title: A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

summary: The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel

ReferenceCitation: Larkin J, Minor D, D'Angelo S, Neyns B, Smylie M, Miller WH Jr, Gutzmer R, Linette G, Chmielowski B, Lao CD, Lorigan P, Grossmann K, Hassel JC, Sznol M, Daud A, Sosman J, Khushalani N, Schadendorf D, Hoeller C, Walker D, Kong G, Horak C, Weber J. Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial. J Clin Oncol. 2018 Feb 1;36(4):383-390. doi: 10.1200/JCO.2016.71.8023. Epub 2017 Jul 3.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Weber JS, D'Angelo SP, Minor D, Hodi FS, Gutzmer R, Neyns B, Hoeller C, Khushalani NI, Miller WH Jr, Lao CD, Linette GP, Thomas L, Lorigan P, Grossmann KF, Hassel JC, Maio M, Sznol M, Ascierto PA, Mohr P, Chmielowski B, Bryce A, Svane IM, Grob JJ, Krackhardt AM, Horak C, Lambert A, Yang AS, Larkin J. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):375-84. doi: 10.1016/S1470-2045(15)70076-8. Epub 2015 Mar 18.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Israel
United Kingdom
Denmark
Brazil
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Canada
France

location_facility: Sir Mortimer B Davis - Jewish General Hospital

location_facility: Network Office of Research and Innovation

location_facility: Washington University School Of Medicine

location_facility: H. Lee Moffitt Cancer Center & Research Institute


type: EudraCT Number

type: Other Identifier

title: A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

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

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Rodbard HW, Cariou B, Pieber TR, Endahl LA, Zacho J, Cooper JG. Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. Diabetes Obes Metab. 2016 Mar;18(3):274-80. doi: 10.1111/dom.12609. Epub 2016 Jan 11.

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

ReferenceCitation: Haluzik M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25.

ReferenceType: derived

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.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Novo Nordisk A/S

location_country:
Norway
Algeria
Austria
United States
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Gilead Sciences

summary: The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

ReferenceCitation: Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ. Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials. Clin Infect Dis. 2016 Dec 1;63(11):1405-1411. doi: 10.1093/cid/ciw580. Epub 2016 Aug 23.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Younossi ZM, Elsheikh E, Stepanova M, Gerber L, Nader F, Stamm LM, Brainard DM, McHutchinson JG. Ledipasvir/sofosbuvir treatment of hepatitis C virus is associated with reduction in serum apolipoprotein levels. J Viral Hepat. 2015 Dec;22(12):977-82. doi: 10.1111/jvh.12448. Epub 2015 Aug 17.

oa_host_type: closed

ReferenceCitation: Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.

oa_colors: green other

evidence: open (via free article)

license: public-domain

license_normalized: public-domain

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

publisher_dissemination: Massachusetts Medical Society

title: A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.

source: euctr

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

location_country:
Germany
Italy
United Kingdom
United States
Spain
Puerto Rico
France

ipd_sharing: Yes


title: A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis

summary: The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore > 1 point.

ReferenceCitation: Sandborn WJ, Cyrille M, Hansen MB, Feagan BG, Loftus EV Jr, Rogler G, Vermeire S, Cruz ML, Yang J, Boedigheimer MJ, Abuqayyas L, Evangelista CM, Sullivan BA, Reinisch W. Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2019 Mar;156(4):946-957.e18. doi: 10.1053/j.gastro.2018.11.035. Epub 2018 Nov 23.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

repositories_concat: LIRIAS (KU Leuven);www.zora.uzh.ch

publisher_dissemination: Elsevier

lead_sponsor: Amgen

location_country:
Germany
Poland
Australia
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Latvia
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Greece
Russian Federation


title: The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)

acronym: DUAL™ III

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

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

ReferenceCitation: Linjawi S, Bode BW, Chaykin LB, Courreges JP, Handelsman Y, Lehmann LM, Mishra A, Simpson RW. The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial. Diabetes Ther. 2017 Feb;8(1):101-114. doi: 10.1007/s13300-016-0218-3. Epub 2016 Dec 10.

ReferenceCitation: Lingvay I, Handelsman Y, Linjawi S, Vilsboll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2019 Feb;25(2):144-155. doi: 10.4158/EP-2018-0284. Epub 2018 Nov 1.

location_country:
Slovakia
Hungary
Australia
United States
France


acronym: VERVE

lead_sponsor: Boehringer Ingelheim

summary: The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.

ReferenceCitation: Gathe J, Andrade-Villanueva J, Santiago S, Horban A, Nelson M, Cahn P, Bogner J, Spencer D, Podzamczer D, Yong CL, Nguyen T, Zhang W, Drulak M, Quinson AM. Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients. Antivir Ther. 2011;16(5):759-69. doi: 10.3851/IMP1803.

location_facility: 1100.1486.0059 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0050 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4912 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3406 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3408 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4401 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3304A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.6102 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4902 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3301C Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0012 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3205 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.1013 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.6103 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.5401 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3204 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4918 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4924 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3206 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3301D Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.5207 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3901 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4101 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3302B Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.6104 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3532 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.1010 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4804 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0038 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3503 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4908 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3207 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0020 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4903 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4906 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3208 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3310A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3501 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4402 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0054 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4930 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4926 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3107 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4106 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3302A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4904 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4905 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3301E Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3301A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3417 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2712 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4927 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3405 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3318C Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4109 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0023 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3312A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3102 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0025 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3101 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3303A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3907 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2703 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.5407 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4107 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.5402 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0043 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3314E Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3908 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2701 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3303C Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4914 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3301I Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.7002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4110 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2710 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3302C Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3317A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3401 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3403 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0027 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.1016 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3318A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0057 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3305A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4403 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4408 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.1004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3404 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0013 Boehringer Ingelheim Investigational Site

