, Siegel R, Fill JA, Wijayawardana S, Walgren RA, Giles B, Jones A, Pitts KR, Drove N, Muro K. Clinical development and evaluation of a VEGF-D assay in plasma from patients with metastatic colorectal cancer in the RAISE study. Curr Med Res Opin. 2021 Oct;37(10):1769-1778. doi: 10.1080/03007995.2021.1940908. Epub 2021 Jul 28.

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

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

publisher_dissemination: Informa

ReferenceCitation: Lim HH, Hopkins AM, Rowland A, Yuen HY, Karapetis CS, Sorich MJ. Effect of Early Adverse Events on Survival Outcomes of Patients with Metastatic Colorectal Cancer Treated with Ramucirumab. Target Oncol. 2019 Dec;14(6):743-748. doi: 10.1007/s11523-019-00683-z.

ReferenceCitation: Yoshino T, Portnoy DC, Obermannova R, Bodoky G, Prausova J, Garcia-Carbonero R, Ciuleanu T, Garcia-Alfonso P, Cohn AL, Van Cutsem E, Yamazaki K, Lonardi S, Muro K, Kim TW, Yamaguchi K, Grothey A, O'Connor J, Taieb J, Wijayawardana SR, Hozak RR, Nasroulah F, Tabernero J. Biomarker analysis beyond angiogenesis: RAS/RAF mutation status, tumour sidedness, and second-line ramucirumab efficacy in patients with metastatic colorectal carcinoma from RAISE-a global phase III study. Ann Oncol. 2019 Jan 1;30(1):124-131. doi: 10.1093/annonc/mdy461.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

repositories_concat: LIRIAS (KU Leuven);PubMed Central;ddd.uab.cat;recercat.cat

ReferenceCitation: Grothey A, Yoshino T, Bodoky G, Ciuleanu T, Garcia-Carbonero R, Garcia-Alfonso P, Van Cutsem E, Muro K, Mytelka DS, Li L, Lipkovich O, Hsu Y, Sashegyi A, Ferry D, Nasroulah F, Tabernero J. Association of baseline absolute neutrophil counts and survival in patients with metastatic colorectal cancer treated with second-line antiangiogenic therapies: exploratory analyses of the RAISE trial and validation in an electronic medical record data set. ESMO Open. 2018 Apr 24;3(3):e000347. doi: 10.1136/esmoopen-2018-000347. eCollection 2018.

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

repository_normalized: dnet

repositories:
PubMed Central
ddd.uab.cat
dnet

repositories_concat: PubMed Central;ddd.uab.cat;dnet

ReferenceCitation: Tabernero J, Hozak RR, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Prausova J, Muro K, Siegel RW, Konrad RJ, Ouyang H, Melemed SA, Ferry D, Nasroulah F, Van Cutsem E. Analysis of angiogenesis biomarkers for ramucirumab efficacy in patients with metastatic colorectal cancer from RAISE, a global, randomized, double-blind, phase III study. Ann Oncol. 2018 Mar 1;29(3):602-609. doi: 10.1093/annonc/mdx767.

ReferenceCitation: Obermannova R, Van Cutsem E, Yoshino T, Bodoky G, Prausova J, Garcia-Carbonero R, Ciuleanu T, Garcia Alfonso P, Portnoy D, Cohn A, Yamazaki K, Clingan P, Lonardi S, Kim TW, Yang L, Nasroulah F, Tabernero J. Subgroup analysis in RAISE: a randomized, double-blind phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab or placebo in patients with metastatic colorectal carcinoma progression. Ann Oncol. 2016 Nov;27(11):2082-2090. doi: 10.1093/annonc/mdw402. Epub 2016 Aug 29.

ReferenceCitation: Tabernero J, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Van Cutsem E, Grothey A, Prausova J, Garcia-Alfonso P, Yamazaki K, Clingan PR, Lonardi S, Kim TW, Simms L, Chang SC, Nasroulah F; RAISE Study Investigators. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015 May;16(5):499-508. doi: 10.1016/S1470-2045(15)70127-0. Epub 2015 Apr 12. Erratum In: Lancet Oncol. 2015 Jun;16(6):e262.

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, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine

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:
Finland
Germany
Argentina
Australia
Brazil
Japan
Czechia
France
Slovenia
Portugal
Hungary
Denmark
United States
India
Romania
Belgium
Puerto Rico
Italy
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Israel


title: A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy

acronym: HEPCAT

summary: The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

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

location_facility: University Of North Carolina, Chapel Hill

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

location_facility: Upper Delaware Valley Infectious Diseases, Pc

location_facility: University Of California At San Francisco

location_facility: Instituto De Investigacion Cientifica Del Sur

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: Transplant Center And Hepatology Clinic, B-154


lead_sponsor: Boehringer Ingelheim

summary:
The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.

The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).

As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.

ReferenceCitation: Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Special. Hospital for Active Treatment, Sv. Sofia 2nd Clinic

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Scientific Research Institute of Pulmonology

location_facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente

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

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Royal Perth Hospital-Lung Transplant Unit

location_facility: University of Pecs, 1st internal Med. Dept., Pulmonology

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: QEII Health Sciences Centre (Dalhousie University)

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: University Hospital of Heraklion, University Pulmonology Cl

location_facility: Central Scientific Research Insitute of Tuberculosis

title: A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

design_allocation: Non-Randomized

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Portugal
Hungary
Belgium
China
Italy
United Kingdom
Netherlands
Mexico
Spain
Greece
Bulgaria
Russian Federation


title: A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy

summary: The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

ReferenceCitation: Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.

