acronym: TEAMSTA Severe HTN

summary: The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.

location_facility: 1235.20.107G Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.202 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.254 Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.109A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.354 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.206 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.307 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.103C Boehringer Ingelheim Investigational Site

location_facility: 1235.20.355 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.513 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.452 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.106F Boehringer Ingelheim Investigational Site

location_facility: 1235.20.153 Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.106B Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.515 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.455 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.107E Boehringer Ingelheim Investigational Site

location_facility: 1235.20.107A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.108A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.104D Boehringer Ingelheim Investigational Site

location_facility: 1235.20.101C Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.453 Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.101D Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.005 Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.157 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.104A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.529 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.530 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.311 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.353 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.309 Boehringer Ingelheim Investigational Site

title: An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).

location_country:
Slovakia
Hungary
Romania
United States
Korea, Republic of
Spain
Bulgaria
Ukraine
Czech Republic
Russian Federation
France


intervention_type: Drug

lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.

ReferenceType: result

ReferenceCitation: DeVries JH, Bain SC, Rodbard HW, Seufert J, D'Alessio D, Thomsen AB, Zychma M, Rosenstock J; Liraglutide-Detemir Study Group. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care. 2012 Jul;35(7):1446-54. doi: 10.2337/dc11-1928. Epub 2012 May 14.

ReferenceCitation: Rosenstock J, Rodbard HW, Bain SC, D'Alessio D, Seufert J, Thomsen AB, Svendsen CB, DeVries JH; Liraglutide-Detemir Study Group. One-year sustained glycemic control and weight reduction in type 2 diabetes after addition of liraglutide to metformin followed by insulin detemir according to HbA1c target. J Diabetes Complications. 2013 Sep-Oct;27(5):492-500. doi: 10.1016/j.jdiacomp.2013.04.008. Epub 2013 Jun 6.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

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version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.

evidence: open (via free pdf)

license_normalized: no license

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

status: Completed

title: The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes. A 26 Week, Randomised, Open-label, Parallel-group, Multicentre, Multinational Trial With a 26 Week Extension

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

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

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


title: Observational Cohort Study to Evaluate the Safety and Efficacy of Pradaxa (Dabigatran Etexilate) for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery in a Routine Clinical Setting.

summary: An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Rosencher N, Samama CM, Feuring M, Brueckmann M, Kleine E, Clemens A, Frostick S. Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting. Thromb J. 2016 Apr 1;14:8. doi: 10.1186/s12959-016-0082-4. eCollection 2016.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Ireland
Italy
Poland
United Kingdom
Sweden
Austria
Spain
France

location_facility: 1160.85.04901 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.35301 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3325A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04913 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4604 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3307A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3404 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04933 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3314A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04928 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3322A Boehringer Ingelheim Investigational Site

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location_facility: 1160.85.04405 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04904 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4308 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3324A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4603 Boehringer Ingelheim Investigational Site

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location_facility: 1160.85.04940 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3315A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3301A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04910 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04944 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04946 Boehringer Ingelheim Investigational Site

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location_facility: 1160.85.04941 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4804 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4806 Boehringer Ingelheim Investigational Site

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location_facility: 1160.85.04949 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3304A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04924 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4302 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04926 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3320A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3405 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04402 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3323A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3302A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4310 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04916 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3311A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03904 Boehringer Ingelheim Investigational Site

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location_facility: 1160.85.04404 Boehringer Ingelheim Investigational Site

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location_facility: 1160.85.04906 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03905 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3306A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03907 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4805 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04938 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4311 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3333A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3309A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04922 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03913 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4307 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3313A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3401 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04905 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3305A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03901 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04939 Boehringer Ingelheim Investigational Site

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location_facility: 1160.85.03910 Boehringer Ingelheim Investigational Site

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location_facility: 1160.85.3310A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03911 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04931 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4312 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3321A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03909 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04952 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4802 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3318A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4304 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04947 Boehringer Ingelheim Investigational Site

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location_facility: 1160.85.04406 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04914 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3308A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04920 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4309 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3331A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3319A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4301 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04918 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3334A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04903 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03914 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04403 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04923 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4305 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04912 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04401 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04934 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3317A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4803 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04945 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4303 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04902 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04943 Boehringer Ingelheim Investigational Site


lead_sponsor: Ferring Pharmaceuticals

summary: The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.

