title: NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM)

summary: The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.

ReferenceCitation: Gregorc V, Gaafar RM, Favaretto A, Grossi F, Jassem J, Polychronis A, Bidoli P, Tiseo M, Shah R, Taylor P, Novello S, Muzio A, Bearz A, Greillier L, Fontana F, Salini G, Lambiase A, O'Brien M. NGR-hTNF in combination with best investigator choice in previously treated malignant pleural mesothelioma (NGR015): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2018 Jun;19(6):799-811. doi: 10.1016/S1470-2045(18)30193-1. Epub 2018 May 9.

lead_sponsor: AGC Biologics S.p.A.

location_country:
Poland
Spain
Ireland
Italy
United Kingdom
Canada
Sweden
United States
France
Belgium
Netherlands
Egypt

location_facility: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

location_facility: H. Lee Moffitt ancer Center and Research Institute

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Azienda Ospedaliero-Universitaria Careggi di Firenze

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: A.O. Salvini Garbagnate, Ospedale di Rho

location_facility: Maria Sklodowska Memorial Cancer Center and Institute of Oncology

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

location_facility: Azienda Unità Sanitaria locale di Ravenna

location_facility: Edinburgh Cancer Centre, Western General Hospital

location_facility: UAB - Alberta Cancer Board - Cross Cancer Institute


title: A 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior or Panuveitis Requiring Immunosuppression (INSURE Study)

acronym: INSURE

summary: This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Dick AD, Tugal-Tutkun I, Foster S, Zierhut M, Melissa Liew SH, Bezlyak V, Androudi S. Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials. Ophthalmology. 2013 Apr;120(4):777-87. doi: 10.1016/j.ophtha.2012.09.040. Epub 2013 Jan 3.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
United Kingdom
Canada
Switzerland
Hungary
United States
France
India
Israel
Singapore
Japan
Germany
Egypt

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


type: EudraCT Number

title: Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis

summary: This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Actelion

location_country:
Poland
Serbia
Spain
United Kingdom
Austria
Netherlands
Russian Federation
Canada
Finland
Switzerland
Ukraine
Sweden
Hungary
United States
France
Israel
Romania
Germany
Bulgaria
Czechia

status_simplified: Ongoing


title: Study on the Signature Personalised Patient Care System With the Vanguard Knee System

summary: The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively.

lead_sponsor: Zimmer Biomet

location_country:
Denmark
Portugal
United Kingdom
Austria
Australia
Sweden
United States
France
Belgium
Netherlands

location_facility:
Medipole de Savoie
Logan Hospital
General Hospital Kreuzschwestern
The Orthopaedic Hospital Speising
St Luc General Hospital
Insall Scott Kelly Institute
Danderyd Hospital
Aalborg University Hospital
The Queen Elizabeth Hospital
Addenbrooke's Hospital
Amphia Ziekenhuis Breda
Torres Verdras Hospital

intervention_type: Procedure


title: Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.

acronym: GARFIELD-AF

summary: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is a non-interventional, observational study that characterized a global population of non-valvular atrial fibrillation patients. The registry was used to document global baseline characteristics, current treatment strategies and outcome measures. Characterisation of a number of AF sub-populations was also completed. GARFIELD-AF is an independent academic research initiative sponsored by the Thrombosis Research Institute (London, UK) and supported by an unrestricted research grant from Bayer AG (Berlin, Germany).

status: Completed

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Verheugt FW, Jamal W, Misselwitz F, Rushton-Smith S, Turpie AG. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J. 2012 Jan;163(1):13-19.e1. doi: 10.1016/j.ahj.2011.09.011. Epub 2011 Nov 20.

ReferenceCitation: Apenteng PN, Murray ET, Holder R, Hobbs FD, Fitzmaurice DA; UK GARFIELD Investigators and GARFIELD Steering Committee. An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol. BMC Cardiovasc Disord. 2013 Apr 23;13:31. doi: 10.1186/1471-2261-13-31.

ReferenceCitation: Aalbers J. GARFIELD: a window on the real-life treatment of atrial fibrillation - South Africa joins the GARFIELD registry. Cardiovasc J Afr. 2012 Oct;23(9):528.

ReferenceType: result

ReferenceCitation: Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Turpie AG, van Eickels M, Misselwitz F, Rushton-Smith S, Kayani G, Wilkinson P, Verheugt FW; GARFIELD Registry Investigators. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One. 2013 May 21;8(5):e63479. doi: 10.1371/journal.pone.0063479. Print 2013.

ReferenceCitation: Fox KAA, Virdone S, Bassand JP, Camm AJ, Goto S, Goldhaber SZ, Haas S, Kayani G, Koretsune Y, Misselwitz F, Oh S, Piccini JP, Parkhomenko A, Sawhney JPS, Stepinska J, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF investigators*. Do baseline characteristics and treatments account for geographical disparities in the outcomes of patients with newly diagnosed atrial fibrillation? The prospective GARFIELD-AF registry. BMJ Open. 2022 Jan 7;12(1):e049933. doi: 10.1136/bmjopen-2021-049933.

ReferenceCitation: Pope MK, Hall TS, Schirripa V, Radic P, Virdone S, Pieper KS, Le Heuzey JY, Jansky P, Fitzmaurice DA, Cappato R, Atar D, Camm AJ, Kakkar AK; GARFIELD-AF investigators. Cardioversion in patients with newly diagnosed non-valvular atrial fibrillation: observational study using prospectively collected registry data. BMJ. 2021 Oct 27;375:e066450. doi: 10.1136/bmj-2021-066450.

ReferenceCitation: Cools F, Johnson D, Camm AJ, Bassand JP, Verheugt FWA, Yang S, Tsiatis A, Fitzmaurice DA, Goldhaber SZ, Kayani G, Goto S, Haas S, Misselwitz F, Turpie AGG, Fox KAA, Pieper KS, Kakkar AK; GARFIELD-AF Investigators. Risks associated with discontinuation of oral anticoagulation in newly diagnosed patients with atrial fibrillation: Results from the GARFIELD-AF Registry. J Thromb Haemost. 2021 Sep;19(9):2322-2334. doi: 10.1111/jth.15415. Epub 2021 Jul 23.

ReferenceCitation: Fox KAA, Virdone S, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Kayani G, Oto A, Misselwitz F, Piccini JP, Dalgaard F, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation. Eur Heart J Qual Care Clin Outcomes. 2022 Mar 2;8(2):214-227. doi: 10.1093/ehjqcco/qcab028.

ReferenceCitation: Pope MK, Atar D, Svilaas A, Hole T, Nielsen JD, Hintze U, Crisby M, Raatikainen P, Airaksinen KEJ, Virdone S, Pieper K, Kayani G, Le Heuzey JY, Steffel J, Stepinska J, Bassand JP, Camm AJ; GARFIELD-AF Investigators. Risk profile, antithrombotic treatment and clinical outcomes of patients in Nordic countries with atrial fibrillation - results from the GARFIELD-AF registry. Ann Med. 2021 Dec;53(1):485-494. doi: 10.1080/07853890.2021.1893897.

ReferenceCitation: Sayin BY, Al Mahmeed W, Ragy HI, Elbahry A, Virdone S, Kakkar AK, Ersanlı M, Oto A. Middle East Treatment Strategies and Clinical Outcomes in Patients with Atrial Fibrillation: One-Year Follow-up Data from Garfield-AF Study. Adv Ther. 2021 May;38(5):2391-2405. doi: 10.1007/s12325-021-01670-5. Epub 2021 Mar 27.

ReferenceCitation: Gibbs H, Freedman B, Rosenqvist M, Virdone S, Mahmeed WA, Ambrosio G, Camm AJ, Jacobson B, Jerjes-Sanchez C, Kayani G, Oto A, Panchenko E, Ragy H, Kakkar AK; GARFIELD-AF Investigators. Clinical Outcomes in Asymptomatic and Symptomatic Atrial Fibrillation Presentations in GARFIELD-AF: Implications for AF Screening. Am J Med. 2021 Jul;134(7):893-901.e11. doi: 10.1016/j.amjmed.2021.01.017. Epub 2021 Feb 16.

ReferenceCitation: Bassand JP, Virdone S, Badoz M, Verheugt FWA, Camm AJ, Cools F, Fox KAA, Goldhaber SZ, Goto S, Haas S, Hacke W, Kayani G, Misselwitz F, Pieper KS, Turpie AGG, van Eickels M, Kakkar AK. Bleeding and related mortality with NOACs and VKAs in newly diagnosed atrial fibrillation: results from the GARFIELD-AF registry. Blood Adv. 2021 Feb 23;5(4):1081-1091. doi: 10.1182/bloodadvances.2020003560.

ReferenceCitation: Camm AJ, Fox KAA, Virdone S, Bassand JP, Fitzmaurice DA, Berchuck SI, Gersh BJ, Goldhaber SZ, Goto S, Haas S, Misselwitz F, Pieper KS, Turpie AGG, Verheugt FWA, Cappato R, Kakkar AK; GARFIELD-AF investigators. Comparative effectiveness of oral anticoagulants in everyday practice. Heart. 2021 Feb 16. pii: heartjnl-2020-318420. doi: 10.1136/heartjnl-2020-318420. [Epub ahead of print]

ReferenceCitation: Camm AJ, Cools F, Virdone S, Bassand JP, Fitzmaurice DA, Arthur Fox KA, Goldhaber SZ, Goto S, Haas S, Mantovani LG, Kayani G, Grierson Turpie AG, Antoon Verheugt FW, Kakkar AK; GARFIELD-AF Investigators. Mortality in Patients With Atrial Fibrillation Receiving Nonrecommended Doses of Direct Oral Anticoagulants. J Am Coll Cardiol. 2020 Sep 22;76(12):1425-1436. doi: 10.1016/j.jacc.2020.07.045.

ReferenceCitation: Bassand JP, Apenteng PN, Atar D, Camm AJ, Cools F, Corbalan R, Fitzmaurice DA, Fox KA, Goto S, Haas S, Hacke W, Jerjes-Sanchez C, Koretsune Y, Heuzey JL, Sawhney JP, Oh S, Stępińska J, Cate VT, Verheugt FW, Kayani G, Pieper KS, Kakkar AK, Garfield-Af Investigators FT. GARFIELD-AF: a worldwide prospective registry of patients with atrial fibrillation at risk of stroke. Future Cardiol. 2021 Jan;17(1):19-38. doi: 10.2217/fca-2020-0014. Epub 2020 Jul 22.

ReferenceCitation: Hacke W, Bassand JP, Virdone S, Camm AJ, Fitzmaurice DA, Fox KA, Goldhaber SZ, Goto S, Haas S, Kayani G, Mantovani LG, Misselwitz F, Pieper KS, Turpie AG, van Eickels M, Verheugt FW, Kakkar AK; GARFIELD-AF Investigators. Prior stroke and transient ischemic attack as risk factors for subsequent stroke in atrial fibrillation patients: A report from the GARFIELD-AF registry. Int J Stroke. 2020 Apr;15(3):308-317. doi: 10.1177/1747493019891516. Epub 2019 Dec 17.

