title: A Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

summary: This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Participants will receive rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8, 15 and 22.

ReferenceCitation: Melega S, Brogan P, Cleary G, Hersh AO, Kasapcopur O, Rangaraj S, Yeung RSM, Zeft A, Cooper J, Pordeli P, Kirchner P, Lehane PB. Evaluation of Serious Infection in Pediatric Patients with Low Immunoglobulin Levels Receiving Rituximab for Granulomatosis with Polyangiitis or Microscopic Polyangiitis. Rheumatol Ther. 2022 Apr;9(2):721-734. doi: 10.1007/s40744-022-00433-0. Epub 2022 Mar 12.

ReferenceCitation: Brogan P, Yeung RSM, Cleary G, Rangaraj S, Kasapcopur O, Hersh AO, Li S, Paripovic D, Schikler K, Zeft A, Bracaglia C, Eleftheriou D, Pordeli P, Melega S, Jamois C, Gaudreault J, Michalska M, Brunetta P, Cooper JC, Lehane PB; PePRS Study Group. Phase IIa Global Study Evaluating Rituximab for the Treatment of Pediatric Patients With Granulomatosis With Polyangiitis or Microscopic Polyangiitis. Arthritis Rheumatol. 2022 Jan;74(1):124-133. doi: 10.1002/art.41901. Epub 2021 Dec 5.

lead_sponsor: Hoffmann-La Roche

location_country:
Serbia
United Kingdom
Italy
Canada
United States
France
Turkey
Germany

location_facility: Great Ormond Street Children's Hospital; Centre of Paediatric & Adolescent Rheumatology

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

location_facility: Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie

location_facility: University of Utah; Immunology/Rheumatology/Allergy

location_facility: The Hospital for Sick Children Research Institute

location_facility: Univ. Di Padova - Dip. Di Pediatria - Unita' Reumatol. Pediatrica

location_facility: Istanbul University, Cerrahpasa Medical Faculty; Pediatrics Department

location_facility: Children's and Women's Health Center / BC Children's Hospital

location_facility: COLUMBIA PRESBYTERIAN MEDICAL CENTER, Research Pharmacy, William Black Medical Research Building

location_facility: Hacettepe University, School of Medicine; Pediatrics Department

location_facility: Alder Hey Children s Hospital; Department of Pediatrics

location_facility: KfH-Nierenzentrum fur Kinder und Jugendliche

location_facility: The Cleveland Clinic Foundation; Rheumatic and Immunologic Diseases

location_facility: University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit

location_facility: Universitätsklinikum für Kinder und Jugendmedizin Hamburg

location_facility: Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina


title: Clinical Investigation of the Nucleus® CI532 Cochlear Implant

summary:
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode design.

Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Hey M, Wesarg T, Mewes A, Helbig S, Hornung J, Lenarz T, Briggs R, Marx M, Ramos A, Stöver T, Escudé B, James CJ, Aschendorff A. Objective, audiological and quality of life measures with the CI532 slim modiolar electrode. Cochlear Implants Int. 2019 Mar;20(2):80-90. doi: 10.1080/14670100.2018.1544684. Epub 2018 Nov 22.

lead_sponsor: Cochlear

location_country: Australia France Germany Spain

location_facility: Klinikum der J. W. Goethe-Universität Frankfurt

location_facility: Ear, Nose and Throat Department, Medizinische Hochschule

location_facility: Ear, Nose and Throat Department, Universitätsklinikum Erlangen

location_facility: Ear, Nose and Throat Department, University of Freiburg

location_facility: Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan

location_facility: Complejo Hospitalario Universitario Insular Materno Infantil

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study

summary:
The primary objectives of the study are:

-To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

location_country: Poland Italy Netherlands Ukraine Hungary France Israel Japan Germany Slovakia Czechia

intervention_type: Drug


ipd_sharing: No

title: An Open-Label, Extension (Rollover) Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized

study_start_date_type: Actual

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
South Africa
Portugal
Russian Federation
Israel
Cyprus
Egypt
Bosnia and Herzegovina
Brazil
Canada
Hungary
Germany
Belarus
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Hospital General Universitario Santa Lucia

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: N.N. Alexandrov National Cancer Centre of Belarus

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Siouxland Regional Cancer Center d/b/a June E. Nylen Cancer Center

location_facility: Hospital General Universitario de Valencia

location_facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

location_facility: Hospital Regional Universitario de Malaga; Oncologia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit

location_facility: St. Petersburg SHI "City Clinical Oncology Dispensary"

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Cancercare Langenhoven Drive Oncology Centre

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: University of Chicago Medical Center; Medicine, Section of Pulmonary

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

location_facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: University General Hospital of Heraklion

location_facility: University of Pennsylvania Health System

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke

location_facility: Mary Crowley Medical Research Center; Oncology

location_facility: New York University Medical Center PRIME

location_facility: SBIH " Clinical Oncological Dispensary # 1"; Chemotherapy department #1 and #2

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Kyungpook National University Chilgok Hospital

summary: This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first.


title: Assessment of Surgical Mediastinal sTaging in cN1 Lung canceR

summary: In case of PET or CT based cN1 (suspected) NSCLC, ESTS guidelines propose mediastinal staging by echo-endoscopy OR mediastinoscopy. Recent data show a sensitivity of less than 50% for echo-endoscopy to detect N2 disease in cN1 NSCLC patients, while prevalence of mediastinal nodal disease was 24% (unpublished data Aster II).2 The investigators plan to perform a prospective multicentric observational study to measure the sensitivity of mediastinal staging by video-assisted mediastinoscopy (VAM) in cN1 operable and resectable (suspected) NSCLC patients.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Decaluwé H, Dooms C, D'Journo XB, Call S, Sanchez D, Haager B, Beelen R, Kara V, Klikovits T, Aigner C, Tournoy K, Zahin M, Moons J, Brioude G, Trujillo JC, Klepetko W, Turna A, Passlick B, Molins L, Rami-Porta R, Thomas P, Leyn P. Mediastinal staging by videomediastinoscopy in clinical N1 non-small cell lung cancer: a prospective multicentre study. Eur Respir J. 2017 Dec 21;50(6). pii: 1701493. doi: 10.1183/13993003.01493-2017. Print 2017 Dec.

lead_sponsor: Johnny Moons

location_country: Spain Switzerland France Turkey Belgium Germany

location_facility: Istanbul University, Cerrahpasa Medical Faculty

location_facility: Aix-Marseille University & Hospitals System of Marseille (AP-HM)

location_facility: University Hospital, Division of Thoracic Surgery


title: A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (NEURO-TTR Study)

summary: The purpose of this study is to evaluate the efficacy and safety of inotersen given for 65 weeks in participants with Familial Amyloid Polyneuropathy (FAP).

design_allocation: Randomized

ReferenceType: result

ReferenceCitation: Benson MD, Waddington-Cruz M, Berk JL, Polydefkis M, Dyck PJ, Wang AK, Planté-Bordeneuve V, Barroso FA, Merlini G, Obici L, Scheinberg M, Brannagan TH 3rd, Litchy WJ, Whelan C, Drachman BM, Adams D, Heitner SB, Conceição I, Schmidt HH, Vita G, Campistol JM, Gamez J, Gorevic PD, Gane E, Shah AM, Solomon SD, Monia BP, Hughes SG, Kwoh TJ, McEvoy BW, Jung SW, Baker BF, Ackermann EJ, Gertz MA, Coelho T. Inotersen Treatment for Patients with Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5;379(1):22-31. doi: 10.1056/NEJMoa1716793.

ReferenceCitation: Karam C, Brown D, Yang M, Done N, Zhu JJ, Greatsinger A, Bozas A, Vera-Llonch M, Signorovitch J. Long-term treatment effects of inotersen on health-related quality of life in patients with hATTR amyloidosis with polyneuropathy: Analysis of the open-label extension of the NEURO-TTR trial. Muscle Nerve. 2022 Oct;66(4):438-446. doi: 10.1002/mus.27675. Epub 2022 Aug 4.

ReferenceCitation: Karam C, Brown D, Yang M, Done N, Dieye I, Bozas A, Vera Llonch M, Signorovitch J. Factors associated with increased health-related quality-of-life benefits in hereditary transthyretin amyloidosis polyneuropathy patients treated with inotersen. Muscle Nerve. 2022 Sep;66(3):319-328. doi: 10.1002/mus.27668. Epub 2022 Jul 15.

ReferenceCitation: Yarlas A, Lovley A, McCausland K, Brown D, Vera-Llonch M, Conceição I, Karam C, Khella S, Obici L, Waddington-Cruz M. Early Data on Long-term Impact of Inotersen on Quality-of-Life in Patients with Hereditary Transthyretin Amyloidosis Polyneuropathy: Open-Label Extension of NEURO-TTR. Neurol Ther. 2021 Dec;10(2):865-886. doi: 10.1007/s40120-021-00268-x. Epub 2021 Aug 5.

ReferenceCitation: Yarlas A, Lovley A, Brown D, Kosinski M, Vera-Llonch M. Responder analysis for neuropathic impairment and quality-of-life assessment in patients with hereditary transthyretin amyloidosis with polyneuropathy in the NEURO-TTR study. J Neurol. 2022 Jan;269(1):323-335. doi: 10.1007/s00415-021-10635-1. Epub 2021 Jun 14.