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location_facility: 1100.1486.4803 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.5408 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4910 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2704 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4919 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4915 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3531 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4406 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3303D Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0010 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0005 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.6101 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4909 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3307A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2605 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.1011 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3414 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2711 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3203 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3415 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0029 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3209 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3301H Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4405 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.1002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4102 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0028 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0048 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2709 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4923 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0055 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.5404 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4928 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4932 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4108 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2603 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0026 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0019 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0044 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0024 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4404 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3201 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4929 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4104 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4907 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3416 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3303B Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.5409 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2702 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2707 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4925 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0018 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3905 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0037 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3410 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3402 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0009 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3316B Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3305B Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3103 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.1014 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3906 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0031 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.5405 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0017 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3306A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4916 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0039 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.1005 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.5403 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.7001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3301G Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0032 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3301B Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3318D Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0034 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3202 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4913 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0046 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0007 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3308C Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4407 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0033 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4922 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2706 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3407 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3309B Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3308A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4901 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4801 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0035 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3301F Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4911 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3504 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3316A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0053 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3312B Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.5204 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3309A Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.4001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0014 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0041 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.2601 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.0040 Boehringer Ingelheim Investigational Site

location_facility: 1100.1486.3318B Boehringer Ingelheim Investigational Site

title: A Randomised, Double Blind, Double Dummy, Parallel Group, Active Controlled Trial to Evaluate the Antiviral Efficacy of 400 mg QD neVirapine Extended Release Formulation in Comparison to 200 mg BID neVirapinE Immediate Release in Combination With Truvada® in Antiretroviral Therapy naïve HIV-1 Infected Patients (VERxVE)

location_country:
Germany
Ireland
Poland
Argentina
Australia
Canada
France
Portugal
Switzerland
United States
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Mexico
Spain
Botswana
South Africa
Russian Federation


title: An Eight-week Randomized, 4-arm, Double-blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy

summary: The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

location_country:
Finland
Norway
Denmark
Sweden
Netherlands
Belgium
Korea, Republic of
South Africa
Taiwan
Canada
Philippines
France

location_facility: 1235.5.32009 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.31003 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3303A Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3304B Boehringer Ingelheim Investigational Site

location_facility: 1235.5.63001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.32007 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.32004 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.27008 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.82003 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.27002 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.45009 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.45006 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3307A Boehringer Ingelheim Investigational Site

location_facility: 1235.5.46001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20014 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.63009 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3302D Boehringer Ingelheim Investigational Site

location_facility: 1235.5.46005 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3303C Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3307E Boehringer Ingelheim Investigational Site

location_facility: 1235.5.31005 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.27001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3307C Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301H Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3306D Boehringer Ingelheim Investigational Site

location_facility: 1235.5.27010 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.32005 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301G Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3309E Boehringer Ingelheim Investigational Site

location_facility: 1235.5.32003 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.31007 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20011 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3302F Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3306F Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3308F Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3309F Boehringer Ingelheim Investigational Site

location_facility: 1235.5.45005 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3308E Boehringer Ingelheim Investigational Site

location_facility: 1235.5.27003 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3303B Boehringer Ingelheim Investigational Site

location_facility: 1235.5.88605 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.82005 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301N Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301J Boehringer Ingelheim Investigational Site

location_facility: 1235.5.32002 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.46004 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.35004 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.27004 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.63007 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.63003 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.31010 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301D Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301E Boehringer Ingelheim Investigational Site

location_facility: 1235.5.35003 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.31008 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.45007 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.31006 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20007 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3307G Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3308A Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3309C Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3305A Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20008 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301A Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20012 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3302C Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20005 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.27005 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3307D Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20006 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.35002 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.45008 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.63002 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3308B Boehringer Ingelheim Investigational Site

location_facility: 1235.5.82008 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3309D Boehringer Ingelheim Investigational Site

location_facility: 1235.5.31001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.47001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301I Boehringer Ingelheim Investigational Site

location_facility: 1235.5.63006 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.88603 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3309B Boehringer Ingelheim Investigational Site

location_facility: 1235.5.45002 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3308D Boehringer Ingelheim Investigational Site

location_facility: 1235.5.31004 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20010 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3302A Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301M Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301B Boehringer Ingelheim Investigational Site

location_facility: 1235.5.45001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.35001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.82006 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.27009 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.32001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.45003 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3306A Boehringer Ingelheim Investigational Site

location_facility: 1235.5.47003 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.63005 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.46003 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.88608 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3306C Boehringer Ingelheim Investigational Site

location_facility: 1235.5.88601 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3308C Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3304A Boehringer Ingelheim Investigational Site

location_facility: 1235.5.63008 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3304C Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20003 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20013 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301L Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3309A Boehringer Ingelheim Investigational Site

location_facility: 1235.5.27006 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.82002 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.46002 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.82004 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3305B Boehringer Ingelheim Investigational Site

location_facility: 1235.5.82007 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.20009 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3307F Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3310A Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301C Boehringer Ingelheim Investigational Site

location_facility: 1235.5.47002 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3301F Boehringer Ingelheim Investigational Site

location_facility: 1235.5.32008 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3306B Boehringer Ingelheim Investigational Site

location_facility: 1235.5.82001 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.47004 Boehringer Ingelheim Investigational Site

location_facility: 1235.5.3306E Boehringer Ingelheim Investigational Site

location_facility: 1235.5.32010 Boehringer Ingelheim Investigational Site


title: EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)

summary: The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

ReferenceCitation: Kereiakes DJ, Windecker S, Jobe RL, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Underwood P, Allocco DJ, Meredith IT. Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. Circ Cardiovasc Interv. 2019 Sep;12(9):e008152. doi: 10.1161/CIRCINTERVENTIONS.119.008152. Epub 2019 Aug 27.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Christen T, Allocco DJ, Dawkins KD. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002372. doi: 10.1161/CIRCINTERVENTIONS.114.002372.

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

lead_sponsor: Boston Scientific Corporation

location_country:
Finland
Italy
Poland
New Zealand
Singapore
Denmark
Australia
Japan
Netherlands
Austria
Belgium
United States
Latvia
Spain
Canada
France

location_facility: Clinique Saint-Hilaire - Centre Frédéric Joliot

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Lahey Clinic Medical Center - Burlington

location_facility: P. Stradins Clinical University Hospital

location_facility: Centre Hospitalier de Lagny - Marne La Vallée

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Instytut Kardiologii im.Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: University of Miami McKnight Brain Institute

location_facility: Washington University School of Medicine

location_facility: SK Przemienienia Panskiego UM im.K.Marcinkowskiego

location_facility: Lindner Center for Research and Education at Christ Hosp

location_facility: University of California Davis Health System

location_facility: University Hospitals Case Medical Center

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Prairie Cardiovascular Consultants, Ltd.