ReferenceCitation: Garon EB, Scagliotti GV, Gautschi O, Reck M, Thomas M, Iglesias Docampo L, Kalofonos H, Kim JH, Gans S, Brustugun OT, Orlov SV, Cuyun Carter G, Zimmermann AH, Oton AB, Alexandris E, Lee P, Wolff K, Stefaniak VJ, Socinski MA, Perol M. Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy. ESMO Open. 2020 Jan;5(1):e000567. doi: 10.1136/esmoopen-2019-000567.

repository_institution: California Digital Library - eScholarship

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

ReferenceCitation: Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S, Perol M. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014 Aug 23;384(9944):665-73. doi: 10.1016/S0140-6736(14)60845-X. Epub 2014 Jun 2.

ReferenceCitation: Garon EB, Cao D, Alexandris E, John WJ, Yurasov S, Perol M. A randomized, double-blind, phase III study of Docetaxel and Ramucirumab versus Docetaxel and placebo in the treatment of stage IV non-small-cell lung cancer after disease progression after 1 previous platinum-based therapy (REVEL): treatment rationale and study design. Clin Lung Cancer. 2012 Nov;13(6):505-9. doi: 10.1016/j.cllc.2012.06.007. Epub 2012 Jul 31.

location_country:
Germany
Poland
New Zealand
Argentina
Brazil
Turkey
Canada
France
Hungary
Switzerland
United States
India
Romania
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

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


title: A Prospective Open Randomized Trial on the Efficacy of Gonadotropin-releasing Hormone Agonist Depot-Triptorelin- to Prevent Chemotherapy Induced Premature Ovarian Failure in Lymphoma Patients.

acronym: Erasme-POF

summary:
Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to treat neoplastic and benign diseases. These drugs are definitely associated with premature ovarian failure (POF), resulting in an important decrease of the long-term quality of life and an increase of morbidity. A recent study showed that the patients treated by alkylating agents had a 4.52 fold higher risk to lose their ovarian function compared with those who were treated by other agents. The rate of POF after treatment ranged from 40 to 80%, according to the age of the patients and the total doses administered.

Young women who experience POF have to face with the prospects of infertility and to consider years of hormonal replacement therapy. The possibility of minimizing gonadal damage by administering of protective therapy during chemotherapy represents an attractive option for these patients.

The aim of this study is to evaluate the protective effect on the ovarian function of the gonadotropin-releasing hormone agonist (GnRha) administered concomitantly to alkylating agents. Preliminary data in the literature on animals (rat and monkeys) are promising. Data in human are, however, highly controversial.

primary_purpose: Prevention

ReferenceCitation: Demeestere I, Brice P, Peccatori FA, Kentos A, Gaillard I, Zachee P, Casasnovas RO, Van Den Neste E, Dechene J, De Maertelaer V, Bron D, Englert Y. Gonadotropin-releasing hormone agonist for the prevention of chemotherapy-induced ovarian failure in patients with lymphoma: 1-year follow-up of a prospective randomized trial. J Clin Oncol. 2013 Mar 1;31(7):903-9. doi: 10.1200/JCO.2012.42.8185. Epub 2012 Nov 5.

lead_sponsor: Erasme University Hospital

collaborators: Fonds National de la Recherche Scientifique

location_country: Italy Belgium France

location_facility:
Henry-Mondor Hospital
Erasme Hospital
CHU Nancy
AZ St Jan
Hôpital Hotel Dieu
St Louis Hospital
Centre Henri Beckerel
AZ-VUB
CHU St Antoine
CHRU Lille
Algemeen Ziekenhuis Stuivenberg
Instituto Europeo di oncologia
CHU Dijon
St Luc University
Bordet

lead_sponsor_type: academique


title: A Phase II (BRF113710) Single-arm, Open-label Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

summary: BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.

ReferenceType: background

ReferenceCitation: Ascierto PA, Minor D, Ribas A, Lebbe C, O'Hagan A, Arya N, Guckert M, Schadendorf D, Kefford RF, Grob JJ, Hamid O, Amaravadi R, Simeone E, Wilhelm T, Kim KB, Long GV, Martin AM, Mazumdar J, Goodman VL, Trefzer U. Phase II trial (BREAK-2) of the BRAF inhibitor dabrafenib (GSK2118436) in patients with metastatic melanoma. J Clin Oncol. 2013 Sep 10;31(26):3205-11. doi: 10.1200/JCO.2013.49.8691. Epub 2013 Aug 5.

ReferenceCitation: Hauschild A, Ascierto PA, Schadendorf D, Grob JJ, Ribas A, Kiecker F, Dutriaux C, Demidov LV, Lebbe C, Rutkowski P, Blank CU, Gutzmer R, Millward M, Kefford R, Haas T, D'Amelio A Jr, Gasal E, Mookerjee B, Chapman PB. Long-term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy: Analysis from phase 2 and 3 clinical trials. Eur J Cancer. 2020 Jan;125:114-120. doi: 10.1016/j.ejca.2019.10.033.

repository_institution: UWA - UWA Profiles and Research Repository

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)
escholarship.org

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Ouellet D, Gibiansky E, Leonowens C, O'Hagan A, Haney P, Switzky J, Goodman VL. Population pharmacokinetics of dabrafenib, a BRAF inhibitor: effect of dose, time, covariates, and relationship with its metabolites. J Clin Pharmacol. 2014 Jun;54(6):696-706. doi: 10.1002/jcph.263. Epub 2014 Jan 17.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Australia
United States
France


title: A Randomised Phase III Study of Elacytarabine vs. Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia

acronym: CLAVELA

summary: The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator's choice treatment in patients with relapsed or refractory acute myeloid leukemia (AML).