ReferenceCitation: Yu RZ, Wang Y, Norris DA, Kim TW, Narayanan P, Geary RS, Monia BP, Henry SP. Immunogenicity Assessment of Inotersen, a 2'-O-(2-Methoxyethyl) Antisense Oligonucleotide in Animals and Humans: Effect on Pharmacokinetics, Pharmacodynamics, and Safety. Nucleic Acid Ther. 2020 Oct;30(5):265-275. doi: 10.1089/nat.2020.0867. Epub 2020 Aug 19.

ReferenceCitation: Dyck PJB, Kincaid JC, Wiesman JF, Polydefkis M, Litchy WJ, Mauermann ML, Ackermann EJ, Guthrie S, Pollock M, Jung SW, Baker BF, Dyck PJ. mNIS+7 and lower limb function in inotersen treatment of hereditary transthyretin-mediated amyloidosis. Muscle Nerve. 2020 Oct;62(4):502-508. doi: 10.1002/mus.27022. Epub 2020 Aug 13.

ReferenceCitation: Dyck PJB, Coelho T, Waddington Cruz M, Brannagan TH 3rd, Khella S, Karam C, Berk JL, Polydefkis MJ, Kincaid JC, Wiesman JF, Litchy WJ, Mauermann ML, Ackermann EJ, Baker BF, Jung SW, Guthrie S, Pollock M, Dyck PJ. Neuropathy symptom and change: Inotersen treatment of hereditary transthyretin amyloidosis. Muscle Nerve. 2020 Oct;62(4):509-515. doi: 10.1002/mus.27023. Epub 2020 Aug 7.

ReferenceCitation: Coelho T, Yarlas A, Waddington-Cruz M, White MK, Sikora Kessler A, Lovley A, Pollock M, Guthrie S, Ackermann EJ, Hughes SG, Karam C, Khella S, Gertz M, Merlini G, Obici L, Schmidt HH, Polydefkis M, Dyck PJB, Brannagan Iii TH, Conceição I, Benson MD, Berk JL. Inotersen preserves or improves quality of life in hereditary transthyretin amyloidosis. J Neurol. 2020 Apr;267(4):1070-1079. doi: 10.1007/s00415-019-09671-9. Epub 2019 Dec 18.

ReferenceCitation: Pinto MV, Dyck PJB, Gove LE, McCauley BM, Ackermann EJ, Hughes SG, Waddington-Cruz M, Dyck PJ. Kind and distribution of cutaneous sensation loss in hereditary transthyretin amyloidosis with polyneuropathy. J Neurol Sci. 2018 Nov 15;394:78-83. doi: 10.1016/j.jns.2018.08.031. Epub 2018 Aug 30.

ReferenceCitation: Waddington-Cruz M, Ackermann EJ, Polydefkis M, Heitner SB, Dyck PJ, Barroso FA, Wang AK, Berk JL, Dyck PJB, Monia BP, Hughes SG, Tai L, Jesse Kwoh T, Jung SW, Coelho T, Benson MD, Gertz MA. Hereditary transthyretin amyloidosis: baseline characteristics of patients in the NEURO-TTR trial. Amyloid. 2018 Sep;25(3):180-188. doi: 10.1080/13506129.2018.1503593. Epub 2018 Aug 31.

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Brazil
Portugal
Spain
Italy
United Kingdom
New Zealand
Argentina
United States
France
Germany

location_facility: CHP-HGSA, Unidade Clinica de Paramiloidose

location_facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico San Matteo

location_facility: Boston University School of Medicine - Amyloid Treatment & Research Program

location_facility: Universita Degli Studi Di Messina - Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino"

location_facility: UKM; Universitätsklinikum Münster, Klinik für Transplantationsmedizin

location_facility: CHU Bicetre Aphp French Referral Center for FAP/Cornamyl Network

location_facility: University College London - National Amyloidosis Centre

location_facility: Johns Hopkins University Bayview Medical Center

location_facility: Columbia University Medical Center - The Neurological Institute

location_facility: CHU Henri Mondor - Department of Neurology

location_facility: Federal University of Rio de Janeiro - University Hospital


status: Active, not recruiting

title: An Open Label, Multi-center Nilotinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Nilotinib Study and Are Judged by the Investigator to Benefit From Continued Nilotinib Treatment

study_completion_date_type: Anticipated

lead_sponsor: Novartis Pharmaceuticals

location_country:
Hong Kong
Spain
Italy
Austria
Russian Federation
United Kingdom
Canada
Sweden
Hungary
Korea, Republic of
United States
France
Israel
Singapore
Netherlands
Slovakia

location_facility: University of Texas/MD Anderson Cancer Center SC - 5

summary: The purpose of this study is to allow continued use of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator

status_simplified: Ongoing


title: A Retrospective Analysis of Hematological Relapse Free Survival and Overall Survival in Adult Patients With Philadelphia-Negative B-Precursor Acute Lymphoblastic Leukemia in Complete Hematological Remission With Minimal Residual Disease

summary: A retrospective analysis of historical data looking at relapse free survival and overall survival rates in adult philadelphia negative B-pre-cursor acute lymphoblastic leukemia patients.

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Gökbuget N, Dombret H, Giebel S, Brüggemann M, Doubek M, Foa R, Hoelzer D, Kim C, Martinelli G, Parovichnikova E, Maria Ribera J, Schoonen M, Tuglus C, Zugmaier G, Bassan R. Blinatumomab vs historic standard-of-care treatment for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukaemia. Eur J Haematol. 2020 Apr;104(4):299-309. doi: 10.1111/ejh.13375. Epub 2020 Jan 24. Erratum in: Eur J Haematol. 2021 Apr;106(4):593.

lead_sponsor: Amgen

location_country:
Poland
Spain
Italy
Russian Federation
United Kingdom
France
Germany
Czechia


type: Other Identifier

title: Retrospective Registry Providing Baseline Data on the Outcome of Left Atrial (LA) or LA Appendage (LAA) Thrombus in Patients With Nonvalvular Atrial Fibrillation (AF) or Atrial Flutter After Standard of Care (SoC) Anticoagulant Therapy

acronym: CLOT-AF

summary:
Thrombus outcome data will be collected retrospectively during 2011-2012 as a historical baseline of SoC with oral VKA (Vitamin K Antagonist(s) for the treatment of patients with nonvalvular AF or atrial flutter documented with LA/ LAA thrombi on transesophag-eal echocardiography (TEE).

The study is a company-sponsored, global, multi-center, retrospective, non-interventional study. Patients who suffered from hemodynamically stable nonvalvular AF or atrial flutter and had a diagnosed LA/ LAA thrombus between January 1st, 2011 and December 31st, 2012 will be identified through screening and review of medical records and included in the registry. Retrospective patient data will be collected from May 2nd, 2013 to May 2nd, 2014. The observation of each patient will cover the period from the diagnosis of an LA/ LAA thrombus until the end-of-treatment TEE following the 3-12 week SoC anticoagulation (AC) therapy. If no end-of-treatment TEE has been performed during 3-12 weeks of AC therapy, the observational period will end at 12 weeks after diagnosis at the latest. If more than one TEE was performed during treatment, the thrombus outcome will be collected from the last TEE performed within 12 weeks of treatment start.

ReferenceCitation: Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, Morandi E, van Eickels M, Cohen A. Rationale and design of a study exploring the efficacy of once-daily oral rivaroxaban (X-TRA) on the outcome of left atrial/left atrial appendage thrombus in nonvalvular atrial fibrillation or atrial flutter and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2015 Apr;169(4):464-71.e2. doi: 10.1016/j.ahj.2014.12.020. Epub 2015 Jan 6.

lead_sponsor: Bayer

location_country:
Poland
Russian Federation
Ukraine
France
Turkey
Germany
Bulgaria

intervention_type: Other


title: Women's INternational Transcatheter Aortic Valve Implantation Registry

acronym: WINTAVI

summary: The study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.

ReferenceCitation: Buchanan GL, Chieffo A, Montorfano M, Maisano F, Latib A, Godino C, Cioni M, Gullace MA, Franco A, Gerli C, Alfieri O, Colombo A. The role of sex on VARC outcomes following transcatheter aortic valve implantation with both Edwards SAPIEN™ and Medtronic CoreValve ReValving System® devices: the Milan registry. EuroIntervention. 2011 Sep;7(5):556-63. doi: 10.4244/EIJV7I5A91.

ReferenceCitation: Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16. Review.

ReferenceCitation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449.

