title: A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia

summary: This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

lead_sponsor: Sumitomo Pharma America, Inc.

location_country:
Italy
Slovakia
United States
South Africa
Serbia
Russian Federation
France

location_facility: Clinical Centre Kragujevac, Clinic for psychiatry

location_facility: Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)

location_facility: Clinical Centre Nis, Clinic for mental health protection

location_facility: A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4

location_facility: Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)

location_facility: St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: Medical Research Group of Central Florida

location_facility: PsychoLine s.r.o. Psychiatricka ambulancia

location_facility: Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie

location_facility: Specialized hospital for psychiatric diseases "Sveti Vracevi"

location_facility: Research Unit, Department of Psychiatry Free State Psychiatric Complex

location_facility: Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'

location_facility: Department of Psychiatry, University of Utah Health Sciences Center

location_facility: Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie

location_facility: Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'

location_facility: California Neuropsychopharmacolgoy Clinical Research Insitute

location_facility: Military Medical Academy, Clnic for Psychiatry

location_facility: St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"

location_facility: St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)

location_facility: Clinical Centre Vojvodine, Clinic for Psychiatry


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Pfizer

summary: This is a multi-center, open-label, dose finding, Phase Ib dose escalation study to estimate the MTD(s) and/or RP2D(s) for the dual combination of LGX818 and MEK162 and the triple combination of LGX818 and MEK162 and LEE011, followed each independently by a Phase II part to assess the clinical efficacy and to further assess the safety of the combinations in selected patient populations. Oral LGX818 and MEK162 will be administered on a continuous schedule. Oral LEE011 will be administered once daily on a three weeks on, one week off schedule. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. A cycle is defined as 28 days. The dose escalation parts of the trial will be conducted in adult patients with BRAF V600-dependent advanced solid tumors and is expected to enroll at least 18 patients for the dual combination and at least 12 patients for the triple combination. The dose escalation will be guided by a Bayesian logistic regression model (BLRM). Following MTD/RP2D declaration, patients will be enrolled in three Phase II arms for the dual combination and one Phase II arm for the triple combination. All patients will be followed for 30 days for safety assessments after study drugs discontinuation. All patients enrolled in the Phase II part of the study will be followed for survival.

ReferenceType: derived

ReferenceCitation: Sullivan RJ, Weber J, Patel S, Dummer R, Carlino MS, Tan DSW, Lebbe C, Siena S, Elez E, Wollenberg L, Pickard MD, Sandor V, Ascierto PA. A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with BRAFV600E/K -mutant Solid Tumors. Clin Cancer Res. 2020 Oct 1;26(19):5102-5112. doi: 10.1158/1078-0432.CCR-19-3550. Epub 2020 Jul 15.

oa_host_type: repository

evidence: oa repository (via page says license)

host_type: repository

license: cc-by

license_normalized: cc-by

version: submittedVersion

repositories_concat: closed

unpaywall_oa_status: green

publisher_dissemination: American Association for Cancer Research

location_facility: Hospital Universitario HM Sanchinarro ? CIOCC

location_facility: H. Lee Moffitt Cancer Center & Research Institute, Inc.

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Service de radiologie - Hopital Saint Louis

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale

location_facility: Ophthalmic Consultants of Boston Inc (OCB)

location_facility: Sir Mortimer B. Davis-Jewish General Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

status: Completed

title: A Phase Ib/II, Multicenter, Open-label, Dose Escalation Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF V600 - Dependent Advanced Solid Tumors

primary_purpose: Other

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

design_allocation: Non-Randomized

study_completion_date_type: Actual

location_country:
Italy
Singapore
Australia
Switzerland
Belgium
United States
Spain
Canada
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


title: Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY

acronym: REDUCE-HTN

summary: The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation device.

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Sievert H, Schofer J, Ormiston J, Hoppe UC, Meredith IT, Walters DL, Azizi M, Diaz-Cartelle J, Cohen-Mazor M. Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. EuroIntervention. 2015 Feb;10(10):1213-20. doi: 10.4244/EIJY14M12_01.

oa_host_type: closed

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323. No abstract available.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
New Zealand
Australia
Netherlands
Austria
Belgium
Switzerland
France

location_facility: Hamburg University Cardiovascular Center

location_facility: Monash Cardiovascular Research Centre (Monash Heart)

location_facility: St. Vincenz Krankenhaus Abt. Kardiologie

location_facility: Vascular Center Berlin, Ev. Königin Elisabeth Hospital

location_facility: University Hospital of Geneva, Cardiology Center

location_facility: The Prince Charles Hospital, Cardiology Clinical Research Centre

location_facility: CardioVascular Center, Sankt Katharinen Krakenhaus

location_facility: Salzburger Landeskliniken Universitats Krankenhaus

location_facility: Switzerland University Hospital Clinic for Cardiology

location_facility: Saarland University Hospital Department of Internal Medicine III Non-surgical Intensive Care, Cardiology and Angiology

intervention_type: Device


acronym: Ellipse™

lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.

ReferenceType: background

ReferenceCitation: Tamborlane WV, Barrientos-Perez M, Fainberg U, Frimer-Larsen H, Hafez M, Hale PM, Jalaludin MY, Kovarenko M, Libman I, Lynch JL, Rao P, Shehadeh N, Turan S, Weghuber D, Barrett T; Ellipse Trial Investigators. Liraglutide in Children and Adolescents with Type 2 Diabetes. N Engl J Med. 2019 Aug 15;381(7):637-646. doi: 10.1056/NEJMoa1903822. Epub 2019 Apr 28.

ReferenceCitation: Bensignor MO, Bomberg EM, Bramante CT, Divyalasya TVS, Hale PM, Ramesh CK, Rudser KD, Kelly AS. Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial. Pediatr Obes. 2021 Aug;16(8):e12778. doi: 10.1111/ijpo.12778. Epub 2021 Feb 25.