ReferenceCitation: Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Mason M, Maldonado Pijoan X, Steidle C, Guerif S, Wiegel T, van der Meulen E, Bergqvist PB, Khoo V. Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):190-6. doi: 10.1016/j.clon.2012.09.010. Epub 2012 Dec 17.

oa_host_type: closed

location_facility: University General Hospital of Loannina, Medical School

location_facility: Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre

location_facility: Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie

location_facility: Oncology Royal United Hospital Bath NHS Trust

location_facility: Hôpital Saint Louis, Radiotherapy Departement

location_facility: General University Hospital of Alexandroupolis

location_facility: CRLC Val d'Aurelle Oncology Radiotherapy

location_facility: Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie

location_facility: Northern Centre for Cancer Treatment, Newcastle General Hospital

location_facility: General Hospital of Athens, "Sismanogleio", University of Athens, Marouse

location_facility: Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau

location_facility: Albert Schweitzer Ziekenhuis, Ioc., Dordwijk

location_facility: Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie

location_facility: DCT -Celebration, LLC dba Discovery Clinical Trials

title: A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)

location_country:
Germany
United Kingdom
Netherlands
United States
Spain
Greece
France


lead_sponsor: H. Lundbeck A/S

summary: The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

ReferenceCitation: Gual A, He Y, Torup L, van den Brink W, Mann K; ESENSE 2 Study Group. A randomised, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence. Eur Neuropsychopharmacol. 2013 Nov;23(11):1432-42. doi: 10.1016/j.euroneuro.2013.02.006. Epub 2013 Apr 3.

ReferenceCitation: Aubin HJ, Reimer J, Nutt DJ, Bladstrom A, Torup L, Francois C, Chick J. Clinical relevance of as-needed treatment with nalmefene in alcohol-dependent patients. Eur Addict Res. 2015;21(3):160-168. doi: 10.1159/000371547. Epub 2015 Mar 31.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: S. Karger AG

ReferenceCitation: Laramee P, Brodtkorb TH, Rahhali N, Knight C, Barbosa C, Francois C, Toumi M, Daeppen JB, Rehm J. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model. BMJ Open. 2014 Sep 16;4(9):e005376. doi: 10.1136/bmjopen-2014-005376.

repository_institution: Université de Lausanne - SERVAL

repositories_concat: PubMed Central;serval.unil.ch

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

publisher_dissemination: British Medical Journal

ReferenceCitation: van den Brink W, Aubin HJ, Bladstrom A, Torup L, Gual A, Mann K. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013 Sep-Oct;48(5):570-8. doi: 10.1093/alcalc/agt061. Epub 2013 Jul 19. Erratum In: Alcohol Alcohol. 2013 Nov-Dec;48(6):746.

oa_colors: green hybrid

evidence: open (via page says license)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Oxford University Press

title: Nalmefene Efficacy Study II: Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy Study of 20 mg Nalmefene, as Needed Use, in Patients With Alcohol Dependence

location_country:
Italy
Poland
Portugal
Belgium
Spain
Czech Republic
France


acronym: RELY-ABLE

summary:
The purposes of this study are:

To evaluate the long-term safety of dabigatran etexilate
To assess the effect of a knowledge translation intervention on patient outcomes

ReferenceCitation: Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013 Jul 16;128(3):237-43. doi: 10.1161/CIRCULATIONAHA.112.001139. Epub 2013 Jun 14.

publisher_dissemination: Wolters Kluwer Health

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title: RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes

location_country:
Finland
Germany
Poland
Australia
Brazil
Thailand
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
India
Romania
Belgium
China
Malaysia
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Greece
Taiwan
Bulgaria
Russian Federation
Israel


title: AdreView™ Myocardial Imaging for Risk Evaluation - A Multicentre Trial to Guide ICD Implantation in NYHA Class II & III Heart Failure Patients With 25%≤LVEF≤35%

acronym: ADMIRE-ICD

summary: This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class II and III heart failure participants with 25%<=left ventricular ejection fraction (LVEF)<=35%, and in particular, for identifying participants who are at low risk for sudden cardiac death and who would not benefit, or may suffer harm, from implantation of an ICD device.

study_start_date_type: Actual

status: Terminated

primary_purpose: Prevention

lead_sponsor: GE Healthcare

sponsor_collaborators:
GE Healthcare
Advanced Clinical, LLC
TFS
H2O Clinical LLC
AG Mednet Inc.
ICON CEAC
ICON Clinical
ABX CRO
TransPerfect

location_country:
Germany
Italy
Poland
Hungary
Netherlands
United States
Spain
Czechia
Canada
France