ReferenceCitation: Hayashida K, Morice MC, Chevalier B, Hovasse T, Romano M, Garot P, Farge A, Donzeau-Gouge P, Bouvier E, Cormier B, Lefèvre T. Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis. J Am Coll Cardiol. 2012 Feb 7;59(6):566-71. doi: 10.1016/j.jacc.2011.10.877.

lead_sponsor: Icahn School of Medicine at Mount Sinai

location_country:
Spain
Italy
United Kingdom
United States
France
Netherlands

location_facility: Radboud University Nijmegen Medical Center

location_facility: Department cardiovascular Sciences Policlinico Umberto I


title: A Phase Ib/II Multi-center, Open-label, Dose Escalation Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in Patients With BRAF Mutant Metastatic Colorectal Cancer

summary: This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer

ipd_sharing: Yes

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

lead_sponsor: Pfizer

location_country:
Spain
Italy
Australia
Netherlands
Canada
Korea, Republic of
United States
France
Norway
Belgium
Japan
Germany

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON

location_facility: Westwood Bowyer Clinic, Peter Morton Medical Building

location_facility: Ospedaliero Universitaria di Modena Policlinico

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: UCLA Santa Monica Medical Center & Orthopaedic Hospital

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

location_facility: Pharmacy of National Cancer Center Hospital East

location_facility: Smilow Cancer Hospital Care Center at North Haven

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: University of Utah - Huntsman Cancer Institute - PPDS

location_facility: Redwood Health Center - ARUP Lab Draw Location

location_facility: UCLA University of California Los Angeles

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis


title: Neo-AEGIS (NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study): Randomised Clinical Trial of Neoadjuvant and Adjuvant Chemotherapy (Modified MAGIC or FLOT Regimen) vs. Neoadjuvant Chemoradiation (CROSS Protocol) in Adenocarcinoma of the Oesophagus and Oesophago-gastric Junction

summary:
This is a multicentre phase III open-labelled, randomised controlled trial. Eligible patients will be randomised in a 1:1 fashion between neoadjuvant and adjuvant chemotherapy (Investigator's choice modified MAGIC (ECF/ECX or EOF/EOX) or FLOT regimen) and surgery or Arm B (CROSS protocol: chemotherapy with radiation therapy and surgery as per multimodal protocol).

Primary Objective:

To evaluate one, two and three year survival of patients treated with resection plus neoadjuvant and adjuvant chemotherapy versus resection plus neoadjuvant chemo radiotherapy.

Secondary Objective(s):

To evaluate the effect of both neoadjuvant regimens on clinical and pathological response rate (in particular relief of dysphagia, improvement in health related quality of life (HRQL), endoscopic regression, and CT-PET evidence of tumour response), tumour regression grade, node-positivity, post-operative pathology, disease-free survival, time to treatment failure, toxicity, post-operative complications and Health Related Quality of Life (HRQL).

Exploratory Objective(s):

Translational Research: The collection of blood and tissue samples for storage in the bio bank for future research.

ReferenceCitation: Reynolds JV, Preston SR, O'Neill B, Baeksgaard L, Griffin SM, Mariette C, Cuffe S, Cunningham M, Crosby T, Parker I, Hofland K, Hanna G, Svendsen LB, Donohoe CL, Muldoon C, O'Toole D, Johnson C, Ravi N, Jones G, Corkhill AK, Illsley M, Mellor J, Lee K, Dib M, Marchesin V, Cunnane M, Scott K, Lawner P, Warren S, O'Reilly S, O'Dowd G, Leonard G, Hennessy B, Dermott RM. ICORG 10-14: NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study (Neo-AEGIS). BMC Cancer. 2017 Jun 3;17(1):401. doi: 10.1186/s12885-017-3386-2.

lead_sponsor: Cancer Trials Ireland

location_country:
Denmark
United Kingdom
Ireland
France
Sweden

location_facility: Hull and East Yorkshire Hospitals NHS Trust, Castle Hill Hospital,

location_facility: The Newcastle upon Tyne Hospital NHS Foundation TrustFreeman Hospital, Freeman Road, High Heaton

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Oxford University Hospital NHS Trust Churchill Hospital

location_facility: University Hospitals Coventry & Warwickshire

location_facility: Karolinska Institutet and Karolinska University Hospital

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Imperial College Healthcare NHS Trust St Mary's Hospital

location_facility: Belfast Health and Social Care Trust, Northern Ireland Cancer Centre, Belfast CityHospital

location_facility: SLRON- St Luke's Radiation Oncology Network

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Centre Hospitalier Régional, Universitaire de Lille 2 Avenue Oscar Lambret, 59000

intervention_type: Radiation


title: Neurodegeneration as Early Event in Pathogenesis of Diabetic Retinopathy:Multicentric, Prospective, Ph. II-III,Random.Controlled Trial to Assess Efficacy of Neuroprotective Drugs Administered Topically to Prevent/Arrest Diabetic Retinopathy

acronym: EUROCONDOR

summary: To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes

primary_purpose: Prevention

ReferenceCitation: Cunha-Vaz J, Ribeiro L, Costa M, Simó R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.

ReferenceCitation: Santos AR, Ribeiro L, Bandello F, Lattanzio R, Egan C, Frydkjaer-Olsen U, García-Arumí J, Gibson J, Grauslund J, Harding SP, Lang GE, Massin P, Midena E, Scanlon P, Aldington SJ, Simão S, Schwartz C, Ponsati B, Porta M, Costa MÂ, Hernández C, Cunha-Vaz J, Simó R; European Consortium for the Early Treatment of Diabetic Retinopathy (EUROCONDOR). Functional and Structural Findings of Neurodegeneration in Early Stages of Diabetic Retinopathy: Cross-sectional Analyses of Baseline Data of the EUROCONDOR Project. Diabetes. 2017 Sep;66(9):2503-2510. doi: 10.2337/db16-1453. Epub 2017 Jun 29.

lead_sponsor: BCN Peptides

location_country:
Denmark
Portugal
Spain
Italy
United Kingdom
France
Germany

location_facility: Gloucestershire Hospitals NHS Foundation Trust (CHGH)

location_facility: Universita degli Study di Padova(UPadova)

location_facility: Aston University (UAston)Heart of England NHS Foundation Trust

location_facility: Moorfields Eye Hospital NHS Foundation Trust (MEH)

location_facility: Universita Vita-Salute San Raffaele (USR)

location_facility: Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH)


title: CoreValve® ADVANCE Direct Aortic Study

summary: This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.

lead_sponsor: Medtronic Bakken Research Center

location_country:
United Kingdom
Italy
Netherlands
France
Germany
Czechia

location_facility: Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital

location_facility: Azienda spedaliera Niguarda Ca' Granda Milano

location_facility: Azienda spedaliera Spedali Civili Di Brescia


title: BREATHER (PENTA 16) Short-Cycle Therapy (SCT) (5 Days on/2 Days Off) in Young People With Chronic HIV-infection

acronym: BREATHER

summary:
The overall aim of the BREATHER trial is to evaluate the role of Short-Cycle Therapy (SCT) in the management of HIV-infected young people who have responded well to antiretroviral therapy (ART) and to determine whether young people with chronic HIV infection undergoing Short-Cycle Therapy of five days on ART and two days off maintain the same level of viral load suppression as those on continuous therapy, over 48 weeks.

To assess the advantages and disadvantages of the strategy, the incidence of toxicities, immunological control, resistance mutations, acceptability, quality of life and adherence to the randomised strategy will also be compared.

Importantly, because of insufficient data on short-term viral load rebound after stopping ART in this population, the trial will incorporate an initial pilot phase in selected centres, to assess the safety of the SCT strategy by evaluating detailed HIV-1 RNA profiles of participants on the SCT strategy.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Turkova A, Moore CL, Butler K, Compagnucci A, Saïdi Y, Musiime V, Nanduudu A, Kaudha E, Cressey TR, Chalermpantmetagul S, Scott K, Harper L, Montero S, Riault Y, Bunupuradah T, Volokha A, Flynn PM, Bologna R, Ramos Amador JT, Welch SB, Nastouli E, Klein N, Giaquinto C, Ford D, Babiker A, Gibb DM; BREATHER (PENTA 16) trial Group. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents and young adults (BREATHER): Extended follow-up results of a randomised, open-label, non-inferiority trial. PLoS One. 2018 Apr 23;13(4):e0196239. doi: 10.1371/journal.pone.0196239. eCollection 2018.