ReferenceCitation: Roboz GJ, Rosenblat T, Arellano M, Gobbi M, Altman JK, Montesinos P, O'Connell C, Solomon SR, Pigneux A, Vey N, Hills R, Jacobsen TF, Gianella-Borradori A, Foss O, Vetrhusand S, Giles FJ. International randomized phase III study of elacytarabine versus investigator choice in patients with relapsed/refractory acute myeloid leukemia. J Clin Oncol. 2014 Jun 20;32(18):1919-26. doi: 10.1200/JCO.2013.52.8562. Epub 2014 May 19.

lead_sponsor: Clavis Pharma

location_country:
Germany
Ireland
Italy
Poland
Norway
United Kingdom
Romania
Australia
Belgium
United States
Spain
Canada
France

location_facility: USC/Norris Comprehensive Cancer Center and Hospital

location_facility: Fundeni Clinical Institute "Stefan Berceanu" Center for Hematology and Bone Marrow Transplant

location_facility: St. Spiridon" University Hospital, Hematology Department

location_facility: Universitätsklinikum Ulm, Klinik für Innere Medizin III, Comprehensive Cancer Center Ulm (CCCU)

location_facility: The Blood and Marrow Transplant Group of GA

location_facility: Christie Hospital, Haematology and Transplant Day Unit

location_facility: Wake Forest University, Health Sciences Section on Hematology and Oncology

location_facility: Heinrich-Heine Universität Düsseldorf, Klinik für Hämatologie/Onkolog. und Klin. Immunologie

location_facility: III. Medizinische Klinik und Poliklinik;Hämatologie, Onkologie und Pneumologie

location_facility: Oncology Institute ,,Ion Chiricuta" Cluj Napoca , Hematology dept.

location_facility: Gartnavel General Hospital: Beatson WOS Cancer Centre

location_facility: Evangelische Kliniken Johanniter- und Waldkrankenhaus Bonn GmbH

location_facility: Rocky Mountain Blood and Bone Marrow Transplant Program

location_facility: UCLA School of Medicine, Division of Hematology/Oncology

location_facility: Universitätsklinikum Münster, Medisinische Klinik & Poliklinik A

location_facility: Hospital Universitario La Fé, Servicio de Hematología

location_facility: Charité-Campus B. Franklin Med. Klinik Haematology

location_facility: Froedtert Hospital, Medical College of Wisconsin

location_facility: New York Presbyterian Hospital, Weill-Cornell Medical College

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu


title: A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and Frequency of Hospital Admissions in Patients With Heart Failure (HF) and Sleep Apnea (SA)-The ADVENT-HF Trial

acronym: ADVENT-HF

summary: Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.

ReferenceCitation: Perger E, Inami T, Lyons OD, Alshaer H, Smith S, Floras JS, Logan AG, Arzt M, Duran Cantolla J, Delgado D, Fitzpatrick M, Fleetham J, Kasai T, Kimoff RJ, Leung RST, Lorenzi Filho G, Mayer P, Mielniczuk L, Morrison DL, Parati G, Parthasarathy S, Redolfi S, Ryan CM, Series F, Tomlinson GA, Woo A, Bradley TD; ADVENT-HF Investigators. Distinct Patterns of Hyperpnea During Cheyne-Stokes Respiration: Implication for Cardiac Function in Patients With Heart Failure. J Clin Sleep Med. 2017 Nov 15;13(11):1235-1241. doi: 10.5664/jcsm.6788. Erratum In: J Clin Sleep Med. 2018 Apr 15;14(4):703.

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

repositories_concat: PubMed Central;boa.unimib.it

publisher_dissemination: American Academy of Sleep Medicine (AASM)

lead_sponsor: Toronto Rehabilitation Institute

collaborators: Canadian Institutes of Health Research (CIHR)

location_country:
Germany
Italy
United Kingdom
Japan
Brazil
United States
Spain
Canada
France

location_facility: Kingston General Hospital Sleep Disorders Laboratory/Queen's University

location_facility: Groupe Hospitalier Pitié-Salpêtrière Charles Foix, AP-HP

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Wissenschaftliches Institut Bethanien e.V.

location_facility: Pole d'exploration de L' apnée du sommeil, Nouvelle Clinique Bel Air

location_facility: Glacier View Research Institute, Kalispell Regional Medical Center

location_facility: McMaster University Medical Centre, Hamilton Health Sciences

location_facility: Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires, Centre Hospitalier Universitaire de Grenoble

location_facility: Pronto Socorro Cardiologico de Pernambuco

location_facility: University of Ottawa-Ottawa Heart Institute

location_facility: The Sleep Disorders Centre -Nuffield House, Guy's Hospital

location_facility: University Health Network/TRI/Mount Sinai

location_facility: CDEC Brasil - Centro de Desenvolvimento em Estudos Clínicos Brasil

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Instituto do Coração do Hospital das Clínicas da FMUSP

location_facility: Istituto Auxologico Italiano - Ospedale San Luca

location_facility: Istituto Scientifico di Montescano, Istituti Clinici Scientifici Maugeri (ICS Maugeri)

location_facility: McGill University Health Centre, Glen Site

location_facility: Istituto Scientifico di Veruno, Istituti Clinici Scientifici Maugeri

location_facility: University of Arizona/Southern Arizona VA Health Care System

intervention_type: Device


title: A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma

summary: The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.

lead_sponsor: Clovis Oncology, Inc.