ReferenceCitation: Atar D, Berge E, Le Heuzey JY, Virdone S, Camm AJ, Steffel J, Gibbs H, Goldhaber SZ, Goto S, Kayani G, Misselwitz F, Stepinska J, Turpie AGG, Bassand JP, Kakkar AK; GARFIELD-AF Investigators. The association between patterns of atrial fibrillation, anticoagulation, and cardiovascular events. Europace. 2020 Feb 1;22(2):195-204. doi: 10.1093/europace/euz292.

ReferenceCitation: Verheugt FWA, Ambrosio G, Atar D, Bassand JP, Camm AJ, Costabel JP, Fitzmaurice DA, Illingworth L, Goldhaber SZ, Goto S, Haas S, Jansky P, Kayani G, Stepinska J, Turpie AGG, van Eickels M, Kakkar AK; GARFIELD-AF Investigators. Outcomes in Newly Diagnosed Atrial Fibrillation and History of Acute Coronary Syndromes: Insights from GARFIELD-AF. Am J Med. 2019 Dec;132(12):1431-1440.e7. doi: 10.1016/j.amjmed.2019.06.008. Epub 2019 Jul 12.

ReferenceCitation: Haas S, Camm AJ, Bassand JP, Angchaisuksiri P, Cools F, Corbalan R, Gibbs H, Jacobson B, Koretsune Y, Mantovani LG, Misselwitz F, Panchenko E, Ragy HI, Stepinska J, Turpie AG, Sawhney JP, Steffel J, Lim TW, Pieper KS, Virdone S, Verheugt FW, Kakkar AK; GARFIELD-AF Investigators. Predictors of NOAC versus VKA use for stroke prevention in patients with newly diagnosed atrial fibrillation: Results from GARFIELD-AF. Am Heart J. 2019 Jul;213:35-46. doi: 10.1016/j.ahj.2019.03.013. Epub 2019 Apr 11.

ReferenceCitation: Corbalan R, Bassand JP, Illingworth L, Ambrosio G, Camm AJ, Fitzmaurice DA, Fox KAA, Goldhaber SZ, Goto S, Haas S, Kayani G, Mantovani LG, Misselwitz F, Pieper KS, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Analysis of Outcomes in Ischemic vs Nonischemic Cardiomyopathy in Patients With Atrial Fibrillation: A Report From the GARFIELD-AF Registry. JAMA Cardiol. 2019 Jun 1;4(6):526-548. doi: 10.1001/jamacardio.2018.4729.

ReferenceCitation: Jerjes-Sanchez C, Corbalan R, Barretto ACP, Luciardi HL, Allu J, Illingworth L, Pieper KS, Kayani G; GARFIELD-AF Investigators. Stroke prevention in patients from Latin American countries with non-valvular atrial fibrillation: Insights from the GARFIELD-AF registry. Clin Cardiol. 2019 May;42(5):553-560. doi: 10.1002/clc.23176. Epub 2019 Apr 9.

ReferenceCitation: Goto S, Angchaisuksiri P, Bassand JP, Camm AJ, Dominguez H, Illingworth L, Gibbs H, Goldhaber SZ, Goto S, Jing ZC, Haas S, Kayani G, Koretsune Y, Lim TW, Oh S, Sawhney JPS, Turpie AGG, van Eickels M, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Management and 1-Year Outcomes of Patients With Newly Diagnosed Atrial Fibrillation and Chronic Kidney Disease: Results From the Prospective GARFIELD - AF Registry. J Am Heart Assoc. 2019 Feb 5;8(3):e010510. doi: 10.1161/JAHA.118.010510.

ReferenceCitation: Bassand JP, Virdone S, Goldhaber SZ, Camm AJ, Fitzmaurice DA, Fox KAA, Goto S, Haas S, Hacke W, Kayani G, Mantovani LG, Misselwitz F, Pieper KS, Turpie AGG, van Eickels M, Verheugt FWA, Kakkar AK. Early Risks of Death, Stroke/Systemic Embolism, and Major Bleeding in Patients With Newly Diagnosed Atrial Fibrillation. Circulation. 2019 Feb 5;139(6):787-798. doi: 10.1161/CIRCULATIONAHA.118.035012.

ReferenceCitation: Sawhney JP, Kothiwale VA, Bisne V, Durgaprasad R, Jadhav P, Chopda M, Vanajakshamma V, Meena R, Vijayaraghavan G, Chawla K, Allu J, Pieper KS, John Camm A, Kakkar AK; GARFIELD-AF Investigators. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry. Indian Heart J. 2018 Nov - Dec;70(6):828-835. doi: 10.1016/j.ihj.2018.09.001. Epub 2018 Sep 12.

ReferenceCitation: Cools F, Wollaert B, Vervoort G, Verstraete S, Voet J, Hermans K, Heyse A, De Wolf A, Hollanders G, Boussy T, Anné W, Vercammen J, Faes D, Beutels M, Mairesse G, Purnode P, Blankoff I, Vandergoten P, Capiau L, Allu J, Bassand JP, Kayani G; GARFIELD-AF Investigators. Treatment patterns in anticoagulant therapy in patients with newly diagnosed atrial fibrillation in Belgium: results from the GARFIELD-AF registry. Acta Cardiol. 2019 Aug;74(4):309-318. doi: 10.1080/00015385.2018.1494089. Epub 2018 Oct 27.

ReferenceCitation: Bassand JP, Accetta G, Al Mahmeed W, Corbalan R, Eikelboom J, Fitzmaurice DA, Fox KAA, Gao H, Goldhaber SZ, Goto S, Haas S, Kayani G, Pieper K, Turpie AGG, van Eickels M, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Risk factors for death, stroke, and bleeding in 28,628 patients from the GARFIELD-AF registry: Rationale for comprehensive management of atrial fibrillation. PLoS One. 2018 Jan 25;13(1):e0191592. doi: 10.1371/journal.pone.0191592. eCollection 2018.

ReferenceCitation: Apenteng PN, Gao H, Hobbs FR, Fitzmaurice DA; UK GARFIELD-AF Investigators and GARFIELD-AF Steering Committee. Temporal trends in antithrombotic treatment of real-world UK patients with newly diagnosed atrial fibrillation: findings from the GARFIELD-AF registry. BMJ Open. 2018 Jan 13;8(1):e018905. doi: 10.1136/bmjopen-2017-018905.

ReferenceCitation: Verheugt FWA, Gao H, Al Mahmeed W, Ambrosio G, Angchaisuksiri P, Atar D, Bassand JP, Camm AJ, Cools F, Eikelboom J, Kayani G, Lim TW, Misselwitz F, Pieper KS, van Eickels M, Kakkar AK; GARFIELD-AF Investigators. Characteristics of patients with atrial fibrillation prescribed antiplatelet monotherapy compared with those on anticoagulants: insights from the GARFIELD-AF registry. Eur Heart J. 2018 Feb 7;39(6):464-473. doi: 10.1093/eurheartj/ehx730.

ReferenceCitation: Fox KAA, Lucas JE, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Kayani G, Oto A, Mantovani LG, Misselwitz F, Piccini JP, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation. BMJ Open. 2017 Dec 21;7(12):e017157. doi: 10.1136/bmjopen-2017-017157.

ReferenceCitation: Fox KAA, Accetta G, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Kayani G, Kakkar AK; GARFIELD-AF Investigators. Why are outcomes different for registry patients enrolled prospectively and retrospectively? Insights from the global anticoagulant registry in the FIELD-Atrial Fibrillation (GARFIELD-AF). Eur Heart J Qual Care Clin Outcomes. 2018 Jan 1;4(1):27-35. doi: 10.1093/ehjqcco/qcx030.

ReferenceCitation: Camm AJ, Accetta G, Al Mahmeed W, Ambrosio G, Goldhaber SZ, Haas S, Jansky P, Kayani G, Misselwitz F, Oh S, Oto A, Raatikainen P, Steffel J, van Eickels M, Kakkar AK; GARFIELD-AF Investigators. Impact of gender on event rates at 1 year in patients with newly diagnosed non-valvular atrial fibrillation: contemporary perspective from the GARFIELD-AF registry. BMJ Open. 2017 Mar 6;7(3):e014579. doi: 10.1136/bmjopen-2016-014579.

ReferenceCitation: Haas S, Ten Cate H, Accetta G, Angchaisuksiri P, Bassand JP, Camm AJ, Corbalan R, Darius H, Fitzmaurice DA, Goldhaber SZ, Goto S, Jacobson B, Kayani G, Mantovani LG, Misselwitz F, Pieper K, Schellong SM, Stepinska J, Turpie AG, van Eickels M, Kakkar AK; GARFIELD-AF Investigators. Quality of Vitamin K Antagonist Control and 1-Year Outcomes in Patients with Atrial Fibrillation: A Global Perspective from the GARFIELD-AF Registry. PLoS One. 2016 Oct 28;11(10):e0164076. doi: 10.1371/journal.pone.0164076. eCollection 2016.

ReferenceCitation: Camm AJ, Accetta G, Ambrosio G, Atar D, Bassand JP, Berge E, Cools F, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Kayani G, Koretsune Y, Mantovani LG, Misselwitz F, Oh S, Turpie AG, Verheugt FW, Kakkar AK; GARFIELD-AF Investigators. Evolving antithrombotic treatment patterns for patients with newly diagnosed atrial fibrillation. Heart. 2017 Feb 15;103(4):307-314. doi: 10.1136/heartjnl-2016-309832. Epub 2016 Sep 19.

ReferenceCitation: Oh S, Goto S, Accetta G, Angchaisuksiri P, Camm AJ, Cools F, Haas S, Kayani G, Koretsune Y, Lim TW, Misselwitz F, van Eickels M, Kakkar AK; GARFIELD-AF Investigators. Vitamin K antagonist control in patients with atrial fibrillation in Asia compared with other regions of the world: Real-world data from the GARFIELD-AF registry. Int J Cardiol. 2016 Nov 15;223:543-547. doi: 10.1016/j.ijcard.2016.08.236. Epub 2016 Aug 13.

ReferenceCitation: Bassand JP, Accetta G, Camm AJ, Cools F, Fitzmaurice DA, Fox KA, Goldhaber SZ, Goto S, Haas S, Hacke W, Kayani G, Mantovani LG, Misselwitz F, Ten Cate H, Turpie AG, Verheugt FW, Kakkar AK; GARFIELD-AF Investigators. Two-year outcomes of patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF. Eur Heart J. 2016 Oct 7;37(38):2882-2889. Epub 2016 Jun 29.