location_facility: Department of Cardiology, Tokyo Women's Medical University

location_facility: Moses H. Cone Memorial Hospital-LeBauer Cardiovascular Research Foundation

location_facility: Medisch Spectrum Twente, Haaksbergerstraat

location_facility: Hospital Universitario Clínico San Carlos

location_facility: National Cerebral and Cardiovascular Center

intervention_type: Device


title: An Observational Disease and Clinical Outcomes Registry of Patients With Lysosomal Acid Lipase (LAL) Deficiency

summary: This is an observational, multi-center, international disease registry designed to collect longitudinal data and create a knowledge base that will be utilized to improve the care and treatment of patients with LAL Deficiency. Participation in the Registry by both physicians and patients is voluntary.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Soll D, Spira D, Hollstein T, Haberbosch L, Demuth I, Steinhagen-Thiessen E, Bobbert T, Spranger J, Kassner U. Clinical outcome of a patient with lysosomal acid lipase deficiency and first results after initiation of treatment with Sebelipase alfa: A case report. Mol Genet Metab Rep. 2019 Jun 18;20:100479. doi: 10.1016/j.ymgmr.2019.100479. eCollection 2019 Sep.

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repositories_concat: PubMed Central;refubium.fu-berlin.de

ipd_sharing: No

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
Ireland
Poland
Australia
Brazil
Croatia
Czechia
Canada
France
Slovenia
Portugal
Denmark
United States
Belgium
Italy
United Kingdom
Netherlands
Mexico
Saudi Arabia
Spain
Greece
Israel

status_simplified: Ongoing


title: A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

acronym: ARCH

summary: The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

ReferenceType: background

ReferenceCitation: Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.

ReferenceCitation: Brown JP, Engelke K, Keaveny TM, Chines A, Chapurlat R, Foldes AJ, Nogues X, Civitelli R, De Villiers T, Massari F, Zerbini CAF, Wang Z, Oates MK, Recknor C, Libanati C. Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial. J Bone Miner Res. 2021 Nov;36(11):2139-2152. doi: 10.1002/jbmr.4409. Epub 2021 Aug 10.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Cosman F, Lewiecki EM, Ebeling PR, Hesse E, Napoli N, Matsumoto T, Crittenden DB, Rojeski M, Yang W, Libanati C, Ferrari S. T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial. J Bone Miner Res. 2020 Jul;35(7):1333-1342. doi: 10.1002/jbmr.3996. Epub 2020 May 22.

repository_institution: Monash University - Monash University Research Portal

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories_concat: PubMed Central;monash.edu;unige.ch

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Lithuania
Colombia
Slovakia
Hungary
Hong Kong
Denmark
United States
Latvia
Dominican Republic
Romania
Belgium
Peru
Estonia
Italy
Guatemala
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


acronym: OPPORTUNITY

summary:
This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.

The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis.

ReferenceCitation: Kopple JD, Cheung AK, Christiansen JS, Djurhuus CB, El Nahas M, Feldt-Rasmussen B, Lange M, Mitch WE, Wanner C, Wiedemann J, Ikizler TA. OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients. Clin J Am Soc Nephrol. 2008 Nov;3(6):1741-51. doi: 10.2215/CJN.02760608.

ReferenceCitation: Raff AC, Meyer TW, Hostetter TH. New insights into uremic toxicity. Curr Opin Nephrol Hypertens. 2008 Nov;17(6):560-5. doi: 10.1097/MNH.0b013e32830f45b6.

status: Terminated

title: Efficacy and Safety of Somatropin in Adult Patients on Chronic Haemodialysis

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Canada
France
Portugal
Hungary
Denmark
United States
India
China
Puerto Rico
Italy
United Kingdom
Sweden
Spain
South Africa
Russian Federation
Israel

status_simplified: Unknown


title: TOP: TYSABRI Observational Program

acronym: TOP

summary: The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of Tysabri in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

status: Active, not recruiting

ReferenceCitation: Butzkueven H, Kappos L, Spelman T, Trojano M, Wiendl H, Su R, Liao S, Hyde R, Licata S, Ho PR, Campbell N. No evidence for loss of natalizumab effectiveness with every-6-week dosing: a propensity score-matched comparison with every-4-week dosing in patients enrolled in the Tysabri Observational Program (TOP). Ther Adv Neurol Disord. 2021 Sep 27;14:17562864211042458. doi: 10.1177/17562864211042458. eCollection 2021.

publisher_dissemination: SAGE Publications

ReferenceCitation: Butzkueven H, Kappos L, Wiendl H, Trojano M, Spelman T, Chang I, Kasliwal R, Jaitly S, Campbell N, Ho PR, Licata S; Tysabri Observational Program (TOP) Investigators. Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP). J Neurol Neurosurg Psychiatry. 2020 Jun;91(6):660-668. doi: 10.1136/jnnp-2019-322326. Epub 2020 Mar 31.

evidence: open (via page says license)

repository_institution: Augsburg University - OPUS - Augsburg University Publication Server

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repository_institution: University of Turku - UTUPub

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;Zenodo;monash.edu;uni-augsburg.opus-bayern.de;www.utupub.fi

repositories_institution: Monash University - Monash University Research Portal

publisher_dissemination: British Medical Journal

ReferenceCitation: Butzkueven H, Kappos L, Pellegrini F, Trojano M, Wiendl H, Patel RN, Zhang A, Hotermans C, Belachew S; TYSABRI Observational Program (TOP) Investigators. Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1190-7. doi: 10.1136/jnnp-2013-306936. Epub 2014 Feb 14.

location_country:
Finland
Germany
Italy
Portugal
Slovakia
Norway
Argentina
United Kingdom
Australia
Brazil
Netherlands
Mexico
Belgium
Spain
Greece
Czechia
Canada
France

location_facility: Research site 177, rue de Versailles- Dr Servan

location_facility: Research site ,1 Allée du Château- Dr Wagner


title: An Open-label Extension to Study AVA102670 and AVA102672, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.

summary: This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status.

ReferenceCitation: Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606. doi: 10.2174/156720511796391935.

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Germany
Poland
Argentina
Australia
Chile
Czechia
Canada
France
Slovenia
Portugal
Slovakia
Hungary
Hong Kong
United States
India
Belgium
Philippines
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Sweden


title: The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: An Open-Label, Randomized, 78-Week Study - The IMAGINE 1 Study

acronym: IMAGINE 1

summary:
The purpose of this study is:

To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment.
To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment.
To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 78 weeks of treatment.
To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment.