location_country:
Germany
Italy
Norway
Argentina
United Kingdom
Australia
Brazil
Netherlands
Sweden
Belgium
United States
Canada
Ukraine
Russian Federation
France

location_facility: Centre Regional de Lutte contre le Cancer Val d'Aurelle

location_facility: Centre Hospitalier Régional Universitaire Hôpital Saint Eloi

location_facility: "Public Healthcare Institution ""Kharkiv Regional Clinical Oncology Center"", Abdominal Department

location_facility: National Cancer Institute, Department of Tumors of Abdominal Cavity and Retroperitoneum

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Beatson West of Scotland Cancer Centre, Cancer Research UK Clinical Trials Unit (CTU)

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk State Medical Academy, Department of Oncology and Medical Radiology

location_facility: Hôpital Saint André, Service d'Oncologie Médicale

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: State Regional Diagnostics and Treatment Oncology Center, Chemotherapy Department

location_facility: Policlínica Privada Instituto de Medicina Nuclear

location_facility: Zakarpatya Regional Clinical Oncology Center, Chemotherapy Department

location_facility: Mykolayiv Regional Oncology Center, Surgery Department #1

location_facility: Klinik der Otto-Von-Guericke-Universität Magdeburg

location_facility: Southern Medical Day Oncology Care Centre

location_facility: Public Clinical Treatment and Prophylaxis Institution "Donetsk Regional Antitumor Center", Oncosurgery Department #6

location_facility: Border Medical Oncology, Murray Valley Private Hospital

location_facility: Instituto Especializado Alexander Fleming

location_facility: Mechnikov St. Petersburg State Medical Academy

location_facility: Instituto Oncologico Veneto, Oncologia Medica 1

location_facility: Institut Gustave-Roussy - Centre de Lutte Contre le Cancer

location_facility: Clinical Facility: Public Institution "Zaporizhya City Clinical Hospital #3", Regional Center of Hepatic, Biliary Tract and Pancreatic Surgery, Surgery Department #1

location_facility: Medizinische Universitätsklinik Ulm, Abt. Innere Medizin I

location_facility: Ludwig-Maximilians-Universität, Medizinische Klinik und Poliklinikversität München


acronym: INTENSE

lead_sponsor: Astellas Pharma Inc

summary: Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.

ReferenceCitation: White PL, Posso R, Parr C, Price JS, Finkelman M, Barnes RA. The Presence of (1-->3)-beta-D-Glucan as Prognostic Marker in Patients After Major Abdominal Surgery. Clin Infect Dis. 2021 Oct 5;73(7):e1415-e1422. doi: 10.1093/cid/ciaa1370.

repository_institution: Cardiff University - ORCA Online Research @Cardiff

ReferenceCitation: Knitsch W, Vincent JL, Utzolino S, Francois B, Dinya T, Dimopoulos G, Ozgunes I, Valia JC, Eggimann P, Leon C, Montravers P, Phillips S, Tweddle L, Karas A, Brown M, Cornely OA. A randomized, placebo-controlled trial of preemptive antifungal therapy for the prevention of invasive candidiasis following gastrointestinal surgery for intra-abdominal infections. Clin Infect Dis. 2015 Dec 1;61(11):1671-8. doi: 10.1093/cid/civ707. Epub 2015 Aug 13.

repository_institution: Université de Lausanne - SERVAL

repository_institution: reroDoc Digital Library

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL
reroDoc Digital Library

title: An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis Versus Placebo in High Risk Surgical Subjects - A Multicentre, Randomized, Double-blind Study

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

location_country:
Finland
Germany
Italy
Hungary
Israel
Denmark
Romania
United Kingdom
Switzerland
Austria
Belgium
Spain
Greece
Turkey
France


intervention_type: Biological

lead_sponsor: Affiris AG

summary: This is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. Patients will be randomized to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.

location_facility: Centre Mémoire de Ressources et de Recherche, Service de Neurologie

location_facility: "BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju

location_facility: Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie

location_facility: Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt

location_facility: Arzneimittelforschung Leipzig GmbH, Studienzentrum

location_facility: Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München

location_facility: Christian Doppler Klinik, Univ. Klinik f. Neurologie

location_facility: MUW Klin. Pharmakologie und Klinik für Neurologie

location_facility: CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard

location_facility: University Hospital Motol, Clinic of Neurology

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie

location_facility: Opća bolnica Varaždin, Klinika za Neurologiju

location_facility: Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju

location_facility: Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie

location_facility: Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju

location_facility: Centre Hospitalier Universitaire (CHU) de Dijon

location_facility: Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie

title: A Randomized, Controlled, Parallel Group, Double-blind, Multi-center, Phase II Study to Assess the Clinical- and Immunological Activity,as Well as the Safety and Tolerability of Different Doses/Formulations of AFFITOPE AD02 Administered Repeatedly to Patients With Early Alzheimer's Disease

location_country:
Germany
Slovakia
Austria
Croatia
Czech Republic
France


title: A Randomized, Placebo-controlled, Double-blinded Phase 2 Study of Second-line Treatment With OSI-906 in Patients With Advanced Hepatocellular Carcinoma (HCC) After Failure of First-line Treatment With Sorafenib

summary: This is a randomized, placebo-controlled, double-blind phase 2 study of OSI-906 or placebo at a continuous 150 mg twice daily (BID) dose.

ipd_sharing: No

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

location_country:
Germany
Italy
Hong Kong
Singapore
Belgium
United States
Korea, Republic of
Spain
Taiwan
France

location_facility: IRCCS Istituto Nazionale per lo studio e la cura dei tumori Fondazione G. Pascale-SSD Epatobiliare

location_facility: Tulane University Health Services Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hopital Jean Verdier - Dervice d'Hepato-Gastroenterologie

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Johns Hopkins Singapore International Medical Centre

location_facility: Ospedale Fatebenefratelli, Dipartimento Medicina Interna

location_facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ISMETT-Dipartimento di Epatologia e Gastroenterologia

location_facility: Seattle Cancer Care Alliance University of Washington

location_facility: Fondazione Ca' Granda Ospedale Maggiore Policlinico, Divisione di Gastroenterologia I

location_facility: Chang Gung Medical Foundation LinKou Branch


acronym: BEGIN™

lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs) qualifying for intensified treatment.