ReferenceCitation: Bernays S, Paparini S, Seeley J, Namukwaya Kihika S, Gibb D, Rhodes T. Qualitative study of the BREATHER trial (Short Cycle antiretroviral therapy): is it acceptable to young people living with HIV? BMJ Open. 2017 Feb 17;7(2):e012934. doi: 10.1136/bmjopen-2016-012934.

lead_sponsor: PENTA Foundation

location_country:
United Kingdom
Ireland
Thailand
Uganda
Ukraine
United States
France
Germany

location_facility: Program for HIV Prevention and Treatment (PHPT)/IRD 174

location_facility: HIV-NAT Thai Red Cross AIDS Research Centre

status_simplified: Unknown


title: Screening for Advanced Heart Failure Treatment (SEE-HF)

acronym: SEE-HF

summary: Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.

lead_sponsor: Abbott Medical Devices

location_country:
Denmark
United Kingdom
Netherlands
Sweden
France
Germany

location_facility: University Hospital of South Manchester NHS Trust


title: Airflow Limitation in Cardiac Diseases in Europe

acronym: ALICE

summary: This is a cross-sectional, observational study, investigating the point prevalence of Airflow Limitation in current or former smokers with established ischemic heart disease. The study will recruit up to 3000 patients from cardiology clinics at hospitals across Europe.

time_perspective: Cross-Sectional

ReferenceCitation: Franssen FM, Soriano JB, Roche N, Bloomfield PH, Brusselle G, Fabbri LM, García-Rio F, Kearney MT, Kwon N, Lundbäck B, Rabe KF, Raillard A, Muellerova H, Cockcroft JR. Lung Function Abnormalities in Smokers with Ischemic Heart Disease. Am J Respir Crit Care Med. 2016 Sep 1;194(5):568-76. doi: 10.1164/rccm.201512-2480OC.

lead_sponsor: GlaxoSmithKline

location_country: Spain Ireland Greece Italy Netherlands Sweden France Belgium Germany

intervention_type: Procedure


title: A Phase III, 12-week, Multicentre, Multinational, Randomised, Double-blind, Double-dummy, 3 Arm-parallel Group Study to Test the Efficacy of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate (BDP) Plus Formoterol Fumarate (FF)) Versus a Free Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate and Versus a Monotherapy of Beclomethasone Dipropionate in Partly Controlled Asthmatic Children

lead_sponsor: Chiesi Farmaceutici S.p.A.

location_country:
Poland
Spain
Italy
Russian Federation
Ukraine
Hungary
France
Romania
Germany
Bulgaria
Slovakia

location_facility: NZZ- Detská pneumologická a ftizeologická ambulanci

location_facility: Spitalul Clinic Universitar de Urgenta Elias

summary: The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP) and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung functions in asthmatic children patients.


title: A Single-arm Dose-finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE225 in Combination With Nilotinib in Chronic or Accelerated Phase of Chronic Myeloid Leukemia Patients Who Have Failed Prior Therapy With Other BCR-ABL Tyrosine-kinase Inhibitors

summary: The purpose of this study is to determine the feasibility of administering the combination of nilotinib and LDE225 to patients with chronic or accelerated phase of chronic myeloid leukemia and to establish the maximum tolerated dose (MTD) and/or recommended Phase II dose level (RP2D) of LDE225 in combination with nilotinib.

location_country: Spain Italy Canada France Germany


title: A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

summary: The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.

status: Terminated

lead_sponsor: Aeris Therapeutics

location_country: Austria Germany France Israel

location_facility: Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice

location_facility: LMU Medizinische Klinik und Poliklinik Klinikum Großhadern

location_facility: Rabin Medical Center, Beilinson Hospital


title: Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)

summary: A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.

lead_sponsor: Edwards Lifesciences

location_country:
Austria
Germany
France
United Kingdom

location_facility: University Hospital Essen, West German Heart Center

location_facility: Medizinische Universitat Wien Univ.Klinik f.Chirurgie


title: A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis

acronym: EYEGUARD™-A

summary: The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.

lead_sponsor: XOMA (US) LLC

location_country:
Spain
Armenia
United Kingdom
United States
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Tunisia
Israel
Turkey
Mexico
Brazil
China
Germany
Taiwan
Greece
Korea, Republic of
France


title: Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

summary: Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.

location_country:
United Kingdom
Greece
Italy
Russian Federation
Czech Republic
Sweden
Hungary
France
Israel
Germany
Slovakia


title: Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

acronym: CAPTURE

summary:
To monitor post-market performance through evaluation of short and long-term performance via:

Efficacy
Safety
Patient reported outcomes

lead_sponsor: ASTORA Women's Health

location_country:
Slovenia
Spain
United Kingdom
Canada
United States
France
South Africa
Germany

location_facility: German Pelvic Floor Center, St. Hedwig Hospital

location_facility: The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre

location_facility: Female Pelvic Medicine Institute of Virginia

location_facility: Hospital Clínico y Provincial de Barcelona


title: A Large, International, Randomized, Placebo-controlled Trial to Assess the Impact of Dabigatran (a Direct Thrombin Inhibitor) and Omeprazole (a Proton-pump Inhibitor) in Patients Suffering Myocardial Injury After Noncardiac Surgery

acronym: MANAGE

summary: Patients who have myocardial injury after noncardiac surgery are at a higher risk of dying than those who do not. One in 10 patients with myocardial injury will die within 30 days of surgery. This risk of death exists up to one year after myocardial injury. There are currently no treatments or guidelines available for heart injury after surgery, but there is evidence that taking a blood-thinner can prevent some of the deaths, both in the short and long-term. The purpose of this trial is to test the effect of two drugs (dabigatran and omeprazole) that may prevent mortality, major cardiovascular complications and major upper gastrointestinal bleeding in patients who have had myocardial injury after noncardiac surgery.

ReferenceCitation: Duceppe E, Yusuf S, Tandon V, Rodseth R, Biccard BM, Xavier D, Szczeklik W, Meyhoff CS, Franzosi MG, Vincent J, Srinathan SK, Parlow J, Magloire P, Neary J, Rao M, Chaudhry NK, Mayosi B, de Nadal M, Popova E, Villar JC, Botto F, Berwanger O, Guyatt G, Eikelboom JW, Sessler DI, Kearon C, Pettit S, Connolly SJ, Sharma M, Bangdiwala SI, Devereaux PJ. Design of a Randomized Placebo-Controlled Trial to Assess Dabigatran and Omeprazole in Patients with Myocardial Injury after Noncardiac Surgery (MANAGE). Can J Cardiol. 2018 Mar;34(3):295-302. doi: 10.1016/j.cjca.2018.01.020. Epub 2018 Feb 2.

ReferenceCitation: Lamy A, Tong W, Mian R, Vincent J, Szczeklik W, Biccard BM, Duceppe E, Franzosi MG, Srinathan SK, Meyhoff CS, Parlow J, Xavier D, Devereaux PJ. The Cost Implications of Dabigatran in Patients with Myocardial Injury After Non-Cardiac Surgery. Am J Cardiovasc Drugs. 2022 Jan;22(1):83-91. doi: 10.1007/s40256-021-00489-3. Epub 2021 Jul 26.

ReferenceCitation: Devereaux PJ, Duceppe E, Guyatt G, Tandon V, Rodseth R, Biccard BM, Xavier D, Szczeklik W, Meyhoff CS, Vincent J, Franzosi MG, Srinathan SK, Erb J, Magloire P, Neary J, Rao M, Rahate PV, Chaudhry NK, Mayosi B, de Nadal M, Iglesias PP, Berwanger O, Villar JC, Botto F, Eikelboom JW, Sessler DI, Kearon C, Pettit S, Sharma M, Connolly SJ, Bangdiwala SI, Rao-Melacini P, Hoeft A, Yusuf S; MANAGE Investigators. Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial. Lancet. 2018 Jun 9;391(10137):2325-2334. doi: 10.1016/S0140-6736(18)30832-8. Erratum in: Lancet. 2018 Jul 7;392(10141):30.

lead_sponsor: Population Health Research Institute

location_country:
Kenya
Denmark
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Argentina
Canada
United States
France
India
Peru
Colombia
Philippines
Germany
South Africa
Czechia

location_facility: Specjalistyczny Szpital im. E. Szczeklika

location_facility: IRCCS Istituto Ortopedico Galeazzi Milan

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

location_facility: Amrita Institute of Medical Sciences and Research Institute

location_facility: Russell Halls Hospital, Dudley Group NHS

location_facility: M.S. Ramaiah Medical College & Hospitals

location_facility: Hospital e Maternidade Celso Pierro - PUCCAMP

location_facility: Queens University - Kingston General Hospital

location_facility: VA North Texas Health Care System Dallas VA Medical Center

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Belfast Health and Social Care Trust, Royal Victoria Hospital

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Centre Hospitalier Universitaire de Montreal - St. Luc Hospital

location_facility: Clinica Parra - Centro de Investigaciones

location_facility: University Hospital, London Health Sciences Centre

location_facility: Klinikum der J. W. Goethe-Universität Frankfurt

location_facility: Fundacion Cardioinfantil - Instituto de Cardiologia

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: Victoria Hospital, London Health Sciences Centre

location_facility: Zakład Opieki Zdrowotnej im. Jana Pawła II

location_facility: Bispebjerg Hospital, University of Copenhagen


title: The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) Post Approval Study

acronym: PSR-REVERSE

summary: The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.

lead_sponsor: Medtronic

location_country:
United Kingdom
Italy
Netherlands
Canada
Switzerland
Sweden
United States
France
Belgium
Germany


type: Other Grant/Funding Number

title: Evaluation of Integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease

acronym: EVINCI

summary:
Main purpose of the study:

To comparatively assess the diagnostic performance of non invasive anatomical and functional imaging modalities to detect significant obstructive coronary artery disease as demonstrated at invasive coronary angiography and functional evaluation of coronary lesions (fractional flow reserve).

primary_purpose: Diagnostic

ReferenceCitation: Caselli C, De Caterina R, Smit JM, Campolo J, El Mahdiui M, Ragusa R, Clemente A, Sampietro T, Clerico A, Liga R, Pelosi G, Rocchiccioli S, Parodi O, Scholte A, Knuuti J, Neglia D; EVINCI and SMARTool. Triglycerides and low HDL cholesterol predict coronary heart disease risk in patients with stable angina. Sci Rep. 2021 Oct 20;11(1):20714. doi: 10.1038/s41598-021-00020-3.