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

repositories_concat: PubMed Central

publisher_dissemination: Wiley

title: Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

type: Registry Identifier

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

design_allocation: Randomized

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Thailand
Turkey
Croatia
Canada
Serbia
France
Portugal
Hungary
Denmark
United States
Morocco
North Macedonia
India
Romania
Lebanon
Belgium
Malaysia
Puerto Rico
Egypt
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) for Previously Treated Chronic Lymphocytic Leukemia A Companion Trial to Study GS-US-312-0116: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia

summary: The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.

status: Terminated

ReferenceCitation: Coutre SE, Furman RR, Sharman, JP, Cheson BD, Pagel JM, Hillmen P, et al. Second Interim Analysis of a Phase 3 Study of Idelalisib (Zydelig®) Plus Rituximab for Relapsed Chronic Lymphocytic Leukemia: Efficacy Analysis in Patient Subpopulations with Del(17p) and Other Adverse Prognostic Factors. Blood 2014; 124 (21):330

ReferenceCitation: Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, et al. Efficacy of Idelalisib in CLL Subpopulations Harboring Del(17p) and Other Adverse Prognostic Factors: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Trial [Poster 7011]. American Society of Clinical Oncology (ASCO) 50th Annual Meeting; 2014 May 30-June 3; Chicago, IL. J Clin Oncol 32:5s, 2014 (suppl; abstr 7011)

ReferenceCitation: Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn IW, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Tausch E, Cramer P, Huang J, Mitra S, Hallek M, O'Brien SM, Stilgenbauer S. Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia. J Clin Oncol. 2019 Jun 1;37(16):1391-1402. doi: 10.1200/JCO.18.01460. Epub 2019 Apr 17.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

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

repository_institution: University of California - eScholarship University of California

repositories:
PubMed Central
Zenodo
escholarship.org

repositories_concat: PubMed Central;Zenodo;escholarship.org

unpaywall_oa_status: hybrid

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.

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
United Kingdom
United States
France

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

location_facility: University of California, San Diego - Moores Cancer Center

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Hämatologische und Internistische Gemeinschaftspraxis Dres. Eckart / Häcker

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Rocky Mountain Blood and Marrow Transplant Program

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.

location_facility: Georgetown University Medical Center Lombardi Cancer Center

status_simplified: Unknown


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Polysomnography Study to Investigate Safety and Efficacy of the Rotigotine Transdermal Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis

summary:
This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.

The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigotine on quality of life and sleep.

lead_sponsor: UCB BIOSCIENCES GmbH

location_country:
Finland
Germany
Italy
Austria
United States
France


title: Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry

acronym: ANCHOR

summary:
The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study.

Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure.

Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS guidance.

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Jordan WD Jr, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Ouriel K, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry (ANCHOR) Workgroup Members. Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy. J Vasc Surg. 2014 Oct;60(4):885-92.e2. doi: 10.1016/j.jvs.2014.04.063. Epub 2014 Jul 31.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

publisher_dissemination: Elsevier

ReferenceCitation: Jordan WD Jr, Mehta M, Ouriel K, Arko FR, Varnagy D, Joye J, Moore WM Jr, de Vries JP. One-year results of the ANCHOR trial of EndoAnchors for the prevention and treatment of aortic neck complications after endovascular aneurysm repair. Vascular. 2016 Apr;24(2):177-86. doi: 10.1177/1708538115590727. Epub 2015 Jun 10.

publisher_dissemination: SAGE Publications

ReferenceCitation: van Noort K, Vermeulen JJM, Goudeketting SR, Ouriel K, Jordan WD Jr, Panneton JM, Slump CH, de Vries JPM. Sustainability of Individual EndoAnchor Implants in Therapeutic Use to Treat Type Ia Endoleak After Endovascular Aneurysm Repair. J Endovasc Ther. 2019 Jun;26(3):369-377. doi: 10.1177/1526602819837753. Epub 2019 Mar 25.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: University of Twente - University of Twente Research Information

unpaywall_oa_status: bronze

ReferenceCitation: Arko FR 3rd, Stanley GA, Pearce BJ, Henretta JP, Fugate MW, Mehta M, Torsello G, Panneton JM, Garrett HE Jr. Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. J Vasc Surg. 2019 Sep;70(3):732-740. doi: 10.1016/j.jvs.2018.11.033. Epub 2019 Mar 6.

ReferenceCitation: Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. J Vasc Surg. 2018 Jun;67(6):1699-1707. doi: 10.1016/j.jvs.2017.10.059. Epub 2017 Dec 18.

ReferenceCitation: Jordan WD Jr, de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Henretta J. Midterm outcome of EndoAnchors for the prevention of endoleak and stent-graft migration in patients with challenging proximal aortic neck anatomy. J Endovasc Ther. 2015 Apr;22(2):163-70. doi: 10.1177/1526602815574685.

ReferenceCitation: Jordan WD Jr, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR. Outcome-based anatomic criteria for defining the hostile aortic neck. J Vasc Surg. 2015 Jun;61(6):1383-90.e1. doi: 10.1016/j.jvs.2014.12.063. Epub 2015 Feb 28.

ReferenceCitation: de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Jordan WD Jr; Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry ANCHOR Trial. Analysis of EndoAnchors for endovascular aneurysm repair by indications for use. J Vasc Surg. 2014 Dec;60(6):1460-7.e1. doi: 10.1016/j.jvs.2014.08.089. Epub 2014 Oct 3.

ipd_sharing: No

lead_sponsor: Medtronic Cardiovascular

location_country:
Germany
Italy
New Zealand
Slovakia
United Kingdom
Australia
Sweden
Netherlands
Austria
Switzerland
United States
Spain
France

location_facility: University of California Irvine Medical Center

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: University of North Carolina (UNC) Memorial Hospital

location_facility: Allgemeines Krankenhaus - Universitätskliniken Wien

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Kaiser Permanente Moanalua Medical Center and Clinic

location_facility: Unihospital San Giovanni di Dio Ruggi d'Aragona

location_facility: Medical University of South Carolina (MUSC)

location_facility: A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: New York University Langone Medical Center

location_facility: MedStar Georgetown University Hospital Vascular Surgery Dept.

location_facility: Harborview Medical Center, University of Washington

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital

location_facility: Washington University School of Medicine, Barnes Jewish West County Hospital

location_facility: Narodny ustav srdcovych a cievnych chorob

location_facility: John L McClellan Memorial Veterans Hospital

location_facility: Hospital Clínico Universitario de Valladolid

status_simplified: Ongoing


title: An Open-label, Multicenter, Single-arm, Phase I Dose-escalation With Efficacy Tail Extension Study of Vemurafenib (RO5185426) in Pediatric Patients With Surgically Incurable and Unresectable Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations

summary: This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Chisholm JC, Suvada J, Dunkel IJ, Casanova M, Zhang W, Ritchie N, Choi Y, Park J, Das Thakur M, Simko S, Wan Rachel Tam N, Ferrari A. BRIM-P: A phase I, open-label, multicenter, dose-escalation study of vemurafenib in pediatric patients with surgically incurable, BRAF mutation-positive melanoma. Pediatr Blood Cancer. 2018 May;65(5):e26947. doi: 10.1002/pbc.26947. Epub 2018 Jan 19.