ReferenceCitation: Lip GY, Rushton-Smith SK, Goldhaber SZ, Fitzmaurice DA, Mantovani LG, Goto S, Haas S, Bassand JP, Camm AJ, Ambrosio G, Janský P, Al Mahmeed W, Oh S, van Eickels M, Raatikainen P, Steffel J, Oto A, Kayani G, Accetta G, Kakkar AK; GARFIELD-AF Investigators. Does sex affect anticoagulant use for stroke prevention in nonvalvular atrial fibrillation? The prospective global anticoagulant registry in the FIELD-Atrial Fibrillation. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2 Suppl 1):S12-20. doi: 10.1161/CIRCOUTCOMES.114.001556. Epub 2015 Feb 24.

lead_sponsor: Thrombosis Research Institute

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
India
Turkey
Mexico
Norway
Singapore
Sweden
Egypt
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Finland
Thailand
Korea, Republic of
France
Chile
Netherlands
United Arab Emirates

location_facility: Prof. Seil Oh, National Coordinating Investigator, National University Hospital

location_facility: Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital

location_facility: Prof. Barry Jacobson, National Coordinating Investigator, University of the Witwatersrand

location_facility: Dr Matyas Keltai, National Coordinating Investigator, Hungarian Institute of Cardiology

location_facility: Dr Antonio Barretto, National Coordinating Investigator, Hospital Santa Marcelina,

location_facility: Professor Dan Atar, National Coordinating Investigator, Oslo University Hospital

location_facility: Prof Joern Dalsgaard Nielsen, National Coordinating Investigator, Bispebjerg & Frederiksberg Hospitals

location_facility: Professor Ali Oto, National Coordinating Investigator, Memorial Ankara Hospital

location_facility: Dr Jan Steffel, National Coordinating Investigator, University Hospital

location_facility: Prof Janina Stępińska, National Coordinating Investigator, Institute of Cardiology, Warsaw

location_facility: Prof. Wael Al Mahmeed, National Coordinating Investigator, SKMC Cardiac Siences

location_facility: Dr Marten Rosenqvist, National Coordinating Investigator, Karolinska Institute

location_facility: Dr Petr Jansky, National Coordinating Investigator, Cardiovaskular Center, Motol Univesity Hospital

location_facility: Dr. Hany Ragy, National Coordinating Investigator, Hayat Hospital

location_facility: Profs Giancarlo Agnelli and Giuseppe Ambrosio, National Coordinating Investigators, University of Perugia

location_facility: Dr Sawney, National Coordinating Investigator, Sir Ganga Ram Hospital, New Delhi

location_facility: Dr Ramon Corbalan, National Coordinating Investigator, Pontifica Universidad Catolica de Chile

location_facility: Dr Hector Luciardi, National Co-ordinating Investigator, National University of Tucuman

location_facility: Prof Stuart Connolly and Dr John Eikelboom, National Coodinating Investigators, Mc Master University

location_facility: Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou

location_facility: Prof Harald Darius, National oordinating Investigator, Vivantes Klinikum Neukölln

location_facility: Professor Elizaveta Panchenko, National Coordinating Investigator, Cardiology Research and Production Center

location_facility: Prof. Pantep Angchaisuksiri, National Coordinating Investigator, Ramathibodi Hospital, Mahidol University

location_facility: Dr Carlos Jerjes Sanchez Diaz, National Coordinating Investigator,Tecnologico de Monterrey

location_facility: Dr Xavier Vinolas, National Coordinating Investigator, Hospital Santa Creu y San Pau

location_facility: Professor Hugo ten Cate, National Coordinating Investigator, Cardiovascular Research Institute Maastricht

location_facility: Prof. David Fitzmaurice, National Coordinating Investigator, University of Warwick

location_facility: Prof Zin-Cheng, National Coordinating Investigator, Peking Union Medical College & Chinese Academy Medical Sciences People Hospital

location_facility: Prof Pekka Raatikainen, National Coordinating Investigator, Univesrsity of Tampere

location_facility: Prof. Alexandr Parkhomenko, National Coordinating Investigator, Strazhesko Institute of Cardiology

location_facility: Professor Yukihiro Koretsune, National Coordinating Investigator, Osaka National Hospital

location_facility: Dr Frank Cools, National Co-ordinating Investigator, AZ Klina

location_facility: Dr Toon Wei Lim, National Coordinating Investigator, National University Hospital

location_facility: Marianne Brodmann: National Co-ordinating Investigator, Medizinische Universität Graz

status_simplified: Completed


title: A Large, International, Placebo-controlled, Factorial Trial to Assess the Impact of Clonidine and Acetyl-salicylic Acid (ASA) in Patients Undergoing Noncardiac Surgery Who Are at Risk of a Perioperative Cardiovascular Event

summary: Major surgeries not involving the heart are common, and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested. There is encouraging data suggesting that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine can prevent heart attacks and deaths from heart problems around the time of surgery.

primary_purpose: Prevention

ReferenceCitation: Devereaux PJ, Mrkobrada M, Sessler DI, Leslie K, Alonso-Coello P, Kurz A, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, VanHelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Baigent C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.1056/NEJMoa1401105. Epub 2014 Mar 31.

ReferenceCitation: Devereaux PJ, Sessler DI, Leslie K, Kurz A, Mrkobrada M, Alonso-Coello P, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, Vanhelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Clonidine in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1504-13. doi: 10.1056/NEJMoa1401106. Epub 2014 Mar 31.

ReferenceCitation: Garg AX, Kurz A, Sessler DI, Cuerden M, Robinson A, Mrkobrada M, Parikh C, Mizera R, Jones PM, Tiboni M, Rodriguez RG, Popova E, Rojas Gomez MF, Meyhoff CS, Vanhelder T, Chan MT, Torres D, Parlow J, de Nadal Clanchet M, Amir M, Bidgoli SJ, Pasin L, Martinsen K, Malaga G, Myles P, Acedillo R, Roshanov P, Walsh M, Dresser G, Kumar P, Fleischmann E, Villar JC, Painter T, Biccard B, Bergese S, Srinathan S, Cata JP, Chan V, Mehra B, Leslie K, Whitlock R, Devereaux PJ; POISE-2 Investigators. Aspirin and clonidine in non-cardiac surgery: acute kidney injury substudy protocol of the Perioperative Ischaemic Evaluation (POISE) 2 randomised controlled trial. BMJ Open. 2014 Feb 25;4(2):e004886. doi: 10.1136/bmjopen-2014-004886.

ReferenceCitation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2:CD008834. doi: 10.1002/14651858.CD008834.pub4. Review.

ReferenceCitation: Biccard BM, Sigamani A, Chan MTV, Sessler DI, Kurz A, Tittley JG, Rapanos T, Harlock J, Szalay D, Tiboni ME, Popova E, Vásquez SM, Kabon B, Amir M, Mrkobrada M, Mehra BR, El Beheiry H, Mata E, Tena B, Sabaté S, Zainal Abidin MK, Shah VR, Balasubramanian K, Devereaux PJ. Effect of aspirin in vascular surgery in patients from a randomized clinical trial (POISE-2). Br J Surg. 2018 Nov;105(12):1591-1597. doi: 10.1002/bjs.10925. Epub 2018 Jul 18.

ReferenceCitation: Graham MM, Sessler DI, Parlow JL, Biccard BM, Guyatt G, Leslie K, Chan MTV, Meyhoff CS, Xavier D, Sigamani A, Kumar PA, Mrkobrada M, Cook DJ, Tandon V, Alvarez-Garcia J, Villar JC, Painter TW, Landoni G, Fleischmann E, Lamy A, Whitlock R, Le Manach Y, Aphang-Lam M, Cata JP, Gao P, Terblanche NCS, Ramana PV, Jamieson KA, Bessissow A, Mendoza GR, Ramirez S, Diemunsch PA, Yusuf S, Devereaux PJ. Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery. Ann Intern Med. 2018 Feb 20;168(4):237-244. doi: 10.7326/M17-2341. Epub 2017 Nov 14.

ReferenceCitation: Garg AX, Kurz A, Sessler DI, Cuerden M, Robinson A, Mrkobrada M, Parikh CR, Mizera R, Jones PM, Tiboni M, Font A, Cegarra V, Gomez MF, Meyhoff CS, VanHelder T, Chan MT, Torres D, Parlow J, Clanchet Mde N, Amir M, Bidgoli SJ, Pasin L, Martinsen K, Malaga G, Myles P, Acedillo R, Roshanov PS, Walsh M, Dresser G, Kumar P, Fleischmann E, Villar JC, Painter T, Biccard B, Bergese S, Srinathan S, Cata JP, Chan V, Mehra B, Wijeysundera DN, Leslie K, Forget P, Whitlock R, Yusuf S, Devereaux PJ; POISE-2 Investigators. Perioperative aspirin and clonidine and risk of acute kidney injury: a randomized clinical trial. JAMA. 2014 Dec 3;312(21):2254-64. doi: 10.1001/jama.2014.15284.

ReferenceCitation: Devereaux PJ; POISE-2 Investigators. Rationale and design of the PeriOperative ISchemic Evaluation-2 (POISE-2) trial: an international 2 × 2 factorial randomized controlled trial of acetyl-salicylic acid vs. placebo and clonidine vs. placebo in patients undergoing noncardiac surgery. Am Heart J. 2014 Jun;167(6):804-9.e4. doi: 10.1016/j.ahj.2014.01.007. Epub 2014 Feb 22.

ReferenceCitation: Chludzinski A, Irani C, Mascha EJ, Kurz A, Devereaux PJ, Sessler DI. Protocol understanding and anxiety in perioperative clinical trial patients approached for consent on the day of surgery. Mayo Clin Proc. 2013 May;88(5):446-54. doi: 10.1016/j.mayocp.2012.12.014.

lead_sponsor: Hamilton Health Sciences Corporation

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
South Africa
Hong Kong
Austria
Australia
Argentina
India
Malaysia
Brazil
Canada
Switzerland
Germany
Denmark
New Zealand
France
Chile
Colombia
Pakistan

location_facility: National Coordination Office Australia and New Zealand


title: Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study

summary: The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.

lead_sponsor: Medtronic

location_country:
Denmark
Spain
Italy
Austria
Australia
Netherlands
Canada
Switzerland
Former Serbia and Montenegro
Sweden
United States
France
Belgium
Germany


title: Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study

summary: Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).

time_perspective: Other

location_country:
Denmark
Serbia
Spain
Italy
Austria
Australia
Netherlands
Canada
Switzerland
Sweden
United States
France
Belgium
Germany


title: An Extension Treatment Protocol for Subjects Who Have Participated in a Phase 3 Study of Tivozanib vs. Sorafenib in Renal Cell Carcinoma (Protocol AV-951-09-301).

lead_sponsor: AVEO Pharmaceuticals, Inc.

source: euctr

design_allocation: Non-Randomized

location_country:
Poland
Serbia
United Kingdom
Italy
Russian Federation
Canada
Ukraine
Hungary
United States
Chile
France
India
Romania
Bulgaria
Czechia

location_facility:
Site 455
Site 440
Site 460
Site 432
Site 498
Site 444
Site 452
Site 431
Site 484
Site 465
Site 185
Site 182
Site 441
Site 496
Site 172
Site 110
Site 123
Site 402
Site 404
Site 156
Site 494
Site 454
Site 450
Site 464
Site 161
Site 491
Site 462
Site 443
Site 459
Site 434
Site 466
Site 422
Site 463
Site 150
Site 442
Site 492
Site 497
Site 461
Site 160
Site 436
Site 151
Site 481
Site 456
Site 162
Site 433
Site 451
Site 401
Site 411
Site 184
Site 122
Site 153
Site 152
Site 457
Site 493
Site 403
Site 435
Site 154
Site 430
Site 483
Site 490
Site 170
Site 191
Site 482
Site 158
Site 480
Site 133
Site 187
Site 453
Site 467
Site 495
Site 421
Site 186
Site 458
Site 423
Site 400

summary: Open-label, multi-center extension treatment protocol to allow access to tivozanib and sorafenib for subjects who have participated on the AV-951-09-301 protocol. Eligible subjects who were randomized to receive sorafenib on AV-951-09-301 and had documented progression of disease will receive a tivozanib dose of 1.5 mg/day. Eligible subjects who were randomized to tivozanib or sorafenib in AV-951-09-301, and displayed clinical benefit and acceptable tolerability to treatment, will continue to receive tivozanib or sorafenib at the same dose and schedule as in AV-951-09-301.


title: Validation of Dyskinesia Rating Scales

summary:
This study will evaluate the responsiveness of a variety of available dyskinesia rating scales to treatment with amantadine or placebo in Parkinson's disease patients with dyskinesia. The study will be a parallel, double-blind, randomized trial of 68 patients treated with amantadine or placebo for 8 weeks. Pre-treatment evaluations will be performed and compared to end of study evaluations on the best treatment dose (200 or 300 mg amantadine or matching placebo) daily. Safety evaluations will be conducted.