ReferenceCitation: Caselli C, Del Turco S, Ragusa R, Lorenzoni V, De Graaf M, Basta G, Scholte A, De Caterina R, Neglia D. Association of PCSK9 plasma levels with metabolic patterns and coronary atherosclerosis in patients with stable angina. Cardiovasc Diabetol. 2019 Oct 31;18(1):144. doi: 10.1186/s12933-019-0949-3.

ReferenceCitation: Carpeggiani C, Picano E, Brambilla M, Michelassi C, Knuuti J, Kauffman P, Underwood SR, Neglia D; EVINCI Study Investigators. Variability of radiation doses of cardiac diagnostic imaging tests: the RADIO-EVINCI study (RADIationdOse subproject of the EVINCI study). BMC Cardiovasc Disord. 2017 Feb 16;17(1):63. doi: 10.1186/s12872-017-0474-9.

ReferenceCitation: Neglia D, Rovai D, Caselli C, Pietila M, Teresinska A, Aguadé-Bruix S, Pizzi MN, Todiere G, Gimelli A, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Perrone Filardi P, Fernández-Golfín C, Rincón LM, Graner FP, de Graaf MA, Fiechter M, Stehli J, Gaemperli O, Reyes E, Nkomo S, Mäki M, Lorenzoni V, Turchetti G, Carpeggiani C, Marinelli M, Puzzuoli S, Mangione M, Marcheschi P, Mariani F, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Kaufmann PA, Underwood SR, Knuuti J; EVINCI Study Investigators. Detection of significant coronary artery disease by noninvasive anatomical and functional imaging. Circ Cardiovasc Imaging. 2015 Mar;8(3). pii: e002179. doi: 10.1161/CIRCIMAGING.114.002179.

lead_sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
Finland
Switzerland
France
Germany

location_facility:
NIC
UZH
UniGE
Ospedale Versilia
UniNA
Huvhebron
RBHT
QUEEN MARY Hospital London
SERMAS
FGM
APHP
KAE Goeppingen
U.Turku
CNR
LUMC
TUM


title: A Multicenter, Two Stage, Phase II Study, Evaluating the Efficacy of Oral BEZ235 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.

summary:
This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy.

Study design: This was a Phase II, two-stage, multicenter study, where Stage 1 was a single arm, open label design and Stage 2 was planned to be a randomized, double-blind study.

However, at the end of Stage 1, the futility was met and hence the Stage 2 was not initiated.

ReferenceCitation: Fazio N, Buzzoni R, Baudin E, Antonuzzo L, Hubner RA, Lahner H, DE Herder WW, Raderer M, Teulé A, Capdevila J, Libutti SK, Kulke MH, Shah M, Dey D, Turri S, Aimone P, Massacesi C, Verslype C. A Phase II Study of BEZ235 in Patients with Everolimus-resistant, Advanced Pancreatic Neuroendocrine Tumours. Anticancer Res. 2016 Feb;36(2):713-9.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
United States
France
Belgium
Germany

location_facility: Dana Farber Cancer Institute GastrointestionalCancer Clinic

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital SC


title: A Phase I/II, Open-label, Dose-escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Twice Daily Oral Midostaurin and to Evaluate the Preliminary Clinical and Pharmacodynamic Response in Pediatric Patients With Relapsed or Refractory Leukemia

location_country:
Italy
Sweden
United States
France
Netherlands

location_facility: Seattle Children's Hospital CPKC412A2114

summary: This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients <18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.


title: A Prospective, Multi-center Study to Evaluate the Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

summary: The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.

ReferenceCitation: Milani AL, Hinoul P, Gauld JM, Sikirica V, van Drie D, Cosson M; Prolift+M Investigators. Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes. Am J Obstet Gynecol. 2011 Jan;204(1):74.e1-8. doi: 10.1016/j.ajog.2010.08.036. Epub 2010 Oct 20.

lead_sponsor: Ethicon, Inc.

location_country: Germany France Netherlands Belgium

location_facility:
DRT Krankenhaus
Universitatsklinik Tubingen
Kreiskrankenhaus
Martin Luther University
Sint Lodewijkstraat 78
Reinier de Graaf Gasthuis
St. Marien-Hospital
CHRU de Lille


title: An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment

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

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

location_country: Germany Finland Italy France

summary: The purpose of this multicenter, single-arm, exact binomial single-stage, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors


title: Double-blind, Randomized, 8-week Placebo-controlled, and 16-week Open-label Extension Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic Sclerosis

summary:
Primary Objective:

- To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis.

Secondary Objectives:

To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor signaling markers in blood and skin;
To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the modified Rodnan Skin Score (mRSS);
To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ);
To document long term safety of SAR100842 during the extension part.

ReferenceCitation: Allanore Y, Distler O, Jagerschmidt A, Illiano S, Ledein L, Boitier E, Agueusop I, Denton CP, Khanna D. Lysophosphatidic Acid Receptor 1 Antagonist SAR100842 for Patients With Diffuse Cutaneous Systemic Sclerosis: A Double-Blind, Randomized, Eight-Week Placebo-Controlled Study Followed by a Sixteen-Week Open-Label Extension Study. Arthritis Rheumatol. 2018 Oct;70(10):1634-1643. doi: 10.1002/art.40547. Epub 2017 Nov 6.

lead_sponsor: Sanofi

location_country:
United Kingdom
Italy
Switzerland
United States
France

location_facility:
Investigational Site Number 250003
Investigational Site Number 840004
Investigational Site Number 840002
Investigational Site Number 840001
Investigational Site Number 826002
Investigational Site Number 840006
Investigational Site Number 840003
Investigational Site Number 826001
Investigational Site Number 756001
Investigational Site Number 840008
Investigational Site Number 250001
Investigational Site Number 840007
Investigational Site Number 380001


title: Idiopathic Pulmonary Fibrosis International Group Exploring NAC I Annual Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)

acronym: IFIGENIA

summary: The purpose of this study is to determine whether NAC added to prednisone, and azathioprine has a better effect on lung function, radiology and clinical condition than placebo + prednisone in combination with azathioprine after 6 and 12 months.

ReferenceCitation: Demedts M, Behr J, Buhl R, Costabel U, Dekhuijzen R, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Capron F, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Corvasce G, Lankhorst I, Sardina M, Montanari M; IFIGENIA Study Group. High-dose acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med. 2005 Nov 24;353(21):2229-42.

ReferenceCitation: Behr J, Demedts M, Buhl R, Costabel U, Dekhuijzen RP, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Lankhorst I, Sardina M, Boissard G; IFIGENIA study group. Lung function in idiopathic pulmonary fibrosis--extended analyses of the IFIGENIA trial. Respir Res. 2009 Oct 27;10:101. doi: 10.1186/1465-9921-10-101.

lead_sponsor: Zambon SpA

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany

location_facility: The University of Edinburgh-Medical School


title: Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants

acronym: NEOBRAIN

summary: NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage mainly observed in preterm newborns. (Copy from www.neobrain.eu)

ReferenceCitation: Dammann O, Cesario A, Hallen M. NEOBRAIN--an EU-funded project committed to protect the newborn brain. Neonatology. 2007;92(4):217-8. Epub 2007 May 21.

lead_sponsor: Hannover Medical School

location_country: Italy Austria Netherlands Switzerland Sweden France Germany

location_facility: Fondazione I.R.C.C.S Ospedale Maggiore Policlinico MA.RE.

location_facility: Azienda Ospedaliera Universitaria Senese


title: A Randomized, Open-label, Active-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride (HCl) Formulation Versus 5% Amorolfine Nail Lacquer for 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis

summary: This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.

lead_sponsor: Novartis

location_country:
Poland
Spain
Russian Federation
Finland
Hungary
France
Turkey
Iceland
Norway
Germany


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Fixed-Dose, 8-Week Treatment, Multi-Center Trial Evaluating the Efficacy and the Safety of 3 Oral Doses of Surinabant as an Aid to Smoking Cessation in Cigarette Smokers

summary:
Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which might be clinically useful in the treatment of dependence to nicotine.

The primary study objective is the assessment of efficacy of 3 doses of surinabant on abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of surinabant on body weight and its clinical and biological safety.

ReferenceCitation: Tonstad S, Aubin HJ. Efficacy of a dose range of surinabant, a cannabinoid receptor blocker, for smoking cessation: a randomized controlled clinical trial. J Psychopharmacol. 2012 Jul;26(7):1003-9. doi: 10.1177/0269881111431623. Epub 2012 Jan 4.

location_country: Spain Italy Switzerland Sweden France Belgium Norway Germany


title: A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention

acronym: LEADERS

summary: The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.

ReferenceCitation: Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.

ReferenceCitation: Garg S, Sarno G, Serruys PW, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, Di Mario C, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P, Windecker S. The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer. EuroIntervention. 2010 Jun;6(2):233-9. doi: 10.4244/.

ReferenceCitation: Sarno G, Garg S, Onuma Y, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, Eerdmans P, Garcia-Garcia HM, van Es GA, Goedhart D, de Vries T, Jüni P, Meier B, Windecker S, Serruys P. The impact of body mass index on the one year outcomes of patients treated by percutaneous coronary intervention with Biolimus- and Sirolimus-eluting stents (from the LEADERS Trial). Am J Cardiol. 2010 Feb 15;105(4):475-9. doi: 10.1016/j.amjcard.2009.09.055. Epub 2010 Jan 5.