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Semmelweis Egyetem Nuklearis Medicina Kozpont

location_facility: Azienda Ospedaliera Universitaria G. Martino

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Department of Cardiology, K-14 (Henry Ford Health System)

location_facility: CIUSSS de L'Estrie - CHUS Hopital Fleurimont

location_facility: Fakultni nemocnice v Kralovske Vinohrady

location_facility: Veterans Affairs North Texas Healthcare System

location_facility: Hospital Universitario San Juan de Alicante

location_facility: Institut Universitaire De Cardiologie Et De Pneumologie De Quebec

location_facility: Kliniken Maria Hilf GmbH, Klinik fur Nuklearmedizin

location_facility: Azienda Ospedaliero-Universitaria Federico II Dipartimento ad Attivita Integrata di Cardiologia,Cardiochirurgia ed Emergenze Cardiovascolari

location_facility: Regions Hospital and Regions Heart Center Clinic

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Kardiológia Osztály/Nuklearis Medicina Osztaly

location_facility: Klinik & Poliklinik fur Nuklearmedizin, LMU, Campus Grobhader

location_facility: CHU Clermont-Ferrand, 63003 Montalembert

location_facility: Hospital General Universitario de Valencia

location_facility: Debreceni Egyetem, Kardiologia Intezet and ScanoMed Nuclear Medicine Institute

location_facility: Vascular Biology and Hypertension Program, University of Alabama at Birmingham

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Instituti Clinici Scientifici Maugeri Spa Societa Benefit

location_facility: Ospedale dell'Angelo, 30174, Venezia Mestre

location_facility: Dolnośląski Szpital Specjalistyczny im. T. Marciniaka Centrum Medycyny Ratunkowej

location_facility: Varosmajori Sziv es Ergyogyaszati Klinika

location_facility: Area Cardiologia Critica - IRCCS Centro Cardiologico Mozino

location_facility: Cardiology Physicians PA/Red Clay Research, LLC

location_facility: VA Connecticut Healthcare System (VACHS)

location_facility: Venezia Mestre - Azienda ULSS 12 "Veneziana"

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University of Florida Health Jacksonville

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Dipartimento di Scienze Cardiovascolari, Respiratorie Neufrologiche e Geriatriche - Universita di Roma "La Sapienza"

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Comprehensive Cardiovascular Medical Group

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità, Dipartimento Cardiologico, Cardiologia 1

status_simplified: Unknown


acronym: STABILITY

lead_sponsor: GlaxoSmithKline

summary: This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.

ReferenceCitation: Sjolin K, Aulin J, Wallentin L, Eriksson N, Held C, Kultima K, Oldgren J, Burman J. Serum Neurofilament Light Chain in Patients With Atrial Fibrillation. J Am Heart Assoc. 2022 Jul 19;11(14):e025910. doi: 10.1161/JAHA.122.025910. Epub 2022 Jul 15.

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

repositories_concat: DiVA.org;PubMed Central

ReferenceCitation: Held C, Hadziosmanovic N, Aylward PE, Hagstrom E, Hochman JS, Stewart RAH, White HD, Wallentin L. Body Mass Index and Association With Cardiovascular Outcomes in Patients With Stable Coronary Heart Disease - A STABILITY Substudy. J Am Heart Assoc. 2022 Feb;11(3):e023667. doi: 10.1161/JAHA.121.023667. Epub 2022 Jan 21.

ReferenceCitation: Siddiqui MK, Smith G, St Jean P, Dawed AY, Bell S, Soto-Pedre E, Kennedy G, Carr F, Wallentin L, White H, Macphee CH, Waterworth D, Palmer CNA. Diabetes status modifies the long-term effect of lipoprotein-associated phospholipase A2 on major coronary events. Diabetologia. 2022 Jan;65(1):101-112. doi: 10.1007/s00125-021-05574-5. Epub 2021 Sep 25.

repository_institution: University of Dundee - Discovery Research Portal

repository_institution: Uppsala University - Uppsala University Publications

ReferenceCitation: Wallentin L, Eriksson N, Olszowka M, Grammer TB, Hagstrom E, Held C, Kleber ME, Koenig W, Marz W, Stewart RAH, White HD, Aberg M, Siegbahn A. Plasma proteins associated with cardiovascular death in patients with chronic coronary heart disease: A retrospective study. PLoS Med. 2021 Jan 13;18(1):e1003513. doi: 10.1371/journal.pmed.1003513. eCollection 2021 Jan.