ReferenceType: result

ReferenceCitation: Weatherall J, Bloudek L, Buchs S. Budget impact of treating commercially insured type 1 and type 2 diabetes patients in the United States with insulin degludec compared to insulin glargine. Curr Med Res Opin. 2017 Feb;33(2):231-238. doi: 10.1080/03007995.2016.1251893. Epub 2016 Nov 18.

ReferenceCitation: Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.

ReferenceCitation: Gough SC, Bhargava A, Jain R, Mersebach H, Rasmussen S, Bergenstal RM. Low-volume insulin degludec 200 units/ml once daily improves glycemic control similarly to insulin glargine with a low risk of hypoglycemia in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, multinational, treat-to-target trial: the BEGIN LOW VOLUME trial. Diabetes Care. 2013 Sep;36(9):2536-42. doi: 10.2337/dc12-2329. Epub 2013 May 28.

publisher_dissemination: American Diabetes Association

ReferenceCitation: Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.

repositories:
LIRIAS (KU Leuven)
PubMed Central
eprints.whiterose.ac.uk

repositories_concat: LIRIAS (KU Leuven);PubMed Central;eprints.whiterose.ac.uk

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Vora J, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1.

publisher_dissemination: Springer

ReferenceCitation: Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014.

ReferenceCitation: Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.

ReferenceCitation: Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.

ReferenceCitation: Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18.

ReferenceCitation: Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.

title: A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: LOW VOLUME)

location_country:
Ireland
United Kingdom
United States
South Africa
Canada
Ukraine
Russian Federation
France


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

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 have reduced kidney function.

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.

publisher_dissemination: The Endocrine Society

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.

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

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.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
India
New Zealand
Romania
Australia
Brazil
Mexico
Belgium
United States
Korea, Republic of
Latvia
Spain
Malaysia
South Africa
Canada
Russian Federation
France


summary: This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. There will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to their renal situation.

title: A Multicenter Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged Greater Than or Equal to 13 Years

location_country:
Italy
Lithuania
Poland
Hungary
Denmark
Romania
United States
Spain
France


acronym: BOOST™

summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.

ReferenceCitation: Freemantle N, Mamdani M, Vilsboll T, Kongso JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. doi: 10.1007/s13300-015-0142-y. Epub 2015 Nov 18.

ReferenceCitation: Kumar S, Jang HC, Demirag NG, Skjoth TV, Endahl L, Bode B. Efficacy and safety of once-daily insulin degludec/insulin aspart compared with once-daily insulin glargine in participants with Type 2 diabetes: a randomized, treat-to-target study. Diabet Med. 2017 Feb;34(2):180-188. doi: 10.1111/dme.13125. Epub 2016 Jul 28.

ReferenceCitation: Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.

title: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (BOOST™ : INTENSIFY BASAL)

location_country:
Poland
India
Sweden
United States
Korea, Republic of
South Africa
Croatia
Turkey
France


title: Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1

summary: The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

ReferenceCitation: Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.

ReferenceCitation: McPhee F, Hernandez D, Yu F, Ueland J, Monikowski A, Carifa A, Falk P, Wang C, Fridell R, Eley T, Zhou N, Gardiner D. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013 Sep;58(3):902-11. doi: 10.1002/hep.26388. Epub 2013 Jul 16.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Lok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, Reindollar R, Rustgi V, McPhee F, Wind-Rotolo M, Persson A, Zhu K, Dimitrova DI, Eley T, Guo T, Grasela DM, Pasquinelli C. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012 Jan 19;366(3):216-24. doi: 10.1056/NEJMoa1104430.

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
Puerto Rico
France

location_facility: University Of Colorado Denver & Hospital


title: A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis

summary: This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.

ReferenceCitation: Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Blanco R, Kadva A, Dimonaco S. Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial. Ann Rheum Dis. 2017 Jul;76(7):1279-1284. doi: 10.1136/annrheumdis-2016-210561. Epub 2017 Apr 7.

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

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Kelman A, Dimonaco S, Mitchell N. Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial. Ann Rheum Dis. 2016 Jun;75(6):1081-91. doi: 10.1136/annrheumdis-2015-207628. Epub 2015 Oct 28.