ReferenceCitation: Wykrzykowska JJ, Serruys PW, Onuma Y, de Vries T, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S. Impact of vessel size on angiographic and clinical outcomes of revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer the LEADERS trial substudy. JACC Cardiovasc Interv. 2009 Sep;2(9):861-70. doi: 10.1016/j.jcin.2009.05.024.

ReferenceCitation: Wykrzykowska JJ, Räber L, de Vries T, Bressers M, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Regar E, Jüni P, Windecker S, Serruys PW. Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy. EuroIntervention. 2009 Aug;5(3):310-7.

ReferenceCitation: Yuan H, Wu Z, Lu T, Wei T, Zeng Y, Liu Y, Huang C. Comparison of biodegradable and durable polymer drug-eluting stents in acute coronary syndrome: a meta-analysis. BMJ Open. 2022 Jun 8;12(6):e058075. doi: 10.1136/bmjopen-2021-058075.

ReferenceCitation: Koskinas KC, Siontis GC, Piccolo R, Franzone A, Haynes A, Rat-Wirtzler J, Silber S, Serruys PW, Pilgrim T, Räber L, Heg D, Jüni P, Windecker S. Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients. Circ Cardiovasc Interv. 2016 Feb;9(2):e003255. doi: 10.1161/CIRCINTERVENTIONS.115.003255.

ReferenceCitation: Grundeken MJ, Wykrzykowska JJ, Ishibashi Y, Garg S, de Vries T, Garcia-Garcia HM, Onuma Y, de Winter RJ, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Meier B, Jüni P, Yazdani A, Copt S, Windecker S, Serruys PW. First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial. Catheter Cardiovasc Interv. 2016 Jun;87(7):E248-60. doi: 10.1002/ccd.26344. Epub 2015 Dec 9.

ReferenceCitation: Zhang YJ, Iqbal J, Windecker S, Linke A, Antoni D, Sohn HY, Corti R, van Es GA, Copt S, Eerdmans P, Saitta R, Morice MC, Di Mario C, Juni P, Wijns W, Buszman P, Serruys PW. Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction. Heart. 2015 Feb;101(4):271-8. doi: 10.1136/heartjnl-2014-306359. Epub 2014 Nov 25.

ReferenceCitation: Vranckx P, Kalesan B, Stefanini GG, Farooq V, Onuma Y, Silber S, de Vries T, Jüni P, Serruys PW, Windecker S. Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention. EuroIntervention. 2015 Jun;11(2):171-9. doi: 10.4244/EIJV11I2A31.

ReferenceCitation: Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, Rademaker-Havinga T, van Es GA, Meier B, Jüni P, Windecker S. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013 Aug;6(8):777-89. doi: 10.1016/j.jcin.2013.04.011.

ReferenceCitation: Gutiérrez-Chico JL, Räber L, Regar E, Okamura T, di Mario C, van Es GA, Windecker S, Serruys PW. Tissue coverage and neointimal hyperplasia in overlap versus nonoverlap segments of drug-eluting stents 9 to 13 months after implantation: in vivo assessment with optical coherence tomography. Am Heart J. 2013 Jul;166(1):83-94. doi: 10.1016/j.ahj.2013.04.001. Epub 2013 May 3.

ReferenceCitation: Stefanini GG, Kalesan B, Pilgrim T, Räber L, Onuma Y, Silber S, Serruys PW, Meier B, Jüni P, Windecker S. Impact of sex on clinical and angiographic outcomes among patients undergoing revascularization with drug-eluting stents. JACC Cardiovasc Interv. 2012 Mar;5(3):301-10. doi: 10.1016/j.jcin.2011.11.011.

ReferenceCitation: Gutiérrez-Chico JL, Jüni P, García-García HM, Regar E, Nüesch E, Borgia F, van der Giessen WJ, Davies S, van Geuns RJ, Secco GG, Meis S, Windecker S, Serruys PW, di Mario C. Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: comparative sequential assessment with optical coherence tomography until complete resorption of the polymer. Am Heart J. 2011 Nov;162(5):922-31. doi: 10.1016/j.ahj.2011.09.005. Epub 2011 Oct 7.

ReferenceCitation: Stefanini GG, Kalesan B, Serruys PW, Heg D, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, van Es GA, Meier B, Windecker S, Jüni P. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. Lancet. 2011 Dec 3;378(9807):1940-8. doi: 10.1016/S0140-6736(11)61672-3. Epub 2011 Nov 8.

ReferenceCitation: Klauss V, Serruys PW, Pilgrim T, Buszman P, Linke A, Ischinger T, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, van Es GA, Kalesan B, Wenaweser P, Jüni P, Windecker S. 2-year clinical follow-up from the randomized comparison of biolimus-eluting stents with biodegradable polymer and sirolimus-eluting stents with durable polymer in routine clinical practice. JACC Cardiovasc Interv. 2011 Aug;4(8):887-95. doi: 10.1016/j.jcin.2011.03.017.

ReferenceCitation: Gutiérrez-Chico JL, Regar E, Nüesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Jüni P, Serruys PW. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011 Aug 2;124(5):612-23. doi: 10.1161/CIRCULATIONAHA.110.014514. Epub 2011 Jul 18.

ReferenceCitation: Wykrzykowska JJ, Garg S, Onuma Y, de Vries T, Goedhart D, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW. Value of age, creatinine, and ejection fraction (ACEF score) in assessing risk in patients undergoing percutaneous coronary interventions in the 'All-Comers' LEADERS trial. Circ Cardiovasc Interv. 2011 Feb 1;4(1):47-56. doi: 10.1161/CIRCINTERVENTIONS.110.958389. Epub 2011 Jan 4.

ReferenceCitation: Wykrzykowska JJ, Garg S, Girasis C, de Vries T, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW. Value of the SYNTAX score for risk assessment in the all-comers population of the randomized multicenter LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. J Am Coll Cardiol. 2010 Jul 20;56(4):272-7. doi: 10.1016/j.jacc.2010.03.044.

lead_sponsor: Biosensors Europe SA

location_country:
Poland
United Kingdom
Netherlands
Switzerland
France
Belgium
Germany

location_facility: Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39

location_facility: Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1

location_facility: University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100

location_facility: L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert

location_facility: Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77

location_facility: Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital

location_facility: University Medical Center Rotterdam Erasmus, Thoraxcentrum

location_facility: Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164


title: A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment

ReferenceCitation: Wu YL, Zhang L, Kim DW, Liu X, Lee DH, Yang JC, Ahn MJ, Vansteenkiste JF, Su WC, Felip E, Chia V, Glaser S, Pultar P, Zhao S, Peng B, Akimov M, Tan DSW. Phase Ib/II Study of Capmatinib (INC280) Plus Gefitinib After Failure of Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy in Patients With EGFR-Mutated, MET Factor-Dysregulated Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Nov 1;36(31):3101-3109. doi: 10.1200/JCO.2018.77.7326. Epub 2018 Aug 29. Erratum in: J Clin Oncol. 2019 Jan 20;37(3):261.

location_country:
Taiwan
Spain
Italy
Australia
Netherlands
Thailand
Korea, Republic of
France
Israel
China
Singapore
Belgium
Japan
Germany

summary: This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.


title: The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.

summary: The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

ReferenceCitation: Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.

ReferenceCitation: Brodmann M, Lansink W, Guetl K, Micari A, Menk J, Zeller T. Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1276-1287. doi: 10.1007/s00270-022-03214-y. Epub 2022 Jul 21.

ReferenceCitation: Zeller T, Brodmann M, Ansel GM, Scheinert D, Choi D, Tepe G, Menk J, Micari A. Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study. EuroIntervention. 2022 May 30:EIJ-D-21-01098. doi: 10.4244/EIJ-D-21-01098. Online ahead of print.

ReferenceCitation: Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen FEG, Jaff MR, Guo J, Dobranszki R, Zeller T; IN.PACT Global Investigators. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25.

ReferenceCitation: Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieché C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.

ReferenceCitation: Reijnen MMPJ, van Wijck I, Zeller T, Micari A, Veroux P, Keirse K, Lee SW, Li P, Voulgaraki D, Holewijn S. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. 2019 Jun;26(3):305-315. doi: 10.1177/1526602819839044. Epub 2019 Apr 1.

ReferenceCitation: Tepe G, Micari A, Keirse K, Zeller T, Scheinert D, Li P, Schmahl R, Jaff MR; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):484-493. doi: 10.1016/j.jcin.2018.12.004.

ReferenceCitation: Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25. Review. Erratum in: J Am Coll Cardiol. 2019 Feb 28;:.

ReferenceCitation: Zeller T, Brodmann M, Micari A, Keirse K, Peeters P, Tepe G, Scheinert D, Jaff MR, Rocha-Singh KJ, Li P, Schmahl R, Ansel GM; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain. Circ Cardiovasc Interv. 2019 Jan;12(1):e007730. doi: 10.1161/CIRCINTERVENTIONS.118.007730.

ReferenceCitation: Banerjee S, Khalili H. Drug-Coated Balloon for Long Femoropopliteal Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007084. doi: 10.1161/CIRCINTERVENTIONS.118.007084.