ReferenceCitation: White HD, Stewart RAH, Dalby AJ, Stebbins A, Cannon CP, Budaj A, Linhart A, Pais P, Diaz R, Steg PG, Krug-Gourley S, Granger CB, Hochman JS, Koenig W, Harrington RA, Held C, Wallentin L; STABILITY Investigators. In patients with stable coronary heart disease, low-density lipoprotein-cholesterol levels < 70 mg/dL and glycosylated hemoglobin A1c < 7% are associated with lower major cardiovascular events. Am Heart J. 2020 Jul;225:97-107. doi: 10.1016/j.ahj.2020.04.004. Epub 2020 Apr 18.

ReferenceCitation: Hilvo M, Wallentin L, Ghukasyan Lakic T, Held C, Kauhanen D, Jylha A, Lindback J, Siegbahn A, Granger CB, Koenig W, Stewart RAH, White H, Laaksonen R; STABILITY Investigators. Prediction of Residual Risk by Ceramide-Phospholipid Score in Patients With Stable Coronary Heart Disease on Optimal Medical Therapy. J Am Heart Assoc. 2020 May 18;9(10):e015258. doi: 10.1161/JAHA.119.015258. Epub 2020 May 7.

ReferenceCitation: Stewart RAH, Held C, Krug-Gourley S, Waterworth D, Stebbins A, Chiswell K, Hagstrom E, Armstrong PW, Wallentin L, White H. Cardiovascular and Lifestyle Risk Factors and Cognitive Function in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2019 Apr 2;8(7):e010641. doi: 10.1161/JAHA.118.010641.

ReferenceCitation: Held C, White HD, Stewart RAH, Budaj A, Cannon CP, Hochman JS, Koenig W, Siegbahn A, Steg PG, Soffer J, Weaver WD, Ostlund O, Wallentin L; STABILITY Investigators. Inflammatory Biomarkers Interleukin-6 and C-Reactive Protein and Outcomes in Stable Coronary Heart Disease: Experiences From the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Oct 24;6(10):e005077. doi: 10.1161/JAHA.116.005077.

ReferenceCitation: Hagstrom E, Norlund F, Stebbins A, Armstrong PW, Chiswell K, Granger CB, Lopez-Sendon J, Pella D, Soffer J, Sy R, Wallentin L, White HD, Stewart RAH, Held C. Psychosocial stress and major cardiovascular events in patients with stable coronary heart disease. J Intern Med. 2018 Jan;283(1):83-92. doi: 10.1111/joim.12692. Epub 2017 Oct 23.

ReferenceCitation: Guimaraes PO, Granger CB, Stebbins A, Chiswell K, Held C, Hochman JS, Krug-Gourley S, Lonn E, Lopes RD, Stewart RAH, Vinereanu D, Wallentin L, White HD, Hagstrom E, Danchin N. Sex Differences in Clinical Characteristics, Psychosocial Factors, and Outcomes Among Patients With Stable Coronary Heart Disease: Insights from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Sep 14;6(9):e006695. doi: 10.1161/JAHA.117.006695.

ReferenceCitation: Stewart RAH, Hagstrom E, Held C, Wang TKM, Armstrong PW, Aylward PE, Cannon CP, Koenig W, Lopez-Sendon JL, Mohler ER 3rd, Hadziosmanovic N, Krug-Gourley S, Ramos Corrales MA, Siddique S, Steg PG, White HD, Wallentin L; STABILITY Investigators. Self-Reported Health and Outcomes in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2017 Aug 22;6(8):e006096. doi: 10.1161/JAHA.117.006096.

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

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

ReferenceCitation: Lindholm D, Lindback J, Armstrong PW, Budaj A, Cannon CP, Granger CB, Hagstrom E, Held C, Koenig W, Ostlund O, Stewart RAH, Soffer J, White HD, de Winter RJ, Steg PG, Siegbahn A, Kleber ME, Dressel A, Grammer TB, Marz W, Wallentin L. Biomarker-Based Risk Model to Predict Cardiovascular Mortality in Patients With Stable Coronary Disease. J Am Coll Cardiol. 2017 Aug 15;70(7):813-826. doi: 10.1016/j.jacc.2017.06.030.