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
France
Italy
Poland
Slovakia
United Kingdom
Australia
United States
Spain
Israel


title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period

acronym: EDITION I

summary:
Primary Objective:

To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus

Secondary Objectives:

To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

ReferenceCitation: Riddle MC, Bolli GB, Ziemen M, Muehlen-Bartmer I, Bizet F, Home PD; EDITION 1 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014 Oct;37(10):2755-62. doi: 10.2337/dc14-0991. Epub 2014 Jul 30.

publisher_dissemination: American Diabetes Association

ReferenceCitation: Yale JF, Aroda VR, Charbonnel B, Sinclair AJ, Trescoli C, Cahn A, Bigot G, Merino-Trigo A, Brulle-Wohlhueter C, Bolli GB, Ritzel R. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL versus glargine 100 U/mL: A patient-level meta-analysis examining older and younger adults with type 2 diabetes. Diabetes Metab. 2020 Apr;46(2):110-118. doi: 10.1016/j.diabet.2018.10.002. Epub 2018 Oct 23.

repositories_concat: Zenodo

ReferenceCitation: Bonadonna RC, Renard E, Cheng A, Fritsche A, Cali A, Melas-Melt L, Umpierrez GE. Switching to insulin glargine 300 U/mL: Is duration of prior basal insulin therapy important? Diabetes Res Clin Pract. 2018 Aug;142:19-25. doi: 10.1016/j.diabres.2018.03.041. Epub 2018 Apr 9.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_country:
Finland
Germany
Hungary
Romania
Netherlands
Mexico
United States
Latvia
South Africa
Czechia
Canada
Estonia
France

location_facility:
Investigational Site Number 840065
Investigational Site Number 840126
Investigational Site Number 348012
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Investigational Site Number 528005
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Investigational Site Number 203006
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Investigational Site Number 428005
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Investigational Site Number 276002
Investigational Site Number 348015
Investigational Site Number 840022
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Investigational Site Number 840059
Investigational Site Number 840048
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title: PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Small Vessel Sub-trial

acronym: PLATINUM SV

summary: The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions can be located in vessels that are smaller than average-sized.

ReferenceCitation: Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrie D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070.

ReferenceCitation: Teirstein PS, Meredith IT, Feldman RL, Rabinowitz AC, Cannon LA, Lee TC, Dens J, Dubois CL, Mooney MR, Pompili VJ, Saito S, Allocco DJ, Dawkins KD, Stone GW. Two-year safety and effectiveness of the platinum chromium everolimus-eluting stent for the treatment of small vessels and longer lesions. Catheter Cardiovasc Interv. 2015 Feb 1;85(2):207-15. doi: 10.1002/ccd.25565. Epub 2014 Jul 4.

ipd_sharing: Undecided

ipd_sharing_description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

location_country:
New Zealand
Australia
Japan
Belgium
United States
France

location_facility: Ohio Health Research and Innovation Institute

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

location_facility: Lindner Center for Research and Education at The Christ Hospital

location_facility: Mediquest Research at Munroe Regional Medical Center

location_facility: Oklahoma Foundation for Cardiovascular Research


title: A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study

summary: This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.

location_country:
Lithuania
Colombia
India
Slovakia
Romania
South Africa
Serbia
Canada
Ukraine
Czech Republic
Russian Federation
France

location_facility: Crimean republican Clinical Psychiatric Hospital

location_facility: Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)

location_facility: Clinical Centre Nis, Clinic for mental health protection

location_facility: Regional Clinical Psychiatric Hospital, Dept #11

location_facility: Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1

location_facility: Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine

location_facility: Brij Psychiatry Hospital & Muskaan Research Centre

location_facility: PsychoLine s.r.o. Psychiatricka ambulancia

location_facility: Seth K M School of P G Medicine & Research

location_facility: Dnipropetrovsk Regional Clinical Hospital named Mechnikov

location_facility: Brain Mind Behavior Neuroscience Research Institute

location_facility: Pro mente sana s.r.o. Psychiaricka ambulancia

location_facility: Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'

location_facility: Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry

location_facility: Vijayawada Institute of Mental Health and Neurosciences

location_facility: St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"

location_facility: Seskines Outpatient Clinic, Public Institution

location_facility: St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)

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

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations


title: A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors

summary: The purpose of the study is to evaluate the safety and to define the Maximal Tolerated Dose (MTD) or the Maximal Administered Dose (MAD) of oral azacitidine as a single agent and in combination with carboplatin (CBDCA) or paclitaxel protein bound particles (ABI-007,ABX) in subjects with relapsed or refractory solid tumors.

ReferenceCitation: LoRusso P, et al. A Phase Ib study of CC-486 (Oral Azacitidine) as a priming agent for carboplatin or NAB-paclitaxel in subjects with relapsed and refractory solid tumors . Presented at 25th AACR-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics, October 19-23, 2013, Boston, MA. Abstract No. A120.

lead_sponsor: Celgene

location_country:
United States
Spain
Netherlands
France

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Scottsdale Healthcare Research Institute

location_facility: South Texas Accelerated Research Therapeutics

location_facility: The Netherlands Cancer Instiute Antoni Van Leeuwenhoekziekenhuis


title: Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration

acronym: NSsaFe

summary: The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®

lead_sponsor: Guerbet

location_country:
Germany
Italy
Colombia
United Kingdom
Argentina
Belgium
United States
Korea, Republic of
Spain
Turkey
France

location_facility: IATM (Instituto de alta tecnologia Medica de Antoquia)

location_facility: Medeniyet University Goztepe Research and Training Hospital

location_facility: University Hospital of North Staffodshire

location_facility: CRC Hospital Universitari Sant Joan de Reus

location_facility: Institute of Radiology and Neuroradiology

location_facility: University of Texas Health Science Center


title: Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Lower Limb

acronym: PLUS

summary: The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Germany
Italy
Poland
United States
Spain
Canada
Czech Republic
Russian Federation
France