ReferenceCitation: Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.

ReferenceCitation: Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Poland
Japan
Austria
Mexico
United States
Russian Federation
France

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


title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma That Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen

summary: The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.

ReferenceCitation: Hecht JR, Benson AB 3rd, Vyushkov D, Yang Y, Bendell J, Verma U. A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Simtuzumab in Combination with FOLFIRI for the Second-Line Treatment of Metastatic KRAS Mutant Colorectal Adenocarcinoma. Oncologist. 2017 Mar;22(3):243-e23. doi: 10.1634/theoncologist.2016-0479. Epub 2017 Feb 28.

license: unspecified-oa

license_normalized: unspecified-oa

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

repository_institution: University of California - eScholarship University of California

version: submittedVersion

location_country:
Germany
Italy
Poland
United States
Spain
Russian Federation
France

location_facility: Suburban Hematology Oncology Associates, PC

location_facility: State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"

location_facility: TORI Network (Translational Oncology Research Intl)

location_facility: Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Ludwig-Maximilians-Universität München Klinikum Großhadern

location_facility: Centre Hospitalier Régional Universitaire Hôpital Saint Eloi

location_facility: Cancer Research Center n.a. Blokhin, Chemotherapy Dept.

location_facility: Krankenanstalt Mutterhaus der Borromäerinnen e.V.

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Central Hematology Oncology Medical Group, Inc.

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: The Center for Cancer and Blood Disorders

location_facility: State Institution "Blokhin Cancer Research Centre RAMS"

location_facility: University of California San Diego Medical Center

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Providence Saint Joseph Medical Center-Disney Family Cancer Center

location_facility: Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique

location_facility: New York University Clinical Cancer Center

location_facility: Comprehensive Hematology Oncology Centers, Inc.

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie

location_facility: Hospital Universitario de Girona Doctor Josep Trueta

location_facility: State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: Hôpital Trousseau - Service de Gastroenterologie

location_facility: Kaiser Permanente Northwest Region Oncology Hematology

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Universitätsklinikum der Friedrich-Schiller-Universität Jena

location_facility: Klinikum Region Hannover GmbH, Krankenhaus Siloah

location_facility: Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD"

location_facility: Hematology and Oncology Associates at BridgePoint

location_facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o.

location_facility: Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o.

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Nizhny Novgorod City Oncology Dispensary

location_facility: Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Peachtree Hematology Oncology Consultants, PC

location_facility: N.N.Petrov Research Institute of Oncology


title: A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)

summary: The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV

ReferenceCitation: Sulkowski MS, Fessel WJ, Lazzarin A, Berenguer J, Zakharova N, Cheinquer H, Cote P, Dieterich D, Gadano A, Matthews G, Molina JM, Moreno C, Pineda JA, Pulido F, Rivero A, Rockstroh J, Hernandez D, McPhee F, Eley T, Liu Z, Mendez P, Hughes E, Noviello S, Ackerman P. Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study. Hepatol Int. 2017 Mar;11(2):188-198. doi: 10.1007/s12072-017-9788-z. Epub 2017 Feb 16.

location_country:
Germany
Italy
United Kingdom
Argentina
Australia
Brazil
Belgium
United States
Spain
Canada
Puerto Rico
Russian Federation
France

location_facility: Southern California Permanente Medical Group

location_facility: Upper Delaware Valley Infectious Diseases, Pc

location_facility: University Of Puerto Rico School Of Medicine

location_facility: University Of North Carolina At Chapel Hill


title: A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Solid Tumors and Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

summary: The purpose of the study is to assess the safety, tolerability, pharmacokinetics and immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma

design_allocation: Non-Randomized

location_country:
United States
Spain
Germany
France

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hospital Of The University Of Pennsylvania

location_facility: Division Of Hematology & Oncology Ctr. For Health Sciences


title: LUX-Lung 7: A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung

summary: This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.

ReferenceCitation: Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Marten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.

repository_institution: Queensland University of Technology - QUT ePrints

repository_institution: Trinity College Dublin - Trinity's Access to Research Output (TARA)

ReferenceCitation: Paz-Ares L, Tan EH, O'Byrne K, Zhang L, Hirsh V, Boyer M, Yang JC, Mok T, Lee KH, Lu S, Shi Y, Lee DH, Laskin J, Kim DW, Laurie SA, Kolbeck K, Fan J, Dodd N, Marten A, Park K. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol. 2017 Feb 1;28(2):270-277. doi: 10.1093/annonc/mdw611.

ReferenceCitation: Park K, Tan EH, O'Byrne K, Zhang L, Boyer M, Mok T, Hirsh V, Yang JC, Lee KH, Lu S, Shi Y, Kim SW, Laskin J, Kim DW, Arvis CD, Kolbeck K, Laurie SA, Tsai CM, Shahidi M, Kim M, Massey D, Zazulina V, Paz-Ares L. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol. 2016 May;17(5):577-89. doi: 10.1016/S1470-2045(16)30033-X. Epub 2016 Apr 12.

location_country:
Germany
Ireland
Norway
Hong Kong
Singapore
Australia
Sweden
United Kingdom
Korea, Republic of
China
Spain
Taiwan
Canada
France

location_facility: Cross Cancer Institute (University of Alberta)

location_facility: British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer

location_facility: Oslo Universitetssykehus HF, Radiumhospitalet

location_facility: Johns Hopkins Singapore International Medical Center

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Haematology & Oncology Clinics of Australasia (HOCA)

location_facility: The Affiliated Cancer Hospital, Guangxi Medical University

location_facility: Hospital Regional Universitario de Málaga

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Cancer Hospital of Chinese Academy of Medical Science

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: CTR Oncologie du Pays Basque, Onco, Bayonne

location_facility: The First Hospital of Chinese Medical University


intervention_type: Biological

summary: The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

ReferenceCitation: Vansteenkiste JF, Cho BC, Vanakesa T, De Pas T, Zielinski M, Kim MS, Jassem J, Yoshimura M, Dahabreh J, Nakayama H, Havel L, Kondo H, Mitsudomi T, Zarogoulidis K, Gladkov OA, Udud K, Tada H, Hoffman H, Bugge A, Taylor P, Gonzalez EE, Liao ML, He J, Pujol JL, Louahed J, Debois M, Brichard V, Debruyne C, Therasse P, Altorki N. Efficacy of the MAGE-A3 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive non-small-cell lung cancer (MAGRIT): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):822-835. doi: 10.1016/S1470-2045(16)00099-1. Epub 2016 Apr 27.