ReferenceCitation: Vedin O, Hagstrom E, Ostlund O, Avezum A, Budaj A, Flather MD, Harrington RA, Koenig W, Soffer J, Siegbahn A, Steg PG, Stewart RAH, Wallentin L, White HD, Held C; STABILITY Investigators. Associations between tooth loss and prognostic biomarkers and the risk for cardiovascular events in patients with stable coronary heart disease. Int J Cardiol. 2017 Oct 15;245:271-276. doi: 10.1016/j.ijcard.2017.07.036. Epub 2017 Jul 17.

repository_institution: University of East Anglia - UEA Digital Repository

ReferenceCitation: Hagstrom E, Held C, Stewart RA, Aylward PE, Budaj A, Cannon CP, Koenig W, Krug-Gourley S, Mohler ER 3rd, Steg PG, Tarka E, Ostlund O, White HD, Siegbahn A, Wallentin L; STABILITY Investigators. Growth Differentiation Factor 15 Predicts All-Cause Morbidity and Mortality in Stable Coronary Heart Disease. Clin Chem. 2017 Jan;63(1):325-333. doi: 10.1373/clinchem.2016.260570. Epub 2016 Nov 3.

ReferenceCitation: Wallentin L, Held C, Armstrong PW, Cannon CP, Davies RY, Granger CB, Hagstrom E, Harrington RA, Hochman JS, Koenig W, Krug-Gourley S, Mohler ER 3rd, Siegbahn A, Tarka E, Steg PG, Stewart RA, Weiss R, Ostlund O, White HD; STABILITY Investigators. Lipoprotein-Associated Phospholipase A2 Activity Is a Marker of Risk But Not a Useful Target for Treatment in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2016 Jun 21;5(6):e003407. doi: 10.1161/JAHA.116.003407.

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

ReferenceCitation: Hijazi Z, Lindback J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25.

ReferenceCitation: Vedin O, Hagstrom E, Budaj A, Denchev S, Harrington RA, Koenig W, Soffer J, Sritara P, Stebbins A, Stewart RH, Swart HP, Viigimaa M, Vinereanu D, Wallentin L, White HD, Held C; STABILITY Investigators. Tooth loss is independently associated with poor outcomes in stable coronary heart disease. Eur J Prev Cardiol. 2016 May;23(8):839-46. doi: 10.1177/2047487315621978. Epub 2015 Dec 16.

ReferenceCitation: Vedin O, Hagstrom E, Gallup D, Neely ML, Stewart R, Koenig W, Budaj A, Sritara P, Wallentin L, White HD, Held C. Periodontal disease in patients with chronic coronary heart disease: Prevalence and association with cardiovascular risk factors. Eur J Prev Cardiol. 2015 Jun;22(6):771-8. doi: 10.1177/2047487314530660. Epub 2014 Apr 10.

ReferenceCitation: STABILITY Investigators; White HD, Held C, Stewart R, Tarka E, Brown R, Davies RY, Budaj A, Harrington RA, Steg PG, Ardissino D, Armstrong PW, Avezum A, Aylward PE, Bryce A, Chen H, Chen MF, Corbalan R, Dalby AJ, Danchin N, De Winter RJ, Denchev S, Diaz R, Elisaf M, Flather MD, Goudev AR, Granger CB, Grinfeld L, Hochman JS, Husted S, Kim HS, Koenig W, Linhart A, Lonn E, Lopez-Sendon J, Manolis AJ, Mohler ER 3rd, Nicolau JC, Pais P, Parkhomenko A, Pedersen TR, Pella D, Ramos-Corrales MA, Ruda M, Sereg M, Siddique S, Sinnaeve P, Smith P, Sritara P, Swart HP, Sy RG, Teramoto T, Tse HF, Watson D, Weaver WD, Weiss R, Viigimaa M, Vinereanu D, Zhu J, Cannon CP, Wallentin L. Darapladib for preventing ischemic events in stable coronary heart disease. N Engl J Med. 2014 May 1;370(18):1702-11. doi: 10.1056/NEJMoa1315878. Epub 2014 Mar 30.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

ReferenceCitation: Vedin O, Hagstrom E, Stewart R, Brown R, Krug-Gourley S, Davies R, Wallentin L, White H, Held C. Secondary prevention and risk factor target achievement in a global, high-risk population with established coronary heart disease: baseline results from the STABILITY study. Eur J Prev Cardiol. 2013 Aug;20(4):678-85. doi: 10.1177/2047487312444995. Epub 2012 Apr 10.