location_facility:
Merz Investigational Site #001207
Merz Investigational Site #001210
Merz Investigational Site #001183
Merz Investigational Site #420047
Merz Investigational Site #048044
Merz Investigational Site # 001110
Merz Investigational Site #049079
Merz Investigational Site #034028
Merz Investigational Site #007010
Merz Investigational Site #034027
Merz Investigational Site #007012
Merz Investigational Site #049304
Merz Investigational Site #001204
Merz Investigational Site #001202
Merz Investigational Site #048080
Merz Investigational Site #049071
Merz Investigational Site #420030
Merz Investigational Site #420031
Merz Investigational Site #039006
Merz Investigational Site #034026
Merz Investigational Site #049303
Merz Investigational Site #420024
Merz Investigational Site #049302
Merz Investigational Site #048056
Merz Investigational Site #049148
Merz Investigational Site #001208
Merz Investigational Site #001198
Merz Investigational Site #048031
Merz Investigational Site #048051
Merz Investigational Site #034029
Merz Investigational Site #048022
Merz Investigational Site #048053
Merz Investigational Site #007009
Merz Investigational Site #007011
Merz Investigational Site #034030
Merz Investigational Site #001244
Merz Investigational Site #033018
Merz Investigational Site #048033
Merz Investigational Site #001206
Merz Investigational Site #001009
Merz Investigational Site #039012
Merz Investigational Site #001184
Merz Investigational Site #048054
Merz Investigational Site #048023
Merz Investigational Site #048055
Merz Investigational Site #001209
Investigational site #001188
Merz Investigational Site #049022
Merz Investigational Site #033024
Merz Investigational Site #048081
Merz Investigational Site #049072
Merz Investigational Site #039011
Merz Investigational Site #048057


title: A Randomised Open-Label Phase II Study to Assess the Efficacy & Safety of AZD4547 Monotherapy Versus Paclitaxel in Patients With Advanced Gastric Adenocarcinoma (Inc. Adenocarcinoma of the Lower Third of the Oesophagus or the Gastro-Oesophageal Junction)With FGFR2 Polysomy or Gene Amplification.

acronym: SHINE

summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
India
Hungary
United Kingdom
Romania
Japan
Belgium
Korea, Republic of
Spain
Taiwan
Ukraine
Bulgaria
Canada
Czech Republic
France


title: A Phase 1b/2 Randomized Study of MEDI-573 in Combination With an Aromatase Inhibitor (AI) Versus AI Alone in Women With Metastatic Breast Cancer (MBC)

summary: Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.

lead_sponsor: MedImmune LLC

location_country:
Germany
Poland
Bahamas
Hungary
Israel
United Kingdom
Belgium
United States
Spain
Canada
France


title: Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001

summary: The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.

ReferenceCitation: Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14.

repository_institution: Tampere University - Tampere University Institutional Repository

ReferenceCitation: Fizazi K, Massard C, Bono P, Kataja V, James N, Tammela TL, Joensuu H, Aspegren J, Mustonen M. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Castration-resistant, CYP17 Inhibitor-naive Prostate Cancer: Results from Extended Follow-up of the ARADES Trial. Eur Urol Focus. 2017 Dec;3(6):606-614. doi: 10.1016/j.euf.2017.01.010. Epub 2017 Feb 27.

ReferenceCitation: Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25.

repository_institution: Cardiff University - ORCA Online Research @Cardiff

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
Finland
United Kingdom
United States
Estonia
Czech Republic
France

location_facility: Eastern CT Hematology and Oncology Associates

location_facility: Klinika onkologie a radioterapie LFUK a FN


title: An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Etravirine (ETR) in Combination With Other Antiretrovirals (ARVs) in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects

summary: The purpose of this study is to learn more about the safety and tolerability of etravirine. Etravirine is a type of non-nucleoside reverse transcriptase inhibitor (NNRTI) which has shown high activity against wild-type human immunodeficiency virus (HIV-1), and HIV strains resistant to other non-nucleotide agents.

ReferenceCitation: Arathoon E, Bhorat A, Silaghi R, Crauwels H, Lavreys L, Tambuyzer L, Vanveggel S, Opsomer M. Week 48 results of a Phase IV trial of etravirine with antiretrovirals other than darunavir/ritonavir in HIV-1-infected treatment-experienced adults. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19783. doi: 10.7448/IAS.17.4.19783. eCollection 2014.

lead_sponsor: Janssen R&D Ireland

location_country:
Guatemala
Argentina
Romania
Mexico
United States
South Africa
Peru
Ukraine
Puerto Rico
Russian Federation
France


title: A Prospective, Randomized, Double-Blind Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 2 Study

acronym: ELEMENT 2

summary: The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.

ReferenceCitation: Nishiyama H, Shingaki T, Suzuki Y, Ilag LL. Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus(R) Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation. Diabetes Ther. 2018 Aug;9(4):1469-1476. doi: 10.1007/s13300-018-0450-0. Epub 2018 May 31.

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

ReferenceCitation: Pollom RK, Costigan T, Lacaya LB, Ilag LL, Hollander PA. Similar Efficacy and Safety of Basaglar(R) and Lantus(R) in Patients with Type 2 Diabetes in Age Groups (< 65 Years, >/= 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study. Diabetes Ther. 2018 Apr;9(2):827-837. doi: 10.1007/s13300-018-0405-5. Epub 2018 Mar 14.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Boehringer Ingelheim

location_country:
Germany
Poland
Hungary
Mexico
United States
Korea, Republic of
Spain
Greece
Taiwan
Czech Republic
Puerto Rico
France

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


summary: This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).

ReferenceCitation: Foeldvari I, Constantin T, Vojinovic J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Susic G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dolezalova P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

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

location_facility: FGBNU Research Institute of Rheumatology n.a. V.A. Nasonovoy

location_facility: Fakultni nemocnice Brno - Detska nemocnice, Ambulance detske revmatologie

location_facility: Szpital Specjalistyczny im. A. Falkiewicza we Wroclawiu, Oddzial Pediatryczno - Reumatologiczny

location_facility: University Medical Centre Ljubljana, University Children's Hospital

location_facility: Klinika detskeho a dorostoveho lekarstvi 1. LF UK a VFN v Praze

location_facility: Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego

location_facility: Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,

location_facility: Centro di Ricerca Clinica - Fondazione dell'Universita' degli Studi "G. D'Annunzio"

location_facility: Children's Hospital at Vilnius University Hospital "Santaros klinikos"

location_facility: SBEI HPE Saint Petersburg State Pediatric Medical University

location_facility: Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie

location_facility: Universitair Ziekenhuis Utrecht, Wilhelmina Kinderziekenhuis, Room number KC 03-063

title: AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014)

location_country:
Germany
Poland
Australia
Czechia
Serbia
France
Slovenia
Lithuania
Colombia
Slovakia
Hungary
Latvia
Belgium
Italy
Norway
Netherlands
Mexico
Spain
Russian Federation


title: A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients Previously Undiagnosed Peripheral T-cell Lymphoma Who Achieved an Objective Response After Initial Treatment With CHOP-based Chemotherapy

summary: The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. Patients will either receive pralatrexate or be under observation. All patients will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their disease and health.