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Hospital Univ. Central de Asturias; Servicio de Reumatologia

location_facility: Hadassah University Hospital, Ein Karem; Rheumatology

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Policlinico Universitario; Cattedra Di Reumatologia, Edificio 3

location_facility: Sunshine Coast Rheumatology Research Unit

location_facility: Phramongkutklao Hospital; Dept. of Medicine, Rheumatology

location_facility: FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"

location_facility: Southwest Rheumatology & Research Group, LLC

location_facility: Markhot Ferenc Hospital; Dep. of Rheumatology

location_facility: Rheumatology Associates of North Alabama

location_facility: Hospital General Universitario de Guadalajara; Servicio de Reumatologia

location_facility: Ramathibodi Hospital, Mahidol Uni ; Allergy, Immunology & Rheumatology, Dept of Medicine

location_facility: Hospital Universitario Reina Sofia; Servicio de Reumatologia

location_facility: Karolinska Sjukhuset; Reumatologkliniken D2-1

location_facility: Chulalongkorn Hospital; Division of Rheumatology - Medicine

location_facility: Instytut Reumatologii im. Prof. Dr hab. Eleonory Reicher; Oddzial Wczesnej Diagnostyki Stawow

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Reumatologia

location_facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Rheumatologie/Immunologie

location_facility: Arcispedale Santa Maria Nuova; Reumatologia

location_facility: St.Vincent's University Hospital; Rheumatology Department

location_facility: Karolinska University Hospital, Huddinge; Rheumatology

location_facility: FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences

location_facility: Maidstone Hospital; Dept of Rheumatology

location_facility: Hospital Universitario de la Princesa; Servicio de Reumatologia

location_facility: SBIH of Moscow "City clinical hospital #1 n.a. N.I. Pirogov" of Moscow Healthcare Department

location_facility: Royal Hallamshire Hospital; Rheumatology

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia

location_facility: Haywood Hospital; Staffordshire Rheumatology Centre

location_facility: Royal Prince Alfred Hospital; Rheumatology

location_facility: Fondation Hopital Saint Joseph; Rhumatologie

location_facility: Klinikum der Universität München; Bereich Pettenkoferstr.; Rheumaeinheit der medizinischen Klinik IV

location_facility: State Institution of Healthcare of Yaroslavl Region Clinical Hospital #8

location_facility: ASST FATEBENEFRATELLI SACCO; Reumatologia (Sacco)

location_facility: The Third Affiliated Hospital of Sun Yat-Sen University

location_facility: Hospital de Sao Joao; Servico de Reumatologia

location_facility: Russells Hall Hospital; Rheumatology Department

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Hospital Infanta Sofia; Servicio de Reumatologia

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

location_facility: Arthritis & Osteoporosis Associates, LLP

location_facility: Hospital de Merida ;Servicio de Reumatologia

location_facility: Szpital Specjalistyczny Nr 1; Oddzial Reumatologii I Rehabilitacji

location_facility: Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"

location_facility: Adelaide and Meath Hospital; Rheumatology Department

location_facility: Uni of Santo Tomas Hospital; Rheumatology

location_facility: Valerius Medical Group & Research Ctr of Greater Long Beach

location_facility: Clnical & Translational Reseach Center for Alabama, PC

location_facility: CH Jean Rougier; Rhumato Reed Fonctionnelle

location_facility: Campus Bio-Medico; Immunologia e Allergologia

location_facility: Hopital Maisonneuve- Rosemont; Rheumatology

location_facility: Asheville Arthritis & Osteoporosis Center, PA

location_facility: Kaiser Franz Josef Spital; Ii. Medizinische Abt.

location_facility: Hospital e Maternidade Celso Pierro - PUCCamp; Reumatologia

location_facility: Centro especializado de rehabilitacion fisica y del dolor cerfid - unidad de inv. En reumatologia

location_facility: Ryazan State Medical University Named after I.P.Pavlov

location_facility: Royal Victoria Infirmary; Clinical Research Facility

location_facility: Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"

location_facility: Budai Irgalmasrendi Kórház KHT. II. Reumatológia

location_facility: Arthritis Health Associates; Clinical Research

location_facility: Philippine General Hospital; Rheumatology

location_facility: QUEEN MARY HOSPITAL; Division of Rheumatology & Clinical Immunology

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Reumatologia

location_facility: State Institution of Healthcare of Tula Region "Tula Regional Clinical Hospital"

location_facility: Laiko General Hospital; Hematology Clinic

location_facility: North Shore Hospital, STAR Unit; Rheumatology Department

location_facility: Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie

location_facility: National University Hospital; Dept of Medicine

location_facility: Ohio State University; Dept of Immunology

location_facility: Hadassah Mount Scopus Hospital; Rheumatology

location_facility: Arthrocare, Arthritis Care and Research, P.C.

location_facility: Hospital de Santa Maria; Servico de Reumatologia

location_facility: Università Degli Studi Di Genova - Dimi; Reumatologia

location_facility: Addenbrooke'S Hospital; Rheumatology Research Unit

location_facility: Uni of California - San Diego; Division of Rheumatology

location_facility: Centro Medico Privado de Reumatologia; Reumathology

location_facility: Unidad de Enfermedades Reumaticas y Cronicodegenerativas

location_facility: Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

location_facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

location_facility: Universidade Federal de Sao Paulo - UNIFESP; Reumatologia

location_facility: Dr. William G. Bensen Medicine Professional Corporation

location_facility: Sjællands Universitetshospital, Køge; Reumatologisk Afdeling

location_facility: Hopital Porte Madeleine; Service de Rhumatologie

location_facility: North Mississippi Medical Ctr; Internal Medicine Associates

location_facility: Chaim Sheba Medical Center; Rheumatology

location_facility: Klinik der Uni zu Köln; Klinik für Innere Medizin

location_facility: Centro Paulista de Investigacao Clinica - CEPIC

location_facility: Ospedale Di Magenta Fornaroli; U.O. Di Reumatologia

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Policlinico Umberto I - Universita' La Sapienza ; Cattedra Di Reumatologia - Dept. Terapia Medica

location_facility: Wojewodzki Szpital Zespolony; Oddzial Reumatologii

location_facility: Clinica Medica Del Dr Eduardo Alfredo Samayoa

location_facility: Dres. Florian Schuch, Ruediger de la Camp, Martin Hammerschmidt u.w.