title: LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

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

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Pakistan
Chile
Czechia
Canada
France
Slovakia
Hungary
Hong Kong
Denmark
United States
Ukraine
India
Romania
Belgium
China
Peru
Estonia
Philippines
Italy
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Sweden


title: A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation

acronym: IDHENTIFY

summary: This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Celgene

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Brazil
Austria
Belgium
United States
China
Korea, Republic of
Spain
Turkey
Taiwan
Czechia
Canada
Russian Federation
France

location_facility: Montefiore Medical Center Albert Einstein Cancer Center

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Florida Health Cancer Center at Orlando Health

status_simplified: Ongoing


title: A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)

summary: The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

ReferenceCitation: Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.

ReferenceCitation: Shi J, Liu J, Tu X, Li B, Tong Z, Wang T, Zheng Y, Shi H, Zeng X, Chen W, Yin W, Fang W. Single-cell immune signature for detecting early-stage HCC and early assessing anti-PD-1 immunotherapy efficacy. J Immunother Cancer. 2022 Jan;10(1):e003133. doi: 10.1136/jitc-2021-003133.

ReferenceCitation: Yau T, Park JW, Finn RS, Cheng AL, Mathurin P, Edeline J, Kudo M, Harding JJ, Merle P, Rosmorduc O, Wyrwicz L, Schott E, Choo SP, Kelley RK, Sieghart W, Assenat E, Zaucha R, Furuse J, Abou-Alfa GK, El-Khoueiry AB, Melero I, Begic D, Chen G, Neely J, Wisniewski T, Tschaika M, Sangro B. Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2022 Jan;23(1):77-90. doi: 10.1016/S1470-2045(21)00604-5. Epub 2021 Dec 13.

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Germany
Poland
Australia
Japan
Czechia
Canada
France
Hong Kong
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Sweden
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Scott & White Memorial Hospital And Clinic

location_facility: University of Washington - Seattle Cancer Care Alliance


title: A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

summary: A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
Hungary
Israel
Australia
Netherlands
Belgium
United States
Spain
Canada
Russian Federation
France

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Clinical Research of West Florida - Corporate

location_facility: University of Texas Health Science Center at Houston

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Arizona Arthritis & Rheumatology Research, PLLC


title: A MULTICENTER OPEN-LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE

acronym: RE-EMBARK

summary: The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.

ReferenceCitation: Van den Bosch F, Wei JC, Nash P, Blanco FJ, Graham D, Zang C, Arthur E, Borlenghi C, Tsekouras V, Vlahos B, Deodhar A. Etanercept Withdrawal and Retreatment in Nonradiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label Phase IV Trial. J Rheumatol. 2023 Apr;50(4):478-487. doi: 10.3899/jrheum.220353. Epub 2022 Nov 15.

oa_colors: green other

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

repository_institution: Ghent University - Ghent University Academic Bibliography

publisher_dissemination: The Journal of Rheumatology

ipd_sharing: Yes

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

lead_sponsor: Pfizer

location_country:
Finland
Germany
Poland
Colombia
Hungary
Australia
Sweden
Netherlands
Belgium
United States
Spain
Taiwan
Czechia
France

location_facility: Complexo Hospitalario Universitario A Coruna

location_facility: Diagnostic-Med Centrum Diagnostyki Radiologicznej

location_facility: Samodzielny Publiczny Zespol Opieki Zdrowotnej

location_facility: Reumed Sp z.o.o. Zespool Poradni Specjalistycznych Filia nr 1

location_facility: Complejo Hospitalario Universitario Santiago

location_facility: Northwestern Medical Group; Division of Rheumatology

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont

location_facility: Winthrop University Hospital, Clinical Trials Center

location_facility: Centro Integral de Reumatologia Reumalab S.A.S.

location_facility: Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob

location_facility: Oregon Health and Science University Research Pharmacy

location_facility: SANUS Szpital Specjalistyczny Sp. z o.o.

location_facility: Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

location_facility: Complejo Hospitalario Regional Virgen Macarena

location_facility: Zaklad Radiologii i Diagnostyki Obrazowej

location_facility: Swedish Medical Center Investigational Drug Services Pharmacy

location_facility: Northwestern University Clinical and Translational Sciences Institute (NUCATS)

intervention_type: Biological