The responsiveness of the different scales will be evaluated statistically with a mixed model in which changes in the outcome measures over time will include a fixed effect of treatment group assignment. The model will additionally account for random effects of intercepts (the scale scores at baseline) that will include both random variation (person-specific) and specific variation associated with rate of change in outcome. The investigators may include adjustments for possible confounding covariates, including baseline demographics and center. The goal of the program is to provide researchers with the best scale(s) to distinguish dyskinesia change in Parkinson's disease (PD) associated with amantadine in comparison to placebo and to establish the magnitude of effect achievable with amantadine as a comparator "gold standard" that must be met or surpassed by future anti-dyskinetic agents. Additionally, with the use of paper and pencil questionnaires, the study will investigate the impact of patient optimism and patient and rater expectation of positive effects on the dyskinesia rating outcomes.

lead_sponsor: Rush University Medical Center

location_country:
Austria
United States
Canada
France

location_facility: Oregon Health & Science University (OHSU)

location_facility: Centre d'investigation Clinique, CHU de Toulouse

location_facility: Toronto Western Hospital (Movement Disorder Center)

lead_sponsor_type: academique


title: ACR/EULAR Endorsed Study to Develop New Diagnostic and Classification Criteria for Primary Systemic Vasculitis

acronym: DCVAS

summary:
Vasculitis is group of diseases where inflammation of blood vessels is the common feature. Patients typically present with fever, fatigue, weakness and muscle and joint aches. These symptoms are very common among many different diseases, not just vasculitis. A clustering of other symptoms, physical examination findings, blood tests, radiology and biopsy help make the diagnosis. There are currently no criteria to help doctors make a diagnosis of vasculitis when a patient presents with these non specific symptoms and they are reliant on previous experience and disease definitions. One of the aims of this project is to develop diagnostic criteria for the primary systemic vasculitides (granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, Churg Strauss syndrome, polyarteritis nodosa, giant cell arteritis, Takayasu arteritis). We, the investigators, will do this by studying a large group of patients with vasculitis and comparing them to a large group of patients that present in a similar way, but do not have vasculitis. By comparing the 2 groups we will create a list of items to differentiate between vasculitis and 'vasculitis mimics'.

We also aim to update the current classification criteria. Classification criteria are used to group patients into different types of vasculitis, once a diagnosis of vasculitis has been made, and are useful for studying patients in clinical trials with similar or identical diseases. The current classification criteria (American college of Rheumatology 1990 criteria) were developed 20 years ago, before the availability of some important diagnostic tests (e.g. antineutrophil cytoplasmic antibodies [ANCA]), and are now not consistent with some of the current disease definitions. Therefore to progress future research in vasculitis, it is important that the classification criteria are updated. We will recruit 260 patients with each of the 6 types of vasculitis and compare them with 1300 controls (patients with the 5 other types of vasculitis), in order to determine the optimal combination of symptoms, signs and investigations that classify each person into the appropriate group.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Singh JA, Solomon DH, Dougados M, Felson D, Hawker G, Katz P, Paulus H, Wallace C; Classification and Response Criteria Subcommittee of the Committee on Quality Measures, American College of Rheumatology. Development of classification and response criteria for rheumatic diseases. Arthritis Rheum. 2006 Jun 15;55(3):348-52.

ReferenceCitation: Rao JK, Allen NB, Pincus T. Limitations of the 1990 American College of Rheumatology classification criteria in the diagnosis of vasculitis. Ann Intern Med. 1998 Sep 1;129(5):345-52.

ReferenceCitation: Hunder GG, Arend WP, Bloch DA, Calabrese LH, Fauci AS, Fries JF, Leavitt RY, Lie JT, Lightfoot RW Jr, Masi AT, et al. The American College of Rheumatology 1990 criteria for the classification of vasculitis. Introduction. Arthritis Rheum. 1990 Aug;33(8):1065-7.

ReferenceCitation: Fries JF, Hunder GG, Bloch DA, Michel BA, Arend WP, Calabrese LH, Fauci AS, Leavitt RY, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of vasculitis. Summary. Arthritis Rheum. 1990 Aug;33(8):1135-6.

ReferenceCitation: Jennette JC, Falk RJ, Andrassy K, Bacon PA, Churg J, Gross WL, Hagen EC, Hoffman GS, Hunder GG, Kallenberg CG, et al. Nomenclature of systemic vasculitides. Proposal of an international consensus conference. Arthritis Rheum. 1994 Feb;37(2):187-92. Review.

ReferenceCitation: Sørensen SF, Slot O, Tvede N, Petersen J. A prospective study of vasculitis patients collected in a five year period: evaluation of the Chapel Hill nomenclature. Ann Rheum Dis. 2000 Jun;59(6):478-82.

ReferenceCitation: Felson DT, Anderson JJ. Methodological and statistical approaches to criteria development in rheumatic diseases. Baillieres Clin Rheumatol. 1995 May;9(2):253-66. Review.

ReferenceCitation: Yates M, MacGregor AJ, Robson J, Craven A, Merkel PA, Luqmani RA, Watts RA. The association of vascular risk factors with visual loss in giant cell arteritis. Rheumatology (Oxford). 2017 Apr 1;56(4):524-528. doi: 10.1093/rheumatology/kew397.

lead_sponsor: University of Oxford

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
India
Turkey
Mexico
Norway
Sweden
Egypt
Sri Lanka
Canada
Switzerland
Hungary
China
Germany
Denmark
Ireland
New Zealand
Finland
Czech Republic
Korea, Republic of
France
Netherlands

location_facility: New York University Langone Medical Centre

location_facility: University of Manchester, Manchester Royal Infirmary

location_facility: University of Debrecen Medical and Health Science Center

location_facility: Vasculitis Center, Boston University School of Medicine

location_facility: Nottingham University Hospitals NHS Trust (QMC)

location_facility: NHS Fife, Whyteman's Brae Hospital, Windygates

location_facility: The University Hospital of Northern Norway, Tromsø

location_facility: NHS Greater Glasgow & Clyde, Gartnavel Hospital

location_facility: St. Vincent's University Hospital, Dublin

location_facility: Epsom and St Helier University Hospitals NHS Trust

location_facility: Basildon and Thurrock University Hospitals NHS Foundation Trust

location_facility: Ramos Mejia Hospital, University of Buenos Aires

location_facility: Cochin Hospital, Université Paris-descartes

location_facility: Christian Medical College & Hospital, Vellore

location_facility: Istanbul University, Istanbul Medical School

location_facility: University of Michigan, Internal Medicine

location_facility: Southampton University Hospitals NHS Trust

location_facility: North Cumbria University Hospitals, The Cumberland Infirmary

location_facility: Istanbul University, Cerrahpasa Medical School

location_facility: Dartmouth-Hitchcock Medical Centre, Lebanon, NH

location_facility: Heatherwood & Wexham Park Hospitals NHS Foundation Trust

location_facility: Postgraduate Institute of Medical Education and Research, Chandigarh

location_facility: Waitemata District Health Board, North Shore Hospital

location_facility: Peking Union Medical College Hospital, Beijing

location_facility: Haydarpasa Education and Research Hospital

location_facility: Nizam's Institute of Medical Sciences, Hyderabad

location_facility: Assiut University, Assiut University Hospitals

location_facility: Oxford University Hospitals NHS Trust (The Churchill Hospital)

location_facility: Instituto Nacional de Enfermedades Respiratorias

location_facility: Santa Maria Nuova Hospital, Reggio Emilia

location_facility: Chatrapathi Shahuji Maharaj Medical Center, Lucknow (IProcess)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital


title: A Single Blind, Multi-centre, Randomised Multinational Phase III Study to Compare the Efficacy and Tolerability of Anagrelide vs Hydroxyurea in Patients With Essential Thrombocythaemia

acronym: ANAHYDRET

summary:
Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was not inferior to HU with respect to efficacy in patients with ET. This approach to demonstrate non-inferiority was based on the following decision points:

• ET is a rare disease and recruitment of large patient number (> 1600) to prove superiority was not considered possible.

. It was decided to recruit only treatment naïve high risk patients to avoid pre-treatment bias, which further limited the number of patients eligible for the study.

ReferenceCitation: Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. doi: 10.1182/blood-2012-07-443770. Epub 2013 Jan 11.

lead_sponsor: AOP Orphan Pharmaceuticals AG

location_country:
Poland
Slovenia
Italy
Austria
Lithuania
Czech Republic
Hungary
France
Singapore
Germany

location_facility:
Center Warszawa
Center Saarbrücken
Center Berlin
Center Halle
Center AKH
Center Singapore
Center Vilnius
Center Praha
Center Ljubljana
Center Lublin
Center Ulm
Center Brno
Center Katowice
Center Lodz
Center Innsbruck
Center Paris
Center Krakow
Center Pavia
Center Munich
Center Olomouc
Center Modena
Center Hanusch
Center Budapest
Center Gdansk


title: ADenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination: the ADVICE Trial

acronym: ADVICE

summary: Atrial fibrillation (AF) is the most common heart rhythm disorder, impairs quality of life and increases stroke risk and mortality. Despite advances in medical treatment, AF remains uncontrolled in many patients. In many patients, AF is initiated by abnormal electrical impulses from the pulmonary veins. A catheter ablation procedure called pulmonary vein isolation (PVI) has therefore been developed, using heat to isolate the PV foci from the heart. PVI is very effective, but must be repeated in up to 50% of cases because the foci isolation is not permanent after initial PVI. The intravenous administration of a drug called adenosine during the PVI procedure can unmask residual conduction that would otherwise remain unnoticed, so-called "dormant conduction". In our experience, additional ablation guided by adenosine reduces AF recurrence and the need for a repeat PVI procedure. However, the adenosine-guided approach has not yet been proven as standard therapy. The present study, to be conducted at 15 clinical centres in Canada, Europe and Australia is therefore intended to evaluate the efficacy of adenosine-guided ablation to prevent AF recurrence. Five hundred twenty-six patients will be included in the study, which should be completed within 2 years. In all patients, the presence of dormant conduction will be tested with adenosine during PVI. If dormant conduction is observed, additional ablation will be performed in half of these patients selected randomly. If there is no dormant conduction, randomly selected patients will be followed in a registry. If the adenosine-guided approach is demonstrated to improve the success rate of PVI procedures, it should become the standard approach for a "permanent cure" of AF, and therefore benefit patients by reducing arrhythmia recurrence, hospitalizations and the need for repeat interventions.