ReferenceCitation: Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFNgamma Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15.

ReferenceCitation: Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3.

title: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Thailand
Czechia
Canada
France
Hungary
Hong Kong
Switzerland
United States
Ukraine
India
Belgium
China
Estonia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis - An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)

acronym: RHAPSODY

summary:
Due to the rigor of the clinical development program of adalimumab for the indication of AS, the population of subjects with active AS that could enroll in previous phase 3 studies was limited. Therefore, it is necessary to further evaluate the use of adalimumab in a setting that mimics day-to-day clinical practice to obtain further safety and efficacy data by allowing subjects meeting the characteristics noted below to enter this study:

Subjects who failed another TNF inhibitor (etanercept, infliximab)
Subjects with advanced spinal ankylosis
Subjects with AS associated disorders (i.e., uveitis, IBD, and psoriasis)

ReferenceCitation: Rudwaleit M, Van den Bosch F, Kron M, Kary S, Kupper H. Effectiveness and safety of adalimumab in patients with ankylosing spondylitis or psoriatic arthritis and history of anti-tumor necrosis factor therapy. Arthritis Res Ther. 2010;12(3):R117. doi: 10.1186/ar3054. Epub 2010 Jun 16.

ReferenceCitation: Rudwaleit M, Claudepierre P, Kron M, Kary S, Wong R, Kupper H. Effectiveness of adalimumab in treating patients with ankylosing spondylitis associated with enthesitis and peripheral arthritis. Arthritis Res Ther. 2010;12(2):R43. doi: 10.1186/ar2953. Epub 2010 Mar 15.

ReferenceCitation: Rudwaleit M, Claudepierre P, Wordsworth P, Cortina EL, Sieper J, Kron M, Carcereri-De-Prati R, Kupper H, Kary S. Effectiveness, safety, and predictors of good clinical response in 1250 patients treated with adalimumab for active ankylosing spondylitis. J Rheumatol. 2009 Apr;36(4):801-8. doi: 10.3899/jrheum.081048. Epub 2009 Feb 27.

ReferenceCitation: Rudwaleit M, Rodevand E, Holck P, Vanhoof J, Kron M, Kary S, Kupper H. Adalimumab effectively reduces the rate of anterior uveitis flares in patients with active ankylosing spondylitis: results of a prospective open-label study. Ann Rheum Dis. 2009 May;68(5):696-701. doi: 10.1136/ard.2008.092585. Epub 2008 Jul 28.

lead_sponsor: Abbott

location_country:
Finland
Germany
Ireland
Italy
Norway
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Greece
France


type: Registry Identifier

title: APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis

acronym: APPLES

summary: This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.

ReferenceCitation: D3T01.1J No increased risk of cancer in children using topical tacrolimus for atopic dermatitis: A 10-year prospective cohort study Prof. Dr. Regina Fölster-Holst - Germany 12 October 2019 11:00 - 11:15 EADV 2019

lead_sponsor: LEO Pharma

location_country:
Germany
Ireland
Poland
United Kingdom
Netherlands
Austria
United States
Canada
France

location_facility: University Dermatology Consultants, Inc.

location_facility: Children's Hospital of the Kings Daughters

location_facility: HOPITAL CHARLES NICOLLE Service de Dermatologie

location_facility: Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego w Bydgoszczy, Wojewodzka Przychodnia Specjalistyczna Dla Dzieci Poradnia ermatologiczna, Budynek "A"

location_facility: North Florida Dermatology Associates, P.A.

location_facility: Universitaetsklinikum Muenster, Klinik & Poliklinik Fuer Hautkrankheiten

location_facility: SPZOZ Szpital Specjalistyczny im. S. Zeromskiego

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Haber Dermatology and Cosmetic Surgery, Inc

location_facility: Pediatric & Adult Asthma and Allergy, P.C.

location_facility: Licca Fachklinik f. aesthetisch- operative Dermatologie und Chirurgie

location_facility: Universitaetsklinikum Klinische Forschung, Zentrum d. Dermatologie u. Venerologie

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: Midwest Center for Dermatology and Cosmetic Surgery

location_facility: Universitaet Bonn Klinik und Poliklinik fuer Dermatologie

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Oklahoma University Health Sciences Center

location_facility: Szpital Dzieciecy Specjalistyczny Z.O.Z. nad Matka i Dzieckiem

location_facility: Charite - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie u. Allergologie

location_facility: University of N. Texas Health Science Center

location_facility: Johns Hopkins University, Division of Pediatric Dermatolgy

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Amersham Hospital, Department of Dermatology

location_facility: Eastern Canada Cutaneous Research Association

location_facility: Allergy Associates of the Palm Beaches, PA

location_facility: University of Arkansas for Medical Sciences

location_facility: Connecticut Children's Medical Center Dept of Dermatology

location_facility: Asthma & Allergy Center of North Jackson

location_facility: University of Miami Miller School of Medicine

location_facility: Cabinet de Dermatologie - Boulogne-Sur-Mer

location_facility: Allergy Associates, PA dba East Tennessee Center for Clinical Research

location_facility: Dermatology Treatment and Research Center, PA

location_facility: Carolina Dermatology & Skin Cancer Surgery

location_facility: Lubbock Dermatology and Skin Cancer Center

location_facility: AeroAllergy Research Labs of Savannah, Inc.