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
Ireland
Italy
Poland
New Zealand
Israel
United Kingdom
Australia
Belgium
United States
Spain
Canada
Puerto Rico
France

location_facility: Sandwell & West Birmingham Hospitals NHS Trust

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Complejo Hospitalario Universitario A Coruña- Hospital A Coruña

location_facility: Complejo Hospitalario de Navarra, Servicio de Hematologia

location_facility: Auckland City Hospital / Auckland University

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Poole Hospital NHS Foundation Trust, Poole General Hospital

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Az. Ospedaliera Universitaria S. Orsola Malpighi

location_facility: UHCW (University Hospital Coventry and Warwickshire)

location_facility: NHS Greater Glasgow and Clyde Western Infirmary

location_facility: Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie


title: A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab

acronym: STATURE

summary: The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
India
Slovakia
Japan
Austria
United States
Canada
France


title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study

summary: The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

ReferenceCitation: Currow D, Temel JS, Abernethy A, Milanowski J, Friend J, Fearon KC. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. 2017 Aug 1;28(8):1949-1956. doi: 10.1093/annonc/mdx192.

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

lead_sponsor: Helsinn Therapeutics (U.S.), Inc

location_country:
Germany
Belarus
Italy
Poland
Slovenia
Hungary
Israel
Australia
Belgium
United States
Spain
Czechia
Canada
Ukraine
Serbia
Russian Federation
France


acronym: paradigm™ 4

lead_sponsor: Novo Nordisk A/S

summary:
This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B.

This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).

ReferenceCitation: Young G, Collins P, Tehranchi R, Chuansumrit A, Hanabusa H, Lentz SR, Mahlangu J, Mauser-Bunschoten E, Negrier C, Oldenburg J, Patiroglu T, Santagostino E, Zak M, Abdul Karim F. Safety and efficacy of nonacog beta pegol (N9-GP) for prophylaxis and treatment of bleeding episodes in previously-treated patients with hemophilia B: results from an extension trial. American Society of Hematology - 56th Annual Meeting (ASH) in San Francisco, CA, US

ReferenceCitation: Young G, Collins PW, Colberg T, Chuansumrit A, Hanabusa H, Lentz SR, Mahlangu J, Mauser-Bunschoten EP, Negrier C, Oldenburg J, Patiroglu T, Santagostino E, Tehranchi R, Zak M, Karim FA. Nonacog beta pegol (N9-GP) in haemophilia B: A multinational phase III safety and efficacy extension trial (paradigm4). Thromb Res. 2016 May;141:69-76. doi: 10.1016/j.thromres.2016.02.030. Epub 2016 Mar 2.

ReferenceCitation: Chowdary P, Kearney S, Regnault A, Hoxer CS, Yee DL. Improvement in health-related quality of life in patients with haemophilia B treated with nonacog beta pegol, a new extended half-life recombinant FIX product. Haemophilia. 2016 Jul;22(4):e267-74. doi: 10.1111/hae.12995. Epub 2016 Jun 28.

title: Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

location_country: Macedonia, The Former Yugoslav Republic of


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease

summary: This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.

ReferenceCitation: Panes J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher_dissemination: British Medical Journal

lead_sponsor: Pfizer

location_country:
France
Germany
Hungary
Israel
Australia
Japan
Netherlands
Austria
United States
Korea, Republic of
Spain
Greece
South Africa
Ukraine
Bulgaria
Canada
Czech Republic

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Shands Hospital at the University of Florida

location_facility: Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2

location_facility: Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,

location_facility: Advanced Clinical Research Institute-Phase 1, LLC

location_facility: North Florida Gastroenterology Research, LLC

location_facility: Gulfshore Endoscopy Center (Endoscopies Only)

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia

location_facility: Hôpital Haut-Lévêque/Service d hépato-gastroentérologie

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: Medical Clinical Research Center of Medical Center "Health Clinic" LLC

location_facility: Gasteroenterology Consultants of Clearwater

location_facility: Wisconsin Center for Advanced Research - GI Associates, LLC

location_facility: Universitaetsklinikum Ulm, Klinik Fuer Innere Medizin I

location_facility: Investigational Drug Services - University Hospitals Case Medical Center

location_facility: MBAL Sofiamed OOD, Otdelenie po gastroenterologia

location_facility: The Hospital of Hyogo College of Medicine

location_facility: ASAN Medical Center,Division of Gastroenterology,Department of Internal Medicine

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium

location_facility: Laboratórium Kft. Somogy Megyei Mikrobiológiai Laboratórium

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat

location_facility: Office of Drs. Ranjith Andrew Singh and Jamie D. Papp,

location_facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department

location_facility: East Ann Arbor Health and Geriatrics Center

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", Odesa Regional Centre of Gastroenterology.

location_facility: Medial Pharma spol.s.r.o. (Pharmacy only)

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Metropolitan Gastroenterology Group, P C

location_facility: London Health Sciences Centre - University Hospital

location_facility: University of Florida - College of Medicine

location_facility: Samsung Medical Center, Division of Gastroenterology, Department of Internal Medicine

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

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital


title: Phase 3 Prospective, Randomized, Blinded, and Controlled Investigation of HepaSphere/QuadraSphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Carcinoma

acronym: HiQuality

summary: The purpose of this study is to evaluate overall survival in patients diagnosed with hepatocellular cancer (HCC) treated with HepaSphere/QuadraSphere Microspheres loaded with chemotherapeutic agent doxorubicin compared to conventional transarterial chemoembolization with particle PVA, lipiodol, and doxorubicin.

lead_sponsor: Merit Medical Systems, Inc.

location_country:
Italy
Belgium
United States
Greece
France

location_facility: MUSC Medical Center (Medical University of South Carolina)

location_facility: University Hospitals K.U. Leuven (Dept of Hematology)

location_facility: Hospital of the University of Pennsylvania

location_facility: Palo Alto Veterans Institute for Research

location_facility: VA Greater Los Angeles Healthcare System


title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

summary: The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

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

ReferenceCitation: Temel JS, Abernethy AP, Currow DC, Friend J, Duus EM, Yan Y, Fearon KC. Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials. Lancet Oncol. 2016 Apr;17(4):519-531. doi: 10.1016/S1470-2045(15)00558-6. Epub 2016 Feb 20.

location_country:
Germany
Belarus
Italy
Poland
Slovenia
Hungary
Netherlands
Belgium
United States
Spain
Czechia
Canada
Ukraine
Serbia
Russian Federation
France


acronym: paradigm™ 3

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

The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.