ReferenceCitation: Willems S, Khairy P, Andrade JG, Hoffmann BA, Levesque S, Verma A, Weerasooriya R, Novak P, Arentz T, Deisenhofer I, Rostock T, Steven D, Rivard L, Guerra PG, Dyrda K, Mondesert B, Dubuc M, Thibault B, Talajic M, Roy D, Nattel S, Macle L; ADVICE Trial Investigators*. Redefining the Blanking Period After Catheter Ablation for Paroxysmal Atrial Fibrillation: Insights From the ADVICE (Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination) Trial. Circ Arrhythm Electrophysiol. 2016 Aug;9(8). pii: e003909. doi: 10.1161/CIRCEP.115.003909.

ReferenceCitation: Macle L, Khairy P, Weerasooriya R, Novak P, Verma A, Willems S, Arentz T, Deisenhofer I, Veenhuyzen G, Scavée C, Jaïs P, Puererfellner H, Levesque S, Andrade JG, Rivard L, Guerra PG, Dubuc M, Thibault B, Talajic M, Roy D, Nattel S; ADVICE trial investigators. Adenosine-guided pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation: an international, multicentre, randomised superiority trial. Lancet. 2015 Aug 15;386(9994):672-9. doi: 10.1016/S0140-6736(15)60026-5. Epub 2015 Jul 23.

ReferenceCitation: Andrade JG, Pollak SJ, Monir G, Khairy P, Dubuc M, Roy D, Talajic M, Deyell M, Rivard L, Thibault B, Guerra PG, Nattel S, Macle L. Pulmonary vein isolation using a pace-capture-guided versus an adenosine-guided approach: effect on dormant conduction and long-term freedom from recurrent atrial fibrillation--a prospective study. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1103-8. doi: 10.1161/CIRCEP.113.000454. Epub 2013 Oct 4. Erratum in: Circ Arrhythm Electrophysiol. 2015 Feb;8(1):247.

ReferenceCitation: Macle L, Khairy P, Verma A, Weerasooriya R, Willems S, Arentz T, Novak P, Veenhuyzen G, Scavée C, Skanes A, Puererfellner H, Jaïs P, Khaykin Y, Rivard L, Guerra PG, Dubuc M, Thibault B, Talajic M, Roy D, Nattel S; ADVICE Study Investigators. Adenosine following pulmonary vein isolation to target dormant conduction elimination (ADVICE): methods and rationale. Can J Cardiol. 2012 Mar-Apr;28(2):184-90. doi: 10.1016/j.cjca.2011.10.008. Epub 2012 Jan 2.

lead_sponsor: Montreal Heart Institute

location_country: Austria Australia Canada France Belgium Germany

location_facility: Centre hospitalier universitaire de Sherbrooke

location_facility: McMaster University and Hamilton Health Sciences

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec


title: A Phase II, Multi-center, Non-randomized, Open-label Study of TKI258 in Patients With Relapsed or Refractory Multiple Myeloma, Who Are With or Without t(4;14) Translocation

ReferenceCitation: Scheid C, Reece D, Beksac M, Spencer A, Callander N, Sonneveld P, Kalimi G, Cai C, Shi M, Scott JW, Stewart AK. Phase 2 study of dovitinib in patients with relapsed or refractory multiple myeloma with or without t(4;14) translocation. Eur J Haematol. 2015 Oct;95(4):316-24. doi: 10.1111/ejh.12491. Epub 2015 Jan 22.

location_country:
Australia
Netherlands
Canada
United States
France
Turkey
Germany

location_facility: St. Jude Heritage Medical Group Virginia Crosson Cancer Center

location_facility: Central Hematology Oncology Medical Group

location_facility: Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2

location_facility: Cancer Centers of the Carolinas Dept. of CC of the Carolinas

location_facility: Medical College of Wisconsin Med College of Wisconsin

location_facility: Duke University Medical Center Dept. of DUMC (4)

location_facility: University of Tennessee Cancer Institute SC-2

location_facility: University of Texas Southwestern Medical Center UTSW Medical Center

location_facility: Memorial Sloan Kettering Cancer Center MSKCC

location_facility: Central Coast Medical Oncology Corporation

location_facility: University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.

location_facility: Kootenai Medical Center Kootenai Medical Center

summary: This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma


title: A Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple Sclerosis

acronym: SURPASS

summary: This was a multicenter, randomized, open-label, parallel-group, active-controlled study. Prior to randomization, participants were to have been treated with glatiramer acetate or interferon β-1a (44 μg). Participants were to be randomized to receive natalizumab, interferon β-1a 44 μg, or glatiramer acetate.

lead_sponsor: Biogen

location_country:
Poland
Slovenia
Italy
Latvia
Australia
Spain
Finland
Czech Republic
Canada
Hungary
United States
France
Sweden


title: Retrospective Observational Study Of Subjects With Cytokine-Refractory Metastatic Renal Cancer Treated With Axitinib (AG-013736) To Estimate 5-Yr Survival

summary: The primary objective of this observational study is to retrospectively collect current survival data for patients originally included in axitinib A4061012 [NCT00076011] study to estimate the 5-year survival rate in subjects with metastatic renal cancer cell treated with axitinib.

time_perspective: Retrospective

lead_sponsor: Pfizer

location_country:
Germany
United States
France


title: Spinal Cord Stimulation With Precision® Spinal Cord Stimulation System Versus Reoperation for Failed Back Surgery Syndrome

acronym: Evidence

summary: The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as persistent or recurrent pain following one or more lumbosacral spine surgical procedures. Surgical procedures that can result in FBSS can be categorized as either decompression or decompression followed by fusion with or without instrumentation. The pain of FBSS is categorized as neuropathic, which involves pathological nerve activity and is commonly characterized by patients as shooting or burning and/or nociceptive, which signals actual or impending tissue damage or inflammation.

lead_sponsor: Boston Scientific Corporation

location_country:
United Kingdom
United States
Canada
France

location_facility: The University of Illinois Medical Center


type: Other Identifier

title: Open-Label Extension for Alzheimer's Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)

acronym: Identity XT

summary:
The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0 of this study (LFBF).

Preliminary results from LFAN and LFBC showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC and LFBF have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.

lead_sponsor: Eli Lilly and Company

location_country:
Poland
Spain
Italy
Australia
Finland
Canada
Sweden
United States
Chile
France
Israel
South Africa
Japan
Germany

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 Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures

summary: The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.

ReferenceCitation: Devière J, Nageshwar Reddy D, Püspök A, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, González-Huix Lladó F, Barkun AN, Kortan PP, Navarrete C, Peetermans J, Blero D, Lakhtakia S, Dolak W, Lepilliez V, Poley JW, Tringali A, Costamagna G; Benign Biliary Stenoses Working Group. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Gastroenterology. 2014 Aug;147(2):385-95; quiz e15. doi: 10.1053/j.gastro.2014.04.043. Epub 2014 May 4.

ReferenceCitation: Poley JW, Ponchon T, Puespoek A, Bruno M, Roy A, Peetermans J, Rousseau M, Lépilliez V, Dolak W, Tringali A, Blero D, Carr-Locke D, Costamagna G, Devière J; Benign Biliary Stenoses Working Group. Fully covered self-expanding metal stents for benign biliary stricture after orthotopic liver transplant: 5-year outcomes. Gastrointest Endosc. 2020 Dec;92(6):1216-1224. doi: 10.1016/j.gie.2020.04.078. Epub 2020 May 15.

ReferenceCitation: Tringali A, Reddy DN, Ponchon T, Neuhaus H, Lladó FG, Navarrete C, Bruno MJ, Kortan PP, Lakhtakia S, Peetermans J, Rousseau M, Carr-Locke D, Devière J, Costamagna G; Benign Biliary Stenoses Working Group. Treatment of post-cholecystectomy biliary strictures with fully-covered self-expanding metal stents - results after 5 years of follow-up. BMC Gastroenterol. 2019 Dec 12;19(1):214. doi: 10.1186/s12876-019-1129-3.

ReferenceCitation: Lakhtakia S, Reddy N, Dolak W, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, González-Huix Lladó F, Kortan PP, Peetermans J, Rousseau M, Costamagna G, Devière J; Benign Biliary Stenoses Working Group. Long-term outcomes after temporary placement of a self-expanding fully covered metal stent for benign biliary strictures secondary to chronic pancreatitis. Gastrointest Endosc. 2020 Feb;91(2):361-369.e3. doi: 10.1016/j.gie.2019.08.037. Epub 2019 Sep 5.

location_country: Spain Italy Austria Australia Netherlands Canada France Chile India Belgium Germany

location_facility: Università Cattolica del Sacro Cuore Policlinico A. Gemelli

location_facility: Hospital Universitari Doctor Josep Trueta

location_facility: Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital

intervention_type: Device


title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple Sclerosis

summary: This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

ReferenceCitation: Olsson T, Boster A, Fernández Ó, Freedman MS, Pozzilli C, Bach D, Berkani O, Mueller MS, Sidorenko T, Radue EW, Melanson M. Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1198-208. doi: 10.1136/jnnp-2013-307282. Epub 2014 Mar 21.

ReferenceCitation: Gisleskog PO, Valenzuela B, Scherz T, Burcklen M, Pérez-Ruixo JJ, Poggesi I. An Exposure-Response Analysis of the Clinical Efficacy of Ponesimod in a Randomized Phase II Study in Patients with Multiple Sclerosis. Clin Pharmacokinet. 2021 Sep;60(9):1227-1237. doi: 10.1007/s40262-021-01020-2. Epub 2021 Apr 29.