location_facility: Dartmouth-Hitchcock Medical Center, Rheumatology 5C

location_facility: Centro de Estudos em Terapias Inovadoras - CETI

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Reumatologia

location_facility: Hopital Lapeyronie; Immunologie Rhumatologie

location_facility: Waikato Hospital; Rheumatology Outpatients

location_facility: St. Joseph'S Health Care Centre; Rheumatology

location_facility: Centro de Investigación Clínica de Morelia, S.C.; Reumatologia

location_facility: Pamela Youde Nethersole Eastern Hospital; Department of Medicine

location_facility: General Hospital of Chinese PLA; Department of Hematology

location_facility: Iu Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali; Romatoloji Bilim Dali

location_facility: Tuen Mun Hospital; Medicine & Geriatrics

location_facility: Rheuma-Zentrum Baden-Baden Gmbh; Klinik Für Innere Medizin-Rheumatologie

location_facility: Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin

location_facility: Clinic of Rheumatology; Clinical Centre Skopje

location_facility: Hospital das Clinicas - UFG;Reumatologia

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék

location_facility: Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases

location_facility: Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

location_facility: SBIH of Moscow "City Clinical Hospital #20 of Moscow Healthcare Department"

location_facility: Inst. de Rehabilitacion Psicofisica; Reumathology

location_facility: Medyczne Centrum Hetmanska; Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: University General Hospital of Larissa; Rheumatology Unit

location_facility: FSBI "National medico-surgical Centre n.a. N.I. Pirogov" of the Ministry of Healthcare

location_facility: Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia

location_facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Rheumatology

location_facility: Istituto Ortopedico Rizzoli; Unità di Reumatologia

location_facility: Centro Internacional de Pesquisa; Reumatologia

location_facility: Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie

location_facility: State institution of healthcare "Regional hospital for war veterans"

location_facility: Unidad De Enfermedades; Cronico Degenerativas, SC.

location_facility: Helsinki University Central Hospital; Rheumatology Clinic

location_facility: Centro de Infusion Marbella; Consultorios Royal Center Num 214

location_facility: Chaim Sheba Medical Center; Interna Dept B

location_facility: SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF

location_facility: Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie

location_facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

location_facility: Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Ospedale S. Giovanni Bosco; S.C. A Direzione Uni Ria Di Immunologia Clinica

location_facility: Krankenhaus der stadt wien hietzing; ii. Med. Abt. / zentrum für rheumatologie


title: A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy

acronym: GENERATION

summary: This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.

ReferenceCitation: Perl S, Cook W, Wei C, Ohman P, Hirshberg B. Effects of Glimepiride versus Saxagliptin on beta-Cell Function and Hypoglycemia: A Post Hoc Analysis in Older Patients with Type 2 Diabetes Inadequately Controlled with Metformin. Clin Ther. 2016 Dec;38(12):2578-2588. doi: 10.1016/j.clinthera.2016.10.006. Epub 2016 Nov 4.

ReferenceCitation: Schernthaner G, Duran-Garcia S, Hanefeld M, Langslet G, Niskanen L, Ostgren CJ, Malvolti E, Hardy E. Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION). Diabetes Obes Metab. 2015 Jul;17(7):630-8. doi: 10.1111/dom.12461. Epub 2015 Apr 7.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Bristol-Myers Squibb

location_country:
Finland
Germany
Italy
Hungary
Norway
Denmark
United Kingdom
Sweden
Austria
Mexico
Spain
Greece
France


title: A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

acronym: PROMPT

summary: The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.

ReferenceCitation: Hermans MP, Delibasi T, Farmer I, Lohm L, Maheux P, Piatti P, Malvolti E, Jorgens S, Charbonnel B. Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes: the PROMPT study. Curr Med Res Opin. 2012 Oct;28(10):1635-45. doi: 10.1185/03007995.2012.735646. Epub 2012 Oct 12.

location_country:
Germany
Italy
United Kingdom
Belgium
Spain
Turkey
France


title: A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Ventilated Patients With Nosocomial Pneumonia Due to Gram Negative Organisms

summary: This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).

ReferenceCitation: Niederman MS, Chastre J, Corkery K, Fink JB, Luyt CE, Garcia MS. BAY41-6551 achieves bactericidal tracheal aspirate amikacin concentrations in mechanically ventilated patients with Gram-negative pneumonia. Intensive Care Med. 2012 Feb;38(2):263-71. doi: 10.1007/s00134-011-2420-0. Epub 2011 Dec 7.

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
Nektar Therapeutics

location_country:
United States
Spain
France


acronym: ALPHEE

lead_sponsor: Sanofi

summary:
The Primary objective was to assess the efficacy of Celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death.

Secondary objectives were:

To assess the tolerability and safety of the different dose regimens of Celivarone in the selected population.
To document Celivarone plasma levels during the study.