ReferenceCitation: Escobar M, Colberg T, Karim F, Caliskan U, Chowdary P, Giangrande P, Giermasz A, Mancuso ME, Serban M, Tsay W, Zak M and Mahlangu J. Perioperative hemostatic management of major surgery in hemophilia B with long-acting recombinant glycopegylated factor IX: results from the paradigm™3 clinical trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR348]

title: An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B


title: A Randomised, Double-blind, Dose-finding, Multicenter Study of the Safety, Tolerability, and Efficacy of GSK2251052 Therapy Compared to Imipenem-cilastatin in the Treatment of Adult Subjects With Febrile Complicated Lower Urinary Tract Infections and Acute Pyelonephritis

summary: This study is being conducted to evaluate the safety, efficacy (clinical and microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it would be a suitable antibiotic for the treatment for febrile lower cUTI and pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cUTI.

ReferenceCitation: O'Dwyer K, Spivak AT, Ingraham K, Min S, Holmes DJ, Jakielaszek C, Rittenhouse S, Kwan AL, Livi GP, Sathe G, Thomas E, Van Horn S, Miller LA, Twynholm M, Tomayko J, Dalessandro M, Caltabiano M, Scangarella-Oman NE, Brown JR. Bacterial resistance to leucyl-tRNA synthetase inhibitor GSK2251052 develops during treatment of complicated urinary tract infections. Antimicrob Agents Chemother. 2015 Jan;59(1):289-98. doi: 10.1128/AAC.03774-14. Epub 2014 Oct 27.

publisher_dissemination: American Society for Microbiology

lead_sponsor: GlaxoSmithKline

location_country:
United States
Spain
Greece
Canada
Russian Federation
France


acronym: Rollover study

summary: This was an open-label study to permit subjects with solid tumors or leukemia, who were clinically benefitting on another GSK sponsored trial with GSK1120212 either monotherapy or in combination continued access to GSK1120212.

title: MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors or Leukemia

location_country:
Netherlands
United States
Korea, Republic of
Taiwan
Canada
France


title: A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System

summary: This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.

lead_sponsor: TriVascular, Inc.

location_country:
Germany
Italy
United Kingdom
Sweden
Austria
Belgium
Greece
France

location_facility: "CA Gefäßchirurgie Theresienkrankenhaus/St. Hedwig"

location_facility: Frimley Park Hospital NHS Foundation Trust

location_facility: Univeristà La Sapienza/Policlinico Umberto I

location_facility: A.O. Ospedale di Circolo e Fondazione Macchi

location_facility: Università La Sapienza/Policlinico Umberto I

location_facility: Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology

location_facility: Städtisches klinikum Karlsruhe Klinik für Gefäß- und Thoraxchirurgie

location_facility: Universitäres Herz und Gefaßzentrum Hamburg


summary: The primary objective of this study is to test the hypothesis that appendicular lean body mass (aLBM) will increase after 12 weeks of LY2495655 treatment versus placebo in older participants undergoing elective total hip arthroplasty (eTHA).

ReferenceCitation: Woodhouse L, Gandhi R, Warden SJ, Poiraudeau S, Myers SL, Benson CT, Hu L, Ahmad QI, Linnemeier P, Gomez EV, Benichou O; STUDY INVESTIGATORS. A Phase 2 Randomized Study Investigating the Efficacy and Safety of Myostatin Antibody LY2495655 versus Placebo in Patients Undergoing Elective Total Hip Arthroplasty. J Frailty Aging. 2016;5(1):62-70. doi: 10.14283/jfa.2016.81.

publisher_dissemination: SERDI

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 Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Undergoing Elective Total Hip Arthroplasty

location_country:
Finland
Denmark
Japan
Sweden
Austria
Belgium
United States
Spain
Canada
Estonia
France


lead_sponsor: UCB Pharma SA

summary: This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.

ReferenceCitation: Lagae L, Klotz KA, Fogarasi A, Floricel F, Reichel C, Elshoff JP, Fleyshman S, Kang H. Long-term safety and efficacy of adjunctive brivaracetam in pediatric patients with epilepsy: An open-label, follow-up trial. Epilepsia. 2023 Nov;64(11):2934-2946. doi: 10.1111/epi.17754. Epub 2023 Sep 5.

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.

title: Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy

location_country:
Germany
Ireland
Italy
Poland
Hungary
United Kingdom
Mexico
Belgium
United States
Spain
Czechia
France


title: An Open-label, Phase 2a Study to Evaluate Pazopanib Eye Drops Administered for 12 Weeks to Patients With Neovascular Age-related Macular Degeneration

summary: The purpose of this 12 week, open-label study is to investigate the safety and efficacy of a single dose regimen of pazopanib eye drop for neovascular AMD.

ReferenceCitation: Singh R, Wurzelmann JI, Ye L, Henderson L, Hossain M, Trivedi T, Kelly DS. Clinical evaluation of pazopanib eye drops in healthy subjects and in subjects with neovascular age-related macular degeneration. Retina. 2014 Sep;34(9):1787-95. doi: 10.1097/IAE.0000000000000179.

location_country:
United States
Germany
France


summary: This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.

ReferenceCitation: Bailey DB Jr, Berry-Kravis E, Wheeler A, Raspa M, Merrien F, Ricart J, Koumaras B, Rosenkranz G, Tomlinson M, von Raison F, Apostol G. Mavoglurant in adolescents with fragile X syndrome: analysis of Clinical Global Impression-Improvement source data from a double-blind therapeutic study followed by an open-label, long-term extension study. J Neurodev Disord. 2016;8:1. doi: 10.1186/s11689-015-9134-5. Epub 2015 Dec 15.