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Sweden
Canada
Switzerland
Hungary
Germany
Bulgaria
Finland
France
Netherlands

location_facility:
Clinical Investigative Site 2104
Clinical Investigative Site 3118
Clinical Investigative Site 2706
Clinical Investigative Site 3133
Clinical Investigative Site # 3201
Clinical Investigative Site 3127
Clinical Investigative Site 3100
Clinical Investigative Site 3004
Clinical Investigative Site # 1205
Clinical Investigator 3126
Clinical Invesigative Site 3116
Clinical Investigative Site 2302
Clinical Investigative Site 1100
Clinical Investigative Site 2101
Clinical Investigative Site 2802
Clinical Investigative Site 2203
Clinical Investigative Site 3113
Clinical Investigative Site 1000
Clinical Investigative Site 2402
Clinical Investigative Site 1601
Clinical Investigative Site 2105
Clinical Investigative Site 3102
Clinical Investigative Site 1401
Clinical Investigative Site 3125
Clinical Investigative Site 2701
Clinical Investigative Site 2800
Clinical Investigative Site # 3206
Clinical Investigative Site 1600
Clinical Investigative Site 2502
Clinical Investigative Site 2000
Clinical Investigative Site 1701
Clinical Investigative Site 2001
Clinical Investigative Site 3119
Clinical Investigative Site 1101
Clinical Investigative Site 3303
Clinical Investigative Site # 1904
Clinical Investigative Site 1805
Clinical Investigative Site 2801
Clinical Investigative Site 1501
Clinical Investigative Site 1502
Clinical Investigative Site 3300
Clinical Investigative Site 1900
Clinical Investigative Site 2202
Clinical Investigative Site 1504
Clinical Investigative Site 1201
Clinical Investigative Site 3132
Clinical Investigative Site # 2106
Clinical Investigative Site 1603
Clinical Investigative Site 1506
Clinical Investigative Site 1302
Clinical Investigative Site # 1401
Clinical Investigative Site 3304
Clinical Investigative Site 2103
Clinical Investigator 3104
Clinical Investigative Site 2705
Clinical Investigative Site # 3203
Clinical Investigative Site 3112
Clinical Investigative 1807
Clinical Investigative Site 3200
Clinical Investigative Site 1803
Clinical Investigative Site 2702
Clinical Investigative Site # 3204
Clinical Investigative Site 1902
Clinical Investigative Site 2303
Clinical Investigative Site 3115
Clinical Investigative Site 2002
Clinical Investigative Site 2305
Clinical Investigative Site 1602
Clinical Investigative Site 3120
Clinical Investigative Site 3105
Clinical Investigative Site 1908
Clinical Investigative Site 2901
Clinical Investigative Site 2501
Clinical Investigative Site 3107
Clinical Investigative Site 1804
Clinical Investigative Site 2503
Clinical Investigator 3136
Clinical Investigative Site 2900
Clinical Investigative Site 2400
Clinical Investigative Site 1102
Clinical Investigative Site 1204
Clinical Investigative Site 2003
Clinical Investigative Site # 1001
Clinical Investigative Site 3209
Clinical Investigative Site 3117
Clinical Investigative Site 1203
Clinical Investigative Site 1802
Clinical Investigative Site # 3202
Clinical Investigative Site 1500
Clinical Investigative Site 3208
Clinical Investigative Site 2704
Clinical Investigative Site 2700
Clinical Investigative Site 2102
Clinical Investigative Site 1901
Clinical Investigative Site # 3128
Clinical Investigative Site 1304
Clinical Investigative Site 3111
Clinical Investigative Site 3003
Clinical Investigative Site 3002
Clinical Investigative Site 2304
Clinical Investigative Site 1301
Clinical Investigative Site 3130
Clinical Investigative Site # 1806
Clinical Investigative Site 3129
Clinical Investigative site 1800
Clinical Investigative Site 3101
Clinical Investigative Site 2201
Clinical Investigative Site 1400
Clinical Investigative Site 3201
Clinical Investigative Site 1905
Clinical Investigative Site 1303
Clinical Investigative Site # 3135
Clinical Investigative Site 1503
Clinical Investigative Site 3302
Clinical Investigative Site 2401


title: RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)

acronym: RECHARGE

summary: The purpose of this study is to assess the recharge feature of the Activa RC System in patients who are receiving Deep Brain Stimulation (DBS) for Parkinson's Disease (PD), Essential Tremor (ET), or dystonia.

lead_sponsor: MedtronicNeuro

location_country:
Spain
United Kingdom
Austria
United States
France
Germany


title: Patterns of Non-Adherence to Dual Anti-Platelet Regimen In Stented Patients: An Observational Single-Arm Study (The PARIS Registry)

acronym: PARIS

summary: The purpose of this observational research study is to determine when and why patients discontinue, interrupt, or disrupt the regimen of anti-platelet medications prescribed following stent implantation, and to examine the relationship between specific patterns of non-adherence and patient outcomes.

ReferenceCitation: Baber U, Leisman DE, Cohen DJ, Gibson CM, Henry TD, Dangas G, Moliterno D, Kini A, Krucoff M, Colombo A, Chieffo A, Sartori S, Witzenbichler B, Steg PG, Pocock SJ, Mehran R. Tailoring Antiplatelet Therapy Intensity to Ischemic and Bleeding Risk. Circ Cardiovasc Qual Outcomes. 2019 Jan;12(1):e004945. doi: 10.1161/CIRCOUTCOMES.118.004945.

ReferenceCitation: Shah B, Baber U, Pocock SJ, Krucoff MW, Ariti C, Gibson CM, Steg PG, Weisz G, Witzenbichler B, Henry TD, Kini AS, Stuckey T, Cohen DJ, Iakovou I, Dangas G, Aquino MB, Sartori S, Chieffo A, Moliterno DJ, Colombo A, Mehran R. White Blood Cell Count and Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention in the Contemporary Era: Insights From the PARIS Study (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients Registry). Circ Cardiovasc Interv. 2017 Sep;10(9). pii: e004981. doi: 10.1161/CIRCINTERVENTIONS.117.004981.

ReferenceCitation: Baber U, Mehran R, Giustino G, Cohen DJ, Henry TD, Sartori S, Ariti C, Litherland C, Dangas G, Gibson CM, Krucoff MW, Moliterno DJ, Kirtane AJ, Stone GW, Colombo A, Chieffo A, Kini AS, Witzenbichler B, Weisz G, Steg PG, Pocock S. Coronary Thrombosis and Major Bleeding After PCI With Drug-Eluting Stents: Risk Scores From PARIS. J Am Coll Cardiol. 2016 May 17;67(19):2224-2234. doi: 10.1016/j.jacc.2016.02.064. Epub 2016 Apr 11.

ReferenceCitation: Mehran R, Baber U, Steg PG, Ariti C, Weisz G, Witzenbichler B, Henry TD, Kini AS, Stuckey T, Cohen DJ, Berger PB, Iakovou I, Dangas G, Waksman R, Antoniucci D, Sartori S, Krucoff MW, Hermiller JB, Shawl F, Gibson CM, Chieffo A, Alu M, Moliterno DJ, Colombo A, Pocock S. Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study. Lancet. 2013 Nov 23;382(9906):1714-22. doi: 10.1016/S0140-6736(13)61720-1. Epub 2013 Sep 1.

lead_sponsor: Icahn School of Medicine at Mount Sinai

location_country:
Italy
Greece
United States
France
Germany

location_facility: LeBauer Cardiovascular Research Foundation

location_facility: Saint Luke's/ Mid-America Heart Institute


acronym: FIND-CKD

title: An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject High and Low Dosage Regimens) Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease

lead_sponsor: Vifor Pharma

ReferenceCitation: Roger SD, Gaillard CA, Bock AH, Carrera F, Eckardt KU, Van Wyck DB, Cronin M, Meier Y, Larroque S, Macdougall IC; FIND-CKD Study Investigators. Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial. Nephrol Dial Transplant. 2017 Sep 1;32(9):1530-1539. doi: 10.1093/ndt/gfw264.

ReferenceCitation: Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Meier Y, Larroque S, Roger SD; FIND-CKD Study investigators. Renal function in patients with non-dialysis chronic kidney disease receiving intravenous ferric carboxymaltose: an analysis of the randomized FIND-CKD trial. BMC Nephrol. 2017 Jan 17;18(1):24. doi: 10.1186/s12882-017-0444-6.

ReferenceCitation: Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Roubert B, Nolen JG, Roger SD; FIND-CKD Study Investigators. FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant. 2014 Nov;29(11):2075-84. doi: 10.1093/ndt/gfu201. Epub 2014 Jun 2.

location_country:
Denmark
Poland
Portugal
Romania
Spain
Greece
Austria
Australia
Italy
Netherlands
Czech Republic
United Kingdom
Sweden
United States
France
Turkey
Belgium
Norway
Germany

location_facility: Hospital Universitario Marqués de Valdecilla - Servicio de Nefrología

location_facility: Nemocnice s poliklinikou v Novem Jicine, p.o. p.o. Interni oddeleni - nefrologie a dialyza

location_facility: Ospedali Riuniti Anzio-Nettuno ASL ROMA H U.O. Nefrologia e Dialisi

location_facility: Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin IV

location_facility: RHMS Baudour - Department of Nephrology and Dialysis

location_facility: Meander Medisch Centrum - Locatie Amersfoort Lichtenberg

location_facility: Miedzyleski Szpital Spec. Oddzial I Wewnetrzny I Nefrologii

location_facility: Spitalul Clinic de Nefrologie"Dr Carol Davila"

location_facility: Cukurova University Medical Faculty Balcali Hospital - Department of Nephrology

location_facility: Lillebalt Frederica Sygehus Department of Nephrology

location_facility: General Hospital of Arta - Nephrology Department

summary: Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).


title: A Randomized, Double-Blind, Placebo Controlled Multi-Center and Parallel Group Study of the Safety, Tolerability and Efficacy of YM150 in Combination With Standard Treatment in Secondary Prevention of Ischemic Vascular Events in Subjects With Acute Coronary Syndromes

lead_sponsor: Astellas Pharma Europe B.V.

ReferenceCitation: Steg PG, Mehta SR, Jukema JW, Lip GY, Gibson CM, Kovar F, Kala P, Garcia-Hernandez A, Renfurm RW, Granger CB; RUBY-1 Investigators. RUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome. Eur Heart J. 2011 Oct;32(20):2541-54. doi: 10.1093/eurheartj/ehr334. Epub 2011 Aug 30.

location_country:
Ukraine
Romania
South Africa
Belgium
Poland
Russian Federation
Australia
Argentina
India
Mexico
Slovakia
Brazil
Canada
Hungary
Germany
Denmark
Czech Republic
Korea, Republic of
France
Colombia
Netherlands

summary: The purpose of this study is to evaluate the safety and efficacy of various doses of YM150 (the experimental drug) in the prevention of ischemic vascular events in subjects with recent acute coronary syndromes.


title: A Confirmatory, Placebo-controlled, Randomised, Double-blind, Single-dummy, Parallel Group, Ratio-finding Study in Constipated Pain Patients to Establish an Optimal Hydromorphone - Naloxone Ratio With an Improved Bowel Function and a Comparable Analgesic Efficacy Compared to Hydromorphone Alone

summary: The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.

lead_sponsor: Mundipharma Research GmbH & Co KG

location_country:
Denmark
Poland
Romania
United Kingdom
Austria
Australia
Netherlands
Finland
Czech Republic
Switzerland
France
Israel
Belgium
Germany

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Szpital Uniwersytecki w Krakowie Zakład Badania


title: A Phase 2a, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Who Have Chronic HCV-1/HIV-1 Co-Infection and Are Treatment-Naïve for Hepatitis C

summary: The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).

ReferenceCitation: Sulkowski MS, Sherman KE, Dieterich DT, Bsharat M, Mahnke L, Rockstroh JK, Gharakhanian S, McCallister S, Henshaw J, Girard PM, Adiwijaya B, Garg V, Rubin RA, Adda N, Soriano V. Combination therapy with telaprevir for chronic hepatitis C virus genotype 1 infection in patients with HIV: a randomized trial. Ann Intern Med. 2013 Jul 16;159(2):86-96. doi: 10.7326/0003-4819-159-2-201307160-00654.

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Germany
United States
Spain
France

intervention_type: Biological


title: A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL and POETIC

summary: Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.

lead_sponsor: Therapeutic Advances in Childhood Leukemia Consortium

location_country:
Italy
Austria
Australia
Canada
United States
France
Netherlands

location_facility: Children's Hospital New York-Presbyterian

location_facility: Childrens Hospital & Clinics of Minnesota

location_facility: Children's Healthcare of Atlanta, Emory University

location_facility: Levine Children's Hospital at Carolinas Medical Center

location_facility: The Children's Hospital, University of Colorado


title: Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2) NATHAN1 A Randomized, Placebo-controlled, Double-blind Multi-centre Trial With 2 Parallel Groups

summary: To assess clinical efficacy and safety of long-term orally administered thioctic acid in the treatment of diabetic polyneuropathy.