ReferenceCitation: Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. 2018 Oct;11(10):e005654. doi: 10.1161/CIRCINTERVENTIONS.117.005654.

ReferenceCitation: Ansel GM, Brodmann M, Keirse K, Micari A, Jaff MR, Rocha-Singh K, Fernandez EJ, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study. J Endovasc Ther. 2018 Dec;25(6):673-682. doi: 10.1177/1526602818803119. Epub 2018 Oct 3.

ReferenceCitation: Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.

lead_sponsor: Medtronic Endovascular

location_country:
United Kingdom
Italy
Lithuania
Belgium
Czechia
Poland
Portugal
Slovenia
Russian Federation
Austria
Australia
Argentina
Israel
Singapore
Sweden
Slovakia
Egypt
Canada
Switzerland
Hungary
Germany
Greece
Finland
Korea, Republic of
France
Colombia
Netherlands

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2

location_facility: Helsingin Seudun Yliopistollinen Keskussairaala

location_facility: Les Hospitaux Universitaires de Strasbourg

location_facility: Centre hospitalier universitaire Sherbrooke (CHUS)

location_facility: Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)

location_facility: Rabin Medical Center - Beilison Hospital

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)

location_facility: Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)

location_facility: City Clinical Hospital named after M.E. Zhadkevich

location_facility: Ziekenhuis Oost Limburg - Campus St.-Jan


title: Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

acronym: RENEW

summary: Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System

ReferenceCitation: Hartman JE, Shah PL, Sciurba F, Herth FJF, Slebos DJ; RENEW Study Group. Endobronchial coils for emphysema: Dual mechanism of action on lobar residual volume reduction. Respirology. 2020 Nov;25(11):1160-1166. doi: 10.1111/resp.13816. Epub 2020 Apr 8.

ReferenceCitation: Slebos DJ, Cicenia J, Sciurba FC, Criner GJ, Hartman JE, Garner J, Deslée G, Delage A, Jantz M, Marquette CH, Strange C, Hatipoglu U, Mehta AC, LaPrad AS, Schmid-Bindert G, Herth FJF, Shah PL; RENEW Study Group. Predictors of Response to Endobronchial Coil Therapy in Patients With Advanced Emphysema. Chest. 2019 May;155(5):928-937. doi: 10.1016/j.chest.2019.02.012. Epub 2019 Feb 21.

ReferenceCitation: Sciurba FC, Criner GJ, Strange C, Shah PL, Michaud G, Connolly TA, Deslée G, Tillis WP, Delage A, Marquette CH, Krishna G, Kalhan R, Ferguson JS, Jantz M, Maldonado F, McKenna R, Majid A, Rai N, Gay S, Dransfield MT, Angel L, Maxfield R, Herth FJ, Wahidi MM, Mehta A, Slebos DJ; RENEW Study Research Group. Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial. JAMA. 2016 May 24-31;315(20):2178-89. doi: 10.1001/jama.2016.6261.

ipd_sharing: Undecided

lead_sponsor: Boston Scientific Corporation

location_country:
United Kingdom
Netherlands
Canada
United States
France
Germany

location_facility: Yale University School of Medicine - Yale New Haven Hospital

location_facility: University of Wisconsin School of Medicine & Public Health

location_facility: Emphysema COPD Research Center, University of Pittsburgh

location_facility: Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

location_facility: University of Alabama Lung Health Center

location_facility: University of Texas Health Sciences Center at San Antonio

location_facility: Royal Brompton Hospital & Chelsea Westminster

location_facility: New York Presbyterian Columbia University Medical Center

location_facility: Illinois Lung and Critical Care Institute

location_facility: Pulmonary and Critical Care Associates of Baltimore

location_facility: University of Illinois Hospital and Health Center

location_facility: El Camino Hospital/Palo Alto Medical Foundation


title: An Adaptive, Randomized, Double-blind, Dose Exploration, Parallel Group, Placebo Controlled, Multicenter Phase 2 Trial to Evaluate the Efficacy, Safety and Tolerability of LNP023 in Combination With Standard-of-care With and Without Oral Corticosteroids in Patients With Active Lupus Nephritis Class III-IV, +/- V

summary: The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

status: Recruiting

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

location_country:
Hong Kong
Spain
Hungary
United States
France
Israel
Malaysia
Singapore
Turkey
Germany


title: RFC1 Natural History Study

summary: This international, multi-center, multi-modal and prospective observational study aims to determine the phenotypic spectrum and the natural progression of the RFC1 repeat expansion disease, and to seek and validate digital, imaging, and molecular biomarkers that aid in diagnosis and serve as outcome measures in future clinical trials of this novel, but frequent ataxia with late adult-onset.

lead_sponsor: Prof. Dr. Matthis Synofzik

location_country:
Brazil
Italy
Australia
New Zealand
France
Turkey
Germany

location_facility: German Center for Neurodegenerative Diseases (DZNE)

location_facility: Center for Neurology & Hertie-Institute for Clinical Brain Research, Dept. for Neurodegenerative Diseases

location_facility: Department of Neurology University Hospital Schleswig Holstein

location_facility: Department of Neurology, Ataxia Unit, Universidade Federal de São Paulo

location_facility: Centre of Brain Research Neurogenetics Research Clinic, University of Auckland

location_facility: Service de Neurologie, Hôpitaux Universitaires de Strasbourg

location_facility: Department of Neuroscience, Central Clinical School, Monash University

location_facility: Università degli Studi di Napoli 'Federico II', c/o AOU Federico II


title: Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients With Advanced Solid Tumors

summary: Despite recent advances in the treatment of solid tumors in general, advanced (metastatic) disease remains mostly incurable and there is an urgent need to develop new therapeutic options for these patients, particularly investigational drugs with novel mechanisms of action. The investigation of new combination regimens of non-crossresistant agents with acceptable-and not completely overlapping-toxicities has been a major way to improve response rate and outcome of patients with advanced solid tumors.

lead_sponsor: PharmaMar

location_country:
United States
Spain
France

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Hospital Universitario Fundación Jiménez Díaz


title: Real-world Performance Study Testing an Algorithm to Predict the Future Bleeding Profile of Women After Insertion of Intrauterine Systems for Contraception

acronym: MyIUS

summary:
Researchers are looking to learn more about future menstrual bleeding in women who have started using intrauterine contraception methods. "Intrauterine contraception" means that a device is inserted into a woman's uterus by her doctor. The device then releases a birth control treatment into the uterus.

Researchers have found that when women use intrauterine contraception, its effects on the menstrual cycle can cause changes to how often and for how long women will bleed. This is one of the main reasons women may stop using their intrauterine contraception.

So, the researchers in this study wanted to learn about a tool that can be used to predict future bleeding events. This tool was developed based on the results of previous clinical studies that researched menstrual bleeding. This tool is a smartphone application called MyIUS.

This study will include about 3,000 women who have recently had intrauterine contraception inserted and who use the MyIUS app.

There will be no visits with a study doctor in this study. After the intrauterine contraception has been inserted, the women will start to record any events of bleeding in the MyIUS app. After they have recorded events of bleeding for a total of 90 days, the MyIUS app will give a prediction of menstrual bleeding expected for the next 180 days. The women who sign the electronic informed consent form will continue to record their bleeding events for a total of 6 months.

The researchers will then collect this information. They will use this information to find out how well the MyIUS app can predict future menstrual bleeding.

ipd_sharing_description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Denmark
Brazil
Portugal
Spain
United Kingdom
Sweden
France
Mexico
Germany


title: Value-based Healthcare for Outcomes In Breast and Lung Cancer in Europe

acronym: VOICE

summary:
VOICE project aims to guide health services in their reorganization towards the provision of the highest value care for the patient at the best cost. VOICE is targeted to patients with breast and lung cancer. The purpose is to offer a new innovative strategic framework based on value-based healthcare model to these patients in Europe. VOICE Community consists of 13 hospitals across Europe working collaboratively to implement this approach.

The Community addresses what matters most to patients by measuring patient reported health outcomes in routine clinical practice on a systematic and long-term basis, by including patients´ perspective in clinical decision-making, improving patient empowerment and physician-patient communication, assessing the impact on costs of the processes implemented, identifying factors for a successful implementation of value-based healthcare and boosting knowledge generation and best practice exchange across Europe.

The VOICE ambition is to collect the health-related Quality of Life evidence from more than 1000 patients (patients with breast cancer and patients with lung cancer), by means of health related and patient reported questionnaires (ICHOM, International Consortium for Health Outcome Measurements, standard sets). Hospitals will go further by assessing the satisfaction, acceptability, relationship with professionals or decision-making process with patients.

The VOICE Community will benchmark health outcomes and related costs to improve care delivery of these patients.

primary_purpose: Health Services Research

lead_sponsor: Kronikgune

location_country: Portugal Spain Italy France Belgium

location_facility: Instituto Português de Oncologia do Porto

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

location_facility: Hospital Universitari i Politècnic La Fe


title: An Open Label, Single-Arm, Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Biologic Activity of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria

summary: The purpose of this study is to evaluate the safety, effectiveness, and biological activity (how the investigational medication is processed by the body) of pegcetacoplan in 12-17 year-olds (adolescents) who have paroxysmal nocturnal hemoglobinuria (PNH).