ReferenceCitation: Berry-Kravis E, Des Portes V, Hagerman R, Jacquemont S, Charles P, Visootsak J, Brinkman M, Rerat K, Koumaras B, Zhu L, Barth GM, Jaecklin T, Apostol G, von Raison F. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials. Sci Transl Med. 2016 Jan 13;8(321):321ra5. doi: 10.1126/scitranslmed.aab4109.

publisher_dissemination: American Association for the Advancement of Science

title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of AFQ056 in Adolescent Patients With Fragile X Syndrome

location_country:
Germany
Italy
Israel
United Kingdom
Denmark
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Turkey
Canada
Indonesia
France


title: A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma, Ependymoma and ATRT

acronym: MEMMAT

summary: Patients with relapsed medulloblastoma, ependymoma and ATRT have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenetic therapy has emerged as new treatment option in solid malignancies. The frequent, metronomic schedule targets both proliferating tumor cells and endothelial cells, and minimizes toxicity. In this study the investigators will evaluate the use of biweekly intravenous bevacizumab in combination with five oral drugs (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide and cyclophosphamide), augmented with alternating courses of intrathecal etoposide and cytarabine. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma and ATRT, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The primary objective of the MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these heavily pretreated children and young adults. Additionally, progression-free survival (PFS), overall survival (OS), as well as feasibility and toxicity will be examined.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Slavc I, Mayr L, Stepien N, Gojo J, Aliotti Lippolis M, Azizi AA, Chocholous M, Baumgartner A, Hedrich CS, Holm S, Sehested A, Leblond P, Dieckmann K, Haberler C, Czech T, Kool M, Peyrl A. Improved Long-Term Survival of Patients with Recurrent Medulloblastoma Treated with a "MEMMAT-like" Metronomic Antiangiogenic Approach. Cancers (Basel). 2022 Oct 19;14(20):5128. doi: 10.3390/cancers14205128.

publisher_dissemination: MDPI

lead_sponsor: Medical University of Vienna

location_country:
Norway
Denmark
Sweden
Austria
United States
Spain
Czechia
France

location_facility: Dana-Farber Cancer Institute and Boston Children's Hospital

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Dell Children's Medical Group SFC-HEM/ONC

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Onkologisk-hematologisk seksjon Barneklinikken Haukeland universitetssjukehus

location_facility: Kepler Universitätsklinikum Med Campus IV

lead_sponsor_type: academique


summary: The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adult patients with FXS who have participated in the CAFQ056A2212 (NCT01253629).study and patients who have participated in the previous proof-of-concept study CAFQ056A2204 (NCT00718341).

title: An Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Switzerland
United States
Spain
Canada
France


title: A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)

acronym: ANDANTE II

summary: This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.

ReferenceCitation: Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.

location_country:
France
Germany
Ireland
Italy
New Zealand
Hungary
Israel
Denmark
Australia
Brazil
Switzerland
United Kingdom
Belgium
United States
Canada
Czech Republic

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Clinical Pathologiy Laboratories, Inc, DBA DRL Labs

location_facility: IBD Center-Vanderbilt University Medical Center

location_facility: Laboratório de Análises Clínicas do HUCFF/UFRJ

location_facility: Hospital Universitário Fraga Filho da UFRJ

location_facility: New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy

location_facility: Hopital Saint-Antoine - Service De Gastroenterologie

location_facility: Heritage Medical Research Clinic - University of Calgary

location_facility: Setor de Endoscopia Digestiva do Hospital Nossa Senhora das Gracas

location_facility: Gastointestinal Specialists of Georgia, PC

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: London Health Science Centre - University Hospital

location_facility: Aarhus Universitetshospital, Aarhus Sygehus

location_facility: Vanderbilt University Medical Center: IBD Clinic

location_facility: Hadassah university Hospital (HUH) - Ein Karem, Hadassah Medical Organization (HMO)

location_facility: "Kirurgisk Afdeling 0143 Hilleroed Hospital

location_facility: VC Medical Center Investigative Drug Service (IDS) [Ship Drug To]

location_facility: Barts Health NHS Trust-Royal London Hospital

location_facility: Research Protocol Management Specialists

location_facility: The University of TX Health Sci. Ctr at Houston

location_facility: Vanderbilt University Medical Center-IDS

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Weill Cornell Medical College of Cornell University-Greenberg

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: The University of Texas Health Science Center at Houston

location_facility: International Clinical Research - US, LLC

location_facility: Hepato-Gastroenterologie HK, s.r.o. Poliklinika III

location_facility: Pathology, Haematology and Biochemistry Laboratories, St. Vincent's Healthcare Group

location_facility: St Bartholomew's Hospital (Barts Health NHS Trust)

location_facility: Colonoscopy and X-rays: OU Physicians Building

location_facility: Vanderbilt University Medical Center-GI Research

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Medicinsk Afdeling, Gastroenterologisk Sektion

location_facility: The University of Chicago Medical Center

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Weill Cornell Imaging at New York Presbyterian Hospital

location_facility: Azienda Ospedaliera - Universita di Padova

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Universita Campus Biomedico UOC di Gastroenterologia

location_facility: Oklahoma Foundation for Digestive Research

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology

location_facility: Setor de Cardiologia do Hospital Nossa Senhora das Gracas

location_facility: Szegedi Tudomanyegyetem altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika

location_facility: Gastroenterology Consultants of Clearwater

location_facility: University of Kentucky Chandler Medical Center

intervention_type: Biological


title: A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain

summary: People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

ReferenceCitation: Ziegler D, Duan WR, An G, Thomas JW, Nothaft W. A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain. Pain. 2015 Oct;156(10):2013-2020. doi: 10.1097/j.pain.0000000000000263.

license: unspecified-oa

license_normalized: unspecified-oa

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
Germany
Mexico
United States
Czech Republic
France

location_facility:
Site Reference ID/Investigator# 52346
Site Reference ID/Investigator# 51425
Site Reference ID/Investigator# 52744
Site Reference ID/Investigator# 51269
Site Reference ID/Investigator# 51505
Site Reference ID/Investigator# 51804
Site Reference ID/Investigator# 51548
Site Reference ID/Investigator# 51946
Site Reference ID/Investigator# 51424
Site Reference ID/Investigator# 52743
Site Reference ID/Investigator# 51522
Site Reference ID/Investigator# 51427
Site Reference ID/Investigator# 51925
Site Reference ID/Investigator# 51423
Site Reference ID/Investigator# 51263
Site Reference ID/Investigator# 51302
Site Reference ID/Investigator# 51506
Site Reference ID/Investigator# 51271
Site Reference ID/Investigator# 51642
Site Reference ID/Investigator# 51468
Site Reference ID/Investigator# 51268
Site Reference ID/Investigator# 51079
Site Reference ID/Investigator# 51806
Site Reference ID/Investigator# 51924
Site Reference ID/Investigator# 51504
Site Reference ID/Investigator# 51078
Site Reference ID/Investigator# 51502
Site Reference ID/Investigator# 51426
Site Reference ID/Investigator# 51265
Site Reference ID/Investigator# 51503
Site Reference ID/Investigator# 51076
Site Reference ID/Investigator# 51807
Site Reference ID/Investigator# 51077
Site Reference ID/Investigator# 51428
Site Reference ID/Investigator# 51945


acronym: BRITE™

lead_sponsor: UCB BIOSCIENCES, Inc.