ReferenceCitation: Ziegler D, Low PA, Litchy WJ, Boulton AJ, Vinik AI, Freeman R, Samigullin R, Tritschler H, Munzel U, Maus J, Schütte K, Dyck PJ. Efficacy and safety of antioxidant treatment with α-lipoic acid over 4 years in diabetic polyneuropathy: the NATHAN 1 trial. Diabetes Care. 2011 Sep;34(9):2054-60. doi: 10.2337/dc11-0503. Epub 2011 Jul 20.

lead_sponsor: MEDA Pharma GmbH & Co. KG

location_country:
Denmark
Croatia
Spain
Italy
United Kingdom
Sweden
United States
France
Netherlands

location_facility: East Carolina University, School of Medicine

location_facility: University Clinic for Diabetes, Endocrinology and Metabolic

location_facility: Manchester Royal Infirmary Department of Medicine

location_facility: University of Texas South Western Medical Center

location_facility: Hospital Geriatrico Diabetological Service

location_facility: Health Partners Riverside Neurology Clinic

location_facility: Hospital del Mar Department Neurophysiology

location_facility: University of Missouri Dept. of Neurology

location_facility: University Hospital Utrecht Department of Internal Medicine


title: REVERSEII: Validation of the "Men and HERDOO2"- A Clinical Decision Rule to Identify Patients With "Unprovoked" Venous Thromboembolism Who Can Discontinue Anticoagulants After 6 Months of Treatment.

acronym: REVERSEII

summary: The main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral anticoagulant therapy after 5-7 months of treatment.

primary_purpose: Diagnostic

ReferenceCitation: Rodger MA, Kahn SR, Wells PS, Anderson DA, Chagnon I, Le Gal G, Solymoss S, Crowther M, Perrier A, White R, Vickars L, Ramsay T, Betancourt MT, Kovacs MJ. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ. 2008 Aug 26;179(5):417-26. doi: 10.1503/cmaj.080493.

ReferenceCitation: Rodger MA, Le Gal G, Anderson DR, Schmidt J, Pernod G, Kahn SR, Righini M, Mismetti P, Kearon C, Meyer G, Elias A, Ramsay T, Ortel TL, Huisman MV, Kovacs MJ; REVERSE II Study Investigators. Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: multinational prospective cohort management study. BMJ. 2017 Mar 17;356:j1065. doi: 10.1136/bmj.j1065.

lead_sponsor: Ottawa Hospital Research Institute

location_country:
Australia
Canada
Switzerland
United States
France
India
Belgium

location_facility: Centre Hospitalier Regional Universitaire de Brest

location_facility: CDHA-Queen Elizabeth II Health Science Centre

intervention_type: Other


acronym: ISPR

summary:
The Implantable Systems Performance Registry (ISPR) was developed to evaluate the long-term reliability and performance of market-released Medtronic Neuromodulation infusion and stimulation products.

Completion Notice: The ISPR was created by Medtronic to monitor the performance of commercially available products. This registry was initially designed to track performance of Medtronic's implantable infusion and spinal cord stimulation systems beginning in August 2003 and June 2004, respectively. Medtronic DBS Systems were added to the ISPR in June 2009, and Sacral Neuromodulation Systems in April 2010. Medtronic retired the ISPR in April 2016 and merged the data collected from this registry into the Product Surveillance Registry (PSR). Please refer to that record, Clinical Trials identifier: NCT01524276, for further information.

location_country:
Spain
Italy
Austria
United Kingdom
United States
France
Germany

location_facility: Site is recruiting for Deep Brain Stimulation

location_facility: Site recruiting for sacral nerve stimulation


title: Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study

lead_sponsor: Seagen Inc.

ReferenceCitation: Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. doi: 10.1186/1756-8722-7-24.

ReferenceCitation: Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.

location_country:
United States
France

location_facility: Loyola University Medical Center - Cardinal Bernadin Cancer Center

location_facility: MD Anderson Cancer Center /The University of Texas

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: The John Theurer Cancer Center, Hackensack University Medical Center

location_facility: Washington University School of Medicine

location_facility: University of Miami Miller School of Medicine / Sylvester Comprehensive Cancer Center

location_facility: Seattle Cancer Care Alliance / University of Washington Medical Center

location_facility: St. Francis Medical Group Oncology & Hematology Specialists

summary: This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.


title: A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat (LBH589) Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).

summary: The purpose of this randomized, two-arm, open-label expansion phase study was to collect preliminary efficacy data of panobinostat at the recommended phase II dose (RPIID) level in combination with azacytidine (5-Aza) versus an active control arm 5-Aza alone. This randomized phase II part also allowed collecting safety data of panobinostat in combination with 5-Aza in comparison to single-agent 5-aza.

ReferenceCitation: Garcia-Manero G, Sekeres MA, Egyed M, Breccia M, Graux C, Cavenagh JD, Salman H, Illes A, Fenaux P, DeAngelo DJ, Stauder R, Yee K, Zhu N, Lee JH, Valcarcel D, MacWhannell A, Borbenyi Z, Gazi L, Acharyya S, Ide S, Marker M, Ottmann OG. A phase 1b/2b multicenter study of oral panobinostat plus azacitidine in adults with MDS, CMML or AML with ⩽30% blasts. Leukemia. 2017 Dec;31(12):2799-2806. doi: 10.1038/leu.2017.159. Epub 2017 May 26.

ipd_sharing: Yes

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
Austria
United Kingdom
Canada
Thailand
Switzerland
Sweden
Hungary
Korea, Republic of
United States
France
Belgium
Germany

location_facility: Georgia Health Sciences University Dept. of MCG

location_facility: University of Kansas Hospital and Medical Center SC - Univ KS

location_facility: University of Texas MD Anderson Cancer Center Dept of MD Anderson (16)

location_facility: Memorial Sloan Kettering Sloan Kettering 2

location_facility: Cleveland Clinic Foundation Cleve Clinic

location_facility: Medical University of South Carolina -Hollings Cancer Center MUSC

location_facility: Goshen Center for Cancer Care IU Cancer Center

location_facility: Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr


acronym: ENCORE

title: A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients With Gaucher Disease Type 1 Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)

lead_sponsor: Genzyme, a Sanofi Company

ReferenceCitation: Lukina E, Watman N, Arreguin EA, Banikazemi M, Dragosky M, Iastrebner M, Rosenbaum H, Phillips M, Pastores GM, Rosenthal DI, Kaper M, Singh T, Puga AC, Bonate PL, Peterschmitt MJ. A phase 2 study of eliglustat tartrate (Genz-112638), an oral substrate reduction therapy for Gaucher disease type 1. Blood. 2010 Aug 12;116(6):893-9. doi: 10.1182/blood-2010-03-273151. Epub 2010 May 3.

ReferenceCitation: Lukina E, Watman N, Arreguin EA, Dragosky M, Iastrebner M, Rosenbaum H, Phillips M, Pastores GM, Kamath RS, Rosenthal DI, Kaper M, Singh T, Puga AC, Peterschmitt MJ. Improvement in hematological, visceral, and skeletal manifestations of Gaucher disease type 1 with oral eliglustat tartrate (Genz-112638) treatment: 2-year results of a phase 2 study. Blood. 2010 Nov 18;116(20):4095-8. doi: 10.1182/blood-2010-06-293902. Epub 2010 Aug 16. Erratum in: Blood. 2011 May 19;117(20):5551.

ReferenceCitation: McEachern KA, Fung J, Komarnitsky S, Siegel CS, Chuang WL, Hutto E, Shayman JA, Grabowski GA, Aerts JM, Cheng SH, Copeland DP, Marshall J. A specific and potent inhibitor of glucosylceramide synthase for substrate inhibition therapy of Gaucher disease. Mol Genet Metab. 2007 Jul;91(3):259-67. Epub 2007 May 16.

ReferenceCitation: Kamath RS, Lukina E, Watman N, Dragosky M, Pastores GM, Arreguin EA, Rosenbaum H, Zimran A, Aguzzi R, Puga AC, Norfleet AM, Peterschmitt MJ, Rosenthal DI. Skeletal improvement in patients with Gaucher disease type 1: a phase 2 trial of oral eliglustat. Skeletal Radiol. 2014 Oct;43(10):1353-60. doi: 10.1007/s00256-014-1891-9. Epub 2014 May 10.

ReferenceCitation: Lukina E, Watman N, Dragosky M, Pastores GM, Arreguin EA, Rosenbaum H, Zimran A, Angell J, Ross L, Puga AC, Peterschmitt JM. Eliglustat, an investigational oral therapy for Gaucher disease type 1: Phase 2 trial results after 4 years of treatment. Blood Cells Mol Dis. 2014 Dec;53(4):274-6. doi: 10.1016/j.bcmd.2014.04.002. Epub 2014 May 15.

ReferenceCitation: Cox TM, Drelichman G, Cravo R, Balwani M, Burrow TA, Martins AM, Lukina E, Rosenbloom B, Goker-Alpan O, Watman N, El-Beshlawy A, Kishnani PS, Pedroso ML, Gaemers SJM, Tayag R, Peterschmitt MJ. Eliglustat maintains long-term clinical stability in patients with Gaucher disease type 1 stabilized on enzyme therapy. Blood. 2017 Apr 27;129(17):2375-2383. doi: 10.1182/blood-2016-12-758409. Epub 2017 Feb 6.

ReferenceCitation: Cox TM, Drelichman G, Cravo R, Balwani M, Burrow TA, Martins AM, Lukina E, Rosenbloom B, Ross L, Angell J, Puga AC. Eliglustat compared with imiglucerase in patients with Gaucher's disease type 1 stabilised on enzyme replacement therapy: a phase 3, randomised, open-label, non-inferiority trial. Lancet. 2015 Jun 13;385(9985):2355-62. doi: 10.1016/S0140-6736(14)61841-9. Epub 2015 Mar 26. Erratum in: Lancet. 2015 Jun 13;385(9985):2354.

location_country:
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Argentina
Canada
United States
France
Germany
Egypt

location_facility: Instituto de Estadual de Hematologia Arthur de Siqueria Cavalcanti

location_facility: Hospital General de Agudos J.M Ramos Mejia

location_facility: Katholische Kliniken Oberhausen gem. GmbH

location_facility: Hospital de Clinicas da Universidade Federal do Parana

location_facility: Hospital General de Ninos Dr. Ricardo Gutierrez

location_facility: University of Iowa Hospitals and Clinics

location_facility: Cambridge University Hosptials, Addenbrookes Hospital

location_facility: Northwest Oncology Hematology Associates PA

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Colorado Health Science Center - Aurora

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Mount Sinai Hospital and the Samuel Lunenfeld Research Institute

location_facility: Azienda Ospedialiero-Universitaria S. Maria Della Misericordia

location_facility: Hematology Research Center of Ministry of Healthcare of the Russian Federation

location_facility: Abou El Reesh Children's University Hospital (El Mounira), Faculty of Medicine (Kasr Al-Aini), Cairo University Hospitals, El Mounira, Cairo, Egypt

summary: This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals with enzyme replacement therapy (ERT).


title: A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Dose Finding Study To Investigate the Safety and Tolerability of YM150 in Subjects With Non-Valvular Atrial Fibrillation and to Compare the Safety and Tolerability With Warfarin

lead_sponsor: Astellas Pharma Inc

location_country:
Spain
United Kingdom
Ukraine
South Africa
Philippines
Japan
Poland
Austria
Australia
Russian Federation
India
Israel
Malaysia
Slovakia
Hungary
Germany
Bulgaria
Estonia
Czech Republic
Thailand
Korea, Republic of
France
Netherlands

summary: The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.


title: A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome

acronym: RADAR

summary: The purpose of this study is to evaluate the safety and efficacy of the REG1 anticoagulation System in Acute Coronary Syndrome (ACS) patients undergoing cardiac catheterization.