location_facility: Dermatology and Laser Center of Charleston

location_facility: Helendale Dermatology & Medical Spa, LLC

location_facility: Department of Pediatric Allergy and Immunology

location_facility: Klinik und Poliklinik f. Dermatologie Universitaetsklinikum Dresden

location_facility: Universitaetsklinikum Giessen+ Marburg Dermatolgie und Allergologie

location_facility: Dermatology Center for Children and Young Adults

location_facility: Hautklinik des Universitaetsklinikums Erlangen

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Wales College of Medicine, Cardiff University, Heath Park

location_facility: Richter - Fachaerztin fuer Kinder- und Jugendmedizin

location_facility: Klinik fuer Kinder u. Jugendmedizin der Ruhr Universitaet Bochum im St.-Josef-Hospital

location_facility: Capital Allergy & Respiratory Disease Center

location_facility: Harrogate & District Foundation NHS Trust Hospital

location_facility: NZOZ Przychodnia Dermatologiczna DERMED s.c

location_facility: Centre Hospitalier Service de Dermatologie

location_facility: Columbia University Medical Center., Dept. of Medicine

location_facility: Georgia Pollens Clinical Research Centers, Inc

location_facility: Leeds General Infirmary, Dept of Dermatology

location_facility: Dermatology Research Associates of Tyler

location_facility: University of Manchester, Dermatology-Pharmacology Unit Hope Hospital

location_facility: North Texas Institute for Clinical Trials

location_facility: Ludwig - Maximilians Universitaet, Klinik u. Poliklinik fuer Dermatologie u. Allergologie

location_facility: Fort Lauderdale Dermatology & Cosmetic Skin Center

location_facility: National Allergy and Asthma Research, LLC

location_facility: Wake Forest University School of Medicine


title: A Randomized, Placebo-controlled, Dose-ranging, Multi-centre Trial of QAW039 (1-450 mg p.o.), to Investigate the Effect on FEV1 and ACQ in Patients With Moderate-to-severe, Persistent, Allergic Asthma, Inadequately Controlled With ICS Therapy.

summary: This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.

ReferenceCitation: Bateman ED, Guerreros AG, Brockhaus F, Holzhauer B, Pethe A, Kay RA, Townley RG. Fevipiprant, an oral prostaglandin DP2 receptor (CRTh2) antagonist, in allergic asthma uncontrolled on low-dose inhaled corticosteroids. Eur Respir J. 2017 Aug 24;50(2):1700670. doi: 10.1183/13993003.00670-2017. Print 2017 Aug.

publisher_dissemination: European Respiratory Society

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Argentina
Japan
Turkey
Canada
France
Colombia
Hungary
United States
India
Romania
Peru
Italy
Guatemala
United Kingdom
Netherlands
Austria
Mexico
Greece
South Africa
Bulgaria
Russian Federation


acronym: ENESTnd

summary:
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.

ReferenceCitation: Hughes TP, Hochhaus A, Kantarjian HM, Cervantes F, Guilhot F, Niederwieser D, le Coutre PD, Rosti G, Ossenkoppele G, Lobo C, Shibayama H, Fan X, Menssen HD, Kemp C, Larson RA, Saglio G. Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily. Haematologica. 2014 Jul;99(7):1204-11. doi: 10.3324/haematol.2013.091272. Epub 2014 Feb 14.

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

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

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Hughes TP, Saglio G, Kantarjian HM, Guilhot F, Niederwieser D, Rosti G, Nakaseko C, De Souza CA, Kalaycio ME, Meier S, Fan X, Menssen HD, Larson RA, Hochhaus A. Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib. Blood. 2014 Feb 27;123(9):1353-60. doi: 10.1182/blood-2013-06-510396. Epub 2013 Dec 11.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Hochhaus A, Saglio G, Larson RA, Kim DW, Etienne G, Rosti G, De Souza C, Kurokawa M, Kalaycio ME, Hoenekopp A, Fan X, Shou Y, Kantarjian HM, Hughes TP. Nilotinib is associated with a reduced incidence of BCR-ABL mutations vs imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase. Blood. 2013 May 2;121(18):3703-8. doi: 10.1182/blood-2012-04-423418. Epub 2013 Mar 15.

ReferenceCitation: Branford S, Kim DW, Soverini S, Haque A, Shou Y, Woodman RC, Kantarjian HM, Martinelli G, Radich JP, Saglio G, Hochhaus A, Hughes TP, Muller MC. Initial molecular response at 3 months may predict both response and event-free survival at 24 months in imatinib-resistant or -intolerant patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase treated with nilotinib. J Clin Oncol. 2012 Dec 10;30(35):4323-9. doi: 10.1200/JCO.2011.40.5217. Epub 2012 Oct 29.

ReferenceCitation: Larson RA, Yin OQ, Hochhaus A, Saglio G, Clark RE, Nakamae H, Gallagher NJ, Demirhan E, Hughes TP, Kantarjian HM, le Coutre PD. Population pharmacokinetic and exposure-response analysis of nilotinib in patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase. Eur J Clin Pharmacol. 2012 May;68(5):723-33. doi: 10.1007/s00228-011-1200-7. Epub 2011 Dec 30.

ReferenceCitation: Kantarjian HM, Hochhaus A, Saglio G, De Souza C, Flinn IW, Stenke L, Goh YT, Rosti G, Nakamae H, Gallagher NJ, Hoenekopp A, Blakesley RE, Larson RA, Hughes TP. Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. Lancet Oncol. 2011 Sep;12(9):841-51. doi: 10.1016/S1470-2045(11)70201-7. Epub 2011 Aug 17. Erratum In: Lancet Oncol. 2011 Oct;12(11):989.

ReferenceCitation: Cortes JE, Hochhaus A, le Coutre PD, Rosti G, Pinilla-Ibarz J, Jabbour E, Gillis K, Woodman RC, Blakesley RE, Giles FJ, Kantarjian HM, Baccarani M. Minimal cross-intolerance with nilotinib in patients with chronic myeloid leukemia in chronic or accelerated phase who are intolerant to imatinib. Blood. 2011 May 26;117(21):5600-6. doi: 10.1182/blood-2010-11-318949. Epub 2011 Apr 5.