summary: This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

ReferenceCitation: Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.

title: An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy

location_country:
Finland
Germany
Poland
Japan
Brazil
Czechia
Canada
France
Lithuania
Hungary
Hong Kong
United States
Latvia
India
Belgium
Estonia
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Sweden


acronym: FUTURE 3 Ext

lead_sponsor: Actelion

summary: The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).

location_facility: CARE Hospitals, Cardiology Dep. Hyderabad - Site 5302

location_facility: Children's National Medical Center - Site 9104

location_facility: Cardiovascular Institute and Fuwai Hospital

location_facility: Universitätsklinikum Bonn Abteilung für Kinderkardiologie - Site 1404

location_facility: Justus-Liebig-Universität Giessen, Kinderherzzentrum - Site 1403

location_facility: RAMS Institution, Research Institute for complex issues of cardiovascular diseases, Siberian branch of the Russian Academy of Medical Sciences - Site 3805

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu Oddział Kardiologii Dziecięcej z pododdziałem Intensywnego Nadzoru Kardiologicznego - Site 3605

location_facility: Columbia University Medical Center Children's Hospital of New York Presbyterian - Site 9101

location_facility: Università Degli Studi di Padova - Dipartimento di Pediatria - Servizio di Cardiologia Pediatrica - Site 1501

location_facility: Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, Gyermekgyógyászati Klinika és Gyermekegészségügyi Központ - Site 3402

location_facility: Division of Paediatric Cardiology, Steve Biko Academic Hospital - Site 6002

location_facility: Moscow Scientific Research Institute for Pediatrics and Childrens Surgery of Rosmedtechnologies - Site 3804

location_facility: Clinical Diagnostic Center - Pediatric Cardiovascular and ANES and Intensive Care Department - Site 4103

location_facility: Gusak Ins Urgent and Recovery SUR AMS - Cardiovascular Rehabilitation Pediatric Department - Site 4101

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca - Site 3604

location_facility: Deutsches Herzzentrum Kinderkardiologie - Site 1401

location_facility: Instituto Nacional de Cardiologia (INC) Ignacio Chavez - Site 8401

location_facility: State Educational Institution of Higher Professional Education "Saint Petersburg State Pediatric Medical Academy of Roszdrav" - Site 3801

location_facility: Shanghai Children's Medical Center - Site 5102

location_facility: Hopital Necker-Enfants Malades, Service de Cardiologie Pédiatrique - Site 2201

location_facility: Institut za zdravstvenu zaštitu majke i deteta Srbije "Dr Vukan Čupić", Služba za ispitivanje i lečenje bolesti srca i krvnih sudova - Site 3902

location_facility: Schneider Children's Medical Center- Institute of pediatric cardiology - Site 7101

location_facility: Hospital Universitatario Vall d'Hebron, Neumologia - Site 1907

location_facility: CHU de Toulouse - Hôpital des Enfants, Service de Cardiologie Pédiatrique - Site 2202

location_facility: Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301

location_facility: Univerzitetska dečja klinika, Služba za kardiologiju - Site 3901

location_facility: The Republican Scientific-Practical Center "Cardiology" - Site 3001

location_facility: Scientific Center of Cardiovascular Surgery named after A.N.Bakulev of the RAMS - Site 3803

location_facility: Royal Children's Hospital Melbourne, Cardiology - Site 5001

location_facility: Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies" - Site 3802

location_facility: Gottsegen György Országos Kardiológiai Intézet, Gyermekszív Központ, Gyermek Kardiológiai osztály - Site 3401

location_facility: Department of Paediatric Cardiology University of the Free State - Site 6001

location_facility: Gover INS - Scientific Practical Cardiovascular Pediatric Center - MOH Ukraine - Site 4102

location_facility: Hospital Universitario La Paz - Paediatric Cardiology Department - Site 1906

location_facility: Ospedale Pediatrico "Bambino Gesù" - Dipartimento Medico Chirurgico di Cardiologia Pediatrica - Site 1502

title: A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension

location_country:
Germany
Belarus
Italy
Poland
India
Hungary
Israel
Australia
Mexico
United States
China
Spain
South Africa
Czechia
Ukraine
Serbia
Russian Federation
France


acronym: paradigm™ 2

summary: This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.

ReferenceCitation: Collins PW, Young G, Knobe K, Karim FA, Angchaisuksiri P, Banner C, Gursel T, Mahlangu J, Matsushita T, Mauser-Bunschoten EP, Oldenburg J, Walsh CE, Negrier C; paradigm 2 Investigators. Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial. Blood. 2014 Dec 18;124(26):3880-6. doi: 10.1182/blood-2014-05-573055. Epub 2014 Sep 26.

title: A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B

location_country: Macedonia, The Former Yugoslav Republic of


title: Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component

summary: The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

ReferenceCitation: Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25.

repositories_institution: Cardiff University - ORCA Online Research @Cardiff

sponsor_collaborators:
Orion Corporation, Orion Pharma
Endo Pharmaceuticals

location_country:
Finland
United Kingdom
United States
Estonia
Czech Republic
France

location_facility: Eastern CT Hematology and Oncology Associates

location_facility: Klinika onkologie a radioterapie LFUK a FN

location_facility: Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo


lead_sponsor: Insmed Incorporated

summary: The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of LAI were evaluated for up to approximately 2 years.

ReferenceCitation: Bilton D, Fajac I, Pressler T, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Sole A, Quittner AL, Jumadilova Z, Ciesielska M, Konstan MW; CLEAR-110 Study Group. Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection. J Cyst Fibros. 2021 Nov;20(6):1010-1017. doi: 10.1016/j.jcf.2021.05.013. Epub 2021 Jun 16.

title: Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

location_country:
Germany
Ireland
Italy
Poland
Slovakia
Hungary
United Kingdom
Denmark
Netherlands
Austria
Belgium
Spain
Greece
Bulgaria
Canada
Serbia
France