ReferenceCitation: Kowey PR, Crijns HJ, Aliot EM, Capucci A, Kulakowski P, Radzik D, Roy D, Connolly SJ, Hohnloser SH; ALPHEE Study Investigators. Efficacy and safety of celivarone, with amiodarone as calibrator, in patients with an implantable cardioverter-defibrillator for prevention of implantable cardioverter-defibrillator interventions or death: the ALPHEE study. Circulation. 2011 Dec 13;124(24):2649-60. doi: 10.1161/CIRCULATIONAHA.111.072561. Epub 2011 Nov 14.

location_facility:
Investigational Site Number 276005
Investigational Site Number 840012
Investigational Site Number 276003
Investigational Site Number 056007
Investigational Site Number 703002
Investigational Site Number 643007
Investigational Site Number 032002
Investigational Site Number 724004
Investigational Site Number 840029
Investigational Site Number 036005
Investigational Site Number 392001
Investigational Site Number 528005
Investigational Site Number 276006
Investigational Site Number 392004
Investigational Site Number 124006
Investigational Site Number 840003
Investigational Site Number 724001
Investigational Site Number 840038
Investigational Site Number 124007
Investigational Site Number 036012
Investigational Site Number 203002
Investigational Site Number 203003
Investigational Site Number 840020
Investigational Site Number 036014
Investigational Site Number 840049
Investigational Site Number 056003
Investigational Site Number 616003
Investigational Site Number 208001
Investigational Site Number 380007
Investigational Site Number 348001
Investigational Site Number 840013
Investigational Site Number 250007
Investigational Site Number 348005
Investigational Site Number 250002
Investigational Site Number 348003
Investigational Site Number 036008
Investigational Site Number 392006
Investigational Site Number 840002
Investigational Site Number 208002
Investigational Site Number 056004
Investigational Site Number 840037
Investigational Site Number 616008
Investigational Site Number 840014
Investigational Site Number 203005
Investigational Site Number 710002
Investigational Site Number 724007
Investigational Site Number 840039
Investigational Site Number 840025
Investigational Site Number 380008
Investigational Site Number 840043
Investigational Site Number 036003
Investigational Site Number 124002
Investigational Site Number 616006
Investigational Site Number 792003
Investigational Site Number 056005
Investigational Site Number 703001
Investigational Site Number 840054
Investigational Site Number 840017
Investigational Site Number 616002
Investigational Site Number 724003
Investigational Site Number 840024
Investigational Site Number 620003
Investigational Site Number 124010
Investigational Site Number 643011
Investigational Site Number 032004
Investigational Site Number 124004
Investigational Site Number 208004
Investigational Site Number 616007
Investigational Site Number 616011
Investigational Site Number 840026
Investigational Site Number 840009
Investigational Site Number 250004
Investigational Site Number 643008
Investigational Site Number 203004
Investigational Site Number 376001
Investigational Site Number 840030
Investigational Site Number 724006
Investigational Site Number 203006
Investigational Site Number 392005
Investigational Site Number 840032
Investigational Site Number 276002
Investigational Site Number 620004
Investigational Site Number 840022
Investigational Site Number 036009
Investigational Site Number 840048
Investigational Site Number 250005
Investigational Site Number 620005
Investigational Site Number 348004
Investigational Site Number 036004
Investigational Site Number 124008
Investigational Site Number 376002
Investigational Site Number 792001
Investigational Site Number 840006
Investigational Site Number 528004
Investigational Site Number 643006
Investigational Site Number 376003
Investigational Site Number 528001
Investigational Site Number 276001
Investigational Site Number 124005
Investigational Site Number 840033
Investigational Site Number 752003
Investigational Site Number 752002
Investigational Site Number 840045
Investigational Site Number 246004
Investigational Site Number 250003
Investigational Site Number 484002
Investigational Site Number 840004
Investigational Site Number 208005
Investigational Site Number 792002
Investigational Site Number 840042
Investigational Site Number 036013
Investigational Site Number 840016
Investigational Site Number 056002
Investigational Site Number 032003
Investigational Site Number 643005
Investigational Site Number 724002
Investigational Site Number 124009
Investigational Site Number 203001
Investigational Site Number 250006
Investigational Site Number 528007
Investigational Site Number 616001
Investigational Site Number 840034
Investigational Site Number 840007
Investigational Site Number 250001
Investigational Site Number 036006
Investigational Site Number 124001
Investigational Site Number 840019
Investigational Site Number 380001
Investigational Site Number 840035
Investigational Site Number 246001
Investigational Site Number 380004
Investigational Site Number 528002
Investigational Site Number 840031
Investigational Site Number 528003
Investigational Site Number 036007
Investigational Site Number 724009
Investigational Site Number 392002
Investigational Site Number 152001
Investigational Site Number 376004
Investigational Site Number 840015
Investigational Site Number 392003
Investigational Site Number 578003
Investigational Site Number 643004
Investigational Site Number 840010
Investigational Site Number 643003
Investigational Site Number 036010
Investigational Site Number 380002
Investigational Site Number 840011
Investigational Site Number 752001
Investigational Site Number 840005
Investigational Site Number 056001

title: Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Celivarone at 50, 100 or 300 mg OD With Amiodarone as Calibrator for the Prevention of ICD Interventions or Death

location_country:
Finland
Germany
Poland
Argentina
Australia
Japan
Turkey
Chile
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
Denmark
United States
Belgium
Italy
Norway
Sweden
Netherlands
Mexico
Spain
South Africa
Russian Federation
Israel


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Filibuvir Plus Pegylated Interferon Alfa-2a And Ribavirin In Treatment-Naive, HCV Genotype 1 Infected Subjects

acronym: FITNESS

summary: The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.

ReferenceCitation: Rodriguez-Torres M, Yoshida EM, Marcellin P, Srinivasan S, Purohit VS, Wang C, Hammond JL. A phase 2 study of filibuvir in combination with pegylated IFN alfa and ribavirin for chronic HCV. Ann Hepatol. 2014 Jul-Aug;13(4):364-75.

lead_sponsor: Pfizer

location_country:
Germany
Hungary
Belgium
United States
Korea, Republic of
Spain
Canada
Puerto Rico
France