ReferenceCitation: Saglio G, Kim DW, Issaragrisil S, le Coutre P, Etienne G, Lobo C, Pasquini R, Clark RE, Hochhaus A, Hughes TP, Gallagher N, Hoenekopp A, Dong M, Haque A, Larson RA, Kantarjian HM; ENESTnd Investigators. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2251-9. doi: 10.1056/NEJMoa0912614. Epub 2010 Jun 5.

location_facility: University of Cincinnati / Barrett Cancer Center Dept.of Internal Med.

location_facility: Kaiser Permanente - California Southern Dept of Kaiser South 3

location_facility: Rocky Mountain Cancer Centers RMCC - Colorado Springs

location_facility: Kaiser Permanente - California Northern Kaiser Med

location_facility: Hematology Oncology Consultants, Inc. Deptof Hem. Onc.Consunsultants

location_facility: Kaiser Permanente - California Northern Vallejo Med Center/Med Offices

location_facility: Memorial Sloan Kettering Cancer Center Clinical Trials Office

location_facility: Advanced Medical Specialties Research Dept.

location_facility: Florida Cancer Specialists Dept. FloridaCancerSpecialists

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

location_facility: University of California at Los Angeles Dept. of Hematology Clinic

location_facility: University of North Carolina UNC Lineberger Cancer Center

location_facility: Cancer Centers of Florida PA Cancer Centers of FL

location_facility: Kansas City Cancer Center KCCC Business Office

location_facility: Texas Cancer Center ( Medical City Dallas Hospital)

location_facility: Michigan State University / Breslin Cancer Center Breslin Cancer Center

location_facility: Northwest Cancer Specialists Compass Oncology -BKM

location_facility: University of Iowa Hospitals and Clinics Dept.of U of Iowa Hosp&Clinics

location_facility: Florida Retina Institute Flordia Cancer Affilates

location_facility: Hackensack University Medical Center Department of Research

location_facility: Tennessee Oncology Dept. of Centennial Medical

location_facility: University of Chicago Section of Hematology/Oncology

location_facility: Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology

location_facility: Indiana Blood and Marrow Institute Dept. of Indiana Blood&Marrow

location_facility: LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center

location_facility: Cancer Care Centers of South Texas HOAST CCC of So.TX- Medical Center

location_facility: Missouri Cancer Associates Dept. of Boone Hospital Center

location_facility: Wake Forest University Health Sciences Dept. of Industry Research

title: A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Finland
Germany
Poland
Argentina
Japan
Brazil
Thailand
Turkey
Czechia
Canada
France
Colombia
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Belgium
Malaysia
Egypt
Italy
Norway
Singapore
United Kingdom
Venezuela
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Sweden


acronym: IMUNITI

lead_sponsor: Janssen Research & Development, LLC

summary: The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.

ReferenceCitation: Narula N, Aruljothy A, Wong ECL, Homenauth R, Alshahrani AA, Marshall JK, Reinisch W. The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies. United European Gastroenterol J. 2021 Jun;9(5):581-589. doi: 10.1002/ueg2.12094. Epub 2021 Jun 2.

ReferenceCitation: Sandborn WJ, Rebuck R, Wang Y, Zou B, Adedokun OJ, Gasink C, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG, Lynch JP. Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn's Disease: The IM-UNITI Trial. Clin Gastroenterol Hepatol. 2022 Mar;20(3):578-590.e4. doi: 10.1016/j.cgh.2021.02.025. Epub 2021 Feb 19.

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236. Erratum In: Inflamm Bowel Dis. 2021 Jun 15;27(7):1175.

ReferenceCitation: Li K, Friedman JR, Chan D, Pollack P, Yang F, Jacobstein D, Brodmerkel C, Gasink C, Feagan BG, Sandborn WJ, Rutgeerts P, De Hertogh G. Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1019-1031.e7. doi: 10.1053/j.gastro.2019.06.037. Epub 2019 Jul 4.

repositories_concat: LIRIAS (KU Leuven)

ReferenceCitation: Hanauer SB, Sandborn WJ, Feagan BG, Gasink C, Jacobstein D, Zou B, Johanns J, Adedokun OJ, Sands BE, Rutgeerts P, de Villiers WJS, Colombel JF, Ghosh S. IM-UNITI: Three-year Efficacy, Safety, and Immunogenicity of Ustekinumab Treatment of Crohn's Disease. J Crohns Colitis. 2020 Jan 1;14(1):23-32. doi: 10.1093/ecco-jcc/jjz110.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark)

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum In: Drug Saf. 2019 Apr 22;:

repository_institution: PubMed Central - Europe PMC

repositories:
PubMed Central
Pure (Denmark)
escholarship.org

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Rutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel JF, Wolf DC, Jacobstein D, Johanns J, Szapary P, Adedokun OJ, Feagan BG, Sandborn WJ. Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease. Gastroenterology. 2018 Oct;155(4):1045-1058. doi: 10.1053/j.gastro.2018.06.035. Epub 2018 Aug 29.

ReferenceCitation: Sandborn WJ, Rutgeerts P, Gasink C, Jacobstein D, Zou B, Johanns J, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG. Long-term efficacy and safety of ustekinumab for Crohn's disease through the second year of therapy. Aliment Pharmacol Ther. 2018 Jul;48(1):65-77. doi: 10.1111/apt.14794. Epub 2018 May 24.

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Jacobstein D, Szapary P, Johanns J, Gao LL, Davis HM, Hanauer SB, Feagan BG, Ghosh S, Sandborn WJ. Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease. Gastroenterology. 2018 May;154(6):1660-1671. doi: 10.1053/j.gastro.2018.01.043. Epub 2018 Feb 1.

ReferenceCitation: Hibi T, Imai Y, Murata Y, Matsushima N, Zheng R, Gasink C. Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies. Intest Res. 2017 Oct;15(4):475-486. doi: 10.5217/ir.2017.15.4.475. Epub 2017 Oct 23.

publisher_dissemination: Korean Association for the Study of Intestinal Diseases

ReferenceCitation: Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, Blank MA, Johanns J, Gao LL, Miao Y, Adedokun OJ, Sands BE, Hanauer SB, Vermeire S, Targan S, Ghosh S, de Villiers WJ, Colombel JF, Tulassay Z, Seidler U, Salzberg BA, Desreumaux P, Lee SD, Loftus EV Jr, Dieleman LA, Katz S, Rutgeerts P; UNITI-IM-UNITI Study Group. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960. doi: 10.1056/NEJMoa1602773.

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repository_institution: St George's University of London - St George's Online Research Archive

title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Croatia
Czechia
Canada
Serbia
France
Hungary
Denmark
United States
Iceland
Belgium
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel


lead_sponsor: Bayer

summary: This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).

ReferenceCitation: EINSTEIN-PE Investigators; Buller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, Chlumsky J, Verhamme P, Wells P, Agnelli G, Cohen A, Berkowitz SD, Bounameaux H, Davidson BL, Misselwitz F, Gallus AS, Raskob GE, Schellong S, Segers A. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr 5;366(14):1287-97. doi: 10.1056/NEJMoa1113572. Epub 2012 Mar 26.