ReferenceCitation: TCT-176: Access and non-Access Site Bleeding in Acute Coronary Syndrome Patients Treated with a Novel Actively Reversible Factor IXa Inhibitor. Results from the RADAR Trial J Am Coll Cardiol 2011 58: B47

ReferenceCitation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. Review.

ReferenceCitation: Povsic TJ, Vavalle JP, Alexander JH, Aberle LH, Zelenkofske SL, Becker RC, Buller CE, Cohen MG, Cornel JH, Kasprzak JD, Montalescot G, Fail PS, Sarembock IJ, Mehran R; RADAR Investigators. Use of the REG1 anticoagulation system in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the phase II RADAR-PCI study. EuroIntervention. 2014 Aug;10(4):431-8. doi: 10.4244/EIJY14M06_01.

ReferenceCitation: Povsic TJ, Cohen MG, Chan MY, Zelenkofske SL, Wargin WA, Harrington RA, Alexander JH, Rusconi CP, Becker RC. Dose selection for a direct and selective factor IXa inhibitor and its complementary reversal agent: translating pharmacokinetic and pharmacodynamic properties of the REG1 system to clinical trial design. J Thromb Thrombolysis. 2011 Jul;32(1):21-31. doi: 10.1007/s11239-011-0588-3.

ReferenceCitation: Povsic TJ, Cohen MG, Mehran R, Buller CE, Bode C, Cornel JH, Kasprzak JD, Montalescot G, Joseph D, Wargin WA, Rusconi CP, Zelenkofske SL, Becker RC, Alexander JH. A randomized, partially blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system in patients with acute coronary syndromes: design and rationale of the RADAR Phase IIb trial. Am Heart J. 2011 Feb;161(2):261-268.e1-2. doi: 10.1016/j.ahj.2010.10.022.

lead_sponsor: Regado Biosciences, Inc.

location_country:
Germany
United States
Canada
France

location_facility: Universitaetsklinik Magdeburg Klinik fÃ¼r Kardiologie Angiologie und Pneumologie

location_facility: Klinikum Quedlinburg GmbH Klinik fuer Innere Medizin und Kardiologie

location_facility: University of Florida-Medicine Cardiology Research

location_facility: Klinikum Fulda gAG Medizinische Klinik I

location_facility: Jim Moran Heart & Vascular Research Institute

location_facility: University of Pennsylvania Health System

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Cardiovascular Institute of the South - Houma

location_facility: Klinikum der Universitaet Muenchen GroÃŸhadern Medizinische Klinik und Poliklinik I der LMU

location_facility: Klinikum Coburg GmbH 2. Med. Klinik Ebene 3 Studienbuero

location_facility: MVZ am Kuechwald GmbH Ambulantes Herzzentrum

location_facility: University of North Carolina - School of Medicine

location_facility: Universitaetsklinikum Halle/Saale Klinik fÃ¼r Innere Medizin III

location_facility: Universitatsklinikum Freiburg Abt. Innere Medizin III

location_facility: Montreal Heart Institute Research Center


title: A Randomised Open-label Study Comparing the Safety and Efficacy of Ritonavir Boosted Lopinavir and 2-3N(t)RTI Backbone Versus Ritonavir Boosted Lopinavir and Raltegravir in Participants Virologically Failing First-line NNRTI/2N(t)RTI Therapy

acronym: SECOND-LINE

summary:
The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and raltegravir.

The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks.

The primary endpoint is virological: a comparison of virological suppression in plasma < 200 copies/mL between the randomized arms after 48 weeks.

Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life.

ReferenceCitation: Henry RT, Jiamsakul A, Law M, Losso M, Kamarulzaman A, Phanuphak P, Kumarasamy N, Foulkes S, Mohapi L, Nwizu C, Wood R, Kelleher A, Polizzotto M; SECOND-LINE Study Group. Factors Associated With and Characteristic of HIV/Tuberculosis Co-Infection: A Retrospective Analysis of SECOND-LINE Clinical Trial Participants. J Acquir Immune Defic Syndr. 2021 May 1;87(1):720-729. doi: 10.1097/QAI.0000000000002619.

ReferenceCitation: Amin J, Boyd MA, Kumarasamy N, Moore CL, Losso MH, Nwizu CA, Mohapi L, Kerr SJ, Sohn AH, Teppler H, Renjifo B, Molina JM, Emery S, Cooper DA. Raltegravir non-inferior to nucleoside based regimens in second-line therapy with lopinavir/ritonavir over 96 weeks: a randomised open label study for the treatment of HIV-1 infection. PLoS One. 2015 Feb 27;10(2):e0118228. doi: 10.1371/journal.pone.0118228. eCollection 2015. Erratum in: PLoS One. 2015;10(10):e0140623.

ReferenceCitation: Martin A, Moore CL, Mallon PW, Hoy JF, Emery S, Belloso WH, Phanuphak P, Ferret S, Cooper DA, Boyd MA; Second-Line Study Team. HIV lipodystrophy in participants randomised to lopinavir/ritonavir (LPV/r) +2-3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTI) or LPV/r + raltegravir as second-line antiretroviral therapy. PLoS One. 2013 Oct 30;8(10):e77138. doi: 10.1371/journal.pone.0077138. eCollection 2013.

ReferenceCitation: SECOND-LINE Study Group, Boyd MA, Kumarasamy N, Moore CL, Nwizu C, Losso MH, Mohapi L, Martin A, Kerr S, Sohn AH, Teppler H, Van de Steen O, Molina JM, Emery S, Cooper DA. Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study. Lancet. 2013 Jun 15;381(9883):2091-9. doi: 10.1016/S0140-6736(13)61164-2.

lead_sponsor: Kirby Institute

location_country:
Taiwan
Hong Kong
United Kingdom
Ireland
Nigeria
Australia
New Zealand
Argentina
France
Chile
India
Malaysia
Mexico
Peru
Germany
Singapore
South Africa

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion "Salvado Zubiran"

location_facility: Hospital General de Agudos 'Teodoro Alvarez'

location_facility: Hospital Interzonal General de Agudos, Oscar Alende

location_facility: Hospital de la Universidad Catolica Pontificia

location_facility: Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia


title: Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study

summary: The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).

lead_sponsor: Medtronic

location_country:
Spain
Italy
Austria
Canada
United States
France
Belgium
Netherlands


title: A Prospective Multicenter Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Major Depression Disorder (MDD)

summary: The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications.

lead_sponsor: Brainsway

location_country:
Canada
United States
Israel
France
Germany

location_facility: Advanced Mental Health Care Inc. - Juno Beach

location_facility: Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie

location_facility: Center for Addiction and Mental Health (CAMH)

location_facility: Advanced Mental Health Care Inc. - Royal Palm Beach

location_facility: Columbia University / New York State Psychiatric Institute

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Duke Medical Center Department of Psychiatry & Behavioral Sciences

location_facility: Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität


acronym: Study of the Effects of Oral AT1001 in Patients with Fabry Disease

title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamics of AT1001 in Patients With Fabry Disease and AT1001-Responsive GLA Mutations

lead_sponsor: Amicus Therapeutics

ReferenceCitation: Bichet DG, Aerts JM, Auray-Blais C, Maruyama H, Mehta AB, Skuban N, Krusinska E, Schiffmann R. Assessment of plasma lyso-Gb(3) for clinical monitoring of treatment response in migalastat-treated patients with Fabry disease. Genet Med. 2021 Jan;23(1):192-201. doi: 10.1038/s41436-020-00968-z. Epub 2020 Sep 30. Erratum in: Genet Med. 2020 Nov 20;:.

ReferenceCitation: Germain DP, Nicholls K, Giugliani R, Bichet DG, Hughes DA, Barisoni LM, Colvin RB, Jennette JC, Skuban N, Castelli JP, Benjamin E, Barth JA, Viereck C. Efficacy of the pharmacologic chaperone migalastat in a subset of male patients with the classic phenotype of Fabry disease and migalastat-amenable variants: data from the phase 3 randomized, multicenter, double-blind clinical trial and extension study. Genet Med. 2019 Sep;21(9):1987-1997. doi: 10.1038/s41436-019-0451-z. Epub 2019 Feb 6.

ReferenceCitation: Schiffmann R, Bichet DG, Jovanovic A, Hughes DA, Giugliani R, Feldt-Rasmussen U, Shankar SP, Barisoni L, Colvin RB, Jennette JC, Holdbrook F, Mulberg A, Castelli JP, Skuban N, Barth JA, Nicholls K. Migalastat improves diarrhea in patients with Fabry disease: clinical-biomarker correlations from the phase 3 FACETS trial. Orphanet J Rare Dis. 2018 Apr 27;13(1):68. doi: 10.1186/s13023-018-0813-7.

ReferenceCitation: Benjamin ER, Della Valle MC, Wu X, Katz E, Pruthi F, Bond S, Bronfin B, Williams H, Yu J, Bichet DG, Germain DP, Giugliani R, Hughes D, Schiffmann R, Wilcox WR, Desnick RJ, Kirk J, Barth J, Barlow C, Valenzano KJ, Castelli J, Lockhart DJ. The validation of pharmacogenetics for the identification of Fabry patients to be treated with migalastat. Genet Med. 2017 Apr;19(4):430-438. doi: 10.1038/gim.2016.122. Epub 2016 Sep 22.

ReferenceCitation: Germain DP, Hughes DA, Nicholls K, Bichet DG, Giugliani R, Wilcox WR, Feliciani C, Shankar SP, Ezgu F, Amartino H, Bratkovic D, Feldt-Rasmussen U, Nedd K, Sharaf El Din U, Lourenco CM, Banikazemi M, Charrow J, Dasouki M, Finegold D, Giraldo P, Goker-Alpan O, Longo N, Scott CR, Torra R, Tuffaha A, Jovanovic A, Waldek S, Packman S, Ludington E, Viereck C, Kirk J, Yu J, Benjamin ER, Johnson F, Lockhart DJ, Skuban N, Castelli J, Barth J, Barlow C, Schiffmann R. Treatment of Fabry's Disease with the Pharmacologic Chaperone Migalastat. N Engl J Med. 2016 Aug 11;375(6):545-55. doi: 10.1056/NEJMoa1510198.

location_country:
Denmark
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Argentina
Canada
United States
France
Turkey
Egypt

summary: The primary objective of this study was to compare the effect of migalastat (123 milligrams [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) versus placebo on kidney globotriaosylceramide (GL-3).