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Serbia
Spain
United Kingdom
Netherlands
Thailand
United States
France
Malaysia
Czechia

location_facility: Phramongkutklao Hospital and College of Medicine


title: Outcomes of Endoscopically Resected High-risk Mucosal Adenocarcinoma and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus: an International Multicenter Retrospective Cohort Study

summary: The purpose of this study is to assess lymph node metastasis rate, distant metastasis rate, disease-specific mortality, and overall mortality in patients with Barrett's related T1b and high risk T1a esophageal adenocarcinoma (EAC) who underwent a diagnostic endoscopic resection.

lead_sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

location_country:
United Kingdom
Australia
Netherlands
Switzerland
France
Belgium
Germany

location_facility:
CHU Nantes
EVK Duesseldorf
Westmead hospital
MRI TUM
Barmherzige Brüder Regensburg
Catharina Hospital
Erasmus MC - University Medical Center
University College London Hospital
UZ Gasthuisberg
Universitätsklinikum Augsburg
St. Antonius Hospital
Hirslanden private hospital group
Amsterdam UMC, location VUmc
University Medical Center Groningen
Isala Clinics
Haga Medical Center

lead_sponsor_type: academique


title: A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm the Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems in Low to Moderate Exuding Chronic Wounds

acronym: ASOLO-CW

summary: The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.

lead_sponsor: Molnlycke Health Care AB

location_country: Portugal Italy Ireland France Belgium Germany

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista

location_facility: Trofa Saúde Hospital Central Hospital da Trofa

location_facility: Unidade de Cuidados Continuados António Francisco Guimarães

location_facility: Klinik fur Dermatologie, Venerologie und Allergologie Campus Benjamin Franklin


title: Central Nervous System Disorders Following Hematopoietic Stem Cell Transplantation: a Prospective Observational Trial From the Infectious Diseases Working Party and the Transplant Complications Working Party of the European Society for Blood and Marrow Transplantation

summary:
All patients undergoing allogeneic or autologous HSCT at the participating centres will be observed. Once a diagnosis of CNS disorder is made, additional data will be reported for these patients.

We will identify clinical and diagnostic characteristics such as cerebrospinal fluid (CSF) and neuroimaging patterns, risk factors, response to treatment (including novel antifungal agents such as isavuconazole) and outcome. In addition, risk factors for CNS disorders after allogeneic and autologous HSCT will be analyzed using a prospectively assessed matched control group. In the future, this study might be the basis for an interventional trial (e.g. using a prophylactic approach).

location_country:
Poland
Spain
Italy
Russian Federation
Australia
Tunisia
Hungary
France
Turkey
Colombia
Germany

location_facility: Raisa Gorbacheva Research Institute for Oncology

location_facility: University Hospital, Collegium Medicum UMK

location_facility: Hacettepe University Children's Hospital

location_facility: University Children's Hospital in Krakow


title: Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies

summary: The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.

ReferenceCitation: Lesokhin AM, Ansell SM, Armand P, Scott EC, Halwani A, Gutierrez M, Millenson MM, Cohen AD, Schuster SJ, Lebovic D, Dhodapkar M, Avigan D, Chapuy B, Ligon AH, Freeman GJ, Rodig SJ, Cattry D, Zhu L, Grosso JF, Bradley Garelik MB, Shipp MA, Borrello I, Timmerman J. Nivolumab in Patients With Relapsed or Refractory Hematologic Malignancy: Preliminary Results of a Phase Ib Study. J Clin Oncol. 2016 Aug 10;34(23):2698-704. doi: 10.1200/JCO.2015.65.9789. Epub 2016 Jun 6.

ReferenceCitation: Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med. 2015 Jan 22;372(4):311-9. doi: 10.1056/NEJMoa1411087. Epub 2014 Dec 6.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Italy
Greece
United States
France
Belgium

location_facility: The Sidney Kimmel Comprehensive Cancer Center

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

location_facility: OHSU Center for Hematologic Malignancies

location_facility: Huntsman Cancer Institute At The Univ. Of Utah

intervention_type: Biological


title: 2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

acronym: TESLA

summary: A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

ReferenceCitation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review.

ReferenceCitation: Raal FJ, Honarpour N, Blom DJ, Hovingh GK, Xu F, Scott R, Wasserman SM, Stein EA; TESLA Investigators. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jan 24;385(9965):341-50. doi: 10.1016/S0140-6736(14)61374-X. Epub 2014 Oct 1.

ReferenceCitation: Stein EA, Honarpour N, Wasserman SM, Xu F, Scott R, Raal FJ. Effect of the proprotein convertase subtilisin/kexin 9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia. Circulation. 2013 Nov 5;128(19):2113-20. doi: 10.1161/CIRCULATIONAHA.113.004678. Epub 2013 Sep 6.

lead_sponsor: Amgen

location_country:
Hong Kong
Spain
Italy
Lebanon
New Zealand
Canada
France
United States
South Africa
Belgium
Netherlands
Czechia


title: Phenotypes, Biomarkers and Pathophysiology in Spastic Ataxias

acronym: SPAX-PBP

summary: The aim of this study is to determine the clinical spectrum and natural progression of Spastic Ataxias (SPAX) and related disorders in a prospective multicenter natural history study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the genetic etiology and molecular mechanisms of these diseases.

lead_sponsor: Dr. Rebecca Schule

location_country:
United Kingdom
Italy
Netherlands
Canada
France
Turkey
Germany

location_facility: Radboud University Medical Center; Department of Neurology & Donders Institute for Brain, Cognition, and Behaviour

location_facility: Département d'information médicale (DIM); Département de Biostatistique, Santn 3emé Publique et Information Médicale (BIOSPIM)- Bâtiment Mazarie étage; Hôpitaux Universitaires Pitié Salpêtrière

location_facility: Center for Neurology & Hertie-Institute for Clinical Brain Research, Dept. for Neurodegenerative Diseases

location_facility: Department of Clinical Neurosciences, University of Cambridge; John Van Geest Cambridge Centre for Brain Repair

location_facility: Montreal Neurological Institute of McGill University, Department of Neurology and Neurosurgery and Human Genetics


title: Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms

acronym: MPN-DOACs

summary:
Patients with myeloproliferative neoplasms (MPN) are predisposed to have an increased thrombotic and hemorrhagic risk and, in this context, the use of newly approved direct oral anticoagulants (DOACs) may have improved bleeding risk compared to warfarin use. However, the published experience is very limited and does not allow any conclusion. In the cohort of patients with MPN and venous thromboembolism (VTE) of European Leukemia-net, only 3.3% of patients had been treated with DOACs. Similarly, in a recent publication of a series of 760 patients with single-center MPN, only 25 (3.3%) were treated with a DOAC (13 for atrial fibrillation and 12 for thrombotic events).

While it is known that the risk of thrombotic recurrence and haemorrhagic event during warfarin treatment is about 30% at 5 years from the first event, the actual risk of such events in MPN patients is not known.

The aim of the present study is therefore to obtain information on patients with MPN treated with DOAC for atrial fibrillation (AF) and VTE. This is an international multi-center retrospective survey aimed at describing the efficacy / safety of DOAC in the prevention of:

cardioembolic stroke in patients with MPN with AF
recurrent thrombosis in patients with MPN with VTE
major bleeding in all patients with MPN.

The results will allow to design future prospective studies that evaluate the benefit / risk profile of DOAC compared to warfarin in these pathologies characterized by high risk of thrombosis and, in some subgroups, of bleeding.

lead_sponsor: Fondazione per la Ricerca Ospedale Maggiore

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Germany

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo

location_facility: Divisione Ematologia, Ospedale Borgo Roma

location_facility: ASST MONZA Ospedale San Gerardo Clinica Ematologica

location_facility: Ospedale San Bortolo di Vicenza - U.O.C di Ematologia

location_facility: A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia

location_facility: Fondazione IRCCS Policlinico San Matteo S.C Ematologia

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia

location_facility: Guy's and St Thomas' NHS Foundation Trust


title: Prospective Epidemiological Study to Estimate the O-serotype Distribution of Extraintestinal Pathogenic Escherichia Coli (ExPEC) Isolated From Hospitalized Patients Aged 60 Years or Older With Invasive ExPEC Disease (IED) and to Evaluate the Clinical Case Definition and Risk Factors.

summary:
The purpose of this study is to collect information from study participants who are hospitalized with an invasive disease caused by Extraintestinal pathogenic E. coli (ExPEC). This information will be used to support the development of a new vaccine to prevent Extraintestinal pathogenic Escherichia coli (ExPEC). E. coli bacteria are a leading cause of serious infections. Especially adults older than 60 years have a higher risk of developing such infections. To date, there is no vaccine available to prevent E. coli infections. To support the development of a vaccine, more information about E. coli infections is first needed. This information will be collected in the current study, such as:

Medical information such as medical history, diagnosis, duration of hospitalization
Treatment and outcome of the Extraintestinal pathogenic Escherichia coli (ExPEC)
Laboratory information

lead_sponsor: UMC Utrecht

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

location_facility: Andalusian Public Foundation for Health Research Management in Seville (FISEVI)