ReferenceCitation: Prins MH, Lensing AW. Derivation of the non-inferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism. Thromb J. 2013 Jul 6;11(1):13. doi: 10.1186/1477-9560-11-13.

publisher_dissemination: Springer

ReferenceCitation: Prins MH, Lensing AW, Bauersachs R, van Bellen B, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Raskob GE, Berkowitz SD, Wells PS; EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013 Sep 20;11(1):21. doi: 10.1186/1477-9560-11-21.

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: University of Ottawa - uO Research

ReferenceCitation: Wang Y, Wang C, Chen Z, Zhang J, Liu Z, Jin B, Ying K, Liu C, Shao Y, Jing Z, Meng IL, Prins MH, Pap AF, Muller K, Lensing AW; Chinese EINSTEIN Investigators. Rivaroxaban for the treatment of symptomatic deep-vein thrombosis and pulmonary embolism in Chinese patients: a subgroup analysis of the EINSTEIN DVT and PE studies. Thromb J. 2013 Dec 16;11(1):25. doi: 10.1186/1477-9560-11-25.

ReferenceCitation: van Bellen B, Bamber L, Correa de Carvalho F, Prins M, Wang M, Lensing AW. Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism. Curr Med Res Opin. 2014 May;30(5):829-37. doi: 10.1185/03007995.2013.879439. Epub 2014 Jan 22.

publisher_dissemination: Informa

ReferenceCitation: Ten Cate H, Lensing AWA, Weitz JI, Middeldorp S, Beyer-Westendorf J, Kubitza D, Brighton T, Raskob GE, Mismetti P, Prandoni P, Gebel M, Prins MH. The prothrombin time does not predict the risk of recurrent venous thromboembolism or major bleeding in rivaroxaban-treated patients. Thromb Res. 2018 Oct;170:75-83. doi: 10.1016/j.thromres.2018.08.008. Epub 2018 Aug 15.

ReferenceCitation: Di Nisio M, Vedovati MC, Riera-Mestre A, Prins MH, Mueller K, Cohen AT, Wells PS, Beyer-Westendorf J, Prandoni P, Bounameaux H, Kubitza D, Schneider J, Pisters R, Fedacko J, Fontes-Carvalho R, Lensing AW. Treatment of venous thromboembolism with rivaroxaban in relation to body weight. A sub-analysis of the EINSTEIN DVT/PE studies. Thromb Haemost. 2016 Sep 27;116(4):739-46. doi: 10.1160/TH16-02-0087. Epub 2016 Aug 18.

publisher_dissemination: Georg Thieme

ReferenceCitation: Wells PS, Gebel M, Prins MH, Davidson BL, Lensing AW. Influence of statin use on the incidence of recurrent venous thromboembolism and major bleeding in patients receiving rivaroxaban or standard anticoagulant therapy. Thromb J. 2014 Nov 26;12:26. doi: 10.1186/1477-9560-12-26. eCollection 2014.

repositories_institution:
PubMed Central - Europe PMC
University of Ottawa - uO Research

ReferenceCitation: Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap AF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014 Oct;1(1):e37-46. doi: 10.1016/S2352-3026(14)70018-3. Epub 2014 Sep 28.

ReferenceCitation: Bauersachs RM, Lensing AW, Prins MH, Kubitza D, Pap AF, Decousus H, Beyer-Westendorf J, Prandoni P. Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment. Thromb J. 2014 Nov 24;12:25. doi: 10.1186/1477-9560-12-25. eCollection 2014.

ReferenceCitation: Cohen AT, Dobromirski M. The use of rivaroxaban for short- and long-term treatment of venous thromboembolism. Thromb Haemost. 2012 Jun;107(6):1035-43. doi: 10.1160/TH11-12-0859. Epub 2012 Feb 28.

sponsor_collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

title: Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Thailand
Canada
France
Czech Republic
Andorra
Lithuania
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Indonesia
India
Belgium
China
Malaysia
Estonia
Puerto Rico
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Israel


acronym: The Einstein-Extension Study

summary: This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).

ReferenceCitation: EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.

ReferenceCitation: Wells PS, Prins MH, Levitan B, Beyer-Westendorf J, Brighton TA, Bounameaux H, Cohen AT, Davidson BL, Prandoni P, Raskob GE, Yuan Z, Katz EG, Gebel M, Lensing AWA. Long-term Anticoagulation With Rivaroxaban for Preventing Recurrent VTE: A Benefit-Risk Analysis of EINSTEIN-Extension. Chest. 2016 Nov;150(5):1059-1068. doi: 10.1016/j.chest.2016.05.023. Epub 2016 Jun 1.

repositories_concat: PubMed Central;ruor.uottawa.ca

title: Once-daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study

primary_purpose: Prevention

location_country:
Finland
Germany
Poland
New Zealand
Australia
Brazil
Thailand
Canada
France
Czech Republic
Hungary
Hong Kong
Denmark
Switzerland
United States
Indonesia
India
Belgium
China
Malaysia
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Israel

collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


type: Other Grant/Funding Number

title: Relevance of Maintenance Therapy Using Lenalidomide (Revimid®) After Autologous Stem Cell Transplantation Patients Under the Age Of 65. (Open, Randomised, Multi-centric Trial Versus Placebo).

summary: Maintenance treatment of myeloma.

ReferenceCitation: Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.

ReferenceCitation: Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, Stoppa AM, Hulin C, Benboubker L, Garderet L, Decaux O, Leyvraz S, Vekemans MC, Voillat L, Michallet M, Pegourie B, Dumontet C, Roussel M, Leleu X, Mathiot C, Payen C, Avet-Loiseau H, Harousseau JL; IFM Investigators. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1782-91. doi: 10.1056/NEJMoa1114138.

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Intergroupe Francophone du Myelome
Celgene

location_country: Switzerland Belgium France

location_facility: Centre hospitalier Argenteuil Victor Dupouy

location_facility: Center of Oncology/Hematology and transfusion Medicine, Kantonsspital

location_facility: Istituto Oncologico Sviss. Italiana IOSI Ospedale Regionale Bellinzona e Valli

location_facility: Onkologie/Hämatologie Kantonsspital st Gallen

location_facility: Centre hospitalier de la région d'Annecy

location_facility: Institute of Oncology and Hematology Stadtspital Triemli

lead_sponsor_type: academique